john kiernan, vice president & managing director, quintiles ireland
DESCRIPTION
BioPharma SummitTRANSCRIPT
Copyright © 2012 Quintiles
John KiernanManaging Director
Quintiles Ireland LimitedVice President Quintiles Commercial
Ireland & the NordicsGlobal Bio Pharma Summit
NCC Dublin, Ireland31st October 2012
2
Three Areas
1. Pharmaceutical Research & Development
2. The changing health landscape
3. The New Healthcare Model for the Future.
3www.glasbergen.com
Copyright © 2012 Quintiles
Clinical Research & Development
The Challenges & the Opportunities
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.
6
Life ExpectancyGlobally
7
Life ExpectancyBetween 10 and 30 years added in past 50 years.
“New drugs are no small part of this medical miracle” – Mark McClellan, FDA*
*Source: CDC
8
New medicines contribute 40% to 60% of gains in life expectancy: 1988-2000
• Source: Lichtenberg, National Bureau of Economic Research, June 2003
0.120.23
0.30
0.570.45
0.76
0.56
1.07
0.62
1.37
0.70
1.65
0.79
1.96
0.0
0.5
1.0
1.5
2.0
2.5
Num
ber of Y
ears
Incre
ased L
ongevity
1988 1990 1992 1994 1996 1998 2000
Increase in Longevity Due toNew Drug Launches
Total Increase in Longevity
9
The therapeutic revolution• 1,095 Novel Drug Therapies: 1963-2011
Sources: FDA; Dorland Healthcare Information, 2004
Beta blockers
Cancer drugs, ACE inhibitors
Antipsychotics, Antidepressants, Antivirals (Herpes; HIV), First monoclonal antibody (OKT)
Alzheimer’s drugs, Smoking cessation drugs, Asthma (corticosteroids), Statins (cholesterol reducers)
First cancer vaccine (HPV), First gene therapy (neck cancer)
1960s
1970s
1980s
1990s
2000s
10
Source: Lichtenberg, National Bureau of Economic Research
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
12
Life Cycle of an Innovative Medicine
Pharmaceutical Healthcare Facts and Figures 2012
Estimated cost of development $1.3bn to $1.8bn.
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)
14
Changing New Health Landscape
Divergent economic conditions
Rise of new markets
Socio-demographic
shifts
Strained healthcare
environment
Challenging biopharma
environment
Promise of technological
(r)evolution
15
The current environment
16
The Current Environment for BioPharmaRegulatory Pressures:
Complexity of technology/innovation
Approval Times
Intense FDA/EMA Scrutiny
Ethical Concerns & Patients needed
Numerous Regulatory Agencies
Health Technology Assessment
Real World evaluation
Financial Pressures:
Costs
Capital Constraints
Demand for Value
Payer Pressure
ROI
Development Pressures:
Stakeholders Scrutiny
Patient Access Demands
Commercialization Stakeholders
R&D Timelines
Productivity
Patent Cliff
Product Pipelines
17
Other factors impacting BioPharmaPopulation changesNew technologies and Screening proceduresEscalating health care costsPublic expectations and patient empowermentInformation sources…internet, TV…Disease areasPersonalisation of medicineGlobal economic environmentMarket AccessReal world analysis and value determination.
18
Map of All Studies in ClinicalTrials.gov25th October 2012
19
Map of European StudiesOctober 25th, 2012
20
Clinical Trials - GloballyCurrently 134,668
Total OpenUnited States 64766 19339Canada 10128 3213Germany 9462 2842France 8251 3118UK 7119 2271Italy 5386 1758Spain 4808 1743Netherlands 4308 1324Belgium 4057 1141
Total OpenDenmark 3403 1061Sweden 2816 740Norway 1899 536
Total OpenIreland 691 209
Source: www.clinicaltrials.gov
21
Clinical Trials - USA• Currently 64,766
Source: www.clinicaltrials.gov
Total Open
California 17765 4306
Texas 14759 3445
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
Ireland691 / 209 / 4.6m
22
• More than half the clinical trials being conducted worldwide are happening in North America>United States / Canada 56%
26% in EuropeIreland
is 1.9% European total
23
Greater Stakeholder CooperationCulture 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
24
What is a CRO?
