View source for InnoMed PredTox

{{Research-Project|
name=InnoMed PredTox|
title=Innovative Medicines for Europe - Predictive Toxicology|
keywords=[[Toxicogenomics]], [[Drug development]], [[Pre-clinical development]]|
fundingAgency=European Commission|
frameworkProgramme=[[Sixth Framework Programme|FP6]]|
image=|
projectType=Integrated Project|
researchObjective=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|
projectReference=FP6-518170|
coordinator=[[EFPIA]]|
participants='''EFPIA Companies'''<br/>
[[Bayer Schering Pharma AG|Bayer Schering Pharma]]<br/>
[[Boehringer-Ingelheim]]<br/>
Johnson and Johnson<br/>
[[Eli Lilly and Company|Lilly]]<br/>
[[Merck Serono]]<br/>
[[Novartis]]<br/>
[[Novo Nordisk]]<br/>
Nycomed<br/>
[[Hoffmann–La Roche|Roche]]<br/>
[[Sanofi-Aventis]]<br/>
[[Schering-Plough]]<br/>
[[Servier]]<br/><br/>
'''Universities'''<br/>
University of Würzburg<br/>
University College Dublin<br/>
Hacettepe University<br/><br/>
'''Technology Providers'''<br/>
[[Bio-Rad]]<br/>
[[Genedata]]
|
budget=8 Mio. EUR|
funding=|
start=1 October 2005|
end=31 January 2009|
website=http://www.innomed-predtox.com
}}
{{SI}}


'''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 [[toxicogenomics|omics]] technologies together with the results from more conventional [[toxicology]] methods for more informed decision making in [[Pre-clinical development|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]]<ref>IMI website by EFPIA [http://www.imi-europe.org/pilot%20project/pages/default.aspx]</ref><ref>European Commission website [http://imi.europa.eu/innomed_en.html]</ref>

As part of '''InnoMed PredTox''' the partners ran a series of regular 14 days toxicological studies in [[rattus norvegicus|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 [[kidney|kidneys]].

The project collected and jointly analysed [[Expression profiling|transcriptomics]], [[proteomics]], [[metabonomics]] and conventional toxicological data on 14 failed drug candidates together with two reference compounds<ref>Mulrane et al., Exp Toxicol Pathol. 2008 Aug;60(4-5):235-45 [http://www.ncbi.nlm.nih.gov/pubmed/18479893]</ref>, [[troglitazone]]<ref>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 [http://www.toxicology.org/ai/pub/publications.asp] [http://www.innomed-predtox.com/media__events/publications/index_eng.html (slides)]</ref> and [[gentamicin]]<ref>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 [http://www.toxicology.org/ai/pub/publications.asp] [http://www.innomed-predtox.com/media__events/publications/index_eng.html (slides)]</ref>. As data integration across different data areas and technology platforms is considered a prerequisite to building a consistent standardised data schema for joint analysis<ref>A.M. Richard, Chem Res Toxicol. 2006 Oct;19(10):1257-62[http://www.ncbi.nlm.nih.gov/pubmed/17040094]</ref> all project data are stored in a database<ref>W.B. Mattes, Methods Mol Biol. 2008;460:221-38. [http://www.ncbi.nlm.nih.gov/pubmed/18449490]</ref> 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 [[biomarker|biomarkers]] of toxic [[Adverse effect (medicine)|(side-) effects]]. In particular, as the consortia facilitate the efficient exchange of experience in this pre-competitive area of [[Drug development|drug development]] and early involvement of regulatory authorities like the [[U.S. Food and Drug Administration|FDA]] and [[European Medicines Agency|EMEA]].<ref>{{cite journal|last=Hughes|first=Bethan|date=September 2008|title=Industry concern over EU hepatotoxicity guidance|journal=Nature Reviews Drug Discovery|volume=7|pages=719|url=http://www.nature.com/nrd/journal/v7/n9/full/nrd2677.html}}</ref>

===Milestones===
Status: August 2008

{| class="wikitable"
|-
! Date
! Event
|-
| 5 July 2005
| Consortium Formation
|-
| 1 October 2005
| '''Official project start'''
|-
| 28 November 2005
| Selection of Study [[Chemical compound|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 [[Expression profiling|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 ==
{{reflist|2}}

== See also ==
* [[EFPIA]]
* [[Toxicogenomics]]
* [[Innovative Medicines Initiative]]

== External links ==
* [http://www.innomed-predtox.com/ InnoMed PredTox] official project website
* [http://www.imi-europe.org/ Innovative Medicines Initiative] - [[EFPIA]] website
* [http://imi.europa.eu Innovative Medicines Initiative] - European Commission website
* [http://www.innomed-predtox.com/links/index_eng.html List of Related Projects]



[[Category:Pharmaceutical industry]]
[[Category:Genomics]]
[[Category:Drug discovery]]
[[Category:Eli Lilly and Company]]
[[Category:research]]

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