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Update on a recently launched European R&D endeavour: The Innovative Medicines Initiative (IMI)

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 2007.

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Update on a recently launched European R&D endeavour: The Innovative Medicines Initiative (IMI)

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

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

  3. 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.

  4. 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 20th 2007. • 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

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

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

  7. Financing of Research Projects EU FP7 Budget Cash €1 billion In kind €1 billion IMI RESEARCH PROJECTS / CONSORTIA e.g. Imaging e.g. Imaging PharmaceuticalCompanies € Funding Regulators € Funding € Funding Patients Academia € Funding SmallMedium Enterprises

  8. 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.

  9. 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: 30th April ’08 • Calls published on official European IMI websites of EU and EFPIA, but also on the ERS website: • www.imi.europa.eu (EU) • www.imi-europe.org (EFPIA-IMI) • www.ersnet.org • More general info on IMI: • see ERS Newsletter, March 2008 • see ERJ Editorial, May 2008

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

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