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Lessons from Drugs to Devices: A Pediatric Perspective

Considerable progress has been made to advance pediatric drug research and to ensure appropriate drug product labeling for children. The Best Pharmaceuticals for Children Act (BPCA) provides drug manufacturers with significant incentives to pursue pediatric drug research. Analogous efforts have been made in the pediatric device arena. Namely, the 2007 Pediatric Medical Device Safety and Improvement Act (PMDSIA) was a well-intentioned step to narrow the gap. Great strides have been made and still much needs to be done. Among the 22 medical devices approved through the PMA process for use in a pediatric subpopulation, only one device was indicated for use in patients under age 18 and few pediatric patients were exposed to the devices before market availability.

To address this challenge, the Sheikh Zayed Institute for Pediatric Surgical Innovation will be hosting a conference on October 24, 2014 in Washington DC. The conference theme is: “Lessons from Drugs to Devices: A Pediatric Perspective.” The conference will bring together a diverse group of experts representing multiple disciplines (life sciences, medicine, engineering, law, and regulatory affairs) and sectors (industry, government, academe, and advocacy).
The objectives of the conference are:
• To forge consensus on critical issues germane to pediatric surgical innovation;
• To identify concrete, achievable action items and assigning them to relevant parties;
• To establish a set of scientific, clinical, regulatory, and policy recommendations required to advance the field;
• To agree upon a select and targeted publication, presentation, legislative, regulatory, appropriate media strategy and targeted outreach campaign to forward conference objectives.

Key Features

  • Dynamic Keynote Speakers and Plenary Sessions
  • Issue-Oriented Program Discussions
  • Participation by 250+ stakeholders from FDA, NIH, capitol hill, children's hospitals, medtech and biotech companies, and payors
  • Closing Reception on the spectacular 8th Floor Terrace of the Knight Conference Center at the Newseum in Washington, DC
  • Presentation of the Sheikh Zayed Prizes for Pediatric Surgical Innovation
  • Networking opportunities throughout the event

2013 Symposium Participants

2013

Speakers

DrHamburg Margaret A. Hamburg, MD
Food and Drug Administration
BatshawMarkMark Batshaw, MD
Children's National Health System
BentleyWilliam Bentley, PhD
University of Maryland
BerulCharlesCharles Berul, MD
Children's National Health System
Campbell Robert M. Campbell, MD
The Center for Thoracic Insufficiency Syndrome Children’s Hospital of Philadelphia
Chandler Photo Mark Chandler, MBA
Upstream Partners
not-pictured Tara Federici
AdvaMed
Fitzgerald PhotoMark Fitzgerald, JD
Wilson Sonsini Goodrich & Rosati
Geiger PhotoJames Geiger, MD
Michigan Pediatric Device Consortium
Gilkerson PhotoJames Gilkerson, DVM
Boston Scientific
Gingles PhotoBruce Gingles
Cook Medical
Goodall Photo Simon Goodall
Author of BCG study on Regulation and Access to Innovative Medical Technologies
Haas Photo Kara Haas, MD, MPH
Johnson & Johnson
Hirschfeld Photo Steven Hirschfeld, MD, PhD
National Institute of Child Health and Human Development
DrMHarrison Michael Harrison, MD
University of California-San Francisco
Jones Photo Evan Jones, MBA
jVen Capital, LLC
Peyvand Khaleghian Peyvand Khaleghian, MD, PhD
Avicenna Partners
Kim Photo Peter Kim, MD, CM, PhD
Children's National Health System
Klein Photo Michael Klein, MD
American Pediatric Surgical Association
Laughon PhotoMatthew M. Laughon, MD, MPH
Duke Clinical Research Institute
SandlerAnthonyJames Love, JD
Oblon Spivak
Maldonado PhotoSam Maldonado, MD, MPH, FAAP
Janssen Pharmaceuticals Company of Johnson & Johnson
Grey MathisonGreg Mathison
Regulatory Strategies, Inc
Migliori PhotoRichard Migliori, MD
UnitedHealth Group
Mindrebo PhotoScott J. Mindrebo
Cyberonics, Inc.
Moran Photo Tim Moran, MBA
PediaVascular
Newman Photo Kurt Newman, MD
Children's National Health System
Owen Photo Loudon Owen, MBA
McLean Watson Capital
DrLPedersen Luke Pedersen, JD
Baker Botts L.L.P
JeanmarieSalesJeanmarie Sales
Medtronic, Inc.
SandlerAnthonyAnthony Sandler, MD
Children's National Health System
DrSachs Hari Cheryl Sachs, MD
Food and Drug Administration
Sen Photo Semih Sen
Mubadala Healthcare
Sheldon Photo Murray Sheldon, MD
Food and Drug Administration
UlrichPhoto Linda Ulrich, MD
Food and Drug Administration
not-pictured Jeffrey Smith, PhD
McKinsey & Company

Sponsors & Partners

Diamond Sponsor

diamond1

Silver Sponsor

Silver1

Bronze Sponsor

bronze1

Session Sponsors

sponsors2 sponsors3 sponsors4 advaMedLogo

Partners

partner1 partner1 partner3 partner2 partner2 WBJ


The Location

The Knight Conference Center at the Newseum
555 Pennslyvania Ave NW
Washington, Dc 20001