NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)
ID: 358045Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/358045

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-335.html
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity through the NEI Translational Research Program for Therapeutics, aimed at advancing innovative therapies for visual system diseases. This program utilizes a bi-phasic R61/R33 grant mechanism, where the R61 phase supports the refinement of preliminary data, and the R33 phase focuses on advancing promising candidates through FDA regulatory processes leading to Investigational New Drug (IND) applications. The initiative encourages multidisciplinary collaboration among scientists, clinicians, and regulatory experts, with a budget cap of $500,000 for R61 applications and $1,000,000 for R33 applications. Interested applicants must submit their proposals by March 17, 2025, with the program opening for applications on January 16, 2025. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-335-Full-Announcement.html
    PAR-25-335.html
    The National Eye Institute (NEI), under the Department of Health and Human Services, is soliciting proposals for its Translational Research Program targeting innovative therapy development for visual system diseases. The funding opportunity aims to transition preclinical research findings into therapeutic applications, with a bi-phasic R61/R33 approach. The R61 phase supports preliminary data refinement, while the R33 phase focuses on advancing promising candidates through FDA regulatory studies leading to Investigational New Drug (IND) applications. Eligible organizations include educational institutions and nonprofits, among others, with a budget cap of $500,000 for R61 applications and $1,000,000 for R33 applications. The initiative seeks multidisciplinary collaboration among scientists, clinicians, and regulatory experts to explore therapies for conditions like retinal diseases and glaucoma. Applications must conform to strict guidelines, including the establishment of clear milestones, and failure to meet these criteria can result in rejection. Key dates include an application due date of March 17, 2025, opening on January 16, 2025. The program emphasizes diversity among applicants to enhance scientific innovation and effectiveness. This funding opportunity reflects the NEI's commitment to advancing eye health through the development of novel therapeutic solutions.
    Similar Opportunities
    NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NEI Translational Research Program for Therapeutics (Funding Opportunity Number: PAR-25-363), aimed at advancing innovative therapeutic solutions for visual system diseases. This program seeks to support multidisciplinary teams in generating preclinical data that will facilitate the development of treatments leading to FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications, particularly targeting significant ocular disorders such as retinal diseases and glaucoma. With a funding cap of $1 million annually for a maximum of three years, applicants must demonstrate milestone-driven progress in IND/IDE-enabling studies, with applications due by February 16, 2025. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.
    NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) has announced the NEI Translational Research Program for Therapeutics, aimed at accelerating the translation of innovative laboratory research into therapeutics for visual system diseases. This program seeks to fund multidisciplinary teams that can generate preclinical data leading to Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications, with a focus on developing biological, pharmacological, and medical device interventions. The initiative underscores the federal commitment to translating biomedical research into practical therapies, ultimately enhancing patient care in ocular health. Grants of up to $1 million per year are available, with applications due by March 16, 2025. Interested applicants can find more information and contact NIH Grants Information at grantsinfo@nih.gov for inquiries.
    NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled the NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed) aimed at accelerating the translation of innovative laboratory research into therapeutic interventions for visual system diseases. This program employs a bi-phasic, milestone-driven mechanism consisting of an Exploratory (R61) phase lasting up to two years and a Developmental (R33) phase lasting up to three years, focusing on generating preclinical data that supports applications for Investigational New Drug (IND) or Investigational Device Exemption (IDE) submissions to the FDA. The initiative is designed to engage diverse organizations, including historically black colleges, tribal governments, and community-based organizations, to foster collaborative efforts in ocular research, ultimately improving health outcomes through vision research. Interested applicants can find more information and guidelines at the provided link, with a funding ceiling of $500,000 and a submission deadline of March 16, 2025.
