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

Purpose

The purpose of this FOA is to support one shared STTR regional accelerator hub 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 tech transfer accelerator hubs would act as regional consortia to provide expertise to develop the needed infrastructure and promote an entrepreneurial culture at the IDeA institutions in the region. They will help support the growth of businesses by facilitating networking and team formation between universities and small businesses, sharing and transferring information, best practices and guidelines. They will also provide assistance and one-on-one mentoring to investigators in the region, and facilitate information sharing on state and local resources and programs available, such as commercialization funds or state matching funds. Technology transfer accelerator hubs will be created by the awardee SBCs in partnership with academic institutions in IDeA states. The commercial product of these grants will be educational and 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 relevant to rural and medically underserved populations. The 23 IDeA states and Puerto Rico have historically had a disproportionately low number of SBIR/STTR awards (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. 

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 directive, 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 tech transfer and SBIR/STTR programs; and a lack of awareness of available resources at the state and local levels. The workshop made three major recommendations: 1) create IDeA Regional Network Incubators/Hubs to generate infrastructure and build entrepreneurial culture; 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 IDeA institutions.

The need to support regional networks of shared technology transfer accelerator hubs is 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."

Overview

Although NIH invests billions of dollars each year in biomedical research, leading to great advances in scientific tools and biological insights, 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, with limited expertise, incentives, and opportunities for technology transfer. For this FOA, therefore, a small business concern (SBC) 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 in that IDeA state region to develop programs that address a comprehensive set of activities that will facilitate and accelerate the translation of promising early-stage technologies into commercial technologies. The academic partners 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 will be expected to serve a network of academic institutions throughout the IDeA states in the region where the academic partners are located. The Small Business Administration supports Small Business Development Centers (SBDC) (https://www.sba.gov/offices/headquarters/osbdc) in every state with the purpose of aiding existing and prospective small business owners. The tech transfer accelerator hubs do not seek to replicate or compete with existing resources such as the SBDC, although many of these may not have the expertise or knowledge specific for biomedical sciences.

This initiative will leverage 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]) with efforts that can 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.

Definitions

This FOA for a Fast-Track STTR UT2 cooperative agreement requires both Phase I and Phase II components. 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.  

Hub Characteristics

There will be one tech transfer accelerator hub in each IDeA region. For this FOA, an SBC from anywhere in the U.S. will collaborate with a non-profit academic partner in an IDeA state, which will partner with academic institutions in other IDeA states in that region to develop a regional network. The STTR SBC partner is expected to have substantial experience in all aspects of technology transfer, have knowledge of development of training materials, web sites, etc. 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 small businesses. 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 travel across the IDeA region to hold workshops, give seminars and consult with academic investigators, postdoctoral fellows and students about the design and conduct of product definition studies and the commercialization processes.

A regional accelerator hub should be organized as a “spoke and wheel” model in which the SBC is linked to technology transfer interests of each participating institution in the IDeA regional network. SBCs will work with institutional leadership to formulate a strategy that ensures the Hub and its activities function in the best interests of biomedical innovators at their institutions. The SBC, through collaboration with one academic partner, must include at least one institution from each IDeA state in the region as a part of the regional hub network. The Hub “spoke and wheel” model is critical for the success of the program. Hubs require adequate resources, support, and coordination to manage and conduct all program activities in a way that is not only tailored to each Hub’s ecosystem but also interacts across the Hubs, the NIH, and other partners.

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 and strengthen infrastructure for an Office of Technology Transfer Office and Commercialization 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; 4) provide entrepreneurial educational opportunities for innovators and create cultural and systemic changes to move scientific advancements to products that will improve human health; 5) provide innovators with skills development, hands-on entrepreneurial experience, educational and networking activities with linkages to local or virtual resources; 6) develop courses at graduate and undergraduate levels to enhance student awareness skills for careers in industry; and 7) develop and implement a plan for transitioning to a self-sustaining structure at the IDeA institutions.

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 from projects at a range of stages of research and development, from early stage laboratory-based studies up to early phase clinical testing. Through a combination of in-house efforts and collaboration across the regional network, each Hub funded under this FOA 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 have a structure that leverages technology development expertise and partnerships necessary to funnel discoveries into the commercialization pipeline. Hubs should consider working with existing NIH or federal resources as appropriate, including: NIH IDeA program (COBRE, INBRE and IDeA-CTR (https://www.nigms.nih.gov/Research/CRCB/IDeA/Pages/default.aspx); NIH Research Evaluation and Commercialization Hub [REACH] and Centers for Accelerated Innovations [NCAI] (https://ncai.nhlbi.nih.gov/ncai/); Clinical and Translational Science Awards [CTSA] (https://ctsacentral.org/); and Cancer Centers (https://cancercenters.cancer.gov/)). Each Hub should establish an infrastructure that will promote synergies that enable successful technology development. The cooperative approach outlined in this FOA also encourages interactions among four regional Hubs to promote the development of integrated plans, best practices, resource sharing, and strategies required for successfully reaching the goals of this funding announcement.

