Regional Technology Transfer Accelerator Hubs for IDeA States (STTR) (UT2 - Clinical Trial Not Allowed)

Purpose The purpose of this FOA is to support STTR regional technology transfer accelerator hubs serving a network of institutions in each of the four Institutional Development Award (IDeA) regions. These regions are: Central (Kansas, Nebraska, North Dakota, Oklahoma, and South Dakota); Northeast (Delaware, Maine, New Hampshire, Rhode Island, and Vermont); Southeast (Arkansas, Kentucky, Louisiana, Mississippi, Puerto Rico, South Carolina, and West Virginia) and Western (Alaska, Idaho, Hawaii, Montana, New Mexico, Nevada, and Wyoming). NIGMS recognizes the importance of using available resources efficiently to provide maximal benefit to IDeA states considering the vast geographical distances involved and the uneven entrepreneurial ecosystems present in these states. Many of the academic institutions in IDeA states do not have the infrastructure and expertise needed to move scientific and technological discoveries out of the laboratories towards the marketplace. The technology transfer accelerator hubs are regional consortia that provide expertise to develop the needed infrastructure and promote an entrepreneurial culture at the IDeA institutions in the region. They support the growth of businesses by facilitating networking and team formation among universities, venture capital groups, business development organizations, and small businesses, sharing and transferring information, best practices, and guidelines. They also provide assistance and one-on-one mentoring to investigators in the region, and facilitate information sharing on regional, state, and local resources and programs available such as commercialization funds or state matching funds. Technology transfer accelerator hubs are created by the awardee Small Business Concerns (SBCs) in partnership with academic institutions in IDeA states. The overall goals of the networks that will be supported through this FOA are to: 1) build on regional technology transfer programs to further strengthen the capacity to bring scientific results from academic institutions in IDeA states into the market; 2) fund a pilot project program for product definition studies (e.g., feasibility studies, prototype development, proof-of-concept, and preclinical studies); 3) provide access to expertise and resources in areas required for early stage technology development; 4) provide skills development and hands-on experience in entrepreneurship; and 5) promote a sustainable culture of biomedical entrepreneurship within IDeA states. Establishing public-private partnerships and securing additional non-federal funds will be critical for long-term success. The commercial product of these grants will be educational and entrepreneurial training tools such as curricula, webinars, and texts that can be licensed or sold to other institutions throughout the U.S. that wish to create similar accelerator hub programs or develop their internal commercialization capacity. Background The Institutional Development Award (IDeA) Program helps broaden the geographical distribution of biomedical research funding and promotes research and research training in states that historically have received low levels of NIH funding. The 23 IDeA states and Puerto Rico have historically had a disproportionately low number of SBIR/STTR awards from NIH (https://sbir.nih.gov/statistics/award-data). 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 STTR program helps foster regional economic and workforce development by spurring high-tech small business growth and “lab-to-marketplace” development. NIH invests billions of dollars each year in biomedical research, leading to great advances in scientific tools and biological insights. However, there are barriers to effectively translating basic science discoveries from academia to products that benefit patients. 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 technologies are brought to market; and 3) a lack of access to sufficient technology development and commercialization resources required for early-stage technology development. These barriers are particularly high in the 23 states and Puerto Rico that are eligible for the IDeA program, where there are limited expertise, incentives, and opportunities for technology transfer. The 2012 Defense Authorization Act (P.L. 112-81) reflected Congress' recognition of the inequality in SBIR/STTR awards within IDeA states by requiring 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, including this requirement, was reauthorized through FY 2022 by the National Defense Authorization Act for FY 2017 (P.L. 114-328). To respond to the 2012 Congressional request, NIGMS held a workshop on August 21, 2014, entitled “Finding Ways to Foster SBIR/STTR Applicants from IDeA States” (https://www.nigms.nih.gov/Research/CRCB/IDeA/Documents/IDeASBIR-STTRWorkshopReportJan2015.pdf). The goal of this workshop was to gain greater insight into the types of activities that would provide the most impact for promoting and attracting entrepreneurs from IDeA states into the SBIR/STTR program and increasing the participation of IDeA states in these programs. This group identified several limiting factors, including the need for effective institutional offices of technology transfer and commercialization; absence of a medical school in the campus and/or state; an insufficient number of local tech businesses to create a critical mass of entrepreneurial expertise and culture; lack of exposure to commercialization education, training, and mentoring (e.g., in areas such as patents, startups, business plans, venture capital, and angel investors); limited knowledge of technology transfer and SBIR/STTR programs; and a lack of awareness of available resources at the state and local levels. One of the major recommendations made by the workshop attendees was to create sustainable Regional Technology Transfer Hubs in IDeA states to generate infrastructure, build an entrepreneurial culture, and educate and train academic researchers about how to develop commercial products and apply for SBIR/STTR grants. The need to support regional networks of shared technology transfer accelerator hubs was consistent with the FY2017 Senate Appropriations Committee Labor-HHS Report, which stated, "Small Business Research Funding. --The Committee supports the initiative to direct small business research funding to IDeA States to foster the development of products