1 Case Study Innovative 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 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 % 23% 4% US Europe ROW

Idea Medicine years Gaining approval Risk assessment analysis Studies in 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 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 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 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 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 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? 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 Approach – Keep focus on the patients Patient National Governments EMEA & national authorities Academia & Hospitals Industry European Commission Health Professionals SMEs

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

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 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