Case Study Innovative Medicines Initiative (IMI)

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

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

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

6. 4% 23% US Europe ROW 73% 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

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

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. IMI History • First discussion with the EC at the RDG meeting of June 2004 • First stakeholder meeting organised by the EC October 2004 • FP6 Integrated project submitted to the EC by EFPIA November 2004 • Vision paper published December 2004 • Nine stakeholder workshops Jan.to May 2005 • Review and support by the EFPIA Board April 2005 • First Member States group meeting May 2005 • Strategic Research Agenda published July 2005 • Second Member States group meeting September 2005 • FP6 IP negotiations finalised and project start October 2005 • FP6 IP contract signed by EFPIA and EC December 2005

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

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

13. 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 Different drivers – commongoal Foster biomedical Innovation

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

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

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

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

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

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

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