Welcome

Kathy Giacomini, PhD, BSPharm - Dean, School of Pharmacy, UCSF

Kuldev Singh, MD, MPH - Professor of Ophthalmology, Stanford University

Opening Remarks

Sam Hawgood, MBBS - Chancellor, University of California San Francisco, UCSF

Lloyd Minor, MD - Dean, Stanford University School of Medicine

Innovative Research in Regulatory Science

Kathy Giacomini, PhD, BSPharm - Dean, School of Pharmacy, UCSF

Lightning Talk: Artificial Intelligence (AI) for Regulatory Efficiency

Russ Altman, MD, PhD - Kenneth Fong Professor of Bioengineering, Genetics, Medicine, Biomedical Data Science, and (by courtesy) Computer Science

Panel 1: What Are the Major Barriers to Drug Development and Approval That Can Be Solved with AI and New Technologies?

Moderators:

Russ Altman, MD, PhD - Kenneth Fong Professor of Bioengineering, Genetics, Medicine, Biomedical Data Science, and (by courtesy) Computer Science

Kathy Giacomini, PhD, BSPharm - Dean, School of Pharmacy, UCSF

Panelists:

Danielle Belgrave, PhD - Vice President, Artificial Intelligence / Machine Learning, GSK

Cristina Duran - President, Evinova

James Zou, PhD - Associate Professor, Biomedical Data Science, Stanford University

Lightning Talk: The Acute Pain Pathways Study

Molly Jeffery, PhD - Scientific Director of Emergency Medicine Research and Associate Professor of Emergency Medicine and Health Services Research, Mayo Clinic

Debate 1: Is It Time to Get Rid of Animal Testing?

Moderators:

Steven Kozlowski, MD - Chief Scientist, US FDA

Joseph Wu, MD, PhD - Professor and Director, Stanford Cardiovascular Institute, Stanford University

Debaters:

(Yes) Paul Watkins, MD - Howard Q Ferguson Distinguished Professor, University of North Carolina, Chapel Hill

(No) Jorg Blumen, PhD, ERT - Sr. Vice President, Development Sciences, Genentech

How AI Could Transform Pre-Clinical Drug Discovery

James Fraser, PhD - Professor and Chair, Dept. of Bioengineering and Therapeutic Sciences, UCSF

Andy Kilianski, PhD - Acting Deputy Director, Health Science Futures, Advanced Research Projects Agency for Health

Lightning Talk: Early Endpoints

Keli Santos-Parker, MD, MS, PhD, T32, Surgical Oncology Fellow, UCSF

Panel 2: New Opportunities to Improve the Development and Use of Robust Early Endpoints to Accelerate Identification and Approval of Agents to Prevent and Reduce Chronic Diseases

Moderators:

Laura Esserman, MD, MBA - Professor of Surgery and Radiology, UCSF

Jane Perlmutter, PhD, MBA - Founder and President, Gemini Group

Panelists:

Hal Barron, MD - Chief Executive Officer, Founder and Board Co-Chair, Altos Labs

Kate Goodrich, MD, MHS - Executive in Residence, Optum, Inc.

Anthony Letai, MD, PhD - Director, National Cancer Institute

Richard Pazdur, MD - Former Director, Oncology Center of Excellence, US FDA

Lightning Talk: Helping American Manufacturing

Clifford Rossi, PhD, Executive-in-Residence and Professor of the Practice, Robert H. Smith School of Business, University of Maryland

Panel 3: FDA Leaders Forum

Moderators:

Kuldev Singh, MD, MPH - Professor of Ophthalmology, Stanford University

Steven Kozlowski, MD - Chief Scientist, US FDA

Panelists:

Kyle Diamantas, JD - Deputy Commissioner for Human Foods, US FDA

Michelle Tarver, MD, PhD - Director, Center for Devices and Radiological Health, US FDA

Mary Thanh Hai, MD - Director, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), US FDA

Sarah Yim, MD - Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, US FDA

Debate 2: Should Biosimilars Be Approved Based on Analytical Equivalence and RWE Data Follow-Up?

Co-Moderators:

Joseph Wu, MD, PhD - Professor and Director, Stanford Cardiovascular Institute, Stanford University

Robert Califf, MD - Former FDA Commissioner

Debaters:

(Yes) Dan Hartman, MD - Director, Integrated Development, Gates Foundation

(No) Hope Rugo, MD - Director, Women's Cancer Program and Division Chief, Breast Medical Oncology, City of Hope Cancer Center

Panel 4: Innovation at a Crossroads: Science, Strategy, Policy, and Global Forces Shaping Biopharma's Future

Moderator:

Andy Plumb, MD, PhD - President, Research and Development, Takeda Pharmaceutical

Panelists:

Scott Gottlieb, MD - Sr. Fellow, American Enterprise Institute for Public Policy Research and Partner, New Enterprise Associates

Rajiv Kaul - Portfolio Manager, Fidelity Select Biotechnology Fund, Fidelity Investments

John Maraganore, PhD - CEO and Principal, JMM Innovations, LLC

Closing Remarks

Kathy Giacomini, PhD, BSPharm - Dean, School of Pharmacy, UCSF

Kuldev Singh, MD, MPH - Professor of Ophthalmology, Stanford University