White Oak Facility, FDA Headquarters • Silver Spring, Maryland• February, 19 2015
Meeting Agenda
8:00am-5:05pm
| Session Time | Topics & Speakers |
|---|---|
| 8:00am-8:10am | Introduction– Philip Sager, MD (Stanford University/Sager Consulting Experts) (10min) |
| 8:10am-9:55am | Plenary Session: The Landscape for Innovation in CV Safety Moderators: Mitchell Krucoff, M.D., FDA Priorities and the CSRC – Robert M. Califf, M.D. (20min) DIA Priorities and the CSRC– Barbara Lopez Kunz (20min) Panel Discussion (65min) Speakers and John Finkle, MD GSK 9:55am-10:10am-Break (15min) |
| 10:10am-11:40am | Mini- Think Tank 1: Replacing the Thorough QT Study-Is The Time Now? Moderators: Philip Sager, M.D., Borje Darpo M.D., Ph.D. CSRC/IQ- use of early human study QT date to replace the TQT Results of the prospective study and implications– Borje Darpo M.D., Ph.D. (Consultant) (15min) CIPA- replacing the TQT with non-clinical proarrhythmia testing? What is the need for a new paradigm and Current status, opportunities, and challenges– Hugo Vargas, Ph.D. (Amgen) (20min) Panel Discussion (55mins) Norman Stockbridge, M.D., Ph.D. (FDA), Christine Garnett, Pharm.D.(FDA), Corina Dota, M.D.(AstraZeneca) |
| 11:40am-12:25pm | CSRC Think Tank Updates Moderators: John Finkle, M.D. (GSK), Jerrold Levy, M.D. (Duke University) Key issues concerning the development of reversal agents for novel anticoagulants- Consensus pathway forward and how to evaluate post-marketing risk– Jeffrey Weitz, M.D. (McMaster University) (10min) Use and feedback on the CV data collection forms– Mary Beth Sabol, M.D. (GSK) (10min) Brief Panel Discussion (25min) Speakers and Jonathan Seltzer, M.D., MBA (ACI Clinical) 12:25pm-12:55pm-Working Lunch (30min) |
| 12:55pm-3:05pm | Mini-Think Tank 2: CV Outcome Studies and Scientific Advances in Registries to Evaluate CV Safety Moderators: Jeffrey Anderson, M.D. (Intermountain Heart Institute) Thresholds for requiring Randomized CV outcome studies for safety assessment Updates from the CSRC Outcome Study Thresholds Think tank and future directions- Philip Sager, M.D. (Sager Consulting Experts)(10min) FDA Viewpoint- Thresholds for requiring CV Outcome studies for safety-Norman Stockbridge, M.D., Ph.D. (FDA)(10min) How is benefit and risk appropriately balanced with respect to CV outcomes (to include a discussion of hazard ratio selections and number needed to harm boundaries)?– Sanjay Kaul, M.D., Ph.D (Cedar-Sinai Medical Center)(10min) The roles for Adjudication of CV Events in drug development- Jonathan Seltzer, M.D., MBA (ACI Clinical)(10min) Registries for CV Safety Assessment Methodological issues in safety signal detection using heterogeneous data sources and the accuracy of diagnoses – Sharon- Lise Normand, Ph.D. (Harvard University)(10min) The use and challenges of using electronic health care data for CV safety assessment David Graham, M.D., MPH(FDA) (10min) Panel Discussion (60min) 3:05pm-3:35pm-Break (30min) |
| 3:35pm-4:05pm | Abstract presentations on potential new CSRC initiatives Moderators: Catherine Ortemann-Renon, Pharm.D., Ph.D. (Sanofi) Abstract Update: Drug-Induced Cardiac Abnormalities in Premature Infants and Neonates– Luana Koplowitz, M.D., Ph.D. (Duck Flats)(8mins) Concentration-QTc analysis to obviate the need for a dedicated QTc study in cancer patients: ixazomib, an oral proteasome inhibitor, as a case study– Neeraj Gupta, Ph.D. (Takeda)(8min) Arrhythmia Normal Limits in Healthy Clinical Research Volunteers– Polina Voloshko, M.D. (Cardiocore)(8min) |
| 4:05pm-5:05pm | Areas of future direction and impact for the CSRC Moderators: Theresa Wright, M.D. (Eli Lilly), Mary Jane Geiger, M.D., Ph.D. (Regeneron) Global Regulatory and Academic Partnerships- How Can The CSRC Increase Its Impact Regulatory Japan– Kaori Shinagawa, M.D., Ph.D. (PMDA)(5min) Canada- Colette Strnadova, Ph.D. (Health Canada) (5min) CDER- Norman Stockbridge, M.D. Ph.D. (FDA)(5min) Academic Jeffrey Anderson, M.D (Intermountain Heart Institute)(5min) Sanjay Kaul, M.D., Ph.D. (Cedar-Sinai Medical Center)(5min) Panel Discussion (60min) Speakers and John Finkle, M.D. (GSK), Mitchell Krucoff, M.D. (Duke University), Philip Sager, M.D.,(Sager Consulting Experts) |