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HEAL Commercialization Readiness Pilot (CRP) Program: Embedded Entrepreneurs for Small Businesses in Pain Management (SB1 Clinical Trial Not Allowed)


The goal of this FOA is to support the commercialization of SBIR/STTR-funded pain management technologies through the addition of an experienced entrepreneur within small business leadership teams and by supporting private fundraising and partnership activities. This Commercialization Readiness Pilot (CRP) funding opportunity is specifically open to Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II or Phase IIb awardees who are focused on advancing pain management therapies and technologies that have been funded by the HEAL Initiative or through HEAL-specific SBIR/STTR funding opportunities. This FOA is part of the NIH HEAL (Helping to End Addiction Long-term) Initiative an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. More information about the HEAL Initiative is available at More than 25 million Americans suffer from chronic pain, a highly debilitating medical condition that is complex and lacks effective treatments. In recent decades, there has been an overreliance on opioids for chronic pain despite their poor ability to improve function. This contributed to a significant and alarming epidemic of opioid overdose deaths and addictions. Small Business support through the HEAL Initiative is dedicated to bringing innovative pain management technologies and treatments for pain to the market. Due to their long and expensive development timelines, many pain management technologies, including small molecule and biologic analgesics, medical technologies, and diagnostics, require significant funding beyond federal support to reach the marketplace. Within small biotech companies, third-party funding is primarily achieved through attracting private investment and/or partnerships with industry. Successfully attracting private partners requires dedicated time, significant knowledge, and unique skillsets. Early-stage biotech companies formed by technical experts may lack experience in business development, fundraising, private partnership, and entrepreneurship. In addition, Small Business Concerns (SBCs) primarily supported through SBIR/STTR awards often lack funding for non-R&D activities, thus these SBCs may not be able to support the salaries of business development staff. Gaps in entrepreneurial and business development expertise within SBCs may negatively impact the likelihood of attracting private funding and ultimately delay or undermine commercialization of innovative pain management products. This FOA will prioritize applicants who demonstrate a need for private partnership to achieve commercialization of their pain management technologies, and SBCs who have not previously garnered significant private funding. Small businesses who have previously obtained private funding should provide a clear rationale as to why additional business management expertise and federal support of partnering goals are needed to support future private partnering. In demonstrating a need for federal support for successful private partnering, applicants should also address the relative accessibility of private partners in the geographical vicinity of the applying SBC. The CRP Program is an authorized component of the SBIR and STTR programs. The CRP program permits utilization of SBIR/STTR set-aside funds to support eligible SBCs in conducting technical assistance activities which may not include an R&D component. In concordance with the CRP program, funding through this FOA is intended to facilitate the transition of previously funded SBIR/STTR Phase II and Phase IIb projects focused on pain management to the commercialization stage by supporting private partnering activities. Please note: Only those applicants who have received Phase II or Phase IIB funding from NIH are eligible for CRP funding, as described in Section III.1. Specifically, applying SBCs must have at least one of the following: Phase II or IIB SBIR/STTR award that has ended within the last 36 months or will close out by the requested start date ("Type 2" Renewal application). Phase II or IIB SBIR/STTR award that will be active at the requested Project Start date ("Type 1" New application). Scope This FOA is specifically designed to support addition of an expert in entrepreneurship and business development within small business leadership teams which currently lack this knowledge base, and to utilize this expertise in efforts to attract private funding. This FOA is designed to support applications with the following components within the Research Plan section of the application package (see Section IV for application instructions): A detailed hiring plan to fill gaps in business expertise within the current small business leadership through hiring of a qualified individual Clear identification of the specific skillsets and expertise missing from the current leadership team (or are only available in a leadership member with less than a 50% commitment) that must be filled to improve likelihood of attaining private partnering goals. Methods by which at least three candidates filling the identified gaps in expertise will be identified, interviewed, and evaluated, including how the search will encourage applications from people of diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women. Identification of the executive level position, roles and responsibilities, anticipated compensation (including contributions of the applying small business), and level of effort (50%-100%) of the individual to be hired through this funding opportunity to fill identified gaps in expertise Biosketches and letters of support from one or more candidates fitting the identified gaps in expertise, indicating the candidate supports the proposed leadership role, compensation, and