Evolution from IMI1 to IMI2: challenges ahead

1. Evolution from IMI1 to IMI2: challenges ahead Elmar Nimmesgern, PhD DG Research & Innovation

2. Public-private partnerships under FP7 • Public-Private Partnerships between EU and industry in sectors of key strategic importance • Innovative Medicines Initiative (IMI1) in health research • Largest PPP in pharmaceutical research in the world set up under FP7 with €1b contribution each from the EU and from the European pharmaceutical industry represented by EFPIA • Successes: has become a model for open innovation, research breakthroughs in diabetes, brain research, antimicrobial resistance

3. Key figures IMI calls 1-10 IMI contribution: 790 mil EFPIA contribution: 771 mil Academia, Research Organisations 622 Patient organisations 26 5000 researchers 42 on-going projects SMEs 142 Others, including regulators 84 plus 10 projects for calls 8, 9 and 10 Call 10, 1st stage deadline 28 January 2014, 17:00:00 Brussels time Call 11, 1st stage deadline 8 April 2014, 17:00:00 Brussels time (CEST)

4. Some IMI achievements Innovation • Faster development of diabetes drugs through the first ever human pancreatic beta-cell line • New models to better predict drug toxicity • New definition of severe asthma which promises to unlock new therapies • The world’s largest database of schizophrenia studies to develop targeted treatments • Better understanding of the mechanisms of chronic pain Research • 440 academic publications - Average citation impact double the world average – on par with Wellcome Trust • 30% rank in the top quartile of journals in their specific research fields

5. Evolution Expanding scope of research addressed • Research agenda initially focussed on overcoming hurdles in early stages of drug development through 4 pillars: efficacy, safety, knowledge management, education & training • Revision of research agenda in 2011 to address drug research and innovation value chain more broadly • Research supported in 7 areas of interest: patients in the focus, diseases and drug efficacy, tools and techniques, development in regulatory framework, strategies in R&D, knowledge management and science communication More flexibility • Initially one call per year – now calls launched when topics are ready • Call for exploitation of new scientific opportunities to quickly valorise outcomes from IMI project

6. In the pipeline: IMI2 • Commission proposal adopted on 10 July as part of the Innovation Investment Package • Mission: create an even more powerful research and innovation machine – with broader objectives and a wider range of activities and partners • Proposed budget from public and private partners: 3.45 Billion Euro; 1.725 Billion Euro EU contribution: • Up to EUR 1 500 million to match EFPIA's contribution • Up to EUR 225 million to match additional contributions from other future Members or Associated Partners • All EU funding goes to SMEs, academia, patient organisations and regulatory agencies

7. Scope and objectives • IMI2 will expand the scope of IMI1 to cover the entire medical research and innovation value chain: • Actively involve life science industries other than pharmaceuticals; for example the vaccine, the animal health or the biomedical imaging industry • Enable top quality research and innovations with great public health benefits and commercial possibilities • Pave the way for the breakthrough vaccines, medicines and treatments which we will need in the near future: • Develop new therapies for diseases with high unmet need, such as Alzheimer's disease, and limited market incentives, such as antimicrobial resistance

8. Way forward for IMI2: legal framework • Final adoption of Horizon 2020 package on 3 December forms the basis for moving forward with IMI2 • Legislative process for the IMI2 Regulation ongoing in the European Parliament and the Council: • Agreement of the Member States on a common position reached under the Lithuanian presidency at recent meeting of the Competitiveness Council on 3 December • Discussion in the European Parliament ongoing at the level of the relevant committee (ITRE), plenary opinion expected in spring 2014

9. Is being developed under the leadership of EFPIA • Based on the WHO Report: Innovative Medicines for Europe and the World • Goal: The right prevention and treatment, to the right patient, at the right time Scientific research agenda for IMI2

10. Westill have the ongoing IMI calls, will lead to fundingprojectsaddressing important public healthneeds • Calendar for legislative process is tight, ahead of the end of May elections of the European Parliament • In addition to the "basic act" (the Council Regulation setting up IMI2), a number of documents will have to be adopted – we can benefit from experience setting up IMI • New organisational structure to be established Challenges moving from IMI to IMI2

11. Practical aspects 20 days Council adoptsRegulation Entry into force JU Criteria for SC candidates Nomination of SC members Consultation on topics Consultation on annualwork plan Establishing GB Establishing SRG Call topics AnnualWork Plan Establishing SC Processestake time SRG proposes candidates • Commission has strong interest in seeing IMI-2 calls launched as early as possible Detailed planning is being worked out; will require many steps to be taken in parallel and/or 'at risk'