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

The National Institute of Neurological Disorders and Stroke (NINDS) under the NIH is offering the U44 Small Business Innovation Research (SBIR) Cooperative Agreements for “Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders.” This funding opportunity aims to support small U.S.-based businesses in developing and validating analytical methods for measuring biomarkers relevant to neurological and neuromuscular conditions. With a focus on biomarkers poised to enhance therapeutic development and clinical use, projects funded under this opportunity will work toward validating the accuracy, sensitivity, and specificity of the detection methods for these biomarkers in clinical trials and practice. This program emphasizes the need for a “Plan for Enhancing Diverse Perspectives” (PEDP) to foster inclusivity, with the PEDP being a critical part of both the review and funding decision processes. This funding opportunity supports SBIR Fast-Track applications that propose rigorous biomarker analytical validation for use in clinical or therapeutic settings, focusing on measurable aspects such as accuracy, precision, reportable range, and sensitivity. Projects should specify one or two contexts of use for the biomarker, address existing unmet clinical or research needs, and align with biomarker categories from the NIH Biomarkers, EndpointS, and other Tools (BEST) resources. A PEDP should outline how diverse scientific perspectives and partnerships across institutions or career stages will be integrated. Multidisciplinary teams and multi-site approaches are encouraged, though single-site projects are allowable with justification. Additionally, plans should account for inter-operator and inter-laboratory variability as part of harmonizing detection methods. This cooperative agreement provides funding up to $700,000 per year for Phase I projects (up to 2 years) and $1.5 million per year for Phase II projects (up to 3 years), with a maximum project duration of 4 years for Fast-Track projects. Applicant budgets may also include costs associated with PEDP implementation. Milestones are required to structure go/no-go decision points, and applicants should anticipate close involvement and oversight from NINDS program staff. NINDS recommends that applicants incorporate existing resources such as the NINDS BioSEND repository or other biospecimen repositories to enhance sample sharing and community research impact. Eligible applicants must be U.S.-based small businesses with fewer than 500 employees, and the primary employment of the Principal Investigator must be with the small business at the time of award and throughout the project. Multiple applications from the same organization are permitted, provided that each is scientifically distinct. Benchmarks for Phase I to Phase II transition rates apply, along with commercialization benchmarks for companies with more than 15 prior Phase II awards. A letter of intent, while optional, is encouraged 30 days before the application deadline to assist with the review workload. The application process involves submitting through Grants.gov, the NIH ASSIST system, or institutional solutions, with the NIH eRA Commons system used for application tracking. Key components of the application include the PEDP, a team management plan detailing roles and collaborative workflows, and a project timeline with specific milestones. Applicants must also prepare an intellectual property plan if applicable, and all necessary registrations (SAM, UEI, SBA Company Registry, eRA Commons, and Grants.gov) must be completed well in advance. Applications are due on set cycles, with upcoming deadlines on March 22, 2024, June 21, 2024, and February 21, 2025, among others, all due by 5:00 PM local time. Each application will undergo scientific merit review, advisory council review, and earliest possible start dates range from December 2024 to April 2027, depending on the cycle. The program’s expiration date is June 26, 2026.