Transcript Governing Board - 8 June 2011 - EESC European Economic and

Innovative Medicines Initiative:
The European response to the innovation
challenge in the pharmaceutical sector
Michel Goldman, MD, PhD
Executive Director
The Productivity Gap in Pharma
R&D
60
$55
50
45
40
40
35
30
30
25
20
20
15
10
10
5
0
92
93
94
95
96
97
98
99
00
01
02
03
04
Source: Burrill & Company; US Food and Drug Administration.
05
06
07
0
Pharma R&D ($ billions)
New Drug Approvals
50
The Decline of Pharmaceutical
Industry in Europe
Europe
Best selling medicines
10
20
5
10
1992
2005
USA
R&D Sites (2002-2006)
Closed
New
Source: EFPIA & IFPMA
Innovative Medicines Initiative:
Joining Forces in the Healthcare Sector
2 Billion Euro
1 Billion €
Public
1 Billion €
Partnership
Private
Core objectives defined in 2007
•
To overcome research bottlenecks in drug development
through collaborative approaches
•
To increase investments in the biopharmaceutical sector
and provide socio-economic benefits across Europe
•
To contribute to the health of European citizens
Key Hurdles in R&D
• Knowledge fragmentation
• Insufficient mechanistic understanding
• Disease heterogeneity
• Multitude of unvalidated models
• Lack of predictive biomarkers for drug efficacy/ safety
• Insufficient pharmacovigilance tools
• Need for improved manufacturing
• Late involvement of regulators
• Insufficient involvement of patients
• Inappropriate clinical designs
• Insufficient incentives for industry
A Typical IMI Consortium
EFPIA
Private
Investment
‘n kind
(€1 billion)
EU Public
Funding
cash
(€1 billion)
Pharma 4
Pharma 1
Pharma 2
Pharma 5
Pharma 6
Pharma 3
SMALL AND
MEDIUM-SIZED
ENTERPRISES
ACADEMIA
PATIENTS’
ORGANISATIONS
HOSPITALS
REGULATORS
Key Concepts
• Non-competitive research for EFPIA companies
• Competitive calls for IMI beneficiaries
• Open collaboration in public-private consortia
Science Translational Medicine (2011), 76: 1-2
IMI Executive Office as a
Neutral Third-Party
• Ensures that projects are carried out in the
common interest of all stakeholders
• Guarantees fair conditions for knowledge
exploitation and dissemination
• Facilitates the dialog between industry, patients’
organizations and regulatory agencies
Nature Medicine 18:341, 2012
Intellectual property
• Facilitation of Call 2 and Call 3 agreements (“honest broker”)
• IMI Policy recognized as “model” for PPPs
Science Translational Medicine
22 February 2012
Overview of IMI projects
* Small and medium-sized enterprises
Key Deliverables of
Non-Competitive Research
• Establishment of common databases
• New tools for identification of drug targets
• Standardization of models and assays
for drug efficacy and safety
• Patient reported outcomes
• Classification of diseases
THANK YOU !