6th Annual CERSI Innovations in Regulatory Science Summit
Sunday, January 12, 2025 | 9 am - 5:30 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:
- There Should be a Firewall Between Regulatory Approval and Reimbursement
- FDA Should/Should Not be More Transparent Publicly in Reporting Sponsor-Level Decisions
- The Emergency Use Authorization Authority Should be Used More Frequently to Approve Medical Products: Pro and Con
Call for Poster Abstracts - TBA
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:
Janet Woodcock, MD – Former FDA Principal Deputy Commissioner
Liang Zhao, PhD, MAS, MBA – Director, Division of Quantitative Methods and Modeling, Office of Regulatory Science (ORS)/Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER) at FDA
10:45 - 11:05 am
Break / Networking
11:05 - 11:25 am
Debate 1: There Should be a Firewall Between Regulatory Approval and Reimbursement
11:25 - 12:25 pm
Panel 2: Women's Health
Moderator:
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF
12:25 - 1:25 pm
Lunch / Poster session / Networking
1:25 - 2:20 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
Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research (CBER) at FDA
Jeff Shuren, MD, JD – Director, Center for Devices and Radiological Health (CDRH) at FDA
2:25 - 2:45 pm
Debate 2: FDA Should/Should Not be More Transparent Publicly in Reporting Sponsor-Level Decisions
Moderator:
Andy Plump, MD, PhD – President, Research and Development at Takeda Pharmaceutical
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
2:05 - 3:20 pm
Break / Networking
3:20 - 4:20 pm
Panel 5 - 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
4:30 - 4:40 pm
Intro to Networking Reception
Kathy Giacomini, PhD, BSPharm – Co-PI, UCSF-Stanford CERSI
4:40 - 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
Rahul Arora
OpenAI
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
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
Jeff Shuren
U.S. Food and Drug Administration
Kuldev Singh
Stanford University
Janel Woodcock
Former FDA Principal Deputy Commissioner
Liang Zhao
U.S. Food and Drug Administration
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.