Workshop: Substantial Evidence in 21st Century Regulatory Science: Borrowing Strength from Accumulating Data · American Course on Drug Development and Regulatory Sciences

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	Introduction.pdf 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 Tutorial Frequentist Bayesian - Statistical Frameworks for Substantial Evidence.pdf Stephen Ruberg, Eli Lilly and Company Fisher, Naymen and Bayes at FDA.pdf Donald Rubin, Harvard University CDER and CBER Experience.pdf Lisa LaVange, US Food and Drug Administration Bayesian Submissions to FDA and the Evidentiary Standard for Effectiveness: the CDER Experience.pdf 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 John Scott, US Food and Drug Administration	Overview of DIA Bayesian Scientific Working Group.pdf Karen Price, Eli Lilly and Company The Value of Bayesian Methods for Evidence-Based Medicine.pdf Steven Goodman, Stanford University An Industry Perspective of the Value of Bayesian Methods.pdf David Ohlssen, Novartis Regulatory Perspective of the Value of Bayesian Methods - Telba Irony.pdf Telba Irony, US Food and Drug Administration
	Luncheon talk Reverend 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	What a Bayesian Owes a Frequentist.pdf Frank Harrell, Vanderbilt University The Role of Simulations for Bayesian Analyses and Regulatory Approval.pdf Scott Berry, Berry Consultants Bayesian Methods in Regulatory Science: Identifying Patient Subgroups with Positive Treatment Effects.pdf Bradley Carlin, University of Minnesota Panel Discussion.pdf
4	Substantial Evidence through a Bayesian Lens Co-chairs: Stephen Ruberg, Eli Lilly and Company Gregory Campbell, Independent Consultant	Clinical Drug Development with a Bayesian Lens - Stephen Ruberg.pdf Stephen Ruberg, Eli Lilly and Company Points to Consider Panel Discussion (no slides)

ACDRS 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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