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2023 TSIF Program Application Form

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This form serves as your application for the Translational Science Interagency Fellowship (TSIF) Program. Please complete the following application form and upload all additional required documents (including personal statement, CV, academic transcripts, and FDA Form 4083) by 11:59pm ET January 15, 2024. Incomplete applications will not be considered.

Thank you for your interest in the TSIF Program!

First Name:

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Middle Name (if any):

Last Name / Surname:

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Date of Birth:

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M-D-Y

Preferred email:

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Preferred Phone Number:

Citizenship:

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U.S. Citizen

U.S. Permanent Resident

Foreign Citizen

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Do you currently have a Ph.D., M.D., or other doctoral degree in a related discipline?

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Yes

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Will you have a Ph.D., M.D. or other doctoral degree in a related discipline before the start of the fellowship (Sept. 9th, 2024)?

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Yes

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Will you have no more than two years of prior postdoctoral training before the start of the fellowship program (September 9th, 2024)?

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Yes

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Please read the FDA Ethics for Non-employee scientists, found here: https://www.fda.gov/about-fda/office-chief-scientist/fda-ethics-non-employee-scientists

I confirm that I have read and understand the FDA Ethics for Nonemployee Scientists requirements.

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Kindly download and fill out the FDA Form 4083, which pertains to the reporting of financial interests and other relationships for non-employee scientists at the FDA. Ensure that the document is compressed to a size less than 2 MB for uploading with your additional application materials. If assistance is required during this process, feel free to reach out to Belen Hurle at Bhurle@mail.nih.gov. It's important to note that the inability to upload Form 4083 will not hinder the submission of your complete application.

Attachment:FDA-4083_Expires 01.31.2026.pdf

Completed FDA Form 4083

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Please select your top choice of project:

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Combining machine learning and in vitro genotoxicity assays for assessing potential carcinogenicity and mutagenicity of nitrosamine impurities in drug products
Mentors: Huixiao Hong (NCTR/FDA), Ru Chen (CDER/FDA), Menghang Xia (NCATS), and Ruili Huang (NCATS)

Developing iPSC-derived macrophage reporter assays to assess immune cell responses to nucleic acid therapeutics
Mentors: Daniela Verthelyi (CDER/FDA) and Mark Henderson (NCATS)

Measuring generic drug impact on US health outcomes
Mentors: Markham Luke (CDER/FDA), Liang Zhao (CDER/FDA), Silvana Borges (CDER/FDA), and Jessica Binder (NCATS)

Developing Novel Strategies to Improve Adeno-Associated Virus (AAV) Vector for Gene Therapy
Mentors: Nirjal Bhattarai (CBER/FDA), Elizabeth Ottinger (NCATS), and Venkata Mangalampalli (NCATS)

Developing Analytical Methods for the Analysis and Evaluation of Human Growth Hormones and Biosimilar Products
Mentors: Kang Chen (CDER/FDA), Christopher LeClair (NCATS), and Dingyin Tao (NCATS)

Investigate neurotoxicity associated with poly-substance exposure using functional neural spheroid and blood-brain-barrier tissue chip models of Alzheimer's and Parkinson's Disease
Mentors: John Talpos (NCTR/FDA), Hector Rosas Hernandez (NCTR/FDA), and Emily Lee (NCATS)

Data-Driven Innovation and Regulation for Next-Generation Diagnostics
Mentors: Sara Brenner (CDRH/FDA), Keith Campbell (CDRH/FDA), Sam Michael (NCATS), and Marc Ferrer (NCATS)

CURE ID: Expanding the Platform's Capabilities to include Automated Extraction and Adverse Event Reporting
Mentors: Heather Stone (CDER/FDA), Suranjan De (CDER/FDA), and Ewy Mathe (NCATS)

Enhancing Intestinal Barrier Research through Integrative High-Throughput TEER Analysis and Mechanistic Elucidation for Intestinal Toxicity Screening
Mentors: Sangeeta Khare (NCTR/FDA), Kuppan Gokulan (NCTR/FDA), Xin Xu (NCATS), and Elias Carvalho Padilha (NCATS)

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Please select your second choice of project:

Developing iPSC-derived macrophage reporter assays to assess immune cell responses to nucleic acid therapeutics
Mentors: Daniela Verthelyi (CDER/FDA) and Mark Henderson (NCATS)

Measuring generic drug impact on US health outcomes
Mentors: Markham Luke (CDER/FDA), Liang Zhao (CDER/FDA), Silvana Borges (CDER/FDA), and Jessica Binder (NCATS)

