7th Annual CERSI Innovations in Regulatory Science Summit
Sunday, January 11, 2026 | 9:00 am - 6:00 pm Pacific Time
Confirmed Speakers, Panelists, and Moderators:
Russ Altman
Stanford University
Hal Barron
Altos Labs
Danielle Belgrave
GlaxoSmithKline
Laura Esserman
University of California, San Francisco
James Fraser
University of California, San Francisco
Kathy Giacomini
University of California, San Francisco
Scott Gottlieb
Former FDA Commissioner
Dan Hartman
Bill and Melinda Gates Foundation
Sam Hawgood
University of California, San Francisco
Rajiv Kaul
Fidelity Investments
Lloyd Minor
Stanford University
Steven Kozlowski
U.S. Food and Drug Administration
Rick Pazdur
U.S. Food and Drug Administration
Andy Plump
Takeda Pharmaceutical
Kuldev Singh
Stanford University
Michelle Tarver
U.S. Food and Drug Administration
George Yancopoulous
Regeneron
James Zou
Stanford University
About This Event
The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) is pleased to present the seventh 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 2026 CERSI Innovations in Regulatory Science Summit will highlight the latest developments in regulatory science, with panels on artificial intelligence, early endpoints, FDA leaders, and biopharmaceutical company leaders. We will also host two exciting debates on key issues 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.
The summit will be held at Robertson Auditorium at the Mission Bay Conference Center at UCSF, 1675 Owens St, San Francisco, CA. In person and virtual attendance options are available. Please visit https://cersisummit.eventbrite.com to register.
Panels:
- Addressing barriers to drug development with artificial intelligence
- Using early endpoints to accelerate drug development
- FDA Leaders Forum
- Biopharmaceutical Leaders
Debates and Discussions include:
- Is It Time to Get Rid of Animal Testing?
- Should Biosimilars Be Approved Based on Analytical Equivalence and RWE Data Follow-up?
Call for Poster Abstracts - Deadline: December 1, 2025 at 11:59 PT
The 2026 CERSI Innovations in Regulatory Science Summit Planning Committee is inviting abstract submissions to be considered for presention at our in-person poster sessions in San Francisco, CA on Sunday, January 11, 2026.
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)
Lloyd B. Minor, MD – Dean, Stanford University School of Medicine
9:15 - 9:25 am
Science Meets Regulation: Critical Achievements of the CERSI Network
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: What Are the Major Barriers to Drug Development and Approval That Can Be Solved with AI and New Technologies?
Moderators:
Russ B. Altman, MD, PhD – Co-PI, UCSF-Stanford CERSI
Kathy Giacomini, PhD, BSPharm – Co-PI, UCSF-Stanford CERSI
Panelists:
Danielle Belgrave, PhD – Vice President, Artificial Intelligence/Machine Learning, GSK
Elina Kansikas, PhD – Director, Global R&D Science Communications, AstraZeneca
James Zou, PhD – Associate Professor, Biomedical Data Science, Stanford University
10:45 - 11:05 am
Break / Networking
11:05 - 11:25 am
Debate 1: Is It Time to Get Rid of Animal Testing?
Moderator:
Steven Kozlowski, MD – Chief Scientist, US FDA
11:25 - 11:35 am
Post-Debate Talk
James Fraser, PhD,- Professor and Chair, Department of Bioengineering and Therapeutic Sciences, UCSF
11:35 am - 12:45 pm
Panel 2: New Opportunities to Improve the Development and Use of Robust Early Endpoints to Accelerate Identification and Approval of Agents to Prevent and Reduce Chronic Diseases
Moderator:
Laura Esserman, MD, MBA – Professor of Surgery and Radiology at UCSF
Panelists:
Hal Barron, MD – Chief Executive Officer, Founder and Board Co-Chair, Altos Labs
Richard Pazdur, MD – Director, Oncology Center of Excellence, US FDA
Additional panelists TBD
12:45 - 1:45 pm
Lunch / Poster Session / Networking
1:45 - 2:45 pm
Panel 3: FDA Leaders Forum
Moderators:
Kuldev Singh, MD, MPH – Professor of Ophthalmology at Stanford University
Michelle Tarver, MD PhD – Director, Center for Devices and Radiological Health, US FDA
Panelists:
Steven Kozlowski, MD – Chief Scientist, US FDA
Additional panelists TBD
2:25 - 2:45 pm
Debate 2: Should Biosimilars Be Approved Based on Analytical Equivalence and RWE Data Follow-up?
3:05 - 3:20 pm
Break / Networking
3:20 - 4:20 pm
Panel 4: Innovation at a Crossroads: Science, Strategy, Policy, and Global Forces Shaping Biopharma’s Future
Moderator:
Andy Plump, MD, PhD – President, Research and Development at Takeda Pharmaceutical
Panelists:
Scott Gottlieb, MD – Senior Fellow, American Enterprise Institute for Public Policy Research and Partner, New Enterprise Associates
Rajiv Kaul – Portfolio Manager, Fidelity Select Biotechnology Fund, Fidelity Investments
George D. Yancopoulos, MD, PhD – Board co-Chair, President, and Chief Scientific Officer, Regeneron
Additional panelists TBD
4:20 - 4:30 pm
Closing Remarks
4:30 - 6:00 pm
Poster Session & Networking Reception
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.
Sponsors
We are always looking for organizations interested in sponsoring this event. If your organization would like to learn more about sponsorship opportunities, please contact us at info@ucsfstanfordcersi.org.