Get ready for a day of forward-looking conversations, practical insights, and meaningful connections across Maryland’s life sciences ecosystem. The Bio Innovation Conference agenda brings together industry leaders, innovators, and experts to explore the technologies, strategies, and opportunities shaping the future of life sciences.

FIRESIDE CHAT

Inside the FDA: An Honest Conversation

In this rare and candid conversation, former senior FDA leaders Julie Tierney and Dr. Tala Fakhouri will go beyond the surface to unpack the realities behind FDA decision-making that no guidance document can fully capture. The fireside chat will delve into how the agency weighs scientific uncertainty, navigates internal disagreement, interprets sponsor behavior, and decides whether an innovative regulatory strategy inspires confidence or creates concern.

Tierney brings an extraordinary agency-wide perspective from her roles as FDA chief of staff, deputy director of CBER, FDA counsel, Senate health policy advisor, and leader in rare disease policy, expedited programs, complex biologics, and landmark FDA legislation. Fakhouri adds deep technical expertise from CDER, where she led policy at the intersection of data science, artificial intelligence, real-world evidence, digital health, and regulatory decision-making, including development of CDER’s first draft AI guidance and creation of its AI Council.

Together, they will give life sciences executives, scientists, investors, and regulatory leaders an unusually direct look at what FDA reviewers and decision-makers need from sponsors, why seemingly strong programs can lose momentum, and how companies can engage the agency more strategically at the moments that matter most.

PANEL

Beyond the Hype: Breakthrough Platforms that Could Reshape Biotech

Breakthrough platforms have the capability to transform how therapies are discovered, manufactured, financed, and delivered-but which are actually positioned to create lasting value? This panel brings together leaders from across the product lifecycle to separate the hype from actionable progress. Panelists will examine the evidence, economics, scalability, regulatory considerations, and patient delivery implications of emerging platforms-and identify the signals organizations should monitor, test, and prepare for in the near future.

PANEL

Beyond Borders: Building a Global Development Strategy from Day One

For many emerging biotech companies, the FDA represents the primary regulatory target. However, companies that think globally from the start may unlock faster development timelines, lower clinical costs, broader partnership opportunities, and greater enterprise value.

This panel will explore how biotech and life science companies can design development programs that support multiple regulatory jurisdictions, preserve international commercialization opportunities, and navigate today’s evolving global landscape. Panelists will share practical experiences related to international clinical trials, manufacturing, regulatory strategy, licensing, investor expectations, and geopolitical considerations that influence business success beyond the U.S. market.

PANEL

From Pitch to Term Sheet: Capital Raising & Dealmaking for Early-Stage Life Science Startups

Securing capital and closing deals are pivotal milestones for early-stage life science companies, yet navigating the complexities of valuation, legal structuring, and negotiation requires a multi-faceted approach.

This panel brings together three critical perspectives—an investor, an attorney, and a transaction specialist—to demystify the funding and dealmaking landscape. Attendees will gain actionable insights into what drives investor decisions, how to avoid common legal pitfalls during diligence, and strategies for structuring strategic transactions and partnerships that accelerate growth.

PANEL

Cell and Gene Therapy Manufacturing: Scaling Access from Vein to Vein

Session details coming soon.

PANEL

AI in Life Sciences: What Is Working Now

Session details coming soon.

Roundtable Discussions

Engage in interactive, peer-to-peer conversations focused on timely topics and emerging issues across the life sciences industry. Roundtable topics and discussion leaders will be announced soon.

More Agenda Details Coming Soon

We’re continuing to build an exciting program featuring industry leaders, innovators, and thought-provoking conversations. Check back soon for additional session details, speakers, and agenda updates.