8:00AM – 9:30AM

Registration Open | Exhibit Hall Open | Breakfast and Networking 

8:00AM – 4:00PM

One2One Partnering

9:30AM

Welcome Remarks and Policy Update

9:45AM – 10:45AM

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. 

10:45AM – 11:00AM

Networking Break

11:00AM – 11:50AM

Concurrent Sessions

PANEL

Breaking the Cell & Gene Therapy Bottleneck

What will it take to move cell and gene therapies from highly specialized treatments to broadly accessible options for patients? Experts spanning manufacturing, supply chain, and patient access will examine the operational tradeoffs, lessons learned, and emerging approaches needed to scale delivery—reducing complexity, shortening timelines, lowering cost, and overcoming the distinct challenges when delivering cell and gene therapies to patients. 

Moderator

• Brian Stamper, Executive Director, Manufacturing Excellence, AstraZeneca

Panelists

• John Higgins, Vice President, Technical Ops, Cartesian Therapeutics  
• Anna Griffin, Strategy Lead – Oncology, Gilead Government Affairs 
• Nesha Miller, Director, Supply Chain, Kite, a Gilead Company 
• Don Startt, Executive Director, Process Development and Program Development Lead, REGENXBIO 

INTERACTIVE ROUNDTABLES

Beyond SBIRS: Non-Dilutive Funding Strategies to Advance Your Pipeline and Bottom Line

Host – Sabarni K. Chatterjee, Ph.D., M.B.A., Deputy Director, Office of Technology Transfer, National Institutes of Health, Deputy Director

Did you know you can receive non-dilutive support from the federal government without writing grants?! This roundtable will discuss non-dilutive support strategies apart from rolling the dice with grant submissions. Topics could include:

• Partnerships providing indirect/in-kind support – for which federal labs expend monies, expertise and capabilities on your behalf
• The wide range of company and technology development stages that can benefit
• Utilizing indirect support to achieve value inflection points
• Leveraging these relationships to impact burn-rate
• Enhancing the valuation of your pipeline through licensing

 

MTCEdge for Procurement: Smarter Buying in Life Sciences

Host – MTC and Thermo Fisher Scientific  

Join this interactive roundtable to learn how MTCEdge is helping Life Sciences companies streamline purchasing, reduce costs, and access trusted suppliers. Meet with MTC and the Thermo Fisher Scientific staff to explore how your team can benefit.

11:50AM – 1:10PM

Fuel the Future: Networking Lunch

1:10PM – 2:00PM

Concurrent Sessions

PANEL

Beyond U.S. Borders: The Global Strategy for Biotech

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. 

Moderator:

• Bill Enright, Chief Executive Officer & Board Director, Barinthus Biotherapeutics

Panelists:

• Jeff Hung, Ph.D., Co-Founder and CEO, Accufy Diagnostics
• Reg Seeto, Chief Executive Officer and President, Scipher Medicine
• Xin Tao, Partner, Hogan Lovells Cadwalader

INTERACTIVE ROUNDTABLES

Mapping Opportunity: Building the Next-Generation Biotech and Biomanufacturing Workforce 

Hosts:  Paige Korbakes, Director, JFF, Brian Stamper, Executive Director, Manufacturing Excellence, AstraZeneca

This roundtable would bring together life sciences stakeholders to review and discuss the development Maryland’s biotech and biomanufacturing career pathway maps, created in partnership between Maryland Department of Labor, Maryland’s Governor’s Workforce Development Board, and Jobs for the Future (JFF). Discussion will examine both the “how” and the “why” behind developing place-based career pathway maps, including stakeholder engagement and vetting, occupation selection, employer-validated skills, and applications for field providers, educators, and employers. An interactive discussion will then explore how these tools can support work-based learning, skills-based hiring, incumbent-worker advancement, and workforce readiness. 

 

Recent Development in the FDA

Host: Georgia Ravitz, Orrick

2:00PM – 2:15PM

Networking Break

2:15PM – 2:55PM

FEATURED KEYNOTE

The Next Frontier of Biomedical Innovation with Jayanta “Jay” Bhattacharya, M.D., Ph.D., NIH Director

Dr. Bhattacharya will share his insights from leading the nation’s flagship medical research agency since April 2025 and shed light on the agency’s research and public health priorities. A renowned doctor, researcher, and health economist, Dr. Bhattacharya previously held a tenured professorship at the Stanford University School of Medicine.

3:10PM – 3:50PM

Concurrent Sessions

FEATURED SPEAKER

Navigating the FDA Pathway for Novel Therapies 

•  Denise Gavin, Ph.D., Director, Office of Gene Therapy, OTP/CBER FDA

INTERACTIVE ROUNDTABLES

From Research to Production: Facility Considerations for Biomanufacturing and Critical Laboratory Infrastructure 

Host: Theodore (Ted) Traum, PE, CCP, DGCP, WorldBioHazTec

As organizations expand biomanufacturing capacity, facility leaders face challenges balancing research flexibility, manufacturing reliability, compliance requirements, and operational resilience. This discussion will explore key considerations for designing, renovating, commissioning, and maintaining biomanufacturing and critical laboratory facilities, including HVAC redundancy, utility infrastructure, containment, contamination control, and long-term operational sustainability.

 

2 Engines for Success. Execute Today. Build Tomorrow

Host: Peter Allen, Founder/EOS Implementer, Copper Spur Group

Growing companies have to run two engines at the same time. Engine 1. Execute today. Serve customers. Deliver the work. Hit the numbers. Solve problems. Generate cash. Engine 2. Build tomorrow. Develop people. Improve process. Research breakthroughs. Create an organization that can support the next stage of growth. In this roundtable we will explore how founders balance competing demands. Where should leaders spend their time? How do you keep urgent work from crowding out important work? What should you build now versus later? How do you know when you’re the bottleneck? Participants will share experiences, challenges, and practical approaches that can perform today while becoming more capable tomorrow.

3:50PM – 4:00PM

Networking Break

4:00PM – 5:00PM

FEATURED KEYNOTE

John Carreyrou, Investigative Reporter and Author of Bad Blood: Secrets and Lies in a Silicon Valley Startup

5:00PM – 6:00PM

Maryland Bio and Beyond Cocktail Reception and Book Signing