Workshop Background and Objectives
The purpose of the workshop was to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
The Forum invited representatives from the U.S. Food and Drug Administration (FDA), the National Institutes of Health, the American Academy of Pediatrics, the pharmaceutical industry, academia, and several patient advocacy groups to discuss the current regulatory framework, current challenges in prescribing and developing drugs for children, models for enhancing pediatric drug development, and challenges and opportunities for the future.
Workshop Planning Committee
Gail H. Cassell, Eli Lilly and Company
Jeffrey M. Drazen, New England Journal of Medicine
Barbara M. Alving, National Center for Research Reources
Naomi Aronson, Blue Cross and Blue Shield Association
Hal Barron, Genentech, Inc.
Leslie Z. Benet, University of California, San Francisco
Nina Bhardwaj, New York University School of Medicine
Catherine Bonuccelli, AstraZeneca Pharmaceuticals
Linda Brady, National Institute of Mental Health
Robert M. Califf, Duke University Medical Center
Scott Campbell, American Diabetes Association
C. Thomas Caskey, The University of Texas-Houston Health Science Center
Francis D. Chesley, Jr., Agency for Healthcare Research and Quality
Mark Clanton, National Cancer Institute
Peter Corr, Celtic Therapeutics
James H. Doroshow, National Cancer Institute
William E. Evans, St. Jude Children's Research Hospital
Joseph M. Feczko, Pfizer, Inc.
Wayne Fenton, National Institute of Mental Health
Garret A. FitzGerald, University of Pennsylvana School of Medicine
Elain K. Gallin, The Doris Duke Charitable Foundation
Steven K. Galson, Office of the Surgeon General
Alan M. Garber, Stanford University
Robert L. Garnick, Genentech, Inc.
Mikhail Gishizky, Entelos, Inc.
Stephen Groft, National Institutes of Health
Carole A. Heilman, National Insittute of Allergy and Infectious Diseases
Peter K. Honig, Merck & Co., Inc.
Dale Hu, Centers for Disease Control and Prevention
Richard A. Justman, United HealthGroup
Michael Katz, March of Dimes Foundation
Williiam F. Kean, Merck & Co, Inc.
Chaitan Khosla, Stanford University
Antonia Kolokathis, Pfizer, Inc.
Allan M. Korn, Blue Cross and Blue Shield Association
David Korn, Association of American Medical Colleges
Ronald L. Krall, GlaxoSmithKline
Jeffrey M. Leiden, Clarus Ventures
John M. Leonard, Abbott Laboratories
Nancy Loving, National Coalition for Women with Heart Disease
John R. Marler, National Institute of Neurological Disorders and Stroke
Musa Mayer, AdvancedBC.org
Mark B. McClellan, The Brookings Institution
Garry A. Neil, Johnson & Johnson
Joshua J. Ofman, Amgen, Inc.
Suzanne R. Pattee, Cystic Fibrosis Foundation
Cecil B. Pickett, Schering-Plough Research Institute
Joanne L. Rhoads, National Institute of Allergy and Infectious Diseases
Todd Rich, Genentech, Inc.
Brian Schuster, U.S. Department of Veterans Affairs
B.A. Schwetz, U.S. Department of Health and Human Services
Janet Shoemaker, American Society for Microbiology
Lana Skirboll, National Institutes of Health
Nancy S. Sung, Burroughs Wellcome Fund
James R. Swartz, Stanford University
Jorge A. Tavel, National Institute of Allergy and Infectious Diseases
Reed V. Tuckson, UnitedHealth Group
Sean Tunis, Centers for Medicare & Medicaid Services
Janet Woodcock, U.S. Food and Drug Administration
Below are materials for the workshop, including an agenda and presentations.
For additional information on the workshop, please visit our project page.