The National Institute of Neurological Disorders and Stroke (NINDS) is accepting applications for PAR-25-024, Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional).
Deadline: October 20, 2026 at 5:00 PM local time of the applicant organization. The NOFO remains active through January 8, 2028, with additional listed receipt dates in 2027.
Funding: application budgets are not capped but must reflect the actual needs of the project. The R61 phase may last one to three years and the R33 phase one to three years, with a combined project period of no more than five years. Cost sharing is not required.
Eligibility: eligible applicants include public and private institutions of higher education, nonprofits, small businesses and other for-profit organizations, state and local governments, tribal entities, eligible federal agencies, independent school districts, public housing authorities, faith- and community-based organizations, and regional organizations. Foreign organizations and non-U.S. components of U.S. organizations are not eligible. UAMS is eligible as an Arkansas public institution of higher education.
Program scope: this phased mechanism supports proof-of-concept development followed by preliminary clinical validation of candidate biomarkers or composite biomarker signatures for neurological or neuromuscular disorders within the NINDS mission. Biomarker modalities may include genomic, transcriptomic, proteomic, histologic, metabolomic, imaging, behavioral, physiologic and digital measures. The R61 phase must use human clinical samples, tissues and/or data and establish construct validity plus a standardized detection approach; the R33 phase tests preliminary clinical utility for one or two defined Contexts of Use. Quantitative Go/No-Go milestones are required for transition to R33.
Key application requirements: applicants must explain the unmet need, biological rationale, proposed Context of Use, study design, detection method, preliminary analytical performance, and how the result would inform individual-level clinical-trial or clinical-care decisions. The application must include a one- to two-page Timeline and Proposed Milestones section with quantitative transition criteria. An intellectual-property strategy is expected unless the products will be open source, and academic applicants should include a technology-transfer letter of support when applicable.
Arkansas / Atlas fit: UAMS has an unusually relevant movement-disorders pathway through its Virmani Gait Laboratory, which studies objective motor and non-motor measures in Parkinson’s disease, predictive algorithms for disease progression, rural telehealth participation, and validated objective assessments for home monitoring of neurodegenerative disease. N9+ has a conditional role where structured remote physical-examination observations, physiologic/vital-sign data, or other digitally captured measures are scientifically justified as part of a candidate or composite neurological biomarker and are rigorously validated for a defined Context of Use. N9+ should not be presented as a stand-alone equipment purchase or as an already validated biomarker.
Dr. Miltie falls within an organizationally eligible for-profit class, but Atlas has not independently verified the candidate biomarker, neurological dataset, clinical-validation program, or research infrastructure needed for a defensible direct application. A UAMS-led research collaboration or technology/data-acquisition role is the more realistic pathway unless those scientific gates are independently established.
Applications may be submitted through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution, with eRA Commons used for tracking. NIH lists Carol Taylor-Burds, Ph.D., NINDS, 301-496-1779, as the scientific/research contact and strongly encourages pre-application consultation.