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ABIRISK

Anti-Biopharmaceutical Immunization: Prediction and Analysis of Clinical Relevance to Minimize the Risk
Summary A growing number of medicines are based on biological molecules such as proteins and monoclonal antibodies. These novel drugs have resulted in new, more effective treatments for a number of serious conditions. Yet sometimes these medicines trigger a response from the patients immune system, which can decrease the effectiveness of the drug or cause severe side effects. The aim of the IMI-funded ABIRISK project is to shed new light on the factors behind this immune response. The project, which represents the first concerted effort to solve this problem, will aid in the creation of new, safer biopharmaceuticals and also generate tools to determine how individual patients are likely to respond to them both in clinical trials and after release to the market.

Biopharmaceuticals are drugs that are biological in origin (i.e. are made of proteins or DNA for example) and are manufactured using biotechnology. A number of biopharmaceuticals are already in use and have dramatically improved quality of life for patients with serious, hard to treat conditions such as multiple sclerosis, Crohns disease, diabetes, rheumatoid arthritis, haemophilia A and some cancers. However, in some patients, biopharmaceuticals can trigger an immune reaction, a phenomenon known as immunogenicity. When this happens, the immune system produces antibodies (ADAs) that neutralise the drug, which can reduce the effectiveness of the biopharmaceutical. In some patients, the immune response causes side effects such as a rash, chest pains, or a fall in blood pressure. In the most severe cases, it can trigger anaphylactic shock and even prove fatal. Immunogenicity the known unknowns Diverse factors appear to be involved in immunogenicity. On the drug side, both the compound and the route and duration of administration seem to play a role, while on the patient side, the type of disease, age, genetic background and interactions with other medicines may be risk factors. Therefore it is extremely hard to predict which biopharmaceuticals will have immunogenicity problems; although many tests exist, these are not always accurate. Furthermore, knowing which patients are at greatest risk of mounting an immune response to a given biopharmaceutical is extremely difficult. Reducing the risks Even though immunogenicity continues to pose a problem in the development of new drugs, until now there has been no major effort to solve the problem. Enter the ABIRISK project, which aims to give biopharmaceuticals a much-needed boost and represents the first concerted effort to tackle the immunogenicity problem by bringing together leading experts from hospitals, academia, industry and small companies. The project will set up laboratory tests to probe the immunogenicity of several biopharmaceuticals that are already used on patients. The scientists will then match their test findings with the effect the drug actually has on patients. This will help the team to develop tools that are better at predicting immunogenicity during drug development. Many pharmaceutical companies, academic institutions and patient registries have large amounts of data on biopharmaceuticals and patients responses to them. In ABIRISK, these diverse databases will be assembled into a single immunogenicity databank that will help researchers pinpoint the factors that influence a drugs immunogenicity and patients risk of it. This will allow the researchers to generate tools that will accurately predict whether a patient will mount an immune response to a biopharmaceutical and how that immune response will affect the efficacy and safety of the drug. Safer, more effective drugs for patients Immunogenicity means many patients today are denied the life-changing benefits of biopharmaceuticals. ABIRISK will ultimately result in a new generation of biopharmaceuticals with lower immunogenicity that can be safely and effectively used by more patients. In addition, the project will allow clinicians to determine which patients will respond best to which biopharmaceutical, thereby preventing patients from suffering the side effects of a drug that does not suit them. For Europes pharmaceutical industry, better tests will help companies identify the safest, most effective biopharmaceuticals and weed out those that pose a high immunogenicity risk earlier in the drug development
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process. This will save companies both time and money. Finally, by adding to our knowledge of the mechanisms behind immunogenicity, the project will help to improve regulatory guidelines for the approval of biopharmaceuticals.

Participants EFPIA GlaxoSmithKline Research & Development Limited, Brentford, UK Bayer Pharma AG, Berlin, Germany IPSEN Innovation SAS, Paris, France Merck KGaA, Darmstadt, Germany Novartis Pharma AG, Basel, Switzerland Novo Nordisk A/S, Bagsvrd, Denmark Pfizer Limited, Sandwich, UK Sanofi-Aventis Research and Development, Paris, France UCB Pharma SA, Brussels, Belgium Universities, research organisations, public bodies, non-profit groups Institut National de la Sant et de la Recherche Mdicale (INSERM), Paris, France Academisch Medisch Centrum, Amsterdam, the Netherlands Academisch Ziekenhuis Leiden Leids Universitair Medisch Centrum, Leiden, the Netherlands Centre National de la Recherche Scientifique, Paris, France Commissariat a LEnergie Atomique et aux Energies Alternatives, Paris, France DRK-Blutspendedienst Baden-Wrttemberg Hessen gemeinntzige GmbH, Mannheim, Germany Fondazione per lIstituto di Ricerca in Biomedicina, Bellinzona, Switzerland Fundaci Institut de Recerca de L'hospital Universitari Vall D'hebron, Barcelona, Spain Groupe dEtudes Therapeutiques des Affections Inflammatoires du Tube Digestif, Paris, France Istituto Giannina Gaslini, Genova, Italy Johann Wolfgang Goethe Universitt, Klinikum und Fachbereich Medizin, Frankfurt, Germany Karolinska Institutet, Stockholm, Sweden Klinikum rechts der Isar der Technischen Universitt Mnchen, Munich, Germany Medizinische Universitt Innsbruck, Innsbruck, Austria Paul-Ehrlich-Institut, Bundesinstitut fr Impfstoffe und biomedizinische Arzneimittel, Langen, Germany Queen Mary and Westfield, University of London, London, UK Rambam Medical Center, Haifa, Israel Region Hovedstaden, Hillerd, Denmark Universit di Firenze, Firenze, Italy Universittsklinikum Bonn, Bonn, Germany Universittsklinikum Dsseldorf, Dsseldorf, Germany University College London, London, UK University Hospital Basel, Basel, Switzerland Univerzita Karlova v Praze, Prague, Czech Republic SMEs ALTA Ricerca e Sviluppo in Biotecnologie Srlu, Siena, Italy Biomonitor A/S, Copenhagen, Denmark

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start Date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/03/2012 60 months

Links and Documents Project website: www.abirisk.eu IMI funding per project participant 18 200 000 11 200 000 5 500 000 34 900 000

Contact Project Coordinator Daniel Sikkema GlaxoSmithKline USA Tel: +1 610 270 6054 E-mail: dan.x.sikkema[AT]gsk.com Managing Entity for EU funds Marc Pallardy INSERM UMR 996 France Tel: +33 1 46 83 54 92 E-mail: marc.pallardy[AT]u-psud.fr

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BioVacSafe
Biomarkers for Enhanced Vaccine Immunosafety
Summary Since their discovery, vaccines have protected millions of people worldwide from a broad range of infectious diseases, making them one of the most effective public health interventions out. New and better vaccines are still urgently needed, yet their introduction is hampered by lengthy and expensive vaccine safety testing procedures. The aim of the IMI-funded BIOVACSAFE project is to develop cutting edge tools to speed up and improve the testing and monitoring of vaccine safety, both before and after release to the market. By bringing together Europes top industrial and academic teams for the first time, the project will ultimately usher in a new generation of safer, more effective vaccines.

Vaccines are widely acknowledged to be one of the cheapest and most efficient ways to combat infectious diseases in both developed and developing countries. With billions of doses of vaccines administered globally every year, vaccine safety is a top priority for pharmaceutical companies, regulators and the public alike. The problem is that testing and monitoring new vaccines for safety is a slow, cumbersome, and extremely expensive process; the development of a new vaccine costs millions of euros, and less than 1 vaccine in 10 makes it through clinical testing. As companies add new components to vaccines to make them more effective, testing them for safety becomes even more challenging. And, while severe adverse reactions to vaccines are rare, predicting who is at risk of a severe reaction is extremely difficult; this problem will be further complicated by the ageing of the population and the growing burden of chronic conditions and diseases of the immune system. A new approach to vaccine safety The BIOVACSAFE project will draw on the latest life science research findings to profile, in great detail, how individuals respond to the different components of vaccines at the cellular, genetic and molecular level. This will allow the project team to develop tools that can rapidly and accurately identify warning signs that a potential vaccine may be reactogenic. The tools could be employed early on in vaccine development, before vast amounts of time and money have been spent. Meanwhile, the team will develop new ways to identify, classify and record adverse reactions to vaccines; this should also boost researchers ability to pick up on problems early in vaccine development. Finally, the team will probe how natural illnesses and infections, particularly diseases of the immune system, interact with vaccines. By identifying these interactions, the team hopes to find ways of preventing them occurring in the first place. Finally, the team will create databases that can be used to store information on and explore reactions to vaccines. Towards the next generation of vaccines By coming up with novel ways to identify and better understand the causes of adverse reactions to vaccines at all stages of development, BIOVACSAFE will accelerate the development and introduction of a new generation of safer, more effective vaccines to combat infectious diseases, cancer and chronic diseases. As well as speeding up vaccine development, the new, more accurate tools developed by BIOVACSAFE should help to boost public confidence in vaccine safety. Furthermore, because the project includes studies of populations in both developed and developing countries, its findings should be of global relevance. An injection of health for Europes vaccine development sector BIOVACSAFE brings together for the first time three of Europes leading vaccine development and manufacture companies as well as top experts from academic institutions and small and medium-sized enterprises (SMEs). By sharing their expertise as well as access to data and patient groups, all project partners will see their knowledge base and their competitiveness grow. Crucially, by pooling their expertise, the BIOVACSAFE partners have a unique opportunity to make progress in this important area.

Participants EFPIA Novartis Vaccines and Diagnostics, Siena, Italy GlaxoSmithKline Biologicals, Rixensart, Belgium Sanofi Pasteur, Lyon, France

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Universities, research organisations, public bodies, non-profit groups University of Surrey, Guildford, UK Chalmers University of Technology, Gothenburg, Sweden Charite? Universittsmedizin Berlin, Berlin, Germany Commissariat a? l'e?nergie atomique et aux e?nergies alternatives, Paris, France Gteborgs universitet, Gothenburg, Sweden Health Protection Agency, London, UK Imperial College London of Science, Technology and Medicine, London, UK Liverpool School of Tropical Medicine, Liverpool, UK Max-Planck-Gesellschaft zur Frderung der Wissenschaften, Berlin, Germany Statens Serum Institut, Copenhagen, Denmark Universita? degli Studi di Siena, Siena, Italy Universiteit Gent, Ghent, Belgium Universiteit Utrecht, Utrecht, the Netherlands SMEs CDISC European Foundation, Woluwe-Saint Lambert, Belgium ImmunArrray, Rehovot, Israel Islensk Erfdagreining ehf, Reykjavik, Iceland

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/03/2012 60 months 17 400 000 7 600 000 5 200 000 30 200 000

Links and Documents

Contact

Project website: www.biovacsafe.eu Project Coordinator Aldo Tagliabue IMI funding per participant Novartis (Ext) Tel: +39 0577 243508 E-mail Publications Project Coordinator & Managing Entity of EU funds David Lewis University of Surrey Tel: +44 1483 689797 E-mail Press Contact Mike Findlay University of Surrey Tel: +44 1483 686076 E-mail

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

BTCURE
Be The Cure
Summary New developments in our understanding of the pathology of Rheumatoid Arthritis (RA), a chronic disease affecting many patients, show how disease-inducing immune and inflammatory reactions develop from an asymptomatic phase with autoimmune reactions into a phase of non-specific symptoms and then further into the full-blown disease causing pain, joint destruction and functional deterioration. The ultimate goal for therapeutic development is to identify the disease-causing molecular events early in the disease and then influence immunity and inflammation so that functional deterioration is halted, immunity is re-regulated and the disease is cured.

The work from groups within the BTCure consortium (and others) has recently shown that very different genetic, environmental and thus molecular events are needed to trigger different subsets of the disease. Our aim is to develop an understanding of the early process in arthritis subsets that will enable us to develop precise and eventually curative treatments to be used before irreversible destruction and loss of joint function and mobility have occurred in patients. The BTCure project will develop new diagnostic methods to discover the early forms of RA and RA-like diseases and new tools to differentiate the different forms of RA and RA-like diseases, where different molecular mechanisms are involved and where different therapies may be required. To achieve these goals, samples from biobanks will be analysed in vitro and models will be aligned with different variants of human arthritis. In addition, new models will be established using similar molecular pathways as the relevant human arthritis subsets, leading to the understanding of the etiology and early pathology of the disease for a program aimed at early and curative treatment of RA and RA-like diseases. A major focus of these efforts will be to understand and subsequently alter the adaptive immune reactions in patients from a disease-inducing mode into either a protective mode against the disease or become asymptomatic. Advances made through initial research into the pathology of this group of diseases have been successful, given enough information available on the nature and regulation of disease-inducing and disease-protective immunity. With these tools at hand, we will be able to use new understanding of aetiology and early pathology of human disease for a program aimed at early and ultimately curative treatment of human RA and RA-like diseases.

Participants EFPIA AstraZeneca AB, Sweden Boehringer Ingelheim International GMBH, Germany Bristol Myers Squibb EMEA sarl, USA CENTOCOR B.V., Netherlands F. Hoffmann-La Roche AG, Switzerland Merck, Germany NovoNordisk A/S, Denmark Pfizer Limited, UK UCB Pharma, SA,Belgium UNIVERSITIES, RESEARCH ORGANISATIONS, PUBLIC BODIES & NON-PROFIT Alexander Fleming Biomedical Sciences Research Center, Greece
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AMC/University of Amsterdam, Netherlands Charit-University of Medicine, Berlin, Germany Diakonhjemmet Hospital, Norway Foundation for Research and Technology, Greece German Rheuma Research Centre Berlin, Germany Humanitas Foundation for Research, Italy Imperial College London, UK Karolinska Institute, Sweden King's College London, UK National Institute for Health and Medical Research (INSERM), France National University of Ireland, Dublin Phadia AB, Sweden Revmatologicky Institute, Czech Republic Spanish National Research Council, Spain Stichting Catholic University Netherlands University College Dublin, Ireland, University Hospital Centre, Montpellier, France University Hospital Leiden (LUMC), Netherlands University of Erlangen, Germany University of Glasgow, UK University of Leeds, UK University of Manchester, UK University of Zrich, Switzerland SMEs TcLand Expression, France

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start Date Duration Contributions IMI funding EFPIA in-kind Other Total Cost 01/04/2011 60 months

Links and Documents Project website: www.btcure.eu IMI Funding per project participant 16 137 872 14 172 302 7 807 923 38 118 097 Publications

Contact PROJECT COORDINATOR UCB Pharma SA Dr Neil Gozzard Pharmacology Alle de la Recherche, 60 1070 Brussels Belgium Email: neil.gozzard[AT]ucb.com MANAGING ENTITY OF IMI BENEFICIARIES Professor Lars Klareskog Karolinska Institute, Sweden Nobels vg, 5 17177 Stockholm Sweden Email: lars.klareskog[AT]ki.se Tel: +46 851774529

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

CHEM21
Chemical manufacturing methods for the 21st century pharmaceutical industries
Summary The CHEM21 project plans to generate a range of methods to make the drug development process more environmentally friendly. Whats more, as well as being good for the planet, the methods developed by CHEM21 will also help the pharmaceutical industry to cut costs, resulting in cheaper medicines for patients.

Towards more sustainability in drug manufacture Today, drug manufacture often requires 100 kg of materials to produce just 1 kg of active ingredient. This inefficiency means that many products require long lead times and large facilities for their production and to deal with any waste materials. This is not just bad for the environment; medicines produced in this way are expensive to develop and produce. Meanwhile, another emerging issue for the pharmaceutical sector is the scarcity of precious metals, like platinum, that are essential in the synthesis of many drugs but are being depleted at alarming rates. Solving these problems will require a major revision in the way drugs are synthesised. Smarter synthesis CHEM21 will link leading academics in the field of green chemistry with scientists working in drug synthesis in industry to tackle the challenges found in the commercial manufacture of drugs. Specifically, the CHEM21 project aims to generate a range of technologies for medicines manufacture that are demonstrably more sustainable that existing methods. Part of the project will be devoted to designing catalysts based on common metals (such as copper, iron and nickel) instead of the rarer and more expensive precious metals used now. The team also aims to reduce the amount of solvent used and develop methods that favour starting materials that result in less harmful waste. An additional aim of the team is to provide new tools for medicinal chemists which are greener and are robust for scaling up. Elsewhere, the project plans to boost the use of enzymes as catalysts and to investigate what steps are needed to implement synthetic biology for the sustainable production of more complex molecules. In addition to promoting green and sustainable methodologies among current medicinal and process chemists, CHEM21 wants to make green drug production second nature for the next generation of scientists in this area. To this end, the project will develop and disseminate educational material, case studies, and reviews and trial them in selected universities and EFPIA companies. Cheaper medicines for patients Inefficient production processes and the use of rare precious metals raise the costs of drug production. By making drug production more efficient and swapping expensive materials for cheaper alternatives, CHEM 21 will help to lower the cost of medicines.

Participants EFPIA GlaxoSmithKline Research and Development Ltd, Brentford, UK


Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Bayer Pharma AG, Berlin, Germany Janssen Pharmaceutica NV, Beerse, Belgium Orion Corporation, Espoo, Finland Pfizer Limited, Sandwich, UK Sanofi Chimie, Gentilly, France Universities, Research Organisations, Public bodies & non-profit University of Manchester, Manchester, UK Leibniz Institute for Catalysis, Rostock, Germany Stichting VU-VUMC, Amsterdam, Netherlands Technische Universitt Graz, Graz, Austria Universitt Graz, Graz, Austria Universitt Stuttgart, Stuttgart, Germany Universiteit Antwerpen, Antwerp, Belgium University of Durham, Durham, UK University of Leeds, Leeds, UK University of York, York, UK SMEs ACIB GmbH, Graz, Austria CatScI Ltd, Wentloog, Cardiff, United Kingdom Charnwood Technical Consulting Ltd, Quorn, UK Evolva Biotech A/S, Copenhagen, Denmark Reaxa Limited, Leeds, UK

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind* Other Total Cost 01/10/2012 48 months 9 800 000 13 600 000 3 000 000 26 400 000

Links and Documents Project website: www.chem21.eu

Contact Project Corodinator Philip Dell'orco GlaxoSmithKline Research and Development Ltd Tel: +1 610 270 7316 E-mail: Philip.C.Dell'Orco[AT]@gsk.com Managing Entity Nick Turner University of Manchester Tel: +44 161 306 5100 E-mail: Nicholas.Turner[AT]manchester.ac.uk

*includes non-EU contribution of 0.3 million

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

COMBACTE
Combatting Bacterial Resistance in Europe
Summary Antimicrobial resistance (AMR) is a growing problem worldwide, and with few new drugs making it to the market, there is an urgent need for new medicines to treat resistant infections. Enter the IMI-funded COMBACTE project, which aims to give antibiotic drug development a much-needed boost by pioneering new ways of designing and implementing efficient clinical trials for novel antibiotics. COMBACTE forms part of the New Drugs for Bad Bugs (ND4BB) initiative, IMIs wider programme to tackle AMR.

The AMR arms race developing New Drugs for Bad Bugs AMR represents a serious and growing threat to human and animal health worldwide. According to the World Health Organization (WHO), antibiotic resistance is becoming a public health emergency of yet unknown proportions. In the EU, AMR is responsible for some 25 000 deaths every year, and the annual treatment and social costs have been estimated at some 1.5 billion. Meanwhile, new forms of resistance continue to arise and spread, leaving clinicians with few weapons to bring infections under control. Yet despite the recognised need for new antibiotics, the reality is that only two new classes of antibiotics have been brought to the market in the last three decades. The reasons for this are manifold. On the scientific front, there is an urgent need for a greater understanding of how antibiotics work, how bacteria develop resistance to them, and what molecular mechanisms could be exploited to get round bacterial defence mechanisms. Running clinical trials on new antibiotics is also problematic due to regulatory requirements and the large numbers of patients required put simply, a lot of patients have to be recruited to the major studies of efficacy performed for each clinical indication sought in order to be sure of having enough patients with the resistant bacteria under investigation and to demonstrate that the new antibiotic is not inferior to comparable antibacterial drugs. These issues mean that the costs of carrying out a clinical trial on a new antibiotic are extremely high. At the same time, because some antibiotics will only be used on a very small number of patients, the costs of development often exceed the potential return on investment. In other words, antibiotic development is simply no longer a financially viable option for pharmaceutical companies, and just a handful of pharmaceutical companies remain in the field. If no action is taken to address these issues, we risk leaving society in a situation where doctors will have few, if any, options to treat resistant bacterial infections. To avoid a public health emergency, the entire antibiotic research community, including researchers in universities, small and medium-sized enterprises (SMEs), and pharmaceutical companies must work together to reinvigorate research into new antibiotics. As a public-private partnership (PPP), IMI is the ideal platform to launch such an initiative. In its Action Plan against the rising threats from Antimicrobial Resistance of November 2011, the European Commission called for unprecedented collaborate research and development efforts to bring new antibiotics to patients by, among other things, launching an IMI programme for research on new antibiotics aimed at improving the efficiency of research and development of new antibiotics through unprecedented open sharing of knowledge. The result is the New Drugs for Bad Bugs (ND4BB) programme, the first two topics of which were launched as IMIs 6th Call for proposals in May 2012. COMBACTE is the result of one of those topics. A third topic under ND4BB was launched as part of IMIs 8th Call for proposals in December 2012. Since the launch of ND4BB, the European Parliament has also weighed in on the issue. In December 2012 it adopted a resolution on the rising threat of AMR that highlights the important role of PPPs in reinvigorating antimicrobial R&D. COMBACTE improving clinical trials for antibiotics The COMBACTE project focuses on addressing the
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

barriers to clinical development. A key outcome of the project will be a high quality, pan-European clinical trial network. Dubbed COMBACTE CLIN-Net, it will be capable of recruiting sufficient patients into multinational trials at all stages of development. Alongside this, the project will also establish a pan-European laboratory network (COMBACTE LAB-Net), which will deliver epidemiological information and data from microbial surveillance work to guide the selection of clinical trial sites. Crucially, the COMBACTE team aims to generate innovative trial designs to facilitate the registration of novel antibacterial agents. It will also design and validate tests to support the diagnosis of patients, identify the most appropriate treatments, and monitor the patients response. A large part of the project will be devoted to the performance of clinical trials of drugs under development in the pharmaceutical companies involved in the project. The first antibiotic to undergo clinical trials under COMBACTE is GSK1322322, which inhibits the action of a bacterial enzyme called peptide deformylase (PDF) and appears to be effective against multi-drug resistant respiratory and skin pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). Most importantly, GSK1322322 represents a new class of antibiotics with a novel mode of action. In COMBACTE, experts will run clinical trials to evaluate GSK1322322s efficacy at treating acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Looking to the future, trials of other drugs are planned. For example, IMIs 8th Call for proposals included a subtopic on the conduct of early clinical studies on MEDI4893, a new human immunoglobulin monoclocal antibody which targets S. aureus alpha toxin, which is behind much of the tissue and organ damage associated with S. aureus infection. The outcome of the 8th Call for proposals will be made public in the second half of 2013. Hope for the future The challenge of antimicrobial development is so great that no organisation could take it on alone. By bringing together leading experts from universities, hospitals, and pharmaceutical companies who are skilled in microbiology, epidemiology, drug development, and clinical trial design, COMBACTE is set to give antibiotic development in Europe a major boost. Unique in its scale, ambition, and its potential benefits for patients, public health and pharmaceutical research in Europe, COMBACTE has the potential to become the powerhouse of antimicrobial drug development in Europe that could serve as a standard for other groups. Ultimately, the hope is that COMBACTE will provide a framework for the rapid and efficient development of new treatments as well as diagnostic tests that can be speedily commercialised for use on the patients that so urgently need them.

Participants EFPIA companies GlaxoSmithKline Research and Development Ltd, UK AstraZeneca AB, Sweden Janssen Infectious Diseases Diagnostics BVBA, Belgium Universities, research organisations, public bodies, non-profit groups University Medical Center Utrecht, The Netherlands Centre Hospitalier Rgional Universitaire de Besanon, France Centre Hospitalier Universitaire de Limoges, France Cliniques Universitaires Saint Luc, Belgium Fundacio Centre de Recerca en Salut International de Barcelona, Spain Helmholtz-Zentrum fr Infektionsforschung GmbH, Germany Hospices Cantonaux CHUV, Switzerland Institut National de la Sant et de la Recherche Mdicale, France
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North Bristol National Health Service Trust, UK Servicio Andaluz de Salud, Spain Stichting Katholieke Universiteit / Radboud University Nijmegen Medical Centre, The Netherlands Universittsklinikum Freiburg, Germany Universittsklinikum Kln, AR (University Hospital of Cologne), Germany Universit de Genve, Switzerland Universit Joseph Fourier, Centre de Recherche Inserm, France University of Antwerp, Belgium Small and medium-sized enterprises (SMEs) Julius Clinical Research BV, The Netherlands

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start Date Duration Contribution IMI Funding EFPIA in kind Other Total cost 01/01/2013 84 months 83 033 010 104 398 189 7 129 184 194 560 383

Contact Project coordinator Scott White GlaxoSmithKline Research and Development Ltd Tel.: +1 610 917 7000 E-mail: scott.m.white[AT]gsk.com Managing entity Marc J M Bonten University Medical Center Utrecht Tel.: +31 88 7557394 E-mail: mbonten[AT]umcutrecht.nl Clinical trials lead Bruno Franois Centre Hospitalier Universitaire de Limoges Tel.: +33 5 55 05 69 84 E-mail: b.francois[AT]unilim.fr and bruno.francois[AT]chu-limoges.fr

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

COMPACT
Collaboration on the optimisation of macromolecular pharmaceutical access to cellular targets
Summary Many new medicines are based on biological molecules such as proteins, peptides or nucleic acids. The goal of the COMPACT project is to shed new light on the obstacles these drugs (which are known as biopharmaceuticals) need to overcome to get to where they are needed in the body. The team will then use this information to develop and validate biopharmaceutical formulations to deliver these novel drugs to their targets.

New drugs with a lot of potential Biopharmaceuticals, medicines based on biological molecules such as proteins and nucleic acids, have already delivered effective treatments for a number of serious, often hard to treat diseases, such as Crohns disease and multiple sclerosis, dramatically improving patients quality of life. The pharmaceutical industry is keen to expand its work on these novel drugs, but biopharmaceuticals still have a number of drawbacks which are hampering their broader application. For example, because these molecules tend to be complex and delicate, most biopharmaceuticals have to be injected; if they were administered orally (a more patient-friendly route), they would be destroyed by the harsh environment of the stomach. Furthermore, even once biopharmaceuticals are in the body, their large size means it is hard for them to get to their targets. Overcoming obstacles The overall aim of the COMPACT project is to overcome the delivery and targeting bottlenecks for biopharmaceuticals. It will do this by tackling a number of key issues. Firstly, it will identify and characterise the main transport routes across biological barriers and through cell membranes that could be exploited for drug delivery purposes. These include the intestinal barrier, skin barrier, and blood-brain barrier. Secondly, the researchers will devise and characterise formulations to allow the delivery of peptide and protein-based drugs via non-invasive routes (e.g. orally, via the airways, and via the skin). The team will also work to find ways to get these drugs across the blood-brain barrier. Another goal involves transporting drugs based on nucleic acids (e.g. RNA) into and through the cell. Throughout the project, the team will use advanced imaging techniques to track the movement of biopharmaceuticals at the (sub) cellular, tissue, and whole body level. Benefits for patients Biopharmaceuticals have the potential to improve the lives of many patients with diseases and conditions that are currently hard or even impossible to treat. By finding more effective ways of administering these drugs, and improving their ability to travel through the body to where they are needed, COMPACT will allow more patients to benefit from biopharmaceuticals. Furthermore, designing less invasive administration routes and reducing the dose (and therefore the side effects) and frequency of administration will help to improve patient compliance with treatments.

