The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) was pleased to present the 4th annual Innovations in Regulatory Science Summit, "Accelerating Healthcare Innovation Through a Regulatory Lens," a gathering of leaders in the academia, industry, and regulatory sectors to discuss the role of regulatory science in medical product development on January 8, 2023, 9am-4pm PST.
The 2023 CERSI Innovations in Regulatory Science Summit had a major focus on emerging issues in regulatory science including diversity in clinical trials, FDA/CMS decision making, and global drug development. In addition, we brought back our exciting panel from 2022 featuring former FDA Commissioners discussing the latest issues facing the Agency.
The goal of the summit was 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
- Disparities in Clinical Trial Enrollment: What Will it Take to Close the Gap?
- Cross Agency Synergy to Accelerate Access to Safe and Effective Medical Products
- Building a Global Regulatory Vision for Product and Drug Development: Challenges and Opportunities
- FDA Chiefs Chat
Summit Agenda
Times shown in Pacific Time (UTC-8)
| 8:30 - 9:00 am | Breakfast & Sign-In |
| 9:00 - 9:10 am | Welcome Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI Kuldev Singh, MD, MPH - Professor of Ophthalmology, Stanford University |
| 9:10 - 9:15 am | Opening Remarks Sam Hawgood, MBBS - Chancellor, University of California San Francisco (UCSF) |
| 9:15 - 9:35 am | Year in Review Robert Califf, MD - FDA Commissioner, 2016-2017, 2022-present |
| 9:35 - 10:35 am | Panel 1: Disparities in Clinical Trial Enrollment: What Will it Take to Close the Gap? Moderators: Laura Esserman, MD, MBA - Professor of Surgery and Radiology, UCSF Patrizia Cavazzoni, MD - Director, Center for Drug Evaluation and Research (CDER), FDA Panelists: Michael Drake, MD - President, University of California Congresswoman Anna Eshoo - Chair of the Health Subcommittee in the US House of Representatives Ricki Fairley, MBA - Chief Executive Officer at Touch, The Black Breast Cancer Alliance Sohail Rao, MD, MA, DPhil - Founding President & Chief Executive Officer, DHR Health Institute for Research & Development Ramona Sequeira, MBA - President, Global Portfolio Division, Takeda Pharmaceutical |
| 10:35 - 10:55 am | Break |
| 10:55 - 11:55 am | Panel 2: Cross-Agency Synergy to Accelerate Access to Safe and Effective Medical Products Moderators: Kuldev Singh, MD, MPH - Professor of Ophthalmology, Stanford University Mark McClellan, MD, PhD - Professor of Business, Medicine, and Policy, Duke University Panelists: Rena Conti, PhD - Associate Research Director of Biopharma & Public Policy, Boston University Institute for Health System Innovation & Policy Lee Fleisher, MD - Chief Medical Officer and Director of the Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services (CMS) Mathai Mammen, MD, PhD - Executive Vice President, Pharmaceuticals, Research & Development, Johnson & Johnson Jeff Shuren, MD, JD - Director, Center for Devices and Radiological Health (CDRH), FDA |
| 11:55 am - 12:55 pm | Panel 3: Building a Global Regulatory Vision for Product and Drug Development: Challenges and Opportunities Moderators: Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI Dan Hartman, MD - Director, Integrated Development, Global Health, Bill & Melinda Gates Foundation Panelists: Moji Christianah Adeyeye, PhD, FAS - Director-General, National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria Emer Cooke, MBA - Executive Director of the European Medicines Agency (EMA) Frank Gupton, PhD - Floyd D. Gottwald, Jr. Chair in Pharmaceutical Engineering and Chair, Professor, Department of Chemical and Life Science Engineering, Virginia Commonwealth University Peter Marks, MD, PhD - Director, Center of Biologics Evaluation and Research (CBER), FDA Jacques Mascaro, PhD, MBA - Sr. Vice President, Global Head of Oncology Regulatory Science and Strategy, AstraZeneca |
| 12:55 - 1:40 pm | Lunch |
| 1:40 - 2:40 pm | Panel 4: FDA Chiefs Chat Moderators: Andy Plump, MD, PhD - President, Research and Development, Takeda Pharmaceutical Janet Woodcock, MD - FDA Principal Deputy Commissioner Confirmed Panelists: Robert Califf, MD - FDA Commissioner, 2016-2017, 2022-present Scott Gottlieb, MD - FDA Commissioner, 2017-2019 Margaret (Peggy) A. Hamburg, MD - FDA Commissioner, 2009-2015 Mark McClellan, MD, PhD - FDA Commissioner, 2002-2004 |
| 2:40 - 2:55 pm | Closing Remarks Janet Woodcock, MD - FDA Principal Deputy Commissioner Laura Esserman, MD, MBA - Professor of Surgery and Radiology, UCSF |
| 2:55 - 4:00 pm | Poster Session & Networking Kathy Giacomini, PhD, BSPharm - Co-PI, UCSF-Stanford CERSI Tina Morrison, PhD - Director, Office of Regulatory Science and Innovation (ORSI), FDA |
| 4:00 pm | Adjournment |
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