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

Date
Thursday, April 21, 2016 - 8:00 am to 4:30 pm
Event sponsor
American Course on Drug Development and Regulatory Sciences

1608 Rhode Island Ave NW, Washington DC

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;
and Donald Rubin, Harvard University
 
Carl Peck, University of California, San Francisco
 
Keynote Address (no slides)
Janet Woodcock, US Food and Drug Administration
 
Bayesian Methods, Regulatory Decisions, and the Evidence Development Landscape
Mark McClellan, Duke University
 
Stephen Ruberg, Eli Lilly and Company
 
Donald Rubin, Harvard University
 
Lisa LaVange, US Food and Drug Administration
 
Gregory Campbell, Independent Consultant
 

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; and
John Scott, US Food and Drug Administration
Karen Price, Eli Lilly and Company
 
Steven Goodman, Stanford University
 
David Ohlssen, Novartis
 
Telba Irony, US Food and Drug Administration
 

 

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; and
Lisa LaVange, US Food and Drug Administration
Frank Harrell, Vanderbilt University
 
Scott Berry, Berry Consultants
 
Bradley Carlin, University of Minnesota
 
 

4

Substantial Evidence through a Bayesian Lens
Co-chairs: Stephen Ruberg, Eli Lilly and Company; and
Gregory Campbell, Independent Consultant
Stephen Ruberg, Eli Lilly and Company
 
Points to Consider Panel Discussion (no slides)
 

PDF iconACDRS Workshop Final Program 2016

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 and 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].