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OpenR61Clinical trial: Not allowed

NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)

National Institutes of Health (NIH) · NIH Institute/Center · PAR-28-072

Source: Grants.gov · View original posting ↗

Award
Amount not listed
Deadline
Nov 16, 2029
Letter of intent
—
Mechanism
R61
Duration
—
Expected awards
—
Funding cycle
Standard NIH dates
Open date
Sep 25, 2026
Total funding
—
Clinical trial
Not allowed
Higher educationGovernmentSmall businessNonprofitForeign entities

Research areas

Basic mechanisms & biologyTherapeutics & drug discoveryClinical trials

Auto-classified from the title and description (keyword-based) — may be imperfect.

Description

The purpose of NEI's Translational Research program (TRP) is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. The TRP will support the product development of biological, pharmaceutical, medical device, and/or combination therapies for any disease or disorder of the visual system.The TRP will utilize a bi-phasic, milestone-driven mechanism of award. The R61 phase can be up to two years and will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The R33 phase can be up to four years and will support research that is in the final states of preclinical development with potential for near-term clinical development. The total duration of both R61 and R33 cannot exceed five years. The R33 is to focus on advancing a single therapeutic candidate through Investigational New Drug or Investigational Device Exemption (IND/IDE) enabling studies, filing an IND/IDE package with the FDA, and designing future clinical trials. R33 recipients must submit or obtain an IND/IDE application to FDA, or must transition the product to clinical practice, within the period of performance. The specific activities appropriate for the R33 phase will depend on the product under study and available preliminary data on the product. Delineation of milestones by the applicant for the R61 and R33 phases is a key characteristic of this program. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. This program will support applications that propose a series of milestones including manufacturing and product development goals. Applications that address contingency plans to proactively confront potential delays in meeting the milestones are strongly encouraged. Milestones are required for both phases. Milestones must be specific, measurable, achievable, relevant, and time-bound (SMART). All projects will begin with a R61 phase regardless of therapeutic starting point.

Data notes: award amount not published in the source feed; administering NIH institute could not be identified from the opportunity number.