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Pediatric Subcommittee to ODAC

Pediatric Subcommittee to ODAC. Mission and Function Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee October 20, 2005. subcommittees - general. Subcommittees are advisory to the “parent” committee do not directly advise FDA

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Pediatric Subcommittee to ODAC

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  1. Pediatric Subcommittee to ODAC Mission and Function Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee October 20, 2005

  2. subcommittees - general • Subcommittees are advisory to the “parent” committee • do not directly advise FDA • Parent committee reviews subcommittee recommendations; advises FDA • At least 2 members of parent committee serve on the subcommittee • No charter or official roster

  3. Pediatric Subcommittee to ODAC BPCA– Sec 15 • Evaluate and to the extent practicable, prioritize new and emerging therapeutic alternatives to treat pediatric cancer • Provide recommendations and guidance to ensure that children with cancer have timely access to the most promising new cancer therapeutics • Advise on ways to improve consistency in the availability of new therapeutic agents

  4. Pediatric Subcommittee to ODAC- membership • Not > than 11 voting members from PPAC & ODAC • As necessary: • at least 2 from NCI, • at least 4 from: COG and other pediatric experts or consortia, • at least 2 from pediatric cancer patient and patient-family community • at least 1 statistician • at least 1 rep from the nursing community • at least 1 rep from the pharmaceutical industry

  5. Issues in pediatric oncology for discussion at an AC • New product approvals for pediatric cancer • Parent ODAC, include pediatric oncologists • PDUFA timelines an issue for scheduling • Advise on specific studies for pediatric cancers, • phase 4 commitments (under AA, PREA) • Advise/prioritize off patent drugs under BPCA • General advice on drug development for specific pediatric cancers • Animal models for pediatric cancers • Ethical issues in pediatric oncology research

  6. Office of Oncology Drug Products Center for Drug Evaluation and Research (CDER) Effective July 11, 2005

  7. Office of Oncology Drug Products Rick Pazdur, M.D., Director Karen Weiss, M.D., Deputy David Ross, M.D., Ph.D., Assoc. Dir. Glen Jones, Ph.D., Assoc. Dir. Oncology Program RDRC Program Division of Drug Oncology Products Division of Biological Oncology Products Division of Medical Imaging and Hematology Products

  8. Oncology Program • Staff of ~ 4-5 project managers • Internal activities • Coordinate oncology-related review, policy • Within CDER, across the agency (CBER, CDRH) • External activities • Outreach with OSHI • Other government agencies • Coordinate speaking, publications • Training

  9. The Radioactive Drug Research Committee • Established in 1975 – Title 21 CFR 361.1 • Conditions for RDRC Research (no IND required) • Basic Science Research • No pharmacologic effect • Radiation dose limits • FDA approves committee members • RDRC Responsibilities • Reviews and approves research protocols with IRB concurrence • Submits variety of regulatory reports to FDA

  10. RDRC program at FDA • Review qualifications of proposed members to each institution’s RDRC • Approve institutional RDRC • Review annual reports • Provide technical support to FDA inspectors

  11. Division of Drug Oncology Products • Robert Justice, M.D. – acting director • Traditional small molecules: • “Older” chemotherapeutics – new indications, new formulations, etc. • Newer agents, e.g.; • TK inhibitors • Anti-angiogenesis • Cancer prevention

  12. Division of Biological Oncology Products • Patricia Keegan, M.D., Director • Therapeutic Proteins, Monoclonal Antibodies, ex: • Antibodies to EGFR, VEGF • Hematologic Growth Factors for supportive care • Tumor vaccines, cellular and gene therapy for cancer regulated in CBER

  13. Division of Medical Imaging and Hematologic Products • George Mills, M.D., MBA- Director • Imaging, e.g., • FDG PET • Hematologics, e.g., • Iron supplements, Fe chelation (Exjade) • Anti-coagulants

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