Presentation from the conference Science diplomacy in action Governance for international science co-operation: the example of Health Research 11-12 February, 2013, arranged by the French and British embassies as a follow up to the OECD STIG project, see http://beyondstig.oecd.org

1. Boosting drug development through Public-
Private Partnerships: The IMI Model
Hugh Laverty
Senior Scientific Project Manager
Science Diplomacy in Action - Paris Feb 2013

2. The Challenges
Difficulties reaching international agreement on common
priorities
Insufficient modalities of funding
Obstacles to the transfer of science, technology and
innovation into practice
Insufficient participation of relevant actors in society
The lack of integration of countries with weak scientific
infrastructure
Problems of intellectual property mangement for
applications of new technologies

3. The role of Public-Private Partnerships in
driving international science co-operation
PPPs originated in areas focusing on neglected or orphan
diseases, or helping poorer countries
The approach to PPPs has evolved and the model is being
applied to other areas e.g., chronic diseases, and more
mature economies
The emergence of PPPs has been helped by a convergence
of different pressures such as societal, health care and
economic

4. Challenges for society and industry
Society Industry
• Healthcare challenges • Costs for developing new drugs
continue to raise around the continue to increase
world
• Pharma incentive systems and
profitability are under pressure
• A lot of these challenges are
not addressed • We are pushing towards
Personalized Medicine but in
• Pressure on healthcare general, progress in basic science
systems and budgets continue is not translated to medical
to rise innovation and benefits to
patients

5. Innovative Medicines Initiative
The European Union and the
pharmaceutical industry
have joined forces to make
drug R&D processes in Europe more
innovative and efficient
and enhance Europe’s
competitiveness in the sector
& address key societal challenges
by forming
the biggest PPP in Life Science

6. IMI Governance

7. IMI Project Architecture
A Typical IMI Consortium
Private EFPIA
40 Projects
Investment Pharma
1
Pharma
4
in kind Pharma Pharma
2 5 362 EFPIA teams
(€ 1 billion)
Pharma Pharma
3 6
557 Academic &
research teams
SMALL AND
ACADEMIA MEDIUM-SIZED
EU Public ENTERPRISES
91 SMEs
Funding PATIENTS’
cash ORGANISATIONS
16 Patient organisations
(€ 1 billion)
HOSPITALS REGULATORS 6 Regulators

8. Value Chain Coverage - Calls

9. Antibiotic drug development:
‘New Drugs 4 Bad Bugs’
Challenges of AB R&D:
• Unique scientific
bottlenecks
• Challenging
regulatory
environment
• Low return on
investment
Challenges too great for any single entity to solve,
collaboration is essential

10. Antibiotic drug development:
Major challenges
Scientific challenge: screening approaches often fail,
difficult to obtain needed spectrum & safety—challenge
increased for Gram-negative pathogens due to inherent
penetration barriers
Regulatory challenge: large trials needed, non-
inferiority designs, etc.
Economic challenge: (low Return on Investment) ABs
expensive to develop, often give cure in days, new ABs
will be used only when truly needed

11. European Lead Factory
 Joint European Compound Library
Joint European Compound Library
accessible for private and public
lead discovery projects
 JECL is comprised of a Pharma
Consortium Collection (≥ 300.000
compounds) and a Public Collection
(up to 200.000 cpds.)
 The Screening Centre – as an
independent novel business
entity – takes responsibility for
cpd. logistics, HTS (internal and
out-sourced), data analysis &
handling, and project mgtm.
 Screening Centre functions as a
market place to broker public-private
discovery projects with the Pharma Consortium

12. How IMI makes a difference
Fosters large scale industry collaboration and engagement
with scientific community
Promotes active involvement of patients, regulators and
payers
Enables innovation via join effort where singular
approach has failed so far
Facilitates Intellectual Property agreements

13. One IMI IP policy, multiple interests
Direct exploitation rights
(academia /SME) Facilitating Fair and reasonable terms
Terms known at outset access for Research Use purposes
(Pharma) for third parties
Dissemination
Incentive to of information
participate
Dissemination
Innovative Medicines within a year
Support for Compensation
EU for IP
Industry
Terms accommodate the needs of
Only necessary background included
a spectrum of interests - large and
Compensation within fair and reasonable
small
terms

14. The Evolution of IMI
From bottlenecks in industry to bottlenecks in society
From push to pull – business & HC impact
+ Drive Regulatory Change
What: translate science into regulatory
Need for a neutral platform
pathways: real life data
How: Collaborate with regulators and payers
Since 2012
+ Facilitate ‘pull’ incentives
What: Reconcile research and health care agendas
How: Engage with regulators and payers
Since 2011
Reduce Attrition and Time to Market
What: Decrease risk by developing improved tools and methodologies, secure
sustainability of outputs
How: Large scale industry collaboration and engagement with scientific community
Since 2008
R&D cycle: From inventive to innovative steps

15. The Challenges
Difficulties reaching international agreement on common
priorities
Insufficient modalities of funding
Obstacles to the transfer of science, technology and
innovation into practice
Insufficient participation of relevant actors in society
The lack of integration of countries with weak scientific
infrastructure
Problems of intellectual property mangement for
applications of new technologies

16. The Challenges
Difficulties reaching international agreement on common
priorities
Insufficient modalities of funding
Obstacles to the transfer of science, technology and
innovation into practice
Insufficient participation of relevant actors in society
The lack of integration of countries with weak scientific
infrastructure
Problems of intellectual property management for
applications of new technologies

17. Ensuring success from future global
initiatives
Mechanisms to allow individuals and institutions
to engage internationally
Inclusive and flexible approach
Clearly defined IPR Policy
Focus on addressing societal needs
Neutral broker