achievements october 2011

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EARLY ACHIEVEMENTS

The Innovative Medicines Initiative

builds networks of open innovation in order to create a morecollaborative ecosystem for pharmaceutical R&D in Europe.

has a €2 billion budget, making it the world’s largest public-privatepartnership in health research and development (R&D).

supports research to make the discovery and development of better medicines for patients more efficient by focusing on safety,efficacy, knowledge management and education & training.

invites experts from industry, universities, hospitals, small andmedium-sized enterprises (SMEs), patient organisations, publicauthorities and other groups to participate in its research projects.

IMI is a joint undertaking between the European Union and theEuropean Federation of Pharmaceutical Industries and

Associations (EFPIA).

"By linking the best academic teams withhigh-level industry scientists, IMI isbuilding the research capacity needed tocure the major diseases of our time."

Michel Goldman, IMI Executive Director



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INNOVATIVE MEDICINES INITIATIVEEARLY ACHIEVEMENTS

SEPTEMBER 2011

INTRODUCTION

The first projects that have been launched by the Innovative MedicinesInitiative (IMI), in 2009 and 2010, are already generating impressiveresults. The early achievements highlighted here confirm that IMI is ontrack to achieving its goals: creating new insights that help move drug

development forward by pooling knowledge and expertise from public andprivate partners. By sharing research results that have not been broughttogether previously, the partners in the IMI Research projects arebuilding methods for testing and developing new drugs. The IMIEducation & Training projects are already presenting their EU-wideachievements. None of this would have been possible without IMI.

SELECTED ACHIEVEMENTS OF IMI R ESEARCH PROJECTS

Chronic pain affects one in five European citizens and adequate

treatments are often lacking. The EUROPAIN consortium has revealedsimilarity between pain caused by chemotherapy and coldhypersensitivity, a finding that contributes to a better understanding of the mechanisms of chronic pain. Studying images (scans) of the brain, theresearchers have found changes in the brain activity of patients with lowback pain that can be used to predict the intensity of the pain. They havealso identified several molecules in the body that could be potential newtargets for the treatment of pain.

The companies involved in NEWMEDS have pooled data to create the

largest known database of studies on schizophrenia. The databasecontains information on 23 401 patients from 67 studies in over 25countries. It offers the industry and the academic community uniqueopportunities for the development of tools, methods and models that willhelp find targeted treatments for schizophrenia. The consortium has alsoassembled a database with data on 2 500 patients with majordepression, which they are scanning for new clues to treat the disease inpatients that do not respond to existing therapies and for predicting theresponse in those who do. Genetic analysis of DNA-samples of thesepatients has already identified clues (targets) for predicting the response

to treatment and the limits of current predictions.



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The IMIDIA consortium has generated cell lines that continue to live inthe laboratory in test tubes and that closely resemble the beta-cells thatmalfunction in the human pancreas of patients with diabetes. The celllines represent an invaluable new tool that was so far missing in diabetesresearch, allowing studies that otherwise would have to be done on freshcells extracted from the human body. The mechanisms of the failinginsulin production and the death of the beta-cells in diabetes is poorlyunderstood, and this hampers the development of better treatmentsagainst this disease which affects increasing numbers of people aroundthe world. The new cell lines will be used to test potential new drugsagainst diabetes and to further unravel the mechanisms that cause thisdisease.

The SUMMIT consortium is developing methods to identify patients with ahigh risk of developing complications of diabetes. Diabetic complicationsleading to stroke or problems with the heart, kidneys and eyes impose animmense burden on the quality of life of the patients and account for morethan 10% of health care costs in Europe. The researchers have searchedthrough the scientific literature in order to identify changes in the bodythat predict such complications and they have identified a strategy for anew computer model that will help with that prediction. They have also

started studies with patients aiming to identify non-invasive markers of complications in the blood vessels.

