Save the Date!

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 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. Generative AI in Regulatory Science
  2. Women’s Health
  3. FDA Center Directors Forum
  4. FDA Chiefs Chat

Debates and Discussion:

  1. TBA
  2. TBA
  3. 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)
L
loyd 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

10:45 - 11:05 am

Break / Networking

11:05 - 11:25 am

Debate 1: TBA

Moderator:
TBA

Debaters:
(Yes) – TBA
(No) – TBA

11:25 - 12:25 pm

Panel 2: Women's Health

Moderator: 
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF

Panelists:
TBA

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: TBA

Moderator:
TBA

Debaters:
(Yes) – TBA
(No) – TBA

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

Debaters:
(Yes) – TBA
(No) – TBA

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

TBA

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

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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