I M I The Innovative Medicines Initiative Member/Associated States Contact Group 20 March 2006 Octavi Quintana-Trias, EC.

I M I The Innovative Medicines Initiative

Member/Associated States Contact Group

20 March 2006

Octavi Quintana-Trias, EC

The Political SituationJTI’s

Some European Technology Platforms may be proposed to be established as Joint Technology Initiatives via Art. 171 of the EC Treaty.

Basis for decision: • European added value• Inability of existing instruments to achieve its objectives • Degree and clarity of definition of objectives to be pursued• Strength of financial/resource commitment by industry• Contribution to broader policy objectives• Scale of the impact on industrial competitiveness and growth

Decision by the Competitiveness Council.

JTI candidates: Innovative Medicines, Aeronotics, Hydrogen and Fuel Cells, Embedded systems, Nano electronics, GMES (Global Monitoring for Environment

and Security)

Competitive Environment in the World

It will be done…

Innovative Medicines Initiative (EFPIA-European Commission)

FDA Critical Path Initiative (NIH)

Safe and Innovative Medicines (PhRMA)

Biomarker Initiative (PhRMA)

Critical Path Institute (University of Arizona)

Center for Biomedical Innovation (MIT)

Toxicogenomics Project (JPMA)

Proteome Factory Consortium (JPMA)

Large-scale Clinical Trial Network

Innovative Medicines Initiative - IMI

Strategic Research Agenda

- First draft SRA published on IMI website (July 2005)- Member States (MS) /Associated States (AS) invited to comment the

proposed SRA (July-Oct 2005)- Consolidated comments received from ~ 50 % of the countries - EMEA’s Committee for Human Medicinal Products (HCMP) and

Committee for Orphan Medicinal Products (COMP), both composed by Member states representatives) were invited to provide their comments

- Some individuals and organisations has send comments- Some countries has provided supporting letters/messages

The InnoMed Project started November 2005

Consortium composed by 16 Companies – 14 Universities – 7 SMEs

Predictive Toxicology

– 13 large Companies: Altana, Bayer, Boehringer-Ingelheim, Johnson & Johnson, Merck AG, Novartis, Novo-Nordisk, Organon, Roche, Sanofi-Aventis, Schering, Serono, Servier

– 3 Universities: University of Wuerzburg, Dublin and Hacettepe – 1 SME: Genedata

Biomarkers in Alzheimer’s Disease– 3 large Companies: AstraZeneca, GSK, Lilly– 11 Universities: King’s College London, University of Kuopio,

Perugia, Stockholm, Toulouse, Karolinska, Southampton, Thesalonikki, Roskilde University, University College London, University of Lodz

– 6 SMEs: BioWisdom, Capsant, Cerebricon, Pharmidex, Proteome Sciences, Hunter Fleming

Innovative Medicines Initiative - IMI

Discussion on Host site postponed

- Fear that the discussion on possible host site distracts from the KEY discussion on its objectives and research focus

- Complex political situation – Financial Perspectives → reduced EU budget → delayed FP7 decision and reduced FP7 budget

- Further development of JTI concept (s) - similarities and differences between the proposed JTI’s

IMIComments on SRA (version July 2005)

MSCG meeting

20 March 2006

Bernd Rainer

Concerted Feedback/Input

on SRA received from:

• Austria, Denmark, France, Germany, Hungary, Ireland, The Netherlands, Poland, Sweden, UK, Romania, Turkey, Norway.

Changes to the Strategic Research Agenda based on the

consultation process

Member States MeetingMarch 20th, 2006

Karima Boubekeur

Chapter 1: Introduction

• Streamlined• Objectives of the IMI made more clear:

it is not about the discovery of new medicines but about the development of new tools to help the discovery process

• Clarification that it is not about cell and gene therapy

• Clarification that it is not about healthcare policy but about science and medicine

The Innovative Medicines Initiative

Intellectual Property Policy

March 20th, 2006

Issues to Consider

• Possible intellectual property protection

• Ownership issues• Access issues• Utilization issues • Dissemination• Platform issues

Research Use shall mean the right to make and use of (but not sell or otherwise dispose of) products or processes which are protected by Foreground IP or Background IP for all purposes relating to research, development and approval of diagnostic or pharmaceutical products (4).

Foreground IP shall mean rights in data and information, inventions(whether or not patentable), patents and applications, know-how, copyrights,databases and designs which are generated by a Participant under the Project (2).

Background IP shall mean rights in data and information, inventions (whether or not patentable), patents and applications, know-how, copyrights, databases and designs owned by a Participant before the accession to the Grant Agreement and the Project Agreement, which is necessary for carrying out the Project or for using the Foreground IP or which are generated during the Project but which are incidental to the Project Objective as defined in the Grant Agreement (2).

A regulatory standard is any project or part of a project as defined in the Grant Agreement where the objective or part of the objective is to generate data that (i) may be used to progress, modify or create new regulations, regulatory guidance or processes related to the discovery, development or pharmacovigilance of medicinal products or (ii) may be required to be included in a regulatory submission for approval to conduct clinical trials or to market a medicinal product (4).

Definitions

Ownership (2)

• Each Participant will remain the owner of its Background IP

• Ownership of the foreground IP belongs in the first instance to the Participant(s) who generated it

• Participants may agree on a different allocation of ownership in the project agreement

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 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

The Board, the Executive Office and the ScientificCommittee

SCIENTIFIC COMMITTEE

EXECUTIVE OFFICE

BOARD

The Scientific Committee Is responsible for the content of the SRA, its updates and prioritisation.

The Executive Office is responsible for day to day management regarding the implementation of the SRA

The Board shall be composed by the Founding Members (EC and EFPIA) (and potential new funding members)

IMI

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.

BOARD

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

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.

SCIENTIFIC COMMITTEE

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.

SCIENTIFIC COMMITTEE

IMI Additional groups

MEMBER STATES GROUP

STAKEHOLDER FORUM

The Stakeholder Forum shall be open to all Stakeholders. It shall convene a General Assembly annually where the IMI activities should be presented and discussed to ensure openness and transparency to all stakeholders.The Stakeholder Forum can provide advice to the Board regarding the orientation of IMI activities.

The Member States Group shall approve the composition of the Scientific Committee.It shall facilitate rapid dissemination of information between IMI and Member State activities, and it shall ensure co-ordination with national activities.It shall be responsible for the implementation of important aspects of the SRA (i.e. Education & Training)

IMI Proposed governance structure

SCIENTIFIC COMMITTEE

STAKEHOLDER FORUM

EXECUTIVE OFFICE

BOARD

MEMBER STATES GROUP

The bodies of the IMILegal entity shall be:The Board, The Scientific Committee and the Executive Office

Innovative Medicines Initiative - IMI

Conclusion from today’s meeting

- Copies of today’s presentation will be sent via e-mail

- Minutes from the meeting will be sent to the Members of the group (with copy to the Science Counsellors of the Permanent Representations in Brussels)

- Member/Associated states are invited to provide comments on the presented materials before the 21 April 2006.

Innovative Medicines Initiative - IMI

Conclusion from today’s meeting

- Member/Associated states are invited to step up the identification process of national (and international) activities contributing towards IMI objectives

- Member/Associated states are encouraged to organize national information meetings to present IMI objectives and the SRA.

- Discussion regarding possible host site is postponed until further notice