1st Annual Pediatric Surgical Innovation Symposium
June 13, 2013 | The Ritz-Carlton, Washington, DC
Program
7:00A
Breakfast & Networking
7:45A
Welcome & Introduction
Kurt Newman, MD | President & CEO, Children’s National Health SystemPeter Kim, MD, PhD | Vice President, Sheikh Zayed Institute for Pediatric Surgical Innovation
8:00A
Pioneers, Cowboys, and Desperados: A Brief History of Pediatric Surgical Innovation
Keith Georgeson, MD | Lead Surgeon, Providence Medical Group8:30A
The Innovation Pathway Program at FDA (CDRH): A New Way of Doing Business
Murray Sheldon, MD | Associate Director of Technology & Innovation, Food & Drug Administration9:00A
Morning Keynote
The Role of the Policymaker as an Advocate for Children's Health
10:00A
Break & Networking
10:15A
Device Development & Regulation
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 Medicine10:45A
Device Development & Regulation
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 Sciences11:15A
Device Development & Regulation
510(k) Clearance Process Panel Discussion
MODERATORAnthony 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 & Networking
1:00P
Regulation & Innovation
International Perspectives
Panel Discussion
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
Panel Discussion
2:00P
CONCURRENT SESSION
Breakout I | Bioethics
The Ethics of Research vs. Innovative Care Discussion & Audience Questions
Jerry Menikoff, MD, JD | HHS, OHRP Director2:00P
CONCURRENT SESSION
Peter Dillion, MD, MSc | John A. & Marian T. Waldhausen Professor of Surgery, Chair, Department of Surgery, Penn State Milton S. Hershey Medical Center PANEL
Michael Harrison, MD | UCSF Andre Muelenaer, MS, MD | PMDI Barbara Boyan, PhD | Atlanta Jonathan Hofius, MS | Stanford Pedro del Nido, MD | Boston
Breakout II | Device Development PDC Panel Discussion & Audience Questions
MODERATORPeter Dillion, MD, MSc | John A. & Marian T. Waldhausen Professor of Surgery, Chair, Department of Surgery, Penn State Milton S. Hershey Medical Center PANEL
Michael Harrison, MD | UCSF Andre Muelenaer, MS, MD | PMDI Barbara Boyan, PhD | Atlanta Jonathan Hofius, MS | Stanford Pedro del Nido, MD | Boston
2:00P
CONCURRENT SESSION
Zenaide Quezado, MD | Director, Pain Neurobiology Lab, Children’s National Medical Center
PANEL Eric Silfen, MA, MHSA, MD | Senior VP, CMO, Philips Simon Soligen | Director, Product Development, Karl-Storz Endoscopy America Rita Barksdale, MBA, WEMBA | GE Healthcare
Breakout III | Industry Innovation in the Medical Device Industry: Will the Phoenix Rise from the Ashes?
MODERATORZenaide Quezado, MD | Director, Pain Neurobiology Lab, Children’s National Medical Center
PANEL Eric Silfen, MA, MHSA, MD | Senior VP, CMO, Philips Simon Soligen | Director, Product Development, Karl-Storz Endoscopy America Rita Barksdale, MBA, WEMBA | GE Healthcare
2:00P
CONCURRENT SESSION
Breakout IV | Research NICHD Innovative Device Discoveries, Barriers and Strategies
Constantine Stratakis, MD | Scientific Director, NICHD2:30P
CONCURRENT SESSION
Breakout I | Bioethics
Minimal Risk: Is It the Limit for Ethical Pediatric Research
Dave Wendler, PhD | NIH Bioethics2:30P
CONCURRENT SESSION
Breakout III | Industry Medical Devices: Business Development Issues & Venture Financing
Brian Duncan, MD | VP, BioEnterprise2:30P
CONCURRENT SESSION
Breakout IV | Research
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 Center3:00P
CONCURRENT SESSION
Breakout I | Clinical
Enabling Innovation and Innovators in a Pediatric Academic Health Center - Creating a Framework for Success
Richard Azizkhan, MD | President, WOFAPS3:00P
CONCURRENT SESSION
Breakout II | Professional Societies
The Role of Organized Pediatric Surgery in Innovation 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 PANEL Michael Klein, MD | President-Elect, APSA Thomas McInerny, MD | President, AAP3:00P
CONCURRENT SESSION
Breakout III | Legal Landscape Patents: A Valuable Tool for Promoting Innovation
David Schlitz, JD | Senior Partner, Baker Botts LLP3:00P
CONCURRENT SESSION
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
Breakout IV | Policy
MODERATORDavid 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
3:30P
CONCURRENT SESSION
Breakout I | Clinical
From STEP to TESLA: Patient-Inspired Surgical Innovation
Heung Bae Kim, MD | Director, Pediatric Transplant Center, Boston Children's Hospital3:30P
CONCURRENT SESSION
Breakout III | Legal Landscape Medical Products & Device Malpractice Litigation
Stephanie Smith, JD | Fulbright & Jaworski LLP4:00P
Break & Networking
4:15P
Afternoon Keynote
Elazer Edelman, MD, PhD | MIT, Professor of Health, Sciences & Technology, Director of Harvard-MIT Biomedical Engineering Center4:45P
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 Emirates5:00P
Closing Remarks
Peter Kim, MD, CM, PhD | Vice President, The Sheikh Zayed Institute for Pediatric Surgical InnovationPartners
