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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:00 PM - Apr 10, 2019 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Biostatistics Industry and Regulator Forum

Session 2: Challenges and Opportunities for Bayesian Methods in Confirmatory Setting

Session Chair(s)

Min  Lin, MD, PhD

Min Lin, MD, PhD

Statistical Science Director

Astrazeneca, United States

Karen Lynn Price, PhD

Karen Lynn Price, PhD

Senior Research Fellow, Statistical Innovation Center/Design Hub

Eli Lilly and Company, United States

The use of Bayesian methods within medical product development has increased significantly in recent years. While Bayesian methods are more routinely used in design, adaptations within a study, analysis, and decision-making at many points throughout the development process, their use in the confirmatory setting is quite limited. Certainly the use of Bayesian methods in the confirmatory setting is no less scientifically valid than traditional approaches, so questions remain as to what we can do to increase the appropriate use of Bayesian methods to improve the medical development process.
In this session we will provide an overview of challenges and opportunities for the use of Bayesian methods in the confirmatory setting. We will explore specific areas of particular opportunity for their use, and discuss best practices for evaluating the operating characteristics of a design that utilizes a Bayesian approach in the confirmatory setting. This session is related to the recent Complex Innovative Design pilot program session, part of the agency’s broader program to modernize drug development, which includes submission of designs that may utilize Bayesian methods.

Speaker(s)

Telba  Irony, PhD, MS, MSc

Speaker

Telba Irony, PhD, MS, MSc

Janssen R&D, United States

Senior Scientific Director, Quantitative Sciences

Mark  Rothmann, PhD

Bayesian Analysis in Pediatric Settings

Mark Rothmann, PhD

FDA, United States

Division Director

Melanie  Quintana, PhD

Benefits and Complexities of a Bayesian Analysis in Confirmatory Trials

Melanie Quintana, PhD

Berry Consultants, LLC, United States

Director & Senior Statistical Scientist

J. Kyle  Wathen, PhD, MS

A Bayesian Approach in the Non-Inferiority Setting

J. Kyle Wathen, PhD, MS

Cytel Inc., United States

Vice President, Scientific Strategy and Product Innovation

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