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Case StudyInnovative Medicines Initiative (IMI)

Karen Strandgaard

EFPIA

EuroConference, Brussels April 26th, 2006

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The European Federation of Pharmaceutical Industries and Associations (EFPIA)

EFPIA represents the research-based pharmaceutical industry operating in Europe:

– 45 leading pharmaceutical companies,– 29 national pharmaceutical industry associations

It also has two specialised groups;– Emerging Biopharmaceutical Enterprises (EBE), an

association representing the needs and interests of biopharmaceutical companies

– European Vaccine Manufacturers (EVM), an association representing the needs and interests of vaccine manufacturers

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The EFPIA Research Directors Group

Works to strengthen the EU Science base by: – Promoting the importance of research for the biopharmaceutical

industry and participating in the increasing debate on Europe’s competitiveness in biopharmaceutical research.

– Developing and implementing industry policy to encourage and support of biomedical and biopharmaceutical Research and Development activities in Europe to the benefit of patients and society

– Working towards goals in partnership with biomedical stakeholders such as patients, regulators, academia, etc

Objectives relevant to the ETP concept

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Agenda

Background on The Innovative Medicines Initiative

Challenges

Key success factors

Lessons learned

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Agenda

Background on The Innovative Medicines Initiative

Challenges

Key success factors

Lessons learned

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Europe losing the ‘R&D Race’:Global biopharmaceutical R&D investment

Note: Global R&D expenses of € 16,475 million (USA: 11,993; Europe: 3,742; Canada: 548; Asia/Pacific: 192)Source: Ernst & Young, 11th Annual European Biotechnology Report 2004

73%

23%

4%

USEuropeROW

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15

10

5

Idea

Medicine

years

Gaining approval

Risk assessmentanalysis

Studies in 100-300patients (Phase II)

Studies in healthyvolunteers (Phase I)

Extensive safety studies

Early safetystudies

Candidate

Formulationsdeveloped

Screening

Synthesis ofcompounds

Creating new medicines is a high risk journey

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The Innovative Medicines Initiative….

….. Will– Improve the way new medicines are created– Establish Public-Private-Partnerships

…..Will Not– Deliver new medicines per se

Enabling the discovery of new medicines for the benefit of

patients

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IMI History

First discussion with the EC at the RDG meeting of June 2004

First stakeholder meeting organised by the EC October 2004

FP6 Integrated project submitted to the EC by EFPIA November 2004

Vision paper published December 2004

Nine stakeholder workshops Jan.to May 2005

Review and support by the EFPIA Board April 2005

First Member States group meeting May 2005

Strategic Research Agenda published July 2005

Second Member States group meeting September 2005

FP6 IP negotiations finalised and project start October 2005

FP6 IP contract signed by EFPIA and EC December 2005

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IMI - A compelling case for JTI Status

Innovation and development of science base is crucial to Europe

Health is high on the political agenda with our ageing population

Pharmaceutical innovation brings benefits to people’s health and wealth to society

Focused on creating the environment which will enable important new medicines to get to patients faster

IMI has a clear focus on outcomes, an agreed and proven collaborative approach, and is ready to start implementation

Commitment of industry to contribute 100% of own costs

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Agenda

Background on The Innovative Medicines Initiative

Challenges

Key success factors

Lessons learned

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Main challenges

Novelty of the JTI instrument – no established way of working

Number of stakeholders and communication between all these stakeholders

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Different drivers – common goal

Political orientation

Focus on process

Focus on consultation

Focus on Member States interest

Business orientation

Focus on productivity

Focus on science

Focus on patients’ interest

Foster biomedical Innovation

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The usual instruments are inadequate

Low industry participation

Bureaucratic and lengthy process

Lack of transparency

Focus on social agenda, i.e. balance between genders, countries, etc. distracts from the science

Not conducive to real partnerships

JTI's can address these inadequacies

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What is the Environment of the IMI?

RDG

EFPIA BoardEFPIA CommitteesPhRMA S&R Committees

Member StatesUKItaly

SpainFrancePoland SwedenGermany

Etc.

Res

earc

h

Ent

erpr

ise

Info

rmat

ion

Soc

iety

San

Co

European CommissionAZGSKBayerRocheServierNovartisScheringNovo-NordiskSanofi-Aventis etc

Biopharmaceutical industry

EMEA & national authoritiesAcademia & Hospitals

Health ProfessionalsPatients’ organisations

Biotechs: EuropaBio, EBE

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Approach – Keep focus on the patients

Patient

National Governments

EMEA & national authorities

Academia & Hospitals

Industry

European Commission

Health Professionals

SMEs

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Agenda

Background on The Innovative Medicines Initiative

Challenges

Key success factors

Lessons learned

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Industry will not be funded by the EC

Research performed by industry funded by industry

50%50%

IMI to be funded equally by pharma industry and European Commission

100%

Research performed by public organisations funded by EC

100%

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Key success factors

Constant/regular communication between EC and EFPIA at all levels:

– Decision level– Implementation level

Building understanding and trust

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Key success factors (contd.)

Alignment of the EFPIA companies around the strategic research agenda and the core values of the IMI:

– Focus on science– Focus on patients– Lean and agile

Building a strong value proposition for the community

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Agenda

Background on The Innovative Medicines Initiative

Challenges

Key success factors

Lessons learned

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Lessons Learned

Building trust through exchange of information and views

Focus on science drives consensus on objectives

The Association as «one-stop-shop» for industry involvement

Results driven

Top executive buy-in

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The ultimate beneficiaries ...

People living longer, healthier and more prosperous lives in the EU