8:00am- 8:20am- Introduction
- Welcome & Introductions
- Co-Chairs : Brief statements review of goals of the meeting and the agenda-Theressa Wright, MD (Eli Lilly) (10min)
- Collaboration, Cardiac Safety & Children: The CSRC View
- Who, What, & Why: The Mission of the CSRC- Mitchell Krucoff, MD (Duke University) (10min)
8:15am-9:00am-Plenary Session
- Sudden Cardiac Death in the Young – Recap of the Feb. 20, 2015 Think Tank- Salim Idriss, MD PhD (Duke University) (15min)
- Successes and Lessons Learned from the CHSS/STS database- Eugene Blackstone, MD (Cleveland Clinic) (15min)
- An example of success: FDA ECG Warehouse- Jose Vicente, MS (FDA) (15min)
9:00am 10:20am- Session I: The Importance of knowing normal.
Moderator: Elizabeth Saarel, MD (Cleveland Clinic)
- Academia/Clinical Perspective – Elizabeth Saarel, MD (Cleveland Clinic) (10min)
- Industry Perspective – Albert Allen, MD PhD (Eli Lilly) (10min)
- FDA Perspective Lynne Yao, MD (10min) (Teleconference)
- Athletic Perspective Rachel Lampert, MD (Yale)(10min)
Moderated Discussion (40min)
10:20am 10:35-Break (15min)
10:35am-12:15pm- Session II: Working Group 1: Screening data collection
Moderator: Stuart Berger, MD (University of California-Davis)Goal: Develop a core uniform screening dataset
- Current State in US-Prior and current survey results? Stuart Berger, MD (University of California-Davis) (10 min)
- Screening Group Perspective – Sharon Bates, Anthony Bates Foundation (10min)
- International Perspective-
- Naokata Sumitomo, MD (Japan PMDA) (10 min)
- Dominique Heon, M.D. (Health Canada)
(10min)
- Inclusion of echo in core dataset- Nancy Cutler, MD (Beaumont Student Heart Check) (10min)
Moderated Discussion: Moving to a uniform screening dataset (50min)
12:15pm-12:35pm- Working Lunch (20min)
12:35pm- 2:00pm- Session III-Working Group 2: Optimizing Digital Data Collection and Warehousing,
Moderator: Elizabeth Saarel, MD (Cleveland Clinic)
Goal: Define best data collection methods and best universal data formats for warehouse of core screening dataset for following long term outcomes.
- Foundation Perspective- Darren Sudman, JD (Simon’s Fund) (10min)
- Clinical Perspective- Fabio Badilini, PhD (AMPS) (10min)
- Industry Perspective-
- Barry Brown, MS (Mortara Instruments) (10 min)
- Margaret Keehn & Kathy Hebert, MD (GE Healthcare) (10 min)
Moderated Discussion: What are the barriers to uniform digital dataset collection and long term storage? (65 min)
2:00pm-2:10pm-Break (10min)
2:10pm -3:00pm- Session IV- How do we address long term outcomes?
Moderator: Mitchell Krucoff
- Cardiac Perspective–Eugene Blackstone, MD (Cleveland Clinic) (10min)
- Collaborative translational database platforms: How can we use modern IT to solve the problem of rare diseases like sudden cardiac death in the young?- David Booth, MD (10 min)
Moderated Discussion (30min)
3:00pm-3:30pm – Next steps for action and closing comments
- Identification of gaps- Salim Idriss, MD, PhD (Duke University Medical Center) and Theressa Wright, MD (Eli Lilly) (15min)
- Discussion- How to close the gaps: Partnerships & Collaborations (15min)