Oss, The Netherlands, 2006/07/18
Organon, the human healthcare business unit of Akzo Nobel, announced today its partnership with Innovative Medicines for Europe (InnoMed), a collaboration between the European Commission and the Pharmaceutical Industry to help Europe move towards more efficient and competitive drug development [1].
Organon is part of PredTox - one of the two areas that fall under the InnoMed research strategy. The PredTox consortium consists of 15 pharmaceutical companies and 3 universities that will collaborate to understand toxic reactions to drugs at the molecular level with the aim of developing predictive tests for use in early drug development.
“Organon is delighted to be involved in this important pre-competitive initiative that will not only have important implications for improving drug development but will also demonstrate that as an industry, pharma can work together productively and constructively to benefit patients and development outcomes,” commented David Nicholson, Organon’s Executive Vice President Research and Development. The announcement coincides with the start of the first phase of the PredTox project within Organon and by consortium partners.
More than 30 % of compounds in development fail either because of toxicity in animals which is not detected early in the development program or due to unexpected adverse events uncovered in clinical studies [2]. Organon and its consortium partners are jointly studying 14 proprietary compounds that have been dropped from development after failing conventional toxicology tests.
PredTox project will employ and integrate three important ‘omics technologies – toxicogenomics, toxicoproteomics and toxicometabonomics - to better understand the toxic properties of these failed development candidates at the molecular level [3]. Advanced statistics and specialized database technologies provided by the Swiss based bioinformatics company Genedata will be used to analyze the immense volume of data generated.
The ultimate aim is to use this knowledge to develop biomarkers which will predict toxicity earlier in the development process. The consortium and the EU will share the costs of the work. The EU supports this initiative by a grant, within the Life Sciences priority of the 6th Framework Program.
avid Nicholson added: “While the science is only just beginning and many challenges remain, the consortium has already successfully navigated some very complicated and challenging preparatory work, such as compound selection, study design elaboration, study logistics preparation and monitoring of the experience including the necessary administrative prerequisites.”
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Notes
1. The InnoMed strategic research agenda has been developed by the European Federation of Pharmaceutical Industry and Associations with the aim of revitalizing the European biopharmaceutical research environment. The InnoMed strategy addresses the complex issues associated with the future of biomedical research in the EU and addresses ways of achieving accelerated development of safe and more effective medicines. A key priority is to improve current understanding of the potential for adverse drug reactions and preclinical toxicity. A separate arm is focussing on drug efficacy.
2. Nature Rev Drug Discovery 2004; 2; 711-715
3. Toxicogenomics detects drug-induced changes in gene expression in cells Toxicoproteomics detects abnormal patterns of proteins. Metabonomics is the detection of changes in the internal cellular metabolism of a cell or an organism.