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Optimizing drug discovery by Investigative Toxicology: Current and future trends

Beilmann, Mario and Boonen, Harrie and Czich, Andreas and Dear, Gordon and Hewitt, Philip and Mow, Tomas and Newham, Peter and Oinonen, Teija and Pognan, Francois and Roth, Adrian and Valentin, Jean-Pierre and Van Goethem, Freddy and Weaver, Richard J. and Birk, Barbara and Boyer, Scott and Caloni, Francesca and Chen, Alice E. and Corvi, Raffaella and Cronin, Mark T. D. and Daneshian, Mardas and Ewart, Lorna C. and Fitzgerald, Rex E. and Hamilton, Geraldine A. and Hartung, Thomas and Kangas, Joshua D. and Kramer, Nynke I. and Leist, Marcel and Marx, Uwe and Polak, Sebastian and Rovida, Costanza and Testai, Emanuela and Van der Water, Bob and Vulto, Paul and Steger-Hartmann, Thomas. (2019) Optimizing drug discovery by Investigative Toxicology: Current and future trends. ALTEX, 36 (2). pp. 289-313.

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Official URL: https://edoc.unibas.ch/77931/

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Abstract

Investigative Toxicology describes the de-risking and mechanistic elucidation of toxicities, supporting early safety decisions in the pharmaceutical industry. Recently, Investigative Toxicology has contributed to a shift in pharmaceutical toxicology, from a descriptive to an evidence-based, mechanistic discipline. This was triggered by high costs and low throughput of Good Laboratory Practice in vivo studies, and increasing demands for adhering to the 3R (Replacement, Reduction and Refinement) principles of animal welfare. Outside the boundaries of regulatory toxicology, Investigative Toxicology has the flexibility to embrace new technologies, enhancing translational steps from in silico, in vitro to in vivo mechanistic understanding to eventually predict human response. One major goal of Investigative Toxicology is improving preclinical decisions, which coincides with the concept of animal-free safety testing. Currently, compounds under preclinical development are being discarded due to the use of inappropriate animal models. Progress in Investigative Toxicology could lead to humanized in vitro test systems and the development of medicines less reliant on animal tests. To advance this field a group of 14 European-based leaders from the pharmaceutical industry founded the Investigative Toxicology Leaders Forum (ITLF), an open, non-exclusive and pre-competitive group that shares knowledge and experience. The ITLF collaborated with the Centre for Alternatives to Animal Testing Europe (CAAT-Europe) to organize an "Investigative Toxicology Think-Tank", which aimed to enhance the interaction with experts from academia and regulatory bodies in the field. Summarizing the topics and discussion of the workshop, this article highlights Investigative Toxicology's position by identifying key challenges and perspectives.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften
UniBasel Contributors:FitzGerald, Reginald Edward
Item Type:Article, refereed
Article Subtype:Research Article
ISSN:1868-596X
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:18 Aug 2020 16:23
Deposited On:18 Aug 2020 16:23

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