1. The Innovative Medicines Initiative (IMI) High level the IMI Concept, Strategic Research Agenda and Call topics Eva Lindgren

2. IMI History “Make Europe, by 2010, the most competitive and the most dynamic knowledge-based economy in the world“ European Research Area: « internal market » for research 2000: Lisbon strategy 2004: European Technology Platforms Informal networks led by industry Strategic research agendas 2007-2013: Framework Programme 7 Joint Technology Initiatives 2008-2017: IMI Joint Undertaking Roof for all EU-funded research projects Joint Technology Initiatives: new instrument of FP7 for integrated projects (Public-Private Partnership as legal entities) Public-Private Partnership founded by the European Federation of Pharmaceutical Industries (EFPIA) and Associations and the European Commission

3. What is the Innovative Medicines Initiative? 2 Billion EURO 1 Billion Euro Public Private Partnership

4. Aim Removing major bottlenecks in drug development, where research is the key Long term goal Re-invigorate the European bio-pharmaceutical sector and foster Europe as the most attractive place for pharmaceutical R&D; thereby, long term, enhancing access to innovative medicines. …for the benefit of patients, scientists and European citizens Why the Innovative Medicines Initiative?

5. The drivers for a new R&D model of public-private partnership Wealth of novel opportunities from new science and technology – How to pick the right molecules and bring them to the right patients Cost and timelines of drug development – Need a change the paradigm of drug discovery to decrease attrition and improve effectiveness The potential of increased cooperation with stakeholders – Greater public understanding, increased patient involvement and greater dialogue with regulators The need for increased openness – transparency of operation eg publication of CT data, sharing toxicology data,

6. What shall the Innovative Medicines Initiative do? Support ‘pre-competitive pharmaceutical research and development to accelerate the development of safer and more effective medicines for patients Foster collaboration between all stakeholders, e.g. industry, public authorities (including regulators), Patient organisations, academia, SMEs and clinical centres No new medicines will be developed. Focus on delivery of new approaches, methods and technologies, improve knowledge management of research results & data, support training of professionals

7. IMI supports research following open and competivite Calls for project proposals The Calls should be tailor-made to serve the objectives of IMI Topics included in the first Call are derived from the IMI Research Agenda four pillars, ie safety, efficacy, knowledge management, education & training Areas in the IMI Research Agenda not addressed in the 2008 Call will be addressed in consecutive Calls. Call projects will be funded by combining financial contribution from EU and ‘in kind’ contribution from the participating EFPIA companies. IMI launched its first Call for proposals April 30, 2008

8. Executive Director (+ staff) How will IMI be managed? IMI JTI = IMI JU + External Advisory Groups Stakeholder Forum IMI States Representatives Group IMI Joint Undertaking (IMI JU) Scientific Committee Governing Board (5 EFPIA + 5 EC)

9. The Innovative Medicines Initiative (IMI) The Strategic Research Agenda Creating Biomedical R&D Leadership for Europe to Benefit Patients and Society

10. Creation of the SRA – a living document 2004 - EC consultation with stakeholders 2005 – Series of thematic workshops to define content April 2005 Stakeholder meeting 2006 published on the IMI web site Regular updates by Scientific committee Interactions with other Technology Platforms

13. Cancer Brain Disorders Metabolic Diseases Predictive pharmacology Predictive toxicology Identification and validation of biomarkers Patient recruitment Regulatory Risk assessment IMI Research agenda: Efficacy and Safety are often disease specific Inflammatory Diseases Infectious Diseases

15. Annual IMI Scientific Priorities will govern the Call topics IMI Scientific Priorities – annual scientific priorities –derived from the IMI Research Agenda –based on EFPIA companies research priorities (estimated in kind contributions) –consulted with Scientific Committee and IMI States Representatives Group –presented in the IMI Annual Implementation plan –serve as the basis for the topics to be included in calls for proposals

16. How call topics are written EFPIA Member Companies European Commission EFPIA Working Party In Kind Individual contributions Project Description, Deliverables and Duration of the project To match industry contribution in cash Review of projects

17. IMI First Call: 18 Call Topics 5 on safety prediction 1 on pharmacovigilance 2 on diabetes 3 on brain disorders 2 on pulmonary diseases 5 on Education & Training

18. Strong industry commitment Strong Industry Commitment €172.5m # 2008 Call Topics CompaniesIn-kind (m) 1 Improve Predictivity of Immunogenicity 12€13 2 Non-genotoxic Carcinogenesis 8€12,5 3 Expert Systems for in silico Toxicity Prediction 10€5 4 Improved Predictivity of non-clinical Safety Evaluation 11€10 5 Qualification of Translational Safety Biomarkers 12€21 6 Strengthening the Monitoring of Benefit/Risk 15€15 7 Islet Cell Research 11€10 8 Surrogate Markers for Vascular Endpoints 7€20 9 Pain Research 12€7,5 10 New Tools for the Development of Novel Therapies in Psychiatric Disorders 13€10 11 Neurodegenerative Disorders 14€7,5 12 Understanding Severe Asthma 10€12,5 13 COPD Patient Reported Outcomes 9€10 14 European Medicines Research Training Network 24€5 15 Safety Sciences for Medicines Training Programme 24€3 16 Pharmaceutical Medicine Training Programme 24€4 17 Integrated Medicines Development Programme 24€3 18 Pharmacovigilance Training Programme 24€3,5

19. The Innovative Medicines Initiative (IMI) First Call for Proposals published: http://imi.europa.eu Deadline for Expressions of Interest: 15 July 2008 (17.00 hours) http://imi.europa.eu