# Biological Therapeutics Product Development Subject Matter Expert Consultants to Support the Development of Therapeutic Biotechnology Products (Biologics)

Canonical: https://abierto.us/opportunities/nihnindssbssn25000977

- Solicitation number: NIH-NINDS-SBSSN-25-000977
- Notice type: Sources sought
- Status: Closed. Deadline was December 6, 2024 at 9:00 AM EST
- Department: Department of Health and Human Services
- Agency: National Institutes of Health
- Contracting office: National Institutes of Health Nida (75N950)
- 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: November 22, 2024
- Last posted: November 22, 2024
- SAM.gov: https://sam.gov/workspace/contract/opp/18aec109355242479b3ff1c4ccc9a909/view

## Description

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.

## Publications

- November 22, 2024: Sources sought, due December 6, 2024 at 9:00 AM EST. Notice 18aec109355242479b3ff1c4ccc9a909. https://sam.gov/workspace/contract/opp/18aec109355242479b3ff1c4ccc9a909/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/nihnindssbssn25000977.