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Evaluation and Selection of the Optimal Endpoints for Clinical Studies
Program Code:
109
Date:
Monday, June 24, 2013
Time:
11:00 AM to 12:30 PM
EST
CHAIR
:
Freda W. Cooner,
PhD (SCHAGY), Mathematical Statistician, Div. of Biometrics III, OB, OTS, CDER,
FDA, United States
Freda Cooner is a Mathematical Statistician at the Office of Biostatistics, CDER, FDA, supporting the Division of Gastroenterology and Inborn Errors Products. She received her Ph.D. from Division of Biostatistics at the University of Minnesota. She worked at CDRH, FDA, prior to joining CDER.
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SPEAKER
(S):
Debra G Silberg,
MD,PhD (SPKNON), Senior Director, Clinical Medicine,
Shire Specialty Pharmaceuticals, United States
Debra Silberg is a Senior Director at Shire Pharmaceuticals leading GI Clinical Development. She is a Gastroenterologist, trained at the University of Pennsylvania where she then became faculty prior to joining Industry. She is currently on the C-Path dyspepsia working group.
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Anil Rajpal, MD,MPH (SPKAGY), Medical Team Leader, Div. Gastroenterology and Inborn Errors Products, OND, CDER, FDA, United States
Nandini Raghavan,
PhD,MSc (SPKNON), Associate Director, Biostatistics & Reporting,
Janssen Research & Development, LLC, United States
Nandini Raghavan is Associate Director of Biostatistics at Janssen R&D. At Janssen, Dr. Raghavan has worked extensively on functional genomics and biomarkers. More recently, she has been working in the field of Alzheimer’s Disease on developing novel endpoints for early-stage trials.
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Description
An endpoint for measuring the disease severity and treatment comparison is not always readily definable. We will discuss why it is important to select true patients and properly quantify treatment effects in considering endpoints.