Participants EFPIA Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany


Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Abbott GmbH & CoKG, Wiesbaden-Delkenheim, Germany Boehringer Ingelheim International GmbH, Ingelheim, Germany GlaxoSmithKline Research and Development Ltd, Brentford, UK Merck KGaA, Darmstadt, Germany Novo Nordisk A/S, Bagsvrd, Denmark Pfizer Limited, Sandwich, UK Universities, research organisations, public bodies, non-profit groups Universiteit Utrecht, Utrecht, Netherlands Bioneer A/S, Hrsholm, Denmark Cardiff University, Cardiff, UK Helmholtz-Zentrum fr Infektionsforschung GmbH, Braunschweig, Germany Helsingin Yliopisto, Helsinki, Finland Ludwig-Maximilians-Universitt Mnchen, Munich, Germany Norges Teknisk-Naturvitenskapelige Universitet NTNU, Trondheim, Norway Stockholms Universitet, Stockholm, Sweden Universitt Wien, Vienna, Austria Universitt Zurich, Zurich, Switzerland Universiteit Gent, Ghent, Belgium Universiteit Leiden, Leiden, Netherlands University of Copenhagen, Copenhagen, Denmark University of Oxford, Oxford, UK SMEs Pharmacoidea Development and Service Ltd, Szeged, Hungary

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind* Other Total Cost 01/10/2012 60 months 10 200 000 16 600 000 3 200 000 30 000 000

Links and Documents Project website: www.compact-research.org Project Launch Press Release IMI funding per project participant

Contact Project Coordinator Ekkehard Leberer Sanofi-Aventis Deutschland GmbH Tel: +49 69 305 18998 E-mail: Ekkehard.Leberer[AT]sanofi.com Managing Entity Enrico Mastrobattista Universiteit Utrecht Tel: +31 6 22736567 E-mail: e.mastrobattista[AT]uu.nl

*includes non-EU contribution of 1.6 million

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

DDMoRe
Drug Disease Model Resources
Summary Model based-drug development (MBDD) is accepted as a vital approach in understanding patient risk/benefit and attrition. At the core of MBDD lies Modelling and Simulation (M&S), a technology providing the basis for informed, quantitative decision-making.

M&S facilitates the continuous integration of available information related to a drug or disease into constantly evolving mathematical models capable of describing and predicting the behaviour of studied systems to address the questions researchers, regulators and public health care bodies face when bringing drugs to patients. The full adoption of MBDD is perturbed by a lack of common tools, languages and ontologies for M&S, which often leads to inefficient reuse of data and duplication of effort by academic, industrial and regulatory stakeholders. The Drug Disease Model Resources (DDMoRe) consortium strategy will have standards as its core: a newly developed common definition language for data, models and workflows, along with an ontology-based standard for storage and transfer of models and associated metadata. A drug and disease model library will be developed as a public resource. Its flexibility and power will be showcased by the addition of proof of concept drug and disease models from key therapeutic areas such as diabetes and oncology. An open-source interoperability framework will be the backbone for the integration of M&S applications into seamless standardized but flexible workflows. Initially, currently-used tools (e.g. NONMEM,WinBUGS, Matlab, R) will be integrated into the framework. From the outset resources will also be dedicated to new application development which will be steered by identified gaps in the M&S software ecosystem. The DDMoRe projects standards and tools intended as the gold standard for future collaborative drug and disease M&S - will be supported by comprehensive training and will be made publicly accessible. The DDMoRe consortium draws together its expert partners from across Europe including 5 SMEs and 9 academic partners who will be working together to accomplish the aims of the project with 10 EFPIA companies.

Participants EFPIA AstraZeneca AB, Sweden Eli Lilly & Co Ltd, UK F. Hoffmann-la Roche AG, Switzerland GlaxoSmithKline Research & Development Ltd, UK Merck KGaA, Germany Novartis Pharma AG Novo Nordisk A/S, Denmark Pfizer Ltd, UK Servier International Institute of Research, France UCB Pharma SA, Belgium UNIVERSITIES, RESEARCH ORGANISATIONS,PUBLIC BODIES & NON-PROFIT

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European Molecular Biology Laboratory, Germany Freie Universitt Berlin, Germany National Institute of Research in IT Technology (NRIA), France National Research Council, Italy University of Leiden, Netherlands University of Navarra, Spain University of Pavia, Italy University of Uppsala, Sweden University Paris Diderot, France SMES Cyprotex Discovery Ltd, UK Interface Europe, Belgium Lixoft SAS, France Mango Business Solutions Ltd, UK Optimata Ltd, Israel Simcyp Ltd, UK

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start Date Duration Contributions IMI funding EFPIA in-kind Other Total Cost 01/03/2011 60 months

Links and Documents Project website: www.ddmore.eu IMI funding per project participant 9 615 058 9 820 120 1 729 833 21 165 061 Publications

Contact PROJECT COORDINATOR Lutz Harnisch Pharmacometrics Pfizer Ltd UK Email: Lutz.O.Harnisch[AT]pfizer.com MANAGING ENTITY OF IMI BENEFICIARIES Mats Karlsson Uppsala University Sweden Email: Mats.Karlsson[AT]farmbio.uu.se

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DIRECT
Diabetes research on patient stratification
Summary Diabetes treatment gets personal Type 2 diabetes patients are a diverse group; in some, the disease progresses rapidly, while in others it takes a slower course. Similarly, a treatment that works well in one patient may prove less effective in another. This has led researchers to acknowledge that there are actually a number of different subtypes of type 2 diabetes. The goal of the IMI-funded DIRECT project is to identify these subtypes and determine most appropriate treatments for them. The project brings together Europes leading researchers from academia, healthcare, and the pharmaceutical industry.

Some 285 million people worldwide have type 2 diabetes, and that figure is set to rise to 439 million by 2030. It arises when the body cannot make enough insulin (the hormone responsible for managing blood sugar levels), or when the body fails to respond to insulin. Although type 2 diabetes is a chronic, lifelong condition, it can be managed through a combination of medicines and lifestyle changes. If left unmanaged, patients blood sugar levels become too high, triggering damage to the cardiovascular system, kidneys, eyes, and nerve endings. Although there are a number of risk factors for type 2 diabetes (such as obesity), it is not always clear why some people develop the condition while others do not. Furthermore, the course of the disease and the effectiveness of different medicines vary from one patient to another. In other words, there are a number of different kinds of type 2 diabetes, and that is where the DIRECT project comes in. Variations on a theme The focus of the DIRECT project is patient stratification, which involves identifying different subgroups of patients. The project will develop and validate tests to predict who will get diabetes, whose condition will deteriorate rapidly after diagnosis, and who will respond well or badly to certain drugs. The tests will then allow the DIRECT project to determine which existing drugs are effective for different varieties of type 2 diabetes. DIRECT will gather large amounts of data as well as samples from people at risk of diabetes, people with diabetes, and people undergoing diabetes treatment. This will enable the project team to identify biomarkers (biological markers such as the level of a certain molecule in the blood) associated with different subtypes of type 2 diabetes and different rates of disease progression. These biomarkers will then be tested in prospective clinical trials, paving the way for their use as new diagnostic tests as well as in the creation of personalised therapies. Getting the right treatments to the right patients. The tests developed by DIRECT will ultimately usher in a new era of personalised medicine for diabetes patients. In practice, this means doctors will be able to diagnose their patients more accurately and tailor treatments to suit their own particular subtype of type 2 diabetes. In this way, patients will be able to manage their condition more effectively and hopefully avoid the complications associated with diabetes. Furthermore, patients who are at risk of diabetes could be identified and monitored. A boost for the drug development sector The work carried out under the DIRECT project will substantially boost industrys understanding of the underlying causes of type 2 diabetes, helping it to develop tailored treatments that can be targeted to the right patients. Pieces of a pharma puzzle The work carried out in DIRECT complements the efforts of IMIs other diabetes projects. IMIDIA (Improving beta-cell function and identification of diagnostic biomarkers for treatment monitoring in diabetes) is studying the beta cells of the pancreas, which are responsible for producing insulin, with a view to developing a cure for diabetes. Meanwhile SUMMIT (Surrogate markers for micro- and macro-vascular hard endpoints for innovative diabetes tools) is developing tools to identify the patients at greatest risk of developing complications relating to diabetes.

Achievements & News IMI diabetes projects sign Memorandum of Understanding IMI currently has three projects working on diabetes DIRECT, SUMMIT, and IMIDIA which have a combined budget ofjust over100 million. The projects tackle diabetes in different ways. For example, IMIDIA focuses on studying the pancreatic beta cells which are responsible for producing insulin; it aims to use this knowledge develop treatments that can slow down the progress of diabetes. Meanwhile, SUMMITs work addresses the urgent need for new treatments to tackle the
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complications associated with diabetes, such as eye, kidney, and blood vessel problems. Finally, DIRECT takes a personalised medicine approach to diabetes, as it works to identify different varieties of diabetes and effective treatments to tackle them. The projects already work together on an informal basis (as evidenced by their new joint leaflet produced with the support of the IMI Executive Office). However, IMIDIA and SUMMIT have now taken their collaboration to a new level with the signature of a Memorandum of Understanding (MoU). The MoU covers the handling of intellectual property, the transfer of knowledge and materials, and confidentiality. The projects believe that the MoU could serve as a template for collaboration between other IMI projects in the future. (November 2012)

Participants EFPIA Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany Eli Lilly and Company Ltd, Hampshire, UK Institut de Recherches Internationales Servier, Suresnes, France Novo Nordisk A/S, Bagsvrd, Denmark Universities, research organisations, public bodies, non-profit groups University of Dundee, Dundee, UK Centre Hospitalier Regional et Universitaire de Lille, Lille, France Centre National de la Recherche Scientifique. Paris, France Consiglio Nazionale delle Ricerche, Rome, Italy Consorci Institut d'Investigacions Biomediques August Pi i Sunyer, Barcelona, Spain Eberhard Karls Universitt Tbingen, Tbingen, Germany Helmholtz Zentrum Mnchen Deutsches Forschungszentrum fr Gesundheit und Umwelt GmbH, Neuherberg, Germany Imperial College of Science, Technology and Medicine, London, UK Kungliga Tekniska Hgskolan, Stockholm, Sweden Leiden University Medical Center, Leiden, the Netherlands Lunds Universitet, Lund, Sweden Technical University of Denmark, Kgs. Lyngby, Denmark Universitt Ulm, Ulm/Donau, Germany Universit de Genve, Geneva, Switzerland University of Bath, Bath, UK University of Copenhagen, Copenhagen, Denmark University of Eastern Finland, Kuopio, Finland University of Exeter, Exeter, UK University of Newcastle upon Tyne, Newcastle upon Tyne, UK University of Oxford, Oxford, UK Vereniging voor christelijk hoger onderwijs, wetenschappelijk onderzoek en patintenzorg, Amsterdam, Netherlands

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/01/2012 60 months 21 400 000 16 500 000 5 200 000 43 100 000

Links and Documents Project website: www.direct-diabetes.org IMI funding per project participant The IMI Diabetes Platform

Contact Project Coordinator Hartmut Rtten Sanofi Tel: +49 69 305 13547 E-mail: hartmut.ruetten[AT]sanofi.com Managing Entity Ewan Pearson University of Dundee Tel: +44 1382 740081 E-mail: e.z.pearson[AT]dundee.ac.uk Press Contact Bernd Jablonka Sanofi Tel: +49 69 305 5955 E-mail: bernd.jablonka[AT]sanofi.com

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

EHR4CR
Electronic Health Records Systems for Clinical Research
Summary Current medical needs, the growth of targeted therapies and personalized medicines and escalating R&D costs result in formidable cost pressures on healthcare systems and the pharmaceutical industry.Clinical research is also growing in complexity, labour intensity and cost. There is a growing realization that the development and integration of Electronic Health Record systems (EHRs) for medical research can: enable substantial efficiency gains make Europe more attractive for R&D investment provide patients better access to innovative medicines and improved health outcomes.

EHRs can now be designed to seamlessly integrate with existing research platforms and healthcare networks to create opportunities for many stakeholders, including the pharmaceutical and bio-pharma industries. However, key challenges are compliance with various ethical, legal and privacy requirements (and acceptance by the general public, patients, and medical professionals), providing a platform that works across many EHR systems and is sustainable within a scalable business model. A 4-year project, EHR4CR will involve a team of recognised European academic and industrial partners. The project will build a platform to enable the use of EHR for more efficient medical research and run pilots (on interoperability, security, data quality, data storage solutions, organisational issues,accreditation and certification, etc) to demonstrate the viability and scalability of an EHR4CR business model. The EHR4CR project supports the IMI strategic agenda with an information gateway solution to enhance clinical research efficiency and innovation. A key IMI aspect is the development of a knowledge management capability that can, for example, provide information management support for other research on personalized medicines, now an IMI 2010 call topic. EHR4CR also supports other IMI R&D projects by enabling the use (and reuse) of large amounts of health data in an ethical and cost-effective way. The EHR4CR project consortium draws its expert partners from academia, with 20 organisations and 4 SMEs working with 10 EFPIA companies and is an example of the scale of collaboration made possible through IMI.

Achievements & News Stakeholders in favour of using electronic health records for clinical research, EHR4CR project survey shows An overwhelming majority (95%) of stakeholders are in favour of using electronic health records (EHR) in clinical research, according to the results of a recent survey run by IMI project EHR4CR (Electronic health records for clinical research).The goal of the project is to come up with a platform and business model to enable the re-use of data from EHRs for clinical research in Europe. The EHR4CR team set up the survey to identify opportunities and challenges in this area. The survey gathered around 200 responses from researchers in academia, the pharmaceutical industry, EHR system providers, patients organisations and others. Most highlighted complying with legislative, regulatory, ethical and privacy requirements as a top priority for the successful use of EHR services for clinical research. The results of this survey confirm a high interest in re-using EHR data for clinical research with the objective to optimise drug development efficiency and access to innovative medicines in Europe, the project team states. This survey provides valuable information towards achieving the development and implementation of EHR4CR services and of a sustainable and scalable business model. The teams findings will be published in a forthcoming issue of iHealth Connections. (November 2011)

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Participants EFPIA Amgen NV, Belgium AstraZeneca AB, Sweden Bayer Schering Pharma AG, Germany Eli Lilly, UK F. Hoffmann-La Roche Ltd, Switzerland GlaxoSmithKline Research & Development, UK Janssen Pharmaceutica NV, Belgium Merck KGaA, Germany Novartis Pharma AG, Switzerland Sanofi-Aventis Research and Development, France UNIVERSITIES, RESEARCH ORGANISATIONS, PUBLIC BODIES & NON-PROFIT eClinical Forum Association, France European Association of Health Law, University of Edinburgh, UK European Institute for Health Records, France European Molecular Biology Laboratory, Germany European Platform for Patients Oganisations, Science and Industry, Belgium Friedrich-Alexander University, Erlangen-Nrnberg, Germany Heinrich-Heine University, Dsseldorf (representing ECRIN), Germany Kings College London, UK Medical University of Warsaw, Poland National and Kapodistrian University of Athens, Greece National Institute for Health & Medical Research (INSERM), France Public Service Hospitals of Paris, France Telematics Platform Medical Research Networks, Germany University College London, UK University Hospital of Geneva, Switzerland University of Dundee, UK University of Edinburgh, UK University of Glasgow, UK University of Manchester, UK University of Rennes 1, France Westflische Wilhelms University, Mnster, Germany SMEs Assero Limited (representing CDISC), UK Custodix NV, Belgium Data Mining International, Switzerland (sub-contracting partner) XClinical GmbH, Germany

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Facts & Figures Start Date Duration Contributions IMI funding EFPIA in-kind Other Total Cost 01/03/2011 48 months

Links and Documents Project website: www.ehr4cr.eu IMI funding per project particpant 7 019 046 7 042 616 1 989 852 16 051 514 Publications

Contact Project Coordinator Mats Sundgren Global Clinical Development AstraZeneca Sweden Email: Mats.Sundgren[AT]astrazeneca.com Managing entity of IMI beneficiaries Prof. Dr. Georges de Moor The EuroRec Institute Belgium Email: Georges.DeMoor[AT]UGent.be For press inquiries: press@ehr4cr.eu

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European Lead Factory


European Lead Factory
Summary The European Lead Factory is a pan-European platform for drug discovery supported by the Innovative Medicines Initiative (IMI) that is set to give a major boost to drug discovery in Europe. Comprising a collection of half a million compounds (derived from new public and existing private company collections) and a screening centre, the European Lead Factory will offer researchers in academia, small and medium-sized enterprises (SMEs) and patient organisations an unprecedented opportunity to advance medical research and develop new medicines.

A key tool in the earlier stages of drug development is a technique called High Throughput Screening (HTS), in which researchers screen large collections of chemical compounds in the hunt for molecules that could be potential drugs or be used in drug development in other ways. Although pharmaceutical companies have built up large libraries of compounds over the years, access to these collections has been tightly restricted to in-house use by the owners. Meanwhile, the academic community is becoming increasingly interested in HTS, but public compound collections tend to be rather small and expertise in the area is scattered across many institutions. As a result, few public drug targets have been screened against large, high-quality compound libraries. This has hampered efforts to generate promising leads for the development of innovative drugs. A unique resource Enter the European Lead Factory, which will provide a select group of researchers in universities, small business and patient organisations with access to an industry-like platform for the identification of hits. Hits are compounds that could potentially be developed into new medicines. The pharmaceutical companies in the consortium will contribute a total of over 300 000 compounds to the project to create a joint compound collection. To this will be added an estimated additional 200 000 novel compounds generated by public partner contributions during the project, resulting in a unique Joint European Compound Collection with some 500 000 compounds. Proposals for novel compounds from the public partners will be submitted to a transparent selection and validation process addressing several criteria such as novelty, diversity potential, innovative design and synthetic tractability. Once approved, the SMEs together with the academic institutions will seamlessly translate the most compelling ideas into high quality compound libraries to be shipped to the consortiums HTS facilities. The project will also establish a screening centre providing HTS services for projects for the selected public projects from academia and SMEs. It will also handle all logistics for the Joint European Compound Collection, acting as a neutral, honest broker in the transfer, handling and analysis of confidential data. The project in practice Once up and running, the European Lead Factory will provide the compounds and support for 48 HTS screens per year. Of these, 24 will come from the industry partners, who will run their own screens. The other 24 HTS projects will be selected from the public sector following competitive Calls for proposals. Public programmes selected by the project will be further advanced by the European Lead Factory. It will provide guidance in the design of the experiments, support on medicinal chemistry, and help setting up partnerships with others if needed. Once the HTS has been run, the target owner (i.e. the organisation that submitted the target for inclusion in the project) will receive a list of a maximum of 50 compounds that have been identified. The project hopes to attract public screening proposals in a variety of therapeutic areas. Strength in diversity
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The European Lead Factory combines the power of the pharmaceutical industrys previously inaccessible compound libraries with the innovation of the academic communities in designing novel compounds and the expertise of many SMEs in HTS and library generation. Importantly, it will provide a screening platform of industrial quality focused on value generation. Looking to the future, the European Lead Factory is set to become a centre of excellence in Europe for small molecule drug discovery programmes in the public sector. A key output of the project is a comprehensive business plan that will ensure the viability of the initiative once the initial IMI project has ended.

Participants EFPIA companies Bayer Pharma AG, Germany AstraZeneca AB, Sweden H. Lundbeck A/S, Denmark Janssen Pharmaceutica NV, a Pharmaceutical Company of Johnson & Johnson, Belgium Merck KGaA, Germany Sanofi, France UCB Pharma SA, Belgium Universities, research organisations, public bodies, non-profit groups Foundation Top Institute Pharma (Stichting Top Instituut Pharma), The Netherlands Leiden University, The Netherlands Max Planck Gesellschaft zur Frderung der Wissenschaften E.V., Germany Radboud University Nijmegen, The Netherlands Stichting Het Nederlands Kanker Instituut, The Netherlands Technical University of Denmark, Denmark Universitt Duisburg-Essen, Germany University of Dundee, UK University of Groningen, The Netherlands University of Leeds, UK University of Nottingham, UK University of Oxford, UK VU-University Amsterdam, The Netherlands SMEs BioCity Scotland Ltd, UK ChemAxon, Hungary Edelris S.A.S, France Gabo:Mi Gesellschaft fur Ablauforganisation:Milliarium Mbh & Co Kg, Germany Lead Discovery Center GmbH, Germany Mercachem B.V., The Netherlands Pivot Park Screening Centre B.V, The Netherlands Sygnature Discovery Limited, UK Syncom, The Netherlands Taros Chemicals GmbH & Co KG, Germany

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start Date Duration IMI Funding EFPIA in kind Other Total cost 01/01/2013 60 months 79 999 157 91 337 070 25 202 832 196 539 059

Links and Documents IMI funding per project participant

Contact Project Coordinator Jrg Hser Bayer Tel: +49 202 36 3938 E-mail: joerg.hueser[AT]bayer.com Head Chemistry Consortium Dimitrios Tzalis Taros Chemicals Tel: +49 231 97 427211 E-mail: dtzalis[AT]taros-chemicals.de Head Screening Consortium Ton Rijnders TI Pharma Tel: +31 71 332 2035 E-mail: ton.rijnders[AT]tipharma.com

Contributions

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EMIF
European Medical Information Framework
Summary The EMIF project aims to develop a common information framework of patient-level data that will link up and facilitate access to diverse medical and research data sources, opening up new avenues of research for scientists. To provide a focus and guidance for the development of the framework, the project will focus initially on questions relating to obesity and Alzheimers disease.

Difficulties with data Recent years have seen an explosion in the number of databases containing medical and research data, from Electronic Health Records (EHRs), cohort studies (in which a group of individuals are followed for a number of years), disease-specific studies, and biobanks, to name a few. Because this data is scattered across diverse platforms, it cannot be fully exploited. Linking up the data would allow scientists to significantly advance medical research and drug development. However, in practice, this is rather difficult. Not only is the data fragmented, differences in coding systems and languages, plus legal and ethical restraints, hamper efforts to combine these sources of data. Furthermore, there are often information gaps. There is therefore a need for a single system that allows researchers to link data on an immense scale, including patient health records, research data, survey and administrative data, imaging, social, environmental and economic data. Such a system should also be able to bring together data from different populations; this would increase sample sizes and facilitate the study of rare or highly specific subgroups. A common information framework EMIF will develop a common information framework that will not only facilitate access to existing data sources, but ease the creation of links between sources and, where needed, collect additional information. The work will require the team to address a number of issues, including data standards, semantic interoperability, ethics, data privacy, legal issues, and the development of an IT platform that allows access to multiple data sources. To guide the development of the framework, the team will initially focus on two key research issues: identifying the mechanisms that make some people more susceptible to dementias (such as Alzheimers disease) than others; determining which individuals with obesity are most likely to develop complications such as diabetes. Obesity and dementia are two of the greatest healthcare challenges of our time; EMIFs work will pave the way for new diagnostic tools and treatments to help patients with these conditions. Looking to the future, additional research areas may be added to the framework through future IMI Calls for proposals.

Participants EFPIA GlaxoSmithKline Research and Development Ltd, Brentford, UK Amgen NV, Brussels, Belgium Boehringer Ingelheim International GmbH, Ingelheim, Germany F. Hoffmann-La Roche AG, Basel, Switzerland
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Institut de Recherches Internationales Servier, Suresnes, France Janssen Pharmaceutica NV, Beerse, Belgium Novo Nordisk A/S, Bagsvrd, Denmark Pfizer Limited, Sandwich, UK UCB Pharma SA, Brussels, Belgium Universities, research organisations, public bodies, non-profit groups Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands Aarhus Universitetshospital, Aarhus Sygehus, Aarhus, Denmark Agenzia Regionale di Sanita, Florence, Italy Assistance Publique - Hpitaux de Paris , Paris, France Brighton Collaboration Foundation, Basel, Switzerland Ealing Hospital NHS Trust, Southall, UK European Institute for Health Records, Lille, France European Molecular Biology Laboratory, Heidelberg, Germany Fondazione PENTA - for the Treatment and Care of Children with HIV-ONLUS, Padova, Italy Gteborgs Universitet, Gothenburg, Sweden Helsingin Yliopisto, Helsinki, Finland Institut fr Epidemiologie und Prventionsforschung GmbH, Bremen, Germany Institut National de la Sant et de la Recherche Mdicale, Paris, France It-Suomen Yliopisto, Kuopio, Finland Karolinska Institutet, Stockholm, Sweden Kings College London, London, UK Maastricht University, Maastricht, Netherlands Max-Planck-Gesellschaft zur Frderung der Wissenschaften, Munich, Germany Medical Research Council UK, Swindon , UK Provincia Lombardo-Veneta - Ordine Ospedaliero di San Giovanni di Dio Fatebenefratelli, Milan, Italy Tartu Ulikool, Tartu, Estonia Teknologian tutkimuskeskus VTT, Espoo, Finland Universidade de Aveiro, Aveiro, Portugal Universit degli Studi di Pisa, Pisa, Italy Universitt Leipzig, Leipzig, Germany Universitat Pompeu Fabra, Barcelona, Spain Universiteit Antwerpen, Antwerp, Belgium University College London, London, UK University of Cambridge, Cambridge, UK University of Copenhagen, Copenhagen, Denmark University of Glasgow, Glasgow, UK University of Leicester, Leicester, UK University of Manchester, Manchester, UK University Pierre et Marie Curie, Paris, France Vereniging Voor Christelijk Hoger Onderwijs Wetenschappelijk Onderzoek en Patintenzorg, Amsterdam, Netherlands VIB, Zwijnaarde, Belgium Patients organisations Alzheimer Europe, Luxembourg, Luxembourg Universittsklinikum Erlangen, Anstalt des ffentlichen Rechts, Erlangen, Germany Vestische Kinder- und Jugendklinik Datteln, Dattien, Germany SMEs

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Concentris Research Management GmbH, Frstenfeldbruck, Germany Custodix NV, Sint-Martens-Latem, Belgium Electrophoretics Ltd, Cobham, UK GENOMEDICS S.R.L., Florence, Italy MAAT France, Archamps, France Pharmo Cooperatie UA, Utrecht, Netherlands Synapse Research Management Partners S.L., Barcelona, Spain Societa Servizi Telematici SRL, Padova, Italy Synapse Research Management Partners S.L., Barcelona, Spain

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/10/2012 60 months 24 400 000 24 100 000 7 900 000 56 400 000

Links and Documents IMI funding per project participant

Contact Project Coordinator Bart Vannieuwenhuyse Janssen Pharmaceutica NV Tel: +32 14 600320 E-mail: BVANNIEU[AT]its.jnj.com Co-coordinator Simon Lovestone King's College London Tel: +44 20 7848 0239 E-mail: simon.lovestone[AT]kcl.ac.uk Managing Entity Johan van der Lei Erasmus Universitair Medisch Centrum Rotterdam Tel: +31 10 70 441 22 E-mail: j.vanderlei[AT]erasmusmc.nl

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

EMTRAIN
European Medicines Research Training Network
Summary The European Medicines Research Training Network (EMTRAIN) will establish a sustainable, pan-European platform for education and training (E&T) covering the whole life-cycle of medicines research, from basic science through clinical development to pharmacovigilance. This will be achieved by integrating the strengths and competencies of the ESFRI BMS Infrastructures, the EFPIA companies, the current and future IMI E&T programmes as well as other scientific projects.

