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Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints
Session Chair(s)
Min Min, PHD
Mathematical Statistician, OB, OTS, CDER, FDA, United States
This session will provide a platform for researchers to discuss the challenges and issues they faced, share the lessons they learned, and offer possible strategies for future development programs in assessing drug's efficacy by utilizing biomarkers.
Learning Objective : Discuss the issues and challenges facing future development programs in assessing drug's efficacy by utilizing biomarker endpoints and develop possible strategies.
Speaker(s)
Brenda Crowe, PHD
Associate Vice President, Statistics, Eli Lilly and Company, United States
Individualized Treatment Recommendation Through Machine Learning Algorithms
Bettina Hansen, PHD, MSC
Associate Professor, Senior Biostatistician, UHN, TCLD & TGHRI, Canada
Validation of Biomarkers as a Surrogate for Clinical Endpoints: The Global PBC Experience
Aloka Chakravarty, PHD
Director, Data Analytics, Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Evidentiary Considerations of Integration of Biomarkers in Drug Development
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