MDEpiNet Annual Meeting 2014

MDEpiNet-Globe-80-Logo3 Days of MDEpiNet Meetings


White Oak Campus, FDA Headquarters
10903 New Hampshire Avenue, Silver Spring, MD

Contact for additional details or comments

Day 1: October 14, 2014
10:00 – 17:30

 MDEpiNet Annual Meeting:

Data, Infrastructure and Methods – Crossroads & Bridges

Meeting Agenda: (View as PDF)

09:30-10:00  Arrival/Registration

 10:00-10:10  Welcome, Introduction, and Goals for the Day 

             Mitchell Krucoff, Duke and Danica Marinac-Dabic, FDA/CDRH

10:10-11:10  National Investments: Synergies and Potential for Medical Device Research and Surveillance                Moderators:  Mitchell Krucoff, Duke and Elizabeth Paxton, Kaiser

  • William Maisel, FDA/CDRH
  • Joe Selby, PCORI
  • Richard Kronick, AHRQ
  • Jodi Daniel, ONC
  • Patrick Archdeacon, FDA/CDER

11:10-13:00  The MDEpiNet Accomplishments

     Moderators:  Daniel Caños and Nilsa Loyo-Berrios, FDA/CDRH 

11:10-11:25  MDEpiNet Alignment with FDA Priorities

            Danica Marinac-Dabic, FDA/CDRH

11:25-12:05  MDEpiNet: Building Innovative Infrastructure

 11:25-11:35  Registries, Consortia, Implant Classification Libraries: Art Sedrakyan, Cornell

11:35-11:45  International Vascular Registry Consortium:  Jack Cronenwett, Dartmouth

11:45-11:50  International TAVR consortium:  Michael Mack, Baylor Scott

11:50-11:55  Infrastructure for Non-Implantable Devices:  Jo Ann Broeckel Elrod, University of Washington

11:55-12:05  Partnership Development:  Mitchell Krucoff, Duke

12:05-12:25  MDEpiNet:  Developing Innovative Methodologies

 12:05-12:10  Common Methodological Issues with Surveillance:  Sharon-Lise Normand, Harvard

12:10-12:15  Shrinkage Targets: Laura Hatfield, Harvard

12:15-12:20  Loss Functions: Laura Hatfield, Harvard

12:20-12:25  Opportunities of Linked Registries and Claims Data: Matthew Brennan, Duke

12: 25-12:40  MDEpiNet: Active Surveillance Efforts

 12:25-12: 30  DELTA in the National Registries:  Frederic Resnic, Lahey

12:30-12:35  Current Surveillance Practices:  Joseph Ross, Yale

12:35-12:40  Device Specific Surveillance/UDI Demonstration and Beyond:  Joseph Drozda, Mercy

12:40-13:00  Discussion

 13:00-14:00  Lunch Session: Overarching  Issues:  Legal, Access,  Transparency and International

     Moderators:  James Saviola and Benjamin Eloff, FDA/CDRH

  • Ralph Hall, University of Minnesota
  • Kathleen Hewitt, ACC
  • Ann Ferriter, FDA/CDRH
  • Philip Desjardins, Arnold &Porter’s
  • Kimberly Trautman, FDA/CDRH

Open Discussion

 14:00-15:30  Big Data/ Big Analytics: National and International Challenges and Opportunities  

Moderators:   Frederic Resnic, Lahey and James Tcheng, Duke

14:00-14:10  Industry Challenges: Richard Kuntz, Medtronic

 14:10-14:30  Integration of Disparate Data for Regulatory Science:

                             Simonyan Vahan, FDA/CBER and Yelizaveta Torosyan, FDA/CDRH

 14:30-14:40  The Interdisciplinary Journey Through the Big Data/Big Analytics:  Joseph Ross, Yale

 14:40-14:50  Experiences from the World’s Largest Orthopedic Registry: Richard Armstrong, Northgate, UK

 14:50-15:00  Big data:  Where Conventional Methods Meet Unconventional:  Sharon-Lise Normand, Harvard