EMTRAIN will establish a pan-European platform for education and training, covering the entire life-cycle of medicines, from basic research, clinical tests and market authorisation to follow-up research of drugs already on the market. The consortium will provide a mechanism to ensure that industry and academia cooperate on courses that can be rapidly designed and implemented, in order to enable a faster implementation of new scientific and technological developments in academic teaching. Through harmonisation and accreditation of Master level, PhD programmes and continuous education programmes, EMTRAIN aims to improve the mobility across disciplines and national borders, as well as between academia, industry and regulatory authorities. The EMTRAIN consortium will develop innovative concepts and methods in order to support the content for the training programmes, in close collaboration with three other IMI Education and Training projects, SafeSciMET, PharmaTrain and Eu2P. National implementation will be facilitated through contacts with university authorities, ministries of higher education and national liaison offices. The consortium includes six established pan-European biomedical research infrastructures that cover a broad spectrum of competencies, from structural biology, bioinformatics, animal models, biobanks, translational research and clinical research.

Achievements & News Check out the IMI Education & Training projects video Four of IMIs Education & Training projects have put together a short video on their activities.In the six-minute clip, the coordinators of the EMTRAIN, SafeSciMET, Eu2P, and PharmaTrain projects present their courses and the benefits they offer for students and course providers alike. The film also features a presentation by IMI Executive Director Michel Goldman. (November 2012) on-course launches video on-course has released a video explaining how different groups (especially current and potential students and course providers) can get the most out of on-course . Developed by IMIs EMTRAIN project, on-course is the most comprehensive and sustainable biomedical and medicines research and development postgraduate course portal in Europe. Currently, the portal contains information on over 3 800 courses, and more are being added all the time. While on-course is probably EMTRAINs most visible outcome so far, the project is also making good progress on its other activities. The team sets out the projects highlights so far in a recent press release and concludes: EMTRAIN has made considerable progress in the first 2.5 years of the project. We are now in the process of developing robust performance metrics to assess the impact of the project, and we are exploring models of sustainability beyond the public funding period of the project. (July 2012) Give your career a boost with on-course IMI Education & Training project EMTRAIN has launched on-course Europes most comprehensive biomedical and medicines research and development postgraduate course portal. The portal gathers together information on over 3 000 courses taught in 20 languages in 39 countries and covering over 60 scientific and therapeutic areas. Free and easy to use, on-course allows users to search for courses by type (Masters, PhD, short course), schedule (full or part time, modular), learning type (distance, face-to-face, mixed), language, location, and scientific / therapeutic area. Users can also search for courses delivered by IMIs Education & Training projects. For each course on the site, on-course provides a course description, list of
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modules (if relevant), details of fees, contact information, and links to the course website. In addition, users can compare courses quickly and easily. Finally, for people looking for courses while on the move, there is the on-course app , which can be downloaded to smartphones for free from Google Play (for Android phones) or the AppStore (for Apple products). EMTRAIN holds first PhD workshop Some 26 students involved public-private partnerships, including IMI projects, took part in the inaugural EMTRAIN PhD workshop in Manchester, UK in February. The aim of the event was to create a forum for the students to share experiences and help them develop as industry-aware scientists. During the four-day workshop, experts from academia and industry provided an insight into the various aspects of industry-driven drug development, the opportunities for public-private partnership, and the relevant European initiatives and accessible European research infrastructures. (March 2012) OECD report spotlights IMI projects IMI projects EMTRAIN and EUPATI (European Patients' Academy on Therapeutic Innovation) are mentioned in a new report on facilitating international cooperation in non-commercial clinical trials.The report, by a working group of the OECD (Organisation for Economic Co-operation and Development) Global Science Forum, sets out recommendations to overcome the main barriers facing the international clinical research community in setting up international clinical trials. Among other things, the report highlights the need to improve education and training support as well as the infrastructure framework in clinical research, and to enhance the involvement of patients in trials. EMTRAIN is mentioned in the section on infrastructure support, while EUPATI (which will start soon and is funded under IMIs 3rd Call for proposals) is highlighted in the section on patient involvement. (January 2012) IMI projects launch continuous professional development initiative IMIs Education & Training projects have successfully launched an initiative to draw up a common framework for Continuous Professional Development (CPD) in the pharmaceutical sector.The first LifeTrain workshop, held in early October in the UK, gathered representatives of professional and scientific bodies from across Europe to start work on the development of a common framework for CPD. Such a framework will help scientists working on all aspects of drug discovery and development to maintain their professional skills and knowledge and adapt to changes in the sector. The hope is that this will ultimately help to make Europe more competitive. There was tremendous enthusiasm from all participants to combine forces for the good of research and development in Europe, commented AstraZenecas Mike Hardman, who chaired the LifeTrain workshop steering committee. The workshop outputs exceeded our expectations and we are now working together on the next steps. More information on LifeTrain can be found on the EMTRAIN website. (October 2011) EMTRAIN joins group promoting quality in higher education EMTRAIN, on behalf of all of IMIs Education & Training (E&T) projects, has become an affiliate of the European Association for Quality Assurance in Higher Education (ENQA), a pan-European body that aims to contribute to the maintenance and enhancement of the quality of European higher education. Joining the ENQA is an important move for the IMI E&T programmes, which are jointly developing standards for the quality assessment of continuous professional development courses in biomedical and medicines research. It is also important for the IMI life-long learning/continuous professional development initiative LIFETRAIN, in which the IMI E&T programmes work together with professional and scientific bodies, course providers, and employers across Europe to encourage them to recognise these quality standards. Finally, ENQA affiliate status will enable the IMI E&T programmes to keep abreast of the latest developments, engage with experts, and share experiences with other ENQA members. (September 2011)

Participants EFPIA AstraZeneca AB, Sdertlje, Sweden (Project Coordinator) Genzyme Europe B.V., Naarden, The Netherlands
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Novartis Pharma AG, Basel, Switzerland Bayer Schering Pharma AG, Berlin, Germany Pfizer LTD, Sandwich, United Kingdom F. Hoffmann-La Roche AG, Basel, Switzerland GlaxoSmithKline Research and Development LTD, Brentford, UK UCB Pharma SA, Brussels, Belgium Novo Nordisk A/S, Bagsvaerd, Denmark Sanofi-Aventis Deutschland GMBH, Frankfurt/Main, Germany Boehringer Ingelheim International GmbH, Ingelheim, Germany Janssen Pharmaceutica NV, Beerse, Belgium Orion Corporation, Espoo, Finland Laboratorios Almirall S.A., Barcelona, Spain H. Lundbeck A/S, Valby, Denmark Laboratorios del Dr Esteve SA, Barcelona, Spain Universities, Research Organisations, Public Bodies & Non-Profit Medizinische Universitt Wien, Wien, Austria Karolinska Institutet, Stockholm, Sweden Karolinska Universitetssjukhuset, Stockholm, Sweden The University of Manchester, Manchester, United Kingdom Institut National de la Sante et de la Recherche Medicale (Inserm), Paris, France European Molecular Biology Laboratory, Heidelberg, Germany Helmholtz-Zentrum fr Infektionsforschung Gmbh, Braunschweig, Germany Medizinische Universitt Graz, Graz, Austria Centre de Recherche en Biologie et Medecine, Illkirch, France Helmholtz Zentrum Mnchen Deutsches Forschungszentrum fr Gesundheit und Umwelt GMBH, Mnchen Neuherberg, Germany Ministry of Health, Social and Family Affairs, Medical Research Council , Budapest, Hungary

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Facts & Figures Start Date Duration Contributions IMI funding EFPIA in kind Total cost 01/10/2009 84 months 4 000 000 3 722 663 7 722 663

Links and Documents Project website: www.emtrain.eu

Contact

Project Coordinator Michael Hardman R&D Science Policy Publications AstraZeneca Macclesfield Cheshire UK Tel: +44 (0)1625 519566 Email: IMI Education & Training Programmes Mike.hardman [AT] astrazeneca.com Managing entity of IMI beneficiaries Michael Wolzt Department of Clinical Pharmacology Medizinische Universitt Wien Vienna Austria Tel: +431404002981 Email: michael.wolzt [AT] meduniwien.ac.at

IMI funding per project participant

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

eTOX
Integrating bioinformatics and chemoinformatics approaches for the development of Expert systems allowing the in silico prediction of toxicities
Summary The eTOX project partners will develop innovative strategies and novel software tools to better predict the safety and the side-effects of new candidate medicines for patients. Reliable prediction of side-effects in the initial phases of drug development lowers the failure rate in later phases, significantly reduces the number of animal tests needed and accelerates the development of new drugs. The eTOX scientists will use the complex relationships between the structure of a substance, its metabolism and disposition, and its toxic effects in the body. The combination of this knowledge will enable them to create more reliable computer models to better predict potential side-effects that would otherwise only be discovered in a later stage of the drug development or when the drug is already on the market.

Top experts in toxicology, knowledge management, bioinformatics, chemoinformatics, biostatistics and software development from industry and academia will join forces in the multidisciplinary consortium. To overcome the lack of publicly available toxicological data of 'drugable' chemicals which hampered progress so far, the multidisciplinary team will share and jointly exploit the archived results of more than 10.000 toxicological studies of the industry partners. This data, which was previously only accessible to the owning pharmaceutical companies, will be integrated with publicly available and new data, resulting in a unique database a treasure trove of toxicological information, which will be analysed using innovative approaches in data analysis.

Achievements & News eTOX explains ontologies One of the goals of IMI project eTOX is to predict safety issues in silico (i.e. using computer models) bylearning from companies existing preclinical data. The extraction of reports containing this data is now well advanced, raising the issue of standardisation. The question facing eTOX is: how can the project make sure that everybody uses the same term to describe the same thing? The answer lies in ontologies: the description of preferred terms and synonyms to be used in various places, as well as the relationships between the terms. Within eTOX, many ontologies are employed. Some of these are already available in the public domain in order to increase interoperability, while others have been created by the consortium because nothing was available yet. These new ontologies will be released into the public domain and discussed with interested partners (e.g. CDISC and IMI project OpenPhacts). The consortium will also release its annotation software, the first truly collaborative interface dedicated to crowd sourcing of ontology annotations. (November 2012) eTOX library goes public Since its launch in April 2010, IMI toxicology project eTOX has been compiling a vast library ofinformation and data on the toxicology field. Now the project team has decided to make its eTOX Library available to the public, so that scientists outside eTOX can benefit from it. The library has three sections. Under Articles, the project provides links to relevant journal articles; each reference has a list of keywords and a synopsis highlighting the articles relevance to eTOXs goals. The Journals section includes links to journals that cover toxicology issues, and the Links section includes links to public databases, computer modelling tools, projects, and more. For their part, eTOX researchers are using the library to identify new data that can be integrated into the projects databases, find out about new computational models, and identify potential drug targets and biological markers relevant to toxicity. The library is updated regularly. (October 2012) eTOX makes progress on predictive toxicology IMI project eTOX is making progress towards its goal of developing a predictive toxicology system called eTOXsys, which is now at the prototype stage. In a recent article in the International Journal of Molecular Sciences, the eTOX partners describe eTOXsys as 'a software tool able to provide useful toxicological risk and hazard assessment.' Users will simply need to enter a small amount of information, such as the structure of the compound they are interested in, and the system will use a series of
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advanced models to deliver information on the likelihood of potential toxicity of the compound. The system will base its risk assessment on predictive tools built on data held in diverse databases, coming from public sources and, most notably, legacy toxicity reports held by participating pharmaceutical companies, in what constitutes an unprecedented concerted effort at the international level. The data is currently being extracted, formatted and analysed by tools developed by the eTOX project. According to the project team, eTOXsys should significantly improve the quality of the current state of the art when it comes to computational predictions of the toxicity of new drug candidates. (April 2012) eTOX SMEs speak out Four small and medium-sized enterprises (SMEs) working on IMIs eTOX project have highlighted the importance of their contribution to the project in a letter published in Nature Biotechnology. In their letter, the four SMEs note that they all have a proven track record for scientific innovation and possess state of the art technologies that are considered innovative and valuable to achieve the projects goals.The companies state that they: represent an expert ensemble of innovative biochemoinformatics companies and thus offer an optimal complement to the rest of the eTOX consortium that will ensure that novel approaches to predictive toxicology are developed and implemented in an efficient integrated system. They also note that in their opinion, EFPIA members access to SMEs [intellectual property] should not be considered an argument against, or limitation when, applying to an IMI project. (October 2011) eTOX in heart toxicity test breakthrough Scientists in the IMI project eTOX have developed a computer model to test potential medicines for cardiotoxicity. Currently, many promising drug candidates fail because they turn out to cause serious heart problems in patients. The new eTOX system should help researchers pick up on these problems earlier on in the drug development process. Users simply have to enter the molecular formula of the compound into the tool, and the system generates a simulated ECG (electrocardiograph). Clinicians routinely use ECGs to diagnose heart problems in their patients; in the same way, users can study the simulated ECG generated by the eTOX system to determine whether or not a compound is toxic to the heart. It provides better results than the currently used computational systems, commented eTOX project coordinator Ferran Sanz of Fundaci IMIM in Spain. Details of the new tool are published in the Journal of Chemical Information and Modelling. (May 2011)

Participants EFPIA Novartis Pharma AG, Basel, Switzerland AstraZeneca AB, Sdertlje, Sweden Boehringer Ingelheim International GmbH, Ingelheim, Germany Bayer Schering Pharma AG, Berlin, Germany Laboratorios del Dr Esteve, S.A., Barcelona, Spain GlaxoSmithKline Research and Development LTD, Brentford, UK Janssen Pharmaceutica NV, Beerse, Belgium UCB Pharma SA, Brussels, Belgium H. Lundbeck A/S, Valby, Denmark Pfizer Limited, Sandwich, UK F. Hoffmann-La Roche AG, Basel, Switzerland Sanofi-Aventis GmbH, Frankfurt, Germany Les Laboratoires Servier SA, Neuilly-sur-Seine, France Universities, Research Organisations, Public Bodies & Non-profit Fundaci IMIM, Barcelona, Spain Fundacin Centro Nacional de Investigaciones Oncolgicas Carlos III, Madrid, Spain European Molecular Biology Laboratory, Heidelberg, Germany Liverpool John Moores University, Liverpool, UK Technical University of Denmark, Kgs. Lyngby, Denmark
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Universitt Wien, Vienna, Austria Vereniging voor christelijk hoger onderwijs, wetenschappelijk onderzoek en patintenzorg, Amsterdam, The Nederlands Lhasa Limited, Leeds, UK SMEs Inte:Ligand GmbH, Vienna, Austria Molecular Networks GmbH, Erlangen, Germany Chemotargets SL, Barcelona, Spain Lead Molecular Design S.L., Sant Cugat del Valls, Spain

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total costs 01/01/2010 60 months

Links and Documents Project website: www.e-tox.net IMI funding per project participant 4 737 991 7 909 119 1 238 361 13 885 461 Publications

Contact Project Coordinator Francois Pognan Novartis Institutes for BioMedical Research Basel Switzerland For press inquiries Joan Pitt Novartis Institutes for BioMedical Research Novartis Pharma AG Tel: +41 61 6962632 Email: joan.pitt[AT]novartis.com Managing entity of IMI beneficiaries Ferran Sanz Research Programme on Biomedical Informatics Fundaci IMIM Barcelona Spain Email: fsanz [AT] imim.es

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eTRIKS
Delivering European Translational Information & Knowledge Management Services
Summary Many IMI projects involve the integration of data from different sources, and until now every project has had to devise its own solutions to the problems raised by data sharing. Enter eTRIKS, which aims to create and run an open, sustainable research informatics and analytics platform for use by IMI (and other) projects with knowledge management needs. In addition, the project partners will provide associated support, expertise and services to ensure users gain the maximum benefit from the platform.

Reducing redundancy By the beginning of 2012, IMI had launched 30 projects, many of which involve the integration and analysis of diverse types of biological and medical data from a range of sources. This approach helps to speed up and improve drug discovery by allowing researchers to uncover new insights into disease progression and drug safety and efficacy for example. However, merging and managing all this data is far from easy. IMIs first Strategic Research Agenda highlighted the need for a common knowledge management platform for IMI projects, but until now this has not been set up. As a result, each project has had to invest in its own knowledge management system, resulting in considerable duplication of efforts and raising the risk that data will be lost when the project ends. Furthermore, to date there has been no agreed knowledge platform technology that could be used to build such a common service. Enter eTRIKS eTRIKS aims to deliver an open, sustainable translational research informatics / knowledge management platform based on agreed standards. The starting point of the project will be tranSMART, an open source platform that is already being applied successfully in IMIs severe asthma project U-BIOPRED. The eTRIKS team will provide a suite of support services covering the whole translational research project life cycle, including business analysis, platform development, curation and hosting support, standards development, and ethics consultation. Significant savings By creating a single, open source platform that meets industry needs while remaining affordable for public partners, eTRIKS will deliver considerable cost savings for public private partnerships that use it. Furthermore, by ensuring the consistent implementation of format and content standards, eTRIKS will facilitate the reuse of data (with appropriate governance) to study new issues and speed up the development of new drugs for patients. In the longer term, the project plans to develop a business model that will allow the platform to continue to operate after the initial IMI funding period. The partners also hope that their work will result in the formation of an active international translational research analytics and informatics community.

Participants EFPIA AstraZeneca AB, Sodertalje, Sweden Bayer Schering Pharma AG, Berlin, Germany Eli Lilly, Basingstoke, UK F. Hoffmann-La Roche AG, Basel, Switzerland GlaxoSmithKline Research and Development Ltd, Brentford, UK
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

H. Lundbeck A/S, Valby, Denmark Janssen Pharmaceutica NV, Beerse, Belgium Merck KGaA, Darmstadt, Germany Pfizer Limited, Sandwich, UK Sanofi-Aventis Research and Development, Chilly-Mazarin, France Universities, research organisations, public bodies, non-profit groups Imperial College of Science, Technology and Medicine, London, UK Centre National de la Recherche Scientifique, Paris, France CDISC Europe Foundation, Woluwe-Saint Lambert, Belgium University of Luxembourg, Luxembourg, Luxembourg SMEs BioSci Consulting, Maasmechelen, Belgium Other organisations ID Business Solutions Limited, Guildford, UK

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding Other** Total cost 01/10/2012 60 months 10 300 000 3 100 000 23 700 000

Links and Documents IMI funding per project participant

Contact Project Coordinator Ian Dix AstraZeneca Tel: +44 7748 761282 E-mail: ian.dix[AT]astrazeneca.com Managing Entity Yike Guo Imperial College London Tel: +44 207 594 8182 E-mail: y.guo[AT]imperial.ac.uk

EFPIA in-kind* 10 300 000

* includes non-EU contribution of 0.6 million ** includes 1 million from ID Business Solutions Limited

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EU-AIMS
European Autism Interventions - a Multicentre Study for Developing New Medications
Summary Around 1% of children are diagnosed with autism spectrum disorders (ASD), yet there are currently no drugs designed specifically to treat their main symptoms. Working to change this is the IMI-funded EU-AIMS project. The goal of EU-AIMS is to generate tools that will enhance our understanding of ASD, and ultimately pave the way for the development of new, safe and effective treatments for use in both children and adults. As well as dramatically improving quality of life, good treatments would help to cut the social and economic costs of ASD.

ASD refers to a diverse group of development disorders that are characterised by difficulties in social interaction and communication, and the presence of unusual repetitive behaviours. It affects one child in 110, with boys at greater risk of developing ASD than girls. ASD is a lifelong condition, and for reasons which are not fully understood, the prevalence of ASD is rising. The precise symptoms and their severity vary widely from one person to another; some are only mildly afflicted and can lead relatively independent lives, while others are severely disabled and require a lot of specialist care. Furthermore, while some individuals are intellectually impaired, others excel in areas like maths and music. Finally, to add to the complication, many people with ASD suffer from other conditions, such as seizures. This diversity of symptoms means that diagnosing ASD is far from easy, and in fact it was only formally recognised as a condition relatively recently. An urgent need for effective treatments Today, there are no drugs designed specifically to treat ASD; instead, those affected are treated with medicines designed for other conditions. The good news is that recent research has shed new light on the neurobiology behind ASD and identified some genes that increase the risk of autism. The findings suggest that it may actually be possible to treat ASD, something that was once thought to be impossible. EU-AIMS aiming high EU-AIMS represents the first time that major pharmaceutical companies are joining forces, along with experts from academia, regulatory authorities and patient groups, to accelerate the development of innovative drugs to treat this complex disorder. In terms of both budget and scope, it is the largest initiative of its kind in the world. EU-AIMS will generate new tools to study the biology behind ASD and test the efficacy of potential treatments. For example, the team will gather samples from people bearing certain mutations associated with ASD; this will pave the way for the generation of cell lines that can be used to test treatments. Elsewhere, the researchers will advance the use of brain scans as a tool to boost ASD drug discovery and also identify which people with ASD might respond best to a given drug. The project will also create a pan-European network of clinical sites. As well as making it easier to run clinical trials, this network will create an interactive platform for those with ASD and professionals. Ultimately, the project aims to come up with methods and tools to develop effective treatments for ASD (in both children and adults) as well as tools to diagnose ASD and assess symptoms in the clinic. Relief for patients Despite the lack of effective, dedicated ASD treatments, almost three quarters of children with ASD are on medication developed to tackle symptoms like tics, seizures, and hyperactivity. However, there is little evidence to suggest that the benefits outweigh the unpleasant side-effects of these drugs. Furthermore, little is known about what treatments are effective in adults. By paving the way for the development of new treatments, EU-AIMS is set to dramatically improve the quality of life of the growing numbers of people with ASD. In addition, EU-AIMS will help to cut the heavy economic and social costs of autism. Turning Europe into a hotspot for autism research EU-AIMS brings together Europes top ASD researchers from academia, the pharmaceutical industry and patients organisations. The partners have expertise in disciplines such as cell biology, behaviour, drug discovery, patient advocacy, clinical trials, genetics, psychiatry, brain imaging, and more.
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By linking up these experts and creating a pan-European network for both people with ASD and professionals, EU-AIMS will place Europe firmly on the ASD research map and give Europes pharmaceutical sector a competitive edge when it comes to getting novel ASD drugs to the market and the patient.

Achievements & News IMI brain projects in the spotlight in New Orleans Autism project EU-AIMS held an IMI networking event at the annual meeting of the Society for Neuroscience (SfN) in New Orleans, US, on 16 October. The SfN annual meeting is the worlds biggest gathering of neuroscientists, attracting 30 000 attendees from around the world. The networking event was therefore an excellent opportunity for EU-AIMS to promote its work to the neuroscience community. (November 2012) IMI-funded scientist wins major neuropsychopharmacology award Andreas Meyer-Lindenberg of the Central Institute of Mental Health in Mannheim, Germany and a participant in IMIs NEWMEDS and EU-AIMS projects has been awarded the prestigious ECNP Neuropsychopharmacology Award 2012for his groundbreaking work linking genetic variation associated with risk of mental illness to brain structure and function. The award, handed out at the annual congress of the ECNP (European College of Neuropsychopharmacology), recognises innovative and distinguished research achievements in neuropsychopharmacology and related fields. Dr Meyer-Lindenbergs work focuses on the genetic and environmental risk factors associated with psychiatric diseases such as schizophrenia. Especially our recent work on rare, high-risk genetic variants associated with schizophrenia and autism would not have been possible without the cooperative science funded in IMI, Dr Meyer-Lindenberg said. (November 2012) Could autism brain changes be reversed? Autism Spectrum Disorders (ASD) refers to a complex of different conditions. In some cases autism is present together with other conditions (e.g. epilepsy) as part of a syndrome caused by a single, specific gene mutation (e.g. Fragile X), but in the majority of patients its causes are largely unknown and could include different genetic and environmental factors. Certain brain changes in syndromes with autism appear to be reversible, and new research from the IMI-funded EU-AIMS project suggests that this may also be the case for the broader autism population. The study, published in Science, looked at the effects of the loss of the neuroligin-3 gene in mice. Neuroligin-3 is involved in the transmission of nerve signals and has been linked to heritable forms of autism. In this study, researchers found that mice lacking neuroligin-3 produced unusually high levels of a specific glutamate receptor. Glutamate receptors are proteins that are known to be involved in memory and learning; the high levels of glutamate receptor production in the mice in this study impaired the learning process, thereby disrupting brain development in the long term. However, the researchers did not stop there they reactivatedneurligin-3 production in the mice and found that this effectively returned glutamate receptor production levels to normal. Furthermore, the structural, autism-like defects in the brains of the mice disappeared. The findings suggest that there may be common deficits in the brains of individuals affected by many different forms of autism, and that drugs designed to target these glutamate receptors could halt the development of autism or even reverse it. The work was widely covered in the press, including in the Wall Street Journal and on Swiss TV (in French). (October 2012) IMI autism project EU-AIMS on the cover of Nature IMI autism project EU-AIMS starred as Natures cover story with its research revealing that the fathers age when a child is conceived is the biggest single contributor to the number of new mutations passed on to a child. The findings suggest that the increase in the number of autism cases may be due in part to the fact that the average age of fathers at the time of conception is on the rise. The researchers arrived at their results after studying the genomes of around 2 000 Icelanders, including some with a diagnosis of autism or schizophrenia. On average, for every one-year increase in the fathers age, an additional two mutations were passed on to the offspring. Our results all point to the possibility that as a man ages, the number of hereditary mutations in his sperm increases, and the chance that a child would carry a deleterious mutation that could lead to diseases such as autism and schizophrenia increases proportionally, said lead author Kari Stefansson of Icelands deCODE Genetics . It is of interest here that conventional wisdom has been to blame developmental disorders of children on the age of
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mothers, whereas the only problems that come with advancing age of mothers is a risk of Down syndrome and other rare chromosomal abnormalities. It is the age of fathers that appears to be the real culprit. (August 2012) EU-AIMS adds to understanding of underlying causes of heritable autism Elsewhere in the EU-AIMS project, researchers have shed new light on the workings of proteins called neuroligins that are involved in the transmission of nerve signals and have been linked to a heritable form of autism. Nerve signals are transmitted from one nerve cell to another at junctions called synapses. Neuroligins are found on the receiving side of synapses; if they malfunction or are absent, nerve signals are not transmitted correctly. The research, published in the Biochemical Journal , focuses on the functioning of neuroligins in mice. Mice have four kinds of neuroligin (dubbed neuroligins 1-4), and this study reveals that these neuroligins form pairs (dimers) featuring either the same kind of neuroligin or different kinds of neuroligin. This is important because if neuroligin 3 pairs up with neuroligin 1, a mutation affecting neuroligin 3 will also indirectly impact neuroligin 1s functioning. As neuroligin 3 is linked with heritable autism, many scientists use mice with mutated neuroligin genes as a mouse model of autism in their work. These new findings will help to determine how well these mouse models work. Looking to the future, the team now plans to study the physiological and functional consequences of the loss of neuroligin 3. Elsewhere, the EU-AIMS team has had a paper published in Molecular Psychiatry setting out some of the latest findings in autism research and highlighting their potential importance. (August 2012)

Participants EFPIA F. Hoffmann-la Roche AG, Basel, Switzerland Eli Lilly and Company Ltd, Basingstoke, UK Institut de Recherches Servier, Suresnes, France Janssen Pharmaceutica NV, Beerse, Belgium Pfizer Ltd, Sandwich, UK Vifor SA, Villars-sur-Glne, Switzerland Universities, research organisations, public bodies, non-profit groups Kings College London, London, UK Birkbeck College, London, UK Central Institute of Mental Health, Mannheim, Germany Commissariat a lEnergie Atomique et aux Energies Alternatives, Paris, France European Molecular Biology Laboratory, Heidelberg, Germany Institute of Education, London, UK Institut Pasteur, Paris, France Karolinska Institutet, Stockholm, Sweden Max-Planck-Gesellschaft zur Frderung der Wissenschaften eV, Munich, Germany Stichting Katholieke Universiteit / Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands Universita Campus Bio Medico di Roma, Rome, Italy Universitair Medisch Centrum Utrecht, Utrecht, Netherlands Universitt Basel, Basel, Switzerland Universitt Ulm, Ulm, Germany University of Cambridge, Cambridge, UK Patients organisations Autism Speaks, Princeton, US SMEs
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

GABO: millarium, Munich, Germany Islensk Erfdagreining ehf, Reykjavik, Iceland NeuroSearch A/S, Ballerup, Denmark

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind EFPIA US Other Total cost 01/04/2012 60 months 19 500 000 7 900 000 1 700 000 6 800 000 35 900 000

Links and Documents Project website: www.eu-aims.eu IMI funding per project participant Publications

Contact Project Coordinator Will Spooren F. Hoffmann-la Roche AG Tel: +41 61 688 6350 E-mail: will.spooren[AT]roche.com Managing Entity for EU funds Declan Murphy Kings College London Tel: +44 207 848 0984 E-mail: declan.murphy[AT]iop.kcl.ac.uk

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Eu2P
European programme in Pharmacovigilance and Pharmacoepidemiology
Summary Eu2P aims to improve the understanding of the risks and benefits of medicines in large groups of people, by developing a European training and education platform in pharmacovigilance and pharmacoepidemiology. Pharmacovigilance involves collecting and analysing information from patients and health care providers on potential adverse effect of medications that are already on the market. In pharmacoepidemiology, scientists study, predict and compare the risks and benefits of commercial or experimental medicines in populations.

