Internal Deadline: Closed.
External Deadline: February 9, 2023
Award Type: Cooperative Agreement
Estimated Number of Awards: 5
Anticipated Award Amount: $20,000,000
Who May Serve as PI: Standard NIH requirements.
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the USC Research and Innovation (R&I) Application Portal: https://rii.usc.edu/oor-portal/.
Materials to submit include:
- (1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
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.
Objectives and Requirements for this FOA
Each Hub will assemble a diverse group of experts in biomedical product development and will have the expertise to identify and source technology development projects that have progressed to a point where a potential commercial product can be envisioned, but additional research and development efforts are required to define the product (demonstrate feasibility and proof-of-concept). Through a combination of in-house efforts and collaboration, each Hub funded under this FOA will perform functions to address the critical knowledge and funding gaps that hinder the early steps needed to turn novel discoveries into products with health, economic, and societal impact. The work supported by the REACH Hubs should include technical validation, facilitating business development opportunities, clarifying intellectual property and identifying barriers to entry, performing market research (including market needs and competitive advantages), and clarifying regulatory, manufacturing, clinical, or payer requirements.
Hubs must meet all the following requirements:
1) Hub Leadership: Be governed by leadership with a documented track record of success in biomedical product development.
2) Collaborations and Partnerships: Develop the necessary collaborations and partnerships with stakeholders (including academic, non-profit, and industry sectors) to meet the goals of this FOA. Each Hub is expected to partner with existing federal government resources, including those within the Hub’s ecosystem, as appropriate, such as: EDA’s Build to Scale (B2S), NSF’s Regional Innovation Engines, Innovation Corps (I-Corps™) and the National Innovation Network; SBA Growth Accelerators, SBA Federal and State Technology (FAST) Awardees, NCATS Clinical and Translational Science Awards (CTSA), NIBIB’s Concept to Clinic: Commercializing Innovation Program (C3i) and Point-of-Care Technologies Research Network (POCTRN); NIGMS’ Regional Technology Transfer Accelerator Hubs for IDeA States and IDeA Regional Entrepreneurship Development Program (I-RED), IDeA Networks of Biomedical Research Excellence (INBRE), IDeA Networks for Clinical and Translational Research (IDeA-CTR), and Centers of Biomedical Research Excellence (COBRE); NIH Centers for Accelerated Innovations (NCAI) and REACH, and the Coulter Translational Partnership Award in Biomedical Engineering (TP) or other appropriate programs identified by the Hub.
Hubs are strongly encouraged to partner with several educational institutions, particularly those that are Minority Serving Institutions [including but not limited to Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and/or Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)], those institutions that have not been major recipients of past NIH support, and/or institutions in IDeA states.
This FOA encourages cost matching. Each Hub is encouraged to have identified at the time of application and committed at the time of award a minimum of $250,000/year of matching funds to augment the federal investment for product definition studies. Matching funds can originate from any non-federal source (e.g., awardee institution, foundations, for-profit investors, state or local economic development resources).
3) Regional and Local Impact: Make a unique impact on small business development, entrepreneurial culture, workforce diversity, and health disparities. Hubs should serve innovators from diverse backgrounds (see Notice of NIH’s Interest in Diversity) or meet pressing local or regional needs in areas such as economic development, entrepreneurial education, research funding, disease burden, and health disparities.
4) Technology Development: Demonstrate the ability to support technology development ranging from early-stage laboratory-based technology feasibility through pre-clinical testing for technologies across the breadth of the NIH mission. Hubs must provide infrastructure to solicit, evaluate, and select the most promising technology opportunities with health, economic, and societal impact that otherwise would not receive support for early-stage proof-of-concept work. In addition to supporting technology development projects from innovators within the Hub’s partner institutions, each Hub should develop and implement efficient strategies to support technology development projects from innovators at other institutions within their research and development ecosystem. The budget of any technology development project can utilize a maximum of $100,000 from the REACH award, with the balance coming from the Hub’s matching funds. It is expected that Hubs will be continuously developing 4 – 6 technologies each year.
5) Project Management: Develop and implement milestone-driven, market-focused project management oversight and decision-making processes. Each Hub should use project management processes that enable continuous assessment of progress relative to established milestones in order to make strategic decisions regarding the support of each technology development project (e.g., discontinue a failing project early, pivot to a new application, or provide additional resources). Hubs are expected to provide agile management to assemble a package of resources and services tailored to each technology development project. Hubs are strongly encouraged to utilize project managers with formal project management training and/or biomedical industry experience. Salary support for the project manager is considered to be part of the direct cost of each technology development project. The Hubs should leverage best practices from current pilot programs and any other relevant program to promote and facilitate the open exchange of information regarding the scope, methods, analysis, results, and lessons learned from each technology development project.
6) Educational Activities: Provide innovators from diverse backgrounds, including innovators from underrepresented groups access to skills development, hands-on entrepreneurial experience, and educational and networking activities. Each Hub must provide entrepreneurial educational opportunities to academic investigators at all career levels about the design and conduct of technology development projects and the commercialization processes required for transition promising technologies to the next stage of commercialization (e.g., additional financing, spinout company development, or university licensing). The Hub should catalyze professional development by:
- Training innovators to assess the commercial potential of their research discoveries and to develop comprehensive product development plans
- Bringing together experienced entrepreneurs and scientists to provide guidance and mentoring
- Providing the broader investigator community with access to forums, seminars, workshops, and related activities
- Providing connections between research performing institutions and life science businesses, industries, and sources of private capital
- Providing focused entrepreneur support and “hands-on learning” targeted at the needs of the innovator, so that scientists have the opportunity to engage in entrepreneurial activities. Cross-disciplinary (science, business, regulatory, reimbursement, etc.) career development is highly encouraged to achieve the goal of exposing innovators to the myriad processes required to translate discoveries into marketable products.
Applicants are encouraged to review examples of Healthcare Commercialization Programs, which are designed to teach innovators to identify valuable product opportunities resulting from academic research, and gain entrepreneurial skills through stakeholder discovery and guidance from development experts.
7) Sustainability Plan: Develop and implement a plan for ensuring that the capacity developed under their REACH award will be sustained at their institutions, including assimilation into existing or new innovation management strategies, academic entrepreneurship support functions, technology transfer or commercialization offices, and other supportive programs and policies at their institutions.
Each Hub should demonstrate the core competencies necessary to fulfill all the objectives of this FOA.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.