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Session 9 – Phase 2 Dose-Finding Studies, Part II
Session Chair(s)
Jose C. Pinheiro, PhD
Head of Statistical Modeling and Methodology, SDS
Janssen Research & Development, LLC, United States
H. M. James Hung, PhD
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
FDA, United States
The second session will feature the presentation of a case study of a real dose finding trial, followed by an expert panel, which will include the three speakers from the first session plus two additional discussants. The discussion will include the topics and methods presented in the first session and the case study, but will also cover future directions and trends in dose finding studies.
Speaker(s)
Characterizing Dose-Response in the development of Novel Treatments for Multiple Sclerosis
David Ohlssen, PhD
Novartis Pharmaceuticals Corporation, United States
Senior Expert Methodologist
Discussants
Neal Thomas, PhD
Pfizer Inc, United States
Executive Director, Biostatistics
Sue-Jane Wang, PhD, MA, MS
FDA, United States
Mathematician Statistician
Frank Bretz, PhD
Novartis , Switzerland
Distinguished Quantitative Research Scientist
H. M. James Hung, PhD
FDA, United States
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
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