Innovations in Regulatory Science Summit

Time

Title

8:00 am

Welcome

Kuldev Singh, MD, MPH | Professor of Ophthalmology at Stanford University

8:05 am

Overview of UCSF-Stanford CERSI

Russ Altman, MD, PhD and Kathy Giacomini, PhD | Co-Directors of UCSF-Stanford CERSI

8:25 am

Opening Remarks from Stanford

Marc Tessier-Lavigne, PhD | President, Stanford University

Opening Remarks from UCSF

Sam Hawgood, MD | Chancellor, University of California San Francisco (UCSF)

8:45 am

Lightning Talk - Defining the Strength of Evidence in Therapeutic Development

Steven Goodman, MD, MHS, PhD | Associate Dean of Clinical and Translational Research at Stanford

8:55 am

Panel Discussion - Accelerating Clinical Trials in the Development and Approval of Innovative Medical Products

Moderators:
Laura Esserman, MD, MBA | Professor of Surgery at UCSF
Janet Woodcock, MD | Director, Center for Drug Evaluation and Research at FDA

Panelists:
Amy Abernethy, MD, PhD | Principal Deputy Commissioner at FDA
Steven Goodman, MD, MHS, PhD | Associate Dean of Clinical and Translational Research at Stanford
Sandra Horning, MD | Former Chief Medical Officer at Genentech/Roche
Carl Peck, MD | Chairman of NDA Partners
Alfred Sandrock, MD, PhD | Executive Vice President, Chief Medical Officer at Biogen

9:55 am

Break

10:10 am

Lightning Talk - Patient Preferences in Upper Limb Prostheses

Leslie Wilson, PhD | Professor of Clinical Pharmacy at UCSF

10:20 am

Panel Discussion - Academia, Government and Industry in Regulatory Science: Cross-Sector Collaboration and Avoiding Conflicts of Interest

Moderators:
Howard Bauchner, MD | Editor-In-Chief of the Journal of the American Medical Association
Robert Califf, MD | Former FDA Commissioner, Head of Health Policy and Strategy, Google Health and Verily Life Science (Alphabet)

Panelists:
Mildred Cho, PhD | Professor of Pediatrics (Center for Biomedical Ethics) at Stanford
Arthur Ciociola, PhD | Vice President, Head Regulatory Affairs, Global Drug Development Ophthalmology at Novartis
Malvina Eydelman, MD | Director, Office of Health Technology 1 at FDA
Carol Linden, PhD | Director, Office of Regulatory Science and Innovation at FDA
Andrew Weber, MS | Accelerating Therapeutics for Opportunities in Medicine (ATOM), GlaxoSmithKline

Keynote Address

Janet Woodcock, MD | Director of Center for Drug Evaluation and Research at FDA

Moderated by Russ Altman, MD, PhD | Professor of Bioengineering at Stanford

11:50 am

Lunch

12:40 pm

Lightning Talk - Safer Labeling of Pediatric Medications: Reducing Literacy-related Health Disparities among Chronically Ill Adolescents

Lee Sanders, MD | Associate Professor of Pediatrics at Stanford

12:50 pm

Panel Discussion - Real-World Evidence, Artificial Intelligence and Novel Medical Devices

Moderators:
Adam Gazzaley, MD, PhD | Professor of Neurology, Physiology and Psychiatry at UCSF
Anne Wojcicki | CEO of 23andMe

Panelists:
Russ Altman, MD, PhD | Professor of Bioengineering at Stanford
Edward Chang, MD | Professor of Neurological Surgery at UCSF
Daphne Koller, PhD | Founder & CEO of Insitro

1:50 pm

Break

2:05 pm

Lightning Talk - The Activity of Inactive Ingredients

Brian Shoichet, PhD | Professor of Pharmaceutical Chemistry at UCSF

2:15 pm

Panel Discussion - Advancing Discovery to First-In-Human Clinical Trials for New Medical Products

Moderators:
Jay Bradner, MD | President of Novartis Institutes for Biomedical Research
Joseph Wu, MD, PhD | Director of the Stanford Cardiovascular Institute

Panelists:
Hal Barron, MD | Chief Scientific Officer at GlaxoSmithKline
Mathai Mammen, MD, PhD | Global Head of Research and Development at Janssen
Peter Marks, MD, PhD | Director, Center for Biologics Evaluation and Research at FDA

3:15 pm

Closing Keynote

Peter Marks, MD, PhD | Director, Center for Biologics Evaluation and Research at FDA

Moderated by George Scangos, PhD | CEO of Vir Biotechnology

3:45 pm

Closing Remarks

Russ Altman, MD, PhD and Kathy Giacomini, PhD | Co-Directors of UCSF-Stanford CERSI

4:00 pm

Reception and Poster Session (co-sponsored by the UCSF School of Pharmacy)

Hosted by B. Joseph Guglielmo, PharmD - Dean, UCSF School of Pharmacy