2024 CERSI Innovations in Regulatory Science Summit
Sunday, January 7, 2024
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 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, 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 also 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?
- Accelerating CMC Commercialization
- FDA Center Directors Forum
- FDA Chiefs Chat
Debates and Discussion:
- Is Direct to Consumer Advertising Good for Patients?
- Case Studies in Regulatory Problem Solving Across International Borders
- Should Advisory Committees Always Have a Vote?
Call for Poster Abstacts - Deadline: November 3, 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
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
9:45 - 10:45 am
Panel 1 – Why is Medical Misinformation killing us?
Moderators:
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF
Panelists:
Jack Resneck Jr., MD – Intermediate Past President at American Medical Association
10:45 - 11:00 am
Break / Networking
11:00 - 11:20 am
Debate 1: Is Direct to Consumer Advertising Good for Patients?
Debaters:
Rita Redberg, MD, MSc, FACC – Professor of Medicine at UCSF
11:20 - 12:00 pm
Discussion: Case Studies in Regulatory Problem Solving Across International Borders
12:00 - 12:55 pm
Lunch / Poster session / Networking
12:55 - 1:55 pm
PANEL 2 – 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
Matthew Porteus, MD, PhD – Professor of Pediatrics – Stem Cell Transplantation at Stanford University
1:55 - 2:40 pm
Panel 3: FDA Center Directors Forum
Moderators:
Kuldev Singh, MD, MPH – Professor of Ophthalmology at Stanford University
Namandjé Bumpus, PhD – Chief Scientist, Office of the Chief Scientist (OCS) at FDA
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 4 - fda chiefs chat
Moderators:
Andy Plump, MD, PhD – President, Research and Development at Takeda Pharmaceuticals
Janet Woodcock, MD – FDA Principal Deputy Commissioner
Panelists:
Scott Gottlieb, MD – FDA Commissioner, 2017-2019
4:00 - 4:20 pm
Debate 2: Should Advisory committees Always vote?
Debaters:
Aaron Kesselheim, MD, JD, MPH – Professor of Medicine at Harvard Medical School
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:
Namandjé Bumpus
U.S. Food and Drug Administration
Lynne Krummen
Vir Biotechnology
PATRIzIA CAVAZZONI
U.S. Food and Drug Administration
Laura Esserman
University of California, San Francisco
Kathy Giacomini
University of California, San Francisco
SCOTT GOTTLIEB
U.S. Food and Drug Administration
Chetan Goudar
Amgen
Aine Hanly
Vir Biotechnology
aaron kesselheim
Harvard University
Peter Marks
U.S. Food and Drug Administration
Tina Morrison
U.S. Food and Drug Administration
Andy Plump
Takeda Pharmaceutical
Matthew porteus
Stanford University
Rita redberg
University of California, San Francisco
Jack Resneck Jr.
American Medical Association
Jeff Shuren
U.S. Food and Drug Administration
Kuldev Singh
Stanford University
JANET 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.