Roberta Duncan

22-March-2011

GLOBAL DEMAND FOR SERVICING FSPS

OVERVIEW
 Observations and Perspectives
 Asia and the Global Clinical FSP Demand
 Human Capital Clinical FSP Strategy
FSP OBSERVATIONS AND PERSPECTIVES
 PARADIGM SHIFTS
t
Talen
The FSP Engine

Techn
ology
Convert Strategic Alliances
Fixed Costs
to Variable Vested Outsourcing /
Costs
Performance Partnerships
Strategic
Functional
and/or
Full Service
Preferred Supplier Geographic
Capabilities
Alignment
with increasing
global footprint
Functional
Expertise ASIA
limited service
capabilities
Transactional
UNDERPINNING
Strategic Alignment
Functional
Expertise 
‘Think
Global, Act
Expansion
Local”
Full Service
Science and
Innovation 
Offering
Functional Expertise
Off-set sponsor’s Leverage
Single Service
engage earlier Geographic capacity technical
Providers
in the supply Footprint constraints expertise
chain

Functional IT solutions Science and

Expertise
Aligned to (a) technical
know how (b) services
associated with patient
access (c) local knowledge
transcend borders innovation
Spurred by (a) “local”
(a) access talent at lower
talent (b) economic
labor costs (b) centralised
development strategies (c)
service centers (c) 24 hr
development of clinical
work day
research infrastructure
ERA OF MULTIPLE STRATEGIC PARTNERSHIPS

Eli Lilly – Quintiles, Proteome Sciences – Parexel, Takeda – Quintiles, Global

Monitoring US and Biomarker discovery and Clinical Development (emphasis
Puerto Rico qualification on Asia)
Eli Lilly – I3, Data BMS – ICON, Global Clinical Dako – Quintiles, Personalized
Management Development Medicine
Eli Lilly – Covance, BMS – Parexel, Global Clinical Biomada – Quintiles, Personalized
Toxicology and Early Development Medicine
Stage Drug Sanofi-Aventis – Covance, Drug London Genetics – Quintiles,
Development Development Personalized Medicine
2008 2010 2011

2009 2011
Eisai – Quintiles, Elan – PPD, Global Clinical
Oncology pipeline Development
development Merck – Parexel, Biosimilar
AstraZeneca – Clinical Development
Quintiles, Clinical Takeda – Covance, Global
Development Clinical Development
Otsuka – Covance, (emphasis on Asia)
Clinical Development Eli Lilly – Parexel, Clinical
Monitoring Asia
 Drivers for Success

ASIA AND THE GLOBAL FSP DEMAND

COUNTRY DATA

Source: World Bank Data Statistics, 2005-2010

ASIAN COUNTRIES: PHASE II AND III
MULTINATIONAL CLINICAL TRIALS

Source: clinicaltrials.gov data retrieved by PRTM, “Trends in Asia: Clinical Outsourcing,” March
2010
GLOBAL COMPANY OPERATING IN ASIA
(EXCEPT JAPAN)

Source: PRTM, “Trends in Asia: Clinical Outsourcing,” 2010

 Elements and Opportunities

ASIA: HUMAN CAPITAL STRATEGY

TALENT
Elements To be
Supporting addressed
Strategy

 Lower labour rates  Recruitment - Relatively small

 Highly educated research
talent
 “Sea Turtles”
pool of experienced talent; Rising
wages and pay demands
 Retention – Poaching; Job
hopping; Perception of career
opportunities
 Blending western and
eastern cultures (global
integration) – relationship,
leadership, delivery, and language
INFRASTRUCTURE
Elements
Supporting
Strategy
 Governments prioritizing
research in key therapeutic
areas
 Regulatory agencies adopting
more global standards
 Growing acceptance of and
adherence to ICH-GCP
guidelines
 Motivated investigators
Growth
Opportunities
 Data quality and integrity
 Intellectual property
protection
 Regulatory harmonization
 Access to patients in rural
areas
 Informed consent
 Investigator training
SCIENCE, INNOVATION AND TECHNOLOGY
Elements Growth
Supporting Opportunities
Strategy

 Development of R&D  Supply chain management

biocentres, campuses, and  EDC capabilities
facilities  Drug discovery
 Research in diseases
relevant to the Asian
population
 Population demonstrating
more “typically” western
diseases
Questions / Comments

THANK YOU
BACK-UP SLIDES
 CRO MARKET SIZE ($US MN)
(IN TOTAL AND BY PHASE, 2009)

2009 India China S Korea Taiwan Singapore Thailand Philippines

Tot market 433 255 65 100 128.4 8.6 45.1
size
Phase I 48 30 14 11 20.3 0.2 3.6

Phase II 99 52 14 34 33.8 0.9 9.5

Phase III 234 85 23 53 47.3 5.7 22.5

Phase IV 52 88 14 2 27 1.8 9.5

Source: Primary research with CROs and sponsors, Frost & Sullivan, 2009
GLOBAL COMPANY OPERATING IN JAPAN

Source: PRTM, “Trends in Asia: Clinical Outsourcing,” 2010

CORE R&D FACILITIES IN ASIA
10 PHARMA COMPANIES

Source: “Evolving R&D for Emerging Markets,” Drug Discovery, 9:417-420, 2010
CORE R&D FACILITIES IN ASIA
10 PHARMA COMPANIES (CONT’D)
COMPETITIVENESS OF ASIAN COUNTRIES
FOR BIOTECH IPOS

Source: Frost & Sullivan, 2009