2008 Application Catalog

Program Description

NCI-FDA Joint Training in Cancer Prevention

Cancer Prevention Fellows are eligible to participate in the newly established NCI-FDA joint training in cancer prevention initiative. This novel component of the CPFP provides training in cancer prevention and in the development and approval processes of drugs, biologic agents, devices, or nutritional products. The program’s interdisciplinary training will enable scientists to more rapidly move novel chemopreventive agents and early detection methods from the laboratory to the community. This training incorporates unique features while maintaining the identical structure of the parent program, including eligibility, stipend, benefits, application procedures, and evaluations.

Background and Rationale. In 2003, the NCI Director and the FDA Commissioner joined forces to more rapidly identify effective cancer preventive agents and cancer treatments, thereby accelerating the process of introducing new agents into the clinic. Arising from this joint commitment was an initiative to train postdoctoral scientists and clinicians in research in cancer prevention, drug development, and regulatory review. Research training opportunities exist in several centers at the FDA in the areas of biologics (Center for Biologics Evaluation and Research (CBER)), drugs (Center for Drug Evaluation and Research (CDER)), medical devices and imaging (Center for Devices and Radiologic Health (CDRH)), and nutrition science and policy (Center for Food Safety and Nutrition (CFSAN)).

The NCI-FDA joint training in cancer prevention initiative will provide the opportunity for fellows to participate in all the activities of the CPFP at the NCI and in research and product development and regulatory review at the FDA. Combining training in public health, cancer prevention, and product development and regulatory research will allow individuals to develop expertise across three disciplines, thus offering the possibility of developing novel agents and products, designing and implementing clinical trials in chemoprevention and early detection, and advancing the nutritional sciences.

Brief Program Description. The program provides:

Master’s degree in clinical investigation (M.S.) or public health (M.P.H.) at any one-year, accredited university program
NCI Summer Curriculum in Cancer Prevention
Mentored research opportunities among the product and clinical divisions of participating FDA Centers, including CBER, CDER, CDRH, and CFSAN
Coursework and training in product development and approval processes, in development of product standards and guidance documents, and in research-related regulatory review
Additional coursework in clinical trials methodology, Institutional Review Board (IRB) processes, epidemiology and biostatistics, toxicology and pharmacology, bioethics, and health policy, as needed
Professional development and leadership training

Research Opportunities. General categories of research topics include:

Cancer risk of drug, device, and gene therapy products
Cellular substrates in vaccine development
Clinical trial design and analytic methodology
Development and selection of biomarkers and clinical endpoints in clinical trials
Development of chemopreventive agents
Genetic toxicology and cancer prevention
Genomic and proteomic approaches to early detection of cancer
Molecular and genetic approaches in product development
Nutrition science and policy
Screening and early detection
Vaccination and cancer prevention

Further information is available at http://iotftraining.nci.nih.gov/prevent.html

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