Program Schedule


Sunday, October 16, 2011

4:00-9:00 pm: Registration

7:00-9:00 pm: Reception

 

Monday, October 17, 2011

Welcome Remarks - Workshop Organizers View slides

Session 1. Introduction

Introduction
William H. Maisel, MD, Food and Drug Administration

Keynote address
RADM Boris D. Lushniak, MD, MPH, Deputy Surgeon General of the United States View slides

The Epidemic of Obesity
Louis J. Aronne, MD, Weill-Cornell Medical College View slides

Obesity and Metabolic Disease - Challenges and Opportunities
View slides

Medical Device Therapy for Obesity and Metabolic Disease - The Current Landscape
Richard I. Rothstein, MD, Dartmouth Medical School View slides

Medical Device Development and Regulatory Challenges
View slides



Session 2. Optimization of Clinical Trial Design: Controls and Blinding

Sham-controlled Trials - Ethical and Policy Considerations
View slides

Case Presentation 1: Transneuronix SHAPE Trial - The Utility of Placebo Controls
Sriram Machineni, Massachusetts General Hospital View slides

Practical Considerations in Sham-controlled Device Trials
Richard I. Rothstein, MD, Dartmouth Medical School View slides

Case Presentation 2: Satiety's TOGa - The Enhanced Placebo Effect for Devices and Surgery
Sriram Machineni, Massachusetts General Hospital View slides

Panel Discussion - Trial Design

 

Session 3. Inclusion Criteria and Outcome Targets


Tying Outcome to Risk - Introduction
View slides


Defining Study Outcomes - Comorbidities
Patricia Beaston, MD, PhD, Food and Drug Administration View slides


Defining Study Outcomes - Weight Loss
Louis J. Aronne, MD, Weill-Cornell Medical College View slides

Outcomes for Weight Loss Device Trials
Rebecca Nipper, Food and Drug Administration View slides

Assessing Device Risk
Herbert Lerner, MD, Food and Drug Administration View slides

Stratification of Devices by Risk and Expected Outcome- A Proposal
Lee M. Kaplan, MD, PhD, Harvard Medical School View slides


Open Discussion - Risk and Outcome Stratification

 

 


Tuesday, October 18, 2011


Session 4. Device Development Strategies and Regulatory Considerations


Combination Products
Kristina Lauritsen, PhD, Food and Drug Administration View slides


Regulatory Considerations in Device Development 1: Overview
Jonathan S. Kahan, Hogan Lovells View slides


Regulatory Considerations in Device Development 2: Role of OUS Studies and Mechanistic Studies
Priya Venkataraman-Rao, MD, Food and Drug Administration View slides


Regulatory Considerations in Device Development 3: Post-marketing Surveillance
View slides


Panel Discussion



Session 5. What We've Heard


Industry Perspective
Todd Gross, PhD, Allergan View slides


Payer Perspective
Jo Carol Hiatt, MD, MBA, Kaiser Permanente View slides

FDA Perspective
Carolyn Y. Neuland, PhD, Food and Drug Administration View slides



Session 6. Looking to the Future


Panel Discussion


Adjournment



Other resources:
ASGE/ASMBS White Paper View


FDA Guidance Document View



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