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HEALTH AND HUMAN SERVICES, DEPARTMENT OF | NATIONAL INSTITUTES OF HEALTH has floated a tender for Biological Therapeutics Product Development Subject Matter Expert Consultants to Support the Development of Therapeutic Biotechnology Products (Biologics). The project location is USA and the tender is closing on 06 Dec 2024. The tender notice number is NIH-NINDS-SBSSN-25-000977, while the TOT Ref Number is 110600132. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.
Procurement Summary
Country : USA
Summary : Biological Therapeutics Product Development Subject Matter Expert Consultants to Support the Development of Therapeutic Biotechnology Products (Biologics)
Deadline : 06 Dec 2024
Other Information
Notice Type : Tender
TOT Ref.No.: 110600132
Document Ref. No. : NIH-NINDS-SBSSN-25-000977
Competition : ICB
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
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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.
Active Contract Opportunity
Notice ID : NIH-NINDS-SBSSN-25-000977
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NATIONAL INSTITUTES OF HEALTH NIDA
General Information
Contract Opportunity Type: Sources Sought (Original)
Original Published Date: Nov 22, 2024 02:35 pm EST
Original Response Date: Dec 06, 2024 09:00 am EST
Inactive Policy: 15 days after response date
Original Inactive Date: Dec 21, 2024
Initiative: None
Classification
Original Set Aside:
Product Service Code:
NAICS Code:
Place of Performance: Bethesda, MD USA
Documents
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