• Research Category Research & Development Services & Subcontracts
• Vendor Name Leidos Biomedical Research, Inc.
• Solicitation Number S24-062
• NCI OA Contract Number 75N91019D00024 – NCI-FFRDC

Description

In support of the NIAID DMID NextGen clinical trials, Leidos Biomed is tasked with the management, oversight, and conduct of activities to support customized gap-filling for the vaccine candidate. This includes completion of reports and documentation that will enable regulatory filing, and evaluation of the vaccine candidate in DMID’s NextGen clinical trial. In support of one vaccine candidate, Leidos Biomed seeks to subcontract with a Contract Development and Manufacturing Organization (CDMO) with a Fill & Finish unit capable of filling single-dose vials of the vaccine candidate, which will be used in a US-based Phase 1 clinical trial.
In support of this effort, the Subcontractor will be provided with ready-to-fill (RTF) bulk drug product in single-use polyethylene terephthalate glycol (PETG) bottles.
Leidos Biomed is seeking a US-based CDMO to provide Fill & Finish services for a messenger Ribonucleic Acid (mRNA) encapsulated in lipid nanoparticles (mRNA-LNP) vaccine for use in a US-based Phase 1 clinical trial. Services shall be conducted in accordance with current Good Manufacturing Practices (cGMP). Leidos Biomed is targeting initiation of Fill & Finish services in the November – December 2024 timeframe. The Subcontractor shall confirm their facility is capable of meeting this timeline.
Subcontractor shall furnish all necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by Leidos Biomed or NIAID DMID. Project Description and Requirements. Subcontractor shall conduct tasks in accordance with all applicable host country, federal, state, and local laws, codes, ordinances and regulations.

Proposal Instructions

Questions and request for clarifications are due no later than 3:30 PM (EST) FRIDAY SEPTEMBER 20, 2024, and offer submissions are due no later than 3:30 PM (EST) FRIDAY SEPTEMBER 27, 2024. Please reach out to Mario Salerno at mario.salerno@nih.gov, to receive the Request for Proposal package containing additional detail & instruction.