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Fri, Jul 29


FDA White Oak Bldg 32

GI Coordinated Registry Network: A Case for Obesity Devices

Registration is Closed
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Time & Location

Jul 29, 2016, 7:00 AM

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

About the Event


Morning session:

After lunch:

After afternoon break:


8:30-9:00Breakfast9:00-9:05Welcome and Introductions

Deborah Fisher (Duke), Tony Du (FDA)

9:05-10:20Stakeholder Perspectives

Moderator:  Ben Fisher (FDA)

Speakers/Affiliations9:05-9:15Use of Real World Evidence in Regulatory DecisionsOwen Faris (FDA)9:15-9:25Clinically Meaningful Outcomes for Weight Loss Procedures and DevicesMarina Kurian (SAGES)9:25-9:35Challenges in Generating Evidence for Obesity TherapiesLaura Eaton (Apollo)9:35-9:45Patient Perspective: Meaningful Weight Loss and Associated Tolerance for RiskJoseph Nadglowski (OAC)9:45-10:05Moderated Talk and Q&A Session:

§  What are the Benefits of Registry Data in Regulatory Decision Making: A Case for Collaboration

§  Medical Product Development in the Obesity Space

§  Recent Approvals (gives background and helps to make the case for better data and possibly smaller PAS studies), Opportunity to Standardize Collection of Data


Cynthia Long (FDA), Jeff Cooper (FDA)

10:05-10:20DiscussionAll Above as Panelists10:20-11:45Capitalizing on National Data Infrastructure

Moderator:  Kathy Crothall (Aspire Bariatrics)

10:20-10:30Existing Registry LandscapePankaj Jay Pasricha (AGA)10:30-10:40Strategic Priorities and Strategically Coordinated Registry Networks: Foundations of the Medical Device EcosystemDanica Marinac-Dabic (FDA)10:40-10:45Partnering with Patients Strategic PriorityMartin Ho (FDA)10:45-10:55A Perspective on MedicareLouis Jacques (ADVI)10:55-11:05Experience in Registry DevelopmentRobin Scamuffa (Ethicon Endo-Surgery)11:05-11:15Governance and Sustainability ModelsMitchell Krucoff (Duke)11:15-11:25The MBSAQIP Database: PROs, Post Market Surveillance and Performance Metrics (QCDR)Matthew Hutter (ASMBS)11:25-11:45Panel Discussion:

Existing/National Standards for Interoperability, UDI, Claims Data, and Methodological Opportunities

Lisa Lang (NLB), Julia Skapik (ONC), Leslie Steen (FDA), Behnaz Minaei (FDA), TBA (Sentinel), Laura Hatfield (Harvard), Barry Greene (ASMBS)11:45-12:00Charge to Working Groups

Deborah Fisher (Duke)

See Below – Groups 1, 2 and 312:00-12:45Lunch13:00-14:30Small Group DiscussionsGroup 1:  Clinical issues

§  Exposure (implantation of device) and outcomes

§  Clinical questions/gaps (technology vs. disease)

§  Minimum core datasets (pre- and post-market endpoints)

§  Data dictionary, collection method/form, agreed upon endpoints/elements

§  Follow-up requirements and possibilities for and issues with longer-term follow-up

Chair:  Cynthia Long (FDA)

Rapporteur:  Barry Greene (ASMBS)

Group 2: PROs

§  Existing PROs, gaps needing validation – and developing the endpoints, means of capturing in registry (via mobile app)

§  Patient protection

Co-chairs:  Martin Ho (FDA), Karen Ulisney (FDA)

Rapporteur:  Suzanne Schrandt (PCORI)

Group 3: Data quality by design, Data sources

§  Data quality, standardization, integration

§  Linkage between clinical and informatics (CMS etc.)

§  Registry, electronic health record, UDI

Co-chairs:  Deborah Fisher (Duke), Irfan Khan (FDA)

Rapporteur:  Leslie Steen (FDA),  Behnaz Minaei (FDA)

14:30-14:45Break 14:45-16:00Report Out of Work Group Decisions

Moderator:  Deborah Fisher (Duke)

14:45-15:15Group 1, 2 and 3 report out (10 minutes each)15:15-15:30Select first project for development15:30-15:45Define requirements for registry participation15:45-16:00Define mechanism for data sharing16:00-16:30Directions and Action Items

Ben Fisher (FDA) and Danica Marinac-Dabic (FDA)

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