Attachment 1 -SOW.pdf

Attachment 1

STATEMENT OF WORK

Title: NIA Entrepreneur in Residence (EiR) Technical Expertise Service

Program: National Institute on Aging (NIA), Division of Extramural Activities (DEA), Office of Strategic Extramural Programs (OSEP)

PURPOSE and BACKGROUND The NIA Office of Strategic Extramural Programs (OSEP) supports the NIA innovator community in their efforts to validate the potential health impacts of promising scientific discoveries and advance them into healthcare products that improve patient care and enhance health. In FY24, the NIA provided ~$150M to small businesses developing aging-related innovations through NIA’s SBIR/STTR programs. NIA’s SBIR/STTR programs are a critical tool used to meet NIA’s mission of extending and enhancing the healthspan of older adults as the programs fund the development of products that improve the prevention, treatment, diagnosis and care of older adults and their caregivers. Developing products across the biomedical and technology spectrums requires NIA’s collaboration with universities and research institutions, small businesses, trade associations and societies, angel investors, venture capitalists, and strategic partners. OSEP leads initiatives that develop these relationships and build opportunities for NIH innovators to further their product development efforts.

OSEP’s core objectives are to provide both the funding and services that best enable investigators to convert scientific discoveries into impactful healthcare solutions by facilitating the advancement of these technologies towards commercialization. These efforts include the development and fostering of a diverse entrepreneurial workforce through entrepreneurial training and outreach initiatives.

NIA/DEA/OSEP has a variety of programs and resources to support NIH awardees at various stages of product development bring their innovations to life. NIA’s commercialization support programs connect awardees with expertise in multiple specialized knowledge areas. NIA’s entrepreneurial development programs ensure that entrepreneurs new to the aging sector are provided with the resources and guidance needed to be successful. These activities focused on technical direction of awardees on successful startup commercialization efforts have been performed primarily by OSEP contractors that are referred to as Entrepreneurs in Residence (EiRs) and have very specialized expertise.

NIA requires EiRs that have expertise across business development, intellectual property, the agetech market, small business financials therapeutic innovation, regulatory, and reimbursement pathways. The EiRs also have proven track records in industry and networks that include organizations and potential partners of SBIR-funded startups. Thus, their ability to provide such focused technical expertise and contacts complements the expertise of government personnel and are pivotal to NIH’s efforts to drive innovation forward towards commercialization and successfully meet the statutory goals of the agency and of the SBIR program. The EiRs are experts that meet (in-person and virtually) with innovators focused on topics including:

Establishing advisory boards Layering intellectual property protection Understanding and preparing for regulatory interactions Gathering evidence to support reimbursement value Engaging with investors or strategic partners Strengthening value proposition to address market needs

The vast majority of EiR-led sessions with innovators are conducted virtually. In rare occasions (2-3 times per year per EiR, pending federal approval), EiR’s may also participate in pavilions and other efforts where SBIR-funded innovators are actively connecting with potential partners necessary to advance innovations forward with non-federal funding. In these cases, EiRs are assisting with onsite connections, facilitating discussions and providing technical direction.

SCOPE

NIA requires a contractor to provide support for NIA OSEP’s mission of facilitating development and advancement towards commercialization of products that would extend and enhance the health of older adults. NIA OSEP will achieve this by providing a single EiR that would support NIA 20 hours/week. The proposed EiR must possess professional expertise in entrepreneurship, investment, and product development activities, to advise funded innovators. Optionally, this contractor may be required to develop contractual agreements with specific life science and healthcare event organizers to enable the connection of NIH-supported innovators to the investors and strategic partners required for their continued product and service development.

MANAGEMENT

The contractor shall:

Work with NIA OSEP staff to identify knowledge gaps and propose highly qualified EiR and business analyst candidates as needed.

Provide a summary, on December 15th and May 15th of each year enumerating EiR activities that might impact the impartiality of any given EiR (Conflict of Interest summary) to the Director of NIA OSEP.

Period of Performance The anticipated period of performance is for a 12-month base period, two 12-month option periods as follows:

Base Period: 9/10/2025 – 9/9/2026 Option Period 1: 9/10/2026 – 9/9/2027 Option Period 2: 9/10/2027 – 9/9/2028

Level of effort NIA anticipates that the EIR would provide support 20 hours per week in the base year and each of two option years.

TECHNICAL REQUIREMENTS

Independently and not as an agent of the government, the contractor shall be required to furnish all the necessary services, qualified personnel, material, resources, equipment, and facilities, not otherwise provided by the government, as needed to perform this Statement of Work (SOW).

