Limited Competition: IDeA Regional Entrepreneurship Development (I-RED) Program (STTR) (UT2 Clinical Trial Not Allowed)

Background The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, also known as America’s seed fund, support US-owned and operated small businesses to engage in federal research and development that has a strong potential for commercialization. NIH’s SBIR and STTR programs invest over 1.2 billion dollars into health and life science companies that create innovative technologies that align with NIH’s mission to improve health and save lives. Specifically, the STTR program encourages public-private partnerships by funding cooperative research and development conducted jointly by start-up companies in early-stage technology and research institutions. Among other activities, the STTR program funds the systematic application of knowledge toward the production of useful materials, devices, and systems or methods. The IDeA program is a congressionally mandated program that builds research capacity in states that historically have had low levels of NIH funding. It supports basic, clinical, and translational research, faculty development, and infrastructure improvements. There are 24 IDeA-eligible jurisdictions located in four geographic regions: Northeast (Delaware, Maine, New Hampshire, Rhode Island, and Vermont); Southeast (Arkansas, Kentucky, Louisiana, Mississippi, Puerto Rico, South Carolina, and West Virginia); Central (Kansas, Nebraska, North Dakota, Oklahoma, and South Dakota); and West (Alaska, Idaho, Hawaii, Montana, New Mexico, Nevada, and Wyoming). These states and territory, collectively known as IDeA states, submit a low number of SBIR/STTR grant applications to the NIH and consequently receive a similarly low number of awards. NIH is strongly interested in strengthening IDeA states’ participation in the SBIR/STTR programs. Recognizing the inequality in SBIR/STTR awards within IDeA states in the 2012 Defense Authorization Act (P.L. 112-81), this 2012 Act requires agency program coordination to better support IDeA states through the SBIR/STTR program (Div. E, Title LI, Sec. 5168, codified at 15 USC 638 note). The SBIR/STTR program was reauthorized through FY 2022 by the National Defense Authorization Act for FY 2017 (P.L. 114- 328). In response to this Congressional directive, NIGMS held a workshop in 2014, entitled “Finding Ways to Foster SBIR/STTR Applicants from IDeA States”, to identify approaches that would provide the most impact in increasing the participation of IDeA states in NIH SBIR/STTR programs. Participants of the workshop, including investigators from IDeA states and NIH staff, identified several factors with the most significant negative impact including: limited resources and expertise to support technology transfer and commercialization programs at academic institutions; an insufficient number of local technology businesses to create a critical mass of entrepreneurial expertise and culture; lack of access to education, training, and mentoring in areas such as patents, start-ups, business plans, venture capital and angel investors; limited knowledge of SBIR/STTR programs; and a lack of awareness of available resources at the state and local levels. Information from the workshop led to three recommendations: 1) create initiatives to generate infrastructure and build entrepreneurial programs in the IDeA states; 2) educate and train academic researchers about how to develop commercial products and apply for SBIR/STTR grants; and 3) increase outreach by the NIH to institutions in IDeA states. To continue the NIH’s effort to strengthen entrepreneurship in IDeA states, NIGMS funded three IDeA Regional Entrepreneurship Development (I-RED) programs, one in each of the Southeast, Central, and West regions of IDeA states in FY2022. This FOA encourages meritorious applications in the Northeast region of IDeA states (ME, VT, NH, RI, and DE). Definitions This FOA for Fast-Track STTR UT2 cooperative agreement applications requires both Phase I and Phase II components be submitted together. UT2 Phase I supports activities and plans needed to prepare for UT2 Phase II. The Fast-Track mechanism requires that milestones of Phase I must be completed before Phase II funding will be released. For this funding opportunity announcement, UT2 Phase I and II refer to the project phases of the STTR program. The UT2 is a cooperative agreement mechanism, with NIGMS Program staff participation in developing the project plan, monitoring research progress, and appropriate go/no-go decision-making. See Section VI. Award Administration Information for more information about the Cooperative Agreement Terms and Conditions of Award. Program Description This FOA is intended to fund I-RED programs that support the development of educational products to meet the needs of the Northeast region of IDeA state academic institutions in developing and/or strengthening technology transfer programs and the needs of IDeA state investigators to stimulate technological innovation by translating scientific discoveries and technologies from research laboratories into commercial products. Key features of the I-RED program are described as follows: Applicant Organizations and Program Directors/Principal Investigators (PDs/PIs) An applicant for an STTR award must be an Small Business Concern (SBC) that partners with an academic institution. For this FOA, an applicant SBC must be from the Northeast region of the IDeA states, and partner with one academic institution in the same IDeA region. An applicant SBC should have substantial expertise in technology transfer and commercialization and experience in developing and marketing entrepreneurship educational products. It should have a solid understanding of the biomedical research community, the business community, and health-related entrepreneurship needs of the Northeast region of IDeA states. It should be able to demonstrate an alignment between the company’s business plan and the goal of the I-RED program. The academic partner must be an institution with robust biomedical research programs and an established technology transfer office. The academic partner is expected to contribute significantly to the product development by providing additional expertise in the design, testing, and validation of the education products. An I-RED program must be led by a Program Director/Principal Investigator (PD/PI) from the applicant SBC. Additional PD(s)/PI(s) from either the SBC or the academic partner institution are encouraged. The PD(s)/PI(s) must possess the expertise and experience to drive the design, testing, validation, and commercialization of the health-related entrepreneurship educational products. The Northeast regional I-RED program is expected to collaborate with other funded I-RED programs and is encouraged to work with existing federal resources as appropriate such as the NIH IDeA Program (COBRE, INBRE and IDeA-CTR); NIH Research Evaluation and Commercialization Hub (REACH); NIH Centers for Accelerated Innovations (NCAI); and the NSF Innovation Corps program. They are also encouraged to work with local and state governments and non-governmental business-development organizations such as chambers of commerce. Product Development I-RED programs must develop entrepreneurship educational products that can be utilized by academic institutions, especially those in IDeA states, to inspire, train, and support their students and faculty to explore entrepreneurial opportunities. The products may be didactic or interactive forms of courses (in-person, virtual, or recorded), manuals, casebooks, databases, and/or algorithms, etc. They are expected to develop and/or enhance academic scientists’ entrepreneurial knowledge and skills such as patent filing, business plan development, capital raising, bookkeeping, financial management, business operation, and marketing. Products that develop and/or enhance skills to compete for SBIR/STTR grants and to pursue entrepreneurial interests in academic environments are strongly encouraged. The products are expected to be developed through a rigorous research and development (R&D) process and be marketed for commercialization. Product Design: Entrepreneurship educational products to be developed by an I-RED program must meet the needs of the Northeast IDeA region, have commercialization potential, and enrich the knowledge base that helps turn biomedical research discoveries and technologies into products for enhancing human health. Thorough research, including but not limited to analyzing the gap assessment of the regional ecosystem resources and institutional needs that was completed by the IDeA Regional STTR Hub, should be conducted to inform the decision of what products to develop. Information about entrepreneurship educational materials currently utilized by other institutions, and that are available through commercial or non-commercial means, should be gathered and analyzed to help ensure adaptation of proven effective features and potential for commercialization of these products. The SBC and the academic partner must leverage their collective expertise and resources to assemble a team(s) that is capable of developing designs based on appropriate methodologies, building prototypes, and implementing a robust reiterative testing/assessing and adjusting process to refine the prototypes. Prototype Testing: The prototypes of the educational products developed by an I-RED program must be tested at academic institutions in the Northeast IDeA region . The institutions in the Tech Transfer Network established by the Regional STTR Hubs should be leveraged for the testing effort. The SBC and the academic partner should assemble a testing team(s) to conduct entrepreneurship training to students and faculty in these institutions and other institutions appropriate in the region using testable prototypes of the educational products and additional educational materials through appropriate venues such as lectures, workshops, and consultation. Recognizing that effective testing of the prototypes may require concerted training on related entrepreneurship topics, training with educational materials in addition to the testable prototypes will be supported as integral components of the