Bioengineering Partnerships with Industry (U01 Clinical Trial Optional)

The NIH’s Bioengineering Partnerships with Industry (BPI) U01 grant opportunity seeks to accelerate the development and deployment of bioengineering technologies and tools to address unmet biomedical needs. This Funding Opportunity Announcement (FOA), a reissue of PAR-22-123, aims to support partnerships between academic and industrial entities. These partnerships are expected to drive innovation and produce well-characterized, practical solutions for advancing biomedical science and healthcare applications within a 5-10 year timeframe. Importantly, the BPI encourages the creation of new collaborations or the solidification of existing ones, with a required involvement of at least one industrial partner for each project. The FOA’s main objectives are to establish multidisciplinary partnerships that apply bioengineering approaches to real-world biomedical issues, including tool development, technology validation, and clinical integration when applicable. The program supports a range of projects involving engineering and life, physical, or computational sciences. Suggested areas of technological focus include biomedical imaging, biomaterials, biosensors, nanotechnology, bioinformatics, molecular and cellular imaging, organ and body imaging, disease screening, and surgical technology. Additionally, the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Cancer Institute (NCI), National Institute on Aging (NIA), and National Eye Institute (NEI) each have distinct research areas of interest aligned with this program’s goals, and applicants are encouraged to consult specific Institute contacts to ensure alignment with their proposal. The BPI grant requires projects to demonstrate a design-directed research approach, including clear end goals and intermediate milestones with quantitative benchmarks. Supported activities may span technology adaptation, enhancement, optimization, and validation but should avoid commercial production or late-phase clinical trials (Phases II or III). Eligible projects may involve technologies like prototype production, diagnostic tools, device validation, data systems, or the development of clinically useful biomarkers. Substantive contributions from industrial partners are critical, and applicants must differentiate the roles of all partners within their project proposals. A strong leadership plan detailing team organization, conflict resolution, communication plans, and data-sharing agreements is required to ensure productive collaboration. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state and local governments, tribal organizations, foreign institutions, and independent school districts. An essential eligibility criterion is the establishment of an academic-industrial partnership. All applicants must complete registrations with SAM, NCAGE, UEI, eRA Commons, and Grants.gov, which may take over six weeks, thus early initiation is advised. Applications requesting $500,000 or more in direct costs in any single year are required to contact NIH Scientific/Research staff six weeks before submission. Reviewers will assess applications based on three main criteria: the significance of the proposed research, rigor and feasibility, and the expertise and resources of the project team. Evaluation factors will include the project's ability to address a biomedical challenge, the innovation and potential for widespread adoption of the technology, and the collaborative strength between academic and industrial partners. Projects must include quantitative success criteria in their milestones and demonstrate an achievable timeline. An independent panel will review applications, which will compete for funding based on scientific merit, available funds, and alignment with NIH priorities. Applicants are required to submit a detailed data-sharing plan and a strategy for resource dissemination, covering the sharing of raw data, techniques, and technologies. The NIH expects recipients to share data in a way that enables reproducibility and transparency across research communities. The application process requires electronic submission through Grants.gov and adherence to the Research (R) Instructions in the NIH Application Guide. Any missing components, including a clearly defined academic-industrial partnership, may render the application non-compliant, excluding it from peer review. Key deadlines begin on January 28, 2025, with subsequent deadlines every May and January until the program’s expiration on September 8, 2027. The earliest start dates for awarded projects are in December of each review cycle. For additional support, NIH provides contacts for scientific inquiries, submission support, and technical assistance through their grants management contacts listed in the FOA.