 15:00-15:30  Open Discussion

 15:30-15:45  Break

 15:45-17:15  Building Sustainable Partnership Models: MDEpiNet Value Added

 15:45-16:00  Moving Forward:  Terrie Reed, Duke

16:00-17:00  Panel: Stakeholders View

Moderator: Art Sedrakyan, Cornell

  • Murray Sheldon, FDA/CDRH
  • Richard Armstrong,  Northgate, UK
  • Bray Patrick-Lake, Patient Representative
  • Gregory Daniel, Brookings Institution
  • Jeffrey Secunda,AdvaMed
  • Elise Berliner, AHRQ
  • Kathleen Hewitt,  ACC
  • Bram Zuckerman,  FDA/CDRH
  • Elizabeth Paxton, Kaiser
  • Ralph Brindis, ACC

17:00-17:15  Summary and Next Steps:  Danica Marinac-Dabic, FDA/CDRH and Mitchell Krucoff, Duke

Day 2: October 15, 2014

MDEpiNet in the Cardiovascular Arena:

Predictable And SuStainable Implementation Of National
Registries for Cardiovascular Devices
Launching The PASSION Registries for Cardiovascular Devices,
An MDEpiNet PPP Think Tank

Meeting Agenda: (View as PDF)

07:30-08:00  Continental Breakfast

08:00-08:10  Welcome & Introductions

08:10-09:00  Plenary Session: Infrastucture Transformation & the Innovation Ecosystem (10 minute presentations)

  • What we can and need to implement in the USA: An FDA View: William Maisel
  • What we can and need to implement in the USA: An Industry View: Mark Carlson
  • What we can and need to implement in the USA: An Academic View: Ralph Brindis
  • The value of information accrual over the total product life cycle through registry infrastructure: A Legacy View: David Feigal
  • The PASSION Registries Program: Brief Overview: Mitch Krucoff

09:00-10:30  Overarching Issues for Registries & Medical Device Benefit/Risk Assessment (5 minute presentations)

  • Overview of Key Regulatory Issues: Jim Saviola (10 min)
  • Governance & business models for clinical trials or safety surveillance: Predictable ownership, cost & contracting across partners
    • Industry view: Kristi Mitchell
    • FDA view: Danica Marinac Dabic
  • Methodologic approaches to heterogeneous data sources:
  • Claims data for long term follow up: a rational resource?
    • CMS view: Rosemarie Hakim
    • Academic view: Jessica Jalbert
  • Open Discussion (35 minutes) Lead Discussants: Joe Drozda; Julia Skapik; Owen Faris

10:45-11:00  Break

11:00-12:30  PASSION for Coronary Stents

12:30-12:45  Break

12:45-13:30  Luncheon Panel: International PASSION: Perspectives from home & abroad
(Lead Discussants: Kazuhiro Sase (Japan); Marie Claude Morice (EU); Kimberly Trautman (USA); Larry Kessler (USA)

13:30-15:00  PASSION for Aortic & Mitral Valves

15:00-16:30  PASSION for Rhythm & Heart Failure

  • Overview: Update on ICD and CRT registries: Academic view (10 min) Sana Al-Khatib
  • Registry-based IDEs for ICDs: Industry View (5 min): Eric Schorsch
  • Registry-based IDEs for ICDs: Regulatory View (5 min): FDA Mitch Schein
  • Registry-based IDEs for CRT: Industry View (5 min): Ken Stein
  • Registry-based IDEs for CRT: Regulatory View (5 min): Mitch Schein
  • Open Discussion (55 minutes) Lead Discussants: Todd Fonseca; Daniel Caños; Hussein Al-Khalidi, Jeff Brinker

16:30-17:30  PASSION for Peripheral and Endovascular (5 min presentations)

17:30-17:45  Final Comments & Next Steps:

  • Lead Discussants:
    • Bram Zuckerman
    • Terrie Reed
    • Danica Marinac-Dabic


Day 3: October 16, 2014

 MDEpiNet in the Orthopedic Arena:

Integrating International Consortium of Orthopaedic Registries (ICOR)
Surveillance Capabilities and the Global Orthopedic Classification Database

