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Tryp Barcelona Apolo

Nov 10, 2014 9:00 AM - Nov 11, 2014 4:00 PM

Avinguda del Parallel, 57-59, 08004 Barcelona, Spain

Joint DIA/AEMPS Statistics Workshop

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Session 3: HOW PRECISE CAN PRECISION MEDICINE BE?

Session Chair(s)

Hans Ulrich Burger, PhD

Senior Director of Biostatistics

F. Hoffmann-La Roche Ltd., Switzerland

Tim Friede

Professor of Biostatistics and Chair, Department of Medical Statistics

University Medical Center Goettingen, Germany

Precision medicine becomes more and more important in drug development. Among the many topics possible we picked out two, biomarker identification and seamless enrichment designs. There will be a short introduction into the topic, an overview and different methods, then two examples from industry and a regulatory evaluation. Finally the two sessions will be rounded up by a panel discussion.

Speaker(s)

Adaptive Enrichment Designs for Stratified Medicine

Tim Friede

University Medical Center Goettingen, Germany

Professor of Biostatistics and Chair, Department of Medical Statistics

Kaspar Rufibach, PhD, MSc

How Good is Your Biomarker? Comparison of Development Plans for Confirmatory Biomarker Enrichment

Kaspar Rufibach, PhD, MSc

Roche, Switzerland

Expert Statistical Scientist, Methods, Collaboration, and Outreach Group

Heinz Schmidli, PhD, MSc

Bayesian Approaches to Enrichment Designs

Heinz Schmidli, PhD, MSc

Novartis Pharma AG, Switzerland

Executive Director, Statistical Methodology

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