S07: EU Research Framework Programme 6 – Innovative medicines for Europe – InnoMed: Integrated project predictive toxicology – PredTox

Abstract

In order to increase early attrition in preclinical pharmaceutical drug development, the new omics technologies have been assessed by investigational toxicologists and technology experts. The InnoMed PredTox consortium with participation of 3 academic institutions, 2 technology vendors and 15 major pharmaceutical companies, has focused on a systematic and integrated -omics approach assessed against conventional toxicology assessment in the rat. EFPIA (European Federation of Pharmaceutical Industries and Associations) is the coordinator of the InnoMed project. As a unique feature, the consortium members have selected 14 proprietary compounds, troglitazone that had been withdrawn from the market, and a reference nephrotoxicant, gentamycin. The drug development program of the proprietary compounds was abandoned for hepato-/nephrotoxicity reasons at different development stages. The presentation will summarize the project plan and goals. The project involves the construction of a relational database populated with data from in vivo experiments of compounds with known toxicity profile. It will include traditional endpoints, esp. toxicological pathology supplemented with information from newer techniques, i.e. transcriptomics, metabonomics and proteomics. The goal was to obtain better insight into drug-induced organ toxicity and to confirm and detect early molecular biomarkers of organ toxicity for predicting toxicity earlier in the development process.