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The Innovative Medicines Initiative Strategic Research Agenda

The Innovative Medicines Initiative Strategic Research Agenda. Member States Contact Group, 18th May 2005 Dr. Karima Boubekeur F. Hoffmann-La Roche Ltd, CH-Basel. Objectives of the Presentation. Understanding the background and the activities to-date

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The Innovative Medicines Initiative Strategic Research Agenda

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  1. The Innovative Medicines InitiativeStrategic Research Agenda Member States Contact Group, 18th May 2005 Dr. Karima Boubekeur F. Hoffmann-La Roche Ltd, CH-Basel

  2. Objectives of the Presentation • Understanding the background and the activities to-date • Understanding of the Strategic Research Agenda

  3. Pharmaceutical R&D expenditure in Europe, USA and Japan (at 2002 exchange rates) • Declining investment in R&D in Europe • European Commission is exploring ways to achieve the Lisbon goals • EFPIA set the Priority of Strengthening the EU Science base • European Technology Platform: “Innovative Medicines for Europe” Billion euros Source: EFPIA’s ’Pharmaceutical Industry in Figures’ 2004 edition

  4. We need:- a common European Vision and - a Strategic Research Agenda The Vision Creating biomedical R&D leadership for Europe to benefit patients and society

  5. Components of the Strategic Research Agenda for Innovative Medicines • Identification of the R&D bottlenecks for new medicines • Analysis of current strengths and weakness in Europe • Recommendations to address bottlenecks • Definition of the necessary research and technical priorities in the medium to long term • Estimation of resources and timelines • Framework agreed upon by all stakeholders to foster productive Public-Private-Partnerships

  6. What are the bottlenecks?Safety and Efficacy are main reason for failure of new medicines

  7. Discoveryresearch Preclinicaldevelop. Translationalmedicine Clinical develop. Pharmaco- vigilance Predictive pharmacology Predictive toxicology Identification of biomarkers Patient recruitment Validation of biomarkers Risk assessmentwith regulatory authorities Efficacy Safety Informal stakeholders consultation showed agreement on bottlenecks in R&D

  8. Efficacy and Safety are often disease specificFocus initially on four disease areas with high scientific challenges Predictive pharmacology Identification of biomarkers Patient recruitment Validation of biomarkers Risk assessment Diabetes Brain Cancer Inflammatory Diseases

  9. Additional critical elements for success in addressing bottlenecks Predictive pharmacology Predictive toxicology Identification of biomarkers Patient recruitment Validation of biomarkers Risk assessmentwith regulatory authorities Knowledge Management Education & Training

  10. Priorities Efficacy Goal: improve clinical performance and early access to innovative medicine: • Biomarkers / Surrogate markers • Tissue banks • Imaging • Develop a better common understanding of the trade-off between risk and reward that comes with innovation How can we identify the important new medicines faster? Stakeholders: clinicians (industry and academia), pharmacologists (industry and academia), regulatory authorities, patients

  11. Main Outcome of the Efficacy Workshop • April 4-5, 2005: • Workshop gained agreement of all stakeholders to work on four disease areas initially and identified the research priorities in all of these as well as cross cutting themes for development of European R&D. • Workshop leader: Dr. Ian Ragan • Inflammation leader: Dr. Damian O’Connell • Cancer leader: Dr. Jim Carmichael • Diabetes leader: Dr. Veikko Koivisto • Brain leader: Dr. Lars Sundstrom

  12. Priorities Safety Goal: improve the predictability of toxicological observations using: • In silico tools • Toxicogenomics • Toxicoproteomics • Metabonomics How can these technologies be used in an integrated approach? How can the in silico and in vitro data be validated by safety data in human? Stakeholders: toxicologists (industry and academia), regulators, patients, doctors, technology specialists.

  13. Main Outcome of the Safety Workshop • March 16-17, 2005: • Creation of a European framework for biomarker development, • Further investigation of the human relevance of rodent carcinogenicity / other intractable toxicities • Establishment of a "virtual" European office of toxicology • May 13, 2005: Second workshop • Workshop leader: Dr. Friedlieb Pfannkuch

  14. Priorities Knowledge Management Goal: manage and organise data to create knowledge to predict benefit and risk of new therapies What information do we need? Which tools do we need to create this information? How do we create coherent information? How do we effectively mine this information?Which tools do we need to analyse information to create knowledge and predict risk/benefit? Stakeholders: patients, doctors, regulatory agencies, funding agencies, toxicologists, pharmacologists, information specialists .

  15. Main Outcome of the Knowledge Management Workshop • Knowledge Management (January 27-28, 2005): • Erase technical and organizational boundaries: provide the infrastructure for collaboration, data sharing, and interoperability of services across the InnoMed community • April 9, 2005: Second workshop • May 19, 2005: Third workshop • Workshop leader: Nicolas Grandjean

  16. Priorities Education & Training Europe should support the interdisciplinary education essential to the bioscience sector and in particular: • Clinical scientists (MD, PhD) • Molecular pathologists • Molecular pharmacologists • Information management experts Stakeholders: medical schools, pharmaceutical schools, biomedical science universities, national governments, industry

  17. Main Outcome of the Education & Training Workshop • February 24-25, 2005: • Bridging educational gaps to align with the requirements of the InnoMed Technology Platform • May 20, 2005: Second workshop • Workshop leader: Dr. Jorgen Dirach

  18. Balanced Stakeholder Participation to the Four Thematic Workshops

  19. Next Steps • Communicate and discuss the Strategic Research Agenda for Innovative Medicines • Detail outcome of first workshops into specific actionable recommendations • Evaluate the costs of these recommendations • Consolidate stakeholders commitment • Deliver the Strategic Research Agenda to the European Commission

  20. Continuum of Activities across Framework Programmes 6 and 7 2002 2005 2007 2013 FP6 FP7 Integrated Project Developing the SRA Updating the SRA Implementing the SRA

  21. Critical Success Factor: Foster a Collaborative Culture and put the patient at the center! National Governments European Commission Industry Regulatory Agencies Patient And others… Academe

  22. Results – A positive outcome for all stakeholders • Vibrant and dynamic scientific environment • More effective healthcare • Creation of significant economic value through small and large enterprises in Europe

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