GLS News Archives

Nutrivert announces first close on $6 million Series A-2 funding round

Fri, 17 Apr 2026 00:26:00 GMT

April 17, 2026 - Nutrivert Inc., a developer of non-antibiotic replacements for antibiotic growth promoters in livestock, today announced it has completed the first close, raising $2.375 million, of its Series A-2 funding round of $6 million. The round was led by global animal health investor Arrow Ventures with participation from other investors. The funding will be used to further develop Nutrivert’s manufacturing, human food safety and target animal safety and efficacy packages for the company’s lead product Nutrivert LDPP.

Nutrivert LDPP is a proprietary, novel, orally available, lipidated synthetic enantiomeric desmuramyl analog of muramyl dipeptide, the smallest conserved immunoactive component of bacterial peptidoglycan. LDPP has no antibacterial effect but has consistently promoted growth and improved feed efficiency in pig studies. LDPP binds to the mammalian NOD2 receptor and is the only NOD2 ligand reported to inhibit the inflammatory signal NF-κB. In pilot studies, LDPP rescued 70kg pigs from an otherwise lethal dose of porcine reproductive and respiratory syndrome virus (PRRSV) and abrogated influenza disease symptoms in piglets.

The Company intends to develop LDPP for all major livestock species worldwide. Patents have been granted in most major markets.

The global antibiotic growth promoter market is worth an estimated $5.8 billion. Approximately 73% of all antibiotics are fed to livestock. The market is believed to be the world’s largest drug market by volume, with ~100,000 tons of active pharmaceutical ingredient administered annually. FDA’s latest data, for 2024, show a 13% rise in U.S. livestock antibiotic use since 2017. The Food and Agriculture Organization reports that livestock antibiotics are mostly given to speed animal growth. Regulators and non-governmental organizations have called for reduction of antibiotic use in livestock, citing concerns that the global, intensive use of antibiotics, often at subtherapeutic doses, selects for antimicrobial resistance: bacteria that are “immune” to antibiotics and that therefore pose a threat to public health. Spillovers of antibiotic-resistant bacteria from livestock to humans have been documented.

“Nutrivert LDPP has consistently improved feed efficiency in pigs without antibiotics,” said Bernhard Kaltenboeck, CSO. “We are excited to have the support of Arrow Ventures and our other investors in bringing a new tool that will help producers reduce production costs and reduce selection pressure for antimicrobial resistance.”

About Nutrivert LDPP: LDPP is an investigational compound currently undergoing clinical evaluation. It has not been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other global regulatory authority for any indication. The safety and efficacy of LDPP have not been established. Any mention of potential use is based on preliminary data and does not guarantee future regulatory clearance or commercial availability.

USDOL Approves National Biomanufacturing Technician Standards

Thu, 16 Apr 2026 20:51:09 GMT

[Seattle, WA] April 15, 2026 – Apprenti, the leading national intermediary for Registered Apprenticeship (RA), is proud to announce the formal approval and filing of the National Biomanufacturing Technician Standards with the U.S. Department of Labor (USDOL). Crafted under the strategic guidance of the Apprenti Life Science Advisory Board—which includes leaders from Pfizer, Merck, Thermo Fisher, and Biogen—these standards were developed in close partnership with the Life Sciences Workforce Collaborative (LSWC) and InnovATEBIO as part of a high-impact NIIMBL project.

This approval represents a foundational shift for the industry, moving away from a fragmented, state-by-state approach to a scalable, consistent model for developing biomanufacturing professionals at sites across all 50 states. The national standards provide a “plug-and-play” framework that ensures a technician trained in Massachusetts or North Carolina meets the same rigorous, industry-vetted benchmarks as one in Ohio or Missouri. The foundational development of these national standards was informed by existing Life Science RA programs from organizations across the country, including: MassBioEd, Oregon Life Sciences, National Center for Therapeutics Manufacturing (NCTM), BioSTL, Wistar Institute, North Carolina Life Sciences Apprenticeship Consortium (NCLSAC) and others.

A National Engine for Talent: The filing of these standards is a cornerstone of NIIMBL’s efforts to strengthen domestic biomanufacturing capabilities and develop the workforce of the future. Beyond the standards themselves, the project is delivering a suite of resources and tools—including a comprehensive Employer Toolkit and specialized screening rubrics—that state-based organizations and employers can leverage to implement RA programming for their most in-demand roles.

“These national standards set the stage for a sustainable, skills-first pipeline that mirrors the rigor of the industry’s most complex manufacturing processes,” said Daniel Weagle, Director of Life Science Business Development at Apprenti. “By providing a unified approach, we are empowering national employers to scale their workforce development efforts strategically and accessibly.”

The Value Proposition of Registered Apprenticeship For Life Science employers, the Registered Apprenticeship model offers a compelling business case rooted in cost-effectiveness and long-term stability:

High Retention: RA programs boast exceptional retention rates—historically as high as 89% to 90%—as apprentices are trained within a company’s specific culture and protocols from day one.

Cost Efficiency: Research indicates that for every dollar spent on apprenticeship, employers see an average return of $1.47 in increased productivity and reduced recruitment costs.

Inclusive Innovation: The model expands access to untapped talent pools, including non-degreed individuals and career-switchers, ensuring the biomanufacturing workforce reflects the demographics of the communities it serves.

As the global biopharmaceutical market is projected to exceed $570 billion by 2032 , this partnership between Apprenti, NIIMBL, and industry leaders ensures that the U.S. workforce is not just prepared for the future of manufacturing, but is actively driving it.

This project was developed with an award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance from the U.S. Department of Commerce, National Institute of Standards and Technology (70NANB21H086).

About Apprenti:

Apprenti is a 501(c)(3) nonprofit organization and a U.S. Department of Labor recognized Intermediary. Apprenti designs and delivers scalable Registered Apprenticeship (RA) programs in high-demand industries. By adapting the proven apprenticeship model, Apprenti helps employers meet workforce needs while training the next generation of skilled professionals. Apprenti’s programs are industry-recognized, federally approved, and supports employers across the country. Since launching in 2015, Apprenti has partnered with employers, government agencies, and education providers to create new apprenticeship pathways.

About NIIMBL

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of industry standards, and educate a world-leading workforce.

Media Contact: Dan Maiese, Communications Manager, dmaiese@niimbl.org , 302-831-3824

About the Life Sciences Workforce Collaborative (LSWC)

The Life Sciences Workforce Collaborative (LSWC) is a national nonprofit coalition of state, regional and national life science associations and institutes who are working together to build a competitive, and future-ready life sciences workforce. Originally founded in 2012 as the Coalition of State Bioscience Institutes (CSBI), LSWC connects industry, academia, and government partners through data-driven insights, best practice sharing, and collaborative programs. Learn more at www.LifeSciencesWorkforce.org

About InnovATEBIO

InnovATEBIO is a National Center for Biotechnology Education, working to advance the education of highly skilled technicians for the nation’s biotechnology workforce. Toward this goal, InnovATEBIO provides leadership in biotechnology technician education, including support for development and sharing of best practices and emerging technologies in biotechnology workforce development.

Read LSWC's full announcement here.

BIO Statement on the Section 232 Pharmaceutical Proclamation

Sat, 04 Apr 2026 17:30:46 GMT

April 2, 2026- WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO) , released the following statement on Section 232 Pharmaceutical Proclamation.

“A thriving American biotechnology ecosystem is essential to growing the U.S. economy, strengthening national security, and improving the health and well‑being of everyday Americans. While we appreciate the Administration’s recognition of the need for tariff exemptions for certain critical biotech products, the reality is that any tariffs on America’s medicines will raise costs, impede domestic manufacturing, and delay the development of new treatments - all while doing nothing to enhance our national security.

“U.S. biotech companies have been eager to expand investments here at home, but tariffs, along with an uncertain policy environment and efforts to force “most‑favored nation” schemes, work directly against that goal. The risks are especially acute for small and mid‑size biotech companies, which develop more than half of all FDA‑approved medicines yet often lack the capital to build dedicated manufacturing facilities as they weather an industry defined by high costs, long development timelines, and significant risk.

“The fact is: tariffs divert scarce resources away from research and development, weaken American biotech against China’s rising industry, and ultimately, harm health and economic wellbeing of Americans.

“We stand ready to work with the Administration on a long‑term strategy that encourages biotechnology investment, reduces the time, cost, and uncertainty of developing new medicines, expands U.S. biomanufacturing capacity, and ensures American innovation is fairly valued overseas. Tariffs and MFN are not the answer."

Source - https://www.bio.org/press-release/bio-statement-section-232-pharmaceutical-proclamation

Georgia Life Sciences Announces 2026 Georgia BioGENEius Challenge Winner

Wed, 01 Apr 2026 15:31:04 GMT

Atlanta, GA (April 1, 2026) – Georgia Life Sciences (GLS) is proud to announce that Saisurya Lakkimsetti, a junior at Lakeside High School in Columbia County, has been named the winner of the 2026 Georgia BioGENEius Challenge. The Georgia BioGENEius Challenge took place, as part of the statewide Georgia Science and Engineering Fair (GSEF) at the Classic Center in Athens, Georgia. Forty-seven students from across Georgia competed for this year’s title and cash prize.

Jaehyeon Lee, an 11th-grade student from Walton High School, was named runner-up in this year’s competition.

The Georgia BioGENEius Challenge recognizes outstanding high school students who are conducting innovative biotechnology research with real-world applications. This year’s top projects, presented in the Global Healthcare Challenge track, demonstrated exceptional scientific rigor and forward-thinking potential in addressing critical healthcare challenges.

Saisurya’s research focuses on identifying potential inhibitors for Endocan, a protein known to play a role in glioblastoma tumor growth. Using advanced computational modeling techniques—including AlphaFold and molecular docking tools—she screened thousands of small molecules to identify compounds that may block tumor-promoting signaling pathways. Her work identified several promising candidates that could serve as a foundation for future drug development targeting glioblastoma.

Jaehyeon’s project investigates how varying glucose concentrations affect regeneration in planaria, modeling impaired wound healing in diabetic conditions. By testing graded glucose environments and measuring regeneration indicators such as growth and differentiation, Jaehyeon demonstrated that lower glucose levels enhance regeneration while higher levels inhibit healing. The study establishes a model to better understand hyperglycemia’s impact on diabetic wound healing.

“The work by these students is a powerful example of the innovation and determination we see in Georgia’s next generation of life sciences leaders,” said Maria Thacker Goethe, President and CEO of Georgia Life Sciences. “The BioGENEius Challenge is critical because it provides students with a platform to apply cutting-edge science to real-world problems, while also strengthening the future workforce that will drive breakthroughs in healthcare, biotechnology, and beyond.”

The Georgia BioGENEius Challenge is part of Georgia Life Sciences’ broader commitment to advancing workforce development and fostering innovation across the state’s rapidly growing life sciences ecosystem.

Judging the 2026 Georgia BioGENEius Challenge: Ian Biggs; Ralph Cordell, CDC; Alex Harvey, ViaMune; Jamie Graham, Smith Gambrell Russell; and Evan Scullin, LuminiSci.

Georgia Life Science's Feature in Very First Atlanta Edition of Inside Medicine

Tue, 24 Mar 2026 18:27:12 GMT

Georgia Life Sciences is thrilled to be featured in the very first Atlanta edition of Inside Medicine . This inaugural issue represents something truly special. Atlanta’s healthcare and life sciences community is driven by innovation, collaboration, and outstanding leadership—and we’re honored to be part of this exciting launch.

Also in the issue, GLS's Kennedy Dumas is featured, sharing her journey on how observation and research evolved into a powerful practice of journaling. As the founder of Stationery Black, she creates notebooks designed to showcase, uplift, and inspire people of color.

Read the full article here.

Market Signals Align with Georgia’s Life Sciences Roadmap

Tue, 24 Mar 2026 17:09:13 GMT

A new national outlook on the life sciences real estate market is reinforcing what many in Georgia’s ecosystem have been building toward: a more disciplined, workforce-driven, and manufacturing-focused future for the industry.

CBRE’s 2026 U.S. Life Sciences Market Outlook points to a sector in transition—moving away from rapid, speculative expansion toward a more measured phase defined by targeted growth, capital efficiency, and long-term sustainability.

For Georgia, these trends are not just informative—they are validating.

A Market Reset Creates Opportunity

After several years of rapid expansion in major coastal markets, the national lab space market is recalibrating. Construction has slowed significantly, and vacancy rates—while still elevated—are stabilizing.

This shift favors emerging markets like Georgia that have taken a more measured approach to growth.

Rather than contending with oversupply, Georgia is well-positioned to scale intentionally—aligning infrastructure, workforce, and industry demand in a way that supports long-term success.

Manufacturing and Scale-Up Are Driving Growth

One of the clearest signals from the CBRE report is the increasing role of large pharmaceutical and biomanufacturing investments in driving demand.

This aligns directly with Georgia’s recent momentum.

From major facility expansions to increased interest in onshoring and domestic production, the Southeast—and Georgia in particular—is becoming a destination for advanced manufacturing in the life sciences.

The Georgia Life Sciences Roadmap has consistently emphasized this opportunity:

Strengthening biomanufacturing capacity
Building workforce pipelines to support production scale
Positioning Georgia as a hub for both innovation and commercialization

Workforce as the Differentiator

As capital becomes more selective and companies prioritize execution, talent—not space—is emerging as the defining constraint.

Georgia’s investments in workforce development, including partnerships with the Technical College System of Georgia and the Georgia Bioscience Training Center, position the state to meet this moment.

Through coordinated efforts across education, industry, and government, Georgia is building the kind of workforce infrastructure that enables companies to not only locate here—but to grow here.

A Converging Ecosystem

Another key trend highlighted in the report is the convergence of life sciences with adjacent sectors such as digital health, robotics, and advanced technologies. This is an area where Atlanta stands out.

With strengths in medtech, health IT, and data-driven healthcare solutions, the region offers a broader definition of “life sciences”—one that reflects where the industry is headed, not where it has been.

Looking Ahead

The national life sciences sector is entering a new phase—one that rewards strategic alignment, ecosystem coordination, and long-term investment.

Georgia is not starting from scratch in this environment. It has been building toward it. The Georgia Life Sciences Roadmap anticipated many of these shifts, prioritizing:

Workforce development
Manufacturing and scale-up capacity
Industry-academic collaboration
Capital and commercialization pathways

As national trends continue to evolve, Georgia’s focus on disciplined, intentional growth positions the state—and the broader Southeast—as a compelling partner in the next chapter of the life sciences industry.

Read report - CBRE Chapter 9, Life Sciences - U.S. Real Estate Market Outlook 2026

https://www.cbre.com/insights/books/us-real-estate-market-outlook-2026/life-sciences

UCB Sticks With Georgia, Placing $2 Billion Bet on State’s Life Sciences Ecosystem

Tue, 24 Mar 2026 01:06:23 GMT

B y Trevor Williams , March 24, 2026 | Global Atlanta

More than 60 Belgian firms have found a home in Georgia, but nothing on this scale has yet been seen in the state. The amalgam of Belgian investment, carried out over a half-century, translates to about 5,000 current jobs. Gwinnett offered $174 million in incentives to win the project, including property tax abatements, fee waivers and utility improvements, according to Rowen.

UCB is set to bring in artificial intelligence, advanced robotics and automation at the site. Biologics are therapies made from living organisms, promising cutting-edge research and manufacturing.

Maria Thacker Goethe , president and CEO of Georgia Life Sciences , said the move gives state leaders even more impetus to work collaboratively to build Georgia’s talent pipeline “across every stage — from high school exposure and technical credentials to community college, university, and incumbent-worker upskilling.”

“UCB’s decision underscores the strength of Georgia’s talent base, manufacturing capacity, and collaborative business climate, and it reflects the kind of long-term investment that helps build a more resilient U.S. biomanufacturing footprint,” Ms. Goethe told Global Atlanta in an email.

Nine of the 16 FDA approvals for UCB drugs and therapies have come within the last three years, showing its prioritization of the U.S. market, where headcount has grown 73 percent since 2017 to 2,000 people.

UCB’s products treat severe neurological and immunological conditions like epilepsy, lupus, Parkinson’s disease, rheumatoid arthritis and many more.

Read the full article here: UCB Sticks With Georgia, Placing $2 Billion Bet on State’s Life Sciences Ecosystem - Global Atlanta

Georgia General Assembly Establishes Life Sciences Caucus to Advance Innovation and Industry Growth

Tue, 17 Mar 2026 13:11:42 GMT

Georgia Life Sciences leads effort to establish bipartisan caucus focused on advancing the state’s growing life sciences economy

March 17, 2026, Atlanta, GA – The Georgia General Assembly has announced the formation of the Life Sciences Caucus through HR 1474, a bipartisan, bicamural, initiative designed to strengthen understanding of Georgia’s rapidly growing life sciences sector and support policies that drive innovation, company growth, and economic opportunity across the state.

Developed and championed by Georgia Life Sciences (GLS), the caucus will serve as a platform for legislators to engage with industry leaders, researchers, and educators to better understand the opportunities and challenges shaping biotechnology, medical technology, pharmaceuticals, and advanced biomanufacturing in Georgia.

“The life sciences industry plays a vital role in Georgia’s economy, advancing groundbreaking research, creating high-quality jobs, and improving health outcomes,” said Maria Thacker Goethe, President & CEO of Georgia Life Sciences. “The Life Sciences Caucus will provide an important forum for collaboration and dialogue as policymakers work to support an environment where innovation and companies can thrive.”

Georgia’s life sciences sector continues to expand, with companies and institutions across the state driving new discoveries, scaling manufacturing capabilities, and attracting investment. The caucus will help ensure lawmakers have access to insights and perspectives from across the ecosystem as they consider policies that impact the industry’s continued growth.

Georgia Life Sciences extends its sincere thanks to the legislators who sponsored and supported the formation of the caucus, including Senators Drew Echols, Frank Ginn, Chuck Hufstetler, Michael ‘Doc” Rhett, Shawn Still, Carden Summers, Ben Watson, and Kenya Wicks, as well as House members Matt Dubnik, John LaHood, Karen Mathiak, Ron Stephens, Brad Thomas, and Bill Yearta.

Through the Life Sciences Caucus, legislators will have opportunities to learn more about the state’s innovation ecosystem, workforce needs, and policy priorities that can help Georgia remain competitive as a national hub for life sciences research, development, and manufacturing.

About Georgia Life Sciences

Georgia Life Sciences (GLS) is the state’s leading industry organization representing biotechnology, pharmaceutical, medical device, and digital health companies, along with research institutions and other ecosystem partners. GLS works to advance Georgia’s life sciences sector by supporting innovation, advocating for policies that enable growth, and developing the workforce needed to power the industry’s future.

Education And Opportunity Mark Strength Of Atlanta Biotech Industry

Fri, 13 Mar 2026 15:39:57 GMT

A skilled workforce is the engine that will drive growth across America’s biotechnology industry, and Atlanta has built multi-faceted training programs that are developing and sustaining the talent pipeline for everything from advanced laboratory research to industrial biomanufacturing.

March 13, 2026 - Atlanta, Georgia – Today, the National Security Commission on Emerging Biotechnology (NSCEB) traveled to Atlanta for its second Georgia stop on the Biotech Across America Roadshow. Commissioners Paul Arcangeli, Dawn Meyerriecks, and Dov Zakheim visited a biotechnology workforce training center and a cutting-edge research facility to learn more about the innovation, policy, and the unique opportunities for biotech in Atlanta. Workforce development initiatives were key recommendations in the NSCEB’s April 2025 action plan for Congress to boost the U.S. biotech industry and strengthen national security.

“America’s biotechnology leadership will ultimately depend on people as much as technology,” said NSCEB Commissioner Paul Arcangeli. “The Commission’s action plan makes it clear that building and maintaining a pipeline of skilled workers—from the trades to advanced laboratory research—is essential for actually scaling innovation. We have the talent, and in Atlanta, they have the opportunities needed to drive their success.”

“Biotechnology has immense job-creating power across the American economy,” said NSCEB Commissioner Dawn Meyerriecks. “Atlanta is a show of force when it comes to biomanufacturing job creation and this formula is repeatable in communities all over the country. These types of jobs will bring growth and prosperity to towns and cities in every state.”

“To move discoveries from lab to market, we need a talented workforce prepared to work at the leading edge of biotech innovation,” said NSCEB Commissioner Dov Zakheim. “The opportunities in Atlanta are shaping the next generation of biotechnology innovators and developing a legacy of leadership when it comes to training the future workforce.”

“Georgia’s life sciences sector is helping strengthen America’s national security by expanding domestic biomanufacturing capacity, advancing biotechnology innovation, and building a highly skilled workforce,” said Maria Thacker Goethe, President & CEO, Georgia Life Sciences. “We were honored to host the National Security Commission on Emerging Biotechnology and showcase how Georgia’s collaborative ecosystem—spanning industry, research institutions, and workforce training partners—is driving the next generation of the bioeconomy. The work happening across our state demonstrates how regional leadership in biotechnology directly contributes to national resilience and global competitiveness.”

Event Details:

Commissioners first visited the Georgia Bioscience Training Center in Covington. The facility is part of a public-private partnership with the State of Georgia to drive biomanufacturing training opportunities in the region. The center provides customized life science industry training and is helping attract more biotech business to Georgia. Partnerships like this are critical to biotech industry growth and the NSCEB’s research highlights how stronger public-private partnerships contribute not only to industry growth, but to greater innovation and improved economic resilience.

In Atlanta, Commissioners visited the National Science Foundation (NSF) Engineering Research Center for Cell Manufacturing (CMaT) at Georgia Tech where they met students from the Achievement Rewards for College Scientists (ARCS) Foundation, and the International Genetically Engineered Machine (iGEM) program. Access to the NSF facility and the training opportunities for ARCS participants are transformative advantages for regional biotech businesses.

At the end of the day, Commissioners joined a roundtable discussion on Georgia’s biotech ecosystem. Biotech industry leaders, representatives from academia, and state officials discussed how innovation in biotechnology is shaping the future direction of the industry, workforce development, and educational needs. They also discussed state and federal policy issues impacting industry growth both in Georgia and across the country.

Participants Included:

Accuitis
Achievement Rewards for College Scientists Foundation
Andson Biotech
ArunA Biomedical
Emory University
Focused Cryo, Inc.
Frugal Science Academy
Georgia Bioscience Training Center
Georgia Department of Economic Development
·Georgia Life Sciences
Georgia Life Sciences Institute
Georgia Quick Start
Georgia Research Alliance
Georgia Tech
GeoVax
Lambert High School iGEM team
Micron Biomedical
Moonlight Therapeutics
NSF Engineering Research Center for Cell Manufacturing Technologies
Nutrivert
Office of U.S. Representative Lucy McBath
Soal Therapeutics
Takeda
TopoDx
UCB

Biotech Across America Roadshow

The Commission is hitting the road to highlight biotechnology across America, including the companies, academic institutions, workforce development programs, and policy initiatives that are driving the future for this rapidly growing industry. Commissioners will continue learning about the work being done across this vibrant ecosystem while engaging on the key findings and recommendations from the Commission’s recent report to Congress.

About NSCEB: The National Security Commission on Emerging Biotechnology is a time-limited, high-impact legislative branch advisory entity whose purpose is to advance and secure biotechnology, biomanufacturing, and associated technologies for U.S. national security and to prepare the United States for the bioindustrial revolution. The Commission published a comprehensive report in April 2025, including recommendations for action by Congress and the federal government. The bipartisan Commission is composed of Congressionally-appointed Commissioners with members from both the Senate and the House of Representatives as well as experts from industry, academia, and government. For more information about the Commission and to view the report, visit: biotech.senate.gov .

Contacts:

NSCEB: press@biotech.senate.gov

Growing Georgia Biomanufacturing Industry Transforming American Industrial Strength

Thu, 12 Mar 2026 15:36:31 GMT

On March 12, 2026, Augusta, Georgia served as the setting for an important conversation about the future of American biotechnology and manufacturing. Manus welcomed members of the U.S. National Security Commission on Emerging Biotechnology (NSCEB) to its Augusta BioFacility to highlight how advanced biomanufacturing is strengthening U.S. supply chain resilience and supporting the growing bioeconomy.

During the visit, Manus unveiled a significant expansion of its 44-acre Augusta BioFacility, increasing domestic capacity to produce critical biobased ingredients. The expansion further positions Georgia as a key hub for advanced biomanufacturing and demonstrates the growing role of biotechnology in strengthening national economic and supply chain security.

Commission members met with leaders from industry, government, and academia to discuss strategies for scaling manufacturing infrastructure, strengthening resilient supply chains, and preparing the workforce needed to support the next generation of the U.S. bioeconomy. The visit also included conversations with Manus employees about the practical realities of building and operating advanced biomanufacturing facilities in the United States.

The Augusta site has become one of the largest advanced biomanufacturing facilities in the country, producing a growing portfolio of bioalternatives at industrial scale. Among these products is high-purity Reb M, recently launched as Yume™ M Stevia Sweetener , supported by an all-Americas supply chain.

“As we scale the Manus bioalternatives platform, Augusta has become a powerful example of what the modern U.S. bioeconomy looks like in practice,” said Manus Founder and CEO Ajikumar Parayil.

The visit underscores Georgia’s expanding leadership in life sciences manufacturing and highlights how regional ecosystems can help advance U.S. leadership in biotechnology and biomanufacturing.

Learn more about the expansion and visit:

Manus welcomes U.S. National Security Commission on Emerging Biotechnology to unveil major Augusta BioFacility expansion

Growing Georgia Biomanufacturing Industry Transforming American Industrial Strength

GLS Advocacy Success: HB 139 Tabled Ahead of Crossover

Fri, 06 Mar 2026 19:29:58 GMT

Message from CEO

Georgia Life Sciences, and our patient partners, successfully led the effort to defeat HB 139, legislation sponsored by Rep. Todd Jones (District 25) that would have prohibited drug manufacturers and wholesalers from preventing licensed pharmacies from acquiring drugs through entities participating in the federal 340B drug discount program .

The bill was put on Thursday's House Health and Human Services agenda unexpectedly at 8:30pm Wednesday night for consideration at 2:30pm Thursday. In response, we quickly mobilized with an impressive group of over 20 colleagues and worked the committee, engaging key legislators to raise concerns about the legislation and its potential impact.

As importantly, we were able to persuade a few legislators who were on the fence or against us to be absent for the vote. As a result of these efforts, the committee voted to table the bill by a resounding 10-4 margin. Because this action occurred the day before crossover in the second year of the biennium, the measure is effectively dead for the remainder of the legislative session. We will remain vigilant through the end of the session to ensure similar language or policy proposals do not reappear in other legislation.

Thanks to all who worked together to defeat this legislation.

Maria Thacker-Goethe

President & CEO, Georgia Life Sciences

Senate Passes Ernst Updates to Put Small Businesses First in America’s Innovation Program

Wed, 04 Mar 2026 15:53:36 GMT

SBIR-STTR programs will now prioritize truly small businesses over mills and deter foreign influence.

WASHINGTON DC, March 4, 2026 – The U.S. Senate unanimously passed Chair of the U.S. Senate Committee on Small Business and Entrepreneurship Senator Joni Ernst’s (R-Iowa) major reforms to better safeguard and steward our nation’s research and development dollars in the SBIR-STTR programs.

Even though the SBIR-STTR programs are supposed to be America’s seed fund for small businesses, Ernst has exposed how they have prioritized a few large companies over truly small businesses, wasted tax dollars that should be producing innovation for our national interests, and failed to protect taxpayer-funded technologies from foreign influence.

Ernst has worked with small businesses, stakeholders, and across the aisle to change this unacceptable status quo, prioritize truly small businesses, and protect our innovations from Beijing.

“I will always fight to put small businesses first,” said Ernst. “When confronted with the status quo of the SBIR program, I knew I could no longer let China win, allow waste to run rampant, fail our warfighters, or let large companies crowd out actual small businesses. After working across the aisle, these necessary reforms will strengthen the integrity of America’s seed fund while unlocking new innovation, and I look forward to working with this administration to make sure taxpayers’ investments are turned into a reality. Now, with these commonsense changes, America’s seed fund can serve our truly small businesses.”

Ernst secured key updates in this legislation, which include:

Strengthening due diligence standards and closing loopholes to ensure awardees safeguard tech against Chinese espionage
Holding recipients accountable to producing cutting-edge technologies and capabilities for the warfighter
Requiring for the first time all SBIR offices to place an annual limit on applications to prioritize truly small businesses over large, entrenched companies that know how to game the system
Establishing the first-of-its-kind Strategic Breakthrough awards to enable agencies to scale the most promising technologies while ensuring businesses have skin in the game by requiring matching dollars and buy-in from the agency
Creating transparency of the use of tax dollars by improving data collection and reporting

Full remarks:

“I rise today as the Senate puts small businesses first in America’s innovation program and gives them the certainty they need to build and grow.

“For too long, our nation’s seed fund programs, SBIR and STTR, have been allowed to prioritize a few large companies over truly small businesses.

“Until now, these programs received blank checks to squander tax dollars meant to advance innovation in our national interest and have not protected taxpayer-funded technologies from foreign influence.

“When confronted with this unacceptable status quo, I knew Congress could work together to find a solution for our truly small businesses.

“After working across the aisle and with our small businesses, we now have the necessary reforms to strengthen America’s seed fund while unleashing small businesses to deliver for taxpayers and our warfighters.

“Together, our bipartisan, bicameral legislation will ensure awardees safeguard tech against Chinese espionage; hold recipients accountable to actually producing cutting-edge technologies and capabilities – no more blank checks; require for the first time an annual limit on applications to prioritize truly small businesses over large companies who know how to game the system; establish the first-of-its-kind strategic breakthrough awards; and finally, provide taxpayers with transparency into who receives these awards.

“These changes were necessary and worth taking the time to absolutely get it right.

“And tonight, I am proud the Senate is unanimously passing these long-overdue updates for innovators.”

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Georgia Life Sciences designates City of Brookhaven as newest BioReady® Gold Community

Fri, 20 Feb 2026 16:58:31 GMT

Recognition highlights Brookhaven’s commitment to life sciences growth and biomanufacturing readiness

Brookhaven, GA, Feb. 18, 2026 – The City of Brookhaven has been designated a BioReady Gold Community by Georgia Life Sciences, the state’s leading life sciences membership organization. The BioReady Community program evaluates a community’s preparedness to support life sciences development across key areas, including zoning and permitting, utilities and infrastructure, workforce readiness, and coordination among local government and economic development partners. The Gold distinction represents a high level of readiness and alignment with industry needs.

“Achieving Gold BioReady status underscores Brookhaven’s commitment to being a competitive destination for life sciences innovation and manufacturing,” said Aaron Szarowicz, City of Brookhaven Economic Development Director. “This designation reflects the intentional investments and partnerships we’ve built to support companies as they scale and create high-quality jobs in our community.”

Brookhaven’s BioReady assessment highlighted the City’s modern infrastructure, strategic location within metro Atlanta, access to a skilled workforce, and collaborative approach between City leadership, regional partners, and the business community. Together, these assets position Brookhaven to support companies across the life sciences value chain—from research and development to scale-up and manufacturing.

The BioReady rating system evaluates communities across three tiers—Bronze, Silver, and Gold—based on their readiness to attract and support life sciences facilities. Through these ratings, Georgia Life Sciences helps municipalities better showcase biotech-zoned sites, strengthen infrastructure planning, and clearly identify life sciences-friendly locations. This approach enables communities like Brookhaven to compete more effectively for private investment and job creation.

Georgia Life Sciences works to advance innovation, strengthen the workforce pipeline, and grow Georgia’s life sciences economy through the BioReady Community program, modeled after MassBio’s nationally recognized rating system which assesses a community’s readiness to host life sciences facilities based on zoning practices and infrastructure capacity. For more information on the non-profit, membership-based organization, visit www.galifesciences.org .

For more information about Brookhaven’s economic development initiatives, visit www.BrookhavenGA.gov/EconDev .

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Media Contact:

Ann Marie Quill,

Assistant Communications Director
404-205-3832

AnnMarie.Quill@BrookhavenGA.gov

Georgia Life Sciences Releases “Pathways & Partnerships: A Roadmap for Georgia’s Life Sciences Sector”

Wed, 18 Feb 2026 14:02:07 GMT

Georgia Life Sciences Releases “Pathways & Partnerships: A Roadmap for Georgia’s Life Sciences Sector”

Strategic roadmap positions Georgia as the Scale-Up Manufacturing Hub of the Southeast

ATLANTA, GA —February 18 — Georgia Life Sciences (GLS) today announced the release of Pathways & Partnerships: A Roadmap for Georgia’s Life Sciences Sector, a strategic framework designed to strengthen Georgia’s position as a national leader in biotechnology, medical technology, and life science innovation—and to position the state as the scale-up manufacturing hub of the Southeast.

Developed through extensive stakeholder interviews and ecosystem engagement, the roadmap outlines key opportunities, challenges, and bold ideas to accelerate growth across Georgia’s life sciences landscape. It reflects the priorities of those shaping the sector’s future, including startups, manufacturers, educators, investors, and policymakers.

“Georgia has all the ingredients to lead the next chapter of life sciences growth—innovation, talent, infrastructure, and collaboration,” said Maria Thacker Goethe, President and CEO, Georgia Life Sciences. “This roadmap provides a clear, shared framework to help align efforts, scale innovation, and drive long-term economic impact across the state.”

The roadmap focuses on five strategic pillars critical to Georgia’s continued leadership and competitiveness:

Scale-Up Manufacturing Infrastructure
Workforce and Talent Pipeline
Capital and Investment
Policy, Incentives, and Regulatory Environment
Ecosystem Coordination and Collaboration

Together, these priorities and recommendations establish a coordinated approach to accelerating discovery, scaling manufacturing, supporting talent development, and ensuring Georgia remains a destination for life sciences growth.

The Roadmap for Georgia’s Life Sciences Sector serves as a guide for industry, academia, government, and economic development partners working together to build a resilient, inclusive, and globally competitive life sciences ecosystem.

Over a 10-year horizon, the roadmap aims to:

Establish Georgia as the Southeast’s preferred location for scaling biopharma, medtech, diagnostics, agricultural and industrial biotech companies.
Generate thousands of high-wage jobs and retain more companies through later growth stages across all major life sciences subsectors.
Build a self-sustaining ecosystem that relies less over time on ad-hoc-or one-off incentives, as private capital and market-driven investment strengthen.

To learn more and access the roadmap, visit galifesciences.org/roadmap .

New study says Georgia can lead in brain health innovation

Tue, 17 Feb 2026 16:36:47 GMT

by Maria Saporta February 9, 2026

Georgia can dominate as a hub for brain health and neuroscience.

That’s according to an extensive nine-month-long study conducted by the Georgia Research Alliance (GRA) and Deloitte.

The study examined the academic and research assets that currently exist in Georgia, how the state compares to other states and how Georgia can move forward to leverage its potential.

“This is a once-in-a-generation opportunity to advance brain health,” said Tim Denning, president and CEO of the Georgia Research Alliance (GRA), a public-private entity that includes key civic and business leaders, university presidents and top state officials. “This is a key moment in time — a once-in-a-generation inflexion point.”

The study, funded by a $475,000 grant from the Robert W. Woodruff Foundation , mapped the major assets that already exist in Georgia. Denning presented a summary of the study’s findings at GRA’s Jan. 29 quarterly board meeting, which was held virtually.

The presentation included a map of Georgia’s key assets in brain health and neuroscience. It also showed a wide array of research centers, laboratories, universities and medical facilities that specialize in the field. Read more...

Georgia Life Sciences Board of Directors Update 2026

Wed, 04 Feb 2026 18:13:05 GMT

Georgia Life Sciences Announces New Board Members and Executive Committee Leadership

February 4, 2026. Georgia Life Sciences (GLS) is pleased to welcome five new leaders to its Board of Directors and announce its newly appointed Executive Committee, strengthening the organization’s leadership at a pivotal time for Georgia’s growing life sciences ecosystem.

New Board Members

Kenny Cordell , Senior Audit Manager, Crowe
Lori Chmura , CEO, Nyra Medical
Emily Dinu , Founding Partner, Numinous Capital
Courtney Law , Vice President, Life Sciences Commercial Banking, J.P. Morgan
Samir Patel , President & CEO, Moonlight Therapeutics

These new board members bring deep expertise across finance, investment, entrepreneurship, and life sciences innovation, reflecting the breadth and momentum of Georgia’s sector.

New Executive Committee

Dave Penake , Saol Therapeutics – Chair
Scott Rizzo , Bend Bioscience – Vice Chair
Wayne Elowe , Greenberg Traurig – Secretary
Nathan Caplinger , Avantor – Finance & Audit Committee
Ashley Cornelison , Portal Innovations – Governance & Nominating Committee

“This leadership team represents the strength, diversity, and ambition of Georgia’s life sciences community,” said Maria Thacker Goethe, President and CEO, Georgia Life Sciences. “Their collective experience will help guide GLS as we advance policies, partnerships, and programs that enable companies to start, scale, and stay in Georgia.”

Georgia Life Sciences looks forward to the contributions of its new board members and executive leadership as it continues to support innovation, workforce development, and economic growth across the state.

Georgia Life Sciences Designates Paulding County as Newest BioReady® Silver Community

Tue, 20 Jan 2026 15:52:21 GMT

January 20, 2026. Paulding County has been designated a BioReady Silver Community by Georgia Life Sciences, the state’s leading life sciences membership organization. The BioReady designation recognizes communities that demonstrate strong zoning practices, infrastructure capacity, and readiness to support biotechnology and life sciences development.

“We are proud to recognize Paulding County as our newest BioReady Silver community,” said Maria Thacker-Goethe, President and CEO of Georgia Life Sciences. “Paulding County’s proactive planning, growing workforce, and access to regional healthcare and transportation infrastructure position it well to support life sciences manufacturing and commercialization. Through the BioReady program, we champion communities that are intentionally preparing to compete for industry investment and job growth.”

Paulding County’s designation reflects its commitment to thoughtful land-use planning, scalable infrastructure, and business-friendly development policies that support life sciences and advanced manufacturing uses. Located in the northwest Atlanta metro region, the county offers access to a strong labor pool, major transportation corridors, and regional healthcare systems, making it an attractive option for biotechnology, medical device, diagnostics, and related life sciences companies seeking room to grow.

“Georgia BioReady designation validates Paulding County’s readiness to support bioscience investment and strengthens our position as a growing hub for advanced industries,” said Alex Almodovar, President & CEO, Paulding County Economic Development Inc. & Industrial Building Authority

The BioReady rating system evaluates communities across three tiers—Bronze, Silver, and Gold—based on their readiness to attract and support life sciences facilities. Through these ratings, Georgia Life Sciences helps municipalities better showcase biotech-appropriate sites, strengthen infrastructure planning, and clearly identify life sciences-friendly locations. This approach enables communities like Paulding County to compete more effectively for private investment and high-quality job creation.

Georgia Life Sciences advances innovation, strengthens the workforce pipeline, and grows Georgia’s life sciences economy through the BioReady Community program, modeled after MassBio’s nationally recognized rating system, which assesses a community’s readiness to host life sciences facilities based on zoning practices and infrastructure capacity.

About Georgia Life Sciences

Georgia Life Sciences, founded in 1989, is a non-profit, membership-based organization that promotes the interests and growth of the life sciences industry. It is the state’s largest and most influential life sciences advocacy and business leadership organization working to improve access to innovative discoveries that have lifesaving impact. The association connects business, academia, government, and other allied entities involved in the application of life sciences products to fuel growth and collaboration through policy development, community programs, national industry initiatives, and a portfolio of educational and networking events. Learn more at galifesciences.org.

StandTogether | Georgia Life Sciences Institute - EPIC

Wed, 14 Jan 2026 23:33:16 GMT

What happens when students see real work before choosing a future

GLS is a proud partner of the U.S. Chamber of Commerce Foundation’s EPIC (Employer Provided Innovation Challenges) Program to Bring “Real-World Innovation Challenges” into Georgia High Schools. Last year's program, led by Georgia Life Sciences Institute's Executive Director, Philip Gibson , welcomed over 60 students in this workforce- and education-oriented effort which aims to develop future biotech talent—exposing students early to regulatory, biomanufacturing, and ag-tech problems, helping build a sustainable pipeline of future scientists, engineers, and innovators.

America's Biotech Leadership Depends on the States

Thu, 08 Jan 2026 00:39:39 GMT

By: Patrick Plues | RealClearHealth January 8, 2026

For decades, America has led the global biotech industry – thanks, in part, to state-level policies that encourage research and manufacturing investments.

But other countries, including China, are sparing no expense in the bid to overtake us. Beijing has officially made biotechnology a national strategic priority and is pouring billions into state-backed research and manufacturing efforts.

All states should consider impactful biotech policies that grow and strengthen our domestic biotechnology industry. If states fail to utilize and replicate what are considered to be the best and most successful policies in biotech-focused economic development, the United States will soon lose its long-term leadership in developing medicines and medical technologies, which underpin our health, our economy, and our national security.

Thankfully, many governors and state legislatures around the country are already answering this call -- as our new study, The U.S. Bioscience Industry: A Powerful Engine for State Economies, demonstrates.

Keep Reading at https://www.realclearhealth.com/2026/01/08/americas_biotech_leadership_depends_on_the_states_1157584.html

GLS 2025 Year in Review

Mon, 22 Dec 2025 17:24:19 GMT

Dear Georgia Life Sciences Community,

As we reflect on the past year, I want to extend my sincere thanks to our Georgia Life Sciences members for making it such an impactful one. Your engagement and leadership continue to move our industry forward and advance our shared strategic priorities— driving strong policy, expanding the talent pipeline, and creating intentional spaces for collaboration across Georgia’s life sciences ecosystem.

Our Year in Review captures the progress we’ve made together across these priorities and highlights the collective impact our members are having statewide—from strengthening the workforce and supporting manufacturing growth to elevating Georgia’s position as a national life sciences leader. This progress is only possible because of the collaboration, commitment, and insight of our member community.

To those who are not yet members, we invite you to explore our Year in Review and see how Georgia Life Sciences is convening leaders, advocating for the industry, and creating meaningful opportunities to engage. We welcome you to join this growing community and be part of shaping the future of life sciences in Georgia.

Thank you to our members, partners, and supporters for a remarkable year. We wish you a joyful holiday season and a healthy, successful year ahead.

With gratitude,

Maria Thacker Goethe
CEO, Georgia Life Sciences

As we close out the year, please note that the Georgia Life Sciences offices will be closed for a holiday break December 23 through January 5, 2026, to allow our team to spend time with family and friends.

Our BioBeat newsletter will resume January 9 . We wish you a joyful holiday season and a healthy, successful year ahead—and look forward to continuing this important work together in 2026.

Investing in America’s Biopharmaceutical Infrastructure Strengthens the Economy and Supports Union Workers

Sat, 20 Dec 2025 01:16:07 GMT

The biopharmaceutical industry is growing America’s manufacturing and R&D capabilities to develop the next generation of treatments. A recent study from PILMA quantified the impact of the industry’s investment in American infrastructure on the economy and union workforce across 18 states from 2019-2024.

The study found that across the 18 states included, the biopharmaceutical industry:

Supported the American economy by investing $86.5B in R&D and manufacturing infrastructure and developing 1000+ construction projects at over 700 distinct facilities.
Strengthened the American workforce by generating $2.6B in skilled union wages and providing $19M in support for union apprenticeships.

The impact of the biopharmaceutical industry’s investment in American manufacturing and union jobs extends beyond direct benefits, spurring additional economic activity in the communities where workers live. This is known as the multiplier effect .

On average, every $1 of new investment in a U.S. biopharmaceutical manufacturing facilities generates an additional $1.59 in further economic activity (2.59x times the initial investment value).
The industry’s $86.5B investment in R&D and manufacturing infrastructure has a total economic impact of $224B.

Check out this resource to learn more about how biopharmaceutical investment in American infrastructure supports America’s workers and communities. For more on how biopharmaceutical companies are investing in America’s future, visit innovation.org/america-investment .

Georgia Life Sciences Joins National Coalition Urging Congressional Action on Key Innovation Policies

Wed, 10 Dec 2025 18:52:24 GMT

Georgia Life Sciences has joined 43 state and regional life sciences organizations in signing a national Council of State Bioscience Associations (CSBA) letter calling on Congress to take immediate action on three bipartisan policy priorities that are essential to sustaining U.S. leadership in biomedical innovation and supporting patients nationwide. With Congress back in session and several critical programs at risk of expiring, the letter urges congressional leaders to advance the following provisions without delay:

1. Reauthorize the Rare Pediatric Disease Priority Review Voucher (PPRV) Program

The PPRV program has been instrumental in incentivizing the development of therapies for children with rare and life-threatening conditions. Its lapse threatens to slow or halt research that families across the country are counting on.

2. Extend the SBIR/STTR Programs

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs provide crucial early-stage capital for emerging biotech and medtech companies—many of them in Georgia. Without reauthorization, hundreds of innovative small businesses face uncertainty, jeopardizing new therapies, diagnostics, and technologies in the pipeline,

3. Advance PBM Transparency Reforms

Greater transparency and accountability within pharmacy benefit manager (PBM) practices are needed to ensure that savings reach patients and employers. Reforming PBM operations is essential to strengthening access and affordability across the healthcare system.

A Unified Message from the Life Sciences Community

The sign-on letter reflects broad, bipartisan alignment across the national life sciences ecosystem: researchers, entrepreneurs, investors, patient advocates, and state associations all share a common message— these programs underpin America’s global competitiveness and are vital to patients who rely on continued scientific progress.

Georgia Life Sciences has shared the letter with members of Georgia’s congressional delegation and will continue engaging with policymakers to emphasize the importance of swift action.

GLS Joins Georgia Partners in Calling for Federal PBM Reform

Sun, 07 Dec 2025 19:42:33 GMT

Georgia Life Sciences is proud to stand with patient advocates, providers, and employers across the state in urging Congress to take meaningful action on pharmacy benefit manager (PBM) reform. We recently signed on to a joint letter to Georgia’s Congressional Delegation stressing the urgent need for transparency, fair practices, and policies that ensure savings flow directly to patients.

GLS’ President and CEO, Maria Thacker Goethe in December's issue of Georgia Trend

Thu, 04 Dec 2025 22:57:11 GMT

Georgia Life Sciences’ CEO, Maria Thacker Goethe shares her perspective on the value of Georgia’s research universities in this month’s issue of Georgia Trend.

“Georgia research institutions have felt a very significant impact from the federal rollbacks, specifically in NIH and NSF funding. Thacker Goethe’s message about the impact of research cuts is simple: Disruption shatters the foundational trust researchers have in grant continuity….” To read the full article, click here .

Giving Tuesday 2025

Tue, 02 Dec 2025 23:18:44 GMT

Your Giving Tuesday Gift Builds Georgia’s Life Sciences Workforce

Dear friends and partners,

On this Giving Tuesday, we invite you to join us in building a strong, diverse, and innovation-ready life sciences workforce for Georgia.

The Georgia Life Sciences Institute (GLSI) —our nonprofit 501(c)(3) foundation—is dedicated to expanding hands-on STEM education, strengthening the educator pipeline, and connecting students to real opportunities across biotechnology, biomanufacturing, and scientific research.

Your support today helps us reach students and communities who need it most.

Your Giving Tuesday gift makes a direct impact :

$25 provides supplies for teacher training workshops
$50 supports teacher training stipends
$75 provides meals and refreshments during our Biotech Teacher Training Workshops
$100 funds lab materials and educational resources for classrooms across Georgia
$250 sustains GLS and GLSI programs, including conferences and workforce initiatives
$500 helps build Georgia’s life sciences talent pipeline

This year, we’re working to expand access to STEM experiences statewide, especially in underserved and rural communities where students often have limited exposure to real-world scientific careers. With your help, every student in Georgia can see themselves as a future scientist, innovator, or biotech leader. And if you scroll down, you’ll see a real example of how GLSI programs, like our Equipment Depot, are helping Georgia students achieve nationally recognized breakthroughs.

Make your Giving Tuesday gift today and invest in Georgia’s life sciences future:

Donate Here

Thank you for your continued partnership and belief in the power of science, education, and opportunity.

With gratitude,
Maria Thacker Goethe
CEO, Georgia Life Sciences
Georgia Life Sciences Institute (501(c)(3))

Winter Membership Drive 2025

Mon, 17 Nov 2025 19:08:33 GMT

Join Georgia Life Sciences! 50% Off New Memberships

Georgia Life Sciences is the hub for Georgia’s growing life sciences ecosystem — connecting industry leaders, academic innovators, startups, and policymakers. We’re excited to invite new members to join today with 50% off your first year of membership .

This is a great opportunity to:

Access exclusive networking and learning events,
Gain visibility and advocacy support at the state and national level,
Connect with peers across biopharma, medtech, digital health, and more,
Stay informed on critical trends shaping Georgia’s life sciences landscape.
Don’t miss the chance to be part of the network driving innovation and growth in Georgia’s life sciences sector.

Join now and claim your 50% first-year discount when you apply by December 15. We look forward to welcoming you to Georgia Life Sciences!

GLS President & CEO, Maria Thacker Goethe Recognized as One of Georgia's 2025 Top 500 Most Influential Leaders

Thu, 06 Nov 2025 19:44:39 GMT

GLS President & CEO, Maria Thacker Goethe Recognized as One of Georgia's 2025 Top 500 Most Influential Leaders

Congratulations to our President & CEO, Maria Thacker Goethe, on being named to the 2025 Georgia 500, recognizing the state’s most influential leaders shaping Georgia’s economy and communities.

Maria’s inclusion reflects the growing impact of Georgia’s life sciences industry and the collaborative efforts of our members, partners, and statewide ecosystem advancing innovation, workforce development, and health.

This recognition isn’t about one person’s success — it’s about the collective strength of Georgia’s life sciences community. We would also like to congratulated leaders in the life sciences community recognized including, Tim Denning, GRA; Lynn Durham, Georgia CORE; and Mason Ailstock, Rowen.

We’re proud to see Georgia’s life sciences leadership recognized on this statewide stage!

Read the full Georgia 500 issue here .

Legal Experts Signal Continued Uncertainty for Life Sciences M&A

Wed, 22 Oct 2025 20:21:31 GMT

“Evolving FTC and DOJ policies leave investors and innovators navigating a cautious M&A landscape

Recent commentary from senior Federal Trade Commission (FTC) and Department of Justice (DOJ) officials signaled a continued commitment to activist antitrust enforcement – compounding the uncertainty for thousands of small and early-state life science companies that depend on mergers and acquisitions (M&A) to bring new treatments to patients.

During Fordham’s Competition Law Institute annual conference , leaders from across both agencies reaffirmed their commitment to active, aggressive enforcement, particularly in innovation-driven sectors like health care. Yet they also articulated a “case-by-case” approach to antitrust enforcement, as opposed to the broad brushstroke approach to merger enforcement taken under the Biden Administration.

Importantly, a balanced case-by-case approach to antitrust enforcement is essential when considering the fundamentally different nature of life sciences M&A, which has been empirically shown to improve the odds of bringing new, approved treatments to patients . New research shows that:

Drugs in development which undergo M&A are nearly twice as likely to launch as those that do not.
When smaller, inexperienced firms undergo M&A with companies that have experience launching a drug, their drugs programs are nearly three times more like to launch , and their drugs programs with a new mechanism of action are 24 times more likely to launch.
Even after controlling for drug candidate and firm characteristics, there is a large, positive, statistically significant association between M&A and new and novel drug launches.

What’s behind these research findings? Biopharmaceutical M&A enables experienced companies to provide smaller, early-stage firms with the significant resources, infrastructure and experience needed to traverse the long, costly and risky process of launching a new medicine.

Misguided aggressive antitrust policies threaten this dynamic and thereby threaten American leadership in life sciences innovation. In his remarks, FTC Bureau of Competition Director Daniel Guarnera also highlighted FTC Chairman Andrew Ferguson’s recommendations for rescinding or revising “anticompetitive regulations” in order to reverse “regulatory processes [that] may have been coopted to stifle competition.”

These efforts by the Trump administration to address anticompetitive regulations are a critical opportunity to reduce barriers to pro-competitive life sciences M&A – such as the Hart-Scott-Rodino premerger notification rule and the 2023 Merger Guidelines. PULSE highlighted these priorities in recent comments to the Office of Management and Budget (OMB) and FTC and DOJ.

As FTC and DOJ officials recalibrate their enforcement approach, they would do well to recognize the unique, differentiated role of life sciences M&A. New medicines for patients depend on it.

Georgia Life Sciences Launches New Podcast Series, Vitals, in Partnership with Cloudcast Media

Mon, 06 Oct 2025 18:21:43 GMT

Atlanta, GA — October 6 — Georgia Life Sciences today announced the launch of Vitals, a new podcast series developed in partnership with Cloudcast Media, a leader in branded podcast production. The series will spotlight the people, ideas, and innovations shaping the future of Georgia’s rapidly growing life sciences sector.

Hosted by Georgia Life Sciences’ CEO, Maria Thacker Goethe, Vitals will feature in-depth conversations with scientists, entrepreneurs, investors, educators, policymakers, and patient advocates. Each episode will explore the challenges and opportunities facing Georgia’s life sciences ecosystem—spanning biopharma, medical technology, digital health, and advanced manufacturing.

“Vitals gives us a powerful platform to showcase the remarkable work happening within our state,” said Maria Thacker Goethe. “By sharing these stories, we’re highlighting not only groundbreaking science but also the collaboration and talent that make Georgia such a vibrant hub for health innovation.”

Cloudcast Media, known for its expertise in storytelling and high-quality podcast production, will bring industry insights and technical support to ensure the series reaches audiences across Georgia and beyond.

“We’re proud to partner with Georgia Life Sciences on Vitals,” said Charles Parisi, Founder and CEO of Cloudcast. “This series will elevate the voices of innovators who are advancing science, improving patient outcomes, and building Georgia’s reputation as a global life sciences leader. We are very excited that Cloudcast Atlanta can play a role in supporting Maria and the impactful work of Georgia Life Sciences.”

The first episode of Vitals launched today and is available on Apple Podcasts, Spotify, and other major streaming platforms, as well as through the Georgia Life Sciences website.

BIO Statement on Most Favored Nation Policies

Wed, 01 Oct 2025 17:10:55 GMT

September 30, 2025

WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO) released the following statement on Most Favored Nation policies:

"For too many years, Americans have subsidized the research and development necessary to bring newer and better medicines to patients around the world. As we saw with defense spending and NATO, the solution is not to weaken a strategically important American industry, but for other countries to pay their fair share.

“Today’s announcement in the Oval Office highlights the problems with a drug delivery system where half of the cost of innovative medicines goes to middlemen and distributors, and where the supply chain distorts prices paid by the American people. We support a new framework that addresses the cost of medicines by simplifying the system - and making medicines directly available to patients.

“But importing socialist price controls through most-favored nation policies fundamentally does not address the imbalance in international pricing for innovative medicines. MFN will not lower the out-of-pocket prices that most Americans pay for medicines. Even worse, it will jeopardize the entrepreneurial spirit and deter the capital necessary for a vibrant and essential American biotechnology industry to thrive and may cause most harm to small and midsize biotech companies, which are responsible for discovering more than half of all new treatments.

“Without these biotech innovators and a free-market system, we risk slower scientific progress, decreased access to new medicines, compromised national security, fewer American jobs and perhaps most tragically, a diminished hope for those suffering with illness and disease. There are much better ways to address this problem than MFN.”

###

September GBG Report Now Available – Federal Funding Insights for Georgia Life Sciences Members

Thu, 11 Sep 2025 17:17:47 GMT

Members are invited to join G2G’s Monthly GBG Reporting Service Webinar on September 18, 2025 . The first portion ( 12:00–12:30 PM ET ) is free and open to all, offering a high-level overview of current federal funding trends. The second half ( 12:30–1:00 PM ET ) is a premium consultation available only to Georgia Life Sciences members, offering direct access to G2G’s expert team—who have helped secure over $550 million in non-dilutive government funding since 2007. Register here: https://www.g2gconsulting.com/event/non-dilutive-funding-g2gs-monthly-gbg-reporting-service-webinar-14-3/2025-09-18/

Key opportunities this month include DARPA’s Expedited Research Innovation System for CBRN threat defense technologies, BARDA’s I-CREATE diagnostic funding and VANGUARD biomanufacturing tools development (each offering up to $200,000), NIAID tuberculosis and influenza research units (up to $1.5–$2.5 million annually), DoD’s $4 million Advanced Medical Monitor development through MTEC, and multiple SBIR opportunities for sensors and field-deployable diagnostics (up to $209,575 for Phase I awards).

The September GBG report highlights 13 immunology and infectious disease opportunities, 10 cognitive and brain health programs, and several biotechnology and biomanufacturing initiatives across federal agencies including the Army, ARPA-H, BARDA, and NSF. Georgia Life Sciences members can access the complete 29-page report with detailed deadlines and eligibility requirements [insert link or portal instructions here].

GLS members can access the full 29-page report with deadlines and submission details by logging into your member portal.

Advocating for U.S. Agricultural Biotechnology Leadership

Fri, 05 Sep 2025 18:00:18 GMT

Protecting U.S. Leadership in Agricultural Biotechnology

Georgia Life Sciences has joined with leading scientific societies and state bioscience associations in signing a stakeholder letter to USDA regarding its proposed reorganization plan. Together, we urged the Department to keep Biotechnology Regulatory Services (BRS) staff based in the National Capital Region (NCR).

BRS provides critical oversight for the importation, interstate movement, and environmental release of crops, insects, and microbes developed through modern genetic techniques. Its expertise is central to ensuring that agricultural innovation moves forward safely, efficiently, and competitively.

Maintaining BRS in the NCR is not just about convenience—it is about preserving effective coordination across federal agencies. BRS works closely with the FDA and EPA as part of the Coordinated Framework for the Regulation of Biotechnology. The proximity of these agencies allows for faster decisions, clearer communication, and stronger support for stakeholders.

Relocating BRS staff outside of Washington would risk delays in approvals, loss of critical expertise, and reduced stakeholder engagement. It would weaken the nation’s ability to keep pace with global competitors at a time when agricultural biotechnology is rapidly advancing.

As the letter notes, the United States cannot afford to diminish BRS’s capacity. Farmers, innovators, and patients alike rely on this regulatory expertise to bring forward the next generation of agricultural solutions. Georgia Life Sciences is proud to stand alongside our partners in calling on USDA to maintain BRS’s presence in the National Capital Region and protect America’s leadership in agricultural biotechnology.

View the Sign On Letter Here

2025 Georgia Life Sciences Summit Poster Session Winners

Fri, 29 Aug 2025 23:40:29 GMT

Celebrating the Next Generation of Scientific Breakthroughs in Georgia

At the 2025 Georgia Life Sciences Summit, we proudly hosted the annual Scientific Poster Session , showcasing cutting-edge research from students, academic innovators, and industry leaders across our state. The session continues to honor the legacy of Dr. Anthony Shuker , a visionary scientist and mentor who championed early-stage innovation in life sciences.

This year’s winners exemplify the creativity, rigor, and impact that Georgia’s life sciences community is bringing to patients, science, and industry:

�� 1st Prize – Academic
Casandra Slocum , Medical College of Georgia at Augusta University
The Effect of Butyrate on Short-Term Memory in C. elegans

�� 2nd Prize – Academic
Arpita Shome, Ph.D. , University of Georgia
Surface Engineering ‘Liquid-Like’ Solid Surfaces with Endothelium Mimicking Bioactivity to Combat Biofouling

�� Industry Award
Kiki Diorgu , Saol Therapeutics
Development of SL1002 (Phenol-Cyclodextrin Complex) for the Treatment of Spasticity

�� Rick Hillstead Medical Device Award
Amritha Harikumar , Georgia State University | TReNDS Center
Classifying Schizophrenia Patients and Healthy Individuals via Whole Brain SPECT Functional Connectivity

We congratulate all of this year’s winners and participants for their outstanding contributions to scientific discovery and innovation. Your work reflects the strength and promise of Georgia’s life sciences ecosystem—and inspires us all to keep pushing boundaries in research and patient impact.

�� Photos from the Summit are available online here.

General Catalyst: Pro-Competitive Partnerships Drive “Steady Drumbeat of Innovation” in the Life Sciences

Fri, 29 Aug 2025 22:00:42 GMT

Investment in early-stage life sciences companies is critical to sustain America’s global leadership in discovering and developing new medical breakthroughs for patients, according to a recent General Catalyst blog, “ The Future of Life Sciences Investment .” Early-stage life sciences companies are unique for their ability to leverage specialized scientific knowledge and a nimble structure to pursue new, innovative approaches to treat a disease. However, these companies often rely on external investment, such as from venture capital (VC), to be able navigate the cost pressures and considerable risks associated with early-stage drug development.

Life sciences mergers and acquisitions (M&A) represent a clear exit point for VC investors, attracting investment and allowing companies of all sizes to combine their complementary resources, skills and expertise to bring new medicines to patients. Amidst an increasingly challenging investment landscape, preserving M&A is critical to continue supporting the hundreds of pre-clinical companies working to bring new therapies to patients.

Highlights from the blog are included below:

“Over the past decade, the biopharmaceutical industry has quietly produced a steady drumbeat of significant medical advances…Despite these advances, there’s global pressure to innovate faster. While the U.S. has historically been the global leader in scientific research and development, it now faces increased international competition…”
“For America to maintain its competitive advantage, it must continue investing in research and clinical development… We believe that venture capital can meaningfully contribute to fill this investment gap, providing support for America’s continued ability to innovate and advance global human health."
“This isn’t just our belief — venture-backed companies are driving enhanced R&D productivity and efficiency. Recent data shows that roughly 65% of new medicines originated from outside of large pharmaceutical companies.”
“We believe the most meaningful breakthroughs in life sciences are rarely achieved in isolation. They’re the result of deep, sustained collaboration — between scientists and clinicians, industry and academia, and increasingly, founders and investors.”

As this blog highlights, life sciences M&A remains a critical pathway for fueling investment and supporting America’s role as a global leader in life sciences innovation. Policymakers must recognize the value of life science M&A and support enforcement policies that encourage these pro-competitive partnerships and the innovative medicines they bring to patients.

About the Partnership for U.S. Life Science Ecosystem (PULSE)

The U.S. life sciences ecosystem depends on mergers and acquisitions (M&A) as well as other collaborations to bring together the resources, investment and expertise needed to develop and deliver new treatments and cures for patients. PULSE is dedicated to raising awareness about the unique life sciences ecosystem and the importance of M&A in leveraging efficiency and experience across companies of all sizes. PULSE will help advance a national dialogue focused on fostering innovation across the life sciences while supporting a competitive U.S. market that advances next generation treatments and cures for patients. For more information, visit https://pulseforinnovation.org/.

Golden Helix Awards recognize achievements in Georgia's life sciences sector

Thu, 21 Aug 2025 18:39:08 GMT

August 18, 2025
By Lauren McDonald – Originally published in the Atlanta Business Chronicle

The Georgia Life Sciences advocacy organization will honor numerous Atlanta businesses and other key players in the state's life sciences industry with this year’s Golden Helix Awards. The Golden Helix Awards celebrate “excellence and achievement” across Georgia’s life sciences ecosystem. The recognition honors individuals, companies and institutions “making significant contributions to scientific discovery, health innovation, and economic growth in the state and beyond,” according to the Georgia Life Sciences organization.

Georgia Life Sciences is an Atlanta-based nonprofit that promotes the growth of the life sciences industry and works to connect businesses, academic institutions, government and others to develop products and fuel industry expansion.

“The Golden Helix Awards shine a spotlight on the bold ideas and visionary leaders propelling Georgia’s life sciences sector forward,” said Maria Thacker Goethe, president and CEO of Georgia Life Sciences. The state’s life sciences industry supports around 78,000 jobs and includes close to 4,000 companies, according to the nonprofit. A partnership between the German pharmaceutical company Boehringer Ingelheim and the University of Georgia for a Sustainable Development Excellence Certificate Program earned the Phoenix Award, which celebrates an industry and academic collaboration.

A new neuromuscular diagnostic technology called Myomatrix, developed during Muneeb Zia’s studies at Georgia Tech in 2018, will receive the Innovation Award recognizing work that “goes beyond the traditional paradigms and has the potential to significantly impact human health, agriculture or environmental sustainability.” Myomatrix enables researchers to better record muscle activity through minimally invasive access and with cellular-level detail. It’s used by more than 200 researchers globally today.

Numerous Atlanta businesses will also receive Deal of the Year awards, including Andson Biotech for closing a $3.6 million seed round and Micron Biomedical for securing $16 million to expand manufacturing of needle-free vaccine delivery technology and to advance multiple vaccine candidates toward commercialization. The Deal of the Year awards recognize companies making the most significant transactions in the biotech industry over the past year. Moonlight Therapeutics will receive the award for closing its first equity round to advance an allergen immunotherapy platform for treating food allergies. Synaptrix will receive the award in recognition of its $13 million fundraise to develop a drug-free postoperative pain management device. Artelon, a Sandy Springs–based medical technology innovator, is being recognized with this award in celebration of its acquisition agreement with Michigan-based Stryker. And Duracell will be recognized for selecting Georgia as the site of its new North American research and development headquarters. Alimera Sciences, an Alpharetta-based biopharmaceutical company, is being recognized with this award in celebration of its $453 million acquisition agreement with Minnesota-based ANI Pharmaceuticals, which will expand ANI’s global footprint to three commercial rare disease assets.

Benjamin Siciliano with Atlanta-based Radyus Research will receive the Emerging Leader of the Year award, and Amanda Barrett at Marietta High School will earn the Teacher of the Year award. Sen. Chuck Hufstetler, representing the 52nd District in Rome, will receive the Legislator of the Year award.

This year’s winners will be honored at a ceremony Aug. 26 during the Georgia Life Sciences Summit in Sandy Springs.

Georgia Life Sciences, AdvaMed, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech

Thu, 21 Aug 2025 18:27:09 GMT

August 20, 2025 -

The Honorable Dr. Mehmet Oz

Administrator Centers for Medicare & Medicaid Services

7500 Security Blvd. Baltimore, MD 21244

A dm

inistrator Oz, We, the undersigned organizations, urge the Centers for Medicare & Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access breakthrough medical technology. Closely aligning the efforts of the Food and Drug Administration (FDA) and CMS, the rule will streamline regulatory coordination and eliminate unnecessary obstacles standing between physicians and patients, helping to make Americans healthier.

Every day, Medicare patients across the country confront diagnoses, unexpected health emergencies, and the challenges of managing chronic conditions. Simultaneously, new and innovative medtech are continuously developed, offering profound improvements in patient care, health, and outcomes. Medtech has helped shrink the duration of hospital stays by 38%, reduce deaths from breast cancer by 43%, and decrease fatalities from heart disease and stroke by 49%. Medtech also aids in earlier identification of diseases such as Alzheimer’s and Parkinson’s, underscoring the critical importance of patient access to these advancements.

Despite this remarkable impact and the continuous pace of innovation, Medicare patients face a significant and unacceptable barrier to accessing innovative medical technology. A recent study alarmingly revealed that for technologies requiring a new reimbursement pathway, nearly six years passed between FDA market authorization and Medicare coverage. Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life.

Existing programs, including the Transitional Coverage of Emerging Technologies (TCET) program, fall short of providing the consistent, timely, and predictable access that breakthrough technologies demand. Its voluntary nature and limited scope – among other issues – fall short of delivering the life-changing innovations to patients who need them most. This administration has a significant opportunity to course correct and make meaningful progress on improving American health.

We have long supported a swift and streamlined approach to Medicare coverage of innovative medical devices and diagnostics that improve health outcomes for patients with debilitating or life-threatening illnesses. We are encouraged by Administrator Oz’s early focus on exploring options for a better pathway for recently approved medical devices, and we encourage CMS to take bold action. A program mirroring the core tenets of the original Medicare Coverage of Innovative Technology (MCIT) framework, embodied in legislative proposals like S. 1717, offers a superior solution.

This would provide coverage for FDA market authorized breakthrough technologies – including diagnostics – ensuring that Medicare patients and their care teams have more timely access to innovations upon FDA clearance. Crucially, it would also provide a clear, predictable roadmap for CMS to collect additional necessary evidence for making a permanent coverage decision. This would – in addition to removing or bridging regulatory obstacles – demonstrate CMS’s commitment to patient-centered care and ensure that Medicare beneficiaries can benefit from the rapid advancements in medtech without unnecessary delays, helping make for a stronger, healthier country.

Sincerely,

Access Ready, Inc

AdvaMed
All Wheels Up
Alliance for Aging Research
Alzheimer's Association
Alzheimer's Impact Movement
American Association for Homecare
American Cancer Society Cancer Action Network
American Diabetes Association
American Music Therapy Association
Arizona Bioindustry Association, Inc. (AZBio)
Arthritis Foundation Association of Black Cardiologists
Autistic Women & Nonbinary Network
Bio Nebraska
Biocom California
BioFlorida
BioForward
Wisconsin BioUtah
Breakthrough T1D
Brem Foundation to Defeat Breast Cancer
California Life Sciences
CDx Diagnostics
Colorado BioScience Association
Conquering CHD
CureLGMD2i Foundation
Florida Medical Manufacturers Consortium (FMMC)
Georgia Life Sciences
HealthCare Institute of New Jersey (HINJ)
HealthyWomen Heart Valve Voice US
Hydrocephalus Association
Illinois Biotechnology Innovation Organization, iBIO
Indiana Life Sciences Association
International Registry of Rehab Technology Suppliers
Life Science Oklahoma
Life Science Tennessee
Life Science Washington
Life Sciences Pennsylvania
LifeSciencesNY
Maryland Tech Council
MassMEDIC
Medical Alley
Michigan Biosciences Industry Association (MichBio)
Missouri Biotechnology Association
Montana Bioscience Alliance
National Health Council
National Psoriasis Foundation
NC Life Sciences Organization
New Mexico Biotechnology & Biomedical Association
NewYorkBIO
NH Life Sciences (NHLS)
ONE CANCER PLACE
Oregon Bioscience Association
Patients Rising
Rehabilitation Engineering and Assistive Technology Society of North America (RESNA)
RI Bio
Right Scan
Right Time Say YES to Hope
South Dakota Biotech
Spina Bifida Association
Texas Healthcare & Bioscience Institute
The Mended Hearts, Inc.
The Ohio Life Sciences Association
Virginia Biotechnology Association
Voices of Alzheimer’s
Women's Health Advocates

Georgia's life sciences sector has grown, but key ingredients still lacking

Mon, 18 Aug 2025 18:25:40 GMT

“If you're not affiliated with a university, you can't really access their labs,” said Eddie Lai, director of business development at venture capital firm Portal Innovations. “If you're trying to build your own facility, that costs a lot of money.”

By Tyler Wilkins – Staff Reporter, Atlanta Business Chronicle

This year, Shriners Children’s picked Atlanta to carry out its mission to advance pediatric care.

The Tampa-based hospital network plans to establish a research institute at Science Square, an emerging life sciences hub on the doorstep of Georgia Tech’s campus. The announcement is one of the latest wins for Georgia’s life sciences industry, which has rapidly expanded in recent years.

Economic development professionals tend to point to Georgia’s relative affordability, labor and real estate costs, net migration patterns, talent pool and academic institutions as some of the state’s attributes that have helped attract all the investment. But insufficient access to capital, shortfalls in skilled labor and other challenges have the potential to hinder innovation — limiting the industry's pace of expansion and opening a window of opportunity for rival states.

Georgia’s life sciences industry is the third-largest among Southeastern states based on the number of companies and economic impact, behind North Carolina and Florida. Despite impressive growth in recent years, the Peach State is locked in fierce competition with its neighbors. “We're seeing Tennessee creep up, and they might be able to surpass us in the next couple of years, if we don't make some significant changes,” said Maria Thacker Goethe, president and CEO of Georgia Life Sciences, an industry association formerly known as Georgia Bio.

Venture capital, federal funding drove growth in recent years

Georgia's life sciences industry began to take off after the state hosted the BIO International Convention in 2009, Thacker Goethe said. The multi-day event drew thousands of executives and other professionals to Atlanta. Hosting the event allowed state and local leaders to showcase Georgia’s strengths to the life sciences community. It caught the industry’s attention, likely helping to attract some of the big companies that have set up operations in the state. A decade later, Georgia’s life sciences industry would experience a big surge during the Covid-19 pandemic. The state captured records level of venture capital and angel investment in 2021, as well as a strong amount of National Institutes of Health funding sent to state institutions.

The region is home to approximately 18,000 life sciences jobs. Nearly 5,600 of those jobs are research and development roles, which grew by 44% from 2019 to 2022, according to a CBRE report. Georgia employed more than 78,000 people across 4,000 establishments in the

life sciences industry as of 2021, ranging from biopharma companies and medical device firms to R&D and manufacturing, according to a TEConomy report. The state added 11,000 net new jobs between 2015 and 2021, a 20% increase that outpaced the national average, according to the report. Major companies have planted operations in the state, including Takeda Pharmaceuticals, Intuitive Surgical and Alcon. Meissner Corp. is expected to create more than 1,700 jobs through a $250 million facility in Athens-Clarke County, and Boston Scientific recently expanded its presence in the state with a new research and development hub in Johns Creek.

Academic and research institutions such as Georgia Tech and Emory University have undoubtedly aided in the industry's growth. Shriners considered several locations in the Southeast for its research institute, said Leslie Stewart, the chairman of its board of trustees. It ultimately landed on Science Square to be close to Georgia Tech, with which the organization has had a longtime partnership. "Attracting new organizations [such as Shriners] creates momentum for future opportunities in recruitment and nurturing existing ecosystems," said Misti Martin, deputy commissioner of global commerce for Georgia's Department of Economic Development, in a statement. "Each new organization is a new potential partner for those already in the state or considering locating in Georgia."

Companies don’t necessarily come to Atlanta in search of moderate weather and Southern hospitality, said Katherine Lynch, a principal at Trammell Crow Co., the developer behind Science Square. “But many shared with me that they found themselves pleasantly surprised

at how much of an impact these qualities made on their ultimate decision,” Lynch said.

Georgia needs more local investors, non-university lab space

Georgia has a robust labor force with applicable skills, but its members may be working in other fields or simply not aware of the career opportunities, according to subject-matter experts.

Early-stage companies can benefit from bringing on senior talent with business know-how. But it can be difficult to persuade high-level executives to leave their jobs at a major company in another state. “In terms of venture capital in life sciences in the region, I think there's room to grow in that space,” said Kristi Brigman, chief economic development officer at the Metro Atlanta Chamber

After all, startups don’t always last. There are more opportunities to fall back on in larger markets such as Boston or San Francisco than Atlanta. For entry-level jobs, part of the problem is perception. Many people assume a graduate-level degree is needed to work in life sciences. A majority of the talent needs require a high school diploma or associate’s degree, Thacker Goethe said. Many companies provide training for those jobs, which can be high-paying and fulfilling, she said. “If you're manufacturing something that's going to help treat cancer or get the device someone needs to move and live their best life, that is very meaningful for people,” Thacker Goethe said.

The federal government provides early-stage funding to support development and commercialization through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. Many states offer to match funds awarded through the programs. Georgia Research Alliance has a matching program, but it is only available to companies affiliated with member universities, Thacker Goethe said. The absence of a statewide program limits startup scaling, Thacker Goethe said. One innovator told her it was a deal-breaker in deciding where to launch his company. “He's going to set up the office in Tennessee, keep a house in Atlanta and

work remotely from Atlanta to support the company,” she said. “That’s a real problem.”

Universities play a critical role in the startup space as development and funding partners. The Trump administration's efforts to cut federal research grants could impact the ecosystem in Georgia and beyond. In the first six months of 2025, the NIH had awarded fewer grants than the previous year and had terminated or frozen funding for thousands of grants, according to a Business Journals report. “In terms of venture capital in life sciences in the region, I think there's room to grow in that space,” said Kristi Brigman, chief economic development officer at the Metro Atlanta Chamber.

There are more avenues for Atlanta startups to line up private funding than in the past. But it can still be difficult for those in life sciences to raise what they need. One of the selling points of markets such as Boston and San Francisco is the proximity to a wide array of venture capitalists. “In terms of venture capital in life sciences in the region, I think there's room to grow in that space,” said Kristi Brigman, chief economic development officer at the Metro Atlanta Chamber.

A lack of nonacademic lab space is another challenge. Tech startup founders can launch their business out of their garage if necessary. That won’t cut it for someone who needs access to lab equipment. “If you're not affiliated with a university, you can't really access their labs,” said Eddie Lai, director of business development at venture capital firm Portal Innovations' Atlanta site. “You’re stuck in the dark. If you're trying to build your own facility, that costs a lot of money.”

There have been efforts to address some of the obstacles. Consider Portal, the first tenant at Science Square Labs. The national firm

provides lab and office space to early-stage startups at a base price, with the option to pay for additional services and amenities as a company grows. Members can network with peers across the country, and they can work from other locations when they're out of town. In an effort to bolster the industry, Georgia Life Sciences is working with large employers, small companies and universities to develop a "road map." The study will produce recommendations to guide the state’s strategy around economic development, workforce pipelines and innovation investment.

'Two-edged sword': Lack of lab space was a barrier to growth but prevented a glut

Unlike Boston, Raleigh-Durham and other markets, metro Atlanta hasn’t had a physical hub centered around life sciences innovation. Academic institutions, local leaders and real estate developers are trying to create that kind of environment. In the suburbs, Gwinnett County has invested millions of dollars into Rowen. The 2,000-acre development is intended to become a major employment and research hub centered around the environment, agriculture and medicine.

Inspired by Research Triangle Park, Rowen has an ample supply of land to accommodate companies that want to establish offices and research facilities. The project is located between Athens and Atlanta, providing access to Georgia Tech, University of Georgia, Emory University and other institutions. Roads, green space, multi-use trails and other forms of infrastructure have been built in the area.

Gwinnett officials gave the green light for Rowen in the early days of the pandemic. Years later, it’s still uncertain who could become the first tenant. It took decades for North Carolina leaders to create RTP, the largest research park in the U.S. In May, Rowen Foundation President and CEO Mason Ailstock told Atlanta Business Chronicle that more than a dozen companies have considered locating at the so-called “knowledge community,” including four in just that past quarter. "We continue to make progress down that short list line for several companies today, as we compete nationally to win these huge, multimillion-dollar projects,” Ailstock said. Landing that first tenant could lead to a ripple effect, putting Rowen on the radar of other companies in expansion mode, Thacker Goethe said. “They just need one,” Thacker Goethe said. “The plan, the idea and the leadership is all in place. It’s just getting that first domino to fall.”

Trammell Crow Co. developed the first phase of Science Square with the help of Georgia Tech. The first phase includes a 13-story tower with more than 350,000 square feet of lab and office space, as well as retail and an apartment building. Shriners plans to build out its research institute in phases, with the option to take up almost half of the space in Science Square Labs, Stewart said. Earlier this year, battery manufacturer Duracell announced that it would relocate its R&D headquarters from Connecticut to two full floors at Science

Square Labs. The Georgia Department of Agriculture also leases space in the tower. Science Square is a true test of “build it and they’ll come,” said David Hartnett, former chief economic development officer at Metro Atlanta Chamber. “That is the biggest win that the life science community has had in two decades,” said Hartnett, who has held senior roles at medical device companies. “I can’t think of another deal of more importance and significance than Science Square.”

Outside of Science Square, lab-ready space available to lease is almost nonexistent in Atlanta proper, said Eric Ross, executive vice president of CBRE’s Landlord Representation Group in Atlanta and part of the leasing team for Science Square. That is a “two-edged sword” for Atlanta, Ross said. It is a challenging environment for life sciences companies across the U.S. to raise funds through private equity and venture capital, he said, resulting in leasing concerns for existing space in other markets. “From a real estate investment standpoint over the next five to 10 years, Atlanta is going to be in a much better position to attract outside institutional capital to build appropriate lab office space, because we're not going to have an overbuilt inventory,” Ross said.

Georgia Life Sciences Names 2025 Golden Helix Award Winners

Tue, 12 Aug 2025 15:50:42 GMT

Academic Innovators and Industry Leaders to be Honored at the Georgia Life Sciences Summit

August 12, 2025 - The Georgia Life Sciences Golden Helix Awards celebrate excellence and achievement across Georgia’s life sciences ecosystem, recognizing the individuals, companies, and institutions making significant contributions to scientific discovery, health innovation, and economic growth in the state and beyond.

This year’s winners will be honored at the welcome reception and awards ceremony on day one of the Georgia Life Sciences Summit , August 26-27 at the Sandy Springs Performing Arts Center.

We are pleased to announce this year’s slate of 2025 Golden Helix Award winners:

PHOENIX AWARD : Boehringer-Ingelheim / University of Georgia for the Sustainable Development Excellence Certificate Program

This award, sponsored by the Metro Atlanta Chamber, celebrates an industry/academic collaboration, or other allied partnership, that demonstrate strength, tenacity, and leadership. Like the mythical phoenix, together they exemplify how strategic partnerships can accelerate discovery, fuel commercialization, and create meaningful impact for patients and communities.

INNOVATION AWARD : Myomatrix

Presented to an institution, team, or individual whose innovation goes beyond the traditional paradigms and has the potential to significantly impact human health, agriculture, or environmental sustainability. Eligible innovations may include—but are not limited to—advancements in biotechnology, pharmaceuticals, diagnostics, medical devices, digital health, or life science-related AI and data platforms.

DEAL OF THE YEAR AWARD :

Andson Biotech (Private Financing), biotools company revolutionizing sample preparation for mass spectrometry workflows, for closing a $3.6M seed round led by industry veterans and expanding from three to ten employees while launching its DynaChip X1 platform into commercial markets.
Micron Biomedical (Private Financing), for securing $16M to expand manufacturing of its needle-free vaccine delivery technology and advance multiple vaccine candidates toward commercialization.
Moonlight Therapeutics (Private Financing), or closing its first equity round, Series A, co-led by Portal Innovations, to advance its novel intradermal allergen immunotherapy platform for treating food allergies, beginning with MOON101 for peanut allergy.
Synaptrix (Private Financing), a medical device company developing the groundbreaking NOVABLOC™ system for drug-free postoperative pain management, for raising $13M in Series A funding led by Hatteras Venture Partners to support pivotal studies, regulatory submission, and commercialization.
ANI Pharmaceuticals (Acquisition) for its definitive agreement to acquire Alimera Sciences , for $453M, expanding its global footprint and portfolio to three commercial rare disease assets.
Stryker (Acquisition), for its definitive agreement to acquire Artelon, expanding its portfolio of soft tissue fixation solutions for orthopedic surgeons.
Duracell (Economic Development), for selecting Georgia as the site of its new North American R&D headquarters, further strengthening the state’s life sciences and advanced manufacturing ecosystem.

Presented to a company or institution who has made the most significant transaction of the year (between January 1, 2024-March 31, 2025), a deal that exemplifies strategic vision, market influence, and long-term value creation. Whether it’s a transformative partnership, acquisition, licensing agreement, IPO, or major funding round, this deal represents a defining moment for the companies involved and a milestone for the state’s biotech ecosystem.

COMMUNITY AWARD :

ARCS Foundation – Atlanta
Jeffrey Gray , Founder and CEO, AgeTech Atlanta
Christopher Kunney , Managing Partner and Digital Transformation Strategist, IOTech Consulting, LLC
Lisa Middleton, Ph.D. , Director, Scientific Affairs, Georgia Cancer Center/Augusta University

Presented to a life sciences organization or individual that has demonstrated continuous commitment to making a positive, lasting impact on their local community. This award recognizes organizations/ individuals that go beyond their day-to-day operations through career development initiatives, outreach programs, patient advocacy, corporate philanthropy, or other significant community contribution.

EMERGING LEADER OF THE YEAR AWARD : Benjamin Siciliano, PhD , Radyus Research

Presented to an individual in the first decade of their career whose achievements are significantly contributing to or transforming the life sciences industry.

TEACHER OF THE YEAR AWARD : Amanda Barrett , Marietta High School

Presented to a Georgia biotechnology high school teacher who exhibits innovative teaching, mentorship, and unwavering dedication to inspire the next generation of thinkers, problem-solvers, and future leaders in STEM/ biotechnology.

LEGISLATOR OF THE YEAR AWARD : Senator Chuck Hufstetler , 52nd District, Rome

Honors select legislators in recognition of their leadership in advancing federal and state policies to promote life sciences research, investment, and innovation.

Winners are selected by the Golden Helix Awards Committee, a select group of leaders from Georgia’s life sciences, academic, and business communities who are responsible for identifying and recommending the most impactful individuals, companies, and organizations for recognition at the Golden Helix Awards. The committee reviews nominations across categories including scientific advancement, public policy, entrepreneurship, education, and community impact, aligning with the mission of the Golden Helix Awards to honor those whose ideas and achievements are leading the way in health and science.

To register for the summit, click here .

Message from CEO: Mounting Federal Pressures and a Vital Moment for Georgia

mthacker@gabio.org (Maria Thacker Goethe) — Fri, 01 Aug 2025 19:42:55 GMT

As Washington heads into August recess, Georgia Life Sciences is counting down the days to the 2025 Georgia Life Sciences Summit , taking place August 26–27 in Sandy Springs . With just one month to go, this pivotal gathering will bring together innovators, investors, policymakers, and ecosystem leaders at a time when the national policy landscape is shifting rapidly—and not always in our favor.

In just the past week, we’ve seen:

A short-lived but deeply disruptive pause in NIH funding : The White House Office of Management and Budget (OMB) temporarily halted the issuance of NIH research grants, contracts, and training awards—impacting institutions nationwide, including here in Georgia. After significant backlash from Congress, research leaders, and advocacy groups, the administration quickly reversed course and released the funds. However, this episode underscores the growing unpredictability of federal research funding—one of the lifelines for our academic and startup ecosystem.

The return of pharmaceutical tariffs : The administration announced a 15% tariff on European pharmaceutical imports , though it will not take effect until a national security review is completed. While far lower than the previously floated 200% rate, this move still poses a concern for supply chains and U.S. companies relying on EU-based manufacturing.

Escalating pressure on drug pricing : President Trump has now issued direct letters to CEOs of 17 major pharmaceutical companies demanding implementation of Most Favored Nation (MFN) pricing within 60 days. The directive includes MFN pricing for all existing Medicaid drugs, future Medicare and commercial launches, and even repatriation of foreign revenues. While regulatory specifics remain vague, the message is clear: the administration is increasing its pressure on pricing reform—and that could have broad implications for biotech innovation, particularly among smaller companies.

At the same time, a new BIO report shows that early-stage biotech funding continues to contract. Series A investment remains flat, IPOs are sluggish, and Q2 startup funding dropped to just $900 million—down from $2.6 billion in Q1. Layoffs across the sector have surged. This paints a sobering picture for many companies in Georgia and beyond.

In this environment, Georgia Life Sciences remains committed to elevating our state’s voice, regionally and nationally . We continue to advocate for stable federal funding, smart policies, and the resources innovators need to survive and thrive.

The Georgia Life Sciences Summit will be a platform to do just that, demonstrating the resilience of our ecosystem, celebrating homegrown successes, and shaping the future of health innovation in Georgia. I hope to see you there.

Emerging biotechs get bearish to weather market trends, finds BIO report

mthacker@gabio.org (Maria Thacker Goethe) — Mon, 28 Jul 2025 22:32:05 GMT

By: Clary Estes

“Small companies are the lifeblood of the industry and a lot of what they do, and what they’re experiencing, greatly affects the industry as a whole,” said Chad Wessel, Director of Industry Analysis at the Biotechnology Innovation Organization (BIO).

He spoke with Bio.News in an interview about BIO’s 2025 report, “ The State of Emerging Biotech Companies: Investment, Deal, and Pipeline Trends ,” focused on the biotech industry from the early-stage perspective. As researchers found, the current landscape is challenging, but there are still opportunities.

“In the last couple years, we’ve had a little bit of a contraction of the industry. During COVID, we kind of had this sugar rush for the industry,” said Wessel. “A lot of companies were being created. A lot of money was being thrown out there. A lot more companies were being funded. And in the last couple of years, there has been a little bit more of a correction, and we’re seeing funding levels going down to what we’ve seen prior to COVID.”

“But when you add on other challenges, like the political landscape and everything, it is leaning towards a very challenging environment for a lot of companies,” he continued.

