Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
ID: PAR-24-096Type: BOTH
Overview

Topic

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2024

Topic Link

https://www.sbir.gov/node/2504559

Additional Information

https://grants.nih.gov/grants/guide/pa-files/PAR-24-096.html
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the clinical validation of a candidate biomarker for neurological or neuromuscular disorders. Biomarkers are indicators of biological processes or responses to interventions, and they play a crucial role in the development of therapeutics and clinical care decisions. This solicitation aims to advance the validation of biomarkers for neurological and neuromuscular disorders through rigorous clinical validation of the biomarker detection method. The research should focus on one or two specified contexts of use and include evidence of preliminary testing and development of the detection method. The funding opportunity uses a cooperative agreement, milestone-driven mechanism, and the results may be used to support submissions to the FDA's Biomarker Qualification program. The application should include a clear study design, statistical design, and timeline, as well as collaborations with relevant experts. Rigor, reproducibility, data sharing, and intellectual property considerations are also emphasized. The funding priority will be given to applications that address unmet medical needs, have a strong biological rationale, and provide a justification for the utility of the biomarker in the clinical setting or clinical trial design.

    Files
    No associated files provided.
    Similar Opportunities
    Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
    Active
    Department of Health and Human Services
    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the clinical validation of a candidate biomarker for neurological or neuromuscular disorders. Biomarkers are indicators of biological processes or responses and are crucial for the development of therapeutics and clinical decision-making. This solicitation aims to advance the validation of biomarkers for neurological and neuromuscular disorders through rigorous clinical validation of the biomarker detection method. The research should focus on one or two specified contexts of use and include evidence of preliminary testing and development of the detection method. The funding opportunity uses a cooperative agreement, milestone-driven mechanism, and supports the optimization and standardization of the detection method. The research should also include a clear study design, statistical design, and a feasible timeline with quantitative annual milestones. Collaboration among scientific investigators, clinical scientists, and other experts is encouraged. The funding opportunity is open until June 23, 2026. For more information, visit the solicitation agency URL: link.
    Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
    Active
    Department of Health and Human Services
    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the analytical validation of a candidate biomarker for neurological or neuromuscular disorders. This solicitation aims to address the gap in biomarker validation by encouraging rigorous analytical validation of the biomarker detection method for one or two specified contexts of use. The research should optimize and standardize the detection method, as well as test the analytic and pre-analytic variables to evaluate and reduce sources of variability when measuring the biomarker. The project duration is from 2024 to 2026, and multiple application due dates are specified. The funding specifics can be found on the grants.nih.gov website.
    Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
    Active
    Department of Health and Human Services
    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the analytical validation of a candidate biomarker for neurological or neuromuscular disorders. This solicitation aims to address the gap in biomarker validation by encouraging rigorous analytical validation of the biomarker detection method for one or two specified contexts of use. The research should optimize and standardize the detection method, as well as test the analytic and pre-analytic variables to evaluate and reduce sources of variability when measuring the biomarker. The project duration is from 2024 to 2026, and multiple application due dates are specified. The funding specifics can be found on the grants.nih.gov website.
    Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)
    Active
    Department of Health and Human Services
    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the Blueprint Neurotherapeutics Network (BPN) program. This program focuses on small molecule drug discovery and development for disorders of the nervous system. The goal is to facilitate drug discovery and development by offering funding to neuroscience researchers for activities that can be conducted in their own laboratories. Researchers have the opportunity to collaborate with NIH-funded consultants and contract research organizations (CROs) specializing in various aspects of drug development. The Principal Investigator (PI) will be responsible for conducting disease- or target-specific assays and models, and can collaborate with BPN contractors on various activities. Each funded project will have a customized Lead Development Team (LDT) consisting of the PI, BPN consultants, and NIH staff. The LDT will establish an overall strategy for the project and coordinate activities across different research sites. The program is open for applications until August 19, 2026, and more information can be found on the grants.gov website.
    Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)
    Active
    Department of Health and Human Services
