Translational Science Interagency Fellowship

About TSIF

Our common goal with the FDA is to bring safe and effective drugs, regimens and devices from the bench to the bedside as quickly and efficiently as possible. Scientists who are knowledgeable about both preclinical translational science and regulatory science can help to achieve this goal.    

To develop scientists with these essential skills, we created the TSIF program. This initiative provides training opportunities at both NCATS and FDA. By combining training in translational science and research-related regulatory review, the TSIF program enables 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 develop valuable skills applicable to future careers in academia, the pharmaceutical industry and government.

Fellows in the TSIF program are matched with an NCATS/FDA mentor pair to work on a specific project. Read about our current fellows and their research below: 

• Elia Lopez, Ph.D., Translational Research in Developing Predictive Toxicology for Antisense Oligonucleotides
• Keyla Tumas, Ph.D., Repurposing for Neglected Infectious Diseases: Project Lifecycle From Bench to Translational to Regulatory Science
• Kristin A. Altwegg, Ph.D., The Bioassay as a Predictive Model of Drug Efficacy in Repurposing Drug Screen for Oncology Indications
• Tsung-Jen Liao, Ph.D., Incorporating in Vitro and in Silico Data to Improve Drug-Induced Liver Injury Predictive Models for Supporting FDA Review Process
• Justine Noel, Ph.D.,  Evaluation of the Effect of Cell-Based Products on Placental Immunity Using 3-D Human Placental Barrier Models
• Zoe Li, Ph.D., Opioid Agonists/ Antagonists Knowledgebase (OAK) to Assist Development of Analgesic Products for Pain Management and Opioid Use Disorder treatment.

Eligibility Requirements

TSIF is a three-year program, accepting up to two new fellows* per year. Applicants 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 medical 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 three of the last five 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 (or 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.
• If an NCATS/FDA Translational Science Interagency Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at the FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

*Selection of fellows will be dependent upon the availability of funds.

Curricula and Responsibilities

Fellows are expected to spend three years in combined training at the FDA and NCATS. It is anticipated that fellows will spend 12 to 18 months of the fellowship at the FDA and the remainder of the fellowship at NCATS. The exact timing of the transition between the two agencies will be project and mentor dependent.

At the FDA, fellows will receive formal training and mentoring in:  

• Relevant federal statutes
• Regulations, principles and practices of FDA medical product review

At NCATS, fellows will receive formal training and mentoring in:

• Early stages of technology development
• 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 personal statement how their research goals are aligned with one or more of the mentor pairs and projects listed.

Additional Program Details    

1. Every effort will be made to match fellows with their first choice of mentors. 
2. Mentors provide training in preclinical translational science, clinical trial design/methodology, epidemiology, medical product development and review of regulatory files. In addition, mentors supervise all regulatory and research activities conducted by the fellow. Mentors also encourage fellows to participate in the regulatory courses offered by various FDA centers as well as discuss and support fellows’ training and travel for relevant scientific conferences and meetings.
3. Fellows participate in the regulatory process at FDA and are 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. Please see eligibility requirements for additional details.
4. Fellows participate in scientific and professional development activities sponsored by the NCATS Intramural Research Program when onsite at NCATS facilities.

Burden Statement           
OMB# 0925-0761           
Expiration Date: 07/31/2025

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 for 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.

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 the 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.