NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)
ID: 351149Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Small Businesses

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) is inviting applications for the NINDS Exploratory Clinical Trials for Small Business (R43/R44) grant, aimed at supporting small business concerns (SBCs) in conducting exploratory clinical trials related to neurological disorders. This funding opportunity focuses on projects that evaluate drugs, biologics, devices, and various therapeutic strategies, with an emphasis on advancing diagnostics and therapies aligned with the mission of the National Institute of Neurological Disorders and Stroke (NINDS). Eligible applicants must demonstrate plans for future clinical development and include a Plan for Enhancing Diverse Perspectives (PEDP) to promote inclusivity in research. The funding caps are set at $295,924 for Phase I and $1,972,828 for Phase II, with an application deadline of January 5, 2024. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    Files
    Title
    Posted
    The National Institutes of Health (NIH) is soliciting applications through its NINDS Exploratory Clinical Trials for Small Business (R43/R44) funding opportunity, focused on exploratory clinical trials targeting neurological disorders. This funding initiative aims to support Small Business Concerns (SBCs) in advancing diagnostics and therapies relating to the mission of the National Institute of Neurological Disorders and Stroke (NINDS). Eligible projects include studies of drugs, devices, biologics, and various therapeutic strategies. Applications should demonstrate plans for future clinical development, with a requirement to include a Plan for Enhancing Diverse Perspectives (PEDP) to promote inclusivity in research. The funding is structured in phases, with budgets capped at $295,924 for Phase I and $1,972,828 for Phase II. The NIH encourages collaboration with third-party investors to facilitate the commercialization of projects initiated with NIH funding. Key dates include an application due date of January 5, 2024, with a focus on exploratory clinical trials, rather than those designed to establish definitive efficacy. This initiative reflects NIH's commitment to fostering diversity and supporting small businesses in advancing medical innovation.
    Similar Opportunities
    NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)" aimed at supporting Small Business Concerns (SBCs) in conducting investigator-initiated exploratory clinical trials related to neurological disorders. This initiative encourages applications for Phase I and II studies focusing on drugs, biologics, devices, and therapies that align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS), emphasizing the inclusion of a Plan for Enhancing Diverse Perspectives (PEDP) to foster innovation. The maximum funding amounts are $295,924 for Phase I and $1,972,828 for Phase II projects, with applications required to demonstrate readiness for eventual FDA regulatory approval. Interested applicants can begin submitting proposals on December 5, 2023, with the application deadline set for September 5, 2026; for further inquiries, contact NIH Grants Information at grantsinfo@nih.gov.
    NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering NINDS Renewal Awards of Small Business Innovation Research (SBIR) Phase II Grants (Phase IIB) to support clinical trials and clinical research projects focused on neurological disorders. This funding opportunity encourages small business concerns (SBCs) to seek additional funding for projects previously funded by NIH SBIR and STTR Phase II awards, with an emphasis on facilitating the transition of these projects to commercialization through partnerships with third-party investors. The initiative aims to address the "Valley of Death" funding gap in medical biotechnology, particularly for products related to the mission of the National Institute of Neurological Disorders and Stroke (NINDS). Interested applicants must submit a Commercialization Plan and a Plan for Enhancing Diverse Perspectives (PEDP), with the application opening on August 5, 2024, and a closing date of April 5, 2027. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS), is offering a funding opportunity for investigator-initiated exploratory clinical trials under the UG3/UH3 mechanism. This initiative aims to support Phase 1 and Phase 2 clinical trials that address critical questions related to neurological disorders, focusing on studies involving drugs, biologics, devices, and early interventions. The program emphasizes rigorous research design and encourages diverse and innovative research teams, with grants potentially spanning up to five years, beginning with a planning phase before transitioning to execution. Interested applicants can find more information and application details at the provided link, with a submission deadline of March 10, 2025, and no cost-sharing or matching requirement.
    NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) to support pre-clinical research aimed at bridging funding gaps that impede the commercialization of medical biotechnology products. This funding opportunity specifically targets previously funded SBIR or STTR Phase II projects, with the objective of advancing products or technologies that require federal regulatory approval, while fostering partnerships between small businesses and external investors to enhance commercialization prospects. Applicants are encouraged to secure independent third-party funding that equals or exceeds one-third of the requested NINDS funds, and must include a Plan for Enhancing Diverse Perspectives (PEDP) to promote inclusivity in the research environment. The application deadline is April 5, 2027, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. More details can be found in the full announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-24-222.html.
    Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Optional) to support innovative and exploratory research projects in neuroscience. This grant aims to facilitate early-stage studies that assess novel avenues of investigation, particularly those that may involve significant risk but hold the potential for breakthroughs in understanding neuroscience or developing new methodologies. Eligible applicants include a wide range of organizations such as educational institutions, nonprofits, and tribal governments, with funding available up to $200,000 over two years. Interested parties should submit their applications by January 7, 2025, and can find additional information and application guidelines at the NIH website or contact grantsinfo@nih.gov for assistance.
    Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) invites applications for the Blueprint Neurotherapeutics Network (BPN), aimed at supporting small businesses in advancing small molecule drug discovery and development for disorders of the nervous system. This funding opportunity, categorized as a Cooperative Agreement under the U44 Small Business Innovation Research (SBIR) program, encourages applicants to conduct disease-specific assays and collaborate with NIH-funded consultants and contract research organizations to facilitate the transition of promising drug candidates from discovery to clinical testing. The program emphasizes compliance with Good Laboratory and Clinical Practices, rigorous study designs, and diversity in research teams, making it a vital resource for small businesses lacking the necessary infrastructure for clinical development. Applications will be accepted starting January 9, 2024, with a closing date of August 19, 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.
    NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for investigator-initiated efficacy clinical trials through the NINDS Efficacy Clinical Trials (UG3/UH3 Clinical Trial Required) program. This initiative aims to support clinical studies that evaluate drugs, biologics, devices, and various interventions targeting neurological disorders, requiring a phased approach where UG3 planning must precede UH3 execution. The trials must be well-designed with robust scientific rationale and diverse participant inclusion, emphasizing collaboration with patient advocacy groups and national networks. Interested applicants can find more information and application guidelines at the provided NIH link, with a submission deadline of January 9, 2025, and no cost-sharing or matching requirements. For inquiries, contact the NIH OER Webmaster at grantsinfo@nih.gov.
    NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (FON PAR-24-099) aimed at small business concerns proposing investigator-initiated clinical trials that align with the NIAID's research mission. This program supports hypothesis-driven and milestone-driven clinical trials, particularly those classified as high-risk, which may involve unique interventions or the use of licensed products for unapproved indications. The initiative underscores the government's commitment to advancing innovative clinical research to address significant healthcare challenges, with funding of up to $1 million annually available for meritorious applications. Interested applicants must adhere to strict guidelines and submit their applications by the various deadlines, with the first due date on April 12, 2024, and the final deadline on January 13, 2027. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Small Business Transition Grant for New Entrepreneurs (R41/R42 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the Small Business Transition Grant for New Entrepreneurs (R41/R42 Clinical Trial Required) to support early-career scientists transitioning into entrepreneurial roles within small businesses. This funding opportunity aims to facilitate the career development of investigators by providing entrepreneurial training, mentorship, and support for research and development projects that align with NIH's mission to improve health. Eligible small business concerns (SBCs) can apply for Phase I and Fast-Track grants, with funding amounts typically reaching $306,872 for Phase I and $2,045,816 for Phase II awards. Applications will be accepted starting August 5, 2024, with a closing date of April 5, 2027. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-24-134.html.
    Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders," aimed at supporting the rigorous analytical validation of biomarker measurement methods for neurological diseases. This initiative seeks proposals from small businesses to conduct analytical validation, requiring applicants to justify their chosen biomarkers, outline contexts of use, and include a Plan for Enhancing Diverse Perspectives (PEDP) to foster inclusivity in research. Grants are available under U44 Small Business Innovation Research (SBIR) cooperative agreements, with funding amounts up to $700,000 annually for Phase I and up to $1.5 million for Phase II, and applications are due by June 25, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-24-098.html.