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Wednesday, June 27 • 2:00pm - 3:15pm
#375: Statistical Challenges in Assessing Drugs’ Efficacy by Utilizing Biomarker Endpoints

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-672-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Discuss the issues and challenges facing future development programs in assessing drug's efficacy by utilizing biomarker endpoints and develop possible strategies.


Min Min, PhD


Individualized Treatment Recommendation Through Machine Learning Algorithms
Brenda Crowe, PhD

Validation of Biomarkers as a Surrogate for Clinical Endpoints: The Global PBC Experience
Bettina Hansen, PhD, MSc

Evidentiary Considerations of Integration of Biomarkers in Drug Development
Aloka Chakravarty, PhD

avatar for Aloka Chakravarty

Aloka Chakravarty

Deputy Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Dr. Chakravarty joined CDER in 1992. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development and has presented and published widely on it. Dr. Chakravarty received the FDA Award of Merit in 2008 and... Read More →
avatar for Brenda Crowe

Brenda Crowe

Senior Research Advisor, Global Statistical Sciences, Eli Lilly and Company
Brenda Crowe is a Senior Research Advisor at Eli Lilly and Company (Lilly) where she leads a Safety Analytics team. She obtained a PhD in Statistics from the University of Toronto in 1997 and has 20 years of pharmaceutical industry experience.

Bettina Hansen

Associate Professor, Senior Biostatistician, Institute of Health Policy, Management and Evaluation (IHPME), Univ of Toronto
Dr. Hansen mentors PhD candidates in their clinical research which is reflected in a high productivity with over 230 publications. In collaboration with national and international scientists, she has coordinated several large impact studies on treatment for viral hepatitis and autoimmune... Read More →

Min Min

Mathematical Statistician, OB, OTS, CDER, FDA
Min Min received her PhD in Statistics from University of Maryland, College Park in December 2007. She joined the FDA in June 2008 and worked as a statistical reviewer with Pharmacology and Toxicology team for the six and half years. Currently, she is a stat reviewer for Division... Read More →

Wednesday June 27, 2018 2:00pm - 3:15pm EDT
Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session