1. 1 Case Study Innovative Medicines Initiative (IMI) Karen Strandgaard EFPIA EuroConference, Brussels April 26th, 2006

2. 2 The European Federation of Pharmaceutical Industries and Associations (EFPIA)  EFPIA represents the research-based pharmaceutical industry operating in Europe: – 45 leading pharmaceutical companies, – 29 national pharmaceutical industry associations  It also has two specialised groups; – Emerging Biopharmaceutical Enterprises (EBE), an association representing the needs and interests of biopharmaceutical companies – European Vaccine Manufacturers (EVM), an association representing the needs and interests of vaccine manufacturers

3. 3 The EFPIA Research Directors Group  Works to strengthen the EU Science base by: – Promoting the importance of research for the biopharmaceutical industry and participating in the increasing debate on Europe’s competitiveness in biopharmaceutical research. – Developing and implementing industry policy to encourage and support of biomedical and biopharmaceutical Research and Development activities in Europe to the benefit of patients and society – Working towards goals in partnership with biomedical stakeholders such as patients, regulators, academia, etc Objectives relevant to the ETP concept

4. 4 Agenda  Background on The Innovative Medicines Initiative  Challenges  Key success factors  Lessons learned

5. 5 Agenda  Background on The Innovative Medicines Initiative  Challenges  Key success factors  Lessons learned

6. 6 Europe losing the ‘R&D Race’: Global biopharmaceutical R&D investment Note: Global R&D expenses of € 16,475 million (USA: 11,993; Europe: 3,742; Canada: 548; Asia/Pacific: 192) Source: Ernst & Young, 11th Annual European Biotechnology Report 2004 73% 23% 4% US Europe ROW

7. 7 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 Creating new medicines is a high risk journey

8. 8 The Innovative Medicines Initiative….  ….. Will – Improve the way new medicines are created – Establish Public-Private-Partnerships  …..Will Not – Deliver new medicines per se Enabling the discovery of new medicines for the benefit of patients

9. 9 IMI History  First discussion with the EC at the RDG meeting ofJune 2004  First stakeholder meeting organised by the ECOctober 2004  FP6 Integrated project submitted to the EC by EFPIANovember 2004  Vision paper published December 2004  Nine stakeholder workshopsJan.to May 2005  Review and support by the EFPIA BoardApril 2005  First Member States group meetingMay 2005  Strategic Research Agenda publishedJuly 2005  Second Member States group meetingSeptember 2005  FP6 IP negotiations finalised and project startOctober 2005  FP6 IP contract signed by EFPIA and ECDecember 2005

10. 10 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 to 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

11. 11 Agenda  Background on The Innovative Medicines Initiative  Challenges  Key success factors  Lessons learned

12. 12 Main challenges  Novelty of the JTI instrument – no established way of working  Number of stakeholders and communication between all these stakeholders

13. 13 Different drivers – common goal  Political orientation  Focus on process  Focus on consultation  Focus on Member States interest  Business orientation  Focus on productivity  Focus on science  Focus on patients’ interest Foster biomedical Innovation

14. 14 The usual instruments are inadequate  Low industry participation  Bureaucratic and lengthy process  Lack of transparency  Focus on social agenda, i.e. balance between genders, countries, etc. distracts from the science  Not conducive to real partnerships JTI's can address these inadequacies

15. 15 What is the Environment of the IMI? RDG EFPIA Board EFPIA Committees PhRMA S&R Committees Member States UK Italy Spain France Poland Sweden Germany Etc. Research Enterprise Information Society SanCo European Commission AZ GSK Bayer Roche Servier Novartis Schering Novo-Nordisk Sanofi-Aventis etc Biopharmaceutical industry EMEA & national authorities Academia & Hospitals Health Professionals Patients’ organisations Biotechs: EuropaBio, EBE

16. 16 Approach – Keep focus on the patients Patient National Governments EMEA & national authorities Academia & Hospitals Industry European Commission Health Professionals SMEs

17. 17 Agenda  Background on The Innovative Medicines Initiative  Challenges  Key success factors  Lessons learned

18. 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. 19 Key success factors  Constant/regular communication between EC and EFPIA at all levels: – Decision level – Implementation level Building understanding and trust

20. 20 Key success factors (contd.)  Alignment of the EFPIA companies around the strategic research agenda and the core values of the IMI: – Focus on science – Focus on patients – Lean and agile Building a strong value proposition for the community

21. 21 Agenda  Background on The Innovative Medicines Initiative  Challenges  Key success factors  Lessons learned

22. 22 Lessons Learned  Building trust through exchange of information and views  Focus on science drives consensus on objectives  The Association as «one-stop-shop» for industry involvement  Results driven  Top executive buy-in

23. 23 The ultimate beneficiaries... People living longer, healthier and more prosperous lives in the EU