The Eu2P programme will offer courses in pharmacovigilance and pharmacoepidemiology with specialties in benefit assessment, regulatory aspects, risk quantification, public health and risk communication, as there is a clear need to explain and sensitize the public to the reality of risks and benefits associated with medicines. Eu2P targets specialists such as pharmacists, physicians, scientists and experienced professionals, but also non specialists such as journalists, laypersons and patients, especially for risk communication training. Eu2P users will build custom training programmes that can lead to certificates, a masters diploma and a PhD in the framework of the Bologna process. Emphasis will be put on "hands-on training" to maximise post-training employment opportunities. Eu2P courses will be delivered in English using a unique and innovative modular approach integrating face-to-face lectures, eteaching (live videoconferences) and e-learning formats through the Eu2P e-learning platform.

Achievements & News Eu2P scoops education technology award IMI Education & Training project Eu2P was awarded an education technology prize in the higher education categoryat the recent Salon Educatec-Educatice in Paris, France. The awards, which are supported by the various organisations including the French ministries of education and research, recognise the most innovative education technology initiatives. Eu2Ps courses are delivered via distance learning, and students have the option to study for certificates, Masters degrees, or even a PhD in the evaluation of the benefits and risks of medicines. Elsewhere, the projects efforts have also been recognised by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), a collaborative scientific network coordinated by the European Medicines Agency. (December 2012) Check out the IMI Education & Training projects video Four of IMIs Education & Training projects have put together a short video on their activities.In the six-minute clip, the coordinators of the EMTRAIN, SafeSciMET, Eu2P, and PharmaTrain projects present their courses and the benefits they offer for students and course providers alike. The film also features a presentation by IMI Executive Director Michel Goldman. (November 2012) Coming soon the Eu2P PhD programme Applications open on 3 September for the Eu2P PhD programme in pharmacovigilance and pharmacoepidemiology.Applicants are expected to have a postgraduate diploma and a solid background in public health, especially in pharmacovigilance and pharmacoepidemiology. Candidates will initially be selected on the basis of their academic profile and grades; their professional profile and experience; their English proficiency; their scientific activities; and their letters of reference. Those who pass this first round will be invited to an interview during which they will be judged on their research project synopsis and their oral performance. The deadline for applications is 10 December 2012. Eu2P online training programmes applications now open for autumn intake IMI Education& Training project Eu2P is now accepting applications for the next academic year for its certificate programmes and for Year 2 of its joint Eu2P Master in pharmacovigilance and pharmacoepidemiology.The deadline for applications is 24 June 2012. The courses are delivered online and qualifications are awarded jointly by the academic partners in the project. The Eu2P Master course covers medicines risk identification and quantification; medicines and public health; medicine
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

risk communication; assessing the benefits of medicines; and regulatory processes. Currently, 10 students are following the Year 2 Master programme that began in autumn 2011; the students, who come from all over the world, are mostly already working in the pharmaceutical sector. Scholarships have been awarded to four of the students to facilitate access to the course. (February 2012) Eu2P applications for courses now open IMI Education & Training project Eu2P has launched its online application tool for its Certificate and Master courses in pharmacovigilance and pharmacoepidemiology. Certificates are available in a wide range of subject areas and run over 9 weeks (for a standard certificate) or 18 weeks (for an extended certificate). The Masters course offers six curricula that address the professional needs of key specialisations in pharmacovigilance and pharmacoepidemiology. The application period runs until 20 June for the Masters course and 19 August for the Certificates. The first courses will start in September this year. Courses are delivered largely online using interactive web technologies. In 2011, the Masters course is only open to people wishing to embark directly on the Master Year 2. Applications for the Master Year 1 and the Eu2P PhD programme will be launched in April 2012. (May 2011)

Participants EFPIA F. Hoffmann-La Roche AG, Basel, Switzerland Amgen NV, Brussels, Belgium AstraZeneca AB, Sdertlje, Sweden Bayer Schering Pharma AG, Berlin, Germany Boehringer Ingelheim International GmbH, Ingelheim, Germany Eli Lilly And Company Limited, Basingstoke, United Kingdom GlaxoSmithKline Research and Development LTD, Brentford, UK H. Lundbeck A/S, Valby, Denmark Janssen Pharmaceutica NV, Beerse, Belgium Laboratorios Almirall S.A., Barcelona, Spain Novartis Pharma AG, Basel, Switzerland Novo Nordisk A/S, Bagsvaerd, Denmark Orion Corporation, Espoo, Finland Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France UCB Pharma SA, Brussels, Belgium Universities, Research Organisations, Public Bodies & Non-Profit Universit Victor Segalen Bordeaux II, Bordeaux Cedex, France Agence Franaise de Scurit Sanitaire des Produits de Sant, Saint-Denis Cedex, France Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, The Netherlands European Medicines Agency, London, United Kingdom Fundaci Institut Catal De Farmacologia, Barcelona, Spain Karolinska Institutet, Stockholm, Sweden The University of Hertfordshire, Higher Education Corporation, Hatfield, United Kingdom Universiteit Utrecht, Utrecht, The Netherlands Universita degli Studi di Verona, Verona, Italy

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Total cost 01/09/2009 60 months

Links and Documents Project website: www.eu2p.org Publications 3 479 725 3 791 161 7 270 886 IMI funding per project participant IMI Education & Training Programmes

Contact Project Coordinator Deborah Szafir Pharma Development Safety Risk Management F. Hoffmann-La Roche Neuilly-sur-Seine Cedex France Tel: +33 1 46 40 27 35 Email: deborah.szafir [AT] roche.com Managing entity of IMI beneficiaries Annie Fourrier-Rglat Department of Pharmacology Universit Victor Segalen Bordeaux 2 Bordeaux France Tel: +33 5 57 57 15 60 Email: annie.fourrier [AT] pharmaco.u-bordeaux2.fr Eu2P office Tel: +33 5 57 57 92 57 / 56 50

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

EUPATI
European Patients' Academy on Therapeutic Innovation
Summary Medicines research and development (R&D) is an increasingly complex process that remains a mystery for the majority of patients and the general public. Lifting the lid on the medical R&D process is the IMI-funded EUPATI project. EUPATI is a patient-led initiative that aims to develop the first European Patients Academy on Therapeutic Innovation, with training courses, educational material and an online public library that will empower patients to engage more effectively in the development and approval of new treatments and become true partners in pharmaceutical R&D.

While patients are keen to have access to better and safer treatments, many find it hard to understand the benefits and risks of novel therapies. With demand for healthcare rising, and a growing emphasis on both the quality and sustainability of healthcare services, it is critical to address this major gap in public perception and knowledge. There is therefore a proven need for information resources, designed specifically for patients and the public, on how medicines R&D and clinical trials are conducted. This should cover diverse aspects of pharmaceutical research and innovation, including translationalresearch and personalised and predictive medicine, as well as the ways in which patients can support the research process and contribute to therapeutic breakthroughs. Well-informed patients are not only better placed to understand and make decisions about their treatments, but can also help to put patients needs at the heart of drug development, for example by joining scientific, ethical and regulatory committees and getting involved in clinical trial design. Power to the patients The Patients Academy will produce comprehensive, scientifically reliable and user-friendly information for patients on the of medicines development. It will increase the capacity and ability of well-informed patients and patients organisations to be effective advocates and advisors in medicines research. The patient-led consortium, which includes patients organisations, academic groups, non-governmental organisations (NGOs) and pharmaceutical companies, will generate educational resources in six key areas, namely the medicines development process; personalised medicine; drug safety and risk/benefit assessments; health economics and health technology assessment; clinical trials; and patients roles and responsibilities in medicines development. Material will be developed in English, French, German, Italian, Polish, Russian, and Spanish. Objectivity, transparency and independence are essential if EUPATI is to achieve its goals. The projects robust governance structure includes a multidisciplinary Project Advisory Board, a Regulatory Advisory Panel, and an Ethics Panel comprising renowned experts in bioethics, law, genetics, drug development, and patient advocacy, as well as representatives from regulatory authorities. The project addresses three audiences. The Expert Level will deliver a EUPATI Certificate Training Programme for patient experts, patient ambassadors and patient journalists. The accredited qualification will ensure that patients have the expertise and capacity to collaborate with all stakeholders involved in medicines R&D, wherever a strong patient voice is needed. Advocacy leaders from patients organisations will be encouraged to access the Education Level material in the EUPATI Toolbox. This will include a diverse range of cutting-edge resources such as e-learning courses, webinars, videos, slide shows for presentations, print material and face-to-face meetings. Finally, all patients and the wider public will gain access to the EUPATI Internet Library, which will guide patients, including those with relatively low health literacy, through the complexities of the pharmaceutical R&D process. Patients: industrys partners in drug development Involving patients in research can hugely benefit the drug development process; patients bring their own priorities and perspectives to the table and can offer fresh insights and challenge long-held beliefs, often resulting in entirely novel ideas and leading to better treatments for patients.
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Furthermore, greater patient involvement in R&D will boost the efficacy and safety of new treatments and raise public support for medical research. Inducing a paradigm shift in patient involvement in medicines R&D The Patients Academy is set to trigger a major rethink in the way patients and the public view the medicines development process and their own involvement in it. Armed with a deeper understanding of how the pharmaceutical sector works, patient experts and advocates will be empowered to work effectively with the relevant authorities, agencies, clinicians and industry to influence the drug development process for the benefit of patients.

Achievements & News First EUPATI public workshop attracts over 100 participants Over 100 people from 24 countries signed up to IMI Education & Training project EUPATIs inaugural public workshop, which was held in Frankfurt, Germany in early September. The goal of the event was to gather feedback on the initial findings of the project, which aims to create a European Patients Academy on Therapeutic Innovation. Nothing is set in stone, commented Project Coordinator Nicola Bedlington of the European Patients Forum. We have a framework and clear ideas, but the input of all participants, being experts with different backgrounds and form different geographical areas, is absolutely vital to shape what we do. The floor is open. Items on the agenda in Frankfurt included how to raise awareness of EUPATI, how to establish national platforms, how to enhance the collection of information, and how to ensure that as many patients as possible benefit from the information generated by EUPATI. A full report of the workshop, as well as photos and webstreams from the workshops, are available from the project website. (October 2012) Join the EUPATI Network EUPATI (the European Patients Academy on Therapeutic Innovation) is inviting people to join the newly-created EUPATI Network. Open to patients and patient organisations, caregivers, academia, pharmaceutical & biotech companies, journalists, and anyone else interested in finding information on medicine research & development in lay language, the network offers members a number of benefits. In addition to information on EUPATI activities, events and networking opportunities, network members will also receive invitations to participate in EUPATI surveys or focus groups and will have the opportunity to collaborate with other network members, for example on the organisation of national events. Membership of the EUPATI Network is free of charge. (July 2012)

Participants Patients organisations European Patients Forum (EPF), Luxembourg European AIDS Treatment Group (EATG), Dsseldorf, Germany European Genetic Alliances Network (EGAN), Brussels, Belgium European Organisation for Rare Diseases (EURORDIS), Paris, France EFPIA member companies Amgen Belgium SA/NV, Brussels, Belgium
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

AstraZeneca AB, Sdertlje, Sweden Bayer Pharma AG, Berlin, Germany Boehringer Ingelheim International GmbH, Ingelheim, Germany Chiesi Farmaceutici SpA, Parma, Italy Eli Lilly and Company Ltd, Basingstoke, UK F. Hoffmann-La Roche Ltd, Basel, Switzerland Farmaindustria, Madrid, Spain GlaxoSmithKline R&D Ltd, Middlesex, UK Janssen Pharmaceutica NV, Beerse, Belgium Laboratorios del Dr Esteve, SA, Barcelona, Spain Merck KGaA, Darmstadt, Germany Novartis Pharma AG, Basel, Switzerland Novo Nordisk A/S, Bagsvaerd, Denmark Sanofi Aventis R&D, Chilly-Mazarin, France UCB Pharma SA, Brussels, Belgium Verband forschender Artzneimittelhersteller eV, Berlin, Germany Universities, research organisations, public bodies, non-profit groups Biopeople / Copenhagen University, Denmark DIA Europe GmbH, Basel, Switzerland European Forum for Good Clinical Practice, Brussels, Belgium European Organisation for Research and Treatment of Cancer, Brussels, Belgium Hibernia College, Dublin, Ireland International Society for Pharmacoeconomics and Outcomes Research Inc., New Jersey, US Irish Platform for Patients' Organisations, Science and Industry, Rathmines, Ireland Nowgen / University of Manchester, Manchester, UK

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Total cost 01/02/2012 60 months 5 300 000 4 800 000 10 100 000

Links and Documents Project website: www.patientsacademy.eu IMI funding per project participant

Contact Project Secretariat Jan Geissler EUPATI Tel: +49 89 66086968 E-mail: info[AT]patientsacademy.eu

Project Coordinator & Managing IMI Education & Training Programmes Entity Nicola Bedlington European Patients Forum Tel: +32 2 280 2334 E-mail: nicola.bedlington[AT]eu-patient.eu Industry Coordinator Barbara Haake Verband forschender Artzneimittelhersteller Tel: +49 30 2060 4143 E-mail: b.haake[AT]vfa.de

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Europain
Understanding chronic pain and improving its treatment
Summary The EUROPAIN project aims to improve the treatment of patients with chronic pain. Three renowned academic pain consortia, from Germany, Denmark and the UK, will join forces with a Spanish SME and with Europes most active pharmaceutical companies working on pain. The scientists will search for changes in the nervous system that contribute to pain, in order to fill the gaps in the current knowledge of chronic pain. They will elucidate the mechanisms of pain, using novel experimental models, human volunteers and clinical data of pain patients. They will search objective methods to measure pain in patients and they will examine the mechanisms that are activated by placebo (fake) pain medication.

The scientists will also examine how genetic factors, depression or anxiety, and psycho-social factors increase the risk of developing chronic pain, as well as the influence of gender on pain. By identifying the mechanisms involved in chronic pain, the EUROPAIN consortium will open possibilities for better treatments for patients. As new pain medication may hold a risk of abuse, the scientists will scan the effect of new pain drugs on the brain. They will test if the brain areas involved in craving and addiction to cocaine and nicotine, show increased activity in response to the new drug.

Achievements & News IMI team pinpoints molecule that puts the burn in sunburn Scientists from the IMI project EUROPAIN have identified a molecule that causes the pain of sunburn, raising hopes for the development of new, more effective painkillers. Writing in Science Translational Medicine, the scientists explain how the molecule CXCL5 brings immune cells to the injured tissue, triggering pain and tenderness. This study isnt just about sunburn we hope that we have identified a potential target which can be utilised to understand more about pain in other inflammatory conditions like arthritis and cystitis, commented Kings College Londons Stephen McMahon. Im excited about where these findings could take us in terms of eventually developing a new type of analgesic for people who suffer from chronic pain. Read a press release about the findings from Kings College London. (September 2011)

Participants EFPIA AstraZeneca AB, Sdertlje, Sweden Boehringer Ingelheim International GmbH, Ingelheim, Germany Eli Lilly and Company Limited, Basingstoke, United Kingdom Grnenthal, Germany Laboratorios del Dr Esteve SA, Barcelona, Spain UCB Pharma SA, Brussels, Belgium Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France Pfizer Limited, Sandwich, UK Wyeth Pharmaceuticals, USA Universities, Research Organisations, Public Bodies & Non-Profit King's College London, London, United Kingdom University College London, London, United Kingdom University of Oxford, Oxford, United Kingdom Imperial College of Science, Technology and Medicine, London, United Kingdom Christian-Albrechts-Universitaet zu Kiel, Kiel, Germany
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Ruprecht-Karls-Universitt Heidelberg, Heidelberg, Germany Technische Universitaet Muenchen, Muenchen, Germany University Hospital Bergmannsheil Bochum, Bochum, Germany Klinikum der Johann Wolfgang Goethe Universitt, Frankfurt, Germany Aarhus Universitetshospital, Aarhus Sygehus, Aarhus, Denmark Region Hovedstaden, Hillerod, Denmark Syddansk Universitet, Odense M, Denmark SMEs Neuroscience Technologies, S.L., Barcelona, Spain

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/10/2009 60 months 5 999 344 11 513 835 719 279 18 232 458

Links and Documents Project website: www.imieuropain.org Publications IMI funding per project participant

Contact Project Coordinator Mrta Segerdahl Grunenthal GmbH Aachen Germany Email: Maerta.SegerdahlSt orck[AT]grunenthal.com Press contacts Irene Roth Email: Irene.roth[AT]grunenthal.com Managing entity of IMI beneficiaries Stephen Brendan McMahon Wolfson CARD Neurorestoration Group Kings College London UK Tel: +44 (0) 20 7848 6270 Email: stephen.mcmahon [AT] kcl.ac.uk

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

IMIDIA
Improving beta-cell function and identification of diagnostic biomarkers For treatment monitoring in diabetes
Summary A complete or relative decrease in insulin secretion by pancreatic beta-cells underlies the development of, respectively, type 1 and type 2 diabetes. These diseases impose a huge burden on welfare systems, both in Europe and in other developed and developing countries. So far, symptomatic therapeutic options for treatment of diabetes are available, but none to cure or prevent this pandemic disease. This is largely due to our limited knowledge of beta-cell biology in health and disease. Although considerable amount of knowledge has been gained on the function of beta-cells from animal models, knowledge of human beta-cell function, survival, and of the pathophysiological mechanisms that lead to their demise remains limited.

The scientific program aims at delivering: Novel tools for the study of human beta-cell development, function and survival; their modulation by potential therapeutic compounds; and for in vivo beta-cell imaging. Biomarkers for the diagnosis and prognosis of beta-cell failure and for monitoring diabetes progression and treatment. Knowledge on novel molecular pathways and sites that control beta-cell life & death as well as mass and function. This public-private-partnership consisting of academic teams, pharmaceutical companies and a SME provides a unique blend of expertise and forms a strong basis for a successful enterprise to ultimately improve industrial competitiveness and Public Health in Europe.

Achievements & News IMI diabetes projects sign Memorandum of Understanding IMI currently has three projects working on diabetes DIRECT, SUMMIT, and IMIDIA which have a combined budget ofjust over100 million. The projects tackle diabetes in different ways. For example, IMIDIA focuses on studying the pancreatic beta cells which are responsible for producing insulin; it aims to use this knowledge develop treatments that can slow down the progress of diabetes. Meanwhile, SUMMITs work addresses the urgent need for new treatments to tackle the complications associated with diabetes, such as eye, kidney, and blood vessel problems. Finally, DIRECT takes a personalised medicine approach to diabetes, as it works to identify different varieties of diabetes and effective treatments to tackle them. The projects already work together on an informal basis (as evidenced by their new joint leaflet produced with the support of the IMI Executive Office). However, IMIDIA and SUMMIT have now taken their collaboration to a new level with the signature of a Memorandum of Understanding (MoU). The MoU covers the handling of intellectual property, the transfer of knowledge and materials, and confidentiality. The projects believe that the MoU could serve as a template for collaboration between other IMI projects in the future. (November 2012) IMIDIA secures additional funding from major diabetes charity IMI diabetes project IMIDIA has secured additional support of up to $1 million (approx. 750 000) in funding from the US-based JDRF , the worlds largest supporter of research to cure, treat, and prevent type 1 diabetes (T1D). The additional support allows IMIDIA participants to expand their research efforts that are focused on speeding up the search for a cure for diabetes. The first two JDRF-funded projects are already underway, and more are in the pipeline. JDRF will support projects that address issues not covered by IMIDIAs original work plan, thereby ensuring that the funds will be used for novel research. IMI is an attractive partner for JDRF, because through their IMIDIA project, we share a common goal of accelerating the development of better treatments and cures for type 1 diabetes, commented Adrianne Wong, Senior Scientist for Cure Therapies at JDRF. - Read the joint IMI - IMIDIA JDRF press release (June 2012)

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Cell Metabolism paper picks out IMI diabetes project An article in Cell Metabolism on the urgent need to develop novel treatments for diabetes and obesity highlights the IMI project IMIDIA as the way forward. Future success requires a closer relationship between industry and academia as well as active knowledge sharing between research groups through multiparty partnerships and consortia, the paper reads. The Innovative Medicines Initiative for Diabetes is an excellent example. The paper also underscores the need for more personalised medicine in diabetes; this will be addressed in the IMI project DIRECT, which will be launched shortly. (January 2012) IMIDIA team reveals gene that affects insulin secretion Scientists from the IMI project IMIDIA have identified a gene that disrupts insulin secretion in individuals with a rare form of type 2 diabetes called maturity onset diabetes of the young (MODY). The gene produces a protein called PASK (PAS kinase). Normally, when blood sugar levels are low, insulin production is close to zero. However, in people with the mutated form of PASK, insulin production at low blood sugar levels is rather high. The researchers believe that this may render other tissues in the body less responsive to insulin, causing problems when blood sugar levels rise. The findings, published in the Journal of Biological Chemistry , represent the first demonstration in humans that the PASK protein plays a key role in insulin secretion. The discovery may have implications for diabetes treatment. PASK is an interesting potential drug target since the structure of the protein lends itself to the binding of small molecules, explains Guy Rutter of Imperial College London in the UK, who lead the research. The development of such compounds may provide new regulators of insulin secretion which may be of value in the clinic in years to come. (December 2011) IMI experts make major diabetes research breakthrough Researchers from the IMI project IMIDIA have generated a human pancreatic beta cell line that not only survives in the lab, but behaves in much the same way as beta cells in the body. When pancreatic beta cells malfunction, the result is diabetes. Scientists are therefore keen to study these cells in the lab to determine the underlying causes of diabetes and work out ways of treating and even curing it. Until now, researchers have had to rely on rodent beta cell lines for studies in the lab. Writing in the Journal of Clinical Investigation, IMIDIA researchers explain how they generated the novel human cell line and state: These cells represent a unique tool for large-scale drug discovery and provide a preclinical model for cell replacement therapy in diabetes. (September 2011)

Participants EFPIA Sanofi-Aventis GmbH, Frankfurt/Main, Germany Institut De Recherches Servier, Suresnes, France AstraZeneca AB, Sdertlje, Sweden Boehringer Ingelheim International GmbH, Ingelheim, Germany Eli Lilly Ltd., Basingstoke, United Kingdom Novartis Pharma AG, Basel, Switzerland Novo Nordisk A/S, Bagsvaerd, Denmark F. Hoffmann-La Roche AG, Basel, Switzerland Universities, Research Organisations, Public Bodies & Non-Profit Universit de Lausanne, Lausanne, Switzerland Centre National de la Recherche Scientifique (CNRS), Paris, France Commissariat l' Energie Atomique, Paris, France Imperial College of Science, Technology and Medicine, London, United Kingdom Institut Suisse de Bioinformatique, Lausanne, Switzerland Institut National de la Sant et de la Recherche Medicale (INSERM), Paris, France Medizinische Hochschule Hannover, Hannover, Germany Technische Universitt Dresden, Dresden, Germany Universita di Pisa, Pisa, Italy
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Universit Paris Diderot - Paris 7, Paris, France Universit de Geneve, Geneva, Switzerland Vrije Universiteit Brussel, Brussel, Belgium SMEs Endocells SARL, Paris, France

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/02/2010 60 months

Links and Documents Project Website: www.imidia.org Email: info [AT] imidia.org 7 074 760 15 081 800 3 750 920 25 907 480 The IMI Diabetes Platform Publications IMI funding per project participant

Contact Project Coordinator Sanofi-Aventis GmbH Frankfurt Germany Managing entity of IMI beneficiaries Bernard Thorens Department of Physiology & Center for Integrative Genomics Universit de Lausanne Lausanne Switzerland

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

K4DD
Kinetics for Drug Discovery
Summary Drugs work by binding with molecules in the body and to either block or alter the action of the target molecule. The goal of the K4DD project is to improve our understanding of how potential drugs bind with their target, and develop methods and tools to allow researchers to study drug-target interactions with greater ease. These tools would help researchers to determine whether a drug candidate is likely to be safe and effective much earlier in the drug development process.

The difficulties of drug development A major difficulty for those attempting to develop new medicines is predicting whether or not a potential drug will be effective in humans. The laboratory tests used to evaluate this today are simply not accurate enough. Currently, researchers spend a lot of time studying how strongly a potential drug binds with its target. However, less attention is given to the question of how long the drug remains bound to the target. Nevertheless, there is mounting evidence to suggest that the kinetics of the interaction between a drug and its target have a strong influence on the clinical success of a drug. For example, studies have shown that many recently-marketed drugs have improved kinetic profiles. This is logical; as drugs only work when they are bound to the target, the lifetime of the drug-target complex is key to the success of a drug. Towards a better understanding of binding kinetics Today, a lot of the expertise and data on binding kinetics is scattered across numerous smaller projects, institutions and organisations. By bringing together these diverse groups, K4DD is set to give a major boost to this important area of drug development. The first goal of the K4DD team is to enhance our understanding of binding kinetics; exactly how do small molecules interact with their targets? Ultimately, the project aims to develop a range of robust techniques, methods and models that could be easily incorporated into the drug development pathway and enable scientists and drug designers worldwide to reliably predict a molecules kinetic properties (its kinotype). This information will allow drug developers to more easily determine the safety and efficacy of a molecule. In the long run, this will weed out ineffective or unsafe molecules earlier in the drug development process. Finally, the project also hopes to raise awareness of the importance of considering the kinetic aspects of drug-target interactions throughout drug development. For patients, the benefits of K4DD lie in its efforts to speed up and improve the drug development process.

