Track 2: Oncology Product Research and Review for Board Certified Oncologists
This track 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 post-marketing approval.
*Selection of fellows will be dependent upon the availability of funds.
Eligibility Requirements
- Applicants must be Board Certified in Oncology
- Completion of clinical residency or clinical fellowship
- U.S. citizenship or permanent residents, who have resided in the US for a total of three of the past five years
- Must pass the FDA Ethics or Non-Employees Scientists review
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.
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 typically open in May. As part of the application, you will be asked to submit:
Please submit:
- Curriculum Vitae
- Personal statement of research goals
- Two letters of reference
For more detailed information and application guidelines visit Train at NCI.
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
Email: IOTFfellowship@nih.gov
Mentors
While at FDA, fellows will each be assigned a mentor who will be a senior member of FDA scientific review staff.
Burden Statement
OMB No.: 0925-0761
Expiration Date: 07/31/2025
Public reporting burden for this collection of information is estimated to average 60 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing he collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0761). Do not return the completed form to this address.