1. Innovative Medicines Initiative:
The European response to the innovation challenge in the pharmaceutical sector
Michel Goldman, MD, PhD
Executive Director

2. The Productivity Gap in Pharma R&D60
$55 50 50 45 40 40 35 30
New Drug Approvals
Pharma R&D ($ billions) 30 25 20 20 15 10 10 5 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07
Source: Burrill & Company; US Food and Drug Administration. 2

3. The Decline of Pharmaceutical Industry in Europe
USA
Best selling medicines
R&D Sites ( ) 10 20
Closed
New 5 10
1992
2005
Source: EFPIA & IFPMA

4. Innovative Medicines Initiative: Joining Forces in the Healthcare Sector
2 Billion Euro
1 Billion €
1 Billion €
Public Private
Partnership

5. 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

6. 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

7. Private Investment ‘n kind (€1 billion)
A Typical IMI Consortium
EFPIA
Private
Investment
‘n kind
(€1 billion)
Pharma 4
Pharma 1
Pharma 5
Pharma 2
Pharma 6
Pharma 3
SMALL AND MEDIUM-SIZED ENTERPRISES
ACADEMIA
EU Public
Funding
cash
(€1 billion)
PATIENTS’ ORGANISATIONS
HOSPITALS
REGULATORS

8. Key Concepts Non-competitive research for EFPIA companies
Competitive calls for IMI beneficiaries
Open collaboration in public-private consortia

9. Science Translational Medicine (2011), 76: 1-2

10. 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

11. Nature Medicine 18:341, 2012

12. 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

13. Overview of IMI projects
* Small and medium-sized enterprises

14. Non-Competitive Research
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

15. THANK YOU !