6/23/2010: Shifting the Balance of Potency and Bleeding Risk for Anti-Coagulant and Anti-Platelet Agents Through Radial Arteriotomy

6/23/2010: Shifting the Balance of Potency and Bleeding Risk for Anti-Coagulant and Anti-Platelet Agents Through Radial Arteriotomy

June 23, 2010 TransRAdial Education Training and Therapy Initiative Think Tank Meeting Program and Slides

FDA White Oak Facility, FDA Headquarters  10903 New Hampshire Ave, Silver Spring, MD 20993

Presentations, agendas, and other material pertinent to the recently concluded 2010 TREATT Think Tank are provided below.

(All files are in Adobe Acrobat PDF format. Download the free Acrobat Reader Program.)

Wednesday, June 23, 2010

7:00-8:00AM Registration and Breakfast

8:00-8:15AM Welcome: Norman Stockbridge, MD

Introduction of Attendees: Mitchell Krucoff, MD

Anatomy of a Thinktank/Incubator: Mitchell Krucoff, MD

8:15-9:30AM Session I: Plenary Overviews: Critical Path Collaborations, Drug-related Bleeding Safety and Transradial Catheterization

  • Critical Path and Obligatory Drug-Device Safety Interactions: Device Perspective: Jeffrey Shuren, MD
  • Critical Path and Obligatory Drug-Device Safety Interactions: Drug Perspective: Douglas Throckmorton, MD
  • Novel Collaborative Paradigms: The CSRC Signature: Mitchell Krucoff, MD
  • Arterial Bleeding in Antithrombotic Drug Labeling: Industy View: Clive Meanwell, MD
  • Transradial PCI: Advantages, Disadvantages, and Uptake in the US and Abroad: David Holmes Jr., MD
  • TREAT Today and Tomorrow: Pilot Program and Assumptions, Educational Objectives and Nested Studies: Sunil Rao, MD
  • NCRI: A Long-Term Perspective of the TREAT Pilot: David F. Kong, MD

9:30-11:00AM Session II: Informing Drug Labeling and Practice Guidelines: Transradial PCI, Antithrombotic Safety and Potency: What Do We Know, What Do We Need to Know?

11:00-11:15AM     Break

11:15AM-12:15PM Session III: Anti-thrombotic Safety and Trans-Radial Catheterization: A World View

12:15-1:15PM WORKING LUNCH: Key Regulatory Questions for the TREAT Registry (open microphone) Panel Discussion

(Panelists)

  • CSRC View: John Finkle, MD (moderator)
  • Drug Industry View: William Daley, MD
  • Device Industry View: David Rutledge, PharmD
  • Academic View: Mitchell Krucoff, MD
  • FDA CDER View: Norman Stockbridge, MD
  • FDA CDER View: Mary Ross Southworth, MD
  • FDA CDRH View: Tara Ryan, MD, MS, MBA
  • FDA Office of the Commissioner View: Benjamin Eloff, PhD
  • ACC-NCDR View: David Holmes Jr., MD

1:15-2:35PM Session IV: Devilish Definitions: Bleeding, Procedural Outcomes and Other Key Endpoints/Variables

2:35-2:50PM     Break

2:50-4:15PM Session V: High Quality, Prospective Registry Design: Statistical Recommendations, Issues and Answers for TREAT

4:15-5:45PM Special Focus Session: TREAT Pilot Roll Out, Registry Structure and Next Steps

  • Options for Site Selection, Steering Group, CRF and Data Flow: Sunil Rao, MD
  • Statistical Assumptions for discussion: Kevin Anstrom, PhD
  • Next Steps, Drug Industry View: Clive Meanwell, MD
  • Next Steps, Device Industry View: Janine Lane, MD
  • Next Steps, Professional Society View: Ian Gilchrist, MD
  • Next Steps, OUS Academic View: Olivier Bertrand, MD
  • Discussion: Lead Discussant: Steve Wiviott, MD
  • Wrap Up: David F. Kong, MD

5:45-6:00PM     Adjournment