The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) was pleased to present the 6th annual CERSI Innovations in Regulatory Science Summit, "Regulatory Frontiers in Healthcare Innovation," a gathering of leaders in the academic, industry, and regulatory sectors to discuss the role of regulatory science in medical product development on January 12, 2025, 9am-6pm.
The 2025 CERSI Innovations in Regulatory Science Summit highlighted the latest developments in regulatory science, with a particular focus on generative artificial intelligence and women's health. Additionally, we were pleased to welcome back our engaging panels of former FDA Commissioners, who explored the current challenges the Agency was facing. The FDA Center Directors panel also returned, alongside a series of stimulating debates on key issues 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
- Generative AI in Regulatory Science
- Women's Health
- FDA Center Directors Forum
- FDA Chiefs Chat
Debates and Discussions
- Should FDA be more Transparent Publicly in Reporting Sponsor-Level Decisions?
- Should there be a Firewall Between FDA Regulatory Policy and Drug Costs?
- Food for Thought: What the FDA Needs to Improve What We Eat
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) Lloyd Minor, MD - Dean, Stanford University School of Medicine |
| 9:15 - 9:25 am | Updates on 2024 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: Generative AI in Regulatory Science Moderators: Russ Altman, MD, PhD - Co-PI, UCSF-Stanford CERSI Rahul K. Arora, DPhil - AI and Bio-AI Policy, OpenAI Confirmed Panelists: Mark Taisey - Sr. Vice President, Global Regulatory Affairs & Strategy, Amgen Janet Woodcock, MD - Former FDA Principal Deputy Commissioner |
| 10:45 - 11:05 am | Break / Networking |
| 11:05 - 11:25 am | Debate 1: Should FDA be more Transparent Publicly in Reporting Sponsor-Level Decisions? Moderator: Mark McClellan, MD, PhD - FDA Commissioner, 2002-2004 Debaters: (Yes) Mathai Mammen, MD, PhD - CEO, President and Chairman, Parabilis Medicines (No) Donna Boyce - Sr. Vice President and Head, Global Regulatory Sciences, Pfizer |
| 11:25 am - 12:25 pm | Panel 2: Women's Health Moderators: Laura Esserman, MD, MBA - Professor of Surgery and Radiology, UCSF Michelle A. Williams, ScD - Professor of Epidemiology and Population Health, Stanford University School of Medicine Confirmed Panelists: Laleh Amiri-Kordestani, MD - Oncology Center of Excellence (OCE) Associate Director of Cardio-Oncology, FDA Diana Blithe, PhD - Chief, Contraceptive Development Program, DIPHR, NICHD, NIH Michael Drake, MD - President, University of California Hilary D. Marston, MD, MPH - Chief Medical Officer, FDA |
| 12:25 - 1:25 pm | Lunch / Poster Session / Networking |
| 1:25 - 2:25 pm | Panel 3: FDA Center Directors Forum Moderators: Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI Kuldev Singh, MD, MPH - Professor of Ophthalmology, Stanford University Confirmed Panelists: Patrizia Cavazzoni, MD - Director, Center for Drug Evaluation and Research (CDER), FDA Michelle Tarver, MD, PhD - Acting Director, Center for Devices and Radiological Health (CDRH), FDA |
| 2:25 - 2:45 pm | Debate 2: Should there be a Firewall Between FDA Regulatory Policy and Drug Costs? Moderator: Andy Plump, MD, PhD - President, Research and Development, Takeda Pharmaceutical Debaters: (Yes) Scott Gottlieb, MD - FDA Commissioner, 2017-2019 (No) Joshua M. Sharfstein, MD - FDA Principal Deputy Commissioner, 2009-2011 |
| 2:45 - 3:05 pm | Food for Thought: What the FDA Needs to Improve What We Eat Janet Woodcock, MD - Former FDA Principal Deputy Commissioner |
| 3:05 - 3:20 pm | Break / Networking |
| 3:20 - 4:20 pm | Panel 4: FDA Chiefs Chat Moderators: Andy Plump, MD, PhD - President, Research and Development, Takeda Pharmaceutical Janet Woodcock, MD - Former FDA Principal Deputy Commissioner Confirmed Panelists: Robert Califf, MD - FDA Commissioner Scott Gottlieb, MD - FDA Commissioner, 2017-2019 Mark McClellan, MD, PhD - FDA Commissioner, 2002-2004 |
| 4:20 - 4:30 pm | Closing Remarks Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI Kuldev Singh, MD, MPH - Professor of Ophthalmology, Stanford University |
| 4:30 - 6:00 pm | Poster Session & Networking Reception Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI Joy Battles, MS, MPH - Biologist / CERSI Program Leader, FDA |
| 6:00 pm | Adjournment |
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