Bioengineering Partnerships with Industry (U01 Clinical Trial Optional)
Funding Agency:
- National Institutes of Health
The primary objective of this NOFO is to support Bioengineering Partnerships with Industry (BPI) to: 1) establish a robust engineering solution to a problem in biomedical research or the practice of medicine; 2) develop a strategic alliance of multi-disciplinary partners, one of which must be an industrial partner, based on a well-defined leadership plan; and 3) realize a specific endpoint and deliverables within 5-10 years based on a detailed plan with a timeline and quantitative milestones.
A distinguishing feature of this NOFO will be the requirement of an appropriate academic-industrial partnership: a strategic alliance of academic and industrial investigators who work together as partners to identify and translate a technological solution to advance human health. These partnerships are expected to solidify pre-existing collaborations or spur the creation of new collaborations to drive the fields of bioengineering and biomedical imaging further than if they had not been formed.
Achieving the goal of the BPI program will likely require leveraging the expertise of engineering and the life, physical, or computational sciences. Engaging clinical researchers or clinician scientists in the relevant biomedical fields, when appropriate, is strongly encouraged, although not required.
Scope of the Program
Projects proposed in response to this NOFO must propose to accelerate the development and adoption of promising, integrative, and quantitative bioengineering tools and technologies as robust, well-characterized solutions that can address an important and unmet biomedical need. Projects may span the development in the research settings, validation, translation into clinical settings as needed, and incorporation of these solutions as endpoints into research protocols to enhance our understanding of life science processes or the practice of medicine to benefit patients.
Funding may be requested to develop, adapt, enhance, optimize, validate, or otherwise accelerate the adoption of promising biomedical engineering solutions, but not for support of commercial production or later stage (Phase II or Phase III) clinical trials.
A project may bring together new or existing technologies to form creative and practical solutions that have the potential to be widely adopted and improve human health. To deliver practical solutions within the time-frame of 5-10 years, applicants are encouraged to use a design-directed research strategy with well-defined end goals and intermediate, quantitative milestones. Goals may include, but are not limited to, establishing proof of concept, pre-commercial prototype production, licensure, release of software packages, designs, or models, demonstrating the biological effectiveness of engineered constructs, elucidating the structural and functional relevance of biomolecules or tissues, first-in-human testing, or starting the investigational device exemption or investigational new drug process.
Key to this NOFO is the required partnership with industry, which typically consists of partners from multiple institutions or multiple departments from the same institution and industrial partners, with each partner bringing critical strengths to the project. Both the academic and industrial partners are expected to provide substantive contributions to the intellectual or technical aspects of the project. The roles of the industrial partner(s) should be clearly differentiated from team members who supply necessary but not unique components for the project. The team may require experience in technology development, appropriate model systems for validation, human factors research, regulatory approval, project management or commercialization to realize and disseminate a robust solution. Potential beneficiaries should be active participants in the partnership from the beginning, to provide assurance that proposed solutions will meet community needs. Partnerships with companies and industrial partners that have relevant expertise or may eventually engage in future commercialization or with organizations that can test and disseminate technologies are encouraged.
To be responsive to this FOA, application must include an academic-industrial partnership. Applications that do not include an academic-industrial partnership will not go forward to peer review. Additionally, projects must be consistent with the mission of one or more of the NIH Institutes or Centers (ICs) participating in this NOFO. Investigators are strongly encouraged to contact the Scientific/Research contacts identified in this NOFO to discuss the scope and relevance of their proposed project and guidance on the development of appropriate goals and milestones.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
January 28, 2025; May 28, 2025
Guoying Liu, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone:301-594-5220
Email: liug@mail.nih.gov
Leonid Tsap, Ph.D.
National Institute on Aging (NIA)
Phone: 301-402-7747
Email: tsapl@mail.nih.gov