They combine results from molecular profiling (omics) technologies together with the findings from conventional toxicology. For this purpose, the InnoMed PredTox consortium members have been compiling a comprehensive set of pre-clinical toxicology data, studying two reference compounds and 14 proprietary compounds that had previously failed in clinical development for toxicity reasons.
At the 47th annual meeting of the Society of Toxicology earlier this year, InnoMed PredTox presented joint analyses of the compiled transcriptomics, proteomics and metabolomics profiling data with conventional toxicological endpoints in blood, urine, liver and kidney samples from rats. The results nicely demonstrate the merits of the systematic, integrated approach adopted by the consortium, and pave the way towards new biomarkers, a better mechanistic understanding of individual toxicological responses, and subsequently to more efficient development processes.
Genedata has provided the computational infrastructure for InnoMed PredTox, in particular the software for data management and analysis. Developed as a customization of the Genedata Expressionist® database, the PredTox database currently hosts about 1.3 TB of data and represents the central access point for the consortium members. Data analysis services based on the Genedata Expressionist product suite facilitate the comparison of data between sites and accross compounds, which proves to be essential for biological interpretation by the InnoMed PredTox toxicology experts.
“I am very happy about the success of the InnoMed PredTox project, as it validates Genedata's philosophy of supporting the integrated analysis of large sets of different omics technologies and clinical data. With our Genedata Expressionist platform, we provide a scalable system for efficient biomarker discovery,” said Dr. Othmar Pfannes, CEO of Genedata.
Genedata (genedata.com) specializes in software and professional services for pharmaceuticals, biotech and related life sciences. The Company offers expertise in research informatics combined with open and scalable computational solutions. Our solutions include Genedata Phylosopher® for integrating, structuring, and analyzing research data; Genedata Screener® for high throughput screening analysis; and Genedata Expressionist® for omics data integration, processing and analysis. Founded in 1997, Genedata is privately held, with headquarters in Basel, Switzerland, and subsidiaries in Tokyo (Japan), Munich (Germany), Konstanz (Germany), Boston (USA) and San Francisco (USA).
About InnoMed PredTox
InnoMed PredTox (innomed-predtox.com) aims at reducing a key bottleneck in the R&D process, namely the assessment of drug safety before new drugs enter the market. It has secured €8 million of budget over 40 months, partly funded by the European Commission Life Sciences, Genomics and Biotechnology for Health Priority (LSHB-CT-2005-518170). The project is coordinated by the European Federation of Pharmaceutical Industries and Associations (EFPIA), a body representing the research-based pharmaceutical industry and biotech SMEs operating in Europe. The members in the consortium include: Bayer Schering Pharma AG, Boehringer Ingelheim, F. Hoffmann-La Roche , Johnson & Johnson Pharmaceutical R & D, Lilly S.A., Merck KGaA, MerckSerono, Nycomed, Novo Nordisk A/S, DK, Novartis, Organon, Sanofi-Aventis (Germany, France), Servier, the Universities of Dublin, Hacettepe and Würzburg, as well as Bio-Rad and Genedata.