1. Successful applications from EU12 countries & Tips for success IMI Open Info Day, Bucharest 10 December 2012 Magali Poinot, Legal Manager Angela Wittelsberger, Scientific Project Manager

2. Participants from EU12 countries in IMI projects IMI Open Info Day, Bucharest 10 December 2012 Project Acronym Research fieldCoordinator/ Managing Entity Legal NameCityCountry PROTECT Pharmacoepidemiological Research EMA/DKMA-Danish Medicines Agency Poznan University of Medical Sciences PoznanPoland U-BIOPRED Biomarkers for the Prediction of Respiratory Disease Outcomes Novartis/Amsterdam Medical Center Uniwersytet JagiellonskiKrakowPoland Semmelweis UniversityBudapestHungary Pharmatrain Pharmaceutical Medicine Training Programme European Federation of Courses/University Basel Semmelweis UniversityBudapestHungary Faculty of Medicine University of Belgrade BelgradeSerbia EMTRAIN European Medicines Research Training Network AstraZeneca/Medical University Vienna Ministry of Human Resources, Medical Research Council BudapestHungary BTCURE BeTheCureUCB/Karolinska Institute Revmatologicky ustavPrahaCzech Republic PREDECT New Models for Preclinical Evaluation of Drug Efficacy in Common Solid Tumours Servier/University of Helsinki University of TartuTARTUEstonia EHR4CR Electronic Health Record systems for Clinical Research AstraZeneca/EuroRecMedical University of WarsawWarsawPoland ABIRISK Immugenicity of biopharmaceuticals GSK/InsermUniverzita Karlova v PrazePrague 1Czech Republic MIP-DILI Prediction of Drug-Induced Liver Injury AstraZeneca/University of Liverpool SOLVO BIOTECHNOLOGY ZRTSZEGEDHungary Compact Macromolecular Pharmaceuticals Sanofi/University of Utrecht PHARMACOIDEA Development and Service Ltd. SzegedHungary EMIF European Medical Information Framework J&J/Erasmus University MC Rotterdam Tartu UlikoolTartuEstonia

3. Unbiased Biomarkers in the Prediction of Respiratory Disease Outcome The Objective Developing biomarker profiles from molecular, physiological, and clinical data integrated by into handprints for the prediction of clinical course, therapeutic efficacy and identification of novel targets in the treatment of severe asthma Progress Developed an international consensus on diagnostic criteria Creating novel phenotype ‘handprints’ by combining molecular, histological, clinical and patient-reported data – validation and refining is on-going Two novel animal models have been identified (FCA/HDM, CT & MRI imaging of chronic HDM model) Preparation and recruitment for cohort clinical study have started, 14 centres across Europe targeting 1025 subjects, to validate the handprints for their predictive efficacy in gold standard and experimental therapeutic intervention

4. Example: U-BIOPRED IMI Open Info Day, Bucharest 10 December 2012 University of Amsterdam University of Southampton Imperial College London University of Manchester University of Nottingham Fraunhofer institute Hannover Centr Nat Recherche Sc Villejuif Paris Université de Méditerranee Montpellier Karolinska Institute Stockholm University Umea UniversityTor Vergata Rome Università Cattolica del Sacro Cuore Rome University of Catania Hvidore Hospital Copenhagen University Hospital Copenhagen Haukeland University Bergen Semmelweis University Budapest Jagiellonan University Krakow University Hospital Bern University of Ghent Novartis GlaxoSmithKline AstraZeneca Chiesi Pfizer Roche UCB Boehringer Ingelheim Almirall Johnson & Johnson / Janssen Biosci Aerocrine Synairgen Philips Research Netherlands Asthma Foundation Asthma UK European Lung Foundation EFA Int Primary Care Respir Group Lega Italiano Anti Fumo

5. U-BIOPRED: participants from EU12 country IMI Open Info Day, Bucharest 10 December 2012 1. Department of Medicine, University Medical Colloge, Krakow, Poland: -Role in project: patient cohort building, data analysis -Had multi-center international trial experience -Had existing collaborations with several partners of the consortium 2. Department of Pulmonology, Semmelweis University, Budapest, Hungary: -Role in project: patient cohort building, data analysis, pre-clinical laboratory model studies -Had experience from multiple multi-center international trials -Had existing collaborations with two partners of the consortium

6. Example: BTCure (Be the Cure) IMI Open Info Day, Bucharest 10 December 2012 Facts & Figures Start Date 01/04/2011 Duration 60 months Contributions € IMI funding 16 137 872 EFPIA in-kind 14 172 302 Other 7 807 923 Total Cost 38 118 097 The Objective to further broaden our knowledge of disease causing factors and disease progression in Rheumatoid Arthritis (RA), thereby identifying improved or targeted therapeutic treatments development of new diagnostic methods to discover the early forms of RA as well as tools to separate the different forms of RA Strategy to achieve this goal by using a transnational, collaborative approach and by driving this ambitious project forward in a joint effort

7. Example: BTCure 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 A. Fleming Biomedical Sciences Research Center, Greece AMC/University of Amsterdam, Netherlands Charité-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 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 Zürich, Switzerland SMEs TcLand Expression, France

8. BTCure: participant from EU12 country IMI Open Info Day, Bucharest 10 December 2012 Institute of Rheumatology, Prague, Czech Republic: -Role in project: development of tools to search, access and share clinical data, development of some other procedures -Previous experience with FP6 project (WP leader) -Participation in other world-wide, EU-wide, and nation-wide studies

