The Innovative Medicines Initiative (IMI)

Creating Biomedical R&D Leadership for Europe

to Benefit Patients and Society

Radu Albulescu,

Natl. Inst. Chem. Pharm. R&D

The Innovative Medicines InitiativeBackground

The Lisbon Agenda <<The way forward>>

5. The Union has today set itself a new strategic goal for the next decade: to become the most competitive and dynamic knowledge-based economy in the world, capable of sustainable economic growth with more and better jobs and greater social cohesion. Achieving this goal requires an overall strategy aimed at:

- preparing the transition to a knowledge-based economy and society by better policies for the information society and R&D, as well as by stepping up the process of structural reform for competitiveness and innovation and by completing the internal market;

- modernizing the European social model, investing in people and combating social exclusion;

- sustaining the healthy economic outlook and favorable growth prospects by applying an appropriate macro-economic policy mix.

The Innovative Medicines InitiativeBackground

The Innovative Medicines InitiativeBackground

The Innovative Medicines Initiative (IMI) is a unique pan-European public and private sector collaboration between large and small biopharmaceutical and healthcare companies, regulators, academia and patients.

The aim of IMI is to support the faster discovery and development of better medicines for patients and enhance Europe’s competitiveness by ensuring that its biopharmaceutical sector remains a dynamic high-technology sector. The Innovative Medicines Initiative will ensure that Europe’s biopharmaceutical sector receives targeted strategic support for the benefit of patients, as well as the scientists and citizens of Europe.

IMI proposes a number of clear, practical paths that will accelerate the discovery and development of more effective innovative medicines with fewer side-effects. IMI will implement innovative Patient Centered Projects that address the principles causes of delay or bottlenecks in the current biomedical R&D process.

These bottlenecks have been identified as predicting safety, predicting efficacy, bridging gaps in knowledge management and bridging gaps in education and training.

The Strategic Research Agenda (SRA) describes the recommendations to address these bottlenecks and a plan to guide their implementation.

“Innovative medicines”Background

The Stakeholders

The Strategic Research Agenda

The Strategic Research Agenda addresses issues in all of the areas where pre-competitive bottlenecks exist, and proposes specific areas of research to improve the overall efficiency of medicine development in Europe. This is an ambitious aim, but one that is not considered to be beyond the collective capabilities of Europe’s biomedical sector. The sector has recognized the urgent need to revolutionize the conventional drug development paradigm to support the faster discovery and development of better medicines.

The development of a new drug is a long, complex and resource-intensive process. Various estimates have placed the costs between $400 mn and $900 mn during the period 1994 to 20004. There is a high possibility that a new drug will fail to reach the market because projects may fail for different reasons at different points in the overall process. During the previous 10 years, global R&D expenditure in the pharmaceuticals and biotechnology sector has steadily increased, without a corresponding increase in output of new medicines,.

Radically different initiatives are urgently needed to reduce the rate of attrition during the downstream phases of the drug discovery and development process. Such initiatives would support the faster discovery and development of better medicines, and provide a boost to Europe’s biomedical R&D base. This would enable Europe to become a preferred location for biopharmaceutical industry investment. In recognition of this opportunity, the Research Directors Group of EFPIA has identified the pre-competitive barriers in the drug discovery and development process on which the biopharmaceutical industry, as well as other stakeholders in the biomedical R&D process such as academia, can collaborate.

Strategic research agendaKey components

SRA encloses four major components (“The 4 pillars”), considered to address the existing bottlenecks in pharmaceutical R&D:

The complete updated version of the Strategic Research Agenda can be downloaded at: http://www.imi-europe.org/

“Innovative medicines”Legal status

Responsibility: The European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA) will hold joint responsibility for creating and operating a Joint Technology Initiative (JTI) that will implement the Strategic Research Agenda of the IMI.

Legal status: IMI will be established based on article 171 of the Treaty establishing the European Community (“The Community may set up joint undertakings or any other structure necessary for the efficient execution of Community research, technological development and demonstration programmes”). It will be an international not-for-profit organisation.

