The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) was pleased to present the 5th annual CERSI Innovations in Regulatory Science Summit, "A Bold Vision for the Future of Regulatory Science," a gathering of leaders in the academia, industry, and regulatory sectors to discuss the role of regulatory science in medical product development on January 7, 2024, 9am-5:30pm PST.
The 2024 CERSI Innovations in Regulatory Science Summit had a major focus on emerging issues in regulatory science. The summit included panels on medical misinformation and its impact on public health, regulatory decision making among different countries, manufacturing and supply chain of medical products, and the return of our exciting panel featuring former FDA Commissioners on the latest issues facing the Agency. New this year was the FDA Center Directors panel as well as debates on exciting topics in regulatory science.
The goal of the summit was to stimulate discussion across sectors and to critically consider lessons learned and scientific issues that need addressing to expeditiously and safely advance the development, approval, and monitoring of medical products.
Panels
- Why is Medical Misinformation Killing Us?
- Variation in Regulatory Approaches Across the Globe: How Can We Work Together to Make Medical Products Commercially Viable and Available Worldwide?
- Accelerating CMC Commercialization
- FDA Center Directors Forum
- FDA Chiefs Chat
Debates and Discussion
- Is Direct to Consumer Advertising Good for Patients?
- Should Advisory Committees Always Have a Vote?
Summit Agenda
Times shown in Pacific Time (UTC-8)
| 8:30 - 9:00 am | Breakfast & Sign-In / Networking |
| 9:00 - 9:05 am | Welcome Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI Kuldev Singh, MD, MPH - Professor of Ophthalmology, Stanford University |
| 9:05 - 9:15 am | Opening Remarks Sam Hawgood, MBBS - Chancellor, University of California San Francisco (UCSF) |
| 9:15 - 9:25 am | Updates on 2023 Summit Panels Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI |
| 9:25 - 9:45 am | FDA Year in Review Robert Califf, MD - FDA Commissioner |
| 9:45 - 10:45 am | Panel 1: Why is Medical Misinformation Killing Us? Moderators: Robert Califf, MD - FDA Commissioner Laura Esserman, MD, MBA - Professor of Surgery and Radiology, UCSF Panelists: Rahul K. Arora, DPhil - AI and Bio-AI Policy, OpenAI Michael Drake, MD - President, University of California Jack Resneck Jr., MD - Immediate Past President of the American Medical Association Nirav D. Shah, MD, JD - CDC Principal Deputy Commissioner Claire Wardle, PhD - Professor of the Practice of Health Services, Policy and Practice, Brown University |
| 10:45 - 11:00 am | Break / Networking |
| 11:00 - 11:25 am | Debate 1: Direct to Consumer Advertising - Is it Good for Patients? Moderator: Anne Wojcicki - Co-Founder and CEO, 23andMe Debaters: (Yes) Tomas Philipson, PhD, MA - Daniel Levin Professor of Public Policy Studies Emeritus, University of Chicago (No) Rita Redberg, MD, MSc, FACC - Professor of Medicine, UCSF |
| 11:25 am - 12:00 pm | Panel 2: Variation in Regulatory Approaches Across the Globe: How Can We Work Together to Make Medical Products Commercially Viable and Available Worldwide? Moderators: Laura Esserman, MD, MBA - Professor of Surgery and Radiology, UCSF Tina Morrison, PhD - Director, Office of Regulatory Science and Innovation (ORSI), FDA Panelists: Ali Abbasi, MD - General Surgery Resident, UCSF Thierry Berney, MD, MSc, FEBS - Emeritus Professor of Surgery, University of Geneva, Switzerland Wiley Chambers, MD - Director, Division of Ophthalmology (CDER), FDA Doug Kelly, MD - Deputy Center Director for Science, Chief Scientist (CDRH), FDA Neel Pasricha, MD - Assistant Professor of Ophthalmology, UCSF James Shapiro, MD - Professor of Surgery, Medicine, and Surgical Oncology, University of Alberta Peter Stock, MD, PhD - Professor of Surgery, UCSF |
| 12:00 - 12:55 pm | Lunch / Poster Session / Networking |
| 12:55 - 1:55 pm | Panel 3: Accelerating CMC Commercialization Moderators: Aine Hanly, PhD - Executive Vice President and Chief Technology Officer, Vir Biotechnology Peter Marks, MD, PhD - Director, Center for Biologics Evaluation and Research (CBER), FDA Panelists: Chetan Goudar, PhD, Vice President, Process Development, Amgen Lynne Krummen, PhD - Executive Vice President, Regulatory / Program Leadership, Vir Biotechnology Alison Moore, PhD - CMC Executive Matthew Porteus, MD, PhD - Professor of Pediatrics, Stem Cell Transplantation, Stanford University Noemi Romero, Sr. Vice President, Global Supply Chain & Manufacturing Strategy, Eli Lilly |
| 1:55 - 2:40 pm | Panel 4: FDA Center Directors Forum Moderators: Namandje Bumpus, PhD - Chief Scientist, Office of the Chief Scientist (OCS), FDA Kuldev Singh, MD, MPH - Professor of Ophthalmology, Stanford University Panelists: Patrizia Cavazzoni, MD - Director, Center for Drug Evaluation and Research (CDER), FDA Peter Marks, MD, PhD - Director, Center for Biologics Evaluation and Research (CBER), FDA Jeff Shuren, MD, JD - Director, Center for Devices and Radiological Health (CDRH), FDA |
| 2:40 - 3:00 pm | Break / Networking |
| 3:00 - 4:00 pm | Panel 4: FDA Chiefs Chat Moderators: Andy Plump, MD, PhD - President, Research and Development, Takeda Pharmaceutical Janet Woodcock, MD - FDA Principal Deputy Commissioner Confirmed Panelists: Robert Califf, MD - FDA Commissioner Scott Gottlieb, MD - FDA Commissioner, 2017-2019 Margaret (Peggy) A. Hamburg, MD - FDA Commissioner, 2009-2015 Mark McClellan, MD, PhD - FDA Commissioner, 2002-2004 |
| 4:00 - 4:20 pm | Debate 2: Should Advisory Committees Always Have a Vote? Moderator: Kuldev Singh, MD, MPH - Professor of Ophthalmology, Stanford University Debaters: (Yes) Aaron Kesselheim, MD, JD, MPH - Professor of Medicine, Harvard Medical School (No) Genevieve P. Kanter, PhD - Associate Professor of Public Policy, University of Southern California |
| 4:20 - 4:30 pm | Closing Remarks Janet Woodcock, MD - FDA Principal Deputy Commissioner |
| 4:30 - 5:30 pm | Poster Session & Reception Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI Tina Morrison, PhD - Director, Office of Regulatory Science and Innovation (ORSI), FDA |
| 5:30 pm | Adjournment |
Sponsors
Platinum
Gold
Silver
