UCSF

Innovations in Regulatory Science Summit

Date: 
Sunday, January 12, 2020 - 8:00 am to 5:00 pm
Location: 
Mission Bay Conference Center

1675 Owens St, San Francisco, CA 94158

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) is pleased to present the inaugural Innovations in Regulatory Science Summit, a gathering of leaders in the academia, industry and regulatory sectors to discuss the role of regulatory science in medical product development. This event will take place before the 2020 J.P. Morgan Healthcare Conference, and will comprise primarily of panel discussions and short research talks by CERSI investigators on ongoing collaborative research projects with FDA investigators. Panel topics include:

  • Accelerating Clinical Trials in the Development and Approval of Innovative Medical Products
  • Real-World Evidence, Artificial Intelligence and Novel Medical Devices
  • Academia, Government and Industry in Regulatory Science: Cross-Sector Collaboration and Avoiding Conflicts of Interest
  • Advancing Discovery to First-In-Human Clinical Trials for New Medical Products

 

flyer

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Registration

Registration Fee: $200 ($25 for academia or government)

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Agenda

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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

8:35 am

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, Division of Ophthalmic and Ear, Nose & Throat Devices (CDRH) 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

11:20 am

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
Bakul Patel, MSEE, MBA | Associate Director for Digital Health (CDRH) at FDA

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

Contact

Please direct questions to Lawrence Lin, Director of External Relations and Outreach at UCSF-Stanford CERSI at [email protected].