The Innovative Medicines Initiative (IMI)

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. Pharmaceutical R&D expenditure in Europe, USA and Japan (at 2003 constant exchange rates) 27.1 • 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 21.5 Billion euros n.a. 2004 figures are estimated Source: EFPIA, PhRMA, JPMA

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

6. The FP6 Integrated Project16 Companies – 12 Universities – 7 SMEs • Biomarkers in Alzheimer’s Disease: • 3 Companies: AstraZeneca, GSK, Lilly • 9 Universities: King’s 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. The Strategic Research AgendaContribution from over 350 stakeholders 9% 9% 3% European Commission SME 6% Regulatory Academia Patient Pharma 16% 34% Others 23%

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

10. Why a JTI?Strong Industry Commitment

11. Why a JTI? Innovative funding structure

12. Why a JTI?Implementation requires a different approach

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

16. Member States E C Patient Industry Regulators And others… Academia 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 enterprisesin Europe