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Bethesda North Marriott Hotel and Conference Center

Apr 19, 2015 1:30 PM - Apr 19, 2015 4:30 PM

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

Tutorial 4: Dose Finding in Drug Development: Methods and Implementation

Speakers

Frank  Bretz, PhD

Frank Bretz, PhD

Distinguished Quantitative Research Scientist, Novartis , Switzerland

Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has supported the methodological development in various areas of drug development, including dose finding, estimands, multiple testing, and adaptive designs. He was a member of the ICH E9(R1) Expert Working Group on 'Estimands and sensitivity analysis in clinical trials' and currently serves on the ICH E20 Expert Working Group on 'Adaptive clinical trials'.

Jose C. Pinheiro, PhD

Jose C. Pinheiro, PhD

Head of Statistical Modeling and Methodology, SDS, Janssen Research & Development, LLC, United States

José Pinheiro has a Ph.D. in Statistics from the University of Wisconsin – Madison, having worked at Bell Labs and Novartis Pharmaceuticals, before his current position as Global Head of Statistical Modeling & Methodology in the Statistics and Decision Sciences department at Janssen Research & Development. He has been involved in methodological development in various areas of statistics and drug development, including dose-finding, adaptive designs, and mixed-effects models. He is a Fellow of the American Statistical Association, a past-editor of Statistics in Biopharmaceutical Research, and past-president of ENAR

Bjoern  Bornkamp, PhD, MSc

Bjoern Bornkamp, PhD, MSc

Senior Director, Statistical Methodology, Novartis Pharma AG, Switzerland

Björn Bornkamp works in the Statistical Methodology Group at Novartis in Basel, where he provides consulting to statisticians and clinical teams on topics related to dose-finding, subgroup analyses, Bayesian statistics as well as estimands and causal inference.

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