9:00 AM-4:00 PM: Partnering - Meeting Rooms C & D (Studio Theatre/Main Stage)

9:00 AM: Check-In & Continental Breakfast

9:30 AM: Keynote

10:15 AM: Panel Discussion| Building Biotech Ecosystems: Infrastructure, Incentives & Innovation

From garage labs to GMP manufacturing, infrastructure is the foundation of a thriving biotech economy—but it takes more than space. It requires intentional strategy, smart incentives, and public-private collaboration. This panel explores how states, cities, and industry partners are building innovation hubs that support growth from discovery to commercialization.

With recent reshoring announcements from companies like Lilly, Noramco, and AbbVie, regions like Georgia are emerging as national leaders in biotech manufacturing and supply chain reinvestment. Panelists will discuss how shared lab spaces, tax incentives, state backed funding, and workforce pipelines are converging to make these hubs competitive.

Crucially, this conversation will also highlight why small companies should care: proximity to infrastructure, talent, and funding ecosystems can dramatically shorten time to market, improve fundraising potential, and position startups to partner with or supply larger industry players. Whether you’re building a lab, planning a facility, or just trying to land your next grant, this session will provide a roadmap to navigating—and benefiting from—emerging biotech ecosystems.

11:00 AM: Panel Discussion | Navigating FDA Interactions for Early Stage Companies: Strategies for Successful Regulatory Engagement and Clinical Development

Early and effective engagement with the FDA is critical to the success of emerging companies. This session offers a comprehensive roadmap for navigating regulatory interactions, emphasizing the importance of building a proactive, integrated regulatory strategy from the outset. Experts will provide practical insights on when and how to initiate dialogue with the FDA, including best practices for preparing for key meeting types (Pre-IND, Type B, End-of-Phase 1/2 meetings) and setting clear objectives for each interaction.

Attendees will also learn how to develop and present a compelling data package to support an IND submission, and how to anticipate and address common regulatory red flags often identified during due diligence or early development gap analyses. The discussion will highlight how early regulatory alignment can not only de-risk clinical development but also enhance valuation during financing and partnering. Real-world case studies will illustrate successful—and cautionary—examples, equipping attendees

with actionable strategies to better position their programs for long-term success.

NOON: Boxed Lunch/Company Presentations (Terrace Meeting Room

& Cityview Terrace)

1:30 PM: Scientific Poster Winners Announced

1:45 PM: Panel Discussion | Innovating Without a Safety Net: Medical Device Development in an Era of Vanishing Grants

NIH and SBIR grants have long been lifelines for early-stage medical device development—supporting innovation that drives both health outcomes and economic growth. But with increasing uncertainty around federal funding, entrepreneurs, startups, and health system innovation centers must adapt to a new reality: doing more with less.

This session will explore how device developers can build capital-efficient, milestonedriven programs that avoid costly missteps and duplicative testing. Panelists will share strategies for sequencing activities with precision, knowing when to pause R&D to invest in foundational elements like quality systems, and identifying overlooked opportunities that yield high return on modest investment.

Key questions addressed include:

• What are the most common (and avoidable) process errors that delay development?

• How can early-stage innovators streamline design and testing without compromising outcomes?

• What low-cost, high-impact activities deliver outsized ROI in early development?

• What non-dilutive or hidden funding opportunities still exist—and how can they be accessed?

• Why is operational discipline increasingly viewed as a proxy for fundability?

Whether you're a startup founder, health system innovator, or investor, this discussion will provide actionable insights on surviving—and thriving—without traditional grant support.

2:30 Panel Discussion | Smarter, Faster, Safer: How AI Is Revolutionizing the Medtech & Biomanufacturing Supply Chain

AI isn’t just the future—it’s already reshaping how medtech and biomanufacturing companies of all sizes navigate global supply chain pressures. From startups scaling new technologies to established device makers ensuring speed and safety, intelligent supply chains are becoming essential for survival and growth.

This panel will explore how AI, machine learning, and automation are unlocking new levels of efficiency, agility, and resilience across the life sciences supply chain. Discover how digital twins, predictive analytics, and real-time data integration can reduce lead times, mitigate risk, and support compliance—without adding overhead.

Topics will include:

*AI-driven inventory and demand planning

*Risk mitigation across global logistics

*Building smarter, scalable systems with lean teams

*Integrating digital tools across R&D, manufacturing, and quality

Whether you're an innovator in medical devices, diagnostics, or biomanufacturing, this session offers timely strategies to future-proof your operations and compete smarter in a rapidly evolving landscape.

3:15 Break

3:30 Fireside Chat

4:15 Closing Remarks

4:30 Summit End