The eTOX consortium has developed an innovative computer model thatpredicts if a candidate-drug is likely to cause serious heart problems inpatients. Currently, many promising drug candidates fail because theyturn out to be toxic to the heart. The new eTOX system should helpresearchers pick up drug safety problems earlier on in the drugdevelopment process. The new tool provides better results than thecomputational systems currently used.

The SAFE-T consortium is developing new tools (biomarkers) that willfacilitate the faster development of safer medicines. Less than 10% of alldrug candidates tested on patients will complete clinical development,because of potential drug safety issues. The SAFE-T scientists haveevaluated and prioritised 153 potential biomarker candidates for tests withpatients that could help predict drug-induced injury of the kidney, liverand vascular system. A scientific strategy adopted by the SAFE-T consortium for the testing of biomarkers on patients’ blood and othersamples has been agreed with the European Medicines Agency (EMA) and



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the U.S. Food and Drug Administration (FDA). This is a very importantachievement, as obtaining scientific advice from regulatory authorities is akey step in the standardisation of novel biomarkers.

The MARCAR project has developed and proved the effectiveness of amethod that helps identify chemical changes in the genetic material(chromosomes) that are related to cancer (non-genotoxiccarcinogenesis). The detection of these so-called epi-genetic changes canbe used as early biological indicators (biomarkers) to predict if drugs indevelopment are likely to cause unwanted effects (cancer) in patients. Thefindings will therefore contribute to a better assessment of the safety of candidate-drugs.

The U-BIOPRED consortium has recruited the first of over 1000 peopleinto a major new study of severe asthma, a life-threatening condition.U-BIOPRED researchers will draw on data related to blood, tissue, lungfunction, exhaled air and the airways, plus reports of people’s ownexperiences, to build up a detailed picture of each individual’s condition.By comparing data from hundreds of people, the team hopes tocharacterise different kinds of severe asthma, paving the way towardspersonalised treatments for patients – an undertaking that would be

impossible for any research team on its own. The consortium has alreadyproduced an international consensus statement for the diagnosis anddefinition of severe asthma, which represents a key step towards thedevelopment of innovative patient-tailored therapies

In the journal Nature Genetics, researchers from the Open PHACTS project put forward the concept of publishing data and assertions in theform of nanopublications. The nanopublication is the smallest unit of publication and is essentially a single assertion and its associated data andmaterial. 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 forscientists and others to follow up individual assertions or develophypotheses. Open PHACTS will test the nanopublication concept to createan Open Pharmacological Space (OPS), an innovative open platform,which will be freely accessible for knowledge discovery and verification.

Over seven million Europeans suffer from Alzheimer’s disease and otherforms of dementia, and effective drugs are lacking. The PHARMA-COG consortium is developing methods to identify the most promising



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candidate drugs earlier in the development process. The researchers haveproven that sleep deprivation induces cognitive impairment similar to thatof patients with Alzheimer’s disease in human volunteers. The studieshave shown that commercially available drugs for Alzheimer’s disease canreverse this cognitive impairment. This suggests that sleep deprivationcould be used as a model of cognitive impairment to test the effectivenessof new candidate-drugs.

EDUCATION AND TRAINING

The IMI Education & Training project SafeSciMET has launched its firstcourse, 'Drug Discovery and Development', which is the introductorycourse to the new European Master's Degree for Advanced SafetySciences for Medicines designed by SafeSciMET. The course started inNovember 2010 and consists of 5 days at the University of Copenhagenwith lectures, presentations and discussions, followed by one week of remote study looking at case studies and course questions.

The PharmaTrain consortium has launched new and upgraded Europe-wide Education and Training programmes on Integrated Drug

Development Sciences in autumn 2010. The programme includes Basecourses and Master's programmes taught at partner universities all acrossEurope. PharmaTrain has also published a 2010 European TrainingSyllabus for Pharmaceutical Medicine on the PharmaTrain website.The syllabus has been internationally recognised and adopted by theInternational Federation of Associations of Pharmaceutical Physicians(IFAPP) and the Faculty of Pharmaceutical Medicine of the Royal Collegesof Physicians of the United Kingdom.

