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

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 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],EARMA Annual Meeting 23 rd June 2011

eTOX ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],First achievements J. Chem. Inf. Model. 2011; 51:483-92 EARMA Annual Meeting 23 rd June 2011

SAFE-T ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],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…. ,[object Object],[object Object],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 ,[object Object],[object Object],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 ,[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],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) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],[object Object],Grant agreement Project agreement ,[object Object],Signature of Grant Agreement ,[object Object],[object Object],EARMA Annual Meeting 23 rd June 2011

CALL 4 TOPICS (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],EARMA Annual Meeting 23 rd June 2011

CALL 4 TOPICS (2) ,[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],EARMA Annual Meeting 23 rd June 2011

THANK YOU ! www.imi.europa.eu EARMA Annual Meeting 23 rd June 2011

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

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