Potential for PPP's

1. Potential for PPPs

2. What
• More than
– Clinical trial agreements
– Sponsorships
– Technology transfer agreements
• Long contract
• Complex Goals

3. Reasons for PPPs
• Collaborative environment
– Maximise cross-disciplinary expertise
– Solve complex problems
– Maximise resources
– Share risk
• Not just looking for industry finance

4. What’s In it for the Population?
Therapeutic Area Impact and Benefits
Heart disease Increased survival; treatments contributing to both the prevention
and management of the disease
Diabetes Delayed onset of complications; improved disease management
and patient outcomes
Cancer Reduction in mortality despite increase in incidence; evolution of
personalised medicine offers improved efficacy
Infectious diseases Treatment and prevention of diseases resulting in decreased
incidence of several more common diseases
Rheumatoid arthritis Inhibition of disease progression; reduced morbidity
Orphan diseases Enhanced survival; addressing unmet need of small patient
populations
Mental health Newer medications offer fewer unwanted side effects and
reduced rates of patients residing in psychiatric units

5. What’s In It for Industry?
Pharmaceutical
innovation
Prevention of illness
Inhibition and reversal of
disease-related damage
Reduced disease progression
and disease-related events
Increased survival
Improved public
health and
increased life
expectancy
Social benefits and improved
quality of life
Reduced adverse events
Increased therapeutic
options
Continued pharmaceutical innovation is vital for the continued improvement of public
health

6. Key Hurdles in Pharma R&D
• Disease heterogeneity
• Lack of predictive biomarkers
for drug efficacy/ safety
• Insufficient pharmacovigilance tools
• Unadapted clinical designs
• Societal bottlenecks
• Lack of incentive for industry

7. Why are we doing so poorly?
The IOM Quality Chasm
report says:
• “The current care systems
cannot do the job.”
• “Trying harder will not
work.”
• “Changing care systems
will.”

8. Informed,
Activated
Patient
Productive
Interactions
Prepared,
Proactive
Practice Team
Improved Outcomes
Delivery
System
Design
Decision
Support
Clinical
Information
Systems
Self-
Management
Support
Health System
Resources and Policies
Community
Health Care Organization
Chronic Care Model

9. Shojania, K. G. et al. JAMA 2006;296:427-440.
The Effectiveness of QI Strategies: Findings from a Recent
Review of Diabetes Care

10. What are the Issues?
• Tachibana Nutrition Reviews® Vol. 71(10):682–691
“Industry-academic collaborations are like partners
skilled in different dances trying to reach a compromise
between waltz and salsa. Rhythms, pace, and expected
outcomes can be frustratingly at odds, as university
researchers prioritize education and basic research and
corporate scientists pursue products and profits.
Success depends on finding common goals and
negotiating plans that pay off financially and
intellectually for all parties.”

11. Nature
Medicine
18: 341, 2012

12. Suggested Rules (1)
1. Have a clearly defined and achievable goal to improve the
health of the public
2. Articulate a clear statement of work, rules, and partner
roles, responsibilities, and accountability, to build in trust,
transparency, and mutual respect as core operating
principles – acknowledging there may be “deal breakers”
precluding the formation of an effective partnership in the
first place
3. Ensure that objectives will meet stakeholder partners’
needs, with a clearly defined baseline to monitor progress
and measure success
4. Considering the importance of balance, ensure that all
members possess appropriate levels of bar- gaining power

13. Suggested Rules (2)
5. Minimize conflict of interest by recruiting a sufficient
number of partners to mitigate influence by any single
member and to broaden private-sector perspectives and
expertise
6. Engage partners who agree upon specific and fundable
research question(s) to be addressed by the partnership
7. Enlist partners who are committed to the long- term goals as
well as to the sharing of funding and research data
8. Along with government and the private sector, include
academics and other members of civil society as partners

14. Suggested Rules (3)
9. Select objective scientific measurements capable of
providing common ground for both public- and private-
sector research goals
10. Adopt research questions and methodologies established by
partners with no vested financial interest in them, ideally in
the precompetitive space
11. Be flexible and ensure ongoing transparent communications
12. Consider a third-party convener to ensure equality at the
table, clarify rules, establish operational guidelines, and
specify funding arrangements.

15. Executive
Director
(+ staff)
Example – IMI management
IMI JTI = IMI JU + External Advisory Groups
Stakeholder
Forum
IMI States
Representatives
Group
IMIJointUndertaking(IMIJU)
Scientific Committee
Governing Board
(5 EFPIA + 5 EC)

16. IMI Projects Address Hurdles in R&D

17. The two approaches to organising
clinical research in Ireland
University led Disease group led
ICTRIN
iPROSPECT (€750K grant)
NPCRC
BREAST PREDICT (€7.5M)

18. Significant investment committed to
infrastructure
PRTLI FUNDED HRB FUNDED €42.5m

19. Early recognition of need for a
collaborative approach….
• Result of PRTLI funding
of infrastructure
• Formed in 2006
• Operating within MMI
• Core funding by HRB
and HSE
• Clinical trials liaison
officer funded by EI
• Goal was to share
support services