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ISS-1b

The Investigative Toxicology Consortium Symposium - Part 2

Programme of the Session

  • Stem cells, organoids and microphysiological systems coupled to modeling & simulation guide drug discovery and enhance translational safety risk assessment 
    Pete Newham

    Drug Safety & Metabolism, AstraZeneca, Cambridge, United Kingdom

  • Case study: Identification of off/on target mechanisms effects inducing genotoxicty
    Andreas Czich
    Preclinical Safety - Global Operation Germany, Sanofi, Frankfurt, Germany

  • Case study: Addressing human relevance preclinical tumor findings using advanced cell models  
    Adrian Roth
    Pharmaceutical Sciences, Roche Innovation Centre Basel, Hoffmann-La Roche Ltd, Basel, Switzerland

  • Chemoproteomic approaches for off-target hazard identification
    Marcus Bantscheff
    Cellzome, GSK, Heidelberg, Germany

  • How advanced cell models can be used for toxicity investigations during drug development – a case example
    Mario Beilmann 
    Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany

  • Integrating transcriptomic profiling in early safety screening – a case study
    Freddy Van Goethem
    Mechanistic & Investigative Toxicology, Janssen R&D, Beerse, Belgium

Session Abstract

The Investigative Toxicology Consortium is an initiative of 13 pharmaceutical companies, i.e. AstraZeneca, Bayer, Boehringer Ingelheim, GSK, Janssen, Lundbeck, Merck, Novartis, Novo Nordisk, Orion Pharma, Roche, Sanofi, Servier and UCB. This consortium aims at exchange of pre-competitive knowledge and exchange of knowledge with academia and regulatory bodies in the field of investigative toxicology. The aim is to elaborate robust and reliable and accepted investigative toxicology concepts for decision making for early attrition, de-risking, and mechanistic elucidation of effects. The support of regulatory decision making over finding on the base of mechanisms and also to non-valid investigations. The consortium aims at scientific discussion with academics and regulators and other industry scientists on organ-focused toxicity assessment, new concepts of adverse outcome pathways and integrated risk assessment in order to work out chances, challenges and limitations. Furthermore, an additional focus lays on the translation of in vitro to in vivo mechanistic data. Also the adaptation of new technologies (e.g. microphysiological systems) and assays into the portfolio is targeted by the consortium
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