Transcript Document

The Innovative Medicines Initiative

A winning case for Joint Technology Initiative Status

In our discussion today … 1.

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

5 15 Creating new medicines is a high risk journey Medicine Risk assessment analysis Gaining approval 10 Studies in 100-300 patients (Phase II) Studies in healthy volunteers (Phase I) Synthesis of compounds Extensive safety studies Candidate Formulations developed Early safety studies Screening years Idea

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 30 25 20 15 10 5 0 Japan Europe USA

Europe is losing it’s scientists

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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 Relative importance of national issues to Europeans % in top 3 responses Job Creation Quality of Health Care Education/schools Inflation/cost of living Anti-terrorism Environmental Protection Social Benefits Crime/law enforcement Narcotics/drug addiction Public Housing Immigration Issues 0 10 20 30 54 40 41 47 50 60 68 68 67 66 72 71 80 77 70 80 90 100

Source : Consensus Research (2004 )

It’s an opportunity to regain EU competitiveness

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EU and Member States

Gain competitive advantage for EU, if we act fast

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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

The population in the EU is ageing rapidly 70 65 60 55 55-64 years 50 45 15-24 years 40 1995 2000 2005 2010 2015 2020 2025

Absolute size in millions for young and old age groups for EU 25, 1995-2030

2030

The elderly consume more healthcare resources

20 15

Spain United Kingdom France Germany Italy

10 5 0 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”

New medicines bring value to patients, health care systems and society

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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 …

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

Science and technology advances present significant opportunities ‘omics Better understanding of disease/drug mechanisms More efficient drug discovery and development Collaborative Research Imaging Better medicines, faster IT Health benefits for EU citizens

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 safer

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Efficacy: Making Medicines more effective - O ften disease specific, initial focus on 5 disease areas with high scientific challenges: Cancer; Brain disorders; Inflammatory diseases, Diabetes and Infectious diseases Knowledge Management: Using new technologies to manage and organise data to create knowledge so scientists can predict benefit and risk of new therapies Education and Training: Addressing expertise gaps in Europe

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 Alzheimer’s Disease: 

Better and earlier diagnosis of onset of disease

Predictive Toxicology: 

New approaches to measure earlier potential medicine side effects

Recognised and supported by a wide community All Patient Associations consulted are very positive EU Policy Makers Member State policy makers Research based pharmaceutical Industry Patients SMEs Regulators France: INSERM and its academic partners are strongly supportive Physicians / healthcare professionals Academia UK enthusiastically supports the IMI’s priorities and goals Mirror National Initiative are mushrooming in Spain, Nordic countries, Poland, etc

Industry will not be funded by the EC 100% 50% 50% IMI to be funded equally by pharma industry and European Commission Research performed by industry funded by industry 100% Research performed by public organisations funded by EC

IMI - A compelling case for JTI Status

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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 …

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Why Europe needs the Innovative Medicines Initiative About the Innovation Medicines Initiative 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 IMI Keeping an eye on 7 th FP calls Creating 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

For further information…

http://europa.eu.int/comm/research/imi.html

[email protected]