InnoMed PredTox

InnoMed PredTox is a joint Industry and European Commission collaboration to improve drug safety. The consortium is composed of 15 research groups from 12 pharmaceutical companies, three academic institutions and two technology providers. The goal of InnoMed PredTox is to assess the value of combining results from omics technologies together with the results from more conventional toxicology methods for more informed decision making in preclinical safety evaluation.

The project was initiated in October 2005 with a term of 40 month. It receives funding as an Integrated Project under the Sixth Framework Programme. The project had been set up jointly by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission as a pilot project for the subsequent design of the Innovative Medicines Initiative

As part of InnoMed PredTox the partners ran a series of regular 14 days toxicological studies in rats with daily dosing. The compounds had been selected representing compounds with promising drug-like properties but that had been terminated due to toxic effects on the liver and/or kidneys.

The project collected and jointly analysed transcriptomics, proteomics, metabonomics and conventional toxicological data on 14 failed drug candidates together with two reference compounds, troglitazone and gentamicin. As data integration across different data areas and technology platforms is considered a prerequisite to building a consistent standardised data schema for joint analysis all project data are stored in a database custom developed by Genedata.

Joint research activities like InnoMed PredTox are seen by the pharmaceutical industry as the most promising approach to increasing the number of generally accepted, measurable indicators biomarkers of toxic (side-) effects. In particular, as the consortia facilitate the efficient exchange of experience in this pre-competitive area of drug development and early involvement of regulatory authorities like the FDA and EMEA.

Milestones
Status: August 2008