Novartis Pharma AG is a multinational pharmaceutical company based in Basel, Switzerland with approximately 100,000 associates in 140 countries worldwide. Novartis focuses on discovering, developing and successfully marketing innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life. Products are concentrated in major therapeutic areas: Cardiovascular and Metabolism, Oncology and Hematology, Neuroscience and Ophthalmics, Respiratory, Immunology and Infectious Diseases. Novartis is also committed to innovative research and development of new tools for drug development, and participates in collaborative research projects with other industrial and academic partners. For example the Critical Path Initiative or in the European InnoMed PredTox program for non-clinical safety assessment. Investigative toxicology (iTox) which is the main unit involved in the MARCAR consortium is part of Novartis Pre-Clinical Safety (PCS) department.

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Researchers:

• Jonathan Moggs
• Harri Lempiäinen

The University of Dundee is one of the UK's leading universities, internationally recognised for its expertise across a range of disciplines including science, medicine, engineering and art and is home to 18,000 students and more than 3000 staff. It has a reputation for excellence in research and continues to successfully attract leading researchers from across the world. The University is a recognised world leader in the fields of cancer, diabetes, drug metabolism and toxicology. According to ISI ratios, it is the most cited university in Europe in the areas of pharmacology and toxicology. Work at the University is being carried out on almost every aspect of the disease from the cell to the community.

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Researchers:

• Roland Wolf
• Colin Henderson
• Lynsey Chatham
• Amy Cameron
• Jennifer Kennedy

CXR Biosciences is a unique biotechnology company that works with Pharmaceutical, Biotechnology, Agrochemical, Consumer product and Chemical companies to accelerate drug discovery and to evaluate the risk to man of chemicals. A key objective of the company is to develop new technology platforms transforming the way metabolism and safety liabilities of molecules are evaluated. CXR is an established business collaborating with companies around the globe. CXRs proprietary models and cutting edge technologies have helped numerous blue chip companies and smaller organisations to solve issues relating to the safety of compounds or the selection of drug candidates. CXR Biosciences has exploited preclinical models to rapidly determine the role of hepatic cytochrome P450s in drug disposition (the HRN mouse), to non-invasively determine the in vivo mechanisms of toxicity (toxicity reporter models), and to non-invasively determine the cellular mechanism of action and efficacy of anti cancer agents in vivo (Smart Xenografts). CXR uses Ingenuity Pathway Analysis bioinformatics software (IPA) to generate hypotheses and identify potential mechanisms that may be involved in the biological actions of compounds or drugs. Using humanised mouse models CXR have replaced murine PXR and CAR by human genes, and these humanised reflect known species differences in drug disposition and toxicity and they also produce Engineered Biomarker mouse models, containing specifically engineered biomarkers.

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Researchers:

• Cliff Elcombe
• Joanne Quinney
• Mike Piper

The Medical University of Vienna (MUW) is one of the largest Medical Universities in Europe. 11,000 students are enrolled in the study programs, mainly in human medicine. It provides scientific work environment for about 3,000 scientists in all major medical and many basic research fields. The Division Institute of Cancer Research in the Department of Internal Medicine (ICR) is a national and federal reference centre for experimental carcinogenesis. It has all the necessary equipment to perform the experiments proposed in the project, including Bio-safety level 2 lab and fully equipped animal lab for experiments under standard pathogen free conditions. The ICR also shares the MolTecNet platform for Molecular Technologies of the University which is equipped with; spotter/arrayer/reader; Affymetrix; proteome (2DE-nano-liquid chromatography; ESI-ion-trap; AP-MALDI- and shotgun-mass spectrometry), and a Bio-informatics unit. Research is multi-disciplinary covering Molecular Biology, Cell Biology, Molecular Toxicology, Preclinical Research and Molecular Epidemiology. Focused for 20 years on hepatocarcinogenesis, identification of genotoxic and non-genotoxic compounds, mechanisms of tumour promotion and chemoprevention.