partnering plan A detailed partnering plan to attract private funding through private investment and/or partnership with industry (such as licensing or acquisition) the includes the following components: A description of the types of private investors or industry partners that will be targeted and how they align with the company, pain management technology, and mission of the HEAL Initiative Methods for identifying and contacting potential private partners A timeline for execution of proposed activities extending throughout the proposed grant period Interim goals or milestones throughout the grant period This funding opportunity is intended to bolster the core competencies of NIH-funded SBC leadership teams in areas of business expertise and private partnering in an effort to improve success in private funding and partnering. Therefore, applicants are expected to incorporate this expertise into the SBC leadership team at a significant commitment of no less than 50% effort to the company. Note that the level of effort of this individual on the proposed project may be less than the overall commitment to the company. For example, the individual may be a full time hire and be proposed to contribute 50% effort to the activities proposed to this funding opportunity. Level of effort on the proposed project should be commensurate with the involvement of the individual in the proposed partnering activities. Award funding may only support the labor costs affiliated with the proposed activities. Applying small businesses are expected to contribute to the compensation of individual(s) hired through this award, such as through equity agreements or other funds.The proposed hire is expected to be responsible for significant portions of business development and private partnering activities, and therefore it is anticipated that executive positions such as Chief Business Officer (CBO), Chief Finance Officer (CFO), Chief Executive Officer (CEO), Chief Operations Officer (COO), Senior VP of Business Development, or similar may be appropriate. It is anticipated that relevant skillsets and expertise needed to conduct partnering activities may include a track record of raising venture funding to support development of related technologies and/or experience overseeing successful licensing of similar technologies to large industry partners. Ultimately, the skillsets of the proposed business executive hire should align with those needed to execute the proposed partnering plan. While applying small businesses are not required to execute proposed hiring agreements prior to application submission, this FOA is designed to support applications that have identified at least one candidate within the application who provides the necessary expertise, along with a letter of support from the proposed candidate (see Section IV for application instructions). The application also requires a letter of support from this candidate confirming interest and their support of the proposed hiring plan and activities described in the application. Please note that funding for this award may be restricted until a candidate that meets the required skillsets and expertise is officially hired. Applicants are expected to describe efforts by which they will encourage applications from candidates of diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women (see the Notice of NIH's Interest in Diversity,, for more information).. Applicants are highly encouraged to utilize their network of advisors, board members, and consultants to identify strong candidates. Applicants should be actively seeking private funding or partnering at the time of application or within one year of application submission. Readiness for fundraising and/or partnering activities should be demonstrated, such as through inclusion of letters of support from private funders, industry, and advisors; prior engagement with private partners; prior participation in company showcase opportunities or pitch competitions; and/or examples of comparable technologies and companies who succeeded in partnering at a similar development stage. Activities proposed within applications to this funding opportunity must be directly related to private fundraising and partnering activities. Partnering activities supported by this grant may include but are not limited to US-based travel to meet with potential partners, attendance at partnering meetings, legal activities related to partnering, and business development activities to address areas of interest of private partners (e.g. market and IP landscape analyses, regulatory plan development, business plan development, customer discovery research). Partnering goals or milestones may include completing a number of meetings with investors, establishing a board of directors, finalizing pitch decks, and other business development activities that directly serve the proposed partnering goals. This funding opportunity may support activities of other company staff, advisors, board members, consultants, lawyers, and/or vendors who will contribute to the proposed hiring and partnering activities. Applicants are expected to meet with a minimum of ten potential partners over the duaration of the project fitting an appropriate target profile for the technology and company (e.g., angel investors, VC firms, pharma venture branches, industry search and evaluation staff, etc). Costs associated with conducting these meetings, including US-based travel and legal fees, are within scope. Activities outside of product R&D that may directly contribute to successful partnering are within scope, such as market and intellectual property (IP) analyses, regulatory plan development, assembling a data room, and business plan development. The contribution of these activities to partnering success should be made clear by the applicant.
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