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The Thorough QT Study: Isn't There a Better Way to Do This?
Program Code:
205
Date:
Tuesday, June 25, 2013
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Charles Benson,
MD,PhD (SCHNON), Medical Fellow,
Eli Lilly and Company, United States
Dr. Benson is a Medical Fellow with Eli Lilly & Co, where he has worked for 13 years. He graduated from M.I.T. before receiving a M.D. Ph.D. from Indiana University. He then trained in Internal Medicine at the Scripps Clinic. He is currently a member of the ICH E14 Implementation Working Group.
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SPEAKER
(S):
Charles Benson,
MD,PhD (SPKNON), Medical Fellow,
Eli Lilly and Company, United States
Dr. Benson is a Medical Fellow with Eli Lilly & Co, where he has worked for 13 years. He graduated from M.I.T. before receiving a M.D. Ph.D. from Indiana University. He then trained in Internal Medicine at the Scripps Clinic. He is currently a member of the ICH E14 Implementation Working Group.
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Jay W. Mason,
MD (SPKNON), Chief Medical Officer,
Spaulding Clinical Research, United States
Dr. Mason is Professor of Medicine (Cardiology) at the Univ of Utah, Chief Medical Officer at Spaulding Clinical Research, and an independent consultant in cardiac safety. He obtained his MD degree at the Univ of Pennsylvania and trained in Medicine and Cardiovascular Diseases at Stanford Univ.
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David Strauss, MD,PhD (SPKAGY), Medical Officer, Office of Science and Engineering Laboratories, CDRH, FDA, United States
Description
QT studies are required for drug approval but are expensive and inappropriately scheduled. A better repolarization assessment can be achieved earlier and at lower cost and risk to subjects as compared to the ICH E-14 thorough QT study approach. This session will review efforts now underway to revise the process for assessing repolarization and related arrhythmia risk during drug development.