InnoMed PredTox
| InnoMed PredTox | |
| Innovative Medicines for Europe - Predictive Toxicology | |
| Keywords | Toxicogenomics, Drug development, Pre-clinical development |
|---|---|
| Funding agency | European Commission |
| Project type | Integrated Project |
| Reference | FP6-518170 |
| Objective | 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 |
| Participants | EFPIA (coordinator), EFPIA Companies |
| Budget | Overall: 8 Mio. EUR Funding: |
| Duration | 1 October 2005 - 31 January 2009 |
| Web site | http://www.innomed-predtox.com |
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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[1][2]
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[3], troglitazone[4] and gentamicin[5]. As data integration across different data areas and technology platforms is considered a prerequisite to building a consistent standardised data schema for joint analysis[6] all project data are stored in a database[7] 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.[8]
Milestones
Status: August 2008
| Date | Event |
|---|---|
| 5 July 2005 | Consortium Formation |
| 1 October 2005 | Official project start |
| 28 November 2005 | Selection of Study Compounds |
| 7 April 2006 | Start in vivo studies |
| 10 October 2006 | PredTox Database goes live |
| 5 March 2007 | Reporting of in vivo studies |
| 9 July 2007 | Reporting of Transcriptomics results |
| 1 October 2007 | Reporting of Proteomics results |
| 14 January 2008 | Formation of Expert Working Groups |
| 21 July 2008 | Reporting of individual integrated analyses per compound study |
| 13 October 2008 | Reporting of concluding study reports and discussion of project summary and conclusions |
References
- ↑ IMI website by EFPIA [1]
- ↑ European Commission website [2]
- ↑ Mulrane et al., Exp Toxicol Pathol. 2008 Aug;60(4-5):235-45 [3]
- ↑ E. Troesken et al., Application of a Systems Toxicology Approach to Investigate Troglitazone Hepatotoxicity in the Rat, Abstract ID 675, The Toxicologist CD — An official Journal of the Society of Toxicology, Volume 102, Number S-1, March 2008 [4] (slides)
- ↑ E. Com et al., Integrated Transcriptomic and Proteomic Evaluation of Gentamicin Nephrotoxicity in Rats, Abstract ID 676, The Toxicologist CD — An official Journal of the Society of Toxicology, Volume 102, Number S-1, March 2008 [5] (slides)
- ↑ A.M. Richard, Chem Res Toxicol. 2006 Oct;19(10):1257-62[6]
- ↑ W.B. Mattes, Methods Mol Biol. 2008;460:221-38. [7]
- ↑ Hughes, Bethan (September 2008). "Industry concern over EU hepatotoxicity guidance". Nature Reviews Drug Discovery. 7: 719.
See also
External links
- InnoMed PredTox official project website
- Innovative Medicines Initiative - EFPIA website
- Innovative Medicines Initiative - European Commission website
- List of Related Projects