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
8
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
9
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
11
12. Pharmaceutical Healthcare Facts and Figures
Life Cycle of an Innovative
2012
Medicine
Estimated cost of development
$1.3bn to $1.8bn.
12
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)
13
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
14
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
16
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.
17
18. Map of All Studies in ClinicalTrials.gov
25th October 2012
18
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
22
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
23
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.
25
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.
26
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%
20
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
27
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.
28
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
29
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
31
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
32
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
33
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.
34
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
35
36. Future Focus
Cultural
Change in
Medical
Education
Better
Greater
Patient
Stakeholder
Engageme
Cooperation
nt
Real
Evidence
world
/ Value
research
based
outcome
medicine
s
36
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
37
Notas do Editor
Declining productivityIncreasing costsIncreasing complexityBigger and more difficult challengesDecreased willingness to pay by governments (society)Opportunities remainMuch more now about the quality of life as against the earlier focus on the length of a life.
In many ways this cartoon tells the story of the success of modern medicine and healthcare over the past 60 years.
Ireland 69.7 in 1960, to 71 in 1970 to ………..80.4 in 2010China 43 in 1960 to 73 in 2010.India 42 to 65.USA 70 in 1960 t0 71 in 1970 to 78 in 2010UK 71 IN 1960 TO 72 IN 1970 to 80.4 in 2010In the developed world the average increase in life expectancy has risen by around 10 yearsIn Asia it’s nearly 30 yearsIn Africa it’s between 15 and 20 years
Pharma spend around 8% of revenues on R&D every year.
57% of all are in North America ( 48% in the US, 7.5% in Canada)26% in EuropeIndia and China are growing fast with over 5000 studies combined. (3000 in China, 2000 in India)About 2,500 in Russia and the CIS countries
This is an industry that was virtually non existent 30 years ago.
So, let’s take a closer look as to how our services can be tailored to meet the needs of your program. You will benefit from our comprehensive menu of high-quality services, which you can use in combination to gain even greater value. Our clinical development services include the design and execution of trials, as well as support in finding new efficiencies within your existing clinical trial framework and in forging new models for clinical development. When trial services are purchased as an integrated whole, you receive a broad range of benefits due to the integration, including lower overall study costs, reduced timelines and simplified trial management. We also serve as a functional service provider of outsourced services development, working with you to find the model that will bring you the highest return on investment. Some of the decentralized functions and activities outsourced to us by customers in FSP models include clinical monitoring, data management, pharmacovigilance, biostatistics, medical writing, and IVR.Our late phase services provide you the support you need to determine what’s going on with your product once it enters the marketplace. They include observational studies/safety surveillance, Rx to OTC switch monitoring, claims and alternate indication studies, and outcomes studies.Importantly, in addition to actual clinical trial development, we also provide advisory services that focus on the operational elements that impact your product. These services include: consulting, capital investment, scientific advisory boards, CRA training.We also provide regulatory services, including regulatory submissions, regulatory consulting and IND preparation, to help ensure that your trial begins and ends in a way that is within full compliance.