product testing. For example, to effectively test a product that enhances SBIR/STTR grant writing skills, a course on Small Business 101 might be a prerequisite for the participants. The testing teams should also develop methods and metrics to assess the effectiveness of the prototypes and carry out the assessment to enable refinement of the prototypes. Product Validation: The efficacy of the educational product prototypes must be tested in a real world setting. The prototypes are expected to be used for the entrepreneurship training of a cohort of academic investigators who are likely to soon be in positions to translate technologies, devices, materials, and/or services into commercial products. To enable this efficacy testing, the I-RED program must support a pilot project program that develops the process and criteria to identify this cohort of investigators from institutions in the Tech Transfer Network and fund them with pilot project awards that accelerate the translation of their product ideas. The SBC and the academic partner should assemble a validation team with appropriate entrepreneurship and education expertise to provide entrepreneurship training to these investigators utilizing the products the program has developed and other necessary materials to meet their collective and individualized needs. The training is expected to be carried out through the course of the pilot projects and utilizing methods considered appropriate by the validation team such as lecturing, one-on-one consultation, and apprenticeship. The validation team should also develop methods, metrics, and milestones to assess the entrepreneurship growth of these investigators and the performance of their pilot projects throughout the product validation process. Product Commercialization The I-RED program must assemble commercialization teams with experience in marketing educational products and develop commercialization plans to market their products among IDeA state institutions and other institutions with similar needs. Acceptable commercialization outcomes of the educational products developed under this FOA include, but are not limited to, selling or licensing the products to academic institutions, and the SBCs continuing to deliver these products to academic institutions as fee-based services post the I-RED award. The commercialization plan should outline the planned path, efforts, timeline, and milestones toward reaching the commercialization goals. Governance and Operation The I-RED program is required to have a Steering Committee (SC), an Administrative Committee (AC), and an External Advisory Committee (EAC) for governance and operation: SC: The SC is the governance body that provides scientific and administrative oversight of the I-RED program. It will establish the policies and operating procedures of the program. A product design must be reviewed and approved by the SC. The SC establishes rules defining the composition of the EAC and the tenure of its Chairperson. The SC is expected to seek the EAC’s advice on strategic decisions and critical activities, leveraging the expertise of the EAC. The SC is also responsible for the development and management of an Evaluation Plan to assess the progress and performance of the I-RED. The membership of the SC consists of the PD(s)/PI(s), a corporate officer of the SBC unless one of the PDs/PIs is one already, a member of the institutional leadership (e.g., dean, vice president for research, or their surrogate) from the academic partner institution, a representative from each state in the Northeast IDeA region and the NIH Project Coordinator. Each member of the SC has one vote. The PD/PI (or Contact PD/PI in case of Multiple PD/PI award) serves as the Chairperson of the SC. The SC will meet quarterly in the first year of the award and the frequency of meetings in succeeding years will be decided by the SC at the beginning of each budget period as described in Section VI.2 under Cooperative Agreement Terms and Conditions of Award. AC: The AC is the administrative arm of the SC that administers the award in accordance with NIH policies and under the guidance of the SC. The PD/PI (or Contact PD/PI in case of Multiple PD/PI award) serves as the Chairperson of the AC. Other members of the AC should include the leads or representatives of the product design, testing, validation, and commercialization teams, the lead of the Pilot Project Program, and additional members deemed necessary by the Chairperson. EAC: The I-RED program must establish an EAC to provide consultation and advice to the SC. Membership of the EAC consists of six to eight individuals not employed by the SBC and academic partner institution. Members are selected by the PD(s)/PI(s) in consultation with the SC. EAC members must have appropriate expertise including start-up, venture capital, technology, finance, academic technology transfer programs, etc. In addition to providing advice to the SC, the EAC may participate in or lead specific program activities at the SC’s request. For example, the SC may request the EAC to lead the Pilot Project evaluation and selection, assist in program