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.

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](https://grants.nih.gov/grants/guide/pa-files/PAR-24-096.html).

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 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.

Novel Tools and Devices for Animal Research Facilities and to Support Care of Animal Models (R43/R44 Clinical Trial Not Allowed)

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 development of novel tools and devices to improve animal welfare and support care of animal models in research facilities. The Office of Research Infrastructure Programs (ORIP) is particularly interested in applications from small business concerns (SBCs) for Small Business Innovation Research (SBIR) projects. The goal of this solicitation is to address the issue of poor reproducibility in experiments that use animal models, which has negatively impacted biomedical research. The variation of intrinsic and extrinsic factors that can affect the physiological and biological response of animals has been identified as a source of irreproducibility. Therefore, there is a need for devices that can accurately monitor and control environmental conditions in animal facilities, such as temperature, humidity, vibrations, and ultrasonic noise. Additionally, devices that can identify pathogens, allergens, and other pollutants in animal research environments are desired. Noninvasive or minimally invasive bio-logging devices for real-time monitoring of animal behavior, food/water consumption, and bodily functions are also needed. These devices should be discreet, robust, and easy to apply. Furthermore, tools and devices that can ease the handling and restraining of animals, reduce stress, and improve the efficiency of animal-handling practices and experimental procedures are sought. Connecting diet, environmental conditions, and physiological measurements is also important for understanding the effects of extrinsic factors on experimental outcomes. The solicitation emphasizes that innovation is crucial for designing useful tools and devices. The development and implementation of novel tools and devices, as well as the enhancement of existing equipment, are encouraged. Examples of specific areas of interest include portable software for managing and evaluating animal colonies, noninvasive technology for tracking and monitoring animals, automated feeding systems, devices for drug delivery and measurement, and improved systems for data collection and analysis. The solicitation is open for applications, with multiple due dates throughout the year. The project duration and funding specifics can be found in the solicitation document available at the provided links. Applicants are advised to discuss their projects with the Scientific/Research contacts before submitting an application.

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.

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