Presentation lined up to EARMA annual Conference in Bragança - Portugal

1. The writing and implementation of the Innovative Medicines Initiative projects Part I Elisabetta Vaudano Principal Scientific Manager EARMA Annual Meeting 23 rd June 2011

2. What is IMI ? An European Public-Private Partnership Focused on Needs Common to Pharmaceutical Industry and Patients EARMA Annual Meeting 23 rd June 2011

3. The History of IMI 2000: Lisbon Strategy wants to make Europe most competitive and dynamic knowledge-based economy by 2010 2004: Industry-led European Technology Platforms (ETPs) develop Strategic Research Agendas addressing bottlenecks to competitiveness 2007: 7th Framework Programme for Research establishes the European Research Council and Joint Technology Initiatives 2008: Establishment of the Joint Undertakings to implement the Joint Technology Initiatives 2009: Appointment Executive Director & Autonomy IMI JU EARMA Annual Meeting 23 rd June 2011

4. Governance EARMA Annual Meeting 23 rd June 2011

6. Source: Burrill & Company; US Food and Drug Administration . Why IMI? The Productivity Gap in Pharma R&D 0 10 20 30 40 50 60 0 5 10 15 20 25 30 35 40 45 50 $55 New Drug Approvals Pharma R&D ($ billions) 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07

7. … M&A Impact on R&D Innovation Munos B., Nature Reviews Drug Discovery 8, 959-968 (December 2009) 1+1=1 Big is not Beautiful EARMA Annual Meeting 23 rd June 2011

8. Why IMI? Society and Patients Need Innovative Treatments Alzheimer’s Drugs: Summary of Recommendations The medicines used to slow mental decline in people with Alzheimer's disease are not particularly effective. When compared with a placebo, only 10 to 20 percent more people taking an Alzheimer's drug seem to benefit at all. And it is the rare person who has a significant delay in the worsening of their symptoms over time. However, there is no way as yet to predict who will respond and who will get little or no benefit from one of the five drugs approved to treat Alzheimer's disease. Thus, the decision to try one is a gamble and judgment is based on whether the treatment is worth the cost and the risk of side effects. EARMA Annual Meeting 23 rd June 2011

10. Collaborative Innovation to Deliver Innovative Medicines Page 502

11. Clinical pharmacology & Therapeutics | VOLUME 87 NUMBER 5 | MAY 2010 Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. Precompetitive Research to Boost Innovation in Biomedicine EARMA Annual Meeting 23 rd June 2011

12. IMI Supports Precompetitive Research IMI EARMA Annual Meeting 23 rd June 2011

13. 2 Billion Euro 1 Billion € 1 Billion € Public Private Partnership Innovative Medicines Initiative: the Largest PPP in Life Sciences R&D EARMA Annual Meeting 23 rd June 2011

14. EMA Supports IMI Research EARMA Annual Meeting 23 rd June 2011

15. N ENGL J MED 362: 865-869, March 11, 2010 Patients are Active IMI Stakeholders EARMA Annual Meeting 23 rd June 2011

16. The Four Pillars of the original IMI Strategic Research Agenda EARMA Annual Meeting 23 rd June 2011

17. EARMA Annual Meeting 23 rd June 2011 IMI Projects Overview Call 1 &2

18. EFPIA Member Companies Participating companies (Q2 2011): EARMA Annual Meeting 23 rd June 2011

23. IMI Education and Training Projects EARMA Annual Meeting 23 rd June 2011

24. The IMI Scientific Research Agenda is under Revision EARMA Annual Meeting 23 rd June 2011

25. The Pharmaceutical Industry is under pressure The Product replacement Ratio is the ratio of revenue from new products (that is, those launched in the previous 5 years) to the revenue lost from declining products. A ratio of less than 1 reflects a failure to replace former successful products with new revenue drivers. Harrison C., Nature Reviews Drug Discovery 10, 12-13 (January 2011) EARMA Annual Meeting 23 rd June 2011

27. Pharma Patients Academia Physicians Biotechs Insurers Digital healthcare Governments CROs MedTech Social media Regulators The New Environment of “Big Pharma” EARMA Annual Meeting 23 rd June 2011

29. Step 2: Consortia eligible for EU funding compete through expressions of interest which are ranked by independent experts Step 1: A set of EFPIA companies define a topic on which they commit to collaborate Pharma 1 Pharma 5 Pharma 2 Pharma 3 Pharma 4 Pharma 6 Step 3: The top-ranked EU-fundable consortium join the EFPIA companies to form the final consortium which develops the full proposal, subject to peer-review before final approval Building a IMI Consortium Acad 1 Acad 2 Acad 3 Acad 4 Patients’ Organ 1 Regul 1 Patients’ Organ 2 Other* SME 1 SME 2 Pharma 1 Pharma 5 Pharma 2 Pharma 3 Pharma 4 Pharma 6 Acad 1 Acad 2 Acad 3 Acad 4 Patients’ Organ 1 Regul 1 Patients’ Organ 2 Other* SME 1 SME 2

38. THANK YOU ! www.imi.europa.eu EARMA Annual Meeting 23 rd June 2011