evaluation, or participate in the assessments of product testing and validation. Evaluation Plan An evaluation plan must be developed to monitor and document the overall progress towards achieving target goals of the program. The program evaluation, to be led by the SC, should assess the fitness of products proposed, the quality of the product design, effectiveness of the product development process, whether the approaches taken are appropriate, and efforts devoted adequate to meet the goals of developing the products proposed. Entrepreneurship growth of academic investigators who receive the entrepreneurship training and benefit from the successes of pilot projects funded by the I-RED program provide the strongest validation for product commercialization. Effective evaluation metrics and criteria include, but are not limited to, numbers of investigators being trained, duration and frequency of training provided, new applications for SBIR/STTR funding submitted, new SBIR/STTR grants awarded, capital raised through other sources including venture capital and angel investments, number of patents filed, number of licensing agreements signed, and number of companies started. Institutional Commitment and Regional Support Applicants need to demonstrate evidence of strong and specific institutional commitment by the academic partner institution to support the I-RED program. This may include providing research infrastructure and complementary funds for pilot projects at their institutions, allowing entrepreneurial faculty release time, and recognizing faculty’s entrepreneurial efforts and success in forms of rewards/incentives/promotion. The institutions’ commitment to leveraging I-RED resources for undergraduate and graduate entrepreneurship courses related to biomedical technology and product development is highly valued and encouraged. Applicants should seek similar institutional commitment from other academic institutions including those in the Tech Transfer Network only after the awards are made. Support for the I-RED program from other local or regional sources such as state governments or business development organizations is also highly valued and encouraged. Phase I Scope The following activities must be completed during Phase I of the award. Additional activities to prepare for Phase II may also be proposed in the application. Establish functional SC, AC, and EAC Develop a Memorandum of Understanding (MOU)/contract describing the arrangements between the SBC and academic institutions, including the partner institution and the institutions in the Tech Transfer Network where product testing and validation will take place through conducting entrepreneurship training, and possible award(s) of pilot projects. This should be completed in the Phase I of the award, but not prior to the submission of the applications. Complete research and needs analyses to set product development goals Set product development goals Complete product design Develop prototypes Develop/adapt effective strategies and plans for product testing through conducting entrepreneurship training at academic institutions Develop a pilot project funding opportunity announcement and solicit applications from investigators at academic institutions. Establish a process to evaluate and select pilot projects for funding. Implement an evaluation plan to monitor the Phase I progress of the I-RED program The length of Phase I should not exceed one year and can be shorter if milestones are met. Phase II Scope The following activities must be completed during Phase II of the award. Additional activities appropriate for Phase II may also be proposed. Continue the iterative process of product development, including testing at academic institutions, assessing the effectiveness of the products, and product refinement Fund pilot projects and testing the I-RED entrepreneurship training products, in conjunction with any other needed training materials, with the pilot project investigators to meet their entrepreneurship needs such as patent filing, business plan development, and raising capital, bookkeeping, financing, business operation, and marketing Test training products designed to build the skills needed to develop successful SBIR/STTR applications Advise pilot project investigators, in coordination with institutional technology transfer offices, to facilitate the commercialization of technologies and other products developed through the pilot projects Implement an evaluation plan to monitor the success of the I-RED program Develop and implement commercialization plans UT2 Phase I/II Transition An administrative review will be conducted by NIGMS Program staff to decide whether a project will be considered for transition from Phase I to Phase II. To be transition eligible, an I-RED must have completed all Phase I requirements. Pre-Application Consultation Applicants are strongly encouraged to consult with NIGMS Scientific/Research staff listed in Section VII when planning an application. Early contact provides an opportunity for NIGMS staff to provide guidance on program scope, goals, appropriate milestones, and budget.