Complex in vitro models positioned for impact to drug testing in pharma: a review.

Autor:	Kang S; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Chen EC; Department of Drug Metabolism and Pharmacokinetics, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Cifuentes H; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Co JY; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Cole G; Investigative Toxicology, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Graham J; Product Quality & Occupational Toxicology, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of Americaica., Hsia R; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Kiyota T; Investigative Toxicology, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Klein JA; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Kroll KT; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Nieves Lopez LM; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Norona LM; Investigative Toxicology, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Peiris H; Human Genetics, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Potla R; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Romero-Lopez M; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Roth JG; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Tseng M; Investigative Toxicology, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Fullerton AM; Investigative Toxicology, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America., Homan KA; Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America.
Jazyk:	angličtina
Zdroj:	Biofabrication [Biofabrication] 2024 Aug 27; Vol. 16 (4). Date of Electronic Publication: 2024 Aug 27.
DOI:	10.1088/1758-5090/ad6933
Abstrakt:	Recent years have seen the creation and popularization of various complex in vitro models (CIVMs), such as organoids and organs-on-chip, as a technology with the potential to reduce animal usage in pharma while also enhancing our ability to create safe and efficacious drugs for patients. Public awareness of CIVMs has increased, in part, due to the recent passage of the FDA Modernization Act 2.0. This visibility is expected to spur deeper investment in and adoption of such models. Thus, end-users and model developers alike require a framework to both understand the readiness of current models to enter the drug development process, and to assess upcoming models for the same. This review presents such a framework for model selection based on comparative -omics data (which we term model-omics), and metrics for qualification of specific test assays that a model may support that we term context-of-use (COU) assays. We surveyed existing healthy tissue models and assays for ten drug development-critical organs of the body, and provide evaluations of readiness and suggestions for improving model-omics and COU assays for each. In whole, this review comes from a pharma perspective, and seeks to provide an evaluation of where CIVMs are poised for maximum impact in the drug development process, and a roadmap for realizing that potential. (Creative Commons Attribution license.)
Databáze:	MEDLINE
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