Post #1419

CSRC Annual Meeting 2015

White Oak Facility, FDA Headquarters • Silver Spring, Maryland• February, 19 2015

Meeting Agenda

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
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)
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)