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Predictive Enrichment: Design, Development Strategies, and Methodological Issues
Session Chair(s)
Zoran Antonijevic, MSC
Vice President, Statistical Consulting, Abond CRO Inc., United States
This session will analyze implications of predictive enrichment on drug approvability and labeling, and illustrate situations when it is most beneficial. It will also address uncertainty about the prognostic value of the predictive biomarker.
Learning Objective : Discuss the impact of an enrichment design on drug approvability and label; Demonstrate scenarios under which application of an adaptive enrichment design is most beneficial; Analyze uncertainty about the prognostic value of the putative predictive biomarker.
Speaker(s)
Zoran Antonijevic, MSC
Vice President, Statistical Consulting, Abond CRO Inc., United States
Strategic and Methodological Considerations for Predictive Enrichment in Drug Development
Robert A. Beckman, MD
Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University Medical Center, United States
Integration of Predictive Biomarkers and Classifiers into Oncology Clinical Development Programs
Sue-Jane Wang, PHD, MA, MS
Mathematician Statistician, FDA, United States
FDA Perspective
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