2013 AGENDA

 

1st ANNUAL PEDIATRIC SURGICAL INNOVATION SYMPOSIUM

June 13, 2013 | The Ritz-Carlton, Washington, DC

7:00a

Continental Breakfast

7:45a

Introduction

Peter Kim, MD, CM, PhD | Vice President, The Sheikh Zayed Institute for Pediatric Surgical Innovation
Kurt Newman, MD | President & CEO, Children’s National Medical Center

8:00a

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


10:00a

Break / Networking

10:15a

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

12:00p

Lunch

Informal Discussion and Networking

1:00p

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


2:00p

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

2:15p

Concurrent Sessions:

CLINICAL - BREAKOUT I

Moderator:

Sarah Rebstock, MD, PhD | Medical Director, Pain Medicine Care Complex, The Sheikh Zayed 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 Sheikh Zayed 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

4:00p

Break / Networking

4:15p

Afternoon Keynote Speaker

Elazer Edelman, MD, PhD | MIT, Professor of Health, Sciences & Technology, Director of Harvard-MIT Biomedical Engineering Center

4:45p

Presentation of the 2013 SHEIKH ZAYED PRIZE FOR PEDIATRIC SURGICAL INNOVATION:

Presented by:

His Excellency Omar Al Shamsi | Deputy Chief of Mission, Embassy of United Arab Emirates

5:00p

Closing

Peter Kim, MD, CM, PhD | Vice President, The Sheikh Zayed Institute for Pediatric Surgical Innovation

Download 2013 Agenda