1. The Innovative Medicines Initiative (IMI) High-Level Meeting with Member States on Public-Private Partnerships in Research Brussels, November 11, 2005 Karima Boubekeur, F. Hoffmann-La Roche Ltd

2. 2 Pharmaceutical R&D expenditure in Europe, USA and Japan (at 2003 constant exchange rates) Declining investment in R&D in Europe European Commission is exploring ways to achieve the Lisbon goals EFPIA sets the Priority of Strengthening the EU Science base Innovative Medicines Initiative Billion euros 2004 figures are estimated Source: EFPIA, PhRMA, JPMA 27.1 21.5 n.a.

3. 3 Sector R&D investment as % of all sectors EU top 500 companies – 101 bio euros 2003 Note: Sector of economic activities according to the Financial Times Stock Exchange (FTSE) index classification Data relate to the top 500 companies with registered offices in the EU ranked by the size of their R&D investments (over 8.5 million) Source: The 2004 EU industrial R&D investment scoreboard, European Commission

4. 4 The European Technology Platform: - a common European Vision - a common Strategic Research Agenda The Vision Creating biomedical R&D leadership for Europe to benefit patients and society

5. 5 Next steps 2007 Joint Technology Initiative FP6 Integrated Project Nov 2004 Strategic Research Agenda July 2005 Gover- nance Intelect. Property Intelect. Property Pharma c vigilance Pharma c vigilance 2005 Technology Platform

6. 6 The FP6 Integrated Project 16 Companies – 12 Universities – 7 SMEs Biomarkers in Alzheimers Disease: –3 Companies: AstraZeneca, GSK, Lilly –9 Universities: Kings College London, University of Kuopio, Perugia, Stockholm, Toulouse, Karolinska, Southampton, Roskilde University, University College London, –6 SMEs: BioWisdom, Capsant, Cerebricon, Pharmidex, Proteome Sciences, Hunter Fleming –1 Association: Greek AD Association Predictive Toxicology: –13 Companies: Altana, Bayer, Boehringer-Ingelheim, Johnson & Johnson, Merck AG, Novartis, Novo-Nordisk, Organon, Roche, Sanofi-Aventis, Schering, Serono, Servier –3 Universities: University of Wuerzburg, Dublin, and Istanbul –1 SME: Genedata

7. 7 9% 34% 23% 16% 6% 3% 9% European Commission Academia Pharma SME Regulatory Patient Others The Strategic Research Agenda Contribution from over 350 stakeholders

8. 8 The Strategic Research Agenda Initial feedback from more stakeholders EMEA-CHMP: The document is ambitious and most of the points well taken France: INSERM and its academic partners.. are strongly supportive of this initiative Ireland: The initiative is worthwhile and sound The Netherlands: in general we welcome this initiative Norway; An ambitious research agenda which addresses important topics with well coordinated plans Sweden has a strong potential to contribute to the realisation of PPP, as the initiative suggests

9. 9 Why a JTI? Unprecedented collaborative effort Involving all stakeholders Covering the entire value chain Consensus about the scientific recommendations Industry SMEs Regulators Academia Physicians Discovery research Preclinical develop Translational medicine Clinical development. Pharmaco vigilance EU policy makers MS Policy makers Patients

10. 10 Why a JTI? Strong Industry Commitment

11. 11 Why a JTI? Innovative funding structure StakeholderContributionHow ECFunding of the secretariat Funding of research Contract between EC and secretariat and EFPIA and secretariat (50% each) EFPIAFunding of the secretariatContract between EC and secretariat and EFPIA and secretariat (50% each) Pharmaceutica l companies Research Data Infrastructure Expertise Funding via companies AcademiaResearch Data Infrastructure Expertise Funding via IMI SMEResearch Data Expertise Funding via IMI and possibly loans from European Investment Bank

12. 12 Why a JTI? Implementation requires a different approach Critical Success Factors Traditional Framework Instruments New Joint Technology Initiative Strategic co-ordination across projects X Integration of KM and E&T X Strong industry involvement X Streamlined focussed and efficient administration X

13. 13 The ETP on Innovative Medicines meets the JTI criteria proposed by the Commission (1) Added value of European-level intervention –Requires co-ordination and application of EU-wide expertise (critical mass and synergies) and translation into regulatory process The degree of clarity of definition of the objective to be pursued –To apply advances in science and technology to the process of drug discovery and development as described in the Strategic Research Agenda

14. 14 The ETP on Innovative Medicines meets the JTI criteria proposed by the Commission (2) Strength of the financial and resource commitment from industry –Industry will jointly fund the JTI secretariat and 100% of industry involvement Importance of the contribution to broader policy objectives –Important contribution to health and the Lisbon agenda Capacity to attract additional national support and leverage current or future industrial funding Inability of existing instruments to achieve the objective

15. 15 A Win: Win situation for all stakeholders Especially EU citizens EU Competitiveness Knowledge- based economy 3% of GDP invested in R&D Regain attractiveness for new technologies Stop brain drain Biopharmaceutical R&D Better understanding of disease mechanisms Address R&D bottlenecks Get better medicines to patients faster Win : Win A collaborative science-based culture Attracting new investment in R&D Better medicines get to patients faster Enlarged pool of talented scientists

16. 16 What we want – A positive outcome for all stakeholders Vibrant and dynamic scientific environment More effective healthcare Creation of significant economic value through small and large enterprises in Europe Patient Member States Regulators Academia Industry E C And others…