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Session 5 - Proarrhythmia
Session Chair(s)
Norman Stockbridge, MD, PhD
Director, Division of Cardiology and Nephrology, OND, CDER
FDA, United States
This session introduces two very different concepts for non-clinical assessment of proarrhythmic risk, one highly integrative, the other highly mechanistic. Then, two very different approaches to clinical assessment of risk are presented--both very different from the “Thorough QT Study"—one obtaining QT information from early phase studies conducted for other purposes, the other seeking to get mechanistic insight from a more detailed analysis of the ECG than just the QT interval.
Speaker(s)
Assessment of Dysrhythmic Potential in Isolated Cardiac Myocytes
Blake D. Anson, PhD
Cellular Dynamics International, Inc, United States
Product Manager, iCell Cardiomyocytes
Comprehensive Mechanistic Assessment of Proarrhythmic Potential of Drugs
Gary Gintant, PhD
AbbVie Inc., United States
Research Fellow
Early QT Assessment - "Thorough QT" - Like Assessment in Phase 1 Clinical Studies
Börje C. Darpö, MD, PhD
Clario, Sweden
Chief Scientific Officer, Cardiac Safety
Going Beyond QT to Improve the ECG Assessment of Proarrhythmic Risk
David Strauss, MD, PhD
FDA, United States
Director, Division of Applied Regulatory Science, OCP, OTS, CDER
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