# Presentation: 280351

## 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)**