Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional)
ID: 356874Type: 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/356874

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-024.html
Timeline
    Description

    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.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-024.html
    The National Institutes of Health (NIH) invites applications for the Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders under the phased award mechanism (R61/R33). This funding opportunity aims to enhance the development of candidate biomarkers that can improve the efficiency of clinical trials and clinical care decisions. Applicants are expected to validate biomarkers in a phased manner: the R61 phase focuses on proof of concept studies to confirm their potential, while the R33 phase conducts preliminary clinical validation concerning specific contexts of use. The application requires a detailed plan for enhancing diverse perspectives and the submission of pre-defined milestones for assessment. Key dates for submissions span from January 2025 to 2027, with budgets reflecting project needs and a total project duration of up to five years. The funding opportunity emphasizes multidisciplinary team collaboration and the importance of leveraging existing NIH resources. NIH seeks to support innovative biomarker research that addresses critical clinical needs within neurological disorders, thereby contributing to advancements in therapeutic development and healthcare quality.
    Similar Opportunities
    Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)
    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.
    Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
    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)
    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.
    Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
    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)
    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)
    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 (U44 Clinical Trial Optional)
    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)
    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.
    Innovation Grants to Nurture Initial Translational Efforts (IGNITE): Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Innovation Grants to Nurture Initial Translational Efforts (IGNITE)" aimed at developing and validating model systems for neurotherapeutic discovery. This initiative encourages proposals for animal models or ex vivo systems that accurately replicate the characteristics of specific neurological or neuromuscular disorders, with the goal of enhancing the translational relevance of these models to improve drug development processes. The program utilizes a phased award mechanism (R61/R33) and requires collaboration with clinical experts, along with a Plan for Enhancing Diverse Perspectives (PEDP) to promote inclusivity in research. The total funding available is $750,000 over three years, with a maximum of $499,000 in direct costs per year. Key submission dates begin with the earliest application due date of January 18, 2025. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Translational Neural Devices (R61/R33 - Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Translational Neural Devices (R61/R33 - Clinical Trial Optional)" aimed at advancing the development of therapeutic and diagnostic devices for neurological and neuromuscular disorders. This initiative encourages investigators to engage in translational activities and small clinical studies, focusing on the implementation of clinical prototype devices, non-clinical safety and efficacy testing, and obtaining necessary regulatory approvals for clinical trials. The program emphasizes a milestone-driven approach, requiring collaboration with NIH staff throughout the project, and aims to address health disparities in neurological health. Interested applicants, including various educational and community organizations, must submit their proposals by January 28, 2027, and can find additional information and application guidelines at NIH Grants.