NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)
ID: 357073Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Small Businesses

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357073

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-133.html
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity titled "NeuroNEXT Small Business Innovation in Clinical Trials," aimed at encouraging small businesses to conduct exploratory clinical trials of investigational agents related to neurological disorders. This initiative seeks applications for Phase II Small Business Innovation Research (SBIR) projects, with a budget of up to $3 million over five years, focusing on trials that align with the strategic plan of the National Institute of Neurological Disorders and Stroke (NINDS). The program is designed to foster public-private partnerships to enhance the development and commercialization of innovative therapies, ultimately improving clinical outcomes in neuroscience research. Interested applicants must adhere to a Community Engagement and Research Inclusion (CERI) plan, with the first application deadline set for January 5, 2025, and additional deadlines throughout 2026 and 2027. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-133.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Stroke (NINDS), has issued a funding opportunity titled "NeuroNEXT Small Business Innovation in Clinical Trials." This initiative encourages small businesses to submit applications for exploratory clinical trials of investigational agents related to neurological disorders, aligned with NINDS's strategic plan. Awardees will leverage the NeuroNEXT infrastructure for trial execution and data coordination. The program accepts Phase II Small Business Innovation Research (SBIR) applications, allowing for a project budget of up to $3 million over a period of five years. Applications must adhere to a Community Engagement and Research Inclusion (CERI) plan. Key deadlines begin with the first application due date set for January 5, 2025, with subsequent deadlines throughout 2026 and 2027. Eligible applicants include U.S.-based small business concerns that are at least 50% owned by U.S. citizens or permanent residents. The program aims to foster public-private partnerships and enhance the development and commercialization of innovative therapies for neurological conditions, ultimately improving clinical outcomes and advancing neuroscience research. Interested parties are encouraged to engage with NINDS representatives for feasibility discussions before submitting their applications.
    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 for Small Business (R43/R44 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for small business concerns (SBCs) through the NINDS Exploratory Clinical Trials program (R43/R44), aimed at supporting investigator-initiated exploratory clinical trials related to neurological disorders. This program invites applications for studies that evaluate drugs, biologics, devices, or therapies, generating preliminary data to inform future clinical development, with a focus on enhancing diverse perspectives within research teams. Eligible U.S.-based SBCs can apply for funding caps of up to $295,924 for Phase I and $1,972,828 for Phase II, with applications due by September 5, 2026. For further inquiries, applicants 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-23-311.html.
    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.
    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 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 align with NINDS's mission, focusing on innovative approaches to evaluate drugs, devices, and interventions for neurological disorders. The funding is structured as a cooperative agreement with a maximum support period of five years, where the UG3 phase lasts up to two years, followed by a potential transition to the UH3 phase for executing clinical trials. Interested applicants should note that the application process opens on January 10, 2025, with a submission deadline of March 11, 2025. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    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.
    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.
    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.
    Blueprint Neurotherapeutics Network (BPN): Biologic-based 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) is offering a funding opportunity through the Blueprint Neurotherapeutics Network (BPN) for Biologics, aimed at supporting biologic-based drug discovery and development for disorders of the nervous system. This initiative invites applications from U.S.-based small businesses to develop diverse therapeutic modalities, including antibodies and gene therapies, with a focus on specific nervous system disorders and a requirement for preliminary data demonstrating efficacy. The program emphasizes a phased, milestone-driven cooperative agreement, facilitating the transition of promising biotherapeutics from lead optimization to first-in-human trials while ensuring regulatory compliance and effective intellectual property management. Applications are due by January 2025, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. More details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-24-294.html.