Inactive

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 ... 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.