Biological Therapeutics Product Development Subject Matter Expert Consultants to Support the Development of Therapeutic Biotechnology Products (Biologics)
Closed Pre-Solicitation Posted
- Solicitation number
- NIH-NINDS-SBSSN-25-000977
- 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
- Not on record
- PSC
- Not on record
- Place of performance
- Bethesda, Maryland, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (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 required support covers all aspects of drug discovery and development through Phase 1 clinical trials, including chemistry, manufacturing, and controls (CMC), pharmacokinetics and pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME), toxicology, regulatory affairs, medical writing, and quality assurance. NINDS is seeking vendors who can supply a broad array of Biologics SMEs across all modalities and cell and gene therapies to support programs such as BPN-Biologics, URGenT, and HEAL-PTDP. Respondents must demonstrate at least 10 years of relevant experience in biologics product development, and responses are limited to 10 pages, due by December 6, 2024.
This is an unrestricted procurement, with no set-aside designation. The notice does not identify any potential incumbents or provide details on award values or budget ranges. The key numerical detail is the requirement for Biologics SMEs with at least 10 years of relevant experience.
Notice text
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.
This requirement supports the NIH Biologics development projects under the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH drug discovery and development programs.
Files
| File | Type | Posted |
|---|---|---|
| Sources Sought_Biologics.pdf |
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