Genedata, a leading provider of in-silico solutions for pharmaceutical R&D and related life sciences, today announced the successful completion of the InnoMed PredTox Non-Clinical Safety Project organized around a series of animal studies using compounds terminated in drug development due to nephro- and hepatotoxicity. The project showed that biomarkers could be identified based on a novel systems toxicology approach that integrates the analysis of different omics data and conventional experimental data. The project workflows and research processes were supported by a computional infrastructure developed and provided by Genedata. Genedata now offers these process supporting workflows as part of Genedata Expressionist® to all interested parties and will continue to develop the software to support the quickly emerging approach of systems toxicology.
Over the course of the three-year consortium project aimed at improving the assessment of drug safety before new drugs enter the clinical research phase, Genedata has developed software for omics and conventional experimental data integration, processing and analysis. Genedata customized and extended the relational database included in the computational biomarker discovery system Genedata Expressionist to support integrated molecular profiling workflows. The experience gained during the project positions Genedata as a partner of choice for systems toxicology projects across multiple research sites.
The resulting project-specific database, ‘PredTox DB’, represents one of the most comprehensive collections of molecular profiling (omics) across various technologies and conventional endpoint data on any selection of compounds. Multiplex-assay technologies employed included microarrays for mRNAs, LC-MS and NMR for metabolites as well as 2D-PAGE and 2D-DIGE for proteins, complemented by conventional clinical chemistry, histopathology and in life observations.
The integrated analysis of complex data structures performed by Genedata in close collaboration with the project partners has led to refined mechanistic models of specific drug-induced pathologies and a number of promising biomarker candidates. Some of these results will be presented by scientists from Bayer Schering Pharma and the University of Wuerzburg during the upcoming annual meeting of the American Society of Toxicology in Baltimore, Maryland (USA) on March 15-19, 2009.
“Participating in InnoMed PredTox has been a perfect opportunity to leverage our leadership in data integration, processing, standardization, and analysis for supporting non-clinical toxicology. The PredTox DB customization has clearly demonstrated the versatility and power of the Genedata Expressionist computational system,” said Othmar Pfannes, CEO of Genedata. “We look forward to expanding on this work and further establishing Genedata as the leader in the field of systems toxicology.”
Prof. Friedlieb Pfannkuch at F. Hoffmann-La Roche, coordinator of the project, commented, “InnoMed PredTox has been a great collaboration between EFPIA (European Federation of Pharmaceutical Industries and Associations) pharmaceutical companies, academia as well as small and medium-sized enterprises (SMEs). A key achievement of the project was the demonstration of the technical and operational feasibility of the systems toxicology approach across technologies and sites. The centralized data storage, processing and analysis infrastructure and know-how made available by Genedata was instrumental for this.”
Genedata (genedata.com) develops and globally markets sophisticated computational solutions for drug discovery and related research processes in the life sciences. Genedata’s solutions enable scientists to process, integrate, analyze, and manage large and complex experimental data sets generated by high throughput technologies. Solutions include Genedata Phylosopher® for target discovery and integrative biological data management, Genedata Screener® for automated high throughput screening and high content screening, and Genedata Expressionist® for biomarker discovery and personalized medicine. Founded in 1997, Genedata is privately held, with headquarters in Basel, Switzerland, and offices in Boston & San Francisco, USA, Konstanz & Munich, Germany and Tokyo, Japan.
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, 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 Wuerzburg, as well as Bio-Rad and Genedata.