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Proarrhythmic Risk Assessment WITHOUT the Thorough QT: FDA and Pharmaceutical Company Perspectives

Track:
Nonclinical and Translational Development/Early Phase Clinical Development

Day & Time:
June 16, 11:00AM - 12:30PM (Pacific Standard Time)

Session Number:
128

Room Number:
7B

Level:
Intermediate

Type:
Forum

Title:
Proarrhythmic Risk Assessment WITHOUT the Thorough QT: FDA and Pharmaceutical Company Perspectives

Chair(s):
Norman Stockbridge, MD, PhD
Director, Division of Cardiovascular and Renal Products, OND, CDER
FDA, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
The Need for a New Paradigm to Assess Proarrhythmic Effects of Drugs
Philip T. Sager, MD, FACC
Consulting Professor of Medicine-Stanford; Chair, Scientific Programs Committee
Stanford University, United States

Industry Perspective on Nonclinical Proarrhythmia Assessment
Gary Gintant, PhD, MA
Research Fellow
AbbVie Inc., United States

Implementation and Implications of Nonclinical Proarrhtyhmia Assessment
Norman Stockbridge, MD, PhD
Director, Division of Cardiovascular and Renal Products, OND, CDER
FDA, United States

Design of a Comprehensive In Vitro Proarrhythmia Assay
Royce A. Morrison, MD, MS
Principal Consultant
RMD Insight LLC, United States