 Meeting Agenda: (View as PDF)

07:30-08:00  Arrival / Registration

 08:00-08:15  Welcome, Introduction, and Goals for the Day
Danica Marinac-Dabic, FDA/CDRH and Art Sedrakyan, Cornell

08:15-09:15  Global Orthopedic Classification Library: Current Efforts        

Moderators: Art Sedrakyan, Cornell and Elizabeth Paxton, Kaiser

 08:15-08:22  Current State of Harmonization Efforts: Rob Nelissen, Netherlands

08:22-08:29  UK Classification Efforts: Martyn Porter/Keith Tucker, UK

08:29-08:36  German Classification Database: Christof Veit, Germany

08:36-08:43  Dutch Classification Database: Rob Nelissen, Netherlands

08:43-08:50  ICOR Global Classification Library: Stephen Graves, Australia

08:50-08:57  Update on UDI implementation Efforts: Indira Konduri, FDA/CDRH

08:57-09:15  Discussion

09:15-09:30  Break

  09:30-11:30  ICOR Database Rules of Engagement: Governance, Maintenance, Access, Funding

 Moderators:  Art Sedrakyan, Cornell and Richard Armstrong, Northgate, UK

09:30-09:45  FDA View: Danica Marinac-Dabic and Mark Melkerson, FDA/CDRH

09:45-10:00  Industry View: Blair Fraser, Smith & Nephew

10:00-10:15  Registry View: Elizabeth Paxton, Kaiser

10:15-10:30  European Perspective: Gerold Labek, Austria

 10:30-11:30  Panel

Martyn Porter, UK
Blair Fraser, Smith & Nephew
Elizabeth Paxton, Kaiser
Rob Nelissen, Netherlands
Wilhelm Blömer, Germany

 11:30-12:30  Lunch Session: Evidence Gaps and Innovative Solutions

 Moderators: Patricia Franklin , UMass and Rosemary Hakim, CMS

 11:30-11:35  Overarching Infrastructure Gaps: David Lewallen, AJRR

11:35-11:40  Existing Efforts to Advance Data Quality/Gaps Standards: FDA/CDRH/ODE

11:40-11:45  Potential of Unconventional Data Sources: Yelizaveta Torosyan, FDA/CDRH

11:45-11:50  Explant Analysis: Value Added, Daniel MacDonald, Drexel

11:50-11:55  Innovative Methods: Points to Consider: Sharon-Lise Normand, Harvard

11:55-12:00  Quality Measures: Jay Lieberman, AJRR

12:00-12:05  Outlier Detection: Experiences from Australian Registry: Stephen Graves, Australia


12:05-12:30  Discussion

 12:30-14:30  How to Leverage Registries to Advance Life Cycle Evidence Evaluation?    

 Moderators: Sharon-Lise Normand, Harvard and Yelizaveta Torosyan, FDA/CDRH

12:30-12:37  ICOR USA/BO-PIE Model Vision: Danica Marinac-Dabic, FDA/CDRH

12:37-12:44  Industry Perspective: Jing Xie, Biomet

12:44-12:51  Global Academic Research Organization: Henrik  Malchau, Sweden/ Stephen Graves, Australia)

12:51:12:58  Beyond Compliance (Martyn Porter/Keith Tucker), UK

12:58:13:05  Current US Orthopedic Registries Harmonization Efforts: Elizabeth Paxton, Kaiser

13:05-13:12  Payer’s Perspective: Rosemarie Hakim, CMS

13:12-13:19  Opportunities to Advance Premarket Evaluation via Registries: Telba Irony/Phyllis Silverman/Pablo Bonangelino, FDA/CDRH

13:19-13:26  What Can MDEpiNet PPP Add? Art Sedrakyan, Cornell

 13:26-14:30  Panel: National / International Registry Leads

Health East

14:30-14:45  Break

14:45-16:45  Leveraging Existing Efforts: Bringing It All Together to Enhance Evidence Evaluation

