Track 2: Oncology Product Research and Review for B.C. Oncologists
This fellowship will train physicians in aspects of the drug, biologic, or device development and related issues and standards for assessing medical product safety and efficacy, to facilitate the movement of drugs, biologics, and devices from basic bench science to commercialization.
Fellows will receive formal training and mentoring in the relevant federal statutes, regulations, principles and practices of FDA medical review, including issues related to the assessment of safety and efficacy, for limited human exposure in clinical trials, and later potential exposure to the broader patient population postmarketing approval.
- Completion of clinical residency or clinical fellowship
- U.S. citizenship or permanent residency
Training Goals and Outcomes
- Training and experience in clinical trial design, clinical pharmacology, pharmacoepidemiology, and the drug development process in the context of clinical research
- Understanding the review process for regulatory pathways
- Understanding of the various legal and regulatory aspects of cancer product development
- Understanding of critical ethical issues and requirements in product research, development, and review, including protection of human research subjects and conflict of interest
- Understanding of mechanisms of pathogenesis and cancer biology
Curricula and Responsibilities
This is a one-year program for up to three fellows per year.
Fellows will choose one of the product or clinical divisions in FDA Centers for supplemental training. In a particular product or clinical division, these fellows will be matched to a pre-screened pool of principal investigators for regulatory research and review or to a branch chief for regulatory review and policies. These fellows will have the option to participate in translational research in the participating division.
Fellows will undertake and participate in various regulatory activities of the chosen division. The division director or their designee will oversee these activities.Regulatory activities include but are not limited to training courses and reviews of files to become proficient in the process of product, pharmacology/toxicology or clinical reviews; and policy and guidance document development. Fellows will also participate in branch, lab, division, and office meetings; grand rounds; and regulatory presentations offered at the participating Center. They will also participate in regulatory meetings with investigators and sponsors.
During the training program, these fellows will be expected to attend and take and pass required tests in reviewer training and various courses offered by participating FDA Centers.
How to Apply
Applications are due January 31, 2017 for an earliest start date of July 1, 2017.
- Curriculum Vitae
- Personal statement of research goals
- Three letters of reference
For more detailed information and application guidelines view the NCI-FDA Research and Regulatory Review Fellowships Guidelines for Application(PDF)
Send application materials to:
Jonathan S. Wiest, Ph.D.
Director, Center for Cancer Training, NCI
9609 Medical Center Dr.
Rm. 2W104, MSC 9707
Bethesda, MD 20892-9707
Office Phone: 240-276-5628
While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff.