Notice Number: NOT-OD-19-033
Key Dates
Release Date: November 20, 2018Estimated Publication Date of Funding Opportunity Announcement: December 15, 2018
First Estimated Application Due Date: March 15, 2019
Earliest Estimated Award Date: August 15, 2019
Earliest Estimated Start Date: September 15, 2019
Related Announcements
RFA-OD-14-005
RFA-OD-19-014
Issued by
National Institutes of Health (NIH)
Purpose
The National Institutes of Health (NIH) intends to publish a Funding Opportunity Announcement (FOA) to establish 5 new awards for the Research Evaluation and Commercialization Hubs (REACH) program to address the problems that hinder the critical, early steps necessary to translate novel scientific advances and discoveries into commercially viable diagnostics, devices, therapeutics, and tools that improve patient care and advance public health. The five awardees will participate in a technology development consortium that incorporates best practices from current pilot programs and fulfills the objectives of the Phase 0 Proof of Concept Partnership pilot program, in accordance with Section 5127 of the 2011 SBIR/STTR Reauthorization Act (P.L. 112-81) and reauthorized through FY 2022 within H.R. 5515 Sec 854. The REACH program advances FY2020 Administration Research and Development Budget Priorities, including educating and training a workforce for the 21stcentury economy, transferring technology from the laboratory to the marketplace, and partnering with industry and academia to advance the R&D enterprise.
The REACH program will not support hypothesis-driven, basic science research. Rather, the REACH hubs will nurture the development of early-stage technologies that address high priority areas of unmet medical by (1) scouting for promising biomedical projects; (2) conducting scientific and business reviews by life science experts; (3) funding projects with up to $200,000 (50% federal funds and 50% matching funds) and providing industry-experienced project managers; (4) delivering product development and entrepreneurship training catalyzing professional development; and (5) developing, strengthening and promoting sustainable partnerships with industry and the private sector such as accelerators/incubators, and other sources of private funding and intellectual capital required to accelerate technology transfer and development. In addition, the hubs are expected to leverage and partner with existing NIH or other federal resources and non-federal resources such as EDA’s Regional Innovation Strategies (RIS) Program i6 Challenge, NSF Innovation Corps (I-Corps ), SBA Growth Accelerators, NCI-designated Cancer Centers, NIAID Centers for AIDS Research (CFAR), 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, IDeA Networks of Biomedical Research Excellence (INBRE), and Centers of Biomedical Research Excellence (COBRE); current NIH Centers for Accelerated Innovations (NCAI) and REACH, and the Coulter Translational Partnership Award in Biomedical Engineering (TP). Funding for each project is tied to milestones that advance the technology toward a viable product, facilitating an innovative succeed (or fail) fast model that is nimbler than traditional grant funding models. During development, the hubs will also provide access to resources for marketing, business strategy, regulatory planning, and identifying strategic partners and investors. Hands-on educational activities, including entrepreneurial education programs and coaching by seasoned industry veterans is intended to improve the ability of innovators to develop their business plans and pitch their technologies to investors to attract partners for continued development following their period of federal support. The program is intended to create cultural and systemic changes by providing the necessary resources to proactively and rapidly move from breakthrough innovations to products that will have health, economic, and societal impact. This Notice is provided to allow prospective applicants time to consider the REACH Program and develop essential collaborations and plans prior to submitting an application in response to the published FOA.
The FOA is expected to be published in the NIH Guide for Grants and Contracts in December 2018 with an expected application due date in March 2019. The FOA will utilize the U01 funding mechanism, which is a cooperative agreement that requires significant interaction between the awardees and the NIH staff.Research Initiative Details
1. Each hub should systematically solicit, select, and support technology development projects that address a disease or conditions that (a) create a high burden on the US healthcare system or (b) address a disease or conditions that do not have an apparent broad commercial market, but compelling reasons exist for continued development (e.g., targets a rare disease; environmental exposures and related health effects).
2. Each hub should provide up to $200,000 for individual technology development projects to conduct feasibility studies or develop prototypes. The REACH hub will be expected to support each project with a maximum of $100,000 from the NIH award and an equal match from non-federal sources (e.g., recipient institutions, foundations, for-profit investors, other state resources). REACH hubs should advance technologies to a stage suitable to continue product development in the private sector (e.g., spinning out a small business to continue development, licensing to a for-profit or not-for-profit entity, or securing additional non-federal funding to continue product development).
3. Each hub should provide access to expertise and mentoring related to:
- product development
- business development
- entrepreneurship
- regulatory submission, evaluation, and review
- market and commercial evaluation
- intellectual property protection
- pre-clinical and clinical studies
4. Each hub should use project management processes that enable continuous assessment of the progress of the feasibility studies relative to established milestones in order to make strategic decisions regarding each project (e.g., discontinue a failing project early (quick kill), direct a project to additional sources of support (e.g., disease advocacy organization), or provide additional resources.
5. Each hub should train and mentor innovators to allow them to assess the medical and commercial potential of their research by bringing together experienced entrepreneurs and scientists and by providing connections between the businesses, industries, and research performing institutions. Furthermore, a hub would provide 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.
6. Each hub is expected to expand the participation of women and individuals from underrepresented groups in innovation, technology translation, and entrepreneurship and include graduate students and post-docs.
In summary, the REACH program will support hubs that create an ecosystem to benefit public health by identifying, accelerating, and increasing the number of highly innovative scientific discoveries relevant to US disease burden that are translated into marketable products designed to extend healthy life and to reduce the burdens of illness and disability. The program is structured to create public-private partnerships with an integrated environment of resources (funding, knowledge, expertise) and the culture needed for sustained technology development.
Funding Information
Estimated Total Funding Up to $1,000,000 per hub per year for up to 4 years
Expected Number of Awards 5
Estimated Award Ceiling $1,000,000 per year total costs for no more than 4 years
Primary CFDA Numbers TBD
Anticipated Eligible Organizations
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Applicants must be a university or other research institution that participates in the NIH STTR program. Participation means that a university or other research institution has been a formal partner to a small business on an STTR grant. Many NIH-supported universities or other research institutions will be eligible. Please contact the Scientific staff listed below for clarification.
Non-eligible Organizations
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
- Non-domestic (non-U.S.) components of U.S. Organizations
- Businesses are not eligible to serve as the primary applicant organization
- Current NCAI and REACH awardees are not eligible to serve as the primary applicant organization
- Government entities
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
Dr Kathleen Rousche
National Heart, Lung, and Blood Institute (NHLBI)
Scientific Program Manager
Kathleen.rousche@nih.gov
and Human Services (HHS)
