BioPharma Summit

1. John Kiernan
Managing Director
Quintiles Ireland Limited
Vice President Quintiles Commercial
Ireland & the Nordics
Global Bio Pharma Summit
NCC Dublin, Ireland
31st October 2012
Copyright © 2012 Quintiles

2. Three Areas
1. Pharmaceutical Research & Development
2. The changing health landscape
3. The New Healthcare Model for the Future.
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3. www.glasbergen.com 3

4. Clinical Research &
Development
The Challenges & the Opportunities
Copyright © 2012 Quintiles

5. The development of new medicines
has contributed enormously to life
expectancy and to the quality of life
of mankind over the past 60 years.
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6. Life Expectancy
Globally
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7. Life Expectancy
Between 10 and 30 years added in past 50 years.
“New drugs are no small part of this medical miracle” – Mark McClellan, FDA*
*Source: CDC 7

8. New medicines contribute 40% to 60% of
gains in life expectancy: 1988-2000
2.5
Number of Years Increased Longevity
Increase in Longevity Due to
New Drug Launches
Total Increase in Longevity 1.96
2.0
1.65
1.5 1.37
1.07
1.0
0.76 0.79
0.70
0.57 0.62
0.56
0.5 0.45
0.30
0.23
0.12
0.0
1988 1990 1992 1994 1996 1998 2000
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9. The therapeutic revolution
• 1,095 Novel Drug Therapies: 1963-2011
1960s Beta blockers
1970s Cancer drugs, ACE inhibitors
1980s Antipsychotics, Antidepressants, Antivirals (Herpes; HIV),
First monoclonal antibody (OKT)
1990s Alzheimer’s drugs, Smoking cessation drugs,
Asthma (corticosteroids), Statins (cholesterol reducers)
2000s First cancer vaccine (HPV),
First gene therapy (neck cancer)
Sources: FDA; Dorland Healthcare Information, 2004
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10. Source: Lichtenberg, National Bureau of Economic Research
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11. Global Research Based Pharmaceutical
Industry
Global Sales $825bn
Annual Global Spend on R&D $68bn
Proportion outsourced to CROs 44%
Global Revenues for CROs c.$28.2bn
CRO Employees globally c.120,000
Bio Pharma R&D Employees Ireland c.2,000
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12. Pharmaceutical Healthcare Facts and Figures
Life Cycle of an Innovative
2012
Medicine
Estimated cost of development
$1.3bn to $1.8bn.
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13. Rising costs threaten
healthcare advances…
Clinical Drug Development:
• Time: 7 to 10 years
• Cost: $1.3 billion per approval
• Success Rate: 8% for candidates entering Phase I
U.S. Health Expenditure:
• 13.6% of GDP in 2000
• 18.2% of GDP in 2011
Ireland Health Expenditure: IPHA , 3rd Oct
• 13,317m 2012
• 9.5% GDP (2009)
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14. Changing New Health Landscape
Divergent Challenging
economic biopharma
conditions environment
Promise of
Rise of technological
new markets (r)evolution
Socio- Strained
demographic healthcare
shifts environment
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15. The current environment
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16. The Current Environment for BioPharma
Regulatory Pressures:
Complexity of technology/innovation Development Pressures:
Approval Times Stakeholders Scrutiny
Intense FDA/EMA Scrutiny Patient Access Demands
Ethical Concerns & Patients needed Commercialization Stakeholders
Numerous Regulatory Agencies R&D Timelines
Health Technology Assessment Productivity
Real World evaluation Patent Cliff
Financial Pressures: Product Pipelines
Costs
Capital Constraints
Demand for Value
Payer Pressure
ROI
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17. Other factors impacting BioPharma
 Population changes
 New technologies and Screening procedures
 Escalating health care costs
 Public expectations and patient empowerment
 Information sources…internet, TV…
 Disease areas
 Personalisation of medicine
 Global economic environment
 Market Access
 Real world analysis and value determination.
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18. Map of All Studies in ClinicalTrials.gov
25th October 2012
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19. Map of European Studies
October 25th, 2012
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20. Clinical Trials - Globally
Currently 134,668
Total Open
United States 64766 19339
Canada 10128 3213
Germany 9462 2842
France 8251 3118
UK 7119 2271
Italy 5386 1758
Total Open
Spain 4808 1743 Denmark 3403 1061
Netherlands 4308 1324 Sweden 2816 740
Belgium 4057 1141 Norway 1899 536
Total Open
Ireland 691 209
Source: www.clinicaltrials.gov 20

21. Clinical Trials - USA
• Currently 64,766
Total Open
California
Texas
17765
14759
4306
3445
Ireland
691 / 209 / 4.6m
New York 14733 3667
Florida 11726 2436
Maryland 10957 2905
Ohio 10564 2376
Total Open Population
Rhode Island 2282 491 1m
New Hampshire 1392 338 1.3m
Vermont 1298 248 0.6m
Hawaii 1283 253 1.4m
Source: www.clinicaltrials.gov 21