Participants EFPIA Bayer Pharma AG, Berlin, Germany AstraZeneca AB, Sodertalje, Sweden F. Hoffmann-La Roche AG, Basel, Switzerland GlaxoSmithKline Research and Development Ltd, Brentford, UK
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Janssen Pharmaceutica NV, Beerse, Belgium Merck KGaA, Darmstadt, Germany Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany Universities, research organisations, public bodies, non-profit groups Universiteit Leiden, Leiden, Netherlands Foundation Top Institute Pharma (Stichting Top Instituut Pharma), Leiden, Netherlands Imperial College Of Science, Technology & Medicine, London, UK Ruhr-Universitt Bochum, Bochum, Germany Stichting VU-VUMC , Amsterdam, Netherlands Universitt Wien, Vienna, Austria University of Dundee, Dundee, UK University of Nottingham, Nottingham, UK University of Oxford, Oxford, UK SMEs European Screening Port GmbH, Hamburg, Germany Heptares Therapeutics Limited, Welwyn Garden City, UK HITS gGmbH, Heidelberg, Germany Sierra Sensors GmbH, Hamburg, Germany

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/10/2012 60 months 8 300 000 9 800 000 2 800 000 20 900 000

Contact Project Coordinator Anke Mller-Fahrnow Bayer Pharma AG Tel: +49 30 4681 7699 E-mail: anke.mueller-fahrnow[AT]bayer.com Managing Entity Ad Ijzerman Universiteit Leiden Tel: +31 71 5274651 E-mail: ijzerman[AT]lacdr.leidenuniv.nl

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

MARCAR
Biomarkers and molecular tumour classification for non-genotoxic carcinogenesis
Summary The efficiency of drug development could be increased if undesired effects of candidate drugs are detected in an earlier phase of development. Therefore, the researchers in the MARCAR project will search and test biological clues biomarkers that can be used for the early detection of drug-induced tumour formation. Biomarkers that help to predict tumour growth more accurately in a very early stage, will reduce the need for animal testing, speed up drug development and increase drug safety for patients.

The MARCAR project will focus on non-genotoxic carcinogenesis, which is tumour formation that is not directly caused by 'writing errors' in the DNA 'text' (mutations), but by other changes in the structure of the genetic material that can alter the 'readability' of the DNA. The scientists suspect that these so-called epigenetic changes play a bigger role in the earliest stages of tumour formation than previously thought. Therefore, the MARCAR consortium will further unravel the epigenetic effects, using a combination of novel and sophisticated molecular technologies. Combining their expertise in the field of biomarkers, human and rodent cancer models, imaging, molecular profiling and bioinformatics, the researchers will focus on liver tumours, because it is the organ most affected by non-genotoxic carcinogenesis during the preclinical safety evaluations of candidate-medicines. Their findings will facilitate tumour identification in other organs as well, and will give better insight in the mechanisms of tumour growth, facilitating a more targeted search for safer and more effective treatments.

Achievements & News MARCAR demonstrates new way of tracking tumour development over time IMI project MARCAR has demonstrated that magnetic resonance imaging (MRI) can be used to reliably detect liver tumours in mice when they are just 1 mm across previously more invasive techniques were needed to pick up tumours of this size.The findings, published in the journal Toxicological Sciences, are important for two reasons. Firstly, because MRIs are non-invasive, they can be repeated at different stages of the study, meaning that fewer animals are needed to obtain reliable results. This will therefore help to reduce the number of animals used in experiments. Secondly, the fact MRIs can be used to detect tumours at an early stage and monitor their reversibility makes them an invaluable tool in assessing the cancer risk of potential drugs. Looking to the future, the work will ultimately help MARCAR achieve its goal of discriminating between spontaneously occurring liver tumours, and tumours that represent the unwanted side effect of a drug candidate. (February 2012) MARCAR tracks down biomarkers The goal of the MARCAR project is to identify early biological indicators (biomarkers) that can be used to predict the effects of non-genotoxic carcinogens (NGCs). Now scientists from the MARCAR consortium have used genome-wide profiling of changes to DNA methylation to detect early markers of NGC activity in rodents. The researchers have published their findings in the journal PLoS ONE and write: This study contributes to understanding the scale and nature of drug-induced epigenetic changes in an in vivo setup relevant for drug safety assessment. (April 2011)

Participants EFPIA Novartis Pharma AG, Basel, Switzerland Boehringer Ingelheim International GmbH, Ingelheim, Germany Bayer Schering Pharma AG, Berlin, Germany UCB Pharma SA, Brussels, Belgium
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

H. Lundbeck A/S, Valby, Denmark Universities, Research Organisations, Public Bodies & Non-profit University of Dundee, United Kingdom Medizinische Universitt Wien, Vienna, Austria Medical Research Council, Edinburgh, United Kingdom Eberhard Karls Universitt Tbingen, Tbingen, Germany NMI Natural and Medical Sciences Institute, Reutlingen, Germany Institut National de la Sante et de la Recherche Medicale, Montpellier, France SMEs CXR Biosciences Limited, Dundee, UK

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/01/2010 60 months 6 049 578 5 155 604 2 114 051 13 319 233

Links and Documents

Contact

Project website: www.imi-marcar.eu Project Coordinator Jonathan Moggs Novartis Institutes for Publications BioMedical Research, Novartis Pharma AG For press inquiries: IMI funding per project participant Joan Pitt Novartis Institutes for BioMedical Research Novartis Pharma AG Tel: +41 61 6962632 Email: joan.pitt[AT]novartis.com Managing entity of IMI beneficiaries Roland Wolf Biomedical Research Centre University of Dundee Tel: +44 (0)1382 632621 Email: c.r.wolf [AT] dundee.ac.uk

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

MIP-DILI
Mechanism-Based Integrated Systems for the Prediction of Drug-Induced Liver Injury
Summary Many medicines are harmful to the liver, and drug-induced liver injury (DILI) now ranks as the leading cause of liver failure and transplantation in western countries. However, predicting which drugs will prove toxic to the liver is extremely difficult, and often problems are not detected until a drug is already on the market. For the first time, the IMI project MIP-DILI brings together Europes top industrial and academic experts in the field. Together, they will develop new tests that will help researchers detect potential liver toxicity issues much earlier in development, saving many patients from the trauma of liver failure.

Clinicians and drug manufacturers recognise two kinds of DILI. Dose-dependent DILI is usually detected early on in drug development and, as the name suggests, the risk of an adverse reaction increases with the dosage. However, most DILIs are so-called idiosyncratic reactions. These cannot be predicted in experimental systems, occur only in certain patients, and are not dose dependent. Very often, idiosyncratic DILI problems are only picked up very late in drug development or even after regulatory approval. Over 1 000 approved drugs have been associated with idiosyncratic DILI; in most cases, around 1 in 10 000 patients are affected, although for some drugs the incidence of DILI is higher, at around 1 patient in 100. Estimates suggest that one in seven cases of liver failure are triggered by an adverse drug reaction, and DILI is now the leading cause of liver transplantation in many countries. A new look at liver toxicity The goal of MIP-DILI is to dramatically improve the tools used to test for liver toxicity during drug development. The team aims to deepen our understanding of the science behind drug-induced liver injury, and use that knowledge to overcome the many drawbacks of the tests currently used. A major focus will be on a systematic and evidence-based evaluation of both currently available and new laboratory test systems, including cultures of liver cells in one-dimensional and three dimensional configurations. The more complex models integrate different types of liver cells to form three-dimensional units that accurately mimic human liver physiology. The project will also develop models that take into account the natural differences between patients. This is important because factors such as certain genes, the livers immune response, and viral infections have all been associated with an increased risk of DILI. The project will seek to address the current lack of human liver cells available to researchers by using induced pluripotent stem cells (iPSCs, i.e. cells that have been altered so that they can turn into any kind of cell found in the body) generated from patients who are particularly sensitive to DILI. Another strand of the project will develop computer models to unravel the complex, often inter-related mechanisms behind DILI. Finally, the team will assess how accurate the results of laboratory tests are at predicting actual outcomes in patients. A leap forward for liver safety Until now, the quest to develop better tests for DILI risk in potential drugs has been hampered by a lack of collaboration between industry and academia. By bringing together experts from these sectors in a single, coordinated effort, MIP-DILI promises to both advance our understanding of drug-induced liver injury and deliver tests to detect it early on in drug development. Academic partners in the project will benefit from access to reference compounds, with known liver toxicity, that are held by pharmaceutical companies. For their part, pharmaceutical companies will gain a greater understanding of the complex science behind DILI. The stakes are high; all too often, DILI and other toxicity problems are only identified extremely late in drug development, when vast amounts of time and money have been spent on a potential drug. According to a report from the Society for Medicines Research, just a 10% improvement in predicting failure before the start of clinical trials could cut the costs of drug development by upwards of 75 million. Safer treatments for patients Although DILI is rare, when it happens, it is often extremely serious or even fatal for the patient concerned. Yet too many drugs that pose a risk of DILI still make it to the market, and DILI is a common reason for withdrawing drugs from the market. By helping researchers to detect DILI problems during drug research, before drugs are evaluated in clinical trials and approved for use, MIP-DILI will prevent considerable pain and suffering on the part of patients.

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Participants EFPIA AstraZeneca AB, Sdertlje, Sweden Abbott GmbH & CoKG, Wiesbaden-Delkenheim, Germany Bristol Myers Squibb EMEA sarl, New York, US GlaxoSmithKline Research and Development Ltd, Middlesex, UK H. Lundbeck A/S, Valby, Denmark Institut de Recherches Internationales Servier, Suresnes, France Janssen Pharmaceutica NV, Beerse, Belgium Merck KGaA, Darmstadt, Germany Orion Corporation, Espoo, Finland Sanofi-Aventis Research and Development, Chilly-Mazarin, France UCB Pharma SA, Brussels, Belgium Universities, research organisations, public bodies, non-profit groups University of Liverpool, Liverpool, UK Albert-Ludwigs-University Freiburg, Freiburg, Germany Deutsches Krebsforschungszentrum, Heidelberg, Germany Karolinska Institutet, Stockholm, Sweden Universittsklinikum Bonn, Bonn, Germany Universit de Rennes 1, Rennes, France Universiteit Leiden, Leiden, the Netherlands Universiteit Utrecht, Utrecht, the Netherlands Vereniging voor christelijk hoger onderwijs, wetenschappelijk onderzoek en patintenzorg, Amsterdam, the Netherlands SMEs Cellartis AB, Gothenburg, Sweden CXR Biosciences Ltd., Dundee, UK Interface Europe, Brussels, Belgium KaLy-Cell, Illkirch, France Lhasa Ltd., Leeds, UK Solvo Biotechnology ZRT, Szeged, Hungary

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind EFPIA US Other Total cost 01/02/2012 60 months 15 300 000 11 000 000 1 600 000 4 500 000 32 400 000

Links and Documents

Contact

Project website: www.mip-dili.eu IMI Interface Europe Tel: +32 2 funding per participant 2130030 E-mail: monique.marrec-fairl ey[AT]interfaceurope.eu Publications

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

NEWMEDS
Novel methods leading to new medications in depression and schizophrenia
Summary Despite remarkable advances in medical technologies and nearly 15.000 articles on schizophrenia and depression every year, there have been few truly innovative new medicines which have made it to the patients. There has been a tremendous explosion of new knowledge: dozens of genetic variations linked to the disease, hundreds of new molecules and mechanisms in the body identified, numerous scanning techniques distinguishing patients from healthy people, but it has been hard to translate these findings into novel therapies for patients.

Therefore, the NEWMEDS consortium will develop three important missing tools that will facilitate the translation of scientific findings into benefits for patients. They will search for detectable signs of disease (biomarkers) in the DNA and the proteins of patients, in order to develop tests, based on these biomarkers, than can divide patients into subcategories of disease. A more precise characterisation of their disease within the biologically heterogeneous group of 'depression' or 'schizophrenia' will allow a more targeted treatment. In order to decrease the long time needed to test the efficacy of new treatments, the scientists will develop new techniques for the interpretation of brain scan images, in order to predict which candidate drugs are most likely to have a beneficial effect, in an early stage of testing on human volunteers. Additionally, they will develop improved experimental models that mimic schizophrenia or depression in humans. They will also develop and validate tests, such as electrical monitoring of the brain, to analyse the disease progression across species. The models and the tests will enable researchers to monitor the effects of candidate drugs in an early stage, and to identify new disease related targets for treatment in the brain.

Achievements & News NEWMEDS presents results at major psychiatric genetics congress IMIs NEWMEDS project presented some of its findings at a symposium held during the 20th World Congress of Psychiatric Genetics (WCPG) in Hamburg, Germany in October. The symposium, entitled Identification and functional consequence of genetic variants conferring risk of psychiatric disease outcome of NEWMEDS collaboration, featured presentations of NEWMEDS work on how Copy Number Variations (CNVs, in which sections of DNA are present in more or fewer copies than usual) affect intellectual disability, autism, and schizophrenia. The presentations also discussed how NEWMEDS is attempting to model these conditions in mice. The hope is that these studies will shed light on the link between CNVs and the brain and deliver novel and more relevant animal models for research into psychiatric disorders. (November 2012) IMI-funded scientist wins major neuropsychopharmacology award Andreas Meyer-Lindenberg of the Central Institute of Mental Health in Mannheim, Germany and a participant in IMIs NEWMEDS and EU-AIMS projects has been awarded the prestigious ECNP Neuropsychopharmacology Award 2012for his groundbreaking work linking genetic variation associated with risk of mental illness to brain structure and function. The award, handed out at the annual congress of the ECNP (European College of Neuropsychopharmacology), recognises innovative and distinguished research achievements in neuropsychopharmacology and related fields. Dr Meyer-Lindenbergs work focuses on the genetic and environmental risk factors associated with psychiatric diseases such as schizophrenia. Especially our recent work on rare, high-risk genetic variants associated with schizophrenia and autism would not have been possible without the cooperative science funded in IMI, Dr Meyer-Lindenberg said. (November 2012) NEWMEDS triggers rethink on negative symptom treatments Negative symptoms of schizophrenia could respond better to existing treatments than was previously thought, according to new research from IMIs NEWMEDS project.Schizophrenia patients are said to have negative symptoms when they lack behaviours that are found in healthy people. For example, people with schizophrena may appear to lack emotion or the ability to feel pleasure or act spontaneously. (For comparison, symptoms such as hallucinations which are not normally
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

experienced by healthy people are called positive symptoms). NEWMEDS Jonathan Rabinowitz of Bar Ilan University in Israel and his colleagues studied data from large numbers of clinical trials studying various second generation antipsychotics in schizophrenia amassed by the NEWMEDS project. Their analyses revealed that the overall response to treatment was similar in patients with only prominent negative symptoms to patients who had either only prominent positive symptoms or both prominent negative and positive symptoms before treatment. Moreover, around two thirds of all patients who complete six weeks of treatment with second generation antipsychotic drugs have no residual negative symptoms of moderate or higher severity. Only a minority of patients were still suffering from prominent negative symptoms that would make such patients suitable to be studied in adjunctive treatment with new compounds particularly developed for the treatment of negative symptoms. It has generally been maintained that negative symptoms do not respond to currently-used second generation antipsychotic medications, commented Professor Rabinowitz. Our results suggest that they do respond. The findings suggest that it will be harder than expected for new medicines to prove themselves against existing medicines. The findings were shared with drug developers and regulators who expressed interest in this work, said Professor Rabinowitz. (June 2012) Clinical trials could be shorter, study suggests The length of clinical trials in which patients on active treatment are compared to patients taking a placebo could be shortened by one or two weeks, according to research from the IMI project NEWMEDS. Speaking at the recent European College of Neuropsychopharmacology (ENCP) congress, Professor Jonathan Rabinowitz of Israels Bar Ilan University explained how the team studied 29 trials of schizophrenia drugs sponsored by 5 pharmaceutical companies. The research revealed that in many trials lasting 6 weeks or longer, significant results can be observed in weeks 4 and 5, suggesting that such trials could be shortened. In addition, the researchers highlight the importance of including far more women in trials, as women appear to respond less to placebos than men, yet less than a third of the participants in the trials studied were female. The findings contribute to NEWMEDS goal of improving the design of clinical trials of schizophrenia treatments. (October 2011) NEWMEDS advances schizophrenia research In a remarkable and unprecedented collaboration in schizophrenia research, the companies involved in the NEWMEDS project have pooled their data to create a large collaborative dataset that brings together the data of 23 401 anonymized patients from 67 trials on 11 compounds in over 25 countries.This makes it by far the single largest database of clinical trial data ever amassed in psychiatric research. The academic community will greatly benefit from the partnership, as the exceptionally large and valuable database on schizophrenia will be made available to all participants in the project. Read the full press release. (April 2011)

Participants EFPIA H. Lundbeck A/S, Valby, Denmark Abbott Laboratories, USA AstraZeneca AB, Wilmington, USA Eli Lilly and Company Ltd, Basingstoke, UK Janssen Pharmaceutica NV, Beerse, Belgium Novartis Pharma AG, Basel, Switzerland Orion Corporation, Espoo, Finland Pfizer Limited, Sandwich, UK - Wyeth Pharmaceuticals, USA F. Hoffmann-La Roche AG, Basel, Switzerland Institut De Recherches Servier, Suresnes, France Universities, Research Organisations, Public Bodies & Non-Profit King's College London, London, UK Karolinska Institutet, Stockholm, Sweden
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

University of Cambridge, Cambridge, UK Zentralinstitut fr Seelische Gesundheit, Mannheim, Germany Agencia Estatal Consejo Superior de Investigaciones Cientficas, Madrid, Spain The University of Manchester, Manchester, UK Bar Ilan University, Ramat Gan, Israel SMEs Psynova Neurotech Ltd, Cambridge, UK Islensk Erfdagreining EHF, Reykjavik, Iceland GABO:mi Gesellschaft fr Ablauforganisation:milliarium mbH & Co KG, Munich, Germany

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in-kind Other Total cost 01/09/2009 60 months 8 211 206 12 356 191 2 608 120 22 215 143

Links and Documents Project website: www.newmeds-europe.com Publications IMI funding per project participant

Contact Project Coordinator Tine Bryan Stensbl Discovery Pharmacology Research H. Lundbeck Copenhagen-Valby, Denmark Tel: +45 3630 1311 Ext. 33638 Email: tbs [AT] lundbeck.com Managing entity of IMI beneficiaries Shitij Kapur Institute of Psychiatry Kings College London UK Tel: +442078480593 Email: Shitij.Kapur [AT] iop.kcl.ac.uk

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Onco Track
Methods for systematic next generation oncology biomarker development
Summary The OncoTrack project will focus on its goal of identifying biological markers that will help our understanding of the variable composition of tumors and the relationship between biological heterogeneity and tumor variation in response to treatment. In particular, biomarkers for cancer of the colon will be analysed through the development and application of research techniques with unprecedented high sensitivity levels.

The research will allow the identification and qualification of biomarkers predictive of patient response as well as those useful for monitoring of therapeutic efficacy. The OncoTrack consortium will use an approach based on the Virtual Patient computer modelling system and state-of-art omics technologies and systems biology approaches to develop new generation biomarkers and diagnostics that can be used to implement personalized medicine. The aim is to validate available and predicted biomarkers in large studies which will ultimately produce useable data in a suitable format for point-of-care diagnostic tools. Oncotrack is coordinated by Bayer Healthcare Pharmaceuticals and Hoffmann La-Roche AG and the managing entity of IMI JU funding is the Max-Planck Society for the Advancement of Science, Germany. In total there are 18 multidisciplinary partners -11 academic and SMEs and 7 from EFPIA spread across 6 European countries.

Participants EFPIA AstraZeneca AB, Sweden Bayer Schering Pharma AG, Germany Boehringer Ingelheim International GmbH, Germany F. Hoffmann La-Roche AG, Switzerland Janssen Pharmaceutica NV, Belgium Merck Serono, Germany Pfizer Ltd , UK UNIVERSITIES, RESEARCH ORGANISATIONS, PUBLIC BODIES & NON-PROFIT Charit University of Medicine, Berlin, Germany Max-Planck Society for the Advancement of Science, Germany Medical University of Graz, Austria South Paris XI University, France Technical University, Dresden, Germany University College London, UK University of Uppsala, Sweden SMEs Alacris Theranostics GmbH, Germany EPO Experimental Pharmacology & Oncology GmbH, Germany GABO MI Society for workflow management, Germany
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

International Prevention Research Institute SAS, France

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start Date Duration Contributions IMI funding EFPIA in-kind Other Total Cost 01/01/2011 60 months 16 050 282 9 726 557 4 906 606 30 683 445

Links and Documents

Contact

Project website: www.oncotrack.eu PROJECT COORDINATOR Dr.David Henderson Translational IMI funding per project particpant Sciences Bayer Schering Pharma AG Muellerstrasse 178 13353 Berlin Publications Germany Email: David.henderson[AT]bayer.com Tel: +49 30 468 11350 MANAGING ENTITY OF IMI BENEFICIARIES Prof Hans Lehrach Max-Planck-Institute for Molecular Genetics Department of Vertebrate Genomics Ihnestrasse 73 14195 Berlin Germany Email: lehrach[AT]molgen.mpg.de

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Open PHACTS
The Open Pharmacological Concepts Triple Store
Summary Drug discovery is data-hungry and all major pharmaceutical companies maintain extensive in-house instances of public data. Analysis and hypothesis generation for drug-discovery projects requires assembly,overlay and comparison of data from many sources as well as development of shared identifiers and common semantics. Expression profiles need to be overlaid with gene or pathway identifiers and reports on compound pharmacology. Alignment and integration of internal and public data and information sources requires a significant effort and the process is repeated across companies, institutes and academic laboratories. This represents significant waste and increases opportunity cost.

To address these challenges, the OpenPHACTS project will develop an open access innovation platform, called Open Pharmacological Space (OPS), via a semantic web approach. OPS will be comprised of data,vocabularies and infrastructure needed to accelerate drug-oriented research. The aim is to develop an enabling resource for drug discovery projects which is open to all users and freely available in the public domain. This semantic integration hub will remove key bottlenecks in small molecule drug discovery, such as disparate information sources, and lack of standards and common identifiers. In order to ensure broad applicability in pharmaceutical research, the development of OPS will be guided by well-defined research questions from drug discovery. Workflows for data capture, processing, interoperability, visualization, chemogenomics will all be developed creating a comprehensive Systems Chemical Biology Analysis Network. Security issues around proprietary data, shared via the nanopublication system and accessible for safe querying and reasoning, will be properly addressed with expert trusted parties. The OpenPHACTS consortium comprises 14 European academic and SME partners, with leading experts in the fields of data mining, annotation, small molecule data storage and manipulation, target bioinformatics, RDF information handling, massive in silico reasoning and chemical biology. The 8 EFPIA members of OpenPHACTS will contribute drug discovery expertise, data sets, software engineering and programming capacity to the project.

Achievements & News Open PHACTS produces new brochure IMI knowledge management project Open PHACTS has produced a brochure setting out its work.The project, which is building a platform to integrate data from diverse sources, is attracting growing numbers of associate partners. Associate partners receive regular updates on the latest developments from the project and are also able to present ideas and use cases to the Open PHACTS team. The project is also presented in a recent edition of Drug Discovery Today. (December 2012) Open PHACTS releases nanopublication guidelines Scientists from IMI project Open PHACTS have put together a set of guidelines on nanopublications. A nanopublication is the smallest unit of publishable information: an assertion about anything that can be uniquely identified and attributed to its author, the guide reads.The guidelines set out the elements of a nanopublication and outline the developments since the Anatomy of a Nanopublication paper. The guidelines explain the Open PHACTS approach to nanopublication and how this relates to real-world data. This first set of guidelines will guide the next stage of implementation within the Open PHACTS project where nanopublications will be integrated with other forms of data to provide a unique view across pharmacology-related data. (April 2012) Open PHACTS tool shows early promise A prototype of a novel data mining tool developed by IMI project Open
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

PHACTS has proven its worth, identifying relevant information in just seconds, while a traditional human search took days.Open PHACTS is using semantic web technology to develop a tool called the Open Pharmacological Space (OPS). The OPS will allow scientists to analyse diverse databases and texts from both public and private sources in their hunt for new drugs and drug targets. A prototype platform is now ready, and when challenged with a simple query (to find compounds that block a given drug target), it delivered the information in a matter of seconds. In contrast, a traditional search took two scientists three working days each. The OPS system not only correctly identified all compounds, it also found one additional drug, which was later on confirmed in a manual search, commented Open PHACTS academic coordinator, Gerhard Ecker of the University of Vienna. The team hopes to have a more advanced version ready for the full consortium to test by March. (February 2012) IMI project Open PHACTS on the value of data Researchers from the Open PHACTS project have published a paper in Nature Genetics that proposes representing data and assertions in the form of nanopublications.The nanopublication is the smallest unit of publication and is essentially a single assertion and its associated data and material. According to the team, using nanopublications will make it easier to place a value on data, support research by tapping into vast, interoperable reserves of information, and also make it easier for scientists and others to follow up individual assertions or develop hypotheses. Open PHACTS will test the nanopublication concept to create an Open Pharmacological Space (OPS). In the OPS, a layer of data and text extraction methods is placed over existing data of different kinds (e.g. rough data, processed datasets and literature). The methods allow close to real time updates of nanopublications from these databases and make them publicly available via the OPS, but do not interfere with local database management. The Open PHACTS consortium thus creates an extra, computer readable layer that works across previously isolated datasets, explains the lead author of the paper, Barend Mons of Leiden University Medical Center and the Netherlands Bioinformatics Centre. (May 2012)

Participants EFPIA AstraZeneca AB, Sweden Eli Lilly and Company Ltd, UK GlaxoSmithKline Research & Development Ltd, UK H. Lundbeck A/S, Denmark Laboratorios del Dr. Esteve S.A, Spain Merck, Germany Novartis Pharma, AG, Switzerland Pfizer Ltd, UK UNIVERSITIES, RESEARCH ORGANISATIONS, PUBLIC BODIES & NON-PROFIT Christian Association for Higher Education, Research and Patient Care, Netherlands Barcelona Mar Parc Health Consortium, Spain Leiden University Medical Centre (LUMC), Netherlands National Centre for Cancer Research (CNIO), Spain Royal Society of Chemistry, UK Technical University of Denmark, Denmark University of Hamburg, Germany University of Maastricht, Netherlands University of Manchester, UK University of Santiago de Compostela, Spain University of Vienna, Austria University of Bonn, Germany SMEs

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Academic Concept Knowledge

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start Date Duration Contributions IMI funding EFPIA in-kind Other Total cost 01/03/2011 36 months 9 988 867 4 142 649 2 265 938 16 397 454

Links and Documents Project Website: www.openphacts.org IMI funding per project particpant Publications

Contact PROJECT COORDINATOR Bryn Williams-Jones Computational Biology Pfizer Ltd UK Email: bryn.I.williams-jones[AT]pfizer.com MANAGING ENTITY OF IMI BENEFICIARIES Prof Gerhard Ecker Department of Medicinal Chemistry University of Vienna Austria Email: gerhard.f.ecker[AT]univie.ac.at

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

ORBITO
Oral biopharmaceutics tools
Summary Most drugs are taken orally, as tablets or capsules for example. However, designing these pharmaceutical products in such a way that the active ingredient is absorbed at an appropriate rate and extent by the gut is far from easy. The ORBITO project aims to enhance our understanding of how orally-administered drugs are taken up from the gastrointestinal tract into the body, and apply this knowledge to create new laboratory tests and computer models that will better predict the performance of these drugs in patients.

