Late-Stage Translation of Biomedical and Behavioral Research Results in Arthritis and Musculoskeletal and Skin Diseases from Academic/Non-profit Lab to Marketplace (SBIR [R43/R44] Clinical Trial Not Allowed)

The National Institutes of Health (NIH), specifically through the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), is offering a funding opportunity titled Late-Stage Translation of Biomedical and Behavioral Research Results in Arthritis and Musculoskeletal and Skin Diseases from Academic/Non-profit Lab to Marketplace under the Small Business Innovation Research (SBIR) Grant mechanism, activity codes R43/R44. This grant opportunity aims to support the translation of innovative technologies and therapeutic developments from academic and non-profit research sectors to the marketplace, with a focus on advancing diagnostic and prevention tools or treatments for musculoskeletal, rheumatic, or skin diseases. The funding opportunity is a reissue of PAR-21-030 and reflects updated agency priorities as of March 31, 2025. NIH and NIAMS have heavily invested in developing new technologies through various mechanisms such as R01, R15, R21, R61, P50, and REACH Awards. This funding has led to significant intellectual property in areas like drug candidates, biomarkers, diagnostic tools, and tissue engineering products. However, moving these innovations from lab to commercial products requires close collaboration between academic institutions and small businesses. This FOA supports that transition, emphasizing late-stage pre-clinical research and development necessary for regulatory approval or clinical applicability. Projects must involve partnerships between the original technology developers and small business concerns (SBCs), with clear agreements in place to facilitate technology transfer. The scope of funding includes late-stage pre-clinical studies to evaluate technology feasibility and readiness for regulatory approval or practical clinical use. Acceptable project areas include developing therapies (drugs, biologics, devices, cells, genes, behavioral interventions), innovative drug delivery strategies, biomarker studies, new outcome measures and methodologies, and 3D human tissue models. Clinical trials are not allowed under this FOA, though human subjects research such as sample analysis or subject interviews may be included. The FOA explicitly excludes projects not originating from academic/non-profit labs or those proposing intervention studies. Eligible applicants are United States-based small business concerns meeting specific ownership and operational criteria. Eligible entities must have no more than 500 employees and meet detailed ownership and operational requirements defined by the Small Business Administration (SBA) and NIH. Foreign institutions and foreign components are not eligible. The application types allowed include New (Phase I, Fast-Track), New (SBIR Direct Phase II), Renewal (Phase II), Resubmission (all phases), and Revision. Award budgets can go up to $300,000 for Phase I and up to $2,000,000 for Phase II. Project durations can be up to 1 year for Phase I and up to 3 years for Phase II. Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. All applicants must follow the SBIR/STTR Application Guide and include detailed plans for project milestones and timelines, which should be reflected in a Gantt chart. Required elements include a Data Management and Sharing Plan, certifications for certain ownership structures, and a technology transfer agreement between the academic/non-profit institution and the SBC. Applications are subject to NIH’s rigorous review process, considering factors such as significance, innovation, approach, and environment. Additional review elements include the quality of collaboration between academic/non-profit labs and SBCs. Key dates for this opportunity include multiple annual deadlines: January 5, April 5, and September 5 of each year through September 5, 2025. The earliest open date was December 5, 2022, and the expiration date is September 6, 2025. There is no letter of intent required. The FOA is not subject to intergovernmental review. Contact persons include Dr. Xibin Wang for scientific/research questions (wangx1@mail.nih.gov, 301-451-3884) and Victoria Matthews for financial/grants management questions (victoria.matthews@nih.gov, 301-594-3968). This funding opportunity provides a robust pathway for moving promising academic/non-profit innovations into practical, commercial health solutions.