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Session 5: Biomarkers
Session Chair(s)
Jeff Maca, PhD
Senior Director, Biostatistics; Advisory Services Analytics
Quintiles, United States
Sue-Jane Wang, PhD, MA, MS
Mathematician Statistician
FDA, United States
The BEST (Biomarker, EndpointS and other Tools) resources, developed through a collaboration of FDA and NIH, recently became available on the National Center for Biotechnology Information’s Bookshelf. In light of this new development, speakers in this session will introduce the BEST resources to clarify what we mean when we talk about biomarkers, present the roadmap to qualify biomarkers and share a real case study utilizing biomarker in phase II to take a go/no-go decision with or without enrichment for phase III. The session will then open to the floor for discussion.
Speaker(s)
Harmonization of Terminology for Biomarkers and Endpoints To Strengthen Quality and Improve Efficiency of Translational Science
Lisa M. McShane, PhD
National Cancer Institute Biometric Research Branch, United States
Professor of Pediatrics
Roadmap to Biomarker Qualification: Strategy and Process
Shashi Amur, PhD
FDA, United States
Scientific Lead, Biomarker Qualification Program Office of Translational Science
A Phase II/III Biomarker-Based Bayesian Design
Marc E. Buyse, DrSc
IDDI, United States
Chief Scientific Officer