Bearish venture capital

“In venture capital, yes, you have a lot of money, but it’s going to fewer companies at higher average amounts,” explained Wessel. “It’s creating this competitive haves and have-nots type marketplace or environment. So it just makes it a lot more competitive and more challenging to raise funds.”

Instead of finding new opportunities, venture capitalists are investing more in companies they are already working with. As the BIO report found, the amount of new series A-1 investment rounds into biopharma remained flat between 2023 and 2024, while the number of U.S. companies receiving their first series A-1 tranche went from 102 to 100. This is in comparison to 181 in 2021, reflecting the COVID influx to emerging biotechs.

Comparatively, as the BIO report found, the average amount for A-1 transactions in the U.S. saw a remarkable increase of 700% in the last 15 years, with the average amount raised sitting at $60 million in 2024. The rest of the world stayed relatively steady in comparison to the U.S.’s persistent growth.

And with the more bearish tendencies of investors, Wessel and team observed an interesting trend.

“2024 was the first year that clinical programs actually raised more venture dollars than pre-clinical, which hasn’t happened in a while,” said Wessel. “I think the last time that happened was in 2018. This ties into some of the information that we’ve heard anecdotally, which is that a lot of VC firms are focusing on the companies that they currently have in their portfolio, rather than adding new companies.”

Licensing and deals dip

It is not too surprising, then, that as investors shore up what they already have in the pipelines, the R&D pipeline and licensing have slowed somewhat.

As the BIO report observed, long-term growth in the R&D pipeline continues with an overall growth of 145% since 2010. Yet, the 2024 expansion rate (4.6%) subsided slightly, trailing the 5-year average of 6.7%.

“The growth has slowed on new programs, and more of those programs are being licensed with larger companies,” explained Wessel. “There are fewer options for big companies to backfill their pipeline with products because a lot of them are already out.”

The data also shows a notable slowing of the R&D typically done by large biopharma companies.

“The areas that are not licensed out as much are the ones with some of the higher patient populations and subsequently the ones that are not being run by small companies,” said Wessel. “These are areas like endocrine and cardiovascular diseases, which are areas where there are a lot of things like type 2 diabetes, psoriasis , high blood pressure, etc. Those all have a lot of burden on the healthcare sector or the patient population, and those aren’t really being worked on that much by smaller companies.”

Comparatively – and also not surprisingly – oncology has stayed at the top of the clinical pipeline, along with neurology and infectious disease.

“Same thing with licensing,” said Wessel. “While there are deals that are still happening, the upfront amount is lower currently than it has been in years past, and most of the value is tied up into milestone payments, which may or may not happen.”

This is also being felt when it comes to new companies going public, which has been an oft-discussed challenge in the biotech industry for the last few years.

“The IPO market has still been challenging,” Wessel says. “We went from having 40 companies a year going public, down to 15 in 2023, and now we’re back up in 2025, but it’s still down from the pre-COVID era timeframe.”

Biopharma layoffs

Another notable characteristic of this year’s biopharma landscape has been uptick in layoffs.

“Sometimes it’s just the nature of the economy. But the amount that we’ve seen in the last few years is quite a bit higher,” said Wessel. “To counter that, we don’t really have a way of measuring job creation, but we do know it’s happening. We just are unable to put a value on that.”

The BIO report found that layoff announcements ticked up to 65 during Q1 of 2025. While two points lower than Q1 of the previous year, this still marks a jump from 2024’s Q2, Q3, and Q4, which saw the number of layoff announcements at 41, 54, and 46, respectively.

All in all, Wessel noted, the biotech industry is still in a bit of a holding period when it comes to trying to navigate the coming months.

“It’s too early to be able to say much about the coming years for the industry based on these numbers,” he said. “It takes a little time for reality to kind of catch up for multiple reasons. But what I can say is that we do know that companies are reducing their pipelines. We do know that companies are laying off individuals. We do know that companies are having a challenge of raising funds and continue doing their best to try to maintain operations as long as they can until they can get funds.”

“We know the challenge is out there, but we’re going to have to kind of wait and see a little bit on the data side of things to understand how everything is going to catch up going forward.”

Source: https://bio.news/bioeconomy/bio-2025-state-of-emerging-biotechs-report-market-trends/?mkt_tok=NDkwLUVIWi05OTkAAAGb7m5php-rTOf0a_GTaj5pj7Zl-HlpVM25WtyVvCYudM82a9GKjoazUg9sqU66hlAbhqbEuYvcX3C4EqfBG7Q

New 2025 Data Sheds Light on 340B Activity in Georgia

Sat, 26 Jul 2025 17:35:59 GMT

Pioneer Institute has released updated #340B state fact sheets for 2025

The Pioneer Institute has released updated 340B State Fact Sheets for 2025, offering a detailed look into how the 340B Drug Pricing Program is operating in each state—including Georgia. The findings raise key questions about equity, oversight, and impact on low-income communities.

In Georgia:

30% of the state’s 340B contract pharmacies are located outside of Georgia , including some as far away as Hawaii.
43% of contract pharmacies intended to serve low-income Georgians are actually located in affluent neighborhoods .
Some hospitals, such as Northside Hospital and AU Medical Center, operate dozens of contract pharmacies—many out of state—while others serve patients effectively with far fewer.
PBM-owned and chain pharmacies dominate the list of top 340B contract pharmacies in Georgia.
Despite these concerns, Georgia 340B hospitals reported above-average charity care : 4.92% of operating expenses compared to the national average of 2.15%.

The data also explores:

Which hospitals have the most (and most out-of-state) contract pharmacies
How charity care levels vary between insured and uninsured patients
The correlation between hospital wealth and charitable contributions

➡️ View Georgia’s full 2025 fact sheet and explore national comparisons: https://pioneerinstitute.org/340babuse/340b-state-fact-sheets

As policymakers continue to examine the effectiveness and transparency of the 340B program, this report highlights the importance of tracking how resources intended for underserved populations are actually being deployed.

GLS is proud to announce a new partnership with Apprenti

admin@gabio.org (Georgia Bio Admin) — Thu, 24 Jul 2025 18:07:36 GMT

GLS is proud to announce a new partnership with Apprenti

This is a key step toward expanding Registered Apprenticeship programs across Georgia’s thriving life sciences sector.

July 24, 2025

ATLANTA – GLS is proud to announce a new partnership with Apprenti — a key step toward expanding Registered Apprenticeship programs across Georgia’s thriving life sciences sector.

“Our partnership with Georgia Life Sciences represents a critical step toward expanding Registered Apprenticeship programs across Georgia’s growing life sciences sector. By aligning Apprenti’s proven model with Georgia Life Sciences’ commitment to advancing the industry, we’re creating new, demand-driven pathways to build a skilled workforce that meets the needs of today’s life science industry and prepares them for tomorrow’s innovations.” - Jennifer Carlson, CEO & Co-Founder

Join us at the Apprenti National Apprenticeship & Workforce Summit , August 20-22 in Atlanta. GLS CEO, Maria Thacker Goethe, will lead a powerhouse conversation on the future of talent in the life sciences. From biomanufacturing to lab support, she will highlight how using registered apprentices to solve the mid-skill talent crunch is critical for the industry. Register today .

About Georgia Life Sciences

Georgia Life Sciences is the statewide association advancing the life sciences ecosystem through policy advocacy, economic development, workforce initiatives, and industry-led innovation. From breakthrough biomanufacturing to patient access, GLS is committed to making Georgia a leader in global health and biotechnology.

COMMUNITY NEWS CBO Analysis Shows Significant Impact of NIH Funding Cuts and FDA Delays on Drug Development

mthacker@gabio.org (Maria Thacker Goethe) — Tue, 22 Jul 2025 22:24:56 GMT

What It Means for Georgia

A new report released July 18, 2025, by the Congressional Budget Office (CBO) provides the first quantitative look at how changes to federal research funding and regulatory timelines could impact pharmaceutical innovation in the U.S.

Key Findings

The report models two policy scenarios: a permanent 10% cut to NIH's external preclinical research funding and a nine-month extension of FDA review timelines for new drug applications.

NIH Funding Cuts

A 10% permanent cut to NIH-funded preclinical research would lead to:

~2 fewer new drugs entering the market each year
1 fewer drug in the first decade
9 fewer drugs in the second decade
20 fewer drugs per decade by the third decade and beyond

FDA Review Delays

A 9-month increase in FDA review times would result in:
3 fewer drugs in the first decade
10 fewer drugs per decade in the second and third decades
A 2% overall annual reduction in drug approvals

Implications for Georgia’s Life Sciences Ecosystem

Research Impact:
Georgia institutions such as Emory University, Georgia Tech, Augusta University, and Morehouse School of Medicine rely on NIH funding to drive foundational biomedical research. A permanent NIH funding cut could weaken the early-stage research pipeline and limit opportunities for academic-commercial partnerships.

Biotech Vulnerability:
Extended FDA review times pose a serious challenge for Georgia’s small and emerging biotech companies—particularly those operating in Augusta, Atlanta, and Athens—with limited capital to absorb regulatory delays. This may force earlier exits, reduce investor confidence, or deter innovation altogether.

Economic Risk:
Georgia’s position as a growing life sciences hub could be jeopardized. States with stronger public-private investment ecosystems may be better positioned to weather these changes—intensifying regional competition for jobs, talent, and investment.

Industry Perspective

"Without the foundational support of NIH-funded research, Georgia’s innovation engine would stall. Our universities, startups, and investors all rely on a robust federal research ecosystem to drive discoveries from bench to bedside," said Maria Thacker Goethe, President & CEO of Georgia Life Sciences. "This report confirms what many of us already feared—policy decisions made in Washington have ripple effects that directly impact patients, jobs, and innovation here in Georgia."

Looking Ahead

The CBO report makes it clear: NIH funding and FDA efficiency are not abstract policy issues—they shape the future of health innovation in Georgia. As federal budget debates unfold, Georgia Life Sciences remains committed to advocating for sustained investments in research and a regulatory environment that supports timely, equitable access to new therapies.

Read the full CBO report: https://www.cbo.gov/publication/61373

Healthcare and Life Sciences Brace for Policy Impact

mthacker@gabio.org (Maria Thacker Goethe) — Tue, 22 Jul 2025 22:18:57 GMT

60% of industry leaders expect tariffs and pricing policies to affect business operations

60% of industry leaders expect tariffs and pricing policies to affect business operations

A new Deloitte survey reveals that the healthcare and life sciences sectors are preparing for significant disruption from evolving trade and pricing policies. The study, conducted in late June 2025 with 120 global executives, found that three in five industry leaders anticipate at least "some impact" from current and anticipated regulatory changes.

Strategic Planning vs. Operational Readiness

While companies are actively engaging in scenario planning, a gap appears to exist between strategic preparation and operational execution:

73% of US-based firms have implemented scenario-planning strategies
64% have taken steps to secure supply chains against global disruptions
Only 10% have altered organizational structures

The survey suggests most organizations remain in planning mode rather than implementing transformative operational changes.

Key Industry Responses

Life sciences companies are adapting their business models in several ways:

R&D Investment: Despite policy uncertainty, 60% of companies are maintaining current research and development funding levels while adjusting strategies around clinical trial locations and supply sourcing.

Manufacturing Shifts: 17% of respondents plan to relocate manufacturing to the US, with 62% expecting new facilities to be operational within five years.

Service Evaluation: Half of surveyed companies are reassessing how policy changes might affect services including digital health offerings and patient support programs.

The "Quantum Corporation" Approach

Deloitte researchers advocate for what they term "quantum corporation" strategies—organizations that operate in parallel states of readiness and build infrastructure for multiple potential outcomes simultaneously. This hyper-adaptive approach emphasizes continuous learning and real-time operational adjustments over traditional contingency planning.

The survey was conducted prior to the enactment of the One Big Beautiful Bill Act (OBBBA), signed into law on July 4, 2025, suggesting additional impacts may emerge as companies respond to the new legislation.

The full Deloitte report emphasizes that organizations combining strategic foresight with operational agility will be best positioned to navigate the evolving regulatory landscape.

Source: https://www.deloitte.com/us/en/Industries/life-sciences-health-care/blogs/health-care/sixty-percent-life-sciences-health-care-firms-expect-impact-from-tariffs-policy.html

Georgia Life Sciences Partners with U.S. Chamber Foundation to Bring Real-World Innovation to Georgia Classrooms

mthacker@gabio.org (Maria Thacker Goethe) — Mon, 07 Jul 2025 20:12:12 GMT

Georgia Life Sciences Partners with U.S. Chamber Foundation to Bring Real-World Innovation to Georgia Classrooms

60 + high school students tackle real industry challenges through national EPIC program

July 7, 2025

ATLANTA – Georgia Life Sciences (GLS) has successfully completed its first collaboration with the U.S. Chamber of Commerce Foundation’s Employer Provided Innovation Challenges (EPIC) program, bringing hands-on, real-world learning into Georgia classrooms and spotlighting the state’s growing leadership in workforce innovation.

Through this groundbreaking initiative, GLS developed and piloted three challenge-based projects designed to spark student interest in the life sciences:

Navigating Medical Device Regulatory Pathways
Innovative Solutions in Food Production
Automated Biomanufacturing

Over 60 high school students across the state formed 12 teams to tackle these challenges, working directly with industry volunteer mentors to co-design creative solutions. All participants earned credentials for their work, demonstrating not only career awareness but real-world readiness for Georgia’s growing bioscience sector.

One standout team—composed of homeschool students from the Georgia Black Home Educators Network (GBHEN), sponsored by Blue Heron Urban Farm and Sanctuary—was selected to present at the EPIC National Convening on June 24 in Washington, D.C., hosted at the U.S. Chamber of Commerce. The team shared their innovations in sustainable food production, highlighting the role of student ingenuity in solving global challenges.

“This program gave students a window into the real world of biotech, medical devices, and agtech,” said Dr. Phil Gibson, Executive Director for the Georgia Life Sciences Institute. “It also gave our industry partners a powerful new way to engage with the future workforce—and even shape it.”

EPIC, launched by the U.S. Chamber Foundation, is redefining the connection between business innovation and workforce development by giving students access to real problems, real collaboration, and real career exposure.

This effort is part of Georgia Life Sciences’ broader mission to build a sustainable talent pipeline in the life sciences—from classroom to career. Through initiatives like this partnership with the Us Chamber Foundation and the public/private partnership with Georgia’s Department of Education, the Biotech Teacher Training Initiative (BTTI) , GLS provides immersive, standards-aligned professional development for Georgia educators to bring modern biotech concepts and techniques into biology, chemistry, agriculture, and environmental science classrooms statewide.

Why It Matters

As Georgia’s life sciences industry continues to grow, workforce demand is outpacing supply. Programs like EPIC play a vital role in bridging that gap by increasing industry awareness early in the pipeline. Building student familiarity with bioscience careers—and connecting them with real industry mentors—is essential to strengthening Georgia’s long-term competitiveness in biotechnology, biomanufacturing, and global health innovation.

About Georgia Life Sciences

Georgia RDAC Publishes Its 2024-2025 Annual Report: Building Momentum for Georgia’s Rare Disease Community

mthacker@gabio.org (Maria Thacker Goethe) — Sat, 05 Jul 2025 02:32:40 GMT

Georgia’s Rare Disease Advisory Council (RDAC) has released its inaugural Annual Report, covering activities from April 2024 through June 2025. Established by law on May 6, 2022, and fully seated in early 2024, the Council’s mission is to ensure every Georgian living with a rare disease has timely diagnosis, coordinated care, evidence-based resources, and access to effective treatments.

Key Highlights

Operational Launch & Governance
First official meeting in April 2024; Council now meets monthly and is guided by adopted bylaws, a mission statement, and three strategic goals.
Diverse 2025 membership of clinicians, patient advocates, researchers, industry, and state-agency representatives brings cross-sector expertise to the table.
Strategic Goals & Early Wins

Policy Resource: Engaged state legislators and multiple agencies, delivered testimony, and supplied technical feedback on rare-disease legislation during the 2025 session.
Empower the Rare Community: Drafted Georgia’s first Quality of Life Needs Assessment Survey (to launch in 2026) and attended community events such as Rare Wish and NORD’s conferences to elevate patient voices.
Support the Medical Community: Provided guest lectures at Emory Medical School, the GA Bio Patient Engagement Summit, and other venues to raise clinical awareness of rare diseases.

Outreach & Education
Hosted nationally recognized speakers from NORD, PhRMA, and academic researchers to share best practices and policy insights with Council members.
Launched a new RDAC website, improving public access to resources and Council updates.
Metrics at a Glance
10 direct support requests from rare-disease patients or groups answered.
3 patient testimonials shared with policymakers.
2 community events attended and 3 listening-style presentations delivered.
2 bills supported or shaped through Council engagement.

Looking Ahead to 2026

The Council will broaden its impact by hosting statewide listening sessions, finalizing and deploying the Quality of Life Survey, expanding collaborations with healthcare providers, and solidifying its role as a trusted policy resource for Georgia’s General Assembly.

“United, we will help our rare community thrive for years to come.” — Beth Nguyen, RN, RDAC Chairperson

Read the full 2024-2025 Annual Report HERE to see detailed accomplishments, financials, and the complete roadmap for advancing rare-disease care and research in Georgia.

Study Finds Trump’s Most Favored Nation Drug Proposal Could Still Raise Out-of-Pocket Costs Without PBM Reform

Fri, 27 Jun 2025 18:19:37 GMT

Study Finds Trump’s Most Favored Nation Drug Proposal Could Still Raise Out-of-Pocket Costs Without PBM Reform

Editorial Staff : June 25, 2025

Study Finds Trump’s Most Favored Nation Drug Proposal Could Still Raise Out-of-Pocket Costs Without PBM Reform - Pioneer Institute

BOSTON — Out-of-pocket drug costs for seniors may rise under President Trump’s Most Favored Nation (MFN) proposal if policymakers do not address the role of pharmacy benefit managers (PBMs), according to a brief released today by Pioneer Institute.

The MFN proposal aims to link U.S. drug prices to the lowest prices in developed countries. However, if rebate contracting remains in place, lower drug prices could still translate into higher out-of-pocket costs for seniors, who may be forced to skip medications to avoid the financial burden.

“We can say with confidence that pharmacy benefit managers are profiting substantially from rebates, fees, and concessions tied to popular medications commonly prescribed to seniors,” said Dr. Bill Smith, co-author of the brief with Dr. Robert Popovian . “These rebate payments can reach into the billions each year, creating strong incentives for PBMs to maintain the current system, even though many seniors on Medicare cannot afford the rising out-of-pocket costs. Policymakers must address this imbalance and ensure drug pricing works for patients, not just middlemen.”

Under the current U.S. pharmaceutical market, PBMs negotiate deals with drug manufacturers promising better coverage in exchange for rebates, various concessions, and fees. To fulfill these contracts, PBMs may increase patients’ out-of-pocket costs or impose extra paperwork to steer patients toward certain drugs. While generous rebates can sometimes reduce costs and administrative burdens, the system also incentivizes PBMs to favor higher-priced drugs that offer larger rebates, resulting in higher overall patient costs.

This rebate system is largely unregulated and operates behind the scenes. PBMs argue rebates help lower overall drug costs and keep insurance premiums down. However, the lack of transparency creates incentives that don’t always benefit patients.

Smith and Popovian’s brief hypothesizes that under the Inflation Reduction Act (IRA), PBMs faced lost revenue due to federal price controls, leading them to shift costs to patients. According to Pioneer Institute’s IRA Tool, out-of-pocket costs rose by 32 percent on average for nine commonly prescribed drugs, with seven seeing significant increases.

“Simply put, for the drugs with prices lowered by federal controls, seniors ended up paying more out-of-pocket,” said Dr. Popovian . “If drug prices fall under the President’s new policy but the flawed rebate system remains, patients will still struggle to afford their medications, and well-intentioned policies will backfire.”

This warning follows last month’s launch by Pioneer, a public tool to monitor the real impact of federal drug price controls under the IRA. The Medicare Drug Access Tracker focuses on Medicare patients served by the four largest PBMs, which cover 87 percent of the market, tracking whether price controls improve affordability over time.

Pioneer’s initial analysis found out-of-pocket costs increased for seven of nine drugs studied. Key findings include an average cost increase from $74.51 to $98.42 and individual drug cost hikes ranging from $10.56 to $316.81.

The public can access the tool at https://pioneerinstitute.org/rxpricewatch/ .

###

Dr. William S. Smith is Senior Fellow & Director of Pioneer Life Sciences Initiative. Dr. Smith has 25 years of experience in government and in corporate roles. His career includes senior staff positions for the Republican House leadership on Capitol Hill, the White House Office of National Drug Control Policy, and the Massachusetts Governor’s office where he served under Governors Weld and Cellucci. He spent ten years at Pfizer Inc as Vice President of Public Affairs and Policy where he was responsible for Pfizer’s corporate strategies for the U.S. policy environment. He later served as a consultant to major pharmaceutical, biotechnology and medical device companies. Dr. Smith earned his PhD in political science with distinction at The Catholic University of America.

Dr. Robert Popovian is the Founder of the strategic consulting firm Conquest Advisors. He also serves as Chief Science Policy Officer at the Global Healthy Living Foundation, Senior Healthy Policy Fellow at the Progressive Policy Institute, and Visiting Health Policy Fellow at the Pioneer Institute. He previously served as Vice President, U.S. Government Relations at Pfizer.

One of the country’s foremost experts on every significant facet of biopharmaceuticals and the healthcare industry, he is a recognized authority on health economics, policy, government relations, medical affairs, and strategic planning. To learn more about Dr. Popovian please click here .

About Pioneer Institute

Pioneer empowers Americans with choices and opportunities to live freely and thrive. Working with state policymakers, we use expert research, educational initiatives, legal action and coalition-building to advance human potential in four critical areas: K-12 Education, Health, Economic Opportunity, and American Civic Values.

REPRESENTATIVES HOULAHAN, BICE ANNOUNCE BIOTECH CAUCUS

Thu, 26 Jun 2025 18:41:34 GMT

Bipartisan House Caucus Will Advance Domestic Bioeconomy and Competitive Posture

House.gov : June 26, 2025

REPRESENTATIVES HOULAHAN, BICE ANNOUNCE BIOTECH CAUCUS

Washington, D.C.... Today Representatives Chrissy Houlahan (D-PA) and Stephanie Bice (R-OK) announced the formation of the BIOTech Caucus. The Caucus’ mission is to advance bipartisan policy solutions to keep the United States at the forefront of global biotechnology leadership, to engage and learn from sector leaders, and to build awareness and bioliteracy among Members of Congress. Joining Co-Chairs Houlahan and Bice on the BIOTech Caucus are Vice-Chairs Representatives Ro Khanna (D-CA), Gus Bilirakis (R-FL), Jake Auchincloss (D-MA) and Pete Sessions (R-TX).

The Caucus recognizes the strategic economic and national security imperatives of federal policy investments in emerging biotechnology. The Caucus’ founding comes after the release of the National Security Commission on Emerging Biotechnology (NSCEB)’s comprehensive report to Congress in April of this year. The NSCEB report showed that China is surging ahead in key areas of emerging biotechnology, and Congress must act now to ensure the United States regains and retains its competitive edge. Failure to respond urgently to this and other national vulnerabilities risks the United States falling dangerously, and potentially irrecoverably, behind. Ceding biotechnology leadership will also cripple the robust industry job growth in America. On a national scale, the bioscience industry had a $2.9 trillion impact on the economy in 2021, supporting 2.1 million jobs.

The BIOTech Caucus will collaborate to advance, support and champion legislation to bolster the domestic bioeconomy, with three primary areas of focus:

1. Ensuring domestic bio-security

2. Driving bio-innovation

3. Unlocking bio-opportunity, in particular job growth, across the country

“I believe strongly that the United States must lead the world, with its democratic values, in shaping the future of emerging biotechnology that will fundamentally change our lives across health care, agriculture, manufacturing, and more,” said Representative Houlahan . “I’m thrilled to be working again with Representative Bice and our vice-chairs to tackle a major national issue like we’ve done with paid family leave, and I am committed to working across the aisle to see our biotechnology recommendations come to fruition.”

“Serving as a commissioner on the National Security Commission on Emerging Biotechnology has heighted my awareness of the capabilities and threats from our near-peer adversaries,” said Representative Bice . “The BIOTech Caucus will work to ensure that America remains a leader in biotechnology. We must champion policies that unleash innovation and grow this critical sector.”

“Investments in biotechnology will pave America’s path toward economic and scientific leadership in the 21st-century economy. The BIOTech Caucus will be critical to fostering innovation, biosecurity, and success in industries of the future," said Representative Ro Khanna .

“America’s leadership in biotechnology is critical to our national security, economic strength and public health. The BIOTech Caucus will ensure that Congress remains informed, engaged, and proactive in supporting innovation, advancing responsible policy, and maintaining our global edge in this vital sector,” said Congressman Gus Bilirakis.

“There are a lot of bad ideas about biotech in Washington right now. Congress must promote good ones: expand funding for basic research; protect intellectual property; set high and clear standards; lower co-pays; and take out the middlemen,” said Representative Jake Auchincloss.

Congressman Sessions said, “I am looking forward working to fostering bipartisan collaboration on the BIOTech Caucus to support cutting-edge research and strengthen America’s competitive edge on the global stage. It is our job in Congress to create an environment where the biotechnology sector can thrive, advancing life-saving breakthroughs, generating high-quality jobs, and fueling economic growth. By embracing pro-innovation policies and supporting the entrepreneurial spirit that defines American capitalism, we can secure our future and reinforce the United States as the world leader in innovation."

“Emerging biotechnology is at an inflection point, and the creation of the BIOTech Caucus is a vital and welcome step towards making this impactful technology a national priority,” said NSCEB Vice Chair Michelle Rozo. “I applaud the co-chairs for their thoughtful, bipartisan leadership and look forward to collaborating with them as we work together to implement the NSCEB’s recommendations and strengthen our national and economic security.”

Kelly Seagraves, Vice President of National Security and International Affairs at BIO said, “Biotechnology means hope and health for people and patients around the world, but it also means jobs, economic growth, and national security for Americans. The bipartisan BIOTech Caucus will play a pivotal role in creating the policy and regulatory environment needed to leverage our scientific ingenuity and innovative spirit to advance U.S. leadership in biotechnology. We look forward to working closely with the BIOTech Caucus and its members to address these vital issues."

“EBRC applauds the Chairs of the Congressional BIOTech Caucus for their leadership in launching this important bipartisan effort. Biotechnology holds immense potential to strengthen national security, drive innovation in all sectors, and create economic opportunity across America,” said India Hook-Barnard, Chief Executive Officer, Engineering Biology Research Consortium. “The recent NSCEB report has underscored the urgency of sustained congressional action to ensure U.S. leadership in emerging biotechnology, and we believe the BIOTech Caucus will play a critical role in advancing that goal. EBRC looks forward to working towards supporting this mission alongside our peer organizations.

“Today's launch marks an important milestone in American efforts to lead the world in biomanufacturing,” said Brooke Coleman, Executive Director of the newly formed American Alliance for Biomanufacturing. “U.S. biomanufacturers are delivering a new generation of bio-based products spanning industries as diverse as energy, defense, agriculture, chemicals, ingredients, sweeteners, materials, fabrics, and nutrition, but we need smart policy to stay ahead of the competition. We look forward to working with the BIOTech Caucus to turbo-charge resilience and growth across America's bioeconomy."

Below is the BIOTech Caucus Framework:

Mission:

The House bipartisan Congressional BIOTech Caucus is founded and chaired by Representatives Chrissy Houlahan (D-PA) and Stephanie Bice (R-OK) and Vice Chairs Ro Khanna (D-CA), Gus Bilirakis (R-FL), Jake Auchincloss (D-MA) and Pete Sessions (R-TX). The Caucus’ mission is to advance bipartisan policy solutions to keep the United States at the forefront of global biotechnology leadership, to engage and learn from sector leaders, and to build awareness and bioliteracy among Members of Congress.

Goals:

Advance, support, and champion legislation to bolster U.S. biotechnology leadership and strengthen the domestic bioeconomy
Convene regular meetings to strategize efforts and learn from key officials and industry leaders
Hold public events in coordination with experts and stakeholders with the goal of building bioliteracy across the U.S. Capitol and calling attention to the urgency of action

BIOTech Caucus Focus Areas:

Biosecurity: Federal investments in emerging biotechnology are critical for U.S. national security. We cannot afford to fall behind as Beijing makes strides towards controlling global bio-supply chains and enhancing Chinese military capabilities. Congress must ensure the U.S. leads the world in the development of biotechnologies with our democratic values, supports U.S. military defense applications in biotechnology, and makes advancements to keep Americans safe from bio-threats.

Innovation : The U.S. government can play a key role in incentivizing bio-entrepreneurship and leveraging our leading capital markets. However, too often, the complicated federal bureaucracy can stand in the way of progress. Congress must advance smart policies to elevate bio-innovation among agencies, streamline regulations, and foster a supportive business ecosystem.

Opportunity: There is no question that domestic biomanufacturing will lead to job creation across the country. Biotechnology also stands to solve some of our greatest global challenges, like cancer, food insecurity, environmental protection, and more. Congress has a responsibility to help develop and support the bio-workforce of the future, invest across sectors, and encourage a competitive, robust, and growing domestic bioeconomy.

Read full Commission Report here .

--end--

Houlahan is an Air Force veteran, engineer, entrepreneur, educator, and nonprofit leader. She is serving her fourth consecutive term representing the people of Pennsylvania’s 6th Congressional District, which encompasses Chester County and southern Berks County. Houlahan is the first female veteran to be named as Ranking Member of the House Armed Services Committee’s Military Personnel Subcommittee and a member of the House Permanent Select Committee on Intelligence. Houlahan is also chair of the Economic Growth and Cost of Living Task Force on the New Democrat Coalition.

New Report Reveals National Trends Reshaping the Life Sciences Workforce

Tue, 24 Jun 2025 16:00:57 GMT

The Life Sciences Workforce Collaborative (LSWC) has released the 2025 Life Sciences Workforce Trends Report—offering one of the most comprehensive pictures to date of the hiring, training, and talent dynamics shaping the future of the industry.

Developed in partnership with TEConomy Partners, LLC , and supported by InnovATEBIO , this seventh edition of the biennial report is based on a rich set of national data:

● Survey responses from over 500 life sciences companies across 30 states and Puerto Rico

● Executive interviews with more than 200 industry leaders

● Analysis of 2.9 million unique job postings from the past four years

Together, these inputs paint a nuanced picture of a sector in transition—where innovation is thriving, but economic pressures and rapid technological change are forcing organizations to rethink their workforce strategies.

Slower Growth, But Not a Slowdown in Strategy

The report finds that after several years of rapid post-pandemic hiring, the U.S. life sciences industry experienced a modest employment contraction of 0.3% in 2024. Hiring has become more strategic, and companies are shifting focus from volume to value—investing in automation, workforce upskilling, and future-forward technologies.

Despite the hiring slowdown, long-term growth indicators are strong: more than $200 billion in U.S. life sciences manufacturing and R&D investments have been announced by major companies including Johnson & Johnson, Eli Lilly, Merck, Regeneron, and others. These expansions point to sustained demand for a skilled, resilient, and adaptable workforce.

AI, Automation, and the Rise of Hybrid Talent

One of the clearest trends in the report is the growing integration of AI, machine learning, and industrial automation across R&D, regulatory, and manufacturing operations. Larger companies are leading adoption, but small and mid-sized firms are quickly following.

As these technologies become embedded in daily workflows, employers are seeking “bilingual” workers—those with both technical life sciences expertise and digital fluency. From AI-powered regulatory documentation to predictive maintenance in biomanufacturing, tomorrow’s workforce must be prepared to operate at the intersection of science and software.

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Upskilling, Not Just Hiring

With lower turnover and cautious new hiring, many life sciences companies are turning inward—investing more heavily in their existing workforce. Employers report increasing reliance on internal training, microcredentialing, and competency-based assessments, particularly for technical production roles, quality assurance, and regulatory functions.

Performance-based credentialing programs, like those offered by the Bioscience Core Skills Institute (BCSI), are helping bridge gaps between traditional education and job-readiness—especially for entry-level and mid-career talent.

STEM Engagement Surging Nationwide

The report also highlights a remarkable rise in employer involvement in STEM education. Compared to two years ago, more than twice as many companies report engaging with K–12 students through classroom visits, mentorship programs, science fairs, and summer camps.

At the postsecondary level, internships, co-op programs, and apprenticeships are helping to build direct pathways into the workforce. Nearly 80% of companies surveyed are actively offering internships to students from four-year institutions, and nearly two-thirds to community college students.

This surge in engagement reflects a broader industry focus on ensuring a future-ready talent pipeline—starting early and growing local.

Why This Report Matters

For employers, educators, and policymakers, the 2025 Life Sciences Workforce Trends Report is more than a snapshot—it’s a strategic tool. With workforce challenges affecting everything from drug development to supply chain resilience, coordinated, data-informed action is more urgent than ever.

“This report illustrates a new era in workforce dynamics—where slower overall growth is paired with opportunity in key areas, growing emphasis on upskilling, and a shift toward technology-integrated roles,” said Liisa Bozinovic, Executive Director of Oregon Bio and Chair of LSWC.

“At BIO, we are proud to support these efforts and to champion policies that strengthen our industry’s talent pipeline, from the classroom to the lab and beyond,” added John Crowley, President & CEO of the Biotechnology Innovation Organization (BIO).

“As noted by the National Security Commission on Emerging Biotechnology, keeping pace with the rapidly evolving skills and talent needs of the biotechnology sector is essential to U.S. leadership in this industry,” said Linnea Fletcher, Principal Investigator at InnovATEBIO. “Our national network of advanced technical education programs is working nimbly to build the next generation of biotech talent—one that is diverse, industry-aligned, and ready to power the biotechnology revolution.”

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Access the Full Report

The full 2025 Life Sciences Workforce Trends Report is now available to download: https://www.lifesciencesworkforce.org/national-workforce-trends

To learn more about the Life Sciences Workforce Collaborative and how your organization can engage, visit: www.LifeSciencesWorkforce.org

Follow LSWC on social media for highlights and updates:

�� Twitter/X: X: @LifeSciWork

�� LinkedIn: Life Sciences Workforce Collaborative

�� Instagram: @lifesciworkforce

�� YouTube: @lifesciworkforce

Announcing the Launch of the Life Sciences Workforce Collaborative — and a Preview of What’s Ahead

Tue, 17 Jun 2025 17:01:30 GMT

This week marks an important milestone for workforce development in the U.S. life sciences sector: the official launch of the Life Sciences Workforce Collaborative (LSWC) . Formerly known as the Coalition of State Bioscience Institutes (CSBI) , LSWC premiered at the 2025 BIO International Convention as a new national nonprofit—building on over a decade of state and regional leadership to expand industry-aligned solutions for talent development.

As the life sciences industry confronts evolving technologies, shifting economic headwinds, and persistent workforce challenges - including specialized talent needs, unmet demand for skilled biomanufacturers, positioning for future growth —LSWC offers a unified platform to scale solutions, support workforce readiness, and strengthen public-private partnerships across the country.

Just out of the gate, the new organization is pleased to announce a major insight-driven release later this month: the upcoming 2025 National Life Sciences Workforce Trends

Report , produced in partnership with TEConomy Partners and the NSF-funded InnovATEBIO National Biotech Education Center . Comprised of data from over 700 life science companies and 2.9 million job postings, the report will go live on June 24, 2025.

Why This Matters

The newly launched LSWC builds on more than a decade of trusted collaboration among 50+ state, regional and national life science organizations and workforce partners. Its mission: to align, advise, and accelerate talent development efforts across the entire life sciences talent pipeline—from middle school to mid-career--to build a competitive life sciences workforce.

Next week, the LSWC will launch the 2025 National Workforce Trends Report, the organization’s flagship effort. Now in its seventh edition, this biennial report draws on:

Responses from over 500 companies across 30 states and Puerto Rico
Interviews with over 200 life science executives
Analysis of 2.9 million unique job postings across the U.S. from the last four years

The report is the definitive source for understanding the real-world trends shaping hiring, upskilling, and STEM education engagement across the life sciences ecosystem. More to come next week.

What Comes Next

In the weeks ahead, we’ll be working with our partners to roll out media toolkits, schedule events, and activate coordinated campaigns to bring visibility to both the LSWC launch and the report.

We are deeply grateful to our investor-level supporters—AZBio/AZ Advances, BioNJ, BioUtah, California Life Sciences, Georgia Life Sciences/Institute, Colorado Bioscience Association/Institute, MichBio, NewYorkBIO/Institute, Ohio Life Sciences, Oregon Bioscience Association, SCbio, and Southern California Biomedical Council (SoCalBio)—LSWC partners and connectors, and to every organization that has shaped this initiative from the ground up.

Together, we are building a stronger, competitive, and future-ready workforce—one that ensures the U.S. remains the global leader in biotechnology, biomanufacturing, and life sciences innovation.

Stay tuned and learn how you can partner with us to advance the life sciences workforce.

Learn more at: www.LifeSciencesWorkforce.org
For media inquiries: connect@lifesciencesworkforce.org

Georgia Life Sciences Accepted into ARPA‑H Customer Experience Hub

Mon, 16 Jun 2025 14:04:24 GMT

GLS has been named a new Spoke Member of the ARPA‑H Customer Experience Hub—ARPA‑H’s patient‑centric network dedicated to embedding real-world user insights and representation into health innovation. As part of the nationwide ARPANET‑H hub‑and‑spoke initiative (with hubs in Dallas, Boston, and D.C.), Georgia Life Sciences will help prioritize inclusive design, usability testing, and equitable trial participation in next-gen therapies.

BIO Statement on HHS Dismissal of CDC Advisory Committee Members

SBrown@galifesciences.org (Sheran Brown) — Tue, 10 Jun 2025 17:46:04 GMT

June 9, 2025

WASHINGTON, D.C. - John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement regarding today’s dismissal of the voting members of the CDC Advisory Committee on Immunization Practices: 

“The Advisory Committee on Immunization Practices (ACIP) is vital to ensuring scientific rigor and third-party experts inform decisions about the safe and effective use of vaccines in the US. Under the law, ACIP also plays a critical role determining how the American people access immunizations.

We are greatly concerned about the uncertainty created by the abrupt dismissal of the serving committee members and the loss of years of experience, especially less than three weeks before the next ACIP meeting, with consequential votes on recommendations that will affect Americans’ access to RSV, flu, HPV and other important vaccines.

While the advisors serve on the ACIP at the selection and appointment by the Secretary, the removal of committee members will cause significant disruption in this critical process. Immunization reviews take place through working groups over many months, culminating with discussion during a public meeting. A wholesale change of this manner will negatively affect the Committee’s ability to deliberate and make well-informed recommendations, putting American lives at risk.

We agree that transparency is key to restoring trust in immunizations; however, the actions taken today upend a time-tested system that has protected American public health.”

###

Lawmakers Question Kennedy on Vaccines, Biosecurity, and NIH Cuts

mthacker@gabio.org (Maria Thacker Goethe) — Thu, 29 May 2025 13:53:47 GMT

Lawmakers questioned Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. on key issues like vaccines, biosecurity, and federal research funds in a week of congressional hearings about the HHS budget for 2026.

Kennedy was the sole witness at a May 20 hearing of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies , and two May 14 hearings—before the Senate Health Education, Labor and Pensions (HELP) Committee and the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies .

Kennedy found himself on defense over his positions on vaccines and cuts to National Institutes of Health (NIH) funding. On the subject of China and biosecurity, he urged reshoring of manufacturing, noting Eli Lilly’s efforts in this area.

Vaccines and measles

Many questions on vaccines focused on concerns that Kennedy has not done enough to encourage vaccination in the face of ongoing measles outbreaks.

During the House Appropriations hearing, Kennedy responded to a question from Rep. Mark Pocan (D-WI) about his confidence in measles vaccines, saying he would “probably” choose to vaccinate his children against measles again.

“I don’t think people should be taking medical advice from me,” Kennedy added, saying they should get this advice from NIH Director Dr. Jay Bhattacharya.

At the Senate HELP hearing, Democrats raised alarm over Kennedy’s stance on measles vaccines, arguing his statements eroded public trust and contradicted his confirmation hearing testimony.

Ranking Member Bernie Sanders (I-VT) alleged that Kennedy undermined confidence in vaccines during a major measles outbreak. Sen. Maggie Hassan (D-NH) raised similar concerns. Sen. Chris Murphy (D-CT) said Kennedy’s hesitance to unequivocally endorse measles vaccines is “really dangerous for the American public and for families.”

A few days later in the Senate Appropriations subcommittee hearing, Kennedy gave a direct endorsement for the measles, mumps, and rubella (MMR) vaccine.

“The best way to prevent the spread of measles is through vaccination. We urge people to get their MMR vaccines,” he said.

But he added that he understood why some are hesitant.

“There are groups in this country that don’t want to get vaccinated, many of them for religious reasons. I spend a lot of time with the Mennonites. The MMR vaccine has millions of fragments of human DNA in it from aborted fetal tissues and that’s a religious objection for them that I have to respect,” Kennedy said.

As experts have noted, there is no human DNA in MMR vaccines. The attenuated viruses in the rubella component of the vaccine are produced using a cell line obtained from the lung tissue of a single fetus in the 1960s . But those regenerated cells are only used to grow the rubella viruses, and the viruses made in this manner do not contain DNA from the human cells .

Vaccines and placebo testing

Other vaccine-related questions focused on Kennedy’s views about using placebos for vaccine testing.

Under a new framework announced May 20, the Food and Drug Administration (FDA) is expected to require placebo testing for annual COVID boosters in some circumstances. During the hearings, Kennedy promoted the idea of using placebos to test vaccines. Critics of this position note the ethical problem of denying clinical trial participants protection afforded by a vaccine if they receive a placebo.

“The only vaccine that has been tested in a full-blown placebo trial against an inert placebo was the COVID vaccine,” Kennedy told the HELP Committee.

HELP Committee Chair Bill Cassidy, MD (R-LA) corrected this comment.

“The secretary made the statement that no vaccines except for COVID have been evaluated against placebo. For the record that’s not true,” Sen. Cassidy told the hearing. “The rotavirus, measles and HPV vaccines have been, and some vaccines are tested against previous versions, so just for the record, to set that straight.”

In the Senate Appropriations subcommittee hearing the following week, Kennedy was asked by Sen. Brian Schatz (D-HI) if he believed vaccines that are already approved need to be retested using placebo trials.

“I don’t think it’s ethical to go back and retest those vaccines with a placebo,” Kennedy said. “The Cochrane Collaboration in 2016 published a study that showed that the predictive capacity of placebo control trials, which are the gold standard, is actually not any better than good observational trials and retrospective trials. So we can do those kinds of studies without subjecting people to an unethical experiment.”

NSCEB and biosecurity

Kennedy was also asked to address the findings of the recently released report by the Congressional National Security Commission on Emerging Biotechnology (NSCEB) .

Created by Congress in the 2022 defense budget, the NSCEB in April released its report warning that China’s strategic spending on biotech R&D increased 400-fold in the last decade as they seek to eclipse U.S. dominance in the field. If the U.S. falls behind, it has serious implications for our national security and health, the report warned.

In the House Appropriations subcommittee , Rep. John Moolenaar (R-MI) mentioned the report and asked whether Kennedy saw overreliance on China for biotech as a threat. Kennedy responded that China is stealing U.S. IP and technology and claimed NIH has enabled this IP theft.

Kennedy said it is important to bring drug production home to the U.S. and noted drug makers are beginning to do that.

“I’ve met repeatedly with Eli Lilly, which is now building nine facilities, nine factories, in this country, including for essential medicines (and) the essential ingredients for those medicines.”

In the Senate HELP hearing later that day, Sen. Jim Banks (R-IN) asked for an update on efforts to reshore drug manufacturing from China to the U.S. Kennedy again mentioned Eli Lilly’s efforts to build production facilities in the U.S. and said movement toward reshoring has been encouraged by President Trump’s threats of tariffs on pharmaceutical companies.

Concerns about NIH funding

There was clear concern about the impact that budget cuts to the NIH would have on biomedical research and the innovation that brings us new drugs.

Lawmakers in all three hearings pushed back on Kennedy’s claims that the NIH is beset by corruption, that NIH cuts are focused on DEI programs rather than research, and that AI will enable the same number of clinical trials to continue despite cutbacks.

In the Senate HELP committee, Chair Cassidy warned that NIH budget reductions would impair capacity for crucial research on neurodegenerative diseases, hinder the development of new scientists, and undermine U.S. competitiveness with China.

Sen. Patty Murray (D-WA) detailed a constituent’s delayed stage-four cancer treatment at the NIH Clinical Center due to staff firings and demanded that Kennedy supply information on specific number of staff cuts. Kennedy acknowledged NIH staff cuts would “hurt” but called them necessary.

Sen. Susan Collins (R-ME) criticized the NIH’s proposed 15% cap on indirect research costs, calling it arbitrary, harmful to research, and likely to drive scientists abroad. She asked if Secretary Kennedy was evaluating its impact on laboratories. Kennedy said a review was underway.

Voicing a similar sentiment In the House Appropriations Committee, Ranking Member Rosa DeLauro (D-CT) said China and Europe are taking advantage of the firings of nearly 5,000 employees at NIH by recruiting American scientists.

As she opened the Senate Appropriations subcommittee hearing, Subcommittee Chair Shelley Moore Capito (R-WVA) underlined the importance of the NIH. “NIH-funded basic research is also behind many of the 600+ new cancer treatments the FDA has approved over the last 20 years,” and other important breakthroughs, Capito said.

‘I am concerned that our country is falling behind in biomedical research,” she added. “Investing in biomedical research has proven to save lives while exponentially strengthening the U.S. economy.”

Author: Tom Popper is the Managing Editor of Bio.News.

Georgia Life Sciences Designates Augusta as Newest BioReady® Community

Thu, 15 May 2025 16:42:08 GMT

Georgia Life Sciences Designates Augusta as Newest BioReady® Community

AUGUSTA, GA-May 15, 2025 – The City of Augusta has been designated a BioReady Gold Community by the state’s leading life sciences membership organization, Georgia Life Sciences. To receive this distinction, communities must meet certain criteria related to zoning practices and infrastructure capacity.

“We are proud to recognize the City of Augusta as our latest BioReady community. A hub for life sciences, boasting Augusta University's Health Sciences Campus, including the Medical College of Georgia, and companies like Manus, Augusta is known as the ‘City of Medicine,’” said Maria Thacker-Goethe, President and CEO of Georgia Life Sciences. “Through this program, we champion communities that have made a commitment to expanding access to resources and infrastructure, boosting commercialization.”

The BioReady rating system rates communities in three tiers from Bronze to Silver to Gold. Through these BioReady ratings, Georgia Life Sciences allows local municipalities to better showcase biotech-zoned science parks, streamline permitting, build a robust infrastructure, and identify biotech-friendly sites more effectively, making them a desirable choice for real estate developers and biotechnology companies seeking destinations to locate.  

For more information about this recognition, visit the BioReady Communities website at https://www.galifesciences.org/resources/bioready-communities .  

Georgia Life Sciences Membership Drive 2025

Wed, 14 May 2025 16:44:15 GMT

Strength in Science. Power in Numbers.

In a year filled with political uncertainty, one thing is clear: Georgia’s life sciences industry must speak with a united voice. From federal policy shifts to state-level regulatory changes, the decisions being made are directly impacting funding, innovation pipelines, workforce policy, and healthcare access. If we don’t shape the narrative, someone else will. That’s why now is the time to join Georgia Life Sciences .

Why Join Now?

Policy Advocacy : Amplify your voice where it matters—at the Capitol and in Congress.

Visibility & Influence: Be recognized as part of Georgia’s innovation backbone.

Networking & Growth : Tap into a thriving ecosystem of researchers, entrepreneurs, investors, and executives.

Collective Impact: The greater our numbers, the stronger our position.

The Stakes Are High

As political tides shift, science needs champions—not just in the lab, but at the table where decisions are made. Your membership isn’t just a badge—it’s a signal that science will not sit on the sidelines.

Join Today. Lead Tomorrow.

Membership applications received by June 30 qualify for a 50% discount on first year dues . Applies to new memberships only.

Nominations Now Open – 2025 Golden Helix Awards

Wed, 14 May 2025 16:29:04 GMT

Celebrate Excellence in Georgia Life Sciences

We’re excited to announce that nominations are now open for the 2025 Georgia Life Sciences Golden Helix Awards, which honor outstanding achievements and contributions within our state’s thriving life sciences community. Each year, the Golden Helix Awards recognize individuals, companies, and organizations that drive innovation, support economic development, and create a positive impact in Georgia’s life sciences ecosystem.

This year’s awardees will be celebrated during the Georgia Life Sciences Summit , taking place August 26-27. Award categories include Deal of the Year, Community Impact, Innovation, Emerging Leader of the Year, and more.

The nomination deadline is June 6 . Don’t miss your chance to spotlight the people and organizations who are shaping the future of life sciences in Georgia. Join us in celebrating leadership, innovation, and collaboration at this premier industry event.

Ensure your nominees are considered— submit your nominations before the deadline!

For questions, please contact Stacey Bowlin at sbowlin@galifesciences.org .

Georgia Life Sciences Summit Company Showcase — Applications Now Being Accepted

Wed, 14 May 2025 16:16:37 GMT

We are pleased to invite applications for company presentations at the Georgia Life Sciences Summit taking place on August 26-27 at the Sandy Springs Performing Arts Center . This is a unique opportunity for innovative life sciences companies to showcase their work to an audience of more than 300+ investors, industry leaders, researchers, and decision-makers. Presenting companies will benefit from high visibility, presentation feedback from a panel of advisors, targeted networking opportunities, and potential partnerships.

Eligibility

We welcome applications from Georgia-based companies operating in agriculture, biotechnology, pharmaceuticals, diagnostics, digital health, medical devices, and other life sciences sectors. Companies should have a validated proof-of-concept or market-ready prototype, a clear commercialization plan with milestones, and legal ownership of technology.

Presentation Details

The format includes a 3-minute presentation followed by a 2-minute Q&A. The audience will consist of investors, corporate executives, researchers, and media. The application deadline is June 30.

Apply now to secure your spot in this year’s showcase!

For questions, contact Stacey Bowlin at sbowlin@galifesciences.org .

Georgia Life Sciences Joins National Opposition to “Most Favored Nation” Drug Pricing Proposal Ahead of Potential Executive Order

mthacker@gabio.org (Maria Thacker Goethe) — Thu, 08 May 2025 20:00:10 GMT

Disclaimer: This statement was published on May 9, 2025, at 12:11 PM and is subject to change as the administration moves forward with policy decisions.

In a rapidly developing situation, the White House is poised to take executive action on prescription drug pricing that could significantly impact the biopharmaceutical industry.

Early next week, the president is expected to sign an executive order directing administration officials to pursue a "Most Favored Nation" initiative, which would tie U.S. government drug payments to lower prices paid abroad, according to sources familiar with the matter who were granted anonymity to discuss internal deliberations.

This executive order would bypass the legislative discussions previously reported in Congress, where Republicans on the House Energy and Commerce Committee had been considering similar measures as potential spending cuts. While the plan hasn't been finalized and could still change as officials work through specifics, the move signals the administration's intent to act quickly on drug pricing.

If enacted, the MFN policy could be paired with other proposed changes, such as increasing the 23.1% Medicaid base rebate. Reports suggest that manufacturers might be required to pay either the MFN price or the higher rebate—whichever yields the lowest cost for the government. This policy would create severe financial pressure on drug developers, particularly small and mid-size companies that are essential to Georgia’s thriving life sciences ecosystem.

Georgia is home to a growing network of biotech, pharmaceutical, and medical technology firms—many of which are advancing groundbreaking treatments for rare diseases, pediatric conditions, and underserved populations. These companies often operate with little commercial revenue and rely on a balanced, predictable pricing framework to continue investing in innovation.

In 2023, pharmaceutical companies provided $54 billion in Medicaid rebates nationally, helping keep drug spending to just 5.9% of total Medicaid expenditures . The current system works by ensuring broad patient access to medicine while enabling companies to reinvest in research and development. Drastic changes such as MFN pricing would upend this balance and threaten job creation and investment in states like Georgia.

Moreover, because Medicaid rebate amounts are tied to 340B discount calculations, the impact would extend far beyond Medicaid—further increasing costs in the already-burdened 340B program.

In response, Georgia Life Sciences has joined a coalition of more than 40 state bioscience associations, signing onto a letter from the Council of State Bioscience Associations (CSBA) opposing any MFN or foreign reference pricing schemes. The letter highlights the harm such policies would inflict on rare disease patients, pediatric populations, and emerging biotechnology companies.

“Rather than penalizing innovative companies that develop treatments for vulnerable patients, we should work together to ensure the U.S. maintains its strategic leadership in biopharmaceutical innovation and that American patients have access to the best treatments available.”
— CSBA Letter, May 2025

Georgia Life Sciences is actively monitoring the situation and preparing to advocate on behalf of Georgia’s life sciences community.

Opinion: Georgia's Congressional delegation can lead the way on correcting 'pill penalty'

Thu, 01 May 2025 17:53:48 GMT

Opinion: Georgia's Congressional delegation can lead the way on correcting 'pill penalty'

Maria Thacker Goethe President and CEO, Georgia Life Sciences: May 1, 2025

EPIC Act offers commonsense fix to 'pill penalty' problem

Georgia is home to a thriving life sciences sector, with groundbreaking research and innovation happening across the state. From the laboratories at Emory University to biotech firms in Atlanta and beyond, our state plays a vital role in developing the next generation of medical treatments. But a flaw in federal policy is putting that progress at risk—and unless Congress acts now, patients and businesses alike will pay the price.

The problem is known as the "pill penalty," an unintended consequence of the Inflation Reduction Act (IRA). While the IRA was designed to lower drug costs, it included a provision that discourages investment in small-molecule drugs—the pills and capsules that make up over 90% of prescriptions in the U.S. Unlike biologic drugs, which are administered via injection or infusion and have 13 years before they are subject to Medicare price controls, small-molecule medicines face price controls after just nine years. That four-year difference may seem minor, but in the high-risk world of drug development, it has a major impact.

This disparity is already reshaping the research landscape. A recent analysis by Vital Transformation found that early-stage investment in small-molecule medicines has plummeted by more than 70% since the IRA became law, with companies deprioritizing entire areas of drug development. The result? Fewer innovative treatments for conditions like cancer, heart disease, and mental illness—diseases that affect millions of Georgians.

While the White House issued an Executive Order on April 15 to address the pill penalty, a permanent fix is needed through Congressional action. The Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492) offers a commonsense fix. It levels the playing field by giving small-molecule medicines the same 13-year exemption period as biologics. This change would restore incentives for drug companies to invest in critical pill-based treatments while maintaining the IRA’s broader goals of affordability and access.

Georgia needs a leader in Congress to take up this fight―to ensure patients have access to innovative therapies and to ensure that our bioscience community continues to thrive. Our state’s Congressional delegation is perfect for the job, with a track record of protecting patients’ access to care.

Beyond its impact on patients, the EPIC Act is also critical for Georgia’s economy. According to the Georgia Department of Economic Development, the life sciences industry contributes billions to our state’s economy and supports over 75,000 high-paying jobs. This sector is growing rapidly, but continued investment depends on smart policies that encourage research and development.

The good news is that fixing this problem doesn’t require a massive overhaul—just a simple correction to ensure fairness in drug development timelines. The EPIC Act is a targeted solution that preserves the IRA’s intent while ensuring continued medical breakthroughs. Congressman Buddy Carter has a well-earned reputation as a leader in health policy and a tireless champion for patients. By stepping up on the EPIC Act, he can set the stage for the rest of Georgia’s delegation to follow his lead.

The choice is clear: we can either allow the pill penalty to stifle innovation and limit patient access to new treatments, or we can fix it and keep Georgia at the forefront of medical research. The Georgia delegation has the opportunity to lead on this critical issue, and we urge them to seize it. Georgia’s patients, researchers, and life sciences industry are counting on it.

Study Maps Economic Fallout of NIH Cuts in Georgia

mthacker@gabio.org (Maria Thacker Goethe) — Fri, 18 Apr 2025 04:50:07 GMT

The Science & Community Impacts Mapping Project (SCIMaP) shows how proposed federal funding cuts lead to reduced economic activity and job losses nationwide.

Georgia faces severe economic consequences as the Trump administration plans significant cuts to indirect funding by the National Institutes of Health (NIH). According to the Science & Community Impacts Mapping Project , Georgia stands to lose approximately $327 million in funding and 1,414 jobs, with effects rippling through communities across the state.

Georgia's projected $327 million loss is part of a broader national impact. According to the project's findings, nearly half of all U.S. counties will experience economic losses of at least $250,000, with more than 500 counties losing over $6.25 million in funding.

Ripple Effects on Innovation and Healthcare

Beyond immediate economic losses, the cuts threaten Georgia's position in biomedical innovation. The state has historically leveraged NIH funding to:

Develop groundbreaking medical treatments
Establish biotechnology startups
Train the next generation of healthcare professionals and researchers
Address critical public health challenges

The proposed cuts would affect not only our state's major research universities but also regional institutions and the communities they support throughout the state. For communities already facing economic challenges, the loss of research-related economic activity could exacerbate existing problems.

Looking Forward

The Science & Community Impacts Mapping Project provides a sobering look at what's at stake for Georgia's communities when research funding diminishes, highlighting how federal research investment creates economic value far beyond laboratory walls.

Georgia Life Sciences Selects Fulton County Schools Innovation Academy Student as the 2025 Georgia BioGENEius Winner

Thu, 10 Apr 2025 18:51:45 GMT

Georgia Life Sciences Selects Fulton County Schools Innovation Academy Student as the 2025 Georgia BioGENEius Winner

Sandy Springs & Rockmart Teens Take Top Honors in Statewide Science Competition

Atlanta, GA (April 4, 2025) – Georgia Life Sciences today named Bhavya Alapati , a junior at Fulton County Schools Innovation Academy, as the winner of the 2025 Georgia BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. Eleven students from across Georgia competed for this year’s title and cash prize.

Bhavya’s project investigated a novel method of identifying strokes using a device she created called SpectroStroke, a small-scale spectrophotometer, to detect homocysteine, an amino acid product that is associated with stroke. Bhavya identified the ability of homocysteine to be detected using Ellman’s reagent, which reacts with the free sulfhydryl group on the molecule to produce a yellow color. Bhavya created a wearable patch that contains the Ellman’s reagent. Then, she designed the SpectroStroke to be able to detect the color change when the patch is exposed to elevated levels of homocysteine. Bhavya’s SpectroStroke can detect normal levels of homocysteine up to extremely high levels seen in those experiencing a stroke. The ability to detect a stroke earlier would reduce damage and long-term effects of the condition. A future iteration of the SpectroStroke would include real-time monitoring capabilities to help track changing homocysteine levels.

"Supporting and celebrating outstanding research and innovation in biotechnology is vital for the future of science and medicine. The Georgia BioGENEius Challenge not only encourages the brightest young minds to explore their potential but also nurtures the next generation of leaders who will drive groundbreaking advancements in biotechnology,” said Georgia Life Sciences President and CEO Maria Thacker-Goethe. “By recognizing and empowering these students, we are helping to shape a future where innovation thrives and the possibilities for improving lives are endless. Well done, Bhavya!”

Georgia Life Sciences also congratulates the Georgia BioGENEius runner-up, Shelby Kendrick , who is a senior at Paulding County High School in Dallas, GA. Shelby’s research investigated the ability of Aspergillus terreus, a fungus found in soil, to degrade pre-treated polypropylene plastic (PP). This fungus has been discovered to produce high concentrations of degrading enzymes and raises the moisture level of its substrate. Shelby isolated the fungus from soil samples and confirmed the species using PCR amplification and DNA barcoding.

Samples of polypropylene were pre-treated with 75% ethanol and UV exposure, then placed in a liquid culture of A. terreus in Minimal Salt Medium (MSM) media, and the culture was incubated for 23 days. At the end of the trial period, PP samples were analyzed using Scanning Electron Microscopy. These samples showed changes in their surface layer, indicating evidence of biodegradation. Polypropylene plastic is found in household items such as plastic cups and is a known problem in the environment due to its inability to degrade. Shelby’s future research on the use of A. terreus for biodegradation includes optimizing degradation conditions and assessing methods of application in the environment.

Judging the 2025 Georgia BioGENEius Challenge were Ralph L. Cordell, CDC, and Alex Harvey, ViaMune. Cash prizes were awarded to Bhavya and Shelby.

# # #

About Georgia Life Sciences

Learn more at galifesciences.org.

Georgia Life Sciences Association Statement on the Release of the NSCEB Final Report and Action Plan

mthacker@gabio.org (Maria Thacker Goethe) — Wed, 09 Apr 2025 20:14:56 GMT

Emerging biotechnology is key for U.S. to remain dominant and secure future economic growth in a new era of global competition

Georgia Life Sciences (GLS) applauds the National Security Commission on Emerging Biotechnology (NSCEB) for its leadership and vision in publishing its final report and action plan to Congress. This comprehensive roadmap is a vital step toward securing and advancing U.S. leadership in biotechnology at a critical moment for our nation's competitiveness, security, and economic future.

We strongly support the Commission’s call for urgent federal action, including the proposed $15 billion in new investments over five years, to ensure the U.S. biotechnology sector remains the global leader in innovation and commercialization. These resources will help drive transformative advances across healthcare, manufacturing, national security, and more.

The timing of this report is especially critical as our nation’s life sciences research and innovation infrastructure, particularly at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), faces considerable uncertainty. Strong federal leadership and investment are essential to maintain the momentum of discovery, innovation, and public health progress.

The report’s 49 recommendations, organized across six strategic pillars, offer a bold and actionable framework:

Prioritize biotechnology at the national level
Mobilize the private sector to get U.S. products to scale
Maximize the benefits of biotechnology for defense
Out-innovate our strategic competitors
Build the biotechnology workforce of the future
Mobilize the collective strengths of our allies and partners

Georgia Life Sciences encourages members of the Georgia congressional delegation to endorse the Commission’s report and advocate for its swift and full implementation by the administration. Georgia's leadership in life sciences innovation positions our state to be a key contributor in realizing the report’s vision, and federal support is essential to maximizing this opportunity for both regional and national impact.

As Georgia continues to grow its vibrant life sciences ecosystem, we recognize the immense potential of a coordinated national strategy to accelerate innovation, empower our workforce, and foster public-private partnerships. We look forward to working with policymakers, industry partners, and research institutions to implement these recommendations and deliver biotechnology solutions that improve lives and strengthen our country. As the report states, without this type of transformational investment, our adversaries will work to leverage their biotech advancements to attack, destroy, starve, and harm the U.S.

The full text of the final report can be found here: https://biotech.senate.gov

Announcement: https://www.biotech.senate.gov/press-releases/nsceb-publishes-final-report/

BIO's statement is here .

Georgia Life Sciences Statement on U.S. Tariff Announcement

Fri, 04 Apr 2025 13:11:09 GMT

Updates: Since this statement was made, the administration announced, April 9, a 90-day pause on reciprocal tariffs. See the AdvaMed CEO statement on this change. GLS aligns with this statement.

April 3, 2025

The recent U.S. tariff announcement has sent ripples through the life sciences, biotech, and MedTech industries, raising concerns about its potential impact on innovation, manufacturing, and global supply chains. While some sectors, such as pharmaceuticals, have been temporarily exempt from these new tariffs, the uncertainty surrounding future trade policies remains a significant challenge for our industry.

These tariffs—set to take effect on April 5—include a base 10% tariff on all countries, with reciprocal tariffs reaching up to 50% on certain nations. There are growing concerns that these measures could increase costs for life-saving medical technologies, disrupt supply chains, and hinder job growth. Additionally, the agricultural biotech sector will likely be affected immediately, particularly with higher tariffs on non-USMCA-compliant goods. Pharmaceuticals, while currently exempt, may face their own tariffs in the near future, pending a potential Section 232 investigation into pharmaceutical manufacturing and national security.

Georgia’s life sciences ecosystem thrives on innovation, investment, and global collaboration. Our industry depends on stable, predictable trade policies that support growth, not policies that introduce uncertainty and additional financial burdens. We must ensure that trade policies protect patients, support manufacturers, and sustain the broader biotech and MedTech economy.

Georgia Life Sciences will continue to monitor these developments in partnership with our national associations and work closely with our members and policymakers to ensure our industry’s voice is heard. We encourage our community to stay engaged and share any concerns about how these tariffs may impact your businesses, workforce, and supply chains.

For questions or to provide input on how these policies affect your organization, please reach out to our team.

Biotechnology Advocates Press Congress for R&D Tax Reform

Tue, 01 Apr 2025 14:47:04 GMT

In a coordinated effort on the national stage, Georgia Life Sciences is joining forces with 47 other state biotechnology associations under the Council of State Biosciences Associations (CSBA) umbrella to urge congressional action on research and development tax amortization legislation.

The coalition has sent a formal letter to congressional leadership calling for the immediate passage of the American Innovation and R&D Competitiveness Act (H.R. 1990), bipartisan legislation sponsored by Representatives Ron Estes (D-KS) and John Larson (R-CT). The bill aims to repeal harmful research and amortization provisions that went into effect in 2022 under the Tax Cuts and Jobs Act.

Georgia Life Sciences representatives are heading to Washington DC this week alongside fellow CSBA members to meet directly with Georgia legislators. The group will advocate for this critical tax reform, which would restore immediate expensing of R&D expenditures rather than requiring companies to amortize these deductions over five years for domestic expenditures or 15 years for foreign expenditures.

The current mandatory amortization requirements are "already diverting much-needed funds away from small R&D-intensive companies, potentially jeopardizing the development of future treatments and negatively impacting the local economies where these companies are established," according to the CSBA letter.

During their Capitol Hill visits, the Georgia Life Sciences delegation will also address other pressing issues facing Georgia’s life sciences community while emphasizing the importance of supporting innovation in an industry dominated by pre-revenue companies developing critical medical breakthroughs.

FDA Vaccine Chief Resigns, Citing Concerns Over Kennedy's Stance on Vaccines; BIO Statement

Tue, 01 Apr 2025 14:24:32 GMT

The Food and Drug Administration's top vaccine official, Dr. Peter Marks, has resigned under pressure, directly criticizing Health Secretary Robert F. Kennedy Jr.'s approach to vaccine policy in his departure.

In his resignation letter to Acting FDA Commissioner Sara Brenner, Marks wrote: "It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies." Marks was reportedly given the option to resign or be fired during a meeting at the Department of Health and Human Services on Friday.

In a subsequent interview, Marks reinforced his concerns, stating: "This man doesn't care about the truth. He cares about what is making him followers."

John F. Crowley, president and CEO of the Biotechnology Innovation Organization (BIO) , praised Marks' tenure in a statement following the announcement: "Under the extraordinary leadership of Dr. Peter Marks, the FDA shepherded in a new era of scientific breakthroughs -- from new vaccines to curative cell and gene therapies that have strengthened and saved the lives of millions of patients and families."

Crowley expressed concern about potential ramifications for healthcare innovation, noting: "We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people."

BIO emphasized its commitment to working with the new Commissioner and administration while stressing the importance of upholding scientific expertise and high standards at health institutions.

New survey: U.S. biotechs warn tariffs could impede access to cures, stifle innovation

Wed, 26 Mar 2025 15:37:35 GMT

New survey: U.S. biotechs warn tariffs could impede access to cures, stifle innovation

March 26, 2025

WASHINGTON (March 26, 2025) -- Today, the Biotechnology Innovation Organization (BIO) released results from a membership survey that underscores the significant, global integration of the biomedical supply chain. According to the findings, nearly 90% of U.S. biotech companies rely on imported components for at least half of their FDA-approved products -- making the supply of medicines for US patients and families especially vulnerable to proposed tariffs on the European Union, China, and Canada.

According to the survey, tariffs will:

Reduce Access to Affordable Medicines: A staggering 94% of biotech firms anticipate surging manufacturing costs if tariffs are placed on imports from the European Union.
Stall Medical Innovation: Proposed tariffs on the EU would force 50% of companies to scramble for new research and manufacturing partners. Half of those surveyed say they would have to rework or potentially delay regulatory filings, jeopardizing the pace of innovation.
Create Red Tape: In the face of sudden tariffs, 80% of biotech firms report needing at least 12 months to find alternative suppliers, and a remarkable 44% would require more than two years -- delays that could disrupt the pipeline of breakthrough treatments.

"This survey demonstrates the far reaching and potentially damaging impacts of the proposed tariffs on our biotechnology industry, on biomedical research and on patients,” said BIO President and CEO John F. Crowley. “We fully support strong policies and programs that incentivize the manufacture of medicines here in America. Re-onshoring key parts of the biotechnology supply chain to the U.S. and our allies and strengthening the American manufacturing base should be a high priority for both national and economic security. It will take years, though, for this shift and we need to be mindful of the negative consequences of these proposed tariffs. We look forward to working with the Administration and Congress to develop incentives and policies that drive private sector dollars to spur a renaissance of U.S. biotech manufacturing." Conducted in February 2025, the survey captures perspectives ranging from small, start-up companies to large-cap corporations with more than $1 billion in revenue.

###

About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products. BIO also produces the BIO International Convention , the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

Healthbeat Atlanta: Looming cuts to NIH funding have Atlanta startup founders on edge

SBrown@galifesciences.org (Sheran Brown) — Fri, 21 Mar 2025 18:32:22 GMT

Looming cuts to NIH funding have Atlanta startup founders on edge

Rebecca Grapevine: March 18, 2025

Looming cuts to NIH funding have Atlanta startup founders on edge - Healthbe a t

Disruptions to funding streams from the National Institutes of Health aren’t just rattling university researchers . Atlanta startups that help move scientific innovations to market – creating jobs and furthering industry and academic collaboration – are also on edge.

These are small businesses that use a tiny portion of the NIH’s budget to bridge the gap between research and consumers. They make tape to improve nerve repair, devices that reduce pain without opioids, and digital tools to help people with cognitive challenges navigate daily life, among other innovations.

The NIH awarded $700 million to Georgia universities in fiscal 2024, according to estimates from an agency reporting tool. In contrast, small businesses in the state received less than $27 million for 45 projects at 29 companies in 2024, according to the tool .

Technology transfer from labs to small businesses creates a host of economic benefits, said Stephen Susalka, CEO of AUTM , which represents technology managers who help commercialize discoveries.

“It’s a Swiss Army knife in terms of impact,” Susalka said, creating new products, new companies, and new jobs. “That just leads to economic development, right? So now you have a new tax base. You have new facilities that are purchased. Those people are buying lunch every day.”

The federal funding “can really lead to strong industry and academic collaboration,” said Maria Thacker Goethe, president and CEO of Georgia Life Sciences , a nonprofit industry group. Many startups in Atlanta have “spun off” from local universities, and they play a key role in the state’s innovation economy.

The new Trump administration has frozen some NIH funding, then restarted some of it, amid threats of further cuts to come . Healthbeat Atlanta spoke to the leaders of several startups about how the uncertainty at the NIH is affecting their work. Here are four of their stories.

MapHabit: Tech for people with dementia, autism

NIH funding that flows through the Small Business Innovation Research program has been crucial to MapHabit’s success, co-founder Matt Golden said. The tablet-based platform helps people with conditions like dementia or autism complete daily activities. It placed first in a National Institute of Aging innovation competition in 2019.

MapHabit is part of the health tech portfolio at the Advanced Technology Development Center, the state’s technology incubator at Georgia Tech. The company, which has received four NIH awards, employs 15 full-time and 15 part-time workers, many in Atlanta, Golden said.

Golden’s funds were frozen in February and then restored 24 hours later, he said. Still, proposed changes at NIH like cuts to payments for overhead costs have him worried.

“The shotgun approach is going to reverse decades of progress, unfortunately,” Golden said. “These grants have been given to us so that we can spend the time to publish… to generate the data that proves this work, and that’s essential in health care.” Cuts could mean products like his get stuck on the shelf, Golden said, before they can reach those who need them. “They’ll just basically be halfway complete,” Golden said. “That’s going to put America at a big disadvantage.”

Friendi.fi: AI technology for relationships

An abrupt loss of access to NIH funding in February sent small business founder Chantal Kerssens scrambling.

Her startup, Friendi.fi , which she runs remotely from Atlanta, receives money from the national health agency to develop and test its technology, which uses artificial intelligence to connect people with an AI friend and coach. It’s also designed to help insurers gather information about the needs of their patients. At 6 months old, the company needs the NIH awards, even when it has other sources of funding.

“We need to know what we’re up against,” Kerssens said. She called a meeting of the company’s leaders to discuss how they would cover NIH-supported salaries using funds for other expenses.

Kerssens was unable to access the company’s NIH grant funds through a federal portal for nearly two weeks, even amid reports that the funds had been restored. That lack of clear information added to her anxiety.

And she’s worried about the future of the program.

Dr. Amy Baxter: Drug-free pain relief

Dr. Amy Baxter is a pediatric emergency room doctor who left private practice to develop Buzzy, a device to reduce the pain of getting a shot that won a 2020 Tibbetts Award for SBIR achievement .

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She lost access to her NIH funds for eight days in February. This week, operations were back on track. Baxter is working to develop tools to reduce pain without opioids, including VibraCool , a device that reduces pain with vibrations, heat, and cold, and a product to address low-back pain , the DuoTherm , as part of a federal initiative to end opioid addiction.

She is also using NIH funding to develop a tool to more accurately capture data about people’s opioid use, much of which comes from unused pills from prior prescriptions, Baxter said. This will help researchers better track whether their new inventions truly reduce opioid use.

Vivo: Testing a virtual strength program for seniors

Eric Levitan is using an SBIR award to evaluate the efficacy of a virtual strength program for older adults, Vivo .

He said receiving notice in February that NIH funding was paused was “devastating.” Though the money was unfrozen soon after, “the damage was done,” he said, and it caused his team to “rethink everything.”

Vivo, founded in 2020, weaves together workouts and community building and helps reach older adults where they are, including at senior centers, a key customer, Levitan said. Vivo employs four full-time and 35 part-time workers, 10 of whom are in Atlanta.

The company has raised over $4.1 million from angel investors, respected investors like AARP’s AgeTech Collaborative , and Techstars – and a three-year, $2.3 million award from the NIH.

Levitan teamed with Kathryn Starr , an associate professor at Duke University School of Medicine, to apply for a small business “fast track” grant to conduct a randomized control trial to see whether the Vivo program reduces blood sugar in people with prediabetes.

“Once we realized that all NIH funding may be at risk, it caused a ripple effect across our team and our research partners. …Will it change how we’re looking at R&D, how we manage funds, or [our] approach to growth?” Levitan said. “It forced us to go into contingency mode.”

A proposed NIH policy that would cut how much it pays for the “indirect” costs of research like maintaining a facility and routine bills would amount to a 25% reduction in expected payments, Levitan said. That would likely force him to stop the randomized trial, he said, though the money has been budgeted, and results are expected later this year.

What’s next for the SBIR program?

The proposed NIH policy to cut research funding is on hold due to an injunction from a federal judge, while lawsuits filed by universities and other organizations are pending. It’s not yet clear if the policy – if implemented — would apply to existing SBIR grantees, said Mark Skinner, CEO of SSTI, a national nonprofit focused on bolstering innovation.

The application process for the NIH’s small business grants is rigorous, with the applications reviewed in a two-step process that includes evaluation by industry professionals and academic scientists . In fiscal 2023, just 19% of all applications were funded, according to data from the agency . Meanwhile, Congress must this year reauthorize the SBIR program by Sept. 30, a step it typically takes every three years. That could provide an opportunity for Congress to introduce changes.

Earlier this month, U.S. Senate Small Business and Entrepreneurship Committee Chairwoman Sen. Joni Ernst, an Iowa Republican, proposed a wide-ranging reauthorization bill that would address criticisms of the program. Concerns include so-called SBIR “mills” that repeatedly apply for grants without much commercial success and security concerns over Chinese involvement in American research and business.

That may not be the final version, Skinner said, with other proposals likely to come from the House and Senate. Ernst’s bill would prevent the SBIR program from providing supplemental funds “based on the race, gender, or ethnicity of the principal investigator, founder, or key personnel of a small business concern.’’ If enacted, that could be a problem for Golden of MapHabit, who has used an NIH program designed to promote diversity among entrepreneurs to hire two Black scientists to lead clinical trials and ensure his studies enroll diverse participants.

Rebecca Grapevine is a reporter covering public health in Atlanta for Healthbeat. Contact Rebecca at rgrapevine@healthbeat.org .

Introducing the Georgia Life Sciences Podcast

Thu, 13 Mar 2025 16:43:02 GMT

Introducing the Georgia Life Sciences Podcast , a valuable resource for entrepreneurs, investors, policymakers, and anyone interested in learning more about Georgia's role in the life sciences industry.

The episodes typically cover a range of topics such as:

Interviews with Industry Leaders : Conversations with experts, entrepreneurs, and executives from life sciences companies who are driving innovation and growth in Georgia.
Emerging Trends : Exploration of new technologies, research breakthroughs, and trends that are impacting the life sciences sector, such as biotech, pharmaceuticals, medtech, and healthcare.
State Initiatives and Policies : Discussions on government and economic development programs, partnerships, and policies aimed at fostering the growth of the life sciences industry in Georgia.
Success Stories : Spotlighting successful startups, research institutions, and collaborations that are helping put Georgia on the map as a leader in life sciences.

Season one episodes will be featured bi-weekly in the BioBeat Newsletter or can be downloaded here .

The Georgia Life Sciences Podcast is ideal for anyone looking to stay informed about Georgia's evolving life sciences landscape and learn about opportunities for growth, investment, and collaboration in this exciting field. Sponsorship opportunities available. Please contact Stacey Bowlin, sbowlin@galifesciences.org , to learn more.

Announcing New Partners in Georgia Life Sciences Cost Savings Program

Thu, 13 Mar 2025 16:37:12 GMT

We are excited to welcome several new strategic partners to the Georgia Life Sciences Cost Savings Program. These partnerships are designed to help Georgia-based life sciences companies optimize costs, increase efficiency, and enhance business operations.

The new partners will offer life sciences businesses exclusive savings on products and services ranging from laboratory supplies to essential business services, ensuring companies can focus more on innovation and growth.

The new partners joining the program include:

Biotech Exec - Executive Staffing and Management Consulting
Corporate Traveler - Business Travel Management Services
NexGen BioBanking - Biospecimen Storage and Supply Solutions
Select Gases - Specialty, Medical, and Industrial Gases
SU Group - Equipment Maintenance Management Program (EMMP)

These partnerships bring added value to Georgia’s thriving life sciences ecosystem by providing essential resources to companies at every stage of development. From startups to established industry leaders, these new cost-saving opportunities will help foster continued growth for Georgia Life Science members. To learn more about our portfolio of cost savings partnerships and specific discounts, visit www.galifesciences.org/membership/savings-portfolio .

Driving Leadership in Biopharmaceutical Manufacturing

Fri, 07 Mar 2025 14:07:51 GMT

March 7, 2025- Georgia Life Sciences and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) have announced a reciprocal membership and on-going collaboration aimed at enhancing the production of cell-based therapies and developing a skilled workforce for the biotechnology and pharmaceutical sectors.

Through its BioReady program, Georgia Life Sciences is committed to strengthening the state's life sciences network and meeting specific criteria related to zoning practices and infrastructure capacity.

These efforts underscore Georgia Life Sciences active role in advancing biopharmaceutical manufacturing and innovation, both through direct participation in national initiatives like NIIMBL and through state-level programs that enhance infrastructure and community readiness.

Industry Groups Push for Eliminating "Pill Penalty" in Reconciliation Package

Tue, 04 Mar 2025 15:39:07 GMT

Industry stakeholders are advocating for key healthcare policy changes to be included in an upcoming Republican domestic policy bill expected to pass along party lines. PhRMA and Incubate, a nonprofit supporting venture capital firms, are prominently backing bipartisan legislation that would address disparities in the Inflation Reduction Act's drug price negotiation timeline.

The Ensuring Pathways to Innovative Cures (EPIC) Act, reintroduced by two North Carolina Republicans and one Democrat, aims to extend the negotiation eligibility period for small molecule drugs from seven years after FDA approval to eleven years - matching the timeline currently applied to biologics.

"This is our priority one, two and three," stated John Stanford, executive director of Incubate. The industry argues this "pill penalty" correction is crucial as venture capital firms are already shifting investments away from small molecule drugs due to the shortened exclusivity period.

Additionally, bipartisan support is building for pharmacy benefit manager (PBM) reforms that could be incorporated into the reconciliation package. "Both sides agree on this issue. It's not an issue of contention," noted Rep. Diana Harshbarger (R-TN) during a recent House Energy & Commerce subcommittee hearing.

Other healthcare bills seeking inclusion include legislation to reauthorize the rare pediatric priority review voucher program and a controversial proposal from Texas Republicans that would allow reciprocal drug approvals from certain foreign countries - a measure critics warn could undermine FDA authority.

For comprehensive coverage of these developing healthcare policy initiatives, please visit Endpoints News .

Building a Stronger Life Sciences Network in Georgia

Wed, 26 Feb 2025 18:41:45 GMT

Building a Stronger Life Sciences Network in Georgia

February 26, 2025- We are excited to invite you to take an active role in shaping the future of Georgia's life sciences community. Whether you're an experienced professional or passionate about making an impact, there are opportunities for you to contribute, grow, and connect with fellow leaders in the field.

Georgia Life Sciences currently has several new groups that will work together to support and advance Georgia's life sciences industry:

1. Mentorship Network:
This initiative connects emerging professionals with experienced mentors in the life sciences space. By sharing your expertise and guidance, you'll help foster the next generation of innovators, scientists, and entrepreneurs. Become a mentor .

2. Summit Planning Committee:
The Life Sciences Summit is one of Georgia's premier events, and we need your help in organizing a memorable and impactful experience. As a committee member, you'll have the opportunity to influence the agenda, secure speakers, and collaborate with industry leaders to showcase Georgia's life sciences sector . Apply today .

3. Entrepreneurship Committee:
Georgia is home to a vibrant community of biotech, medtech, and pharma innovators. The Entrepreneurship Subcommittee is dedicated to helping startups and growing companies navigate challenges, access resources, and scale effectively. We need forward-thinking individuals to support and mentor this dynamic ecosystem. Learn about our committees .

4. Emerging Leaders Network:

Georgia Life Sciences' Emerging Leaders Network builds strong, supportive networks for PhDs, postdoctoral fellows, and early career professionals, and leverages the state’s life sciences connectivity to foster growth, collaboration, and career advancement opportunities. Seasoned individuals will provide invaluable advice, guidance, and mentorship, leveraging their experiences and insights to help new leaders avoid common pitfalls and accelerate their growth. Join the collective .

5. HR Network:

Our HR network serves as a place where HR professionals may come together to focus on organizational development and talent management specific to Georgia’s life sciences industry. Join the network .

6. Manufacturing Council:

The Georgia Life Sciences’ Manufacturers Council was established to provide late stage clinical and commercial phase members with a vehicle to advocate for industry interests, including but not limited to quality, regulatory, infrastructure, safety, and workforce training issues. Join the Council .

Why Get Involved?

Make an Impact: Play a crucial role in shaping the future of life sciences in Georgia.
Expand Your Network: Connect with like-minded professionals, innovators, and leaders.
Grow Professionally: Contribute to meaningful projects that will enhance your skill set and build your resume.

We would love for you to be part of one of these exciting initiatives and encourage you to share with your contacts.

If you are interested in joining any of these groups or would like more information, please reach out to Stacey Bowlin, sbowlin@galifesciences.org , or simply reply to this email.

Thank you for considering these opportunities. We look forward to your participation!

Georgia Life Sciences: Growth, Investment, and Future Potential

Tue, 25 Feb 2025 19:55:39 GMT

Hypepotamus: Georgia Life Sciences: Growth, Investment, and Future Potential

Maija Ehlinger: February 14, 2025

Georgia Life Sciences: Growth, Investment, and Future Potential - Hypepotamus

For the last 35 years, Georgia Bio, the state’s main advocacy and business leadership organization, has worked to support pharmaceuticals, biotech startups, medical device companies, universities, research institutes, and government groups who are growing in the Peach State.

The organization recently announced a rebrand with its new name, Georgia Life Sciences . The name better reflects the organization’s “renewed focus and support” for the state’s growing life sciences community, CEO Maria Thacker Goethe told Hypepotamus.

The State of Life Sciences In Georgia

Close to 4,000 life sciences companies are building in the State of Georgia currently, and the industry is the “highest paying and fastest growing [sector] in the state,” according to Thacker Goethe.

“Georgia’s sizable, fast-growing, and high paying life sciences sector is critical to our economic growth. Surrounding states, and beyond, have prioritized and continue to invest in life sciences for many reasons, in large part because relative to other industrial sectors, the extended domestic supply chain of the U.S. industrial bioeconomy generates outsized secondary economic benefits,” she added. “The industry provides a strong mix of scientific and production jobs providing varied employment opportunities, and the biggest gap in the sector’s workforce require a technical degree or even some basic certifications out of high school. Life sciences is a very large sector that encompasses human health but also industrial bioproducts, biofuels, biofeedstocks, medical devices, and much more. According to BIO’s 2024 Economic Impact study , Georgia is in the top 10 states for this sector, and if we can make some progress to grow economic incentives and train our workforce, we will continue to be a leader.”

Georgia’s growing success in the life sciences stems from the state’s academic research institutions, substantial corporate investment, and strategic economic development initiatives.“Georgia is becoming a critical player in biopharma manufacturing,” Thacker Goethe told Hypepotamus, highlighting the presence of industry giants like Takeda, Boehringer Ingelheim, and Johnson & Johnson.

She also pointed to the state’s expanding medical device and diagnostics sectors, thanks to close collaborations with research powerhouses like Georgia Tech and Emory University. The state’s agricultural roots also provide fertile ground for the ‘agbio’ sector, with institutions like the University of Georgia conducting new research in precision agriculture and crop resilience.

When asked to describe the state of the life sciences’ community in Georgia, Thacker Goethe emphasized the state’s potential in becoming a hub for regenerative medicine companies, smart medical devices, and CDMOs (Contract Development and Manufacturing Organizations).

“With increasing demand for renewable materials and biofuels, Georgia’s industrial biotech sector should expand rapidly, leveraging its agricultural strengths and infrastructure. Breakthroughs in CRISPR-based crop modifications may drive Georgia’s role in creating resilient, high-yield crops to combat climate change and food security challenges,” she added.

Potential For Local Growth

But challenges remain.

Access to capital is a primary concern. While venture capital is increasing, securing adequate funding for life sciences startups can be difficult. Thacker Goethe pointed out the need for more wet-lab spaces, incubators, and biomanufacturing facilities to accommodate growing companies. She also warned that neighboring states are making targeted investments in life sciences and could potentially narrow the gap.

“One challenge we are working to address: building a community coalition to establish a Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) matching grants program in Georgia. We are the only state in the southeast that does not have this program (Alabama established theirs a couple of years ago),” she added. “The federal SBIR/STTR program provides early funding for research and development. However, these grants often don’t cover later-stage activities like prototyping, manufacturing, regulatory approvals, or market entry. State matching programs provide the additional capital needed to help startups move beyond research and into product development and commercialization, enabling companies to bring innovative solutions to market faster. We will lose Georgia-grown innovations to others states if we are unable to adopt a matching program.”

National headwinds can also hamper industry growth, according to a recent statement Georgia Life Sciences published around the recent National Institutes of Health (NIH) guidance to limit funding for medical and life sciences research at universities.

You can read the full statement here .

Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

Fri, 21 Feb 2025 16:37:10 GMT

Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

ATLANTA – February 20, 2025- Today, Invest Atlanta announced, the city of Atlanta has been designated a BioReady Gold Community by the state’s leading life sciences membership organization, Georgia Life Sciences. To receive this distinction, communities must meet certain criteria related to zoning practices and infrastructure capacity. This distinctive honor was presented today during Invest Atlanta’s February board of directors meeting.

“We are proud to recognize the City of Atlanta as a BioReady site, as much of our life sciences ecosystem is built around the state’s capital city,” said Maria Thacker-Goethe, President and CEO of Georgia Life Sciences. “Through this program, we champion communities that have made a commitment to growing the life sciences industry, helping to distinguish the state with not only a significant presence of leading biopharma companies and startups, but also with robust funding opportunities to fuel growth, and a collaborative environment with access to resources and infrastructure.”

