This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) having capability to carry out development of formulations, manufacture, quality control tests, stability studies and distribution of pharmaceutical drug products to be used in the medications development program for treating substance use disorders).
This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond.
Background: The National Institute on Aging (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 Small Business Innovation Research, and Small Business Technology Transfer (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.
Purpose and Objectives: 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 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.
Project requirements: 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
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 an EiR, 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.
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.
Anticipated period of performance: NIA anticipates the use of Options to extend the period of performance and Option to Increase Quantity. The anticipated period of performance is for a base year with two additional 12-month option periods.
Other important considerations: 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.
Capability statement /information sought.
Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.
Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.
The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.
The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested.
All responses to this notice must be submitted electronically to the Contracting Officer. Facsimile responses are NOT accepted.
The response must be submitted to Joshua Lazarus, Contracting Officer, at josh.lazarus@nih.gov.
The response must be received on or before July 29, 2025, at 1:00 pm, Eastern Time.
“Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.
Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