Developing Novel Strategies to Improve Adeno-Associated Virus (AAV) Vector for Gene Therapy
Mentors: Nirjal Bhattarai (CBER/FDA), Elizabeth Ottinger (NCATS), and Venkata Mangalampalli (NCATS)

Developing Analytical Methods for the Analysis and Evaluation of Human Growth Hormones and Biosimilar Products
Mentors: Kang Chen (CDER/FDA), Christopher LeClair (NCATS), and Dingyin Tao (NCATS)

Data-Driven Innovation and Regulation for Next-Generation Diagnostics
Mentors: Sara Brenner (CDRH/FDA), Keith Campbell (CDRH/FDA), Sam Michael (NCATS), and Marc Ferrer (NCATS)

CURE ID: Expanding the Platform's Capabilities to include Automated Extraction and Adverse Event Reporting
Mentors: Heather Stone (CDER/FDA), Suranjan De (CDER/FDA), and Ewy Mathe (NCATS)

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Please select your third choice of project:

Developing iPSC-derived macrophage reporter assays to assess immune cell responses to nucleic acid therapeutics
Mentors: Daniela Verthelyi (CDER/FDA) and Mark Henderson (NCATS)

Measuring generic drug impact on US health outcomes
Mentors: Markham Luke (CDER/FDA), Liang Zhao (CDER/FDA), Silvana Borges (CDER/FDA), and Jessica Binder (NCATS)

Developing Novel Strategies to Improve Adeno-Associated Virus (AAV) Vector for Gene Therapy
Mentors: Nirjal Bhattarai (CBER/FDA), Elizabeth Ottinger (NCATS), and Venkata Mangalampalli (NCATS)

Developing Analytical Methods for the Analysis and Evaluation of Human Growth Hormones and Biosimilar Products
Mentors: Kang Chen (CDER/FDA), Christopher LeClair (NCATS), and Dingyin Tao (NCATS)

Data-Driven Innovation and Regulation for Next-Generation Diagnostics
Mentors: Sara Brenner (CDRH/FDA), Keith Campbell (CDRH/FDA), Sam Michael (NCATS), and Marc Ferrer (NCATS)

CURE ID: Expanding the Platform's Capabilities to include Automated Extraction and Adverse Event Reporting
Mentors: Heather Stone (CDER/FDA), Suranjan De (CDER/FDA), and Ewy Mathe (NCATS)

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Would you be interested in interviewing with other TSIF projects beyond your top three listed choices?

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Yes

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If you are not accepted into the TSIF program, would you be interested in having your CV and application information forwarded for other NCATS postdoctoral opportunities?

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Yes

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	Name (First and Last)	Email	Phone Number
1
2
3

Curriculum Vitae (CV)

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Personal Statement: In narrative form, describe your research interests and goals and how these relate to the fields of translational science and regulatory and drug development science. Additionally, indicate how your goals are aligned with one or more of the TSIF projects listed on the TSIF web-page. Please also provide insight into your short- and long-term career goals, and explain how the TSIF program will help you in achieving those goals. Please limit your personal statement to two typed, single-spaced pages and use 12-point font and 1" margins (approximately 1,000 words).

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Proof of terminal degree: Please upload a copy of your graduate transcript as proof of your terminal degree (Ph.D., M.D., etc.).

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Proof of Graduation: All TSIF fellows must have a Ph.D., M.D., or other doctoral degree in a related discipline. Please provide documentation that all degree requirements will be completed before the start of the fellowship (written assurance from dissertation committee chair (for Ph.D. candidates), the dean of the school (for M.D. candidates), etc.).

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Proof of citizenship: Permanent residents of the United States must submit proof of eligibility for citizenship. The I-551 stamp in a passport is acceptable; "Employment Authorization" documents are not acceptable.

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I certify that, to the best of my knowledge, the provided information is true and accurate.

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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 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.

Selection for the fellowship will be based solely on merit, with no discrimination for non-merit reasons, such as race, color, gender, national origin, age, religion, sexual orientation, or physical or mental disability. NIH and FDA provide reasonable accommodations to applicants with disabilities. If you need reasonable accommodation during any part of the application and hiring process, please notify us. The decision on granting reasonable accommodation will be handled on a case-by-case basis.

THE NIH/NCATS AND FDA ARE EQUAL OPPORTUNITY EMPLOYERS.

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