Innovations in Regulatory Science Summit

Mission Bay Conference Center
1675 Owens St, San Francisco, CA 94158

Registration

Registration Fee: $200 ($25 for academia or government)
Register Here: https://cersi-summit.eventbrite.com

Overview

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 2019 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
  • The Role of 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

 

(Click image to download PDF flyer)

Draft Agenda - Subject to Change

Time

Title

Speakers

8:00 am

Welcome and Opening Remarks

Sam Hawgood, MD | UCSF Chancellor

8:10 am

Overview of UCSF-Stanford CERSI

Kathy Giacomini, PhD | Co-Director of UCSF-Stanford CERSI

8:30 am

Keynote Address

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

Session 1

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 of Center for Drug Evaluation and Research at FDA

9:00 am

Lightning Talk Presentations

  • Overview of OneSource
  • Defining the Strength of Evidence in Therapeutic Development

Presenters:
Laura Esserman, MD, MBA | Professor of Surgery at UCSF
Steven Goodman, MD, MHS, PhD | Associate Dean of Clinical and Translational Research at Stanford

9:20 am

Panel Discussion

Moderated by Laura Esserman and Janet Woodcock

 

Laura Esserman, MD, MBA | Professor of Surgery at UCSF
Steven Goodman, MD, MHS, PhD | Associate Dean of Clinical and Translational Research at Stanford
Amita Joshi, PhD | Vice President, Global Head of Clinical Pharmacology at Genentech
Carl Peck, MD | Chairman of NDA Partners
Alfred Sandrock, MD, PhD | Executive Vice President, Chief Medical Officer at Biogen
Janet Woodcock, MD | Director of Center for Drug Evaluation and Research at FDA

10:20 am

Break

 

Session 2

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

10:40 am

Lightning Talk Presentations

  • The Accelerated Digital Clinical Ecosystem
  • Intracranial Closed-Loop Stimulation to Impact Depression

Presenters:
Andrew Auerbach, MD | Director of Research, Division of Hospital Medicine at UCSF
Katherine Scangos, MD, PhD | Assistant Professor of Psychiatry at UCSF

11:00 am

Panel Discussion

Moderated by Adam Gazzaley and Anne Wojcicki

Robert Califf, MD | Professor of Medicine at Duke University and Former FDA Commissioner
Edward Chang, MD | Professor of Neurological Surgery at UCSF
Adam Gazzaley, MD, PhD | Professor of Neurology, Physiology and Psychiatry at UCSF
Daphne Koller, PhD | Founder & CEO of Insitro
Bakul Patel, MSEE, MBA | Associate Director for Digital Health (CDRH) at FDA
Anne Wojcicki | CEO of 23andMe

12:00 pm

Lunch

 

Session 3

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 | Professor of Medicine at Duke University and Former FDA Commissioner

1:00 pm

Lightning Talk Presentations

  • Patient Preferences in Upper Limb Prostheses
  • Patient Reported Outcomes for Minimally Invasive Glaucoma Surgery

Presenters:
Leslie Wilson, PhD | Professor of Clinical Pharmacy at UCSF
TBD

1:20 pm

Panel Discussion

Moderated by Howard Bauchner and Robert Califf

Howard Bauchner, MD | Editor-In-Chief of the Journal of the American Medical Association
Robert Califf, MD | Professor of Medicine at Duke University and Former FDA Commissioner
Mildred Cho, PhD | Professor of Pediatrics at Stanford
Arthur Ciociola, PhD | Vice President, Head Regulatory Affairs, Global Drug Development Ophthalmology at Novartis
Carol Linden, PhD | Director of the Office of Regulatory Science and Innovation at FDA
Leslie Wilson, PhD | Professor of Clinical Pharmacy at UCSF

Session 4

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

2:20 pm

Lightning Talk Presentations

  • Bioequivalence and Excipients in Drug Products
  • Chemoinformatic Tools for Generic Drugs

Presenters:
Kathy Giacomini, PhD | Co-Director of UCSF-Stanford CERSI
Joshua Pottell, PhD | Postdoctoral Scholar at UCSF

2:40 pm

Panel Discussion

Moderated by Jay Bradner and Joseph Wu

Jay Bradner, MD | President of Novartis Institutes for Biomedical Research
Brook Byers, MBA | Founding Partner of Kleiner Perkins (Pending)
Ian Knemeyer, PhD | Director of Pharmacokinetics, Pharmacodynamics and Drug Metabolism at Merck
Peter Marks, MD, PhD | Director, Center for Biologics Evaluation and Research at FDA
Mathai Mammen, MD, PhD | Global Head of Research and Development at Janssen (Pending)
Janet Woodcock, MD | Director of Center for Drug Evaluation and Research at FDA (Pending)
Joseph Wu, MD, PhD | Director of the Stanford Cardiovascular Institute

3:40 pm

Closing Keynote

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

4:10 pm

Reception and Poster Session

 

 

Contact

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