Author: Grobler, Jay A.; Anderson, Annaliesa S.; Fernandes, Prabhavathi; Diamond, Michael S.; Colvis, Christine M.; Menetski, Joseph P.; Alvarez, Rosa M.; Young, John AT.; Carter, Kara L.
Title: Accelerated preclinical paths to support rapid development of COVID-19 therapeutics Cord-id: er8ct8qc Document date: 2020_10_1
ID: er8ct8qc
Snippet: When SARS-CoV-2 emerged at the end of 2019, no approved therapeutics or vaccines were available. An urgent need for countermeasures during this crisis challenges the current paradigm of traditional drug discovery and development, which usually takes years from start to finish. Approaches that accelerate this process need to be considered. Here we propose the minimum data package required to move a compound into clinical development safely. We further define the additional data that should be col
Document: When SARS-CoV-2 emerged at the end of 2019, no approved therapeutics or vaccines were available. An urgent need for countermeasures during this crisis challenges the current paradigm of traditional drug discovery and development, which usually takes years from start to finish. Approaches that accelerate this process need to be considered. Here we propose the minimum data package required to move a compound into clinical development safely. We further define the additional data that should be collected in parallel without impacting the rapid path to clinical development. Accelerated paths for antivirals, immunomodulators, anticoagulants and other agents have been developed and can serve as "roadmaps" to support prioritization of compounds for clinical testing. These accelerated paths are fueled by a skewed risk-benefit ratio and are necessary to advance therapeutic agents into human trials rapidly and safely for COVID-19. Such paths are adaptable to other potential future pandemics.
Search related documents:
Co phrase search for related documents- accelerated response and adequate supply: 1
- acceptable safety and acute ards respiratory distress syndrome: 1
- acceptable safety and additional case: 1
- acceptable safety and lopinavir ritonavir: 1, 2
Co phrase search for related documents, hyperlinks ordered by date