FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
Pediatric
Oncology Subcommittee of the Oncology
Drugs Advisory Committee Meeting
Advisors and Consultants Conference Room, #1066,
The subcommittee will hear
about the structure and function of the Office of Oncology Drug Products in
CDER and discuss issues involved with the conduct of certain pediatric
post-marketing studies for products approved for oncologic indications
Accelerated Approval and Clolar™ (clofarabine) Required Confirmatory Trials
FDA
Presentation Martin
Cohen, M.D.
Medical
Officer, Division of Drug Oncology Products/ODP/CDER/FDA
Genzyme
Presentation Rekha
Abichandani, M.D.
Medical Director,
Clinical Research,
Genzyme Corporation
Pediatric Drug Development Lisa Mathis, M.D.
Initiatives Acting
Director, Division of Pediatric Drug Development, Office of Counterterrorism
and Pediatrics/CDER/FDA
Pediatric Post-Marketing Commitments
Neulasta® (pegfilgrastim)
FDA Presentation Jeff Summers, M.D.
Medical
Officer, Division of Biologic Oncology Products/ODP/CDER/FDA
Amgen
Presentation Lyndah
Dreiling, M.D.
Director,
Clinical Development, Amgen, Inc.
Kepivance™ (palifermin)
FDA Presentation Joseph Gootenberg, M.D.
Medical
Team Leader, Division of Biologic Oncology Products/ODP/ CDER/FDA
Amgen
Presentation Dietmar Berger,
M.D., Ph.D.
Director, Clinical Development, Amgen, Inc.
Open Public Hearing
Speaker Sadhana Dhruvakumar
Director
Medical Testing Issues
People
for Ethical Treatment of Animals
The
committee will review the status of studies for specific off-patent
drugs for pediatric oncology, and consider other off-patent oncology drugs for
which pediatric studies are needed, as mandated by the
Best Pharmaceuticals for Children Act.
The Best Pharmaceuticals for
Children Act (BPCA) Anne Zajicek,
M.D., Pharm.D.
Pediatric
Medical Officer, National Institute of Child Health and Human Development, NIH
Actinomycin-D/Vincristine in
Pediatric Oncology Jeffery
Barrett, Ph.D., FCP
Trials Division
of Clinical Pharmacology & Therapeutics, The Children’s
Future Subcommittee Topics Karen
Weiss, M.D.
ODP/CDER/FDA