Biological Therapeutics Product Development Subject Matter Expert Consultants
Closed Solicitation Posted
- Solicitation number
- NIH-NINDS-CSS-75N95025Q00109
- Agency
-
National Institute on Drug Abuse
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- R499 Support- Professional: Other
- Place of performance
- Bethesda, Maryland, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Neurological Disorders and Stroke (NINDS) is seeking subject matter expert (SME) consultants to support biological therapeutics product development across multiple scientific domains. This labor-hour contract will provide technical recommendations and advice for NIH drug discovery and development programs through Phase 1 clinical trials. The required expertise spans chemistry, manufacturing, controls, pharmacokinetics, toxicology, regulatory affairs, medical writing, biostatistics, and quality assurance/control. Quotations are due by 1:00 PM ET on January 27, 2025, with initial questions due by January 13, 2025. The evaluation will occur in two phases, with the first phase focusing on personnel qualifications, price, and past performance, and the second phase potentially involving oral presentations for the highest-rated quoters. Technical factors will be weighted most significantly in the evaluation process, with the government making an award based on best value.
The solicitation is a small business set-aside under NAICS category 541690 with a size standard of $16.5 million. The contract includes a one-year base period from April 1, 2025, to March 30, 2026, with two additional one-year option periods possible through March 30, 2028. The government anticipates requiring 1-10 SMEs with a minimum of 10 years of professional experience, preferring candidates with MS/PhD/MD credentials. The initial funding will cover 20 hours per expert, with up to 3,980 optional hours annually, and travel reimbursement capped at $1,500 per consultant per year. The primary place of performance will be remote, with potential occasional travel to Bethesda, MD. The contract will support multiple NIH programs, including the Blueprint Neurotherapeutics Network Biologics program, Ultra-Rare Gene Therapy program, and Helping to End Addiction Long-term Pain Therapeutics Development Program.
Notice text
2 versions
Update #2 · Latest ·
Attachment 01 Amend 1_CSS 75N95025Q00109 has been added on 1/15/25 to address questions related to this solicitation.
The NINDS has a need for biological 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. The support included in this contract will cover all aspects of drug discovery and development through the Phase 1 clinical trial, including but not limited to chemistry, manufacturing, and controls (CMC), assay development, pharmacokinetics and pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME), toxicology, regulatory affairs, regulatory operations, medical writing, biostatistics, and quality assurance/quality control (QA/QC), and first-in-human trial planning and design. The NINDS is seeking vendors who can supply a broad array of Biologics subject matter experts, including all modalities and cell and gene therapies.
Update #1 ·
The NINDS has a need for biological 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. The support included in this contract will cover all aspects of drug discovery and development through the Phase 1 clinical trial, including but not limited to chemistry, manufacturing, and controls (CMC), assay development, pharmacokinetics and pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME), toxicology, regulatory affairs, regulatory operations, medical writing, biostatistics, and quality assurance/quality control (QA/QC), and first-in-human trial planning and design. The NINDS is seeking vendors who can supply a broad array of Biologics subject matter experts, including all modalities and cell and gene therapies.
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