Intern
    Lehrstuhl für Toxikologie

    Innovative Medicines for Europe

    Objective

    The discovery and development of new drugs is very costly and attrition rates are high. Initiatives to reduce the rate of attrition during later phases are clearly desirable and if successfully implemented will reduce development costs. The InnoMed proposal addresses the complex issues associated with the future of biomédical research in the EU, and addresses ways of achieving accelerated development of, safe and more effective medicines, aiming to revitalize the European biopharmaceutical research environment. InnoMed's wide consortium base, being led by the European Federation of Pharmaceutical Industry and Associations (EFPIA), guarantee's a commitment from all the stakeholders needed to change the process of drug development in Europe. The course for addressing the necessary changes is to first develop a Strategic Research Agenda (SRA) that will encompass the whole path from discovery of a new drug target to the validation and approval stages of a new drug compound. This will be agreed by all the relevant stakeholders via meetings and workshops. Four key bottlenecks in the drug development process will be addressed: Safety Efficacy Knowledge Management Training and Education This comprehensive strategy with a detailed roadmap will lead to the deployment of a European Technology Platform (ETP). This European Technology Platform will deliver added value to the drug discovery and development process and to individual stakeholders. To ensure the relevance of the ETP InnoMed will validate it using two research proposals, AddNeuroMed, which will develop and validate novel surrogate markers based upon in vitro and in vivo models in animals and humans, using Alzheimer's disease as a testing platform. PredTox will deliver new biomarkers of toxicity and a greater understanding of mechanisms of toxicity. Both of these projects will demonstrate the viability and necessity of the ETP.

    PredTox: Summary Results

    EU Framework 6 Project: Predictive Toxicology (PredTox)—overview and outcome. Suter L, Schroeder S, Meyer K, Gautier JC, Amberg A, Wendt M, Gmuender H, Mally A, Boitier E, Ellinger-Ziegelbauer H, Matheis K, Pfannkuch F. Toxicol Appl Pharmacol. 2011 Apr 15;252(2):73-84. doi: 10.1016/j.taap.2010.10.008. Epub 2010 Oct 16. PMID:20955723

    PredTox: Selected publications

    Development of a pharmaceutical hepatotoxicity biomarker panel using a discovery to targeted proteomics approach. Collins BC, Miller CA, Sposny A, Hewitt P, Wells M, Gallagher WM, Pennington SR. Mol Cell Proteomics. 2012 Aug;11(8):394-410. doi:10.1074/mcp.M111.016493. Epub 2012 Apr 23. PMID: 22527513

    Integrated transcriptomic and proteomic evaluation of gentamicin nephrotoxicity in rats. Com E, Boitier E, Marchandeau JP, Brandenburg A, Schroeder S, Hoffmann D, Mally A, Gautier JC. Toxicol Appl Pharmacol. 2012 Jan 1;258(1):124-33. doi: 10.1016/j.taap.2011.10.015. Epub 2011 Oct 29. PMID: 22061828

    A comparative integrated transcript analysis and functional characterization of differential mechanisms for induction of liver hypertrophy in the rat. Boitier E, Amberg A, Barbié V, Blichenberg A, Brandenburg A, Gmuender H, Gruhler A, McCarthy D, Meyer K, Riefke B, Raschke M, Schoonen W, Sieber M, Suter L, Thomas CE, Sajot N. Toxicol Appl Pharmacol. 2011 Apr 15;252(2):85-96. doi: 10.1016/j.taap.2011.01.021. Epub 2011 Feb 26. PMID:21315101

    Cross-study and cross-omics comparisons of three nephrotoxic compounds reveal mechanistic insights and new candidate biomarkers. Matheis KA, Com E, Gautier JC, Guerreiro N, Brandenburg A, Gmuender H, Sposny A, Hewitt P, Amberg A, Boernsen O, Riefke B, Hoffmann D, Mally A, Kalkuhl A, Suter L, Dieterle F, Staedtler F. Toxicol Appl Pharmacol. 2011 Apr 15;252(2):112-22. doi: 10.1016/j.taap.2010.11.006. Epub 2010 Nov 21. PMID:21081137

    Tissue microarrays and digital image analysis. Ryan D, Mulrane L, Rexhepaj E, Gallagher WM. Methods Mol Biol. 2011;691:97-112. doi: 10.1007/978-1-60761-849-2_6. PMID: 20972749

    The enhanced value of combining conventional and "omics" analyses in early assessment of drug-induced hepatobiliary injury. Ellinger-Ziegelbauer H, Adler M, Amberg A, Brandenburg A, Callanan JJ, Connor S, Fountoulakis M, Gmuender H, Gruhler A, Hewitt P, Hodson M, Matheis KA, McCarthy D, Raschke M, Riefke B, Schmitt CS, Sieber M, Sposny A, Suter L, Sweatman B, Mally A. Toxicol Appl Pharmacol. 2011 Apr 15;252(2):97-111. doi: 10.1016/j.taap.2010.09.022. Epub 2010 Oct 1. PMID: 20888850

    Evaluation of a urinary kidney biomarker panel in rat models of acute and subchronic nephrotoxicity. Hoffmann D, Fuchs TC, Henzler T, Matheis KA, Herget T, Dekant W, Hewitt P, Mally A. Toxicology. 2010 Nov 9;277(1-3):49-58. doi: 10.1016/j.tox.2010.08.013. Epub 2010 Sep 9. PMID: 20816719