The BioReady rating system rates communities in three tiers from Bronze to Silver to Gold. Through these BioReady ratings, Georgia Life Sciences allows local municipalities to better showcase biotech-zoned science parks, streamline permitting, build a robust infrastructure, and identify biotech-friendly sites more effectively, making them a desirable choice for real estate developers and biotechnology companies seeking destinations to locate.

“We are thrilled to witness our city being recognized as a BioReady Gold Community, a testament to our commitment to innovation and sustainability in the life sciences,” said Atlanta Mayor Andre Dickens. This acknowledgment not only highlights our readiness but also paves the way for future growth and collaboration in the bioscience sector. This designation affirms Atlanta’s readiness to support biotech companies and reinforces our position as a hub for scientific innovation.”

“According to BioSpace, the global life sciences market is valued at $13.72 billion and is projected to reach $26.63 billion by 2033,” said Dr. Eloisa Klementich, president and CEO of Invest Atlanta. Earning BioReady Gold status strengthens our efforts to attract and retain biotech and life sciences companies. With the Life Sciences workforce expected to grow 10% from 2022 to 2032, this recognition reinforces Invest Atlanta’s commitment to biotech and life sciences, giving companies confidence in our support and resources.”

For more information about this recognition visit, BioReady Communities .

About Georgia Life Sciences

Georgia Life Sciences, founded in 1989, is a non-profit, membership-based organization that promotes the interests and growth of the life sciences industry. It is the state’s largest and most influential life sciences advocacy and business leadership organization working to improve access to innovative discoveries that have lifesaving impact. The association connects business, academia, government, and other allied entities involved in the application of life sciences products to fuel growth and collaboration through policy development, community programs, national industry initiatives, and a portfolio of educational and networking events. Learn more at  www.galifesciences.org .

Bipartisan PBM Reform Back in Focus as House Committee Plans Hearing

Thu, 20 Feb 2025 18:31:41 GMT

Bipartisan PBM Reform Back in Focus as House Committee Plans Hearing

A renewed push for prescription drug cost reform is gaining momentum in Congress, with the House Energy and Commerce Committee's health subcommittee planning a hearing on pharmacy benefit manager (PBM) reform for late February. The hearing, to be led by Rep. Buddy Carter (R-Ga.), signals a revival of bipartisan efforts to regulate these pharmaceutical intermediaries.

PBMs, which negotiate drug prices for insurers and employers, have become a focal point in the broader discussion of healthcare costs. A previous bipartisan agreement to regulate these entities was crafted by Carter and Rep. Diana DeGette (D-Colo.) in the last Congress, though it ultimately stalled when the larger spending bill it was attached to faced opposition.

The reform efforts enjoy broad support from both parties and the president, making it one of the few areas with potential for bipartisan cooperation. However, new complications have emerged as Republicans consider using PBM regulations to generate savings for their broader policy agenda, potentially requiring up to $880 billion in cost reductions.

The path forward remains uncertain, with ongoing debates about whether such reforms would qualify for budget reconciliation and whether using PBM regulations as a funding mechanism could derail bipartisan cooperation. Meanwhile, stakeholders continue to disagree on the impact of additional PBM regulation, with pharmaceutical companies arguing that PBMs inflate drug costs while PBMs contend that new regulations would increase prices.

Council on State Biotechnology Associations says NIH funds are a critical component of innovation ecosystem

Thu, 20 Feb 2025 18:06:13 GMT

The Council of State Biotechnology Associations (CSBA) has issued a strong warning about proposed cuts to National Institutes of Health (NIH) funding, emphasizing the critical role these grants play in America's biotech innovation ecosystem. The statement, below , comes amid concerns over recent guidance that would reduce NIH funding to key research institutions.

-----------------------

“Today, the US biotech industry employs nearly 2.3 million people across the US and is making positive contributions to economic impact and national security across all 50 states. In fact, for every dollar the National Institutes of Health (NIH) contributes to a successful drug, the private sector invests over $65, underscoring the agency’s unparalleled return on investment.

As the associations representing the bioscience industry across the nation, the Council on State Biotechnology Associations (CSBA) is concerned by recent guidance that would cut funding provided by the NIH to universities, hospitals, and other institutions that perform critical early-stage research.

NIH grant funds are a critical component of our innovation ecosystem. Grants for basic research are the spark that leads to university-driven discoveries, with public-private partnerships and tech transfers that bridge early-stage research to industry-sponsored drug development and ultimately to FDA approved medical advances for hundreds of diseases.

While the administration looks for greater efficiency in the use of taxpayer dollars, it cannot be overstated - once scientific innovation moves abroad, it may never return.

In the race for scientific innovation around the world, as our adversaries continue to increase government investments in research, we encourage President Trump to follow suit and ensure that we maintain our global leadership in an industry that was created and thrives across the US.”

Marguron, Inc. licenses novel technology that could demonstrate an effective HIV functional cure

Thu, 20 Feb 2025 16:42:14 GMT

Marguron, Inc. licenses novel technology that could demonstrate an effective HIV functional cure

February 19, 2025

[Atlanta, GA, Los Angeles, CA, and Miami, FL, USA] Marguron, Inc. (Marguron) and the University of Miami (UM) have entered into a global license agreement based on technology developed by Dr. Ronald C. Desrosiers, Dr. James Termini and colleagues at UM, and Dr. Anjie Zhen at the University of California, Los Angeles (UCLA).

"We are pleased to have licensed the rights to these important technologies," said Vijai Mohan, CEO of Marguron. “The licensed intellectual property from UM and UCLA has the potential to prevent and treat HIV infections with a single intramuscular therapy using adeno-associated virus (AAV) gene therapy, generating a cocktail of powerful, broad-spectrum anti-HIV antibodies (bnAbs). Importantly, the improved technology appears to show lasting treatment effects, mitigating the persistent challenge of anti-drug antibody (ADA) formation.”

In mice and non-human primates, a one-time intramuscular treatment was effective in producing continuous transgene expression thereby reducing HIV-1 viral loads to undetectable levels for a prolonged period without developing anti-drug antibodies, a historical roadblock in the implementation of gene-based delivery of bnAbs. Monkeys demonstrating persistent antibody expression have been followed for over five years, making clear the potential durability of the treatment.

“We are delighted to partner with Marguron to advance the development of the Desrosiers Laboratory’s work for the benefit of persons affected by HIV/AIDS worldwide” said Norma Sue Kenyon, PhD, Vice Provost for Innovation at the University of Miami and Chief Innovation Officer at its Miller School of Medicine.

Dr. Desrosiers, UM professor and a principal Founder of Marguron, stated “in a recent experiment using a proprietary immunomodulatory agent to inhibit ADA formation at the time of gene therapy administration, we successfully achieved therapeutic levels of anti-HIV monoclonal antibodies with potent neutralizing activity against a broad range of HIV isolates in five of five monkeys for more than six months. We are excited to work with an experienced team at Marguron to advance this remarkable technology for a ‘One and Done’ strategy for ART-free HIV remission. Our results were presented in full for the first time at the 2024 HIV-DART meeting in Los Cabos, Mexico.”

About Marguron, Inc ( www.marguron.com )

Marguron, Inc. is at the forefront of gene therapy-based cures for infectious and metabolic diseases, with an initial focus of preventing and treating HIV-1 infections. HIV/AIDS remains one of the most significant infectious disease threats. Globally, forty million people were living with HIV-1 in 2023, with 1.3 million new infections and 630,000 deaths from AIDS-related diseases. While advances in antiretroviral therapy (ART) have markedly improved the outlook for infected individuals in economically developed countries, the stark global statistics reflect the challenges with implementing ART, particularly in resource-limited countries. Even in the developed world, HIV/AIDS remains a disease that markedly impacts millions of lives, without access to an available functional cure. Marguron’s vision is to make reality that "one shot and you are protected for life".

About University of Miami

The University of Miami is one of America's top research universities located in one of the most dynamic and multicultural cities in the world. With more than $456 million in research and sponsored program expenditures annually, the University of Miami is a member of the prestigious Association of American Universities (AAU). Only 3 percent of four-year institutions in the nation are invited to join the AAU, which recognizes breadth and quality of research and scholarship. While the majority of this work is housed at the Miller School of Medicine, investigators conduct hundreds of studies in other areas, including marine science, engineering, education, and psychology.

# # #

MEDIA CONTACTS:

Kai Hill

khill@med.miami.edu

c:-+1-305-332-3189

and

Katie Roach

info@marguron.com

c: +1-404-490-0182

Statement from Georgia Life Sciences on NIH Guidance to Reduce Funding for Medical and Life Sciences Research

mthacker@gabio.org (Maria Thacker Goethe) — Thu, 13 Feb 2025 18:02:05 GMT

February 13, 2025- Georgia Life Sciences (GLS), representing nearly 4,000 establishments across the state, whom are engaged in the research, development, and manufacturing of pharmaceuticals, biotechnology-based medicines and foods, medical devices, biomedical technologies, life-saving technology distribution, and clinical trial management, expresses deep concern over the recent National Institutes of Health (NIH) guidance to limit funding for medical and life sciences research at universities. This decision will significantly impact Georgia’s innovation economy, workforce, patient community, and its ability to sustain its current leadership in cutting-edge research and development.

This guidance will have an array of devastating effects, particularly for patients who rely on groundbreaking research to develop new treatments and cures. NIH funding has been instrumental in advancing therapies for cancer, neurological diseases, rare genetic disorders, and countless other conditions that affect millions of Americans. Patients in Georgia—and across the country—are counting on continued investment in medical innovation to extend and improve their lives. Cutting research funding slows the progress of scientific discoveries, delays critical clinical trials, and ultimately, hinders the ability to bring life-saving treatments to those who need them most.

Our industry also relies heavily on Georgia’s universities and research institutions, which are at the forefront of discoveries in medicine, biotechnology, and life sciences. These advancements are made possible through critical NIH funding that supports both research and the training of the next generation of scientists, clinicians, and innovators.

In 2023, Georgia institutions received over $778.1 million in NIH funding, up 24 percent since 2019, underscoring the state’s leadership in life sciences research and its commitment to improving public health. This NIH guidance severely restricts funding and undermines Georgia’s ability to compete nationally and globally, jeopardizing the state’s position as a hub for life-saving innovation.

The impact of this decision will reach far beyond the laboratory. Georgia’s life sciences sector is a significant driver of economic growth, supporting over 215,000 jobs, contributing $50.2 billion in economic output, and generating over $920M in annual tax revenue. Reduced NIH funding will lead to fewer research projects, fewer opportunities for collaboration with industry partners, and ultimately, job losses in both academia and the private sector. This disproportionately affects Georgia’s communities, where life sciences research and related jobs at institutions like Emory University, Georgia Institute of Technology, Georgia State University, Augusta University, and research centers such as the Centers for Disease Control and Prevention (CDC), Winship Cancer Institute, and the Shepherd Center serve as a foundation for local economic growth.

Additionally, these cuts will harm Georgia’s thriving agribusiness sector, which depends on life sciences research to develop innovative agricultural biotechnology, improve food safety, and combat plant and animal diseases. Georgia is a national leader in agricultural research, with institutions such as the University of Georgia and the USDA Agricultural Research Service playing a crucial role in ensuring food security and sustainability. Reduced funding will impede advancements in crop science, animal health, and precision agriculture, putting farmers and agribusinesses at a disadvantage in an increasingly competitive global market.

This guidance also directly threatens Georgia’s ability to attract top talent and investment. The average wage in Georgia’s life sciences sector is $102,434—49 percent higher than the private sector average and one of the highest paying sectors in the state. A strong innovation ecosystem, fueled by federal research funding, is essential for retaining world-class researchers, entrepreneurs, and businesses. Limiting this support sends a troubling signal to the scientific community and could deter future investments in Georgia’s life sciences industry.

Georgia Life Sciences urges the Administration to reevaluate this guidance and recognize the vital role NIH funding plays in driving medical breakthroughs, supporting economic growth, and improving public health. We stand ready to work alongside policymakers to ensure Georgia remains at the forefront of life sciences innovation, providing researchers with the resources they need to continue pioneering advancements that benefit patients, families, and key industries across the state.

Georgia Life Sciences Workforce Update & Call for Volunteers

Thu, 06 Feb 2025 19:50:54 GMT

The Georgia Life Sciences team has been on the road traveling from Plains to Columbus to Savannah over the last week talking life science careers! We hosted booths and made presentations at the Georgia Science Supervisors Association and Georgia Science Teachers Association Conference and at the Healthcare Science Technology Educators Association conference.

Additionally, Georgia Life Sciences partnered with miniPCR to host five teachers at our Equipment Depot in Tucker for a workshop on miniPCR's Protein Expression and Purification lab. After the workshop, participants were invited to "shop" in the warehouse and took home supplies that will benefit over 1600 students.

This weekend Georgia Life Sciences is holding our regional in-person biotech teacher training workshop at Chattahoochee Technical College in Canton. The final in-person workshop for this year will be March 14 and 15 at Southern Regional Technical College in Thomasville. We are still seeking industry speakers and onsite volunteers for these workshops . Please reach out to Megan Heaphy ( MHeaphy@galifesciences.org ) if interested.

Saol Therapeutics announces FDA acceptance of New Drug Application for SL1009 for treatment of Pyruvate Dehydrogenase Complex Deficiency

Tue, 28 Jan 2025 19:18:33 GMT

ROSWELL, Ga, DUBLIN and HAMILTON, Bermuda, January 28, 2025 – Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for SL1009, Sodium Dichloroacetate Oral Solution (DCA). DCA will be used with a proprietary genetic test to treat an orphan pediatric mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD)1. The FDA granted Priority Review for the NDA and has set a goal date of May 27, 2025, under the Prescription Drug User Fee Act (PDUFA). Priority review is designated to applications for drugs that, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention or diagnosis of a serious medical condition. SL1009 has previously been granted Orphan Drug and Fast Track Designations. SL1009 has also been granted a Rare Pediatric Disease Designation by the FDA and thus is eligible for a Priority Review Voucher (PRV).

PDCD is a rare and life-threatening mitochondrial disorder of carbohydrate oxidation that mostly affects the nervous system and skeletal muscle and leads to decreased ATP production and energy failure. DCA is a targeted therapy that inhibits Pyruvate Dehydrogenase Kinase (PDK) to stimulate residual Pyruvate Dehydrogenase Complex (PDC) activity and increase energy (ATP) production by mitochondria.

"This NDA acceptance brings us one step closer to addressing the critical health challenges faced by these children and their families, where no approved treatment is currently available," said Dave Penake, Chief Executive Officer of Saol Therapeutics. “Reaching this regulatory milestone is both a significant scientific achievement and a deeply meaningful moment for everyone who has dedicated themselves to advancing this therapy. Further, designating our application for priority review reaffirms that the FDA views PDCD as a serious condition”

The NDA is supported by results from a Phase 3 double-blind placebo-controlled cross-over study (SL1009-01) and a survival study (SL1009-02). The totality of evidence submitted for review in the NDA includes mechanistic characterization, along with nonclinical and clinical evidence to demonstrate the safety and clinical benefit of DCA in PDCD patients.

DCA is not currently approved for any indication in the United States.

About Pyruvate Dehydrogenase Complex Deficiency (PDCD)

PDCD is a mitochondrial disorder of carbohydrate oxidation that mostly affects the nervous system and skeletal muscle and leads to decreased ATP production and energy failure. It is estimated that 300-500 patients are treated in expert centers in the US, and the overall prevalence is thought to be as high as 2,000. PDCD is the most common cause of congenital lactic acidosis, a life-threatening condition that may occur as early as the neonatal period. Patients suffering from PDCD may also exhibit extreme tiredness (lethargy), poor feeding, rapid breathing (tachypnea), and other signs of neurological and neuromuscular dysfunction such as developmental delay, low muscle tone (hypotonia), abnormal eye movements and seizures. Signs and symptoms usually begin soon after birth but may appear later in childhood2.

There are currently no FDA-approved therapies for PDCD.

About Saol Therapeutics

Saol Therapeutics (pronounced "Sail") is a privately held, clinical-stage, pharmaceutical company with operations in Roswell, GA, Dublin, Ireland and Hamilton, Bermuda. Saol is focused on development activity in CNS disorders such as spasticity and pain management, and orphan diseases. Saol is committed to providing and advancing therapeutic options for patients and the physicians treating these populations. For more information, visit www.saolrx.com .

Saol Therapeutics Contact
Brian Nappi, Senior Vice President, Strategy
bnappi@saolrx.com

Source: Saol Therapeutics announces FDA acceptance of New Drug Application for SL1009 for treatment of Pyruvate Dehydrogenase Complex Deficiency – Saolrx

Georgia Bio Becomes Georgia Life Sciences

sbowlin@gabio.org (Stacey Bowlin) — Wed, 22 Jan 2025 19:27:43 GMT

Georgia Bio Becomes Georgia Life Sciences

Rebrand reflects organization’s growth state and key expansion of the sector

FOR IMMEDIATE RELEASE

Atlanta, GA (January 22, 2025) – Georgia Bio announced that it has rebranded the organization as Georgia Life Sciences, bringing renewed focus and support to the core strengths of the business and academic organizations within Georgia’s life sciences and healthcare communities.

As the leading advocate for the state’s dynamic and diverse life sciences sector, Georgia Life Sciences promotes policy development, community programs, industry initiatives, and events, as well as the research and products of its associated member and partner organizations.

“This is a key milestone for the association. Our rapidly growing membership is a testament to the strength of our community," said Maria Thacker-Goethe, President and CEO, Georgia Life Sciences. “We recognized that our association's brand should reflect and amplify the essence of our organization and project the impact of our success on behalf of our members. As we determined that a refresh to our visual branding was needed, it became evident that our naming convention no longer reflected our mission in serving Georgia’s expansive and growing life sciences sector.”

Georgia Life Sciences will maintain their established leadership role as a convenor in Georgia by continuing to advocate for effective national, state and local policies that protect and preserve innovation, attract public and private partnerships, improve educational opportunities, and promote the renowned research institutions and cutting-edge technological resources that has established the state as a viable leader in life sciences innovation.

Georgia Life Sciences supports its membership through several organizational areas of focus:

Policy & Advocacy: Advance life sciences innovation through policy and advocacy leadership at all levels of government
Workforce & Talent: Establish Georgia as a center for excellence in life science workforce training and talent development
Economic Development: Provides expert advice and guidance to help companies find suitable locations and resources as they move to and grow in Georgia
Innovation and Entrepreneurship: Serve as catalyst for life sciences innovation by helping entrepreneurs build successful ventures, access capital, and identify non-dilutive funding opportunities
Networking and Collaboration: Foster connection by convening thought leaders around relevant industry topics and peer-to-peer exchange
Cost Savings: Curated discounts on products and services critical to running a successful business

# # #

About Georgia Life Sciences

CONTACT:

Stacey Bowlin

Georgia Life Sciences

sbowlin@galifesciences.org

703-402-7608

Reflecting on a Remarkable 2024; See You in 2025!

mthacker@gabio.org (Maria Thacker Goethe) — Mon, 23 Dec 2024 19:21:15 GMT

It’s our favorite time of the year, which means our team is out of the office from December 24 through January 3, taking a well-deserved break with family and friends.

As 2024 draws to a close, I want to express my heartfelt gratitude to the Georgia Bio community for an extraordinary year. Together, we have continued to advance our shared mission of fostering innovation, collaboration, and growth within the life sciences sector. Last week, we also hosted the final meeting of the year with the Georgia Bio board, sharing our vision for the association’s future growth. A special thank you to our board chair, Steve Damon, for your leadership and vision during a transitional year where we re-emerged as a 501c6 non-profit allowing us to further our policy and advocacy work which our previous designation did not allow. This significant change prepares us to have a stronger voice as we get ready to enter the 2025 legislative session.

Our rapidly growing membership is a testament to the energy, diversity, and strength of our community. Your contributions—whether through new ideas, partnerships, or engagement—continue to propel our industry forward and solidify Georgia as a leader in life sciences innovation. Looking ahead to 2025, we are excited to build on the momentum in 2025. Our focus will be to create high-value programs, strengthen collaborations, advocate for the industry and our members at the state and federal level, and open doors to new opportunities that drive progress and improve lives through science. Together, we will tackle challenges, celebrate achievements, and continue shaping the future of the life sciences.

On behalf of Georgia Bio, I wish you a joyous holiday season filled with peace, happiness, and inspiration. I look forward to welcoming members at the Georgia Bio State Affiliate Reception at JPMorgan in early January and invite you to Save the Date for a Georgia Bio Member Appreciation reception the evening of Feb. 11th.

Thank you for your unwavering support and commitment to our mission. Cheers to a bright and impactful 2025!

Maria

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While we're out, we invite you to share in one to two words, what you are most optimistic about for 2025. Maybe your team is growing, you are starting a clinical trial or expanding your portfolio, excited about a transformative trend in the industry, or maybe you’re a optimistic about changes to the capital markets or regulatory landscape.

Click Here or Scan QR Code.

BIO Statement on the USMCA Biotech Corn Dispute Panel’s Final Ruling

Fri, 20 Dec 2024 19:15:26 GMT

Today the dispute settlement panel formed under the United States-Mexico-Canada Agreement (USMCA) issued a final ruling related to Mexico's restrictions on the importation of genetically modified (GM) corn. In response, John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), issued the following statement:

"Today’s decision by the U.S.-Mexico-Canada Agreement (USMCA) dispute panel serves as a monumental victory for the future innovation of agricultural production technologies and the millions of consumers worldwide who stand to benefit from their use.

“For decades, rules-based trade agreements have allowed the United States and its trading partners to thrive—encouraging the advancement of new technologies designed to mitigate the impact of climate change and increase global food security.

"BIO is grateful for the panel’s time, applauds its thoughtful review of this important issue, and will continue to advocate for the global implementation of food policy standards that are both transparent and science-based with respect to genetic engineering of food products.”

View Statement at BIO.org

View USTR Press Release

BIO Applauds the Inclusion of Important Health Care and Agriculture Priorities and Programs in Year-end Government Funding Bill

sbowlin@gabio.org (Stacey Bowlin) — Tue, 17 Dec 2024 18:54:06 GMT

BIO Applauds the Inclusion of Important Health Care and Agriculture Priorities and Programs in Year-end Government Funding Bill

John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), today released the following statement ahead of an expected vote in the U.S. House of Representatives on a year-end government funding bill that includes many urgent and bipartisan health care and agricultural priorities and programs:

“Congress now has a pivotal opportunity to pass reforms and to authorize funding for programs that will make a meaningful difference to advance the health and well-being of the American people. This bipartisan health care agreement advances policies that will also strengthen American competitiveness in biotechnology, improve our response to future pandemics and help to make life-saving medicines more affordable.

“The agreement includes bipartisan reforms that will bring more transparency to pharmacy benefit managers (PBMs), middlemen who add wasteful costs to the healthcare system. Advancing these PBM reforms will begin to break the pernicious link between the fees that PBMs charge and the cost of medicines. Now is the time to take these important steps toward improving access to prescription medicines for patients, employers and taxpayers.

“The legislation further renews a vitally important law that has helped our nation prepare and respond to public health emergencies. It also extends the Pediatric Priority Review Voucher (PPRV) program until September 2029. This program is a market-based mechanism that has incentivized the development of dozens of new treatments for patients with the most rare and devastating pediatric diseases. I’d like to offer a special thank you to the countless patient advocates who worked with us and others to ensure that the PPRV program was reauthorized.

“Additionally, the extension of the farm bill provides critical support to American farmers, ranchers and innovators, and enables continued research, development and sustainability of our nation’s food and renewable fuel supply.

“We urge lawmakers to support these important policies and programs. We look forward to working with the new Congress and new Trump administration to build upon these reforms in the coming year.”

2025 Life Science and Health Career Fairs in Georgia

Mon, 16 Dec 2024 19:59:16 GMT

Georgia Life Sciences has compiled the following list of career fairs. Companies are encouraged to participate. Please visit the school website for more information.

University of Georgia

Part- Time Job Fair | 8/20/2025| Tate Student Center, Grand Hall - 5th floor
J.M Tull School of Accounting Career Fair | 9/11/2025| Classic Center
Fall Career and Internship fair | 9/29/ 2025| Classic Center
Fall Engineering and Computer Science Career and Internship fair | 9/30/2025/ Classic Center
Risk Management and Insurance Career Day | 10/6/2025| Classic Center
Agricultural and Environmental Career fair | 10/8/2025 |Tate Student Center, Grand Hall - 5th floor
Financial Planning, Housing and Consumer Economics Internship and Career Fair | 10/15/2025| Tate Student Center, Grand Hall - 5th floor
Graduate School Information Day| 10/22/2025| Tate Student Center, Grand Hall - 5th floor

Augusta University

Gace College Career Fair | 11/4/2025| Cobb Energy Performing Arts Theatre

Kennesaw State University

STEM Job Fair | 9/30/2025- 10/2/2025| Marietta Campus - 635 Walter Kelley Road, Marietta GA 30060
All Majors Job Fair | 10/28/2025- 10/29/2025| Kennesaw Campus - 290 Kennesaw State University Rd NW, Kennesaw, 30144
Government and Non- Profit Job Fair | 10/30/2025| Kennesaw Campus - 290 Kennesaw State University Rd NW, Kennesaw, 30144

Clayton State University

Part- Time Job Fair | 8/12/2025| Main Street, University Center
Internship non-profit job fair | 9/11/2025| Main Street, University Center

Spelman College

Law School Fair | 9/24/2025| Upper Manley Concourse

Atlanta University Center Consortium

AUCC Career Fair | 9/19/ 2025| America’s Mart in Downtown Atlanta

Georgia Institute of Technology

Engineering and Science Virtual Career Fair | 8/28/2025| Virtual
All Majors Career Fair | 9/8/2025- 9/9/2025| Georgia Tech Campus Recreation Center
Materials Science and Engineering Career Fair | 9/9/2025| Klaus Advanced Computing Building Atrium
Coulter BME Career Fair | 9/10/2025| Historic Academy of Medicine
School of Electrical and Computer Engineering Career Fair Day 1 |9/12/2025| Klaus Advanced Computing Building Atrium
Supply Chain Day Career Fair | 9/15/2025| Exhibition Hall
School of Electrical and Computer Engineering Career Fair Day 2 | 9/16/2025| Klaus Advanced Computing Building Atrium
Computing Career Fair | 9/16/2025| McCamish Pavillion
ME/ ASME Career Fair | 9/17/2025| Exhibition Hall
Coulter BME Virtual Career Fair | 9/18/2025| Virtual
School of Building Construction Career Fair | 9/23/2025| Exhibition Hall
Government and Non- Profit Job Hiring Event 10/2/2025
Cybersecurity and Technology Virtual Career Fair | 10/16/2025| Virtual

University of North Georgia

Part- Time and Internship Job Fair | 8/18/2025| UNG Gainsville Campus
Career and Internship Fair | 9/23/2025| Hugh Mills physical education center
Career and Internship Fair |9/4/2025| UNG Dahlonega Campus

Atlanta Beltline

Career Fair | 8/27/2025| City of Refuge

New Report Finds Bioscience Sector Generates Over $3 Trillion for U.S. Economy

Mon, 09 Dec 2024 19:03:04 GMT

New Report Finds Bioscience Sector Generates Over $3 Trillion for U.S. Economy

Today, the Biotechnology Innovation Organization (BIO) and the Council of State Bioscience Associations (CSBA) released new national and state-level data on the U.S. bioscience industry's economic performance, its impacts, and its geographic footprint.

The report, " The U.S. Bioscience Economy: Driving Economic Growth and Opportunity in States and Regions ," analyzes the sector's economic impact via employment, overall output, wages/benefits, and tax revenue.

Key takeaways from the report include:

The industry's economic impact, as measured by overall output, totaled more than $3.2 trillion in 2023.
In 2023, the nation's bioscience industry employed nearly 2.3 million Americans across almost 150,000 U.S. business establishments and in every U.S. state. The sector indirectly supports nearly 8 million additional jobs.
The industry's employment has increased significantly, by nearly 15 percent since 2019, maintaining its long-term growth trend and well outpacing the nation's overall private sector job growth during this period.
Between 2019 and 2023, 49 states, DC, and Puerto Rico experienced net job growth in the bioscience industry.

"America’s bioscience sector is vital to addressing the world's most pressing challenges -- from pandemics and national security to preventative health and environmental sustainability. Industry leaders and researchers overcome tremendous obstacles every day to advance innovative solutions and help people lead healthier lives, and this report shows how the sector continues to enrich communities, create jobs, and grow economies across our great country," said John F. Crowley, BIO’s President & CEO.

“For two decades now, this report series has shown the growth and impact of the bioscience industry on the economy. In the wake of the COVID-19 pandemic and economic downturns, it is clear that the biosciences remain a key sector of the growing innovation economy,” said Pete Pellerito, BIO Senior Policy Adviser for Federal and State Economic Development and Technology Transfer Initiatives.

"The bioscience industry's economic footprint extends to every U.S. state and region," said Ryan Helwig, Principal and Project Director with TEConomy Partners. "That means all parts of the country play a part in the industry's breakthroughs and advancements and benefit from its economic impact."

The state-by-state industry assessment is the eleventh in a biennial series, developed in partnership by TEConomy Partners and BIO , and studies the state of the U.S. bioscience industry and its associated innovation ecosystem at the national, state, and metropolitan area levels. The report includes individual fact sheets for all 50 states, the District of Columbia, and Puerto Rico, which can be found alongside the full report and map at www.bio.org/jobs .

Atlanta MedTech Startup Raises $10 Million Series A

Wed, 20 Nov 2024 21:53:12 GMT

A small but mighty team in Atlanta is tackling one of medicine’s biggest challenges: cutting postoperative pain while reducing opioid use.

Shyamy Sastry and his team at the medical device startup Synaptrix, Inc. have developed a proprietary system NOVABLOC™, which is looking to bring new options to the modern pain management world. Its human feasibility studies have demonstrated more than 20 days of pain relief with a single treatment.

The startup says it is “committed to reducing opioids” while bringing more user-friendly options to the pain management space.

“Modern day treatments for postoperative pain management are largely insufficient. They are either plagued by short-lasting pain control, limit physical rehabilitation, or invite opioid use,” said CEO Sastry. “The NOVABLOC™ system is a groundbreaking neuromodulation technology designed to deliver 20+ days of pain relief without impacting motor function or touch. Altogether, the system treats postoperative pain for days to weeks while promoting rehabilitation and reducing the need for opioids.”

As Sastry explained to Hypepotamus, neuromodulation is a “treatment that uses electrical or chemical stimulation to modify neural activity.” For NOVABLOC, that means delivering “electrical stimulation to selectively reduce neural activity transmitted by pain fibers.”

Keep Reading Here: https://hypepotamus.com/startup-news/synaptrix-raises-10-million/

NSF names three new I-Corps Hubs expanding the National Innovation Network across the U.S.

Thu, 31 Oct 2024 03:50:15 GMT

NSF I-Corps Hubs now include colleges and universities across the country

The U.S. National Science Foundation today announced the addition of three new NSF Innovation Corps (NSF I-Corps™) Hubs that will scale the NSF-led National Innovation Network (NIN), accelerating the translation of discoveries into new solutions that benefit society and the economy. Each NSF I-Corps Hub may receive up to $3 million per year for five years and comprises a regional alliance of at least eight universities. Combined with the existing 10 NSF I-Corps Hubs, these 13 NSF I-Corps Hubs presently span 48 states. See the interactive NSF I-Corps Hubs map .

NSF I-Corps Hubs provide experiential entrepreneurial training to researchers across all fields of science and engineering. I-Corps Hubs form the operational backbone of the NIN, a network of universities, NSF-funded researchers, established entrepreneurs, local and regional entrepreneurial communities and other federal agencies, that collectively help researchers learn to investigate the commercial potential of fundamental discoveries in science and engineering. The NSF I-Corps Hubs work collaboratively to build and sustain an innovation ecosystem that engages all Americans throughout the U.S.

“The goal of the I-Corps program is to deploy experiential education to help researchers reduce the time necessary to translate promising ideas from laboratory benches to widespread implementation that in turn impacts economic growth regionally and nationally,” said Erwin Gianchandani, NSF assistant director for Technology, Innovation and Partnerships. “Each regional NSF I-Corps Hub provides training essential in entrepreneurship and customer discovery, leading to new products, startups and jobs. In effect, we are investing in the next generation of entrepreneurs for our nation.”

Established in 2011, the NSF I-Corps program is designed to nurture the commercialization of deep technologies, which grow from discoveries in fundamental and use-inspired science and engineering. Since its inception, over 3,600 NSF I-Corps teams have participated in the I-Corps program. The strategic goals of the NSF I-Corps Hubs are technology translation, entrepreneurial training and workforce development, economic impact and collaboration and inclusion.

Listed below are the new NSF I-Corps Hubs and partner institutions:

NSF I-Corps Hub: Northwest region – NSF 2430389
University of California, Berkeley - Lead
Oregon State University
University of Alaska Fairbanks
University of California, Davis
University of California, Irvine
University of California, San Francisco
University of California, Santa Cruz
University of Washington

NSF I-Corps Hub: Southeast region – NSF 2430380
Georgia Tech - Lead
Clemson University
Morehouse College
The University of Alabama
University of Central Florida
University of Florida
University of Miami
University of South Florida

NSF I-Corps Hub: New England region – NSF 2430342
Massachusetts Institute of Technology - Lead
Brown University
Harvard University
Northeastern University
Tufts University
University of Maine
University of Massachusetts Amherst
University of New Hampshire

Congress Is Best Hope for Breakthrough Medtech Medicare Coverage

Sat, 26 Oct 2024 09:56:44 GMT

By: Scott Whitaker, AdvaMed

After a long delay, a final Medicare policy provides quicker coverage for certain breakthrough medical technologies. While a step in the right direction, the new policy isn’t enough. The best hope for delivering breakthrough medtech to 65 million Medicare beneficiaries is congressional action this fall.

Groundbreaking medical discoveries come online all the time but it can take years for Medicare to make these innovations available to its patients. FDA’s “breakthrough” program allows manufacturers to work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Innovative technologies can better diagnose Alzheimer’s disease or treat certain cancers in a less invasive way, all of them deemed safe and effective by FDA’s rigorous standards.

However, Medicare coverage of these innovations is often too slow or non-existent. The Centers for Medicare & Medicaid Services’ (CMS) Transitional Coverage for Emerging Technologies (TCET) pathway is a partial solution that comes after a long wait.

TCET is a step toward a stronger, more robust policy, but it doesn’t go far enough to help the Medicare beneficiaries depending on breakthrough diagnostics and treatments to alleviate their suffering.

The limited number of devices CMS can handle – only five or fewer per year – demonstrates clearly to Congress the need for greater resources at CMS.

And the exclusion of diagnostics is disappointing, particularly considering the potential for a breakthrough diagnostic technology to save not only lives but costs to the health care system overall through earlier detection. Many patient and provider groups disagree with CMS’ narrow approach.

However, hope isn’t lost. While CMS was finishing its limited proposal, Congress advanced legislation that could be more comprehensive in meeting patients’ needs. The House Ways and Committee passed H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023, in June. The bipartisan measure would allow the designated medical devices to be covered over a four-year transitional period. As amended and passed, the bill also excludes diagnostics, though the committee clarified the intent to cover diagnostics. The Energy and Commerce Health Subcommittee passed H.R. 1691 as well.

Congress has limited legislative days this fall in a busy election year. Passing bipartisan legislation to solve a longstanding challenge and give new medical options to older Americans and their doctors would be a welcome use of the congressional agenda.

In addition to serving patients with new, existing medtech, passage would encourage medtech innovation.

Medtech companies invest millions of dollars in research and development to create transformative technologies. The majority of these innovators are small companies with only a few products in their portfolio. The looming uncertainty of CMS coverage stifles innovation and poses significant concerns for these companies’ long-term viability.

Bigger medtech companies fare no better in getting their groundbreaking medical innovations to Medicare beneficiaries.

Edwards Lifesciences’ tricuspid heart valve replacement system, an FDA-designated breakthrough device, received FDA approval February 1, 2024. Although many patients suffering the debilitating effects of tricuspid valve disease have no other options for treatment, existing Medicare rules delay coverage that may provide quick, equitable access to this procedure for the estimated 1.5 million U.S. patients suffering with tricuspid regurgitation.

Studies show that, on average, patients wait over 5.5 years after FDA approval for valuable therapies to receive coverage. Without swift access to FDA-approved devices and tests, the health of millions of patients, especially those with limited resources, hangs in the balance.

And it's not just about ensuring immediate access; it's also about promoting health equity among older Americans, many of whom rely solely on Medicare for health care coverage. Many breakthrough devices address conditions largely experienced by underserved, underrepresented, and vulnerable patient groups, helping alleviate and address health inequities. By ensuring access to FDA-approved breakthrough devices, better coverage would remove some of the biggest barriers preventing seniors, especially from underserved communities, from accessing treatments.

The United States is the global leader in medtech, continuously pioneering cutting-edge technologies and enhancing patient outcomes. If we want to remain a powerhouse of innovation that does right by patients, we must fix this bureaucratic process and implement a predictable funding pathway. With the CMS policy thinner than it could be, the best chance for getting the job done is Congress this fall. Any must-pass end-of-year legislative wrap-up should include the breakthrough medtech coverage bill.

Scott Whitaker is president and CEO of AdvaMed, the Medtech association, the largest trade association representing medical technology companies worldwide.

------------------------------

Source: AdvaMed & https://www.realclearhealth.com/blog/2024/10/22/congress_is_best_hope_for_breakthrough_medtech_medicare_coverage_1066886.html

Stacey Bowlin Joins Georgia Bio as Senior Vice President of Industry Engagement and Marketing

mcarter@gabio.org (Melissa Carter) — Thu, 24 Oct 2024 15:46:49 GMT

Georgia Bio, the state’s life science trade association, announced today the appointment of Stacey Bowlin as the organization’s Senior Vice President of Industry Engagement and Marketing. Bowlin will collaborate closely with Georgia Bio’s CEO on the company's strategic priorities, including the company’s go-to-market positioning and its integrated work with members.

“Stacey is an association brand strategist who will help both our members and GA Bio harness change to maximize performance and connectivity with key stakeholders across the state. She’ll be invaluable in driving our company’s strategic initiatives forward as we continue to evolve and grow," said Georgia Bio CEO Maria Thacker Goethe. “We’re very pleased to welcome Stacey to the organization.”

Over the course of her career, Bowlin has worked for a range of service organizations delivering marketing and event solutions to drive growth, retention, and revenue. Most recently, Bowlin worked at California Life Sciences, where she served as the association's Senior Vice President of Marketing and Industry Engagement. At CLS, she built a marketing function that included the organization’s communications and profile building efforts, events portfolio, sponsorship and other non-dues revenue initiatives. Stacey also oversaw CLS’ entrepreneurship programs, with an emphasis on expanding opportunities for startup companies, including CLS’s acclaimed FAST advisory program, and new initiatives that support the innovation pipeline.

Previously, she spent more than a decade at the Biotechnology Innovation Organization (BIO), the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.

"I am excited to work with the GA Bio team to amplify their portfolio of programs, events, and initiatives, helping our members advance critical products and services that will transform patient’s lives,” said Stacey Bowlin. “Together, we will continue to focus on the needs of our members.”

Georgia Bio also recently welcomed Katie Rogers to the organization. In her role as Director of Innovation & Entrepreneurship, Katie will focus on entrepreneurship initiatives connecting life science startups to resources needed to help them scale their ventures. She will also serve as the liaison for many of Georgia Bio’s committees and networks to ensure strong partnerships.

About Georgia Bio

Georgia Bio (GaBio) is the state’s most impactful life sciences membership organization, advocating for the sector and its diverse innovation pipeline. For more than 30 years, GaBio has served its members by supporting companies of all sizes, from early-stage innovators and startups to established industry leaders in the fields of biotechnology, pharmaceuticals, and medical technology. GaBio also works closely with universities, academic and research institutions, the investment community, and other critical partners that promote this vibrant sector. GaBio works to shape public policy, improve access to breakthrough technologies, educate lawmakers, provide member programs, strengthens the workforce pipeline, and advance equity within our ecosystem by championing innovative solutions for some of the most pressing challenges of our times. For more information, visit www.gabio.org | www.georgiabioed.org

MEDIA CONTACT:

Melissa Carter

404-920-2043

mcarter@gabio.org

Georgia Bio Announces City of Alpharetta as Newest BioReady® Community at Georgia’s Life Sciences Summit

mcarter@gabio.org (Melissa Carter) — Wed, 23 Oct 2024 20:58:58 GMT

The City of Alpharetta has been designated a BioReady® Gold Community by the state’s leading life sciences membership organization, Georgia Bio. To receive this distinction, communities must meet certain criteria and be able to support the growing biotech industry. This distinctive honor was presented this week to representatives of the City of Alpharetta at Georgia’s Life Sciences Summit, Georgia Bio’s largest annual gathering.

“The life sciences sector is a significant driver in the state of Georgia’s economy, and establishing BioReady® sites, like the City of Alpharetta, signifies Georgia’s readiness for future growth in this industry,” said Maria Thacker-Goethe, President and CEO of Georgia Bio. “This program allows municipalities to showcase biotech-zoned science parks, streamline permitting, build a robust infrastructure, and identify biotech-friendly sites more effectively, making them a desirable choice for industry with proven ability to be an excellent place for companies to do business and call home.”

“The City of Alpharetta is proud to receive the distinction of being a BioReady® Gold Community. Alpharetta is home to a number of innovative biotech and life sciences companies that are conducting important research and developing life-changing products,” said Alpharetta Mayor Jim Gilvin. “The BioReady® distinction speaks to Alpharetta’s commitment to supporting and attracting businesses in this growing industry.”

The BioReady® rating system rates communities in three tiers from Bronze to Silver to Gold. Through these BioReady® ratings, Georgia Bio seeks to provide cities and towns a platform to effectively tell their stories to the biotechnology industry, ultimately helping real estate developers and biotechnology companies find the most favorable destinations to locate.

Georgia Bio launched the BioReady® Community program in Georgia with the support from the non-profit’s partners at MassBio, a global life sciences and healthcare organization dedicated to advancing Massachusetts’ position in the life sciences. With a goal of helping local communities connect with leading life sciences industry representatives, Georgia Bio replicated the MassBio rating system program to determine a municipality’s readiness to host biotechnology facilities based on the community’s zoning practices and infrastructure capacity.

Learn more on the Georgia Bio’s BioReady Communities website .

About Georgia Bio

MEDIA CONTACT:

Melissa Carter

404-920-2043

mcarter@gabio.org

Celebrating Innovation: Georgia Bio Summit 2024 Company Showcase Winners

Fri, 18 Oct 2024 17:12:52 GMT

Celebrating Innovation: Georgia Bio Summit 2024 Company Showcase Winners

The Georgia Bio Summit 2024 was a remarkable gathering of life sciences leaders, innovators, and changemakers. This year’s Company Showcase featured 10 groundbreaking companies, all showcasing the cutting-edge innovation happening right here in Georgia and beyond. The level of competition was truly exceptional, and we are excited to announce the Top 3 Winners of the 2024 Showcase Summit:

1st Place: OrthoPreserve

OrthoPreserve impressed the judges with its innovative solutions in regenerative medicine and tissue preservation, paving the way for advancements in orthopedic care. Their work is not only transforming how we approach patient recovery but also demonstrating the impact of cutting-edge research in improving outcomes.

2nd Place: JellyCo USA

JellyCo USA stood out with its groundbreaking advancements in marine biomaterials. Their work is leading the charge in sustainable and scalable solutions for various applications, creating a meaningful impact on the future of life sciences.

3rd Place: NeurOp

NeurOp continues to push boundaries in neurological drug development, addressing unmet needs for patients with brain and nervous system disorders. Their innovation reflects a deep commitment to improving lives through science and discovery.

Honoring All Participants

While we celebrate our winners, we want to shine a spotlight on the other incredible companies that were part of this year’s showcase. These organizations exemplify the innovative spirit driving life sciences forward:

Atomistic Insights
Autofrax
Lena Biosciences
ARNAV Biotech
Intelligent Dots
Annoviant
OncoSpherix

Your dedication to advancing health and science inspires us all. Each of you contributes to making Georgia a hub for life sciences innovation, and we are honored to have you as part of our community.

A Bright Future for Georgia Life Sciences

This year’s Company Showcase proved that the future of life sciences in Georgia is brighter than ever. The level of talent, innovation, and collaboration on display underscores the importance of fostering a thriving ecosystem for startups and established companies alike.

As we look ahead, Georgia Bio remains committed to supporting these companies through programs, partnerships, and initiatives that drive growth and opportunity in the life sciences sector. Together, we’re not just building businesses – we’re improving lives and creating a healthier tomorrow.

Congratulations again to all participants and especially to our winners, OrthoPreserve, JellyCo USA, and NeurOp. We can’t wait to see the incredible advancements you’ll achieve in the coming years.

#GeorgiaBioSummit #LifeSciences #Innovation #Entrepreneurship #CompanyShowcase2024

Georgia Bio to Present Lifetime Achievement Award Posthumously to Lee Herron

mcarter@gabio.org (Melissa Carter) — Wed, 16 Oct 2024 16:54:13 GMT

Georgia Bio, the state’s life science trade association, will honor the late Lee Herron, an industry leader and long-time supporter of Georgia Bio, with its Lifetime Achievement Award at next week’s Georgia Life Sciences Summit which celebrates the contributions and achievements of Georgia leaders who have been instrumental in advancing the growth of the life sciences industry and elevating Georgia’s overall ecosystem. In its 35-year history, Georgia Bio has only ever presented five Lifetime Achievement awards.

Lee, who will long be remembered as a pillar and irreplaceable leader in the industry, retired from the Georgia Research Alliance (GRA) in the spring of 2024 after a 16-year career with the Alliance, most recently, Lee led GRA’s agricultural technology programs including the Greater Yield initiative. He directed its award-winning venture development program for 15 years, which helped to launch 200+ university-based companies that attracted more than $2 billion in equity investment. A seasoned executive, Lee harnessed his 20 years of entrepreneurial experience to help startups develop sound business strategies. Lee served in many community leadership capacities, including board positions for Georgia Bio and Southeast Life Sciences, the Global Center for Medical Innovation’s Industry Advisory Board, the Biolocity Oversight Committee, and the NSF Center for Cell Manufacturing Technology’s Commercialization Advisory Board.

“Lee was a true visionary whose passion and integrity touched everyone he met," says Georgia Bio President and CEO, Maria Thacker-Goethe. “His unwavering commitment to innovation and his profound impact on the life sciences industry will be felt for generations to come. We are honored to present him with this award posthumously.”

“The Georgia Research Alliance would not be what it is today without Lee Herron,” says GRA President and CEO Tim Denning, PhD. “Lee helped shape our program that moves university inventions to the marketplace — a program that he led and grew for 16 years. Countless technologies are at work in the world today, benefiting companies and consumers alike, because of Lee’s wisdom, guidance, and desire to make a difference.”

Prior to joining GRA, Lee managed the biosciences division of Georgia Tech’s Advanced Technology Development Center (ATDC) and founded four biosciences companies: SeaLite Sciences Inc., Biopool International Inc., CytRx Corporation, and Theragenics Corporation. Herron received a Doctor of Veterinary Medicine degree from the University of Georgia and completed an internship at Cornell University. He also studied experimental pathology at Emory University.

Lee passed away on July 12, 2024, after a long battle with cancer. He was a devout family man, husband to Rita Herron for 50 years, father to three children, and grandfather to eight children. He leaves behind a profound legacy and will be remembered by his friends and colleagues as a dear friend.

Award Presentation

Georgia Bio will honor Lee at the opening reception for the organization’s largest annual gathering, the Georgia Life Sciences Summit, taking place on October 21 at the Sandy Springs Performing Arts Center from 5:00pm to 7:00pm.

# # #

About Georgia Bio

Georgia Bio (GaBio) is the state’s most impactful life sciences membership organization, advocating for the sector and its diverse innovation pipeline. For over 30 years, GaBio has served its members by supporting companies of all sizes, from early-stage innovators and startups to established industry leaders in biotechnology, pharmaceuticals, and medical technology. GaBio also works closely with universities, academic and research institutions, the investment community, and other critical partners that promote this vibrant sector. GaBio works to shape public policy, improve access to breakthrough technologies, educate lawmakers, provide member programs, strengthens the workforce pipeline, and advance equity within our ecosystem by championing innovative solutions for some of the most pressing challenges of our times. For more information, visit www.gabio.org.

MEDIA CONTACT:

Melissa Carter

404-920-2043

mcarter@gabio.org

New Report Provides Critical Context to Government Claims of IRA So-Called Drug Savings and Explores the Law’s True Impact on Patient Costs

Sat, 12 Oct 2024 03:42:44 GMT

From our partners at We Work for Health

New research from the IQVIA Institute for Human Data Science further confirms what We Work For Health (WWFH) and others have warned against: the Inflation Reduction Act’s (IRA) price controls on prescription drugs will not achieve their stated goal of consistently reducing patient costs. Rather, several unintended consequences reduce choices for patients, raise costs for many, and threaten the development of future therapies.

While significant media coverage and political chatter about the impact of the IRA continues, little actual analysis of the law’s policies in practice from the patient perspective is available – until now. Researchers at the IQVIA Institute examined how much patients actually pay for the first 10 medicines subject to Medicare’s price controls and what, if any, impact IRA’s policies would have on patient costs.

The IQVIA Institute researchers also reviewed what savings Medicare would achieve from these policies in 2026 given the changing drug use dynamics and compared that to government estimates of program savings. The researchers found:

Government price controls are unlikely to lead to consistent reductions in patient costs, with many patients experiencing negligible savings or even paying more.
The law is likely to lead to significant changes in the drug coverage Medicare beneficiaries experience, including insurers placing so-called negotiated medicines on higher formulary tiers where patient cost sharing may be higher. Though the price setting does not take effect until 2026, changes in Medicare drug coverage are already causing changes people will experience – including premiums increases in 2026.
CMS’ claim that the IRA will save Medicare $6 billion based on 2023 spending is likely an inaccurate and misleading overestimate, because it assumes there will be no other changes to the net prices or utilization of the selected drugs and that no new biosimilar or generic options will become available between 2023 and 2026.

One of the IRA’s stated goals was to lower the cost of medicines, and it aimed to do so with three main policy changes: a $35/month insulin cap; a $2,000 annual out-of-pocket cost cap; and price controls on prescription drugs. Yet this approach fails to consider the other factors that go into what a patient ultimately pays at the pharmacy counter and the implications the IRA would have on insurance plan design.

While the cap on out-of-pocket spending will reduce costs for some patients with high drug spending, price controls are unlikely to reduce out-of-pocket costs for most patients. This is because the IRA ignores the reality that what patients pay for medicines is determined by their health plan and is the result of a complicated process heavily influenced by insurance plan design and not by the medicine’s initial list price.

This report illustrates how patients taking any of the 10 drugs chosen for price setting would interact with the insurance and their resulting copay or cost sharing under IRA.

Prior research notes that people who pay a fixed copay for their medicines may pay the same amount for their drugs under the IRA, though the drugs are subject to price controls. Whether their access to those medicines remains the same, however, is questionable. If plans change where these drugs are on their formularies, patient costs may shift to coinsurance, resulting in a significant increase in patient costs for most drugs in this group.

Plans may choose to move these drugs to non-preferred tiers due to the reduction in rebates, which would cause a shift in cost sharing structure. A co-insurance design of 40% would be used, resulting in a substantial rise in patient OOP costs for most drugs in this group.

We Work For Health continues to call on policymakers to recognize the consequences and not double down on the IRA’s many flaws. IQVIA’s findings provide more evidence for lawmakers to understand the negative impact of the IRA’s government-mandated drug pricing provisions and the urgent need to prioritize patient- and innovation-centric pathways forward.

Read the full press release and report .

Moonlight Tx nets $5M in Series A round

Thu, 03 Oct 2024 23:45:36 GMT

Moonlight Tx nets $5M in Series A round

With the investment, Georgia Tech-launched Moonlight Therapeutics will evaluate its first food allergy treatment in clinical trials.

How and why: Called MOON101, the treatment is a skin stamp (above) that delivers drugs through needles small enough to be painless. The platform’s first drug is aimed at people with peanut allergies.

What’s unique: MOON101 overcomes skin barriers to deliver an allergen to an area of the skin that has an abundance of immune cells. It’s a complex drug delivery system in a simple stamp that’s applied daily.

The latest backers: Portal Innovations, Inc. co-led the investment round, with AllerFund and Invest Georgia also investing. Based in Chicago, Portal Innovations held its grand opening for its Georgia HQ on Sept. 24 in Atlanta.

Significance: Clinical trials for MOON101 can now begin sooner.

Read the Hypepotamus article on the investment >
See GRA’ s recent feature on Moonlight Therapeutics >

With GCMI’s Help, Micron’s Microarray Needle Technology Nearer To Forever Changing the World for the Better

Thu, 03 Oct 2024 16:50:34 GMT

“This, this success is the desired result”

Medical device and biotech or medtech innovation doesn’t work like consumer electronics or software. It works more like aerospace. Because lives are literally at stake it needs more than a place for people to work, high speed internet, brilliant minds and dedication. It needs certified clean rooms, highly expensive equipment and advanced materials, intensive validation testing and rigor at every level of its pathway to commercialization and positive health outcomes.

What successful university bred biotech innovation looks like

Like many game-changing technological advancements, Micron Biomedical’s story begins in a public institution of higher education, its research labs and an unmet clinical need; this one global in scale. With origins in Professor Mark Prausnitz’ Laboratory for Drug Delivery at Georgia Tech, Micron Biomedical has taken a massive unmet clinical need – safe, effective, affordable delivery and administration of therapies and vaccines in every corner of the globe – and created a device technology proven in its potential to successfully meet that need.

Put simply, Micron’s technology delivers traditionally injected vaccines and medicines without needles through a dissolvable microarray technology. It offers access to life-saving pharmaceuticals for children and adults and allows painless, self-administration of therapeutics and vaccines, in seconds to minutes—at home, in the field, and wherever they are needed—without the need for a medical professional to administer them, all with the push of a button. It eliminates or greatly reduces the need for cold chain during delivery and/or storage; reducing transportation and storage costs; allowing safe vaccine and drug administration by non-medical personnel; reducing medical waste; and offering needle-free solutions to address vaccine hesitancy and improve patient compliance.

Since its inception in 2014, Micron has raised roughly $50 million dollars in non-dilutive funding, venture investment and R&D reimbursement from pharma and biotech collaborators for its demanding journey from the lab to patients. Funding includes seed stage support from the Georgia Research Alliance (GRA), a $23.6 million gift from the Bill and Melinda Gates Foundation in November 2023 along with a $17 million Series A round co-led by Global Health Investment Corporation (GHIC) and LTS Lohmann earlier the same year.

According to the company, “Micron partners with and/or receives funding from private and public pharmaceutical and biotech companies, the [aforementioned] Bill & Melinda Gates Foundation, the Centers for Disease Control and Prevention (CDC), the U.S. Center for Biomedical Advanced Research and Development Authority (BARDA), PATH and the Georgia Research Alliance (GRA).”

“Game changing potential in humanitarian settings”

In May 2024, The Lancet published positive Measles and Rubella (MR) Phase 1/2 trial data utilizing Micron’s novel vaccine delivery device. A comment in the same issue described the implications of the data and recognized microarray technology for its potential as “game-changing in humanitarian settings.”

“Thanks to the support and funding of our partners we are focused on ending preventable diseases in low and middle income nations,” Micron Technologies CEO Steven Damon told our colleague Paul Snyder. “Children are still dying of measles due to lack of access to vaccination. Vaccines need refrigeration in transit and they need qualified clinicians to administer them. Trial results with our microarray needle technology showed prevention against measles better than or equal to subcutaneous injections. These trials and results represent the highest levels of importance in global health improvement. Improved access to vaccinations that utilize Micron’s technology can save lives and may well eradicate measles worldwide.”

Micron’s microarray technology, combined with important vaccines and drugs, including measles and rubella, are manufactured at the Global Center for Medical Innovation (GCMI), a Georgia Tech affiliate.

“We are also focused on effectively addressing the next global pandemic with vaccines that can be administered in the home without the need for a healthcare professional instead of waiting in lines by the thousands at large gathering places,” Steven said.

“Partners like BARDA, the CDC and the Gates Foundation charge us with mandates to solve problems with global impact. Be those national health security problems, pandemic, epidemic, or health issues rooted in problems of social access like measles and rubella, Micron leads the way to improving access. Having spent billions of dollars in response to the Covid-19 pandemic, BARDA now has equity investment in Micron via the Global Health Investment Corporation fund, a sign of how strongly they believe in the technology. Many of the leading minds in global health understand the magnitude of the impact our work has, and can, accomplish.

“This impact would not be possible without GCMI.”

Micron has multiple clinical trials for important vaccines and drugs ongoing and planned with a focus on low and middle income countries as well as high income countries like the United States.

GCMI’s 2024 State of Medtech Innovation Report: Part 1

Sat, 21 Sep 2024 01:39:44 GMT

AI Dominates, But Attention to Manufacturing, Supply Chain and Funding Remain Paramount to Success in Medtech Innovation in 2024 and 2025

AI’s potential and momentum in healthcare and medtech are massive. But the need for safety assurance remains paramount as regulators try to mitigate the risk of a technology that has many waypoints to achieve in the clinical care setting especially for diagnosis.

With support for note taking, scheduling, hybrid engagement moderation and reporting or simply your virtual assistant or pinpoint wayfinder; AI has become ubiquitous in our daily lives, professional and personal, with a relatively rapid rate of accuracy and maturity.

Though it may feel like it when you are juggling multiple tasks at once, lives are not at stake in those activities. While AI has shown high potential in many healthcare endeavors including drug discovery, engagement moderation and reporting, clinical trial design and enrollment, diagnostics, imaging systems and patient monitoring devices, early disease detection, predictive analytics, and personalized medicine, relatively simple tasks assigned to AI like medical summaries are still prone to errors or “hallucination.”

This month, Medcity News reported , “In the 50 summaries produced by GPT-4o, the researchers identified 327 instances of medical event inconsistencies, 114 instances of incorrect reasoning and three instances of chronological inconsistencies.

“The 50 summaries generated by Llama-3 were shorter and less comprehensive than those produced by GPT-4o, [Prathiksha Rumale, one of the study’s authors,] Rumale noted. In these summaries, the research team found 271 instances of medical event inconsistencies, 53 instances of incorrect reasoning and one chronological inconsistency.

“‘The most frequent hallucinations were related to symptoms, diagnosis and medicinal instructions, highlighting the fact that medical domain knowledge remains challenging to the state-of-the-art language models,’ Rumale explained.”

However, regulators like the US FDA are charged with limiting risk and ensuring patient safety first and foremost. AI, especially generative AI, for diagnostic purposes has some distance to go before it can achieve confidence among regulators that it has sufficiently mitigated certain risks and is safe for substantial clinical utility as its potential suggests it might be able.

GCMI Medical Director Emily Blum, MD

The nature of AI and ML will require more substantial investments by innovators for quality systems and post market surveillance

“This field will continue to evolve quickly, and constantly,” said GCMI Medical Director Emily Blum, MD. “Innovators integrating AI technologies into their new devices will need to be nimble. They will need to partner with software engineers with experience managing AI and machine learning (ML) systems long-term, keeping the associated data clean and manageable as regulatory guidance documents change. They will also need a robust quality management system in place to make compliance documents more easily accessible and available to submit to regulatory bodies rather than having to stop what they are doing and scramble to comply.”

“Because the technology is evolving so quickly, and it will continue to do so, innovators need to pay close attention to regulatory news on the topic,” says GCMI Interim Executive Director Saylan Lukas. “Pre-sub calls with the FDA will be a must for new devices with an AI component. They will need to be regulated differently from other medical devices and technologies. Regulatory approvals for these will not be locked in place, approved and frozen once they enter the market and clinical utility. They will require significantly more post market surveillance, which will also impact business models and team investment requirements to support those post market activities and technological evolution inherent in its qualities and nature.”

“If AI by its very nature is constantly evolving, how do we ensure it is not learning the wrong lessons potentially leading to adverse events?” Emily asks.

“The only way to know is to test it,” Saylan says. “But what will be the appropriate post-market interval required by regulators? Is an annual ‘check up’ too burdensome? Is five years too long? Those are questions the industry as a whole, especially regulatory bodies, has to answer.”

“Just like physicians have to take qualification tests and accrue continuing medical education (CME) credits, the FDA is recognizing that AI is trained continuously and needs to be tested at regular intervals just like physicians do,” Emily says. They are establishing standards to do so.”

FDA’s AI/ML Regulatory Framework

The FDA is actively working to create a regulatory framework that addresses the unique challenges, including ethics concerns, posed by AI and ML in medical devices. In January 2021, the FDA released an AI/ML Action Plan, which outlines a pathway for the regulation of software as a medical device (SaMD) that utilizes AI and ML. The plan emphasizes the importance of a “total product lifecycle” approach, where AI/ML-based devices are monitored and updated throughout their use to ensure they remain safe and effective.

According to McKinsey & Company, “ Innovators should develop protocols for implementing updates to AI/ML algorithms, which will need to be reviewed and potentially re-approved by the FDA depending on the risk level of the changes.”

GCMI Interim Executive Director, Saylan Lukas

In the pre-market stage, innovators need to engage with the agency early in the development process to discuss the regulatory pathway along with data and other evidence for market approval. “Presub” meetings are always of high value for innovators,” Saylan says. “They will be paramount for innovators seeking to successfully commercialize technologies with a critical AI component.”

The FDA is collaborating with international bodies to develop standards and best practices for AI/ML development (Good Machine Learning Practices – GMLP), ensuring consistency in how these technologies are validated and implemented. The agency’s 10 “Guiding Principles of Good Machine Learning Practice for Medical Device Development” can be found here .

Like Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), regulators will look closely at adherence to GMLP guidelines. How are you controlling the code? Who can make changes? What does your post market analysis look like?

EU Regulatory Landscape

In Europe, the regulatory environment for AI and ML in medical devices is shaped by the Medical Device Regulation (MDR), which took effect in May 2021. The MDR places a strong emphasis on the clinical evaluation of AI-based devices, requiring robust evidence of safety and performance before they can be marketed. Additionally, the European Commission is developing the Artificial Intelligence Act, which will impose further requirements on high-risk AI applications, including medical devices. This Act is expected to introduce strict compliance obligations related to transparency, risk management, and human oversight of AI systems ( AlphaSense ).

In fact, CNBC reported , “The European Union’s landmark artificial intelligence law officially enters into force [August 1st, 2024] — and it means tough changes for American technology giants.

“The AI Act, a landmark rule that aims to govern the way companies develop, use and apply AI, was given final approval by EU member states, lawmakers, and the European Commission — the executive body of the EU — in May.”

Will the US FDA follow suit? Time will tell, but some level of agreement and alignment is likely.

“The FDA is compelled to do everything in its power to ensure patient safety first and foremost,” Emily says. “Imagine this summer’s Crowdstrike event affecting the healthcare system in many more orders of magnitude than it did.”

AI and ML advancements for healthcare and medtech, along with new and nascent regulatory guidelines reflect a growing recognition of the potential and risks associated with AI and ML in healthcare. As these technologies continue to evolve, regulatory bodies are working to strike a balance between fostering innovation and ensuring patient safety.

Medtech innovators who’s new technologies have critical AI or ML components will need to proactively engage with regulatory bodies early and often to make the approval process as smooth as possible regardless of the disease state or therapeutic area of interest. Gathering clean, quality data to support product development (and improvements) along with strong quality and post-market monitoring systems is paramount throughout the product’s design, development and commercialization lifecycle.

Cybersecurity Regulations

As cybersecurity threats have increased, so have regulatory requirements. As previously mentioned, the Crowdstrike episode wrought havoc on hospitals and health systems. Imagine what it could do to medical technologies reliant upon AI and ML.

The FDA has added Section 524B to the Federal Food, Drug, and Cosmetic Act, which mandates that all new medical device applications include a cybersecurity plan. This plan must detail how manufacturers will monitor, identify, and address potential cybersecurity risks.

Devices, especially those connected to the internet, must have robust security features, and innovators should integrate these considerations from the design phase. Plante Moran succinctly stated, “Detailed cybersecurity documentation must now be a part of regulatory submissions, requiring collaboration between product developers and cybersecurity experts.”

In conclusion, the latest advancements in AI, ML, and other medical technologies offer significant opportunities for innovators in specific therapeutic areas. However, navigating the regulatory landscape and addressing the unique challenges of each application will be crucial for bringing these innovations to market successfully.

Thanks for reading! Stay tuned for part 2 in which we unpack US / EU regulatory alignment, wearable tech, 3D printing, funding and the supply chain should lead medtech innovators’ awareness for the balance of 2024 and 2025.

Proposals to Weaken IP Rights Will Devastate U.S. Life Sciences Industry

mthacker@gabio.org (Maria Thacker Goethe) — Mon, 16 Sep 2024 18:49:11 GMT

From concept to commercialization, the United States is a global leader across all stages of biopharmaceutical product development. Partnerships between research universities, non-profit institutions and the federal government play a significant role in bringing an innovative product from the research stage to a treatment that can transform lives.

However, in an ill-conceived attempt to lower prescription drug costs, the White House is proposing to weaken critical intellectual property protections on certain biopharmaceutical innovations. This decision will weaken our national ability to develop medications, respond to public health threats and advance biomedical innovation.

The U.S. life sciences and biotechnology industry is a significant driver of our national economy. Our biopharmaceutical industry supports nearly 5 million jobs, as companies and employers nationwide work to research, develop and bring to market treatments that address and treat chronic and debilitating health conditions.

Bringing a new treatment from a lab to a patient’s medicine cabinet requires significant time, resources and funding. Strong IP rights, such as patents and copyrights, allow companies to retain market exclusivity and recoup investments made in developing a drug.

Collaboration between our public and private sectors plays a significant role in bringing a product to consumer’s hands. Many companies partner with universities or non-profits to help commercialize their research.

Congress has long recognized the value of this collaboration. In 1980, federal lawmakers passed the Bayh-Dole Act, a law that incentivizes continued partnership between public and private institutions in the name of bringing cutting-edge innovations to Americans. Bayh-Dole enables research universities, non-profit institutions, and small businesses to own, patent and commercialize inventions developed under federally funded research programs.

These entities are at the forefront of research, but often lack the resources needed to successfully bring a product to market. Bayh-Dole encourages these institutions to find commercial partners to help bring inventions to consumers. The legislation contributed to the launch of 300 drugs between 1996 and 201. Federally funded research brings three products to market daily.

However, through a provision in the Bayh-Dole Act that allows the federal government to “march in” and seize patents on drugs created with federal funding, the White House is advancing a proposal to seize patents on drugs deemed to be too expensive. This misguided interpretation of the Bayh-Dole Act directly contradicts the original intent of the legislation and will jeopardize the nation’s life sciences innovation ecosystem.

The law grants the federal government so-called march-in rights only under specific circumstances, all centered on whether the patent holder has made a timely effort to commercialize the product. The National Institutes of Health has previously denied all march-in requests because no request has ever fit the specific circumstances outlined in the law.

Abusing march-in rights will have devastating consequences across the process of bringing medication to patients in need. Should the federal government seize patents on drugs made with federal funding, universities and small biotech companies will have to spend more time navigating bureaucracy and less time researching and developing innovations. Ultimately, vulnerable patient populations will bear the brunt of weakened IP protections, with fewer revolutionary medications and clinical trials available.

Sen. Bill Cassidy, R-La., ranking member of the Senate Health, Education, Labor, and Pensions Committee, recently sent a letter to the Department of Health and Human Services highlighting that the proposals to exercise march-in rights as a means to lower health care costs is just one example of egregious executive agency overreach. He notes that efforts to exercise march-in rights may not stand in the light of the Supreme Court’s decision to reform the ability of federal agencies to interpret ambiguities in laws.

The United States excels in life sciences and biotechnology innovation, partly due to federal policies that facilitate bringing products to consumers, such as the Bayh-Dole Act. It is critical that the White House not move forward with efforts to weaken IP protections through abuse of march-in rights. Without a strong IP framework, universities and small businesses, our local economy, and, most important, patients across the country will suffer the consequences that come with misguided bureaucratic efforts to lower prescription drug costs.

Source: https://dcjournal.com/proposals-to-weaken-ip-rights-will-devastate-u-s-life-sciences-industry/

Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem

Fri, 13 Sep 2024 19:27:50 GMT

In 1984, the Hatch-Waxman Act – formally known as the bipartisan Drug Price Competition and Patent Term Restoration Act – established a legal and regulatory framework that propelled the modern biopharmaceutical industry.

Forty years later, the U.S. biopharmaceutical industry thrives with a balance of innovation and affordability, thanks to the law that encourages companies to research and develop cutting-edge medicines while creating a process for lower-cost generics with the same clinical benefit to come to market.

As we approach this milestone anniversary, however, the system that has created so many breakthroughs faces a critical threat. Misguided attempts by policymakers to address drug costs by weakening intellectual property protections would upend the delicate balance that has enabled America’s life sciences industry to create life-saving cures. A proposal to invoke so-called march-in rights on patents for drugs that were supported in part by federal funding would jeopardize investments in groundbreaking research and undermine the incentives for the discovery of new treatments. This ultimately harms patients who depend on new therapies.

Affordable generics are born from the significant research and investment needed to produce branded drugs. Weakening crucial intellectual property protections will lead to neither being developed.

As we reflect on the 40 years of progress enabled by the Hatch-Waxman Act, patients are counting on policymakers to preserve the delicate balance between innovation and affordability that has made the United States a global leader in developing new medicines.

Learn more about the Hatch-Waxman Act here , and learn more about America’s leadership in the life sciences at www.weworkforhealth.org/ip .

CoreRx, Societal CDMO, and Bend Bioscience Unite Under the Bend Bioscience Brand to Provide World Class CDMO offering

Thu, 05 Sep 2024 00:06:14 GMT

BEND, Ore., Sept. 4, 2024 /PRNewswire/ -- In a significant move, CoreRx, Societal CDMO, and Bend Bioscience have announced their unification under the Bend Bioscience brand. This merger brings together three highly respected organizations, each with a unique legacy and distinct strengths, to form a comprehensive contract development and manufacturing organization (CDMO) that offers an end-to-end suite of services.

The decision to adopt the Bend Bioscience name reflects the company's commitment to innovation, technical excellence and unmatched customer service; a reputation established by Bend Bioscience since its inception. However, this unification equally honors the rich legacies of CoreRx and Societal CDMO, whose contributions and expertise will be foundational to the new brand.

CoreRx has long been recognized for its innovation in formulation development, providing customized, cutting-edge solutions that address some of the most complex challenges in drug development. Their specialized knowledge in the creation of innovative drug delivery systems and complex formulations will continue to be a critical component of Bend Bioscience's expanded service offerings.

Societal CDMO provides deep expertise in scalable manufacturing and commercial production, with a proven track record of quality and reliability. Their robust capabilities in cGMP manufacturing, packaging, and supply chain management complement the scientific and technical strengths of both CoreRx and Bend Bioscience, allowing the newly combined organization to offer a fully integrated development-to-commercialization pathway for its clients.

KEEP READING: https://www.prnewswire.com/news-releases/corerx-societal-cdmo-and-bend-bioscience-unite-under-the-bend-bioscience-brand-to-provide-world-class-cdmo-offering-302237436.html

Website: https://bendbioscience.com/

Georgia Life Sciences: Anti-Racism Statement and Commitment to Diversity, Equity, and Inclusion

mthacker@gabio.org (Maria Thacker Goethe) — Fri, 23 Aug 2024 23:52:10 GMT

At Georgia Life Sciences, we believe inclusive excellence is fundamental to advancing innovation, improving health outcomes, and strengthening the life sciences economy. Our mission—to expand access to breakthrough technologies and enhance the well-being of people worldwide—can only be realized when every voice is heard, valued, and respected.

We denounce all forms of racism, discrimination, and hate. Our organization stands firmly against actions or rhetoric that seek to divide based on race, ethnicity, religion, gender, or any other identity. These principles are non-negotiable and remain central to our work.

We know that diverse perspectives fuel scientific discovery, business innovation, and workforce resilience. As a statewide, nonpartisan convener, Georgia Life Sciences is committed to fostering a life sciences ecosystem that reflects the diversity of the communities we serve.

This commitment includes:

Continual Learning and Accountability: We are committed to listening, adapting, and evolving our practices to ensure fairness, access, and opportunity across our programs and partnerships.
Expanding Access: We work intentionally to ensure underrepresented voices are included in shaping Georgia’s life sciences future—from workforce development to innovation to policy.
Collaborative Leadership: We invite our members, partners, and stakeholders to join us in building a more inclusive, equitable, and impactful life sciences community—together.

Inclusive excellence is not a separate initiative—it is a foundational value that informs everything we do.

BIO Statement On Selected Drugs in Medicare under Inflation Reduction Act

Thu, 15 Aug 2024 22:31:25 GMT

The Biotechnology Innovation Organization (BIO) released the following statement after today’s announcement from the Centers for Medicare & Medicaid Services (CMS) on selected drugs under the Inflation Reduction Act (IRA):

“While the Inflation Reduction Act puts a cap on senior’s out-of-pocket costs, it also contained some very damaging parts that will impede the development of newer and better medicines for all. Important aspects of the IRA are also damaging to the critical role of the United States and our allies to remain the centers of excellence in biotechnology worldwide. With today’s announcement, we see the start of unilateral government mandated price controls. This will inevitably lead the U.S. on a path to higher costs for patients and less access to innovative medicines.

“The lack of transparency and a scientific approach to decision-making throughout this process undermines the value that these medicines bring to patients in the U.S and around the globe. We are also just beginning to see the harm to patients caused by the unintended consequences of penalizing medicines made as pills. The IRA also includes a damaging provision that will curtail the development of medicines for multiple rare genetic diseases.

“At the same time, Congress and the administration must turn their full attention to health insurers and middlemen who profit by denying Medicare patients and others access to the medicines that their doctors prescribe. This is the source of high costs at the pharmacy and the denial of access to lifesaving treatments and cures. Delay and denial from health insurance companies equals suffering and death. This must be addressed, as well as correcting the most egregious parts of the IRA.”

Rowen Foundation - Gwinnett is BioReady Gold Certified

Wed, 14 Aug 2024 21:07:27 GMT

AdvaMed Statement on Final TCET Notice

Fri, 09 Aug 2024 01:18:35 GMT

WASHINGTON – AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker on the final Transitional Coverage for Emerging Technologies (TCET) notice from the Centers for Medicare and Medicaid Services (CMS):

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering. The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS. And the exclusion of diagnostics is disappointing, particularly considering the potential for a breakthrough diagnostic technology to save not only lives but costs to the health care system overall through earlier detection. While we appreciate that CMS has released the rule, we call on Congress to finish the job by passing HR 1691, the Ensuring Access to Critical Breakthrough Products Act. Too many patients in need of breakthrough diagnoses and treatments are counting on it.”

Rea d at AdvaMed: https://www.advamed.org/industry-updates/news/advamed-statement-on-final-tcet-notice/

CMS released the TCET Final Notice; its text is here .

Georgia Bio Names 2024 Golden Helix Award Winners

Fri, 09 Aug 2024 00:56:09 GMT

Georgia Rep. Mark Newton, Academic Innovators, & Industry Leaders to be Honored at Georgia Life Sciences Summit in October

Georgia Bio, the state’s life science trade association, will honor the 2024 Golden Helix awardees October 21 at the opening reception of the Georgia Life Sciences Summit.

The Golden Helix Awards celebrate the contributions and achievements of Georgia legislative, academic, corporate, and advocacy leaders working to advance the growth of the life sciences industry and foster strategic partnerships that can create a healthier world. Traditionally, awardees are honored each spring at the awards gala, but this year Georgia Bio leadership decided to celebrate at the organization’s largest annual gathering. The Georgia Life Sciences Summit is expected to draw 350+ of the state’s life sciences industry leaders and will kick off with a Georgia Company Showcase highlight the best of the state’s emerging companies.

“The life sciences community strives to improve patients’ lives, reduce our environmental footprint, use less and cleaner energy, and support workforce development, all while growing Georgia’s bioeconomy” said Georgia Bio CEO Maria Thacker Goethe, “The Golden Helix Awards highlights those lasting contributions made by many in the life sciences sector in Georgia.”

Companies being honored with the distinguished Deal of the Year award include: Veranex for the acquisition of leading preclinical services provider T3 Labs ; Werfen for the acquisition of transfusion and transplant diagnostics leader Immucor ; life sciences manufacturer Meissner ’s nearly $250 million investment into a new manufacturing facility in Athens-Clarke County; Dalan Animal Health ’s $4.5M series seed 3 funding to accelerate global expansion and product pipeline; Inhibikase Therapeutics ’ $10M raise for the development of treatments for Parkinson’s Disease and chronic myelogenous leukemia; Micron Biomedical ’s $23.6M from the Bill & Melinda Gates Foundation to accelerate commercial manufacturing of their needle-free vaccines; and the NIH grant awarded to Emory, Georgia Tech & Children’s Healthcare to advance diagnostics. The Legislator of the Year Award will honor Georgia Representative Mark Newton of 127th House District for his leadership in sponsoring the rebate pass through bill in 2023, and his overall work on behalf of patients in Georgia.

The Metro Atlanta Chamber will present this year's Phoenix Award for life sciences to Wellstar MCG Health . This award celebrates the best industry and academic collaboration. The 2023 union of Wellstar and Augusta University is a move that bolsters healthcare in the region and will advance innovation.

The awards were selected by a small, distinguished committee of leaders in the Georgia ecosystem who assessed nominations and transactions closed between January 1, 2023 -December 31, 2023.

AWARD WINNERS 

Legislator of the Year Award : Presented to state legislators for their support of the life sciences industry in Georgia. 

The Honorable Mark Newton M.D., Georgia House of Representatives

Phoenix Award :  The Phoenix award represents the iconic "rising from the ashes" of the Phoenix, a symbol of strength, tenacity and leadership and is presented to celebrate the best Industry and Academic collaborations, outstanding healthcare professionals and systems, or other partnerships that drive translation and lead to new treatments and cures. This award is sponsored by the Metro Atlanta Chamber. 

Wellstar MCG Health

Deals of the Year Awards:  Presented to one or more companies or institutions for the most significant financial or commercial transactions closed from January 1, 2022-December 31, 2022, based on the importance of the transaction to Georgia’s life sciences industry. 

Acquisitions 

Veranex completes acquisition of T3 Labs
Werfen completes acquisition of Immucor, Inc.

Economic Development

Meissner

Private Financing 

Dalan Animal Health
Inhibikase Therapeutics
Micron Biomedical

Public Financing 

Emory, Georgia Tech & Children’s Healthcare land major NIH grant for diagnostics

Community Awards:  Presented to a small number of individuals, companies or institutions whose contributions to Georgia’s life sciences community are worthy of special recognition. 

Emily Blum, Global Center for Medical Innovation
Ashley Cornelison, Portal Innovations
Betty Pace, Georgia Cancer Center, Augusta University
Connor Seabrook, Georgia Research Alliance
The United States Patent and Trademark Office (USPTO) New Atlanta Regional Office

Innovation Awards:  Presented to the department, institution, company or individuals who are forging new ground by thinking outside traditional paradigms to create some unique technology. 

Tom Barrows, ProgenaCare Global - ProgenaMatrix®
Jack Huang, University of Georgia - DE-FLUORO

Emerging Leader of the Year Awards : Presented to young individuals who have made a significant impact on the life sciences industry through their studies or employment. 

Eddie Lai, Metro Atlanta Chamber

Teacher of the Year Award:  Presented to a Georgia biotechnology high school teacher who exhibits excellence in STEM teaching and support for the biotechnology pathway. 

Emily Gunderson, Empower College and Career Center, Jackson County

For a list of past award recipients,  click here.  

# # #

About Georgia Bio

MEDIA CONTACT:

Melissa Carter

404-920-2043

mcarter@gabio.org

EIN: https://www.einpresswire.com/article/734167122/georgia-bio-names-2024-golden-helix-award-winners

$11.3 million Program Project grant helping identify causes of vascular disease

Thu, 08 Aug 2024 17:20:32 GMT

AUGUSTA, Ga. (Aug. 8, 2024) – With a new $11.3 million Program Project grant from the National Institutes of Health, experts from the Vascular Biology Center at the Medical College of Georgia at Augusta University are working to better understand the underlying mechanisms of cardiovascular disease.

“Blood vessels are critical for the transport of oxygen, nutrients, and immune cells and when they don’t function properly it not only impacts the function of the heart, but other organs such as the lung, eye, brain and even our muscles. A key regulator of blood vessel function is a thin layer of cells lining the inside of all blood vessels, called the endothelium”, explains co-program director Tohru Fukai, MD/PhD . Those endothelial cells and finding ways to fix them when they become dysfunction is a critical focus of this new five-year grant.

CLICK HERE TO KEEP READING AT https://www.eurekalert.org/

Georgia Bio’s Megan Heaphy Named to the 2024-2025 Education Policy Fellow Program

Tue, 06 Aug 2024 22:08:45 GMT

Atlanta, GA (August 5, 2024) – The Georgia Partnership for Excellence in Education is thrilled to announce the selection of 24 new fellows for the 17th cohort of the Education Policy Fellowship Program (EPFP), including Megan Heaphy, Director of Georgia Bio’s Biotech Teacher Training Initiative & Manager of Workforce & Talent.

This cohort of leaders are embarking on an intensive 10-month journey through Georgia's education policy landscape that will begin in August 2024 and conclude in May 2025.

The participants will hear and discuss education policy with the most respected policy makers in the state and nation. At the end of a year, EPFP Fellows will be better informed, more skillful advocates for sound public policy.

“Georgia Bio congratulates Megan and her acceptance into this prestigious program,” said Maria Thacker-Goethe, President and CEO of Georgia Bio. “This experience will not only provide Megan with valuable leadership training skills, but also the organization more knowledge and networks to advance the core issues of education policy that align with our efforts to strengthening Georgia's bioscience workforce.”

Heaphy has been with Georgia Bio for over 6 years and oversees workforce development efforts spanning the entire workforce pipeline, from K-12 to the current workforce. She has over a decade of experience in science education, having taught Chemistry, Biology and AP Biology in metro Atlanta high schools in Clayton and Gwinnett counties, as well as life sciences courses at Gwinnett Technical College and Georgia State University. Heaphy serves in various leadership roles including with Atlanta Technical College, Central Georgia Technical College, Athens Technical College bioscience program advisory boards, and the Athens Community Career Academy Biomanufacturing Catalyst Committee.

A Georgia native, with degrees from Georgia Institute of Technology and Georgia State University, Heaphy has a passion for helping educators and students gain awareness of pathways to employment within life sciences and ensuring that schools have the materials to do hands-on science labs through the Georgia Bio Equipment Depot.

MEDIA CONTACT:

Melissa Carter

404-920-2043

mcarter@gabio.org

EIN Press Release: https://www.einnews.com/pr_news/733499127/georgia-bio-s-megan-heaphy-named-to-the-2024-2025-education-policy-fellow-program

Georgia Bio Receives Increase in State Funds for Teacher Training Initiative and Reveals Most Recent Impact Numbers

Mon, 05 Aug 2024 22:15:02 GMT

The program has reached 81,413 students and 519 teachers across Georgia.

Atlanta, GA (August 5, 2024) – Georgia Bio’s Biotech Teacher Training Initiative (BTTI), formerly known as the Rural Teacher Training Initiative (RTTI), secured a significant increase in state funding in Georgia’s Fiscal Year 2025 budget. Total state funding now sits at $500,000. This investment from the state will be matched by industry donations in both cash and equipment, bringing the value of this program to $1+ million. Prior to receiving this increase in funding, the program conducted its fifth year of career-relevant instruction via hands-on teacher learning, impacting nearly 30,000 students and 150 teachers. In its first five years, the program has reached 81,413 students and 519 teachers across Georgia. Going forward, in conjunction with the additional funding and gifts from industry, BTTI will be able expand its operations in the urban areas of the state, impacting even more teachers and students.

This programmatic increase will support several initiatives, including hosting an additional cohort of teachers annually in an urban area where the density of industry sits, such as Atlanta or Augusta, and expanding the Equipment Depot and access to lab equipment. Plans for increased access include opening one satellite science equipment loaning office in Northwest Georgia , developing a shipment option with matching private funding, and potential for another satellite location in South Georgia. Further, funds will be allocated toward collaborating with Southwest Georgia RESA to provide teacher training for new science teachers in areas struggling to fill teacher positions, offer training and career path information for guidance counselors on opportunities in the life sciences, explore curriculum enhancement to include medical devices , and network with existing teachers.

“Georgia Bio is the only organization in the State that offers this type of hands-on training program, complemented with classroom supplies and access to career pathway understanding,” said Maria Thacker-Goethe, President and CEO of Georgia Bio . “Investing in improving access to resources for educators can open life changing careers for students and be a boon to Georgia’s economy, and this increase in funding signifies that the State agrees. As the industry continues its rapid growth across the state, our companies need to know there is a workforce pipeline being developed and we help innovatively address that need. I am excited for the future of BTTI and grateful for the support of the State and members of our industry as we endeavor to build upon this program’s value and success.”

“With the explosive growth in biotechnology has come the heightened need for a qualified workforce,” says BTTI Instructor Stan Harrison, also Biotech Pathway Teacher at the Athens Community Career Academy and State Coordinator for the Biotechnician-Assistant Credentialing Exam (BACE) . “We hear it echoed again and again that companies are struggling to hire and retain qualified production staff and therefore unable to manufacture high demand and often life-saving products. Quality training starts with highly trained secondary teachers who understand industry recognized standards. Georgia Bio’s BTTI provides a host of professional learning workshops and along with the Equipment Depot, a structured means to network and access cutting edge materials for modern lab training.”

BTTI is a public/private workforce development partnership between the life sciences sector and the State of Georgia. Led by Program Director, Megan Heaphy, BTTI offers hands-on, immersive science teacher professional development for Georgia teachers state-wide. Curriculum is built to highlight and leverage the biotechnology that exists within traditional science courses, including biology and AP biology, chemistry and AP chemistry, physics, environmental biology, agriculture and horticulture, physical science, and life science.

About Georgia Bio

MEDIA CONTACT:

Melissa Carter

404-920-2043

mcarter@gabio.org

2024 Life Science Career Fairs in Georgia

Fri, 02 Aug 2024 22:01:06 GMT

Georgia Bio has compiled the following list of career fairs. Companies are encouraged to participate.

Visit the school website for more information.