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 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 (faculty, postdoctoral fellows and students), including those from under-represented backgrounds, access to forums, courses, seminars, workshops and related activities is encouraged.

Contractual/Consortium Arrangements

Contractual arrangements or a Memorandum of Understanding (MOU) must be established between the SBC and the participating institutions as a part of Phase I scope. 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 Hub will focus on infrastructure and training needs for entrepreneurial faculty and students, and develop a plan to address those needs.

Hub Structure

The Hubs must build a governance team consisting of the Program Director/Principal Investigator (PD/PI) and the institutional leadership (e.g., deans, vice presidents for research or their surrogate) from the participating institutions to leverage existing resources and unique assets, while addressing the gaps and infrastructure needs that constitute barriers to efficient commercialization at the regional network institutions. Each Hub must have the following committees:

Administrative Committee: The Administrative Committee (AC) of the Hub will provide logistical support for the regional network and for the Internal Advisory Committee (IAC), Program Steering Committee (PSC) and External Advisory Committee (EAC). The AC will consist of the Program Director/Principal Investigator (PD/PI) and administrative staff at the SBC. The Administrative Committee Lead (Program Director/Principal Investigator (PD/PI)) is responsible for management, staffing and resource allocation, and for administering the award in accordance with NIH policies. The Administrative Committee Lead will serve as Chairperson of the Hub IAC and select EAC members in consultation with the IAC. The AC, in consultation with the governance team, will develop biomedical entrepreneurship training programs to meet the career building and enhancement needs of the research faculty, postdoctoral fellows, and graduate and undergraduate students including educational modules, workshops or short courses.

As communication among Hub network institutions is essential, the AC should provide electronic networking to inform investigators both within and outside the network of the availability of and access to technologies and resources both within the network and located at other sites around the country.

Internal Advisory Committee: The PD/PI will serve as Chairperson of the Internal Advisory Committee (IAC). The governance team from the regional network partners must participate as members of the Hub IAC. The IAC will include up to two members from each network partner institution: 1) a senior administrator and 2) a member with scientific expertise or an official from the partner institution's Office of Technology Transfer and Commercialization. The members of the IAC will establish the policies and operating procedures of both the IAC and the Hub. The IAC will meet at least four times during the first year of the award and at least semi-annually thereafter. The IAC will develop strategies as to how it will interact with the External Advisory Committee as described below. The Administrative Committee will provide logistical support to the IAC. The PD/PI, in conjunction with the IAC, will provide management oversight for the development of an Evaluation Plan to measure the impact of the regional Hub. The members of the IAC will regularly review the progress of the Hub activities. This oversight and input are in addition to that provided by the EAC and may not act as a substitute for the EAC.

External Advisory Committee: Each regional Hub must include an External Advisory Committee (EAC). The IAC should establish rules governing the composition of the EAC and the tenure of the Chairperson. The composition of the EAC is to include at least six to eight members with appropriate scientific/business and entrepreneurship expertise, who can provide advice to the IAC for these training programs and other matters. The EAC must meet at least twice per year. The EAC critiques the progress of the Hub activities and offers advice on these matters to the PD/PI. EAC activities include developing and planning concepts and programs, encouraging and assisting faculty development and enhancement, identifying resources, evaluating development of the network, and evaluating progress of the overall Hub program. The PD/PI will share the advice and critiques provided by the EAC with the IAC and other members of the Hub network. Video-, teleconferencing or other means may be used in situations where it would be difficult to hold an in-person meeting. A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NIGMS.

Program Steering Committee: A Program Steering Committee (PSC) will be created that includes NIH and other Federal staff, Hub PD(s)/PI(s), members of the governance team and other Hub staff as appropriate to provide scientific and administrative oversight as described in Section VI.2 under Cooperative Agreement Terms and Conditions of Award.

Evaluation Plan and Milestones:

The 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 approach taken is meeting the goals or benchmarks for building an effective institutional and regional tech 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. Criteria for evaluating the progress of these researchers may include number of participating faculty, new applications for SBIR/STTR funding, development of curricular materials, skills development materials and effective strategies, number of patents, number of licensing agreements, and number of startups.

