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 Time Topics & Speakers
7:30am-8:00am Registration & 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 8:50am Plenary 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-10:10am Pathophysiology 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-12:15pm Global 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- 2:30pm Can 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-4:45pm How 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)
Panel Discussion What are the nuts and bolts of developing a large scale screening data repository? What screening data should be deposited? How should data be stored? Who should have access to these data? What are the legal considerations and needs for such a repository? Who is doing the work on the ground and how do we facilitate making data collection uniform, robust, legal, and lasting? Can data collection be automated? (100min)
Academic Perspective- Paul Kligfield, M.D. (New York-Presbyterian/Weill Cornell)
Industry Perspective- Fabio Badilini, M.D. (AMPS,LLC)
Academic Perspective- Sanjay Parikh, M.D. (Children’s Heart Center at St. Vincent)
4:45pm-5:45pm What are our next steps for action?
Moderator: John Finkle, M.D. (GSK)
Identification of gaps– Salim Idriss, M.D., Ph.D. (Duke University) (10min)
Discussion- How to close the gaps: Partnerships & Collaborations (50min)
5:45pm- 6:00pm-  Closing comments