Georgia College and State University

Part-Time Job Fair | 08/28/2024 1 p.m. - 3 p.m | Georgia College & State University inside the Magnolia Ballroom.
Fall 2024 Nursing Recruitment Fair | 09/09/2024 | 11 am - 1 pm | Georgia College & State University inside the Magnolia Ballroom.
Fall Career and Graduate School Fair | 10/2/24 | 10:30 am - 2:30 pm | Centennial Centre on the campus of Georgia College & State University

University of Georgia

UGA Part-Time Job & Internship Fair 2024 08/21/24 | Tate Student Center, Grand Hall - 5th floor
UGA Fall Career & Internship Fair 2024 | 09/23/24 | Classic Center
UGA Fall Engineering & Computer Science Career & Internship Fair 2024 09/24/24 | Classic Center
UGA Agricultural and Environmental Career and Internship Fair 2024 | 10/2/24 Tate Student Center, Grand Hall, 5th Floor

Georgia Tech

Fall 2024 Georgia Tech All-Majors Career Fair 09/09/24 & 09/10/24 10 am - 4 pm | Campus Recreation Center (CRC)
Fall 2024 Materials Science & Engineering Career Fair 09/10/24 5 pm - 8 pm | Klaus Advanced Computing Building Atrium
Fall 2024 College of Computing Career Fair 09/11/24 9:30 am - 3:30 pm Campus Recreation Center (CRC)
Fall 2024 Supply Chain Day Career Fair 09/12/24 10 am - 2 pm Georgia Tech Exhibition Hall
Fall 2024 Electrical & Computer Engineering (ECE) Career Fair 09/13/24 10 am - 4 pm Klaus Advanced Computing Building
Fall 2024 Biomedical Engineering Career Fair (In-Person) 09/16/24 1 pm - 5 pm Exhibition Hall
Fall 2024 IISE (ISYE) Career Fair 09/16/24 9 am - 3:30 pm McCamish Pavilion
ASME/ME 2024 Fall Career Fair 09/17/24 9 am - 3 pm Exhibition Hall

Georgia Southern University

STEM Networking Night 09/16/24 5 pm - 7:30 pm Russell Union (Statesboro campus)
Fall 2024 D-1 (technical) 09/17/24 11 am - 3 pm RAC (Statesboro campus)
Fall 2024 D-2 (technical & non technical) 09/18/24 11 am - 3 pm RAC (Statesboro campus)

University of North Georgia

UNG Fall 2024 Gainesville Part-Time Job and Internship Fair 08/20/24 11 am - 1 pm Gainesville campus
UNG Fall 2024 Dahlonega All-Majors Career Fair 09/05/24 12 pm - 3 pm
UNG Fall 2024 Gainesville All-Majors Career Fair 09/25/24 3 pm - 6 pm

Emory University

24-25 Student Employment Job Fair 08/30/24 11 am - 3 pm Atlanta, Georgia
Fall 2024 Career & Internship Expo 09/19/24 9 am - 2:30 pm 605 Asbury Circle, Atlanta Georgia 30322
Fall 2024 Post-Grad Pathways Fair 10/17/24 11 am - 2 pm 605 Asbury Circle, Atlanta Georgia 30322

Augusta University

GACE College to Career Fair 11 am - 3 pm Atlanta, Georgia
Campus Student Employment Fair 08/22/24 2 pm - 4 pm Roscoe Williams Ballroom

Kennesaw State University

2024 Fall STEM Job, Co-op, & Internship Fair: Sept. 24-26, 2024
All majors Fall Job & Internship Fair | 10/15/24 - 10/16/24 | 11 am - 3 pm Siegel Recreation and Activities Center (Kennesaw Campus)

Morehouse School of Medicine

Career Connections Career Fair: Nov.. 7 | 10am-2pm

University of Western Georgia

ALETE Career Fair 08/01/24 | 4 pm - 6 pm | Carrollton Campus

Valdosta State University

Part Time job Fair 08/21/24 10 am - 1 pm Fall Career Fair

Albany State University

Fall Career Fair | 09/26/24 | 9 am - 4 pm | Hper-Gym, East Campus

Clayton State University

Student Part-Time Job Fair | 08/13/24 | 10 am - 2 pm | Main Street, University Center
Internship Nonprofit Job Fair | 09/12/24 | 10 am - 1 pm | Main Street, University Center
2024 AUCC Career Fair In Partnership With The UNCF Empowerment Tour

Clark Atlanta University

09/20/24 | 1 pm - 6 pm | 230 Ted Turner Drive Northwest, Atlanta, Georgia 30303, United States
2024 AUCC Career Fair-CAU ATTENDANCE | 09/20/24| 1 pm - 6 pm | 230 John Portman Drive
22nd Annual Atlanta University Center Health Professional School Recruitment Fair | 02/27/25 | 10 am - 4:30 pm | 223 James P Brawley Drive Southwest, Atlanta, Georgia 30314, United States

Spelman College

Nursing & Allied Health Virtual Career Fair | 08/21/24 | 11 am - 3 pm Virtual
Public Health Virtual Fair | 09/24/24 11 am - 3 pm Virtual
Exploring Grad School Virtual Fair 09/26/24 11 am - 3 pm Virtual
Government & Nonprofit Virtual Fair 10/03/24 11 am - 3 pm Virtual
Sustainability & Environmental Virtual Career Fair 10/15/24 11 am - 3 pm Virtual
Cybersecurity & Technology Virtual Career Fair 10/16/24 11 am - 3 pm Virtual
Women in Business & Technology Virtual Career Fair 10/17/24 11 am - 3 pm Virtual
Food and Agricultural Science Virtual Fair 10/22/24 11 am - 3 pm Virtual

If you are interested in posting your career fair please email admin@gabio.org .

Medtech Manufacturing for Innovators & Start Ups: What You Most Need to Know

Thu, 01 Aug 2024 22:21:42 GMT

Insights from a deep dive into medical device innovation and production with GCMI’s Saylan Lukas and GaMEP’s Dean Hettenbach

Given the patient safety requirements codified in the United States Code of Federal Regulations overseen and enforced by the Food and Drug Administration, medical device innovation is a challenging enterprise to say the least.

It is also a landscape filled with pitfalls that need a holistic, long range view to avoid them. Considering what manufacturing at scale means for a new device or technology is one such pitfall that needs consideration earlier in the design and development process than one might know or believe.

Design decisions with manufacturing at the right scale need to be made upfront, even if large-scale production seems far off. A device might serve its purpose perfectly as a 3D printed prototype, but producing it at scale for clinical use based on designs only appropriate for small batch production can become an expensive nightmare.

Last month, GCMI Interim Executive Director Saylan Luke and Georgia Manufacturing Extension Partnership’s Dean Hettenbauch unpacked the common challenges that many face when entering the medical device space and the steps to take to avoid common pitfalls [particularly as it relates to manufacturing].

While we invite you to check out the hour long recording full of high value information and insights, but as long as you’re here, check out some of the top takeaways.

Engage regulators early, but be well prepared.

Start the process of engaging the FDA (assuming you intend to market your device in the United States) as soon as possible. They are there to help and more well equipped and committed than ever to do so. BUT, put in the time prior to any engagement with regulators to be as well informed as possible. Know that they don’t answer vague questions. Seriously consider, vet and engage a regulatory consultant with experience specific to your technology and its prospective pathway or pathways.

AdvaMed Statement on Dr. Jeff Shuren’s Retirement

Wed, 24 Jul 2024 16:54:21 GMT

FDA CDRH Director Jeff Shuren announced he is stepping down; Dr. Michelle Tarver to Serve as Acting Director

WASHINGTON – Today, AdvaMed President and CEO Scott Whitaker released the following statement about U.S. Food and Drug Administration Center for Devices and Radiological Health Director, Dr. Jeff Shuren:

“On behalf of the entire medtech industry, I want to thank Dr. Shuren for his incredible career of service to patients and public health. Jeff understood the critical role a regulator plays in the innovation ecosystem, knowing how to balance the ultimate goal of medical device safety and effectiveness with the important goal of spurring innovations that improve and save lives. He saw AdvaMed and the medtech industry we represent as partners in addressing patients’ needs, and we hope his leadership serves as a model for all future directors of the CDRH. His willingness to work with us to support next-generation innovation, and his strategic vision for the Center have been critical to allowing medtech innovators to do what they do best. We wish him all the best in the next phase of his life and career.”

“We look forward to working with Dr. Michelle Tarver as Interim Director to ensure the transition to new leadership is smooth, and that Dr. Shuren’s vision of a true public-private partnership remains the hallmark of the Center he helped establish as the gold standard for medical device safety worldwide.”

###

View online here: https://www.advamed.org/industry-updates/news/advamed-statement-on-dr-jeff-shurens-retirement/

Click here to view the announcement on MassDevice.

U.S. ‘Industrial Bioeconomy’ Adds $210.4B and 643,992 Jobs, Says Report; Georgia in Top 10

Fri, 19 Jul 2024 20:16:05 GMT

Georgia in Top 10 in Multiple Areas

Biomanufacturing advocates released a new report that provides a closer look at the employment, wages, and economic activity driven by the U.S. industrial bioeconomy. Authored by TEConomy Partners, the report, “The Economic Impact of the U.S. Industrial Bioeconomy,” illuminates an increasingly important segment of the U.S. economy associated with biomanufacturing and bioproducts (those other than food, beverages, and pharmaceuticals).

Included in the report are state and federal figures for economic activity tied to the transformation of renewable biomass into fertilizers, bioplastics, biofuels, bio-lubricants, and a host of other industrial bioproducts, as well as the research and development of microbes, enzymes, biocatalysts, and other technologies used in modern biomanufacturing. Supporting expansion in the sector is a key goal of the National Biotechnology and Biomanufacturing Initiative , as outlined by President Biden.

Georgia is featured prominently in the report.

Click Here to read the AEM Press Release

Click here to View the Report

Georgia Bio Announces Gwinnett County as Newest BioReady® Community

Fri, 19 Jul 2024 19:58:12 GMT

July 19, 2024, Atlanta, GA – Gwinnett County was officially recognized by Georgia Bio, the state’s leading life sciences membership organization, for achieving Gold-Tier BioReady® Community status during the Board of Commissioners meeting this week. To receive this distinction, communities must meet certain criteria and be able to support the growing biotech industry.

Gwinnett County Chairwoman Nicole Love Hendrickson shared, “This prestigious recognition is a testament to Gwinnett County's dedication to supporting the growing biotech sector. Our forward-thinking zoning policies and supportive infrastructure make us an ideal destination for companies looking to establish or expand their biotechnology operations. By fostering a welcoming environment for life sciences companies, we continue to position Gwinnett as a hub for cutting-edge research and development.”

“Gwinnett County is the first county in metro Atlanta to qualify and receive BioReady® gold status,” said Maria Thacker-Goethe, President and CEO of Georgia Bio . “The county has clearly demonstrated a willingness to continue to foster the biotech sector with infrastructure investments like The Water Tower and Rowen Foundation, which in addition to a strong and diverse workforce, help make them a desirable choice for industry and a benefit to Georgia’s overall economy.”

As the state’s largest and most influential life sciences advocacy and business leadership organization, Georgia Bio works to improve access to innovative technologies and grow Georgia’s life sciences economy. Georgia Bio launched the BioReady® Community program in Georgia with the support from the non-profit’s partners at MassBio, a global life sciences and healthcare organization dedicated to advancing Massachusetts’ position in the life sciences. With a goal of helping local communities connect with leading life sciences industry representatives, Georgia Bio replicated the MassBio rating system program to determine a municipality’s readiness to host biotechnology facilities based on the community’s zoning practices and infrastructure capacity.

Learn more on the Georgia Bio’s BioReady Communities website .

About Georgia Bio

Contact

Melissa Carter

Georgia Bio

mcarter@gabio.org

Gold-Tier BioReady® Community status was presented during the Gwinnett County Board of Commissioners Meeting July 16, 2024.

Remembering Longtime Community Leader, Lee Herron

mthacker@gabio.org (Maria Thacker Goethe) — Wed, 17 Jul 2024 03:37:30 GMT

Remembering Longtime Community Leader, Lee Herron

Georgia Bio Members & Partners:

It is with a heavy heart that I share with you the sad news that Georgia has lost one of its long-time innovation and entrepreneurship champions with the passing of Dr. Lee Herron last Friday, July 12.

Lee was a dear friend, colleague, mentor, and irreplaceable leader within our community. He retired from Georgia Research Alliance (GRA) in spring 2024 after a 16-year career with the Alliance. Most recently, Lee led GRA’s agricultural technology programs including the Greater Yield initiative. He directed its award-winning venture development program for 15 years, which helped to launch 200+ university-based companies that attracted more than $2 billion in equity investment. A seasoned executive, Lee harnessed his 20 years of entrepreneurial experience to help startups develop sound business strategies. Prior to joining GRA, Lee managed the biosciences division of Georgia Tech’s Advanced Technology Development Center (ATDC), advising early-stage life science companies. Lee served in many community leadership capacities including on the boards of Georgia Bio, Southeast Life Sciences, the Global Center for Medical Innovation’s Industry Advisory Board, the Biolocity Oversight Committee and the NSF Center for Cell Manufacturing Technology’s Commercialization Advisory Board.

I am at a loss to even estimate the vast impact he has had on so many of us not only in a business capacity but also as a wise and caring leader whose warmth and humanity characterized every interaction with him. I encourage you to read the moving tributes from GRA here , and his protégé, Ashley Cornelison’s LinkedIn post here . For those that did not know Lee, these tributes help to paint the picture of a brilliant and kind man who will leave an indelible mark on many across our industry.

On a personal note, Lee has been a mentor, sounding board, and friend throughout my 18 years at Georgia Bio. A regular volunteer with Georgia Bio for over 2 decades, Lee would provide his feedback on nominees for our annual awards without hesitation and with his trademark candor; he always jumped to help the organization build its network; and served in various leadership capacities including as chair for our Life Sciences Summit in 2017 (pictured). At the same time, he would remember to ask me about my daughter and remind me to take care of myself. Lee enjoyed and excelled at connecting with people, and his health challenges rarely slowed him down. In looking at my last texts with him from mid-May, he was still committing to providing feedback on our Golden Helix Award nominees and suggesting he introduce me to one of his industry colleagues. I am truly heartbroken. His honesty, humor, and guidance on a personal and professional level will be missed.

Lee was an early recipient of Georgia Bio’s highest honor, the Industry Growth Fellow Award in 2008. Georgia Bio will honor Lee and his legacy at this year’s Georgia Life Sciences Summit on October 22.

Please continue sending your thoughts and prayers for Lee’s wife Rita and the Herron family.

A memorial service will take place this Thursday, July 18. More here.

With heartfelt sympathy,

Maria
President & CEO
Georgia Bio

GeoVax Receives BARDA Project NextGen Award to Conduct Phase 2b Clinical Study Evaluating the Company’s Next-Generation COVID-19 Vaccine Candidate, GEO-CM04S1

Wed, 19 Jun 2024 00:28:42 GMT

10,000-participant randomized Phase 2b study will evaluate and compare GeoVax’s multi-antigen, vaccine candidate (GEO-CM04S1) to an approved vaccine against COVID-19 under BARDA’s Clinical Studies Network

Atlanta, GA, June 18, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it received an award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. Preparations for the study are underway, and execution of the study will be fully funded by BARDA under its Clinical Studies Network.

The direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made separate awards through its Clinical Studies Network to support execution of the study. That funding will represent approximately $343M from the Project NextGen program for a CRO to execute the clinical trial using GeoVax’s vaccine.

“We are honored and proud to receive this award from BARDA to advance our next-generation vaccine against COVID-19. This contract not only provides the vital resources for advancing the development of GEO-CM04S1, but it also advances our MVA platform in infectious diseases,” said David Dodd, Chairman & CEO of GeoVax.

Mr. Dodd continued, “First-generation COVID-19 vaccines were beneficial during the peak of the pandemic but are limited in breadth and durability of clinical protection, requiring frequent updates. Now that COVID-19 is in an endemic stage, many people continue to have their everyday lives impacted in meaningful ways. Furthermore, there are an estimated 23 million adults in the U.S. with immunocompromised conditions who are less likely to have an adequate response to current vaccines and are more likely to potentially experience severe COVID-19 symptoms, hospitalization and the risk of death, even after vaccination. GEO-CM04S1 was designed to address these limitations by inducing durable neutralizing antibody and T-cell-based immunity against current and future SARS-CoV-2 variants. Our vaccine has continued to demonstrate induction of potent immune responses with potential to drive broad and durable clinical protection, and we eagerly anticipate commencing the Phase 2b study to further demonstrate the value and advantages of our technology.”

Funding for this award is provided under Project NextGen , a $5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first generation COVID vaccines and medicines. BARDA is supporting the development of new vaccines and therapeutics to better address the waning immunity and resistance to current and future SARS-CoV2 viral strains. GeoVax’s vaccine candidate provides many of the features identified by BARDA including broader protection among variants of concern (VOC) and a longer duration of protection.

This project is being funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number: 75A50123D00005.

About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T-cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.

GEO-CM04S1 is currently being evaluated in three ongoing Phase 2 clinical trials:

As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024 . A recent presentation of unpublished data from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T-cell responses.
As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355 .
As a booster vaccine for healthy adults who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466 .

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, which recently completed enrollment in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Source and Media Contacts: https://geovax.com/investors/press-releases/geovax-receives-barda-project-nextgen-award-to-conduct-phase-2b-clinical-study-evaluating-the-company-s-next-generation-covid-19-vaccine-candidate-geo-cm04s1

CyanVac Receives BARDA-Funded Project NextGen Award to Evaluate its Intranasal COVID-19 Vaccine Candidate in a Phase 2b Study

Fri, 14 Jun 2024 00:16:35 GMT

Award will support a 10,000-participant study comparing CyanVac’s PIV5-based intranasal vaccine candidate CVXGA with a commercial COVID-19 vaccine under BARDA’s Clinical Studies Network

Athens, Ga. and San Jose, Calif., June 13, 2024 – CyanVac LLC, a clinical-stage biotechnology company developing intranasal vaccines using a transformational parainfluenza virus 5 (PIV5)-based vector, announced today that it received federal Project NextGen funding to support a comparative Phase 2b study of CVXGA, the company’s PIV5-based vaccine candidate designed to protect against COVID-19.

Project NextGen is an initiative of the U.S. Department of Health and Human Services (HHS) to advance new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19. The award is one of the first made through the Rapid Response Partnership Vehicle, a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA) part of the Administration for Strategic Preparedness and Response (ASPR) within HHS, to accelerate product and technology development.

The Phase 2b study of PIV-5-based CVXGA intranasal COVID-19 vaccine will be conducted through BARDA’s clinical studies network.

"This award will accelerate the development of our PIV5-based intranasal COVID-19 vaccine, building on our very promising Phase 1 and preliminary Phase 2a clinical trial results,” said Biao He, Ph.D., founder and CEO of CyanVac. “PIV5 is a novel intranasal vaccine vector that has been shown to replicate safely in humans in clinical trials and stimulates all three pillars of immunity – cellular, mucosal, and humoral – with minimal uncomfortable side effects. The successful development of an intranasal COVID-19 vaccine using this new vector will demonstrate the capabilities of our PIV5 platform and benefit the development of PIV5-based vaccines for other emerging infectious diseases.”

Under the award, CyanVac will be the sponsor for a 10,000 participant, randomized double-blinded Phase 2b study that will compare the efficacy, safety and immunogenicity of CyanVac’s next-generation intranasal COVID-19 vaccine candidate to a U.S. Food and Drug Administration (FDA)-approved mRNA-based COVID-19 vaccine. The study will be conducted through BARDA's Clinical Studies Network and will evaluate the vaccine in a subset of participants at higher risk of severe disease. The study is expected to start in the fall of 2024 and will evaluate the efficacy of CVXGA in preventing not only severe COVID-19 infections, but also asymptomatic infections.

"Many vaccines including COVID-19 vaccines are quite effective at preventing serious illness and death, but there is a need for vaccines that can also block transmission of a pathogen to other people,” said Dr. Henry Radziewicz, Chief Medical Officer of CyanVac. “Our intranasal vaccine is delivered to mucosal surfaces, a key focus area for Project NextGen by BARDA because such vaccines have the potential to reduce the spread of disease.”

“We are excited to work with BARDA on this large-scale trial and are grateful for their support,” added Dr. He.

The project is being funded with federal funds from HHS, ASPR, BARDA, under Other Transaction (OT) number 75A50123D00005.

About CVXGA

CVXGA is a clinical-stage COVID-19 vaccine candidate based on a proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector was developed at the University of Georgia and is based on a respiratory virus that is not known to cause disease in humans which has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. CyanVac and its affiliate, Blue Lake Biotechnology, are developing CVXGA as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA is immunogenic and protective and prevents transmission of SARS-CoV-2. Phase 1 data has shown that subjects dosed with CVXGA showed robust mucosal, cellular and humoral immune responses with limited or no reactogenicity and no serious events assessed as related to the vaccine.

About CyanVac and Blue Lake Biotechnology

CyanVac LLC and its affiliate, Blue Lake Biotechnology, Inc., are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and durability with few vaccine-related side effects.

CONTACTS:

Carolyn Hawley

Inizio Evoke Comms

carolyn.hawley@inizioevoke.com

619-849-5382

Samuel Wu, Chief Business Officer

CyanVac LLC and Blue Lake Biotechnology, Inc.

swu@cyanvacllc.com

650-609-2231

Source: https://www.bluelakebiotechnology.com/news/cyanvac-receives-barda-award-for-covid-ph2b-study

Georgia Bio Announces Forsyth County as Newest BioReady® Community at BIO International Convention

Fri, 07 Jun 2024 18:15:53 GMT

June 7, 2024, San Diego, CA – Forsyth County has been designated a BioReady® Bronze Community by the state’s leading life sciences membership organization, Georgia Bio. To receive this distinction, communities must meet certain criteria and be able to support the growing biotech industry. This distinctive honor was presented to Forsyth County this week at the BIO International Convention in San Diego, California, the largest biotechnology gathering in the world.

“The life sciences sector represents a meaningful portion of the vast business being done in this state, and establishing BioReady® sites, like Forsyth County, signifies Georgia’s readiness for future growth in this industry,” said Maria Thacker-Goethe, President and CEO of Georgia Bio. “This program allows municipalities to showcase biotech-zoned science parks, streamline permitting, build a robust infrastructure, and identify biotech-friendly sites more effectively, making them a desirable choice for industry and a benefit to Georgia’s overall economy.”

“Georgia prioritizes long-term partnerships, creating opportunities for collaborative solutions such as BioReady® Communities,” said Kristi Brigman, Deputy Commissioner of Global Commerce at the Georgia Department of Economic Development. “From the top-tier colleges and universities in Georgia that are educating diverse talent to the state’s ‘Georgia Ready for Accelerated Development’ site certification program that accelerates the path to success, Georgia works with companies throughout the life of a project starting with the very first handshake. We are thrilled that Forsyth County is leveraging their assets to further strengthen these relationships with the bioscience community.”

As the state’s largest and most influential life sciences advocacy and business leadership organization, Georgia Bio works to improve access to innovative technologies and grow Georgia’s life sciences economy. Forsyth County has seen recent growth in the sector with wins such as pharmaceutical company Alimera Sciences moving its headquarters to the Halcyon development. Additionally, Forsyth County Schools have been introducing life science careers to students in partnership with the Georgia BioEd Institute for years to support the industry’s workforce needs.

About Georgia Bio

Pictured left to right: Maria Thacker, Georgia Bio; Alex Warner, VP of Economic Development, Forward Forsyth; EJane Caraway, Director, Life Sciences, Georgia Department of Economic Development; and Eddie Lai, Senior Manager, Life Sciences & Digital Health, Metro Atlanta Chamber.

CLARIFICATION: GCMI Design and Development was not sold to Veranex

Wed, 05 Jun 2024 00:48:03 GMT

Veranex did not acquire GCMI. They acquired the preclinical testing arm, T3 Labs, only.

Earlier this year, we shared the news that T3 Labs, the preclinical testing arm of GCMI, was sold to Veranex.

Due to a high number of ecosystem colleagues who have asked us directly, we are compelled to again share the following:

Veranex did not acquire GCMI. They acquired the preclinical testing arm, T3 Labs, only.

GCMI has not been “taken private,” as we have heard colleagues state verbatim.

To restate: Veranex did not acquire GCMI.

Indeed, our comprehensive design and development entity is fully intact as an affiliate of Georgia Tech working every day to bring new technologies out of the labs of researchers, faculty and clinicians and into the realm of clinical care to improve patient outcomes, value provision and lives.

“Our mission is to help direct the development, testing, and commercialization of innovative medical devices that improve quality based outcomes and delivery of healthcare for patients,” GCMI Interim Executive Director Saylan Lukas wrote in January. “Helping to produce powerful, positive impacts on patients’ lives involves translating research from the lab to the clinic, including clinical trials, first in human studies and other required activities for FDA approval. We do this in support of Georgia Tech faculty, students and the ecosystem at large, and we do it every single day.

The dedicated team of engineers and medtech product development experts at GCMI works to support innovators from every background in the spectrum: from individual clinicians to researchers, faculty and students in engineering spaces with strong application to new medical technologies, to industry stalwarts and hospitals with high potential centers for medtech innovation like Children’s Philadelphia and Emory / CHOA.

As a Georgia Tech affiliate, we do this from our home base right here in midtown Atlanta a short distance from Science Square. Right here in Atlanta, Georgia, home to the world’s busiest airport, the Centers for Disease Control and Prevention, funding mechanisms and supporters like the Georgia Research Alliance (GRA), dozens of institutions of higher education including the nation’s top ranked biomedical engineering program and world-class hospitals and health systems. Every single attribute of a high performing center for medtech innovation lives here.

Our pathway expertise includes: market analysis, IP landscape & freedom to operate, Design History File (DHF) generation including prototyping, 3D printing, failure mode and effects analysis (FMEA), associated design verification and validation testing, human factors and useability testing, regulatory pathways, requirements and FDA submission data and manufacturing transfer. We are also capable of serving as “manufacturer of record” for first in human use, clinical trials and initial low volume commercialization of novel medical technologies.

You can see the impact and efficacy of our work in the success of innovators making an impact like Scott Hollister, PhD and his live saving pediatric airway technology, Jud Ready, PhD and Hub Hygiene, James Rains and Kamil Makhnejia at Jackson Medical, Omer Inan, PhD and DetectIV and NFANT Labs among scores of others.

If you have not done so, please follow GCMI’s new LinkedIn feed .

In the recent words of two customer colleagues

“Based on deep experience and variety in products supported, GCMI knows the requirements for commercialization across the breadth and depth of new medical technologies from the simplest to the most complex. But they know what’s even more important. They know what a technology needs to be within those requirements to actually be successful in the clinic and in the market.

“We can’t get where we want to go, as efficiently and effectively as we need to get there without GCMI.” – Kamil Makhneija, Founder and CEO, Jackson Medical

“The quicker you ask and answer the most relevant, pressing, potentially costly questions, the more cost efficient your work will be, not to mention preventing headaches and heartache down the road. GCMI does it every day. They are agile, responsive and can often solve problems with minimal input given their expertise and experience. They absolutely accelerated our commercialization pathway.” – Jud Ready, PhD, Founder & CEO, Hub Hygiene

Get in touch & Source: https://gcmiatl.org/2024/06/04/clarification-gcmi-design-and-development-was-not-sold-to-veranex/

New BIOSECURE bill “reinforces the national security imperative of the biotechnology industry”

Fri, 10 May 2024 19:37:00 GMT

May 9, 2024

Source: BIO

House lawmakers today unveiled a new draft of the BIOSECURE Act. Shortly after, BIO President and CEO, John F. Crowley, made the following statement:

“The BIOSECURE bill released in the House today reinforces the national security imperative of the biotechnology industry as a critical strategic asset of the United States of America. It highlights a key vulnerability in our global supply chain and importantly provides a reasonable timeframe for companies to decouple their reliance on China-based biomanufacturing. It ensures during this transition that important biomedical research will not be slowed and that patients will have unimpeded access to life saving medicines.

“BIO applauds this work and supports this BIOSECURE legislation. On behalf of our member companies and the patients we represent and serve, BIO thanks the bill sponsors and the Committees for taking into consideration the findings of our recently released survey on key elements of the global supply chain.

“We will continue work with lawmakers on future policies that promote the U.S. as the global leader in biotechnology and as the medicine chest of the world. We look forward to advancing the extraordinary and coordinated policies and programs necessary to redomicile all key parts of the global biopharmaceutical supply chain here in the U.S. for the benefit of the American public and for the entire world.”

EPA, FDA and USDA Issues Updates to the Joint Regulatory Plan for Biotechnology

Wed, 08 May 2024 17:31:00 GMT

Contact Information: EPA Press Office ( press@epa.gov )

Source: https://www.epa.gov/newsreleases/epa-fda-and-usda-issues-updates-joint-regulatory-plan-biotechnology

WASHINGTON – Today, May 8, 2024, in response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration and the U.S. Department of Agriculture have developed a plan to update, streamline and clarify their regulations and oversight mechanisms for products of biotechnology.

The plan helps meet the President’s goals of ensuring public confidence in the biotechnology regulatory system and improving its transparency, predictability, coordination and efficiency. Through engagement with developers and stakeholders, as well as horizon scanning for novel biotechnology products, the agencies worked collaboratively to develop a cohesive plan. The plan incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations. The plan supports a whole-of-government approach to the regulation of biotechnology products.

The agencies have identified five major areas of biotechnology product regulation where these actions will focus:

EPA, the FDA and USDA intend to implement the following joint efforts:

The federal government established the Coordinated Framework for the Regulation of Biotechnology in 1986 and most recently updated it in 2017. It describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology products, including how EPA, the FDA and USDA share responsibility for regulating many of the products of biotechnology in the United States. The Executive Order directs the three agencies to improve how they implement the Coordinated Framework.

In response to the Executive Order, the three regulatory agencies, in consultation with the Office of Science and Technology Policy, issued a Request for Information to the public to solicit information on regulatory ambiguities, gaps, uncertainties or inefficiencies in the Coordinated Framework. The agencies received 88 distinct public comments, including a sign-on letter from over 6,000 members from biotechnology developers, producers, manufacturers, non-governmental organizations and academia. The agencies will continue to engage with all interested stakeholders as they implement the plan.

Visit the Unified Website for Biotechnology Regulation for additional information on modernizing the regulatory system for biotechnology products and Executive Order 14081.

Radyus Research and Dt&CRO Join Forces to Pave Way for South Korean Biotech Companies into the U.S. Market

Tue, 07 May 2024 21:02:00 GMT

Source: Radyus/PR Newswire

ATLANTA, May 7, 2024 /PRNewswire/ — Radyus Research, a global drug development organization from Atlanta, Georgia, is excited to announce a pivotal strategic partnership with Dt&CRO, a leading South Korean contract research organization (CRO). This collaboration aims to assist South Korean biotech companies in entering the U.S. market by offering integrated services for drug development planning, regulatory strategy, IND filings, and clinical trial management.

The partnership between Radyus Research and Dt&CRO marks a significant milestone in global biotech collaboration, providing a streamlined pathway for South Korean biotech innovators to access the lucrative U.S. pharma market. Leveraging Radyus Research’s expertise in navigating the complex regulatory landscape and managing preclinical and early-stage clinical trials in the United States, South Korean biotech companies can expedite their entry into this key market.

“At Radyus Research, we are thrilled to partner with Dt&CRO to empower their sponsor companies, which are ambitious and innovative biotech companies from South Korea,” said Marta New, CEO of Radyus Research. “Our collaboration will provide invaluable support and guidance, enabling South Korean innovators to navigate regulatory processes, initiate IND applications, and conduct first-in-human trials in the U.S. These critical steps are essential for South Korean biotech companies to establish a strong presence in this market and attract investment from international stakeholders.”

In return, Radyus Research will rely on Dt&CRO for non-GLP and GLP laboratory testing services tailored to Asia based clients. This reciprocal arrangement further enhances the partnership’s synergy, fostering a collaborative environment conducive to innovation and growth in the global biotech industry.

“We are excited to collaborate with Radyus Research to facilitate the expansion of South Korean biotech companies into the U.S. market,” said Mr. Chaegyu Park, CEO of Dt&CRO. “By combining our expertise in laboratory testing with Radyus Research’s comprehensive support for drug development and regulatory strategy, we can offer a holistic solution that meets the needs of biotech innovators in South Korea and enhances our global CRO competitiveness.”

The partnership between Radyus Research and Dt&CRO exemplifies a commitment to fostering innovation, collaboration, and global growth in the biotech industry. Together, they aim to accelerate the development and commercialization of breakthrough therapies that address unmet medical needs and improve patient outcomes worldwide.

About Radyus Research:

Radyus Research is a drug development organization dedicated to accelerating clients’ drug programs into the clinic. With a commitment to excellence and innovation, Radyus Research offers a range of services aimed at providing comprehensive drug development planning, regulatory filings, and clinical trial management. We act as an operating R&D partner to biotech companies, academic startups, and seed venture capital firms. Most clients start working with us during lead optimization and candidate selection phases, and we manage their programs through IND-enabling studies, IND application and initiation of first in human trials. Our extensive expertise spans various modalities in immunology, oncology, infectious diseases, metabolic diseases, and neurosciences. We are based in Atlanta, Georgia, serving clients across the globe in over 12 countries.

About Dt&CRO:

Dt&CRO is a leading preclinical CRO based in South Korea, specializing in providing global pharmaceutical companies with a wide range of CRO services comprehensive of non-clinical efficacy, GLP toxicology testing, PK testing, bioanalysis, bioequivalence, clinical trials, and licensing consultation in Asia. With a commitment to excellence and innovation, as well as its expertise in pharmaceuticals, chemicals, health-functioning food, cosmetics, and medical devices, Dt&CRO plays a vital role in advancing drug development and improving patient care on a global scale.

SOURCE Radyus Research

6 Cornerstone Truths for Medtech Innovators (Researchers or Clinicians) in the Hospital Setting

Fri, 03 May 2024 19:07:00 GMT

By: Marty Jacobson with Paul Snyder | GCMI

Source-GCMI

Because clinicians have such an intimate knowledge of unmet clinical needs, hospitals are fertile ground for medtech innovations that improve value and outcomes. But bringing a technology or device to bear in clinical use, especially at any scale, works in much different, much more rigorous ways and paths than any other type of innovation.

Launched just last year, “ The Emory Innovation Certificate Program is designed to develop and enrich entrepreneurial skills and business knowledge for faculty and staff interested in learning how to bring technologies to market. The program is directed by Steven Goudy (otolaryngology) and Adam Klein (otolaryngology head and neck surgery) and will include speakers from across the Atlanta Innovation ecosystem from Biolocity, Georgia Tech, Goizueta Business School, Georgia Research Alliance, Emory Office of Tech Transfer and others.”

Following closely on the heels of our presentation to the Children’s Hospital of Philadelphia Academic Entrepreneurship Professional Development Course , GCMI’s Emily Blum, MD and Marty Jacobson recently shared their insights on stakeholder identification, design and development pathway efficiency and the meaning of “minimum viable product” for medtech innovation with the Emory Healthcare Innovation Certificate Program participants.

Marty shares here the following six insights and takeaways for researchers and clinicians with hospital affiliation and innovation imperatives or initiatives.

1. The FDA is not concerned with your funding and its mission or requirements, nor are they concerned with your IP, patents or scientific publications which may be voluminous. They are laser focused on safety.

Hospitals and health systems are full of amazing, high performing innovative people, including clinicians, who know well their unmet clinical needs and often have corresponding funding for associated research, but ‘concept-to-commercialization’ in medtech is its own discipline to which experts dedicate their entire careers. The common presumption among researchers and clinical innovation is that funding from the National Science Foundation or National Institute of Health coupled with high impact research on actual clinical problems is going to successfully align with what it takes for a successful FDA 510k or PMA application.

That is not the case. In reality, IP, publications and research have no inherent overlap with regulatory submissions or approval. A researcher or clinician with medtech innovation, clinical utility and commercialization aspirations can have 50 Nature articles to their credit. It’s not that the FDA doesn’t care, but the aims of those studies and publications are not structured to map onto FDA’s objectives.

The FDA is chartered to protect public safety. Their concern is not scientific advancement to drive forward applications of a technology or ‘painting with a broad brush’ to drive a technology forward. The FDA seeks to assure new medical technologies’ safety and efficacy first and foremost.

A robust innovation ecosystem within a hospital or health care system should have a strategic approach to commercialization. Such an approach leverages clinicians’ knowledge of the unmet clinical need against available funding and research opportunities, ultimately supporting the science, technology and clinical knowledge to successfully bring the new device or technology to market.

2. There are no dumb users, and risk mitigation belongs to you first.

The FDA pays close attention to useability and human factors. Medtech innovators must prove all that can be done has been done to ensure safety including human factors. Innovators cannot depend solely on instructions for use to protect them from liability for an adverse event involving their device or technology. Innovators need to design the device or technology so that the possibility of an adverse event due to user error is inherently mitigated through the device, system or technology’s design.

Consider all foreseeable use cases for your device or technology and be prepared to justify them. For some clinical medtech innovators, a risk mitigation strategy may be to hire an engineer to literally stand side by side with a surgeon to ensure everyone’s safety. To avoid this extremely high cost “strategy,” consider the technology’s use application and make a deliberate effort to make things intuitive, easy to understand and use. Often people don’t read the instructions for use even in a clinical setting.

For example: is a handheld device’s handle entirely clear that it is actually the handle? Is it possible a user can hold it the wrong way? Is the handle legitimately ambidextrous or will you need to have left handed and right handed versions available? You need to know this in no small part because regulators will want to know it as well.

3. Before brainstorming: Define. The. Problem. And craft a user needs assessment specifically tailored to the problem in close alignment with FDA regulatory submission requirements.

Too many technologies go looking for a healthcare problem to solve when the inverse, applying creativity and technological prowess to a well-defined problem is the path to innovation with higher likelihood of clinical success and high commercial potential.

Conduct interviews and make observations from all potential user groups to define the problem as specifically as possible – without presuming a solution. Then craft a needs assessment customized to the regulatory requirements for the technology’s classification. Draft the user needs with support from a career medtech professional, then convert the user needs into design inputs.

Now you’re ready to brainstorm. We use a PUGH matrix to evaluate and rank ideas based on user needs “downselecting” to get to a device that is easily produced and tested as the optimal gateway to a successful minimum viable product (MVP).

4. Minimum Viable Product (MVP) for new medical technologies is probably not what you think it is.

Speaking of MVPs; an MVP for medical technology development will often be less than the minimum needed for clinical utility and commercial adoption. What metrics will be used to assess the device’s value to the clinician, patient, hospital and / or health system? Answering this question effectively often means an innovator does not have to generate expensive clinical data or evidence to satisfy regulatory requirements before it can be put to work or introduced to the market. For example: we just need this connector to connect more quickly than the ones we’re currently using. Excellent. How many seconds faster does the connection happen with the new device versus the old? That is a simply measured answer to a well defined user need. And is it worth an additional $100 per unit? Now you’re getting a feel for the many ways in which medtech innovation can quickly fall from the rails.

MVP for initial regulatory clearance is usually less than what a device company’s sales and marketing folks will want to claim. Ambitious claims are a very quick way to get into trouble in many ways. Here are a few.

First, if you are unwilling to budge on what you want to claim (which can often happen when goals are too heavily influenced by inventor return requirements, or perceived sales and market share opportunities) a $2M, two year path can quickly become a $50M, ten year path to commercialization. If you believe you must be able to make certain claims to capture a certain market segment, size or sales target, stop and reevaluate your options. If you reach that point, it’s time to contact GCMI.

Second, the way an innovator sees their technology is not the way the FDA sees it. Adding AI interpretation in an attempt to make an image “more visible” is enticing. But the FDA may well view that technology as a risky new device with a much longer approval pathway sans a predicate they deem sufficiently equivalent.

In another example, a pill bottle is a low risk, Class I device. But if you want to claim that simply printing the label or embossing the bottle with a larger font will reduce dosage errors and / or complications, you must verify and validate that claim with substantial evidence potentially involving lengthy, expensive clinical trials by making a claim involving life saving benefits. Beware. This approach may work fine for consumer technologies that don’t have life threatening potential. It will not fly in medtech.

In this example, it may be acceptable to launch the bottle with a larger font, but without making that specific claim. Start generating revenue and in post market surveillance, gather clinical evidence and then submit the new data for the purposes of establishing the claim you really want to make. In this way, your own device can serve as “the predicate” and you can build as you go.

5. Failing to align innovation with regulatory requirements is wasteful. And futile.

At the 30,000 foot level, align innovation with regulatory requirements or you’re just wasting time and money. Scope what you’re trying to do. Identify the clinical problem and define it in terms that can be measured or else the scope is likely to be so broad or vague that FDA will require a burdensome evidentiary requirement on almost every element.

If, for example, you want to claim that your new shears cut gauze faster than what’s currently approved for clinical use and are successful in the market, you will now have to monitor surgeries in large numbers, which could be a $30MM study.

6. It’s never too early to get in touch with us

You may be in the early stages as a career faculty or clinician, but if you want to have a company with a technology developed in the next 10 years, there are things you can be doing now to set yourself up for success later you will wish you had been doing from the start.

If you have resources like Emory’s Innovation Certificate Program or Children’s Philadelphia’s Entrepreneurship Development Course for clinicians and researchers available, we are here to provide resources and guidance for those program’s leadership and the innovative clinicians and researchers to generate more actual solutions from deep clinical experience.

Atlanta’s Biotech Scene Prepares for New Heights

Thu, 02 May 2024 18:58:00 GMT

Source: BioSpace

A new project has capped off construction in Midtown Atlanta, providing physical real estate that experts say is sorely needed for the region’s growing biotech ecosystem , now home to more than 4,000 life science companies.

KEEP READING AT BIOSPACE HERE.

Andson Biotech raises $3.6 million seed round

Tue, 30 Apr 2024 19:57:00 GMT

Source: Andson Bio

ATLANTA, April 30, 2024 – Andson Biotech , a biotools company developing streamlined sample prep and data analytics solutions for mass spectrometry workflows, has successfully closed a $3.6 million round in equity financing. This capital will support hiring talent to accelerate the market introduction of its inline mass spec sample prep solution, DynaCHIP . This patented technology seamlessly integrates into existing mass spec workflows, significantly reducing sample prep times. In addition, Andson will deploy funds to develop DynaMARK , a novel analytics tool that supports emerging cell and gene therapy applications.

“This financing round signifies a significant milestone for Andson Biotech , demonstrating our commitment to making mass spectrometry more productive for current and next-gen biotherapeutics,”says CEO and Co-Founder, Mason Chilmonczyk . “We are grateful for the support of investors and advisors who have built successful biotech companies in the past as we embark on this next phase of growth.”

The round was led by Glenn H. Epstein , an investor with a successful track record in funding and advising multiple companies from early-stage formation to robust sales growth from products and services. He will serve on Andson’s board of directors.

“Andson has made significant technical progress since its inception at Georgia Tech in early 2022,” says Tom O’Brien , Executive Chairman of the board at Andson Biotech . “Having collaborated closely with the Andson team for the past year, I am confident in their capabilities and vision. More importantly, I am optimistic about the impact Andson’s products will have in the biotools market.”

‍ About Andson Biotech

‍ Headquartered in Atlanta, GA, Andson Biotech specializes in providing cutting-edge solutions for mass spectrometry, the gold standard for chemical analysis. At the forefront of its offerings is the DynaCHIP , a hardware system designed to enhance mass spec workflows, delivering productivity gains of up to 100x.

Andson Biotech’s initial technology was licensed from Georgia Tech . The Company received early financial support from the Georgia Research Alliance (GRA) and Biolocity . Subsequent support from entities like Y Combinator (Winter, 2022), the Merck Digital Sciences Studio (Inaugural Cohort ‘23), and BioTools Innovator (2023 Finalist) have further propelled the company’s growth, bringing its total funding to over $5 million since January 2022.

AdvaMed Statement on the Release of FDA Rule on Laboratory-Developed Tests

Mon, 29 Apr 2024 19:36:00 GMT

WASHINGTON, D.C. – Today, AdvaMed, the Medtech Association, released the following statements from President and CEO Scott Whitaker and Zach Rothstein, Executive Director of AdvaMedDx, on FDA’s final rule for Laboratory Developed Tests (LDTs):

“We appreciate FDA’s commitment to ensuring the safety and effectiveness of in vitro diagnostic tests, regardless of their source, which is what today’s rule would accomplish,” Whitaker said. “We hope this rule is just the first step toward comprehensive reform of the framework for diagnostic test regulation overall, which the VALID Act would accomplish through Congress. This reform is critical to supporting the continued innovation of safe, effective, and high-quality diagnostic tests.”

“This rule represents significant progress in ensuring that diagnostic tests, regardless of where they were developed, meet FDA’s rigorous standards for safety and effectiveness,” Rothstein said. “We also encourage Congress to pass the bipartisan VALID Act, which would establish a modernized, diagnostics-specific regulatory framework for all diagnostics tests. We remain committed to advocating for this important legislation and we look forward to continuing our collaboration with Congress and all stakeholders in these efforts.”

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ClinicalMind Acquires 11TEN Innovation Partners, Uniting Cutting-Edge Medical Communications with Strategic Consulting to Drive Innovation in Life Sciences

Wed, 24 Apr 2024 21:15:00 GMT

NEW YORK, April 23, 2024 /PRNewswire-PRWeb/ — ClinicalMind, LLC (CM), a premier healthcare marketing and communications company, today announced the acquisition of 11TEN Innovation Partners (11TEN), a leading strategy consulting firm with a robust healthcare innovation ecosystem. This strategic move combines CM’s expertise in medical communications and training with 11TEN’s capabilities in commercial strategy and innovation consulting, offering an unparalleled end-to-end service for healthcare and life science companies.

“We are extremely excited to be bringing 11TEN into the CM family,” said Jeanne Martel, CEO of CM. “Their teams of talented, experienced strategists and visionaries are helping accelerate healthcare innovation in novel and structured ways. CM, in turn, can align our strategic communications, instructional design, and technology expertise to the strategies that 11TEN develops, providing clients with a seamless, integrated experience. I look forward to working with James and the entire 11TEN team as we move forward.”

Keep Reading: https://www.prweb.com/releases/clinicalmind-acquires-11ten-innovation-partners-uniting-cutting-edge-medical-communications-with-strategic-consulting-to-drive-innovation-in-life-sciences-302124477.html

CoreRx strikes $130M deal to snap up struggling small-molecule specialist Societal CDMO

Wed, 24 Apr 2024 21:07:00 GMT

Several months after Societal CDMO launched a restructuring campaign that led to 26 layoffs, the small molecule contract manufacturer has announced it’s being bought by one of its production peers in Florida.

Privately held manufacturer CoreRx has entered a definitive agreement to purchase Societal for $1.10 per share in cash, leading to a total deal value of roughly $130 million, the companies said in a press release late Wednesday.

Societal’s board of directors unanimously approved the deal, which is expected to close early in 2024’s second quarter.

Keep Reading at: https://www.fiercepharma.com/pharma/private-manufacturer-corerx-strikes-130m-deal-snap-struggling-small-molecule-specialist

PONIX AWARDED $5 MILLION USDA GRANTTO BREAK “GROUND” ON CLIMATE-SMART AGRICULTURE IN GEORGIA

Wed, 24 Apr 2024 01:47:00 GMT

Through USDA’s Partnerships for Climate-Smart Commodities Program, the Initiative is Recruiting 24 Minority and Underserved Georgia Farmers to Adopt Hydroponic Farming

ATLANTA (April 22, 2024) – The Coalition of Food Security (CFS), led by
minority-owned AgTech start-up, Ponix, is implementing a $5 million United States
Department of Agriculture (USDA) grant, as part of the Partnerships for Climate-Smart
Commodities program, which helps measure and promote climate-smart farming
practices. The program will design and launch an inclusive marketplace for sustainable
vegetable producers, empowering minority and underserved communities to sell both
their produce and carbon credits to corporate partners.

CFS is researching which farming method produces less harm to the environment – a
tech-enabled farm that grows lettuce with Ponix’s proprietary indoor hydroponic vertical
farming methods or a conventional farm that employs outdoor farming practices.
If successful in emitting less greenhouse gas emissions than its conventional
counterpart, CFS’s tech-enabled farm would allow a new carbon credit program to
develop where farmers, major distributors and retailers, and individual consumers would
be able to earn, buy and sell carbon credits.

“We’re passionate about the benefits of hydroponic farming,” said Ponix CEO, Michael
Choi, who has incubated tech-enabled solutions for public and private sectors
throughout his 15 year career. “It’s hyper local and yields a more nutritious product that
doesn’t require pesticides, recirculates water and conserves land.” he said.

Last month, CFS established Ponix’s hydroponic farm within a 300 square-foot footprint
in a facility in Decatur, which is equivalent to one acre of an outdoor conventional farm.
Its first harvest is slated for mid-May. The Ponix hydroponic farm will grow just under a
ton of lettuce per month. Both the hydroponic and conventional farms are growing red
fire lettuce.

“With current conventional farming-related emissions estimated to account for 24% of
total greenhouse gas emissions, the success of the CFS pilot presents a major
opportunity for the future of the agricultural industry by creating a blueprint on how to
not only mitigate the devastating impact of climate change, but also reduce food
insecurity and racial inequities,” said Choi.

Studies show that nearly 25% of Atlantans live in food deserts – areas that have low
access to healthy, affordable food. Moreover, they are located largely inside minority,
underserved communities, who, without easy access to fresh, healthy food, rely on
inflammatory, unhealthy fast food.

CFS’s diverse coalition of multidisciplinary and minority-focused partners includes
Ponix; the PROPEL Center, the first innovation hub built for the future of HBCUs
powered by Apple and Southern Company; Slater Infrastructure Group, a woman- and minority-owned professional services firm that specializes in water, transportation,
environmental and energy services; GTC 360° Advisors, a business strategy,
government contracting and carbon credit consulting firm; FoodChain, an online
marketplace, which connects sustainable food producers with wholesale buyers; UDC,
an HBCU in Washington, DC; and Georgia Bio, a non-profit that is empowering the
next generation through biotech.

Through these partners, CFS is recruiting and educating 24 minority-owned
landowners, underserved farmers and HBCU students on how to use and adopt Ponix’s
AgTech hardware and software solutions. Additionally, CFS is providing internships to
HBCU students and providing agribusiness opportunities. More information can be
found at coalitionforfoodsecurity.com.

USDA is committed to supporting a diverse range of farmers, ranchers, and private
forest landowners through Partnerships for Climate-Smart Commodities. This effort will
expand markets for America’s climate-smart commodities, leverage the greenhouse gas
benefits of climate-smart commodity production, and provide direct, meaningful benefits
to production agriculture, including for small and underserved producers.

USDA is investing more than $3.1 billion for 141 projects through this effort and all the
projects require meaningful involvement of small and underserved producers.
“Through Partnerships for Climate-Smart Commodities, USDA will provide targeted
funding to meet national and global demand and expand market opportunities for
climate-smart commodities to increase the competitive advantage of American
producers,” said Agriculture Secretary Tom Vilsack. “We want a broad array of
agriculture and forestry to see themselves in this effort, including small and historically
underserved producers as well as early adopters.”

USDA has already invested nearly $2.8 billion in 70 selected projects under the first
pool of the Partnerships for Climate-Smart Commodities and an additional $325 million
in 71 more projects under the second funding pool.

About Ponix:
Ponix, Inc., a pioneering, minority-owned, AgTech company, is revolutionizing the way
we grow food through its proprietary technology and turnkey, modular, smart indoor
farming solutions. Ponix indoor farms cultivate fresh crops year-round with zero
pesticides and require 90% less land and water than conventional methods, directly
addressing public health concerns, nutritional deficiencies, food insecurities and
breathing new life into both urban and rural communities. Discover more at
www.ponixfarms.com

About the USDA:
USDA touches the lives of all Americans each day in so many positive ways. In the
Biden-Harris Administration, USDA is transforming America’s food system with a greater
focus on more resilient local and regional food production, fairer markets for all
producers, ensuring access to safe, healthy, and nutritious food in all communities,
building new markets and streams of income for farmers and producers using climate
smart food and forestry practices, making historic investments in infrastructure and
clean energy capabilities in rural America, and committing to equity across the
Department by removing systemic barriers and building a workforce more
representative of America. To learn more, visit www.usda.gov.

Annoviant™ Awarded $2.99 Million NIH Grant to Advance TxGuard™ Pulmonary-Valved Conduit for Pediatric Heart Disease

Tue, 16 Apr 2024 01:46:00 GMT

Funding represents a significant step forward in Annoviant’s mission to transform the landscape of pediatric cardiac care.

“We are delighted to receive this additional grant from the NIH, accompanied by matching funds from our esteemed investors. This marks a significant milestone for Annoviant as we accelerate our pursuit of impactful innovation to save lives,” said Ajay Houde, Ph.D., MBA, Co-Founder, and CEO of Annoviant.

About Annoviant

NIH: Research reported in this news release was supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) under Award Number 2R44HL147771-04. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

For media inquiries or further information, please contact:

Annoviant Media Relations
pr@annoviant.com

Georgia Bio and Brex Partner to Enhance Member Benefits

Wed, 20 Mar 2024 14:25:00 GMT

Exciting news for Georgia Bio members! The Georgia Bio Brex program, established through our partnership with BIO, has been expanded to provide even greater benefits for your organization. On top of the existing corporate credit card with its industry-specific rewards, members can now access savings on business accounts, spend management software, and travel management solutions.

Upgrade Your Financial Toolkit Learn more and upgrade at bio.org/save/brex

Enhanced Benefits at a Glance

Georgia Bio’s commitment to empowering its members is stronger than ever. With the enhanced Brex program, you can streamline financial processes, gain real-time insights into spending, and optimize travel management, all while earning industry-leading returns on your business accounts.

Webinar Roundtable: Radically Rural biotech: Why and how rural biotech hubs can compete with urban hubs

Tue, 27 Feb 2024 22:08:00 GMT

March 13th, join a conversation with Radically Rural biotech: Why and how rural biotech hubs can compete with urban hubs. For so long, rural has been viewed only as extractive, but we’re changing that narrative. Join this free virtual roundtable with Hannah Grimes Center to learn how they have catalyzed a rural biotech network and how you can be a part of it.

Learn More & Register for the free roundtable https://radicallyrural.org/upcoming-roundtables/

BioSpark Labs Welcomes Artelon

Tue, 27 Feb 2024 22:05:00 GMT

Artelon®, a leader in dynamic biomaterial innovation, is expanding its Manufacturing and Research and Development activities to BioSpark Labs.

“This expansion to BioSpark enhances our capability to support rapid commercial growth and opens new opportunities for biomaterial innovation. Furthermore, this location connects us to the world-class facilities and collaborative biotech talent in the Georgia Tech ecosystem“ stated Jeff Byrne, the Chief Financial Officer with Artelon.
Artelon is headquartered in Sandy Springs, GA, and manufactures FLEXBAND®, a next-generation dynamic biomaterial used in the surgical repair of tendon and ligament injuries. Artelon’s novel solutions are engineered to enhance the strength and natural motion of healing soft tissues.

For more information, please click on the website link here: https://www.artelon.com/

A Letter from GCMI Interim Executive Director Saylan Lukas – GCMI’s Continuing Commitment to Excellence in Medtech Innovation

Fri, 23 Feb 2024 20:22:00 GMT

Medtech and life science innovation is rigorous. It requires high levels of acumen and proficiency in multiple disciplines. It can also be immensely capital intensive.

Tiffany Wilson founded Atlanta’s Global Center for Medical Innovation (GCMI) in 2012 to help medtech innovators de-risk their technologies, increasing their odds of successful commercialization and positive patient outcomes within a capital efficient pathway. The organization originated with support from the Office of Innovation and Entrepreneurship, part of the U.S. Department of Commerce’s Economic Development Administration, and an i6 Challenge Grant.

In 2016 GCMI, a Georgia Tech affiliate, acquired responsibility for T3 Labs – an industry leading preclinical CRO – making GCMI truly an end-to-end medtech innovation center. More than six years on, the institutions determined that demand for costly preclinical work, especially good laboratory practices (GLP) studies required by regulatory submissions, is driven too far downstream in the product development process for optimal operational efficiency. GCMI therefore chose to focus on core design and development pathways in a more concentrated fashion leading to the November 2023 sale of T3 Labs to Veranex.

No, GCMI has not been “taken private.”

GCMI’s Continuing Commitment to Excellence in Medtech Innovation

GCMI remains a non-profit affiliate of Georgia Tech. As we have for more than a decade, we help clinician innovators, start up companies, engineers and scientists with university supported technologies, industry partners, hospitals and health systems realize and commercialize new medical technologies. We maintain ISO 13485 compliant quality management systems and possess expertise in all relevant subject matter critical to successful medtech innovation and commercialization. That expertise includes the imperative clinician’s perspective via our Medical Director and pediatric urologist, Emily Blum, MD. We can also serve as manufacturer of record for novel medical technologies including those used in compassionate use provisions and investigational studies.

Our work in support of Georgia’s life science innovation ecosystem specifically includes Hong Yeo’s flexible wireless stethoscope, multiple projects in collaboration with Children’s Healthcare of Atlanta, Piedmont Healthcare physicians and clinical teams, NFant Labs, OXOS Medical and GloShield by Jackson Medical among others. GCMI also plays a pivotal role in the Center for Medtech Excellence (CMTE), which is focused on catalyzing the development and commercialization of breakthrough biotechnology, medical devices, life science and therapeutic innovations. Within CMTE, we have supported Dr. Noze Best and it’s NozeBot Baby Nasal Aspirator and Hub Hygiene’s easySCRUB device.

Georgia’s medtech innovation ecosystem has all of the assets needed for success with high quality of life and lower cost of living compared to locales like Boston and the Bay Area with more august reputations in the discipline. Our ecosystem of clinicians, hospitals, patients, universities, engineers, entrepreneurs, investors, solutions providers and supporting state and municipal resources is robust. Atlanta specifically has additional biomarkers for medtech innovation like grant funding including the Georgia Research Alliance, startups spun out in the past, a mature funding ecosystem and patents issued. Our foundation is strong. Our growth potential is high and GCMI intends to actively foster that growth.

At the end of the day, GCMI is fully committed to successful medtech commercialization that improves outcomes. We welcome you to contact us at any point in a medical technology’s pathway from the ‘back of the napkin’ to the bench, manufacturing, bedside and beyond.

I invite you to take a moment to follow our new organizational profile on LinkedIn and take a look at our new web presence https://gcmiatl.org

Sincerely,

Saylan Lukas

Interim Executive Director, Global Center for Medical Innovation

Connecting the Dots: Athens Career Academy Unveils Biotech Track, Shaping Real Futures for High School Students

Thu, 22 Feb 2024 17:08:00 GMT

FOR IMMEDIATE RELEASE–February 22, 2024– Athens, Georgia – The Athens Community Career Academy, part of the Clarke County School District, is ushering in a new era of education and community development with its innovative Biotechnology Track. Designed to meet the changing needs of the workforce in Athens, this program aims to prepare high school students for successful careers in the local biotech industry.

The first of its kind in Georgia, the Biotechnology Track is a three-course pathway that equips students with the skills and knowledge to use living organisms and biological processes to solve problems and create useful products in fields like medicine, agriculture, and food science. With the support of Athens-Clarke County Economic Development and local biotech businesses, this program was created for students grades 10-12, aligning with the growing demand in the biomanufacturing and pharmaceutical sectors in Athens.

“Career Pathways offer students choices based on local workforce needs. Our goal is to continue connecting the dots between education, industry, and community, preparing students for successful careers,” says Wesley Mellina, CEO of Athens Community Career Academy.

The creation of this new program began over a year ago, driven by the vision of Ilka McConnell, Director of Economic Development for Athens-Clarke County, and Wesley Mellina, CEO of Athens Community Career Academy, in collaboration with local biotech leaders. By working closely with biotech leaders in the community, the Career Academy ensures that the curriculum meets the needs of the local biotech industry.

“One common concern [with other programs] is the lack of hands-on laboratory experience. This course is designed to better prepare students with practical laboratory skills. However, most importantly this course is designed to instill an enthusiasm for life sciences,” says John Mitchell, CEO of Athens Research and Technology. Over the past eighteen months, Athens Research and Technology has contributed both time and resources, helping to launch and make this program accessible and beneficial for students.

“The talent pipeline John Mitchell has helped us build has been tremendous. Athens Research and Technology really started looking at what level of information is needed to start a career in the industry,” says Ilka McConnell, “They’re doing a standout job at keeping their door open to the workforce and really understanding what level of education is needed to be successful in each role on their team.”

With the introduction of the Biotechnology Track, the Career Academy aims to empower students and inspire parents to see the potential in the Athens community. By offering choices for students at an earlier age and providing internship opportunities, class demonstrations, and industry engagement, the Career Academy strives to create a positive impact and showcase the long-term opportunities available in the biotech industry.

“Athens is a magical place. It’s a beautiful city,” says Ilka McConnell, “We want students to grow their skills, grow their support, and eventually grow their families here.”

Enrolling now for the 2024 Fall semester, the Biotechnology Track is open to 10th-12th graders and offers a comprehensive pathway for students to gain valuable skills in biotech. Students who complete this program will have the chance to earn the Biotility Biotechnician Assistant certification, which further enhances their career prospects in the field.

Diversity in the biotech industry stands as a cornerstone of the Biotechnology Track’s mission. The Athens Community Career Academy, committed to breaking barriers and fostering inclusivity, provides students with opportunities to explore their interests. Stepping back for a broader perspective, biology emerges as the foundational essence of all life. By raising awareness around diversity in the biotech industry and providing students with opportunities to explore their interests, the Career Academy is paving the way for a brighter future where education, industry, and community come together to create a legacy of empowerment and opportunity for the Athens Community. Image from L to R: Wesley Mellina, John Mitchell, Ilka McConnell

Media Contact:
Sydney Lucero

sydney@thecognitivecreative.com

601-455-8590

GeoVax Announces 1-for-15 Reverse Stock Split to Regain Compliance with Nasdaq Minimum Bid Requirement

Tue, 30 Jan 2024 15:39:00 GMT

Atlanta, GA, January 29, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the Company’s Board of Directors has approved a reverse stock split of its issued and outstanding shares of common stock, par value $0.001 per share (the “Common Stock”), at a ratio of 1-for-15. The Company is effecting the reverse split to regain compliance with the $1.00 minimum bid price required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The reverse stock split was approved by the Company’s stockholders at a meeting held January 16, 2024.

The reverse stock split will become effective on January 30, 2024 (the “Effective Date”), and the Common Stock is expected to begin trading on the split-adjusted basis on the Nasdaq Stock Exchange (“Nasdaq”) at the market open on January 31, 2024. Following the reverse split, the Common Stock will continue to trade under the symbol “GOVX”, and the Company’s publicly traded warrants will continue to trade under the symbol “GOVXW”.

On the Effective Date, every 15 issued and outstanding shares of the Company’s Common Stock will be converted automatically into one share of the Company’s Common Stock without any change in the par value per share. The total number of issued and outstanding shares of Common Stock will therefore be reduced proportionately from 29,757,823 shares to approximately 1,983,855 shares. On the Effective Date, the publicly traded warrants will be adjusted to require fifteen (15) warrants to be exercised to receive one (1) share of common stock at a price of $75 per share.

Immediately after the reverse stock split, each stockholder’s percentage ownership interest in the Company and proportional voting power will remain unchanged, except for minor changes and adjustments that will result from the rounding up of any fractional shares to the next whole number of shares. The rights and privileges of the holders of shares of Common Stock will be substantially unaffected by the reverse stock split.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin ^® , presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

https://www.geovax.com/investors/news/geovax-announces-1-for-15-reverse-stock-split-to-regain-compliance-with-nasdaq-minimum-bid-requirement

Aruna Bio Announces FDA Clearance of IND for Lead Program AB126, Enabling the First Exosome to Enter in Human Clinical Trials for a Neurological Indication

Wed, 17 Jan 2024 17:13:00 GMT

January 16, 2024 08:00 ET| Source: Aruna Bio

BOSTON and ATHENS, Ga., Jan. 16, 2024 (GLOBE NEWSWIRE) — Aruna Bio, Inc., a pioneer in the development of neural exosome-based therapeutics for the treatment of neurodegenerative diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of lead program, AB126. This decision paves the way for the Phase 1b/2a clinical trial in acute ischemic stroke, which is expected to initiate in the first half of 2024. AB126 is an unmodified neural-derived exosome with an innate ability to traverse the blood brain barrier and shows evidence of anti-inflammatory and neuroprotective properties.

“We are thrilled with this validation from the FDA, which not only positions AB126 as the first exosome to enter human clinical trials for a neurological indication, but underscores the therapeutic feasibility of our platform,” said Steven Stice, Ph.D., Co-Founder and Chief Scientific Officer of Aruna. “Further, maintaining cells under controlled conditions is a key aspect of exosome manufacturing and we look forward to leveraging our in-house GMP manufacturing expertise to support clinical advancement. Simultaneously, we are expanding AB126’s applications across other indications, including amyotrophic lateral sclerosis, and exploring the broader potential of our neural exosome platform in overcoming existing challenges in CNS treatments.”

Aruna’s proprietary in-house GMP production facility allows for the manufacture of clinical grade batches under conditions that enable optimal and scalable consistency. Additionally, the unique purification techniques allow precise control over critical quality attributes. The establishment of protocols for analytical methods and well-characterized assays ensure therapeutic consistency.

Sean Savitz M.D., Primary Investigator and Professor of Neurology, Director of the Institute for Stroke and Cerebrovascular Disease at UTHealth Houston commented, “We look forward to building on the preclinical findings that showed AB126 may diminish neuro-inflammation, and potentially foster neuroprotection, and promote neuro-regeneration.”

About the Phase 1b/2a Clinical Trial

The planned dose-ascending clinical trial will evaluate the safety, tolerability, and preliminary efficacy of AB126 in patients with an acute ischemic stroke that have undergone a thrombectomy. Patients will receive three intravenous injection treatments of AB126 at a low, medium, and high dose. Patients with a poor prognosis post thrombectomy will be enrolled in the trial.

About Acute Ischemic Stroke

Acute ischemic stroke, caused by a clot blocking blood flow to the brain, is a leading cause of long-term disability and mortality worldwide. Current treatments, such as clot-busting drugs and mechanical thrombectomy, are effective but have strict time constraints for administration, often leaving a significant number of patients ineligible. Additionally, these treatments do not address the complex cascade of cellular and molecular events triggered by ischemia. Therefore, there is a critical need for innovative therapies that can extend the treatment window, mitigate neuronal damage, and enhance recovery, thereby improving outcomes for a broader range of stroke patients.

About Aruna Bio

Aruna Bio is a leader in the development of neural exosomes for the treatment of neurodegenerative diseases. The company is utilizing its proprietary neural exosome platform and manufacturing capability to develop a pipeline of neural exosome-based therapeutics able to cross the blood brain barrier and enhance the body’s anti-inflammatory, self-repair and protective mechanisms to treat a range of neurodegenerative disorders where significant unmet medical need exists today. Additionally, the company’s neural exosome platform can be combined with therapeutics, such as small molecules, siRNAs and proteins, to cross the blood brain barrier and to the site of disease.

Investor Contact:

Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com

LINK: https://www.globenewswire.com/en/news-release/2024/01/16/2809846/0/en/Aruna-Bio-Announces-FDA-Clearance-of-IND-for-Lead-Program-AB126-Enabling-the-First-Exosome-to-Enter-in-Human-Clinical-Trials-for-a-Neurological-Indication.html

Georgia Bio, Nationwide Life Science Leaders Unite To Celebrate Continued Investment In Biotech At New York Stock Exchange

Thu, 04 Jan 2024 21:15:00 GMT

Industry leaders from across the country to ring NYSE closing bell and kick off Biotech Month

FOR IMMEDIATE RELEASE

January 4, 2024, New York, NY – Georgia Bio, the life sciences trade association in Georgia, joined 16 fellow life science trade organizations from across the country yesterday to ring the closing bell at the New York Stock Exchange (NYSE) and kick off national Biotech Month. Maria Thacker-Goethe, immediate past chair for the Council of State Bioscience Associations (CSBA) and President and CEO of Geogia Bio, was among the leaders in attendance at the event, which was held jointly by NewYorkBIO and NYSE to celebrate the link between investment and innovation to best serve patients nationwide.

“I’m honored to ring the closing bell at the New York Stock Exchange with the new CSBA chair, John Conrad of iBio,” said Thacker-Goethe. “Joining my colleagues from across the country underscores that collaboration will help us protect and grow the U.S. innovation ecosystem.”

Georgia is poised to be a hub for life sciences. Georgia Bio’s workforce development program guarantees that the State’s workforce will be well-equipped to meet the demands of the expanding life science community. On the investment side, Georgia Bio along with 6 southeast state associations have partnered with Life Science Nation to launch RESI South in Atlanta on March 25. RESI South will mark the first-even life sciences investor event in the region and will connect start-ups and early-stage investors, an opportunity to showcase the state’s numerous investment opportunities.

“Nationwide collaboration is crucial to driving innovation, finding cures, and ultimately improving health outcomes and quality of life for patients,” added Jennifer Hawks Bland, CEO of NewYorkBIO. “As the worldwide epicenter for the financial sector, New York is uniquely positioned as a nexus for connecting the biosciences industry with the capital that makes groundbreaking research and development possible. NewYorkBIO is grateful to NYSE for this opportunity to welcome our colleagues from across the country to Wall Street, as we bring new meaning to ‘ringing in the new year’ and kick off Biotech Month.”

The event is one of several ongoing collaborations between NewYorkBIO and NYSE, who work together to connect New York’s robust investor community with innovative life science organizations of all types and sizes.

“We are thrilled to host NewYorkBIO and life sciences leaders from across the U.S. at the NYSE to ring our Closing Bell in honor of Biotechnology Month,” said Michael Harris, Global Head of Capital Markets at the New York Stock Exchange. “As we continue to see growth in the life sciences industry, the NYSE looks forward to welcoming many more biotech companies to our community of icons and disruptors.”

Maria Thacker-Goethe joined the below leaders from life science organizations across the country:

First introduced by President Clinton in 2000, National Biotechnology Month is an opportunity for the nation’s biotech community to come together to recognize the industry’s achievements on behalf of patients around the world. Falling in January, the recognition month is also an opportunity for industry leaders to look ahead to the advancements of the upcoming year.

To capture the closing bell on January 3, refer to NYSE’s website: nyse.com/bell/calendar

About Georgia Bio

Contact

Jason Rupp, Georgia Bio, jrupp@gabio.org

GeoVax Announces Issuance of Malaria Vaccine Patent

Wed, 03 Jan 2024 22:33:33 GMT

Patent Covers Multiple Component Vaccine for Both Prevention and Treatment

Atlanta, GA, January 3, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued Patent No. 11,857,611 to GeoVax, pursuant to the Company’s patent application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria."

The claims granted by the patent generally cover compositions comprising GeoVax’s modified vaccinia Ankara (MVA) vector expressing Plasmodium antigens and methods of inducing an immune response to malaria utilizing the compositions. The compositions and methods covered in the claims are useful both prophylactically and therapeutically and may be used to prevent and/or treat malaria.

David Dodd, GeoVax President and CEO, commented, “During 2023, there were the first cases of locally transmitted malaria reported in the United States in 20 years, with cases reported in Florida, Maryland and Texas. Worldwide, there are over 600,000 deaths annually attributed to malaria. This patent represents a potentially significant advance against a most critical deadly threat worldwide. While our focus and priority is to support our clinical-stage programs, we also remain strongly committed to improving public health worldwide and developing vaccines against global public health threats, such as malaria, as a part of our long-term vision for the company.”

According to data from the World Health Organization, globally, malaria causes 227 million infections and 619,000 deaths annually. Despite decades of vaccine research, vaccine candidates have failed to induce substantial protection. Most of these vaccines are based on individual proteins that induce immune responses targeting only one stage of the malaria parasite’s life cycle. GeoVax’s MVA-VLP malaria vaccine candidates incorporate antigens derived from multiple stages of the parasite’s life cycle and are designed to induce an immune response with durable functional antibodies and CD4+ and CD8+ T cell responses, all hallmarks of an ideal vaccine-induced immune response.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Celebrating Evolution and Innovation: Our look back at 2023 and ahead to 2024

Fri, 22 Dec 2023 21:07:00 GMT

The life science industry and its innovations are always advancing, always evolving in a never ending quest to address unmet patient and clinical needs. Industry organizations like Georgia Bio may not experience the frequency of flux – driven in large part by new technologies – as the members and partner entities we serve, but when significant change is needed, we are committed to swift action.

Such was the case earlier this year when Georgia Bio returned to our core mission and re-established our independence as a 501(c)6 advocacy organization from the Center for Global Health Innovation. From our November 1st announcement , “The ‘re-emergence’ of Georgia Bio is an industry demand-driven development. Academic and industry life science leaders have told us directly that they need a strong advocacy organization around which to engage with each other and advance their priorities. Those industry leaders are also prepared to provide the financial support required for Georgia Bio to be the entity that provides those services.”

What other accomplishments can we as an organization and industry celebrate from 2023 and what do we look forward to in 2024?

The Rural Teacher Training Initiative, a program administered by our BioEd Institute, launched its fifth year in September. RTTI provides hands-on, immersive science teacher professional development for rural Georgia teachers. Curriculum is built to highlight and leverage the biotechnology that exists within traditional science courses, including biology and AP biology, chemistry and AP chemistry, physics, environmental biology, agriculture and horticulture, physical science, and life science.

Funded by the State of Georgia, we have reached more than 52,000 students in 87 counties across the state through 370 educators who have participated in the program since its inaugural year, 2019. 70% of these educators and students teach and learn in Title I schools.

RTTI 5.0 will have a Fall Training series followed by Spring Training Series. The Fall Series is virtual, live, hands-on, and will take place over four, two-hour sessions. Participants will be sent supplies to engage and practice during each session.

Back to the Summit!
Our Innovation Summit returned, this time hosted by our friends in Sandy Springs, bringing together more than 300 of our industry, advocacy and higher ed colleagues. Check out the highlights in our recap posts including BIO Board Chair Ted Love’s keynote , venture funding and AI & medtech sessions.

As part of the program, we celebrated Johns Creek and its certification as a BioReady Community, the first municipality in Georgia so designated. As just the second state in the country to formally adopt such a program, the BioReady Communities program will allow Georgia’s municipalities to showcase biotech-zoned science parks, streamline permitting, build a robust infrastructure, and identify biotech-friendly sites more effectively in the interest of attracting companies interested in relocating. Read more .

How about “Southeast Venture Investment”

In the interest of serving the life science ecosystem beyond our historic focus on pharma, ag tech, legislative affairs, education and workforce development, we worked closely with Life Science Nation to create and confirm RESI South. (In a peek behind the curtain, bringing these opportunities to the ecosystem don’t happen in a vacuum. It took the collective team six months to make the upcoming event opportunity real.)

“Dennis Ford, CEO of Life Science Nation [stated], ‘I have seen firsthand the incredible opportunities abounding in the Southeast U.S. with a plethora of colleges, universities, and hospitals, fostering life science research and development. This is combined with an amazing array of incubators, accelerators, regional and governmental entrepreneurial programs, and world-class Bio Clusters supporting startups across all phases of development. LSN’s global partnering network wants to tap into these seven states’ technological and innovative firepower.’” The in-person piece of RESI South is March 24 at the Whitley Hotel in Atlanta. Follow Life Science Nation (and this space) for additional details.

Speaking of next year…

One of our top priorities for 2024 will be supporting our industry colleagues and patient advocacy groups. As we wrote recently, “Americans want policymakers to see lowering out-of-pocket costs for health care as a top priority. Putting pharma and its innovators who invest billions of dollars in R&D for therapies that improve outcomes and save lives in villainous crosshairs is easy to understand and politically expedient, but misguided.

“In 2021, West Virginia became the first state in the nation to adopt ground-breaking legislation related to drug pricing and PBM transparency. The State of Georgia is considering HB343 in its upcoming legislative session, requiring insurers and their PBMs to share the savings they negotiate on medicines directly with patients.”

It is likely more states will consider similar legislation. In this “environment,” it has never been more important for pharma to clearly communicate the value of its therapies or to deliver those therapies with great efficiency.

You can learn more about how we support the industry through legislative affairs by reading out Legislative Watch publication that we issue during GA Session. Take a look at our policy priorities, including support for academic research institutions within the University System of Georgia that feed industry innovation here .

New Digs!

A big thank you to Eversheds Sutherland and Bill Warren for “hosting” our offices for the past seven years, Georgia Bio is now seeking a new home for 2024. Have space? Interesting in sharing? Contact Maria!

Telling our story

During his Summit keynote, Dr. Ted Love emphasized the importance of ‘taking back our narrative’ as it relates to the beating pharma cos have taken in the drug price debate. Georgia Bio will endeavor to follow that lead by developing and sharing more content featuring our members, our partners, industry, advocate, legislative and education in the coming year. Our collective work matters to patients, to business, to our state and local economic growth and we intend to make sure the importance of that work, and its outcomes, is well known.

If you have a story you’d like to share or help tell, we welcome your ideas. Email admin@gabio.org .

Organizationally, we are adding three new committees to our roster: business strategy, medtech (as mentioned in our November 1 missive), and innovation and entrepreneurship. One of the innovation and entrepreneurship committee’s charges will be to support venture events and young company pitch events throughout the state. We are also preparing to launch a new “Fellows Program” which offers companies the opportunity to access Georgia Bio’s extensive services, benefits, and network to help them grow. The program offers a three-year membership providing early-stage life science, biotech, and medtech companies full access to the complete Georgia Bio portfolio of benefits, including the Georgia Bio purchasing consortium and discounted access to seminars, conferences, and networking events.

Again, we encourage you to get in touch with insights on events, organizations, young companies or investors with whom we should be in touch or aware.

In closing: a few asks

We are a member-driven and funded organization. As such, we need your help to not only ensure you and your organization’s membership is accounted for in forward-facing budgets, but also to communicate our value and share our stories encouraging others to become members.

We commit to listening closely to our members and partners to best understand how we can deliver value for your membership and/or sponsorships in events like the Summit.

A few recommendations:

If you’ve made it this far, thank you for reading! Look out for an announcement of our 2024 Board of Directors in the new year.

The Georgia Bio team wishes you joyful, safe and restful holidays, and a healthy, prosperous new year.

If you’re not already doing so, we encourage you to register for our weekly newsletter and follow us on LinkedIn .

Gov. Kemp: Medical Device Manufacturer Gerresheimer Expands in Peachtree City

Fri, 22 Dec 2023 18:35:00 GMT

Atlanta, GA – Governor Brian P. Kemp today announced that Gerresheimer, a manufacturer for the pharma and life science industry, will invest more than $88 million in expanding its manufacturing operations in Peachtree City, creating over 200 new jobs for Fayette County.

“This project is a prime example of the exciting growth of the life sciences industry in our state, with companies like Gerresheimer bringing career opportunities to all four corners of Georgia” said Governor Brian Kemp . “Employers from across the globe can find a skilled workforce here that we are continuously investing in through innovative programs like the GEORGIA MATCH Direct College Admissions Initiative. We’re excited to see how this expansion will further benefit the community and surrounding region.”

Germany-based Gerresheimer offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems, and medical devices as well as solutions for the health and cosmetics industry. Gerresheimer currently supports more than 260 jobs in Peachtree City. The existing Gerresheimer manufacturing facility is already in the midst of an expansion, where it will support an additional 180 jobs with operations beginning in April 2024. Today’s announcement marks yet another investment by the company here in the No. 1 state for business.

“We appreciate the continuous support of the State of Georgia for our expansion in the U.S.,” said Dietmar Siemssen, CEO of Gerresheimer AG . “The U.S. market is an important growth driver for us, and the expansion of our operations in Peachtree City will be key for growing our medical device business in the U.S. We are glad that we have found such favorable conditions and a highly motivated and skilled staff here.”

Gerresheimer’s new facility will be located in the Southpark International Industrial Park in Peachtree City, and will produce medical devices, in particular autoinjectors, to administer injectable drugs. Operations are expected to begin in fall 2024.

The company is currently hiring for various positions from entry level production employees to highly skilled engineers, quality managers, and administrative staff. Hiring for the new facility will start in early summer 2024. Interested individuals can learn more at www.gerresheimer.com/en/careers/jobs/job-openings or contact Vickie Britt at Vickie.Britt@gerresheimer.com .

“We are dedicated to fostering strong partnerships and economic growth in Peachtree City, evidenced by our support of Gerresheimer’s plans to expand their facility here,” said Peachtree City Mayor Kim Learnard . “Gerresheimer’s commitment to innovation in the pharmaceutical packaging industry aligns perfectly with our vision for a prosperous and vibrant city. We are excited about the additional employment opportunities and the positive impact this expansion will have on our community.”

“I am thrilled to witness Gerresheimer’s continued commitment to Fayette County through its expansive growth in Peachtree City. By choosing to expand in our community, they are not only creating job opportunities but also making an investment in the future,” said Darryl A. Hicks, Chairman of the Fayette County Development Authority . “Having been an integral part of our community for three decades, Gerresheimer’s decision to grow here speaks volumes about the quality of our workforce, the strength of our local economy, and the supportive environment that Peachtree City and Fayette County provide.”

Senior Regional Project Manager Fernanda Kirchner represented the Georgia Department of Economic Development (GDEcD) Global Commerce team on this competitive project in partnership with Fayette County Development Authority, the Metro Atlanta Chamber, and Georgia Power.

“Georgia prides itself on creating long-term relationships with companies, and we have been fortunate enough to meet with Gerresheimer’s team in both Peachtree City and their headquarters in Germany multiple times,” said GDEcD Commissioner Pat Wilson . “Companies locate in Georgia for the business friendly environment, and they choose to expand here because of the state’s solutions to the challenges facing businesses, including workforce training. Gerresheimer’s commitment to Peachtree City and Fayette County over the last 30 years shows our approach works, and we look forward to Gerresheimer’s continued growth in Georgia!”

Georgia is outpacing the nation in life sciences employment, with a 20 percent growth rate since 2015. The industry supports more than 78,000 jobs statewide, and at least 4,000 life science organizations operate in Georgia. In 2022, Georgia exported over $1 billion in medical instruments to international markets.

About Gerresheimer
Gerresheimer is an innovative system and solution provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems, and medical devices as well as solutions for the health and cosmetics industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors, and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles, and more. Gerresheimer ensures the safe delivery and administration of drugs to the patient. Learn more at www.gerresheimer.com .  

Source: https://gov.georgia.gov/press-releases/2023-12-21/gov-kemp-medical-device-manufacturer-gerresheimer-expands-peachtree-city

Emory launches new program to improve health equity by accelerating disease diagnostic research

Fri, 22 Dec 2023 18:34:00 GMT

December 18, 2023 | Saporta Report

Striving to ensure advanced medical technologies are reaching the populations who need them most, Emory’s Center for the Advancement of Diagnostics for a Just Society (ADJUST) is launching this year as part of NIH’s RADx program.

The last several years have demonstrated that new technologies are steadily allowing for the diffusion of disease diagnosis and monitoring out of clinical environments and into communities, businesses, schools, and homes. These types of point-of-care technologies offer numerous benefits, but they also introduce a whole new set of issues – not only technological and clinical, but also logistical, regulatory, commercial, social, and ethical. Often times, the patients who need these new technologies the most have the least access.

Emory’s new center is the first-of-its-kind designed to address these issues. Utilizing a two-pronged approach to accelerate diagnostic development while ensuring health equity and justice, the ADJUST Center will serve as both a thinktank focusing on the advancement of future disease diagnosis through research and advocacy, as well as a technology foundry to accelerate diagnostic development.

“Given our vast experience, expertise, and ecosystem in diagnostics, we are well poised to be the only center in the nation dedicated to advancing the entire field of diagnostics forward in this modern era of medicine,” says Wilbur Lam, MD, PhD, pediatric hematologist and oncologist at Children’s Healthcare of Atlanta, and professor of pediatrics and biomedical engineering at Emory University and Georgia Institute of Technology. “As we help develop and translate new diagnostic technologies, our Center will also concurrently address the issues of accessibility, usability, and affordability to ensure these state-of-art tests will serve the populations who need them the most.”

The ADJUST Center is borne out of the NIH-funded point-of-care technologies center, the ACME POCT , which is one of six sites in the U.S. selected by NIH as part of the NIH Point-of-Care Technologies Research Network. ACME POCT played a pivotal role during the onset of the COVID-19 pandemic as the national test verification center to rapidly evaluate COVID-19 tests and help make them widely available.

The ADJUST Center will seek to build off the expertise compiled during the COVID-19 pandemic and apply the lessons learned and proven tactics to ensure equitable access to advanced technology for everyone. Projects already underway include assessing the potential adverse outcomes of consumer health wearable technologies and examining the availability of point-of-care HPV diagnostics.

Emory’s Senior Vice President for Research Deborah Bruner, PhD, says, “The ADJUST Center is an important new initiative that builds upon Emory’s strengths and impacts so many of our institutional goals. It is highly innovative, it is entrepreneurial, it is collaborative, and it is focused on health equity – it encompasses a wide variety of things that make us Emory. I’m extremely excited to see what the center can achieve for our community and the world.”

Source: https://saportareport.com/emory-launches-new-program-to-improve-health-equity-by-accelerating-disease-diagnostic-research/thought-leadership/higher-education/emory-university/

Veranex Acquires Leading Preclinical Services Provider T3 Labs

Fri, 15 Dec 2023 20:00:00 GMT

Recently Veranex acquired T3 Labs, a state-of-the-art, highly reputable preclinical laboratory located in Atlanta, Georgia. This acquisition solidifies our commitment to expanding our preclinical footprint in North America, supporting the increasing regulatory demands and enabling more efficient collaboration with clients in their product development.

While our Paris lab is already well-known as a preeminent leader within the cardiovascular space, the addition of our North American facility brings a broader array of cardiovascular and non-cardiovascular expertise into our portfolio of offerings. We’ve expanded our capabilities to encompass 12 total therapeutic areas including orthopedic, GI/urology, and more as well as offering bioskills training. The staff at T3 Labs brings deep preclinical medical device expertise to our existing team, having contributed to more than 60 products being approved by the FDA over the past 10 years.

Read and Learn More here: https://veranex.com/expanding-our-preclinical-services-and-accessibility-in-north-america/

The United States Patent and Trademark Office (USPTO) has Selected Atlanta for its New Regional Office

Fri, 15 Dec 2023 19:56:00 GMT

New regional office and community outreach office to serve as innovation centers for local/regional innovators

WASHINGTON— The U.S. Patent and Trademark Office (USPTO) today announced that it will open a new regional office in the Atlanta, Georgia metropolitan area serving innovators in the Southeast region, and a new community outreach office in Strafford County, New Hampshire, serving innovators in the New England region. The new regional office and community outreach office will serve as an extension of the agency’s outreach operations. The offices will function as important resource centers to better serve local inventors and entrepreneurs, including those from underrepresented backgrounds. The new regional office in Atlanta is expected to be fully opened and operational by December 2025, with the New Hampshire outreach office soon thereafter.

As Georgia Tech’s Science Square nears completion, it seeks more tenants

Fri, 15 Dec 2023 19:54:00 GMT

From university spinoffs to publicly traded life science companies, activity is swirling around Georgia Tech’s $1 billion development Science Square.

But with the 18-acre project’s completion set for March leasing has been slow. Venture capital company Portal Innovations is building out 33,000 square feet of lab and office space. Otherwise, no leases have been signed. Katherine Lynch, principal for master developer Trammell Crow Co., remains optimistic.

Georgia Tech is the catalyst, she said.

Source: https://www.bizjournals.com/atlanta/news/2023/12/12/science-square-nears-completion-georgia-tech.html

SIRPant Immunotherapeutics Announces FDA Clearance of IND Application for SIRPant-MTM for the Treatment of Solid Tumors

Fri, 15 Dec 2023 19:08:00 GMT

“This second IND clearance in 2023 is a testimony not only to the SIRPant team’s ability to deliver on-time development milestones, but also to the broad potential scope of therapeutic opportunities for SIRPant-M ^TM in multiple tumor types,” said Robert Towarnicki, President & CEO of SIRPant. “We look forward to progressing SIRPant-M ^TM through clinical development and dosing the first patients in both the NHL and solid tumor trial in 2024.”

About SIRPant Immunotherapeutics, Inc.
SIRPant Immunotherapeutics Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation macrophage-based immunotherapies for the treatment of hematological malignancies and solid tumors. The cell therapy technology SIRPant employs is based on the reduction of SIRPα expression combined with activation of the patient’s own macrophages. This population of SIRPαlow activated macrophages are designed to attack the tumor following injection by activating the patient’s immune system to produce broad spectrum anti-tumor activity that utilizes patient T-cells and antibodies targeting cancer neoantigens. Because SIRPant does not genetically engineer its cell therapies, the company believes its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered cell therapies in the clinic, and may provide patients with meaningful clinical benefit. As a result, SIRPant-M ^TM has a compelling product profile when compared to current gene-modified cell therapies. For more information, please visit www.sirpantimmunotx.com .

Source: https://www.wate.com/business/press-releases/globenewswire/8993181/sirpant-immunotherapeutics-announces-fda-clearance-of-ind-application-for-sirpant-mtm-for-the-treatment-of-solid-tumors/

AdvaMed Announces Formation of Medical Imaging Division

Tue, 12 Dec 2023 17:06:00 GMT

World’s largest medical imaging companies join world’s largest medtech association

WASHINGTON, D.C., – Today, AdvaMed, the Medtech Association, announced the establishment of a new Medical Imaging Technology division focused on advocating on behalf of large and small companies for the essential role of medical imaging technology, radiopharmaceuticals, contrast media, and focused ultrasound devices in our nation’s health care system. Leading medical imaging companies – such as Bayer, Fujifilm Sonosite, GE HealthCare, Hologic, Philips, and Siemens Healthineers – have formally established AdvaMed as the new home for advocacy on behalf of medical imaging companies, which previously sat within the Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA) .

