6th Annual CERSI Innovations in Regulatory Science Summit
Regulatory Frontiers in Healthcare Innovation
Sunday, January 12, 2025 | 9:00 am - 6:00 pm Pacific Time
Robertson Auditorium
Mission Bay Conference Center at UCSF
1675 Owens St, San Francisco, CA
About This Event
The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) is pleased to present the sixth annual CERSI Innovations in Regulatory Science Summit, a gathering of leaders in the academia, industry, and regulatory sectors to discuss the role of regulatory science in medical product development.
The 2025 CERSI Innovations in Regulatory Science Summit will highlight the latest developments in regulatory science, with a particular focus on generative artificial intelligence and women’s health. Additionally, we’re excited to announce the return of our engaging panels with former FDA Commissioners who will explore the current challenges the Agency is facing. The FDA Center Directors panel will also make a comeback, alongside a series of stimulating debates on key issues in regulatory science.
The goal of the summit is 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 Discussion include:
- Should FDA be More Transparent Publicly in Reporting Sponsor-Level Decisions?
- Should there be a Firewall Between FDA Regulatory Policy and Drug Costs?
- The Emergency Use Authorization Authority Should be Used More Frequently to Approve Medical Products: Pro and Con
Call for Poster Abstracts - Open now through December 1
The 2025 CERSI Innovations in Regulatory Science Summit Planning Committee will invite abstract submissions to be presented at our in-person poster sessions in San Francisco, CA on Sunday, January 12, 2025.
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 at Stanford University
9:05 - 9:15 am
Opening Remarks
Sam Hawgood, MBBS – Chancellor, University of California San Francisco (UCSF)
Lloyd B. 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 B. Altman, MD, PhD – Co-PI, UCSF-Stanford CERSI
Rahul K. Arora, DPhil – AI and Bio-AI Policy, OpenAI
Confirmed Panelists:
Mark Taisey – Senior Vice President, Global Regulatory Affairs & Strategy, Amgen
Janet Woodcock, MD – Former FDA Principal Deputy Commissioner
Liang Zhao, PhD, MAS, MBA – Professor, Department of Bioengineering and Therapeutic Sciences, School of Pharmacy at UCSF
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 at Parabilis Medicines
11:25 am - 12:25 pm
Panel 2: Women's Health
Moderators:
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF
Michelle A. Williams, ScD – Professor of Epidemiology and Population Health at Stanford University School of Medicine
Confirmed Panelists:
Laleh Amiri-Kordestani, MD – Oncology Center of Excellence (OCE) Associate Director of Cardio-Oncology at FDA
Diana Blithe, PhD – Chief, Contraceptive Development Program, DIPHR, NICHD, NIH
Hilary D. Marston, MD, MPH – Chief Medical Officer at 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 at Stanford University
Confirmed Panelists:
Patrizia Cavazzoni, MD – Director, Center for Drug Evaluation and Research (CDER) at FDA
Jim Jones, MS – Deputy Commissioner for Human Foods at FDA
Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research (CBER) at FDA
Michelle Tarver, MD, PhD – Acting Director, Center for Devices and Radiological Health (CDRH) at 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 at Takeda Pharmaceutical
Debaters:
(Yes) – Joshua M. Sharfstein, MD – Distinguished Professor of the Practice in Health Policy and Management at Johns Hopkins Bloomberg School of Public Health
(No) – Scott Gottlieb, MD – FDA Commissioner, 2017-2019
2:45 - 3:05 pm
Debate 3: The Emergency Use Authorization Authority Should be Used More Frequently to Approve Medical Products: Pro and Con
Moderator:
George Scangos, PhD – Former CEO of Vir Biotechnology
Debaters:
(Pro) – Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research (CBER) at FDA
(Con) – Hal Barron, MD – CEO, Founder and Board Co-Chair at Altos Labs
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 at 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 at Stanford University
4:30 - 6:00 pm
Poster Session & Networking Reception
Kathy Giacomini, PhD, BSPharm – Co-PI, UCSF-Stanford CERSI
6:00 pm
Adjournment
Confirmed Speakers, Panelists, and Moderators:
Russ Altman
Stanford University
Laleh Amiri-Kordestani
U.S. Food and Drug Administration
Rahul Arora
OpenAI
Hal Barron
Altos Labs
Diana Blithe
DIPHR, NICHD, NIH
Robert Califf
U.S. Food and Drug Administration
Patrizia Cavazzoni
U.S. Food and Drug Administration
Laura Esserman
University of California, San Francisco
Kathy Giacomini
University of California, San Francisco
Scott Gottlieb
Former FDA Commissioner
Sam Hawgood
University of California, San Francisco
Jim Jones
U.S. Food and Drug Administration
Mathai Mammen
Parabilis Medicines
Peter Marks
U.S. Food and Drug Administration
Mark McClellan
Duke University
Lloyd Minor
Stanford University
Andy Plump
Takeda Pharmaceutical
George Scangos
Former CEO of Vir Biotechnology
Joshua Sharfstein
Johns Hopkins Bloomberg School of Public Health
Kuldev Singh
Stanford University
Mark Taisey
Amgen
Michelle Tarver
U.S. Food and Drug Administration
Michelle Williams
Harvard T.H. Chan School of Public Health
Janet Woodcock
Former FDA Principal Deputy Commissioner
Liang Zhao
University of California, San Francisco
About UCSF-Stanford CERSI
The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) is a joint effort among members of a world-class team of highly collaborative scientists at the University of California San Francisco, Stanford University, and the U.S. Food and Drug Administration (FDA). The two academic institutions and the FDA work together on projects that promote regulatory science—including innovative research, education, and scientific exchange—in partnership with foundations and commercial entities interested in the development of FDA-approved medical products. The center collaborates, in particular, with the pharmaceutical, biotechnology, and high-tech industries of the San Francisco Bay Area and the West Coast.
Contact
For information or questions about this event, please contact the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation at info@ucsfstanfordcersi.org.
Sponsors
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