New Opportunities in IMI2 Hugh Laverty 14.04.2015 ECSEL Consortium Building Event Brussels
Innovative Medicines Initiative: Joining forces in the healthcare sector The biggest public/private partnership in Life Science aiming to: Make drug R&D processes in Europe more innovative and efficient Enhance Europe s competitiveness Address key societal challenges Features: 1:1 funding, joint decision making All EU funds go to SMEs, academia, patient organisations and regulatory agencies Large pharmaceutical industry, represented by EFPIA, contributes inkind
Typical IMI project life cycle Topic definition phase Stage 1 Stage 2 Negotiation phase Industry consortium Academic research teams Mid-size enterprises SMEs Hospitals Regulators Patients organisations Applicant consortium industry consortium Identification of topics and willingness to collaborate by EFPIA companies and associated partners Call launch Submission of short proposals by applicant consortia & evaluation by independent experts Invitation to selected team to merge with industry team Preparation of full proposal & evaluation by independent experts/ethical panel Start of the negotiation phase Signature of Project Agreement and Grant Agreement Project launch!
An international, cross-sector community 764 academic teams 17 regulators 146 SMEs Over 7 000 researchers 59 public-private consortia 25 patient orgs 433 EFPIA teams
The IMI portfolio
The evolution of IMI: From bottlenecks in industry to bottlenecks in Industry and Society Make Drug R&D processes in Europe more efficient and effective and enhance Europe s competitiveness in the Pharma sector Idea generation Basic research and non-clinical testing Human testing Regulatory Approval HTA and Pharmacovigilance Daily Medical practice Primary focus of early IMI calls 2007 SRA Shift to also addressing challenges in in society and healthcare 2011 SRA IMI 2 includes real life medical practice 2013 SRA
IMI2: Major Axes of Research Reclassification of disease by molecular means Biomarker identification/validation (precision medicine) Innovative methodologies to evaluate treatment effect Target Identification and validation(human biology) Determinants of drug /vaccine Safety and efficacy Target & Biomarker Identification (safety & efficacy) European Health Priorities Innovative clinical trial paradigms Adoption of innovative clinical trial designs Benefit/Risk Assessment Innovative drug delivery methodologies Innovative Medicines Patient tailored adherence programmes Healthcare delivery: focus on the treatment programmes not just the medicine Manufacturing for personalised medicines Discovery and Development of novel preventative and therapeutic agents Innovative adherence programmes Drive change in delivery of medical practice
Strategic Research Agenda Comprehensive framework for a 10-year programme Prepared with input from 80+ organisations (internet and targeted) Project ideas from industry and third parties will be screened against it http://goo.gl/jqmp9g
IMI Europe s partnership for health IMI1 programme 2008-2013 2 bn budget 11 Calls for proposals 60+ projects IMI2 total budget 3.28 bn IMI2 programme 2014-2024 Larger budget Ambitious Strategic Research Agenda Open to other industries 1.638 bn 1.425 bn Other 213 m
1. Participant in IMI2 projects IMI2 total budget 3.28 bn 1.638 bn 1.425 bn Other 213 m Any entity carrying out work relevant to the IMI2 objectives may participate, provided that: At least three legal entities, each established in a different Member State or an associated country (minimum condition for standard collaborative actions) Potential additional conditions in the annual work plan (and Call documents) are fulfilled
1. Participant in IMI2 projects Only beneficiaries established in a EU Member State / H2020 Associated Country are eligible for EU funding, unless: Participation is deemed essential by the JU for carrying out the action, or Additional conditions are set in the annual Work Plan/Calls documents More types of entities are eligible for EU funding under IMI2 than under IMI1: Academic institutions Research organisations Small & medium-sized enterprises (SMEs) NEW: Mid-sized enterprises ( 500M) Non-profit patient organisations Non-profit public bodies and intergovernmental organisations including specialised agencies
2. IMI2 Associated Partner IMI2 total budget 3.28 bn 1.638 bn 1.425 bn Other 213 m
2. IMI2 Associated Partner IMI2 is open to participation from organisations beyond the pharmaceutical companies represented by EFPIA ICT, diagnostics, imaging, animal health, etc. Any legal entity other than a Member or a constituent/affiliated entity of a Member, may apply to join IMI2 as an Associated Partner Entity supporting the objectives of the IMI2 Joint Undertaking in its specific area of research; Upon acceptance of the IMI2 Statutes by a letter of endorsement, that details the scope of the association in terms of contribution (in-kind or in-cash), activities and duration; Application to be addressed to the IMI2 Governing Board
2. Examples Associated Partners: Call 1, topic 1 "Translational approaches to disease modifying therapy of Type 1 Diabetes Mellitus (T1DM)" The Juvenile Diabetes Research Foundation (JDRF) will contribute 2.8 million Leona M. and Harry B. Helmsley Charitable Trust will contribute a further 2.2 million Call 3: Bill and Melinda Gates Foundation will contribute to a topic on Pertussis Vaccination research
3. EFPIA direct or indirect Member IMI2 total budget 3.28 bn 1.638 bn 1.425 bn Other 213 m
Engaging in IMI2 activities as EFPIA director or indirect member Affiliated entities of an EFPIA corporate member, EFPIA specialized group (Vaccines Europe or EBE) or member of an EFPIA association and EFPIA Partner in Research Non-pharmaceutical companies, e.g. imaging, medical information technology, diagnostic, animal health industries,... GE HealthCare, Zeiss, Zoetis, PMB Alcen, Alcediag joined in 2014 Contact: magda.chlebus@efpia.eu katharina.angrosch@efpia.eu
http://imi.efpia.eu/
Key messages IMI2 expands the scope of IMI1 to cover the entire medical research and innovation value chain Involving all relevant partners: pharmaceutical and other health-related industries, patients, academia, SMEs, regulators, in open innovation networks Open to participation from industries beyond the pharmaceutical companies More entities eligible for EU funding: medium-sized industrial partners (annual sales less than 500 million)
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Thank you Hugh Laverty Senior Scientific Project Manager Hugh.Laverty@imi.europa.eu www.imi.europa.eu @IMI_JU
Back-ups www.imi.europa.eu @IMI_JU
EFPIA Partners in Research Impact on IMI2 strategy Yes[1] No IMI Associated Partners Access to and impact on the Programme level and/or projectby-project Project-by-project shape of IMI initiatives Impact on IMI governance Yes[2] No Contribution to IMI administrative costs Impact on EFPIA research and life science policy Access to industry support group (Industry Liaison Group) EU budget available to match industry contributions until 2024 Ability to run sectorial projects (without pharmaceutical industry) Ability to contribute to ongoing IMI1 projects with EU matching funding for public partners Yes[3] Yes Yes No No No 1,425 mln 213 mln Yes - for developing tools necessary in other IMI projects Yes, with IMI matching (if budget available) Yes Yes, but without IMI matching [1] Through thematic Strategic Governing Groups and/or RDG [2] Through EFPIA - contribution to one industry voice expressed by industry representation on IMI Governing Board [3] 3% of company contribution with minimum contribution of 5, 10 or 20 K depending on European sales and cap set at the level of comparable size EFPIA company
IMI2 Member According to the Statutes of IMI2: "Any legal entity that directly or indirectly supports research and innovation in a Member State or in a country associated with the Horizon 2020 Framework Programme may apply to become a Member of the IMI2 Joint Undertaking. Application to be addressed to the IMI2 Governing Board accompanied by a proposal to adapt the composition of the Governing Board