Transcript Slide 1
Case Study
Innovative 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;
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Emerging Biopharmaceutical Enterprises (EBE), an
association representing the needs and interests of
biopharmaceutical companies
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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:
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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
4%
23%
US
Europe
ROW
73%
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
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Creating new medicines is a high risk journey
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Medicine
Risk assessment
analysis
Gaining approval
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Studies in 100-300
patients (Phase II)
Extensive safety studies
Studies in healthy
volunteers (Phase I)
Candidate
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Formulations
developed
Early safety
studies
Screening
Synthesis of
compounds
years
Idea
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The Innovative Medicines Initiative….
….. Will
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Improve the way new medicines are created
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Establish Public-Private-Partnerships
Enabling the discovery of new medicines for the benefit of
patients
…..Will Not
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Deliver new medicines per se
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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
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
April 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
Business orientation
Focus on process
Focus on productivity
Focus on consultation
Focus on science
Focus on Member States
interest
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?
EMEA & national authorities
Academia & Hospitals
Health Professionals
Patients’ organisations
Biotechs: EuropaBio, EBE
UK
Italy
Spain
France
Poland
Sweden
Germany
Etc.
SanCo
Research
Member States
European Commission
Enterprise
AZ
GSK
Bayer
Roche
Servier
Novartis
Schering
Novo-Nordisk
Sanofi-Aventis etc
RDG
Information Society
Biopharmaceutical industry
EFPIA Board
EFPIA Committees
PhRMA S&R Committees
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Approach – Keep focus on the patients
National Governments
European Commission
SMEs
Industry
Patient
EMEA & national
authorities
Health Professionals
Academia & Hospitals
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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
50%
50%
IMI to be funded equally by pharma
industry and European Commission
100%
Research performed by industry
funded by industry
100%
Research performed by public
organisations funded by EC
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Key success factors
Constant/regular communication between EC and EFPIA
at all levels:
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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:
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Focus on science
–
Focus on patients
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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
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