The Translational Science Interagency Fellowship (TSIF) program is jointly sponsored by NCATS and the U.S. Food and Drug Administration (FDA) and aims to provide training in both translational science and regulatory science. The common goal of NCATS and the FDA is to bring safe and effective drugs, regimens and devices from the bench to the bedside as quickly and efficiently as possible. To that end, fellows will be trained in preclinical translational science, technology development, and regulatory research and review.
By combining training in translational science and research-related regulatory review, this program will enable fellows to build awareness of regulatory requirements into the early stages of medical product development, improving efficiencies in both the development and review processes. Fellows in this program will develop skills of value to future careers in academia, the pharmaceutical industry and government.
To learn more, download the NCATS Translational Science Interagency Program Flyer.
This is a three-year program, which accepts up to two new fellows per year. The applicant must meet the following qualifications:
- Have a Ph.D., M.D. or other doctoral degree in a related discipline or have documentation that all degree requirements will be completed before the start of the fellowship. Assurance to this effect must be supplied in writing by the chair of the dissertation committee (for Ph.D. candidates) or the dean of the school (for M.D. candidates).
- Be a citizen or permanent resident of the United States at the time of application. Applicants must have resided in the United States for 3 of the last 5 years.
- Have no more than two years of prior postdoctoral training before joining this fellowship program.
- 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 question pertains to the illegal use of drugs or controlled substances in accordance with federal laws, even though permissible under state laws. Applicants will be required to complete a conflict of interest assessment.
*Selection of fellows will be dependent upon the availability of funds.
Curricula and Responsibilities
Participants will be expected to spend three years in combined training at the FDA and NCATS. It is expected most fellows will spend the first 12–18 months of the fellowship at the FDA and the remainder of the fellowship at NCATS. The exact timing of this transition will be project and fellow dependent.
At the FDA, fellows will receive formal training and mentoring in:
- Relevant federal statutes, and
- Regulations, principles and practices of FDA medical product review.
At NCATS, fellows will receive formal training and mentoring in:
- The early stages of technology development, and
- Preclinical and clinical translational science.
Descriptions of Projects and Mentors
Fellows in the TSIF program will be matched with an NCATS/FDA mentoring pair to work on a specific project. Potential applicants should review the list of current projects and mentors and include in their statement of research goals how their goals are aligned with one or more of the mentor pairs and projects listed.
Additional Program Details
- Every effort will be made to match fellows with their first choice of mentors.
- Mentors will provide training in preclinical translational science, clinical trial design/methodology, epidemiology, medical product development and review of regulatory files. Mentors also will train fellows in ongoing research projects and supervise all regulatory and research activities. Mentors will encourage fellows to participate in the regulatory courses offered by various FDA Centers. Mentors also will discuss relevant scientific conferences and meetings and support fellows’ training and travel.
- All fellows will participate in the regulatory process at FDA and will be subject to all FDA conflict-of-interest/ethics rules. While at FDA, fellows must complete required FDA financial disclosure forms, abide by FDA non-disclosure and confidentiality rules and attend the FDA Orientation for Nonemployee Scientists.
- All fellows will participate in scientific and professional development activities sponsored by the NCATS Intramural Research Program when onsite at NCATS facilities.
TSIF Program Contact Information:
Brittany M. Haynes, Ph.D.
Scientific Program Specialist, Education Branch
National Center for Advancing Translational Sciences
6701 Democracy Boulevard
Bethesda, MD 20892-4874
Email Address: TSIFellowship@nih.gov
Expiration Date: 07/31/2022
Collection of this information is authorized by The Public Health Service Act, Section 479 (42 USC 287). The information collected in this application will be used to facilitate the acceptance and onboarding of applicants. Rights of participants are protected by The Privacy Act of 1974. The information you provide will be included in a Privacy Act system of records, and will be used and may be disclosed for the purposes and routine uses described and published in the following System of Records Notice (SORN): 09-25-0014 – Clinical Research: Student Records, HHS/NIH/OD/OIR/OE. Participation is voluntary, and there are no penalties for not participating or withdrawing at any time. The information collected will be kept private to the extent provided by law. Names and other identifiers will not appear in any report. Information provided will be combined for all participants and reported as summaries.
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