7th Annual Innovations in Regulatory Science Summit
Sunday, January 11, 2026 | 9:00 am - 6:00 pm Pacific Time
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Confirmed Speakers, Panelists, and Moderators:
Russ Altman
Stanford University
Hal Barron
Altos Labs
Danielle Belgrave
GlaxoSmithKline
Jorg Blumel
Genentech
Rob Califf
Former FDA Commissioner
Kyle Diamantas
U.S. Food and Drug Administration
Cristina Durán
Evinova
Laura Esserman
University of California, San Francisco
James Fraser
University of California, San Francisco
Kathy Giacomini
University of California, San Francisco
Kate Goodrich
Optum
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
John Maraganore
JMM Innovations
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
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 Session
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, Stanford University
9:05 - 9:15 am
Opening Remarks
Sam Hawgood, MBBS – Chancellor, University of California San Francisco (UCSF)
Lloyd Minor, MD – Dean, Stanford University School of Medicine
9:15 - 9:25 am
Innovative Research in Regulatory Science
Kathy Giacomini, PhD, BSPharm – Dean, School of Pharmacy, UCSF
9:25 - 9:30 am
Lightning Talk: Artificial Intelligence (AI) for Regulatory Efficiency
Russ Altman, MD, PhD – Kenneth Fong Professor of Bioengineering, Genetics, Medicine, Biomedical Data Science, and (by courtesy) Computer Science
9:30- 10:30 am
Panel 1: What Are the Major Barriers to Drug Development and Approval That Can Be Solved with AI and New Technologies?
Moderators:
Russ 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
Cristina Duran, President, Evinova
James Zou, PhD – Associate Professor, Biomedical Data Science, Stanford University
10:30- 10:35 am
Lightning Talk: The Acute Pain Pathways Study
Molly Jeffery, PhD – Scientific Director of Emergency Medicine Research and Associate Professor of Emergency Medicine and Health Services Research, Mayo Clinic
10:35 - 10:55 am
Break / Networking
10:55 - 11:15 am
Debate 1: Is It Time to Get Rid of Animal Testing?
Moderators:
Steven Kozlowski, MD – Chief Scientist, US FDA
Joseph Wu, MD, PhD – Professor and Director, Stanford Cardiovascular Institute, Stanford University
Debaters:
(Yes) Paul Watkins, MD – Howard Q Ferguson Distinguished Professor, University of North Carolina – Chapel Hill
(No) Jorg Blumen, PhD, ERT – Senior Vice President, Development Sciences, Genentech
11:15 - 11:25 am
How 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
11:25-11:30am
Lightning Talk: Early Endpoints
Keli Santos-Parker, MD, MS, PhD, T32 Surgical Oncology Fellow, UCSF
11:30 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
Kate Goodrich, MD, MHS – Executive in Residence, Optum, Inc.
Anthony Letai, MD, PhD – Director, National Cancer Institute
Richard Pazdur, MD – Former Director, Oncology Center of Excellence, US FDA
12:40 - 1:40 pm
Lunch / Poster Session / Networking
1:40-1:45pm
Lightning Talk: Helping American Manufacturing
Clifford Rossi , PhD, Executive-in-Residence and Professor of the Practice, Robert H. Smith School of Business, University of Maryland
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
Panelists:
Kyle Diamantas, JD – Deputy Commissioner for Human Foods, US FDA
Michelle Tarver, MD, PhD – Director, Center for Devices and Radiological Health, US FDA
Mary Thanh Hai, MD – Director, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), US FDA
Sarah Yim, MD – Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, US FDA
2:45 - 3:05 pm
Debate 2: Should Biosimilars Be Approved Based on Analytical Equivalence and RWE Data Follow-up?
Co-Moderators:
Joseph Wu, MD, PhD – Professor and Director, Stanford Cardiovascular Institute, Stanford University
Robert Califf, MD – Former FDA Commissioner
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, 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
John Maraganore, PhD – CEO and Principal, JMM Innovations, LLC
4:20 - 4:30 pm
Closing Remarks
Kathy Giacomini, PhD, BSPharm – Dean, School of Pharmacy, UCSF
Kuldev Singh, MD, MPH – Professor of Ophthalmology, Stanford University
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