    NEI Regenerative Medicine Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NEI Regenerative Medicine Clinical Trial Planning Grant (R34) to support the development of clinical trial protocols aimed at restoring vision through cell regeneration. This grant is designed to fund essential activities such as creating a Manual of Procedures (MOP), obtaining regulatory approvals, and assessing the feasibility of clinical trials that involve regenerative strategies, particularly those utilizing stem cells. The initiative underscores the federal commitment to advancing vision restoration research, with a funding ceiling of $150,000 per year for projects lasting up to two years. Interested applicants, including various educational institutions and organizations, must adhere to strict submission guidelines via Grants.gov, with applications due by May 7, 2025. For further inquiries, applicants can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NEI Clinical Research Study Planning Grant Program (R34), aimed at supporting the development of clinical trial protocols and procedures specifically for eye and vision-related studies. This grant facilitates the preparation of a comprehensive Manual of Procedures (MOP) and allows for preliminary studies to assess recruitment potential, without generating data on intervention effects. Grants may provide up to $150,000 per year for a maximum of two years, with applications due by May 7, 2025. Eligible applicants include a wide range of institutions, including educational, nonprofit, and government entities, and inquiries can be directed to the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    NEI Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U01 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the National Eye Institute (NEI) for cooperative agreements (U01) aimed at supporting early-stage clinical trials that involve greater than minimal risk, specifically targeting interventions for vision disorders. This initiative encourages applications for Phase I or II trials that are backed by strong preliminary data and require compliance with NIH guidelines, including the establishment of a Data Monitoring and Safety Committee (DSMC) for safety oversight. The funding is crucial for advancing research in the screening, diagnosis, prevention, and treatment of vision disorders, with project budgets reflecting actual needs and a maximum project period of five years. Interested applicants can find more information and contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov, with the application deadline set for May 7, 2025.
    NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed) to support the planning and development of clinical vision research studies. This grant program aims to advance knowledge in eye and vision conditions by funding the development of study protocols and manuals, as well as fostering collaborative research efforts, while explicitly prohibiting the generation of data from clinical trials or preclinical studies. Eligible organizations, including educational institutions and nonprofits, can apply for grants of up to $150,000 per year for a maximum of two years, with applications due by January 7, 2028. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the program's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-25-358.html.
    NEI Research Grant for Vision-Related Secondary Data Analysis (R21 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the NEI Research Grant for Vision-Related Secondary Data Analysis (R21 Clinical Trial Not Allowed). This grant aims to support meritorious research projects that utilize existing databases for secondary data analyses related to vision health, with a focus on enhancing statistical methodologies for analyzing vision data. The initiative is crucial for addressing major causes of blindness and improving the understanding of visual system development and function. Eligible applicants include a wide range of institutions, and the total project budget can reach up to $275,000 over two years. Interested parties should submit their applications by October 16, 2027, and can find more information by contacting NIH Grants Information at grantsinfo@nih.gov or visiting the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-25-357.html.
    NEI Collaborative Clinical Vision Research Project: Resource Center Grant (UG1 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the NEI Collaborative Clinical Vision Research Project, specifically for Resource Center Grants (UG1 Clinical Trial Required). This initiative aims to support large-scale clinical trials focused on screening, diagnosing, preventing, or treating vision disorders, with a particular emphasis on evaluating complex interventions and providing essential services for multi-center trials. The NEI seeks to advance vision health through rigorous research, and applications are encouraged from a diverse range of eligible applicants, including various educational institutions and organizations. Interested parties must submit their applications by May 25, 2026, and can find additional information and guidelines at NIH Grants. For inquiries, contact NIH Grants Information at grantsinfo@nih.gov.
    NEI Research Grant for Vision-Related Secondary Data Analysis (R21 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Eye Institute (NEI), is inviting applications for the NEI Research Grant for Vision-Related Secondary Data Analysis (R21), which focuses on funding innovative research projects that utilize existing vision-related datasets for secondary data analyses. This opportunity aims to enhance understanding of vision health issues by encouraging researchers to leverage data from previous clinical trials or epidemiologic studies, while explicitly excluding support for new data collection. Eligible applicants include a wide range of institutions, such as historically black colleges and universities, tribal colleges, and community-based organizations, with a direct cost ceiling of $275,000 for projects lasting up to two years. Interested parties should submit their applications by May 7, 2025, and can direct inquiries to the NIH OER Webmaster at OERWebmaster03@od.nih.gov for further information.