Predicting performance The majority of drug products are administered orally, yet designing oral formulations and determining dosages involves a lot of trial and error. Current laboratory tests do not mimic accurately the highly variable and dynamic environment of the human gut, and so their ability to predict the performance of an orally-administered drug in the human body is limited. As a result, researchers rely heavily on tests in animals and clinical studies in humans to verify drug performance, rendering the entire process rather lengthy and expensive. The issue is likely to become even more pressing in the future as new drug discovery technologies are increasingly delivering active drugs that are very hard to put into simple oral formulations, for example because they are hydrophobic, have low aqueous solubility, and/or variable uptake in large intestine. There is therefore an urgent need for improved tools to predict the performance of orally-administered drugs. From trial and error to rational models The ORBITO project aims to tackle this problem at all levels, beginning with improving our fundamental understanding of the gastro-intestinal absorption process. This information will be integrated into the development of new (or refinement of existing) laboratory tests and computer-based methods that will deliver more accurate predictions of drug product behaviour in real life. The new methods will be validated with the use of industrial data and material. Crucially, the project will set up a framework to guide the use of these new tools in drug development. What sets ORBITO apart from other projects is the way it will integrate data from many existing studies while also initiating new studies that will generate better data. By combining existing data with new data, and by bringing together so many different partners, it has a good chance of achieving its goals. Ultimately, the project will help to facilitate and speed up the formulation development process and significantly reduce the need for animal experiments in this area as well as for human clinical studies in the future. For patients, the main benefit will be in the form of high quality medicines where the dose required is well calculated and is released in a way that consistently provides an optimal clinical effect.

Participants EFPIA AstraZeneca AB, Sodertalje, Sweden Abbott GmbH & CoKG, Wiesbaden-Delkenheim, Germany Bayer Pharma AG, Berlin, Germany Boehringer Ingelheim International GmbH, Ingelheim, Germany GlaxoSmithKline Research and Development Ltd, Brentford, UK
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

H. Lundbeck A/S, Valby, Denmark Janssen Pharmaceutica NV, Beerse, Belgium Merck Sharp & Dohme Corp, Rahway, US Novartis Pharma AG, Basel, Switzerland Orion Corporation, Espoo, Finland Pfizer Ltd, Sandwich, UK Sanofi-Aventis Research and Development, Chilly-Mazarin, France Universities, research organisations, public bodies, non-profit groups Uppsala Universitet, Uppsala, Sweden Copenhagen University , Copenhagen, Denmark Ernst Moritz Arndt University Greifswald, Greifswald, Germany Johann Wolfgang Goethe-Universitt Frankfurt am Main, Frankfurt am Main, Germany Johannes Gutenberg Universitt Mainz, Mainz, Germany Katholieke Universiteit Leuven, Leuven, Belgium Medical Products Agency, Uppsala, Sweden National and Kapodistrian University of Athens, Athens, Greece Netherlands Organization for Applied Scientific Research TNO, Delft, Netherlands University of Manchester, Manchester, UK University of Strathclyde, Glasgow, UK SMEs Simcyp Limited , Sheffield, UK Sirius Analytical Ltd, Forest Row, UK Simulations Plus, Inc., Lancaster, US

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/10/2012 60 months 9 000 000 11 500 000 4 000 000 24 500 000

Links and Documents IMI funding per project participant

Contact Project Coordinator Bertil Abrahamsson AstraZeneca AB Tel: +46 31 7761262 E-mail: bertil.abraha msson[AT]astrazeneca.com Managing Entity Hans Lennerns Uppsala Universitet Tel: +46 18 471 4317 E-mail: hans.lennernas[AT]farmaci.uu.se

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Pharma-Cog
Prediction of cognitive properties of new drug candidates for neurodegenerative diseases in early clinical development
Summary Currently approved drugs for patients with Alzheimer's disease only treat symptoms and their effect is limited or absent in many patients. No drugs have been approved yet that can actually slow the progression of the disease. Trials with candidate drugs take years and cost tens of millions of euro's, as the beneficial effect in patients may only become clearly apparent after long treatment due to the insensitivity of the tools available to measure the effect of a drug on the progression of the disease.

The Pharma-Cog project aims to develop and validate new tools to test candidate drugs for the treatment of symptoms and disease in a faster and more sensitive way. By bringing together databases of previously conducted clinical trials and combining the results from blood tests, brain scans and behavioural tests, the scientists will develop a 'signature' that gives more accurate information on the progression of the disease and the effect of candidate drugs than current methods do. The scientists will conduct parallel studies in laboratory models, healthy volunteers and patients in order to better predict good new drugs as early as possible. This will enable them, for instance, to find out how memory loss in Alzheimer's disease can be simulated in healthy volunteers, for example with sleep deprivation or drugs that temporarily affect the memory, in order to test the effect of candidate-medicines early in the drug development process. Combining the expertise of twenty nine public and private partners, Pharma-Cog has the unique opportunity to fundamentally change the drug discovery process in Alzheimer disease and to accelerate in Europe the development of effective drugs for patients. The consortium will work in close cooperation with the European Medicines Agency.

Achievements & News PharmaCog reaches out to European Parliament IMI project PharmaCog presented some of its key findings at the European Parliament during a lunch hosted by French parliamentarians Franoise Grossetete and Elisabeth Morin-Chartier.The 40 guests, including 7 Members of the European Parliament (MEPs) learnt about how the PharmaCog project is helping to speed up the discovery of drugs for Alzheimers disease. PharmaCog is developing new tools to identify potential drugs (and screen out ineffective ones) early in the drug development process. The project is also working on tests to determine how well a drug is working in individual patients, e.g. through brain scans, blood tests, and cognitive testing. (March 2012)

Participants EFPIA GlaxoSmithKline Research and Development LTD, Brentford, UK AstraZeneca AB, Sdertlje, Sweden Boehringer Ingelheim International GmbH, Ingelheim, Germany Novartis Pharma AG, Basel, Switzerland Institut De Recherches Servier, Suresnes, France UCB Pharma SA, Brussels, Belgium Merck Serono, Geneva, Switzerland Eli Lilly and Company Ltd, Basingstoke, UK Janssen Pharmaceutica NV, Beerse, Belgium F. Hoffmann-La Roche AG, Basel, Switzerland H. Lundbeck A/S, Valby, Denmark EISAI Ltd, UK
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Universities, Research Organisations, Public Bodies & Non-Profit Universit de la Mditerrane Aix-Marseille II, Marseille, France Institut D'investigacions Biomediques August Pi-Sunyer, Barcelona, Spain Universite Lille II Droit Et Sante, Lille, France Universitt Leipzig, Leipzig, Germany Universidad de Murcia, Murcia, Spain Universittsklinikum Essen, Essen, Germany Centre National De La Recherche Scientifique, Paris, France Institut National de la Sant et de la Recherche Mdicale, Paris Cedex 13, France Universita Degli Studi Di Verona, Verona, Italy Provincia Lombardo-Veneta Ordine Ospedaliero San Giovanni Di Dio Fatebenefratelli, Milan, Italy Universit degli Studi di Foggia, Foggia, Italy Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy Alzheimer Europe, Luxembourg, Luxembourg SMEs Innovative Concepts in Drug Development (ICDD-sas), Aix en Provence, France SAS Alzprotect, Loos, France Qualissima GmbH, Marseille, France Exonhit Therapeutics SA, Paris, France Innovative Health Diagnostics, Strasbourg, France

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Starting date Duration Contributions IMI funding EFPIA in-kind Other Total cost 01/01/2010 60 months 9 658 388 10 187 989 7 860 646 27 707 023

Links and Documents

Contact

Project website: www.pharmacog.eu Project Coordinator Jill C. Richardson RD ChIna UK Group Publications GlaxoSmithKline Research Centre Gunnels Wood Road Stevenage IMI funding per project participant Hertfordshire UK SG1 2NY Tel: +44 (0) 1438 766700 Email: Jill.C.Richardson[AT]gsk.com Managing entity of IMI beneficiaries Celine Damon CIC-UPCET - Hopital de la Timone Universit de la Mditerrane Aix-Marseille II Marceille, France Tel: + 33 4 91 38 46 46 Email: celine.damon[AT]@univ-amu.fr Scientific Coordinator Regis Bordet Email:bordet[T]univ-lille2.fr

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Pharmatrain
Pharmaceutical Medicine Training Programme
Summary The main objective of the PharmaTrain project is to build and implement a new modular Master level programme for advanced studies in Pharmaceutical Medicine and Drug Development Sciences. The programme is based on the Bologna credit and title system and builds on the new PharmaTrain Syllabus 2010 of the European Federation of Courses in Pharmaceutical Medicine (EFCPM).

The modular concept of the training programme also provides an opportunity to professionals to select courses for accredited Continuing Professional Development (CPD), as well as individualised training la carte. The PharmaTrain consortium has identified 6 base courses and 13 master level programmes at European universities that will be standardised at the same quality level. PharmaTrain will set, maintain and constantly improve the standards and quality management of the training schemes and practices for pharmaceutical professionals The programme will encourage exchanges between the industry, regulators and academia, produce and promote distance e-learning programmes, and will enable increased flexibility, transferability and mobility. By providing a chart of available and planned training programmes at the different levels across Europe, PharmaTrain will identify the regions with the greatest needs. A uniform high-level training in Europe will make the drug development process faster, more economical, more tailored to patients needs, and will give Europe a global advantage in developing new innovative medicines. PharmaTrain is a collaboration of 20 EFCPM university training programmes, 13 learned societies including 3 competent authorities, several partner training organizations and 15 pharmaceutical companies. One year after its start, May 1, 2009, PharmaTrain has gained full momentum and has met basically all milestone deliverables in the Prepare Phase and now launches the next two years of the Learn/Execution Phase. First year results include: creation of new postgraduate training curricula with syllabus standardised modularisation and related learning outcomes providing increased mobility unified examination principles different mixes of blended e-learning for comparative testing during the programme combined with a new concept of cooperative training among new EU member states as well as a pan-European accreditation system a continuing Professional Development (CPD) Platform and a comprehensive quality management process

Achievements & News PharmaTrain success 12 universities, 1 degree! IMI project PharmaTrain has successfully launched the Cooperative European Medicines Development Course (CEMDC), a postgraduate qualification inmedicines development. At a ceremony in Budapest, Hungary on 30 October, high-level representatives of 10 universities signed a Memorandum of Understanding formalising the cooperation, which will allow students to take modules offered jointly by the partner universities. Degrees will be formally awarded by Budapests Semmelweis University on behalf of the partner universities. The CEMDC was set up by PharmaTrain to provide a university network that could provide pharmaceutical medicine training in countries where no such education was established. The universities involved in the CEMDC are located in Estonia, Hungary, Lithuania, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, and Turkey. The initiative therefore gives students from the central and Eastern European and Mediterranean regions the opportunity to benefit from the very best teaching offered jointly by all participating universities. The university network concept was developed because in small countries and countries with small pharmaceutical industries, only a network concept can guarantee long-lasting sustainability of the programme. The course will start in April 2013. This is a quite unique cooperation which could only be organised within the IMI
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programme and with the active support of the PharmaTrain cooperation, commented CEMDC Study Director Sandor Kerpel-Fronius of Semmelweis University. (November 2012) Check out the IMI Education & Training projects video Four of IMIs Education & Training projects have put together a short video on their activities.In the six-minute clip, the coordinators of the EMTRAIN, SafeSciMET, Eu2P, and PharmaTrain projects present their courses and the benefits they offer for students and course providers alike. The film also features a presentation by IMI Executive Director Michel Goldman. (November 2012) PharmaTrain goes global IMI Education and Training project PharmaTrain is extending its global reach by signing Memoranda of Understanding (MoUs) with universities around the world. Affiliated institutions benefit from the Quality Standards of IMI PharmaTrain and share the interest to find a common process to train medicines development for integrated drug developers and to foster continuing professional development, explains PharmaTrain coordinator Fritz Bhler of the University of Basel. The move also allows PharmaTrain to benefit from non-European expertise in medicines training, and also highlights Europes leading role in this area. The universities of California and Peking were the first to sign MoUs with PharmaTrain, and the project is in discussions with a number of other institutions. Eventually, one global training concept for medicines development and regulation will emerge which greatly facilitates global medicines development, comments Professor Bhler. (July 2012) All aboard the Pharmatrain! Hibernia College Dublin in Ireland has been named as the first PharmaTrain Centre of Excellence. The college, 1 of 14 training providing partners in the IMI Education & Training project PharmaTrain, used the PharmaTrain Shared Standards to create a new online Master of Medicines Development programme. The announcement means that PharmaTrain is making great strides towards its goal of creating a pan-European, collaborative network for comprehensive post-graduate training. The modular courses devised by the partners allow students to mix and match to tailor their education to their own professional training needs. The projects short and snappy Career Driver newsletter provides regular updates on this successful projects progress, along with lively quotes from both students and project partners. To sign up, visit the PharmaTrain website. (October 2011) PharmaTrain is launching new and upgraded Europe-wide Education and Training programmes on Integrated Drug Development Sciences in Autumn 2010. The programme includes Base courses and Master programmes taught at partner universities all across Europe. A full overview is available at www.pharmatrain.eu . Another early achievement of the PharmaTrain project is the publication of a 2010 European Training Syllabus for Pharmaceutical Medicine on the PharmaTrain website . It summarises the learning content that will be addressed in the courses mentioned above. The syllabus has been internationally recognised and adopted by the International Federation of Associations of Pharmaceutical Physicians (IFAPP) and the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom. In Spring 2011, the corresponding detailed learning outcomes will be published in the 'PharmaTrain Programme Handbook. Shared Curriculum and best practices'. (October 2010)

Participants EFPIA Pfizer Limited, Sandwich, UK Bayer Schering Pharma AG, Berlin, Germany AstraZeneca AB, Sdertlje, Sweden GlaxoSmithKline Research and Development LTD, Brentford, UK Merck KGAA, Darmstadt, Germany Novartis Pharma AG, Basel, Switzerland Amgen NV, Bruxelles, Belgium UCB Pharma SA, Brussels, Belgium F. Hoffmann-La Roche AG, Basel, Switzerland
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Novo Nordisk A/S, Bagsvaerd, Denmark Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France Janssen Pharmaceutica N.V., Beerse, Belgium Laboratorios Almirall S.A., Barcelona, Spain Laboratorios Del Dr Esteve SA, Barcelona, Spain Orion Corporation, Espoo, Finland Universities, Research Organisations, Public Bodies & Non-Profit European Federation of Courses In Pharmaceutical Medicine, Basel, Switzerland (Project Coordinator) Universitt Basel, Basel, Switzerland International Federation of Associations of Pharmaceutical Physicians, Woerden, Netherlands Faculty of Pharmaceutical Medicine of The Royal College of Physicians of the United Kingdom, London, United Kingdom Pharmed, Brussels, Belgium Semmelweis Egyetem, Budapest, Hungary Universite Claude Bernard Lyon 1, Villeurbanne, France Cardiff University, Cardiff, United Kingdom University of Surrey, Guildford, United Kingdom University of Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Hibernia College, Dublin, Ireland The Provost Fellows & Scholars of the College of the Holy and Undivided Trinity of Queen Elizabeth Near Dublin, Dublin, Ireland Vienna School of Clinical Research, Vienna, Austria Universitt Wien, Wien, Austria Faculty of Medicine, University of Belgrade, Belgrade, Serbia Universitt Duisburg-Essen, Essen, Germany PME Institute for Education in Pharmaceutical Medicine GmbH, Witten, Germany Universittsklinikum Freiburg, Freiburg, Germany Universit de Lausanne, Lausanne, Switzerland Karolinska Institutet, Stockholm, Sweden Goeteborgs Universitet, Goeteborg, Sweden Kbenhavns Universitet, Kbenhavn K, Denmark Universite Louis Pasteur, Strasbourg, France Universita Cattolica del Sacro Cuore, Milano, Italy Universitat de Barcelona, Barcelona, Spain Universitat Autonoma de Barcelona, Cerdanyola Del Valles, Spain Universitat Pompeu Fabra, Barcelona, Spain Dia Europe GmbH, Basel, Switzerland European Federation for Pharmaceutical Sciences, Stockholm, Sweden Medicines and Healthcare Products Regulatory Agency, London, United Kingdom Swissmedic, Berne, Switzerland European Organisation for Research and Treatment of Cancer Aisbl, Brussels, Belgium Stichting Top Institute Pharma, Leiden, The Netherlands European Forum for Good Clinical Practice, Brussels, Belgium King's College London, London, United Kingdom

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Total cost 01/05/2009 60 months 3 510 300 3 143 288 6 653 588

Links and Documents Project website: www.pharmatrain.eu Publications IMI funding per project participant

Contact Project Coordinator and Managing entity of IMI beneficiaries Fritz Bhler European Federation of Course Providers in Pharmaceutical Medicine EFCPM University of Basel, Switzerland

IMI Education & Training Programmes Tel: +41 79 358 2875 Email: fritz.buhler [AT] unibas.ch EFPIA Michael Hardman R&D Science Policy AstraZeneca Macclesfield Cheshire UK Tel: +44 (0)1625 519566 Email: Mike.hardman [AT] astrazeneca.com

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

PREDECT
New models for preclinical evaluation of drug efficacy in common solid tumours
Summary The PREDECT project will permit the emergence of faithful models for target validation and beyond. Traditional preclinical discovery methods, particularly for target validation, poorly predict drug efficacy, causing a high attrition rate in pharmaceutical research and development.

The PREDECT consortium will focus on complex but transferable next generation in vitro and in vivo models for breast, prostate and lung cancers. Models will be investigated for their improved potential to validate novel therapeutic targets. Known targets, in canonical pathways, will be interrogated for induction of phenotypic, proteomic and transcriptomic changes using inhibitors. A strategy of seeking a dynamic reciprocity of concordance between the steady and perturbed states of in vitro complex cultures, tissue slices and in vivo tumour models will be pursued by systems biology analyses. The project will develop and generate a repository of advanced complex models in 3 complementary areas: in vitro 2D/3D organotypic (co-)cultures, stirred bioreactor aggregates and tissue slice systems novel (orthotopic) grafts of human and mouse tumour samples genetically-engineered and mosaic mouse models. PREDECT aims to produce results which will shift paradigms in target validation and so leading to greater predictivity of drug efficacy in drug trials. PREDECT is coordinated by Servier and AstraZeneca and the managing entity of IMI JU funding is the University of Helsinki. The team assembles world-class biologists, clinicians and computational scientists from 8 EU institutes, 3 SMEs and 7 EFPIA members who will work to develop and then critically assess new models for target validation.

Participants EFPIA AstraZeneca AB, Sweden Bayer Schering Pharma AG, Germany Boehringer Ingelheim International GmbH, Germany F. Hoffmann-La Roche AG, Switzerland Institut de Recherche Servier, France Orion Pharma, Finland Sigma-Tau S.p.A., Italy UNIVERSITIES, RESEARCH ORGANISATIONS, PUBLIC BODIES & NON-PROFIT Catholic University Foundation, Netherlands Erasmus University Medical Centre, Netherlands Institute of Cancer Research, United Kingdom Ecole Polytechnique Fdrale de Lausanne, Switzerland Robert Bosch Society for Medical Research mbH, Germany Technical Research Centre of Finland University of Helsinki, Finland University of Tartu, Estonia Weizmann Institute of Science, Israel
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SMEs Biomedicum Genomics Ltd, Finland Oncotest GmbH, Germany Institute of Experimental Biology and Technology, Portugal

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start Date Duration Contributions IMI Funding EFPIA in-kind Other Total Cost 01/02/2011 60 months

Links and Documents Project website : www.predect.eu. IMI funding per project particpant 8 100 509 6 587 353 2 532 789 17 220 651

Contact PROJECT COORDINATOR John Hickman Institut de Recherche Servier Rue de la Rpublique 3 92150 Suresnes France Email: john.hickman [AT]fr.netgrs.com MANAGING ENTITY OF IMI BENEFICIARIES Emmy W. Verschuren FIMM-EMBL International Group Leader University of Helsinki Yliopistonkatu 4 FI-00014 Helsinki Finland Email: emmy.verschuren[AT]helsinki.fi

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

PreDiCT-TB
Model-based preclinical development of anti-tuberculosis drug combinations
Summary Tuberculosis (TB) infects over 9 million people worldwide every year and kills 1.7 million. Treatment takes several months, and many patients struggle to take their antibiotics properly, fuelling the rise of drug-resistant strains of the disease. However, putting together a new, shorter treatment regimen could take a quarter of a century using todays methods. The IMI-funded PreDiCT-TB project aims to speed up the search for new, more effective combinations of treatments to tackle the deadly disease. PreDiCT-TB is one of the worlds only initiatives focused on tackling pre-clinical research barriers to the discovery and development of new TB drug combinations.

TB is an airborne, infectious disease caused by the bacterium Mycobacterium tuberculosis. It usually affects the lungs, and symptoms include coughing, weight loss, night sweats, fever, and fatigue. Although it is both preventable and curable, it remains a leading cause of disease and death by infection, particularly in developing countries. TB treatment is tough; patients must take four antibiotics for at least six months. The length and complexity of this regimen mean that many patients do not take their treatment properly, or stop taking the drugs before the bacteria have been completely eradicated from the body. Thus poor compliance may well be driving a rise in multidrug-resistant (MDR) strains of TB that simply do not respond to the main first-line antibiotics. If the treatment regimen for standard TB is tough, the regimen for MDR TB is even tougher, taking upwards of two years and involving drugs that often cause severe side effects such as liver, skin and hearing problems. In addition, recent years have seen growing reports of extensively drug resistant (XDR) TB, which does not respond to a number of the core first and second line antibiotics. There is therefore an urgent need to develop a more potent, yet patient-friendly, combination of drugs to tackle TB. However, very few new TB drugs have been developed in recent decades. Furthermore, to prevent TB from developing resistance, it must be treated with a combination of multiple drugs. Until now, new drug candidates were developed and added to the existing regimen one by one. As it takes at least six years to change one drug in the regimen by either substitution or addition, approving a new four-drug regimen through successive trials would take a quarter of a century. Shortening this period is a top priority for the fight against TB, but current clinical trial methodologies make it very difficult to evaluate the optimal doses and combinations of drugs. PreDiCTing the best treatment regimens We need a way to facilitate the complex decisions around which doses and combinations of new drugs should enter clinical trials, and thats where the PreDiCT-TB project will focus its combined resources. PreDiCT-TB aims to develop an integrated set of laboratory-based models that will provide much-needed data to indicate the most appropriate doses and combinations of drugs for patients. In addition, the project will generate a comprehensive database of patient data from previous and on-going clinical trials for use as a reference for evaluating the performance of combination anti-TB drug regimens in these newly developed laboratory models. Ultimately, they aim to enable researchers to be able to use the information generated by the novel models to design better clinical trials involving TB patients. Therefore PreDiCT-TB brings together internationally-respected TB scientists and physicians with expertise in the biology, immunology and imaging of the disease, as well as those specialising in the behaviour of drugs in the body (pharmacokinetics), their interactions with one another (pharmacodynamics), and clinical trials. A boost for TB patients Todays long, complex TB treatment regimen is simply not patient-friendly enough and potentially raises the risk of patients developing (and passing on to others) drug-resistant forms of the disease. By speeding up the development of better and shorter treatment regimens, PreDiCT-TB should dramatically increase the likelihood of patients completing the course of treatment successfully in future years. New leads for the industry By assessing combinations of new candidate drugs and optimising clinical trial design, PreDiCT-TB is set to revolutionise the speed and effectiveness of drug discovery and development in the field of TB. Making good on a promise Tackling TB is a high priority for governments worldwide; the international Stop TB
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Partnership has set the goal of eliminating TB as a global public health problem by 2050. The results of PreDiCT-TB are set to give a new impetus to efforts to deliver novel treatments against this deadly disease.

Participants EFPIA GlaxoSmithKline Investigacin y Desarrollo SL, Tres Cantos, Spain Sanofi-Aventis Research & Development, Chilly Mazarin, France Janssen Infectious Diseases Diagnostics BVBA, Beerse, Belgium Universities, research organisations, public bodies, non-profit groups University of Liverpool, Liverpool, UK cole Polytechnique Fdrale de Lausanne, Lausanne, Switzerland Erasmus University Medical Centre Rotterdam, Rotterdam, the Netherlands Health Protection Agency, London, UK Institut Pasteur, Paris, France Liverpool School of Tropical Medicine, Liverpool, UK Max Planck Gesellschaft zur Frderung der Wissenschaften E.V., Munich, Germany St Georges University of London, London, UK Universidad Carlos III de Madrid, Madrid, Spain University College London, London, UK University of Leicester, Leicester, UK University of St Andrews, St Andrews, UK Uppsala universitet, Uppsala, Sweden Patients organisations Vrije Universiteit Medisch Centrum, Amsterdam, the Netherlands SMEs Microsens Medtech Ltd, London, UK ZF-Screens BV, Leiden, the Netherlands

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/05/2012 60 months 14 800 000 9 300 000 4 500 000 28 600 000

Links and Documents IMI funding per project participant

Contact Project Coordinator Justin Green GlaxoSmithKline Tel: +44 20 8990 2092 E-mail: justin.a.green[AT]gsk.com Managing Entity Geraint Davies University of Liverpool Tel: +44 151 428 0422 E-mail: gerrydavies[AT]doctors.org.uk

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

PRO-active
Physical Activity as a Crucial Patient Reported Outcome in COPD
Summary The aim of PROactive is to develop new tools that will enable patients, their doctors and clinical researchers to accurately assess the improvement or deterioration of Chronic Obstructive Pulmonary Disease (COPD). COPD is a treatable and preventable disease of the lungs which affects an increasing number of Europeans. Patients usually experience a progressive decline in their condition, they may get easily short of breath, experience leg fatigue and are often forced to reduce their physical activity and their normal way of life.

There are currently no valid tests that measure the impact of the disease on physical activity levels and related dimensions (e.g. the symptoms experienced during physical activity). Hence, accurate mapping of the progression or improvement of the disease in this important patient related domain is difficult. The commonly used lung function tests for COPD provide only limited information on the progression of the disease and on the symptoms and quality of life experienced by patients. Exercise tests, on the other hand are more an assessment of the capacity of the patient, rather than of the problems of patients in daily life. The PROactive consortium will develop Patient Reported Outcome-tools that detect small, but clinically relevant changes in physical activity and its related symptoms and as such, it will offer results more relevant to patients and doctors. A user friendly electronic tool will help patients to assess on a day-to-day basis the activities in which they engage and the symptoms associated to these activities. The second tool will be used during hospital visits to assess the patients' physical activity and experience of the disease. To verify the usefulness of the tools, they will be tested in clinical trials with more than 600 COPD patients. The European Medicines Agency (EMA) and the American Food and Drug Administration will be closely involved in the developments. The new tools will give doctors, nurses and other health care providers unique information on the effect of treatment on their patients in a domain of immediate relevance to their patients. Furthermore, the tests will be useful to test the effect of new COPD treatments in clinical trials. The PROactive project also includes the dissemination of the new tools and the training of scientists and hospital staff that will use the tools. The PROactive scientists believe that their work will pave the way for similar tools in other chronic diseases, such as congestive heart failure.

