ISS-1b

The Investigative Toxicology Consortium Symposium - Part 2

Programme of the Session

ISS_1b-01
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
ISS_1b-02
Case study: Identification of off/on target mechanisms effects inducing genotoxicty
Andreas Czich
Preclinical Safety - Global Operation Germany, Sanofi, Frankfurt, Germany
ISS_1b-03
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
ISS_1b-04
Chemoproteomic approaches for off-target hazard identification
Marcus Bantscheff
Cellzome, GSK, Heidelberg, Germany
ISS_1b-05
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
ISS_1b-06
Integrating transcriptomic profiling in early safety screening – a case study
Freddy Van Goethem
Mechanistic & Investigative Toxicology, Janssen R&D, Beerse, Belgium

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.”