Attachment 1 - Statement of Work.pdf

Attachment 1

STATEMENT OF WORK

Title: NIA Entrepreneurs in Residence (EiR) Support

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 FY23, 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 help 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 have been performed primarily by OSEP contractors that are referred to as Entrepreneurs in Residence (EiRs).

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 are experts that meet (in-person and virtually) with innovators focused on topics including:

• Optimizing drug development activities

• 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

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 EiRs, that 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 event organizers to enable the connection of NIH 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 6-month base period, two 12-month option periods, and one 6-month option period as follows:

Base Period: September 12, 2024-March 11, 2025 Option Period 1: March 12, 2025-March 11, 2026 Option Period 2: March 12, 2026-March 11, 2027 Option Period 3: March 12, 2027-September 11, 2027

Level of effort EIR’s would work 20 hours per week Base year is requested at 2 EIR’s that each work 20 hours per week Option Periods should include option pricing for 1 additional EIR that works 20 hours per week(This should be an option within the option)

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 EIRs who are individually and collectively 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

Among the team of EiRs complementary experience (e.g., therapeutics, diagnostics, agetech, and digital health) is required to provide a robust and well-rounded set of expertise for the benefit of the NIA innovator community.

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

• supporting 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

• advising NIA staff on program development and implementation in the areas of business development and entrepreneurship

1.2 Technical and Logistical Support

Travel and Training As part of their responsibilities, EiRs are expected to support (in-person) at least five investor or partnering events per year where NIA OSEP is supporting registration for awardee companies.

EiRs may also be requested to attend additional events organized by NIH or NIA stakeholder groups. Travel is expected to total an average of up to $15,000 per year per EiR and individual travel requests must be approved by the COR.

EiRs are also encouraged to participate in trainings that will enhance their ability to provide strong expertise to the broad range of awardee companies. Training costs are expected to cost up to $15,000 total per year (total for two EiRs). As with travel requests, training requests must be approved by the COR.

Optional tasks:

1 additional EIR (at 50%) for option years only (not base year)

Contract execution with life science event organizers (for all years) *This should be a T&M line item

The contractor shall provide for the development and execution of subcontracts with event organizers to enable innovators from the NIA portfolio to attend, present, and engage investors and strategic partners (ie: pay for registrations, vendor booth exhibition costs, presentation costs, etc). Contractor will 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 and will be paid at an actual expense.

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 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 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.