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Researchers:

• Bettina Grasl-Kraupp
• Sandra Sagmeister
• Phillip Klepeisz

The Medical Research Council (MRC) is a publicly-funded organisation dedicated to improving human health. It's mission is to improve human health through world-class medical research. MRC supports research across the biomedical spectrum, from fundamental lab-based science to clinical trials, and in all major disease areas. We work closely with the NHS and the UK Health Departments to deliver our mission, and give a high priority to research that is likely to make a real difference to clinical practice and the health of the population.The MRC's high-level objectives are to: Invest in high-quality research to improve human health; Attract and train first-rate researchers; Promote the translation of basic research discoveries into new and improved healthcare policy and practice; Fund research partnerships; Encourage commercial exploitation of our scientists discoveries, for the benefit of the UK health and economy; Provide leadership in the governance of medical research; Promote good practice in our organisation and strive for ongoing improvements, including evaluation of all aspects of performance.

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Researchers:

• Richard Meehan
• John Thomson

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EKUT A - The University of Tubingen has world-wide recognition in both Medical and Natural Sciences. It is one of the oldest German Universities, with 20.000 students. The Department of Toxicology at EKUT has its focus on two topics: molecular mechanisms of chemical hepatocarcinogenesis and drug metabolism in liver. The group is experienced in animal studies, cell culture techniques, biochemical and molecular biological techniques.

Researchers:

• Michael Schwarz
• Elif Unterberger
• Eva Zeller

EKUT B - The bioinformatics group of Prof. Zell has been working in the field of pattern recognition, evolutionary optimization and its application to systems biology for many years. A powerful framework for artificial neural network simulation for pattern recognition, SNNS (Zell 1992), was developed and applied in different fields of research. Huesken et al., for instance, used SNNS to design a siRNA library (Huesken et al. 2005, Nature Biotechnology). Furthermore, Eva2, an open-source programming framework for evolutionary optimization, was developed in Prof. Zell's group (Streichert 2005) and is widely used in academia and industry to solve complex optimization problems. Through the participation in the HepatoSys project the group of Prof. Zell has gained in-depth knowledge in the modelling of xenobiotic detoxification of human hepatocytes. Prof. Zell has published more than 150 papers on machine learning and bioinformatics in the last 10 years.

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Researchers:

• Andreas Zell
• Clemens Wrzodek
• Johannes Eichner

EKUT C - The Eberhard Karls University (EKUT) of Tubingen and its Faculty of Medicine is a world-leading institution in medical research and belongs to the top-ten German medical research institutions. The Laboratory for Preclinical Imaging and Imaging Technology was established at the medical faculty at EKUT in 2005 and developed to an international leading research site for non-invasive imaging in small rodents and also in the development of imaging technology. The laboratory serves as European reference and training laboratory for Siemens Preclinical Solutions, USA.

Researchers:

• Bernd Pichler
• Andreas Schmid

The NMI Natural and Medical Sciences Institute at the University of Tuebingen, Reutlingen, Germany, is a non-profit organization, a private foundation, located at the Science and Technology Park Reutlingen. 150 researchers and technicians are involved in applied R&D in the fields of pharmaceutical biotechnology, medical products as well as surface and interface analysis. The NMI is a leading institute within the field of protein microarray technology; its research activities are focused on assay development of miniaturised multiplexed ligand binding assays and the analysis of cellular signal transduction as part of direct contract research agreements with pharmaceutical and biotechnology companies or within public funded projects. Using an ultra-sensitive reverse phase protein microarray based systems the systematic analysis of regulatory phoshorylation in small amounts of tissue biopsies (<100.000 cells) has become possible and approximately 160 different assays for the analysis of cell signalling pathways are available.

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Researchers:

• Markus Templin
• Ute Metzger
• Fridolin Trendil

Inserm is a public institute devoted to health and medical research. Patrick Maurel's Laboratory (Inserm Unit 632) is specialized in Hepatic Physiopathology. Our research program focuses on three main themes: hepatic detoxication, hepatitis C virus infection and liver stem cells. The work is based on the original methodology of primary cultures of human hepatocytes, and combines both basic and clinical research.

