# Biological Therapeutics Product Development Subject Matter Expert Consultants

Canonical: https://abierto.us/opportunities/nihnindscss75n95025q00109

- Solicitation number: NIH-NINDS-CSS-75N95025Q00109
- Notice type: Combined synopsis and solicitation
- Status: Closed. Deadline was January 27, 2025 at 1:00 AM EST
- Department: Department of Health and Human Services
- Agency: National Institutes of Health
- Contracting office: National Institutes of Health Nida (75N950)
- NAICS: 541690 Other Scientific and Technical Consulting Services
- Product or service code: R499 Other Professional Services
- Place of performance: Bethesda, Maryland
- County: Montgomery County (FIPS 24031). https://abierto.us/counties/montgomery-county-md-24031
- City: Bethesda. https://abierto.us/cities/bethesda-md-2407125
- First posted: January 2, 2025
- Last posted: January 15, 2025
- SAM.gov: https://sam.gov/workspace/contract/opp/03ae3675788844498ab252f5568c912b/view

## Description

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.

## Publications

- January 2, 2025: Combined synopsis and solicitation, due January 27, 2025 at 1:00 AM EST. Notice 3d2dee29eb7a4e949ddf706c3433d106. https://sam.gov/workspace/contract/opp/3d2dee29eb7a4e949ddf706c3433d106/view
- January 15, 2025: Combined synopsis and solicitation, due January 27, 2025 at 1:00 AM EST. Notice 03ae3675788844498ab252f5568c912b. https://sam.gov/workspace/contract/opp/03ae3675788844498ab252f5568c912b/view

## Points of contact

- Shayna Simpson, shayna.simpson@nih.gov
- Kelly Dempsey, kelly.dempsey@nih.gov

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/nihnindscss75n95025q00109.