TransRadial Education and Therapy Thinktank III (TREATT) — June 4, 2012

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

           Roxana Mehran, MD, Mt. Sinai

  • 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

         Kathleen Hewitt, MSN, ACC

        Britt Barham, 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

         Gary Clifton, MBA, Terumo

  • 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

         Chris Pyne, MD, Lahey Clinic

         Ian Gilchrist, MD, SCAI

  • 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

          Michael Lauer, MD, NIH

          Jonathan Helfgott, CDE, BIMO, FDA

         Adam Zucker, MD, CDRH, 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


15:45-16:00:  Wrap Up & Adjournment