UCSF

Workshop: Substantial Evidence in 21st Century Regulatory Science: Borrowing Strength from Accumulating Data

Date: 
Thursday, April 21, 2016 - 8:00 am to 4:30 pm
Location: 
University of California, Washington Center

1608 Rhode Island Ave NW, Washington DC 20036

Archived presentations available

The statutory requirement for substantial evidence of effectiveness of a new drug has generally been interpreted to require demonstration of a low probability (p<0.05), assuming non-effectiveness, based on data from two phase III clinical trials. This Special ACDRS Workshop opens discussion on deriving substantial evidence of effectiveness based on a high probability of effectiveness, utilizing evidence from all reliable sources of effectiveness data.

Program

Session

Title

presentations

1

Introduction and Motivations

Co-chairs:

  • Carl Peck, University of California, San Francisco

  • Donald Rubin, Harvard University

2

Stakeholder Perspectives on the Use of Bayesian Methods in Drug Development and Regulatory Science (DD&R)

Co-chairs:

  • Karen Price, Eli Lilly and Company

  • John Scott, US Food and Drug Administration

 

Luncheon talk

PDF iconReverend Bayes Goes to Washington.pdf

Sharon Bertsch McGrayne, Author of “The Theory that Would Not Die, How Bayes’ Rule Cracked the Enigma Code, Hunted Down Russian Submarines & Emerged Triumphant from Two Centuries of Controversy”

3

Opportunities to Advance the Use of Bayesian Methods for DD&R

Co-chairs:

  • Karen Price, Eli Lilly and Company

  • Lisa LaVange, US Food and Drug Administration

4

Substantial Evidence through a Bayesian Lens

Co-chairs:

  • Stephen Ruberg, Eli Lilly and Company

  • Gregory Campbell, Independent Consultant

PDF iconACDRS Workshop Final Program 2016.pdf

Speakers and panelists

  • Scott Berry, PhD, Berry Consultants
  • Gregory Campbell, PhD, Consultant
  • Bradley Carlin, PhD, University of Minnesota
  • David W. Feigal Jr., MD, MPH, NDA Partners
  • Steven Goodman, MD, MHS, PhD, Stanford University
  • Frank E. Harrell Jr., PhD, Vanderbilt University
  • Telba Irony, PhD, Food and Drug Administration
  • Lisa LaVange, PhD, Food and Drug Administration
  • Mark McClellan, MD PhD, Duke University
  • Sharon Bertsch McGrayne, Author of “The Theory that Would Not Die”
  • David Ohlssen, PhD, Novartis
  • Carl Peck, MD, UCSF and NDA Partners
  • Karen Price, PhD, Eli Lilly and Company
  • Stephen Ruberg, PhD, Eli Lilly and Company
  • Donald Rubin, PhD, Harvard University
  • John Scott, PhD, Food and Drug Administration
  • Robert Temple, MD, Food and Drug Administration
  • Janet Woodcock, MD, Food and Drug Administration

Planning committee

  • Co-Chairs:
    • Carl Peck, MD, UCSF and NDA Partners
    • Stephen Ruberg, PhD, Eli Lilly and Company
  • Gregory Campbell, PhD, Consultant
  • Lisa LaVange, PhD, Food and Drug Administration
  • Karen Price, PhD, Eli Lilly and Company
  • Donald Rubin, PhD, Harvard University
  • John Scott, PhD, Food and Drug Administration

Questions?

Please contact [email protected].

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