The Eu2P project has opened its application period for its onlineinteractive Certificate and Master's courses in pharmacovigilanceand pharmacoepidemiology. The first courses have started inSeptember 2011, including the Master's 2nd Year program. Applications forthe Master's 1st Year program and the Eu2P PhD programme will belaunched in April 2012.

The EMTRAIN consortium is developing a training platform to supportthe pharmaceutical industry and to facilitate continuing professionaleducation and exchange, by mapping existing courses, connectinguniversities as well as industry and by anticipating emerging trainingneeds. The on-course database of existing courses will be launched



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towards the end of 2011. Over 700 Master's courses, over 110 ContinuingProfessional Development courses and over 380 learning tools & methodologies have already been mapped out and catalogued which willhelp scientists identify courses that meet their needs.

PUBLICATIONS

IMI PROJECTS

eTOX

Journal of Chemical Information and Modeling, 2011, Vol. 51, pp.483-92Obiol-Pardo, C. et al. A Multiscale Simulation System for the Prediction of Drug-Induced Cardiotoxicity

Combinatorial Chemistry & High Throughput Screening, 2011, Vol.14, No 5, pp. 375-387Taboureau, O. and Jørgensen, F.S. In silico predictions of hERG channel

blockers in drug discovery: From ligand-based and target-basedapproaches to systems chemical biology

Nucleic Acids Research, 2011, Vol. 9 (Suppl. 1): D367-D372Taboureau, O. et al. ChemProt: a disease chemical biology database

Bioinformatics, 2010, Vol. 26, pp. 2924-2926Bauer-Mehren, A. et al. DisGeNET - a Cytoscape plugin to visualize,integrate, search and analyze gene-disease networks

Expert Opinion on Drug Metabolism & Toxicology, 2010, Vol. 6, pp.1253-1263Garcia-Serna, R. and Mestres, J. Anticipating drug side effects bycomparative pharmacology

Molecular Informatics, 2010, Vol. 29, pp. 543-551Vidal, D. and Mestres, J. In silico receptorome screening of antipsychoticdrugs

PLoS Computational Biology, 2010, Vol. 6(5): e1000788Audouze, K. et al. Deciphering diseases and biological targets forenvironmental chemicals using toxicogenomics networks



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EUROPAINScience Translational Medicine, 2011, Vol. 3, No 90, pp. 90ra60Dawes, J. M. et al. CXCL5 mediates UVB irradiation–induced pain

IMIDIA

Journal of Clinical Investigation, 2011, Vol. 121 (9), pp. 3589-3597Ravassard, P. et al. A genetically engineered human pancreatic beta cellline exhibiting glucose-inducible insulin secretionCommentary: Finally! A human pancreatic beta cell line

Journal of Visualized Experiments, 2011, Vol. 53, Article ID 2962Bötticher, et al. Isolation of Human Islets from Partially PancreatectomizedPatients

Biochimica et Biophysica Acta (BBA) - Molecular Cell Research,2011, Vol. 1813 (10), pp. 1827-1835Mehmeti, I. et al. Induction of the intrinsic apoptosis pathway in insulin-secreting cells is dependent on oxidative damage of mitochondria butindependent of caspase-12 activation

Journal of Molecular Medicine, 2011, Vol. 89 (8), pp. 785-798Gurgul-Convey, E. et al. Cytokine toxicity in insulin-producing cells ismediated by nitrooxidative stress-induced hydroxyl radical formation inmitochondria

Diabetologica, (in press)Koivisto, et al. The Innovative Medicines Initiative – a public privatepartnership to promote European diabetes research

MARCAR

PLoS One, 2011, Vol. 6 (3), e18216Lempiäinen, H. et al. Phenobarbital mediates an epigenetic switch at theconstitutive androstane receptor (CAR) target gene Cyp2b10 in the liver of B6C3F1 mice

