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 (  ) on the top right corner of the video window below to view the full list of videos.

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:

  1. Why is Medical Misinformation Killing Us?
  2. Variation in Regulatory Approaches Across the Globe: How Can We Work Together to Make Medical Products Commercially Viable and Available Worldwide?
  3. Accelerating CMC Commercialization
  4. FDA Center Directors Forum
  5. FDA Chiefs Chat

Debates and Discussion:

  1. Is Direct to Consumer Advertising Good for Patients?
  2. 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

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.

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