Achievements & News PROactive puts activity monitors through their paces IMI project PROactive has selected two activity monitors for further use in its studies on people with chronic obstructive pulmonary disease (COPD). Activity monitors (small devices worn by the patient that measure activity levels) play a key role in PROactive, which is working to accurately determine the impacts of COPD on patients daily lives. The monitors picked by PROactive are the DynaPort MoveMonitor and the ActiGraph GT3X+. In total, PROactive tested 6 monitors on over 100 patients; monitors were scored for both accuracy and usability. According to Thierry Troosters of KU Leuven, the monitors that will be used were considered valid according to our stringent criteria; they were judged as patient friendly by our main stakeholder, the patient; and they were judged as user friendly by investigators. Importantly both vendors of the monitors have pledged to help PROactive integrate data from the monitors into the projects own, larger databases. The monitors and a questionnaire will now be used to gain a comprehensive overview of physical activity in 250 COPD patients. (September 2011) IMI lung disease projects to present findings to press and patients On 28 September IMI projects U-BIOPRED and PROactive and the European Lung Foundation will hold a special event for patients and the public.IMI Executive Director Michel Goldman will open the event with a presentation on how Europe is responding to the needs of respiratory patients. Other talks will explain how patients and scientists are working together in the U-BIOPRED and PROactive projects and Marc Decramer, President of the European Respiratory Society, will
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

discuss the roadmap for respiratory research in the years ahead. There will also be time for attendees to ask questions of some of Europes leading respiratory researchers. The event is part of the 2011 European Respiratory Society (ERS) Annual Congress in Amsterdam. (September 2011) PROactive picking up on patients perceptions of COPD The IMI project PROactive is developing new ways of gauging the impacts of chronic obstructive pulmonary disease (COPD) on patients daily lives. While current activity tests tell doctors what patients can manage in theory, they do not reveal what patients are actually doing on a day-to-day basis or how patients feel about their activity levels. Through interviews with patients, PROactive has found that patients consider three aspects of physical activity to be important to overall quality of life: the amount of physical activity (e.g. how far someone can walk), the symptoms triggered by the activity (e.g. shortness of breath or fatigue) and the way the patient copes with these symptoms (e.g. stopping to rest every few minutes). Based on the findings, the PROactive team has developed some questions that capture the impacts of COPD on patients quality of life. The team now plans to create a tool that combines these questions with input from activity monitors (small external devices that measure activity levels and are worn by the patient) to accurately assess physical activity levels from the patients point of view. The tool could be used by physicians and researchers alike to test the efficacy of treatments, for example. The tool could also be adapted for other chronic conditions that affect physical activity. (September 2011)

Participants EFPIA Chiesi Farmaceutici S.p.A, Parma, Italy (Project Coordinator) GlaxoSmithKline Research and Development LTD, Brentford, UK Pfizer Limited, Sandwich, UK Almirall, S.A., Barcelona, Spain Novartis Pharma AG, Basel, Switzerland AstraZeneca AB, Sdertlje, Sweden UCB Pharma SA, Brussels, Belgium Boehringer Ingelheim International GmbH, Ingelheim, Germany Universities, Research Organisations, Public Bodies & Non-Profit Katholieke Universiteit Leuven, Leuven, Belgium The University of Edinburgh, Edinburgh, UK Thorax Research Center of Intensive & Emergency Thoracic Medicine, Athens, Greece Royal Brompton & Harefield NHS Foundation Trust, London, UK Fundacio IMIM, Barcelona, Spain Universitt Zrich, Zurich, Switzerland Academisch Ziekenhuis Groningen / University Medical Center Groningen, Groningen, Netherlands Astma Fonds Longstichting, Leusden, Netherlands British Lung Foundation, London, UK European Respiratory Society, Lausanne, Switzerland SMEs Choice Pharma, Hitching, UK

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Facts & Figures Starting date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/09/2009 60 months 6 767 597 8 225 389 1 743 482 16 736 468

Links and Documents Project website: www.proactivecopd.com Publications IMI funding per project participant

Contact Project Coordinator Caterina Brindicci Chiesi Farmaceutici S.p.A. Parma Italy Tel: +39- 0521-279.760 Email: info [AT] proactivecopd.com Managing entity of IMI beneficiaries Thierry Troosters Katholieke Universiteit Leuven Leuven Belgium Tel: +3216347107 Email: Thierry.troosters [AT] med.kuleuven.be

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

PROTECT
Pharmacoepidemiological research on outcomes of therapeutics by a European consortium
Summary The PROTECT project will enhance the monitoring of the safety of medicinal products. It will also contribute to better evaluate and communicate their benefit-risk profile throughout their lifecycle. To this end, innovative tools and methodological standards will be developed. The European Medicines Agency coordinates PROTECT and manages a Consortium of 29 public and private participants.

PROTECT aims at explaining discrepancies between the reported outcomes from pharmacoepidemiology studies by studying combinations of drugs and adverse events in several databases. It will identify and further explore sources of variability that may currently affect drug safety studies. Modern ways of collecting data on medication, lifestyle and risk factors directly from consumers using internet and telephony will also be explored in 4 countries with 5600 pregnant women. The ability of these systems to collect regular, accurate and complete reporting without the intervention of health professionals will be tested. Good practice recommendations for the detection of safety signals are developed based on extensive testing of existing and new methods, creation of a database of known adverse drug reactions, and exploring the use of electronic health records and clinical trials data. In addition, PROTECT will use new modeling approaches to integrate existing information from various data sources to facilitate and enhance the continuous monitoring of the benefit-risk of medicines. Particular emphasis will be given on a graphical representation of benefit-riskprofiles for use by patients, healthcare professionals, regulatory agencies, and drug manufacturers.

Participants EFPIA member companies GlaxoSmithKline Research and Development LTD, Brentford, UK Amgen NV, Brussels, Belgium Bayer Schering Pharma AG, Berlin, Germany AstraZeneca AB, Sdertlje, Sweden Genzyme Europe B.V., Naarden, The Netherlands H. Lundbeck A/S, Valby, Denmark Merck KGaA, Darmstadt, Germany Novartis Pharma AG, Basel, Switzerland Novo Nordisk A/S, Bagsvaerd, Denmark Pfizer Limited, Sandwich, United Kingdom F. Hoffmann-La Roche AG, Basel, Switzerland Sanofi-Aventis Research and Development, Chilly-Mazarin, France Universities, Research Organisations, Public Bodies & Non-Profit European Medicines Agency Lgemiddelstyrelsen (Danish Medicines Agency, Copenhagen, Denmark Agencia Espaola de Medicamentos y Productos Sanitarios, Madrid, Spain Fundacin Centro Espaol de Investigacin Farmacoepidemiolgica, Madrid, Spain Fundaci Institut Catal de Farmacologia, Barcelona, Spain International Alliance of Patients Organizations, London, UK Imperial College of Science, Technology & Medicine, London, UK Institut National de la Sant et de la Recherche Mdicale, Paris, France
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Ludwig-Maximilians-Universitt Mnchen, Mnchen, Germany Mario Negri Institute for Pharmacological Research, Milan, Italy Medicines and Healthcare products Regulatory Agency, London, UK Rijksuniversiteit Groningen, Groningen, The Netherlands Stiftelsen WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden University of Newcastle upon Tyne, Newcastle upon Tyne, UK Universiteit Utrecht, Utrecht, The Netherlands SMEs LA Sant pidmiologie Evaluation Recherche, Paris, France Outcome Europe Sarl, St. Prex, Switzerland

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total costs 01/09/2009 60 months 11 009 715 9 984 734 8 816 164 29 810 613

Links and Documents

Contact

Project Website: www.imi-protect.eu Project Coordinator Xavier Kurz European Medicines Agency Publications Pharmacovigilance and Risk Management London United Kingdom IMI funding per project participant EFPIA Elizabeth Swain GlaxoSmithKline Research and Development LTD, Harlow United Kingdom Managing entity of IMI beneficiaries Per Helboe Danish Medicines Agency, Licensing Division Copenhagen Denmark

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Quic-Concept
Quantative imaging in cancer:connecting cellular process with therapy
Summary The QuIC-ConCePT project aims to deliver a significant contribution to progress in standardization and qualification of Imaging Biomarkers (IBs) for use in oncology drug development. The objective is to provide tools to the drug developers to reliably demonstrate the modulation of key pathologic processes in tumours in patients in realistic trials. Looking further into the future, therapies for, and biomarkers of, the processes of invasion and metastasis will be of increasing importance, because in most cases it is metastasis, not the primary tumour, which kills the patient.

Currently available IBs illuminate only a small proportion of the tumour pathologies so there is a pressing need to develop measures of proliferation, apoptosis and necrosis into biomarkers which can reliably support both positive and negative decisions. Through a portfolio of highly innovative approaches to devise, evaluate and introduce IBs of invasion and metastasis, the QuIC-ConCePT vision for January 2016 is that drug developers can incorporate these IBs for decision-making in Phase I trials of investigational therapies that can be readily deployed in multiple cancer centres in a robust, consistent, ethical, and cost-effective way acceptable to patients. The results of the QuIC-ConCePT work should have utility in cancer research and in patient management in a very wide range of other important settings. The managing entity European Organisation for Research and Treatment of Cancer (EORTC) is already a world leader in the qualification of IBs and the consortium includes some of the world's most productive and innovative physicians and scientists in cancer imaging. The QuIC-ConCePT project will work in close collaboration with the newly approved FP7 project EuroBioImaging Research infrastructure for imaging technologies in biological and biomedical sciences coordinated by EIBIR and EMBL. EORTC will ensure the link between the two projects fostering crossfertilization and preventing duplication. The QuIC-ConCept consortium partners consist of 14 academic organisations combined with 1 SME working with 7 EFPIA companies over 5 years.

Achievements & News QuiC-ConCePT scans for new ways of testing cancer treatment efficacy Scientific progress in cancer research has substantially increased our understanding of the molecular biology of cancer, paving the way to novel treatments. However, new tools to rapidly and reliably demonstrate the efficacy of novel cancer drugs are lacking. A new paper by scientists from IMI project QuiC-ConCePT discusses how magnetic resonance imaging (MRI) could be used to assess the efficacy of new drugs. MRI scans are able to highlight differences in the way water moves in different tissues by detecting something called the apparent diffusion coefficient (ADC). This is important because the ADC of healthy tissues is different to that of cancerous tissues. Furthermore, studies have shown that the ADC of cancer cells rises sharply when the cells are killed, for example by chemotherapy. This means that ADC could potentially be used to assess whether a treatment has worked or not. However, more studies are needed before ADC can be used in studies to test the efficacy of new treatments. Writing in the European Journal of Cancer QuiC-ConCePT scientists set out a roadmap highlighting the steps needed before ADC can be used in drug development. (January 2012)

Participants EFPIA

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Amgen NV, Belgium AstraZeneca AB, Sweden Eli Lilly and Company Ltd, UK F. Hoffmann-La Roche AG, Switzerland GlaxoSmithKline R&D Ltd, UK MERCK KgAA, Germany Sanofi-Aventis R&D, France UNIVERSITIES, RESEARCH ORGANISATIONS, PUBLIC BODIES & NON-PROFIT Cancer Research, UK Radboud University Nijmegen Medical Center, Catholic University Foundation,Netherlands Christian Association for Higher Education, Research and Patient Care, Netherlands Erasmus University Medical Center, Netherlands European Organisation for Research and Treatment of Cancer, Belgium Imperial College of Science Technology and Medicine, UK Institute of Cancer Research-Royal Cancer Hospital, UK King's College London, UK Maastricht Radiation Oncology Clinic, (Maastro Clinic), Netherlands University Paris Diderot, National Institute of Health and Medical Research (INSERM), France Swiss Federal Institute of Technology (ETH), Switzerland University Hospital Antwerpen, Belgium University of Manchester, UK European Institute for Molecular Imaging, Westfaelische Wilhelms University,Mnster, Germany SMEs Keosys S.A.S, France

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in-kind Other Total cost 01/04/2011 60 months 7 000 000 8 053 206 2 062 520 17 115 726

Links and Documents

Contact

Project website: www.quic-concept.eu PROJECT COORDINATOR Professor John Waterton IMI funding per project particpant AstraZeneca AB Vstra Mlarehamnen 9 151 85 Sdertlje, Publications Sweden Email: john.waterton[AT]astrazeneca.com Tel: +44 1625 513633 MANAGING ENTITY OF IMI BENEFICIARIES Dr Yan Lui European Organisation for Research and Treatment of Cancer Avenue E. Mounier 83 1200 Brussels, Belgium Email: yan.liu[AT]eortc.be Tel: +32 (0) 2 774 1625

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

RAPP-ID
Development of rapid point-of-care test platforms for infectious diseases
Summary Excellent care for people with suspected infections involves rapid diagnosis and treatment. For instance, administering the correct antibiotic as soon as possible to patients with blood infections, dramatically improves their chances of survival. Equally so, using antibiotics when they do not benefit patients exposes them unnecessarily to side effects and potential antibiotic resistance. In this modern age, we still do not have the technology available that can quickly diagnose what kind of infection and what treatment is needed. Even the best of the currently available diagnostic methods are too slow to help clinicians.

The challenge is to produce a trustworthy rapid Point-of-Care Test (POCT). Exciting technologies,developed with tremendous potential to improve rapid diagnostics need to be integrated to have clinically-useful POCTs and this is now a realistically achievable goal. However this has to be achieved in the context of clinical reality: too many tests have been produced that are miracles of bioengineering but have not provided clinicians with what they require for optimal care. RAPP-ID aims to provide an integrated solution that addresses the technological challenges to enhance clinical decision-making and improve the quality of care and clinical outcomes for the people of Europe and worldwide. The project will develop a POCT for rapid detection of bacteria, tuberculosis bacteria, fungi, as well as viruses and patients markers of infection by combining novel specific probes, novel methods of sample preparation, and demonstrated ultra-high sensitive detection methods in hospital patients in less than 2 hours and for outpatients in less than 30 minutes. The platforms will also determine resistance to the most commonly used antibiotics. The research will focus on the pathogens and markers of infection involved in: Blood infections, Lower respiratory tract Infections, including community-acquired pneumonia and ventilator-associated pneumonia, Tuberculosis Detection of bacteria, fungi and antibiotic resistance will mainly involve Nucleic Acid tests, whereas viral and markers of infection detection will mainly involve selective immunobinding with a probe or with a sensor surface. The diagnostic tests will consist of four functional modules: sample collection and interfacing; upconcentration and extraction; signal and/or sample amplification; and detection. RAPP-ID will integrate the modules required for each disease/syndrome in a matrix to be used with an instrument that reads the results, also developed within the project. The diagnostic platform will be validated on well-characterised clinical samples and compared with the best reference standards and other currently available diagnostic tests. The RAPP-ID consortium draws its expertise from across Europe and includes 10 academic partners, 4 SMEs and 5 EFPIA companies who will work together over a 5-year period.

Achievements & News Clinicians want test results fast, RAPP-ID survey shows The ideal point of care test (POCT) is cheap, easy to use, and delivers highly accurate results in less than half an hour, according to the results of a survey run by IMI project RAPP-ID.POCTs are tests carried out where the patient is being cared for (e.g. at a doctors surgery), as opposed to in a central laboratory. Currently, doctors often have to wait days to find out what infections, if any, their patient has. RAPP-ID aims to develop POCTs that deliver more accurate and faster results. The survey also
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

highlighted the pathogens and antibiotic resistance problems that are most relevant for clinicians. The survey results will therefore help the project team to develop a test that meets clinicians needs. Elsewhere in the project, the consortium has reviewed the state of the art in diagnostic tools. This, along with the results of the survey, will ensure that the results of the RAPP-ID project will be truly game-changing. (March 2012) RAPP-ID survey quizzes clinicians on diagnostic test needs The IMI project RAPP-ID has launched a web-based survey to find out how clinicians currently manage certain infections and what they need for a diagnostic Point Of Care Test (POCT) to be useful in the clinic. POCTs refer to tests that are carried out where the patient is being cared for, such as a doctors office, as opposed to in a central laboratory. Today, doctors and patients often have to wait for days for the results of tests to identify what infection, if any, a patient has. RAPP-ID is working to develop POCTs that will provide information in less than two hours on the cause of infection and, in the case of bacterial infections, whether the bacteria are resistant to certain drugs. This will allow doctors to administer the right medicines sooner. The survey will help the project partners focus the development of POCT platforms and ensure that they are clinically relevant and meet clinicians needs. All clinicians are welcome to complete the survey; the deadline for submitting responses is the end of this year. The results will be released early next year. (November 2011)

Participants EFPIA GlaxoSmithKline Research and Development LTD, UK Johnson & Johnson -Tibotec-Virco Virology, Belgium Merck, USA Novartis Vaccines and Diagnostics Srl, Italy Sanofi-Aventis Research and Development, France UNIVERSITIES, RESEARCH ORGANISATIONS, PUBLIC BODIES & NON-PROFIT University of Cardiff, UK IMEC, Belgium KUL- Catholic University of Leuven, Belgium KTH Royal Institute of Technology, Sweden University of Cambridge, UK University of Geneva, Switzerland University of Antwerp, Belgium University of Gent, PBM Group, Belgium University of Twente, Netherlands University of Uppsala, Sweden SMEs LIONEX, Germany microfluidic ChipShop, Germany Mobidiag Ltd, Finland Q-linea, Sweden

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in-kind Other Total cost 01/04/2011 60 months

Links and Documents Project website: www.rapp-id.eu IMI Funding per project participant 6 828 438 5 848 470 1 771 853 14 448 761 Publications

Contact PROJECT COORDINATOR Jorge Villacian Johnson & Johnson Turnhoutseweg 30 2340 Beerse Belgium Email: jvillaci[AT]its.jnj.com Tel: +32 14 641 868 ACADEMIC COORDINATOR & MANAGING ENTITY OF IMI BENEFICIARIES Herman Goossens Vaccine & Infectious Disease Institute University of Antwerp Universiteitsplein 1 B-2610 Antwerp Belgium Email: Herman.Goossens[AT]uza.be Tel: +32 3 821 37 89

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

SAFE-T
Safer and Faster Evidence-based Translation
Summary One of the key challenges in drug development is improvement of patient safety: many drug side effects are not adequately predictable and often detected too late, when the risk for serious outcome is high. The scientists of the SAFE-T project are developing improved tools for prediction, detection, and monitoring of drug-induced injuries to the kidney, the liver, and the vascular system, using markers in patients blood and/or urine.

More than 140 participants contribute to the consortium, coming from 20 partners overall: eleven pharmaceutical companies, five academic centres, and four small to medium sized enterprises. The consortium will focus on measuring sets of safety biomarkers across a variety of patient populations in order to define background variability, response to specific organ injury, and biomarker profiles under different disease conditions. The ultimate goal is to identify for each of the three organ toxicities a set of biomarkers more specific, more sensitive and more predictive than currently available ones, and to gain regulatory acceptance for routine use of these biomarkers in drug development. To achieve that goal, the consortium is working in close collaboration with the regulatory agencies in Europe and the US, and is establishing links to other consortia and research groups to utilize synergies and maximize output. Samples collected by the consortium will be anonymized and kept in a centralized biobank; data from biomarker measurements will be stored in a dedicated database that will be maintained beyond the five year project lifetime to enable further research. After completion of the project, the thoroughly qualified safety biomarkers will help to significantly improve patient safety and reduce safety related attrition in drug development.

Achievements & News Smart SAFE-T strategy spots drug-induced liver injury IMI project SAFE-T has devised a simple strategy that is able to identify patients with drug-induced liver injury before serious damage has occurred.Writing in the journal PLoS ONE, the project team points out that 1 in 100 hospitalised patients experience liver injury as a result of an adverse drug reaction, but many cases are missed, especially in non-hepatology departments. The SAFE-T scientists used a common indicator of liver damage, namely alanine aminotransferase (ALT) levels. Using the SAFE-T strategy, all patients with ALT levels three times higher than the top end of the normal range were referred to an experienced hepatologist. The SAFE-T strategy was compared to the hospitals standard strategy, in which non-hepatologists refer suspected cases of drug induced liver injury (DILI) to experts. The results show that the SAFE-T strategy is much more sensitive, picking up 12 times more cases than the standard strategy and detecting cases of DILI while they are still in the earlier stages. These results therefore strongly suggest that the centralized [SAFE-T] method could prevent very severe complications, the researchers write. (November 2012) Major kidney SAFE-T studies get underway The IMI project SAFE-T has enrolled the first patients into 4 major studies that aim to boost scientists ability to determine whether or not a potential drug will be toxic to the kidney.Drug-induced kidney injury is a serious problem in drug development and the treatment of patients. All too often, currently-used tests only detect kidney damage when it is already irreversible. The new SAFE-T studies aim to assess the potential of biological markers (biomarkers) that could allow doctors and researchers to detect kidney damage while it is still in the early stages. People participating in the studies include patients treated with medicines known to be toxic to the kidney; people with kidney diseases; and kidney transplant recipients who take immunosuppressant drugs that could be harmful to the kidney. According to the team, putting together studies of this scale would not have been possible without intense interdisciplinary and cross-institutional collaboration. The first results from the studies are expected in six to nine months. In addition to drug-induced kidney injury, SAFE-T researchers are also working on improving tests to pick up on drug-induced liver and vascular problems. Large-scale studies in these areas have also been initiated by the consortium. (July 2011)

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Participants EFPIA Novartis Pharma AG, Basel, Switzerland Laboratorios Almirall S.A., BARCELONA, Spain Amgen, Bruxelles, Belgium AstraZeneca AB, Sdertlje, Sweden Bayer Schering Pharma AG, Berlin, Germany Boehringer Ingelheim International GmbH, Ingelheim, Germany Eli Lilly And Company Limited, Basingstoke, UK GlaxoSmithKline Research and Development LTD, Brentford, UK Pfizer Limited, Sandwich, UK F. Hoffmann-La Roche AG, Basel, Switzerland Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France Universities, Research Organisations, Public Bodies & Non-profit Naturwissenschaftliches und Medizinisches Institut an der Universitt Tbingen, Reutlingen, Germany Charite - Universitaetsmedizin Berlin, Berlin, Germany Assistance Publique - Hopitaux De Paris, Paris, France Consorci Institut Catal de Cincies Cardiovasculars, Barcelona, Spain The Foundation For Medical Research Infrastructural Development And Health Services, Tel Aviv, Israel SMEs Firalis S.A.S., Huningue, France Argutus Medical LTD, Dublin, Ireland EDI Experimentelle und Diagnostische Immunologie GmbH, Reutlingen, Germany Interface Europe, Bruxelles, Belgium

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 15/06/2009 60 months

Links and Documents Project website: www.imi-safe-t.eu Publications 13 901 971 17 855 120 4 113 964 35 871 055 IMI funding per project participant

Contact Project Coordinator Michael Merz Translational Sciences Novartis Institutes for Biomedical Research Basel Switzerland For press inquiries Joan Pitt Novartis Institutes for BioMedical Research Novartis Pharma AG Tel: +41 61 6962632 Email: joan.pitt[AT]novartis.com Communication manager Nicole Schneiderhan-Marra NMI Natural and Medical Sciences Institute, Reutlingen Germany Tel: +49-7121-51530815 Email: schneiderhan [AT] nmi.de

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

SafeSciMET
European Modular Education and Training Programme in Safety Sciences for Medicines
Summary SafeSciMET is a new and unique pan-European network, which will develop and establish a comprehensive modular education and training programme in safety sciences for medicines. The network brings together eighteen top institutes for drug safety education and research and fifteen pharmaceutical industry leaders. The SafeSciMET courses are open to all scientists from industry, academia and regulatory agencies and will encompass the safety, ethical, regulatory and societal aspects of drug discovery and development.

Professionals will be able to follow single courses in safety sciences or selected subsets of courses, to be accredited for Continuing Professional Development (CPD). Scientists successfully completing the full programme, including a Master thesis, will be awarded with an accredited Master of Advanced Safety Sciences of Medicines. All training courses will be aligned with the Bologna process. The training will lead to a new generation of safety specialists with strong competences in the application of novel technologies in risk assessment. They will be able to perform reliable evaluations of the safety of drug candidates and new medicines by linking data from laboratory tests with patient data in a more effective way. More targeted training of scientists will speed up biopharmaceutical innovation and may lead to a cost reduction in drug development. Early insight in the safety aspects of a candidate drug will reduce adverse effects in the later, clinical research phases and will improved the quality of life for patients, as a result of improved drug safety evaluation and regulatory procedures.

Achievements & News Check out the IMI Education & Training projects video Four of IMIs Education & Training projects have put together a short video on their activities.In the six-minute clip, the coordinators of the EMTRAIN, SafeSciMET, Eu2P, and PharmaTrain projects present their courses and the benefits they offer for students and course providers alike. The film also features a presentation by IMI Executive Director Michel Goldman. (November 2012) SafeSciMET courses sign up now! SafeSciMET, the IMI Education & Training program for Safety Scientists, has successfully completed its first cycle of courses in 2012, with participants giving very positive feedback. The project has now announced the start of the second course cycle, which runs from 2012 to 2014. Registration is already open for a number of courses, including Drug safety of stem cells and other novel therapeutics (26-30 November, Liverpool, UK). Topics covered in this course include the basic biology of stem cells and molecular therapies, drug safety aspects of novel therapies, the regulatory requirements for stem cells and novel therapies, and the application of stem cells in the safety assessment of conventional compounds. A full list of forthcoming courses can be found online. - Download an overview of the courses planned up until August 2014. (October 2012) SafeSciMET launches courses on clinical safety IMI Education and Training project SafeSciMET launches three new courses in the area of clinical safety. The course Clinical safety:pre-approval runs on 21-25 May in Basel, Switzerland; Clinical safety: post-approval will run on 11-15 June in Lyon, France; and Stratification, pharmacogenetics and drug safety runs on 27-31 August in Stockholm, Sweden. Applications for the new courses are now open via the project website. (February 2012)

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

SafeSciMET opens it's new 'safety programme New safety programme on safety sciences' which includes courses on safety pharmacology; non-clinical safety assessment: strategies, ethics and protocols; biomolecular analysis: from method development to clinic; and predictive cell culture'. (December 2011) The IMI Education & Training project SafeSciMET has opened registrations to its first course, 'Drug Discovery and Development' This is the introductory course to the new European Masters degree for Advanced Safety Sciences for Medicines designed by SafeSciMET. The course takes place in November 2010 and consists of 5 days at the University of Copenhagen with lectures, presentations and discussions, followed by one week home assignment of case studies and course questions. Registration is open on the SafeSciMET website . A brochure on the course is available here . All the forthcoming SafeSciMET courses are listed on the website , any of them also available one by one, for instance for continuing professional development. (September 2010)

Participants EFPIA F. Hoffmann-La Roche AG, Basel, Switzerland AstraZeneca AB, Sdertlje, Sweden Laboratorios Almirall S.A., Barcelona, Spain Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France Bayer Schering Pharma AG, Berlin, Germany Boehringer Ingelheim International GmbH, Ingelheim, Germany Eli Lilly and Company Limited, Basingstoke, United Kingdom Pfizer Limited, Sandwich, UK GlaxoSmithKline Research and Development LTD, Brentford, UK H. Lundbeck A/S, Valby, Denmark Merck KGAA, Darmstadt, Germany UCB Pharma SA, Brussels, Belgium Novartis Pharma AG, Basel, Switzerland Novo Nordisk A/S, Bagsvaerd, Denmark Orion Corporation, Espoo, Finland Universities, Research Organisations, Public Bodies & Non-profit VU University, Amsterdam, The Netherlands Universitat Konstanz, Konstanz, Germany University of Surrey, Guildford, United Kingdom Uppsala Universitet, Uppsala, Sweden European Federation for Pharmaceutical Sciences, Stockholm, Sweden Kbenhavns Universitet, Kbenhavn K, Denmark Universiteit Leiden, Leiden, Netherlands Top Institute Pharma, Leiden, Netherlands Universitt Basel, Basel, Switzerland Universite Henri Poincare Nancy 1, Nancy, France Hospices Civils de Lyon, Lyon, France Martin-Luther-Universitt Halle-Wittenberg, Halle, Germany Karolinska Institutet, Stockholm, Sweden Universitt Wien, Wien, Austria Universit Paris-Sud XI, Orsay, France The University of Liverpool, Liverpool, United Kingdom Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal Charite - Universittsmedizin Berlin, Berlin, Germany

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start Date Duration Contributions IMI funding EFPIA in-kind Other Total cost 01/01/2010 60 months 2 216 405 786 041 3 391 459 6 653 588

Links and Documents

Contact

Project Website: www.safescimet.eu Project Coordinator Christian Freichel Global Non-clinical Drug Publications Safety, F. Hoffmann-La Roche, Basel Switzerland Email: christian.freichel IMI Education & Training Programmes [AT] roche.com Managing entity of IMI beneficiaries Nico P.E. Vermeulen LACDR, Department of IMI funding per project participant Chemistry and Pharmaceutical Sciences, VU University Amsterdam The Netherlands Tel: +31 (0)20 598 7590 Email: npe.vermeulen [AT] few.vu.nl

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

STEMBANCC
Stem cells for biological assays of novel drugs and predictive toxicology
Summary The aim of the STEMBANCC project is to generate and characterise 1 500 high quality human induced pluripotent stem (iPS) cell lines that can be used by researchers to study a range of diseases, including diabetes and dementia, and test for drug efficacy and safety. The cell lines will help to improve and speed up the drug development process, and ensure that patients benefit from more effective and safer drugs.

