Interagency Oncology Task Force(IOTF)

Research and Regulatory Review Fellowships

http://iotftraining.nci.nih.gov

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 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.

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)