1. The Innovative Medicines Initiative A winning case for Joint Technology Initiative Status

2. In our discussion today … 1.Why Europe needs the Innovative Medicines Initiative 2.About the Innovation Medicines Initiative 3.What we need from you

3. Creating new medicines is a high risk journey 15 10 5 Idea Medicine years Gaining approval Risk assessment analysis Studies in 100-300 patients (Phase II) Studies in healthy volunteers (Phase I) Extensive safety studies Early safety studies Candidate Formulations developed Screening Synthesis of compounds

4. It’s time to re-establish our science base – before it’s too late Over the last decade, Europe’s share of the world’s pharmaceutical research and development has steadily decreased Billion euros

5. Europe is losing it’s scientists  The ‘brain drain’ of researchers away from Europe is increasing  7 out of 10 European-born US doctorate recipients who graduated between 1991 and 2000 had no plans to return to Europe Source: According to the European Commission 2003 ‘Brain Drain Study’

6. Health matters to EU citizens too Source : Consensus Research (2004 ) % in top 3 responses Relative importance of national issues to Europeans

7. It’s an opportunity to regain EU competitiveness  EU and Member States  Gain competitive advantage for EU, if we act fast  Significant economic value through small and large enterprises  More effective healthcare  Retain scientific talent and expand science base  Public and private biomedical community  Faster drug development process  A framework for academia to work in priority areas and establish collaborations  Vibrant and dynamic scientific environment

8. And most importantly …  Patients / society  Faster access to innovative therapies such as personalised medicines  More knowledge-based jobs in the EU  More education and training available in the biomedical arena

9. 15-24 years 55-64 years Absolute size in millions for young and old age groups for EU 25, 1995-2030 Millions 40 45 50 55 60 65 70 19952000200520102015202020252030 The population in the EU is ageing rapidly

10. Italy France United Kingdom Germany Spain 0 5 10 15 20 Average expenditure per head expressed as a share of GDP per capita (% ) 0-45-9 10- 14 15- 19 20- 24 25- 29 30- 34 35- 39 40- 44 45- 49 50- 54 55- 59 60- 64 65- 69 70- 74 75- 79 80- 84 85- 89 90- 94 95+ Age groups Source: Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations” The elderly consume more healthcare resources

11. New medicines bring value to patients, health care systems and society  Mortality rates in Europe have declined by almost 40% over the last 30 years, thanks in part, to new medicines (EU Health Report)  Spending on prescription medicines translates into overall cost savings for healthcare systems and society. When medicines are used to treat an illness, more expensive care – such as surgery and hospital stays – and lost school or work days can often be avoided or decreased

12. It’s about people living longer, healthier and more productive lives

13. In our discussion today … 1.Why Europe needs the Innovative Medicines Initiative 2.About the Innovation Medicines Initiative 3.What we need from you

14. ‘omics IT Imaging Better understanding of disease/drug mechanisms Better medicines, faster Health benefits for EU citizens More efficient drug discovery and development Science and technology advances present significant opportunities Collaborative Research

15. It aims to improve the way new medicines are discovered for the benefit of patients Key R&D bottlenecks to overcome: 1. Safety: Making medicines safer 2. Efficacy: Making Medicines more effective - O ften disease specific, initial focus on 5 disease areas with high scientific challenges: Cancer; Brain disorders; Inflammatory diseases, Diabetes and Infectious diseases 3. Knowledge Management: Using new technologies to manage and organise data to create knowledge so scientists can predict benefit and risk of new therapies 4. Education and Training: Addressing expertise gaps in Europe

16. Our approach has already proven to work  16 Companies – 14 Universities – 7 SMEs from across EU  18 mio euros including European Commission funding  Biomarkers in Alzheimer’s Disease:  Better and earlier diagnosis of onset of disease  Predictive Toxicology:  New approaches to measure earlier potential medicine side effects Pilot project – FP6 – successfully completed

17. Recognised and supported by a wide community Patients Member State policy makers Regulators Academia Research based pharmaceutical Industry EU Policy Makers Physicians / healthcare professionals SMEs UK enthusiastically supports the IMI’s priorities and goals All Patient Associations consulted are very positive Mirror National Initiative are mushrooming in Spain, Nordic countries, Poland, etc France: INSERM and its academic partners are strongly supportive

18. Industry will not be funded by the EC Research performed by industry funded by industry 50% IMI to be funded equally by pharma industry and European Commission 100% Research performed by public organisations funded by EC 100%

19. IMI - A compelling case for JTI Status  Innovation and development of science base is crucial to Europe  Health is high on the political agenda with our ageing population  Pharmaceutical innovation brings benefits to people’s health and wealth to society  Focused on creating the environment which will enable important new medicines get to patients faster  IMI has a clear focus on outcomes, an agreed and proven collaborative approach, and is ready to start implementation  Commitment of industry to contribute 100% of own costs

20. In our discussion today … 1.Why Europe needs the Innovative Medicines Initiative 2.About the Innovation Medicines Initiative 3.What we need from you

21. How you can help to create a healthier and more competitive EU  We would like to count on your help in… Spreading the voice about IMI Keeping an eye on 7 th FP calls Creating a strong collaboration between public and private entities Creating biomedical R&D leadership for Europe to benefit patients and society

22. The ultimate beneficiaries... People living longer, healthier and more prosperous lives in the EU

23. For further information…  http://europa.eu.int/comm/research/imi.html http://europa.eu.int/comm/research/imi.html  defraja@altaweb.eu defraja@altaweb.eu