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.
26
ClinicalPhase I
Healthy Volunteers
Clinical Phases II - III
Patients
Sales & Marketing
Prescribers
Central Laboratories
Bio-sample AnalysisGlobal Product Development commercial services
Phase I and Labs Clinical Development
Services
Consulting
Strategic Research
Services
Commercial
SRS
Patients
New Chemical
Entity
discoverydiscovery
Global
Data
Management
DM
Clinical TrialData
Medicinal Product Continuum
Outcomes /Real World data
Uncertainty
Confidence in drug & disease indication.
27
Market size and Growth
2010 2011 2012 2013 2014 20150.00
5.00
10.00
15.00
20.00
25.00
30.00
35.00
40.00
45.00
50.00
0%
10%
20%
30%
40%
50%
60%
70%
33%38%
44%
50%
58%
66%
22.8026.22
30.15
34.68
39.8843.87
CRO Market Share of global R&D
Value
Bill
ion
s o
f d
olla
rs
Ref: ACRO – Association of Clinical Research Organizations
Ref: CRO Market Outlook to 2016 / Business Insights
CRO market by drug phase ($bn), 2010
0
5
10
15
20
25
30
35
40
45
2010 2011 2012 2013 2014 2015 2016
$bn
US Western Europe Eastern Europe ChinaIndia Other Asia Latin America Other
23.225.5
28.2
31.2
34.6
38.3
42.6
0
5
10
15
20
25
30
35
40
45
2010 2011 2012 2013 2014 2015 2016
$bn
US Western Europe Eastern Europe ChinaIndia Other Asia Latin America Other
23.225.5
28.2
31.2
34.6
38.3
42.6
Source: Business Insights
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.
29
CRO Global Employment Numbers
2008 2010 2011 2012 2013 2014 20150
20000400006000080000
100000120000140000160000180000
66000
100000110000
121000133100
146410
161051
Employees
Ref: ACRO – Association of Clinical Research Organizations
30
End-to-end Development Solutions
• Portfolio Planning• Biomarker Development• Global Regulatory Strategy• Central Laboratory Services• Cardiac Safety Services• Data Management• Biostatistics
Full Service CRO / PSC (Pharmaceutical Services Company)
Fully Integrated Biopharma Services Provider
Coaching
Integrated Full Suite of Clinical Services
Translational Research
Modeling and Simulation
Clinical Trial Management Phase I, II & III
Regulatory Agency Submission
Phase IV
Disease Management & Rx to OTC Switch
Go-to-Market Post Approval Services
> Life Cycle Safety> Medical Device Services> Post-Marketing Surveillance> Rx to OTC Switch> Finance Policy Consulting> Outcomes Research> Health Economics
Market Research, Commercialisation & Global Market Access
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
32
Going DEEPER:
Understanding Disease Causality• Genetics• Proteomics• Cellular lineages and
environments
Going BROADER:
Understanding Real-world Outcomes
• Large Population Databases• Data Analytics
Two Frontiers
Evidence-based medicine
33
Data, Data Everywhere
New data resources and tools to use them will be the
means to improve health outcomes and reduce costs
EXPANDING
DATABASES
Genetics Databases
Observational & EHR Databases
SOPHISTICATED
ANALYTICS
to ask “What If”
questions
MODELING &
SIMULATION
to test treatment
and cost options
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.
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
36
Future FocusCultural
Change in Medical
Education
Greater Stakeholder Cooperation
Evidence / Value based
medicine
Real world
research outcome
s
Better Patient
Engagement
37
Thank [email protected]
Quintiles Ireland Limited, Registration No. 162942 VAT Registration No. IE 6562942T Directors: John G Kiernan (Managing) Alasdair MacDonald UK Michael Wilson UK