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NCI-FDA Research and Regulatory Review Fellowships

1. What are the fellowships?
   
   The National Cancer Institute (NCI), part of the National Institutes of Health, and the U.S. Food and Drug Administration (FDA) – both part of the U.S. Department Health and Human Services (HHS) – are providing fellowship training programs for eligible candidates in cancer-related scientific research and research-related regulatory review.
   
   
2. What are the objectives of the fellowships?
   
   The objective of the NCI-FDA fellowships is to train a cadre of scientists in research and research-related regulatory review so that they can develop skill sets that bridge the two distinct processes. Fellows will learn to build awareness of regulatory requirements into the early stages of medical product development and will devise strategies to improve planning throughout the research and regulatory review phases.
   
   Fellows also will learn how to bring state-of-the art knowledge and technology to bear on the design, conduct, and review of clinical trials.
   
   
3. Why are the fellowships important?
   
   The NCI-FDA fellowships are the first federal government programs designed to encompass the development and regulation of new medical products in a seamless way. The cross-fertilization between NCI and FDA is critical for developing the knowledge base necessary to bring new, molecular-based therapies and diagnostics into clinical practice.
   
   The new generation of targeted therapeutic agents will expand the oncology pipeline. Therefore, it is vital to establish a cadre of scientists and clinicians who are cross-trained to understand the technologies, the development process, and the regulatory review issues. If researchers are more aware of the requirements of safety and efficacy regulatory review from the early stages, they will be better equipped to achieve the common goal of bringing safe and effective drugs, regimens, and devices from the bench to the bedside as quickly as possible.
   
   
4. What NCI-FDA fellowships are available?
   
   • Program One—Clinical Oncology Product Research/Review for Oncology Fellows. This program will train physicians in aspects of clinical trials methodology and analysis, epidemiology, the clinical aspects of medical product development, and product regulation as it relates to the clinical research and development process. This program will prepare fellows to facilitate the movement of drugs, biologics, and devices from basic bench science to commercialization. Designed for M.D.s or M.D./Ph.D.s.
     
     
   • Program Two—Clinical Oncology Product Research/Review for Board-Certified Oncologists. This program will train physicians in the regulatory aspects of drug, biologic, or device development and related issues, as well as in FDA standards for assessing medical product safety and efficacy. The training will facilitate the movement of drugs, biologics, and medical products from basic science to the commercialization stage. Designed for M.D.s or M.D./Ph.D.s.
     
     
   • Program Three—Oncology Product Research/Review Fellows. This program will train individuals in the various aspects of research and review of medical product development. The training will facilitate the movement of drugs, biologics, and devices from the bench to the bedside. Designed for M.D.s , Ph.D.s or M.D./Ph.D.s.
     
     
   • Program Four—Cancer Prevention Fellows. This program will train individuals in cancer prevention (e.g. chemoprevention, vaccination, and early detection). Fellows will be trained in the drug, biologic, or device development and approval processes and in their application to study population, including healthy subjects. Designed for M.D.s, Ph.D.s or scientists with equivalent doctoral degrees.
     
     
5. Where will the fellows train?
   
   The fellows will train onsite primarily at FDA’s offices and laboratories in the Metropolitan Washington, D.C., area. Fellows also will pursue studies in NCI’s oncology-training programs.
   
   
6. Who is eligible to apply?
   
   For most of the programs, candidates must have an M.D. and/or Ph.D. or an equivalent degree with less than five years of postdoctoral experience. They must also be either a citizen of the United States or have permanent residency status. There are additional eligibility requirements specific to each training program which can be found at http://iotftraining.nci.nih.gov.
   
   
7. What skills and knowledge will fellows gain from the programs?
   
   The NCI-FDA Research and Regulatory Review Fellowships offer a unique career opportunity for participating researchers to become remarkably well-positioned to facilitate the new age of molecular medicine.
   
   Graduates of the programs will develop skills of value to academia, the pharmaceutical industry, and government agencies through:
   
   
   • Mentored research opportunities at NCI
   • Regulatory training and hands-on experience at FDA
   • Professional development and leadership preparation
   • Master’s degree in Clinical Investigation or Public Health (Cancer Prevention fellowship only)
     
     
8. How many fellows will be accepted per year?
   
   
   • Program One—Clinical Oncology Product Research/Review for Oncology Fellows: up to two fellows
   • Program Two—Clinical Oncology Product Research/Review for Board-Certified Oncologists: up to three fellows
   • Program Three—Oncology Product Research/Review Fellows: up to six fellows
   • Program Four—Cancer Prevention Fellows: up to two fellows
     
     
9. How long are the programs?
   
   The NCI-FDA fellowship programs run from one to four years depending on the program. Specific information on program lengths and curricula can be found at http://iotftraining.nci.nih.gov or by contacting one of the offices listed below.
   
   
10. What compensation and employee benefits are provided?
    
    Stipends. Each stipend will be determined by the individual’s degree and years of relevant postdoctoral experience. Ph.D.s will receive between $37,900 and $53,000. M.D.s will receive between $42,800 and $53,000; M.D.s who are engaged in approved patient contact during the research years at NCI can receive up to $73,430. Annual increases will be given. Specialty competitive allowances are given for degrees in epidemiology, biostatistics, M.D./Ph.D.s, and for board-certified M.D.s engaged in patient care. Stipends are subject to change, depending on federal guidelines.
    
    Health insurance and leave. Fellows will receive paid individual or family health insurance, Federal holidays, annual leave, and sick leave.
    
    Travel and relocation. NCI may cover the cost of relocation expenses (i.e., travel, shipment of household goods, and temporary storage, if necessary) for the fellow and his/her dependents for one move to the area where master’s training will be pursued or to the Rockville, Md., area, up to a maximum of $3,000. Reimbursement will be in accordance with prevailing government regulations. No return travel is authorized.
    
    Travel expenses for one national, scientific meeting per year are provided while at NCI. Registration fees for meetings also are provided.
    
    Training. Tuition expenses for approved training courses are reimbursable.
    
    
11. When are applications due and how do candidates apply?

Application deadlines for the NCI-FDA Research and Regulatory Review Fellowship program, and other information about the application process, can be found at http://iotftraining.nci.nih.gov or by contacting one of the offices listed below.

Program Administration and Information

Oncology Product Research/Review Fellowships
CCR Office of Training and Education
CCR Office of the Director
National Cancer Institute
Building 31, Room 4A48
31 Center Drive
Bethesda, MD. 20852
Tel: 301-451-9638
Fax: 301-496-0775
Email: wiestj@mail.nih.gov
Web site: http://iotftraining.nci.nih.gov

Cancer Prevention Fellowship
National Cancer Institute
Division of Cancer Prevention
6130 Executive Boulevard
EPN, Suite 3109
Bethesda, MD 20892
Tel: 301-496-8640
Fax: 301-402-4863
Email: cpfpcoordinator@mail.nih.gov
Web site: http://cancer.gov/prevention/pob

(Online application and catalog available at http://cancer.gov/prevention/pob.)

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Remarks by FDA Acting Commissioner Lester M. Crawford (Feb. 16, 2005)

Press Release (Feb. 16, 2005)

Factsheet [PDF 248KB]

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