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Earma Annual Conference 23 june 2011 - Magali Poinot (part 1)
 

Earma Annual Conference 23 june 2011 - Magali Poinot (part 1)

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Presentation lined up to EARMA annual Conference in Bragança - Portugal

Presentation lined up to EARMA annual Conference in Bragança - Portugal

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    Earma Annual Conference 23 june 2011 - Magali Poinot (part 1) Earma Annual Conference 23 june 2011 - Magali Poinot (part 1) Presentation Transcript

    • The writing and implementation of the Innovative Medicines Initiative projects Part I Elisabetta Vaudano Principal Scientific Manager EARMA Annual Meeting 23 rd June 2011
    • What is IMI ? An European Public-Private Partnership Focused on Needs Common to Pharmaceutical Industry and Patients EARMA Annual Meeting 23 rd June 2011
    • The History of IMI 2000: Lisbon Strategy wants to make Europe most competitive and dynamic knowledge-based economy by 2010 2004: Industry-led European Technology Platforms (ETPs) develop Strategic Research Agendas addressing bottlenecks to competitiveness 2007: 7th Framework Programme for Research establishes the European Research Council and Joint Technology Initiatives 2008: Establishment of the Joint Undertakings to implement the Joint Technology Initiatives 2009: Appointment Executive Director & Autonomy IMI JU EARMA Annual Meeting 23 rd June 2011
    • Governance EARMA Annual Meeting 23 rd June 2011
    • IMI Executive Office as a Neutral Third-Party
      • To implement programmes and activities in the
      • common interest of all stakeholders
      • To monitor the combined use of public funds and
      • industry investment
      • To guarantee fair and reasonable conditions for
      • optimal knowledge exploitation and dissemination
      EARMA Annual Meeting 23 rd June 2011
    • Source: Burrill & Company; US Food and Drug Administration . Why IMI? The Productivity Gap in Pharma R&D 0 10 20 30 40 50 60 0 5 10 15 20 25 30 35 40 45 50 $55 New Drug Approvals Pharma R&D ($ billions) 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07
    • … M&A Impact on R&D Innovation Munos B., Nature Reviews Drug Discovery 8, 959-968 (December 2009) 1+1=1 Big is not Beautiful EARMA Annual Meeting 23 rd June 2011
    • Why IMI? Society and Patients Need Innovative Treatments Alzheimer’s Drugs: Summary of Recommendations The medicines used to slow mental decline in people with Alzheimer's disease are not particularly effective. When compared with a placebo, only 10 to 20 percent more people taking an Alzheimer's drug seem to benefit at all. And it is the rare person who has a significant delay in the worsening of their symptoms over time. However, there is no way as yet to predict who will respond and who will get little or no benefit from one of the five drugs approved to treat Alzheimer's disease. Thus, the decision to try one is a gamble and judgment is based on whether the treatment is worth the cost and the risk of side effects. EARMA Annual Meeting 23 rd June 2011
    • IMI Objectives
      • Making the pharmaceutical R&D process faster and more effective, rather than directly delivering new drugs
      • Accelerating the development of safer and more effective medicines for patients in Europe
      • Improving the environment for pharmaceutical R&D in Europe
      • Boosting the biopharmaceutical sector in Europe
      EARMA Annual Meeting 23 rd June 2011
    • Collaborative Innovation to Deliver Innovative Medicines Page 502
    • Clinical pharmacology & Therapeutics | VOLUME 87 NUMBER 5 | MAY 2010 Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. Precompetitive Research to Boost Innovation in Biomedicine EARMA Annual Meeting 23 rd June 2011
    • IMI Supports Precompetitive Research IMI EARMA Annual Meeting 23 rd June 2011
    • 2 Billion Euro 1 Billion € 1 Billion € Public Private Partnership Innovative Medicines Initiative: the Largest PPP in Life Sciences R&D EARMA Annual Meeting 23 rd June 2011
    • EMA Supports IMI Research EARMA Annual Meeting 23 rd June 2011
    • N ENGL J MED 362: 865-869, March 11, 2010 Patients are Active IMI Stakeholders EARMA Annual Meeting 23 rd June 2011
    • The Four Pillars of the original IMI Strategic Research Agenda EARMA Annual Meeting 23 rd June 2011
    • EARMA Annual Meeting 23 rd June 2011 IMI Projects Overview Call 1 &2
