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The Innovative Medicines InitiativeA winning case for Joint Technology Initiative Status
In our discussion today …
1. Why Europe needs the Innovative Medicines Initiative
2. About the Innovation Medicines Initiative
3. What we need from you
Creating new medicines is a high risk journey15
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
It’s time to re-establish our science base – before it’s too late
Over the last decade, Europe’s share of the world’s pharmaceutical research and development has steadily decreased
0
5
10
15
20
25
30
19
90
19
95
20
00
20
03
20
04
Japan Europe USA
Billio
n eu
ros
Europe is losing it’s 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’
Health matters to EU citizens too
41
47
54
6667
68
68
7172
77
80
0 10 20 30 40 50 60 70 80 90 100
Immigration Issues
Public Housing
Narcotics/ drug addiction
Crime/ law enforcement
Social Benefits
Environmental Protection
Anti-terrorism
Inflation/ cost of living
Education/ schools
Quality of Health Care
Job Creation
Source : Consensus Research (2004)
% in top 3 responses
Relative importance of national issues to Europeans
It’s 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
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
15-24 years
55-64 years
Absolute size in millions for young and old age groups for EU 25, 1995-2030
Mil
lio
ns
40
45
50
55
60
65
70
1995 2000 2005 2010 2015 2020 2025 2030
The population in the EU is ageing rapidly
Italy
France
United Kingdom
GermanySpain
0
5
10
15
20
Ave
rag
e ex
pen
dit
ure
per
hea
d e
xpre
ssed
as
a sh
are
of
GD
P p
er c
apit
a (%
)
0-4 5-9 10-14
15-19
20-24
25-29
30-34
35-39
40-44
45-49
50-54
55-59
60-64
65-69
70-74
75-79
80-84
85-89
90-94
95+
Age groups
Source: Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations”
The elderly consume more healthcare resources
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
It’s about people living longer, healthier and more productive lives
In our discussion today …
1. Why Europe needs the Innovative Medicines Initiative
2. About the Innovation Medicines Initiative 3. What we need from you
‘omics
IT
Imaging
Better understanding of disease/drug mechanisms
Better medicines, faster
Health benefits for EU citizens
More efficient drug discovery and development
Science and technology advances presentsignificant opportunities
Collaborative Research
It aims to improve the way new medicines are discovered for the benefit of patients
Key R&D bottlenecks to overcome:1. Safety: Making medicines safer2. 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 diseases3. 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
Our approach has already proven to work
16 Companies – 14 Universities – 7 SMEs from across EU 18 mio euros including European Commission funding Biomarkers in Alzheimer’s Disease:
Better and earlier diagnosis of onset of disease
Predictive Toxicology: New approaches to measure earlier potential medicine side effects
Pilot project – FP6 – successfully completed
Recognised and supported by a wide community
Patients
Member State policy makers
Regulators
Academia
Research based pharmaceutical
Industry
EU Policy Makers
Physicians / healthcare
professionals
SMEs
UK enthusiastically supports the IMI’s priorities and goals
All PatientAssociations consulted are very positive
Mirror National Initiative are mushrooming in Spain, Nordic countries, Poland, etc
France: INSERM and its academic partners are strongly supportive
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%
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 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
In our discussion today …
1. Why Europe needs the Innovative Medicines Initiative
2. About the Innovation Medicines Initiative 3. What we need from you
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 IMIKeeping an eye on 7th FP callsCreating a strong collaboration between public and private entities
Creating biomedical R&D leadership for Europe to benefit patients and society
The ultimate beneficiaries ...
People living longer, healthier and more prosperous lives in the EU
