SOLICITATION NOTICE
65 -- Acquisition of cGMP-grade GS-441524 for the Treatment of COVID-19
- Notice Date
- 11/24/2020 10:57:24 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95021Q00015
- Response Due
- 12/1/2020 5:59:00 AM
- Archive Date
- 12/07/2020
- Point of Contact
- Kimberly Espinosa, Phone: 3018273546
- E-Mail Address
-
kimberly.espinosa@nih.gov
(kimberly.espinosa@nih.gov)
- Description
- The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), with a mission to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. NCATS is evaluating GS-441524 as a potential treatment for SARS-CoV-2 infection. GS-441524 is the parent nucleoside of remdesivir and has similar efficacy to remdesivir in vitro.�GS-441524 is a stable crystalline compound with good physical properties for formulation, and the 3-step synthesis of GS-441524 makes it suitable for large scale production. The purpose of this acquisition is to provide Chemistry, Manufacturing and Controls (CMC) support for the preclinical and clinical development of GS-441524 as a potential antiviral against SARS-CoV-2, the causative agent of the pandemic disease COVID-19. NCATS will perform preclinical and Phase 1 clinical studies with GS-441524, and gather information on its safety and tolerability, efficacy, pharmacokinetics, and dose-range in human. To cover the requirements of the studies, NCATS will need a batch of GS-441524 adhering to current Good Manufacturing Practice (cGMP) guidelines from a qualified Contract Manufacturing Organization (CMO).�� See attached Request for Quotations and associated attachments for complete requirement details.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/c1d10d38341949b68668012ec7bf8bb6/view)
- Record
- SN05860549-F 20201126/201125053805 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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