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

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Grant

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The NEI Translational Research Program is designed to accelerate the development of innovative laboratory discoveries into viable therapeutics for visual system diseases and disorders. The program supports the development of various types of therapies, including biological, pharmaceutical, medical device, and combination products, through a structured, milestone-driven two-phase award mechanism. The initial R61 phase, lasting up to two years, focuses on projects with substantial preliminary data that have not yet reached clinical translation. The subsequent R33 phase, which can last up to three years, supports advanced preclinical development efforts aimed at enabling IND/IDE submissions to the FDA and designing future clinical trials. Successful completion of the R33 phase requires either submission of an IND/IDE application or transitioning the product toward clinical practice within the grant period. Applicants are required to detail a clear series of specific, measurable, achievable, relevant, and time-bound milestones (SMART) for both the R61 and R33 phases, outlining critical steps such as manufacturing and product development goals. Contingency plans to address potential delays in milestone achievement are strongly encouraged. More mature projects that do not require the R61 phase may apply directly to the R33 phase, provided they have conducted a pre-IND/IDE meeting with the FDA. The program excludes clinical trials and emphasizes rapid translation of promising research into clinical application with regulatory readiness. The point of contact for this opportunity is Tony Gover, Ph.D., at the National Institutes of Health.

General Info

Supports developing visual therapeutics through milestone-driven two-phase awards advancing preclinical to clinical readiness.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) View NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

forecast

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health
Office AddressUS
Contacts
Tony Gover Ph.D
contact@example.gov
+1 (555) 000-0000

Full Description

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The purpose of NEI’s Translational Research program 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 three years and will support research that is in the final states of preclinical development with potential for near-term clinical development. 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). Mature efforts that do not require the R61 phase resources may apply directly to the R33 phase. However, evidence of a pre-IND/IDE meeting with the FDA is required to submit an R33 application directly.

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