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ISS-1a

The Investigative Toxicology Consortium Symposium 

Programme of the Session

  • Setting the scene - The Investigative Toxicology landscape in the European pharmaceutical industry

    Adrian Roth
    Pharmaceutical Sciences, Roche Innovation Centre Basel, Hoffmann-La Roche Ltd, Basel, Switzerland

  • A short summary of the first ‘European Think Tank on Investigative Toxicology’
    Thomas Hartung
    Johns Hopkins University, Baltimore, United States

  •  The role of pre-competitive consortia for Investigative Toxicology – a spotlight on the IMI eTOX initiative 
    Thomas Steger-Hartmann

    Investigational Toxcology, Bayer AG, Berlin, Germany

  • De-risking primary and secondary pharmacology mediated adverse effects as a path to increase likelihood of success in drug development
    Jean-Pierre Valentin, Franck Atienzar, Reiner Class, Annie Delaunois, Renaud Fleurance, Helga Gerets, Stéphanie Glineur, Vitalina Gryshkova, Peter Hall, Catrin Hasselgren, Karen Tilmant
    Non-Clinical Development, UCB Biopharma, Braine L'Alleud, Belgium

  • How to integrate Investigative Toxicology in the drug discovery pipeline
    Tomas Mow 
    Safety Pharmacology and Exploratory Toxicology, Novo Nordisk A/S, Maaloev, Denmark
  • Analysis of HSP90 using a toxicity-based triaging approach for drug targets 
    Jennifer Venhorst, Eugene P. van Someren, Fred J. van de Brug, Gino J. Kalkman, Simon Folkertsma, Cyrille A.M. Krul

    TNO, Zeist, Netherlands

Session Abstract

“Investigative Toxicology" is a relatively young discipline in pharmaceutical safety assessment which sees itself complementary to regulatory toxicology. Whereas regulatory toxicology's boundaries are set by international guidelines and its methods and technologies have matured over the last decade, Investigative Toxicology is more driven by the individual company needs.  Investigative Toxicology is seen as a discipline which moves safety assessment from a descriptive to a mechanistic understanding and an improved human translation. Based on such mechanistic understanding Investigative Toxicology’s primary task in drug development is the identification of the most promising (safe) drug candidates and to deselect the most toxic drugs from the portfolio as early as possible to reduce clinical attrition.

A group of 14 European-based Investigative Toxicology leaders from the pharmaceutical industry (AstraZeneca, Bayer, Boehringer Ingelheim, GSK, Janssen, Lundbeck, Merck, Novartis, Novo Nordisk, Orion Pharma, Roche, Sanofi, Servier and UCB-Biopharma) have formed the Investigative Toxicology Leader (ITL) Forum. This Forum aims for an exchange of pre-competitive knowledge among the companies and an interaction with experts from academia and regulatory bodies in the field of Investigative Toxicology. The objective is to elaborate robust, reliable and accepted Investigative Toxicology concepts for decision making for early safety-related attrition, de-risking, and mechanistic elucidation of effects. Another key aspect is the translation of in vitro to in vivo mechanistic data. Furthermore the adoption of new technologies (e.g. micro-physiological systems) and assays into the drug discovery back-bone is targeted by the forum.

In order to initially assess the status quo within the pharmaceutical industry the forum developed a questionnaire which was answered by ITL forum member companies. Results of this analysis will be presented and conclusions discussed. In addition, the symposium will provide an overview of the different technological aspects of Investigation Toxicology based on case examples from the pharmaceutical industry.”

 

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