    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the Blueprint Neurotherapeutics Network (BPN) program. This program focuses on small molecule drug discovery and development for disorders of the nervous system. The goal is to facilitate drug discovery and development by offering funding to neuroscience researchers for activities that can be conducted in their own laboratories. Researchers have the opportunity to collaborate with NIH-funded consultants and contract research organizations (CROs) specializing in various aspects of drug development. The Principal Investigator (PI) will be responsible for conducting disease- or target-specific assays and models, with the option to collaborate with BPN contractors on various activities. Each funded project will have a customized Lead Development Team (LDT) consisting of the PI, BPN consultants, and NIH staff. The LDT will establish an overall strategy for the project and coordinate activities across different research sites. The program is open for applications, with multiple application due dates throughout the year. More information can be found on the grants.gov website.
    NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
    Active
    Department of Health and Human Services
    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required). This solicitation aims to support small business concerns (SBCs) in conducting exploratory clinical trials that contribute to the justification for future trials to establish definitive efficacy. The trials can include Phase 1 and 2 studies of drugs and biologics, feasibility and preliminary efficacy studies of devices, as well as early studies of surgical, behavioral, or rehabilitation therapies. The trials can be single-site or multi-site with up to three clinical sites. The applications must generate data that inform further clinical development of the proposed intervention or diagnostic, and FDA approval is required for FDA-regulated clinical trials. The goal is to advance products/technologies that require federal regulatory approval or bring complex research tools to market. The funding opportunity is open until September 6, 2026. For more information and to apply, visit the solicitation agency URL: link.
    NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
    Active
    Department of Health and Human Services
    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required). This solicitation aims to support small business concerns (SBCs) in conducting exploratory clinical trials that contribute to the justification for future trials to establish definitive efficacy. The trials can include Phase 1 and 2 studies of drugs and biologics, feasibility and preliminary efficacy studies of devices, as well as early studies of surgical, behavioral, or rehabilitation therapies. The trials can be single-site or multi-site with up to three clinical sites. The applications must generate data that inform further clinical development of the proposed intervention or diagnostic, and FDA approval is required for FDA-regulated clinical trials. The goal is to advance products/technologies that require federal regulatory approval or bring complex research tools to market. The funding opportunity is open until September 6, 2026. For more information and to apply, visit the solicitation agency URL: link.
    NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)
    Active
    Department of Health and Human Services
    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required). This solicitation aims to support Small Business Concerns (SBCs) in conducting exploratory clinical trials that contribute to the justification for future trials to establish definitive efficacy. The trials can include Phase 1 and 2 studies of drugs and biologics, feasibility and preliminary efficacy studies of devices, as well as early studies of surgical, behavioral, or rehabilitation therapies. The trials can be single-site or multi-site with up to three clinical sites. The applications must generate data that inform further clinical development of the proposed intervention or diagnostic, and FDA approval is required for FDA-regulated clinical trials. The goal is to advance products/technologies that require Federal regulatory approval or bring complex research tools to market. The solicitation is open until September 6, 2026, and more information can be found at the provided links.
    NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)
    Active
    Department of Health and Human Services
    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required) topic. This solicitation aims to support small business concerns (SBCs) in conducting exploratory clinical trials that contribute to the justification for future trials to establish definitive efficacy. The trials can include Phase 1 and 2 studies of drugs and biologics, feasibility and preliminary efficacy studies of devices, as well as early studies of surgical, behavioral, or rehabilitation therapies. The trials can be single-site or multi-site with up to three clinical sites. The applications must generate data that inform further clinical development of the proposed intervention or diagnostic, and FDA approval is required for FDA-regulated clinical trials. The goal is to advance products/technologies that require federal regulatory approval or bring complex research tools to market. The solicitation is open until September 6, 2026, and more information can be found at the provided links.
    NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
    Active
    Department of Health and Human Services
    The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required). This solicitation encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials, including mechanistic studies associated with clinical trials. The program supports milestone-driven, hypothesis-driven clinical trials related to the research mission of the NIAID that address high-priority research areas. The solicitation encourages high-risk clinical studies, which involve non-routine interventions, administration of unlicensed products, or administration of licensed products for unapproved indications. Mechanistic studies are also encouraged. The funding supports the conduct, completion, and analysis of a single clinical trial, including activities such as training of study personnel, enrollment and recruitment of study subjects, data collection and management, laboratory work, study management and oversight, safety monitoring, and regulatory activities. The project duration is not specified, but the solicitation is open until January 14, 2027. The funding specifics can be found on the grants.nih.gov website.