Agenda and Slides July 23, 2013

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


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

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