the innovative medicines initiative (imi) high-level meeting with member states on public-private...
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The Innovative Medicines Initiative (IMI)
High-Level Meeting with Member States
on Public-Private Partnerships in ResearchBrussels, November 11, 2005
Karima Boubekeur, F. Hoffmann-La Roche Ltd
2
Pharmaceutical R&D expenditure in Europe, USA and Japan (at 2003 constant exchange rates)
0
5
10
15
20
25
301
99
0
19
95
20
00
20
03
20
04
Japan Europe USA
Declining investment in R&D in Europe
European Commission is exploring ways to achieve the Lisbon goals
EFPIA sets the Priority of “Strengthening the EU Science base”
Innovative Medicines Initiative
Bil
lio
n e
uro
s
2004 figures are estimatedSource: EFPIA, PhRMA, JPMA
27.1
21.5
n.a.
3
Sector R&D investment as % of all sectorsEU top 500 companies – 101 bio euros 2003
Note: Sector of economic activities according to the Financial Times Stock Exchange (FTSE) index classification Data relate to the top 500 companies with registered offices in the EU ranked by the size of their R&D investments (over € 8.5 million)
Source: The 2004 EU industrial R&D investment scoreboard, European Commission
23,8
17,0
12,4
10,3
7,2
6,8
4,6
2,8
2,6
1,9
10,6
0 5 10 15 20 25
Automobiles & P arts
P harmaceuticals and Biotechnology
IP Hardware
Electronic & Electrical Equipment
Chemicals
Aerospace & Defence
Engineering & Machinery
Telecommunication Services
Software & Computer Services
Oil & Gas
Others (21 sectors)
4
The European Technology Platform:- a common European Vision - a common Strategic Research Agenda
The Vision
Creating biomedical R&D
leadership for Europe to benefit
patients and society
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Next steps2007 Joint Technology Initiative
FP6 Integrated
ProjectNov 2004
StrategicResearchAgendaJuly 2005
Gover-nance
Gover-nance
Intelect.Property
Intelect.PropertyPharma
cvigilance
Pharmacvigilance
2005Technology Platform
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The FP6 Integrated Project16 Companies – 12 Universities – 7 SMEs Biomarkers in Alzheimer’s Disease:
– 3 Companies: AstraZeneca, GSK, Lilly– 9 Universities: King’s College London, University of Kuopio,
Perugia, Stockholm, Toulouse, Karolinska, Southampton, Roskilde University, University College London,
– 6 SMEs: BioWisdom, Capsant, Cerebricon, Pharmidex, Proteome Sciences, Hunter Fleming
– 1 Association: Greek AD Association
Predictive Toxicology: – 13 Companies: Altana, Bayer, Boehringer-Ingelheim,
Johnson & Johnson, Merck AG, Novartis, Novo-Nordisk, Organon, Roche, Sanofi-Aventis, Schering, Serono, Servier
– 3 Universities: University of Wuerzburg, Dublin, and Istanbul
– 1 SME: Genedata
7
9%
34%
23%
16%
6%
3%9%
European Commission
Academia
Pharma
SME
Regulatory
Patient
Others
The Strategic Research AgendaContribution from over 350 stakeholders
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The Strategic Research AgendaInitial feedback from more stakeholders EMEA-CHMP: “The document is ambitious and most of
the points well taken”
France: “INSERM and its academic partners.. are strongly supportive of this initiative”
Ireland: “The initiative is worthwhile and sound”
The Netherlands: “in general we welcome this initiative”
Norway; ““An ambitious research agenda which addresses important topics with well coordinated plans”
“Sweden has a strong potential to contribute to the realisation of PPP, as the initiative suggests”
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Why a JTI?Unprecedented collaborative effort
Involving all stakeholders Covering the entire value chain Consensus about the scientific
recommendations Industry
SMEs Regulators
AcademiaPhysicians
Discoveryresearch
Preclinicaldevelop
Translationalmedicine
Clinicaldevelopment.
Pharmacovigilance
EU policymakers
MS Policymakers
Patients
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Why a JTI?Strong Industry Commitment
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Why a JTI? Innovative funding structure
Stakeholder Contribution How
EC Funding of the secretariatFunding of research
Contract between EC and secretariat and EFPIA and secretariat (50% each)
EFPIA Funding of the secretariat Contract between EC and secretariat and EFPIA and secretariat (50% each)
Pharmaceutical companies
ResearchDataInfrastructureExpertise
Funding via companies
Academia ResearchDataInfrastructureExpertise
Funding via IMI
SME ResearchDataExpertise
Funding via IMI and possibly loans from European Investment Bank
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Why a JTI?Implementation requires a different approach
Critical Success Factors
“Traditional” Framework Instruments
“New”Joint Technology
Initiative
Strategic co-ordination across projects X Integration of KMand E&T X Strong industry involvement X Streamlinedfocussed and efficientadministration
X
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The ETP on Innovative Medicines meets the JTI criteria proposed by the Commission (1) Added value of European-level intervention
– Requires co-ordination and application of EU-wide expertise (critical mass and synergies) and translation into regulatory process
The degree of clarity of definition of the objective to be pursued
– To apply advances in science and technology to the process of drug discovery and development as described in the Strategic Research Agenda
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The ETP on Innovative Medicines meets the JTI criteria proposed by the Commission (2) Strength of the financial and resource commitment
from industry– Industry will jointly fund the JTI secretariat and
100% of industry involvement
Importance of the contribution to broader policy objectives
– Important contribution to health and the Lisbon agenda
Capacity to attract additional national support and leverage current or future industrial funding
Inability of existing instruments to achieve the objective
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A Win: Win situation for all stakeholdersEspecially EU citizensEU Competitiveness
• Knowledge-based
economy
• 3% of GDP invested in
R&D
• Regain attractivenes
s for new technologies
• Stop brain drain
Biopharmaceutical R&D
•Better understanding of disease mechanisms
•Address R&D bottlenecks
•Get better medicines to
patients faster
Win : Win
• A collaborative science-based
culture
•Attracting new investment in
R&D
•Better medicines get
to patients faster
•Enlarged pool of talented scientists
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What we want – A positive outcome for all stakeholders
Vibrant and dynamic scientific environment
More effective healthcare
Creation of significant economic value through small and large enterprisesin Europe
Patient
Member States
Regulators
Academia
Industry
E C
And others…