Trans-Radial Education And Therapeutics (TREAT) III
A Cardiac Safety Research Consortium Thinktank
Monday, June 4, 2012 • FDA White Oak Facility
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Building 31; Great Room
07:30-08:00 Arrival & Continental Breakfast
08:00-09:30 Plenary Presentations: The Future of Innovation
William Maisel, MD, MPH, CDRH, FDA
Thomas T. Tsai, MD, MSc, American College of Cardiology
- Device Innovation: One Industry View of Barriers & Solutions (15 min)
Chip Hance, Abbott Vascular
Mitchell Krucoff, MD, CSRC, Duke University, DCRI
- Open Discussion (30 min)
Lead Discussants: Eric Peterson, MD, MPH, Duke University, DCRI
09:30-11:30 Update on SAFE PCI for Women Study
- QOL Assessment in Women Undergoing PCI: What We Have, What We Need (10 min)
Daniel Mark, MD, Duke University, DCRI
David Kong, MD, Duke University, DCRI
Sunil Rao, MD, Duke University, DCRI
- Open Discussion (60 min)
Lead Discussants: Julie Miller, MD, Johns Hopkins; David Rutledge, Pharm D, Abbott Vascular
11:30-Noon Break
12:00-13:00 Working Lunch: SAFE PCI for Women: An Industry View
- SAFE PCI for Women – Industry Views (10 min)
David Rutledge, Pharm D, Abbott and Roseann White, MA, Abbott
- Drug and Device Safety: Can We Work From a Common Ground (10 min)
Mark Effron, MD, Eli Lilly
- Open Discussion (30 min):
Lead Discussants: Nicole Sanom, Medtronic
13:00-14:00 SAFE PCI: Issues Beyond SAFE-PCI For Women
Ron Waksman, MD, Washington Heart Center
- Open Discussion: (30 min)
Lead Discussants: Kathryn O’Callaghan, FDA; Judith Hsia, MD, AstraZeneca
14:00-14:15 Break
14:15-15:45 Regulatory Perspectives of SAFE-PCI & Electronic Infrastructure
Jonathan Helfgott, CDE, BIMO, FDA
- NCDR-NCRI Infrastructure: Sufficient for IND/Labeling? (10 min)
Norman Stockbridge MD, PhD, FDA
- Utilizing Electronic Infrastructure for Post-Market Studies (10 min)
Danica Marinac Dabic, MD, PhD, FDA
- Open Discussion (40 min)
Lead Discussants: Roseann White, MA, Abbott; Kevin Anstrom, PhD, DCRI