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Predictive Enrichment: Design, Development Strategies, and Methodological Issues

Track:
Statistical Science and Quantitative Thinking

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
277

Room Number:
5B

Level:
Intermediate

Type:
Session

Title:
Predictive Enrichment: Design, Development Strategies, and Methodological Issues

Chair(s):
Zoran Antonijevic, MSc
Senior Director, Strategic Consulting
Cytel, Inc., United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Strategic and Methodological Considerations for Predictive Enrichment in Drug Development
Zoran Antonijevic, MSc
Senior Director, Strategic Consulting
Cytel, Inc., United States

Integration of Predictive Biomarkers and Classifiers into Oncology Clinical Development Programs
Robert A. Beckman, MD
Executive Director, Clinical Development Oncology
Daiichi-Sankyo, Inc., United States

FDA Perspective
Sue-Jane Wang, PhD, MA, MS
Assoc. Dir., Adaptive Design & Pharmacogenomics, OB, OTS, CDER
FDA, United States