Track 3: Oncology Product Research and Review for Postdoctoral Research Fellows
This 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 from the bench to the bedside.
Fellows will receive formal training and mentoring in the relevant federal statutes, regulations, principles, and practices of FDA medical product review, including issues related to product development, e.g., manufacturing processes, production, purification, characterization, testing, quality control, and quality assurance, understanding the biology, chemistry, pharmacoepidemiology, manufacturing, postmarketing surveillance, and mechanism of action/pathogenesis of disease.
*Selection of fellows will be dependent upon the availability of funds.
Training Goals and Outcomes
- Understanding of cancer biology relevant to molecular targeted therapy
- Understanding of regulatory requirements for product development and approval process and participation in the review of regulatory files (e.g. IND, NDA, BLA, 510k, PMA) for chemistry, manufacturing control, pharmacology/toxicology and clinical trial design
- Participation in the development of product standards and guidance document 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 the manufacturing processes, e.g., production, purification, characterization, testing, quality control, and quality assurance
- Participation in and understanding of product-related research, i.e. understanding the biology, chemistry, pharmacoepidemiology, manufacturing, post-marketing surveillance, and mechanism of action/pathogenesi
- Ph.D., M.D., or M.D./Ph.D.
- Minimum of 3 years of postdoctoral training
- Must be within 5 years of the applicants most advanced degree
- U.S. citizenship or permanent residents, who have resided in the US for a total of three of the past five years.
- Experience and interest in molecular targets or product development and/or design
- Fellows finishing their fourth or fifth year may qualify for a sixth year CRTA extension
NOTE: In order to be approved for logistical and physical access to NIH facilities and systems, candidates must be able to pass a Federal background check using Standard Form-85 (read-SF-85). Section 14 of the Form asks, "in the last year, have you used, possessed, supplied, or manufactured illegal drugs?" The questions pertain to the illegal use of drugs or controlled substances in accordance with Federal laws, even though permissible under state laws. Federal laws supersede all state laws.
Curricula and Responsibilities
The program time frame will be for up to two years and include up to six fellows per year.
Fellows will choose one of the product or clinical divisions in FDA Centers for supplemental training. In a particular product division, these fellows will be matched to a pre-screened pool of principal investigators or to a branch chief for regulatory research and regulatory experience. Fellows with a Ph.D. degree will be matched to a product division or pharmacology/toxicology branch in a clinical division.
Fellows will have the option to perform translational research in the participating division or office. These fellows will undertake and participate in various training activities of the chosen division. The division director or their designee will oversee these activities.
Fellows will spend approximately 40% of their time in training to become proficient in the process of product or pharmacology/toxicology 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.
Fellows are expected to conduct research activities under the guidance of principal investigators in ongoing projects in the lab. These fellows will have option to choose their principal investigator at the beginning of program.
During the training program, fellows will be expected to attend and take and pass required tests in reviewer training and various courses offered by participating FDA Centers.
The first-year curricula and activities may be continued in the second year of the program based on the fellow's performance evaluated by PI, branch chief, division director and associate directors of research at both institutions.
How to Apply
Applications are due May 31, 2020 for an earliest start date of October 1, 2020.
- 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:
Chanelle Case Borden, Ph.D.
IOTF Program Manager
9609 Medical Center Dr.
Rm. 2W234 MSC 9707
Bethesda, MD 20892-9707
Office Phone: 240-276-5956
While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff.
OMB No.: 0925-0761
Expiration Date: 07/31/2022
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