1.1 Entrepreneur in Residence (EiR) Support

Entrepreneur in Residence activities The contractor shall provide an EIR who is individually capable of guiding NIH awardees and program staff in understanding and acting upon the following knowledge areas:

Business development Entrepreneurship Developing product development partnerships Delivering effective pitch presentations Networking skills Understanding and investigating their competitive landscape Commercialization strategy development Other general or specific business advice as needed

The EiR provided by this contract should have significant expertise in the development and commercialization of digital health and agetech. Digital health and agetech represent over 40% of the NIA SBIR/STTR portfolio (as of FY25) which creates a need for this specialized expertise.

NIH SEED, through a separate contract, supports EiRs with complementary expertise that more closely represents the remaining 60% of the NIA SBIR/STTR portfolio including therapeutics and diagnostics.

EiRs shall also possess a strong network of investors and strategic partners whom they are willing to introduce to NIH funded companies at appropriate stages of development. EiRs are expected (upon request of NIA OSEP) to attend Company Showcase program events and provide on-site support to NIH staff and company representatives and contribute to the overall NIH presence as requested.

Typical tasks for the EIRs will include but are not limited to:

preparing innovators to engage in conversations and collaborations with:

o investors (angels, foundations, family offices, venture capital firms, etc.)

o product or service end users and payers (research facilities, clinical providers, clinical sites, payers, etc.)

o the US Food and Drug Administration and other regulatory health authorities or regulatory bodies, o product development partners (contract organizations, strategic partners, larger pharma, biotech, diagnostic, and device companies) o investors (angels, foundations, family offices, venture capital firms, etc.)

engaging with the NIH innovator community in virtual and in-person events to develop and deliver educational materials to illuminate the strategy and practical aspects of life science product and service commercialization activities providing the technical direction for NIA entrepreneurial development programing including the development and implementation of programs to support entrepreneurial development in the aging sector serving as instructors and advisors for the NIA Startup Challenge which is a 5-month accelerator for first time entrepreneurs providing technical direction to NIA staff on program development and implementation in the areas of business development and entrepreneurship Optional tasks:

1.2 Technical and Logistical Support

Travel As part of their responsibilities, each EiR may support (in-person) approximately two-to three investor or partnering events per year where in-person participation will have a tangible benefit.

EiRs will also participate virtually in a larger number of meetings. EiRs may also be requested to attend additional events organized by NIH or NIA stakeholder groups. Travel is expected to total up to $10,000 in the base and each of the option periods under this contract. Individual travel requests must be approved by the COR. The need for in-person travel must be justified and is subject to federal and NIH travel restrictions.

Optional task:

Contract execution with life science event organizers (for the base period and all option periods)

The contractor shall provide for the development and execution of subcontracts with event organizers to enable NIA staff and/or innovators from the NIA SBIR and Startup Challenge portfolio to attend, present, and engage investors and strategic partners (i.e. pay for registrations, vendor booth exhibition costs, presentation costs, meeting space, etc.).

Contractor shall collaborate with NIA OSEP to determine which event organizers will be used.

Details about these subcontracts will be developed collaboratively with the event organizers, OSEP leadership, and the contractor. All payments would be approved by OSEP leadership in advance. Actual costs not to exceed $100,000 total per year which can be split across multiple events and will be paid at an actual expense. (Offerors shall include this in their price proposal and specify any overhead rates)

Historic subcontracts have been executed to support innovator registrations and (occasional) exhibit space for NIH/NIA with the following organizations:

AdvaMed (the MedTech Conference), Angel Capital Association (Annual Sumit of Investing), BIO

International (Annual Meeting), Biotech Showcase, Center for Biotechnology (Life Science Summit), HLTH (ViVE, hlth), Landmark Angel Forum (event series), Life Science Nation (RESI conference event series), Life Science Women’s Conference, MedCity Invest, MedTech Color (Annual Pitch Competition), Longevity Venture Summit, Argentum, Leading Age, and USAging.

NIH/NIA will provide contact information for all organizations with which a relationship has already been established. NIH/NIA may request information about and connection with additional event organizers from the selected vendor to meet emerging trends or currently unaddressed market space. NIA may choose to continue or discontinue relationships with any of these event organizers, this list is intended to be illustrative.

Deliverables:

Bi-monthly Status Report – due by the 15th calendar day every other month. Content and format to be agreed upon by the contractor and the NIA Technical Manager (OSEP TM).

Provide a summary, on October 15th and April 15th of each year enumerating EiR activities that might impact the impartiality of any given EiR (Conflict of Interest summary) to the Director of NIA OSEP Provide a summary, on December 15th and May 15th of each year enumerating EiR activities that might impact the impartiality of any given EiR (Conflict of Interest summary) to the Director of NIA OSE Concise written summaries of events attended by EiRs upon request of the OSEP – due to the OSEP TM by the 3rd business day after the conclusion of the event.