Interagency Oncology Task Force

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Interagency Oncology Task Force

  1. 1. Interagency Oncology Task Force (IOTF) Research and Regulatory Review Fellowships http://iotftraining.nci.nih.gov
  2. 2. Research and Regulatory Review Fellowships • The NCI and FDA are offering fellowship training in cancer-related scientific research and research-related regulatory review. • Objectives: – To train a cadre of scientists in research and research-related regulatory review, policies, and regulations to develop a skill set bridging two disparate processes. – To build awareness of regulatory requirements into the early stages of product development processes. – To improve planning throughout research and regulatory review to facilitate the movement of novel approaches from the bench to the community. – To facilitate the movement of drugs, biologics, and devices from basic bench science to commercialization. • These fellowships will provide fellows with the knowledge to bridge the development and review processes. • Graduates of this program will develop skills of value to academia, the pharmaceutical industry, and government agencies.
  3. 3. Joint Fellowship Training Program Four Programs: Program 1 - Clinical Oncology Product Research/Review for Oncology Fellows Program 2 - Clinical Oncology Product Research/Review for Board Certified (BC) Oncologist Program 3 - Oncology Product Research/Review for Fellows Program 4 - Cancer Prevention Fellows
  4. 4. Program 1 - Clinical Oncology Product Research/Review for Oncology Fellows • To train physicians in aspects of clinical trials methodology and analysis, epidemiology, medical product development, and regulation. • To receive formal training in federal statutes, regulations, principles and practices of medical product and clinical review. • To have the opportunity to participate in product development research projects at both agencies. • The mentor will be a senior member of FDA scientific review staff. • Eligibility: – M.D. or M.D./Ph.D. degree in a relevant field of clinical training – US citizenship or US permanent residency. • Curricula: – First year at NCI in the participating oncology-training programs. – Remaining years at FDA in product research/review. • Fellowships will be for up to 3 years and include up to 2 fellows/year.
  5. 5. Program 2 - Clinical Oncology Product Research/Review for Board Certified (BC) Oncologist • To train physicians following a oncology clinical fellowship. • Training in the aspects of the drug, biologic, or device development and related issues and standards for assessing medical product safety and efficacy. • To receive formal training in federal statutes, regulations, principles and practices of medical product and clinical review. • The mentor will be a senior member of FDA scientific review staff. • Eligibility: – Board certified oncologist – US citizenship or US permanent residency. • This is a one-year program for up to three fellows per year.
  6. 6. Program 3 - Oncology Product Research/Review for Fellows • The fellowship will train individuals in the aspects of research and review of medical product development process to facilitate the movement of drugs, biologics, and devices. • Training in federal statutes, regulations, principles, and practices of medical product review, including issues related to manufacturing processes, characterization, testing, quality control, and quality assurance. • Fellows will also participate in medical product development research. • The mentor will be a senior member of FDA scientific review staff. • Eligibility: – A Ph.D., M.D., or M.D./Ph.D. degree – Minimum of three years of postdoctoral training in a cancer-related topic – US citizenship or US permanent residency. • This program is for up to two years and for up to six fellows per year.
  7. 7. Program 4 - Cancer Prevention Fellows • The fellowship provides training in cancer prevention • Individuals will be trained in the drug, biologic, or device development and approval processes and their application to study populations (including healthy subjects). • Training in federal statutes, regulations, principles, and practices of medical product review, including issues related to manufacturing processes, characterization, testing, quality control, and quality assurance. • Fellows will also participate in medical product development research. • The mentor will be a senior member of FDA scientific review staff. • Eligibility: – Ph.D., M.D., or equivalent degree – US citizenship or US permanent residency • Curricula: – First year; fellows will pursue a master's degree in Clinical Investigation (M.S.) or Public Health (M.P.H). – Fellows may choose to spend up to one year at NCI and up to two years at FDA or all years at FDA. • This program is for up to four years and for up to two fellows per year.
  8. 8. Recruitment and Roll-out • The Program is being advertised in national publications, professional journals, web sites and email listservs. • The Program continues to be presented at national meetings. • An NCI and FDA Review Committee will be established to screen applications for select qualified candidates. • The Review Committee evaluates the Program’s effectiveness and follow-up with Program success and fellows’ outcomes. • Application deadlines have been established for each program. • Mentor’s project overview are posted, allowing the applicants to view and select potential matches.
  9. 9. Program Outcomes Follow-up • Ongoing evaluation process for both mentor and trainee • Biannual training plan update • Tracking of graduates • Exit interviews for trainees Benchmarks • Coursework completion • Minimum skill set – As determined by tests at FDA – Review of Investigation New Drug or Device Exemption
  10. 10. Subcommittee Members FDA: • Brown,David(FDA/CDRH) Co- Chair • Smith, Nancy D. (FDA/CDER) Co- Chair • Chenault, Michelle (FDA/CDRH) • Diamond, Richard (FDA/CBER) • Droke, Beatrice (FDA/OC) • Fritts, Marty (SAIC) • Hewlett, Indira (FDA/CBER) • Hirschfeld, Steve, (FDA/CBER) • Parish, Eileen (FDA) • Pazdur, Richard (FDA/CDER) • Pluhowski, Nancy (FDA/CDRH) • Poos, Mary (FDA Fellow Program Manager) NCI: • Wiest, Jonathan (NCI) Co-Chair • Dores, Graca (NCI) • Murgo, Anthony (NCI) • Weed, Doug (NCI)

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