The Innovative Medicines Initiative

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The Innovative Medicines Initiative A winning
case for Joint Technology Initiative Status
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In our discussion today

• Why Europe needs the Innovative Medicines
  Initiative
• About the Innovation Medicines Initiative
• What we need from you

3
Creating new medicines is a high risk journey
15
Medicine
Risk assessment analysis
Gaining approval
Studies in 100-300 patients (Phase II)
10
Extensive safety studies
Studies in healthy volunteers (Phase I)
Candidate
5
Formulations developed
Early safety studies
Screening
Synthesis of compounds
years
Idea
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Its time to re-establish our science base
before its too late

• Over the last decade, Europes share of the
  worlds pharmaceutical research and development
  has steadily decreased

Billion euros
5
Europe is losing its scientists

• The brain drain of researchers away from Europe
  is increasing
• 7 out of 10 European-born US doctorate recipients
  who graduated between 1991 and 2000 had no plans
  to return to Europe
• Source According to the European Commission 2003
  Brain Drain Study

6
Health matters to EU citizens too
Relative importance of national issues to
Europeans
in top 3 responses
Source Consensus Research (2004)
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Its an opportunity to regain EU competitiveness

• EU and Member States
• Gain competitive advantage for EU, if we act fast
  
• Significant economic value through small and
  large enterprises
• More effective healthcare
• Retain scientific talent and expand science base
• Public and private biomedical community
• Faster drug development process
• A framework for academia to work in priority
  areas and establish collaborations
• Vibrant and dynamic scientific environment

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And most importantly

• Patients / society
• Faster access to innovative therapies such as
  personalised medicines
• More knowledge-based jobs in the EU
• More education and training available in the
  biomedical arena

9
The population in the EU is ageing rapidly
10
The elderly consume more healthcare resources
United Kingdom
20
France
Spain
Germany
15
Average expenditure per head expressed as a
share of GDP per capita ( )
Italy
10
5
0
Age groups
Source Economic Policy Committee (2001)
Budgetary challenges posed by ageing populations
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New medicines bring value to patients, health
care systems and society

• Mortality rates in Europe have declined by almost
  40 over the last 30 years, thanks in part, to
  new medicines (EU Health Report)
• Spending on prescription medicines translates
  into overall cost savings for healthcare systems
  and society. When medicines are used to treat an
  illness, more expensive care such as surgery
  and hospital stays and lost school or work days
  can often be avoided or decreased

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Its about people living longer, healthier and
more productive lives
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In our discussion today

• Why Europe needs the Innovative Medicines
  Initiative
• About the Innovation Medicines Initiative
• What we need from you

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Science and technology advances
presentsignificant opportunities
Better understanding of disease/drug mechanisms
omics

Better medicines, faster
Imaging
Health benefits for EU citizens
IT
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It aims to improve the way new medicines are
discovered for the benefit of patients

• Key RD bottlenecks to overcome
• Safety Making medicines safer
• Efficacy Making Medicines more effective
• - Often disease specific, initial
  focus on
• 5 disease areas with high scientific
  challenges
• Cancer Brain disorders Inflammatory
  diseases, Diabetes and
• Infectious diseases
• 3. Knowledge Management Using new technologies
  to manage and organise data to create knowledge
  so scientists can predict benefit and risk of new
  therapies
• 4. Education and Training Addressing expertise
  gaps in Europe

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Our approach has already proven to work
Pilot project FP6 successfully completed

• 16 Companies 14 Universities 7 SMEs from
  across EU
• 18 mio euros including European Commission
  funding
• Biomarkers in Alzheimers Disease
• Better and earlier diagnosis of onset of disease
• Predictive Toxicology
• New approaches to measure earlier potential
  medicine side effects

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Recognised and supported by a wide community
All Patient Associations consulted are very
positive
UK enthusiastically supports the IMIs priorities
and goals
Mirror National Initiative are mushrooming in
Spain, Nordic countries, Poland, etc
France INSERM and its academic partners are
strongly supportive
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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
100
Research performed by public organisations funded
by EC

• Research performed by industry funded by industry

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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
  peoples health and wealth to society
• Focused on creating the environment which will
  enable important new medicines 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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In our discussion today

• Why Europe needs the Innovative Medicines
  Initiative
• About the Innovation Medicines Initiative
• What we need from you

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How you can help to create a healthier and more
competitive EU

• We would like to count on your help in
• Spreading the voice about IMI
• Keeping an eye on 7th FP calls
• Creating a strong collaboration between public
  and private entities

Creating biomedical RD leadership for Europe
to benefit patients and society
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The ultimate beneficiaries ...
People living longer, healthier and more
prosperous lives in the EU
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For further information

• http//europa.eu.int/comm/research/imi.html
• defraja_at_altaweb.eu