Innovative Medicines Initiative - IMI Proposed Governance Structure

Innovative Medicines Initiative - IMI Governance Taskforce Meets regularly to define the proposed Governance structure for the proposed Innovative Medicines Initiative. Participants: Ruth Alnon (Pfizer), Karima Boubekeur (Roche), Pascale Cid (EC), Melanie Frey Wick (Roche), Fred Gvillo (Schering), Iréne Norstedt (EC), Magali Poinot (EC), Ian Ragan (Eli Lilly), Bernd Rainer (EC), Sean Roberts (GSK) and Karen Strandgaard (EFPIA)

IMI Inability of existing instruments to achieve the objective A real Public Private Partnership cannot be achieved through the existing instruments. Industry contribution 100% via a JTI – 50 % via collaborative research No existing instrument can accommodate the necessary overall co-ordination of the complex R&D activities and the necessary knowledge management

IMI Inability of existing instruments to achieve the objective The collaborative research programme do not provide an adequate flexibility to address the identified research needs. In particular: - Facilitating the focussed problem solving approach addressing very specific research needs - Providing a mechanism for rapid and systematic take up, valorisation and translation of research results into new methods and techniques for use in the medicines development process. - Facilitating the provision of advice by regulators for setting up “tailor made” validations

IMI Added value of European – level intervention (1) Closing the gap in the innovation system The JTI will fill a gap in the European Innovation system by providing mechanisms and networks for rapid valorisation and translation of research results into methods and technologies for industry and regulatory practice. The research results to be taken up can stem from research done at national/EC/international level and from academia as well as industry. IMI is changing the focus of industry collaboration from “competitive” research collaborations (to develop products) to “pre-competitive” collaborative research on scientific challenges.

IMI Added value of European – level intervention (2) Stakeholders are looking for leadership and structure The JTI will provide “neutral ground” for the necessary collaboration between all stakeholders thereby removing the suspicions of “biased collaborations” that undermines collaborations today. Aiming at structuring the strongly fragmented European research base (both national and sector fragmentation will be addressed) → ERA The necessary R&D cannot be done by any of the stakeholders group alone – collaboration is necessary

IMI Added value of European – level intervention (3) Industry commitment and collaboration The role of the EC has been, and will be, instrumental for the increased collaboration between companies. The EC and Industry will facilitate the participation of all stakeholder groups in the research following open calls and peer review. Research can be done by “anybody” as long as it is carried out in Europe. Similar activities has started in the US and Japan. Without a strong European initiative industry will increasingly move its research elsewhere.

IMI Objectives to be pursued IMI shall foster the development a new « toolbox » (toxicology tests, biomarkers, clinical trials protocols, etc.) for drug developers to reduce the risk of failure during clinical trials. IMI shall provide the infrastructure for validation of the new tools in view of rapid uptake into regulatory and industry practice. IMI shall set up ‘knowledge platform’ pooling data from toxicology testing and biomarker validation - will be available to all researchers (industry and academic). IMI shall not develop new medicines or new vaccines – it aims at reducing the attrition rate during development of new medicines!

IMI Structure and Governance IMI’s governance structure should reflect -the science driven approach -the collaboration between stakeholders -facilitate the rapid take up of research results and translate those into new methods and techniques for use in medicines development -convergence and synergies with national and international efforts IMI will be an open structure where the research will be done by: Industry, SMEs, academia, clinics, patient organisations, etc. following open calls and peer review. Rules for IPR must be fair and clear to all participants from the onset.