22. • More than half the clinical trials being
conducted worldwide are happening in
North America
>United States / Canada 56%
26% in
Ireland Europe
is 1.9%
European total
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23. Greater Stakeholder Cooperation
Culture of innovation & collaboration
• Academia
• Industry
• Government
• Health Service
> Clinical research is an integral part of medical education.
• Patient
> Patient advocacy
> Awareness
Bourne out of a greater level of trust, confidence and a
belief that all stake-holders have a shared goal of
delivering improved health outcomes for patients
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24. What is a CRO?
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25. What is a Clinical Research Organization?
• A contract research organization (CRO) is a service organization that
provides support to the pharmaceutical and biotechnology industries
in the form of research & development services outsourced on a
contract basis.
• A CRO can provide such services as biopharmaceutical
development, preclinical research, clinical research, and clinical trials
management. Many CROs (but not all CROs) specifically provide clinical-
study and clinical-trial support for drugs and/or medical devices. CROs
range from large, international full-service organizations to small, niche
specialty groups. CROs that specialize clinical-trials services can offer their
clients the expertise of moving a new drug or device from its conception to
FDA/EMA marketing approval, without the drug sponsor having to maintain
a staff for these services.
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26. Medicinal Product Continuum
Phase I and Labs Clinical Global Consulting Commercial
Development Data Strategic
Services Management Research
Services
New Clinical Central Clinical DM SRS Sales &
Chemical Phase I Laboratories Phases II - III Marketing
Entity Outcomes /Real
World data
Healthy Bio-sample Clinical Trial
discovery
discovery Volunteers AnalysisGlobal Product Development Data
Patients Patients Prescribers
commercial services
Confidence in drug & disease
Uncertainty indication.
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27. Market size and Growth
CRO Market Share of global R&D Value
CRO market by drug phase ($bn), 2010
50.00 66% 70%
45 42.6
45.00 58% 43.87
60% 40 38.3
40.00 39.88 34.6
50% 35
50%
Billions of dollars
35.00 31.2
44% 34.68
30 28.2
30.00 38% 30.15 25.5
40% 25 23.2
$bn
25.00 33% 26.22
22.80 30%
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20.00
15
15.00 20% 10
10.00
5
10%
5.00
0
0.00 0% 2010 2011 2012 2013 2014 2015 2016
2010 2011 2012 2013 2014 2015 Source: Business Insights
US Western Europe Eastern Europe China
India Other Asia Latin America Other
Ref: ACRO – Association of Clinical Research Ref: CRO Market Outlook to 2016 / Business Insights
Organizations
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28. Market size and Growth
• A significant portion of R&D budgets are used for outsourcing services offered
by the CRO industry, approximately $20 billion in 2010.
• This figure is expected to grow at 15% p.a. over the next 4 years and will
increase further with the broadening of the spectrum of services outsourced to
cover the entire value chain.
• Currently the bio-pharmaceutical industry outsources approximately 33% of it’s
R&D* spend globally and this is anticipated to grow by 15% annually over the
next 5 years.
* It is estimated that in 2010 over 60% of all biopharmaceutical product development spend was outsourced.
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29. CRO Global Employment Numbers
Employees
180000 161051
160000 146410
140000 121000
133100
120000 110000
100000
100000
80000 66000
60000
40000
20000
0
2008 2010 2011 2012 2013 2014 2015
Ref: ACRO – Association of Clinical Research Organizations
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30. End-to-end Development Solutions
Full Service CRO / PSC (Pharmaceutical Services Company)
• Portfolio Planning > Life Cycle Safety
• Biomarker Development > Medical Device Services
• Global Regulatory Strategy > Post-Marketing Surveillance
• Central Laboratory Services > Rx to OTC Switch
• Cardiac Safety Services > Finance Policy Consulting
• Data Management > Outcomes Research
• Biostatistics > Health Economics
Clinical Go-to-
Integrated
Coachin Disease
Modeling Trial Regulatory Market Market
Full Suite of
g Translational Management
and Management Agency Phase IV Research, Comme Post
Clinical Research & Rx to OTC
Simulation Phase I, II & Submission rcialisation & Approval
Services Switch
III Global Market Services
Access
Fully Integrated Biopharma Services Provider 30

31. The Challenge: Reinvent Healthcare
Models
Clinical Drug Development
• Time: up to 10 years
• Cost: >$1.3 billion per approval
• Success Rates: as low as 8%
Healthcare Delivery
• Lacks population level safety evaluation
• Lacks population level treatment outcomes
2010 Health Expenditure: US 17.6% of GDP
EU 9.6% of GDP
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32. Evidence-based medicine
Two Frontiers
Going DEEPER: Going BROADER:
Understanding Understanding
Disease Causality Real-world Outcomes
• Genetics
• Proteomics • Large Population Databases
• Cellular lineages and • Data Analytics
environments
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33. Data, Data Everywhere
New data resources and tools to use them will be the
means to improve health outcomes and reduce costs
EXPANDING
SOPHISTICATED MODELING &
DATABASES
ANALYTICS SIMULATION
Genetics Databases to ask “What If” to test treatment
questions and cost options
Observational &
EHR Databases
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34. Emerging Model:
Research-Care Convergence
Leveraging data across all sectors to improve decision-
making…
• Evidence-based drug design
• Evidence-based therapeutic evaluation
• Evidence-based policy and economics
Healthcare must measure standards of care and
cost—and then exceed them—or pay more and
more for sub-optimal solutions.
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35. Convergence in Three Arenas
Therapeutic Innovation
• Targeted therapeutics
• Personalized medicine
Patient Care
• Outcomes evaluation in real-world populations
• Comparative effectiveness/ optimal interventions
Health Management
• Cost-effectiveness / value-based pricing
• Improved resource allocation
• Prevention / positive health behavior programs
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36. Future Focus
Cultural
Change in
Medical
Education
Better
Greater
Patient
Stakeholder
Engageme
Cooperation
nt
Real
Evidence
world
/ Value
research
based
outcome
medicine
s
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37. Thank You
john.kiernan@quintiles.com
Quintiles Ireland Limited, Registration No. 162942 VAT Registration No. IE 6562942T Directors: John G Kiernan (Managing) Alasdair MacDonald UK Michael Wilson UK
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