5th Annual CERSI Innovations in Regulatory Science Summit
A Bold Vision for the Future of Regulatory Science
Sunday, January 7, 2024 | 9 am - 5:30 pm Pacific Time
Robertson Auditorium
Mission Bay Conference Center at UCSF
1675 Owens St, San Francisco, CA
Note: Click the playlist icon ( 
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About This Event
The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) is pleased to present the fifth 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 2024 CERSI Innovations in Regulatory Science Summit will have a major focus on emerging issues in regulatory science. The summit will include 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 will be an FDA Center Directors panel as well as debates on exciting topics 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:
- 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?
Call for Poster Abstacts - Deadline: December 15, 2023 at 11:59 pm Pacific
The 2024 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 7, 2024. Posters will also be accepted at the 2024 CERSI Scientific Symposium, a separate event taking place on Monday, January 8, 2024 in Stanford, CA.
Summit Schedule
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)
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, 2016-2017, 2022-present
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at 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 at Brown University
10:45 - 11:00 am
Break / Networking
11:00 - 11:20 am
Debate 1: Direct to Consumer Advertising - Is It Good for Patients?
Moderator:
Anne Wojcicki – Co-Founder and CEO at 23andMe
Debaters:
(Yes) – Tomas Philipson, PhD, MA – Daniel Levin Professor of Public Policy Studies Emeritus at the University of Chicago
(No) – Rita Redberg, MD, MSc, FACC – Professor of Medicine at UCSF
11:20 - 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 at UCSF
Tina Morrison, PhD – Director, Office of Regulatory Science and Innovation (ORSI) at FDA
Panelists:
Ali Abbasi, MD – General Surgery Resident at UCSF
Thierry Berney, MD, MSc, FEBs – Emeritus Professor of Surgery, University of Geneva, Switzerland
Wiley Chambers, MD – Director, Division of Ophthalmology (CDER) at FDA
Doug Kelly, MD – Deputy Center Director for Science, Chief Scientist (CDRH) at FDA
Neel Pasricha, MD – Assistant Professor of Ophthalmology at UCSF
James Shapiro, MD – Professor of Surgery, Medicine, and Surgical Oncology at the University of Alberta
Peter Stock, MD, PhD – Professor of Surgery at 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 at Vir Biotechnology
Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research (CBER) at FDA
Panelists:
Chetan Goudar, PhD – Vice President, Process Development at Amgen
Lynne Krummen, PhD – Executive Vice President, Regulatory/Program Leadership at Vir Biotechnology
Alison Moore, PhD -CMC Executive
Matthew Porteus, MD, PhD – Professor of Pediatrics – Stem Cell Transplantation at Stanford University
Noemi Romero – Senior Vice President, Global Supply Chain & Manufacturing Strategy at Eli Lilly
1:55 - 2:40 pm
Panel 4: FDA Center Directors Forum
Moderators:
Namandjé Bumpus, PhD – Chief Scientist, Office of the Chief Scientist (OCS) at FDA
Kuldev Singh, MD, MPH – Professor of Ophthalmology at Stanford University
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
2:40 - 3:00 pm
Break / Networking
3:00 - 4:00 pm
Panel 5 - FDA Chiefs Chat
Moderators:
Andy Plump, MD, PhD – President, Research and Development at Takeda Pharmaceutical
Janet Woodcock, MD – FDA Principal Deputy Commissioner
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 Vote?
Moderator:
Kuldev Singh, MD, MPH – Professor of Ophthalmology at Stanford University
Debaters:
(Yes) – Aaron Kesselheim, MD, JD, MPH – Professor of Medicine at Harvard Medical School
(No) – Genevieve P. Kanter, PhD – Associate Professor of Public Policy at 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) at FDA
5:30 pm
Adjournment
Speakers, Panelists, and Moderators:
Ali Abbasi
University of California, San Francisco
Rahul Arora
OpenAI
Thierry Berney
University of Geneva
Namandjé Bumpus
U.S. Food and Drug Administration
Rob Califf
U.S. Food and Drug Administration
Patrizia Cavazzoni
U.S. Food and Drug Administration
Wiley Chambers
U.S. Food and Drug Administration
Michael Drake
University of California
Laura Esserman
University of California, San Francisco
Kathy Giacomini
University of California, San Francisco
Scott Gottlieb
Former FDA Commissioner
Chetan Goudar
Amgen
Margaret A. Hamburg
Former FDA Commissioner
Aine Hanly
Vir Biotechnology
Sam Hawgood
University of California, San Francisco
Genevieve P. Kanter
University of Southern California
Doug Kelly
U.S. Food and Drug Administration
Aaron Kesselheim
Harvard University
Lynne Krummen
Vir Biotechnology
Peter Marks
U.S. Food and Drug Administration
Mark McClellan
Former FDA Commissioner
Alison Moore
CMC Executive
Tina Morrison
U.S. Food and Drug Administration
Neel Pasricha
University of California, San Francisco
Tomas Philipson
University of Chicago
Andy Plump
Takeda Pharmaceutical
Matthew Porteus
Stanford University
Rita Redberg
University of California, San Francisco
Jack Resneck Jr.
American Medical Association
Noemi Romero
Eli Lilly
Nirav Shah
U.S. Centers for Disease Control and Prevention
James Shapiro
University of Alberta
Jeff Shuren
U.S. Food and Drug Administration
Kuldev Singh
Stanford University
Peter Stock
University of California, San Francisco
Claire Wardle
Brown University
Anne Wojcicki
23andMe
Janel Woodcock
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.
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