IMI Legal entity IMI will be proposed to be: established as a Public Private Partnership with Industry via EFPIA (The European Federation for Pharmaceutical Industries and Associations) and the European Commission as Founding Members established as a private non profit organisation responsible for the successful implementation of the Strategic Research Agenda of IMI open to participation of any organisation as long as the research is conducted in Europe

IMI Founding Members and Financial contribution The EC and EFPIA shall be the Founding Members of the IMI legal entity. The Founding Members shall contribute financially to IMI on an equal basis as follows Cost for running the Executive Office (Executive Director and Staff) Equal contributions in cash from EFPIA and the EC (via contribution from FP7 Health research budget) Costs for R&D activities identified via the Strategic Research Agenda Industry contributes primarily via “in kind” contribution for R&D activities conducted by EFPIA Members EC contributes with cash (via contribution from FP7 Health research budget) for research conducted by academic and clinical researchers, SMEs, patient associations, etc. Industry contribution shall match the EC contribution on an annual basis !! Industry (EFPIA Members) shall not use any EC funds for their research!!

IMI Industry contribution The industry contribution shall only be counted for R&D activities done in addition to their normal research activities. Example: Validation of a new liver toxicology test. The test may be developed by an SME. Ten companies validates the test by running it in addition to its normal test procedures. The companies will collect and harmonize the data according to new standards that enables the pooling of data from a vast amount of resources. The co-ordination of the validation and the analysis of results may be done one or several Universities. The Regulatory Authorities (EMEA) will provide scientific advise on the set- up of the validation study, and they will also facilitate the review of the study result. Industry contribution = all costs for running the new test and for the collection and harmonization of data EC contribution = costs for the academic partners + contribution to costs for the SME

IMI Bodies of the Legal Entity

IMI BOARD The Board The Board shall have the overall responsibility for the operations of IMI. It shall oversee the implementation of the SRA by the Executive Office. The Board shall consist of X representatives from each of the Founding Members. The Founding members shall have equal voting rights. It shall approve annually: financial plans concerning the operations of IMI and the annual budget and implementation plans for the SRA; annual accounts and balance sheets and progress reports. The representation and voting rights of any New Member in the Board shall be agreed on a case-by-case basis.

IMI EXECUTIVE OFFICE The Executive office shall be responsible for the implementation of the SRA: operational aspects, day to day management, management of the funds, communication activities and the co-ordination of funded research activities related to IMI. It shall for example: - manage calls for proposals and their evaluation via a peer-review process establish grants for selected projects and manage the project portfolio provide support to the Board, Scientific Committee facilitate communication with the Member States Group and the Stakeholder Forum prepare necessary reports (progress reports, financial reports, annual reports, etc.) It shall also ensure a balanced involvement of stakeholders in the « day to day » business wherever appropriate.

IMI SCIENTIFIC COMMITTEE The Scientific Committee is an advisory body to the Board. It shall conduct its activities in close liaison and with the support of the Executive Office. It shall collectively have the competencies to cover the complete drug development process needed to make strategic science based recommendations. It shall in particular: - advise on the continued relevance of the SRA, and on the prioritisation of its implementation. - review the scientific achievements of the SRA implementation and advise the board accordingly. advise on the composition of the peer review committees.

IMI The Scientific Committee shall consist of no more than 15 Members It shall have a balanced composition including representatives of: academia, patients, industry and regulatory representatives. The Board shall propose criteria for the selection of the Scientific Committee for approval by the Member States Contact Group. The Board will nominate candidates for selection by the Member States Contact Group. The term of appointment shall by for 3 years, renewable once for a further 2 years. The Scientific Committee shall elect a Chairperson from among its members. The term of the Chairperson shall be 2 years.

IMI Additional groups

IMI The Stakeholder Forum The Stakeholder Forum should convene annually and should be open to all stakeholders. It shall ensure the openness and transparency of IMI and the implementation of the SRA. It can provide strategic advice to the Board concerning the overall orientation of IMI.

IMI MEMBER STATES GROUP The Member States Group (including Candidate Countries and Associated States) The Member States Group shall facilitate and ensure good information flow between IMI activities and relevant activities at Member State level. It shall be responsible for implementation of important aspects of the SRA, i.e. the Education and Training Activities. The Member States Group shall approve the composition of the Scientific Committee.

IMI Proposed governance structure The bodies of the IMI Legal entity shall be: The Board, The Scientific Committee and the Executive Office