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RAPID Think Tank

September 14, 2016

Final Agenda

Event Recordings

Part 1 (2 hr 25 min)

Part 2 (1 hr 17 min)

Part 3 (2 hr 59 min)

Hot Topics:

  • 1st Public Release of the Phase I RAPID Core Data Set for PAD Device Evaluation
  • Aligning RAPID with National Evaluation System for Health Technology (NEST), Sentinel, HSPC, and other ongoing initiatives
  • International alignment leveraging RAPID core data elements
  • RAPID implementation and clinical trial opportunities for Peripheral Devices
7:30-8:00 AM Registration and Refreshments
8:00–8:30 AM Welcome & Introductions
Danica Marinac-Dabic, FDA Update on National Evaluation System for Health Technologies (NEST)
William Maisel, FDA 

MDepiNet, PASSION, & RAPID in the Context of NEST
Mitchell Krucoff, DCRI

8:30-9:10 AM
Overview of RAPID
Jack Cronenwett, Society for Vascular Surgery (SVS)


RAPID Phase I Work Product Overviews:

§  Use cases, Flow Diagrams
James Tcheng, DCRI

§  GUDID Working Group Summary
Terrie Reed, FDA

§  Core Minimum Data Set
Schuyler Jones, DCRI

9:10-10:15 AM RAPID towards NEST: Lessons Learned, Common Themes and Potential

Terrie Reed, FDA

§  Use of General Patient Descriptors from Sentinel in RAPID
Richard Platt, Harvard Pilgrim 

§  Addressing issues impacting Adoption of UDI
Joseph Drozda, Mercy Health System 

§  Integrating RAPID Common Data Elements and modeling with the goals of HSPC
Stan Huff, Intermountain Healthcare 

Discussion: Lead Discussant
Greg Pappas, FDA

10:15-10:30 AM Break
10:30-11:45 AM RAPID Phase II:  Implementation core data elements    

§ Implementing RAPID Core Data Elements–NCDR PVI registry view
Thomas Tsai, American College of Cardiology (ACC)/National Cardiovascular Data Registry (NCDR)

§ Implementing RAPID Core Data Elements–VQI PVI registry view
Carrie Bosela, SVS VQI

§  MedStreaming EHR
Ahmed Saad, MedStreaming

§  PAD Characterization within a health system
Schuyler Jones, DCRI 

§  Multidisciplinary PVI Structured Reporting Standards
James Tcheng, DCRI

Discussion, Lead Discussants:
Donna Buckley, FDA
Pablo Morales, FDA

11:45-Noon       Break and Pick-up lunch boxes
12:00-1:00 PM Perspectives on Interactions & Implementation (Working Lunch
Leader: Mitchell Krucoff, DCRI


§  Centers for Medicare and Medicaid Services
Daniel Canos, Centers for Medicare and Medicaid Services (CMS)

Joseph Drozda, Mercy Health System

§  Health Systems Platform Consortium
Stan Huff, Intermountain Healthcare

§  The Pew Charitable Trust 
Anqi Lu, The Pew Charitable Trust 

§  FDA
Misti Malone, FDA

§  Sentinel
Richard Platt, Harvard Pilgrim

§  Industry
Melanie Raska, Boston Scientific  

Discussion, Lead Discussants 
Greg Pappas, FDA
Julia Skapik, ONC

1:00-2:45 PM Multi-Stakeholder Collaborative Approach to RAPID Phase III: Thinking Forward! 

Summary of RAPID Proposals
Robert Thatcher, 4C Medical Technologies

Lessons learned from SAFE-PCI
Britt Barham, DCRI

Lessons learned from VQI Dissection Study
Jack Cronenwett, SVS


Industry Partners
Brian Fortier, Aorta Medical
Aaron Lottes, Cook Medical
Dedra Markovich, Cook Medical
Melanie Raska, Boston Scientific
Justin Recknor, WL Gore
Josh Smale, Bard Peripheral Vascular 

Federal Partners
Misti Malone, FDA
Danica Marinac-Dabic, FDA
Jyme Schafer, CMS
Karen Ulisney, FDA

2:45-3:00 PM Break
3:00–3:45 PM International Opportunities and Methodological Considerations

IMDRF opportunities: Update on Registry Essential Principles (Slides coming soon)
Danica Marinac-Dabic, FDA

‘How will we do this?’ or ‘Now What?’ – Methodological Considerations moving forward
Sharon-Lise Normand, Harvard Medical School

Discussion, Lead Discussant
Art Sedrakyan, Weill Cornell Medical College

 3:45-4:00 PM NEST & Next steps
Pablo Morales, FDA
Jack Cronenwett, SVS
Robert Thatcher, 4C Medical Technologies
Danica Marinac-Dabic, FDA







September 14, 2016
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FDA Headquarters, White Oak Campus
Silver Spring, MD 20993 United States + Google Map