Interagency Oncology Task Force (IOTF) Research and Regulatory Review Fellowships

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.

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

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.

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.

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.

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.

Recruitment and Roll-out The Program is being advertised in national publications, professional journals, web sites and 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.

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

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)