Consolidation, planning and due diligence: The #GCMI Annual Spotlight on the State of Preclinical for 2023

Medical lighting apparatus

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.

By Maria Thacker Goethe May 8, 2025
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.
By Sheran Brown May 1, 2025
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
By Maria Thacker Goethe April 18, 2025
The Science & Community Impacts Mapping Project (SCIMaP) shows how proposed federal funding cuts lead to reduced economic activity and job losses nationwide.
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