Speaker:

John F. Crowley, President & CEO 
Biotechnology Innovation Organization (BIO) 

The United States once drove most of the early clinical research (i.e., proof of concept, FIH, Phase 1) in drug development.  A combination of efficiencies and economic incentives have drawn much of that work outside the US.  The FDA and the innovative biopharmaceutical industry share the goal of enhancing US competitiveness and incentivizing early drug development in the US.  Ensuring the US clinical trial infrastructure is globally competitive enhances national security for all Americans.  In this session, FDA and biotech leadership will explore root causes for running clinical trials outside the US and opportunities for making the US more efficient followed by facilitated audience engagement.  

Moderator:  Tom Mathers, Executive Chairman, Aer Therapeutics, Inc. 

Speakers:

• Annetta Beauregard, Senior Vice President, Science & Regulatory Affairs, Biotechnology Innovation Organization (BIO)   
• Tom DiLenge, Senior Partner, Global Public Policy. Regulatory & Governmental Strategy, Flagship Pioneering 
• Karim Mikhail, Special Advisor, U.S. Food and Drug Administration 

China has spent two decades building a biotechnology ecosystem designed to challenge the United States and dominate on a global stage, moving from “me too” medicines to cutting edge innovation. China’s shift upstream to novel drug discovery and development, combined with shifting dynamics on the global geopolitical stage, presents new risks to the future of US biotech leadership.  Meanwhile U.S. reliance on China for key medicines and materials, partnerships and in-licensing activity signal a rapidly shifting competitive landscape. 

Will the US shape the future of biotechnology or be beholden to one defined by others? This private roundtable will examine the current state of U.S.–China strategic competition in biotechnology, where the status quo leads, and what must change now for the U.S. to sustain its leadership in biotechnology and the future of medicine.  

Moderator:  John F. Crowley, President & CEO. Biotechnology Innovation Organization (BIO) 

Speakers:

• Daniel Brog, Managing Director, Locust Walk 
• Melanie Hart, PhD, Senior Director, Global China Hub, Atlantic Council 
• Chris Hickey, PhD, Executive Director, Global Public Policy & International Government Affairs, Merck & Co., Inc. 
• Alina Meltaus, Chief of Staff, National Security Commission on Emerging Biotechnology (NSCEB) 
• Kelly Seagraves, PhD, Vice President, National Security & International Affairs, Biotechnology Innovation Organization (BIO) 

With healthcare costs rising, regulatory policy in flux, and public trust in experts and institutions under pressure, healthcare is poised to shape the political landscape heading into the 2026 midterm elections. For industry leaders, the stakes are unusually high: decisions made in Washington over the next year could reshape insurance markets, drug pricing policy, FDA oversight, vaccine access, and the future pace of medical innovation. 

This fireside conversation will examine which healthcare issues are most likely to influence voters and policymakers in an intensely polarized environment, where control of Congress may hinge on a narrow band of independent voters. Panelists will unpack how campaign narratives, economic pressures, and evolving Administration priorities could translate into policy outcomes affecting patients, providers, payers, and innovators alike.  This session will provide candid insight into the political crosscurrents shaping the industry—and what leaders should anticipate as election dynamics collide with urgent healthcare challenges.

Moderator:  John F. Crowley, President & CEO. Biotechnology Innovation Organization (BIO)  

Speakers:

• Kellyanne Conway, President of KAConsulting, and former Senior Counselor to President Trump 
• Adrienne Elrod, Co-Founder of the Elrod Gifford Group, and former Senior Advisor to the Biden-Harris campaign 

Speaker:

John F. Crowley, President & CEO 
Biotechnology Innovation Organization (BIO)