NIH Research Evaluation and Commercialization Hubs (REACH) Awards (U01 Clinical Trial Optional)
Funding Agency:
- National Institutes of Health
The NIH Research Evaluation and Commercialization Hub (REACH) program is a partnership program between NIH and the qualifying research institutions to accelerate the creation of small businesses and the transition of discoveries originating from academic research into products that improve patient care and enhance health. REACH Hubs foster the advancement of therapeutics, preventatives, diagnostics, devices, and research tools that address unmet patient and public health needs across the entire NIH mission. Applicants are encouraged to focus on building robust entrepreneurial ecosystems in the areas of highest U.S. burden of disease and disability and areas that historically attract lower levels of private biomedical capital investment.
The new REACH Hubs will build upon lessons learned from previous awardees to transition promising technologies to the next stage of commercialization. Proposed technology development projects should have already advanced from scientific discovery into the early stages of product development. As a guiding principle, proposed technology development projects should be within one or two steps of a commercial transaction (selling, partnering, licensing, startup, or entry into another suitable program to continue development), but require additional validation in order to be considered competitive for a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) award. Although every technology development project is unique, broad guidelines for different types of projects are as follows:
- Small Molecule Therapeutics: The compound is at the lead optimization or preclinical stage. The target is known, and/or there is some method or assay to determine its effect.
- Biologics or Cell Based Therapies: The biologic or cell population has been identified and some reasonable method of development, sourcing, manufacture, or proliferation is proposed. Mechanism of action has been determined to a sufficient level that there is a reasonable understanding of the product to be developed or tested in the project.
- Interventional Medical Device: The proposal includes prototype development and testing, either on the bench or in animals. Physiologic experiments have been conducted or reported in the literature, providing rationale for prototype development.
- Diagnostic Medical Device/IVD/MDx: The proposal includes prototype development and some method of testing.
- Health IT, Software, Apps, and Algorithms: The proposal should be beyond the concept stage and already have an existing code base. The idea should be grounded in previous experiments or solid peer reviewed evidence. The proposal should include steps to validate the technology by demonstrating its efficacy versus the standard of care or utility in pilot studies or user testing, or, if already validated, to refine the technology to make it appropriate for commercialization.
The program aims to strengthen and de-risk technologies toward this goal through a team-based developmental approach that addresses downstream requirements, including but not limited to intellectual property, regulatory, and reimbursement issues, and business case development. It is expected that spinout companies will be in a position to submit strong SBIR and STTR program applications. The Hubs will establish novel partnerships, strengthen existing alliances between stakeholders (including academic, non-profit, and industry sectors), provide entrepreneurial educational opportunities for innovators from diverse backgrounds, and create cultural and systemic changes to more rapidly transform breakthrough innovations into products that will have health, economic, and societal impact.
The maximum budget for a Hub is $1,000,000 total costs per year.
February 09, 2023
Eddie Billingslea, Ph.D., National Institute of General Medical Sciences (NIGMS)Email: eddie.billingslea@nih.gov