Basel, Switzerland, 2007/09/20
Scientists from the Innovative Medicines for Europe consortium are planning a series of critical experiments aimed at improving drug safety. The consortium will meet in October to decide on a shortlist of experiments to investigate the biological mechanisms underlying drug side effects.
With contributions from more than 20 research groups from pharma, supporting industries and academia, the InnoMed PredTox consortium has recently completed a genome-wide
survey of toxic reactions. This survey has been performed comprehensively assaying transcripts, proteins and metabolites in various tissues and body fluids.
This vast inventory of molecular information is accessed via a central database. Consortium members have been scanning the contained data for toxicity biomarkers, namely genes and other biological molecules, that could be used to signal toxic reactions.
Consortium organizers now believe that they have sufficient information to draw up a shortlist of critical follow-up experiments. Taking advantage of the wide scope and high
quality of the data collected so far, these follow-up experiments will test specific hypotheses about the biological pathways involved in toxic reactions.
The next consortium assembly, in October, will decide which follow-up experiments to perform using sensitive laboratory techniques. The follow-up results will be published next
year in a joint session with the US-based Predictive Safety Testing Consortium at the Society of Toxicology annual meeting in Seattle, Washington.
Healthy competition
A recent interview with consortium scientists from Sanofi-Aventis and Merck-Serono revealed that commitment and motivation in the consortium is high. The scientists use innovative analysis methods and the project has adhered to rigorous timelines. “No one wants their company to be the one falling behind the group,” explained Dr. Valérie Barbié, Head of Data Analysis, Clinical Sciences and Biomarkers, Merck-Serono Research.
InnoMed PredTox is pioneering the use of genome-wide biomolecular surveys to pinpoint unsafe drugs. “There is enormous scope for this approach to speed up drug development, while at the same time ensuring greater drug safety,” explained Dr. Jochen Koenig, Consortium Liaison for Genedata AG.
InnoMed PredTox 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.
For further information, contact innomed-predtox@genedata.com.