to advance public health. The Committee asks NIGMS to consider allocating funding for one shared innovation incubator in each of the four IDeA regions that would be competitively bid among IDeA States and would serve IDeA States. NIH shall not use funding from its IDeA allocation for these grants." In response to the Congressional request, in FY 2018, NIGMS made new grant awards to support the creation of one shared STTR accelerator hub in each of the four IDeA regions (RFA-GM-18-001). These hubs provide infrastructure and expertise, and produce educational tools through the development and testing of models to accelerate technology transfer that are needed to promote commercialization of academic research and to build an entrepreneurial culture at IDeA institutions . Hub Characteristics For this FOA, SBCs from anywhere in the U.S. must collaborate with a non-profit university or research institution from an IDeA state, which in turn will partner with other academic institutions as a part of the regional network program. In each IDeA region, the technology transfer accelerator hub is organized as a “spoke and wheel” model in which the SBC is linked to the technology transfer offices of each participating institution in the regional network. The SBC partner is expected to have substantial experience in all aspects of technology transfer and commercialization and have knowledge of the development of training materials and their deployment. The staff of the Hubs will provide consulting services to the faculty and staff of colleges and universities in IDeA states, helping them establish small businesses based on their research or move their intellectual property into existing companies. They will also help institutions in each IDeA region set up the infrastructure they need for effective and efficient technology transfer and to promote entrepreneurship. The Hub staff will hold workshops, give seminars, and consult with academic investigators, postdoctoral fellows, and students across the IDeA region about the design and conduct of product definition studies and the commercialization processes. The academic partners in a Hub play a critical role in outreach to university investigators and in guiding the SBC partner to identify critical training needs and optimal curriculum components. The academic partners will also play an essential role in establishing and strengthening an institutional culture that recognizes and rewards faculty innovation and product development. Each accelerator hub program is expected to serve all academic partners in the region. Each Hub is governed by leadership experienced in translating biomedical technologies from research performing institutions to commercialization. The 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. The Hub must have the ability to help guide commercialization for projects at a range of stages of research and development, from early stage laboratory-based studies to early phase clinical testing. Through a combination of in-house efforts and collaboration across the regional network, each Hub will perform functions to specifically address the critical knowledge and resource gaps that hinder the identification, development, and commercialization of promising products and technologies at the partner institutions. An important characteristic of the regional Hub is the ability to collaborate effectively with entities that possess the resources and expertise required to commercialize technologies developed through the IDeA institutions in the region. A Hub should leverage technology development expertise and partnerships necessary to funnel discoveries into the commercialization pipeline. The regional Hubs must provide entrepreneurial educational opportunities to academic investigators, postdoctoral fellows, and students about the design and conduct of product definition studies and the commercialization processes required for transitioning a study involving drug targets, biomarkers, or biotechnology out of academic labs to the private sector (either as startup small businesses or through licensing opportunities). Cross-disciplinary (science, business, regulatory, etc.) career development is highly encouraged to achieve the goal of exposing innovators to the processes required to translate discoveries into marketable products. Providing the broader investigator community (faculty, postdoctoral fellows, and students), including those from underrepresented groups, access to forums, courses, seminars, workshops, and related activities is encouraged. These Hubs should leverage and strengthen the links with the funded IDeA programs (IDeA Networks of Biomedical Research Excellence [INBRE], Centers of Biomedical Research Excellence [COBRE], and IDeA Clinical and Translational Research centers [IDeA-CTR]). These efforts should identify and specifically assist academic investigators or groups by providing knowledge, development of business skills, information, networking, and business strategies that can result in more successful SBIR and STTR applications and new startups. Hubs are expected to work with existing NIH or federal resources as appropriate, including: NIH Research Evaluation and Commercialization Hub [REACH] and Centers for Accelerated Innovations [NCAI]; Clinical and Translational Science Awards [CTSA]; and Cancer Centers . Although not required, leveraging existing entrepreneurial training activities, such as the NSF I-Corps, NCAI, REACH, CTSA, or other similar programs is encouraged. Under this FOA, regional Hubs are to: expand their current network of academic institutions to additional institutions and colleges including under-represented minority serving institutions; strengthen the current and develop new collaborations and partnerships to meet the goals of the program; provide and strengthen the infrastructure for Technology Transfer and Commercialization office at the academic institutions to assist faculty in soliciting and selecting the most promising studies and technologies predicated on scientific merit, commercial potential, and medical need; provide innovators with skills development, hands-on entrepreneurial experience, educational, and networking activities with linkages to local or virtual resources; provide entrepreneurial educational opportunities for innovators to move scientific advancements to products that will improve human health; develop/adapt curricula at graduate and undergraduate levels to enhance student awareness and skills