 Moderators: Henrik Malchau, Sweden / Stephen Graves, Australia

 William Maloney, AJRR/AAOS
Art Sedrakyan, Cornell
Pamela Plouhar, J&J, AdvaMed,
Martyn Porter, UK
Elizabeth Paxton, Kaiser
Vahan Simonyan, FDA/CDER
Rob Nelissen , Netherlands
Mark Melkerson, FDA/CDRH
Danica Marinac-Dabic, FDA/CDRH
Rosemary Hakim, CMS

16:45  Wrap up and Next Steps
Danica Marinac-Dabic, FDA/CDRH and Art Sedrakyan, Cornell



 Confirmed Faculty:

Jodi Akin
Consultant, MedTech
Hussein Al-Khalidi, PhD
Duke University
Sana Al-Khatib, MD, MHS
Duke University
Richard Armstrong
Northgate, National Joint Registry, UK
Elise Berliner, PhD
Center for Outcomes and Evidence/AHRQ
Kathleen Blake, MD, MPH
American Medical Association
Sandeep Brar, MD
Matthew Brennan, MD, MPH
Duke University
Ralph Brindis, MD, MPH
American College of Cardiology
Jack Cronenwett, MD
Dartmouth-Hitchcock Medical Center
Greg Daniel, PhD, MPH
The Brookings Institution
Joseph Drozda, Jr., MD
Roberta Antoine Dressen, MBA
White Rock Partners
Fred Edwards, MD
University of Florida
Benjamin Eloff, PhD
U.S. Food and Drug Administration
Neal Fearnot, PhD
Cook Group
Tara Federici
Patricia Franklin, MD, MBA, MPH
University of Massachusetts
Elisabeth George
Philips Healthcare
Ralph Hall, JD
University of Minnesota,
Faegre Baker Daniels
Rosemarie Hakim
Centers for Medicare & Medicaid Services
Joachim Hassenpflug, MD
University Hospital of Schleswig-Holstein, Germany
John Hernandez, PhD
Abbott Vascular
Ajay Kirtane, MD
Columbia University Medical Center
David Kong, MD
Duke University
Mitchell Krucoff, MD
Duke University
Harlan Krumholz, MD, PhD
Yale University
Gerold Labek, MD
Medical University Innsbruck, Austria
John Laschinger, MD
U.S. Food and Drug Administration
Russell Leftwich, MD
Tennessee Office of eHealth,
Health Level Seven
Michael Mack, MD
Baylor Healthcare System
Bill Maisel, MD, MPH
U.S. Food and Drug Administration
Danica Marinac-Dabic, MD, PhD
U.S. Food and Drug Administration
Brian McCourt
Duke University
Jose Morales, MD
U.S. Food and Drug Administration
Robert Nelissen, MD, PhD
Leiden University, Netherlands
Graham Nichol, MD, MPH
University of Washington
Sharon-Lise Normand, PhD
Harvard University
Marc Overhage
Siemens Healthcare
Elizabeth Paxton, MA
Kaiser Permanente
Pamela Plouhar, PhD
DePuy Synthes
Terrie Reed, MSIE
Duke University
Frederic Resnic, MD, MSc
Lahey Hospital and Medical Center
David Rutledge, PharmD
Abbott Vascular
Jeffrey Secunda, MBA
Art Sedrakyan, MD, PhD
Cornell University
Joe Selby, MD, MPH
Patient-Centered Outcomes Research Institute
Murray Sheldon, MD
U.S. Food and Drug Administration
Vahan Simonyan, PhD
U.S. Food and Drug Administration
Julia Skapik, MD, MPH
Office of the National Coordinator for Health Information Technology
Kenneth Stein, MD
Boston Scientific
James Tcheng, MD
Duke University
Robert Thatcher, MBA
Cardiovascular Systems, Inc.
Kimberly Trautman
U.S. Food and Drug Administration
Mark Turco, MD
Jing Xie, PhD, MS


* Supported by FDA cooperative agreement #1U01FD004964 *


White Oak Campus, FDA Headquarters
10903 New Hampshire Avenue, Silver Spring, MD

Contact  for additional details or comments