Developing A Rational, Reliable and Sustainable National Health Care Resource

CSRC Think Tank:
Prevention of Sudden Cardiac Death in the Young:
Developing A Rational, Reliable and Sustainable National Health Care Resource

White Oak Facility, FDA Headquarters • Silver Spring, Maryland• February, 20 2015

Meeting Agenda

Session TimeTopics & Speakers
7:30am-8:00amRegistration & Breakfast
8:00am-8:20am-Welcome & Introductions
Co-Chairs : Brief statements review of goals of the meeting and the agenda –Theressa Wright, M.D. (Eli Lilly)(10min)
Collaboration, Cardiac Safety & Children: The CSRC View
Who, What, & Why: The Mission of the CSRC – Mitchell Krucoff, M.D. (Duke University) (10min)
8:20am 8:50amPlenary Session: Sudden Cardiac Death in the Young
An issue of national and international public interest– Jonathan Kaltman, M.D. (NHLBI)(10min)
An issue of the family (personal prospective)- Sharon Bates (Anthony Bates Foundation)(10min)
An issue of public health and cardiac safety?- Norman Stockbridge, M.D., Ph.D (FDA) (10min)
8:50am-10:10amPathophysiology and Detection How do we find who is at risk and what happens when we do?
Moderator: Theressa Wright, M.D. (Eli Lilly)
SCD in the young: How good are we at detection in the best circumstances?-Mitchell Cohen, M.D. (Phoenix Children’s Hospital) (10min)
False positives and negatives: What are our worst fears with screening?- Michael Ackerman, M.D., Ph.D (Mayo Clinic)(10min)
Panel Discussion-Benefits and drawbacks of screening (60mins)
FDA Perspective- Lynne Yao, M.D. (FDA)
Japan Perspective-Kaori Shinagawa, M.D., Ph.D (PMDA Japan Regulatory Agency)
Pharmaceutical perspective- Robert Kleiman, M.D. (ERT)
Parent/Foundation Perspective – Martha Lopez-Anderson (Parent Heart Watch)
Sport Organization Perspective-Brian Hainline, M.D. (NCAA)10:10am-10:25-Break (15min)
10:25am-12:15pmGlobal Perspective on Screening for SCD in the Young
Moderator: John Finkle, M.D. (GSK)
International Perspective “Screening approaches for sudden death in Italy”- Antonio Pelliccia, M.D. (University of Rome/ L’Aquila)(10min)
International Perspective: “Screening approaches for sudden death in Japan”-Kaori Shinagawa, M.D. (PMDA Japan Regulatory Agency)(10min)
International Perspective: Screening approaches for sudden death in Israel”– Sami Viskin, M.D. (Tel Aviv Medical Center ) (10min)
The state of screening in the US: results of a national survey– Christine Lawless M.D., MBA (University of Nebraska) (15min)
Panel Discussion- What are the roadblocks to screening? (65min)
FDA Perspective- Lynne Yao, MD.
Academic Perspective (Psychological)- Irfan Asif, M.D. (Greenville Health System-Greenville, South Carolina)
Industry Perspective- Albert J Allen, M.D., Ph.D. (Eli Lilly)
Academic Perspective- Stuart Berger, M.D. (University of California- Davis)
Foundation Perspective- Lisa Salberg (Hypertrophic Cardiomyopathy Association)12:15pm-1:00pm- Lunch (45min)
1:00pm- 2:30pmCan we develop a uniform standard for screening
Moderator: Salim Idriss, M.D., Ph.D. (Duke University)
Can we develop uniform approach to screening? -Kimberly Harmon, M.D. (University of Washington) (10min)
Can we develop uniform screening parameters for ECG? -Elizabeth Saarel, M.D. (Primary Children´s Hospital-Salt Lake City, UT) (10min)
What is role of echocardiography? -Nancy Goldman Cutler, M.D. (Beaumont Children’s Hospital- Royal Oak, MI ) (10min)
Panel Discussion- Discussion about development of a uniform screening approach, a screening ‘toolkit’ for programs to have uniform approach (60min)
Industry Perspective- Margaret Keehn, RN (GE Healthcare)
Foundation Perspective- Darren Sudman, JD (Simon’s Fund)
Sport Organization Perspective-Brian Hainline, M.D. (NCAA)2:30pm-2:45pm-Break (15min)
2:45pm-4:45pmHow do we develop and utilize a repository of data from screening?
Moderator: Mitchell Krucoff, M.D. (Duke University)
Developing a consensus on formats for digital ECGs: The background of the FDA ECG warehouse Justin Mortara, Ph.D (Mortara Instruments) (5min)
What are essential elements for a screening database? -Darren Sudman, JD (Simon’s Fund) (5min)
What are the nuts and bolts of image storage in a repository? Mark Kohls, MSc, MBA, Esq. (GE Healthcare)(5min)
What are the legal aspects of screening data collection and storage? Jeff Sopp, MBA (PRIVIT)(5min)