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:

  1. Why is Medical Misinformation Killing Us?
  2. Accelerating CMC Commercialization
  3. FDA Center Directors Forum
  4. FDA Chiefs Chat

Debates and Discussion:

  1. Is Direct to Consumer Advertising Good for Patients?
  2. Case Studies in Regulatory Problem Solving Across International Borders
  3. 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.

Scroll to Top