CSRC Annual Meeting 2015

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)