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Bethesda North Marriott Hotel and Conference Center

2015 年 04 月 20 日 8:30 上午 - 2015 年 04 月 22 日 4:30 下午

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

DIA/FDA Statistics 2015 Forum

Session 10: Adaptive Design and Bayesian Working Group Feedback

Session Chair(s)

Lei  Nie, PHD

Lei Nie, PHD

Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER

FDA, United States

Zoran  Antonijevic, MSC

Zoran Antonijevic, MSC

Vice President, Statistical Consulting

Abond CRO Inc., United States

Over the past few years, the DIA has established several multi-disciplinary Scientific Working Groups (SWGs) which bring together representatives from Industry, Government and Academia to address a specific unresolved research problem related to drug development. Two of the most active SWGs are the Adaptive Designs SWG and the Bayesian SWG. This session will highlight recent developments from these ongoing activities. In particular, the speakers will outline how these developments can accelerate the drug development process

Speaker(s)

Zoran  Antonijevic, MSC

Speaker

Zoran Antonijevic, MSC

Abond CRO Inc., United States

Vice President, Statistical Consulting

David  Ohlssen, PHD

Speaker

David Ohlssen, PHD

Novartis Pharmaceuticals Corporation, United States

Senior Expert Methodologist

Estelle  Russek-Cohen, PHD

Panelist (joining the Speakers):

Estelle Russek-Cohen, PHD

FDA, United States

Senior Advisor, Office of Biostat

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