Biological Therapeutics Product Development Subject Matter Expert Consulting Services
Closed Pre-Solicitation Posted
- Solicitation number
- 75N98026R00148
- Agency
-
National Institute of Child Health and Human Development
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- R499 Support- Professional: Other
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health, Office of the Director is conducting a market survey to identify small business capability for providing gene-based therapeutics development subject matter expert consulting services to support translational drug discovery and development programs, with capability statements due by August 19, 2026. This procurement is set aside for small businesses, including 8(a) small businesses, small disadvantaged businesses, women-owned small businesses, service-disabled veteran-owned small businesses, and HUBZone small businesses.
The Statement of Work specifies support for the National Institute of Neurological Disorders and Stroke in developing therapeutic biotechnology products, with particular focus on chemistry, manufacturing, and controls expertise for synthetic oligonucleotides (antisense oligonucleotides and small interfering RNAs) and other gene-based therapeutic modalities including AAV, lentivirus, and non-viral vectors. The contractor shall provide 4–5 consultants during the performance period. Key personnel must hold a Master's, PhD, or MD in a relevant scientific discipline (or PhD-level experience with a Bachelor's or Master's degree), at least ten years of relevant professional experience, at least ten years of demonstrated experience in oligonucleotide and siRNA therapy product development, and at least ten years managing or leading therapeutics development projects in the biopharmaceutical industry. Consultants supporting the URGenT program must have at least five years of experience with rare or ultra-rare product development programs.
The period of performance runs September 21, 2026 through September 2029, consisting of a one-year base period and two one-year option periods. Performance occurs primarily at the contractor's site, with travel within the contiguous United States required on an as-needed basis. NAICS code is 541690 (size standard: $19 million).
Notice text
The National Institutes of Health (NIH), Office of the Director (OD) is conducting a market survey to determine the availability and technical capability of qualified small businesses, including 8(a) small businesses, small, disadvantaged businesses, woman-owned small businesses, service-disabled veteran-owned small businesses or HUBZone small businesses capable of providing the services of Gene-Based Therapeutics development subject matter expert (SME) consultants to provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs.
Interested firms with the capability of providing all the required services shall submit a capability statement to assist the Government in determining in accordance with the Federal Acquisition Regulation 19.104-1.
The intended procurement will be classified under North American Industrial Classification (NAICS) code 541690 with a size standard of $19m. All respondents are required to identify their firm’s size and type of business. Interested firms responding to this market survey must provide (a) capability statement demonstrating their experience, skills and capability to fulfill the Government’s requirements for the above. The capability statement shall be in sufficient enough details so that the Government can determine the experience and capability of your firm to provide the items and services in this posting/notice. Offers must also be accompanied by applicable descriptive literature, delivery timeframe, warranties and other information that demonstrates that the offer meets all the foregoing requirements. Capability statements must include the name and telephone number, and email address of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to the market survey that do not provide sufficient information for evaluation will be considered non-responsive. A copy of the capability statement must be received via email to robinsti@mail.nih.gov Attn: Tina Robinson prior to 10:30 am eastern daylight time on August 19, 2026. Capability statement must reference solicitation# 75N98026R00148. Submission by email must also reference solicitation # 75N98026R00148 on the subject line of the email. Any questions must be sent via email to robinsti@mail.nih.gov and must include solicitation# 75N98026R00148 on the subject line of email. Capability statements, etc will not be returned to firm/sender. This synopsis is for information and planning purposes and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.
Files
| File | Type | Posted |
|---|---|---|
| Statement of Work - Biological Therapeutics.pdf |
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