Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee
Food and Drug Administration
Center for Drug Evaluation and Research
Holiday Inn, 8120 Wisconsin Ave., Bethesda, MD
GERD – Template
Agenda for June 11, 2002
8:00 Call to Order, Introductions:
Joan P. Chesney, M.D., ChairMeeting Statement: Thomas H. Perez, R.Ph., M.P.H., Executive Secretary
Opening Comments: Dianne Murphy, M.D.
8:15 Introduction to the PPI Written Request Template Hugo Gallo-Torres, M.D.
8:30 Pathologic Pediatric GER & Clinical Trial Design: Eric Hassall, M.D.
differences in infants < 1 & > 1 year
8:45 Clinical trial design related to studies of PPIs in the neonate Mark Hudak, M.D.
& premature infant
9:00 Ethical issues of using randomized, placebo-controlled withdrawal Benjamin Wilfond, M.D.
trial design in pediatrics
9:15 Open Public Hearing
9:45 Break
10:00 Introduction to Questions & Charge to the Subcommittee Dr. Victor Raczkowski
10:10 Discussion of Questions
12:00 Lunch
1:00 Introduction: Preliminary Priority List of Drugs Dr. Anne Willoughby
1:05 Background Dr. Rosemary Roberts
1:25 Development of the Preliminary Priority List of Drugs Dr. William Rodriguez
1:35 NIH’s Role in the Development of the Priority List Dr. Anne Willoughby
1:45 Discussion of Preliminary Priority List of Drugs Dr. Dianne Murphy
2:00 Open Public Hearing
2:30 Break
2:45 Presentation of Questions and Goals for Discussion Dr. Dianne Murphy
3:00 Discussion
4:30 Update from Europe Dr. Julia Dunne
Dr. Agnes St. Raymond
5:00 Rule and Exclusivity Update Peds Team
6:00 Close
Consultants (Voting)
Patricia Chesney, M.D., Professor of Pediatrics, University of Tennessee College of Medicine
Robert Fink, M.D., Chairman, Department of Allergy and Pulmonary Medicine, Children
=s National Medical CenterMark Hudak, M.D., Professor and Chief, Division of Neonatology, University of Florida at Jacksonville
Victor Santana, M.D., Associate Professor, Dept. of Hematology/Oncology, St. Jude
=s Children=s Research HospitalNaomi Luban, M.D., Vice Chairman, Department of Laboratory Medicine, Children
=s National Medical CenterDavid Danford, M.D., Associate Professor of Pediatrics, University Nebraska Medical Center
Richard Gorman, M.D., FAAP, Pediatrician, Pediatric Partners
George D. Ferry, M.D., Professor of Pediatrics, Texas Children’s Hospital
Eric Hassall, MBChB FRCPC FACG, Division of Gastroenterology, BC Children's Hospital
Robert Nelson, M.D., Ph.D.,Associate Professor of Anesthesia & Pediatrics, The Children's Hospital of Philadelphia
Guests (Non-voting)
Benjamin Wilfond M.D., Bioethics Research Section,National Institutes of Health
Robert M. Ward, MD., Director, Pediatric Pharmacology Program, University of Utah
Harland Winter, MD., Director, Pediatric IBD Center, MassGeneral Hospital for Children
Ben Gold, M.D., Director, Division of Pediatric Gastroenterology & Nutrition, Emory University School Medicine
Lillian R. Blackmon, M.D. Clinical Associate Professor, Pediatrics, University of Maryland School of Medicine
Ralph E. Kauffman, M.D. Professor, Pediatric Pharmacology, Children’s Mercy Hospital
Laura James, M.D., Professor, Clinical Pharmacology, Arkansas Children’s Hospital
John T. Walkup, M.D., Professor Clinical Psychopharmacology, Johns Hopkins Hospital
Julia Dunne, M.D., National Expert seconded to the European Commission
Agnes Saint Raymond, M.D., Head of Sector Scientific Advice and Orphan Drugs, The European Agency for the Evaluation of Medicinal Products (EMEA)
Guest Industry Representatives (Non-voting)
Steven Spielberg, M.D., Johnson & Johnson Pharmaceutical