AdvaMed President and CEO Scott Whitaker said : “This new division is a big step forward not merely for the medical imaging sector, but for AdvaMed and the entire medtech industry. Never before have medical technologies been so connected and interdependent as they are today—and it’s really only the beginning. From traditional medical devices to digital health tech to AI and medical imaging, the opportunity to unify the industry and advance policy solutions for the health care system has never been better. No trade organization is better prepared than AdvaMed to represent the entire medtech industry and take on these advocacy challenges so that our members can continue focusing on what they do best—meeting the needs of the patients they serve.

“Finally, the timing of Peter Arduini’s election as our new Chair couldn’t be better. His leadership of GE HealthCare, a global leader in medical imaging, pharmaceutical diagnostics and digital solutions, will provide strategic insight and direction to AdvaMed as we work to ensure an aligned and inclusive focus across companies in every sector of medtech.”

Peter J. Arduini, President and CEO of GE HealthCare and newly elected Chair of the AdvaMed Board of Directors, said of the new division : “We are in a new era in which providers and patients rely on medical imaging and digital solutions for critical insights across the entire care pathway from screening, diagnosis, monitoring, and therapy delivery, as well as research and discovery. As Chair, I look forward to working alongside Scott and my colleagues from across the industry to establish AdvaMed’s new imaging division and ensure it is aligned and integrated to our overall goals of the med tech industry.”

Patrick Hope served as executive director of MITA since 2015 and will now serve as executive director of the new Medical Imaging Technology division at AdvaMed. Hope said : “The future is brighter than ever for the medical imaging companies we served at MITA. Our new home at AdvaMed makes perfect sense: For the first time, we will be surrounded by a team, infrastructure, and resources focused entirely on the patients our companies serve. We will be surrounded by and working directly with experts in medtech policy at the state, national, and global levels. I am 100 percent confident that our companies will see more value in our work together under the AdvaMed umbrella than ever before.

Imaging plays a critical role in our health care system, from diagnosis to treatment:

As is the case with AdvaMed’s Accel, Dx, and Digital Health Tech divisions, AdvaMed’s new Medical Imaging Technology division will be led by a Board of Directors comprised of executives from its imaging company members. The new division will be led within AdvaMed by Patrick Hope, former Executive Director of the Medical Imaging Technology Alliance (MITA). Mr. Hope and Peter Weems, who led MITA’s government affairs and policy strategy, as well as other staff, will round out the division’s staffing needs at AdvaMed going forward.

This division’s creation comes on the heels of AdvaMed’s announcement last month that it had established a Digital Health division . The recent creation of these two divisions “further demonstrates that AdvaMed is well positioned to lead the entire medtech industry on the advocacy front,” Whitaker said.

In January, AdvaMed will unveil a refreshed version of its “ Medical Innovation Agenda for the 118 ^th Congress ,” a list of policy and legislative priorities critical to patient care that will include a new set of priorities for the medical imaging sector.

Peter J. Arduini, President and CEO of GE HealthCare, Named Chair of AdvaMed Board of Directors

Tue, 12 Dec 2023 16:54:00 GMT

December 11, 2023 | WASHINGTON, D.C., – Today, AdvaMed, the Medtech Association, announced that Peter J. Arduini, president and CEO of GE HealthCare, will become the Chair of the AdvaMed Board of Directors.

“The entire board and the global industry AdvaMed represents are very excited to have Peter as our new Board Chair during this critical time for medtech. Artificial Intelligence, imaging and digital technology represent important areas of innovation that can significantly accelerate diagnosis and improve the personalization of patient care. Peter’s proven record of leadership across more than three decades in medtech and imaging will enable him to advance AdvaMed’s goal of achieving healthier lives and healthier communities around the world. I look forward to working with him,” said AdvaMed President and CEO Scott Whitaker, who also serves as President of the AdvaMed Board of Directors.

Arduini said, “I appreciate the confidence my fellow AdvaMed Board members have placed in me as the Board’s new chair. Through Scott’s leadership, AdvaMed has become a unifying voice for our industry to foster growth and innovative new solutions for patients, providers and health systems. The medical technology industry is at the forefront of defining the future of healthcare through smart devices, diagnostics and digital solutions that can enable earlier and more precise diagnoses, targeted treatments and improved patient outcomes. We need policies that keep pace with innovation, while fostering the highest ethical standards that improve patient access to the best care possible. With the promise of artificial intelligence and the interconnectivity of medical technologies, there has never been a more important time in our history to make profound and lasting changes in the delivery of care for patients.”

Arduini has been president and chief executive officer of GE HealthCare, a global medical technology, pharmaceutical diagnostics, and digital solutions innovator, since January 2022. He previously served as president and chief executive officer of Integra LifeSciences Holdings Corporation, corporate vice president and president of Medication Delivery, Baxter Healthcare, from 2005 to 2010. He previously spent 15 years at GE Healthcare where in a variety of management roles for domestic and global businesses, culminating in leading the global functional imaging business. Arduini also serves on the Boards of Directors of GE HealthCare, Bristol Myers Squibb and the National Italian American Foundation.

In the wake of former AdvaMed Chair Ashley McEvoy’s departure from Johnson & Johnson Medtech in October, Arduini stepped in to serve as interim chair over the past several weeks. The full Board elected him unanimously to a two-year term, which began immediately Friday.

Arduini will unveil his priorities as AdvaMed Chair in early 2024.

Source: https://www.advamed.org/industry-updates/news/peter-j-arduini-president-and-ceo-of-ge-healthcare-named-chair-of-advamed-board-of-directors/

Using March-In as a Price Control Mechanism Is a “Dangerous Precedent To Set”

Tue, 12 Dec 2023 16:37:00 GMT

The White House just announced plans to use Bayh-Dole “march-in rights” to step in and license patent rights of drugs “developed with federal funding” to other manufacturers when the price of the drug is deemed too high. BIO’s Chief Advocacy Officer, Nick Shipley, made the following statement:

“Using the Bayh-Dole Act’s march-in process as a mechanism to control prices is a dangerous precedent to set. The move would create yet another element of uncertainty within the biotech industry at a time when policy makers have been increasingly adding obstacles to innovation. This type of policy would discourage the exact type of private-public sector partnerships that the Bayh-Dole Act was designed to encourage, and it would undermine a valuable piece of the drug discovery process. For smaller biotech companies, which are responsible for the bulk of medical innovation, this undermines the ability to raise capital and maintain a stable investment base from strong private sector funding, which is the vast majority of investment that allows them to usher in new waves of biomedical innovation. Any policy that encourages the government to seize private company patents is a policy that discourages investing in companies that have accepted government funding, such as SBIR grants or working with universities that have received NIH funding.

“It is also disappointing that the White House chose to include this in its broader statement when there are so many other overdue promising policy recommendations where we could find common ground to work together to bring down health care costs. The announcement touches on reforms to address the long-overdue problem of PBM and provider consolidation, lack of transparency in those sectors, and other elements of oversight that have been long-discussed but never enacted. We look forward to seeing the Administration apply the same rigor and scrutiny they so willingly bring to our industry to the PBM and provider markets so that we can move forward on policies that actually lower spending for patients.”

Industry Leader and Globally Recognized Patient Advocate John F. Crowley Appointed to Lead BIO as President & CEO

Tue, 05 Dec 2023 18:31:00 GMT

Biotech entrepreneur, company founder, tireless patient advocate, and U.S. Navy combat veteran will guide the life science industry in its mission to feed, fuel and heal the world

December 5, 2023 | The Biotechnology Innovation Organization (BIO) is proud to announce that industry leader and military veteran John F. Crowley will be its new President and CEO, effective March 4. He will replace Rachel King, a longtime BIO board member and industry trailblazer who has served as BIO’s CEO on an interim basis for the past year.

Crowley is best known for his role as an entrepreneur in the biotechnology industry following the 1998 diagnosis of his two youngest children with Pompe disease, a rare and often fatal neuromuscular disorder. His children’s diagnosis inspired him to co-found a biotech company to develop a treatment that he credits with ultimately saving his children’s lives. The Crowley family journey was depicted in the major motion picture “Extraordinary Measures” starring Harrison Ford, Brendan Fraser, and Keri Russell. In 2005, Crowley went on to help found Amicus Therapeutics, a now 500+ person global biotechnology company, where he served as Chairman and CEO from 2005-2022 and is presently the company’s Executive Chairman. He will remain in that role until he transitions to BIO.

Crowley’s decades of biotech experience and deep passion for the field will be pivotal in helping BIO reimagine how the world thinks about drug development. He is a strong supporter of policies that empower innovation, enable entrepreneurship, and put patients first. Crowley also has been a leading voice globally for universal access to medicines, especially for children, people living with rare and other life-threatening diseases, and those with disabilities. As the father of two children living with a rare disease, he brings a unique understanding of the challenges patients, their families, and caregivers face, as well as the transformative opportunities that biotechnology presents to alleviate human suffering. This has been his life’s mission.

“In every role I’ve held in my life—biotech founder, U.S. Navy intelligence officer, husband and most importantly, father and grandfather—I have asked myself, ‘What is the mission?’” said Crowley. “When I founded our first company, the mission was to create a therapy to save our children and others from Pompe disease. Today, there are untold millions of children and adults waiting for ‘their’ cures and treatments – as well as literally billions of people who need agricultural advances and climate solutions that biotechnologies can provide. The mission of BIO is the mission of our members: cure patients, protect our climate, and nourish humanity. I am humbled and honored to lead BIO as we enter this golden age of medicine and the coming age of biotechnology. And I am eager to continue working alongside our members and dedicated BIO leadership and staff to drive this mission forward.”

BIO represents roughly 1,000 members, including members working to deliver new animal health, plant, microbial and biobased products of biotechnology to support food security and address climate change. “While my life’s work has centered on creating life-changing and lifesaving medical therapies, I am excited about advancing these critical issues in agriculture and the environment for our society, as well as growing the membership base that drives our mission,” said Crowley, a longtime BIO board member and current BIO Vice Chair. “BIO’s presence at this year’s United Nations Climate Change Conference – COP28 – will give us an exceptional platform to showcase our member companies’ great work.”

“Having worked alongside John for many years, I can attest to his unwavering commitment to patients. He possesses a lifelong dedication to service, whether fighting for his country, wisely negotiating on behalf of our companies in Congress, or advocating in hospitals on behalf of his children and patients with rare disease,” said BIO Board Chair Dr. Ted W. Love. “After an exhaustive search for the right leader, we were thrilled that John decided to take on this influential role. We can’t thank Rachel King enough for her willingness to come out of retirement to lead BIO during this transition. Her dedication has made it possible for us to find the right leader for the job, and we are delighted she will ensure a smooth transition until John assumes the role in early 2024.”

“I’ve had the pleasure of working with John for many years as a Board member, and for the past year as part of BIO’s leadership team,” says Rachel King, co-founder and former CEO of GlycoMimetics, Inc., who has been serving as BIO’s President and CEO since October 2022. “There couldn’t be a better person to lead our members in 2024 and beyond, and I look forward to continuing to work together to advance this incredibly important industry in its pursuit to change people’s lives for the better.”

King will continue to serve in her current role until March 4, when Crowley transitions into his new position at BIO.

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention , the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. Good Day BIO is the only daily newsletter at the intersection of biotech, politics and policy. Subscribe here.

Learn More about John here: https://www.bio.org/about/bio-leadership/john-crowley

Large Majority of Americans Say Consideration of Clinical Trial Participation Should be a Part of Regular Health Care

Tue, 05 Dec 2023 18:23:00 GMT

Arlington, VA – December 5, 2023 – According to survey findings released today, an overwhelming majority of Americans (87%) agree that health care professionals should discuss clinical trials with patients diagnosed with a disease as part of their standard of care. Further, sixty-one (61%) percent agree that consideration of clinical trial participation should be a part of regular health care whether patients are healthy or ill, up from 44% in 2017. Commissioned by Research!America in partnership with the Association of Clinical Research Organizations (ACRO), the October 2023 national survey captures Americans views on clinical trials and clinical research. ( View slide deck of survey results. )

“We are pleased to partner again with Research!America to survey public attitudes toward clinical trials, which are essential to the development of new drugs and new treatments for the people who need them,” said Doug Peddicord, Executive Director of ACRO. “Especially important is that the public believes that clinical trials should be part of everyday health care and that physicians and other healthcare providers should discuss clinical trial options with their patients.”

Despite widespread support for the incorporation of clinical research into health care, only 36% of respondents say their doctor or other health care professional has talked with them about medical, health, or clinical research. That said, this is an encouraging jump from 19% in 2017 who said so. Overwhelmingly, respondents prefer getting information about clinical trials from their doctor or health care provider (77%) rather than other sources and say that doctors and health care providers (50%) have the greatest responsibility in educating the public about clinical trials.

While approximately 8 in 10 respondents say they have heard of a clinical trial, only 26% say they or someone in their family has ever participated in one, up from 18% in 2017. However, of those that had not participated in a clinical trial, 49% are willing to do so. Respondents noted lack of trust (57%) as the top reason individuals do not participate in clinical trials, which grew from 38% in 2017. Adverse side effects (52%), up from 34% in 2017, and lack of awareness/information (55%) follow closely.

Most Americans feel positively about clinical trials with many agreeing that they benefit from clinical research and its findings (73%). Factors important to clinical trial participation are understanding potential risks and benefits (72%), competence and reputation of people or the institution conducting the research (71%) and having an expert guide through the clinical trials process (60%). Eight in 10 respondents said they were likely to participate in a clinical trial at a traditional site (like a hospital or a doctor’s office), but many also indicated that they would be likely to participate at a non-traditional site with 75% likely to participate at a home site and 67% at a community site (like a community health center, clinic, CVS, Walgreens, etc.).

“Clinical trials are essential to progress in medical research. These new survey findings highlight that Americans are not only interested in learning more about clinical trials, they are willing to get involved,” said Mary Woolley, President and CEO of Research!America. “Though a growing lack of trust is cause for concern, it is heartening to see Americans’ strong support for clinical research. It’s clear that it’s time to expand discussion between patients and health care professionals, ensure access to clinical trials, and improve participant diversity.”

Though most respondents expressed willingness to share personal health information, the survey reveals a downward shift in public attitudes on this topic that calls for attention from the research community. Respondents say they are willing to share their health information:

Data suggests that confidence in the U.S. system for reviewing the effectiveness and safety of new medicines and medical technologies has increased with 7 in 10 saying they are confident in the current system, up from 63% in 2017. Respondents are split, however, on the speed with which the U.S. Food and Drug Administration (FDA) should act.

Additional highlights from the Research!America/ACRO survey include:

The online survey was conducted by Zogby Analytics on behalf of Research!America in October 2023, among 1,005 adults plus 1,207 additional adults for minority oversampling. The survey has a theoretical sampling error of +/- 3.1 percentage points.

For questions about the survey, or to set up an interview with Mary Woolley, contact Taylarr Lopez, Director of Communications for Research!America, at 571-482-2719 or tlopez@researchamerica.org with press inquiries.

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About the Association of Clinical Research Organizations (ACRO)

Founded in 2002, ACRO represents the world’s leading clinical research and technology organizations, which provide specialized services that are integral to the development of drugs, biologics and medical devices. ACRO and its members advocate on a global basis for safe, ethical, high-quality medical research so patients can benefit from the development of new treatments and therapies. Our members are dedicated to helping their clients bring efficiency, innovation and value to the clinical research process.

About Research!America Research!America is a non-profit medical and health research advocacy alliance which advocates for science, discovery, and innovation to achieve better health for all. Visit www.researchamerica.org .

Micron Biomedical Receives $23.6 Million to Accelerate Commercial Manufacturing of Needle-Free Vaccines and to Help Eradicate Measles

Thu, 16 Nov 2023 17:43:00 GMT

November 16, 2023

November 16 2023, ATLANTA– Micron Biomedical, a life science company developing first-in-class dissolvable microarray-based products that simplify and improve the transport, storage, and administration of drugs and vaccines, today announced a $23.6 million grant from the Bill & Melinda Gates Foundation that will fund mass production of needle-free vaccines. The manufacturing facility will enable commercialization of the first microarray technology-based measles-rubella vaccine, indicated for children as young as 9 months, once approved by the appropriate regulatory authorities following additional clinical study.

In low- and middle-income countries, measles remains a leading cause of death, primarily due to limited access to vaccines that require refrigeration during transport and storage and clinicians to administer them. Micron is developing a needle-free version of the measles-rubella (MR) vaccine based on its microarray technology. The technology reduces the need for a cold chain and allows a community health worker to vaccinate a child within minutes by applying the technology to the skin and pressing a button that confirms administration. The administration of the vaccine is virtually pain-free.

“Vaccines are among the most effective and cost-effective tools to prevent measles and rubella, diseases that account for an estimated 350 deaths per day with a disproportionate impact on people living in low- and middle-income countries,” said James Goodson, Senior Scientist and Epidemiologist in the Global Immunization Division at the Centers for Disease Control and Prevention (CDC). “Microarray-based measles-rubella vaccines could provide an alternative approach to delivering these life-saving vaccines to children in regions with some of the highest rates of unimmunized children in the world and could help overcome some of the most substantial barriers to eradicating measles and rubella globally.” 

According to the World Health Organization, all children should be vaccinated against measles between the ages of 9 and 15 months, then again between 15–18 months. Earlier this year, Micron announced successful clinical data from a phase I/II study in the Gambia, which evaluated the safety, immunogenicity, and acceptability of the leading commercially available MR vaccine delivered by Micron’s microarray technology in adults, toddlers and infants as young as 9 months old.

“We’re grateful to the Bill & Melinda Gates Foundation for the grant that allows us to build on our collaborative track record of bringing effective and life-saving vaccines to children and adults in communities with limited infrastructure,” said Steven Damon, CEO of Micron Biomedical. “By supporting Micron’s efforts to develop a state-of-the-art, high-quality and large-scale production facility to manufacture our microarray technology, we have an opportunity to greatly improve on access and availability of measles/rubella vaccines, as well as other traditionally-injectable

Global Health vaccines, in underserved populations around the world. This first commercial-scale production facility establishes Micron’s proof of concept for additional commercial vaccines and drugs in all markets globally.”

Micron’s technology has been recognized for its potential to achieve positive global impact.

In addition to the opportunity to improve access to vaccines and therapeutics in low- and middle-income countries, Micron’s technology has an opportunity to improve health globally as the evidence reflects that patient reluctance to receive injectable medicine can lead to delayed therapy, treatment avoidance, and vaccine hesitancy in higher income countries. The technology’s broad impact also includes US national health security, as well as veteran and military health.

About Micron Biomedical

Micron Biomedical is the leader in dissolvable microarray-based, drug and vaccine administration technology. Micron Biomedical is a clinical-stage life science company on a rapid path to commercializing its proprietary dissolvable, microarray technology. Micron’s technology is designed to improve access and achieve better health outcomes globally through injection-free, painless, and simple and/or self-administration of drugs and vaccines, and by eliminating or reducing the need for cold chain transport and storage, enhancing safety and efficacy, and improving patient compliance. Micron partners with and/or receives funding from private and public pharmaceutical and biotech companies, the Bill & Melinda Gates Foundation, the Centers for Disease Control and Prevention (CDC), PATH and the Georgia Research Alliance.

For more information visit www.micronbiomedical.com .

Source-Micron : https://www.prnewswire.com/news-releases/micron-biomedical-receives-23-6-million-to-accelerate-commercial-manufacturing-of-needle-free-vaccines-and-to-help-eradicate-measles-301990341.html

Echoing the Optimism for Medtech and Bioscience Venture Investment in the Southeast

Wed, 15 Nov 2023 22:21:00 GMT

In the final session of the 2023 Georgia Life Sciences Summit, four life science venture investors joined Radyus Research CEO Marta New to discuss best practices and errors to avoid for early stage life science companies building an “investment stack” along with their perceptions of the southeast life science innovation ecosystem and its “investability.”

If the life science ecosystem in Georgia were not ‘robust,’ it would not be responsible for north of $50 billion in economic impact. Venture investment in life science in Georgia, however, has lagged well behind vaunted locales like Boston and the Bay Area. Building on existing infrastructure including intellectual capital emanating from the state’s university system as referenced earlier in Tim Denning’s remarks, and upon lower cost of business operations and a high quality of life, are life science innovators in Georgia slated to have higher volumes of venture funding opportunities available to them?

In April 2022, Portal Innovations announced the expansion of its life sciences-focused venture development operation to Atlanta, in an upcoming development called Science Square.

From Portal’s announcement , “We look forward to supporting the life sciences community to allow companies to grow and scale locally. Between the CDC, and top-tier research universities in the area, we view Atlanta as one of the top emerging life sciences markets in the U.S. and would like to support continued growth here, helping it become a robust biotech startup ecosystem.”

Matt Goldman, a partner with J2 Ventures also pointed to strong science and engineering talent, great outreach from high ed institutions’ tech transfer offices and access to high quality early stage legal advice as strengths in Georgia.

The tyranny of geography has diminished with Covid-19 remote working. There has never been a better time to keep the science where it is and let the team do some self-selecting on where they want to be. If that science is coming from a university in Georgia, there is no longer a need for that team to uproot to Boston or the Bay Area when the technology spins out a startup company. Allowing the human capital to be where it most wants to be, as long as the core scientific team is co-located in a place with the assets and infrastructure it needs to succeed, is no longer a risk, but an asset to life science innovation and investment.

Steven Lehmann, Panelist and Portal’s Director of Venture Operations, told moderator and Radyus Research CEO Marta New that they chose Atlanta for its innovation biomarkers and leading indicators. These include grant funding, strong examples of startups spun out in the past, a mature funding ecosystem and patent generation. coming out.

We like partners that want to bet big, especially when it comes to real estate and we found that for Science Square. We are proud to invest time and money here then provide the connections to capital markets wherever they may be.

What will be the next big hit that stays here and then spins out multiple startups? That’s what’s needed most to help the life science startup environment really mature.

Joshua Eckelberry, principal with Solas BioVentures added, there is some lab space here, but more is coming which is a very good thing for the ecosystem. He pointed to strong investor rates of return in the south and midwest while “the universities and hospitals are just as smart [as they are anywhere in the country].”

Putting the Tech in Bio & MedTech

Wed, 15 Nov 2023 22:12:00 GMT

The convergence of life and data sciences promises to dramatically accelerate the pace of innovation and drug development. Georgia is emerging as a leader in combining these fields to address some of the most challenging problems in life sciences.

While generative AI is not ready to support clinical decision making, “Intelligent call centers, appointment setting, patient documentation, marketing content and co-pilots for other cumbersome tasks” are applications for AI in the life sciences across beneficiary types,” Microsoft Chief Growth Officer, Global Health and Life Sciences Patricia Obermaier said. “Summarizing a patient visit followed by the creation and translation where needed in simple language the patient can understand is a strong example of AI’s support potential in the care curriculum.

On the industry side, Patricia cited research that indicates 64% employees say they do not have enough time or energy to do their job, while 70% say they would delegate repetitive or mundane tasks to AI despite a measure of fear that AI may cost some employees their jobs.

“Understand that change is happening in two dimensions: interactions like migration from a keyboard to a mouse to natural language processing of information, and management of information as in large language models attempting to ‘reasoning on top of data,” Patricia said. “Can it hallucinate? Yes.”

Externally, but on topic, colleagues at Within3 shared , “Getting AI to successfully complete 90 percent of the work required for many common medical affairs tasks like reporting on and insights identification from advisory board committee meetings or congresses and social listening programs, while leaving 10 percent of the last mile to the expertise, critical thinking, nuance and intimacy of knowned based on real world experience to the professional, would represent a promise met by AI for med affairs.”

Where, then, are the current limits for technologies including generative AI in life science innovation?

Could a medical affairs team effectively use a combination of ‘typical’ plus generative AI right now to get 90% of the reporting and insights generation done from a high dollar advisory board meeting? Almost certainly. Could AI currently make clinical trial design more efficient thereby increasing the speed of enrollment and rate of retention? This is likely. Could a pharma manufacturer or CDMO use more advanced robotic technology for inventory management, materials handling or storage? Yes.

Will AI be capable of helping us discover new proteins without formulations? Perhaps. Will AI be capable of helping diagnose rare diseases? Perhaps.

In clinical practice, one of the most intriguing examples of AI being brought to bear in patient care comes from Washington Post Contributing Columnist Leana Wen who recently wrote about Kaiser Permanente’s AI tool for clinical deterioration detection.

“Predictive algorithms have been built to account for a patient’s preexisting medical conditions, vital signs, laboratory tests, bedside nurse reports and other factors. And the tool receives hourly input from electronic medical records. If all this data reveals a significant risk of decline, an alert is issued.

“The key difference in Kaiser’s use of AI is what happens next. First, the alert is reviewed by an off-site team of nurses who examine what triggered it. Then, if the patient needs to be evaluated in person, they have the patient assessed by the hospital’s rapid-response team, which then works with the patient’s physician to determine next steps.

“From 2016 to 2019, this AI-powered alert system was rolled out to all 21 of Kaiser Permanente’s Northern California hospitals. Researchers then examined the outcomes of patients it flagged vs. those who would have triggered an alert if the system had been active at the time of their hospitalization. Their results, published in the New England Journal of Medicine , show there was a 16 percent lower mortality rate among patients who benefited from the AI tool. That’s equivalent to 520 deaths prevented per year.”

The FDA will always lead with risk when it comes to new technologies, therapeutics and diagnostics, Joseph (Robby) Robertson, Product and Technology Lead, US Neurology, UCB said at the Summit. Its view of software, which is ultimately connected to just about every technology, is still quite rigid. It will certainly not tolerate data for clinical decision making that may be prone to hallucination or bias.

Patricia advised finding safe spaces to test AI’s limits for life science and life science innovation can be highly productive as long as the guardrails are known and closely adhered to.

If you asked someone “What is Amazon?” 20 years ago, they would have told you it’s an online bookstore, Robby said. When it comes to technology including AI, life science is at that same intersection, or really just the starting block, where Amazon resided two decades ago. The best is yet to come.

Life Science Nation bringing a medtech investor event to Atlanta in early 2024

Wed, 15 Nov 2023 22:08:00 GMT

In September, Life Science Nation announced “RESI South’ in partnership with a newly formed coalition of life science associations representing Alabama, Florida, Georgia, North Carolina, South Carolina, Tennessee, and Virginia. The conference will come to Atlanta, GA, in [early] 2024. RESI South is expected to draw a crowd of over 500 bioscience and medtech entrepreneurs and 500 premier investors, family offices, and key executives worldwide.

LSN’s Erica Ku told us to stay tuned for the date, still anticipated to be in late March or early April.

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UPDATE : RESI South is confirmed for Monday, March 25th at The Whitley in Atlanta, GA.

Johns Creek Named First “BioReady Community” in Georgia

Wed, 15 Nov 2023 22:03:00 GMT

As the life sciences sector in Georgia continues to grow at a rapid pace, the need for bioready sites grows. As just the second state in the country to formally adopt such a program, the BioReady Community program will allow Georgia’s municipalities to showcase biotech-zoned science parks, streamline permitting, build a robust infrastructure, and identify biotech-friendly sites more effectively in the interest of attracting companies interested in relocating.

After lunch Maria announced that the City of Johns Creek is the first municipality in the state to achieve this designation.

Johns Creek Mayor John Bradbury said, “We need to challenge each other. We can push the ball forward at a grassroots level .… And hopefully that’s going to mean a bigger ecosystem for this industry in our state.”

Given the industry’s large footprint in Georgia including 78,000 direct jobs across 4,000 establishments, nearly 215,000 total jobs and over $50 billion in economic impact, Georgia cities and towns are increasingly adopting local policies that greatly ease the pathway for renovation or new construction of biotech laboratory and manufacturing facilities.

Georgia Bio’s counterpart in Massachusetts, MassBio , has developed a rating system to determine a municipality’s readiness to host biotechnology facilities based on the community’s zoning practices and infrastructure capacity. BioReady® rates these communities in three tiers from Bronze to Gold. Through these BioReady® ratings, Georgia Bio seeks to provide cities and towns a platform to effectively tell their stories to the biotechnology industry that will ultimately help real estate developers and biotechnology companies find the most favorable destinations to locate.

AtlantaInno and Atlanta Business Chronicle Reporter Rebecca Grapevine noted , “Earlier this year, Johns Creek tallied a win when Boston Scientific Corp. (NYSE: BSX) committed to a nearly quarter-million-square-foot lease at the former State Farm campus. The expansion could bring up to 340 jobs, the company said.” [Note: subscription required.]

Click Here to View the Georgia BioReady Page & Learn How to Apply

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Below are Links to the John’s Creek Announcements

Johns Creek Designated as Georgia’s First Ever BioReady® Community

City of Johns Creek, Georgia – Government | Johns Creek GA

The post Johns Creek Named First “BioReady Community” in Georgia appeared first on Georgia Bio .

Johns Creek Named First “BioReady Community” in Georgia

Wed, 15 Nov 2023 22:03:00 GMT

After lunch Maria announced that the City of Johns Creek is the first municipality in the state to achieve this designation.

Click Here to View the Georgia BioReady Page & Learn How to Apply

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Below are Links to the John’s Creek Announcements

Johns Creek Designated as Georgia’s First Ever BioReady® Community

City of Johns Creek, Georgia – Government | Johns Creek GA

Reshaping the narrative on biopharma innovation with BIO Board Chair Dr. Ted Love

Wed, 15 Nov 2023 21:53:00 GMT

Dovetailing closely on access, advocacy, policy and innovation, BIO Board Chair and founder of Global Blood Therapeutics Dr. Ted Love discussed his mission oriented journey in the life sciences in the day’s keynote. This work continues with the need to reshape the narrative around biopharma innovation, access, cost and value.

“Drug cost is not a singular item,” Dr. Love told GRA Senior Advisor Greg Vaughn, MD in their post remarks chat. “We need to get copays out of the system and stop blocking egregious things we do to discourage patients from taking medicines.”

Our recent weekly bioBEAT summarized Dr. Love’s keynote thusly:

“BIO Board Chair Dr. Ted Love founded a company (Global Blood Therapeutics—since acquired by Pfizer ) to develop treatments for sickle cell disease, so he is solidly grounded in the biopharma space. However, he’s enthusiastic about biotech’s potential to help achieve a wide range of societal goals. At Georgia Bio’s Life Sciences Summit this week, Ted spoke about the importance of communicating biotech’s full potential and opening minds to the promise of innovation.

“‘Showing the public how we change lives through innovations is a huge task that we must all embrace!’ he said in his remarks. ‘But, we can do this by telling everyone we talk to [that] biotechnology is our only hope – to fight egregious diseases and future pandemics, to produce clean energy to fight climate change, to solve food insecurity , and to provide biodefense to keep us all secure.’

“Ted shared a story about his own daughter’s (Alex) skepticism toward the biopharma industry—until she spent one summer working at Global Blood Therapeutics and saw firsthand how impactful the company’s work could be for patients. ‘Perhaps we can learn a lesson from my experience with Alex when it comes to reframing the narrative of our industry,’ he said.

“‘We need to increase awareness of what we are achieving in our society,’ he added, ‘by telling our powerful stories of innovation and standing up for science. It will require highlighting the possibilities of mRNA vaccines, gene therapy, crop editing , and the many other amazing technologies that we are investing in. mRNA took years and years to develop, but it arrived in time to treat Covid-19.’ Read Ted’s full remarks here. ”

Access and Advocacy: “Share the Savings”

Wed, 15 Nov 2023 21:42:00 GMT

Americans want policymakers to see lowering out-of-pocket costs for health care as a top priority. Putting pharma and its innovators who invest billions of dollars in R&D for therapies that improve outcomes and save lives in villainous crosshairs is easy to understand and politically expedient, but misguided.

In 2021, West Virginia became the first state in the nation to adopt ground-breaking legislation, HB2263, requiring insurers and their PBMs to share the savings they negotiate on medicines directly with patients. This legislation serves as a roadmap for other states looking to help lower costs for patients. In the upcoming Georgia legislative session, the state joins that effort with HB 343, most specifically “to require pharmacy benefits managers to calculate defined cost sharing for insureds at the point 4 of sale.”

“People are familiar with the ‘negotiated rate’ they see on a bill from their doctor for a procedure or visit,” Zachary Poss, Director of State Advocacy for PhRMA said. “That reflects a discount compared to published or uninsured rates for those services and procedures. Rebates or discounts pharma provides don’t make their way to patients the way discounts reflected in negotiated rates between insurers, providers and patients do. Those rebates for drugs are held by pharmacy benefits managers. They do not make their way to the patients as they should.”

Making HB 343 law in the State of Georgia would be a strong way to change that.

Dorothy Leone-Glasser (RN, HHC), Executive Director of Advocates for Responsible care encouraged all to, “Become more engaged. What you create saves lives. Pay attention to the legislative alerts. Write an op ed. Support this legislation.”

Access and Innovation: Georgia Bio Recommits to Industry as a new c6 & New GRA CEO Opens the 2023 Georgia Life Sciences Summit

Wed, 15 Nov 2023 21:33:00 GMT

Having recently renewed our commitment to advocating for, educating and connecting our member enterprises and stakeholders, the 2023 Georgia Life Sciences Summit by Georgia Bio brought more than 300 members of the ecosystem together in Sandy Springs on November 1st.

We reconnected with friends and colleagues, made new connections, learned from academic, industry and elected leaders, shared news and awarded both the [early stage] Company Showcase Winners and the Anthony Shucker Scientific Poster Winners.

Our CEO Maria Thacker Goethe reinforced a statement made during the October virtual town hall , as a 501c6, Georgia Bio can be more politically active and allows for future creation of a political action committee. The organization is the sole Georgia representative to the life science sector and an official partner to the national Bioscience Industry Organization and AdvaMed, which means practical discounts for purchasing programs, but also provision of a connection to federal government affairs representation to those sectors.

Session by session, we offer the following highlights from our colleague Paul Snyder.

Introducing the new CEO at the Georgia Research Alliance

In literally his first day on the job, Timothy Denning, President and CEO of the Georgia Research Alliance introduced himself and highlighted its impact in the life science innovation ecosystem with the following statistics: 87% of GRA funded startups are still in business four years hence – the national average is just 44%. Further every $1 invested by GRA through its commercialization funding programs has returned $19 in follow on investment in or by those portfolio companies.

Mr. Denning specifically pointed to GRA life science portfolio companies Micron Biomedical (microneedle drug delivery) and EarliTec (early diagnosis of autism) as standouts for what’s possible when marshaling the right resources in promising technologies brought forth by the state’s universities, its faculty, investigators and researchers.

Scientific Poster Award Winners

We also congratulate the Anthony Shuker Scientific Poster Award Winners and thank our judges Stacy Shuker Reece, Rick Hillstead and Jamie Graham. Thank you to all the applicants. View a list of the finalists and all the submission here :

Company Showcase Winners

We congratulate the Company Showcase Winners. And thank you to all presenters and judges in the Company Showcase and Rapid Fire Research Showcase.

Summit 2023: Click a Post Below for a Comprehensive Dive to What We Heard and Learned at the 2023 Georgia Life Sciences Summit

In closing, we thank everyone who helped bring the event and the ecosystem together. This includes our production team, volunteers, showcase and poster judges and sponsors without which this is simply not possible. We encourage you to consider ways to support their interests, goals and businesses.

We hope everyone involved derived high value from our latest response to the life science industry’s need: bringing the ecosystem together to advance our advocacy, education and inspiration through an industry that means more to more lives at home and abroad than we can measure.

Stay in the loop by following Georgia Bio on LinkedIn , Instagram and Twitter/X . You can also subscribe to our weekly bioBEAT by emailing us at admin@gabio.org .

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Dr. Ted W. Love: How to reframe the narrative about biotech – and put patients first

Mon, 06 Nov 2023 21:05:00 GMT

November 2, 2023 / Source BIO News

Remarks from Dr. Ted W. Love, Chairman of the Biotechnology Innovation Organization (BIO) and former President and CEO of Global Blood Therapeutics, as prepared for delivery Georgia Bio’s Life Sciences Summit on November 1, 2023:

Almost ten years ago, when our college-aged daughter Alex lived at home, I had a difficult time convincing her that our industry was a force for good. We talked a lot about the biopharma industry, and I felt like I was living with Bernie Sanders!

So one day I asked her, “Would you work at Global Blood Therapeutics for the summer and help us build our patient advocacy initiative?” She did, and she saw everything that we do – internally, externally, and in partnership with patient advocates.

She saw first-hand that the patients were our inspiration and drove how we approached every issue. She saw our passion to conquer sickle cell disease , particularly because it had been historically overlooked and under-invested in. She embraced our motto that “we can’t fail because patients are dying!”

Alex had a great experience that summer. In fact, many patient advocates continue to ask me, “How is Alex?” Before she went back to school, Alex told me that she was wrong about our industry. She said, “I never imaged a collection of people working so hard, singularly focused on helping others!” Needless to say, I was proud of her and of our industry…in addition to feeling a little victorious.

How to reframe the narrative about the biotech industry

I think every parent here knows that it can be very hard to change your child’s mind. And heaven knows we’re still working on Bernie Sanders. But perhaps we can learn a lesson from my experience with Alex when it comes to re-framing the narrative of our industry.

I would like to remind us that 35 years ago, Fortune Magazine named Merck as the country’s Most Admired Company repeatedly. Yet these days, similar surveys are far less appreciative of our great companies. Frankly, it’s unacceptable to me that our industry, which develops amazing breakthroughs that save countless lives, is viewed so inconsistently.

Sadly, the public does not see the tremendous work, risk, and commitment required to bring innovations to them. This is a huge and unfortunate disconnect. And while image may not be everything, it can be – and has been – hugely consequential for us. It’s long past time to reframe our narrative to better reflect the facts!

For Ted Love, biotech is personal

This is a personal campaign for me. I grew up in Alabama, and the Jim Crow South. I was one of eight children growing up on a farm, and my parents worked hard to provide us with opportunities that they never had.

My father had a fourth-grade education, fought in the Korean War, and worked in a warehouse to support us. My mother held down our house, which was quite an undertaking with five boys and three girls.

I learned so much from my parents, but I was also inspired by the doctor in our segregated community. I decided that I too wanted to be a physician and help others, just as he helped us.

Years later, working at Mass General Hospital in Boston, I saw how medical innovations drastically improved lives. Yet I also witnessed drugs and therapies failing to reach a segment of our society.

It was disappointing, embarrassing, even horrifying to see how the healthcare system could mistreat people of color and the most vulnerable. I’ll never forget watching sickle cell patients endure egregious discrimination and unsympathetic healthcare. Ultimately, my personal experiences, coupled with sage advice from mentors, convinced me to accept a position at Genentech when it was a much smaller and riskier company, to try and impact health care at scale. And that’s what we do every day.

‘Biotechnology is our only hope’

Showing the public how we change lives through innovations is a huge task that we must all embrace! But, we can do this by telling everyone we talk to about biotechnology is our only hope – to fight egregious diseases and future pandemics, to produce clean energy to fight climate change, to solve food insecurity , and to provide biodefense to keep us all secure .

We need to increase awareness of what we are achieving in our society, by telling our powerful stories of innovation and standing up for science.

It will require highlighting the possibilities of mRNA vaccines , gene therapy , crop editing , and the many other amazing technologies that we are investing in.

It will require highlighting both the opportunities and uncertainties of the innovation ecosystem, making it clear that the Inflation Reduction Act threatens our ability to deliver new, life-saving innovations .

Most of all, it will require building on our work to increase access.

I joined Global Blood Therapeutics because I never forgot the suffering of the sickle cell patients that I saw as a medical student and young physician. We developed Oxbryta as a breakthrough to attack the root cause of this insidious fatal disease. And last year, Pfizer acquired GBT to accelerate delivery of our innovative therapies to more patients around the world, particularly in Africa, India, and South America.

Helping to build GBT is one of the greatest achievements of my life. Yet ensuring that these therapies benefit the greatest number of people around the world will be my proudest.

As an industry, how we support our patient communities is critical. When it’s done well, we are appreciated and often treasured.

When sickle cell patients and advocates learned of GBT’s acquisition by Pfizer, the response was emotional. It was like losing a member of their family. But the community also saw the big picture, and the possibility that Pfizer could accelerate the transformation of a long-neglected disease.

They knew that they would remain at the center of what we do.

Why it’s time to elevate the biotech industry’s voice

Re-framing our industry’s narrative and increasing access to our innovations go together, and they have been my top priorities since I became Chair of BIO.

A third priority is helping to elevate the industry voice at the federal, state, and international levels. Here in Georgia, you have the excellent leadership of Maria [Thacker-Goethe] and Georgia Bio. As Chair of the Council of State Bioscience Associations – better known as CSBA – Maria works closely with BIO on a host of policy priorities.

Together, we are fighting to restore the immediate full R&D tax credit so small and mid-sized biotech have more capital . The economic environment is critical for biotech, which is why we are also pushing back on problematic provisions of the Inflation Reduction Act.

These are provisions that reduced incentives, and will limit our ability to bring new therapies and innovations forward. If unaddressed, they will result in fewer drugs and innovations to help our patients and society.

Here in Georgia, your focus on talent development, personalized medicine, and the role of artificial intelligence are critical to ensuring a strong and diverse industry for years to come.

I urge every one of you to participate in our important advocacy work. But I also want you to think big. The mRNA breakthrough took years but arrived in time for COVID. We should all ask ourselves, “What nascent research is happening right now that will be critical and lifesaving tomorrow?”

Biotech is about seeking new opportunities and turning dreams into reality. We must stay true to these principles, while keeping patients and society as our North Star. That will redefine belief in science and biotech.

‘Put patients and our society first’

Lastly, on a more personal note, I want to thank the health community here for your commitment to fighting sickle cell. I came out of retirement to fight this terrible disease, which has affected so many African American families.

One extraordinary person that I so admire is Mapillar Dahn , who I’m sure many of you know here in the Atlanta region. Mapillar gave birth to three beautiful girls, all with sickle cell. She became a leading advocate for sickle cell research and founded the MTS Sickle Cell Foundation. It brings me incredible joy knowing that our work at GBT has helped her daughters lead healthier and happier lives.

We all must be leaders like Mapillar – and so many of you are. My ask to each of you is to take a piece of our challenge back home with you. Put patients and our society first, and make sure we define our narrative. If we do, we will create a more prosperous and sustainable society for all.

Thank you.

Driven by Industry Demand, Georgia Bio Reemerges, Rededicates

Wed, 01 Nov 2023 09:06:00 GMT

A New Start

Founded in 1989, Georgia Bio has been the entity around which the bioscience and medtech industry in the state, including academia, connects and advocates for its needs.

Though recently latent in the visual presence to which stakeholders are accustomed, Georgia Bio has maintained, if not increased, its advocacy for the life science industry at the state level. Over the past two years, Georgia Bio operated under the moniker “Office of Life Sciences and Digital Health” within the Center for Global Health Innovation (CGHI). Given CGHI’s changing scope, Georgia Bio reemerges as a 501c6 trade organization serving its member stakeholders directly inclusive of advocacy and lobbying activities. Georgia Bio has finalized the steps needed to regain its full autonomy and independence from CGHI.

“The ‘re-emergence’ of Georgia Bio is an industry demand-driven development,” Georgia Bio CEO Maria Thacker says. “Academic and industry life science leaders have told us directly that they need a strong advocacy organization around which to engage with each other and advance their priorities. Those industry leaders are also prepared to provide the financial support required for Georgia Bio to be the entity that provides those services.”

Not Just Pharma: A Holistic View of the Life Sciences

Known most for its focus in the biotech and pharmaceutical sectors of the life sciences, Georgia Bio intends to bring the breadth of the life science innovation ecosystem into its “family” inclusive of medical devices, food and agricultural technology and the solutions providers that support them. The increasing number of ‘combination devices,’ medical technologies that are part drug, part device in simplest terms, is one of the easiest ways to understand why the expansion of focus is needed. The affiliated solution providers on which the entire industry relies, including intellectual property experts, contract manufacturers and proving grounds like the Global Center for Medical Innovation is another.

“Ultimately, we intend to foster innovation and growth of Georgia’s life science ecosystem for a healthier world,” Thacker says. “We will advocate for, connect, educate and inspire our member enterprises and stakeholders in much the same way our colleagues have known Georgia Bio since its inception in 1989. We will now do that through an industry-wide lens including new medical technologies and devices.”

Supporting an Industry with $50 Billion Impact and High Workforce Development Needs

A top priority for the organization in addition to advocacy will be continued strengthening of its workforce development programming.

The 2022 Georgia Life Sciences Industry Trends and Impacts Report states, “Job growth in the industry has been driven primarily by the industrial life sciences segment which has increased by nearly 29% and outpaced the nation, while the academic and federal R&D component has experienced more modest growth. In 2021, Georgia’s life sciences industry and its multiplier effects generated: a total employment impact of nearly 215,000 Georgia workers across all sectors, a combined $50.2 billion in total economic impact to Georgia’s economy, and a total value added impact of $26.7 billion to Georgia’s GSP-representing 3.9% of state GSP.”

The growth of the sector across the state has also increased the need for a skilled workforce to support it. In that regard, the Georgia BioEd Institute will serve as the 501c3 public service entity whose education and workforce development endeavors will be administered by the Georgia Bio team as well. The Institute will operate inside of Georgia Bio with the 501c3 status anticipated to be completed by early 2024.

The 2023 Georgia Life Science Summit

Coming out swinging, Georgia Bio hosted The Georgia Life Science Summit on November 1, 2023 at the Sandy Springs Arts Center.

“The Summit was more concentrated in its focus, yet more expansive in its industry-wide inclusion, compared to previous editions of our Bio Innovation Summit,” Thacker says. “In line with what the industry has told us it wants and needs, the event will bring together roughly 300 academic and industry leaders to connect, learn, share and network.”

For more information, visit www.georgiabiosummit.org.

About Georgia Bio

Georgia Bio represents more than 200 organizations in the life sciences industry, including biopharma, medical device, combination product and digital health companies, along with academic institutions, research hospitals, disease foundations and solutions providers on which those entities rely. www.gabio.org

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FDA OKs Sanguina’s at-home test for anemia

Tue, 31 Oct 2023 01:21:00 GMT

People with anemia can now monitor levels of their hemoglobin with a simple test taken in the comfort of their homes. AnemoCheck Home, made by GRA-backed startup Sanguina , this month became the first at-home hemoglobin test kit to receive clearance by the U.S. Food and Drug Administration. Available only by prescription, the test involves a simple finger prick followed by the mixing of a blood droplet with a solution in a small tube; results are available in just two minutes. Sanguina, launched out of Georgia Tech, has received investment from GRA’s venture development program as well as GRA Venture Fund. • See Sanguina’s news release >

UGA scientists pursue new options for biofuel

Tue, 31 Oct 2023 01:20:00 GMT

High cost and inefficiency are huge obstacles to biofuels becoming more commonplace. But GRA Eminent Scholars and their colleagues at the University of Georgia are finding novel ways to overcome aspects of those obstacles. An online feature published in October offers a look at these efforts (and provides a good overview of biofuel’s viability as an energy source). Eminent Scholar C.J. Tsai is using CRISPR and other gene-editing tools to speed the breeding of poplar trees and make them more adaptable to climates. Scholar Robin Buell is re-engineering poplars to maximize their biomass for energy usage. Other researchers are working to change the structure of the cell walls of plants like switchgrass to promote their use as a fuel source. UGA’s contributions to the field could greatly expand America’s capacity for producing billions of gallons of low-carbon biofuels each year. • See the feature >

GT Scholar helps develop process to reduce natural resources needed in fuel production

Tue, 31 Oct 2023 01:19:00 GMT

Turning crude oil into fuel and other products requires a distillation process that uses enormous amounts of energy and water. But a Georgia Tech research team that includes GRA Eminent Scholar Rampi Ramprasad may well revolutionize that process: They’ve formulated a new kind of polymer membrane to separate desirable compounds from undesirable ones at the molecular level. The filtration could replace the boiling and cooling process that’s now part of distillation — an approach that accounts for 1% of all of the energy used in the world. With Ramprasad’s expertise and guidance, the team has also created artificial intelligence tools to predict how well different versions of the newly engineered membranes will work, thus speeding development of new membranes for other purposes. Their findings were published in the Oct. 16 edition of Nature Materials . Above: Ramprasad (left) with Georgia Tech research team members Ryan Lively and M.G. Finn. (Photo by Candler Hobbs.) • A good story on a big invention > • See the journal article in Nature Materials >

GeoVax Commences Site Expansion for Phase 2 Trial of Next-Generation COVID-19 Vaccine

Tue, 31 Oct 2023 01:15:00 GMT

Designed to Protect Immunocompromised Patients Against Severe COVID-19

ATLANTA, GA, October 30, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has commenced the planned site expansion for the Phase 2 clinical trial investigating its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, as a primary vaccine in immunocompromised patients. In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial will be initiating enrollment of eligible patients at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and Fred Hutchinson Cancer Research Center (Seattle, Washington).

The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024 ) is evaluating the safety and immunogenicity of GEO-CM04S1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients with hematologic malignancies who have received either an allogeneic hematopoietic stem cell transplant, an autologous hematopoietic stem cell transplant or chimeric antigen receptor (CAR) T cell therapy. Such patients often have difficulty mounting an adequate protective antibody response after receiving currently available COVID-19 vaccines.

David Dodd, GeoVax Chairman and CEO, commented, “We are pleased with these site activations to expand the scope and reach of this trial, which we expect will accelerate patient enrollment for this important study in one of the highest at-risk patient populations, currently underserved by available vaccines. We believe the unique properties of GEO-CM04S1 potentially offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, not only as a vaccine for highly vulnerable immunocompromised patients for whom the currently authorized mRNA vaccines may be inadequate, but also potentially for healthy patients as a universal booster vaccine to the mRNA vaccines. In the U.S., there are approximately 15 million individuals who, as a result of their compromised immune systems, often do not adequately respond to the current authorized vaccines. Worldwide, there are an estimated 240+ million such patients. Our hope is that GEO-CM04S1 provides robust, durable immune protection for such patients, while also providing a critically important alternative to COVID-19 booster vaccines for healthy individuals.”

A recent publication in Vaccines ( https://doi.org/10.3390/vaccines11091492 ) from the open-label portion of the trial indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses against ancestral as well as recently evolved SARS-CoV-2 virus strains. These data support the progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines.

About GEO-CM04S1

GEO-CM04S1 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.

In addition to this ongoing study, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials:

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin ^® , presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com .

Media Contact:

sr@roberts-communications.com 202-779-0929

Coskun Receives $1.86 Million NIH MIRA Award to Map Spatial Molecular Neighborhoods

Tue, 24 Oct 2023 15:50:00 GMT

Ahmet Coskun has a saying on the homepage of his lab’s website : “Seeing is believing. Quantifying is proving.” So, with that in mind, Coskun and his team have developed multiplex imaging tools and combined them with machine learning techniques – for believing and quantifying.

Now, to support Coskun’s research, the National Institutes of Health has granted him the prestigious Maximizing Investigator’s Research Award (MIRA) from the National Institute of General Medical Sciences. Coskun and his team will use the five-year, $1.86 million award for a project entitled, “Dissecting subcellular and cellular organization by spatial molecular neighborhood networks.”

They plan to probe subcellular and cellular organization, counting molecular neighborhoods and building maps to help researchers better understand the spatial organization of cells and molecules, insights that can open the door to game-changing personalized treatments for multiple diseases.

“The spatial organization of these neighborhoods, of RNA and protein molecules, is important for cellular function,” said Coskun, a Bernie Marcus Early Career Professor in the Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. “So, we’re basically making maps of molecules within the cell.”

The maps can ultimately help researchers identify cell types that would best treat various diseases, while also explaining why some patients will respond to a particular treatment, and others won’t.

The NIH’s MIRA program provides researchers with greater stability and flexibility in funding while enhancing their ability to creatively tackle ambitious scientific problems. And part of the aim, said Coskun, “is to address basic biology questions that have implications on multiple diseases in the future. This single cell work has that kind of potential.”

For Coskun, the MIRA is the next phase of support in a flurry of awards that have come his way recently: it’s the fifth NIH grant his lab has received this year, with a total value of $3.6 million.

“This year has been a great year for us,” said Coskun. “It’s encouraging to receive this kind of recognition and support for research and technology that we believe will play an important role in the lives of patients.”

Contact

Jerry Grillo
Communications
Wallace H. Coulter Department of Biomedical Engineering

LINK: https://bme.gatech.edu/bme/news/coskun-receives-186-million-nih-mira-award-map-spatial-molecular-neighborhoods

ICYMI: State of Georgia Bio Virtual Town Hall Recording

Sun, 22 Oct 2023 17:32:00 GMT

As many of our colleagues are now aware, Georgia Bio (and the Georgia BioEd Institute) is separating from the Center for Global Health Innovation (CGHI) and adopting a more incremental, industry-focused approach to our efforts. Georgia Bio is recommitting to its core mission of advocating for, connecting, educating and inspiring our member enterprises and stakeholders in much the same way our colleagues have known Georgia Bio since its inception in 1989. To achieve this, the organization transitioned from a 501c3 to an independent 501c6 organization, Georgia Biosciences Organization, Inc. Our new EIN# is 27-3855537.

What About My Membership?

CGHI members will receive complimentary membership with Georgia Biosciences Org. until their next scheduled renewal date when they will be invited to renew with Georgia Biosciences Org. We are happy to work to establish the organization as a new vendor with your company/organization as needed.

On Wednesday, October 18, Georgia Bio CEO Maria Thacker led a virtual ‘town hall’ to discuss the state of Georgia Bio, Georgia BioEd and the larger life science ecosystem in the state. If you weren’t able to join us, or would like to share the conversation with colleagues, the recording is here.

The 2023 Georgia Life Sciences Summit – November 1

T he 2023 edition of the Georgia Life Science Innovation Summit is right around the corner. The summit, more concentrated in scope yet expansive in industry inclusion, will be Wednesday, November 1st at the Sandy Springs Arts Center. The program is coming along nicely including a recently secured keynote or plenary address featuring Dr. Ted W. Love, former President and CEO of Global Blood Therapeutics and 2023-2025 Chair of the Board of the Biotechnology Innovation Organization (BIO).

We encourage you to join us in reconnecting with the life science industry ecosystem. Learn more and register here .

The post ICYMI: State of Georgia Bio Virtual Town Hall Recording appeared first on Georgia Bio .

Emory, Georgia Tech & Children’s Healthcare land major NIH grant for diagnostics

Wed, 18 Oct 2023 01:16:00 GMT

The National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health has awarded $7.8 million over the next five years to the Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME POCT) to support inventors across the country in developing, translating and testing microsystems-based point-of-care technologies to help improve patient care.

Point-of-care technologies are medical diagnostic tests performed outside the laboratory in close proximity to where a patient is receiving care. This allows health care providers to make clinical decisions more rapidly, conveniently and efficiently.

AMCE POCT , which is one of six sites in the U.S. selected by NIH as part of the NIH Point-of-Care Technologies Research Network, was originally established in 2018 to foster the development and commercialization of microsystems (microchip-enabled, biosensor-based, microfluidic) diagnostic tests that can be used in places such as the home, community or doctor’s office. The center played a pivotal role during the onset of the COVID-19 pandemic as the national test verification center to rapidly evaluate COVID-19 tests and help make them widely available.

“Our center was just getting its footing established when the pandemic began, and our unique combination of technical, laboratory and clinical expertise allowed us to rapidly pivot our focus and capabilities to address critical needs during the COVID-19 pandemic,” says Greg Martin, MD, one of the three principal investigators and a professor in the School of Medicine’s Division of Pulmonary, Allergy, Critical Care and Sleep Medicine.

Having facilitated the transformation in at-home and point-of-care diagnostics for COVID-19, ACME POCT will apply this experience and expertise to a broad range of health care needs.

“The pandemic has taught us – physicians, scientists, the public, and society as a whole – the importance of point-of-care technologies in rapid disease diagnosis and public health,” says Wilbur Lam, MD, PhD, pediatric hematologist and oncologist at Children’s Healthcare of Atlanta, professor of pediatrics and biomedical engineering at Emory University and Georgia Institute of Technology. “Our center is honored to continue its role as the technology-focused center within the NIH’s POCTRN and we’re excited to apply the lessons we’ve learned to foster POC technologies beyond COVID-19 to ultimately improve patient care and public health on multiple fronts.”

The ACME POCT uniquely leverages Atlanta’s nationally top-ranked clinical programs at Emory Healthcare and Children’s Healthcare of Atlanta, one of the nation’s largest pediatric hospital systems, as well the internationally acclaimed microsystems expertise at the Georgia Institute of Technology.

Microsystems technologies have been employed to develop microfluidic technologies that enable the collection of microliter samples of fluid, such as blood, for downstream analysis. They have also proven useful in smartphones as sensors for medical applications and in wearable electronics, which enable “on patient” sensing of physiologic and biomedical signals.

Eric Vogel, PhD, principal investigator and Hightower Professor of Materials Science and Engineering at Georgia Tech, adds, “because of their small size(<1mm), low power requirements and advanced engineered materials, microsystems diagnostics provide portability that is vital for point-of-care testing. The NIH funding for ACME POCT enables microsystems-based POC inventors from across the country to refine their technology with the objective of accelerating the path to translation and clinical adoption.”

Since its founding in 2018, ACME POCT has funded 22 projects from 17 different institutions or companies. As Atlanta biomedical innovation has flourished in the last 4 years with the launch of the Emory/GT/Children’s ADJUST Center and the AppHatchery clinical smartphone app development program, ACME POCT aims to capitalize on this growing innovation ecosystem and use a “disease inclusive” approach to move the field of microsystems-based technologies forward in Atlanta and beyond.

State of Georgia Bio Virtual Town Hall: Wednesday, October 18 at 9:00 a.m.

Wed, 11 Oct 2023 03:18:00 GMT

As many of our colleagues are now aware, the time has come for Georgia Bio (and the Georgia BioEd Institute) to separate from CGHI and adopt a more incremental, industry-focused approach to our efforts. Georgia Bio is recommitting to its core mission of advocating for, connecting, educating and inspiring our member enterprises and stakeholders in much the same way our colleagues have known Georgia Bio since its inception in 1989. We will now do that through an industry-wide lens more inclusive of new medical technologies and devices, and food and ag innovations.

We also know there are many related questions circling about.

On Wednesday, October 18 at 9:00 a.m. eastern we will host a virtual ‘town hall’ to discuss the state of Georgia Bio, Georgia BioEd and the larger life science ecosystem in the state. Georgia Bio CEO and team members will lead this discussion with ample room for Q&A. We invite you to register and join us .

The 2023 Georgia Life Sciences Summit – November 1

We are also preparing the 2023 edition of the Georgia Bio Innovation Summit. The summit, more concentrated in scope yet expansive in industry inclusion, will be Wednesday, November 1st at the Sandy Springs Arts Center. The program is coming along nicely including a recently secured keynote or plenary address featuring Dr. Ted W. Love, former President and CEO of Global Blood Therapeutics and 2023-2025 Chair of the Board of the Biotechnology Innovation Organization (BIO).

We encourage you to join us in reconnecting with the life science industry ecosystem. Learn more and register here .

In the meantime, please know we are working diligently and with strong industry support to accomplish the following: rebuild trust with industry, strengthen brand awareness, simplify our message and respond to industry demand for a stronger unified voice on behalf of industry for policy priorities. As a 501c6, Georgia Bio can be more politically active and allows for future creation of a political action committee. (Of the 47 BIO/AdvaMed Affiliates all except two are 501c6 organizations.)

The post State of Georgia Bio Virtual Town Hall: Wednesday, October 18 at 9:00 a.m. appeared first on Georgia Bio .

GeoVax Receives Notice of Allowance for HIV Vaccine Patent

Thu, 05 Oct 2023 19:57:00 GMT

ATLANTA, GA, October 5, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/409,574 titled “ Multivalent HIV Vaccine Boost Compositions and Methods of Use.” The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax’s vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.

David Dodd, GeoVax President and CEO, commented, “Our development priorities continue to be our next-generation COVID-19 vaccine, currently in Phase 2 clinical trials, and our cancer immunotherapy program, with Gedeptin ^® as our lead product in a Phase 1/2 clinical trial for advanced head and neck cancer. While we are focusing on these two products in the near-term, our long-term vision includes developing vaccines against other global public health threats such as HIV. Although not currently under active development, our HIV program forms an important part of the dataset underpinning all of our MVA-based development programs. The patent protection associated with the use of this vaccine is an important part of this product platform.”

Mr. Dodd continued, “Earlier this year, data were presented from a clinical study of a combinational HIV therapy that included GeoVax’s HIV vaccine candidate, MVA62B. The goal of the trial was to reduce or eliminate viral replication in the absence of antiviral medications in HIV-positive individuals (a “functional cure”). The data indicated very high levels of immunogenicity of the treatment, particularly the induction of T cell immunity, even though HIV infection compromises the immune system. We are pleased that GeoVax’s MVA-vectored HIV vaccine was selected to be a part of the experimental combination therapy and contributed to the positive findings. MVA62B was also previously tested in multiple clinical trials as a component of vaccine regimens designed to induce immune responses that prevent HIV infection. The team here at GeoVax is committed to help end the HIV epidemic worldwide and recognizes that the consistent results of MVA62B reflected in clinical trials to date may offer promise towards achieving this goal. We remain committed to supporting corporate and/or academic collaborations or partnering of this potentially critically important vaccine.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin ^® , presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com .

Gabe Kwong Leading $50M Study for Earlier Cancer Detection

Thu, 05 Oct 2023 15:46:00 GMT

The Georgia Institute of Technology will lead development of a new generation of cancer tests capable of detecting multiple types of tumors earlier than ever with up to $50 million from President Joe Biden’s Cancer Moonshot initiative.

Led by Gabe Kwong , associate professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, the project will map the unique cellular profiles of cancer cells and leverage that knowledge to build new bioengineered sensors to detect those profiles.

The goal is to create a new kind of multi-cancer early detection test that would allow oncologists to start treating the tumors sooner, when they’re still small and most responsive.

Read the whole story from the College of Engineering right here .

The 2023 Georgia Life Science Summit is Nov. 1, 2023

Wed, 04 Oct 2023 14:06:00 GMT

The state’s premier life sciences gathering for over three decades, Georgia Bio proudly presents the 2023 Georgia Life Science Summit on Wednesday, November 1, 2023 at the Sandy Springs Arts Center.

The 2023 summit, more concentrated in scope yet expansive in industry inclusion, will be Wednesday, November 1st at the Sandy Springs Arts Center. The program is coming along nicely including a recently secured keynote address and chat featuring Dr. Ted W. Love , former President and CEO of Global Blood Therapeutics and 2023-2025 Chair of the Board of the Biotechnology Innovation Organization (BIO).

Other program elements including speakers / presenters currently include:

We encourage you to join us in reconnecting with the life science industry ecosystem.

We also encourage you to REGISTER as soon as you are able as we do indeed expect to sell out.

Learn more and register here .

“Georgia Bio is recommitting to its core mission of advocating for, connecting, educating and inspiring our member enterprises and stakeholders in much the same way our colleagues have known Georgia Bio since its inception in 1989,” Georgia Bio CEO Maria Thacker said. “We will now do that through an industry-wide lens more inclusive of new medical technologies and devices, and food and ag innovations. We expect the 2023 Summit to be a high value, enthusiastic event for all of our participants and stakeholders.”

The post The 2023 Georgia Life Science Summit is Nov. 1, 2023 appeared first on Georgia Bio .

Life Sciences Leaders, Advocates Launch New Partnership to Promote Benefits of Pro-Innovation Mergers & Acquisitions

Wed, 04 Oct 2023 12:06:00 GMT

Partnership for the U.S. Life Science Ecosystem to raise awareness on importance of mergers and acquisitions in advancing future cures and treatments

WASHINGTON, D.C. – More than thirty leading organizations from across the life sciences today launched the Partnership for the U.S. Life Science Ecosystem (PULSE), a coalition to raise awareness of the fundamental role of pro-innovation mergers and acquisitions (M&A) in advancing the next generation of treatments and cures for patients.

The U.S. is home to thousands of life sciences and biopharmaceutical companies, comprising one of the most diverse and highly competitive industries worldwide. Life sciences companies of all sizes engage in M&A to achieve broad, efficient allocation of resources and expertise that are essential to stay in operation and navigate the complex regulatory, reimbursement and distribution systems within the biopharmaceutical market. Pro-innovation M&A offers an indispensable bridge that helps shepherd early discoveries into the lifesaving treatments and cures needed for patients.

Policymakers, regulators and the courts have long recognized the unique aspects of the life sciences industry, including the differentiated and vital role that pro-innovation M&A plays within it. On average, it takes 10-15 years and costs $2.6 billion to develop and bring a new medicine to patients, including the cost of the many failures along the way. Only 12 percent of new molecular entities that enter clinical trials eventually receive U.S. Food and Drug Administration (FDA) approval.

Even when a medicine or treatment receives regulatory approval, the competition that exists – between innovative products already on the market, emerging new therapies in development and, eventually generic and biosimilar competition – all contribute to America’s life sciences ecosystem being one of the most competitive industries in the world.

Recently, the Federal Trade Commission (FTC) articulated a new approach to antitrust enforcement that runs counter to long-standing precedent that has guided pro-innovation M&A for decades. If continued, the FTC’s flawed approach to M&A review and enforcement would undermine the dynamic ecosystem responsible for many of the world’s most innovative and important treatments. Deterring pro-innovation M&A would obstruct the many complementary relationships across the life sciences ecosystem, stalling treatments and cures for patients while risking jobs, wages and economic growth in every state.

PULSE members – representing frontline researchers, employees, and leaders of life sciences companies of all sizes – will collectively highlight the importance of shared efficiencies and expertise that companies leverage across the development process through M&A to make sure patients receive lifesaving treatments as quickly as possible. PULSE members will also provide real-world insight into the economic importance and benefits of M&A within local communities and to broader growth and development.

A full list of partners is included here pulseforinnovation.org/partners .

“When you consider the various milestones where M&A is so vital to a medicine’s discovery, development and distribution, it becomes all the more imperative that policymakers recognize the importance and immediacy in protecting these pro-innovation partnerships,” Joan Koerber-Walker, President and CEO of AZBio , said. “In Arizona, we have multiple examples where two companies have come together. The combined firms were able to leverage increased operational efficiencies and reach more patients as they brought their health innovation to market. The positive impacts are measurable in job creation and economic growth. And, best of all, more patients here in Arizona and around the world, are reaping the benefits.”

“Colorado’s growing life sciences community, recently ranked 8th in the country by JLL, makes important contributions to the state’s economy,” said Elyse Blazevich, President & CEO of Colorado BioScience Association . “Mergers and acquisitions support our state’s health innovators working to bring breakthroughs from the lab bench to a patient’s bedside. We find that acquired companies often retain a foothold in our state because of our top talent and quality of life.”

“The vast majority of life sciences companies are small businesses, and the ability to grow, innovate and consistently scale relies on M&A,” Karen Kerrigan, President and CEO of the Small Business & Entrepreneurship Council , said. “Policymakers and regulators should take great caution in adopting antitrust policies that pose a fundamental disruption to the very essence of partnership that brings patients the innovative and breakthrough medicines they need.”

More information, including on how to become a partner with PULSE, can be found at pulseforinnovation.org .

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SOURCE: https://pulseforinnovation.org/life-sciences-leaders-advocates-launch-new-partnership-to-promote-benefits-of-pro-innovation-mergers-acquisitions/

Georgia Research Alliance Trustees Name New President and CEO

Wed, 27 Sep 2023 15:19:00 GMT

Tim Denning, Ph.D. will succeed retiring Susan Shows in November

The Trustees of the Georgia Research Alliance voted today to appoint Timothy Denning, Ph.D., vice president for research and economic development at Georgia State University, as the fifth president and CEO of GRA. He will take the reins from Susan Shows, who announced her retirement in a planned succession after serving GRA since 2001 and as president and CEO since September 2020 .

Denning, who will take the helm of the Alliance November 1, has led research and commercialization through a period of historic growth at Georgia State. Last month, the university announced it had earned just under $225 million in research funding for FY2023, the highest total in university history.

The university now has more than 70 research centers, including five university-level enterprises that address critical quality-of-life issues such as cancer, cardiovascular disease, brain health and infectious disease. It is also home to nine members of GRA’s Academy of Scientists.

“The extraordinary value GRA creates for our state begins with growing the capacity of Georgia’s research universities to be more competitive in winning grants and addressing some of the greatest challenges facing our world,” says GRA Board Chair David Ratcliffe. “Over a 20-year career, Tim Denning has come to know the world of university research inside and out. He brings not only a wealth of experience and expertise to the Alliance but also a deep understanding of how to build partnerships to drive greater results.”

“I am delighted to join the GRA team and contribute to the thriving collaboration among research universities, the business sector and state government to drive economic growth in Georgia,” Denning says. “By expanding university research and entrepreneurship in our state, GRA plays a unique role in generating new innovations that benefit the people of Georgia and beyond. I look forward to growing GRA’s impact.”

Denning arrived at Georgia State in 2013, joining the university’s Institute for Biomedical Sciences from a research and academic tenure at Emory University. Two years later, he was appointed associate director of the institute, and in November 2020 was named vice president for research and economic development. Notably, he has worked in research centers led by two GRA Eminent Scholars – the Emory Vaccine Center, headed by Rafi Ahmed , and Georgia State’s Institute of Biomedical Sciences, led by Jian-Dong Li .

At Emory, Denning worked on a number of funded research projects in the School of Medicine. His scientific focus is on the body’s immune response inside the gastrointestinal system, particularly its role in regulating the chronic condition of Inflammatory Bowel Disease (IBD). He arrived at Emory in 2004 as a postdoc fellow after holding a similar fellowship at the acclaimed La Jolla Institute for Immunology in San Diego.

Denning’s leadership at Georgia State reflects a breadth and depth of activity that accelerated an already-growing research enterprise. He spearheaded several initiatives to promote interdisciplinary research, innovation and scholarship and cultivated partners in academia, industry and the scientific community. He was also key to bringing top researchers to the university and developed programs to provide students with research experience in the private sector.

“A hallmark of GRA’s working model is forging strong collaborations to grow research and entrepreneurship at Georgia’s universities,” says GRA President and CEO Susan Shows. “Team building is very much a part of Tim Denning’s DNA, and he is an excellent choice to lead the Alliance into its next phase of success.”

Source: https://gra.org/blog/223

GRA President and CEO Susan Shows to Retire with 22-Year Legacy

Wed, 27 Sep 2023 15:17:00 GMT

Tenure marked by shaping all major aspects of the organization

A driving factor in the development and success of the Georgia Research Alliance over a tenure that has spanned more than two decades, President and CEO Susan Shows today announced her retirement from the Alliance at the fall meeting of GRA’s Board of Trustees.

Since joining GRA in 2001 as vice president, Shows was instrumental in shaping each of the organization’s areas of operation. She worked closely with member universities to bring top scientific talent to their campuses, playing an active role in the recruitment of most of GRA’s 78-member Academy of Scientists. She also partnered with university leaders to identify “best investments” in high-tech lab equipment and core research facilities to make Georgia’s institutions more competitive in winning lucrative research grants and contracts.

And 20 years ago, she served as chief architect of GRA’s venture development program, a multi-faceted enterprise that has helped launch 240 high-potential startup companies with operations in Georgia, all based on inventions made by university scientists in Georgia.

While serving in the senior vice president role, Shows placed collaboration and impact at the center of these and other activities. She often brokered working partnerships among scientists and universities and between academia and industry. And she developed the statistical framework for providing funders with an accountability of GRA’s performance and its return on the state’s investment in GRA programs.

Since being named president and CEO of GRA in September 2020, Shows has continued to grow GRA’s talent, infrastructure and entrepreneurship programs while also launching several initiatives that leverage university research strengths to address areas of priority for the state.

“GRA owes so much of its success to Susan, and it would not be the organization it is today without her,” says GRA Board Chair David Ratcliffe. “Her early work in GRA’s program areas was both foundational and durable. As president and CEO, she has brought a new level of agility to the Alliance by creating and seizing opportunities to make an impact in agricultural technology, artificial intelligence, Sickle Cell Disease and workforce development. And the taxpayers of Georgia should be pleased to know that GRA’s return on investment grew to $13 billion this year.”

Shows will continue to serve in an advisory role until the end of GRA’s fiscal year next June. In reflecting on her tenure with the Alliance, Shows said: “GRA works in so many different ways for the single purpose of growing Georgia’s economy. It has been a great privilege to have been a part of this unique organization, and to have worked on teams of true professionals in government, industry and academia, all to benefit Georgia’s excellent universities and the state as a whole.”

Source: https://gra.org/blog/224

Lucid Scientific Secures $7 Million Series A Financing Led by IAG Capital Partners

Tue, 26 Sep 2023 15:20:00 GMT

Maker of continuous real-time metabolic analysis systems experiences growing demand. Will build capacity for new product offerings, manufacturing, and global sales and marketing.

September 26, 2023 05:42 PM Eastern Daylight Time

ATLANTA–( BUSINESS WIRE )–Lucid Scientific, a life science instruments company that manufactures Resipher, announced the completion of a $7 million Series A financing led by IAG Capital Partners. Additional participants include Lucid’s original investor base, the Georgia Research Alliance’s Venture Fund, and Dynamk Capital, bringing Lucid’s total funding to date to approximately $13 million. Proceeds from this round will help the company aggressively expand production, sales and marketing, as well as broaden new product advancements. IAG Venture Partner Dr. Ehsan Jabbarzadeh will join Lucid’s Board of Directors.

“We are thrilled to partner with Lucid Scientific to market a ground-breaking technology for real-time analysis of cell metabolomics,” said Dennis Sacha of IAG Capital Partners. “The platform will provide scientists with a powerful tool to understand dynamic biological responses and the discovery of cures for most difficult diseases.”

The financing accelerates exceptional momentum for Lucid, and for their upcoming launch of new Resipher hardware and consumable products this fall. Resipher provides researchers with valuable insights into cellular metabolism that are of central importance for a wide range of therapeutic applications and drug safety considerations. Resipher converts standard cell culture plates into smart readers that detect and report metabolic changes in real-time. This data significantly accelerates the cell culture research cycle by bridging the gap between performing experiments and gaining actionable insight.

“This financing enables Lucid to continue improving the Resipher line of products for researchers and drug discovery teams whose work directly impacts human health,” said Dr. Walker Inman, CEO of Lucid Scientific. “We are excited to have Ehsan and IAG join our team, as they provide a wealth of experience and help position Lucid to achieve our goals.”

Lucid Scientific is a life science instruments company working to accelerate drug discovery and fundamental biological research by providing systems for real-time cellular analysis. Headquartered in Atlanta, GA at the Advanced Technology Development Center (ATDC), Lucid is supported by public and private sources including IAG Capital Partners, Dynamk Capital and the GRA Venture Fund. lucidsci.com

IAG Capital Partners is based in Charleston, South Carolina and partners with innovative leaders to build companies that will change the world. iagcapitalpartners.com

Dynamk Capital is a growth equity and venture capital firm focused on life sciences industrials. Dynamk’s investment strategy is centered on identifying companies developing disruptive technologies, tools, and services that enable the full biopharma continuum across discovery, development, and manufacturing of biotherapeutics, including cell & gene therapies and vaccines. dynamk.vc

GRA Venture Fund is a public-private venture capital fund investing in research-driven, Georgia-based startup companies. The Fund makes seed, early-stage and mid-stage investments in companies. Fund investors are the State of Georgia, private individuals, corporations and foundations. graventurefund.org

Contacts

info@lucidsci.com
+1-617-237-0665

Source: https://www.businesswire.com/news/home/20230926790900/en/Lucid-Scientific-Secures-7-Million-Series-A-Financing-Led-by-IAG-Capital-Partners

Saol Therapeutics Announces Completion of Enrollment in Both the Phase II COMPASS Osteoarthritis Knee Pain Trial and the Phase II RAISE Limb Spasticity Trial

Tue, 19 Sep 2023 13:23:00 GMT

SL-1002 is currently being developed for the treatment of chronic knee pain associated with osteoarthritis (COMPASS Trial) and mild to severe limb spasticity (RAISE Trial). Topline data for the COMPASS Osteoarthritis Knee Pain Trial will be available in the first quarter of 2024, with topline data from the RAISE Limb Spasticity Trial available shortly thereafter.

ROSWELL, Ga, DUBLIN and HAMILTON, Bermuda, September 19, 2023 / PRNewswire/ – Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, announced today that enrollment has been completed in the company’s two Phase II trials for SL-1002.

Both the COMPASS Osteoarthritis Knee Pain Trial ( NCT05470608 ) and the RAISE Limb Spasticity Trial ( NCT05311215 ) are each fully enrolled, at 132 patients and 32 patients, respectively.

SL-1002 is a novel, chemoneurolytic injection, that utilizes Saol’s proprietary CYCLOPHLEX ^TM technology.

“Running parallel, multi-indication Phase II studies for SL-1002 has only been possible due to our committed investigator partners, their research teams, and the tireless work of the employees at Saol Therapeutics,” said David Penake, CEO of Saol Therapeutics. “This is a tremendous milestone for our company, and we look forward to sharing the results with the medical community. While celebrating this accomplishment, our team has already shifted into preparing for what will be necessary to initiate the Phase III programs and expansion to other important indications.”

The COMPASS Osteoarthritis Knee Pain Trial is a multicenter, randomized (3:1), double-blind, placebo-controlled, single ascending-dose escalation study to assess the safety and efficacy of SL-1002 for the treatment of chronic knee pain associated with osteoarthritis in adult patients. The efficacy of SL-1002 will be assessed in comparison to placebo in its ability to reduce the average pain intensity at 3 months (12 weeks). The safety of SL-1002 will be assessed throughout the study compared to placebo when used for treating chronic knee pain associated with osteoarthritis. Additional secondary measures include improvements in function, concomitant medication, and healthcare utilization.

“The completion of enrollment in the COMPASS Osteoarthritis Knee Pain Trial brings this therapy one step closer to ultimately helping patients,” said Principal Investigator Zachary McCormick, MD, Vice Chair and Associate Professor of Physical Medicine and Rehabilitation at the University of Utah. “Recent developments in our understanding of the neuroanatomy of the knee indicate that this treatment could be incredibly beneficial to the millions of patients who deal with chronic pain related to osteoarthritis of the knee. We have enjoyed collaborating with the Saol Therapeutics team and the 14 additional sites in the COMPASS trial. I look forward to seeing the results soon.”

The RAISE Limb Spasticity Trial is a randomized (3:1), double-blind, placebo-controlled single ascending dose escalation study intended to assess the safety, pharmacokinetics, and efficacy of a single treatment of SL-1002 in patients with mild to severe limb spasticity. Following randomization, the study period will be up to 26 weeks. The primary endpoint is the overall safety profile of a single treatment exposure of SL-1002 in comparison to a placebo.

Saol Therapeutics currently expects topline results for the COMPASS Osteoarthritis Knee Pain Trial in the first quarter of 2024, and the RAISE Limb Spasticity Trial in the second quarter of 2024.

About COMPASS Osteoarthritis Knee Pain Trial

The COMPASS Osteoarthritis Knee Pain Trial is a multicenter, randomized, double-blind, placebo- CO ntrolled, single-ascending dose escalation study to assess the safety and efficacy of SL-1002 injectable for treat M ent of PA in a SS ociated with O steo A rthritis of the knee. ( NCT05470608 ).

About RAISE Limb Spasticity Trial

The RAISE Limb Spasticity trial is a R andomized double-blind, placebo-controlled, single A scend I ng dose escalation study to assess the S afety, Pharmacokinetics and E fficacy of SL-1002 in adult patients with limb spasticity. ( NCT05311215 ).

About SL-1002

SL-1002 is a novel, chemoneurolytic injection, that utilizes Saol’s proprietary CYCLOPHLEX ^TM technology. It is currently being developed for the treatment of chronic knee pain related to osteoarthritis and limb spasticity, both in the adult population (18+) in the United States.

About Saol Therapeutics

Saol Therapeutics (pronounced “Sail”) is a privately held, clinical-stage, pharmaceutical company with operations in Roswell, GA, Dublin, Ireland, and Hamilton, Bermuda. Saol is focused on development activity in CNS disorders such as spasticity and pain management, and orphan diseases. Saol is committed to providing and advancing therapeutic options for patients and the physicians treating these populations. For more information, visit www.saolrx.com .

Saol Therapeutics Contact

Senior Vice President, Strategy
Brian Nappi
bnappi@saolrx.com

Source: https://saolrx.com/saol-therapeutics-announces-completion-of-enrollment-in-both-the-phase-ii-compass-osteoarthritis-knee-pain-trial-and-the-phase-ii-raise-limb-spasticity-trial/

ORPHAN Cures Act a “welcome and bipartisan fix” to the IRA’s negative impact on drug development

Tue, 19 Sep 2023 13:10:00 GMT

September 18, 2023 | BIO

Representatives John Joyce, M.D. (R-PA) and Wiley Nickel (D-NC) today introduced the Optimizing Research Progress Hope And New Cures (ORPHAN Cures Act). BIO President and CEO, Rachel King, made the following remarks:

“This legislation is a welcome and bipartisan fix to the Inflation Reduction Act’s (IRA) negative impact on the development of drugs to treat rare diseases.

“Encouraging R&D for drugs to treat rare diseases is difficult as is. By definition, orphan drugs benefit small patient populations, making investment in this space incredibly risky. But there is tremendous need for these treatments. Fewer than 5 percent of rare diseases have an FDA approved treatment. We have repeatedly warned that the IRA — by subjecting drugs that can treat more than one rare disease to government price controls — creates even more barriers to investment into follow-on research and development for orphan drugs.

“The new bill, introduced by Representatives John Joyce, M.D. (R-PA) and Wiley Nickel (D-NC), changes the incentive structure within IRA to encourage follow-on investment into orphan drug development. Reversing IRA’s perverse incentives will eliminate the significant barrier for scientists to usher in new waves of rare disease drug innovation – all to the benefit of the thousands of patients currently suffering from rare diseases for which no treatments exist.

“BIO looks forward to working with lawmakers to get the Optimizing Research Progress Hope And New Cures (ORPHAN Cures Act) across the finish line as quickly as possible.”

Source: https://bio.org/press-release/orphan-cures-act-welcome-and-bipartisan-fix-iras-negative-impact-drug-development

Danish manufacturing firm breaks ground in Peachtree City; 200 new jobs expected

Wed, 13 Sep 2023 15:45:00 GMT

By The Citizen -August 22, 2023

SP Meditec recently broke ground on a 120,000 square foot, state-of-the-art manufacturing facility that is expected to create 200 new jobs in Peachtree City.

The plant, which will be located off Georgia State Route 74, is scheduled to begin operations in August 2024.

Several factors played into SP Meditec’s selection of Peachtree City for their company’s US expansion. Peter Fejfer, Managing Director for the Denmark-based business, cited the south metro Atlanta community’s proximity to the world’s busiest airport, skilled workforce, and strategic location as reasons behind the decision.

“We aim to tap into Peachtree City’s talented pool of professionals and contribute to the local economy,” Fejfer stated.

SP Meditec develops, manufactures, and assembles plastic solutions for the healthcare industry. Their Peachtree City expansion marks a significant milestone in the company’s strategy and commitment to meeting the growing demand for high-quality injection molded parts worldwide.

“I’m excited to welcome SP Meditec to Peachtree City,” Mayor Kim Learnard said. “This major investment in our city not only underscores our dedication to fostering smart growth and innovation, but also solidifies Peachtree City’s position as a hub for cutting-edge advancements in the healthcare sector.”

Dividend Realty is acting as project developer for the new plant. Their subsidiary, Dividend ECS, will design the facility. Davis Construction will serve as the facility’s construction manager.

“We look forward to completing the project and are committed to continuing our growth in this new market,” Fejfer continued.

GeoVax Completes Enrollment of Phase 2 Trial for Next-Generation COVID-19 Vaccine Booster

Mon, 11 Sep 2023 18:33:00 GMT

Multi-antigen Vaccine Designed to Protect Against Evolving SARS-CoV-2 Variants

ATLANTA, GA, September 11, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that it has met the enrollment target for its Phase 2 clinical trial evaluating GEO-CM04S1 as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466 ).

The study is designed to evaluate the safety profile and immunogenicity of two GEO-CM04S1 dose levels administered as a COVID-19 vaccine booster among healthy individuals previously vaccinated with one of the FDA approved SARS-CoV-2 mRNA vaccines. The immunological responses measured throughout the study will include both the level of neutralizing antibodies against SARS-CoV-2 variants of concern and specific T cell responses.

GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating.

“We would like to thank everyone who partnered with us to complete this important clinical trial enrollment milestone, especially the study volunteers and research staff at our clinical sites in the United States,” said David Dodd, GeoVax Chairman and CEO. “We believe the unique properties of GEO-CM04S1 potentially offer a more robust, durable degree of protection than the current authorized COVID-19 vaccines, not only as a booster vaccine to the currently authorized mRNA vaccines, but as a primary vaccine for highly vulnerable immunocompromised patients.”

Additional Ongoing Trials of GEO-CM04S1

In addition to the booster vaccine trial for which patient enrollment was just completed, GEO-CM04S1 is being evaluated in two other Phase 2 clinical trials:

Further underscoring the need for next-generation COVID-19 vaccines such as GEO-CM04S1, GeoVax scientists co-authored an article titled, “ MVA-Vectored Universal Beta-Coronavirus Vaccine Design & Development ”, published in the June 2023 issue of the online journal Vaccine Insights . The article, accessible here , provides expert insight into the emergence of SARS-CoV-2 (COVID-19), the risk of new “spillover events” from animal hosts, and how this risk can be addressed proactively. Regarding COVID-19 and its continually evolving variants, the authors describe the limitations of first-generation vaccines and the potential for MVA-vectored vaccines such as GEO-CM04S1 to overcome these limitations.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin ^® , presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com .

Forward-Looking Statements

Contact:

GeoVax Labs, Inc.

investor@geovax.com

678-384-7220

Chris Cornelison named interim Associate Vice President for Innovation and Commercialization

Wed, 06 Sep 2023 20:14:00 GMT

KENNESAW, Ga. | September 6, 2023

Kennesaw State University microbiology professor Chris Cornelison will serve as interim Associate Vice President for Innovation and Commercialization, effective September 1.

Cornelison, who for the past three years has served as Director of Intellectual Property Development , will work closely with Vice President for Research Karin Scarpinato on a variety of Office of Research initiatives, focusing on applied research and venture creation.

“Chris has demonstrated his entrepreneurial expertise through the procurement of several externally funded grants, in addition to the support infrastructure he has built for faculty here at KSU,” Scarpinato said. “Moving forward, he will be instrumental in working to expand our industry relations and commercialization portfolio.”

Cornelison will primarily focus on growing applied research and entrepreneurship across the university, a focus that includes Hatchbridge , a business incubator that launched earlier this year and assists local entrepreneurs in growing their businesses by offering resources such as guidance, office space and programming.

With many academic units at KSU already engaged in applied research, Cornelison aims to direct talent across both campuses to maximize the university’s impact on the region. Developing collaborations with Hatchbridge, Coles College of Business, Research Development and Strategic Initiatives, University Advancement, Career Planning and Development, and Government Relations will be crucial in the university reaching its full potential as a source for innovative solutions with market potential.

In addition to Intellectual Property Development duties, Cornelison also operates the BioInnovation Laboratory , which currently has seven active external grants, highlighted by the lab’s work on white-nose syndrome in bats and the development of novel therapeutic interventions.

The lab is also active in culinary mushroom cultivation , which includes technology that is licensed to MycoLogic, a startup Cornelison founded with postdoctoral researcher Kyle Gabriel that has garnered numerous awards in startup competitions.

MycoLogic finished first this summer at the Georgia AgTech Summit, and earlier this year, the KSU-based startup was a finalist at the Ag Innovation Challenge sponsored by the American Farm Bureau Federation.

Cornelison’s entrepreneurial background will be essential in performing the duties of interim Associate Vice President for Innovation and Commercialization.

