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Proarrhythmic Risk Assessment WITHOUT the Thorough QT: FDA and Pharmaceutical Company Perspectives
Session Chair(s)
Norman Stockbridge, MD, PhD
Director, Division of Cardiology and Nephrology, OND, CDER
FDA, United States
In this forum, we will describe development of an assay for the proarrhythmic potential of drugs that is based on characterization of effects on the major human cardiac ion channels. The assay is largely intended to reduce false positives with the thorough QT study.
Learning Objective : Define the proposed new paradigm for the assessment of proarrhythmic risk of new drugs; Describe the state of progress in replacing the current clinical thorough QT study assessing QT prolongation with a nonclinical assessment of drug effects on human cardiac ion channels linked to proarrhythmia; Discuss how drug development can be made more efficient using the new paradigm.
Speaker(s)
The Need for a New Paradigm to Assess Proarrhythmic Effects of Drugs
Philip T. Sager, MD
Stanford University, United States
Adjunct Professor
Industry Perspective on Nonclinical Proarrhythmia Assessment
Gary Gintant, PhD
AbbVie Inc., United States
Research Fellow
Implementation and Implications of Nonclinical Proarrhtyhmia Assessment
Norman Stockbridge, MD, PhD
FDA, United States
Director, Division of Cardiology and Nephrology, OND, CDER
Design of a Comprehensive In Vitro Proarrhythmia Assay
Royce A. Morrison, MD, MS, FACP
Pacific Pharma Group, LLC, United States
Senior Consultant
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