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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)
Individualized Treatment Recommendation Through Machine Learning Algorithms
Brenda Crowe, PHD
Eli Lilly and Company, United States
Associate Vice President, Statistics
Validation of Biomarkers as a Surrogate for Clinical Endpoints: The Global PBC Experience
Bettina Hansen, PHD, MSC
UHN, TCLD & TGHRI, Canada
Associate Professor, Senior Biostatistician
Evidentiary Considerations of Integration of Biomarkers in Drug Development
Aloka Chakravarty, PHD
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Director, Data Analytics