for careers in industry and provide students internships; fund a pilot project program to perform feasibility and proof-of-concept studies, prototype development, and preclinical studies; work with academic partners to strengthen an institutional culture that recognizes and rewards faculty innovation and product development; and develop and implement a plan for transitioning to a self-sustaining structure in each IDeA region. The cooperative approach outlined in this FOA also encourages interactions among four regional networks to promote the development of integrated plans, best practices, resource sharing, and strategies required for successfully achieving the goals of this program. Contractual/Consortium Arrangements Contractual arrangements or a Memorandum of Understanding (MOU) must be established between the SBC and the participating institutions. The MOU/contract must clearly describe the arrangements between the academic partner institutions and the SBC in terms of space, current resources available, and providing incentives, rewards, and appropriate recognition to the faculty involved in the translational efforts. Each program will focus on infrastructure and training needs for entrepreneurial faculty and students, and implement a plan to address those needs and support product definition studies through the Pilot Project Program. Hub Structure Each Hub must have the following three committees for its governance: Steering Committee (SC): The SC is the governance body that provides scientific and administrative oversight to the Hub. It will establish the policies and operating procedures of the Hub. The membership of the SC consists of the (PD(s)/PI(s)), a member of the institutional leadership (e.g., deans, vice presidents for research, or their surrogate) from the lead academic partner institution, a representative from each state in the IDeA region, and the NIH Project Coordinator. Each member of the SC has one vote. The UT2 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 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. The SC will regularly review the progress of the Hub activities. The SC establishes rules defining the composition of the External Advisory Committee (EAC) and the tenure of its’ Chairperson. Administrative Committee (AC): The AC of the Hub will provide logistical support to the regional network and Steering Committee (SC) and External Advisory Committee (EAC). The AC will consist of the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)), technical and administrative staff at the SBC, and representatives from the lead partner institution(s). The AC Lead UT2 PD/PI (or Contact PD/PI in case of Multiple PD/PI award) is responsible for management, staffing, resource allocation, and for administering the award in accordance with NIH policies. The AC is also responsible for the development and management of an Evaluation Plan to measure the impact of the regional Hub. As communication among Hub network institutions is essential, the AC should provide electronic communication to inform investigators both within and outside the network of the availability of, and access to, technologies and resources. External Advisory Committee (EAC): Each regional Hub must include an EAC with six to eight members from organizations not participating in the network. Members of EAC, selected by the UT2 PD/PI (or Contact PD/PI in case of Multiple PD/PI award) in consultation with the SC, must have appropriate scientific/business and entrepreneurship expertise including industry, start-up, venture capital, technical, financial, and business experts, or university technology transfer. The EAC provides advice to the PD(s)/PI(s) on scientific, management and training matters. The EAC critiques the progress of the Hub activities and offers advice on these matters to the PD(s)/PI(s). EAC activities also include developing and planning concepts and programs, encouraging and assisting faculty development and enhancement, identifying resources, evaluating pitches by innovators for pilot funding, and evaluating progress of the overall Hub program. The UT2 PD/PI (or Contact PD/PI in case of Multiple PD/PI award) will share the advice and critiques provided by the EAC with the SC. The EAC must meet at least twice per year. Video-, tele-conferencing, or other means may be used in situations where it would be difficult to hold an in-person meeting. Hub Activities A program that fosters entrepreneurship in biomedical research should encompass: 1) workshops and course series provided by individuals with industry experience and university faculty; 2) individualized consulting and mentorship; 3) institutional change that creates an environment that enables collaboration and development of fundamental or applied research into technologies and products; and 4) pilot project program implementation and management. Under this award, the Hubs will support development and offering of educational courses, modules, workshops in person and/or via webinars; plans for outreach and dissemination to license or sell the products, e.g., curricula, texts, webinars to those who wish to create accelerator hubs or use the resources produced. Courses/skills Development One of the key Hub activities is the development and implementation of educational and training materials such as curricula, webinars, and texts, to provide opportunities for academic investigators to learn about the design and conduct of product definition studies and the commercialization processes required for transitioning a product and technology out of academic labs to the private sector (either as start-up businesses or licensing opportunities). Some examples of workshop/course topics include, but are not limited to: How to determine if an “idea” or “product” is innovative How to protect intellectual property How to develop and implement a comprehensive biomedical entrepreneurship skills development program What it means to be a business entrepreneur, including business plan development, market research, project management, and financing How to use licensing and startups as alternative pathways to advance inventions How SBIR and STTR grants can fund startup companies and academic innovators How to raise capital from non-federal sources How to pitch your invention How to pursue clinical studies and manage the FDA regulatory process Outreach activities, such as forums, seminars, and workshops at academic institutions throughout the IDeA states in the region