    • EFPIA Member Companies Participating companies (Q2 2011): EARMA Annual Meeting 23 rd June 2011
    • NEWMEDS
      • Develops biomarkers and tools and models to allow better targeted
      • treatments for schizophrenia and depression
      • 19 Partners
        • 9 EFPIA companies
        • 7 Public organisations
        • 3 SMEs
      • Has assembled the largest known repository of antipsychotic
      • clinical trail data.
      • The database contains information on 23 401 patients from 67 industry
      • sponsored studies.
      • Bringing together data from public projects and 3 companies on the genetics and clinical response in 1800 well characterized patients with depression.
      Nature, 11 November 2010 First achievements EARMA Annual Meeting 23 rd June 2011
    • U-BIOPRED By comparing data from several hundreds of people, the team will characterise different kinds of severe asthma, paving the way towards a new classification of asthma and personalised treatments for patients 19 Partners - 8 EFPIA companies - 7 Academic Institutions - 3 Patients’ organizations Thorax, in press
      • First achievements
      • Consensus statement on the definition of
      • severe refractory asthma
      EARMA Annual Meeting 23 rd June 2011
    • eTOX
      • Builds a large searchable database containing drug toxicity-related data extracted from relevant pharmaceutical pre-clinical legacy reports
      • Develops innovative methodological strategies and novel software tools to better predict in silico the toxicological profiles of new molecular entities in early stages of the drug development pipeline, using its database background
      • 25 Partners
        • 13 EFPIA companies
        • 8 Public organisations
        • 4 SMEs
      • An innovative multi-scale modelling strategy
      • for the prediction of cardiotoxicity has been developed,
      • successfully tested and published
      First achievements J. Chem. Inf. Model. 2011; 51:483-92 EARMA Annual Meeting 23 rd June 2011
    • SAFE-T
      • Addresses the current lack of sensitive and specific clinical tests to diagnose and monitor drug-induced injury to the kidney, liver and vascular tissues in man, which is a major hurdle in drug development
      • 20 Partners
        • - 11 EFPIA Pharma Companies
        • - 5 Academic Institutions
        • - 4 SMEs
      • First achievements
      • 153 potential biomarker candidates for drug-induced injury of the kidney, liver and
      • vascular system have been evaluated and are currently undergoing clinical evaluation.
      • The strategy adopted has been agreed with the European Medicines Agency (EMA)
      • and the U.S. Food and Drug Administration (FDA).
      Drug Discov Today, in press EARMA Annual Meeting 23 rd June 2011
    • IMI Education and Training Projects EARMA Annual Meeting 23 rd June 2011
    • The IMI Scientific Research Agenda is under Revision EARMA Annual Meeting 23 rd June 2011
    • The Pharmaceutical Industry is under pressure The Product replacement Ratio is the ratio of revenue from new products (that is, those launched in the previous 5 years) to the revenue lost from declining products. A ratio of less than 1 reflects a failure to replace former successful products with new revenue drivers. Harrison C., Nature Reviews Drug Discovery 10, 12-13 (January 2011) EARMA Annual Meeting 23 rd June 2011
    • The Health-care Ecosystem is Changing….
      • Health care reform and health IT, are driving the system to include many companies not traditionally involved in the health care business.
      • Patients from been traditionally relatively passive participants in health delivery are been empowered by technological progress to become educated super-consumers with a much more active role in management of their health care.
      EARMA Annual Meeting 23 rd June 2011
    • Pharma Patients Academia Physicians Biotechs Insurers Digital healthcare Governments CROs MedTech Social media Regulators The New Environment of “Big Pharma” EARMA Annual Meeting 23 rd June 2011
    • Idea generation Basic research and non-clinical testing Human testing Marketed drug Regulatory approval and Health technology assessment
        • Make Drug R&D processes in Europe more efficient and effective
        • and enhance Europe’s competitiveness in the Pharma sector
      The Focus of IMI Research has to Become Broader EARMA Annual Meeting 23 rd June 2011 Primary focus of early IMI calls Primary focus if we want to make EU competitive