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Researchers:

• Martine Daujat-Chavanieu
• Claire Gondeau

Boehringer Ingelheim (for more information: http://www.boehringer-ingelheim.com) is a research-driven pharmaceutical group of companies dedicated to serving humankind by researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life. The focus is on the production of innovative drugs and treatments that represent major therapeutic advances. Boehringer Ingelheim employs 6,400 highly qualified people working in research & development out of almost 40,000 Boehringer Ingelheim employees worldwide. Boehringer Ingelheim's drug discovery focuses on seven major therapeutic areas: cardiovascular diseases, central nervous system (CNS) diseases, immunology & inflammation, metabolic diseases, oncology, respiratory diseases and virology. Two departmetents are involved. The Department of Non-Clinical Drug Safety is responsible for the toxicological assessment of new compounds during their development and on the market.

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Researcher:

• Arno Kalkhul
• Katja Matheis
• Nathalie Motsch

Bayer Schering Pharma AG (BSP; www.bayerscheringpharma .de) is a research driven pharmaceutical company. With its distinctive expertise in research, the company develops new medicines and therapies which make an essential contribution towards improving patient's quality of life. Its research and business activities are focused on the areas womans health, cardiology, oncology and diagnostic imaging. With innovative products Bayer Schering Pharma aims at a leading position in specialized markets worldwide.The contribution for the safety topic of MARCAR will be delivered by the Toxicology function located in Wuppertal, Germany . Its expertise includes methods for traditional toxicology like animal studies, clinical chemistry and histopathology as well as for investigative toxicology like in vitro testing and omics-technologies. There are several years of experience with transcriptional profiling using microarrays and real-time PCR including advanced data analysis strategies and pathway analysis. A specific focus of research during the past years was on the investigation of mechanisms of carcinogenicity in and its prediction with transciptomics methods from rat short time studies.

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Researcher:

• Heidrun Ellinger

Headquartered in Brussels, Belgium, UCB is a global biopharmaceutical leader based on a unique blend of innovation, entrepreneurship and proven experience. UCB is driven by a passionate desire to liberate families living with severe diseases so that they can enjoy normal, everyday lives. The company focuses on central nervous system (CNS) and immunology disorders. UCB is a leader in fields of epilepsy, allergy, and monoclonal antibody research.UCB has Research and Development Centres of Excellence in Europe, Asia and the U.S. and invested 788 million euros in R&D expenditure in 2007. UCB achieved revenue of 3.6 billion euros in 2007 - with net profit (after minority interest) amounting to 160 million euros.The Department of Non-Clinical Development (NCD) is located in Belgium (Braine-l'Alleud) and UK (Slough). With highly skilled pharmacokineticists, pharmacologists, toxicologists and pathologists, it provides global support to New Chemical and New Biological Entities Research and Development activities in the different therapeutic areas. It is accountable for the accurate safety assessment of new entities by using a mix of conventional toxicology together with new innovative approaches. NCD maintains GLP accreditation and is committed to the generation of high quality data in state-of-the-art facilities.

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Researcher:

• Virgile Richard
• Stephane Dhalluin

Lundbeck is an international pharmaceutical company engaged in research development, production, marketing, sale and distributing of pharmaceuticals for the treatment of neurological disorders, including depression, schizophrenia, Alzheimer's disease, Parkinson's disease and insomnia. Lundbeck is one of Denmark's most research-intensive enterprises. Each year, Lundbeck invests about 20% of its revenue into research and development of new pharmaceuticals to improve treatment options for the millions of people around the world suffering from neurological disorders. Lundbeck employs 5,300 people worldwide, 2,100 of whom are based in Denmark. The company has subsidiaries in 55 countries, and the products are registered in more than 90 countries. Lundbeck has production facilities in Italy and Denmark and research centers in Denmark and the USA. Lundbeck generated revenue of approximately DKK 11 billion in 2007. The Non-Clinical Safety Research organisation at Lundbeck is responsible for the safety assessment of new drug candidates. The Drug Safety division provides global support to all phases of drug development by means of both conventional and novel exploratory toxicology methods within the fields of safety pharmacology, toxicology, genetic and molecular toxicology.

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Researcher:

• Nina Ostenfeldt
• Dorthe Toft-Bach