NIH Research Evaluation and Commercialization Hub (REACH) Awards

Date/Time: 
05/06/2014, 5:00 PM

The following is a limited submission opportunity from NIH with only ONEapplication per institution will be accepted. If you are interested in applying to this program please email Michelle Wonsey by May 6, 2014.

 

NIH Research Evaluation and Commercialization Hub (REACH) Awards (U01)

 

http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-14-005.html

 

Program Description:

The NIH Research Evaluation and Commercialization Hubs (REACH Hubs) will foster the development of therapeutics, preventatives, diagnostics, devices, and tools that address diseases within the NIH’s mission in a manner consistent with business case development. The work supported by the REACH Hubs may include technical validation, market research, clarifying intellectual property position and strategy, and investigating commercial or business opportunities. A primary outcome of the Hubs will be the translation of promising technologies to the private sector, either through a viable start-up company or licensing opportunity. The Hubs should establish novel partnerships, strengthen existing alliances between stakeholders (including public, private, non-profit, and academic sectors), provide entrepreneurial educational opportunities for innovators, and create cultural and systemic changes to more rapidly move from breakthrough innovations to products that will have health, economic, and societal impact.

 

Background

Although NIH invests billions of dollars a year in biomedical research, which has led to great advances in scientific tools and biological insights, there are barriers to effectively translating basic science discoveries from academia to patient benefit.  These barriers include (1) a gap in funding between basic research discoveries and scientific proof of feasibility or validation studies required to define the product for early stage technology development; (2) a lack of knowledge and understanding by innovators about how new technologies are brought to market; and (3) a lack of access to sufficient technology development and commercialization resources that are required for early stage technology development. This FOA is designed to address these issues by establishing a Phase 0 Proof of Concept Partnership pilot program in accordance with Section 5127 of the 2011 SBIR/STTR Reauthorization Act (P.L. 112-81).

 

REACH Overview

Each Hub will assemble diverse experts in translational and proof of concept research who have the knowledge required to identify and develop promising early stage technologies in order to accelerate their translation into commercial technologies to enhance human health. Each Hub will focus on research 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 specifically address the critical knowledge and funding gaps that hinder the early steps needed to turn novel discoveries into technologies for biomedical advancement and patient care. Each Hub will:

1) Be governed by leadership experienced in translating biomedical technologies from research performing institutions to the commercial market.

2) Develop the necessary collaborations and partnerships to meet the goals of this FOA.

3) Provide infrastructure for soliciting and selecting the most promising technologies predicated on medical need, scientific merit, and commercial potential.

4) Provide the funding, resources and expertise required for early stage technology development.

5) Develop and implement market-focused project management oversight and decision making processes.

6) Provide innovators with skills development, hands-on entrepreneurial experience, educational and networking activities with linkages to local or virtual resources.

7) Implement a plan for transitioning to a self-sustaining structure.

 

Hub leadership must possess the necessary operational, business, and scientific expertise with a documented track record of success in transitioning technologies from the discovery phase to product commercialization. In addition, each Hub is required to demonstrate the core competencies necessary to fulfill the objectives of this FOA, including access to expertise in business plan development, market research, IP protection, regulatory and reimbursement processes, project management, clinical studies, and appropriate domain experts.  REACH will have the ability to support projects that cover various facets of technology development ranging from early stage laboratory-based technology feasibility or validation studies up to early phase clinical testing. The successful REACH applicant will support the development of relevant technologies using a milestone-driven approach to transition technologies from the Hub to the next appropriate source of independent financing or strategic partner with the ultimate goal of commercialization. 

 

An important characteristic of the REACH is the ability to collaborate effectively with entities that possess the resources and expertise required to commercialize technologies developed through the Hub.  A Hub should have a structure that takes into account the full range of technology development expertise and partnerships necessary to facilitate identifying and developing discoveries into technologies that address defined medical and scientific needs. Hubs should consider leveraging and partnering with existing NIH or federal resources as appropriate, including: the NIH Centers for Accelerated Innovations (NCAI) (http://ncai.nhlbi.nih.gov/); Clinical and Translational Science Awards (CTSA) recipients (https://www.ctsacentral.org); Therapeutics for Rare and Neglected Diseases (TRND) (http://www.ncats.nih.gov/research/rare-diseases/trnd/trnd.html); Bridging Interventional Development Gaps (BrIDGs) (http://www.ncats.nih.gov/research/reengineering/bridgs/bridgs.html); Centers for AIDS Research (http://www.niaid.nih.gov/labsandresources/resources/cfar/Pages/default.aspx); Cancer Centers (http://cancercenters.cancer.gov/cancer_centers/); eligible Institutional Development Award (IDeA) program participants including the Centers of Biomedical Research Excellence (COBRE; http://www.nigms.nih.gov/Training/IDeA/pages/COBRE.aspx) and IDeA Networks of Biomedical Research Excellence (INBRE; http://www.nigms.nih.gov/Training/IDeA/pages/INBRE.aspx) Department of Commerce i6 awardees (http://www.eda.gov/challenges/i6/); and appropriate clinical trial networks. Each Hub should establish an infrastructure that will promote this type of leveraged interaction to successfully develop the technologies accepted into the Hub. The cooperative approach outlined in this FOA allows for interactions among successful applicants to promote the development of integrated plans and processes required to conduct product-definition studies that facilitate translation and commercialization.

 

Each Hub must demonstrate access to adequate numbers of technologies of strategic interest to the NIH such that projects not meeting milestones can be discontinued and funds can be rapidly transitioned to another meritorious project.

 

REACH Hubs must provide entrepreneurial educational opportunities to academic investigators about the design and conduct of product definition studies and the commercialization processes required for transitioning a technology out of academic labs to the private sector (either as startup small businesses or licensing opportunities).  Cross-disciplinary (science, business, regulatory, etc.) career development is highly encouraged to achieve the goal of exposing innovators to the myriad processes required to translate discoveries into marketable products. Providing the broader investigator community, including those from traditionally under-represented backgrounds, with access to forums, seminars, workshops and related activities is encouraged.

 

Although not required, participation or planned participation in the National Science Foundation I-Corps Site program will be viewed as a strong component of a comprehensive educational and skills development program. Applicants with established and proveninnovation or entrepreneurial units are encouraged to submit concurrent applications to the I-Corps Site Solicitation (I-Corps will not fund the creation of such an innovation or entrepreneurial unit) (http://www.nsf.gov/funding/pgm_summ.jsp?pims_id=504802) and to submit a summary of their I-Corps Site participation or planned participation and how it fits into their larger education and skills development efforts in part 6 of their Research Strategy (see Section IV.2 Research Plan). Applicants are strongly encouraged to contact the appropriate NSF Program Officer listed in the I-Corps Site Solicitation prior to submitting an I-Corps Site application.

 

Federal funding provided under this FOA for the REACH is not expected to be adequate to fully fund the completion of the high quality work necessary for a technology to exit the Hub.  Hence, it is expected that the Hub will have additional non-federal funding identified at the time of application and committed at the time of award that can augment the federal investment for product definition studies.  Further, it is expected that the REACH will become financially self-sustaining through support from partnering institutions or other financial arrangements that may include agreements with the source institutions allowing for revenue from licensing, milestone payments, royalties, or other mechanisms. 

 

NIH is especially interested in promoting participation of Institutional Development Award (IDeA) states and programs in the REACH Hubs, and encourages applications from eligible IDeA states as well as outreach from non-IDeA based applicants to existing IDeA programs.

 

Sponsor Deadline:

Letter of Intent – May 26, 2014

Full Proposal – June 26, 2014