    • Step 2: Consortia eligible for EU funding compete through expressions of interest which are ranked by independent experts Step 1: A set of EFPIA companies define a topic on which they commit to collaborate Pharma 1 Pharma 5 Pharma 2 Pharma 3 Pharma 4 Pharma 6 Step 3: The top-ranked EU-fundable consortium join the EFPIA companies to form the final consortium which develops the full proposal, subject to peer-review before final approval Building a IMI Consortium Acad 1 Acad 2 Acad 3 Acad 4 Patients’ Organ 1 Regul 1 Patients’ Organ 2 Other* SME 1 SME 2 Pharma 1 Pharma 5 Pharma 2 Pharma 3 Pharma 4 Pharma 6 Acad 1 Acad 2 Acad 3 Acad 4 Patients’ Organ 1 Regul 1 Patients’ Organ 2 Other* SME 1 SME 2
    • Key Concepts
      • Open collaboration in final consortia
      • Non-competitive research for EFPIA companies
      • Competitive calls for IMI JU beneficiaries
      EARMA Annual Meeting 23 rd June 2011
    • Building a IMI Project (1) IMI Research Agenda (multi-annual plan) Annual Scientific Priorities Definition of research topics Detailed description of research topics Launch of the Call Call definition and launch
      • Contains EFPIA priorities
      • Advice of Scientific Committee (SC)
      • Consultation of States
      • Representatives Group (SRG)
      • Approval by IMI Governing Board
      • Proposed by EFPIA
      • Consultation of SC and SRG
      • Approval by IMI Governing Board
      • Proposed by EFPIA
      • EFPIA + IMI Executive Office
      • Consultation of SC and SRG
      • Approval by IMI Governing Board
      • IMI Executive Office
      EARMA Annual Meeting 23 rd June 2011
    • Building a IMI Project (2) Submission of Expressions of Interest First Peer review First ranked consortium Invitation to submit Full Project Proposal Competition between applicants’ consortia (potential IMI JU beneficiaries)
      • By applicants’ consortia
      • (academics, SMEs, Patient org….)
      • Independ. experts + EFPIA coordin.
      • Independ. experts
      • Approved by IMI Governing Board
      • to first ranked applicants’ consortium
      • + EFPIA consortium
      assessment ranking EARMA Annual Meeting 23 rd June 2011
    • Building a IMI Project (3) Submission of Full Project Proposal Second Peer review (including ethics) Approval of Full Project Proposal Joint Preparation of Full Project Proposal
      • By full project consortium
      • (first ranked applicants’ consortium
      • + EFPIA consortium)
      • Independent experts
      • by IMI Governing Board
      EARMA Annual Meeting 23 rd June 2011
    • Building a IMI Project (4) assessment ranking Preparation of Approval of Project budget Signature of Project Agreement Contract negotiation
      • by full project consortium
      • + IMI JU Executive Office
      • by IMI Governing Board
      • by full project consortium
      Grant agreement Project agreement
      • by full project consortium
      Signature of Grant Agreement
      • by full project consortium
      • + IMI JU Executive Office
      EARMA Annual Meeting 23 rd June 2011
    • CALL 4 TOPICS (1)
      • Cluster A: Medical Information System
      • A European medical information framework (EMIF) of patient-level data to support a wide range of medical research
      • eTriks: European translational information and knowledge management services
      • Cluster B: Chemistry, Manufacturing and Control
      • Delivery and targeting mechanisms for biological macromolecules
      • In vivo predictive biopharmaceuticals tools for oral drug delivery
      • Sustainable chemistry – Delivering medicines for the 21st century
      EARMA Annual Meeting 23 rd June 2011
    • CALL 4 TOPICS (2)
      • Cluster C: Technology and Molecular Disease Understanding
      • Human induced pluripotent stem (hiPS) cells for drug discovery and safety assessment
      • Understanding and optimising binding kinetics in drug discovery
      Indicative total financial contribution from IMI JU for the 7 full projects Up to 105 M€ EARMA Annual Meeting 23 rd June 2011
    • CALL 4 TIMELINE
      • Open Info Day: 17 June 2011
      • Official Launch: End June 2011
      • Deadline submission of Expression of Interests: End October 2011
      • Peer-review Evaluation: November 2011
      • Deadline submission Full Project Proposals: March 2012
      • Approval of Full Project Proposals: May 2012
      EARMA Annual Meeting 23 rd June 2011
    • THANK YOU ! www.imi.europa.eu EARMA Annual Meeting 23 rd June 2011