    Assessment of candidate biomarkers of drug-induced hepatobiliary injury in preclinical toxicity studies. Adler M, Hoffmann D, Ellinger-Ziegelbauer H, Hewitt P, Matheis K, Mulrane L, Gallagher WM, Callanan JJ, Suter L, Fountoulakis MM, Dekant W, Mally, A. Toxicol Lett. 2010 Jun 16;196(1):1-11. doi: 10.1016/j.toxlet.2010.03.018. Epub 2010 Apr 1. PMID: 20362651

    Assessment of candidate biomarkers of drug-induced hepatobiliary injury in preclinical toxicity studies. Adler M, Hoffmann D, Ellinger-Ziegelbauer H, Hewitt P, Matheis K, Mulrane L, Gallagher WM, Callanan JJ, Suter L, Fountoulakis MM, Dekant W, Mally A. Toxicol Lett. 2010 Jun 16;196(1):1-11. doi: 10.1016/j.toxlet.2010.03.018. Epub 2010 Apr 1. PMID:20362651

    Use of SELDI MS to discover and identify potential biomarkers of toxicity in InnoMed PredTox: a multi-site, multi-compound study. Collins BC, Sposny A, McCarthy D, Brandenburg A, Woodbury R, Pennington SR, Gautier JC, Hewitt P, Gallagher WM. Proteomics. 2010 Apr;10(8):1592-608. doi: 10.1002/pmic.200900608. PMID: 20162557

    Performance of novel kidney biomarkers in preclinical toxicity studies. Hoffmann D, Adler M, Vaidya VS, Rached E, Mulrane L, Gallagher WM, Callanan JJ, Gautier JC, Matheis K, Staedtler F, Dieterle F, Brandenburg A, Sposny A, Hewitt P, Ellinger-Ziegelbauer H, Bonventre JV, Dekant W, Mally A. Toxicol Sci. 2010 Jul;116(1):8-22. doi: 10.1093/toxsci/kfq029. Epub 2010 Jan 29. PMID: 20118187

    Comparative analysis of novel noninvasive renal biomarkers and metabonomic changes in a rat model of gentamicin nephrotoxicity. Sieber M, Hoffmann D, Adler M, Vaidya VS, Clement M, Bonventre JV, Zidek N, Rached E, Amberg A, Callanan JJ, Dekant W, Mally A. Toxicol Sci. 2009 Jun;109(2):336-49. doi: 10.1093/toxsci/kfp070. Epub 2009 Apr 6. PMID: 19349640

    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. Mulrane L, Rexhepaj E, Smart V, Callanan JJ, Orhan D, Eldem T, Mally A, Schroeder S, Meyer K, Wendt M, O'Shea D, Gallagher WM. Exp Toxicol Pathol. 2008 Aug;60(4-5):235-45. doi: 10.1016/j.etp.2007.12.004. Epub 2008 May 13. PMID: 18479893

    Coordinator

    EUROPEAN FEDERATION OF PHARMACEUTICAL INDUSTRIES AND ASSOCIATIONS, Belgium

    Participants

    F. HOFFMANN-LA ROCHE LTD, Switzerland

    BOEHRINGER INGELHEIM GMBH, Germany

    EUROPEAN FEDERATION OF BIOTECHNOLOGY, Belgium

    INSTITUT DE RECHERCHES INTERNATIONALES SERVIER, France

    ELI LILLY AND COMPANY, United States

    MERCK KGAA, Germany

    NOVO NORDISK A/S, Denmark

    PHARMIDEX PHARMACEUTICAL SERVICES LIMITED, United Kingdom

    JULIUS-MAXIMILLIAMS-UNIVERSITAET WUERZBURG, Germany

    CAPSANT NEUROTECHNOLOGIES LTD, United Kingdom

    UNIVERSITY OF KUOPIO, Finland

    UNIVERSITA DEGLI STUDI DI PERUGIA, Italy

    ARISTOTLE UNIVERSITY OF THESSALONIKI, Greece

    ROSKILDE UNIVERSITETSCENTER, Denmark

    ASTRAZENECA AB, Sweden

    KUNGLIGA TEKNISKA HOEGSKOLAN, Sweden

    KAROLINSKA INSTITUTET, Sweden

    NOVARTIS PHARMA AG, Switzerland

    N.V. ORGANON, Netherlands

    GENEDATA AG, Switzerland

    KING'S COLLEGE, LONDON, United Kingdom

    ISTITUTO DI RICERCHE BIOMEDICHE "A. MARXER" RBM SPA, Italy

    CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE, France

    GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD, United Kingdom

    UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLIN, Ireland

    PROTEOME SCIENCES PLC, United Kingdom

    HACETTEPE UNIVERSITESI, Turkey

    UNIVERSITY COLLEGE LONDON, United Kingdom

    UNIVERSITY OF SOUTHAMPTON, United Kingdom

    HUNTER FLEMING LIMITED, United Kingdom

    SANOFI-AVENTIS DEUTSCHLAND GMBH, Germany

    ARTTIC IN BRUSSELS SPRL, Belgium

    JANSSEN PHARMACEUTICA N.V, Belgium

    BIOWISDOM LIMITED, United Kingdom

    CEREBRICON LTD., Finland

    EUROPEAN FEDERATION FOR PHARMACEUTICAL SCIENCES, Sweden

    DEPARTMENT OF OLD AGE PSYCHIATRY & PSYCHOTIC DISORDERS, MEDICAL UNIVERSITY OF LODZ, Poland

    CIPHERGEN BIOSYSTEMS, INC., United States

    NYCOMED GMBH, Germany

    AVENTIS PHARMA RECHERCHE-DÉVELOPPEMENT, France

    BAYER PHARMA AG, Germany

    Kontakt

    Lehrstuhl für Toxikologie
    Versbacher Straße 9
    97078 Würzburg

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