Agenda with Presentations from the Thinktank
SAVE THE DATE
TransRadial Education And Therapy (TREAT) II:
A Cardiac Safety Critical Path Thinktank
Monday, March 7, 2011
FDA Headquarters, White Oak, Maryland
7:30-8:00 Registration and Breakfast
8:00-8:15 Welcome & Introductions: Norman Stockbridge, MD, PhD
Anatomy of a Thinktank/Incubator: Mitchell Krucoff, MD
8:15-9:15: Session I: Plenary Overviews: Critical Path Collaborations, Drug-related Bleeding Safety, Transradial Catheterization & Women’s Health
- From Cardiac Safety Critical Path to SAFE PCI for Women–How We Got Here: Mitchell Krucoff, MD (10 min)
- Collaboration Across Drug and Device Stakeholders: Promoting the Future of Public Health: Vicki Seyfert-Margolis, PhD (10 min)
- Can Devices Make Drugs Safer?: Eric Peterson, MD (10 min)
- Bleeding, PCI and Women’s Health: An FDA View: Ameeta Parekh, PhD (10 min)
- Better Understanding Safety Related to Vascular Access: A Global Need : Shigeru Saito, MD (10 min)
- Professional Society Roles In Drug-Device Cardiac Safety: Ralph Brindis, MD (10 min)
9:15-11:30: Session II: TREAT’s First Deliverable: The Study of Access Site for Enhancement of PCI (SAFE-PCI) for Women Protocol
- SAFE-PCI Hypotheses and Basic Design: Sunil Rao, MD (10 min)
- Statistical Assumptions for SAFE PCI for Women: Kevin Anstrom, PhD (10 min)
- Important Data Elements, Definitions and Metrics for Meaningful Results: Roxana Mehran, MD (10 min)
- Leveraging Information Infrastructure for RCT operations: NCDR, NCRI and SAFE PCI for Women: David Kong, MD (10 min)
- Potential SAFE PCI Substudies: Jon Resar, MD (10 min)
- SAFE PCI: Value for Industry: Jenny Lim, PhD (10 min)
- Discussion (75 min): Lead Discussants: Kristin Newby, MD; Roseann White, PhD
11:30-12:00: BREAK
12:00-13:30: Working Lunch: Operational Avenues for SAFE PCI for Women
- Equipoise, Equipment, and Education in Site Selection – Experience & Advice from RIVAL: Sanjit Jolly, MD (10 min)
- “Plugging In” International & Non-NCDR Sites: John Messenger, MD (10 min)
- European Union Interest in Global Trials & Endpoints : Jean-Philippe Collet, MD (10 min)
- Cost & Quality of Life: Not As Simple As It Seems?: David Cohen, MD (10 min)
- Discussion (40 min): Lead Discussants: Thomas Tsai, MD; Julie Miller, MD
13:30-15:00 Session III: TREAT Beyond SAFE PCI for Women: Educational Objectives, Learning Curves & Device Evolution
- What Metrics Do We Need for Society Guidelines?: Ian Gilchrist, MD (10 min)
- Educational Directions & Imperatives for TRI: An Industry View: Gary Clifton, MBA (10 min)
- Global TRI Education: How Can We Work Together: Shigeru Saito, MD (10 min)
- Vascular Access Safety Training (VAST): Can We Develop an Integrated Approach?: Mitchell Krucoff, MD (10 min)
- The Transradial Approach: Hands-On Training Using Cadavers: John Petersen II, MD (10 min)
- Discussion (40 min): Lead discussants: Sidney Cohen, MD, PhD; Ron Waksman, MD
15:00-15:30: BREAK
15:30-16:30: NCDR The Equipoise of Bleeding Safety and Maximal Efficacy for Anti-thrombotic Agents: Do We Know What We Don’t Know If Arteriotomies Don’t Bleed?
- Does Net Benefit Change If Arteriotomy Bleeding Goes Away?: Sunil Rao, MD
- Intracranial, GI and Surgical Bleeding with more potent agents: An Industry View: Mark Effron, MD (10 min)
- Labeling for Current and Future anti-thrombotic agents: FDA View: Norman Stockbridge, MD, PhD (10 min)
- Discussion (30 min): Lead Discussant: TBA
16:30-17:00 Next Steps: Open Discussion
- Lead Discussant: Sunil Rao, MD