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Thu, Oct 01


FDA White Oak Bldg 32

MDEpiNet Annual Meeting

Registration is Closed
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Time & Location

Oct 01, 2015, 7:00 AM – Oct 02, 2015, 4:00 PM

FDA White Oak Bldg 32, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA

About the Event

 Who: Public Meeting

Final agenda and links to presentations


7:30-7:45 am Registration and Refreshments

7:45-7:50 am   Welcome, Introduction, and Goals for the Day – Danica Marinac-Dabic, FDA and Mitch Krucoff, Duke University

7:50-8:05 am  Welcome and Opening Remarks – William Maisel, FDA

8:05-9:05 am   Plenary Session: Ecosystem Approaches to Device Evaluation – Back to the Future

Moderator: Mitch Krucoff, Duke University

8:05-8:15 am Michael Lauer, NIH

8:15-8:25 am  Harlan Krumholz, Yale University

8:25-8:35 am  Richard Kuntz, Medtronic, Inc.

8:35-8:45 am  Leo Chalupa, George Washington University

8:45-8:55 am Hugo Campos, Patient Advocate, Stanford University Recipient of the White House Award for Patient Advocacy in Precision Medicine

8:55-9:05 am   Open discussion

9:05-10:35 am   The MDEpiNet PPP: Who Are We and How We Work?

Moderator: Thomas Maeder, MedTech Intelligence

9:05-9:15 am   FDA MDEpiNet Update: Danica Marinac-Dabic, FDA

9:15-9:25 am   Harvard MDEpiNet Methodology Center Update: Sharon Lise Normand, Harvard University

9:25-9:35 am   Weil Cornell MDEpiNet Science and Infrastructure Center Update: Art Sedrakyan, Weill Cornell Medical College

9:35-9:45 am   MDEpiNet SOC Committee Update: Jesse Berlin, Johnson and Johnson

9:45-9:55 am   MDEpiNet SES Committee Update: Pam Plouhar, DePuy Synthes

9:55-10:35 am Open discussion

10:35-10:45 am Break

10:45-12:15 am  The MDEpiNet Selected Projects In Motion

Moderator: Pablo Morales, FDA

10:45-11:00 am PASSION PAD – RAPID:Jack Cronenwett, Dartmouth-Hitchcock Medical Center/VQI and Pablo Morales, FDA

11:00-11:15 am   PASSION CAD – SAFE PCI STEMI for Seniors: David Kong, Duke University and Andy Farb, FDA

11:15-11:30 am   Innovative Surveillance with Application to ICD Registry: Joseph Ross, Yale University and Jonathan Bates, Yale University

11:30-11:45 am   Building National AED Registry: Graham Nichol, University of Washington

11:45-12:00 pm   Assessing the validity of claims data: Matthew Brennan, Duke University and Daniel Canos, FDA

12:00-12:15 pm   Panel Discussion: Sandeep Brar, Medtronic Inc.; John Hernandez, Abbott Vascular; Robert Thatcher, Cardiovascular Systems; Ralph Brindis, American College of Cardiology/University of California

12:15-1:00 pm   Lunch

1:00-2:30 pm  Moving the National Device Evaluation System Forward: Aligning Medical Device Registries Task Force & Planning Board Recommendations

Moderator: Fred Edwards, University of Florida

1:00-1:15 pm   Planning Board Overview: Gregory Daniel, Brookings Institution

1:15-1:30 pm   National Medical Device Registry Task Force Overview: Mitch Krucoff, Duke University


1:30-1:35 pm   Patient perspective: Anna McCollister-Slipp, Galileo Analytics

1:35-1:40 pm   Payers perspective: Joseph Chin, CMS

1:40-1:45 pm   Perspective from PCORI: Joe Selby, PCORI

1:45-1:50 pm   Perspective from FDA: Gregory Pappas, FDA

1:50-2:30 pm   Open discussion

2:30-3:30 pm MDEpiNet Collaborations: Developing Strategically Coordinated Registry Networks (CRNs)

Moderator: Art Sedrakyan, Weill Cornell Medical College

2:30-2:40 pm   TJ-FORCE contribution to orthopedic CRN: Patricia Franklin, University of Massachusetts

2:40-2:50 pm   AJRR contribution to orthopedic CRN: Jeff Knezovich AJRR/AAOS

2:50-3:00 pm   VQI contribution to Vascular CRN: Jack Cronenwett, Dartmouth-Hitchcock Medical Center/VQI

3:00-3:10 pm   Kaiser Registry contribution to National CRNs: Elizabeth Paxton, Kaiser Permanente

3:10-3:30 pm   Open Discussion

3:30-4:30 pm Panel: Advancing the National System through Optimal Balance between Patient Protection and Transparency: The Common Rule, Open FDA and Beyond

Moderator: Benjamin Eloff, FDA


3:30-3:40 pm   Registry Perspective: Kathleen Hewitt, American College of Cardiology

3:40-3:50 pm   Industry Perspective: Neal Fearnot, Cook Group

3:50-4:00 pm   Patient Perspective: Terrie Cowley, TMJ Association

4:00-4:10 pm   Open FDA: Taha Kass-Hout, FDA


4:10-4:15 pm Nicole Wolanski, FDA

4:30 pm   Adjournment


7:30-8:00 am Registration & Refreshments

8:00-9:30 am Methodologies for Strategically Coordinated Registry Networks (CRNs):Can Statisticians, Epidemiologists, and Machine Learners Play in the Same Sand Box?