“As a founder of a startup at KSU, I have learned what it means to be a faculty entrepreneur,” Cornelison said. “I am thrilled to have the opportunity to support my colleagues in their pursuit of entrepreneurial activities that allow the world to benefit from the great research they are doing.”

Other BioInnovation Laboratory projects include the production of pigments from agricultural and industrial waste materials by using food-grade fungi as biocatalysts, a project that recently received venture development funding and was the research focus of 2023 Birla Carbon Summer Scholar Mark Sheehan.

Cornelison earned his B.S. in microbiology at the University of Georgia in 2009, and his M.S. and Ph.D. in applied and environmental microbiology at Georgia State University in 2011 and 2013, respectively.

It was at Georgia State University while working in the laboratory of Dr. Sidney A. Crow that Cornelison developed an interest in how research intersects with commercialization.

“I was able to see how to build an applied research portfolio and learned about many of the ways in which research products reach their full potential via commercialization,” Cornelison said. “As a postdoc, I was part of an NSF I-Corps team. This further reinforced my desire to be active in driving academic innovations to market and gave me an appreciation for understanding product-market fit and the needs of customers.”

Cornelison carried those lessons into his role of Director of Intellectual Property Development, where he built KSU’s technology transfer operations from the ground floor by creating the Innovation Launch Pad to train faculty and student inventors in lean startup methodology and customer discovery, established the Innovation Seed Grant Program to support inventors in advancing their innovation during the provisional year, and created the KSU Quick Start Licensing Program to allow faculty to quickly obtain freedom to operate for commercial utilization of their innovations.

“Technology transfer at KSU is far more advanced than it was three years ago, and I am proud of the progress we have made,” Cornelison said.

— By David Roberts

Source: https://research.kennesaw.edu/roc/stories/cornelison_avp_innovation_commercialization.php

Biden administration announces $5 billion successor to Operation Warp Speed

Wed, 23 Aug 2023 15:25:00 GMT

The Biden administration announced $5 billion in federal funding will be directed to Project NextGen, the anticipated successor to Operation Warp Speed. Project NextGen will be coordinated by the Department of Health and Human Services (HHS).

The announcement came the same day that President Biden signed H.J.Res. 7 , which terminates the national COVID-19 pandemic emergency.

Read full story: https://bio.news/health/biden-administration-announces-5-billion-successor-to-operation-warp-speed/

Observing:A Renaissance in Rural America

Wed, 23 Aug 2023 13:07:00 GMT

A biotechnology revolution is taking root in rural America. Manus has established one of the largest precision fermentation facilities in the world, on the outskirts of Augusta, Georgia.

This revolution is supported by the recent Biden Administration Executive Order focusing on advancing biotechnology and biomanufacturing innovation, all driving the American bioeconomy.

Learn more about how the Manus biomanufacturing facility in Augusta is more than an industrial plant; it’s a beacon of transformation, a testament to the potential of advanced biotech, and a spark in an industrial rebirth in America: https://bit.ly/3sghBKV

OncoLens is ranked #316 among 5,000 of the fastest growing private companies in America.

Wed, 23 Aug 2023 12:58:00 GMT

We congratulate the amazing team at OncoLens, supporters, well wishers and most importantly customers.

Companies on the 2023 Inc. 5000 are ranked according to percentage revenue growth from 2019 to 2022. To qualify, companies must have been founded and generating revenue by March 31, 2019. They must be U.S.-based, privately held, for-profit, and independent–not subsidiaries or divisions of other companies–as of December 31, 2022. (Since then, some on the list may have gone public or been acquired.) The minimum revenue required for 2019 is $100,000; the minimum for 2022 is $2 million. As always, Inc. reserves the right to decline applicants for subjective reasons. Growth rates used to determine rankings were calculated to four decimal places.

VIEW at inc.com: https://www.inc.com/profile/oncolens

New Fellowships Established in Honor of Neuroscience Institute Founding Director

Tue, 22 Aug 2023 12:58:00 GMT

AUGUST 22, 2023

ATLANTA—Georgia State has established the new Wilczynski-Georgia Research Alliance Future Faculty Fellows in Neuroscience. The fellowships will support a cohort of three high-caliber postdoctoral students in Neuroscience with the goal of attracting and retaining exceptionally promising talent.

The collaborative project is funded by an endowed gift in memory of Dr. Walter Wilczynski, the Founding Director of the Neuroscience Institute .

“We intend these fellowships to champion a culture of inclusion and serve to expand diversity in the field of neuroscience” said Dr. Deborah Greene, whose philanthropy initiated the program.

Additional support will come from the Georgia Research Alliance , a public-private partnership that promotes new scientific discoveries and economic growth, as well as the GSU Research Foundation , the College of Arts & Sciences , the Center for Behavioral Neuroscience and the Neuroscience Institute.

“Georgia State’s research enterprise continues to grow by leaps and bounds, and these new fellowships will bring in top-notch neuroscientists to help us continue our growth and impact,” said Dr. Tim Denning, Vice President for Research and Economic Development at Georgia State. “It’s also a wonderful testament to the work of Dr. Wilczynski.”

Wilczynski became the Founding Director of the Neuroscience Institute at Georgia State in 2008, serving in the role for six years before returning to teaching and research. He was a mentor to numerous undergraduate and graduate students, and postdoctoral research fellows.

The Wilczynski-Georgia Research Alliance Fellows will pursue research in strategically selected areas that capitalize on the strengths in the Neuroscience community at Georgia State and leverage the university’s intellectual and infrastructural resources.

“The College of Arts & Sciences is excited to launch this post-doctoral program,” said Dr. Sara Rosen, Dean of the college. “The program will provide a premier research experience to train and develop the next generation of researchers in neuroscience.”

“We are excited to welcome and support new neuroscience scholars to our vibrant research community with the goal of retaining exceptional talent for years of service to the Georgia State student base,” said Dr. Daniel N. Cox, Director of the Neuroscience Institute.

Potential home appointments for the postdoctoral fellows include the Neuroscience Institute, the Center for Behavioral Neuroscience and the Center for Translational Research in Neuroimaging and Data Sciences.

The fellowships will have a three-year term of support with funds for operating expenses and professional development as well as a footprint of laboratory space for building a research program.

“Neurologists are in short supply, yet more undergraduates are interested in studying neuroscience. These two trends underscore the importance of neuroscience faculty,” said Susan Shows, President and CEO of the Georgia Research Alliance. “The Wilczynski Future Faculty Fellows program will make a meaningful contribution to developing neuroscience faculty by bringing new talent to a strong program at Georgia State. The program is a big win for Georgia.”

Source: https://news.gsu.edu/2023/08/22/new-fellowships-established-in-honor-of-neuroscience-institute-founding-director/

Science Square project tops out largest tower, announces first tenant

Tue, 22 Aug 2023 12:53:00 GMT

First phase of 18-acre, master-planned district quickly takes shape off Northside Drive

A year after breaking ground, the towering lab portion of Georgia Tech’s westward march has officially topped out.

The master-planned Science Square district—an initiative by Georgia Tech and its development partners that’s been in the works for more than a decade—will eventually cover 18 acres on the Westside, offering a blend of uses project leaders say is unlike anything else in Atlanta.

The university picked national developer Trammell Crow Company and its multifamily subsidiary, High Street Residential, to build Science Square in 2021. Georgia Tech affiliate Georgia Advance Technology Ventures is another partner in the project’s two-building initial phase.

The Science Square district’s first phase, which broke ground in August 2022, is rising a total of 27 stories between Georgia Tech’s campus and Westside neighborhoods such as English Avenue, where another multifaceted district, Echo Street West , began opening last year. Its goal is to fuse biomedical research and technology space with more traditional mixed-use components—commercial spaces and apartments.

Phase one’s 13-story Class A lab and office tower called Science Square Labs, a 368,000-square-foot spec project designed by Perkins + Will and developed by TCC, has recently topped out and made its first lease officially official.

Chicago-based Portal Innovations , a venture capital firm that aims to help life sciences companies grow with lab space, seed capital, and management support, has leased the full 10th floor of the labs building, taking 33,136 square feet, TCC reps announced today.

Katherine Lynch, a TCC Atlanta principal, said Atlanta marks the fourth market where Portal will establish “a biotech and medtech ecosystem, further advancing Atlanta’s strong position in the life science industry,” according to a prepared statement. Portal’s space at Science Square will include private offices, wet and dry labs, and collaborative space, alongside an outdoor terrace.

KEEP READING: https://atlanta.urbanize.city/post/georgia-tech-science-square-project-tops-out-images

MORE ARTICLES:

https://www.ajc.com/news/science-square-at-georgia-tech-celebrates-construction-milestone/C34O2U52ZREGFL3SVMGM4FEW5U/

Power 10: Here’s the health care leaders you should know [Subscription needed]

Mon, 21 Aug 2023 13:09:00 GMT

There is no shortage of exceptional health care professionals in metro Atlanta. Here are 10 doing innovative, newsworthy and unique things that business leaders should know about.

Congratulations to our own….

Dr. Dennis Liotta

Professor of Chemistry, Pharmacology and Chemical Biology at Emory University

Education: Ph.D., The City University of New York; Postdoctoral, The Ohio State University

Sherry N. Farrugia

CEO at Global Center for Medical Center

Education: Bachelor of science degree in chemistry, Auburn University

Source: https://www.bizjournals.com/atlanta/news/2023/08/21/power-10-health-care.html

Bayh-Dole Coalition Honors Emory Professor Behind Groundbreaking HIV and Covid-19 Treatments

Mon, 21 Aug 2023 13:07:00 GMT

ATLANTA, GA (August 21, 2023) — Emory University Professor Dennis Liotta has been featured in the Bayh-Dole Coalition’s new “Faces of American Innovation” report for developing chemical compounds used in life-saving medicines.

The Bayh-Dole Coalition is a diverse group of innovation-oriented organizations and individuals committed to celebrating and protecting the Bayh-Dole Act, as well as informing policymakers and the public of its many benefits.

On September 13, Dr. Liotta and four other leading innovators will receive the inaugural Bayh-Dole Coalition American Innovator Award in Washington, D.C.

“This is a wonderful honor, and I am humbled to receive it,” said Dr. Liotta. “Although I had no prior experience in drug discovery and development, at age forty I made the fateful decision to radically change the focus of my research and began what became a three-decade pursuit of the discovery of new drugs to address unmet medical needs. Against all odds, I was successful!”

Dennis Liotta, PhD / Photo: Stephen Nowland

Dr. Liotta discovered two chemical compounds capable of stopping HIV replication. ^[1] Emory later patented the molecules and licensed them to a drug company for further development. ^[2] By 2003, the FDA had approved both of Dr. Liotta’s novel compounds to treat HIV. Dr. Liotta’s lab also invented molnupiravir , which treats Covid-19. ^[3]

Dr. Deborah W. Bruner , Senior Vice President for Research at Emory University, commented, “Dr. Liotta has been at the forefront of bringing new research discoveries to market for over thirty years. His work bringing his discovery of Emtricitabine (in partnership with his two co-inventors) to market has provided a road map for other Emory researchers. He has blazed a trail for faculty and students to gain a deep understanding of pathways to engage with the entrepreneurial side of their research, and to fulfill our mission of doing good in the world by turning research into tangible benefits for humanity. As one of the top researchers of HIV antiretrovirals in the world, he is immensely deserving of this recognition.”

The Bayh-Dole Act was instrumental in bringing Dr. Liotta and his team’s technologies to the marketplace, said Joseph P. Allen, executive director of the Bayh-Dole Coalition.

“Without laws permitting universities to patent and license scientific discoveries made with the help of federal research funding, Dr. Liotta’s compounds may never have exited the lab and millions of people living with HIV/AIDS would not have healthy, productive lives today,” said Allen. “Thanks to the Bayh-Dole Act, private sector companies have a strong incentive to turn promising early-stage research into innovative therapies that save lives.”

“We’re thrilled for Dr. Liotta and this recognition,” said Todd Sherer, PhD, Associate Vice President for Research and Executive Director of Emory University Office of Technology Transfer . “Dennis’ work has directly impacted millions of lives, as most Americans who have HIV – and many around the world – take at least one of the antiretroviral drugs invented at Emory.”

Emtriva, an HIV antiretroviral developed at Emory University by Drs. Dennis Liotta, Raymond Schinazi, and Woo-Baeg Choi.

Regarding his career, Dr. Liotta remarked, “Drug discovery is a team sport that requires synergistic interactions amongst multiple individuals with complementary skills. I have been fortunate to have many amazing co-workers and collaborators who have shared this journey with me. In particular, I want to acknowledge the important contributions of my friends and colleagues, Drs. Woo-Baeg Choi, Raymond Schinazi and George Painter.”

Emory signed a total of 10 exclusive and start-up patent licensing agreements in FY2022 alone, according to the Emory Office of Technology Transfer. ^[4] In the same year, the U.S. Patent and Trademark Office issued 45 patents to Emory inventors, including jointly held patents. ^[5] Over half of Emory-associated start-ups are working to discover new medicines. ^[6] More than 60 life-changing products, from novel diagnostics to virtual reality solutions, have reached the market so far. ^[7]

###

Source: https://scholarblogs.emory.edu/techtransfer/2023/08/bayh-dole-coalition-honors-emory-professor-behind-groundbreaking-hiv-and-covid-19-treatments/?utm_source=social&utm_medium=twitter&utm_campaign=OTT_blog

GeoVax Announces First Patients Vaccinated in Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia

Thu, 10 Aug 2023 14:37:00 GMT

Seeking Improved Immune Response vs mRNA Vaccine Full Patient Enrollment Expected Within Six Months

ATLANTA, GA, August 10, 2023 — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that vaccinations have begun in an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355 ) of GEO-CM04S1 in patients with chronic lymphocytic leukemia (CLL), being conducted at City of Hope National Medical Center.

Despite a high vaccination rate, CLL patients may be at high risk for lethal COVID-19 infection due to poor immune response to currently available vaccines. The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone to carry SARS-CoV-2 virus antigens that may be more effective at inducing COVID-19 immunity in patients with poor humoral immune responses since MVA strongly induces T cell expansion even in the background of immunosuppression. By targeting both the spike (S) and nucleocapsid (N) protein antigens, GEO-CM04S1 broadens the specificity of the immune responses and protects against the loss of efficacy associated with current vaccines due to the significant sequence variation observed with the spike antigen.

The study is examining the use of two injections of GEO-CM04S1, three months apart, to assess immune responses in these vulnerable patients, with an mRNA vaccine (currently, the Pfizer-BioNTech Bivalent vaccine) as the control arm. Participants will be randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the control vaccine. The primary immune response outcome will be assessed at 56 days following the first booster injection. Up to 40 participants in each arm will be vaccinated, with immune responses evaluated and compared at the interim and final analyses.

David Dodd, GeoVax President and CEO, stated, “We are very pleased with the rapid start for this third important study for GEO-CM04S1, which we expect will achieve full patient enrollment within six months. We believe the GEO-CM04S1 vaccine, containing the two antigens, S and N, along with the recognized antibody and cellular immune responses resulting from the MVA approach, has the potential to offer greater booster protection than that from the current vaccines in use, as well as provide a greater degree of protection within immunocompromised patients. We expect the CLL trial will add to the data coming from our other ongoing trials, confirming the potential benefit of GEO-CM04S1 in another population of immunocompromised individuals. We look forward to sharing progress reports as we advance.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.

A recent presentation of unpublished data from the open-label portion of the Phase 2 trial of GEO-CM04S1 ( ClinicalTrials.gov Identifier : NCT04977024 ) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment ) indicates that GEO-CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines. GEO-CM04S1 also continues to advance in another Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466 ). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin ^® , presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com .

Multiple companies eye Gwinnett’s massive life sciences development [subscription needed]

Fri, 04 Aug 2023 14:53:00 GMT

Gwinnett County’s ambitious, 2,000-acre life sciences campus has seven companies interested, said Mason Ailstock, president of the Rowen Foundation.

His foundation is starting to build the Rowen project , which aims to provide a home for research and business development in agriculture, medicine, and environment. The project is located about halfway between Athens and Atlanta and will include lab and office space as well as residential real estate and community amenities.

The foundation is starting to build the infrastructure needed to support tenants, which is expected to be done in early 2024. Then development could start.

https://www.bizjournals.com/atlanta/news/2023/08/04/gwinnett-rowen-shortlist.html

Biotech And The Inflation Reduction Act: Sussing Out The IRA

Sat, 29 Jul 2023 16:44:00 GMT

Source : TD Cowen Insights Podcast –

John Murphy, Chief Policy Officer & Healthcare Counsel at the Biotechnology Innovation Organization (BIO) speaks with Yaron Werber, Biotechnology Analyst about how the Inflation Reduction Act (IRA) will impact innovation in biotech .

They discuss drug pricing reform provisions of the IRA, including drug exclusion, calculation of maximum fair price, and small molecule vs biologics. They also look at how those provisions might impact incentive structures in drug development, the likelihood of revisions to the bill near term, its potential effects on formulary or benefit design, and the first wave of IRA litigation.

CLICK HERE to listen to the podcast.

As Part of President Biden’s Unity Agenda, Cancer Moonshot Announces Launch of New ARPA-H Program to Develop Novel Technologies for More Precise and Accurate Cancer Tumor Removal

Thu, 27 Jul 2023 16:41:00 GMT

Program launch represents major milestone for new agency established and funded by President Biden and bipartisan members of Congress to revolutionize how we improve health outcomes for Americans facing cancer and other diseases

President’s Unity Agenda also delivering progress in fight against cancer thanks to the Bipartisan Honoring our PACT Act and SERVICE Act, with new steps from the Department of Veterans Affairs, including to expand access to breast cancer screenings

Today, the Biden Cancer Moonshot announced a first-of-its-kind Advanced Research Projects Agency for Health (ARPA-H) program to develop novel technologies that will allow surgeons to remove cancerous tumors with more precision and accuracy, resulting in better health outcomes for Americans facing cancer. The launch of this program—ARPA-H’s first program targeting cancer and second program overall—represents a major milestone for ARPA-H, the new agency President Biden established and funded with Democrats and Republicans in Congress last year to generate breakthroughs in ways to prevent, detect, and treat cancer and other diseases.

KEEP READING

Sanguina Raises $2.8M in Series A Funding to Drive Innovation in Home-Based Testing and Wellness Management

Tue, 25 Jul 2023 16:53:00 GMT

PEACHTREE CORNERS, Ga.–( BUSINESS WIRE )–Sanguina, a leading biotech company focused on providing rapid home-based testing and management solutions, announced today the successful completion of its $2.8m Series A funding round . Led by Veritus Holdings , the round saw participation from notable investors, including George Hornig of The Seed Lab and Stephen Ippolito of Veritus Holdings. The funding will be used to accelerate the development and expansion of Sanguina’s innovative blood health management digital and at-home-based platforms.

Sanguina’s mission is to empower individuals by creating a platform of accessible tools for diagnosing, monitoring, and managing wellness and chronic conditions from the comfort of their own homes. Founded in 2019 as a spin-off from prestigious institutions such as the Georgia Institute of Technology, Emory University, Children’s Healthcare of Atlanta, and the Centers for Disease Control and Prevention (CDC), Sanguina has quickly made a mark in the biotech sector.

George Hornig and Stephen Ippolito of The Seed Lab and Veritus Holdings join Forbes 30u30 inventors and Sanguina co-founders Erika Tyburski and Rob Mannino, PhD, and world-renowned hematologist, Wilbur Lam, MD, PhD, on a Board with knowledge spanning decades in the healthcare, consumer behavior, consumer experience, and financial services industries.

Sanguina’s flagship product, the AnemoCheck app, is a digital health platform that estimates hemoglobin levels and aids users in managing anemia. In addition to the app, Sanguina boasts an FDA-cleared point-of-care test, which the company plans to expand for home use later this year. Anemia, characterized by low hemoglobin levels, affects over 1.6bn individuals each year and has always been a marker of both illness and wellness, as it coexists with many chronic diseases and can guide treatment regimens. In June, two large, independent peer-reviewed published studies featured in the Annals of Internal Medicine and Journal of the American Medical Association (JAMA) revealed that anemia is a chronic problem for very large categories of Americans, ranging from those taking daily aspirin to women and girls who have iron deficiency from a variety of conditions. Additionally, clinical hematologists reviewed several studies on anemia and reveal that chronic health inequity has caused many women and minorities to normalize their anemia.

With advancements in home testing and artificial intelligence, the management of anemia and other chronic conditions is moving towards preventive and personalized medicine. The Series A funding round will enable Sanguina to enhance its existing product suite with artificial intelligence and machine learning models, improving utility, performance, and accessibility. Furthermore, this funding will pave the way for the introduction of new biomarkers and indications, including home-based testing for circulation, dehydration, for management of other chronic diseases.

“We are thrilled to have secured this funding to further our mission of providing accessible tools for managing wellness and chronic conditions,” said Erika Tyburski, Co-founder and CEO of Sanguina. “This investment will enable us to enhance our technology and platforms, bringing us closer to our vision of becoming a leading provider of home-based testing solutions.”

With the successful launch of anemia management through the AnemoCheck app and point-of-care test, Sanguina has taken a major stride towards revolutionizing home-based testing and personalized disease management.

About Sanguina, Inc.

Sanguina, Inc. (Sanguina) is a leading biotech company focused on advancing accessible digital and at-home health platforms for rapid home-based testing and disease management. Founded in 2019, Sanguina aims to empower individuals by providing innovative solutions for diagnosing, monitoring, and managing wellness and chronic conditions. With a team of experienced scientists, engineers, and healthcare professionals, Sanguina is committed to positively impacting global healthcare. To learn more about Sanguina, please visit sanguina.com or on social media through Instagram , Facebook , Twitter , or LinkedIn .

Website: www.sanguina.com

Who is Sanguina video

Contacts

Jessica Tackett
Director of Marketing
jessy.tackett@sanguina.com

GeoVax Announces Issuance of Ebola Vaccine Patent

Mon, 24 Jul 2023 15:50:00 GMT

Addressing Multiple Strains of Ebolavirus

Atlanta, GA, July 24, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company’s patent application No. 15/543,139 titled “ Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40).”

The claims granted by the patent generally cover GeoVax’s vector platform for expressing ebolavirus antigens in virus-like particles (VLPs) utilizing an MVA viral vector. The claims encompass multiple ebolavirus strains, including Sudan ebolavirus, Zaire ebolavirus, Taï Forest ebolavirus, and Reston ebolavirus.

GeoVax previously demonstrated that a single intramuscular (IM) dose of its vaccine candidate, GEO-EM01, provided 100% protection in rhesus macaques challenged with a lethal dose of Zaire ebolavirus (EBOV). GEO-EM01 is based on the Company’s novel MVA-VLP platform, which generates noninfectious VLPs in the individual being vaccinated. VLPs mimic a natural infection, triggering the body to produce a robust and durable immune response with both antibodies and T cells.

Additionally, in July 2021, the Company announced results of preclinical efficacy studies of its Sudan ebolavirus (SUDV) vaccine candidate, in which a single dose of the vaccine protected 100% of small animals challenged with a lethal dose of SUDV. Dr. Jason Comer of Sealy Institute for Vaccine Sciences, University of Texas Medical Branch (UTMB), recently discussed GeoVax’s Sudan virus vaccine efficacy. His presentation to the Global Health Preparedness Strategy and Priority Pathogens session at the 23 ^rd Annual World Vaccine Congress demonstrated partial protection following lethal Sudan virus challenge in a rigorous cynomolgus macaque model. This research project has been funded in whole or in part with Federal funds under a Preclinical Services Contract from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

David Dodd, GeoVax President and CEO, commented, “While our focus and development priorities continue to be our COVID-19 vaccine and cancer immunotherapy programs, developing vaccines against lethal hemorrhagic fever viruses, represents our commitment to addressing highly fatal endemic threats throughout the world, as well as our support of critically important biodefense initiatives. This patent allowance adds to our growing portfolio of wholly owned, co-owned, and in-licensed intellectual property, now standing at over 115 granted or pending patent applications spread over 24 patent families.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin ^® , presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com .

Forward-Looking Statements

Investor Relations Contact:

Rich Cockrell

CG Capital

404-736-3838

govx@cg.capital

Media Contact:

Susan Roberts

sr@roberts-communications.com

202-779-0929

GeoVax Announces Initiation of Phase 2 Clinical Trial of COVID-19 Vaccine Booster in Patients with Chronic Lymphocytic Leukemia

Thu, 20 Jul 2023 15:37:00 GMT

Seeking Improved Immune Response vs mRNA Vaccine

ATLANTA, GA, July 20, 2023 — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the start of an investigator-initiated clinical trial (ClinicalTrials.gov Identifier: NCT05672355 ), titled “ Randomized observer-blinded phase 2 trial of COVID-19 booster with GEO-CM04S1 or Pfizer-BioNTech Bivalent vaccine in patients with chronic lymphocytic leukemia ,” at City of Hope National Medical Center, led by Alexey Danilov, M.D., PhD as principal investigator. GEO-CM04S1, a multi-antigenic SARS-CoV-2 vaccine that targets the spike (S) and nucleocapsid (N) proteins of SARS-CoV-2, is actively under clinical study by GeoVax in severely immunocompromised individuals, as well as in healthy adults for use as a universal heterologous booster.

Despite a high vaccination rate, chronic lymphocytic leukemia (CLL) patients may be at high risk for lethal COVID-19 infection due to poor immune response to COVID-19 infections or vaccination. The GEO-CM04S1 vaccine uses a modified vaccinia virus (MVA) backbone that may be more effective at inducing COVID-19 immunity in patients with poor humoral immune responses since MVA strongly induces T cell expansion even in the background of immunosuppression. Targeting both the spike and nucleocapsid protein antigens broaden the specificity of the immune responses and protects against the loss of efficacy associated with the significant sequence variation observed with the spike antigen.

The study will examine the use of two injections of GEO-CM04S1 three months apart to assess immune responses in these vulnerable patients, with the Pfizer-BioNTech Bivalent vaccine as the control arm. Participants will be randomized 1:1 to receive two boosters with either the GEO-CM04S1 or the control vaccine. The primary immune response outcome will be 56 days following the first booster injection. Up to 40 participants will be treated in each arm, with immune responses evaluated at the interim and final analyses in each arm.

Brian Koffman, M.D.C.M., FCFP DABFP (retired) MS Ed, Executive Vice President and Chief Medical Officer of the CLL Society, a nonprofit dedicated to the unmet needs of those diagnosed with CLL/small lymphocytic lymphoma (SLL), commented, “Despite the current authorized COVID-19 vaccines providing protective immunity among the majority of patient populations, individuals with CLL/SLL, regardless of their treatment status, have had less predictable and often insufficient immune responses to the currently authorized vaccines. Within the CLL/SLL patient population, more robust and durable protective immunity is needed, especially next-generation vaccines that could induce stronger T cell and antibody responses. This trial leverages past success with a similar type of vaccine used for protection against a different viral infection in the immunocompromised to develop a vaccine intended to provide enhanced and more durable protection against COVID-19 infections in the high-risk CLL/SLL population. The CLL Society and the CLL/SLL community welcome this study and look forward to the results.”

Kelly McKee, M.D., GeoVax Chief Medical Officer, commented, “Unpublished clinical data recently presented at several medical conferences confirmed our earlier findings in healthy adults that GEO-CM04S1 stimulated a robust, durable, and broad-based humoral and cellular immune response against multiple SARS-CoV-2 variants, and by extension, to immunocompromised patients. Validation of these findings in additional patients with hematologic malignancies, who have received CAR-T and stem cell transplants, is underway as we seek to provide a vaccine solution to those individuals unable to mount adequate protective responses with currently available COVID-19 vaccines. We expect the CLL trial will further confirm the potential benefit of CM04S1 in another population of immunocompromised individuals.”

David Dodd, GeoVax President, and CEO, added, “ We are excited to begin this third important study for CM04S1 and look forward to sharing progress reports as we advance. We believe the CM04S1 vaccine, containing the two antigens, S and N, along with the recognized antibody and cellular immune responses resulting from the MVA approach, has the potential to offer greater booster protection than that from the current vaccines in use, as well as provide a greater degree of protection within immunocompromised patients.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.

A recent presentation of unpublished data from the open-label portion of the Phase 2 trial of CM04S1 ( ClinicalTrials.gov Identifier : NCT04977024 ) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment ) indicates that CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies, and T cell responses. These data support the planned progression of the Phase 2 clinical study, which will include a direct comparison to currently approved mRNA vaccines. CM04S1 also continues to advance in another Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466 ). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin ^® , presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently, in two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient. In addition, GEO-CM04S1 is in Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com .

Source: GeoVax

OncoLens Welcomes Cross Border Impact Venture Fund as Capital Partner to Fuel International Growth

Thu, 13 Jul 2023 20:20:00 GMT

ATLANTA (PRWEB) JULY 13, 2023

OncoLens provides an integration and collaboration platform to cancer centers, helping derive intelligence from swaths of disparate structured and unstructured data to empower centers to identify patients for clinical trials, research, biomarker testing and more. Insights derived are funneled into collaboration workflows and matched with clinical decision support to assist often siloed multi-disciplinary teams to determine the best plan forward for the patient.

With the investment and partnership from Cross Border , OncoLens plans to expand its domestic and global footprint into regions including rural communities and low-middle income countries where there are needs to add capacity, resources and access to shared expertise to identify the right diagnostics and treatments for patients, as well as support much needed diversity and inclusion in access and research.

With more than 200 cancer centers in the U.S and clients in the larger EMEA (Europe, Middle East and Africa) region, OncoLens’ network enables cross collaboration between multiple entities whether they are academic center/NCIs (national cancer institutes) and their community affiliates, large integrated delivery networks (IDNs) or across international borders. “With this new investment from Cross Border, we are excited to align our existing and future clients to international collaboration, improved patient care, and revenue opportunities,” says Anju Mathew, CEO of OncoLens.

“With an established network, OncoLens is on the cusp of creating an unprecedented global network of oncology providers that will open up access to cutting edge solutions for patients, enable global collaboration and intelligence sharing across the oncology ecosystem. We look forward to participating on this journey with the OncoLens team,” says Donna Parr, managing director and partner at Cross Border Impact Ventures.

ABOUT ONCOLENS

OncoLens enables multidisciplinary cancer care across the continuum. Through a streamlined, secure HIPAA-compliant infrastructure, OncoLens drives intra-enterprise, community, and network participation in multidisciplinary care planning, tracking, and delivery. Using OncoLens, cancer care providers view a singular view of the patient including outpatient and in-patient clinical data, pathology, radiology, genomics and genetic information. They can collaborate on treatment plans, track quality for accreditation, and alignment to care pathways. As a result, health systems maximize clinical trial participation, an extended referral stream, and the creation of a center of excellence that can be leveraged to support patient care and provider education. http://www.oncolens.com

ABOUT CROSS BORDER IMPACT VENTURES

Cross-Border Impact Ventures is an impact venture capital firm on a mission to revolutionize venture capital investing in health technology. We invest in early growth stage health technology companies relevant to women, children and adolescent health and located in North America, Europe and Israel with ability to scale technologies to Emerging Markets. We seek to expand access to world class technologies inclusively and globally because good health should not be restricted by gender, age, race, wealth and borders. http://www.crossborder.ventures

CONTACT

OncoLens: info@oncolens.com

Source: https://www.prweb.com/releases/2023/07/prweb19439450.htm

Control Dialysis Cannulation Pain – New Buzzy Pro Receives FDA 510K Indication

Wed, 12 Jul 2023 22:05:00 GMT

Dialysis cannulation pain impacts half a million patients. Proven Buzzy device is now FDA indicated to control dialysis, blood donation & lab draw needle pain.

ATLANTA, GEORGIA, U.S., July 12, 2023/ EINPresswire.com / — Dialysis patients can now get more pain relief during treatment thanks to Buzzy’s recently expanded FDA indications. Pain Care Labs has received augmented Section 510(k) clearance from the United States Food and Drug Administration (FDA) for the Company’s patented, noninvasive Buzzy devices to control pain from dialysis .

“We already used the Buzzy bee for children, but not for adults. We did a little experiment to learn whether Buzzy would work on dialysis shunts,” explains Liesbeth de Boer, Nursing Improvement Advisor in Maastricht, Netherlands. “Several patients experienced less pain and were happy, so we introduced it in our dialysis department. Patients like the control of holding Buzzy in exactly the right spot for the best pain relief when the nurse places the needle.”

Based on feedback from healthcare professionals, the Company adapted the original Buzzy to work optimally for dialysis. Patented Buzzy Pro maximizes the mechanical stimulation and ice surface area to match an arteriovenous fistula or blood draw site.

Dialysis centers and home dialysis rarely provide topical anesthetic creams. “Creams take too long,” observes Amy Baxter, MD, “while reusable Buzzy works on contact.” Buzzy’s expanded indications include needle pain control for blood donation, lab draws, and dialysis.

Pain Care Labs has a pending application for coverage by Medicaid for dialysis patients to afford the Buzzy Pro pain relief device. Public comment for support or need with End-Stage Renal Disease (ESRD) is open through August 25, 2023. The ESRD rule is published, with the Pain Care Labs application summarized on page 149 . Interested parties, whether dialysis patients, their family members, or healthcare providers, are invited to comment here: https://www.regulations.gov/docket/CMS-2023-0110/document

ABOUT PAIN CARE LABS

Pain Care Labs is the industry leader in non-invasive pain relief solutions. Established in 2006 by emergency physician and pain researcher Amy Baxter MD, the Company is dedicated to effective, reusable, drug-free pain solutions. Dr. Baxter speaks on public health topics including vaccine refusal (TEDMED) and the impact of needle fear on COVID vaccination (HHS). Most recently, she spoke at TED2023 about options instead of opioids after surgery. FDA-cleared Buzzy ^® , the flagship product, has been used to block the pain from over 45 million needle procedures. FDA-cleared VibraCool ^® relieves musculoskeletal pain from injury and overuse. The Company’s award-winning solutions are supported by over 80 independent clinical trials. The patented M-Stim ^® neuromodulation platform gives power over pain.

ADDITIONAL LINKS

TEDMED 2014 https://www.tedmed.com/speakers/show?id=299214
HHS Testimony 2021 https://youtu.be/UXNTGFOlw-g
TED2023 https://conferences.ted.com/ted2023/speakers

SOCIAL TAGS

#BugsNotDrugs
#PowerOverPain
#OptionsNotOpioids
#WhatWorksForComfort

Raven Wilson
Pain Care Labs
+1 912-483-9490
email us here

Source: Dr. Amy Baxter and https://www.einnews.com/pr_news/643582048/control-dialysis-cannulation-pain-new-buzzy-pro-receives-fda-510k-indication

Moonlight Therapeutics Receives Clinical Trial Grant to Evaluate MOON101 for Peanut Allergy

Tue, 11 Jul 2023 17:25:00 GMT

Moonlight Therapeutics, a biotechnology company, has received a multi-million dollar clinical trial grant from the National Institutes of Health to evaluate its treatment, MOON101, for peanut allergy in peanut allergic children and adults.

ATLANTA, GEORGIA (PRWEB) JULY 10, 2023

Moonlight Therapeutics, Inc., a biotechnology company developing an intracutaneous treatment for food allergy, announced it has received a multi-million dollar Fast-Track small business clinical trial grant to evaluate its treatment, MOON101, for peanut allergy in peanut allergic children and adults. The clinical trial grant was awarded by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). Moonlight has already completed a pre-IND meeting with the FDA on the first-in-human clinical trial for MOON101.

MOON101 uses Moonlight’s proprietary platform, a small, minimally invasive skin stamp, designed to break through the top-most layers of the skin barrier and deliver allergens to the skin’s immune cells in order to desensitize someone suffering from a food allergy. The dermal stamp is designed for at home self-administration. It is applied for only a few minutes and then removed. The approach has shown promising results in animal models of peanut and other allergies; data from these studies have been published in peer-reviewed journals.

This grant is the second small business grant the company has received from NIAID to develop MOON101 for the treatment of peanut allergy, bringing the company’s total non-dilutive funding to over $5 million. “This clinical trial grant represents further scientific validation of the company’s promising technology to address a large unmet need in the treatment of peanut and other food allergies,” said Samir Patel, Moonlight Therapeutics co-founder and CEO. “We were awarded this grant through a highly competitive review and it represents the meaningful progress we have made in advancing MOON101 towards the clinic.”

The clinical trial will be conducted in conjunction with several leading food allergy centers and clinical investigators in the United States. “There are over 6 million individuals in the United States alone with a peanut allergy and with only one FDA-approved therapy, there is still a large unmet need for patients and their families,” said Dr. Brian Vickery, who is the Director of the Food Allergy Center at Emory and Children’s Healthcare of Atlanta and serves as the lead clinical investigator on this grant. Dr. Vickery has been an investigator in food allergy clinical trials conducted at several stages of development including registration trials. “Clinical data from this grant will allow us to evaluate the effects of MOON101 directly on peanut allergic patients.”

“This award provides validation for the scientific approach Moonlight is taking and will facilitate the company’s entry into clinical trials,” added Dr. James Baker MD who is the founding Director of the Mary H. Weiser Food Allergy Center at University of Michigan and a former CEO of Food Allergy Research and Education (FARE), the national food allergy foundation.

Moonlight will be raising private funds to complement this award in order to accelerate the collection of the clinical data and development of MOON101.

About Moonlight Therapeutics

Moonlight Therapeutics is an early-stage biotechnology company based in Atlanta, Georgia. Moonlight is developing an intracutaneous allergen-specific immunotherapy platform for treating for food allergies. Food allergies are estimated to affect more than 30 million people in the United States. Moonlight has developed its proprietary platform, to break through the skin barrier and deliver allergens to immune cells in the top layer of the skin. This platform can be used to deliver individual or combinations of allergens to treat multiple allergies. This technology was invented at Texas Tech University and is supported by the Georgia Research Alliance. To learn more, visit moonlighttx.com .

NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Moonlight’s plans for pre-clinical and clinical studies, regulatory filings, investor returns and anticipated drug effects in human subjects. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent in Moonlight’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Moonlight undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

New CMS guidance a “missed opportunity” for future medical innovation, patients

Fri, 30 Jun 2023 21:04:00 GMT

June 30, 2023 | Source BIO.org

The Centers for Medicare & Medicaid Services (CMS) today released its guidance for the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 (IRA). John Murphy, BIO’s Chief Policy Officer, made the following statement:

“As we have stated in the past, the Medicare price setting provisions of the IRA will have a profound and lasting negative impact on innovative medicine development and access in the US. Nothing in the final guidance released today will change that. Unfortunately, patients – and their loved ones – will be robbed of the future medical innovation that they’re so desperately waiting for as this law rolls out.

“CMS took some limited steps in the final guidance that will modestly improve the environment around transparency. Although much more could have been done.

“Notably, we were pleased to see CMS take the reasonable position of allowing affected manufacturers to control some of their own disclosures and confidentiality protections surrounding the negotiation process.

“Similarly, CMS clarified the ability of interested parties and patients to have a voice in the negotiation process. Moreover, Part D plans are now on notice that MFP-selected drugs are going to have to be accessible to patients once negotiated. Although, it remains unclear how much CMS will increase formulary review to ensure unreasonable utilization management is not implemented as a barrier to access.

“Yet the Agency missed the opportunity to repair damage to the rare disease community and support more meaningful investment in orphan research by allowing new but unapproved orphan designations to retain the orphan exclusion. We believe CMS has the authority and discretion to make this clarification and to support rare disease patients.

“BIO and our members will continue to pursue all avenues available to protect patient access to medicines and to ensure the US remains an open market for innovation and investment.”

The Coalition of State Bioscience Institutes (CSBI) joined InnovATEBIO at National Summit to Address Booming Bioscience Industry’s Talent Needs

Fri, 30 Jun 2023 20:57:00 GMT

Summit convened diverse stakeholders in a state ecosystem approach aimed at meeting industry’s urgent workforce gaps

June 30, 2023 | WASHINGTON–( BUSINESS WIRE )–Coalition of State Bioscience Institutes (CSBI) and InnovATEBIO convened a national Summit this week at the National Academies of Sciences in Washington, D.C., tasked with developing workforce strategies designed to sustain U.S. leadership in life sciences innovation. Both national organizations and their multi-state members helped to comprise over 250 attendees for the National Science Foundation- (NSF-)supported Envisioning the Next Bioscience Workforce Summit , which brought together thought leaders from industry, academia, and government to forecast the continuing wave of discoveries and corresponding talent needs from the industry’s biopharmaceutical, biomedical device, bioprocessing, bioengineering, synthetic biology, and food production subsectors.

The first-of-its-kind assembly of diverse public and private stakeholders were brought together by InnovATEBIO, an NSF-funded National Advanced Technology Education Center that supports biotechnology education through its robust network of community colleges, and CSBI, a national coalition of bioscience trade associations and institutes who are committed to delivering industry-led workforce development programs. The collaboration between CSBI and InnovATEBIO has intensified over the last five years as part of an effort to address an outsized demand for talent by the life sciences industry and to open access to careers for a broad and diverse talent base.

Inspired by the innovation forecasts from leaders from the industry’s diverse segments, the Summit’s second day catalyzed state teams, comprised of stakeholders from industry, academia and workforce and economic development organizations, to collaborate on strategic solutions to address workforce gaps in their states.

“The bioscience industry’s workforce challenges are too urgent for any single stakeholder to try and address alone,” said Linnea Fletcher, Executive Director of the InnovATEBIO National Biotech Education Center. “We know that some states are doing an admirable job of bringing their community college and other academic partners together with industry, trade associations and governmental agencies to develop targeted programs that both meet and stay abreast of the industry’s rapidly evolving talent needs. We hope the Summit and its aftermath will provide more states with tools to develop similar strategic collaborations that will address gaps in their own states, a clear win-win for the industry and the highly trained students coming out of our ATE and other programs.”

“What I don’t think many recognize is how significantly many of these ATE and other academic programs can – and are – rapidly responding to urgent calls from bioscience employers for highly skilled technicians,” said Liisa Bozinovic, CSBI Chair and Executive Director of the Oregon Bioscience Association. “These programs are not only meeting companies’ immediate talent needs, but also offering a diverse set of students an accessible and rewarding pathway with multiple options for career and educational growth. That is what we sought to do with this Summit – to help more states develop the partnerships and funding to address gaps in their own regions.”

InnovATEBIO and its partners will continue to support the work of the state teams in the aftermath of the Summit to both broaden and deepen this important work.

For additional information on the Summit, click here .

About the Coalition for State Biotech Institutes (CSBI)

The Coalition for State Biotech Institutes is dedicated to ensuring America’s leadership in bioscience innovation by delivering industry-led life sciences education and workforce development programs through a nationally coordinated effort. Programs are uniquely positioned for the life sciences industry to deliver, replicable in states across the U.S., extensible to other STEM industry sectors and are fully aligned with Next Generation Science Standards (NGSS). Learn more at www.csbioinstitutes.org where you can download our 2023 Life Science Workforce Trends Report .

About InnovATE BIO , the National Biotechnology Education Center: InnovATE BIO is supported by a five-year Advanced Technical Education (ATE) grant to advance biotechnology technician education nationally through cutting-edge professional training for instructors and share the best practices among community college programs, administrators, trade organizations, and industry. The Center seeks to develop a collaborative infrastructure that supports innovation and promptly addresses the needs of the biotechnology community. InnovATE BIO aims to coordinate ATE-funded biotechnology projects to identify opportunities to generate partnerships and collaborations that will accelerate innovation in biotechnology education. In addition to these efforts, it seeks to monitor and address emerging biotechnology industry and technician workforce trends.

Follow Innov ATEBIO on Facebook , LinkedIn , and Twitter at #InnovATEBIO to stay current on biotechnology education in community colleges. View posts at #EnvisioningBioscience for the Envisioning the Next Bioscience Workforce Summit.

Contacts

Maria Thacker, Georgia Bio
mthacker@gabio.org
404-920-2042

Consolidation, planning and due diligence: The #GCMI Annual Spotlight on the State of Preclinical for 2023

Thu, 29 Jun 2023 12:58:00 GMT

GCMI and our preclinical arm also known as T3 Labs is a trusted, proven industry-leading preclinical CRO for medical devices and other medical products. We’re an AAALAC accredited facility that conducts feasibility, proof of concept, feasibility, and safety and efficacy GLP medical device testing for studies in any therapeutic area and in small and large models. Since January 2012, we have archived more than 80 GLP studies, including more than three dozen in the last two years alone, for leading medical device manufacturers of which more than 65 products have received regulatory approvals.

Awareness of changes in and the current state of the preclinical landscape can make the difference between an efficient pathway for a new medical technology’s regulatory submission or high numbers of wasted “$10,000” days.

Our Director of Scientific Affairs Evan Goldberg has more than 12 years planning, executing and reporting on preclinical studies; GLP, pilot and everything in between. If you are working on a new medical technology, be it a device, therapeutic or combination product, we encourage you to continue reading our annual Q&A on the current state of preclinical work with Evan immediately below.

Keep Reading Here: https://gcmiatl.com/2023/06/19/consolidation-planning-and-due-diligence-our-annual-spotlight-on-the-state-of-preclinical-for-2023/

AdvaMed Statement on CMS’s Proposed Rule for Breakthrough Technology Coverage

Wed, 28 Jun 2023 19:44:00 GMT

June 23, 2023

WASHINGTON, D.C. – AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker on the recently issued proposed Transitional Coverage for Emerging Technologies (TCET) rule:

“We’re pleased that CMS has finally issued the TCET notice. While the draft rule requires further review, we are pleased that CMS recognizes the need to improve the coverage process for seniors. We continue to believe that immediate coverage of FDA approved technologies represents the best path forward to ensure seniors receive the benefits they need and America’s Medtech companies continue to lead the world in medical innovation. We look forward to reviewing draft rule and working work with CMS and Congress to bring the certainty and transparency to medical innovation that American seniors deserve.”

During the rulemaking process, AdvaMed wrote to CMS , outlining practical considerations the agency could easily incorporate into its proposed rule, reflecting feedback from the medical technology companies that are developing products and methods to diagnose and treat diseases, improve patient quality of life, and save lives.

From the letter : “We believe that CMS, in order to advance its health equity and other goals, can and must play a critical role in advancing access to emerging innovations that would improve health outcomes for the array of Medicare beneficiaries it serves. We also believe that we share a common goal – the establishment of a clear and expeditious coverage process, based on scientifically sound clinical evidence with appropriate safeguards, for emerging technologies that will benefit Medicare-eligible patients.”

In March, the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act was introduced in the House of Representatives by Reps. Brad Wenstrup (OH-02) and Suzan DelBene (WA-01). In response to the introduction of the bill, Whitaker said, “Access to innovative, FDA-approved breakthrough technologies is vital for Medicare beneficiaries who are working with their doctors to treat illnesses and live healthy lives. This legislation is an important part of the ongoing reforms that are taking place within CMS to make this a reality for patients.”

Improving patient access to breakthrough medical technologies is a top priority this year for AdvaMed, highlighted in the organization’s Medical Innovation Agenda for the 118 ^th Congress earlier this year.

GeoVax Universal Coronavirus Vaccine Design & Development Approach Published in Vaccine Insights

Tue, 27 Jun 2023 14:50:00 GMT

Spotlight Content on Pandemic Preparedness: Getting Ready for the Next “Disease X”

ATLANTA, GA, June 27, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer, announced today the publication of an article titled, “ MVA-Vectored Universal Beta-Coronavirus Vaccine Design & Development ” in the June 2023 issue of the online journal Vaccine Insights . The article is co-authored by GeoVax’s Chief Scientific Officer, Mark Newman, PhD, together with other GeoVax scientists, Mary Hauser, PhD, Arban Domi, PhD, Sreenivasa Oruganti, PhD, Pratima Kumari, PhD and Ashley Zuniga, PhD and can be accessed here: Vaccine Insights .

The article provides expert insight into the emergence of SARS-CoV-2 (COVID-19), the risk of new “spillover events” from animal hosts, and how this risk can be addressed proactively. With regard to COVID-19 and its continually evolving variants, the authors describe the limitations of first-generation vaccines and the potential for MVA-vectored vaccines such as GEO-CM04S1 to overcome these limitations.

A bout GEO-CM04S1

GEO-CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.

CM04S1 continues to advance in a second Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466 ). Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin ^® , presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient. In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com .

Dalan Animal Health Raises $4.5M in Series Seed 3 Funding to Accelerate Global Expansion and Product Pipeline

Tue, 27 Jun 2023 14:11:00 GMT

Key Points:

ATHENS, GA. — Tuesday, June 27, 2023 – Dalan Animal Health, Inc. (“Dalan”),

a pioneering biotech company in insect health, today announced the successful closure of a $4.5 million Series Seed 3 funding round. The round was led by Prime Movers Lab with participation from At One Ventures, bringing Dalan’s total funding to $10 million.

The additional funding will enable Dalan to expedite its product pipeline and expand its operations beyond the United States. With the largest honeybee sector residing in Europe, boasting 20 million hives compared to the US’s 2.67 million, the global need for sustainable solutions in bee health is evident. Dalan is committed to making its groundbreaking technology available where it is most needed, as swiftly as possible.

“Dalan’s innovative approach to insect health represents a significant market opportunity,” said Dakin Sloss, Founder and General Partner of Prime Movers Lab . “Their pioneering work in developing the world’s first honeybee vaccine has the potential to transform the agricultural sector and secure the global food supply.”

The recent approval of Dalan’s first-of-its-kind honeybee vaccine by the USDA has highlighted the global interest and pressing need for sustainable solutions in the industry. The vaccine, designed to protect honeybees against the devastating American Foulbrood disease, is set to improve the health and productivity of honeybee colonies, thereby increasing yields for farmers who rely on pollination for their crops.

“Most of terrestrial biomass is plants, and most of those are flowering plants. The first vaccine to protect this commercially critical pollinator is a significant stride for protecting both biodiversity and our food supply,” said Tom Chi, Founder of At One Ventures .

Annette Kleiser, CEO of Dalan Animal Health, expressed her gratitude for the support and shared her vision for the future. “We are excited to accelerate our product pipeline and expand our reach globally. Our work is vital for sustainable agriculture, and this funding will help us bring our solutions to where they are needed most.”

The honey bee vaccine, manufactured by Diamond Animal Health (Des Moines, IA), a wholly-owned subsidiary of Heska (NASDAQ: HSKA), will initially be distributed on a limited basis to commercial beekeepers and queen producers. Beekeepers interested in safeguarding their colonies with Dalan’s vaccine can visit the website at https://www.dalan.com/contact or call 844-483-2526.

About the vaccine

Dalan’s vaccine uses killed whole-cell Paenibacillus larvae bacteria and is administered by mixing it into queen feed consumed by worker bees. The vaccine is incorporated into the royal jelly by the worker bees, who then feed it to the queen. The queen ingests the vaccine, and fragments are deposited in her ovaries, providing immunity to the developing larvae. The non-GMO vaccine can be used in organic agriculture, and pivotal efficacy studies have shown its potential to reduce larval death associated with American Foulbrood infections caused by P. larvae.

About Dalan Animal Health, Inc

Dalan Animal Health ( www.dalan.com ) is dedicated to preventing diseases that affect invertebrates, increasing profitability and yield for producers worldwide. This platform technology uses transgenerational immune priming, allowing the maternal animal to pass immune modulators (e.g., antigens, anti-microbial molecules) to the next generation larvae before they hatch. Dalan plans to develop vaccines for other honeybee diseases and underserved industries, such as shrimp, mealworms, and insects used in agriculture. The company is headquartered in Athens, Georgia, at the University of Georgia’s Innovation Hub.

Media Contact:

Ian Murphy

Phone: (310) 689-6397 Email: press@dalan.com

NEXGEN BioBanking Receives Accreditation from the College of American Pathologists

Wed, 21 Jun 2023 19:48:00 GMT

June 21, 2023 | The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to NexGen Biobanking, Norcross, GA, based on results of a recent on-site inspection as part of the CAP’s Biorepository Accreditation Program. Recognized for rigorous and robust standards, CAP accreditation elevates quality and mitigates risk, an important way that laboratories can contribute to improved patient outcomes.

The facility’s director, Katrina Johansson, MHA, MT (AAB), MLT (ASCP), was advised of this global recognition and congratulated for the excellence of the services being provided. NexGen Biobanking is one of more than 8,000 CAP-accredited facilities worldwide.

“We are proud to have been awarded this accreditation in our first year of operation,” said Ms. Johansson.

Managing partner, Andrew Pazahanick, upon learning of the laboratory’s accreditation, said: “Today, we are storing and managing over 3,500,000 cancer research specimens. NexGen is a customer-centric business, and the CAP accreditation validates the high quality and reliable services we provide.”

During the CAP accreditation process, designed to ensure the highest standard of care for all laboratory patients, inspectors examine the laboratory’s records and quality control of procedures. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management. These reviews help verify activities reflect the most recent best practices.

With over 23,000 laboratory participants, in addition to accreditation, the CAP offers proficiency testing/external quality assessment (PT/EQA) programs, quality improvement tools, and protocols and guidelines to ensure excellence in all areas across the laboratory. Built on a foundation of pathologist expertise, the College of American Pathologists (CAP) partners with laboratories worldwide to elevate the quality of laboratory medicine with best-in-class solutions designed to drive operational excellence, achieve diagnostic confidence, and ensure the best patient care.

About the College of American Pathologists

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP Annual Report at cap.org .

Contact : Katrina Johansson, Director of Operations

678-266-0962(M)

678-679-8776(O)

KJohansson@Nexgenbiobanks.com

Avanos Medical, Inc. Announces Agreement to Acquire Diros Technology Inc.

Mon, 19 Jun 2023 12:42:00 GMT

ALPHARETTA, Ga., June 19, 2023 /PRNewswire/ — Avanos Medical, Inc. (NYSE: AVNS ) today announced it has entered into a definitive agreement to acquire Diros Technology Inc., a leading manufacturer of innovative radiofrequency (RF) products used to treat chronic pain conditions.

Based in Toronto, Canada, Diros Technology has been at the forefront of radiofrequency ablation (RFA) technology since its founding. In the global market, over one million RFA procedures are performed annually in the treatment of chronic musculoskeletal pain. For chronic pain management, Diros Technology’s products deliver RF energy through precisely placed, minimally invasive probes that heat nervous tissue near the probe’s tip, deactivating the nerve’s ability to transmit pain signals.

“The acquisition of Diros Technology strengthens Avanos’ leadership position in RF technology by providing a full range of high-quality, differentiated pain management products,” said Avanos Chief Executive Officer, Joe Woody. “We expect our enhanced portfolio will offer significant opportunities to deliver non-opioid-based, minimally invasive treatments to patients throughout the world. With this comprehensive suite of RF offerings, we believe Avanos is poised for future growth across all major sites of patient care: hospitals, ambulatory surgery centers and physician’s offices.”

The transaction is expected to close in the third quarter of 2023, subject to customary closing conditions. Avanos will finance the acquisition through a combination of funds from its existing credit facility and available cash. The company estimates that the new business will be immediately accretive to revenue growth, gross margins, operating margins and EPS.

The Company plans to share additional details about the transaction during its Investor Day event on June 20, 2023.

About Avanos Medical:
Avanos Medical, Inc. (NYSE: AVNS ) is a medical technology company focused on delivering clinically superior medical device solutions that will help patients get back to the things that matter. Headquartered in Alpharetta, Georgia, Avanos is committed to addressing some of today’s most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Avanos develops, manufactures and markets its recognized brands worldwide. For more information, visit www.avanos.com and follow Avanos Medical on Twitter (@AvanosMedical), LinkedIn and Facebook.

Note Regarding Forward-Looking Statements
This press release contains information that includes, or is based on, “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can generally be identified by the use of words such as “may,” “believe,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” or “continue” and similar expressions, among others. The “forward-looking statements” include, without limitation, statements regarding the acquisition’s impact on the Company’s chronic pain portfolio and on the Company’s revenues and gross and operating margins, the expected timing of the closing, and the Company’s source of funds for the acquisition. Forward-looking statements are based on the current plans and expectations of management and are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Actual results could differ materially from those expected as a result of a variety of factors, including the Company’s ability to successfully achieve the expected benefits of the acquisition of Diros Technology. The information contained herein speaks only as of the date of this press release, and the Company undertakes no obligation to update forward-looking statements, except as may be required by the securities laws. Additional information concerning these and other factors that may impact future results is contained in the Company’s filings with the U.S. Securities and Exchange Commission, including its most recent Form 10-K and Quarterly Reports on Form 10-Q.

SOURCE Avanos Medical, Inc.

Unique tined-probe technology further differentiates Avanos portfolio

Vital Transformations Study Regarding White House Drug Pricing and SMART Act Released

Fri, 16 Jun 2023 18:10:00 GMT

The Vital Transformations study was released this week, and it estimates that there would be more than 235 fewer FDA approvals of new medicines for patients battling cancer, neurological, and rare and infectious diseases over the next decade as well as 15,714 lost jobs for Georgia workers if proposals to expand federal government-mandated drug pricing policies are implemented. Among the proposals under consideration is allowing Medicare to set prices for specific drugs five years after FDA approval, which would lead to significant lost therapies, innovation, and jobs in the biopharma ecosystem at an even more accelerated pace. These proposals are included in the Executive Branch’s FY 2024 budget as well as the Senate’s SMART Prices Act.

Research firm Vital Transformation modeled the impacts of expanded federal government-mandated drug pricing policies at five years following FDA approval. The study analyzed the reduction of new drug approvals and loss of jobs if these policies or others similar to them were enacted into law.

Key Study Highlights:

The study found that, if proposed expansions of government-mandated drug pricing policies are implemented, there are serious consequences around the development of and investment in new medicines, and significant job losses in major innovation hubs like Georgia.

More information available here at We Work for Health.

DOWNLOAD THE: Infographic: New study projects devastating losses to drug development, jobs and patient health in biopharma ecosystem

DOWNLOAD THE: Infographic: Consequences of expanding government-mandated drug pricing policies

Acadia Pharmaceuticals Announces Phase 3 Development Candidate ACP-101 (intranasal carbetocin) for Prader-Willi Syndrome

Wed, 14 Jun 2023 17:51:00 GMT

— Acadia acquired Levo Therapeutics and worldwide rights to ACP-101 in June 2022

— ACP-101 (intranasal carbetocin) is a selective oxytocin-receptor agonist for the treatment of hyperphagia in Prader-Willi syndrome

— Company recently completed a meeting with the FDA and plans to initiate a Phase 3 study in the fourth quarter of 2023

— Webcast to be held today at 5:00 p.m. Eastern Time

SAN DIEGO–( BUSINESS WIRE )– Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the addition of a new Phase 3 development candidate to its rare disease portfolio, ACP-101 (intranasal carbetocin), for the treatment of hyperphagia (a false and unrelenting state of starvation) in Prader-Willi syndrome (PWS). Acadia acquired worldwide rights to develop and commercialize ACP-101 with the acquisition of Levo Therapeutics in June 2022.

“Acadia’s acquisition of ACP-101 demonstrates our commitment to acquiring and developing novel drug candidates that address significant unmet needs in central nervous system disorders. The addition of this drug candidate to our rare disease portfolio is an important next step in the execution of our business development strategy,” said Steve Davis, Acadia’s President and Chief Executive Officer. “Prader-Willi syndrome is a rare genetic disorder with no approved treatments, characterized by life-threatening hyperphagia, in addition to a broad range of severe metabolic issues and behavioral challenges. We look forward to working with the Prader-Willi community and clinical experts as we continue to advance development of this program.”

Prior to Acadia’s acquisition, Levo conducted a Phase 3 multi-center, randomized, double-blind, 8-week placebo-controlled study evaluating two doses of ACP-101, 3.2 mg and 9.6 mg, versus placebo three times daily with an even randomization (1:1:1). Top-line results showed that ACP-101 was safe and well-tolerated and demonstrated nominally statistically significant efficacy at the 3.2 mg dose.

“We recently met with the FDA and reached alignment to further evaluate the 3.2 milligram dose of ACP-101 in a pivotal Phase 3 study,” said Doug Williamson, Acadia’s Executive Vice President, Head of Research and Development. “If positive, we plan to promptly submit a new drug application for the treatment of hyperphagia in PWS to the FDA.”

Prader-Willi syndrome is a rare, neurobehavioral genetic disorder characterized by severe and life-threatening hyperphagia, metabolic issues, intellectual deficits and other behavioral problems that is estimated to affect 8,000 to 10,000 patients in the United States. ^1,2 There is no FDA approved medicine to treat hyperphagia in PWS. ⁵

Conference Call and Webcast Information

Acadia will discuss the ACP-101 program via conference call and webcast today at 5:00 p.m. Eastern Time. The conference call will be available on Acadia’s website, www.acadia.com under the investors section and will be archived there until July 13, 2023. The conference call may also be accessed by registering for the call here . Once registered, participants will receive an email with the dial-in number and unique PIN number to use for accessing the call.

About ACP-101 (intranasal carbetocin)

ACP-101 is an investigational drug in the form of an intranasal formulation of carbetocin being developed for the treatment of hyperphagia in Prader-Willi syndrome (PWS). Carbetocin has improved drug qualities relative to oxytocin, including an extended duration of action and greater specificity for the oxytocin receptors compared to vasopressin receptors which could provide meaningful efficacy with an attractive safety profile in patients with PWS. ⁸ For the treatment of Prader-Willi syndrome specifically, a central nervous system disorder, an intranasal formulation of carbetocin was developed, which provides direct delivery of the drug to the brain, greatly reducing systemic exposure and the potential for side effects. ACP-101 has been granted Orphan Drug, Fast Track, and Rare Pediatric Disease designations by the FDA.

About Prader-Willi Syndrome

Prader-Willi syndrome is a rare neurobehavioral genetic disorder that affects both males and females. ¹ Prevalence estimates range from 1 in 15,000 to 1 in 25,000 live births worldwide translating to an estimated 8,000 to 10,000 patients in the United States. ² PWS affects the functioning of the hypothalamus and other aspects of the brain with symptoms varying by individual. ^1,5 The condition is typically characterized by hyperphagia which is an insatiable appetite and lack of satiety, to which a deficiency in oxytocin is believed to be contributory. Oxytocin is a natural hormone that regulates several functions in the body, including hunger, anxiety, social behavior, and bonding. ¹ Individuals living with PWS have fewer neurons that produce oxytocin in the brain. ⁶ Other defining features of the syndrome may include reduced resting energy expenditure, developmental delays and behavioral challenges including anxiety and depression. Patients may also experience bone disorders, high pain tolerance leading to unsuspected issues such as fractures and gastrointestinal issues, respiratory and temperature regulation abnormalities. ^3-5,7 There is no FDA approved treatment for the hyperphagia associated with PWS. ⁵

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. For almost 30 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapies for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Prader-Willi syndrome, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia.com and follow us on LinkedIn and Twitter.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval, and commercialization. For a discussion of these and other factors, please refer to Acadia’s annual report on Form 10-K for the year ended December 31, 2022, as well as Acadia’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

References

¹ Swaab DF, Purba JS, and Hofman MA. Alterations in the hypothalamic paraventricular nucleus and its oxytocin neurons (putative satiety cells) in Prader-Willi syndrome: a study of five cases.” The Journal of Clinical Endocrinology & Metabolism . 1995; 80 (2): 573-579.
² Burd L, Vesely B, Martsolf J, et. al. Prevalence study of Prader-Willi syndrome in North Dakota. Am J Med Genet . 1990; 37: 97-9.
³ Kayadjanian N, Vrana-Diaz C, Bohonowych J, et al. Characteristics and relationship between hyperphagia, anxiety, behavioral challenges and caregiver burden in Prader-Willi syndrome. PloS ONE. 2021; 16 (3): e0248739.
⁴ Einfeld SL, Kavanagh SJ, Smith A, et al. Mortality in Prader-Willi syndrome. Am J Ment Retard . 2006; 111 (3): 193-8.
⁵ Prader-Willi Syndrome Association. What Is Prader-Willi Syndrome? Retrieved from https://www.pwsausa.org/what-is-prader-willi-syndrome/ . Accessed June 1, 2023.
⁶ Miller JL, Tamura R, Butler MG, et al. Oxytocin treatment in children with Prader–Willi syndrome: A double-blind, placebo-controlled, crossover study. Am J Med Genet A . 2017; 173 (5): 1243-1250.
⁷ Butler MG, Theodoro MF, Bittel DC, et al. Energy Expenditure and Physical Activity in Prader–Willi Syndrome. Am J Med Genet A. 2007; 143A (5): 449-459.
⁸ Engstrom T, Barth T, Villhardt M. Oxytocin receptor binding and uterotonic activity of carbetocin and its metabolites following enzymatic degradation. Eur J Pharmacol . 1998; 355 (2-3): 203-210.

View source version on businesswire.com https://www.businesswire.com/news/home/20230613838233/en/

Contacts

Media Contact:
Acadia Pharmaceuticals Inc.
Deb Kazenelson
(818) 395-3043
media@acadia-pharm.com

Investor Contact:
Acadia Pharmaceuticals Inc.
Mark Johnson, CFA
(858) 261-2771
ir@acadia-pharm.com

Source: Acadia Pharmaceuticals Inc.

VERO Biotech’s GENOSYL® Delivery System recognized as a “Technological Breakthrough” at Premier, Inc.’s Annual Supplier Innovation Celebration

Wed, 14 Jun 2023 17:06:00 GMT

Vero will be honored as an “Innovative Supplier” at Premier’s Annual Breakthroughs Conference and Exhibition (BREAKTHROUGHS 2023) taking place June 20-22 in Nashville, TN

June 14, 2023 – Atlanta, GA – VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced that it will be honored during Premier, Inc.’s annual supplier Innovation Celebration at the 2023 Breakthroughs Conference and Exhibition .

VERO Biotech’s GENOSYL® Delivery System (DS) will be recognized as a “Technological Breakthrough.” VERO Biotech ’s GENOSYL® DS – the first tankless nitric oxide delivery system approved by the FDA – will be one of only seven innovations honored during Premier’s supplier Innovation Celebration, which recognizes groundbreaking healthcare technologies that have been launched throughout the year and the ways these products are helping to improve the health of communities.

“We are honored to receive this recognition from Premier. We are deeply committed to continued innovation so that we may better serve patients, respiratory therapists, and healthcare providers.” said Brent V. Furse, CEO and President, VERO Biotech .

Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,400 U.S. hospitals and 250,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, consulting and other services, Premier enables better care and outcomes at a lower cost.

GENOSYL DS is the first tankless inhaled nitric oxide delivery system approved by the U.S. Food and Drug Administration (FDA). Inhaled Nitric Oxide dilates pulmonary blood vessels and may be used to improve oxygenation in neonates with hypoxic respiratory failure and pulmonary hypertension. Unlike tank-based systems, GENOSYL DS generates and delivers iNO at the bedside using a small disposable cassette. This eliminates the need for hospitals to manage large, cumbersome tanks, helps to simplify clinical workflow, and streamlines patient care.

About GENOSYL®

Indication

GENOSYL (nitric oxide) gas, for inhalation, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Important Safety Information

· GENOSYLis contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.

· Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure.

· Methemoglobin levels in the blood increase with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours.

· Methemoglobin, NO2, and PaO2 should be monitored during nitric oxide administration.

· In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema.

· The most common adverse reaction is hypotension.

· Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia.

· GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems or nasal cannulas should be used in conjunction with GENOSYL.

About GENOSYL ® DS

GENOSYL DS is a tankless system engineered with redundant backup features that delivers a constant concentration of inhaled nitric oxide gas to patients with an easy-to-use interface and portability features. This proprietary delivery system eliminates the need for large nitric oxide tanks and the associated logistical burden. GENOSYL DS recently received FDA approval for its innovative dual-cassette design and secondary adaptive sensor technology to further optimize patient care.

About VERO Biotech

VERO Biotech Inc. is a privately held company headquartered in Atlanta, Georgia focused on saving lives, alleviating suffering, and improving health economics in the neonatal intensive care and the acute care hospital communities.

Forward Looking Statements

This press release and any statements of representatives of VERO Biotech Inc. related thereto that are not historical in nature contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, without limitation, statements with respect to VERO Biotech’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “seeks,” “intends,” “plans,” “potential” or similar expressions, including statements with respect to the potential benefits, advantages or market opportunity of the products. These statements are based upon the current beliefs and expectations of VERO Biotech’s management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various risk factors (many of which are beyond the control of VERO Biotech).

For information, please visit www.vero-biotech.com or contact Ziad Mohamed at contactus@vero-biotech.com .

NSF selects 34 semifinalists for the inaugural NSF Regional Innovation Engines competition

Wed, 14 Jun 2023 13:42:00 GMT

June 14, 2023 | https://new.nsf.gov/funding/initiatives/regional-innovation-engines/updates/nsf-selects-34-semifinalists-inaugural-nsf

NSF announces the list of semifinalists to transparently encourage teaming, diversity and regional growth

The U.S. National Science Foundation announced 34 semifinalists for the first-ever NSF Regional Innovation Engines (NSF Engines) competition, spanning nearly all key technology areas and societal and economic challenges highlighted in the “ CHIPS and Science Act .” The NSF Engines will be led by universities, nonprofits, businesses and other organizations from across U.S. states and territories. NSF is releasing the list of semifinalists to transparently encourage teaming among diverse organizations, innovation, and regional growth. View details and a map of the NSF Engines semifinalists on the NSF website.

The NSF Engines program is anticipated to be transformational for the nation, ensuring the U.S. remains globally competitive in key technology areas for decades to come. Each NSF Engine could receive up to $160 million over 10 years; actual amounts will be subject to a given NSF Engine’s status and overall progress, as assessed annually. NSF anticipates announcing the final list of NSF Engines awards this fall, with each awardee initially receiving about $15 million for the first two years.

NSF initially received 188 concept outlines for NSF Engines. Following a proposers’ day and other activities that encouraged teaming, NSF has now completed initial merit review of proposals, narrowing to the 34 semifinalists . During the next stage, NSF will interview each team to assess their proposed leadership’s ability to rapidly mobilize in the first two years; their competitive advantages; and budget and resources for their planned research and development, translation and workforce development efforts. Those selected to move to the final round in July will be interviewed in person to assess risks and committed resources, as well as the team’s ability to adapt to changing circumstances.

Semifinalists not selected to receive an NSF Engine award may be considered for an NSF Engine Development Award of up to $1 million over two years. These planning awards will help teams build their initial ecosystems, cultivate the necessary partnerships and potentially compete for additional funding, including through future NSF Engines competitions. Learn more about the review process by reading the funding opportunity .

Launched by NSF’s new Directorate for Technology, Innovation and Partnerships (TIP) and authorized by the “CHIPS and Science Act,” the NSF Engines program uniquely harnesses the nation’s science and technology research and development enterprise and regional-level resources. NSF Engines aspire to catalyze robust partnerships to positively impact the economy within a geographic region, address societal challenges, advance national competitiveness and create local, high-wage jobs across the country.

More information about the NSF Engines program can be found on the NSF Engines program website .

VIEW THE FINALISTS HERE

AU Health partners with Inflo Health to elevate the radiology follow-up process to optimize the patient experience

Tue, 13 Jun 2023 18:43:00 GMT

CONTACT: Lisa Kaylor, AU Health, 706-755-3160, lkaylor@augusta.edu ; Alicia Laszewski, Inflo Health, 954-683-7189, alicia@yourbrandethos.com

AUGUSTA, Ga. (June 13, 2023) – Augusta University Health (AU Health), a comprehensive primary, specialty, and subspeciality healthcare network based in Augusta, Georgia, that serves as the primary teaching affiliate for the Medical College of Georgia , announced today that they are partnering with Inflo Health , a radiology follow-up solution powered by advanced AI and natural language understanding (NLU). Augusta University Health will leverage Inflo Health’s innovative solution to automate the radiology follow-up process for hundreds of thousands of their radiology patients per year.

According to an American College of Radiology study, 60% of radiology imaging follow-ups never get completed. Inflo Health estimates that their platform allows their customers the ability to recapture at least 80% of these missed follow-ups.

“The radiology follow-up process can be challenging and time intensive, with life-changing consequences,” added John Crossgrove, Director of Radiology Services at AU Health. “Inflo Health is a smart and powerful technology that stood out to us during our search for a partner in this area for a multitude of reasons. The ability to automate and close the communication loop with 100% of our providers and patients in this area, across all modalities, without adding additional staff is transformational in supporting our world-class patient care mission and objectives.”

Inflo Health will support all areas within AU Health’s radiology program, including support to close any gaps within the incidental findings program. According to the ACR, incidental findings are defined as “an incidentally discovered mass or lesion, detected by CT, MRI, or other imaging modality performed for an unrelated reason.” Many different forms of cancers are discovered incidentally, and lifesaving therapies can be prescribed much earlier in the tumor development, leading to better patient outcomes.

Dr. Annette Johnson, AU Health’s Chair of Radiology and Imaging commented, “Complexity within health systems contributes to the reality that communication breakdowns are responsible for the majority of safety events in health care environments. Test results management is a particularly substantial challenge for physicians and other providers, despite their diligence and focused efforts at information management. Breakdowns in communication of test results occur across the spectrum of clinical settings and can result in delayed diagnoses and harm to patients. Our vision in AU Health Radiology is ‘Better imaging for better health.’ By partnering with Inflo Health, we can further this vision by creating automated processes for identification and tracking of imaging findings that require follow-up—so that we can have a failsafe system for providing timely and potentially life-saving testing and treatment to further ensure the delivery of the very best care for our patients. We are thrilled to have selected Inflo Health as our partner on this journey.”

Angela Adams, CEO of Inflo Health, said, “A recent article published by the American College of Radiology (ACR) cited that over 65% of Emergency Physicians and Radiologists report that their health systems do not have a tracking mechanism for incidental findings today. This is a staggering statistic given the importance of timely identification and communication for healthy patient outcomes. Augusta University Health is an innovative health system, and we are proud to partner with them on this mission-critical enhancement to their radiology team and their patients.”

Inflo Health was founded by a revolutionary radiologist, frustrated by an overworked and inefficient healthcare system, who wanted to improve the patient outcomes. As a result, a team of clinical and technical experts came together to develop large language models and NLU to read and understand radiology reports with the goal of automating identification of which patients have recommendations for additional imaging. Inflo Health then automates communication to the care team and to the patients to help ensure the follow-ups are ordered and scheduled. The Inflo Health platform streamlines the management of radiology follow-up recommendations across all imaging modalities.

About Inflo Health: We harness the power of advanced AI, large language models, and NLU to turn radiology follow-up into a stress-free process. Our proven, automated solution streamlines the management of follow-up recommendations across all imaging modalities, so you can ensure no patient falls through the care gap. With our easy-to-use, integrated platform, your team can focus on delivering top-quality patient care, while also mitigating risk, and maximizing staff efficiency.

###

AU Health is Georgia’s only public academic health center, where world-class clinicians are bringing the medicine of tomorrow to patient care today. As the primary teaching affiliate of the Medical College of Georgia, AU Health provides the most comprehensive routine-to-complex care at AU Medical Center, which houses the region’s only Level 1 trauma center, as well as Children’s Hospital of Georgia, Georgia Cancer Center, historic Roosevelt Warm Springs Rehabilitation and Specialty Hospitals, Georgia War Veterans Nursing Home, and more than 100 primary and specialty care clinics across the state.

augusta.edu augustahealth.org

CSBI Releases the 2023 Life Sciences Workforce Trends Report at BIO International Convention

Wed, 07 Jun 2023 20:32:00 GMT

BOSTON, MASS., U.S.A., June 7, 2023/ EINPresswire.com / — The Coalition of State Bioscience Institutes (CSBI) releases the 2023 Life Sciences Workforce Trends Report with TEConomy Partners this week at the 2023 BIO International Convention in Boston. The biennial report provides a national snapshot of the most pressing current and anticipated talent needs of the nation’s dynamic life science industry. This year’s report distills a set of key themes sourced from 185 executive interviews and nearly 700 survey responses from companies in eighteen states and Puerto Rico, as well as an assessment of nearly 2.8M job postings from life science companies over the last four years.

This sixth edition of the Workforce Trends report looks at trends that have gripped the industry in recent years, including: the implications of technology investments and deployment for high-demand occupations and skills; the industry’s continued and maturing emphasis on advancing diversity, equity, and inclusion (DEI); the solidifying of remote and hybrid work arrangements; and the need to evolve and deepen industry-academic partnerships as a cornerstone of targeted talent solutions to meet the industry’s outsized demand.

“The CSBI TEConomy report continues to stay abreast of our booming industry’s evolving talent needs,” said Rachel King, President & CEO of the Biotechnology Innovation Organization. “Its timely data, collected with the help of so many of our state and territorial trade associations and institutes, positions us to collectively work to develop a diverse workforce that will lead innovative discoveries and solutions across the globe.”

As in 2021, this year’s report has been produced in collaboration with and with support from InnovATEBIO, a National Advanced Technology Education Center supporting biotechnology education in community colleges supported by the National Science Foundation. The report will be featured at InnovATEBIO’s upcoming National Summit in June at the National Academy of Sciences: Envisioning the Next Bioscience Workforce: A Summit on Industry Trends and Needs.

“The National Science Foundation is pleased to once again support this important collaboration for addressing the industry’s need for highly skilled technical talent, an area where demand continues to critically outpace supply,” stated Dr. Celeste Carter, Lead Program Director, NSF Advanced Technological Education Program. “Working together, InnovATEBIO and CSBI are helping to facilitate the industry-academic-government collaborations that will drive targeted workforce solutions for the U.S. life sciences industry.”

As the country and globe begin to climb out of COVID and to wrestle with continued economic uncertainty, regulation, and more, the life science industry continues to surge ahead, today employing 2.2 million people and expanding its labor force by a net 169,000 workers since 2020. This strong growth in hiring has played out as the overall economy has rebounded and ramped up, leading to intense competition for talent and subsequent impacts on wage growth, recruitment, retention and baseline hiring criteria.

“Mid-way into 2023, it is even more clear to us that we need to bring together the thought leadership, resources and will of multiple stakeholders if we are going to help the U.S. life science industry develop and groom the talent needed to keep up with its accelerated workforce and economic engine,” said Liisa Bozinovic, CSBI Chair and Executive Director of the Oregon Bioscience Association. “CSBI will be working to facilitate and deepen several ‘ecosystem’ partnerships and resources over the next year to address these common talent challenges.”

Download key findings and full report at www.csbioinstitutes.org .

About the Coalition for State Biotech Institutes (CSBI)
The Coalition for State Biotech Institutes is dedicated to ensuring America’s leadership in bioscience innovation by delivering industry-led life science education and workforce development programs through a nationally coordinated effort. Programs are uniquely positioned for life science industry to deliver, replicable in states across the U.S., extensible to other STEM industry sectors and are fully aligned with emerging K-12 Common Core Learning Standards. Learn more at www.csbioinstitutes.org .

About TEConomy Partners, LLC
TEConomy Partners, LLC is a global leader in research, analysis and strategy for innovation-driven economic development. Today we’re helping nations, states, regions, universities and industries blueprint their future and translate knowledge into prosperity. The principals of TEConomy Partners include the authors of the biennial TEConomy/BIO State Bioscience Development reports, published since 2004. For further information, please visit www.teconomypartners.com .

New Report Explores Latest Best Practices in State Bioscience Economic Development Initiatives

Tue, 06 Jun 2023 19:12:00 GMT

June 6, 2023 | Today, the Biotechnology Innovation Organization (BIO), in partnership with the Council of State Bioscience Associations (CSBA), released a new report on the best practices in state bioscience economic development measures, “ The U.S. Biosciences Industry in the States: Best Practices in Innovation, Partnerships, and Job Creation .”

The report, now in its seventh edition, analyzes the latest legislative and regulatory economic development initiatives at the state and regional level that help support the bioscience sector.

“At every level of government, public policy has a profound impact on the bioscience ecosystem and its ability to innovate and grow,” said Rachel King, President and CEO of BIO. “This report provides an in-depth guide for how state policymakers can help foster a strong bioscience economy, fuel job creation, and drive an innovative economy in their state.”

The report reviews public policy initiatives in all 50 states and spotlights noteworthy programs that enhance the future of the bioscience industry. In addition to several specific state policy examples, the report identified four national trends that helped retain and grow the bioscience sector at the state level in 2023:

“BIO and CSBA’s new report serves as a roadmap for economic development in the biosciences industry, showcasing proven strategies and innovative practices implemented by states across the US,” said John Conrad, Board Vice Chair of CSBA and President and CEO of Illinois Biotechnology Innovation Organization (iBIO). “Illinois, in particular, has made significant strides in implementing economic incentives to drive growth in the state’s bioscience sector, generating high-quality jobs, and fostering an entrepreneurial ecosystem that remains essential to the industry’s future success.”

“This report confirms the vital role U.S. biosciences companies have in creating jobs and stimulating the economy, and illustrates the continuation of the increasingly-supportive role that state and regional policymakers are playing in company retention and expansion in their locations,” said Pete Pellerito, BIO Senior Policy Adviser and principal author of the report.

The full report is available at bio.org/bestpractices .

The report will be discussed at the BIO International Convention during a session on Tuesday, June 6 at 3:00 pm ET. For more information, visit here .

Augusta University Health partners with Inflo Health to improve patient experience through automated radiology follow-up

Mon, 05 Jun 2023 18:18:00 GMT

CONTACT: Lisa Kaylor, AU Health, 706-755-3160, lkaylor@augusta.edu ; Alicia Laszewski, Inflo Health, 954-683-7189, alicia@yourbrandethos.com

AUGUSTA, Ga. (June 5, 2023) – Augusta University Health , a comprehensive primary, specialty, and subspeciality healthcare network based in Augusta, Ga., announced today that they are partnering with Inflo Health , a radiology follow-up solution powered by advanced AI and NLU. AU Health will leverage Inflo Health’s innovative solution to automate the radiology follow-up process for hundreds of thousands of their radiology patients per year.

According to an American College of Radiology study, 60% of radiology imaging follow-ups never get completed. Inflo Health estimates that the platform allows their customers the ability to recapture at least 80% of these missed follow-ups.

“The radiology follow-up process can be challenging and time intensive, with life-changing consequences,” said John Crossgrove, Director of Radiology Services at AU Health. “Inflo Health is a smart and powerful technology that stood out to us during our search for a partner in this area for a multitude of reasons. The ability to automate and close the communication loop with 100% of our providers and patients in this area, across all modalities, without adding additional staff is transformational in supporting our world-class patient care mission and objectives.”

Dr. Annette Johnson , AU Health’s Chair of Radiology and Imaging commented,

“Our mission at AU Health is threefold – patient care, education, and research. By partnering with Inflo Health, we can automate identification, communication, and provide life-saving radiology follow-ups to further ensure the delivery of world-class care to our patients. We are thrilled to have selected Inflo Health as our partner on this journey.”

Inflo Health was founded by a revolutionary radiologist, frustrated by an overworked and inefficient healthcare system, who wanted to improve the patient outcomes. As a result, a team of clinical and technical experts came together to develop large language models and NLU (natural language understanding) to read and understand radiology reports with the goal of automating identification of which patients have recommendations for additional imaging. Inflo Health then automates communication to the care team and to the patients to ensure the follow-ups are ordered and scheduled. The Inflo Health platform streamlines the management of radiology follow-up recommendations across all imaging modalities.

About Inflo Health : We harness the power of advanced AI, large language models, and NLU to turn radiology follow-up into a stress-free process. Our proven, automated solution streamlines the management of follow-up recommendations across all imaging modalities, so you can ensure no patient falls through the care gap. With our easy-to-use, integrated platform, your team can focus on delivering top-quality patient care, while aso mitigating risk, maximizing staff efficiency, and driving revenue growth by recapturing missed follow-ups.

###

augusta.edu augustahealth.org

GeoVax’s Next-Generation COVID-19 Vaccine Shows High Immunogenicity in Immunocompromised Patients

Wed, 24 May 2023 18:00:00 GMT

Atlanta, GA, May 24, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today the presentation of updates on the development of its next-generation SARS-CoV-2 vaccine, GEO-CM04S1, including preliminary data from an ongoing Phase 2 clinical trial, during the Vaccines Summit Boston 2023 and the Congress for the International Society for the Advancement of Cytometry (CYTO) 2023 meetings.

Each of the presentations included unpublished data from the open-label portion of the Phase 2 trial of CM04S1 (ClinicalTrials.gov Identifier: NCT04977024 ) in patients undergoing hematological cancer treatment (i.e., patients who have reduced immune system function as a result of treatment ). The preliminary analysis indicated CM04S1 is highly immunogenic in these patients, inducing both antibody responses, including neutralizing antibodies as well as T cell responses. These data support the planned progression of the Phase 2 clinical study, which includes a direct comparison to currently approved mRNA vaccines.

Kelly McKee, M.D., GeoVax’s Chief Medical Officer, commented, “These data extend to severely immunocompromised patients our earlier findings in healthy adults that GEO-CM04S1 stimulated a robust, durable, and broad-based humoral and cellular immune response against multiple SARS-CoV-2 variants. Validation of these findings in additional patients with hematologic malignancies, who have received CAR-T and stem cell transplants, is underway as we seek to provide a vaccine solution to those individuals unable to mount adequate protective responses with currently available COVID-19 vaccines.”

About GEO-CM04S1

CM04S1 is a next-generation COVID-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to provide protection against the new and continually emerging variants of COVID-19. Based on data from animal models and a completed Phase 1 clinical study, vaccine-induced immune responses were shown to recognize both early and later variants of SARS-CoV-2, including the Omicron variant. Vaccines of this format should not require repeated modification and updating.

CM04S1 continues to advance in two Phase 2 clinical studies, one as a primary vaccine for immunocompromised cancer patients, in direct comparison to either the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04977024 ), and the second as a booster for healthy patients who have previously received either the Pfizer or Moderna vaccine as their initial inoculation (ClinicalTrials.gov Identifier: NCT04639466 ).

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin ^® , presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in two Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a COVID-19 vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient. In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com .

Atlanta medical device company Artelon to move into new office after capital infusion

Wed, 24 May 2023 17:43:00 GMT

May 24, 2023, 07:24am EDTMarietta-based medical device company Artelon has secured $20 million in Series B funding to support the commercial growth of its proprietary bio-textile for surgical repair of ankles and other joints.

Venture capital firm Vensana led the round of financing for Artelon’s soft-tissue reconstruction material. Artelon expects additional funding from existing investors.

SUBSCRIPTION ACCESS ONLY: https://www.bizjournals.com/atlanta/inno/stories/fundings/2023/05/24/atlanta-medical-device-company-artelon-raises-20m.html

Boston Scientific signs Atlanta’s largest lease of 2023 at former State Farm campus

Wed, 24 May 2023 17:35:00 GMT

May 23, 2023 | Atlanta Business Chronicle: The deal is the latest development in growing the presence of life sciences companies in and around Atlanta.

Subscription Required: https://www.bizjournals.com/atlanta/news/2023/05/23/boston-scientific-deal-johns-creek.html

TCSG selected for National Science Foundation grants

Mon, 22 May 2023 17:46:00 GMT

May 22, 2023 | The Technical College System of Georgia (TCSG) is proud to announce its selection as the workforce partner for three U.S. National Science Foundation (NSF) Regional Innovation Engine grants in Georgia. These grants represent significant milestones in advancing cutting-edge research and innovation in key sectors, and TCSG is honored to be at the forefront of these transformative initiatives.

“These NSF Regional Innovation Engine grants underscore the Technical College System of Georgia’s commitment to driving innovation and economic growth within the state,” said TCSG Commissioner, Greg Dozier. “As the chosen workforce partner for these transformative projects, we are excited to play a vital role in shaping the future of agriculture, healthcare, and cybersecurity. TCSG’s extensive network of colleges is uniquely positioned to deliver industry-relevant training and prepare a skilled workforce that will contribute to the success of these initiatives.”

The first grant, awarded to support the Next Generation Agriculture project , marks a groundbreaking collaboration under the academic leadership of the University of Georgia and Fort Valley State University. This joint effort aims to propel Georgia farmers towards the “Ag 4.0” revolution. By leveraging the latest advancements in technology and data analytics, the project seeks to revolutionize agricultural practices and equip farmers with the tools they need to thrive in the modern era. By leveraging its extensive network of technical colleges and industry connections, TCSG will provide targeted workforce training and support services tailored to the specific needs of farmers in the region. Through this collaboration, TCSG will contribute to the overall success of NextGA by equipping farmers with the skills and knowledge required to thrive in the evolving landscape of agriculture.

