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7:30a
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Registration, Breakfast, & Networking
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8:00a
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Welcome & Introduction
Kurt Newman, MD
President & CEO | Children's National Health System
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8:15a
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Opening Keynote
Geoffrey Ling, MD, PhD
Director | DARPA Biological Technologies
Moderator:
Anthony Sandler, MD
Senior Vice President, Joseph E. Robert, Jr., Center for Surgical Care | Children's National Health System
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9:15a
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Plenary Case 1:
Ventricular Assist Devices for Children – The Case of Berlin Heart EXCOR
Moderator:
Chester Koh, MD
Associate Professor of Urology, Pediatrics; Director, Pediatric Robotic Surgery Program; Pediatric Urology Fellowship Program Director | Texas Children's Hospital / Baylor College of Medicine
Panel:
   
Timothy Baldwin, PhD, MS
Deputy Branch Chief, Advanced Technology & Surgery, National Heart, Lung, and Blood Institute | National Institutes of Health
Charles D. Fraser, Jr, MD
Surgeon-in-Chief | Texas Children's Hospital
Robert Kroslowitz
President & CEO | Berlin Heart, Inc.
Jackson Radandt
Patient Representative
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10:15a
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Break & Networking
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10:30a
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Make Your Medical Device Pitch for Kids! Competition
3rd Annual Belgium Prize in Pediatric Device Innovation
Moderator:
Bryan Vartabedian, MD, FAAP
Pediatric Gastroenterologist | Baylor College of Medicine and Texas Children’s Hospital
Founder | 33 charts
Judges:
     
Charles Berul, MD
Division Chief of Cardiology & Co-Director of the Children's National Heart Institute | Children's National Health System
James Clessuras, JD
Partner | The Law Firm of Wilson Sonsini Goodrich & Rosati
Martha Connolly, PhD
Director, Mtech Baltimore | University of Maryland
Peyvand Khaleghian, MD, PhD
Managing Partner | Avicenna Partners Investment Company LLC
Justin Shaka, MBA
Co-founder & CEO | REBIScan
Tiffany Wilson, MBA
Executive Director | Global Center for Medical Innovation
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12:00p
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Lunch Keynote
Anthony Chang, MD, MBA, MPH
Chief Intelligence & Innovation Officer | Children’s Hospital of Orange County
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1:15p
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Plenary Case 2:
Lessons from Drugs to Devices: Gap Funding in Pediatric Surgical & Medical Devices
Moderator:
Tracy Warren
Managing Partner | Astarte Ventures
Panel:
     
Maria Berkman, MD, MBA
Director | Broadview Ventures
Steven Hirschfeld, MD, PhD
Associate Director for Clinical Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development | National Institutes of Health
Russell Lindemann
Founder & CEO | JustRight Surgical, LLC
Loudon Owen, JD, MBA
Managing Partner | McLean Watson Capital Inc.
Ken Schaner, JD
General Counsel | Cystic Fibrosis Foundation
Eric Stone, EdM, MBA
Co-founder & CEO | Velano Vascular, Inc.
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2:15p
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Plenary Case 3:
Off-Label & Investigational Use of Marketed Medical Devices in Pediatric Population
Moderator:
Matthew Oetgen, MD
Division Chief, Orthopaedic Surgery and Sports Medicine | Children's National Health System
Panel:
    
Michael Harrison, MD
Professor of Surgery, Pediatrics, OB-GYN, and Reproductive Sciences, Emeritus; UCSF Pediatric Device Consortium | University of California San Francisco
Robin Meier
Patient Representative
B. Stephens Richards, MD
Chief Medical Officer |Texas Scottish Rite Hospital
Mark Throdahl
President & CEO | OrthoPediatrics Corp
Warren Vanhout
Manager, Field Clinical Research | Medtronic
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3:15p
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Plenary Case 4:
Pediatric Device Benefit-Risk Assessment: Voice of the Patient
Moderator:
Kara Haas, MD, MPH, FACS
Director, Global Strategic Regulatory Affairs | Johnson & Johnson
Panel:
      
Amy Basken
Patient Representative
Maureen Japha, JD
Associate Director, Regulatory Policy and Legal Counsel | Faster Cures
Michelle McMurray-Heath, MD, PhD
Worldwide Vice President, Medical Devices | Johnson & Johnson
Michael C. Morton
Vice President, Corporate Regulatory Affairs | Medtronic
Andrew Pedtke, MD
Co-founder & CEO | LIM Innovations
Vasum Peiris, MD, MPH
Chief Medical Officer, Pediatrics & Special Populations, Center for Devices & Radiological Health | Food & Drug Administration
Erik D. Skarsgard, MD, MSc, FACS, FAAP, FRCSC
Professor, Pediatric General Surgeon, Chief of Surgery | BC Children’s Hospital
Chair of APSA Innovation Committee
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4:30p
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Closing Keynote
Robert M. Califf, MD, MACC
Deputy Commissioner for Medical Products and Tobacco | Food and Drug Administration
Moderator:
Marshall Summar, MD
Division Chief, Genetics and Metabolism | Children's National Health System
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5:00p
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Award Ceremony & Cocktail Reception
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7:30p
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Adjourned
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