Moderator: Sharon-Lise Normand, Harvard University

8:00-8:05 am   Charge to the Panel: Sharon-Lise Normand, Harvard University

8:05-8:20 am   Myoung Kim, Johnson & Johnson

8:20-8:35 am  Vahan Simonyan, FDA and Lisa Torosyan, FDA

8:35-8:50 am  Patrick Ryan, Johnson & Johnson

8:50-9:00 am   Panel Discussants: Ted Lystig, Medtronic Inc. Michael Matheny, Vanderbilt University

9:00-9:20 am   Open Discussion

9:20-9:30 am   Break

9:30-10:30 am  Key Note – Evidence Generation and Innovation throughout the History of Medicine:

Moderator: Danica Marinac Dabic, FDA

9:30-10:15 am Jeffrey Drazen, New England Journal of Medicine/Harvard University

10:15-10:30 am Q&A

10:30-12:00 am Bridging Innovation and Evaluation Internationally: MDEpiNet as a Citizen of the World

Moderator: Kazuhiro Sase, Juntendo University

10:30-10:45 am  Learning Internationally – IDEAL, IDEAL-D, National Registries: Art Sedrakyan, Weill Cornell Medical College

10:45-11:00 am   Learning from Industry International Collaborations: Larry Wood, Edwards Life sciences

11:00-11:15 am   Innovative Regulatory Efforts – IMDRF update: Danica Marinac-Dabic, FDA


11:15-11:20 am   Nobuhiro Handa, Japan PMDA

11:20-11:25 am   Jack Cronenwett, Dartmouth-Hitchcock Medical Center/VQI

11:25-11:30 am  Jimmy Tcheng, Duke University

11:30-11:35 am   Elizabeth George, Phillips

11:35-12:00 pm   Open discussion

12:00-12:45 pm   Lunch

12:45 – 2:15 pm  Building on Current Investments; Expanding Areas of MDEpiNet Programs; Offering Innovative CRN solutions

Moderator: Elise Berliner, AHRQ

12:45-12:55 pm   PRESERVE Registry Collaborations: Matthew Johnson, Indiana University

12:55-1:05 pm     Pelvic Floor Disorder Registry – Collaborative Platform for TPLC Evidence Generation: Emily Weber-Lebrun, PFDR

1:05-1:15 pm       National Breast Implants Registry – Pathway to Generation of Relevant Evidence: Andrea Pusic, NBRI/ASPS

1:15-1:25 pm     The Public HIVE – Unleashing the High Performance Powers: Raja Mazumder, George Washington University


1:25-1:30 pm     Binita Ashar, FDA

1:30-1:35 pm     JoAnn Kuhne, Sientra

1:35-1:40 pm     Colin Anderson-Smits, FDA

1:40-1:45 pm     Tom Rasmussen, AMS

1:45-2:15 pm     Open discussion

2:15- 3:30  Promoting the Inclusion of Device Identifiers and the Global Unique Device Identification Database in MDEpiNet Demonstration Projects

Moderator: Terrie Reed, FDA

2:15-2:25 pm   Use Case Development to promote UDI adoption: Greg Pappas, FDA and Myoung Kim, Johnson & Johnson

2:25-2:35 pm   Access GUDID – Links to Health IT Adoption Activities: Julia Skapik, ONC

2:35-2:45 pm   Impact of Policy Development on Adoption: Ben Moscovitch, Pew Charitable Trusts

2:45-2:55 pm   RAPID update: Jack Cronenwett, Dartmouth-Hitchcock Medical Center/VQI and Pablo Morales, FDA

2:55-3:05 pm   VANGUARD update: Kevin Baskin, Society of Interventional Radiology

3:05-3:15 pm   BUILD update: Jimmy Tcheng, Duke University and Joseph Drozda, Mercy


3:15-3:20 pm   Ralph Brindis, American College of Cardiology/University of California

3:20-3:25 pm   Zachary Rothstein, AdvaMed

3:25-3:40 pm     Open discussion

3:40-4:30 pm  Moving Forward: MDEpiNet Strategic Goals and Metrics- PI

Danica Marinac-Dabic, FDA

Mitch Krucoff, Duke University

Sharon-Lise Normand, Harvard University

Art Sedrakyan, Weill Cornell Medical College

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