Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
ID: 351914Type: 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/351914

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-24-098.html
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity for the analytical validation of candidate biomarkers for neurological and neuromuscular disorders through the U44 Clinical Trial Optional Cooperative Agreement mechanism. This initiative aims to support the rigorous validation of analytical methods for biomarker measurements, ensuring compliance with FDA guidelines and addressing critical needs in clinical research. Eligible applicants include U.S. small businesses, with funding amounts of up to $700,000 for Phase I and $1.5 million for Phase II over a maximum of four years. Applications will open on February 22, 2024, and must be submitted by June 25, 2026; for further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-24-098.html
    The National Institutes of Health (NIH) announced a funding opportunity aimed at the analytical validation of candidate biomarkers for neurological and neuromuscular disorders through the U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Fast Track mechanism. The goal is to support rigorous validation methods for biomarkers intended for clinical trials or practice, addressing an unmet need within this research area. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) and describe the robust capabilities and validation processes of their proposed biomarker detection methods. Key dates include an application opening on February 22, 2024, with a subsequent due date for applications. The funding is limited to U.S. small business concerns, with budgets of up to $700,000 for Phase I and $1.5 million for Phase II over a maximum of four years. Emphasis is placed on multi-disciplinary collaboration, leveraging existing resources, and providing clear timelines and milestones. Applications must comply with rigor standards and address potential barriers to implementing the biomarker detection methods within clinical settings. Overall, this opportunity reflects NIH's commitment to advancing public health through improved biomarker validation and inclusivity in research.
    Similar Opportunities
    Clinical 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 for the clinical validation of candidate biomarkers for neurological and neuromuscular disorders through the U44 Cooperative Agreement mechanism. This initiative aims to rigorously validate biomarkers that have already been identified and for which detection methods have been developed, ensuring compliance with FDA guidelines to establish their clinical sensitivity and specificity. This program is crucial for advancing therapeutic development in the field of brain health, with funding potentially reaching $700,000 for Phase I and $1.5 million for Phase II projects. Interested applicants must adhere to specific submission guidelines and deadlines, with the application closing on June 22, 2026. For further information, 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-24-096.html.
    Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through a Cooperative Agreement for the analytical validation of candidate biomarkers aimed at neurological and neuromuscular disorders. This initiative seeks to rigorously validate analytical methods for biomarker measurements, ensuring their accuracy and reproducibility in alignment with FDA guidelines, with a focus on addressing unmet clinical needs and potential applications in clinical trials. The program encourages diverse research teams and collaboration, emphasizing the importance of inclusivity in the research process, and applications are due by June 22, 2026, with funding available for a maximum period of four years. Interested applicants can find more information and guidelines at the NIH Grants website or contact NIH Grants Information at grantsinfo@nih.gov.
    Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)." This initiative aims to support the rigorous analytical validation of methods used to measure biomarkers for neurological and neuromuscular disorders, which are critical for clinical trials and practice. Applicants are required to demonstrate the unmet need for the biomarker(s) and measurement methods, detailing activities such as optimizing accuracy, precision, and establishing quality control procedures across multiple sites. The submission portal opens on January 21, 2025, with applications due by June 22, 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov, and additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-25-050.html.
    Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)." This initiative aims to support the clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders, focusing on establishing their clinical sensitivity and specificity in accordance with FDA guidelines. The program is particularly significant as it seeks to enhance public health outcomes by facilitating the implementation of validated biomarkers in clinical settings, thereby addressing critical healthcare needs in these areas. Interested applicants should note that the application period opens on January 21, 2025, and closes on June 22, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov, and additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-25-055.html.
    Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)" under Funding Opportunity Number PAR-24-097. This initiative aims to clinically validate candidate biomarkers for neurological diseases, focusing on establishing their clinical sensitivity and specificity, provided that preliminary conditions such as detection method development are met. The program emphasizes the importance of multidisciplinary collaborations and requires applicants to include a Plan for Enhancing Diverse Perspectives (PEDP) to promote inclusivity in research teams. Interested applicants must submit their proposals by February 22, 2024, with project durations capped at five years. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov, and additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-24-097.html.
    Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)." This initiative aims to promote the discovery and early evaluation of candidate biomarkers that can facilitate the clinical development of neurotherapeutics and their application in clinical practice, focusing on both animal studies and preliminary human evaluations. The funding is structured as a phased R61/R33 award, where the R61 phase emphasizes proof-of-concept studies using human samples, while the R33 phase focuses on clinical validation for specified uses. Interested applicants, including various educational and community organizations, must submit their proposals by May 7, 2025, and can find additional details and application guidelines at the provided NIH link. For inquiries, applicants can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)
    Active
    National Institutes of Health
    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.
    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.
    Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders through a phased grant mechanism (R61/R33). This funding opportunity aims to enhance the discovery and early evaluation of candidate biomarkers that can facilitate the clinical development of neurotherapeutics and improve clinical care decisions. The initiative emphasizes the importance of multidisciplinary collaboration and requires applicants to validate biomarkers in a phased approach, with the R61 phase focusing on proof of concept studies and the R33 phase on preliminary clinical validation. Interested applicants should note that the application deadline is January 7, 2028, and they can direct inquiries to NIH Grants Information at grantsinfo@nih.gov. For further details, applicants can refer to the full announcement available at https://grants.nih.gov/grants/guide/pa-files/PAR-25-024.html.
    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.