Measures of success will be 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 production 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 seen.

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; and 3) institutional change that creates an environment that enables collaboration and development of fundamental or applied research into technologies and products. The product of the funded research will be educational tools – i.e., curricula, texts, webinars – resulting from the development and testing of research accelerator models. It is anticipated that the educational tools developed under this FOA will be licensed or sold to other institutions that wish to create similar programs. The SBC could also become a self-sustaining entity in the future by charging for its services.

Courses/skills development

A key Hub activity is the development 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, and 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 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.

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, seed money 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 and would thus strengthen applications.   

Pilot projects

An optional element of the Hub is the funding of small pilot projects that help scientists gather data for feasibility studies that determine whether a nascent technology or product is worth pushing through the commercialization pipeline. These pilot projects are not to be proposed in the application. After the award is made, applications for pilot projects can be solicited from faculty at participating institutions and selected by the EAC. However, federal funding provided under this FOA may not be used to support pilot projects. If pilot project activities are proposed, 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 to augment the federal investment for product definition and proof-of-concept studies. 

UT2 Phase I Scope

Examples of activities that can be proposed during this Phase include, but are not limited to:

• Establishing Administrative Committee, Program Steering Committee, Internal Advisory Committee and External Advisory Committee and having regular meetings to establish Hub structure, governance and leadership plan
• Developing contractual arrangements or a memorandum of understanding (MOU) describing the arrangements between the SBC and academic partner institutions in the IDeA regional network 
• Assessing infrastructure needs for technology transfer at the academic partner institutions in the regional network
• Assessing innovator skillsets and learning needs, the local ecosystem’s resources for relevant content, and developing new content for education and workshops
• Setting up systems for webinars and making plans for visits to academic institutions for outreach
• Developing a prototype for training and educational courses for faculty, postdoctoral fellows, graduate and undergraduate students
• Developing/adapting effective mentoring strategies
• Developing an evaluation plan to monitor the success of the regional Hub
• Developing strategies for soliciting, evaluating, and selecting scientific and technology development pilot projects
• Soliciting and selecting promising innovative pilot projects for funding using non-Federal sources

The length of Phase I can be brief depending on the maturity of the project at entry and how quickly milestones can be met. 

UT2 Phase II Scope

Examples of activities appropriate for this Phase include, but are not limited to:

• Continued work with Technology Transfer and Commercialization Offices at the regional network institutions to establish infrastructure and train staff to provide advice on project management, regulatory pathways, and intellectual property rights to the faculty who want to commercialize their technologies, discoveries or other products
• Continued development and offering of educational courses, modules, workshops in person and via webinars
• Providing one-on-one mentoring and coaching to promising innovators
• Providing workshops on developing successful SBIR/STTR applications
• Working with institutional Technology Transfer or Commercialization offices to enable academic entrepreneurs to find the best path forward for commercialization of technologies, discoveries or other products
• Developing Standard Operating Procedures for technology transfer, management, small business finance and other business skills including mentoring and coaching for academic investigators 
• Funding innovative pilot projects using non-Federal sources of funding
• Implementing an evaluation plan to monitor the success of the regional Hub
• Planning for outreach and dissemination to license or sell the products, i.e., curricula, texts, webinars to those who wish to create accelerator hubs or use the resources produced

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. Phase II eligible projects must have developed relationships with academic partner institutions in the region and complete needs assessments. Specifically, projects entering the Phase II must satisfy the following milestones:

• Functional Administrative Committee, Internal Advisory Committee, Program Steering Committee and External Advisory Committee that have established the Hub structure, governance and leadership plan
• Contractual arrangements/memoranda of understanding (MOU) between the SBC and academic partners in the IDeA region established and in place 
• Assessment of the infrastructure needs at the academic partners and formulation of an implementation plan
• Assessment of the innovators’ skillset and learning needs, the local ecosystem’s resources for relevant content, and plan for developing additional content for education and workshops
• Develop a prototype for training and educational courses for faculty, post-doctoral fellows, graduate students and undergraduate students
• Establish a system for webinar delivery, organizing webinars, and visiting academic institutions for outreach

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, developing appropriate milestones, and budget.

The NIH will host a pre-submission webinar on November 15, 2017 from 3:00 - 4:30 p.m. (EST). To join the webinar follow the link below: https://nih.webex.com/nih/j.php?MTID=m5bc220e85d7c3aa1206db08b48d59fa9. This information will also be published as an NIH Guide Notice and posted at https://sbir.nih.gov and https://www.nigms.nih.gov.

See Section VIII. Other Information for award authorities and regulations.