Summary
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.
Eligibility
- For Profit Organizations Other Than Small Businesses
- County Governments
- Other
- Independent School Districts
- Public and State Institutions of Higher Education
- City Or Township Governments
- Native American Tribal Governments Federally Recognized
- Private Institutions of Higher Education
- Nonprofits Having A 501(c)(3) Status With the Irs Other Than Institutions of Higher Education
- Native American Tribal Organizations Other Than Federally Recognized Tribal Governments
- Public and Indian Housing Authorities
- State Governments
- Special District Governments
- Small Businesses
- Nonprofits Non Higher Education Without 501c3
Funding categories
- Health
Official source and attribution
This directory republishes federal opportunity information sourced from Simpler.Grants.gov and Grants.gov. Local Business Ranks is not affiliated with or endorsed by the federal government. Always rely on the official opportunity record for application requirements and changes.
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