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. Radioactive Drug Research Committees
(RDRC)
0
20
40
60
80
100
75 -79 80-85 85-89 90-94 95-99 00-04
5 Year interval
Number

12. 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

13. 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

14. 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