Currently, many drugs fail rather late in the drug development process because the tests used in the earlier stages of drug development simply do not reflect what happens in real life when the drug is administered in patients. This is partly because these early tests rely heavily on animal cells, and when human cells are used, they have often been extensively modified to survive in culture and so no longer behave naturally. Those working in drug research and development therefore urgently need a good supply of cells that more accurately mimic what happens in the human body. The power of pluripotency Most adult cells can only divide to produce other cells of the same type for example, skin cells can only make other skin cells, and blood cells can only make other blood cells. Only embryonic stem cells are pluripotent, i.e. able to give rise to all the different kinds of cell that make up the human body. However, in recent years researchers have developed a way of reprogramming ordinary adult cells to create so-called induced pluripotent stem (iPS) cells. Like embryonic stem cells, iPS cells are able to generate any kind of cell; as such, they offer researchers a good supply of different kinds of human cell that can be used in research and drug development. The research resulting in the creation of the first iPS cells was a major scientific breakthrough that won scientists John Gurdon and Shinya Yamanaka the 2012 Nobel Prize in Physiology or Medicine. A unique resource STEMBANCCs goal is to generate 1 500 iPS cell lines from 500 people, characterise them in terms of their genetic, protein, and metabolic profiles, and make them available to researchers. All cell lines will also undergo a rigorous quality check. The raw materials for the project will be largely skin and blood samples taken from patients with certain diseases, people who display adverse reactions to drugs, and healthy individuals. The collection of these samples will be carried out with the individuals informed consent and in line with strict ethical standards. There will be a strong focus on peripheral nervous system disorders (especially pain); central nervous system disorders (e.g. dementias); neurodysfunctional diseases (e.g. migraine, autism, schizophrenia, and bipolar disorder); and diabetes. The project will also investigate the use of human iPS cells for toxicology testing; here the team will use the iPS cells to generate liver, heart, nerve and kidney cells. Ultimately STEMBANCC will be a source of well-characterised, patient-derived iPS cells that will help researchers study diseases, develop new treatments, and test the efficacy and safety of new drugs.

Participants EFPIA
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

F. Hoffmann-La Roche Ltd, Basel, Switzerland Abbott GmbH & Co KG, Wiesbaden-Delkenheim, Germany Boehringer Ingelheim International GmbH, Ingelheim, Germany Eli Lilly, Hampshire, United Kingdom Janssen Pharmaceutica NV, Beerse, Belgium Merck KGaA, Darmstadt, Germany Novo Nordisk A/S, Bagsvrd, Denmark Orion Corporation, Espoo, Finland Pfizer Limited, Sandwich, UK Sanofi-Aventis Research and Development, Chilly-Mazarin, France Universities, research organisations, public bodies, non-profit groups University of Oxford, Oxford, UK Charit - Universittsmedizin Berlin, Berlin, Germany Hebrew University of Jerusalem, Jerusalem, Israel Helmholtz Zentrum Mnchen - Deutsches Forschungszentrum fr Gesundheit und Umwelt (GmbH). Neuherberg, Germany Institut National de la Sant et de la Recherche Mdicale, Paris, France Kings College London, London, UK Linkopings Universitet, Linkping, Sweden Medical Research Council UK, Swindon, UK Medizinische Hochschule Hannover, Hannover, Germany Medizinische Universitt Innsbruck, Innsbruck, Austria Naturwissenschaftliches und Medizinisches Institut an der Universitt Tbingen, Reutlingen, Germany Region Hovedstaden - Capital Region of Denmark, Hillerd, Denmark Tel Aviv University, Tel Aviv, Israel Universittsklinikum Schleswig-Holstein, Lbeck, Germany Universit de Genve, Geneva, Switzerland Universit de Lausanne, Lausanne, Switzerland Universit de Technologie de Compigne, Compigne, France University College London, London, UK University of Birmingham, Birmingham, UK University of Cambridge, Cambridge, UK University of Edinburgh, Edinburgh, UK University of Lbeck, Lbeck, Germany University of Newcastle upon Tyne, Newcastle upon Tyne, UK SMEs Concentris Research Management GmbH, Frstenfeldbruck, Germany Islensk Erfdagreining EHF, Reykjavik, Iceland Univercell-Biosolutions, Toulouse, France

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/10/2012 60 months 26 000 000 21 000 000 8 600 000 55 600 000

Links and Documents Project website: www.stembancc.org

Contact Project Coordinator Martin Graf F. Hoffmann-La Roche Ltd Tel: +41-616889246 E-mail: martin.graf[AT]roche.com Managing Entity Zameel Cader University of Oxford Tel: +44 1865 285875 E-mail: zameel.cader[AT]ndcn.ox.ac.uk

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

SUMMIT
Surrogate markers for micro- and macro-vascular hard endpoints for innovative diabetes tools
Summary There are an estimated 250 million people worldwide suffering from diabetes, and many of them develop devastating chronic complications including coronary heart disease, stroke and peripheral vascular disease, as well as microvascular disorders, leading to damage of kidneys and eyes. These complications impose an immense burden on the quality of life of the patients and account for more than ten percent of the health care costs in Europe.

However, not all patients are at equal risk for those vascular diabetic complications. In order to better predict, monitor and treat the patients at risk, the scientists of the Summit project will identify biological clues (biomarkers) that indicate in advance if a patient is likely to develop vascular complications. Once the predictive biomarkers have been identified, the Summit consortium will demonstrate their usefulness in patient groups and will do the necessary tests to make the markers acceptable by regulatory authorities such as the European Medicines Agency and the American Food and Drug Administration. Furthermore, the team will identify genetic factors that make some patients more susceptible to vascular diabetic complications than others and they will also develop novel computer simulations and models for laboratory test, in order to better predict the outcome and development of complications in human populations. Biomarkers, models and clinical tests for the early prediction and detection of diabetic complications will be a valuable tool to speed up clinical trials with diabetic patients.

Achievements & News IMI diabetes projects sign Memorandum of Understanding IMI currently has three projects working on diabetes DIRECT, SUMMIT, and IMIDIA which have a combined budget ofjust over 100 million. The projects tackle diabetes in different ways. For example, IMIDIA focuses on studying the pancreatic beta cells which are responsible for producing insulin; it aims to use this knowledge develop treatments that can slow down the progress of diabetes. Meanwhile, SUMMITs work addresses the urgent need for new treatments to tackle the complications associated with diabetes, such as eye, kidney, and blood vessel problems. Finally, DIRECT takes a personalised medicine approach to diabetes, as it works to identify different varieties of diabetes and effective treatments to tackle them. The projects already work together on an informal basis (as evidenced by their new joint leaflet produced with the support of the IMI Executive Office). However, IMIDIA and SUMMIT have now taken their collaboration to a new level with the signature of a Memorandum of Understanding (MoU). The MoU covers the handling of intellectual property, the transfer of knowledge and materials, and confidentiality. The projects believe that the MoU could serve as a template for collaboration between other IMI projects in the future. (November 2012) SUMMIT software sets new standards for genome scanning Scientists from the IMI-funded SUMMIT project have developed a software tool that beats the current state of the art when it comes to scanning multiple genomes for mutations that could raise peoples risk of developing a specific disease or condition. Scientists regularly scan and compare the genomes of large numbers of people, some healthy and some with the disease under investigation, hunting for Single Nucleotide Polymorphisms (SNPs mutations where just one letter of the DNA code is changed) that could help to explain peoples genetic predisposition to the disease. Writing in the journal BMC Bioinformatics, the SUMMIT researchers set out how they tested their new Bag of Nave Bays (BoNB) software to identify SNPs that could predict the development of type 1 diabetes. They also compared BoNBs performance against that of two other algorithms used in these studies. Not only did BoNB successfully identify the genetic markers already known to be associated with a raised risk of type 1 diabetes, it outperformed the two other algorithms tested in terms of predicted risk accuracy. The SUMMIT team will now use BoNB to identify the genetic factors that raise peoples risk of developing diabetes-related complications, such as eye, kidney, and blood vessel problems. The source code of the BoNB algorithm is available online. (October 2012)

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

SUMMIT project welcomes new partners EFPIA member companies Sanofi-Aventis and Pfizer have joined IMI project SUMMIT, which is investigating new ways of identifying the diabetes patients at greatest risk of developing complications such as heart disease and stroke, and damage to the blood vessels, kidneys and eyes. The development of novel biomarkers (biological markers) and imaging technologies will help to better predict and monitor the progression of such complications and assess the efficacy of treatments. This will help to shorten clinical trials of novel medications. Among other things, Sanofi-Aventis will contribute to SUMMITs efforts to develop tools to identify patients at risk of kidney problems and atherosclerosis (hardening of the arteries). For example, it will develop an imaging probe to assess levels of calcification within atherosclerotic plaques in an experimental model of arterial stiffness. Pfizer will also contribute to SUMMITs work into the genes and proteins behind kidney disease in diabetics; their involvement will allow the partners to expand work that will help identify the patients who are more likely to develop kidney problems and progress rapidly through the stages of kidney disease. (November 2011)

Participants EFPIA Boehringer Ingelheim International GmbH, Ingelheim, Germany Eli Lilly and Company Limited, Basingstoke, United Kingdom AstraZeneca AB, Sdertlje, Sweden F. Hoffmann-La Roche AG, Basel, Switzerland Sanofi-Aventis Deutschland GmbH, Germany Pfizer Limited, United Kingdom Universities, Research Organisations, Public Bodies & Non-profit Lunds Universitet, Lund, Sweden Karolinska Institutet, Stockholm, Sweden Helmholtz Zentrum Mnchen Deutsches Forschungszentrum Fr Gesundheit und Umwelt GmbH, Mnchen Neuherberg, Germany Istituto Di Ricerche Farmacologiche Mario Negri, Milano, Italy University of Cambridge, Cambridge, United Kingdom University of Dundee, Dundee, United Kingdom The University of Exeter, Exeter, United Kingdom Goeteborgs Universitet, Goeteborg, Sweden Samfundet Folkhlsan I Svenska Finland RF, Helsingfors, Finland Terveyden Ja Hyvinvoinnin Laitos - National Institute For Health And Welfare, Helsinki, Finland Turun Yliopisto, Turku, FinlandIt-Suomen yliopisto, Kuopio, Finland University of Oxford, Oxford, United Kingdom Universita Degli Studi di Padova, Padova, Italy Universita Degli Studi di Pavia, Pavia, Italy Universita di Pisa, Pisa, Italy Universita Cattolica del Sacro Cuore, Milano, Italy Universita di Firenze, Italy University of Edinburgh, Edinburgh, United Kingdom SMEs Biocomputing Platforms LTD OY, Espoo, Finland

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in kind Other Total cost 01/11/2009 60 months 13 999 979 14 143 466 4 456 921 32 600 366

Links and Documents

Contact

Project website: www.imi-summit.eu Project Coordinator Michael Mark Dept. Metabolic Diseases Research, Publications Boehringer Ingelheim Biberach an der Ri Germany Tel: +49 (7351) IMI funding per participant 54-7602 Email: Michael.mark [AT] boehringeringelheim.com The IMI Diabetes Platform Managing entity of IMI beneficiaries Leif Groop Diabetes and Endocrinology, Lund University, Skne University Hospital Malm Sweden Tel: +46-40-391202 Email: leif.groop [AT] med.lu.se

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

TRANSLOCATION
Molecular basis of the bacterial cell wall permeability
Summary As part of the IMI antimicrobial resistance (AMR) programme New Drugs for Bad Bugs, TRANSLOCATION aims to increase the overall understanding of how to get antibiotics into multi-resistant Gram-negative bacteria such as Escherichia coli and Klebsiella pneumoniae and how to stop the bacteria from ejecting the drug. In sharing the knowledge and data discovered, TRANSLOCATION will develop guidelines for designing and developing new drugs to tackle antibiotic resistance and create an information centre for pre-existing and on-going antibacterial research data which will be used to establish best practices for future antibacterial drug discovery efforts.

The AMR arms race developing New Drugs for Bad Bugs AMR represents a serious and growing threat to human and animal health worldwide. According to the World Health Organization (WHO), antibiotic resistance is becoming a public health emergency of yet unknown proportions. In the EU, AMR is responsible for some 25 000 deaths every year, and the annual treatment and social costs have been estimated at some 1.5 billion. Meanwhile, new forms of resistance continue to arise and spread, leaving clinicians with few weapons to bring infections under control. Yet despite the recognised need for new antibiotics, the reality is that only two new classes of antibiotics have been brought to the market in the last three decades. The reasons for this are manifold. On the scientific front, there is an urgent need for a greater understanding of how antibiotics work, how bacteria develop resistance to them, and what molecular mechanisms could be exploited to get round bacterial defence mechanisms. At the same time, todays regulatory pathways mean clinical trials for antibiotics are extremely expensive. This, combined with the likelihood that the use of new antibiotics may be limited to situations where they are truly needed, leads to a low overall return on investment. Thus antibiotic discovery and development is simply no longer a financially viable option for businesses, and just a handful of pharmaceutical companies remain in the field. If no action is taken to address these issues, we risk leaving society in a situation where doctors will have few, if any, options to treat resistant bacterial infections. To avoid a public health emergency, the entire antibiotic research community, including researchers in universities, small and medium-sized enterprises (SMEs), and pharmaceutical companies must work together to reinvigorate research into new antibiotics. As a public-private partnership (PPP), IMI is the ideal platform to launch such an initiative. In its Action Plan against the rising threats from Antimicrobial Resistance of November 2011, the European Commission called for unprecedented collaborate research and development efforts to bring new antibiotics to patients by, among other things, launching an IMI programme for research on new antibiotics aimed at improving the efficiency of research and development of new antibiotics through unprecedented open sharing of knowledge. The result is the New Drugs for Bad Bugs (ND4BB) programme, the first two topics of which were launched as IMIs 6th Call for proposals in May 2012. TRANSLOCATION is the result of one of those topics. A third topic under ND4BB was launched as part of IMIs 8th Call for proposals in December 2012. From single molecule translocation to rational drug design The TRANSLOCATION project will focus on discovering important new information to improve the selection and optimisation of promising molecules which can be used for novel antibiotic drug discovery. The lack of progress in antibacterial drug discovery, especially against Gram-negative pathogens, is partly due to a lack of information about how potential drugs are able to get through the bacterial cell envelope and remain inside long enough to destroy it. Through this new research, TRANSLOCATION will generate knowledge which can be used in the development of new technologies for measuring the transport of molecules across the cell envelope into the bacteria, and for better understanding the mechanisms that bacteria use to flush out certain molecules before they can be effective. Experts will research the structures of porins, proteins which act as portals in the outer membrane of the bacteria for the transport of certain smaller molecules into and out of the bacteria.. Scientists from academia and industry will conduct a screening
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

programme to identify key proteins which are important in understanding bacterias ability to reject certain molecules. Learning from success and failure This second key aspect of the projects scope, learning from success and failure, requires broad knowledge and skill sets and a large body of data from multiple sources. The creation of a cross-project ND4BB information centre and the development of the business model to support the sharing of data will offer the wider antibiotic research community the opportunity to have access to new data from the results of all projects under the IMI AMR programme. TRANSLOCATIONs information centre will be managed through its newly-developed model for data sharing. The project team will coordinate the disclosure and combined analysis of previously confidential information, which is being provided primarily from participating EFPIA companies. Crucially, their data on historical successes and failures in antibacterial research and development allows a more streamlined approach to antimicrobial drug development and will help to speed up the drug discovery process by making it more efficient. Additionally, the TRANSLOCATION project will help coordinate the dissemination of information and knowledge from this and all other topics initiated under IMIs ND4BB programme. Discovery and efficiency will bring a boost to drug development for antibacterials In this project a large number of small and previously separate research problems are combined allowing for synergy and understanding of how antibiotics move in and out of cells on a new and innovative level. This collaboration will bring together the antibacterial know-how of industry and leading academics with expertise in microbiology, biophysics and computational and structural biology to provide a holistic view of the problem and a novel approach to deliver advances in this challenging area. TRANSLOCATION will help close the gap between the burden of infections due to multidrug-resistant bacteria and the development of new antibiotics to tackle the problem.

Participants EFPIA member companies AstraZeneca AB, Sweden Basilea Pharmaceutica AG, Switzerland Glaxosmithkline Research and Development Ltd, United Kingdom Janssen Infectious Diseases Diagnostics BVBA, Belgium Sanofi-Aventis Research and Development, France Non EFPIA company Bruker Daltonik GmbH, Germany Universities, research organisations, public bodies, non-profit groups Assistance Publique - Hpitaux de Paris, France Centre National de la Recherche Scientifique, France Socit Civile Synchrotron SOLEIL, France Fundacio Centre de Recerca en Salut International de Barcelona, Spain Jacobs University Ggmbh, Germany Johann Wolfgang Goethe Universitt Frankfurt am Main, Germany University of St Andrews, United Kingdom Universita degli Studi di Cagliari, Italy Universitt Basel, Switzerland Universittsklinikum Freiburg, Germany Universit d'Aix-Marseille, France Universit de Genve, Switzerland University College Dublin, Ireland University of Newcastle upon Tyne, United Kingdom
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Small and medium-sized enterprises (SMEs) European Screening Port GmbH, Germany Ionovation GmbH, Germany Nanion Technologies GmbH, Germany Nanospot GmbH, Germany Yelen, France

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start Date Duration IMI Funding EFPIA in kind Other Total cost 01/01/2013 60 months 15 984 203 8 135 833 5 207 970 29 328 006

Contact Project Coordinator Robert A. Stavenger GlaxoSmithKline Tel.: +1 610-917-7163 E-mail: Robert.A.Stavenger[AT]gsk.com Managing Entity Mathias Winterhalter Jacobs University Bremen Tel.: +49 421 200 3248 E-mail: m.winterhalter[AT]jacobs-university.de

Contributions

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

U-BIOPRED
Unbiased biomarkers for the prediction of respiratory disease outcomes
Summary The U-BIOPRED project aims to speed up the development of better treatments for patients with severe asthma. Several knowledge gaps today make it hard to predict in the early stages of drug development how well a new experimental medicine will work in patients. One of the major difficulties is the finding that there are many different forms of severe asthma, caused by different mechanisms of disease. Patients with different types of asthma may react differently to new or existing treatments.

The U-BIOPRED consortium brings together the leaders of the major global networks of severe asthma, such as ENFUMOSA, BIOAIR, GALEN, GABRIEL, BTS Severe Asthma, MRC Southampton Severe Asthma and NIH-SARP. Bundling their expertise in U-BIOPRED, the researchers will create and validate innovative testing methods to classify patients into distinct severe asthma types. Using a sophisticated systems biology approach, they will bring together genetic data from patients, results from tissue samples, blood tests and breathing tests, as well as clinical findings and patient reported symptoms. This will be linked to results of preclinical models, in order to facilitate future drug development. By combining this information in a clever way, the researchers will generate a 'handprint' a combination of biological characteristics (biomarkers) that indicates what type of asthma a patient is suffering from. The scientists will test if a patients' asthma handprint can predict how the disease will progress in that patient. Furthermore, they will divide patients into sub-groups, according to their handprint, and examine if patients within the same sub-group react in a similar way to existing or experimental treatments for severe asthma. Such findings would make the efficacy of candidate drugs more predictable and will help to speed up the development of new treatments. Moreover, a better understanding of the differences in drug-response among patients will enable more personalised and targeted treatment of patients with severe asthma.

Achievements & News IMI lung disease projects to present findings to press and patients On 28 September IMI projects U-BIOPRED and PROactive and the European Lung Foundation will hold a special event for patients and the public.IMI Executive Director Michel Goldman will open the event with a presentation on how Europe is responding to the needs of respiratory patients. Other talks will explain how patients and scientists are working together in the U-BIOPRED and PROactive projects and Marc Decramer, President of the European Respiratory Society, will discuss the roadmap for respiratory research in the years ahead. There will also be time for attendees to ask questions of some of Europes leading respiratory researchers. The event is part of the 2011 European Respiratory Society (ERS) Annual Congress in Amsterdam. (September 2011) U-BIOPRED asthma art contest winner announced Dutch student Marije Kootstra has been named as the winner of the U-BIOPRED asthma art contest. The winning painting can be seen on the U-BIOPRED website. Asthma plays an important role in my life, explains Marije, who is 17. In order to control her condition, she takes 10 medicines, sees a specialist regularly and has undergone a nose operation as well as other treatments. Yet despite these efforts, Marijes asthma is still not fully under control; in poor weather, she cannot cycle to school and so misses classes. She has even been hospitalised following severe asthma attacks. Nevertheless, Marije remains hopeful for the future. I hope that with the right medicines I can again get my asthma back under control, she says. Marije wins a trip for two to Amsterdam, where she will pick up her prize at the opening ceremony of the European Respiratory Society meeting in September. U-BIOPRED is working to speed up the development of new, more effective treatments for severe asthma. Patients are strongly represented in the project through the participation of six patients organisations. (July 2011) Knowledge management, the (tran)smart way Knowledge management is key to the success of many IMI projects, and the tranSMART system is proving a popular tool for this. TranSMART is a translational medicine platform based on open source software and data that was originally developed by Johnson & Johnson for its own
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projects. However, it quickly became clear that the system could be extremely useful for other groups. Today, tranSMART is used by research consortia on both sides of the Atlantic. The first IMI project to use tranSMART was U-BIOPRED, which is using it to collate data on asthma and chronic obstructive pulmonary disease (COPD) from four different companies, for example. Eventually, U-BIOPRED partners will be able to access the data and use it to test new hypotheses. Other ongoing projects that are implementing or about to implement tranSMART are OncoTrack, SAFE-T and BT Cure; some of the 3rd Call projects are also planning to use the system. Looking to the future, the 4th Call topic eTRIKS (European Translational Information & Knowledge Management Services) will support efforts to take tranSMART to the next level. (July 2011) U-BIOPRED recruits first adult into major asthma study IMI project U-BIOPRED has recruited the first of over 1 000 people into a major new study of severe asthma. U-BIOPRED researchers will draw on data from blood and tissue samples, lung function tests, exhaled air samples and examinations of the airways, plus reports of peoples own experiences, to build up a detailed picture (or handprint) of each individuals condition. By comparing data from hundreds of people, the team hopes to identify groups of patients with similar handprints. These groups will allow researchers to define different kinds of severe asthma, paving the way towards personalised treatments for patients. U-BIOPRED project coordinator Peter Sterk of the University of Amsterdam said that running such a study would have been unthinkable without IMI. (May 2011) U-BIOPRED new findings demonstrate value of data sharing Work in the U-BIOPRED project has proven the value of data sharing by generating an important result in asthma research. Both GSK and Pfizer were working on a similar animal model of severe asthma, but when data from both companies was combined, it quickly became clear that the model would not be as useful as was hoped. If they had continued working on their own, it would have taken the companies months to realise this.Data sharing in U-BIOPRED has since been given a further boost by the presence in the consortium of a new partner in the form of pharmaceutical company Centocor B.V., a member of the J&J group of companies. In addition to expertise, Centocor brings to the consortium a knowledge management system called TransMART. Elsewhere, U-BIOPRED has published research in the journal Thorax that will help to clarify the diagnosis of severe asthma, something that will help doctors to manage these patients more effectively. The paper provides information on what clinicians should check for when considering classifying a patient as having severe asthma. Developing more individualised characterisations of severe asthma contributes to U-BIOPREDs goal of redefining severe asthma and lays the foundation for personalised treatments for severe asthma sufferers. Finally, as part of its efforts to connect patients with researchers and clinicians, U-BIOPRED has launched an Asthma Art Contest. Anyone with severe asthma can enter the competition, and all art forms are welcome. (April 2011)

Participants EFPIA Novartis Pharma AG, Basel, Switzerland Laboratorios Almirall S.A., Barcelona, Spain AstraZeneca AB, Sdertlje, Sweden Boehringer Ingelheim International GmbH, Ingelheim, Germany Chiesi Farmaceutici S.p.A, Parma, Italy GlaxoSmithKline Research and Development LTD, Brentford, UK F. Hoffmann-La Roche AG, Basel, Switzerland UCB Pharma SA, Brussels, Belgium Centocor, a J&J company Universities, Research Organisations, Public Bodies & Non-Profit Academisch Medisch Centrum bij de Universiteit van Amsterdam, Amsterdam, Netherlands
Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

The University of Southampton, Southampton, UK Imperial College of Science, Technology and Medicine, London, UK Universit degli Studi di Catania, Catania, Italy University of Rome Tor Vergata, Rome, Italy Hvidovre Hospital, Hvidovre, Denmark The Jagiellonian University Medical College, Krakow, Poland Universitt Bern, Bern, Switzerland Semmelweis Egyetem, Budapest, Hungary University of Manchester, Manchester, UK Universit de la Mdietrrane, Aix-Marseille II, Marseille, France Fraunhofer-Gesellschaft zur Frderung der angewandten Forschung e.V., Mnchen, Germany Ume University, Umea, Sweden Universiteit Gent, Gent, Belgium Centre National de la Recherche Scientifique, Paris, France Universita Cattolica Del Sacro Cuore, Milan, Italy Kbenhavns Universitet (University of Copenhagen), Copenhagen, Denmark Karolinska Institutet, Stockholm, Sweden University of Nottingham, Nottingham, UK Universitetet i Bergen, Bergen, Norway Astma Fonds Longstichting, Leusden, the Netherlands European Lung Foundation, Lausanne, Switzerland Asthma UK, London, UK European Federation of Asthma and Allergy Associations, Brussels, Belgium Lega Italiana Anti Fumo ONLUS, Catania, Italy International Primary Care Respiratory Group, Aberdeen, UK SMEs Synairgen Research Limited, Southampton, UK Aerocrine AB, Solna, Sweden BioSci Consulting, Maasmechelen, Belgium Other Philips Electronics Nederland B.V., Eindhoven, the Netherlands

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu

Facts & Figures Start date Duration Contributions IMI funding EFPIA in-kind Other Total cost 01/10/2009 60 months

Links and Documents Project website: www.ubiopred.eu Publications 8 976 474 10 374 199 1 334 568 20 685 241 IMI funding per project participant

Contact Project Coordinator and Managing entity Peter Sterk Dept. Respiratory Medicine, F5-259 Academic Medical Centre Amsterdam, The Netherlands Tel: +31 20 566 43 56 Email: p.j.sterk [AT] amc.nl Industry representative Christopher Compton Respiratory Franchise Novartis Development Novartis Pharma AG Horsham UK Tel: +44 1403 324285 Email: chris.compton [AT] novartis.com

Printed on: 26/04/2013 This project is funded by the Innovative Medicines Initiative, a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) www.imi.europa.eu
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