NEWMEDS

Biological Psychiatry, 2011, Vol. 69 (10), pp. 918–927Santana, N. Activation of Thalamocortical Networks by the N-methyl-D-aspartate Receptor Antagonist Phencyclidine: Reversal by Clozapine



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Frontiers in Psychiatry Schizophrenia, 2011, Vol. 2, Article 14, p.1Kiss, T. et al. Role of thalamic projection in NMDA receptor-induceddisruption of cortical slow oscillation and short-term plasticity

Psychopharmacology, 2011, Vol. 217 (2), pp. 255-269Smith, J. et al. A comparison of the effects of ketamine and phencyclidinewith other antagonists of the NMDA receptor in rodent assays of attentionand working memory

The American Journal of Psychiatry, 2011, Vol. 168, pp. 408-417Ingason A. et al. Maternally Derived Microduplications at 15q11-q13:

Implication of Imprinted Genes in Psychotic Illness

Psychopharmacology , 2010, Vol. 212 (2), pp. 227-242Dix, S. et al. A within-subject cognitive battery in the rat: differentialeffects of NMDA receptor antagonists

Synapse, 2010, Vol. 64 (7), pp. 573-577Finnema S.J. et al. Fenfluramine-Induced Serotonin Release Decreases[11C] AZ10419369 Binding to 5-HT1B-Receptors in the Primate Brain

Nature, 2010, Vol. 468, pp.158-159

Abbott, A. The drug deadlock

OPEN PHACTS

Nature Genetics, 2011, Vol. 43, pp. 281-283Mons, B. et al. The value of data

PROTECT

Pharmacoepidemiology and Drug Safety, 2011 (in press)Belitser, S. V. et al. Measuring balance and model selection in propensity

score methods

European Journal of Epidemiology, 2011, Vol. 26 (8), pp.589-593Groenwold, R. et al. Selection of confounding variables should not bebased on observed associations with exposure

SAFE-T

Drug Discovery Today, 2011, Vol. 16 (Issues 13-14), pp. 600-608Matheis, K. et al. A generic optional strategy to qualify translational safetybiomarkers



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International Clinical Trials (ICT), Vol. Winter 2010, pp. 64-66Keenan, J. Managing Drug Safety

Toxicology Letters, 2009, Vol. 189, Suppl. 1, pp. S157Dieterle, F. et al. The European IMI SAFE-T Consortium: Qualification of translational safety biomarkers

SUMMIT

Diabetologica, (in press)Koivisto, et al. The Innovative Medicines Initiative – a public private

partnership to promote European diabetes research

U-BIOPRED

Thorax, published online 23 NovemberBel, E.H. et al. Diagnosis and definition of severe refractory asthma: aninternational consensus statement from the Innovative Medicine Initiative(IMI)

Chest, Vol. 137 (6), pp. 1410-1416Auffray, C. et al. An integrative systems biology approach to

understanding pulmonary diseases

IMI GENERAL PUBLICATIONS

Nature Biotechnology, 2011, Vol. 29, pp. 689–690Strohmeier, R. et al. IMI moves forward

Nature Reviews Drug Discovery, 2011, Vol. 10, pp. 321-322Goldman, M. Reflections on the Innovative Medicines Initiative

Nature, 2010, Vol. 466, pp. 1040-1041Goldman, M. and De Rijck, K. Opinion: Clarifying knowledge ownership inEurope’s medicines initiative



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A TYPICAL IMI CONSORTIUM

Disclaimer: This brochure does not cover all results generated by IMI projects. Itcontains summarised examples of some key achievements.

PrivateInvestment€

1 billion

EU Public

Funding€1 billion

EFPIA

ACADEMIA

HOSPITALS

PATIENTS’ORGANISATIONS

SMALL ANDMEDIUM-SIZEDENTERPRISES

REGULATORS

achievements october 2011

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