TY - JOUR
T1 - Accelerated Preclinical Paths to Support Rapid Development of COVID-19 Therapeutics
AU - Grobler, Jay A.
AU - Anderson, Annaliesa S.
AU - Fernandes, Prabhavathi
AU - Diamond, Michael S.
AU - Colvis, Christine M.
AU - Menetski, Joseph P.
AU - Alvarez, Rosa M.
AU - Young, John A.T.
AU - Carter, Kara L.
N1 - Publisher Copyright:
© 2020 Elsevier Inc.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/11/11
Y1 - 2020/11/11
N2 - 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. The global COVID19 pandemic underscores the urgent need for an accelerated path for drug discovery and development. In this Perspective, Grobler et al. outline roadmaps to support prioritization of the most promising therapeutic agents while ensuring clinical safety.
AB - 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. The global COVID19 pandemic underscores the urgent need for an accelerated path for drug discovery and development. In this Perspective, Grobler et al. outline roadmaps to support prioritization of the most promising therapeutic agents while ensuring clinical safety.
UR - http://www.scopus.com/inward/record.url?scp=85095427760&partnerID=8YFLogxK
U2 - 10.1016/j.chom.2020.09.017
DO - 10.1016/j.chom.2020.09.017
M3 - Review article
C2 - 33152278
AN - SCOPUS:85095427760
VL - 28
SP - 638
EP - 645
JO - Cell Host and Microbe
JF - Cell Host and Microbe
SN - 1931-3128
IS - 5
ER -