7th Annual 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
Jorg Blumel
Genentech
Kyle Diamantas
U.S. Food and Drug Administration
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
Molly Jeffery
Mayo Clinic
Rajiv Kaul
Fidelity Investments
Andy Kilianski
Advanced Research Projects Agency for Health
Steven Kozlowski
U.S. Food and Drug Administration
Anthony Letai
National Cancer Institute
Lloyd Minor
Stanford University
Rick Pazdur
U.S. Food and Drug Administration
Andy Plump
Takeda Pharmaceutical
Cliff Rossi
University of Maryland
Hope Rugo
City of Hope
Keli Santos-Parker
University of California, San Francisco
Kuldev Singh
Stanford University
Michelle Tarver
U.S. Food and Drug Administration
Mary Thanh Hai
U.S. Food and Drug Administration
Paul Watkins
University of North Carolina- Chapel Hill
Joseph Wu
Stanford University
George Yancopoulous
Regeneron
Sarah Yim
U.S. Food and Drug Administration
James Zou
Stanford University
About This Event
The 2026 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 as a hybrid event 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.
UCSF welcomes all participants to our events. If you need a reasonable accommodation to participate in this event because of a disability, please contact Jaime.Kenyon@ucsf.edu as soon as possible.
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?
Poster Abstracts Deadline: December 1, 2025
The deadline for submitting an abstract for the poster session passed on December 1. Authors should expect to hear back by mid-December.
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 – Dean, School of Pharmacy, UCSF
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 in Regulatory Science Research
Kathy Giacomini, PhD, BSPharm – Dean, School of Pharmacy, UCSF
9:25 - 9:45 am
FDA Year in Review
9:45 - 9:50 am
Innovation in Regulatory Science Lightning Talk: AI for Regulatory Efficiency
9:50- 10:40 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 – Kenneth Fong Professor of Bioengineering, Genetics, Medicine, Biomedical Data Science and (by courtesy) Computer Science
Kathy Giacomini, PhD, BSPharm – Dean, School of Pharmacy, UCSF
Panelists:
Danielle Belgrave, PhD – Vice President, Artificial Intelligence/Machine Learning, GSK
AstraZeneca to be confirmed
James Zou, PhD – Associate Professor, Biomedical Data Science, Stanford University
10:40- 10:45 am
Innovation in Regulatory Science Lightning Talk: Understanding Opioid Use
Molly M. Jeffery, PhD – Scientific Director of Emergency Medicine Research and Associate Professor of Emergency Medicine and Health Services Research, Mayo Clinic
10:45 - 11:05 am
Break / Networking
11:05 - 11:25 am
Debate 1: Is It Time to Get Rid of Animal Testing?
Moderators:
Steven Kozlowski, MD – Chief Scientist, US FDA (to be confirmed)
Joseph C. Wu, MD, PhD – Simon H. Stertzer Professor of Medicine and Radiology, Stanford University
Debaters:
(Yes) Paul B. Watkins, MD – Howard Q Ferguson Distinguished Professor, University of North Carolina – Chapel Hill
(No) Jorg Blumen, PhD, ERT – Senior Vice President, Development Sciences, Genentech
11:25 - 11:35 am
How Artificial Intelligence (AI) Could Transform Pre-clinical Drug Discovery
James Fraser, PhD – Professor and Chair, Department of Bioengineering and Therapeutic Sciences, UCSF
Andy Kilianski, PhD – Acting Deputy Director, Health Science Futures, Advanced Research Projects Agency for Health
11:35-11:40am
Innovation in Regulatory Science Lightning Talk: Early Endpoints
Keli Santos-Parker, MD, MS, PhD, T32 Surgical Oncology Fellow, UCSF
11:40 am - 12:40 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
Moderators:
Laura Esserman, MD, MBA – Professor of Surgery and Radiology, UCSF
Jane Perlmutter, PhD, MBA – Founder and President, Gemini Group
Panelists:
Hal Barron, MD – Chief Executive Officer, Founder and Board Co-Chair, Altos Labs
Richard Pazdur, MD – Director, Center for Drugs and Evaluation Research, US FDA
Anthony Letai, MD, PhD – Director, National Cancer Institute
12:40 - 1:40 pm
Lunch / Poster Session / Networking
1:40 - 1:45 pm
Innovation in Regulatory Science Lightning Talk: Helping American Manufacturing
1:45 - 2:45 pm
Panel 3: FDA Leaders Forum
Moderators:
Kuldev Singh, MD, MPH – Professor of Ophthalmology, Stanford University
Steven Kozlowski, MD – Chief Scientist, US FDA (to be confirmed)
Panelists:
Michelle Tarver, MD PhD – Director, Center for Devices and Radiological Health, US FDA
Mary Thanh Hai, MD – Director, Office of New Drugs (OND), CDER, US FDA (to be confirmed)
Sarah Yim, MD – Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, US FDA (to be confirmed)
Kyle Diamantas, JD – Deputy Commissioner for Human Foods, US FDA
2:45 - 3:05 pm
Debate 2: Should Biosimilars Be Approved Based on Analytical Equivalence and RWE Data Follow-up?
Moderator:
To be confirmed
Debaters:
(Yes) Dan Hartman, MD – Director, Integrated Development, Gates Foundation
(No) Hope Rugo, MD – Director, Women’s Cancer Program and Division Chief, Breast Medical Oncology, City of Hope Cancer Center
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
Contact
For information or questions about this event, please contact Jaime.Kenyon@ucsf.edu.
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.
PLATINUM SPONSORS
SILVER SPONSORS
