October 20, 2005

Pediatric Oncology Subcommittee of the  Oncology Drugs Advisory Committee Meeting

Advisors and Consultants Conference Room, #1066, Rockville, Maryland




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


Opening Remarks                                                          Karen Weiss, M.D.

Deputy Director, Office of Oncology Drug Products (ODP)/CDER/FDA

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Accelerated Approval and Clolar (clofarabine) Required Confirmatory Trials


                        FDA Presentation                                 Martin Cohen, M.D.

                        Medical Officer, Division of Drug Oncology Products/ODP/CDER/FDA

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                        Genzyme Presentation                           Rekha Abichandani, M.D.

Medical Director, Clinical Research,

Genzyme Corporation

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                        Pediatric Drug Development                  Lisa Mathis, M.D.

Initiatives                                              Acting Director, Division of Pediatric Drug Development, Office of Counterterrorism and Pediatrics/CDER/FDA

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Pediatric Post-Marketing Commitments


                        Neulasta® (pegfilgrastim)

                        FDA Presentation                                 Jeff Summers, M.D.

Medical Officer, Division of Biologic Oncology Products/ODP/CDER/FDA

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                        Amgen Presentation                              Lyndah Dreiling, M.D.

                                                                                    Director, Clinical Development, Amgen, Inc.

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                        Kepivance™ (palifermin)

                        FDA Presentation                                 Joseph Gootenberg, M.D.

Medical Team Leader, Division of Biologic Oncology Products/ODP/ CDER/FDA

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                        Amgen Presentation                              Dietmar Berger, M.D., Ph.D.

Director, Clinical Development, Amgen, Inc.

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Open Public Hearing Speaker                                   Sadhana Dhruvakumar

                                                                                    Director Medical Testing Issues

                                                                                    People for Ethical Treatment of Animals

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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

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Actinomycin-D/Vincristine in Pediatric Oncology            Jeffery Barrett, Ph.D., FCP

Trials                                                                            Division of Clinical Pharmacology & Therapeutics, The Children’s Hospital of Philadelphia

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Future Subcommittee Topics                                          Karen Weiss, M.D.


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