7:30a
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Registration & Breakfast
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8:00a
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Welcome & Introduction
Kurt Newman, MD | President & CEO, Children’s National Health System
Peter Kim, MD, PhD | Vice President, Belgium Institute for Pediatric Surgical Innovation at Children's National
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8:15a
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Opening: Lessons from Drugs to Devices
Moderator:
Samuel Maldonado, MD | Vice President of CHILD, Janssen Pharmaceuticals company of Johnson & Johnson
Panelists:
Mark Batshaw, MD | Chief Academic Officer & Physician-in-Chief, Children's National Health System
Michael Klein, MD | President, The American Pediatric Surgical Association
Matthew Laughon, MD, MPH | Faculty, Duke Clinical Research Institute Hari Sachs, MD | FDA
Jeffrey F. Smith, PhD | Partner, McKinsey & Company
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9:15a
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Clinical & Regulatory Pathways for Pediatric Devices
Moderator:
Tim Moran, MBA | Founder & CEO, PediaVascular
Panelists:
Tara Federici | Vice President, AdvaMed
Simon Goodall | Goodall Consulting, LLC
Greg Mathison | Regulatory Strategies, Inc
Scott Mindrebo | Director of Regulatory Affairs, Cyberonics, Inc.
Jeanmarie Sales | Distinguished Regulatory Advisor, Medtronic
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10:15a
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Break & Networking
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10:30a
|
Make Your Medical Device Pitch for Kids!
Moderator:
Mark Fitzgerald, JD | Partner, The Law Firm of Wilson Sonsini Goodrich & Rosatti
Judges:
Charles Berul, MD | Chief of Cardiology, Children’s National Health System
Michael Harrison, MD | founding director of UCSF's Fetal Treatment Center, UCSF
Evan Jones, MBA| Managing Member, jVen Capital, LLC
Peyvand Khaleghian, MD | Managing Partner, Avicenna Partners Investment Company LLC, Dubai
Tim Moran, MBA | Founder & CEO, PediaVascular
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12:00p
|
Lunch
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1:00p
|
Frontline of Pediatric Device Innovation
Moderator:
James Geiger, MD | Executive Director, Michigan Pediatric Device Consortium
Panelists:
Robert Campbell, MD | Pediatric Surgeon, CHOP (Children's Hospital of Philadelphia)
Jim Gilkerson, DVM | Distinguished Corporate Fellow & Medical Advisor, Boston Scientific
Bruce Gingles | Vice President, Global Technology Assessment & Health Policy, Cook Medical
James Love, JD | Partner, Oblon Spivak
Amy Schwartz, PhD | Founder, IDEO's Chicago's User Research Group
Linda Ulrich, MD | Office of Orphan Products Development, FDA
|
2:00p
|
Growth Capital for Pediatric Innovation:
The Good, the Bad, and the Ugly
Moderator:
Margaret Kavalaris, JD | Partner and US General Counsel, Dentons
Panelists:
William Bentley, PhD | Chair, Fischell Department of Bioengineering, A. James Clark School of Engineering, University of Maryland
Mark Chandler, MBA | Managing Director, Upstream Partners
Steven Hirschfeld, MD | Associate Director, Clinical Trials, NICHD
Loudon McLean Owen, MBA | Managing Partner, McLean Watson Venture Capital
Luke Pederson, JD | Partner, Baker Botts
Semih Sen | Senior Advisor, Mubadala Healthcare, Abu Dhabi
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3:00p
|
Break & Networking
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3:15p
|
Coverage & Reimbursement:
What We Learn from Payors
Moderator:
Kara Haas, MD, MPH | Director, Strategic Regulatory Affairs, Johnson & Johnson
Panelists:
William Fried, MD | Vice President, Aetna
Richard Migliori, MD | Executive Vice President, United Health Group
Lakshman Ramamurthy, PhD | Director, Avalere Health
Anthony Sandler, MD | Senior Vice President, Joseph E. Robert, Jr., Center for Surgical Care at Children's National Health System
Murray Sheldon, MD | Associate Director for Technology and Innovation, FDA
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4:15p
|
Keynote: Accelerating Research Development
for Rare Diseases & Orphan Products
Keynote Speaker:
Margaret Hamburg, MD | Commissioner, US Food and Drug Administration
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5:00p
|
Cocktail Reception & Presentations of Awards
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