The second grant, titled Advancing Health Equity and Diagnostic Technologies (GA) Development, will focus on creating an innovative ecosystem to advance health equity throughout the southeast. This project, which includes Georgia Tech, Emory University, Morehouse School of Medicine, University of Georgia, and the Center for Global Health Innovation, aims to bridge the gap in healthcare accessibility. TCSG’s role as the workforce partner will be instrumental in training a skilled healthcare workforce equipped to leverage these innovative technologies for the betterment of the region’s population.

The third grant, titled Advancing Cybersecurity Technologies in the Central Savannah River Area, solidifies Augusta Technical College’s position as the workforce partner. This initiative, being led by Augusta University, recognizes the critical need to bolster cybersecurity measures in an increasingly digitized world. Augusta Technical College will spearhead efforts to develop and implement cutting-edge cybersecurity solutions. The college’s expertise and dedication to producing highly skilled cybersecurity professionals will be pivotal in fortifying the region’s defenses against cyber threats.

Through its involvement as the workforce partner, TCSG will leverage its vast resources and expertise to support these initiatives, ensuring the availability of a highly skilled workforce that meets the evolving demands of each sector. By aligning education with industry needs, TCSG will help drive economic development, innovation, and job creation across Georgia.

To learn more about the NSF Engines Development Awards, visit their website here .

For more information about the Technical College System of Georgia, please visit www.TCSG.edu

Source: https://valdostatoday.com/news-2/region/2023/05/tcsg-selected-for-national-science-foundation-grants/

Micron Biomedical Announces Positive Measles and Rubella Vaccination Results from First Clinical Trial of Microarray Injection-Free Vaccine Delivery in Children

Wed, 17 May 2023 19:52:00 GMT

ATLANTA, May 17, 2023 /PRNewswire/ — Micron Biomedical, a life science company developing first-in-class dissolvable microarray-based products that simplify and improve the administration, transport, and storage of drugs and vaccines, today announced positive Phase 1/2 data from the first-ever clinical trial of microarray technology in children including infants as young as 9 months old.

The study, which evaluated the safety, immunogenicity, and acceptability of the leading commercially available measles-rubella (MR) vaccine from the Serum Institute of India delivered by Micron’s microarray technology in adults, toddlers and infants, was presented today at the MICRONEEDLES 2023 conference in Seattle, Washington.

“Micron, with support from the Bill & Melinda Gates Foundation and the CDC, is thrilled to accomplish a major milestone in the future of injection-free administration of necessary and potentially life-saving vaccines and therapeutics,” said Steven Damon, CEO of Micron Biomedical. “With this completed Phase 1/2 clinical trial in children, in addition to other completed and ongoing Phase 1 and Phase 2 clinical trials, Micron remains at the forefront of the effort to bring microarray-based drug and vaccine products to market.”

In many low- and middle-income countries (LMICs), the MR vaccine coverage rate remains well below the threshold recommended by the World Health Organization (WHO) to sustain disease elimination. Micron’s dissolvable microarray technology, in which vaccines are embedded, is designed to overcome critical logistical vaccination challenges that exist in LMICs and to increase access to life-saving vaccines.

“These are exciting results which show, for the first time, the potential for microarray patches to safely and effectively deliver vaccines to children,” added Ed Clarke, FRCPCH, PhD, Head of Infant Immunology at Medical Research Council, The Gambia (MRCG).

Funded via a grant from the Bill & Melinda Gates Foundation, the study was conducted at the Medical Research Council Unit in The Gambia (“MRCG”), part of the London School of Hygiene and Tropical Medicine (“LSHTM”), under the leadership of Dr. Clarke.

Study Details
In the trial, 45 adults, 120 toddlers (15-18 months old) and 120 infants (9-10 months old) were enrolled in an age de-escalation fashion and randomized to receive MR vaccine either by Micron’s microarray or by subcutaneous (SC) injection.

Vaccination by microarray was safe and well tolerated with no allergic reactions or related serious adverse events. Day-42 immunogenicity showed high and similar seroprotection rates for measles and rubella in all cohorts for both the microarray (93.2% – 100%) and SC injection (89.8% – 100%) groups and in infants who were MR-vaccine naïve at the start of the trial, seroconversion rates were high and similar for both the microarray (92.9% -100%) and SC injection groups (89.7%-100%). Over 90% of the parents of toddlers and infants enrolled in the trial who took part in an acceptability survey said that the microarray technology would be better than SC injection to give vaccines to children.

The technology aims to significantly simplify the transport, storage and administration of vaccines that are traditionally delivered via injection and eliminates sharps waste.

“Supporting innovations in vaccine delivery is critical to addressing ongoing health inequities,” said James Goodson, Senior Scientist and Epidemiologist in the Global Immunization Division at the Centers for Disease Control and Prevention (CDC), and co-investigator for the study. “This clinical trial is an important step forward in the critical development pathway for the MR microarray patch toward licensure, and a major contribution that may help shape future approaches to reaching children and families with life-saving vaccines around the world.”

About Micron Biomedical
Micron Biomedical is the leader in the field of dissolvable microarray-based, drug and vaccine administration technology. Micron Biomedical is a clinical stage life science company on a rapid path to commercializing its proprietary applicator-free, dissolvable, microarray technology. Micron’s technology is designed to improve access and achieve better health outcomes globally through injection free, painless, and simple and/or self-administration of drugs and vaccines, and by eliminating or reducing the need for cold chain transport and storage, enhancing safety and efficacy, and improving patient compliance. Micron partners with and/or receives funding from private and public pharmaceutical and biotech companies, the Bill & Melinda Gates Foundation, the Centers for Disease Control and Prevention (CDC)*, UNICEF, PATH and the Georgia Research Alliance.
For more information visit www.micronbiomedical.com

*Involvement of the Department of Health and Human Services or the Centers for Disease Control and Prevention does not serve as an actual or implied endorsement of the general policies, activities, or products of Micron Biomedical.

Media Inquiries:
Micron Biomedical, Inc
Public Relations
pr@micronbiomedical.com

SOURCE Micron Biomedical, Inc.

Wellstar Health System and Augusta University Health System Announce Definitive Agreement for Statewide Partnership

Fri, 31 Mar 2023 17:35:00 GMT

On March 31, 2023, Wellstar Health System and Augusta University Health System (AUHS), with approval from both organizations’ boards, reached an agreement to form an innovative, new partnership that will create a broader affiliation with the university’s Medical College of Georgia (MCG).

Wellstar, AUHS and MCG share a mission to solve health care challenges across the state, and together, they will drive significant advances in clinical care, academic teaching and research in Georgia. By combining the best of community health care and academic medicine, the organizations will make a transformational impact on improving the health and wellbeing of each patient they serve – creating a healthier future for Georgia.

To accomplish this, the partnership will focus on five key areas:

Most of the day-to-day operations will stay the same, and patients will continue to access care as they currently do. The organizations are excited for the benefits this partnership will provide and are confident about the opportunity to transform health care through a better patient experience, more accessible care and better value.

For more information, read the full announcement here .

Silicon Valley Bank and Georgia Biotechs

Mon, 13 Mar 2023 21:12:00 GMT

Dear Members,

The failure of Silicon Valley Bank (SVB) Friday has been a major shock to life sciences companies and the whole ecosystem in Georgia and across the United States. As the second largest bank failure in U.S. history, we know a number of CGHI: Georgia Bio’s member companies are directly affected by this concerning situation. Since Friday, CGHI: Georgia Bio has been monitoring the situation and is in contact with state and federal policymakers.

What We Know

This is an uncertain and evolving situation.

Early Sunday, Treasury Secretary Janet Yellen said there would be no federal bailout. However, later in the day Yellen, Federal Reserve Chair Jerome Powell, and Federal Deposit Insurance Corporation (FDIC) Chairman Martin Gruenberg issued a joint statement making clear that depositors will have access to all of their money today from SVB, not just the FDIC-insured limit of $250,000. The Federal Reserve will create a new Bank Term Funding Program (BTFP) to support liquidity. The statement also said that none of the costs of the intervention will be on customers or taxpayers, rather, losses to the Deposit Insurance Fund will be recouped by a special assessment on banks. Shareholders and unsecured debt holders will not be protected.

SVB senior management has been removed, and the Federal Reserve added it will make additional funding to eligible depository institutions to help assure they can meet depositor needs.

You can find reactions from House Financial Services Committee Chairman McHenry (R-NC) here , Senate Banking Committee Ranking Member Scott (R-SC) here , and a joint statement from Senate Banking Committee Chair Brown (D-OH) and House Financial Services Committee Ranking Member Waters (D-CA) here .

President Biden addressed the SVB collapse this morning.

The Treasury Department and the Federal Deposit Insurance Corp.’s top priority is to engineer a sale of the bank. House Speaker Kevin McCarthy (R-CA) said that he thinks it is “very possible” to find a buyer for SVB, which he believes would be the “best outcome to move forward and cool the markets.”

BIO’s Take

“The ecosystem that allows America to develop groundbreaking new medicines is extremely important to our nation and to patients who depend on biotechnology companies,” said Rachel King, BIO’s CEO, in a written statement. “The recent actions by the FDIC, the Federal Reserve, and Treasury to allow SVB depositors to have access to all of their money is a very positive development to mitigate the potential harm to companies that are innovating across healthcare, agriculture, and the bioeconomy. We will continue to monitor the situation and will work closely with regulators to ensure that companies can meet payroll and continue to fund cutting-edge science and the development of treatments and therapies that patients are relying on.”

What’s Next?

CGHI: Georgia Bio is continuing to monitor the situation and if a deal is brokered for the sale of the bank. Treasury and the FDIC seem to have stabilized the situation now. We don’t expect quick legislative action from Congress, though there will likely be congressional hearings around the collapse in the future. We do want to note that this Thursday, Secretary Yellen will appear before the Senate Finance Committee at a previously scheduled hearing .

We’ll issue more bulletins as information becomes available.

Maria Thacker Goethe

Chief Executive Officer

Center for Global Health Innovation

Catch up quick: After the collapse of Silicon Valley Bank (SVB) Friday, the U.S. Treasury, Federal Reserve, and Federal Deposit Insurance Corporation (FDIC) stepped in to fully protect all depositors and ensure they have access to all of their money starting today, March 13.

Where to read more: Bloomberg has a comprehensive live blog of recent events, while STAT News has a deep dive into the impact on the biotech industry .

Why it matters to biotech: “Nearly half of all U.S. venture-backed technology and life science companies bank with SVB—the 16th largest bank in the country—with a total of $342 billion in client funds and $74 billion in total loans,” explains Fierce Biotech .

GeoVax Receives Notice of Allowance for Zika Vaccine Patent

Thu, 26 Jan 2023 16:58:00 GMT

ATLANTA, GA, Jan. 25, 2023 (GLOBE NEWSWIRE) — via NewMediaWire — GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today that the U.S. Patent and Trademark Office issued a Notice of Allowance for Patent Application No. 17/000,768 titled, “ Method for Generating a ZIKV Immune Response Utilizing a Recombinant Modified Vaccinia Ankara Vector Encoding the NS1 Protein .”

Read the full press release here.

A Patients Perspective of Clinical Trial Benefits

Fri, 19 Aug 2022 20:17:00 GMT

Dorothy Leone-Glasser, RN, HHC, CEO Advocates for Responsible Care,

Chair Ga Bio Patient Advocacy Alliance

Clinical trials are essential for the development of new treatments for chronic illness patients. Every new medicine and treatment started with volunteers participating in clinical trials. Our current high standards of medical care and newly discovered therapies have improved the lives of so many patients with chronic, incurable illness. In addition to testing new drugs and devices, clinical trials provide a scientific basis for advising and treating patients.

Being diagnosed with an incurable disease at 19 years, I have always participated in clinical trials. Yes, the larger view of clinical trials research is designed to yield scientific knowledge for future patients that improves their health outcome. For me, the decision to take part in trials was a necessity to stay alive. Having serious complications to my Systemic Lupus, medicine was still in the dark as to effective treatment to stop the progression of the disease. I was involved in clinical trials from Plasmapheresis, nutrition and lifestyle changes to drugs used for other diseases. When I was an adult, needing to obtain my own medical insurance, prior to the ACA, I was unable to get insured because of my poor risk rating due to heart attack, stroke, kidney failure and seizures; all related to my disease. With my next diagnosis of cancer at age 30 then another cancer diagnosis five years later, I was once again looking for clinical trials. I was fortunate to know caring physician colleagues who assisted me in my quest. Physicians play a key role in referrals to clinical trials. Being well-prepared to answer common questions will help clinicians guide their patients and family members through the decision process.

I did my research to understand the risks and benefits of each trial, knowing that rules are in place to protect human research subjects and all studies involving humans are reviewed locally to ensure that subjects are treated safely, fairly, and confidentially. Nevertheless, each patient should consider for themselves whether participation in a trial is safe for them and consistent with their values. Every patient must be comfortable to ask the research team any questions they have and to voice their concerns throughout the trial period. Patients must understand that there are risks in clinical trials, such as possible side effects resulting from the treatment and they should be aware that the treatment may not be effective for the participant. Participating in a trial also takes a greater commitment of your time and attention than standard treatment.

The accepted view had been, patients should not misunderstand clinical trials as a substitute for medical care. However, without insurance, I saw the clinical trial as a way to obtain expert medical care at a leading health care institution. The rigorous oversight during the trials helped to empower me to be my best healthcare advocate, keep me on track with my self-care and opened the door to other resources that enabled me to continue my education and career goals even while wheelchair bound.

Clinical trials provide research that helps patients be full participants in their illness, regardless of the trial outcome. Well-designed and executed clinical trials provide an opportunity for participants to:

Participating in clinical trials throughout my illness journey has extended my life, empowering me to have a successful career as a Nurse Specialist, Chronic Illness Counselor and Health Advocacy organizer. They provided an opportunity to understand the complexities of my diseases, to have my voice heard as an involved patient, to ease the stress for my concerned caregivers and to play a role in helping other patients sharing the same illness struggles.

Clinical trials are essential for the development of new treatments. Whether or not to participate in a clinical trial is a personal decision. Each patient and each clinical trial is different. When considering a clinical trial, you must commit to being an active participant; gathering as much information as possible, coordinating with your physician and medical team and then doing what you feel is best for you. Those who decide to volunteer may be contributing directly to our understanding of diseases and how to treat them.

Panelists

Michelle Kimberly Clark

Breast Cancer Survivor, Clinical Trials Patient Participant

In May of 2013, while exercising Michelle felt a small mass on her left breast. In 2015, she met Andre (her husband), starting her life as a young, vibrant, African American woman. They moved to Atlanta and as Michelle states, she was “on her way to living every girl’s dream of love, marriage, and then the baby in the baby carriage!” While showering she noticed that after two years the lump was still in her breast. She scheduled her annual physical, and unfortunately was told by her doctor not to worry about the lump; “You’re too young,” the doctor exclaimed!

In 2019 Michelle sought a second opinion by a new doctor who scheduled her for a mammogram and ultrasound. The COVID-19 pandemic hit and stalled her appointment for what has already been a long and unsettling process. In August 31, 2021, after completing a mammogram and ultrasound., at just 36 years old, Michelle was diagnosed with breast cancer in her left breast with a suspicious area on her right breast.

Michelle made the difficult decision to have double mastectomy surgery. On November 2, 2021, she froze seven (7) embryos and on January 2022 she entered a clinical trial, completing four rounds of intense chemotherapy. A component of her trial included the research team tracking neuropathy in African American women under treatment using the drug Taxane (docetaxel).

Michelle admits she was hesitant to participate in the clinical trial at first, because of the uncertainty and having a bit of selfishness for her own health. However, after voicing her concerns to her doctor and an amazing research nurse, she felt comfortable with being a part of a clinical trial that would allow her to discuss the effects of the treatment. Oftentimes, patients dealing with serious illness hear the words “clinical trial” and they feel reluctant to move forward. Michelle felt reassured this trial allowed her to feel confident in knowing that her experience would benefit more black women undergoing treatment for breast cancer in the future. From her participation in this trial, her research nurse, later became a part of her support group. Michelle believes that clinical trials are important because they allow medications and treatments to be effectively targeted for African American women.

Dr. Del Smith

CEO, Acclinate

Dr. Del Smith is passionate about using business principles to address health inequities that have long plagued communities of color. He is the co-founder and CEO of Acclinate, a growing digital health company on a mission to improve health equity through inclusive research. Del’s career spans healthcare, IT, government, and higher education. He earned his Ph.D. In Management from the University of Alabama and spent seven years as an HBCU business school dean prior to co-founding Acclinate.  

Jessica Williams, MD, MPH

Assistant Professor of Medicine; Division of Rheumatology; Emory University School of Medicine; Director, Lupus Patient Navigator Program Grady Lupus Clinic

Jessica Williams, M.D, M.P.H is an Assistant Professor of Medicine in the Division of Rheumatology at Emory University School of Medicine. Dr. Williams is a graduate of Emory University School of Medicine (MD, 2015), Emory University Rollins School of Public Health (MPH in Epidemiology, 2015), Harvard/Brigham and Women’s Hospital Internal Medicine Residency (2018), and Harvard/Brigham and Women’s Hospital Rheumatology Fellowship (2021). She is passionate about clinical research to advance care for patients living with lupus, with a focus on diverse and underserved patient populations. Her research to date has resulted in twenty-four publications and two oral presentations at the American College of Rheumatology annual meetings. Her recent first-author publications have focused on increasing diversity in lupus clinical trials, racial disparities in contraception care among reproductive age-women with lupus, and use of an integrated care management program to uncover social determinants of health needs among patients with lupus. Dr. Williams is also a practicing rheumatologist at Grady Memorial Hospital in Atlanta, Georgia, where she supervises Emory rheumatology fellows in both the clinic and inpatient consult setting.

Dr. Williams was recently awarded a grant from the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program to study clinical trial perceptions and barriers among a large, population-based, predominantly Black cohort of patients with lupus and to implement the Phase III REGENCY clinical trial for lupus nephritis in a predominantly Black, safety-net clinic setting. She has also received research awards from the Rheumatology Research Foundation and the American Society of Hematology, as well as a Health Equity Innovation Program research grant from the Brigham and Women’s Hospital Department of Medicine to implement a nurse-led pilot clinical trial to reduce acute care utilization and improve preventive care among high-risk patients with lupus. Her other current projects include implementation of a lupus patient navigator program in the Grady Lupus Clinic, development of a lupus cohort in rural Georgia, exploring risk factors for suicidality among patients with lupus, and exploring social determinant of health risk factors for recurrent acute care use among patients with lupus.

The post A Patients Perspective of Clinical Trial Benefits appeared first on Georgia Bio .

The Value of Support Groups

Fri, 19 Aug 2022 19:59:00 GMT

Dorothy Leone-Glasser, RN, HHC, CEO Advocates for Responsible Care,

Chair Georgia Bio Patient Advocacy Alliance

When I was diagnosed with systemic lupus erythematosus at 19 years, I discovered a major void in the treatment of chronic illness –support counseling to help patients understand and cope with the challenges of their disease. To bridge this gap in my own practice as a Nurse Specialist, I took a 3-year internship in Chronic Illness Counseling at Columbia University, NYC. I was determined to fill that void so I created, a national award winning, Coping with Chronic Illness Project. The major component was providing support groups for those with chronic and terminal illness and their caregivers. The groups offered information and practical life-style engineering methods to address the physical and psychological aspects of illness, coping methods, pain and stress management strategies and communication and relationship skills with navigation approaches to our complex healthcare system.

Today we are partnering with GA Bio-Center for Global Health Innovation (CGHI) to focus on the science of patient input for medical research and development with consideration of downstream regulatory and legislative policy decision making. In doing so, we can explore gaps in knowledge and other barriers that impede progress, and discuss the value of patient input for research that addresses gaps and barriers that could help move the patient and Bio community forward.

Survey

To understand the value of support groups on our patient community, Rx in Reach and CGHI launched a digital campaign to collect survey responses from Georgians about chronic illness support groups through Facebook Ads.

The survey generated 157 responses with 49% of all responders saying they belonged to a chronic illness support group. Although, 45% of all responders said they don’t belong to a support group for chronic illness; 63% of all responders said they would like to join a support group.

Other interesting findings from our survey were:

Our findings show there is a strong stigma associated with seeking help from a support group. Support group members believe the public does not understand the need to connect with others who understand their daily challenges of living with chronic illness. Professional facilitated support groups offer a safe, non-judging environment for people to gain valuable information about disease processes, managing illness symptoms and healthcare system barriers while providing worthwhile life-style engineering to better cope with the rollercoaster of emotions and daily living complications. Survey responders, 20%, stated, their support group experience helped them, especially to feel less isolated and 15% of responders stated their group offered them the opportunity to gain new friends who understand their illness journey.

Summary

We know there are many with chronic illness, their caregivers, family members and friends who would want the chance to join a support group. This presents an opportunity for us to extend our outreach to those who are facing illness feeling alone and misunderstood so we can ensure their voices are heard with aid and encouragement offered to help them live their best life despite being ill. The work of this Patient Advocacy Alliance will continue to bring together our Bio community, patient support group members, advocate and medical organizations to improve health equity throughout our healthcare delivery system and clinical trials, while sharing strategy and actions that address important health policy issues.

Panelists

Kelly Barta

Coalition of Skin Diseases, President

After experiencing a prolonged and severe health crisis due to long-term use of topical steroids for eczema, Kelly became a passionate voice for those who were suffering. She was determined to bring change to the way eczema was understood and treated. Her advocacy efforts have led her to serve on several national dermatology nonprofits, bringing awareness to the great needs of this community and supporting those living with eczema and going through topical steroid withdrawal syndrome.

Kelly currently serves as President and CEO of the Coalition of Skin Diseases, an umbrella organization of more than 25 national skin-related patient groups, which exists to raise awareness of skin diseases and advocate for the 84+ million Americans living with skin conditions.

She has served as past president of the International Topical Steroid Awareness Network (ITSAN), and continues to support their mission as member of the Board of Directors. Additionally, Kelly sits on the Patient Advocacy Task Force of the American Academy of Dermatology and the Atopic Dermatitis Advisory Panel for Globalskin. She has presented on eczema and TSW to the FDA as well as before patient, academic and political audiences. Kelly is the recent author of her story, To Eczema With Love, https://toeczemawithlove.com/ .

Kelly resides in Atlanta, Georgia with her two sons and enjoys taking in the great outdoors, whether it be the mountains, oceans, a walk in the woods or digging in her own garden.

Barbara Fleeman

WomenHeart Champion; Support Group Facilitator

Barbara grew up in Atlanta and moved back 6 years ago after spending 40 years building a successful career in entertainment consumer marketing/promotion. She was always very active in her personal and professional life. In 2013 she was diagnosed with severe pericarditis. Over the following 18 months. She continued to experience increasingly difficult episodes of shortness of breath, chest pain, fatigue, nausea, dizziness, and chest pressure. She went to see several doctors and was told that there was nothing wrong with her heart, even though she told them “My heart hurts”. She continued to become sicker. After a long course of indecision by medical professionals, she found help and a correct diagnosis of INOCA and Coronary Microvascular Dysfunction at the Barbra Streisand Women’s Heart Center at Cedars Sinai Medical Center in Los Angeles.

In 2015 she was invited to attend the WomenHeart Science and Leadership Symposium at the Mayo Clinic in Rochester, MN. After an intensive five-day event, she was trained to become a WomenHeart Champion. Barbara continues to share her experience with women to help educate them to the unique signs & symptoms of women’s heart disease, as well as, provide patient advocate support to women who are living with or at risk of heart disease.

J. Christopher Reed

Lupus Foundation of America-Georgia

Support Group Facilitator, Advocacy Chair

Christopher was diagnosed with lupus in 1990 at the age of 16. Lupus attacked his heart, lungs, kidneys, digestive system, veins, and nervous system. Christopher’s lupus journey began with chronic headaches and frequent muscle spasms then progressed to frequent fevers, arthritis, and tremendous weight loss. He was barely able wrap his hands around the steering wheels during driver’s ed class and walking up the stairwell to his bedroom felt like he was having a heart attack. In 2004, he developed stage 3 kidney disease. With his first job out of law school, Christopher was juggling kidney disease and horrible chemotherapy treatments. In 2018, he almost lost his life due to septic shock.

Overtime, Christopher continued to suffer from severe organ involvement. He was constantly worried about a lack of insurance and the cost of his life-saving medication.

Despite these serious lupus attacks, and moving back to his parent’s home, Christopher earned a bachelor’s degree with honors from the Georgia State University and a law degree from Tulane University. He attributes his success to God, the support of family and the support received at an early age from the Lupus Foundation of America, Georgia Chapter (LFAGA).

In speaking with Christopher, one can tell he is an avid advocate passionate about tackling healthcare policy and increasing lupus research. He previously chaired the Georgia Council on Lupus Education and Awareness (Council), a sponsored entity created by the state legislature to improve the lives of Georgians living with lupus. He has worked to establish the Georgia Lupus Collaborative, an advisory group and think tank charged with improving the lives of people with lupus in Georgia.

Christopher currently serves as a Support Group Facilitator, Advocacy Chair, and Project Manager for the Lupus Foundation of America-Georgia Chapter . His support group is specifically designed for men. As Advocacy Chair, he gives presentations on patient advocacy and public health policy as well as being a writer on Lupus. Each year, over a one hundred lupus advocates engage in Lupus Day at the Georgia State Capitol. He remains involved in Health Research and serves to increase African American participation in clinical trials through a series of education sessions, open discussion, and dialogues with African American physicians and African American researchers.

Christopher has been honored to be a recipient of several awards including the Mary Cann Achievement Award from the Lupus Foundation of America, Georgia Chapter.

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Michelle Kimberly Clark’s Story

Fri, 19 Aug 2022 19:42:00 GMT

Michelle Kimberly Clark

Breast Cancer Survivor, Clinical Trials Patient Participant

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Kelly Barta’s Story

Fri, 19 Aug 2022 19:40:00 GMT

Kelly Barta
Coalition of Skin Diseases, President

She has served as past president of the International Topical Steroid Awareness Network (ITSAN), and continues to support their mission as member of the Board of Directors. Additionally, Kelly sits on the Patient Advocacy Task Force of the American Academy of Dermatology and the Atopic Dermatitis Advisory Panel for Globalskin. She has presented on eczema and TSW to the FDA as well as before patient, academic and political audiences. Kelly is the recent author of her story, To Eczema With Love, https://toeczemawithlove.com/.

Kelly resides in Atlanta, Georgia with her two sons and enjoys taking in the great outdoors, whether it be the mountains, oceans, a walk in the woods or digging in her own garden.

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Christopher Reed’s Story

Fri, 19 Aug 2022 19:31:00 GMT

J. Christopher Reed

Lupus Foundation of America-Georgia

Support Group Facilitator, Advocacy Chair

Overtime, Christopher continued to suffer from severe organ involvement. He was constantly worried about a lack of insurance and the cost of his life-saving medication.

Christopher has been honored to be a recipient of several awards including the Mary Cann Achievement Award from the Lupus Foundation of America, Georgia Chapter.

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Barbara Fleeman’s Story

Fri, 19 Aug 2022 19:28:00 GMT

Barbara Fleeman

WomenHeart Champion; Support Group Facilitator

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BioMarin Pharmaceutical commemorates 5 years of helping children with fatal rare disease

Fri, 29 Apr 2022 13:20:00 GMT

CLN2 Batten disease is a rare, inherited, fatal disorder that primarily affects the nervous system as a result of a failure to produce enough of the enzyme TPP1. The signs and symptoms of this condition typically start between the ages of 2 and 4, featuring recurrent seizures and coordination difficulty.

BioMarin Pharmaceutical in San Rafael developed a drug called Brineura five years ago that reduces the rate of decline in children afflicted with this batten disease, which is fatal, hereditary and comes in 13 types. The disorder impacts the body’s ability to get rid of cellular waste. The buildup on the cells causes the symptoms such as seizures, vision loss and problems with movement.

Read the full article here

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Saol Therapeutics and InformedDNA Partner to Offer Genetic Counseling to Patients with Rare Mitochondrial Disease

Thu, 28 Apr 2022 20:15:00 GMT

Program Discusses Access to a Pivotal Phase 3 Trial of Dichloroacetate in Pyruvate Dehydrogenase Complex Deficiency (DCA/PDCD trial; NCT02616484)

Saol Therapeutics, a company researching new treatments for rare diseases, is pleased to announce a partnership with InformedDNA®, the nation’s leading applied genomics solutions company, to offer genetic counseling for the families of individuals with a rare mitochondrial disease, Pyruvate Dehydrogenase Complex Deficiency (PDCD). The counseling will also review potential participation in a Phase 3 clinical trial. PDCD affects less than 300 children in the United States annually and lacks any FDA-approved treatment.

InformedDNA’s board-certified genetic counselors are highly knowledgeable about inherited metabolic disorders and can answer questions and review eligibility to enable individuals to make more informed decisions about clinical trial participation. After speaking with a genetic counselor, families interested in learning more about the clinical research study will be connected with a trial site.

This pivotal phase 3 trial administers the investigational drug dichloroacetate (DCA) to children who have a deficiency of the pyruvate dehydrogenase complex (PDC). PDC deficiency is the most common cause of congenital lactic acidosis and is frequently fatal. DCA has Orphan Product designation from the FDA for congenital lactic acidosis (CLA), including patients with PDCD. (ClinicalTrials.gov link: Trial of DCA in Pyruvate Dehydrogenase Complex Deficiency)

Some of the questions and topics addressed during the genetic counseling appointment include:

Dr. Peter Stacpoole, Principal Investigator of the DCA/PDCD trial and Prof. of Medicine at the University of Florida, notes that “There are currently no FDA-approved treatments for patients with PDCD. This service allows them to make an informed decision about clinical trial participation, which is critical to advancing treatment options for rare diseases.”

Dave Penake, CEO of Saol Therapeutics, is pleased to partner with InformedDNA to provide this valuable service. “Individualized genetic counseling offers families the insights needed to better understand PDCD and to determine if participation in this clinical trial makes sense. Completing the trial and having a potential FDA-approved treatment for PDCD will be a huge milestone for Saol and the families that have participated in the study.”

“Like many rare genetic diseases, PDCD is a severe disease with no proven therapies. Many affected patients do not survive childhood. We are thrilled that Saol Therapeutics is investing in this rare disease, and we are passionate about leveraging InformedDNA’s highly effective virtual screening process to engage and connect appropriate patients to the clinical trial and advance therapeutic progress in this devastating disease,” said Karmen Trzupek, Director of Clinical Trial Services at InformedDNA. Healthcare providers and caregivers for children with Pyruvate Dehydrogenase Complex Deficiency (PDCD) may request a genetic counseling appointment by visiting www.InformedDNA/Saol.

About Saol Therapeutics

Saol Therapeutics (pronounced “Sail”) is a privately held, biopharmaceutical company with operations in Roswell, GA, Dublin, Ireland and Hamilton, Bermuda. Saol is focused on clinical development activity in rare diseases, with a focus on mitochondrial disorders, as well as central nervous system disorders such as spasticity and pain management. Saol is one of the collaborators on a Phase 3 trial studying the first potential treatment for pyruvate dehydrogenase complex deficiency (PDCD). More information on the clinical trial can be found at Phase 3 PDCD Trial. More information about Saol can be found at https://saolrx.com/.

About InformedDNA

InformedDNA is the country’s leading applied genomics solutions company, helping harness the full power of precision medicine. With the largest independent staff of board-certified genetics specialists in the U.S., InformedDNA ensures that health organizations have access to the highest quality, most current genomics insights to optimize clinical decisions. Our solutions, which cover evidence-based guideline development, patient experience management, and value management, have helped optimize the health benefits of more than 135 million covered lives and have navigated hundreds of thousands of people to the right treatments or clinical trials. For more information, visit www.InformedDNA.com.

Clinical Trial Contact:

Kathy Dorsey, Director of Clinical Operations, Saol Therapeutics, KDorsey@Saolrx.com

Media Contacts:

Brian Nappi, Senior Vice President Strategy, Saol Therapeutics, bnappi@saolrx.com

Megan Smith, MERGE for InformedDNA, msmith@mergeworld.com, 404-408-3379

SOURCE Saol Therapeutics

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Georgia Bio Names South Forsyth High School Junior as 2022 Georgia BioGENEius Winner

Thu, 14 Apr 2022 14:31:00 GMT

Mokshith Mannuru Advances to International Competition Against Top Students

Georgia Bio and the BioEd Institute named Mokshith Mannuru , a junior at South Forsyth High School in Cumming, GA, as the winner of the 2022 Georgia BioGENEius Challenge. The BioGENEius Challenge is the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. As Georgia’s BioGENEius finalist, Mokshith will attend the 2022 International BioGENEius competition, which will be held during the 2022 BIO International Convention, the industry’s trade conference from June 13-16 in San Diego, CA. There he will engage with leading companies, scientists and innovators currently transforming the scientific landscape and gain valuable insights into an industry making significant contributions to the world.

While in San Diego, Mokshith will compete against high school students from the U.S., Canada, and Germany in the International BioGENEius Challenge. The student projects will represent a range of biotechnology topics such as healthcare, agriculture, and the environment.

Mokshith’s project uses bioinformatics to identify the common function of genes that are related to Autism Spectrum Disorder (ASD). Over 1,000 genes are evidenced to contribute to ASD but are not understood well enough to use genetics in diagnosing or treating ASD. Mokshith hypothesized that these genes contribute to human development and would therefore affect development if a copy of the gene were faulty. He used data from the International Mouse Phenotyping Consortium (IMPC) to observe the phenotypes of mice where the ASD genes that are also found in mice were knocked out (deleted). The missing genes were found to strongly affect development or behavior, or lead to embryonic lethality. ASD patients would have one mutated copy of a gene related to ASD and one normal copy. This research suggests several pathways and development processes that attribute to ASD and could be used to validate ASD mouse models that are used in biomedical research.

“The level of competition in Georgia was at an all-time high this year,” said Georgia Bio President and CEO Maria Thacker. “Georgia Bio is thrilled to have Mokshith represent our state on the international stage at the upcoming BIO Convention, and we are proud to support this Georgia scholar in his future endeavors.”

Georgia Bio also congratulates the Georgia BioGENEius runner-up, Varun Sendilraj ,who is a senior at Lambert High School in Suwanee, GA. Varun developed a mobile app, DFUCare, which uses deep-learning algorithms to diagnose, analyze and monitor Diabetic Foot Ulcers (DFU) in diabetes patients. DFU is a major complication of diabetes mellitus that can lead to amputation and mortality if left untreated. Caring for DFU can be expensive and time consuming, which limits treatment options for many patients around the globe. DFUCare quantifies the size of wounds, performs tissue analysis, and detects healing potential over time. It can also allow doctors and patients to share medical reports with experts, saving time and resources for treating diabetic foot ulcers.

Judging the 2022 Georgia BioGENEius Challenge were Jamie L. Graham, Boehringer Ingelheim; Ralph L. Cordell, CDC; Ian Biggs, UGA; and Alex Harvey, ViaMune, Inc.

“I am amazed at the quality and thoughtfulness of the projects on display,” said Ian Biggs of UGA’s Innovation Gateway. “The insights displayed, and the obvious effort put into the projects is way beyond my expectations.”

National and International winners will be announced after the competition. See the International BioGENEius website for more information on the 2022 schedule. Winners will receive cash scholarships.

Follow the BioGENEius Challenge: Throughout the challenge, @BiotechInstitut will be tweeting interviews, photos, and engaging with the biotechnology community by using the hashtag #BioGENEius.

About the Biotechnology Institute

The Biotechnology Institute is an independent, national nonprofit organization dedicated to education about the present and future impact of biotechnology. Its mission is to engage, excite and educate the public, particularly students and teachers, about biotechnology and its immense potential for solving human health, food and environmental problems. For more information, visit www.biotechinstitute.org .

About the BioEd Institute

The BioEd Institute, a division of the 501(c)(3) nonprofit the Center for Global Health Innovation, works to strengthen Georgia’s life sciences workforce pipeline through classroom-to-career initiatives that align with industry needs. BioEd works closely with its sister organization Georgia Bio, which serves the state’s life science industry. For more information about BioEd, visit them online at www.georgiabioed.org , or on Facebook (@GeorgiaBioEd), Twitter (@georgiabioed), or LinkedIn (@georgia-bioed).

Contacts

Kristin Boscan
585.943.8699
kboscan@cghi.org

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Georgia Bio Names 2022 Golden Helix Award Winners

Mon, 11 Apr 2022 15:44:00 GMT

Clearside Biomedical’s Rafael Andino and The Georgia Institute of Technology’s Krishnendu Roy to be Honored with Top Award

ATLANTA, GA (April 11, 2022) – Georgia Bio, the state’s life science trade association, will celebrate its annual Golden Helix Awards on Thursday, May 5 ^th . Georgia Bio is pleased to announce the winners of the 2022 Golden Helix Awards and be returning to an in-person celebration.

Clearside Biomedical’s Rafael V. Andino and The Georgia Institute of Technology’s Krishnendu Roy are the recipients of the 2022 Industry Growth Awards for their impact on the life sciences industry in the state. The Industry Growth Awards are the highest honors bestowed each year by Georgia Bio.

The Golden Helix Awards celebrate the contributions and achievements of Georgia legislative, academic, corporate, and other organizational leaders working to advance the growth of the life sciences industry and foster strategic partnerships that can create a healthier world. The event is expected to draw 300 of the state’s life sciences industry leaders.

“We are thrilled to have our annual awards dinner return to being an in-person celebration of the individuals and companies who are making waves in the life sciences industry,” said Maria Thacker Goethe, CEO, Georgia Bio and the Center for Global Health Innovation (CGHI), “Our community strives to improve patients’ lives, support workforce development, grow Georgia’s economy, and be a driving force for good in the world. The Golden Helix Awards highlights those lasting contributions made by many in the life sciences sector in Georgia.”

Now in its 24 ^th year, the Golden Helix Award winners showcase the best in innovation and leadership in Georgia’s community. Georgia Bio presents awards to individuals and companies in eight categories: Industry Growth; Deals of the Year; Community; Innovation; Emerging Leader; Biotech Teacher of the Year; Legislator of the Year; and the Metro Atlanta Chamber sponsored Phoenix Award. Winners are some of Georgia’s hardest working innovators and entrepreneurs producing advanced medicines, diagnostics and technologies to improve medical care.

Companies being honored with the distinguished Deal of the Year award include: Antios Therapeutics for their successful fundraising efforts, which included closing on a Series B financing round totaling $107 million dollars; Axion Biosystems for their sale to Summa Capital; Guide Therapeutics for their sale to Beam Therapeutics; Danimer Scientific for their $700 million dollar expansion of a 2,000,000-square-foot facility in Bainbridge, Georgia; MedShape, Inc. for their sale to DJO; Intuitive Surgical’s commitment to creating 1,200 new jobs that will have an average salary of over $130,000 in Gwinnett County; Kennesaw State University for earning a three-year, $809,000 grant from the National Institutes of Health (NIH) to strengthen the University’s research and diversity infrastructures in the biomedical fields; Sharecare for going public through a merger with Falcon Capital Acquisition Corp.; Strados Labs for raising $4.5M in Pre-series A Funding; and VERO Biotech for receiving $100 million in a Series E financing round led by MVM Partners (MVM).

“The Metro Atlanta Chamber is honored to present the Phoenix Award this year to two titans of economic development in Georgia for their partnership in creating the Delta Innovation Hub at the University of Georgia, said David Hartnett, Chief Economic Development Officer at the Metro Atlanta Chamber, and member of the Georgia Bio Awards Committee. “Their collaboration will invigorate Georgia’s innovation ecosystem for years to come and symbolizes what the spirit of the Golden Helix Awards and Phoenix Awards is all about.”

AWARD WINNERS

Georgia Bio Industry Growth Awards: Presented to two people who have made an extraordinary contribution to the growth of the life sciences industry in Georgia.

Phoenix Award: The Phoenix award represents the iconic “rising from the ashes” of the Phoenix, a symbol of strength, tenacity and leadership and is presented to celebrate the best Industry and Academic collaborations. The two Georgia honorees will have forged academic and industry relationships that will drive translation and lead to new treatments and cures. This award is sponsored by the Metro Atlanta Chamber .

Deals of the Year Awards: Presented to one or more companies or institutions for the most significant financial or commercial transactions closed from January 1, 2021-December 31, 2021, based on the importance of the transaction to Georgia’s life sciences industry.

Acquisitions

Summa Capital acquisition of Axion Biosystems

Beam Therapeutics acquisition of Guide Therapeutics

DJO acquisition of MedShape, Inc.

Economic Development

Danimer Scientific

Intuitive Surgical

Private Financing

Antios Therapeutics

Sharecare

Strados Labs

VERO Biotech

Public Financing

Kennesaw State University

Community Awards: Presented to a small number of individuals, companies or institutions whose contributions to Georgia’s life sciences community are worthy of special recognition.

Innovation Awards: Presented to the department, institution, company or individuals who are forging new ground by thinking outside traditional paradigms to create some unique technology.

Emerging Leader of the Year Awards: Presented to young individuals who have made a significant impact on the life sciences industry through their studies or employment.

Teacher of the Year Award: Presented to a Georgia biotechnology high school teacher who exhibits excellence in STEM teaching and support for the biotechnology pathway.

Legislators of the Year Award: Presented to state legislators for their support of the life sciences industry in Georgia.

For a list of past Georgia Bio Industry Growth Award recipients, click here .

ABOUT GEORGIA BIO (GaBio)

Georgia Bio is a division of the Center for Global Health Innovation (CGHI), a 501(c)(3) organization that was launched in January 2020 to bring together diverse Global Health, Health Technology and Life Sciences entities to collaborate, innovate and activate solutions to enhance human health outcomes around the world. Visit CGHI at cghi.org .

Credentialed members of the news media are invited to attend as guests. Please register with Georgia Bio.

Media Contact:

Ryan Brooks

404-805-2456

rbrooks@cghi.org

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CMS Decision is an Enormous Setback for Alzheimer’s Patients and a Dangerous Infringement on FDA’s Scientific Autonomy

Fri, 08 Apr 2022 15:12:00 GMT

Patients will suffer because of this bureaucratic and unnecessary second-guessing of the FDA, says BIO CEO.

Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to the Centers for Medicare and Medicaid Services’ (CMS’s) National Coverage Determination (NCD) to restrict coverage for drugs used to treat patients suffering from Alzheimer’s Disease:

“The National Coverage Determination released this evening by CMS is an enormous setback for Alzheimer’s patients and an unprecedented and dangerous infringement on the FDA’s scientific autonomy and decision making.

“With this decision, CMS is not just saying it has no confidence in Alzheimer’s drugs approved under the FDA’s Accelerated Approval pathway. It also is undermining confidence in FDA’s traditional drug approval process more broadly.

“CMS will now subject these Alzheimer’s drugs approved under the Accelerated Approval pathway to cumbersome, expensive and time-consuming new trials that will delay and limit access. Even access to products approved under the traditional process by FDA will be significantly limited for patients while they wait for a government agreement to set up CMS-approved registries, which history tells us takes years to establish.

“Patients will suffer because of this bureaucratic and unnecessary second-guessing of the FDA. CMS is chasing innovators out of this critical field and devastating future investment and research going toward treating patients with Alzheimer’s.

“As we have said from the outset, CMS does not have the scientific expertise to do this critical work. While FDA has thousands of experienced scientists and clinicians, CMS has less than 30. FDA staffers are scientifically trained at judging the benefit and risk of all kinds of therapies and have a long history of collaboration with the scientific, patient and academic communities. CMS is not equipped to make these judgments, and today’s decision is a dangerous rebuke of the FDA’s hard-earned scientific prowess.

“In the end, CMS has actually made its initial proposal far worse and expanded the damage it will cause to many more patient populations and their loved ones.”

Read original article here

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Potential drug for Alzheimer’s disease could block early damage, MCG researcher says

Fri, 01 Apr 2022 14:54:00 GMT

Most drugs proposed for Alzheimer’s disease target the gunk that accumulates in the brains of patients but fail to take enough away to make a difference or improve outcomes, said the head of the new Alzheimer’s Therapeutics Discovery program at Medical College of Georgia. It would be better to target a mechanism much earlier in the process, and there appears to be a drug already tested in humans that might do that, Dr. Qin Wang said.

Read the full article here

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Stephanie and Christopher’s Story: Rare Disease and Medical Nutrition

Mon, 28 Feb 2022 16:23:00 GMT

Any parent would agree that having a child changes your world forever. Yet, having a child with a rare disease throws you not only into the role of parent but also advocate, educator, researcher, and medical provider. Those with rare diseases, and the guardians’ that care for them, have different perspectives on the world. We must, or we and those we care for will not survive.

My son Christopher was diagnosed in 2008 via new-born screening with a rare inherited metabolic condition called LCHADD. Ultimately, his body cannot break down long chain fats and use it for energy. Looking at Christopher you would never know that he has a rare disease. He is thriving academically, loves to write, play chess, make music, and compete in baseball. He enjoys magic and loves making his parents and friends laugh. In fact, his laughter is contagious. Christopher is not thriving because his condition is “easy” to navigate. He is doing so well because he is diligent with what little things we understand about his rare disease. He takes a special medical formula daily that gives him the right kinds of fats that his body can process. He eats every two-three hours throughout the day with MCT oil drizzled on his food, so his body will not use his muscles for energy. He also works with me daily to make sure he only consumes 10g of fat through food, so fat does not gather around his heart or infiltrate his liver.

As a parent of a child with a rare disease I work really hard to understand his ever-changing condition. It is not uncommon for my husband to come home from work and find science textbooks, dictionaries and pencil/paper scattered on our living room table, as I am trying to dissect a new medical journal article. Talking with other families and looking at research are my two best avenues of preparation before doctor visits. I have met some amazing doctors, who do not resent it when I ask questions but try to work creatively with us to solve problems. A doctor told me early on, “parents of children with rare diseases quickly become the expert in their child’s disease.” It was comforting to hear a doctor recognize this but also terrifying because I did not go to school for medicine. I might wish that a medical professional could share with me all I need to know about LCHADD, but I understand that realistically when you only see 10 children a year with a specific condition, it is almost unfair to expect a doctor to be the sole source of information. We must work together as a team.

Another area of my life that has changed so much, is having to fight with the insurance company for items that my son needs to survive. When my son first arrived home from the hospital, we were told it would be too dangerous for him to breastfeed and that he needed a special medical nutrition called Lipistart. You can imagine the devastation that settled in when I learned that we were denied coverage. My husband was an Atlanta Public School teacher, and trying to pay $800 a month for medical nutrition was terrifying. We were lucky, we were able to work with local legislators and HR to get this problem resolved, but I couldn’t shake the knowledge of what it would have been like if he was in a different job. Not all private insurance companies cover the cost of medical nutrition, and this devastates families who are already having to fight in so many different ways. Parents and advocates have worked together for over 12 years to try and get this issue resolved for all families. Yet, it is hard to get the right people to listen when there are so few of us.

I still believe that people want to have compassion, want to care for others, and want to help–yet it gets harder and harder to feel this way when I see the issues of the weak and vulnerable set to the side, and that is why we need a Rare Disease Advisory Council. I may be one parent of a child with LCHADD but I am not alone in my struggle with caring for someone with a rare disease. The more people understand our journey, the better we can compassionately craft laws for the good of all.

Read Stephanie’s blog here: harryfamilyblog.blogspot.com

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Nathan’s Story: VCP Disease and the need for a Rare Disease Advisory Council in Georgia

Mon, 28 Feb 2022 15:15:00 GMT

Since I was a freshman at Georgia Tech, I have had a clock ticking in my head. Since my mother presented symptoms of the VCP gene mutation, I had grown up knowing that a rare disease existed in my family and that there was a 50% chance that I might get it as an adult in my 30’s to 40’s. My mother and aunt are both deceased from the disease, and I have two uncles (four out of six siblings) that possess the VCP gene mutation that was passed down from their mother. Symptoms include muscle wasting, Paget’s disease of bone, frontotemporal dementia, ALS and Parkinson’s. A patient can get any combination of symptoms and the disease is fatal. For ten years, my mother could not walk, feed herself, bathe herself or go to the bathroom by herself and my dad was her primary care partner. I know what my future holds, and my advocacy work is for my three boys.

I jumped at every career opportunity to advance as quickly as possible. Some might even say I was reckless. I quit a six-figure job and moved my wife and two sons at the time to Boston to attend grad school at MIT as I knew I might not get another shot. My oldest son lived in six states by the time he was nine and I did everything I could do to advance professionally in the event that I was “lucky” enough to have the gene mutation.

In my late 30’s, after feeling weakness in my muscles and receiving my positive gene mutation diagnosis from a researcher in California, I visited the Emory neuromuscular center to request a nuclear bone scan. There are no treatments for my disease except for Paget’s disease of bone, if detected early enough. During that first appointment, the doctor looked at me and said that he had never heard of my disease and that it might all be in my head. My wife and I spent the next 45 minutes educating him about what to expect with a VCP gene mutation to not much success. It wasn’t until I visited the Emory ALS Clinic that I found a doctor familiar with my genetic mutation. I am his only patient with my genetic mutation. In rare diseases, access to specialty and timely medical care is crucial and can save lives and the unnecessary costs. Because there may be only a few experts in the world, many patients do not receive the care that they need.

After leading multiple businesses, I am now on full disability as we were “blessed” that I made some wise financial decisions to protect my family. I am still somewhat independent now, but my disease is progressive so I will continue to lose strength, energy, and the ability to walk. My wife and children are having to take a larger share of things l feel I should do, like mow the lawn, clean the gutters, and get things from the attic. I wish I could still do dad things like teach my boys to play basketball or take them camping. I am blessed with a wonderful family, but my rare disease is a burden to them. Rare disease affects everyone in the family. One in 10 people have a rare disease, 50% are pediatric diseases and only 5% of rare diseases have a cure. Rare disease affects many families in Georgia.

Others are not so “blessed” as I have been, and it is vital that we protect and advocate for those affected by rare disease. My wife and I started a rare disease non-profit, Cure VCP Disease , in 2018, headquartered in Americus, Georgia, in order to help make life better for other rare disease families. We have funded research, facilitated scientific collaborations, and established a supportive patient community.

There are over 7,000 rare diseases and rare disease is complex. I’ve learned how complex it is only because I am an affected patient. HB 918, which advocates for the creation of a Rare Disease Advisory Council in Georgia will be one voice that can aid legislators, policy makers and the general Georgia population, in making prudent decisions to support and help rare disease patients and care partners in Georgia. Finding a cure and treatment for rare disease is only half the battle. How will it be administered and most importantly, how will it be paid for? Those are only a few of the important issues that the Rare Disease Advisory Council can help advise the people and representatives of Georgia.

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American Red Cross: Celebrate Black History Month by Participating in a ‘Sleeves Up’ Campaign

Mon, 07 Feb 2022 16:59:00 GMT

February is Black History Month – a time to honor the significant achievements of Black Americans while making an impact today. This year’s theme focuses on the importance of Black health and wellness. The American Red Cross is honoring the legacy of Dr. Charles Drew, an African American surgeon, and researcher who pioneered new methods for collecting, preserving, and distributing blood, as well as storing blood plasma for transfusion. We work to celebrate his advancements by putting a challenge out to the entire Georgia Region.

“Dr. Drew’s work with the Red Cross Blood Program helped save the lives of hundreds of thousands of people,” said Dee Dixon, CEO of Georgia’s Red Cross. “With blood transfusions remaining one of the most critical treatments for patients with chronic illnesses such as sickle cell, I invite Georgians everywhere to continue Dr. Drew’s lifesaving legacy by rolling up a sleeve to give blood during Black History Month.”

No bloodmobile or space is needed to answer this challenge, making it especially convenient for students and organizations to get involved. Simply create your campaign online, and send an invitation to your friends and family members anywhere in Georgia to join you in donating blood and saving lives.

Participants can visit www.redcrossblood.org to enter their zip code and find/book a convenient blood donation appointment in February or upcoming months.

Once participants are ready to roll up a sleeve, we want to see it! We invite all campaign blood donors to snap a picture and share it on social media using the hashtags: #TeamUp4SickleCellGA & #BlackBloodDonorsNeeded .

Calendar opportunities for launching an inspiring Sleeves Up Campaign during Black History Month / American Heart Month include:

Blood donations from everyone remain essential to the health of communities. However, African American donors play a critical role in meeting the need for blood – especially for those with sickle cell disease who often rely on closely matched blood products for regular transfusions. Individuals of all blood types are urged to make an appointment now to give blood or platelets in the weeks ahead by using the Red Cross Blood DonorApp , visiting RedCrossBlood.org , or calling 1 800-RED CROSS (1-800-733-2767) .

As an extra thank-you during Black History Month, those who come to give in February will receive a $10 Amazon.com Gift Card via email, thanks to Amazon.

The Red Cross is currently providing free sickle cell trait screening on all donations from self-identified African American donors in addition to a free mini health screening with insights on pulse, blood pressure and hemoglobin levels.

About the American Red Cross:

The American Red Cross shelters, feeds, and provides emotional support to victims of disasters; supplies about 40 percent of the nation’s blood; teaches skills that save lives; provides international humanitarian aid; and supports military members and their families. The Red Cross is a not-for-profit organization that depends on volunteers and the generosity of the American public to perform its mission. For more information, please visit redcross.org or cruzrojaamericana.org .

Read original article here

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Alzheimer’s patient groups protest U.S. Medicare coverage proposal limiting use of new drugs

Mon, 24 Jan 2022 16:55:00 GMT

Alzheimer’s patient groups, disappointed by Medicare’s plan to sharply limit coverage of new drugs for the brain-wasting disease, are planning publicity and lobbying campaigns to protest a proposal they say could delay their use for 10 years.

“Congress has to know how bad this will be for patients,” said John Dwyer, president of Global Alzheimer’s Platform Foundation (GAP) advocacy group.

In a preliminary decision last week, the U.S. Centers for Medicaid and Medicare Services (CMS), which runs the government health plan for people age 65 and older, said it would cover Biogen Inc’s (BIIB.O) already approved Aduhelm, and similar Alzheimer’s disease treatments in development, only for patients enrolled in approved clinical trials.Report ad

That plan would severely limit the number of patients receiving the treatment, undercutting the Food and Drug Administration’s accelerated approval of Aduhelm for patients in the early stages of the memory-robbing condition.

The public disagreement over the drug’s use is unusual for the agencies, both part of the U.S. Department of Health and Human Services.

Alzheimer’s Association Chief Executive Harry Johns said Medicare’s plan “usurps FDA’s role in drug approvals,” calling it “an unprecedented and terrible draft decision.”Report ad

His group, as well as UsAgainstAlzheimer’s and GAP – three of the biggest Alzheimer patient organizations – said they plan to fight the decision by appealing to lawmakers, the Biden administration and the U.S. Health Secretary.

The Alzheimer’s Association said it is using “all avenues of communication” to make its case.

Biogen is also fighting the decision and in a statement said it is “supportive of the community in raising their voices on this important issue of access.”Report ad

The Medicare agency could alter its plan before it is finalized in April, but it is unclear what new evidence or facts would cause it to soften its stance.

“There are only two clinical studies … There isn’t any real-world experience to convince CMS,” said James Chambers, a researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center in Boston. “They will receive a lot of outrage as opposed to new information.”

Medicare has opened a 30-day comment period with a final decision due by April 11.

“If the (CMS) decision changes, it will be because of political pressure,” said Raymond James analyst Chris Meekins.

CONTROVERSIAL DECISION

The FDA’s June decision was the first approval of an Alzheimer’s drug in nearly two decades, but was a controversial one not supported by the agency’s outside advisers. It relied on evidence that the drug can reduce amyloid brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slows progression of the disease.

Only one of Biogen’s two large-scale trials showed that Aduhelm had an impact on cognition.

The three Alzheimer’s patient groups said Medicare’s plan unfairly penalizes people with the disease – probably because there are so many of them and the cost could be enormous.

Aduhelm’s price – cut recently to $28,200 from $56,000 per year – sparked concerns about Medicare’s budget since Alzheimer’s is an age-related disease and around 85% of people eligible for the drug are in the government plan.

The number of Americans with Alzheimer’s is expected to rise to 13 million by 2050 from more than 6 million currently. Biogen has estimated that around 1 million would currently be eligible for Aduhelm.

Other companies, including Biogen partner Eisai Co Ltd and Eli Lilly and Co (LLY.N) , also are pursuing accelerated approval from the FDA for similar medications.

“This decision was not about Aduhelm alone. This was a decision about drugs still in trials,” said UsAgainstAlzheimer’s chairman George Vradenburg. “It is stunning preemption.”

Medicare typically pays for FDA-authorized medications, but by law is required to cover only products and services deemed “reasonable and necessary” for diagnosis or treatment.

Vradenburg said his organization is “communicating with Congress and the Biden Administration” about its dismay.

Read original article here

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Maria Thacker, President & CEO of Georgia Bio, Elected as New Board Chair for the Council of State Bioscience Associations (CSBA)

Fri, 10 Dec 2021 16:51:00 GMT

The Council of State Bioscience Associations (CSBA) today announced the election of new board members to its Board of Directors for the next two-year term (2022-2023). CSBA also announced new board leadership, including new Chair of the Board of Directors, Maria Thacker, President & CEO of Georgia Bio.

“We are thrilled to announce our new slate of incredibly accomplished and esteemed board leaders for the next exciting phase of CSBA,” said Michele Oshman, Executive Director of Council of State Bioscience Associations (CSBA) and Vice President of External Affairs at the Biotechnology Innovation Organization (BIO). “From the global threats of pandemics and climate change to the growing impact of bioscience on local jobs and economies, our industry faces many important challenges today. We look forward to continuing to work together across our new board leadership, members, and stakeholders to confront these threats and expand opportunities for innovation.”

CSBA is pleased to announce the following leaders and members of the board of directors for the 2022-2023 term:

• Maria Thacker, Board Chair
President & CEO, Georgia Bio
• Kelvyn Cullimore, Board Member
President & CEO, BioUtah
• Michael Fleming, Board Member
President, Delaware Bio
• Laura Gunter, Board Member
President, NCBIO
• Sonia Hall, Board Member
President & CEO, BioKansas
• Debbie Hart, Past Chair
President & CEO, BioNJ
• Liisa Bozinovic, CSBI Representative
Executive Director, Oregon Bio

The new leaders and members of the board of directors will join existing members serving for the 2021-2022 term:

• John Conrad, Board Member
President & CEO, iBIO
• Mike Guerra, Board Member
President & CEO, California Life Sciences
• Dawn Hocevar, Board Member
President & CEO, BioCT

“I am honored to be the new CSBA Board Chair and pledge to continue elevating the critical work of state biotechnology associations nationwide,” said Maria Thacker, Board Chair, CSBA and President & CEO, Georgia Bio. ”Our associations play a central role in championing the groundbreaking work of the biotechnology sector as we innovate for human health discoveries, agricultural advancements, and environmental sustainability.”

“It has been my honor to serve as the CSBA Board Chair over these last two years,” said Debbie Hart, Past Chair, CSBA and President & CEO, BioNJ. “Our state associations have faced immense challenges on the policy arena as well as an unprecedented global pandemic. I am proud of what we have collectively accomplished in helping to stave off grave policy proposals, offering unique educational opportunities, and supporting our Members, all despite operating remotely in a time of immense change for our country. I am delighted to see the very talented Maria Thacker take over as the new CSBA Chair and look forward to supporting her in that role and to our ongoing collaboration on behalf of our industry.”

About The Council of State Bioscience Associations

The Council of State Bioscience Associations (CSBA) is a confederation of state-based, nonprofit trade organizations each governed by its own board of directors convened by the Biotechnology Innovation Organization (BIO). The common mission of the members of the CSBA is to promote public understanding and to advocate for public policies that support patient access to lifesaving therapies and the responsible development of the bioscience industry.

Read original article here

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Patient’s Corner: Living with Chronic Illness Vol. 3

Mon, 04 Oct 2021 16:08:00 GMT

By Dorothy Leone-Glasser

Breast cancer survivors face many challenges while going through treatment and in post treatment. They experience a wide range of physical, mental, emotional and spiritual pain. There are lingering side effects to treatment that are long term and can be hard to manage. Many times, the fear of what will happen is overwhelming. Cancer survivors live with fearing a recurrence, especially with Stage 4 Cancer. This is especially real for women of color, since they have the highest recurrence rates and the highest mortality rates.

I met Tiah at an Rx in Reach GA Coalition Capitol Day. Being a survivor of Cancer myself, we knew women we would have a special bond. When we look at the journey of a woman living and thriving beyond cancer, oftentimes they don’t get a chance to take a break from the day-to-day challenges of life. These women are mothers, daughters, sisters and aunties, caregivers and pillars of their families. They are leaders in their community and on their jobs and so much more. One of the biggest needs is how to manage or cope with their daily life challenges while healing from the devastation of cancer and the damaging toll of treatment. Patients seldom receive the information and counseling on how to re-enter life. Cancer survivors and their families and friends need the education, resources and guidance from a healthcare team that supports the health of their mind and body.

Here are some ‘Tips’ from Tiah:

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Patient’s Corner: Living with Chronic Illness Vol. 2

Mon, 13 Sep 2021 22:33:00 GMT

By Dorothy Leone-Glasser

I met Mapillar Dahn and the MTS Sickle Cell Foundation, Inc. at our Rx in Reach GA Coalition Capitol Day. She was excited to participate in our event and had a table set to distribute Sickle Cell Awareness material and to engage visitors, attendees and legislators on the challenges of living with and caring for patients with this illness. She is guiding others to participate in understanding and conquering Sickle Cell Disease. I wanted you to know Mapillar and her journey as she continues her crusade to dispel the myths and ignorance surrounding the devasting sickle cell disease.

Mapillar Dahn founded MTS Sickle Cell Foundation, Inc., a non-profit organization, to bring awareness to sickle cell disease and provide support to families affected by Sickle Cell Disease (SCD). Since its inception in November of 2015, the foundation has implemented many initiatives to assist sickle cell families giving them a community of healing and hope. MTS Foundation has sponsored over 100 children attending week-long summer camp, organizing health fairs, helping families avoid eviction and disconnection of vital utilities while conducting outreach visits to hospitalized sickle cell patients. The MTS Foundation works to spread sickle cell awareness and support clinical trials reaching over 20 million people in the United States and Canada.

SCD is an incredibly complex genetic blood disorder that impacts 100,000 Americans and millions more around the world. Because it is a blood disease, it’s complications can be felt anywhere blood flows in the body. A person can go blind from it, have a stroke, have organ damage, experience excruciatingly painful episodes called crises, and even die from its complications. Sickle Cell is an invisible disease that many outside of the SCD community, simply do not understand. This misunderstanding and a general lack of education around SCD has caused many myths and misconceptions about the disease to fester and cause systemically toxic and stigmatizing beliefs.

Mapillar Dhan is personally inspired to fight for those affected by sickle cell because she is the mother of three (3) beautiful daughters who all battle Sickle Cell Disease. She knows firsthand what people don’t know about living with this challenging disease and caring for children who struggle with its symptoms daily. She is compelled to speak out loud and share a few points to keep in mind when engaging with SCD patients. She believes; the more you know, the more you can crush the barriers to care so patients can be assured they will receive the timely and appropriate treatment that they deserve.

Here are some of her ‘Tips”:

My oldest daughter, Tully, who is now 17, started to have severe bouts of pain, known as pain crises, when she was 6 months old. Until a year ago, she was having two to three crises a year, which means she was hospitalized for at least a week. About a year ago, after a blood transfusion, she developed antibodies to the blood group antigen, Jsb, which means she can only get transfusions from the 1-2% of donors who lack this antigen.
My other daughters have not had pain crises, but my middle daughter, Khadeejah, who is 15, had a stroke when she was 7 years old. Since then, she’s had monthly blood transfusions and 10 surgeries, including a major brain surgery.
My youngest daughter, Hajar, who is 11, struggles with the disease in her own way. She doesn’t have obvious symptoms or require regular blood transfusions, but she has cognitive challenges that are the result of “silent” mini-strokes associated with SCD.

“We have to look at individual patients and treat the disease more broadly. As a community, we know that not much is taught about sickle cell disease in medical and nursing schools. Until we can work to change that, a healthy dose of vulnerability, understanding, compassion, care, and empathy needs to be prescribed when treating people with SCD.”

To learn more about MTS Sickle Cell Foundation click here .

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Patient’s Corner: Living with Chronic Illness Vol. 1

Tue, 22 Jun 2021 20:20:00 GMT

By Dorothy Leon-Glasser

Chronic illness is a disease, condition, or injury that can last years or a lifetime and is typically not curable. In some cases, it may go into remission, however for most patients it is a lifetime journey. It can vary in its severity, with some people able to work and live a somewhat active lifestyle; while others are very sick and may even be homebound. For many people there can be long breaks between subsequent episodes of illness. No matter how frequently they experience flares of their disease, patients must continue life on a daily basis until their symptoms can be treated effectively enough to subside again.

Many people with chronic illness have an invisible disease. The severity of their symptoms is not clearly noticeable, which may lead to a lack of understanding and support from doctors, family, friends, coworkers and the public. From many years of caring for chronically ill patients, and being on my own chronic illness journey, it is a fact that ‘no one wants to feel sick’. People with chronic illness are not lazy. The truth is, chronic illness fatigue is more than what a healthy person experiences as ‘being tired’. Once fatigue kicks in, it’s as if the body “hits a wall” and can’t go further. Being chronically ill is like being on an emotional roller coaster. Chronic illness can change the biochemical makeup of the mood control center in the brain, triggering many emotions.

Just before reaching the age of 20, working as a nurse, I became seriously ill. I was unable to eat, dress myself, could barely speak and was completely bed-ridden. I felt like a huge tractor-trailer ran me over and didn’t leave a license number! I was given multiple medications and went through many clinical trials and experimental treatments. After pain-staking tests, doctor examinations, hospital admissions and years of more questions than answers, I was diagnosed. I had a serious chronic illness with a poor prognosis. Through years of much trial and error, self-awareness techniques, counseling, an exceptional health team and much support; I had a new way to live with illness and a new attitude about wellness.

Cory Lewis, Director of Red Moon Project, Sickle Cell Disease shared some challenges of living with sickle cell disease.

“Some obstacles that have been challenging while living here in Georgia is that a lot of the doctors here are still short on knowledge when it comes to sickle cell patients, the culture around sickle cell disease, and the sickle cell types; as they all tend to react and affect the patient differently.”

Cory affirms that many sickle cell patients are:

Cory shared his story of his emergency medical experience when he started to have symptoms of renal failure.

“After moving to Georgia and working, I began to experience fainting and vaso-occlusion to my organs. My kidneys began to fail and my sickle cell was more sensitive than ever before. I was transported to the hospital. A doctor came into the room and automatically assumed I was drug seeking. He looked in my eyes and said ” You don’t have jaundice in your eyes; I don’t see any sickle cell”. He then politely walked out of the room. I was so surprised because I have never been told this, nor have I ever experienced this reaction from any physician. The physician did not leave any treatment orders. Fortunately, a nurse walked in with two cups of water since I was feeling dehydrated.

This was my first time on my own as a young adult tending to my illness. I was shocked to get hit with this stigma and discrimination from the medical staff. It is not only intimidating to hear a doctor tell you that you don’t have sickle cell but disrespectful when he ignores my knowledge of my body and illness as a sickle cell patient.”

The Ga Bio Patient Advocacy Alliance wants to dispel the myths surrounding chronic illness while telling the story of our advocates who battle their own disease, even as they help others live better lives with theirs. We will be sharing the challenges of having a chronic illness and how we, as patient advocates, can help medical professionals, resources agents and the general public expand their knowledge of what it is like to successfully live with a chronic disease.

In the future, we will continue to hear from other patient advocates who work with people battling chronic illness. We can all make a difference in the lives of those who are ill by gaining a better understanding of what it means to live with a chronic illness. With more understanding of the uniqueness of symptoms and coping skills, we will help make these diseases less “invisible”.

To learn more about Cory and The Red Moon Project, Inc. click here .

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Georgia Made Medical Manufacturing Act Signed Into Law

Tue, 25 May 2021 14:46:00 GMT

On Tuesday, May 4th, Governor Kemp signed Senate Bill 6 into law. SB 6 contains language for the Georgia Made Medical Manufacturing Act, which allows for an additional $1250 tax credit for all new jobs engaged with pharmaceutical and medical supply/device manufacturing. Language for the GMMMA was previously included on several pieces of legislation but received final passage on the last day of session on a Conference Committee Report to SB 6. The law will go into effect on July 1, 2021.

This legislation signals the value that Gov. Kemp and the General Assembly place on the important work of the life sciences industry. We thank them for their support and look forward to working with them to expand our industry and its economic impact here in Georgia.

Click here for full text of Senate Bill 6

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Georgia Bio Responds to Biden Administration’s Federal TRIPS Waiver

Thu, 06 May 2021 18:51:00 GMT

“On behalf of Georgia Bio and the biotechnology industry in Georgia, we have grave concerns about the Biden administration’s decision to waive the intellectual property patent for American vaccine technology. Countless hours went into safely researching, developing, and producing these life-saving vaccines, and this decision could ultimately undermine global supply chains and ongoing vaccination efforts worldwide – especially for healthcare systems in low-and middle-income countries. We join our friends at Biotechnology Innovation Organization (BIO) in asking for a more thoughtful, patient-centered approach as we navigate this new challenge in the fight against COVID-19 and subsequent global health crises.” – Maria Thacker-Goethe, President & CEO, Georgia Bio

Read the full Biotechnology Innovation Organization (BIO) statement here.

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Georgia Bio Applauds Passage of Senate Bill 6 and the Georgia Made Medical Manufacturing Act

Tue, 04 May 2021 19:01:00 GMT

ATLANTA–( BUSINESS WIRE )–Georgia Bio, the state’s life sciences advocacy and business leadership organization, announced today that Governor Brian Kemp’s signing of Senate Bill 6 includes language for the Georgia Made Medical Manufacturing Act.

“The COVID-19 pandemic drew national attention to drug shortages in the U.S., which have become more frequent over the past decade due to an overreliance on pharmaceutical ingredients from overseas,” said Maria Thacker-Goethe, Georgia Bio’s president and CEO. “This legislation strengthens Georgia’s ability to support patients during and after the pandemic, highlights the vital work of our pharmaceutical and medical device and supply manufacturers, and creates jobs by attracting and growing the life sciences industry in Georgia. Thank you to Governor Brian Kemp and his office for prioritizing our industry, healthcare independence, and the health and safety of Georgia’s citizens.”

Senate Bill 6, initially a bill to implement oversight of existing tax credits, became an omnibus tax bill with several issues represented. Part II of the bill allows companies eligible for the existing Jobs Tax Credit to receive an additional $1250 tax incentive for all new employees beginning July 1, 2021 or later engaged in pharmaceutical manufacturing and medical supply manufacturing.

Senate Bill 6 was signed during a bill signing ceremony at the Cobb Chamber of Commerce and will take effect on July 1, 2021. To read the full text of the bill, click HERE .

About Georgia Bio

Georgia Bio ( www.gabio.org ) is the state’s private, non-profit life sciences association. Members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services.

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Georgia Bio Names Milton High School Senior as 2021 Georgia BioGENEius Winner

Tue, 06 Apr 2021 16:52:00 GMT

Priya Soneji Advances to International Competition Against Top Students

ATLANTA–( BUSINESS WIRE )–Georgia Bio and the Georgia BioEd Institute today named Priya Soneji , a senior at Milton High School in Milton, GA, as the winner of the 2021 Georgia BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. As Georgia’s BioGENEius finalist, Priya will attend the 2021 International BioGENEius competition, which will be held virtually and featured during the BIO Digital Convention.

Priya will compete against high school students from the U.S., Canada and Germany in the International BioGENEius Challenge. The student projects will represent a range of biotechnology topics such as healthcare, agriculture, and the environment.

Priya was selected as our winner because of the tracking microscope she developed that automatically focuses on a microorganism as it travels through three-dimensional space. Scientists typically observe microorganisms under a microscope by moving the slide or petri dish manually. Priya improved on this method by creating a mechanized device that uses AI to record video and plot the location of an organism as it travels. By enabling scientists to observe microscopic organisms for longer periods of time and more easily identify fast-moving specimens, this device has the potential to facilitate parasite diagnosis and advance the discovery of previously unknown microorganism behaviors.

“In the biotech industry, young people are the closest thing we have to a crystal ball. The BioGENEius Challenge showcases scientific innovations that are only possible when young minds are given the freedom and resources to convert their ideas into action,” said Georgia Bio President and CEO Maria Thacker. “Georgia Bio is thrilled to have Priya represent our state on the international stage at the upcoming BIO Digital Convention, and we are proud to support this Georgia scholar in her future endeavors.”

Georgia Bio also congratulates the Georgia BioGENEius runner-up, Asmi Kumar, who is also a student at Milton High School in Milton, GA. Asmi’s project focused on treating Cortical Visual Impairment (CVI) with a low-cost, computer app-based therapy, called FollowMe. CVI occurs when neurological damage in a child’s brain causes a disconnect between the optic nerve and the visual cortex. Typically, the connection is restored through coordination therapies, where parents or therapists move an object around in front of a child so that the child may track it. This method is often expensive, time-consuming, and results in inconsistent feedback on what the child’s eyes are seeing. FollowMe uses AI and a standard webcam to track the patient’s gaze as they follow targets generated in the web-based app, which eliminates the need for expensive therapy visits. Asmi plans to continue the development of FollowMe and hopes to introduce this therapy to doctors around the world.

Judging the 2021 Georgia BioGENEius Challenge were Jamie L. Graham, Boehringer Ingelheim; Ralph L. Cordell, CDC; Ian Biggs, UGA; and Alex Harvey, ViaMune, Inc.

National and International winners will be announced after the competition. See the International BioGENEius website for more information on the revised 2021 schedule. Winners will receive cash scholarships.

Follow the BioGENEius Challenge: Throughout the challenge, @BiotechInstitut will be tweeting interviews, photos, and engaging with the biotechnology community by using the hashtag #BioGENEius.

About the Biotechnology Institute

About the Georgia BioEd Institute

The Georgia BioEd Institute, a division of the 501(c)(3) nonprofit the Center for Global Health Innovation, works to strengthen Georgia’s life sciences workforce pipeline through classroom-to-career initiatives that align with industry needs. BioEd works closely with its sister organization Georgia Bio, which serves the state’s life science industry. For more information about BioEd, visit them online at www.georgiabioed.org , or on Facebook (@GeorgiaBioEd), Twitter (@georgiabioed), or LinkedIn (@georgia-bioed).

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Georgia Bio Names 2021 Golden Helix Award Winners

Wed, 03 Mar 2021 13:54:00 GMT

Georgia Department of Economic Development’s EJane Caraway and Georgia Research Alliance’s Susan Shows to be Honored

ATLANTA, GA (March 3, 2021) – Georgia Bio, the state’s life science trade association, will virtually celebrate its annual Golden Helix Awards on Thursday, April 1st. Georgia Bio is pleased to announce the winners of the 2021 Golden Helix Awards.

EJane Caraway , Director of Life Sciences for the Georgia Department of Economic Development (GDEcD) and Susan Shows , President of the Georgia Research Alliance (GRA) are the recipients of the 2021 Industry Growth Awards for their impact on the life sciences industry in the state. The Industry Growth Awards are the highest honors bestowed each year by Georgia Bio.

The Golden Helix Awards celebrate the contributions and achievements of Georgia legislative, academic, corporate and other organizational leaders working to advance the growth of the life sciences industry and foster strategic partnerships that can create a healthier world. The event is expected to draw 300 of the state’s life sciences industry leaders.

“This past year has truly put a spotlight on the importance of the life sciences industry in our everyday lives,” said David Hartnett, Chief Economic Development Officer at the Metro Atlanta Chamber and member of the Georgia Bio Awards Committee. “The coronavirus pandemic created an immediate need for our community to collaborate and foster innovation to combat COVID. Our leaders did not disappoint, and we look forward to celebrating their efforts on April 1 ^st .”

Now in its 23 ^rd year, the Golden Helix Award winners showcase the best in innovation and leadership in Georgia’s community. Georgia Bio presents awards to individuals and companies in nine categories: Industry Growth; Lifetime Achievement; Deals of the Year; Community; Innovation; Emerging Leader; Biotech Teacher of the Year; Legislator of the Year; and the Metro Atlanta Chamber sponsored Phoenix Award. Winners are some of Georgia’s hardest working innovators and entrepreneurs producing advanced medicines, diagnostics and technologies to improve medical care.

Companies being honored with the distinguished Deal of the Year award include: Children’s Healthcare of Atlanta, the Emory University and the Georgia Institute of Technology for receiving $18.2 million to continue their verification of COVID-19 diagnostic tests; CryoLife for its acquisition of Florida-based Ascyrus Medical for up to $200 million; Georgia Cancer Center for receiving a $3.3 million grant to cut cancer cases and deaths in underserved Georgians; Medline Industries economic development in Richmond Hill of a $70 million new distribution center creating 150 new jobs; RWDC Industries economic development in Athens of a $260 million factory and headquarters employing 200 people; and VERO Biotech for its $50 million funding agreement with Runway Capital.

“Though much has been lost to COVID-19, our nation – Georgia especially – has gained a deeper appreciation of the value that our industry provides. I look forward to taking an evening to recognize the individuals and companies who are working to combat this devastating disease with new devices, drugs, and therapeutics,” said Maria Thacker Goethe, President and CEO, Georgia Bio, “Our community strives to improve patients’ lives, support workforce development and grow Georgia’s economy, and our celebration will highlight those lasting contributions made by many in the life sciences sector in Georgia.”

AWARD WINNERS

Georgia Bio Industry Growth Awards : Presented to two people who have made an extraordinary contribution to the growth of the life sciences industry in Georgia.

Georgia Bio Lifetime Achievement Award : Presented to an individual who has dedicated their career to advancing innovation, entrepreneurship, and economic development in the life sciences industry of Georgia.

Phoenix Award : Presented to two Georgia honorees who have fostered innovation and collaboration within the community in Georgia and beyond in response to the coronavirus pandemic. This award is sponsored by the Metro Atlanta Chamber .

Deals of the Year Awards : Presented to one or more companies or institutions for the most significant financial or commercial transactions closed from November 1, 2019-December 31, 2020, based on the importance of the transaction to Georgia’s life sciences industry.

Acquisitions

CryoLife’s Acquisition of Ascyrus Medical

Economic Development

Medline Industries

RWDC Industries

Private Financing

VERO Biotech

Public Financing

Georgia Cancer Center

Children’s Healthcare of Atlanta | Emory University | Georgia Institute of Technology

Community Awards : Presented to a small number of individuals, companies or institutions whose contributions to Georgia’s life sciences community are worthy of special recognition.

Innovation Awards : Presented to the department, institution, company or individuals who are forging new ground by thinking outside traditional paradigms to create some unique technology.

Emerging Leader of the Year Awards : Presented to young individuals who have made a significant impact on the life sciences industry through their studies or employment.

Teacher of the Year Award : Presented to a Georgia biotechnology high school teacher who exhibits excellence in STEM teaching and support for the biotechnology pathway.

Legislators of the Year Award : Presented to state legislators for their support of the life sciences industry in Georgia.

For a list of past Georgia Bio Industry Growth Award recipients, click here .

ABOUT GEORGIA BIO (GaBio)

Georgia Bio (GaBio) is the state’s life science advocacy and business leadership industry association whose members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services. GaBio works closely with industry, government, academia and others to shape public policy, improve access to innovative technologies and grow Georgia’s life sciences economy. Visit GaBio at www.gabio.org , and follow us on Twitter @Georgia_Bio , Facebook , and LinkedIn .

Credentialed members of the news media are invited to attend as guests. Please register with Georgia Bio.

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Maria Thacker-Goethe, Georgia Bio President and CEO, Named to “100 Most Influential Georgians” list by Georgia Trend Magazine

Mon, 11 Jan 2021 19:58:00 GMT

Atlanta, Georgia (January 11, 2021) – Georgia Bio, the state’s public policy and business solutions organization representing Georgia’s life sciences sector, announced today that President and CEO Maria Thacker-Goethe was named to Georgia Trend magazine’s “100 Most Influential Georgians” list for 2021.

“It is an incredible honor to be chosen amongst such esteemed colleagues,” said Maria Thacker-Goethe, Georgia Bio’s president and CEO. “The list contains several of our life sciences partners, exhibiting the influence and impact that our sector has on the state of Georgia. Thank you to Georgia Trend for the merit and for highlighting the importance of the life sciences to our state.”

In its 23 ^rd year, this year’s “100 Most Influential Georgians” list contains CEOs, politicians, college presidents, nonprofit and economic development leaders who “have risen to the challenges of the past year to help make life better for all Georgians.”

Per Georgia Trend : “Under Thacker-Goethe’s leadership, Georgia Bio cultivates a high-growth life sciences

sector vital by many measures, including the nearly 200,000 jobs and approximately $22-billion impact for Georgia. She not only brings 13-plus years of nonprofit management to the role, but also the vision and experience from her concurrent leadership roles at the Georgia BioEd Institute and Global Health Alliance.”

To read more and view the full list of recipients, click HERE .

Thacker-Goethe also serves as CEO for the Center for Global Health Innovation. Georgia Bio is a division of The Center for Global Health Innovation, an Atlanta based 501(c)3 organization that was launched in 2020 to bring together diverse Global Health, Health Technology and Life Sciences entities to collaborate, innovate and activate solutions to enhance human health outcomes around the world. ( innovateglobalhealth.org )

About Georgia Bio

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Letter to Governor Kemp on Vaccines for Essential Workers

Thu, 17 Dec 2020 16:49:00 GMT

Earlier this week, Georgia Bio sent a letter to Governor Kemp requesting that the state consider certain biotechnology industry personnel who reside and/or work in Georgia to be considered as essential workers slated to receive a COVID-19 vaccine during the early phases of immunization. Specifically, we requested that workers involved in research, development, manufacturing and distribution of biopharmaceuticals and agricultural biotechnology products be included in Phase 1B of the CDC’s Advisory Committee on Immunization Practices (ACIP) framework in hopes of mitigating any disruption to our state and nation’s medicine and food supply during the pandemic.

Click HERE to view the entire letter.

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Georgia Bio Names Ashley Williams Haltom New VP of Government Affairs

Fri, 11 Dec 2020 13:46:00 GMT

Atlanta, Georgia (December 11, 2020) – Georgia Bio, the state’s public policy and business solutions organization representing Georgia’s life sciences sector, announced an addition to its team hiring Ashley Williams Haltom as the Vice President of Government Affairs. In this role, she will provide expanded leadership in developing and implementing sound public policy strategies for Georgia Bio members and strengthen the voice of life sciences in the state.

“At this critical juncture, life sciences play a more prominent role than at any point in recent history. My top priority is to provide information and resources to policymakers on Georgia’s life sciences ecosystem and the important role that it plays in our state,” said Mrs. Haltom.

As Georgia’s biotechnology, medical device, agbio, and digital health communities continue to grow, the addition of Mrs. Haltom bolsters the organization’s government relations activities. Those activities seek to drive solution-oriented public policies and advocacy that support life sciences research, investment and innovation in the state.

Mrs. Haltom has almost a decade of experience working in politics and government, serving in roles with then-Governor Deal’s Office of Workforce Development, the Georgia House of Representatives, and state and federal campaigns. Most recently, she served as the Communications Director and Staff Lobbyist for a statewide trade association. She is a graduate of the University of Georgia with a degree in International Affairs.

“This role, with ongoing support from our lobbyist Cornerstone Government Affairs, will deepen our relationship with policymakers,” said Maria Thacker Goethe, Georgia Bio’s president and CEO. “Ashley will enhance awareness at the state level for the contributions our life sciences sector and member companies make to Georgia’s economy and improvements in patient care. I am delighted to welcome her to Georgia Bio.”

About Georgia Bio

Media Contact:
Kristina Forbes
404-920-2043
kforbes@gabio.org

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Georgia Bio Innovation Summit Recap

Wed, 11 Nov 2020 14:13:00 GMT

Last week, Georgia Bio welcomed more than 600 attendees and 110 industry experts to the first-ever virtual Georgia Bio Innovation Summit—and the timing couldn’t have been better.

Starting the day after Election Day, we had three productive days of discussions about four critical challenges ahead: getting through the pandemic and economic crisis; tackling climate change; ending racial injustice; and standing up for science.

The key takeaway from the week: life sciences, including Georgia’s thriving biotechnology industry, will play a key role in finding solutions for all of them.

Here’s how.

1. Biotechnology is critical to building resilience.

COVID-19 has demonstrated the significant impact a pandemic can have on our health, our livelihoods, our food supply, and our economy, said Everett Hoekstra, President of Boehringer Ingelheim Animal Health USA Inc. , during the event kickoff.

This year has provided the life sciences industry with a clear vision of our collective purpose to serve mankind with lifesaving, lifechanging, and life enhancing health care, he continued.

“Now more than ever we’ve seen the importance of biotechnology in our everyday lives,” said U.S. Secretary of Agriculture (and Georgia native) Sonny Perdue .

With the national response to the pandemic and its impacts, we’ve seen “the critical role of innovation—specifically biological innovation—at play in mitigating supply chain risks and building resilience into our food and farming systems of the future,” continued Secretary Perdue.

So, how do we get there?

2. We need trust in science.

While science has been progressing faster than ever before, “we still struggle with how the public views what we do,” said Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO) , during the opening keynote.

“Political interference with science is not a one-party issue,” she said. “It is very tempting for politicians to think that it’s easy to tweak the science or push the science to meet their own political ends.”

This is why the scientific community must “stand up when we see a misuse or misappropriation of science,” and ensure we’re producing the highest-quality, well-tested science.

Biotechnology is “the industry that’s going to build the road for us to recover and grow. I just hope that our companies retain that focus, that I know they have,” she said, as well as “rebuild the pride in the work that we do.”

“How do we go back to having a society that trusts truth and trusts the data?” asked Dr. Seth Berkley, CEO of Gavi, The Vaccine Alliance , later in the week. “Everybody can have their own opinions, but they can’t have their own facts.”

“With that trust in science, I think we can do a lot of healing,” he said.

3. We need collaboration.

The global biotechnology industry has launched more than 800 research programs targeting COVID-19—including 11 vaccine candidates that have reached phase 3 clinical trials—in less than one year. How?

Speakers during a keynote on COVID-19 vaccines agreed: collaboration is key.

Dr. Paul Burton, Chief Global Medical Affairs Officer for Janssen Pharmaceuticals , said partnerships—with government, with health authorities, with industry, and between companies large and small—have been critical to this unprecedented response.

“We are in competition against the virus—we’re not in competition with each other,” he said.

Dr. Kathleen Toomey, Commissioner of the Georgia Department of Public Health, credited collaboration with the state and local response, as well—working together “across districts and counties” with hospitals, health care providers, community organizations, and the business community to “keep people healthy at the same time we can keep the economy open” and communicate more effectively.

“Even though, in many instances, we are competitors, when it comes to finding solutions for humanity, we can be a force,” added Patty Fritz, VP of U.S. Corporate Affairs for UCB, Inc.

4. We need diversity and inclusion.

Given COVID-19’s disproportionate impact on Black, African American, Hispanic, Latinx, and other communities of color, diversity and inclusion are key to overcoming the pandemic, as well—in particular, ensuring minority groups are represented in clinical trials.

“To be successful in vaccine development,” continued Janssen’s Burton, “we have to provide transparency and confidence for ethnic minorities in clinical trials and underrepresented groups.”

This strategy will help us well beyond the pandemic, said Dr. Alejandro Cané, VP, U.S. Medical and Scientific Affairs Lead at Pfizer Vaccines .

But we shouldn’t stop at diversity in clinical trials, said Dr. Clement Lewin, Associate Vice President, Head, BARDA Office and NV Stakeholder Engagement at Sanofi Pasteur . We must eliminate socioeconomic or racial disparities in terms of access and acceptance of the vaccine, as well.

All of this requires the industry itself to be diverse and inclusive, too. (It’s one of the reasons why Day 3 focused on D&I in the workforce and STEM education.)