Mentoring Mentoring of early-stage entrepreneurs could be achieved through one-on-one mentoring/coaching approaches with expert entrepreneurial consultants, through internships in small biomedical businesses, patent attorney offices, and other related activities (licensing, startup, finding the niche for the technology), and through mentoring on how to prepare an SBIR/STTR application. Consulting and Advising Hubs will serve as expert consultants and advisors to the partner academic institutions in areas such as establishing or improving the operations of technology transfer and commercialization offices, enhancing the support for faculty interested in commercialization of ideas and discoveries, leveraging other federal and non-federal resources, sharing of best practices and resources among institutions, and creation of an entrepreneurial culture. Pilot Project Program Each Hub must have a pilot project program with an internal mechanism for obtaining applications and awarding funding for projects that help scientists in the IDeA region gather data for feasibility and proof-of-concept studies to determine whether a nascent technology or product is worth pushing through the commercialization process. These pilot projects are not to be proposed in the application. Each Hub must demonstrate access to adequate numbers of such projects/technologies of broad strategic interest to the NIH at the academic partner institutions. After the award is made, applications for pilot projects can be solicited from innovators (faculty, postdoctoral fellows, and students) at network participating institutions and selected by the EAC. Each Hub should provide infrastructure and expertise that will promote leveraged interaction to successfully develop the pilot projects/technologies funded through this FOA. Applicants to the pilot project program should be encouraged to seek matching funds either by pitching their ideas to entrepreneurs using the skills learned from what the Hubs provide (preferred) or by seeking matching funds from their institutions. Evaluation Plan and Metrics Administrative Committee is responsible for overseeing an evaluation plan for monitoring and documenting progress towards achieving target goals and timelines. The evaluation should assess whether the approaches taken are meeting the goals and benchmarks for building an effective regional technology transfer Hub. The success of researchers from the network partner institutions in the Hub may be measured by attainable metrics that are appropriate to the missions of their institutions. Each Hub should develop metrics tailored to the development of their entrepreneurial educational resources, regional databases, and pilot project program. Criteria for evaluating the progress of the Hubs may include the number of participating faculty, postdoctoral fellows and students in entrepreneurial activities, new applications for SBIR/STTR funding, development of curricular materials, skills development materials and effective strategies, number of patents, number of licensing agreements, number of successful funded projects/technologies transitioned to the next level, and number of startups. Measures of success will be: production and dissemination of educational products and services; an increase in technology transfer from universities and research institutions in IDeA states into the private sector for commercialization; and an increase in the creation of small businesses focused on biotechnology in these regions. In addition, an increase in SBIR/STTR applications and awards will be considered a measure of success. In the long term, the launching of products that facilitate biomedical research and improve human health, and an increase in regional biotechnology–related jobs and economic activity in IDeA states should be evident. Institutional Commitment and Regional Support Applicants need to demonstrate evidence of strong and specific institutional commitment by academic partners to support this effort. This may include adequate laboratory space, complementary funds for pilot projects at their institutions, providing entrepreneurial faculty release time and recognition in terms of rewards/incentives/tenure and promotion, creation of undergraduate and graduate courses in biomedical technology research, development, and entrepreneurship, and career development activities that enhance student awareness of scientific careers outside of academia. Further, it is expected that the regional Hubs will become financially self-sustaining through support from partnering institutions or other financial arrangements, such as agreements with the leadership of academic partners to allow for revenue from fees, licensing, milestone payments, royalties, or other mechanisms. Support for the goals of the Hubs from other local or regional sources such as state governments or business development organizations, while not required, could enhance program impact. Supplements to UT2s UT2 awards may be considered for administrative supplemental funding that will provide support above the cost limit of this FOA, depending on the need, and intention and constraints of the particular supplement program. Demonstrating Program Readiness Only one award will be made per IDeA region. In order for an application to be accepted for review and considered for funding, the proposed regional program must be ready for immediate implementation. The application must demonstrate readiness to start the project with immediate effect, if awarded, as described in Part 2. Section IV.2 Other Project Information. Other Attachments. Accordingly, applicant programs must have achieved the following milestones: Established a hub structure that includes functional Steering Committee, Administrative Committee, and External Advisory Committee; Developed relationships with academic institutions in the regional network including establishing contractual arrangements or memoranda of understanding (MOU); Performed a gap assessment of institutional needs related to infrastructure, technology transfer, training and educational materials, innovator skill sets and learning needs, and local ecosystem resources; Developed prototypes for training and educational courses for faculty, postdoctoral fellows, graduate and undergraduate students based on the gaps assessments. 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 further guidance on program scope, goals, FOA requirements, developing appropriate milestones, and budget.