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戻る Agenda
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)
Strategic and Methodological Considerations for Predictive Enrichment in Drug Development
Zoran Antonijevic, MSc
Abond CRO Inc., United States
Vice President, Statistical Consulting
Integration of Predictive Biomarkers and Classifiers into Oncology Clinical Development Programs
Robert A. Beckman, MD
Georgetown University Medical Center, United States
Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics
FDA Perspective
Sue-Jane Wang, PhD, MA, MS
FDA, United States
Mathematician Statistician