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Pre-Application Information for RFA-AG-21-026: "Preclinical Development of Novel Therapeutics Targeting Aging Mechanisms (SBIR U44)"

RFA-AG-21-026, "Preclinical Development of Novel Therapeutics Targeting Aging Mechanisms (SBIR U44 Clinical Trial Not Allowed)" was published on June 25, 2020. This Funding Opportunity Announcement (FOA) utilizes the SBIR cooperative agreement (U44) activity code to support the preclinical development of emerging therapeutics targeting fundamental mechanisms of aging (e.g., inflammation, cell senescence, proteostasis). This includes the translation of a broad range of potential geroscience-based therapies, such as new classes of compounds (e.g., senolytics), biologics, stem/progenitor cell-based therapies, repositioning of existing investigational drugs, and repurposing of Food and Drug Administration (FDA)-approved drugs for the treatment and prevention of clinical conditions related to aging and common in the aged. Examples of translational research activities eligible under this FOA include target validation, optimization of lead compounds, pharmacokinetics, and drug disposition studies, as well as preclinical safety/toxicology studies. NIA encourages the submission of applications which involve translational research activities across all stages of preclinical drug development. Get information related to FDA review of geroscience-related IND applications.

Applicants must include a Target Product Profile (TPP) based on FDA guidance in their applications. In addition, U44 awardees will be required to convene periodic meetings with the FDA to discuss any necessary modifications to the TPP based on research progress or to meet specific regulatory requirements (e.g., pre-IND meeting).

Please note that important deadlines for this RFA are:

Letters of intent: October 10, 2020
Application due date: November 10, 2020

Notice of change: NOT-AG-20-048 Notice of Change to RFA-AG-21-026 Preclinical Development of Novel Therapeutics Targeting Aging Mechanisms (SBIR U44 Clinical Trial Not Allowed)

Pre-Application Webinar

A pre-application webinar will be held on Thursday, August 27, 2020 at 2 p.m. (Eastern). Register here to attend the webinar. An archived version of the webinar presentation will be made available on this page.

We strongly encourage applicants to contact the NIA to discuss their proposed projects.

Inquiries regarding the scientific scope of the applications may be directed to:

Chhanda Dutta, Ph.D.
Email Chhanda Dutta

Rebecca Fuldner, Ph.D.
Email Rebecca Fuldner

Inquiries specific to the NIA small business research program should be directed to:

Todd Haim, Ph.D.
Email Todd Haim

Please check this page periodically, as FAQ's may be added in the future.