Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
ID: 351915Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351915

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-24-097.html
Timeline
    Description

    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 the cooperative agreement funding instrument. This initiative aims to rigorously validate candidate biomarkers for neurological diseases, requiring applicants to demonstrate previously identified biomarkers and validated detection methods, while also emphasizing the importance of diverse participation through a Plan for Enhancing Diverse Perspectives (PEDP). The funding opportunity is crucial for bridging research gaps and improving therapeutic development for neurological conditions, with applications due by February 22, 2024, and a project duration of up to five years. 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-24-097.html.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-24-097.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH), has issued a Notice of Funding Opportunity (NOFO) for the clinical validation of candidate biomarkers related to neurological and neuromuscular disorders. This initiative, numbered PAR-24-097, seeks to rigorously establish the clinical sensitivity and specificity of identified biomarkers as per FDA guidelines. Applications must demonstrate previously identified candidate biomarkers and validated detection methods, alongside the necessity for diverse participation in research teams, emphasized through a required Plan for Enhancing Diverse Perspectives (PEDP). Eligible entities include various educational institutions and non-profit organizations, with no funding limitations noted but budgets should align with the project scope, up to five years in duration. Key deadlines commence from February 22, 2024, for applications, with mandatory inclusion of yearly milestones and plans for data sharing. The review process will prioritize applications addressing unmet medical needs, supported by strong biological rationale, and aiming to enhance inclusivity in research. This funding opportunity aims to bridge significant gaps in research, ultimately improving therapeutic development and clinical practices for various neurological conditions.
    Similar Opportunities
    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 (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) 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.
    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.
    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.
    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.
    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.
    Analytical and Clinical Validation of Biomarkers for Alzheimers Disease (AD) and AD-Related Dementias (ADRD)?(U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Analytical and Clinical Validation of Biomarkers for Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD)" (PAR-23-258), aimed at supporting the validation of biomarkers to enhance therapy development and clinical practices. This initiative seeks applications that focus on achieving rigorous analytical and clinical validation of biomarkers, aligning with the standards set by the FDA’s Biomarker Qualification Program. The program is crucial for advancing research strategies that validate candidate biomarkers across diverse populations, thereby facilitating their use in clinical trials and medical product development. Interested applicants, including various educational and community organizations, must submit their proposals by March 6, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    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.
    Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System," aimed at supporting the development of biologic therapies for nervous and neuromuscular disorders. This initiative is structured as a cooperative agreement, divided into two phases: UG3 for lead optimization and UH3 for IND-enabling activities, with a focus on specific treatment applications for these disorders. The program encourages collaboration with NIH resources, including access to contract research organizations and experienced consultants, to facilitate the development of innovative therapies. Interested applicants, including higher education institutions and nonprofits, are encouraged to apply by August 18, 2027, and can find more information at the provided NIH grants link or contact NIH Grants Information at grantsinfo@nih.gov.