CSRC-HESI-FDA Meeting Agenda
Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study
10903 New Hampshire Avenue, Silver Spring, Maryland 20993
White Oak Facility, FDA Headquarters • Silver Spring, MD • July 23, 2013
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8:10am-9:30am Session 1: Paradigm Shift: New Approach to Assessing TdP Risk without the Thorough QT Study Moderators: Stockbridge/ Sager
Benefits and limitations of the current paradigm as outlined in ICH S7B and E14
· Overview: Norman Stockbridge, FDA (15 min)
· Impact of the current paradigm on drug discovery and development
o Preclinical: Tim Hammond (10 min)
o Biotechnology and Investment Perspective: Hamish Cameron, SV Life Sciences Advisers, LLP (10 min)
o Clinical Development: Peter Kowey, Lankenau Institute for Medical Research (10 min)
o Regulatory Risk, Uncertainty and Implications: Krishna Prasad, EMA (10 min)
· Beyond S7B/E14 – Why the science supports a new paradigm: John Koerner, FDA (15 min)
· FDA Policy Viewpoint: Robert Temple, FDA (15 min) (no slides available)
Audience/Panel (All Speakers) Discussion (75 min)
Lead discussant: Christine Garnett, Certara
10:45am-11:00am BREAK
11:00am-12:30pm Session 2: Proposed Assay Schema Moderators: Koerner, Valentin,& Gintant
- Mechanisms of arrhythmogenesis: Craig January, University of Wisconsin (10 min)
- Overview and why certain assays were included and others not: Gary Gintant, AbbVie (15 min)
- Individual approaches contributing to the Schema-
In Silico Proarrhythmia Assessment: Gary Mirams, University of Oxford (15 min)
Stem cell Proarrhythmia Assessment- Joseph Wu, Stanford University (no slides available) (15 min)
12:30pm-1:00pm WORKING LUNCH
1:00pm-3:00pm Session 2: Proposed Assay Schema Continued
· Validation concepts pertaining to the new approach and the tension surrounding risk: Brian Berridge, GSK (20 min)
· What success would look like, how the approach would be used, and next steps with respect to Schema refinement: Jean-Pierre Valentin, AstraZeneca (15 min)
Audience/Panel (All speakers and Drs. Roden and Stockbridge) Discussion (85 min)
Lead discussant: Peter Hoffmann, Novartis
3:00pm-3:15pm BREAK
3:15pm-5:20pm Session 3: Implications and Next Steps Moderators: Prasad/ Hammond
· Regulatory acceptance: Krishna Prasad and Norman Stockbridge (no slides available) (20 min)
· Regulatory Acceptance: Pharm Perspective: Jim Keirns, Astellas (10 min)
· Labeling Implications
· Pharm Viewpoint: Andrew Erdman, Genentech (10 min)
· FDA Viewpoint: Doug Throckmorton, FDA (no slides available) (10 min)
Audience/Panel Discussion (all speakers and Dr. Sager) /Case Scenarios (60 min)
Lead discussant: Charles Benson, Eli Lilly & Co.
5:20pm- 5:50pm Summary and Next Steps
Drs. Stockbridge, Sager, Gintant