9. Tips for success 1.Writing a successful proposal IMI Open Info Day, Bucharest 10 December 2012

10. Evaluation process IMI Open Info Day, Bucharest 10 December 2012 Expressions of Interest (EoIs) are reviewed and ranked by a panel of at least 5 independent experts Experts identified by IMI Executive Office Experts in the area Have no conflicts of interest

11. Evaluation criteria IMI Open Info Day, Bucharest 10 December 2012 Scientific and/or technological excellence Excellence of Partnership Work-plan outline Ethical Issues

12. Scientific and/or technological excellence IMI Open Info Day, Bucharest 10 December 2012 Quality and soundness of the scientific and/or technological approach Likelihood of the research proposal to meet all the key objectives in order to complement the EFPIA Consortium. Innovation (i.e. novelty in discovery, practical applicability, adaptation, etc.), progress beyond the state-of-the-art. Degree of scientific and/or technological impact likely to be delivered? Has the Applicant Consortium adequately explained the balance between potential impact and residual risks based on the proposed approach i.e. are potential complications, alternative strategies, and benchmarks for success presented?

13. Excellence of Partnership IMI Open Info Day, Bucharest 10 December 2012 Scientific quality and technological expertise of the individual participants in the Applicant Consortium. Ability to provide the contributions expected from the Applicant Consortium. Unique features, strengths, internal complementarities and balance of the Applicant Consortium (including appropriate allocation of roles, manageability of consortium and input of each participant).

14. Work-plan outline / Ethics IMI Open Info Day, Bucharest 10 December 2012 Conceptual quality and soundness of the work-plan outline, including approximate budget, timelines for deliverables Does this proposal contain ethical issues that may need further attention if selected for Evaluation Stage 2?

15. Common mistakes IMI Open Info Day, Bucharest 10 December 2012 Submission deadline missed At the time of submission: parts of the EoI not uploaded (this should not be a problem anymore with SOFIA) Applicants are not eligible for funding (enterprises that request but are not eligible for funding can still be partners) Legal status of applicants is not clear Consortium eligibility criteria not met (e.g., a single legal entity is not a consortium) Applicant consortia do not have the capabilities to address all of the objectives (e.g., redundancy between partners)

16. Common mistakes IMI Open Info Day, Bucharest 10 December 2012 Submitted text does not respect the EoI template (sometimes received even slides!) Submitted text so concise that it does not clearly state what is proposed in practice The EoI does not address all the objectives (addressing almost all the objectives is not sufficient!) EoI out of scope (if you have doubts on how to respond to the call contact IMI) Ethical issues not addressed

17. Make sure to: IMI Open Info Day, Bucharest 10 December 2012 Read all the Call-relevant material that is provided on the IMI website www.imi.europa.eu www.imi.europa.eu Understand IMI’s Rules and respect them If in doubt ask a member of the IMI Executive Office Your EoI should provide reviewers with all the information requested to allow them to evaluate it Finalise your submission If invited to a hearing answer the questions as precisely and concisely as possible

18. Tips for success 2.How to be onboard of the winning consortium IMI Open Info Day, Bucharest 10 December 2012

19. How to find project partners 1.IMI Partner Search Tool: www.imi.europa.eu/content/partner-search 2.IMI States Representatives Group (SRG) member: www.imi.europa.eu/content/states-representatives-groups 3.Health National Contact Point (NCP): cordis.europa.eu/fp7/health/ncp_en.html 4.Keep up-to-date: Visit www.imi.europa.eu Sign up to the IMI Newsletter Follow us on IMI Twitter: @IMI_JU Join the IMI group on LinkedIn Questions? E-mail us: infodesk@imi.europa.eu IMI Open Info Day, Bucharest 10 December 2012

20. How to find project partners 1.IMI Partner Search Tool: www.imi.europa.eu/content/partner-search 2.IMI States Representatives Group (SRG) member: www.imi.europa.eu/content/states-representatives-groups 3.Health National Contact Point (NCP): cordis.europa.eu/fp7/health/ncp_en.html 4.Keep up-to-date: Visit www.imi.europa.eu Sign up to the IMI Newsletter Follow us on IMI Twitter: @IMI_JU Join the IMI group on LinkedIn Questions? E-mail us: infodesk@imi.europa.eu IMI Open Info Day, Bucharest 10 December 2012 How to be onboard of the winning consortium:

21. How to find project partners 1.IMI Partner Search Tool: www.imi.europa.eu/content/partner-search 2.IMI States Representatives Group (SRG) member: www.imi.europa.eu/content/states-representatives-groups 3.Health National Contact Point (NCP): cordis.europa.eu/fp7/health/ncp_en.html 4.Keep up-to-date: Visit www.imi.europa.eu Sign up to the IMI Newsletter Follow us on IMI Twitter: @IMI_JU Join the IMI group on LinkedIn Questions? E-mail us: infodesk@imi.europa.eu IMI Open Info Day, Bucharest 10 December 2012 1.Clearly identify and communicate what you want and can contribute to the objectives of the Call 2.Get in touch pro-actively with the key players in the field How to be onboard of the winning consortium:

22. THANK YOU ! www.imi.europa.eu IMI Open Info Day, Bucharest 10 December 2012