InnoMed PredTox: Difference between revisions

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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

VisualWikitext

Latest revision as of 18:36, 4 September 2012

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.

External links

InnoMed PredTox official project website
Innovative Medicines Initiative - EFPIA website
Innovative Medicines Initiative - European Commission website
List of Related Projects

Template:WH Template:WS

[1] IMI website by EFPIA [1]

[2] European Commission website [2]

[3] Mulrane et al., Exp Toxicol Pathol. 2008 Aug;60(4-5):235-45 [3]

[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 [4] (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 [5] (slides)

[6] A.M. Richard, Chem Res Toxicol. 2006 Oct;19(10):1257-62[6]

[7] W.B. Mattes, Methods Mol Biol. 2008;460:221-38. [7]

[8] Hughes, Bethan (September 2008). "Industry concern over EU hepatotoxicity guidance". Nature Reviews Drug Discovery. 7: 719.

[1]

[2]

[3]

[4]

[5]

[6]

[7]

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@@ Line 33: / Line 33: @@
 budget=8 Mio. EUR|
 funding=|
-start=[[1 October]] [[2005]]|
+start=1 October 2005|
-end=[[31 January]] [[2009]]|
+end=31 January 2009|
 website=http://www.innomed-predtox.com
 }}
 {{SI}}
-{{EH}}
-'''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.
+'''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>
+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 [[relational database|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]].
+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>
@@ Line 59: / Line 59: @@
 ! Event
 |-
-| [[5 July]] [[2005]]
+| 5 July 2005
 | Consortium Formation
 |-
-| [[1 October]] [[2005]]
+| 1 October 2005
 | '''Official project start'''
 |-
-| [[28 November]] [[2005]]
+| 28 November 2005
 | Selection of Study [[Chemical compound|Compounds]]
 |-
-| [[7 April]] [[2006]]
+| 7 April 2006
 | Start ''[[in vivo]]'' studies
 |-
-| [[10 October]] [[2006]]
+| 10 October 2006
 | PredTox Database goes live
 |-
-| [[5 March]] [[2007]]
+| 5 March 2007
 | Reporting of ''in vivo'' studies
 |-
-| [[9 July]] [[2007]]
+| 9 July 2007
 | Reporting of [[Expression profiling|Transcriptomics]] results
 |-
-| [[1 October]] [[2007]]
+| 1 October 2007
 | Reporting of [[Proteomics]] results
 |-
-| [[14 January]] [[2008]]
+| 14 January 2008
 | Formation of Expert Working Groups
 |-
-| [[21 July]] [[2008]]
+| 21 July 2008
 | Reporting of individual integrated analyses per compound study
 |-
-| [[13 October]] [[2008]]
+| 13 October 2008
 | Reporting of concluding study reports and discussion of project summary and conclusions
 |}
@@ Line 95: / Line 95: @@
 == References ==
-{{reflist}}
+{{reflist|2}}
 == See also ==
@@ Line 108: / Line 108: @@
 * [http://www.innomed-predtox.com/links/index_eng.html List of Related Projects]
-{{SIB}}
 [[Category:Pharmaceutical industry]]
@@ Line 114: / Line 114: @@
 [[Category:Drug discovery]]
 [[Category:Eli Lilly and Company]]
-[[Category:Science and technology in Europe]]
-[[Category:European Union and science and technology]]
 [[Category:research]]
-[[Category:FP6 Projects]]
 {{WH}}
 {{WS}}

InnoMed PredTox: Difference between revisions

Latest revision as of 18:36, 4 September 2012

Contents

Milestones

References

See also

External links

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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