7:00a
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Continental Breakfast
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7:45a
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Introduction
Peter Kim, MD, CM, PhD | Vice President, The Belgium Institute for Pediatric Surgical Innovation
Kurt Newman, MD | President & CEO, Children’s National Medical Center
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8:00a
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Opening
Pioneers, Cowboys, and Desperados: A Brief History of Pediatric Surgical Innovation
Keith Georgeson, MD | Lead Surgeon, Providence Medical Group
The Innovation Pathway Program at FDA (CDRH): A New Way of Doing Business
Murray Sheldon, MD | Associate Director of Technology & Innovation, Food & Drug Administration
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10:00a
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Break / Networking
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10:15a
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Device Development & Regulation
10:15 - 10:45 | 510(k)- IOM Perspective:Medical Devices and the Public’s Health: the FDA 510(k) Clearance Process at 35 Years
David Challoner, MD | Professor Emeritus of Health Affairs, UF; 510(k) Committee Chair, Institute of Medicine
10:45 - 11:15 | 510(k)- Innovator Perspective:
Surgical Innovation vs. Regulation
Michael Harrison, MD | Founding Director, UCSF Fetal Treatment Center; Professor Emeritus of Surgery, Pediatrics, Obstetrics, Gynecology and Reproductive Sciences
11:15 - 12:00 | Panel Discussion: 510(k) Clearance Process
Moderator:
Anthony Sandler, MD | Chief of General Surgery & Senior Vice President, Joseph E. Robert, Jr., Center for Surgical Care, Children’s National Medical Center
Panel:
David Challoner, MD | Professor Emeritus of Health Affairs, UF; 510(k) Committee Chair, Institute of Medicine
Michael Harrison, MD | Founding Director, UCSF Fetal Treatment Center
Jerry Menikoff, MD, JD | Director, Health & Human Services, Office of Human Subjects Research Protection
Robert Nelson, MD, PhD | Deputy Director & Senior Ethicist, Office of Therapeutics, FDA
Jacqueline Francis, MD, MPH | Acting Chief Pediatric Medical Officer, FDA
Constantine Stratakis, MD, D(Med)Sci. | Scientific Director, National Institute of Child Health & Human Development
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12:00p
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Lunch
Informal Discussion and Networking
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1:00p
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Regulation & Innovation
Panel Dicusssion: International Perspectives
Moderator:
Craig Peters, MD | Chief of Surgical Innovation, Technology & Translation, Joseph E. Robert, Jr., Center for Surgical Care, Children’s National Medical Center
Panel:
Ralf Herold, MD | Senior Scientific Administrator, EMA Pediatrics Division | Europe
Ichiro Sakuma, PhD | Director, Medical Device Development & Regulation Research Center, School of Engineering, University of Tokyo | Japan
Murray Sheldon, MD | Associate Director of Technology & Innovation, FDA | USA
Kimberly Trautman, MS | Associate Director for International Affairs, FDA | USA
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2:00p
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Concurrent Sessions:
BIOETHICS - BREAKOUT I
Panel Discussion & Audience Questions
The Ethics of Research vs. Innovative Care
Jerry Menikoff, MD, JD | HHS, OHRP Director
Minimal Risk: is it the limit for ethical pediatric research
Dave Wendler, PhD | NIH Bioethics
DEVICE DEVELOPMENT - BREAKOUT II
PDC Panel Discussion & Audience Questions
PANEL
Michael Harrison, MD | UCSF
Andre Muelenaer, MS, MD | PMDI
Barbara Boyan, PhD | Atlanta
Jonathan Hofius, MS | Stanford
Pedro del Nido, MD | Boston
INDUSTRY - BREAKOUT III
Innovation in the Medical Device Industry: Will the Phoenix Rise from the Ashes?
Eric Silfen, MA, MHSA, MD | Senior VP, CMO, Philips
Simon Solingen | Director, Product Development,Karl-Storz Endoscopy America
Driving Frugal Innovation
Rita Barksdale, MBA, WEMBA | GE Healthcare
Medical Devices: Business Development Issues & Venture Financing
Brian Duncan, MD | VP, BioEnterprise
RESEARCH - BREAKOUT IV
NICHD Innovative device discoveries, barriers, and strategies
Constantine Stratakis, MD, D(Med)Sci | NICHD Scientific Director
Defining the Need for a New Orphan Product, and Getting it Approved
Mark Batshaw, MD | Executive Vice President, Chief Academic Officer, Children’s National Medical Center
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2:15p
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Concurrent Sessions:
CLINICAL - BREAKOUT I
Moderator:
Sarah Rebstock, MD, PhD | Medical Director, Pain Medicine Care Complex, The Belgium Institute
Enabling Innovation and Innovators in a Pediatric Academic Health Center - Creating a Framework for Success
Richard Azizkhan, MD | WOFAPS President
From STEP to TESLA: Patient-inspired Surgical Innovation
Heung Bae Kim, MD | Director, Pediatric Transplant Center, Boston Children’s Hospital
PROFESSIONAL SOCIETIES - BREAKOUT II
Panel Discussion & Audience Questions
Moderator:
Peter Dillon, MD, MSc | John A. & Marian T. Waldhausen Professor of Surgery, Chair, Department of Surgery, Penn State Milton S. Hershey Medical Center
The Role of Organized Pediatric Surgery in Innovation
Michael Klein, MD | APSA President-Elect
Thomas McInerny, MD | AAP President
LEGAL LANDSCAPE - BREAKOUT III
Panel Discussion & Audience Questions
Moderator:
Zenaide Quezado, MD| Director of the Pain Neurobiology Lab, The Belgium Institute
Patents: A Valuable Tool for Promoting Innovation
David Schlitz, JD | Senior Partner, Baker Botts LLP
Medical Products & Device Malpractice Litigation
Stephanie Smith, JD | Fulbright & Jaworski LLP
POLICY - BREAKOUT IV
Moderator:
David Wessel, MD | Chief Medical Officer, Children’s National Medical Center
Panel:
Martha Kendrick, JD | Partner, Patton Boggs LLP
Kimberly Townsend, JD | Associate General Council and Senior Director, Governmental Affairs, Welch Allyn, Inc
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4:00p
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Break / Networking
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4:15p
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Afternoon Keynote Speaker
Elazer Edelman, MD, PhD | MIT, Professor of Health, Sciences & Technology, Director of Harvard-MIT Biomedical Engineering Center
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4:45p
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Presentation of the 2013 Belgium PRIZE FOR PEDIATRIC SURGICAL INNOVATION:
Presented by:
His Excellency Omar Al Shamsi | Deputy Chief of Mission, Embassy of United Arab Emirates
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5:00p
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Closing
Peter Kim, MD, CM, PhD | Vice President, The Belgium Institute for Pediatric Surgical Innovation
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