“We need to make sure we’re putting particular emphasis on those communities, and, again, having people who represent those communities who are spokespeople,” explained Helene Gayle, MD, MPH, President & CEO of The Chicago Community Trust , because these populations have “perhaps the most to gain because of the high burden of disease.”

“We want to make sure that those populations are getting the information that they need, but it’s being done by institutions and individuals who are trusted, so we can build that trust,” she said.

“We are going to travel at the speed of trust. It’s not good enough to just have a vaccine if nobody wants to get vaccinated,” she added.

Did you miss something during the event?

It’s not too late to catch up!

Until November 30 ^th , you can login to the Georgia Bio Innovation Summit platform to access every session on-demand—including 6 keynotes and 20 breakout sessions!

(You can continue networking virtually with sponsors, exhibitors, and fellow attendees until November 30 ^th , too.)

Join the conversation on social media . Follow us on Twitter at @Georgia_Bio and #GaBioSummit .

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STEM Teachers Across Georgia Given Chance to Bring Labs to Life

Tue, 15 Sep 2020 17:24:00 GMT

Georgia BioEd Institute Announces Renewed Funding to Support Life Science Education

Georgia BioEd Institute announced renewed funding today that supports STEM education in school systems across Georgia that will provide teachers with the training and equipment they need to better prepare students for the Georgia workforce.

For the second year, Georgia BioEd has been given funding for the Rural Teacher Training Initiative (RTTI) to provide training on laboratory experiences for teachers in rural areas. To further enrich STEM classes, the Georgia BioEd Institute works with local industries to support the Equipment Depot, which is a ground-breaking program that provides donated lab supplies to enhance STEM education in Georgia’s classrooms. The Equipment Depot, the only one of its kind on the East Coast, has recently expanded to provide even more STEM support to Georgia’s teachers. In its first year, these programs provided training to 72 teachers from 23 schools across the state, impacted 11,500 students, and accepted close to $200,000 in industry equipment donations for classrooms.

With almost 2500 square feet, the Equipment Depot is large enough to accept and store more donated equipment and easily allow educators to reserve and pick up equipment to utilize in their classrooms. In addition, RTTI will continue to help strengthen Georgia’s life science workforce pipeline through proven teacher trainings and equipment support. In fact, during this challenging time, Georgia BioEd has also been able to offer virtual alternatives for labs to ensure students still get the best quality education during the pandemic.

“The life science industry is $21 billion and growing in the state of Georgia,” says Maria Thacker-Goethe, CEO of Georgia Bio. “If we want to be a leader in life sciences then we need to start in our schools, and this means we need to equip our teachers with the right tools to successfully teach STEM. Our goal is to our expand our community of STEM educators and strengthen our industry.”

Lack of equipment is one of the top reasons stated by teachers as a barrier to perform more STEM labs with their students in Georgia schools. The Equipment Depot solves this challenge by collecting lightly used, last generation, and surplus equipment, supplies, and consumables from industry. The Georgia BioEd Institute gets them into the schools for use in STEM labs. A bonus is that these donations also help the environment, keeping thousands of pounds of equipment out of landfills. In the last 12 months, the Equipment Depot has processed almost 4,000 pounds of donations.

“A signature aspect of our training is that we provide equipment to all participants, not just for the training, but also to use in the classroom to implement lessons with students,” said Georgia BioEd Institute Director, Kristin Boscan. “After all, it’s the students who are our future workforce. We need to get the skills, concepts, and inspiration to them . This funding is a win for STEM education.”

Continued funding from the Department of Education to the program partner, the Georgia Youth Science & Technology Centers (GYSTC), will advance the RTTI program. Georgia BioEd expresses our gratitude to the following state legislative leadership for helping to make this valuable initiative real to the benefit of all Georgians: Governor Brian Kemp, Lt. Governor Geoff Duncan, House Appropriations Chairman Terry England, Senate Appropriations Chairman Blake Tillery, House Appropriations Education Subcommittee Chairman Robert Dickey, Senate Appropriations Education Subcommittee Chairman Ellis Black, Senate Agriculture Chairman John Wilkinson, and House Ethics Chairman Randy Nix. We want to especially thank the late Jack Hill, former Senate Appropriations Chairman.

To learn more about Georgia BioEd Institute, RTTI, tour the Equipment Depot, and where to donate, please visit https://gabio.org/georgia-bioed/ . All are invited to attend the virtual Grand Opening of the Equipment Depot , Wednesday, September 16th, 4:30 – 5:30 p.m.

Read original article here

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7.23.2020. Cornerstone Government Affairs COVID-19 Legislative Update

Fri, 24 Jul 2020 16:17:00 GMT

Legislation
Supplemental IV
Timeline: After a couple fire drills between the White House and Senate Republicans, Leader McConnell said on the Senate floor today that Republicans will be releasing the bill early next week . He indicated that various Senate Chairs and other senators will be introducing their portions of the bill on Monday. McConnell had planned to roll out the bill this morning, after reportedly reaching an agreement with the White House last night. However, some last-minute disagreements caused a delay to next week. As there are some difficult sticking points that remain to be worked out between Democrats and Republicans, negotiations will not be quick and painless – there’s no guarantee that the bill is negotiated before the July 31 unemployment insurance expiration. Last week, House Majority Leader Hoyer told members to keep the first week of August open, though now there is talk of voting during the second week of August. The Paycheck Protection Program expires on August 8.

Politics/Process: Republicans have been working to reach consensus over the past week, but the past two days have shown the most volatility. There were reports of Leader McConnell proposing the extension of the enhanced unemployment insurance (UI) for four months at a lower rate of $450 per week, separate from a larger package. The White House reportedly rejected that idea. Severing the UI portion of the package would take significant pressure off lawmakers to get this done quickly. Late last night the White House and Senate Republicans had reportedly reached a deal and McConnell was set to roll it out at 9:30am this morning, but that plan was quickly changed and the roll out was delayed to next week. While the plan is to begin releasing the package in pieces on Monday, we could see another delay if consensus isn’t reached. Some committees had already finished drafting text, while others may still be in process.

Until Republicans introduce a bill, Democrats are in no hurry to begin negotiating with themselves . Minority Leader Schumer and Speaker Pelosi have been in constant conversation and will likely remain so. As Republicans will need 60 votes to pass the bill through the Senate, Democrats will have significant leverage once negotiations begin. Senate Majority Whip John Thune has indicated that when this is all said and done, he may lose as many as 25 Republicans on the final vote.

Policy: While text has yet to be finalized and there could be significant changes from now until Monday , the following represents what the White House and Senate Republicans had agreed to as of last night (agreement here ):

Democrats have continued to roll out new proposals (Sen. Wyden and Leader Schumer proposal on unemployment insurance, white papers on health care and testing) and highlight various provisions from the Heroes Act. Beyond extending unemployment insurance, funding for state/local/tribes, and funding for education and health, Democrats have been highlighting many other issues, including rental assistance and supporting communities of color , which have been disproportionately impacted by the virus.

The House passed the Democrats’ opening bid for the next bill, the Heroes Act, on May 15. While it’s been over two months since House passage of the bill and the contours of the debate and which issues are most pressing have shifted slightly, it can still serve as a marker of what Senate Republicans will be responding to in their bill. Heroes Act text (as of 5/12/2020) here . Section by section here . One pager here . State and Local one pager here . NCAI’s summary on tribal provisions here . Manager’s amendment here . House Rules Committee report here .

Passed Legislation
Moving forward, this section will only include new information and guidance. For past information and guidance and legislation, please refer to the archives . For a summary of all supplementals, please see here .

New Implementation Information and Guidance

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GA Safety Promise Statement from Georgia Bio

Fri, 17 Jul 2020 16:47:00 GMT

Dear Members and Partners,

The Center for Global Health Innovation and Georgia Bio advocate for science, communities, and global health. We believe science must be at the forefront of COVID-19 response and all worldwide health issues.

We believe in science, and we believe in communities. For the businesses who call these communities ‘home,’ science and public health recommendations are more important than ever in helping business owners and essential workers combat COVID-19.

For these reasons, we have signed the Georgia Safety Promise , a statewide public-private partnership that encourages businesses and communities to agree to simple, but critical, measures that will keep communities safe. Our collective knowledge of science shows us that the measures outlined in the Safety Promise are the best way to combat COVID-19 and its impact on our state.

The health and safety of our member companies’ employees is top of mind. We are concerned that any increase in COVID-19 cases in Georgia could impact the important work that the biopharmaceutical and MedTech companies are doing. Georgia companies and institutions have enhanced research and manufacturing capabilities for vaccines and treatments for COVID-19. Our member companies are committed to continuing the important work they do in Georgia, which is critical to our collective success to ultimately have a vaccine and treatment for COVID-19.

We encourage our partners and members to join us in supporting science by signing the Safety Promise. Wearing face coverings, washing your hands, sanitizing surfaces, and staying six feet apart are scientifically proven to reduce transmission of this virus.

I would like to also bring to your attention a new national public health campaign designed to mobilize support for vaccines. The Public Good Projects (PGP) in partnership with BIO launched a national public health campaign called STRONGER —a first-of-its-kind effort designed to combat the spread of vaccine misinformation online.

STRONGER provides a guide for individuals to combat misinformation, explaining how to spot it, and then block, hide, report, or respond to false posts with facts and a list of trusted experts as a resource for good information on vaccines on social media.

For more information, visit www.stronger.org and follow STRONGER on Facebook , Twitter , Instagram and YouTube . And don’t forget…follow us in signing the Safety Promise . Follow us in supporting the science.

Sincerely,
Maria Thacker-Goethe
President and CEO
Georgia Bio | Center for Global Health Innovation
Atlanta, Georgia

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Georgia Bio Sign-on to State Medical Technology Alliance HHS & CMS Letter

Mon, 29 Jun 2020 17:23:00 GMT

Georiga Bio sign-on to the State Medical Technology Alliance (SMTA) letter to U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid. Please see the language below.

The Honorable Alex M. Azar II
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

The Honorable Seema Verma
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Secretary Azar and Administrator Verma:

As members of the State Medical Technology Alliance (SMTA), we are state and regional life sciences associations representing biotechnology, medical device companies, universities, research institutions, and venture capital firms across the country, all dedicated to developing and delivering life-enhancing and life-saving products, we write to express our strong support for your leadership in the U.S. Department of Health and Human Services’ (HHS) efforts to provide coverage for transformative medical devices that are approved as breakthrough devices by the FDA.

The COVID-19 pandemic highlighted the need for our nation’s health care system to better align care for patients. We commend HHS for taking swift action to create appropriate waivers and incentives across different health care stakeholders to better address this devastating disease. Providing patients with access to breakthrough devices would further this push to align care for patients by promoting innovation and providing patients with the latest in life-changing medical technology.

The medical technology industry is an important and thriving sector in the U.S. economy, creating jobs in all 50 states and representing a sizable portion of the nation’s Gross Domestic Product. The industry is responsible for about 1.9 million jobs in the U.S. and an economic output of approximately $381 billion annually.

Access to state-of-the art medical technology and diagnostics can help to improve care and patient outcomes, and CMS has acknowledged the value of breakthrough products by including a Breakthrough Product Pathway for new technology add-on payments (NTAP) in the Final Rule on the FY 2020 Inpatient Prospective Payment System.

We commend HHS and CMS for these efforts and urge you to take the next step by providing coverage for all medical devices that are approved and cleared as FDA-designated breakthrough in all settings. Providing this needed certainty will help ensure the next round of truly life-changing innovation can get to the patients who need them as quickly as possible.

As members of the SMTA, we look forward to working with the Administration to finalize this critical effort.

Sincerely,

Arizona BioIndustry Association (AZBio)

Biocom: Life Science Association of California

BioFlorida

BioForward Wisconsin

BioOhio

Bioscience Association of West Virginia (BioWV)

BioUtah

California Life Sciences Association (CLSA)

Colorado BioScience Association (CBSA)

Florida Medical Manufacturers Consortium (FMMC)

Georgia Bio

Healthcare Institute of New Jersey (HINJ)

Illinois Biotechnology Innovation Organization (iBIO)

Indiana Health Industry Forum (IHIF)

Indiana Medical Device Manufacturers Council (IMDMC)

Iowa Biotechnology Association (IowaBio)

Kentucky Life Sciences Council

Life Sciences Pennsylvania

Life Science Tennessee

Life Science Washington

Massachusetts Medical Device Industry Council (MassMEDIC)

Medical Alley Association

MedTech Association New York

Michigan Biosciences Industry Association (MichBio)

Mississippi Biotechnology Association

Missouri Biotechnology Association (MOBIO)

NCBIO

SCBIO

Southeast Life Sciences

Texas Healthcare & Bioscience Institute (THBI)

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Georgia Champion Takes Top Honor at Prestigious International BioGENEius Challenge

Fri, 12 Jun 2020 18:07:00 GMT

Milton High School Senior Shreya Ramesh Achieves Global Excellence in Scientific Research

ATLANTA–( BUSINESS WIRE )–Shreya Ramesh, a Milton High School senior, from Milton, Georgia, and local winner of the Georgia BioGENEius Challenge, has taken the top prize at the fiercely competitive International BioGENEius Challenge. Shreya’s innovative work on voice recognition data and Amyotrophic Lateral Sclerosis (ALS) stood out among her fellow finalists.

“We just couldn’t be more ecstatic—for Shreya as well as for the future of all biotech innovation,” said Georgia Bio President and CEO Maria Thacker. “We knew how talented she was when we saw her work, but the fact that our local winner’s unbelievably sophisticated research won the top prize at this advanced level shows you just what we can do in biotech here in Georgia, not to mention how brilliant and innovative Georgia students are.”

Organized by the Biotechnology Institute, the annual competition brings together young innovators from across North America and Germany to compete before an accomplished panel of established biotechnology researchers and academics. The winner walks away with the recognition, advisement, and support of some of the world’s best biotech innovators as well $7,500 in prize money.

Shreya’s research topic focused on the problem of Amyotrophic Lateral Sclerosis (ALS) patients, many of whom rely on Automatic Speech Recognition (ASR) tools such as Google Voice, with voice characteristics that can unfortunately be unreadable to ARS programs. As a result of the condition, the voices of ALS patients can be slow and high pitched, making ARS software interaction problematic. Shreya’s solution was to create a novel voice compensation algorithm that converted an ALS patient’s unique vocal texture into one more easily recognized by the programs.

“Winning the BioGENEius Challenge feels absolutely amazing,” said Shreya Ramesh. “It’s great to know that my project has the potential to change lives and that I’ll have a supportive platform to help me do that. The competition was the best experience—I’ve met so many students who are just as passionate as I am about using biotech to change the world!”

Judges of the 2020 International BioGENEius Challenge included BioEd Institute Board Member and past Chair, Jamie Graham, partner at Kilpatrick Townsend & Stockton, to whom Georgia Bio and the Georgia BioEd Institute offer a special thanks.

About the Biotechnology Institute

About the Georgia BioEd Institute

The Georgia BioEd Institute is a division of Georgia Bio, a 501(c)(3) nonprofit organization serving the state’s life science industry. The Institute’s mission is to strengthen Georgia’s life sciences workforce pipeline through classroom-to-career initiatives that align with industry needs. Learn more at www.georgiabioed.org | www.gabio.org .

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AdvaMed and Georgia Bio Send Letter to Natural Resources & Environment Committee Related to Ethylene Oxide

Fri, 12 Jun 2020 17:45:00 GMT

On behalf of the Advanced Medical Technology Association (AdvaMed) and Georgia Bio, we wrote to the Natural Resources & Environment Committee to share our comments on Senate Bill 426, being considered by the legislature, related to ethylene oxide. As you may know, billions of medical devices each year in the U.S. are sterilized using ethylene oxide. The direct impact of severe restriction on the ability to sterilize medical devices could compromise the medical device industry’s ability to provide a consistent, stable, and safe supply of medical supplies to patients nationwide during the COVID-19 pandemic.

As the threat of antimicrobial resistance to disease-causing, mutating microbes continues to rise in the U.S. and around the globe, now more than ever, we need to ensure the medical and surgical equipment health care providers use is sterile. Ethylene oxide allows sterile surgeries to happen.

Please click here to view the full letter to the committee.

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Advocating in the Age of COVID: Best Practices

Tue, 26 May 2020 19:14:00 GMT

By: Cornerstone Government Affairs

As you manage how meetings have changed in the age of COVID-19, consider these best practices as you connect with policymakers in the age of COVID-19:

Before the Meeting

During the Meeting

Special Tips for Phone Meetings

Special Tips for Video Meetings

Staffers may prefer to talk by phone rather than video. Don’t take it personally. Elected officials, on the other hand, may prefer video. Traditional retail politicking is more challenging these days; video is the next best thing. Either way, be gracious. These are new and trying times for everyone, and elected officials’ offices are juggling countless asks and constituent needs while adjusting to this new normal. Be sure to thank them for their time and attention.

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Georgia Bio Names Milton High School Senior as Georgia BioGENEius Winner

Mon, 06 Apr 2020 16:00:00 GMT

Shreya Ramesh Advances in International Competition Against Top Students

Atlanta, GA (April 6, 2020) – Georgia Bio and the Georgia BioEd Institute today named Shreya Ramesh , a senior at Milton High School in Milton, GA, as the winner of the 2020 Georgia BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. As Georgia’s BioGENEius finalist, Shreya will attend the 2020 International BioGENEius competition, which will be held virtually during the BIO Digital Convention.

Shreya will compete against high school students from the U.S., Canada and Germany in the International BioGENEius Challenge. The student projects will represent a range of biotechnology topics such as healthcare, agriculture, and the environment.

Shreya’s award-winning research uses machine learning to assess the voice features of Amyotrophic Lateral Sclerosis (ALS) patients. The voices of ALS patients are characteristically slower, higher pitched, and softer than the voices of individuals who do not have ALS. Using ALS voice feature data, Shreya created a voice compensation algorithm to convert the ALS patient’s voice into one more similar to a non-ALS patient. This allowed the ALS patient’s voice to be better recognized by Automatic Speech Recognition (ARS) programs like Google Voice or Amazon’s Alexa. ALS patients often rely on ARS programs due to their limited mobility, but their voice features are not recognized by these programs.

“The BioGENEius Challenge highlights the breakthroughs made when we invest in and encourage young people to pursue their ideas,” said Georgia Bio President and CEO Maria Thacker. “Georgia Bio is thrilled that Shreya will represent our state at the upcoming BIO Convention. We are proud to support this Georgia scholar as she develops tomorrow’s healthcare innovations.”

Georgia Bio also congratulates the Georgia BioGENEius runner-up, Krish Wadhwani of Denmark High School in Alpharetta, GA. Krish’s project focused on the production of synthetic antibody mimics (SyAMs) as treatment for Huntington’s disease (HD) and Alzheimer’s Disease (AD). The SyAMs are engineered antibodies that can bind to the misshapen proteins responsible for causing symptoms in HD and AD. This would inhibit the proteins and help control symptoms of the disease. Krish plans to continue this research and next hopes to get funding to pursue clinical production and testing of the antibodies.

Judging the 2020 Georgia BioGENEius were Jamie L. Graham, Kilpatrick Townsend & Stockton; Ralph L. Cordell, CDC; and Ian Biggs, UGA.

National and International winners will be announced after the competition. See the International BioGENEius website for more information on the revised 2020 schedule. Winners will receive cash scholarships.

# # #

Follow the BioGENEius Challenge: Throughout the challenge, @BiotechInstitut will be tweeting interviews, photos, and engaging with the biotechnology community by using the hashtag #BioGENEius.

About the Biotechnology Institute

About the GeorgiaBioEd Institute
The Georgia BioEd Institute is a division of Georgia Bio, a 501(c)(3) nonprofit organization serving the state’s life science industry. The Institute’s mission is to strengthen Georgia’s life sciences workforce pipeline through classroom-to-career initiatives that align with industry needs. Learn more at www.georgiabioed.org | www.gabio.org .

MEDIA CONTACT :

Maria Thacker
404-920-2042
mthacker@gabio.org

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USDA Implements Immediate Measures to Help Rural Residents, Businesses and Communities Affected by COVID-19

Thu, 26 Mar 2020 17:36:00 GMT

USDA Rural Development has taken a number of immediate actions to help rural residents, businesses and communities affected by the COVID-19 outbreak. Rural Development will keep our customers, partners, and stakeholders continuously updated as more actions are taken to better serve rural America.

Read the full announcement to learn more about the opportunities USDA Rural Development is implementing to provide immediate relief to our customers, partners, and stakeholders.

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COVID-19 SBA LOAN PROGRAMS

Thu, 26 Mar 2020 16:25:00 GMT

The following is a summary from our lobbying firm Cornerstone Government Affairs of the two small business loan programs created as a result of the COVID-19 Pandemic.

The first program was created through the passage of what we are calling the “COVID-I” legislation. That bill created a $1 billion fund to immediately assist small businesses hit hard by the current economic shutdown. Unlike traditional Small Business Administration (SBA) funding mechanisms, this program is being administered directly by the SBA and is live and accepting applications currently (see more below).

The second program was created through the passage of what we are calling “COVID-III” legislation. That bill created the Paycheck Protection Program and the Economic Injury Disaster Loan (EIDL) program. These programs will be administered more like traditional SBA programs, i.e. through third party, 7(a) lenders.

NOTE #1: Organizations cannot accept funds from both programs, but they are welcome to apply to both and determine which one is the best fit before signing off on final terms.

NOTE #2: Cornerstone enjoys relationships with two SBA 7(a) lenders, who have agreed to provide expedited services to those clients who need to access funds and participate in the program. For more information, please email Campbell Kaufman at ckaufman@cgagroup.com.

COVID-I

The U.S. Small Business Administration is offering designated states and territories low-interest federal disaster loans for working capital to small businesses suffering substantial economic injury as a result of the coronavirus (COVID-19). Upon a request received from a state’s or territory’s governor, SBA will issue under its own authority, as provided by the Coronavirus Preparedness and Response Supplemental Appropriations Act that was recently signed by the President, an Economic Injury Disaster Loan declaration.

Any such Economic Injury Disaster Loan assistance declaration issued by the SBA makes loans available statewide to small businesses and private, non-profit organizations to help alleviate economic injury caused by the coronavirus (COVID-19). This will apply to current and future disaster assistance declarations related to coronavirus.

SBA’s Office of Disaster Assistance will coordinate with the state’s or territory’s governor to submit the request for Economic Injury Disaster Loan assistance.

Once a declaration is made, the information on the application process for Economic Injury Disaster Loan assistance will be made available to affected small businesses within the state.

SBA’s Economic Injury Disaster Loans offer up to $2 million in assistance and can provide vital economic support to small businesses to help overcome the temporary loss of revenue they are experiencing.

These loans may be used to pay fixed debts, payroll, accounts payable and other bills that can’t be paid because of the disaster’s impact. The interest rate is 3.75% for small businesses. The interest rate for non-profits is 2.75%.

SBA offers loans with long-term repayments in order to keep payments affordable, up to a maximum of 30 years. Terms are determined on a case-by-case basis, based upon each borrower’s ability to repay.

SBA’s Economic Injury Disaster Loans are just one piece of the expanded focus of the federal government’s coordinated response, and the SBA is strongly committed to providing the most effective and customer-focused
response possible.

To apply for these loans, click here -https://disasterloan.sba.gov/.

For questions, please contact the SBA disaster assistance customer service center at 1-800-659-2955 (TTY: 1-800-877-8339) or e-mail disastercustomerservice@sba.gov.

COVID-III

The third COVID-19 package expected to become law includes a new SBA loan program, the Paycheck Protection Program, as well as a grant program associated with the EIDL program. The Paycheck Protection Program is intended to keep workers on small business payrolls through offering forgivable loans. The EIDL grant program offers small businesses a one-time $10,000 grant to cover costs in the short term.

The Paycheck Protection Program

Applies to you if:

You were in business and employed fewer than the greater of 500 people or the SBA size standards in number of employees for your industry on February 15, 2020.

You are a small business, nonprofit, veterans’ organization, tribal business, or are self-employed, an independent contractor or sole proprietor.

What it does:

Allows you to apply for a 100% government backed, low interest SBA 7(a) loan up to $10 million. The loan amount will equal 250% of your average monthly payroll costs.

The period covered for the debt forgiveness is from February 15, 2020 until June 30, 2020.

The 100% government backed loans and fee waivers will be authorized through December 31, 2020.

Allows you to use the loan to cover payroll costs, including salaries, paid sick and medical leave, insurance premiums, mortgage, rent and utility payments.

Allows the loan to be forgiven in an amount equal to what you spent on payroll, rent and mortgage interest (on leases and mortgages in effect on February 15, 2020).

Reduces the loan amount forgiven proportionately to the reduction in number of employees retained compared to last year and reduced by the reduction in pay of any employee greater than 25% compared to last year.

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Georgia Bio Signs-on Multi-Association Letter on Buy American Executive Order

Wed, 25 Mar 2020 15:50:00 GMT

Today Georgia Bio joins several other associations to sign-on the U.S. Chamber Letter to Secretary Mnuchin, Secretary Ross, Ambassador Lighthizer, and Director Kudlow.

The letter respectfully ask that the Trump administration defer moves to expand the reach of “Buy American” mandates to the medical equipment and biopharmaceutical sector during the present national emergency.

Please see below to read the full letter:

The undersigned organizations applaud the Trump administration’s focused response to the coronavirus pandemic. In particular, we appreciate the administration’s encouragement of public-private partnerships to quickly develop a vaccine for COVID-19 and expand the supply of medical countermeasures. We also commend the administration’s efforts to work with tech companies to map the spread of the coronavirus as well as FDA efforts to loosen regulations and increase testing capacities. American companies will do whatever it takes to support our country’s pandemic response and will continue to work hand in glove with government to get the job done.

While we are encouraged by this partnership and the administration’s ongoing labors with our international allies to respond to the pandemic with all available resources, we are concerned by reports of a draft “Buy American” executive order that could be counterproductive to these efforts. Such an order may delay the discovery of a COVID-19 vaccine and other treatments, worsen shortages of critically-needed medicines and medical products, and undermine prospects for economic recovery.

Now more than ever, U.S. industries require access to international supply chains to produce critically-needed medical products. The United States simply does not produce all of the raw materials or intermediate goods that are essential to drug development or production of the medical equipment needed to thwart this epidemic. Preventing federal agencies from sourcing medical equipment and pharmaceutical ingredients from abroad — or that are made with non-U.S. inputs — will only exacerbate the supply shortages racking the United States.

Further, as the world’s most innovative economy, the United States cannot shut itself off from the rest of the world. Turning our backs on trading partners during a crisis could damage our relationships long after this pandemic ends. If we implement localization requirements, many of our trade partners would assuredly follow our lead and limit imports from the United States.

For these reasons, we respectfully ask that the Trump administration defer moves to expand the reach of “Buy American” mandates to the medical equipment and biopharmaceutical sector during the present national emergency. This pandemic has raised awareness of vulnerabilities in supply chains, and American industries look forward to working with the administration to solve those challenges with well-thought-out solutions, but those efforts should be deferred until the national emergency is passed.

Today, our shared priority must be to defeat COVID-19. The U.S. business community is committed to doing whatever it takes — working in close partnership with you — to achieve this goal.

The post Georgia Bio Signs-on Multi-Association Letter on Buy American Executive Order appeared first on Georgia Bio .

COVID-19 March 24, 2020 Federal Update

Wed, 25 Mar 2020 15:28:00 GMT

Legislation
Supplemental III – “COVID-III”

The hope continues to be that a deal can come together, that a time agreement can be reached, and that the Senate can vote expeditiously – if not yesterday night, then certainly by today. Absent any deal, the Senate would vote on cloture on the motion to proceed to the COVID-III vehicle one hour after convening tomorrow.

If the Senate passes the package today, the House could pass by unanimous consent on Thursday. If unanimous consent isn’t achievable, the fallback is the suspension calendar on Friday. All of this is dependent on how quickly a deal is reached and text is released.

Process and Politics:

Multiple caucus conference calls were held yesterday and it seems that both caucuses are attempting to marshal their members toward acceptance of passing the bill by unanimous consent in the House. Speaker Pelosi and other House leadership have indicated they would be willing to pass the bill in the House under unanimous consent, but only if the end product is acceptable.

Policy:

Multiple updated drafts of the bill have been circulated yesterday. However, it’s unclear as of right now, as negotiations are still ongoing, what provisions in the draft bill are completely set and what is being further negotiated. As with previous big deals, nothing is final until everything is final . All policies previously discussed continue to be on the table and could be part of a final deal. CARES text (as of earlier today) here . Latest information indicates a final bill may include the following:

Passed Legislation

Supplemental II – Families First Coronavirus Response Act (HR 6201)

The Senate passed the bill 90-8 Wednesday afternoon and the President signed the bill into law that evening. Bill text here . Factsheet here . Bill section by section here . A summary of paid leave provisions, incorporating changes made by technical correction, is here .

Supplemental I – Coronavirus Supplemental

Signed by the President March 6. Text here , summary here .

Members of Congress in Quarantine or Treatment

Tested Positive (3): Sen. Rand Paul (R-KY), Rep. Ben McAdams (D-UT), Rep. Mario Diaz-Balart (R-FL)

Currently Self-Quarantined (26): Rep. Paul Gosar (R-AZ), Rep. Julia Brownley (D-CA), Rep. Jason Crow (D-CO), Rep. Matt Gaetz (R-FL), Rep. Mario Diaz-Balart (R-FL), Rep. Doug Collins (R-GA), Rep. Steve Scalise (R-LA), Rep. Ann Wagner (R-MO), Rep. Sharice Davids (D-KS), Rep. Ben Ray Luján (D-NM), Rep. Kathleen Rice (D-NY), Rep. Kendra Horn (D-OK), Rep. Matt Cartwright (D-PA), Rep. Ben McAdams (D-UT), Rep. Gwen Moore (D-WI), Rep. Frederica Wilson (D-FL), Rep. Stephanie Murphy (D-FL), Rep. Drew Ferguson (R-GA), Rep. Joe Cunningham (D-SC), Rep. Tom Cole (R-OK), Rep. David Schweikert (R-AZ), Rep. Anthony Brindisi (D-NY), Rep. David Price (D-NC), Rep. Andy Kim (D-NJ), Sen. Rick Scott (R-FL), Sen. Cory Gardner (R-CO), Sen. Mike Lee (R-UT), Sen. Mitt Romney (R-UT)

Completed Quarantine (4): Sen. Ted Cruz (R-TX), Rep. Mark Meadows (R-NC), Sen. Lindsay Graham (R-SC), Rep. Don Beyer (D-VA)

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Georgia Bio Sends Governor Kemp Shelter in Place Exemption Language

Tue, 24 Mar 2020 19:57:00 GMT

On behalf of Georgia Bio and our members we asked Governor Kemp to consider shelter in place orders to prevent the spread of COVID-19 in Georgia to allow biopharmaceutical and medical device and diagnostics companies and distributors to operate so that prescription drugs and medical supplies remain accessible to those who need them.

To effectuate this intent, “healthcare operations” is defined to include “companies and institutions involved in the research and development, manufacture, distribution, warehousing, and supplying of pharmaceuticals, biotechnology therapies, consumer health products, medical devices, diagnostics, equipment and services.” Below is language share with the Governors’s office of how this order can be written:

For purposes of this Order, individuals may leave their residence to work for or obtain services at any “Healthcare Operations” including hospitals, clinics, dentists, pharmacies, companies and institutions involved in the research and development, manufacture, distribution, warehousing, and supplying of pharmaceuticals, biotechnology therapies, consumer health products, medical devices, diagnostics, equipment, services and any other healthcare related supplies or services. This shall be broadly construed to include all other activities, supplies, and services required to maintain supply chain operations without disruption. “Healthcare Operations” does not include fitness and exercise gyms and similar facilities.

If Georgia issues a state-wide shelter in place order or provides guidance to local governments for shelter in place orders, we asked Governor Kemp include these provisions.

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GEORGIA BIO HOSTS 2020 LIFE SCIENCES DAY AT THE STATE CAPITOL

Tue, 25 Feb 2020 14:34:00 GMT

Georgia Bio celebrated the life sciences industry at the Georgia State Capitol February 25, 2020. Georgia Bio’s annual Capitol Day is the chance for members to showcase their innovative products, services, and discoveries at the Georgia State Capitol in Atlanta. The event gives members the chance to meet one-on-one with Georgia’s policymakers. The overall mission of the event is to present to the Georgia General Assembly Georgia Bio’s legislative agenda and vision for life sciences economic growth.

During the day at the Georgia State Capitol, Georgia Bio had over thirty members in attendance focused on discussing with legislatures workforce & talent initiatives, patient access to care, and the creation of a Georgia Rare Disease Advisory Council. Below are a breakdown of the issues and what Georgia Bio supports.

To commend Georgia Bio and recognize February 25, 2020 as the Georgia Life Sciences day at the State Capitol, Governor Brian Kemp declared a Proclamation , Representative Robert Dickey (R – Musella) sponsored House Resolution 1056 and Senator John Wilkinson (R-Toccoa) sponsored Senate Resolution 674 . Georgia Bio received special recognition on the Georgia House of Representatives chamber floor and Georgia Senate gallery.

Presenters at our breakfast reception included:

Georgia Bio gives a special thank you to Governor Brian Kemp, Rep. Robert Dickey & Senator John Wilkinson for sponsoring resolutions, and all the guest speakers and members for joining us in celebrating and showcasing their support to advance the life sciences industry in Georgia! Thank you to our event sponsors, Biotechnology Innovation Organization (BIO), AdvaMed, and UCB.

Workforce & Talent Initiatives:
The life science industry continues to fuel breakthrough discoveries that are having profound impacts around the globe. The life science sector in Georgia grew by 14.9% over the last decade. This high-paying and innovative sector is rapidly changing and the demand for new technical skills is on the rise, especially in Georgia. The industry routinely reports shortages of employees with the necessary skills.

Many life science careers utilize biological systems to produce commercially important biomaterials and biomolecules for use in agriculture, medicines, food and beverage processing, and industrial applications. Rural Georgia educators need support in life science career recognition, applicable hands-on teaching techniques, and access to supplies and equipment for their students.

Georgia Bio supports the state of Georgia to continue funding the Department of Education to advance Georgia BioEd’s Rural Teacher Training Initiative to strengthen Georgia’s life sciences workforce pipeline through classroom-to-career initiatives that align with industry needs.

Patient Access to Care:
Too many Georgians face barriers to accessing meaningful and timely care. In rural communities, many hospitals are struggling to keep their doors open. And throughout the state, even Georgians with coverage can face difficulties accessing specialty care or prescription drugs.

Georgia Bio supports patient access to innovative therapies and adequate provider networks through private and public insurance, including Medicaid, while enhancing plan transparency and encouraging competition among providers and insurers.

Establish a Georgia Rare Disease Advisory Council:

With over 7,000 known rare diseases, it is incredibly difficult for anyone to have an in-depth understanding of the entire rare community. Consequently, this lack of awareness contributes to some common difficulties that rare disease patients must face every day, such as delays in diagnosis, misdiagnosis, lack of treatment options, high drug costs, and limited access to medical specialists.

Rare Disease Advisory Councils help represent the needs of the entire rare disease community by giving patients, families, caregivers, and other stakeholders an opportunity to make formal recommendations to state leaders about the most important issue they face. Further, the membership of rare councils includes a variety of stakeholders that represent the entire rare community, including patients, caregivers, doctors, insurers, drug manufacturers, and researchers.

Georgia Bio supports the creation of a Georgia Rare Disease Advisory Council to address the needs of the rare disease community.

About Georgia Bio

Georgia Bio (GaBio), founded in 1989, is a non-profit, membership-based organization that promotes the interests and growth of the life sciences industry. It is the state’s largest and most influential life sciences advocacy and business leadership organization which works to improve access to innovative technologies and grow Georgia’s life sciences economy. Members include companies, universities, research institutions, government groups and other industry associations involved in discovery and application of life sciences products and related services that improve the health and well-being of people throughout the world.

Georgia Bio’s mission is to advance the growth of Georgia’s life sciences industry and foster strategic partnerships that can create a healthier world. To accomplish this mission, GaBio conducts business and economic development activities; advocates on behalf of the industry on public policy matters; educates the public about the benefits of life sciences research and product development; and provides a network for the exchange of ideas, information and opportunities.

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Georgia Bio Names 2020 Golden Helix Award Winners

Thu, 30 Jan 2020 17:09:00 GMT

UCB’s Patty Fritz and Quick Start’s Philip Gibson Honored

ATLANTA–( BUSINESS WIRE )–Georgia Bio, the state’s life science trade association, will celebrate its Golden Helix Awards & Annual Gala on Friday, March 13th at Factory Atlanta in Chamblee. Georgia Bio is pleased to announce the winners of the 2020 Golden Helix Awards.

Patty Fritz, Georgia Bio Chair and VP, U.S. Corporate Affairs for UCB, Inc. and Philip G. Gibson, Ph.D. , Georgia BioEd Institute Chair and Director, Georgia BioScience Training Center at Quick Start are the recipients of the 2020 Industry Growth Awards. The Industry Growth Awards are the highest honors bestowed each year by Georgia Bio.

“Our life sciences community continues to collaborate and foster innovation to create a healthier world,” said Dr. Christopher McKinney, Chair of the Georgia Bio Awards Committee and Associate VP for Innovation Commercialization at Augusta University. “There has been 121% growth in Life Science patents between 2007 and 2017 and an average of 760 clinical trials starting each year in Georgia. Additionally, more than $780 million venture capital was raised in 2018, mostly going towards drug discovery and therapeutic devices. It is important to recognize the individuals and organizations supporting healthcare innovation and leadership here in Georgia. We look forward to bringing the sector together on March 13th for an evening of networking and celebration.”

Georgia Bio presents awards to individuals and companies in eight categories: Industry Growth; Deals of the Year; Community; Innovation; Emerging Leader; Biotech Teacher of the Year; Legislator of the Year; and the Metro Atlanta Chamber sponsored Phoenix Award. Winners are some of Georgia’s hardest working innovators and entrepreneurs producing advanced medicines, diagnostics and technologies to improve medical care.

Companies being honored with the distinguished Deal of the Year award include: Alcon for its acquisition of PowerVision; Aruna Bio for raising $13 million to continue development of therapies for the treatment of neurodegenerative diseases such as ALS, Huntington’s Disease, and stroke; Danimer Scientific for a $6.5 million investment from Advantage Capital to boost capacity and significantly increase its workforce in Bainbridge, GA; Emory Vaccine Center and the University of Georgia Center for Vaccines and Immunology for their NIH grants that could exceed $200 million to advance work toward a universal flu vaccine ; Georgia Cancer Center for their $6.5 million grant to improve access to clinical trials for minorities and underserved communities; Guide Therapeutics for an initial equity investment from GreatPoint Ventures to continue development of lipid nanoparticles (LNPs) that deliver therapeutics for gene therapy; Tempus for its acquisition of AKESOGen ; and Takeda Pharmaceutical for its acquisition of Shire.

“Golden Helix Award winners showcase the best in innovation and leadership in our community,” said Maria Thacker Goethe, President and CEO, Georgia Bio. “They are working to improve patients’ lives, support life science workforce development and grow Georgia’s economy. The awards program is a night for our members and community partners to pause and recognize the individuals and companies who are making lasting contributions to the life sciences sector in Georgia.”

AWARD WINNERS

Georgia Bio Industry Growth Awards : Presented to two people who have made an extraordinary contribution to the growth of the life sciences industry in Georgia.

Phoenix Award : Presented to two Georgia honorees who have forged academic and industry relationships that will drive translation and lead to new treatments and cures. This award is sponsored by the Metro Atlanta Chamber .

Deals of the Year Awards : Presented to one or more companies or institutions for the most significant financial or commercial transactions closed from November 1, 2018-December 31, 2019, based on the importance of the transaction to Georgia’s life sciences industry.

Acquisitions
Alcon
Takeda Pharmaceutical
Tempus and AKESOgen

Private Financing
Aruna Bio
Danimer Scientific
Guide Therapeutics

Public Financing
Emory Vaccine Center
Georgia Cancer Center
University of Georgia Center for Vaccines and Immunology

Community Awards : Presented to a small number of individuals, companies or institutions whose contributions to Georgia’s life sciences community are worthy of special recognition.

Innovation Awards : Presented to the department, institution, company or individuals who are forging new ground by thinking outside traditional paradigms to create some unique technology.

Emerging Leader of the Year Awards : Presented to young individuals who have made a significant impact on the life sciences industry through their studies or employment.

Teacher of the Year Award : Presented to a Georgia biotechnology high school teacher who exhibits excellence in STEM teaching and support for the biotechnology pathway.

Legislators of the Year Award : Presented to state legislators for their support of the life sciences industry in Georgia.

For a list of past Georgia Bio Industry Growth Award recipients, click here .

ABOUT GEORGIA BIO (GaBio)

Credentialed members of the news media are invited to attend as guests. Please register with Georgia Bio.

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Georgia BioEd Completes Inaugural Rural Teacher Training Initiative

Wed, 29 Jan 2020 14:23:00 GMT

The Georgia BioEd Institute, together with Georgia Youth Science and Technology Centers and the Georgia Department of Education, hosted the inaugural Rural Teacher Training Initiative (RTTI) at UGA’s Griffin Campus on January 13 ^th and 14 ^th , 2020.

Seventy-two science teachers in 7th through 12th grade representing 40 Georgia school districts participated. More than 10,000 students in rural Georgia communities stand to benefit. The curriculum for the two-day symposium is based on Georgia life science industry needs and is aligned with Georgia Standards of Excellence as well as the Technical College System of Georgia’s biotechnology programs. Educators practiced new, hands-on, biotech laboratory activities to take back to their classrooms. They connected with industry leaders and recruiters while also collecting contributed laboratory equipment from our industry partners.

The GaBioEd Institute will deliver the balance of all materials necessary to implement the hands-on lab activities to the participant educators. Teachers are now part of an ongoing learning community that regularly meets with their cohort and master instructor throughout the school year for continued support.

“Hands-on teaching takes practice, courage, preparation, and resources,” said RTTI Director Kristin Boscan. “Our goal is to eliminate obstacles to life science education and careers through training, support and equipment supplementation.”

The symposium included an “industry fair” to inform educators about the life science industry in their own backyard, better equipping them to inspire and direct students to successful and frequently lucrative life science careers. The industry fair will certainly foster relationships that lead to industry tours, school field trips and internships.

“You can’t strive towards what you don’t know about,” said Ayesha Okaiwele, a science teacher in the Houston County School System. “When students hear the phrase ‘agriculture careers’ they often think that means farming and becoming a farmer. When, in fact, there’s the technical side of agriculture which involves laboratory work.”

Georgia’s life science industry experienced a 14.9 percent growth in employment from 2007 to 2017, according to the 2019 Georgia Life Sciences State of the Industry Report. Maria Saporta further wrote for the Atlanta Business Chronicle, “The report identified 1,960 unique life science establishments that contributed 68,300 jobs and $10 billion to Georgia’s gross domestic product. When including the multiplier effects, the industry supports a total of about 194,000 jobs, and it contributes $21.8 billion to Georgia’s GDP.”

However, researchers at Georgia Tech found just 4.6 percent of Georgia high schools offer the full biotechnology pathway. They also found that less than one half of one percent of Georgia’s 12th grade students completed the final course in that pathway. This demonstrates a clear need for additional education and workforce development.

In addition to financial and in-kind funding from life science companies in Georgia, the state allocated $323,000 in 2019 for the inaugural program including lab implementation and ongoing support. Georgia BioEd is working to secure state funding during the 2020 legislative session to ensure the program continues on an annual basis.

“The best thing we can do here in Georgia is to create an ecosystem that continues to allow for a growing economy, a talented workforce and significant potential in front of it,” Lt. Governor David Duncan told Georgia Bio last year.

Interested educators can subscribe to the RTTI outreach list and monthly newsletter by emailing mheaphy@gabio.org .

“We are grateful to our board members, industry supporters and state leaders for providing the support needed to ensure Georgia can generate the future workforce for the state’s $21 billion life science industry,” Boscan said.

Georgia Bio expresses our gratitude to the following state legislative leadership for helping to make this valuable initiative real to the benefit of all Georgians: Governor Brian Kemp, Lt. Governor Geoff Duncan, House Appropriations Chairman Terry England, Senate Appropriations Chairman Jack Hill, House Appropriations Education Subcommittee Chairman Robert Dickey, Senate Appropriations Education Subcommittee Chairman Ellis Black, Senate Agriculture Chairman John Wilkinson, and House Ethics Chairman Randy Nix.

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Georgia Bio and the Georgia BioEd Institute would like to thank supporters of the inaugural RTTI Program.

Champions

Key Supporters

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Georgia Bio’s 2020 Legislative Agenda and What to Watch

Tue, 14 Jan 2020 19:06:00 GMT

By Joseph Santoro

The 2020 Georgia state legislative session officially kicked off yesterday. As usual, the first week will set the course for the session, one which we believe will be compressed compared to 2019 primarily because it’s an election year and members need to get home to be close to their constituents.

Our 2020 Georgia Policy and State Legislative Agenda

As the state’s life sciences advocacy group, the following are our areas of focus and goals. Please note: we are working on more detailed policy statements for all focus areas.

Workforce development – Continue funding the Department of Education to advance Georgia Bio’s Rural Teacher Training Initiative (RTTI) to strengthen Georgia’s life sciences workforce pipeline through classroom-to-career initiatives that align with industry needs. The legislature provided more than $300,000 in 2019 to kick start the program. The first ever two-day training session is this week at the University of Georgia’s facility in Griffin. Sixty-four teachers have enrolled with the potential to impact more than 10,000 students across the state.

Biopharma – Cultivate the biopharma R&D and manufacturing ecosystem in Georgia by supporting strong intellectual property protections for patents, data protection and coverage and payment policies that recognize the value of medical innovation.

Economic incentives and tax reforms – Preserve existing economic development incentives and enact new tax policies that spur the life science industry and job growth. We reported last year that Georgia’s life science industry experienced a 14.9% growth in employment in the past decade. Including multiplier effects, the industry supports around 194,000 jobs and contributes $21.8 billion to Georgia’s GDP.

Medtech – Support investment, innovation and patient access to medical device and diagnostic technologies to improve the efficiency of a healthcare system’s ability to detect diseases earlier and to reduce costs through more effective treatments.

Translational Research – Support funding for the Georgia Research Alliance to levels necessary to spur bioscience innovations and commercialization through our research universities; strategically improve funding for post-secondary institutions in order to grow the state’s life science economy.

Digital Health – Streamline regulations and expand the reimbursement of digital apps and devices, remote patient monitoring technologies, and genomic products as well as enhance educational efforts that help patients, providers and caregivers.

Patient Access – Ensure patient access to innovative therapies and adequate provider networks through private and public insurance, including Medicaid, while enhancing plan transparency and encouraging competition among providers and insurers.

Food & Agriculture / Industrial and Environmental Biotech – Support the R&D of cutting-edge innovation in Agricultural & Food and Industrial & Environmental biotechnology to improve crop yields, enhance food quality, help feed a growing population and foster responsible environmental biotech practices.

What we believe the session holds

FY 2021 Budget – Passing a budget is the only constitutional requirement of the Georgia General Assembly. The budget process is going to play a large role in how legislation gets passed, especially with the Governor’s 4-7% budget cuts.

Pharmacy Benefit Managers (PBMs) – As part of the Special Committee on Access to Quality Healthcare Expect discussion, plan to see legislation that seeks to improve patient access to therapies, reduces overall healthcare spending – including consumer costs – and improves transparency from PBMs to be introduced and widely discussed.

Patient advocacy and rare disease advisory council – Senate Bill 274 would create a rare disease advisory council with the intention of addressing the needs of the rare disease community in Georgia by giving patients, families, caregivers and other stakeholders an opportunity to make formal recommendations to state leaders about the most important issues they face. While we have not taken a formal stance on this bill, we are working on a patient advocacy coalition with our colleagues at Pfizer. Because so many of our members have patient advocacy staff or “elements,” we seek to help them align more closely, connect on best practices, address challenges and more clearly understand what our role should be as an organization on the subject.

Ethylene oxide – In light of recent data that have come to light, there are concerns about ethylene oxide levels in our air. Expect to see related legislation, but not necessarily definitive action. It is possible, if not likely, the legislation will generate further study for additional data and details to support a more robust, refined bill in 2021.

Get Engaged!
Join us for Georgia Life Sciences Day at the State Capitol on February 25th. This is an excellent opportunity for members to showcase their innovative products, services, and discoveries at the Georgia State Capitol. Register here.

If you would like to plug into our Legislative Affairs Committee and be added to our bi-weekly calls during the session, email Joseph Santoro – jsantoro@gabio.org

As always, feel free to contact Joseph or Maria on any issues, local, state or federal that impact your ability to grow your life science business or you feel need to be addressed from a legislative affairs perspective to the benefit of our life science ecosystem and patient population.

Follow Georgia Bio on LinkedIn , Twitter and Facebook

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Looking back on a year of growth and ahead to a year of opportunity: our Q&A with Georgia Bio Chair Patty Fritz

Wed, 11 Dec 2019 13:17:00 GMT

Patty Fritz, UCB Vice President, U.S. Corporate Affairs, presided as chair of Georgia Bio during its 30th anniversary year. Looking back on advancements in Georgia’s life sciences industry in 2019 and ahead to what 2020 may hold, she recently shared her thoughts with us. We are pleased to share them with you in the following Q&A.

A: This has been an exciting year of growth for the Georgia life sciences industry. In Georgia Bio’s 30th anniversary year, the organization’s transformation is reflective of the life sciences in Georgia as a whole. I think about all of the rich pieces of the puzzle we enjoy here. Georgia is home to leading academic research institutions, startups, the Centers for Disease Control and Prevention, entrepreneurs along with robust biotech, medical device, pharma, digital, and global health industries.

Global health has risen to a top growth opportunity for the state. This year made clear to us that policy makers and state officials recognize the importance of the life science industry’s contribution to improving lives, economic growth, and opportunities for the future.

A: Our state of the industry report released in April shows the life science industry contributes to 3.7% of total employment in the state and $21.8 billion to the state’s gross domestic product. We are very encouraged by, and thankful for recognition of the industry’s value and importance by the governor, lieutenant governor, and policymakers. The appropriation of state funding for Georgia Bio’s Rural Teacher Training Initiative is one very specific example of this recognition. It serves the interest of furthering our ability to support STEM education and cultivate Georgia’s future workforce in the life sciences.

Q: What do you think 2020 will bring to the ecosystem?

A: I think we will see the industry continue its growth trajectory in 2020. The support of our policymakers and communities to attract and incentivize investment in the life sciences will help more startups grow. It will also encourage future investment in expansion by more established organizations like UCB, Takeda, and Boehringer-Ingelheim and others with existing presence in the state. All of the work at UCB that is done right here in Georgia is aimed at developing medical advancements and interventions for people with severe diseases.

Q: What would you encourage your colleagues – or incoming board chair for example – to make priorities in 2020?

A: Continue to support workforce preparedness through STEM education programming and our research ecosystem. We all need to continue to grow our collective engagement with policymakers. We need to ensure incentives are available to grow and contribute more to the state’s economy. Strengthen your connections between life science ecosystem stakeholders. This supports our need to amplify our impact and opportunity to cultivate and grow a sustainable ecosystem of innovation..

Q: What have you learned during your time as Georgia Bio Chair?

A: Serving as Georgia Bio Chair has helped me recognize how valuable the resources and impact of the community are right here at home. I thought I knew prior to becoming chair, but this experience has given me a better understanding of just what we have here in our own backyard. The leadership of Georgia Bio and other life science organizations here, like the Georgia Global Health Alliance, is very strong.

In my experience, I have found consistently that the goals amongst the life sciences industry leaders are incredibly high. And given the ingredients to support those leaders and those organizations, those goals are achievable.

I would also have to say that the Georgia life sciences has a unique strength that extends beyond the borders of Georgia and even the United States, and that is our ability to lead in the global health ecosystem. I reflect on the presence of the Center for Disease Control and the Georgia Global Health Alliance, just to mention a couple.

We also benefit from a thriving health technology and specifically digital health industry that is growing and having an even greater role in healthcare and in medical innovation.

Overall, we have enormous capability to come together with a shared vision and roadmap for advancing the life sciences and its positive patient impacts in Georgia and beyond. To get there requires us to come together, be intentional and clear about what we want to do, how we’re going to do it, and hold ourselves accountable to deliver.

Q: Who would you like to thank?

A: I want to thank Maria Thacker-Goethe for her leadership. She took on her new role during a year of transition and has done tremendous work. She is a thread between many organizations in the ecosystem and community, balancing their needs along with Georgia Bio’s in order to continue to move us ahead. I thank the Georgia Bio Executive Committee which has been instrumental in supporting her and serving as an important part of the fabric that binds the ecosystem together. I want to thank my own company, UCB, not just for its commitment to our own mission, its impact and value, but for being vibrant contributor to Georgia’s health economy. And I especially thank my family for allowing me to dedicate so much time and work to UCB and the state.

Q: Is there anything else you’d like to share?

We have a leading role to play as an accelerant to amplify the impact of innovative digital health and health tech companies in Georgia like Sharecare, Patientory, and others. They do not live alongside the life sciences industry as traditionally defined, they are interwoven within it. The life sciences industry is more than ever an integrated set of capabilities. Data collected from patients is essential in delivering real world insight into patient experiences, gaps and needs. Aggregating large data sets to which we would not normally have access enable us to learn more about what’s working and what’s not more quickly to inform our research. That research brings better interventions for patients in the future. It’s all connected. We use AI to understand patient populations most likely to be responsive to certain treatments, address unmet needs and bring new therapies to patients.

Thank you, Patty for your service as Georgia Bio Chair and for your insights!

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Georgia Bio Statement on BD Sterilization Plant In Georgia

Fri, 25 Oct 2019 22:39:00 GMT

Closure May Lead to Medical Device Shortage & Impact Patients

October 25, 2019 06:06 PM Eastern Daylight Time

ATLANTA–( BUSINESS WIRE )–Georgia Bio member companies are dedicated to improving patients’ lives-enhancing patient safety and expanding patient access to innovative treatments. Public health and environmental protection are central to the values of the life sciences community. Our member companies continually strive to exceed regulations and reduce their environmental footprint.

We are very concerned with the potential shut down of BD’s Covington facility over the use of EtO. Ethylene oxide is the safest, and sometimes, only method for ensuring the sterilization of medical devices for clinicians and patients. Approximately 50% of all medical devices are sterilized using EtO, accounting for more than 20 billion devices annually in the U.S. Many of our members manufacture devices and products that cannot be sterilized by any other means due to their complex nature, including pacemakers, implantable defibrillators, cardiac catheters, biopsy instruments and surgical fixation devices and vascular access devices including PICCs, midlines and ports. BD is the largest supplier of urinary catheters that are used in almost every surgical procedure that takes longer than 2 hours. They are also one of the only suppliers for pediatric vascular access devices used to deliver chemotherapy to children with cancer.

Georgia Bio believes policy makers have an obligation to protect the public from harmful emissions from any source, and we believe all industrial facilities in our state should meet or exceed safety standards. We support an open and transparent debate regarding EtO that is grounded in scientific fact, but caution that a hasty decision to close this facility or severely restrict the use of ethylene oxide would endanger the health of thousands, possibly even millions, of patients who are relying on sterile medical products.

About Georgia Bio

Georgia Bio is an independent, non-profit 501(c)(3) trade association whose mission is to advance the growth of Georgia’s life sciences industry and foster strategic partnerships that can create a healthier world. Georgia Bio member companies are dedicated to improving patients’ lives – enhancing patient safety and expanding patient access to innovative treatments. Public health and environmental protection are central to the values of the life sciences community. Georgia Bio members include bioscience and medtech companies, academic and research institutions, life science service providers, digital health companies, and related organizations. For more information, visit www.gabio.org or follow us on Twitter @Georgia_Bio .

Contacts

Joseph Santoro
404-334-7538
jsantoro@gabio.org

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What do people live for? A few takeaways from the 2019 Georgia Bio Innovation Summit

Tue, 15 Oct 2019 13:18:00 GMT

Georgia’s life sciences community contributes more than $20 billion to the state’s GDP according to a recent report from RTI for Georgia Bio, the state’s life sciences partnership. Employment in the sector grew by nearly 15% from 2007 to 2017, almost double the national average.

The 2019 edition of the Georgia Bio Innovation Summit convened hundreds of life science executives, scientists, researchers and public policy officials earlier this month. With four industry tracks the program had something for everyone no matter their particular place in Georgia’s science ecosystem.

Remembering the collective “why”

Marc Boutin, CEO of the National Health Council, inspired everyone in attendance during his lunch keynote address. “Your innovations help people live their dreams,” he said. “Those dreams are not always about survival.”

“What do people live for?” What a powerful question. Marc shared the following video ad from TC Bank.

Will healthcare ever realize “value?”

During the fireside chat portion of the lunch session, Sheila Burke, strategic advisor and chair for the government relations and public policy group of Baker Donelson underscored one of the greatest challenges in shifts from fee-for-service to value-based care. Quality and value are highly nuanced and highly personal. Yet patient input where value is currently assigned is limited.

If we define value as outcomes divided by cost, the shift from fee-for-service to value-based care may be impossible or mostly ineffective until this country assigns some dollar amount to quality adjusted life years, particularly when patient interests may not always be about longevity. Much like surgery for men with prostate cancer over 70, therapies and procedures that cost seven figures or more are simply not a value-based proposition for an 80 year old when allocating scarce resources. However, they may well present value for those of a much younger age.

As always, the opportunity to connect with colleagues and expand professional networks was of high value. There were well over 500 registrants and the ballroom was near standing room only for the lunch program. Here are a few other session insights.

The latest boobytrap waiting to maim medtech and life science innovators

Design history file remediation remains a sizeable stumbling block for innovators seeking investment to advance their products is. It can – and does – kill deals. But GCMI CEO Tiffany Wilson brought an emerging issue of equal risk to light. It’s the supply chain. Will the materials for your custom circuitry still be readily available (and at a cost that does not ruin your price structure) in five years?

Who will get your products to markets around the globe? How sensitive are they to time, temperature and other rigors of transport? Georgia’s logistics capabilities make Atlanta an excellent home for medical product companies and innovators. Beyond carriers like UPS, are there better ways to get them there? Dr. Marc Prausnitz at Georgia Tech is developing microneedle technology that presents a better way to get critical medications and vaccines to patients around the globe.

Advice for medical product startups and innovators from the investors

Founders, your team will be talking to the money (VCs, investors, potential acquirers, etc.) and many times you won’t be in the room. This underscores the importance of culture and team building, which is typically not a great strength among founders of medtech and life science companies. Entrepreneurs seeking seed stage funding, up to $2 million or thereabout, your people are your greatest asset, not your technology or IP according to Kim Seals, general partner with The JumpFund.

Protip: if you say your innovation has no competition, you don’t know your market. And if you tell an investor theirs is the ‘last money in,’ you do not have a realistic view of the actual time and cost requirements of commercializing medical products. Thanks to Tom Callaway, venture partner with HealthQuest Capital for driving those points home.

We thank Georgia Bio, the board, staff and program steering committee for arranging and hosting an outstanding event. We are already looking forward to 2020 while putting what we learned to use and advancing conversations with colleagues new and old we saw this year.

Follow Georgia Bio on LinkedIn , Twitter and Facebook .

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Georgia Bio to Showcase State’s Leadership and Patients’ Perspectives in Bioscience Innovation at 2019 Innovation Summit

Fri, 27 Sep 2019 18:36:00 GMT

Atlanta, Georgia (September 26, 2019) – The Georgia Bio Innovation Summit is the southeast’s largest life science conference, showcasing Georgia’s leadership in innovation to improve the health and well-being of people, animals and the environment. This year’s Summit will bring together hundreds of CEOs, senior executives, scientists and public policy officials from Georgia and across the nation on October 8 at the Cobb Galleria in Atlanta.

How important is the life sciences industry to the state of Georgia? From 2007 to 2017, employment in life sciences grew by 14.9%, compared to 7.7% nationally, and 8.7% growth in private employment across all industries in the state.” An RTI report for Georgia Bio published earlier this year identified 1,960 unique life science establishments that contributed 68,300 jobs and $10 billion to Georgia’s Gross Domestic Product. Accounting for multiplier effects, the industry supports a total of approximately 194,000 jobs and contributes $21.8 billion to Georgia’s GDP.

The 2019 Breakfast Keynote is entitled ”Connecting Healthcare” from Dr. Jean-Christophe Tellier, UCB Global CEO. The Luncheon Keynote Address “Personalized Health in a Chaotic Environment” will be delivered by Marc Boutin, CEO of the National Health Council .

“In order to innovate, first and foremost, we must connect the patient to the science,” Tellier told the Harvard Club of Belgium. “We are moving from treating the group of patients on one criteria [towards] a better understanding of patient subpopulations and trying to define much more precise solutions that better match their needs based on biologic signatures.”

Georgia Bio is putting special emphasis on the patient’s perspective into this year’s event. What does patient-centricity really mean in an industry that comprises 20 percent of the U.S. economy? We will hear from four local members of the International Children’s Advisory Network; young advocates for the importance of the patient’s voice in pediatric care. High school senior Ayana Ganesh, sophomore Ava Meisner, eighth grader Kalee Polk, junior Maci Yeager and moderator Leanne West who will share their first person accounts of what patient centricity and the importance of the patient voice means in pediatric care.

View the full program agenda here .

Did you know, according to AdvaMed, Fortune 500 companies with more than three women on the Board have 66% higher return on invested capital and a 42% higher return on sales?

Given those statistics, to ensure we hear directly from the voice of the patient, and to build awareness among aspiring young women for what is attainable in our industry, we have intentionally stacked our presenting faculty with women leading the state’s life science sector. Read more about the industry leading women in Georgia’s life sciences presenting.

“We are entirely confident the 2019 edition of the Georgia Bio Innovation Summit will be of high value for any and all with an interest in Georgia’s life science community and driving better treatments and care to patients in Georgia and around the globe,” says Georgia Bio President and CEO Maria Thacker-Goethe.

About Georgia Bio

Georgia Bio is the state’s trade association committed to driving growth in Georgia’s biosciences industry and its many sectors, including agri-biotech, food and nutrition, bio-based technologies and renewable chemicals, industrial and environmental biotech, medical devices and technologies, pharmaceuticals and consumer healthcare, diagnostics and research products, testing and research services, and clinical research. Georgia Bio members include bioscience companies, academic and research institutions, bioscience service providers, digital health companies, and related organizations. For more information, visit www.gabio.org or follow us on Twitter @Georgia_Bio .

Editor’s Note: Registration is complimentary for credentialed members of the news media. To request media registration, please contact Kristina Forbes at kforbes@gabio.org | 404-920-2043.

Media Contact:
Kristina Forbes
404-920-2043
kforbes@gabio.org

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Georgia Bio Summer Interns look back on experience gained

Mon, 16 Sep 2019 17:54:00 GMT

This summer, Georgia Bio welcomed three ambitious and enthusiastic interns: Isabel Veith, Rob Warren, and Maanav Karamchandani. Our interns took some time to reflect on their internships and told us about their diverse career interests—education, politics, nonprofits—and how their internships influenced their career aspirations.

Isabel Veith, Senior Biology Major at Georgia Tech

Isabel was excited to learn about the inner workings of a nonprofit. “One of the reasons I was interested in this internship was learning the administrative and marketing side of a nonprofit. I have seen how making strategic connections between people and fostering relationships can benefit a cause.”

During her internship, Isabel gained insight into life science education. “I learned how critical education is to the industry and how inconsistent life science opportunities and resources are in some schools. Middle and high school education is the foundation for the workforce, and I never thought about how a lack of opportunities and resources at those ages could have reverberating effects on the industry. I am very passionate about giving back to future generations. I am a firm believer in leaving a place better than you found it. I would like to eventually become a professor and be able to serve in a mentor capacity to students. I think you can make major impacts in a field just by providing encouraging words and guidance to young scientists.”

Whatever her career path, Isabel now knows the importance of connection and working together to achieve a goal. “I would like to end up working in a nonprofit, but I think with any job I take, Georgia Bio has shown me that the way you approach a job or mission is crucial. Building networks and promoting collaboration can make all the difference.”

Rob Warren, Junior International Politics Major at Washington and Lee University

Rob says he gained great knowledge of the life sciences industry during his internship at Georgia Bio. “I had the opportunity to attend the Strategic Planning meeting in June, where I learned about the future of the industry, like drug price transparency. Attending events like this allowed me to learn more about the industry overall.”

“I got to experience the policy and advocacy side of a trade organization. I helped with various projects, including researching policy to promote that aligns with the interests of our member organizations. I also had the opportunity to work on member engagement.”

Rob says his time at Georgia Bio introduced him to a new potential career path. “Before the internship, I had no certain direction for my career. Now, I know I want to pursue business, maybe even lobbying. Working on policy opened me up to the business/politics career possibility.”

Outside of science, Rob has a passion for travel. “I like to travel internationally; I’m studying abroad in Prague this fall. Some of the countries I’ve visited include Argentina, Chile, Italy, France, Canada, Mexico, Belize, and Switzerland. Exploring different cultures and places is very interesting, and I try to use what I learn from my travels in my everyday life.”

Maanav Karamchandani, Junior at Lambert High School

Maanav learned how he might one day break into the life sciences industry. “Before working with Georgia Bio, I had little exposure to the life sciences industry and was not very clear as to how I would get into the field. This internship provided me with countless opportunities to meet people working in the life sciences industry as well as learn how they got there. Georgia Bio made me a part of the team and allowed me to grow.”

He feels he really made an impact during his time at Georgia Bio. “The projects I did were a part of larger ones, and the impact of my work was visible immediately. Some of the projects I worked on include the Global Health ATL social media posts, the new Georgia Bio website, and providing new ways to increase member engagement.”

Manaav’s path to achieving his career goals was clarified thanks to his time at Georgia Bio. “I now know the type of education needed for my future career. I also have a better idea as to how to reach my goals and aspirations in this field. Meeting different people in the field has also allowed me to expand my mindset and see that there are many paths to reach my ambitions.”

Outside of his studies, Manaav has already been making an impact on the world. “I am very passionate about community service. I founded my own nonprofit, www.myjal.org, at the age of seven to provide clean drinking water to people in need across the world.” MyJal has helped provide over 300 children and adults in need clean drinking water and continues to work on new projects. “MyJal is something that I am extremely proud of.”

All three of these interns show great passion when it comes to their career goals, and it sounds like they learned a great deal during their internships at Georgia Bio! We feel lucky to have spent the summer with these students and can’t wait to see what they accomplish in the future. Georgia Bio looks forward to welcoming more interns throughout the year and next summer!

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The First Person Voice of the Pediatric Patient at the 2019 Georgia Bio Innovation Summit

Fri, 13 Sep 2019 20:30:00 GMT

“Patient centricity” lands way at the top of the healthcare buzzword bingo scoring chart. How exactly do patients fit in the middle of an equation that includes 20 percent of the U.S. economy, shareholder demands, venture capital ROI, physician and hospital shortages and perhaps the most confusing insurance system on Earth?

We don’t have all of the answers, but one way we can start to make patient-centricity more real and less nebulous is to ensure we hear from them directly at learning opportunities like the 2019 Georgia Bio Innovation Summit.

On Tuesday, October 8 at 3:30 p.m., we will hear the stories of four members of the International Children’s Advisory Network; young advocates for the importance of the patient’s voice in pediatric care. Please join high school senior Ayana Ganesh, sophomore Ava Meisner, eighth grader Kalee Polk, junior Maci Yeager and moderator Leanne West who will share their first person accounts of what patient centricity and the importance of the patient voice means in pediatric care.

See the full 2019 program.

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40 Under Forty 2019 nomination for Georgia Bio’s Maria Thacker-Goethe

Fri, 13 Sep 2019 19:47:00 GMT

We are delighted to announce that Maria Thacker-Goethe, President & CEO of Georgia Bio and Executive Director of Georgia Global Health Alliance, has been selected by the Atlanta Business Chronicle as a 40 Under Forty 2019 honoree. More than 400 nominations were submitted this year and her professional and personal accomplishments secured her place alongside other prominent Atlanta leaders.

Below are a few of her many accomplishments:

Maria is passionate about her work and community – all while making time for her 2-year old daughter Cecilia and her husband, Patrick. We thank her for championing the efforts to make Georgia’s Life Sciences and Public Health industries known throughout the state, nationally and globally.The honorees will be celebrated at an evening awards event on Nov. 7, 2019, at The Fairmont, 1429 Fairmont Ave. NW, in Atlanta.

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Georgia Bio Members Take Advantage of the Abundant Networking and Partnering Opportunities at BIO 2019

Mon, 08 Jul 2019 13:24:00 GMT

Georgia Bio was delighted to attend the 2019 BIO International Convention in Philadelphia from June 3rd to June 6th. During the four days of programming and exhibitions under the theme, “It Starts with One,” Georgia Bio and some of its members had the opportunity to continue their mission of advancing the growth of Georgia’s life science industry by fostering new and existing relationships with like-minded organizations.

Dr. Amy Baxter, founder and CEO of PainCareLabs in Atlanta, spoke positively about her experience exhibiting at the 2019 Convention and on the support that the State of Georgia was able to provide their affiliated companies that allowed them to take full advantage of their time at the convention.

“Georgia did everything right,” explained Baxter. “They had a gorgeous booth, offered strong support so we could focus on networking, and executed great planning in advance.

“It may seem odd to be a medical device company at a bio/pharma event, but our devices work in conjunction with pharma products to block the pain of their injections and everyone was interested in how we could make the patient journey better for their patients. The explosion in the biosimilars market means companies want a way to differentiate their product and support.”

Amy also noted that the female to men ratio at Convention was significantly higher compared to other industry conferences that she has attended, including J.P. Morgan, and there were several female CEOs that visited their booth. This year, BIO was able to break their own Guinness World Record for “The Largest Business Partnering Event” – previously set at BIO 2018 – by participating in over 48,500 partnering meetings at this year’s convention. Gaining access to an environment that facilitates this many networking and partnering opportunities is exactly why companies like PainCareLabs look forward to attending the annual event.

Tara Lorenz, Senior Marketing Manager at Recro Gainesville , also expressed her company’s enthusiasm for the event and the support that was provided to Georgia organizations.

“Many attendees were excited to see the State of Georgia represented at BIO 2019 and approached our booth to learn about Recro Gainesville’s capabilities as a Contract Drug Manufacturing Organization,” stated Lorenz.

“By attending and exhibiting at events such as BIO 2019, we have the opportunity to learn and reflect on how recent innovations and advances in technology could have a global impact to address unmet medical needs and increase the number of approved orphan drugs and rare disease medications worldwide.”

Lorenz also elaborated on the value of events like BIO that bring together large groups of innovators who don’t normally have the opportunity to collaborate on a day-to-day basis.

“This kind of collaboration is so instrumental for sharing best practices and fostering advancement in healthcare,” she explained. “These new conversations that develop into trusted relationships could advance a new molecule all the way to FDA approval and result in novel therapies for future generations. Events like this one truly help set the stage for manufacturing and commercializing new life saving medications for patients.”

Georgia Bio loved the opportunity to partner with the State of Georgia on the Georgia Pavilion to help drive growth for our members and Georgia’s biosciences industry at the BIO International Convention, and we are looking forward to BIO 2020 in San Diego! For more information on Georgia Bio and our mission, visit www.gabio.org or follow us on Twitter @Georgia_Bio .

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GeorgiaBio to Deliver Life Science Teacher Training Program to Rural Georgia

Tue, 18 Jun 2019 15:53:00 GMT

ATLANTA — Included in Georgia’s 2020 budget signed into law by Governor Brian Kemp on May 10 are funds to support life sciences education in rural school systems through the Georgia Department of Education and the Georgia Youth Science & Technology Centers.

“The life sciences industry is a leading driver of employment nationally, but leaders express concern about the availability of a strong workforce,” said Georgia Bio President & CEO Maria Thacker-Goethe. “We need educators to be aware of the vast, high paying jobs available in the life sciences industry here in Georgia. By expanding our proven teacher trainings statewide, we will equip educators with the academic, technical, and leadership skills to meet the students’ interests and industry’s needs.”

These trainings are the first of their kind nationally and set Georgia to be a premier training location for this skilled workforce. Curriculum developed in collaboration with the Georgia Institute of Technology and University of Georgia, specifically the Center for Cell Manufacturing Technologies (CMaT), will prepare students to work in biomanufacturing and the emerging biotech industry. These hands-on applications of STEM learning will solidify what students learn in other classes, as well as provide skills required for tomorrow’s workforce. More on the programs at www.gabio.org .

Georgia Bio’s membership has been supporting these initiatives for years. Adding State support improves alignment to fuel a high growth, high income industry through educators and students in rural Georgia. Georgia Bio recently reported that employment in the life sciences industry grew by 14.9 percent between 2007 and 2017, a rate nearly twice the national average.

“The best thing we can do here in Georgia is create an ecosystem that continues to allow for a growing economy, a talented workforce and significant potential in front of it,” Lt. Governor Geoff Duncan told us recently.

Georgia Bio is the state’s trade association committed to driving growth in Georgia’s biosciences industry and its many sectors, including agri-biotech, food and nutrition, bio-based technologies and renewable chemicals, industrial and environmental biotech, medical devices and technologies, pharmaceuticals and consumer healthcare, diagnostics and research products, testing and research services, and clinical research. Georgia Bio members include bioscience companies, academic and research institutions, bioscience service providers, digital health companies, and related organizations. For more information, visit www.gabio.org or follow us on Twitter @Georgia_Bio .

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Meeting the workforce needs of the Georgia life science ecosystem: 3 minutes with Georgia BioEd Board Chair Philip Gibson

Wed, 05 Jun 2019 19:30:00 GMT

The future of a state’s life science industry is only as bright as its workforce pipeline. Careers in the life sciences are often born from simple demonstrations of how things like the heart work (a tennis ball and a bit of latex will do) and parent education on what the life science industry can offer students.

Philip Gibson, Georgia BioEd Board Chair talks about about its mission, work and industry ties.

“[One of] Georgia BioEd’s needs is [more] participation of the industry to help us to determine what exactly do they want out of someone that’s coming out of the educational system,” Philip said. “What do they desire in employees, how many employees do they need? We work to generate that information and then to try to meet those needs of the state.”

If you would like to know more about how Georgia Bio supports the state’s life science workforce and educator needs, contact email Senior Director of Member Engagement Kristina Forbes via email: kforbes@gabio.org .

Follow Georgia Bio on LinkedIn , Twitter and Facebook .

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Georgia Bio 2019 Legislative Session Recap

Tue, 04 Jun 2019 16:05:00 GMT

The 2019 Georgia 40-day legislative session concluded with Sine Die on Tuesday, April 2nd. This legislative session was characterized by new leadership in the Governor and Lt. Governor’s office, as well as 40 freshman legislators.

Of the eight measures detailed below, there were two for which Georgia Bio actively advocated on behalf of our members and the people of georgia. Our rural teacher training program received state funding to expand an existing pilot training program for high school teachers that specifically addresses the skill and equipment gap. Workforce development and availability is always a top question we must address with life sciences companies seeking new locations, headquarters or expansions. More on this exciting development and program is coming soon.

We also took a supportive stance on HB 63, which helps protect patients from onerous step therapy requirements. That bill was signed into law by Governor Kemp as well.

We thank our legislative affairs team for their tireless work arranging and executing on awareness and importance meetings with appropriation committee members, the Governor’s and Lt. Governor’s offices. We also thank our members who contributed in person to those meetings to ensure the industry’s position and subject matter expertise were well represented in those conversations with our state legislators.

As Georgia Bio closes out a successful legislative session, we will be meeting with and working with as many members as possible during the remainder of the year to discuss top of mind priorities and construct our legislative efforts going into the 2020 session.

Here is a recap of the top life science industry items that made it through the session and were signed into law last month by Governor Kemp.

2019 Legislative Priorities

Rural Teacher Training Program

As many of you are aware, the life sciences industries require many skills that are in the traditional STEM education area, however what is often lacking is practical laboratory technique combined with hands-on laboratory experience. Thanks to the leadership of state appropriators and Governor Brian Kemp, Georgia Bio was able to secure funding in the FY2020 budget to match private funds that will enable Georgia Bio, through the Georgia BioEd Institute in partnership with the Marcus Center for Therapeutic Cell Characterization and Manufacturing at Georgia Tech, to expand an existing pilot training program for high school teachers that specifically addresses the skill and equipment gap. Partnering with the Department of Education and the Georgia Youth Science Centers, year one of the program will provide 8 training workshops in rural school districts impacting roughly 64 high school teachers and reaching over 5,000 students.

BILL MOVEMENT

This session the Georgia Generally Assembly passed legislation that would establish step therapy protocols for patients, provisions for the licensure of genetic counselors, the authorization to submit a Section 1115 waiver request to the United States Department of Health and Human Services Centers for Medicare and Medicaid Services, and modernizing telemedicine policy in Georgia. Please see below for more details on bills that passed out of the 2019 Georgia Legislative Session and signed into law by Governor Kemp.

HB 63 – Health Benefit Plans to Establish Step Therapy Protocols

Georgia Bio Legislative Affairs Committee voted to SUPPORT HB 63, introduced by Representative Sharon Cooper (R – Marietta) establishes step therapy protocols to protect patients from onerous step therapy requirements. Ensures that step therapy protocols are based on clinical guidelines developed by independent experts. Establishes a basic framework for when it is medically appropriate to exempt patients from step therapy, as well as an exceptions process that is transparent and accessible to patients and health care providers. The step therapy bill passed out of the Senate with a vote of 49-0 and House of Representatives with a vote of 165-0 on April 2 nd .

HB 166 – Genetic Counselors Act

Representative Deborah Silcox (R – Sandy Springs) authored HB 166, requiring licensing for genetic counselors, including physicians, assistants and mandates some continuing education requirements. There are approximately 89 genetic counselors in Georgia and all those individuals have master’s degrees for a specialty in genetic counseling and half work in hospitals. The other half of the genetic counselors work out in the field with physicians, primarily, and primary care doctors. They work primarily in three different areas: prenatal care, cardiac care and oncology. HB 166 passed by the House of Representatives by a vote of 148-15 on February 15 th and was adopted by the Senate with a vote of 45-4 on March 11 th .

HB 321 – Extend Sunset for the Hospital Medicaid Financing Program

Authored by Representative Jodi lott (R – Evans) HB 321 extends Georgia’s hospital provide fee through June 30, 2025 to help finance the state’s Medicaid program. In FY 2020, the state expects to collect more than $310 million from the provider fee which it will utilize to draw more than $650 million in federal funds. The bill also includes new financial disclosure and transparency requirements for nonprofit hospitals and the five-year extension of the state’s $60 million rural hospital tax credit. The House of Representatives passed the bill by a vote of 147-19 on February 28 th and was adopted by the senate with a vote of 50-2 on March 29 th .

HB 514 – Georgia Mental Health Reform and Innovation Commission

HB 514 authored by Representative Kevin Tanner (R – Dawsonville) creates the Georgia Mental Health Reform and Innovation Commission. The FY 2020 budget also included several increases for mental health services. The House of Representatives passed the bill by a vote of 152-10 on March 7 th and the Senate adopted with a vote of 52-0 on April 2 nd .

SB 106 – Patients First Act

SB 106 coined the Patients First Act Authored by Senate Blake Tillery (R – Vidalia) authorizes the Department of Community Health to submit a Section 1115 waiver request to the United States Department of Health and Human Services Centers for Medicare and Medicaid Services. This act is a step toward lowering insurance premiums, enhancing access to quality care, and improving health outcomes in every part of our state. The Senate passed the bill by a vote of 35-20 on February 26 th and the House of Representatives adopted with a vote of 104-67 on March 25 th .

SB 115 – “Medical Practice Act of the State of Georgia

SB 115 sponsored by Senator Renee Unterman (R – Buford) aims to provide telemedicine licenses for physicians in other states and for Georgia to engage in the practice of medicine with patients in the state through telemedicine. The Senate passed the bill by a vote of 54-0 on February 26 th and the House of Representatives adopted with a vote of 161-2 on March 29 th .

SB 118 – Georgia Telemedicine Act

Authored by Senator Renee Unterman (R – Buford), SB 118 modernize the Georgia Telemedicine Act by renaming it to the Telehealth Act. The bill provides the definitions of telemedicine and telehealth and would require that all health insurance policies over appropriately provided telehealth services. The Senate passed the bill by a vote of 50-0 on February 26 th and the House of Representatives adopted with a vote of 168-1 on March 25 th .

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Georgia Bio Quarterly Meeting: State of the Industry Report

Thu, 11 Apr 2019 18:01:00 GMT

April 17, 2019 | 7:30 – 9:00AM
Upstairs Atlanta, 525 Bishop St NW, Atlanta, GA 30318

Join Georgia Bio for a preview of the 2019 Georgia Life Sciences Industry Analysis. This breakfast meeting will provide members, non-members and Georgia community leaders with valuable industry information.

The state of the industry report, supported by funding from the Biotechnology Innovation Organization (BIO), Georgia Department of Economic Development, Georgia Global Health Alliance, Georgia Research Alliance, Johnson & Johnson, PhRMA, UCB, Inc. and VWR, part of Avantor, features employment and economic contribution from Georgia’s life sciences industry. Georgia Bio CEO Maria Thacker-Goethe will deliver a summary and highlights from the report followed by a panel discussion featuring Georgia Lt. Governor Geoff Duncan, Georgia Research Alliance President & CEO Russell Allen and Head of U.S. Gov’t Relations for UCB Joseph Zorzoli.

“While we don’t want to let the cat out of the bag, it can suffice to say Georgia’s life science industry has shown strong growth compared to the national average and other industry sectors in the state,” Thacker-Goethe said. “We look forward to sharing the report and hosting a lively discussion with our distinguished panelists.”

Georgia Bio has long been a go-to source for data on the bioscience industry in our State. Do not miss this chance to network with industry leaders and learn about one of Georgia’s most innovative sectors. The full 2019 Georgia Life Sciences State of the Industry Report will be made public in the coming weeks.

Those unable to attend can live stream the event on Georgia Bio’s Youtube channel .

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Georgia Bio Names Westminster School Junior as Georgia BioGENEius Winner

Wed, 10 Apr 2019 08:42:00 GMT

Ananya Ganesh Advances to Philadelphia in International Competition Against Top Students

Atlanta, GA (April 10, 2019) – Georgia Bio and the Georgia BioEd Institute today named Ananya Ganesh, a junior at The Westminster Schools in Atlanta, GA, as the winner of the 2019 Georgia BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. As Georgia’s BioGENEius finalist, Ananya will attend the 2019 BIO International Convention, the industry’s trade conference from June 3-6 in Philadelphia, PA where she will engage with leading companies, scientists and innovators currently transforming the scientific landscape in order to gain valuable insights into an industry making significant contributions to the world.

While in Philadelphia, Ananya will compete against high school students from the U.S., Canada and Germany in the International BioGENEius Challenge. The student projects will represent a range of biotechnology topics such as healthcare, agriculture, and the environment.

Ananya’s award-winning research uses algorithms to assess and classify lung function in young children with Early Onset Scoliosis (EOS). The purpose of this project was to develop a prediction model for lung function using the shape of the rib cage, and to create a functional classification method for EOS patients. This classification method can replace the traditional testing method of spirometry, which typically provides unreliable results in children.

“The BioGENEius Challenge highlights the breakthroughs made when we invest in and encourage young people to pursue their ideas,” said Georgia Bio President and CEO Maria Thacker. “Georgia Bio is thrilled that Ananya will represent our state at the upcoming BIO Convention. We are proud to support this Georgia scholar as she develops tomorrow’s healthcare innovations.”

Georgia Bio also congratulates the Georgia BioGENEius runner-up, Nicole Frey of Paulding County High School in Dallas, GA. Frey’s project focused on isolation of the chiA gene from a soil bacterium, Serratia marcescens . The chiA gene codes for an enzyme that breaks down chitin, the primary component of the cell walls in fungi. This gene could be inserted into plants to help them defend against disease-causing species of fungi.

Judging the 2019 Georgia BioGENEius were Jamie L. Graham, Kilpatrick Townsend & Stockton; Ralph L. Cordell, CDC; Teshome Mebatsion, Boehringer Ingelheim; and Ian Biggs, UGA.

National and International winners will be announced during June 3-6, 2019 BIO International Convention . Winners will receive cash scholarships.

Follow the BioGENEius Challenge: Throughout the challenge, @BiotechInstitutwill be tweeting interviews, photos, and engaging with the biotechnology community by using the hashtag #BioGENEius.

About the Biotechnology Institute

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GLS President & CEO, Maria Thacker Goethe Recognized as One of Georgia's 2025 Top 500 Most Influential Leaders

GLS President & CEO, Maria Thacker Goethe Recognized as One of Georgia's 2025 Top 500 Most Influential Leaders

Legal Experts Signal Continued Uncertainty for Life Sciences M&A

“Evolving FTC and DOJ policies leave investors and innovators navigating a cautious M&A landscape

Georgia Life Sciences Launches New Podcast Series, Vitals, in Partnership with Cloudcast Media

BIO Statement on Most Favored Nation Policies

September GBG Report Now Available – Federal Funding Insights for Georgia Life Sciences Members

Advocating for U.S. Agricultural Biotechnology Leadership

Protecting U.S. Leadership in Agricultural Biotechnology

2025 Georgia Life Sciences Summit Poster Session Winners

Celebrating the Next Generation of Scientific Breakthroughs in Georgia

General Catalyst: Pro-Competitive Partnerships Drive “Steady Drumbeat of Innovation” in the Life Sciences

Golden Helix Awards recognize achievements in Georgia's life sciences sector

Georgia Life Sciences, AdvaMed, Patient Groups, State Medtech Associations Urge Medicare Coverage of Breakthrough Medtech

Georgia's life sciences sector has grown, but key ingredients still lacking

“If you're not affiliated with a university, you can't really access their labs,” said Eddie Lai, director of business development at venture capital firm Portal Innovations. “If you're trying to build your own facility, that costs a lot of money.”

Georgia Life Sciences Names 2025 Golden Helix Award Winners

Academic Innovators and Industry Leaders to be Honored at the Georgia Life Sciences Summit

Message from CEO: Mounting Federal Pressures and a Vital Moment for Georgia

Emerging biotechs get bearish to weather market trends, finds BIO report

Bearish venture capital

Licensing and deals dip

Biopharma layoffs

New 2025 Data Sheds Light on 340B Activity in Georgia

Pioneer Institute has released updated #340B state fact sheets for 2025

GLS is proud to announce a new partnership with Apprenti

GLS is proud to announce a new partnership with Apprenti

This is a key step toward expanding Registered Apprenticeship programs across Georgia’s thriving life sciences sector.

COMMUNITY NEWS CBO Analysis Shows Significant Impact of NIH Funding Cuts and FDA Delays on Drug Development

What It Means for Georgia

Key Findings

Implications for Georgia’s Life Sciences Ecosystem

Industry Perspective

Looking Ahead

Healthcare and Life Sciences Brace for Policy Impact

60% of industry leaders expect tariffs and pricing policies to affect business operations

Georgia Life Sciences Partners with U.S. Chamber Foundation to Bring Real-World Innovation to Georgia Classrooms

Georgia Life Sciences Partners with U.S. Chamber Foundation to Bring Real-World Innovation to Georgia Classrooms

60 + high school students tackle real industry challenges through national EPIC program

Georgia RDAC Publishes Its 2024-2025 Annual Report: Building Momentum for Georgia’s Rare Disease Community

Study Finds Trump’s Most Favored Nation Drug Proposal Could Still Raise Out-of-Pocket Costs Without PBM Reform

Study Finds Trump’s Most Favored Nation Drug Proposal Could Still Raise Out-of-Pocket Costs Without PBM Reform

REPRESENTATIVES HOULAHAN, BICE ANNOUNCE BIOTECH CAUCUS

Bipartisan House Caucus Will Advance Domestic Bioeconomy and Competitive Posture

New Report Reveals National Trends Reshaping the Life Sciences Workforce

Announcing the Launch of the Life Sciences Workforce Collaborative — and a Preview of What’s Ahead

What happens when students see real work before choosing a future

Georgia Life Sciences Accepted into ARPA‑H Customer Experience Hub

Opinion: Georgia's Congressional delegation can lead the way on correcting 'pill penalty'