Join the 2027 Innovations in Regulatory Science Summit
About This Event
The 8th annual 2027 Innovations in Regulatory Science Summit will highlight the latest developments in regulatory science, with panels on manufacturing and supply chain of medical products, artificial intelligence, FDA leadership, and the role of regulatory science from challenges to solutions. Debates on exciting topics in regulatory science will also be featured. 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.
UCSF welcomes all participants. If you need a reasonable accommodation to participate in this event because of a disability, please contact [email protected] as soon as possible.
Schedule
Times shown in Pacific Time.
| Time | Topic | Presenter(s) |
|---|---|---|
| 8:30 AM | Breakfast & Sign-In / Networking | |
| 9:00 AM | Welcome | Kathy Giacomini, PhD, BSPharm, Dean, School of Pharmacy, UCSF; Kuldev Singh, MD, MPH, Professor of Opthamology, Stanford University |
| 9:05 AM | Opening Remarks | Sam Hawgood, MBBS, Chancellor, UCSF; Lloyd Minor, MD, Dean, Stanford University School of Medicine |
| 9:15 AM | Innovative Research in Regulatory Science | Kathy Giacomini, PhD, BSPharm, Dean, School of Pharmacy, |
| 9:25 AM | TBD | Speaker to be confirmed |
| 9:45 AM | Panel 1: Evaluation and Benchmarks for Artificial Intelligence (AI) Performance in Regulatory Communications | Moderator: Russ Altman, MD, PhD, Kenneth Fong Professor, Stanford University Panelists: Tala H. Fakhouri, PhD, MPH, Chief AI & Regulatory Strategy Officer, Parexel; Robert Lionberger, PhD, Director, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), US FDA |
| 10:45 AM | Break / Networking | |
| 11:05 AM | Debate 1: TBD | |
| 11:25 AM | Panel 2: US FDA Center Directors Forum | Moderator: Kuldev Singh Panelists: Karim Mikhail, MSc, BPharm, Director, Center for Biologics Evaluation and Research, US FDA; Michelle Tarver, MD, PhD, Director, Center for Devices and Radiological Health, US FDA; and others to be confirmed |
| 12:25 PM | Lunch / Poster Session / Networking | |
| 1:15 PM | Panel 3: Harnessing Regulatory Science to Navigate Challenges and Drive Best Practices | Moderators: Kathy Giacomini, PhD, BSPharm, Dean, School of Pharmacy, UCSF; Michelle Rohrer, PhD, Former Senior Vice President, Global Head of Product Development Regulatory, Roche Panelists: Carlos O. Garner, PhD, Senior Vice President, Global Regulatory Affairs and Head, Lilly Regenerative Medicines, Eli Lilly and Company; Nahid Latif, Chief Regulatory Officer, Head of Global Regulatory Affairs, Takeda; and others to be confirmed |
| 1:45 PM | Debate 2: TBD | |
| 2:05 PM | Panel 4: Disruption in Drug Supply and Development in the US: Can Innovation and Onshore Manufacturing Be the Solution? | Moderator: Laura Esserman, MD, MBA, Professor of Surgery and Radiology, UCSF Panelists: B. Frank Gupton, PhD, Floyd D. Gottwald Chair of Pharmaceutical Engineering and Department Chair, Chemical and Biomolecular Engineering, Virginia Commonwealth University; Dan Hartman, MD, Director, Integrated Development, Gates Foundation; and Kevin Schulman, MD, Professor of Medicine, Stanford University |
| 3:05 PM | Break / Networking | |
| 3:20 PM | Panel 5: Chiefs Chat | Moderator: Andy Plump, MD, PhD, President, Research and Development, Takeda Pharmaceutical Panelists: Robert Califf, MD, Adjunct Professor of Medicine, Cardiology, Duke University, and others to be confirmed |
| 4:20 PM | Closing Remarks | |
| 4:30 PM | Introduction to Networking Reception | |
| 4:40 PM | Poster Reception / Networking Reception |
2027 Summit Planning Committee
