Transcript The Innovative Medicines Initiative (IMI) Strategic Research Agenda

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 Initiative
Background
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 Initiative
Background
The Innovative Medicines Initiative
Background





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 agenda
Key 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 panEuropean 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 funding
Structure
IMI Joint Technology Initiative
Board
Three bodies
Executive
office
Two groups
Member
states group
Scientific
committee
Stakeholders
forum
IMI Governance and funding
All stakeholders are eligible to participate in IMI projects, the only
condition being that the research is performed
in 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 of
the 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 transparency
to 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-JTI
Next 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 2007
First 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
Stakeholders
group
Board +
Scientific
Council
Strategic Research
Agenda
Annual Implementation
Plan
Member states
Stakeholders
group
Member states
Calls
Reviewers
Projects
Thank you for your attention