Update on a recently launched European R&D endeavour: The Innovative Medicines Initiative (IMI) FERS meeting Brussels, 7 th April 2008

Background to IMI IMI is a totally new and unique pan-European R&D initiative officially adopted on 20 th December ERS supported IMI in a joint statement co-signed by 9 other medical specialities in October 2007 First IMI calls to be published on 30 th April 2008 including two respiratory calls ERS: Facilitator role to inform and publicise the “respiratory” calls of IMI.

IMI in a nutshell IMI is a public-private partnership between the European Commission and the European Pharmaceutical industry to promote biomedical innovation in Europe and to address the bottlenecks in the R&D process.

Facts about IMI IMI represents a major new European R&D investment under the EU Seventh R&D Framework Programme (FP7). The IMI Joint Undertaking has been set up by the Council Regulation (EC) No 73/2008 of December 20 th The founding members of the IMI Joint Undertaking are the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission (EC) The IMI Joint Undertaking will be established in Brussels The partnership is a €2 billion public-private partnership for biomedical research in Europe

IMI focuses on five disease areas Cancer Brain Disorders Metabolic Diseases Inflammatory Diseases Infectious Diseases Predictive pharmacology Predictive toxicology Identification and validation of biomarkers Patient recruitment Benefit / Risk assessment Includes asthma, COPD, rhinitis

Pre-competitive bottlenecks in the R&D process Discovery research Preclinical develop. Translational medicine Clinical develop. Pharmaco- vigilance Predictive pharmacology Predictive toxicology EfficacySafety Discovery research Preclinical develop. Translational medicine Clinical develop. Pharmaco- vigilance Discovery research Preclinical develop. Translational Clinical Develop. Pharmaco vigilance - Predictive pharmacology Predictive pharmacology Predictive toxicology Predictive toxicology EfficacySafety Identification of biomarkers Identification of biomarkers Validation of biomarkers Validation of biomarkers Benefit/Risk assessment with regulatory authorities Benefit/Risk assessment with regulatory authorities Patient recruitment Patient recruitment Knowledge ManagementEducation & Training

Financing of Research Projects Cash €1 billion e.g. Imaging Regulators € Funding Patients Small Medium Enterprises Academi a Pharmaceutica l Companies IMI RESEARCH PROJECTS / CONSORTIA € Funding EU FP7 Budget In kind €1 billion € Funding

IMI “Respiratory” 2008 calls One call to build an EU severe asthma consortium focused on disease understanding –To harness efforts of already established groups presently working independently. –Ultimately the severe asthma cohorts will enable scientific research, leading to validation of novel biomarkers and clinical measures/ outcomes and will serve as a vehicle to develop relevant translational models One call to on COPD patient-reported outcome (PRO) to be used in clinical trials to evaluate treatments –This call would require development of a framework to understand the patients’ experience of COPD, to inform strategies to measure outcomes meaningful to patients and to develop/ select and validate PRO measurement tools, to use in clinical trials evaluating treatments for the disease.

Role of ERS and FERS members National respiratory societies can help disseminate and publicise information about IMI 2008 calls Publication date of first IMI calls to be published on: 30 th April ’08 Calls published on official European IMI websites of EU and EFPIA, but also on the ERS website: – (EU) – (EFPIA-IMI) – More general info on IMI: –see ERS Newsletter, March 2008 –see ERJ Editorial, May 2008

Next steps: IMI “respiratory” calls Monitor the ERS website for a general summary of the ERS and EFPIA hosted “IMI Summit” held in Leuven, 9-11 th January ’08: –Informing about IMI initiative, and the R&D bottlenecks in drug development. –Brainstorming in asthma & COPD, for 2009 IMI calls