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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
Bayer Schering Pharma
Boehringer-Ingelheim
Johnson and Johnson
Lilly
Merck Serono
Novartis
Novo Nordisk
Nycomed
Roche
Sanofi-Aventis
Schering-Plough
Servier

Universities
University of Würzburg
University College Dublin
Hacettepe University

Technology Providers
Bio-Rad
Genedata

Budget Overall: 8 Mio. EUR

Funding:

Duration 1 October 2005 - 31 January 2009
Web site http://www.innomed-predtox.com

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 ("cross-omics") analysis[6] all project data are stored in a database custom developed by Genedata.[7][8]

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.[9]

Contents

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
31 January 2009 Official end of project

See also

References

  1. ^ IMI website by EFPIA
  2. ^ European Commission website
  3. ^ Mulrane L, Rexhepaj E, Smart V, et al. (August 2008). "Creation of a digital slide and tissue microarray resource from a multi-institutional predictive toxicology study in the rat: an initial report from the PredTox group". Experimental and Toxicologic Pathology 60 (4-5): 235–45. doi:10.1016/j.etp.2007.12.004. PMID 18479893.  
  4. ^ 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 [1] (slides)
  5. ^ 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 [2] (slides)
  6. ^ Richard AM (October 2006). "Future of toxicology--predictive toxicology: An expanded view of 'chemical toxicity'". Chemical Research in Toxicology 19 (10): 1257–62. doi:10.1021/tx060116u. PMID 17040094.  
  7. ^ Mattes WB (2008). "Public consortium efforts in toxicogenomics". Methods in Molecular Biology 460: 221–38. doi:10.1007/978-1-60327-048-9_11. PMID 18449490.  
  8. ^ Gallagher WM, Tweats D, Koenig J (April 2009). "Omic profiling for drug safety assessment: current trends and public-private partnerships". Drug Discovery Today 14 (7-8): 337–42. doi:10.1016/j.drudis.2009.02.001. PMID 19340928.  
  9. ^ Hughes B (September 2008). "Industry concern over EU hepatotoxicity guidance". Nature Reviews. Drug Discovery 7 (9): 719. doi:10.1038/nrd2677. PMID 19172685.  

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