SOURCES SOUGHT
99 -- Biological Therapeutics Product Development Subject Matter Expert Consultants to Support the Development of Therapeutic Biotechnology Products (Biologics)
- Notice Date
- 11/22/2024 11:35:38 AM
- Notice Type
- Sources Sought
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- NIH-NINDS-SBSSN-25-000977
- Response Due
- 12/6/2024 6:00:00 AM
- Archive Date
- 12/21/2024
- Point of Contact
- Shayna Simpson, Kelly Dempsey
- E-Mail Address
-
shayna.simpson@nih.gov, kelly.dempsey@nih.gov
(shayna.simpson@nih.gov, kelly.dempsey@nih.gov)
- 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/18aec109355242479b3ff1c4ccc9a909/view)
- Place of Performance
- Address: Bethesda, MD, USA
- Country: USA
- Country: USA
- Record
- SN07273866-F 20241124/241122230115 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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