2024 Innovations in Regulatory Science Summit
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SUNDAY, JANUARY 7, 2024
UCSF Mission Bay Campus
TUESDAY, JANUARY 9, 2024
Stanford University
About This Event
The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) is pleased to present the fifth annual 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 take place over two days and have a major focus on emerging issues in regulatory science including medical misinformation and its impact on public health, manufacturing and supply chain with an emphasis on lessons learned during the COVID-19 pandemic, and yet another exciting panel featuring former FDA Commissioners on the latest issues facing the Agency. New this year will also be debates on contentious 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.
Panel Discussions:
- Medical Misinformation
- Manufacturing & Supply Chain
- FDA Chiefs Chat
Debates: TBA
Call for Posters: TBA
The 2024 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 and Stanford, CA on Tuesday, January 9, 2024.
Agenda
Times shown in Pacific time (UTC-8)
8:15 - 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 – Medical Misinformation
Moderators:
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF
10:45 - 11:05 am
Debate 1: Direct to Consumer Advertising
11:05 - 11:25 am
Debate 2: US vs Non-US regulatory standards
11:25 - 12:25 pm
Lunch / Poster session / Networking
12:25 - 1:25 pm
PANEL 2 – Manufacturing & Supply Chain
Moderators:
Peter Marks, MD, PhD – Director, Center for Biologics Evaluation and Research (CBER) at FDA
1:25 am - 1:40 pm
Presentation TBA
1:40 - 2:00 pm
Debate 3: TBA
2:00 - 2:20 pm
Break / networking
2:20 - 3:25 pm
panel 3 - fda chiefs chat
Moderators:
Andy Plump, MD, PhD – President, Research and Development at Takeda Pharmaceuticals
3:25 - 3:45 pm
Debate 4: Advisory committees
3:45 - 3:55 pm
closing remarks
Janet Woodcock, MD – FDA Principal Deputy Commissioner
3:55 - 5:00 pm
Poster Session / Networking
Kathy Giacomini, PhD, BSPharm – Co-PI, UCSF-Stanford CERSI
Tina Morrison, PhD – Director, Office of Regulatory Science and Innovation (ORSI) at FDA
5:00 pm
Adjournment
Speakers, Panelists, and Moderators:
Laura Esserman
University of California, San Francisco
Kathy Giacomini
University of California, San Francisco
Peter Marks
U.S. Food and Drug Administration
Andy Plump
Takeda Pharmaceutical
Kuldev Singh
Stanford University
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.