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Oncology Medications: State-of-the-art Identification and Management of Potential CV Safety Issues During Development
Program Code:
315
Date:
Wednesday, June 27, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Philip Sager, Sager Consulting Experts, United States
PRESENTER
(S):
Philip Sager, Sager Consulting Experts, United States
Dr. Finkle is boarded in Internal Medicine, Cardiology and Clinical Cardiac Electrophysiology. He works in the Clinical Safety Department at GSK and is Chair of the Global QT and Cardiology Safety Panels. Dr. Finkle also sits on Executive Steering Committee of the Cardiac Safety Research Consortia
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Dr. Temple is Deputy Center Director for Clinical Science of FDA’s Center for Drug Evaluation and Research and is Acting Director of the Office of Drug Evaluation I, which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products.
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Daniel Lenihan, Vanderbilt University, United States
Description
Increasingly cardiac safety issues have arisen as a concern in the development of oncology medications. This session will focus on the potential safety issues of cardiotoxicity and QT prolongation and arrhythmogenesis and discuss their identification and potential management strategies. In addition, a state-of-the-art framework for collecting potential cardiac safety adverse events will be discussed and audience participation will be encouraged. The attendee will gain deeper theoretical and practical insight into the cardiac safety evaluation and risk-management of oncology medications during their development. This session is hosted by Cardiac Safety Research Consortium (CSRC)
Learning Objectives:
Describe the techniques to identify myocardial toxicity during the development of oncology medications
Identify the different approaches to assessing the potential for a development-stage oncologic compound to be arrhythmogenic and how to manage any potential risks
Explain how to proactively assess potential cardiac adverse events using a standardized methodology.