Rationale for JTI Status: JTI status represents the highest level of pan-European public and private sector collaboration and co-ordination, which is needed because the scientific challenges are too complex for organizations and nations to address in isolation. For IMI to succeed it is essential that it receives JTI status.

“Innovative medicines”Legal status

CONSOLIDATED VERSION OF THE TREATY ESTABLISHING THE EUROPEAN COMMUNITY

24.12.2002 Official Journal of the European Communities C 325/33

TITLE XVIII RESEARCH AND TECHNOLOGICAL DEVELOPMENT

Article 171

The Community may set up joint undertakings or any other structure necessary for the efficient execution of Community research, technological development and demonstration programmes.

Article 172

The Council, acting by qualified majority on a proposal from the Commission and after consulting the European Parliament and the Economic and Social Committee, shall adopt the provisions referred to in Article 171.

“Innovative medicines”Governance and funding

Organizational structure

IMI Governance and fundingStructure

IMI Joint Technology Initiative

Three bodies Board

Executive office

Scientific committee

Member states group

Stakeholders forumTwo groups

IMI Governance and funding

All stakeholders are eligible to participate in IMI projects, the only condition being that the research is performedin Europe. Therefore, there is no official membership of IMI.The IMI Joint Undertaking will comprise the following bodies:

IMI Governance and funding

The IMI Joint Undertaking will comprise the following bodies:• The Member States Group, with nominees from all Member States and Associated Countries, will approve the composition of the Scientific Committee. It will facilitate rapid dissemination of information between IMI and Member State activities, and ensure co-ordination with Member State activities. In addition, it will play a leading role in the implementation of certain strategic parts ofthe SRA, such as Education & Training;

IMI Governance and funding

• The Stakeholders’ Forum will be open to all stakeholders. It will convene annually at the General Assembly, where IMI activities will be presented and discussed to ensure openness and transparencyto all stakeholders. In addition, the Stakeholders’ Forum will be invited to provide advice to the Board on the orientation of IMI activities.

IMI Governance and funding

• The Board will be responsible for directing the operations of the IMI Joint Undertaking. The Board will oversee the implementation of the SRA by the Executive Office. Initially, the Board will be composed of representatives from the European Commission and EFPIA. However, based on future expressions of interest, new Board members representing other stakeholders may join;

IMI Governance and funding

• The Executive Office will be responsible for the overall operational and communication activities of IMI. It will develop a document termed ‘Internal Regulation’ which outlines the activities of the three IMI bodies, and how IMI will conduct its operations;• The Scientific Committee will be an advisory body to the Board. It will conduct its activities in close liaison with, and with the support of, the Executive Office. It will consist of 15 members who reflect a balanced representation of both public and private stakeholders, including: academia, patients, industry and regulators. Collectively, its members will represent expertise from across the entire drug discovery and development process, and be expected to provide scientific recommendations on the scientific strategy of IMI.

“Innovative medicines”Governance and funding

Project Participants and their Contribution

Governance and Funding

Funding - Overview of IMI Costs by Pillar

IME-JTINext steps - roadmap

IMI legal package – will undergo a multi step approval by the Council and by the Parliament:- Finalization of IMI Legal package – February 2007- Inter-service consultation & Commission approval – March 2007- Commission approval – March 2007- Submission to the European Council – April 2007- Consultation to the European Parliament - April 2007- Opinion of the European Parliament - October 2007- Approval by European Council – November 2007.- Governance structures – Board, Scientific committee and Executive – Fall 2007First call: December 2007

Operation cycle

As a rule, IMI will issue 2 calls every year. Except for the first call, the operation cycle will be based on the Annual Implementation Plan (Issued by the Board, in accordance with the SRA); for each Call, a set of topics is selected; EFPIA consortium is associated to each topic and designates Project coordinator

Call publication Stage 1 – Expressions of interest – from R&D groups (organizations or

consortia = “Public consortium”) for pre-determined EFPIA Consortia Stage 2 – Full project proposal submitted by the Public-Private

Consortium Each step includes peer-review Approval by the Board

Operation cycle

Strategic Research Agenda

Annual Implementation Plan

Calls

Projects

Stakeholders group

Member states

Board + Scientific Council

Stakeholders group

Member states

Reviewers

Thank you for your attention