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 - Funding Information:
This work was done on behalf of the ACTIV Preclinical Working Group (https://www.nih.gov/research-training/medical-research-initiatives/activ/preclinical-working-group). We thank Nataliya Natasha Kushnir (Pfizer) for help with referencing and Katinka Vigh-Conrad for assistance with figures. Authors of the manuscript are members of ACTIV Preclinical Working group. Jay A Grobler is a shareholder in Merck. Annaliesa S Anderson is an employee of Pfizer, receives a salary from Pfizer and may own Pfizer stock; she is also a non-salaried member of the Contrafect Scientific Advisory Board. Michael S. Diamond is a consultant for Inbios, Vir Biotechnology, and NGM Biopharmaceuticals and is on the Scientific Advisory Board of Moderna and Immunome. The Diamond laboratory has received unrelated funding support in sponsored research agreements from Moderna, Vir Biotechnology, and Emergent BioSolutions. John A.T. Young is an employee and shareholder of F.Hoffmann-La Roche, Ltd. Kara Carter is on the Scientific Advisory Board for the Alabama Drug Discovery and Development Consortium and owns stock in Evotec and Celldex Therapeutics.
Publisher Copyright:
© 2020 Elsevier Inc.
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
SN - 1931-3128
VL - 28
SP - 638
EP - 645
JO - Cell Host and Microbe
JF - Cell Host and Microbe
IS - 5
ER -