Download - FSP Presentation_Mar2011_DuncanRoberta
GLOBAL DEMAND FOR SERVICING FSPS
Roberta Duncan22-March-2011
OVERVIEW
Observations and Perspectives Asia and the Global Clinical FSP
Demand Human Capital Clinical FSP Strategy
FSP OBSERVATIONS AND PERSPECTIVES
PARADIGM SHIFTS
Functional Expertise limited service capabilities
Full Service Capabilities with increasing global footprint
Strategic Functional and/or Geographic Alignment
Transactional
Preferred Supplier
Vested Outsourcing / Performance Partnerships
Strategic Alliances
Convert Fixed
Costs to Variable
Costs
Technology
Talent The FSP
Engine
ASIA
UNDERPINNING
Strategic AlignmentFunctional Expertise
‘Think Global, Act
Local”
Science and Innovation
engage earlier in
the supply chain
ExpansionFull Service
Offering
Geographic Footprint
Functional ExpertiseSingle Service
Providers
Off-set sponsor’s capacity
constraints
Leverage technical expertise
IT solutions transcend borders
(a) access talent at lower labor costs (b) centralised service
centers (c) 24 hr work day
Science and innovation
Spurred by (a) “local” talent (b) economic
development strategies (c)
development of clinical research
infrastructure
Functional ExpertiseAligned to (a)
technical know how (b) services associated
with patient access (c) local knowledge
ERA OF MULTIPLE STRATEGIC PARTNERSHIPS
Eli Lilly – Quintiles, Monitoring US and Puerto RicoEli Lilly – I3, Data ManagementEli Lilly – Covance, Toxicology and Early Stage Drug Development
2008
2009Eisai – Quintiles, Oncology pipeline developmentAstraZeneca – Quintiles, Clinical DevelopmentOtsuka – Covance, Clinical Development
Proteome Sciences – Parexel, Biomarker discovery and qualificationBMS – ICON, Global Clinical DevelopmentBMS – Parexel, Global Clinical DevelopmentSanofi-Aventis – Covance, Drug Development
2010
2011Elan – PPD, Global Clinical DevelopmentMerck – Parexel, Biosimilar Clinical DevelopmentTakeda – Covance, Global Clinical Development (emphasis on Asia)Eli Lilly – Parexel, Clinical Monitoring Asia
Takeda – Quintiles, Global Clinical Development (emphasis on Asia)Dako – Quintiles, Personalized MedicineBiomada – Quintiles, Personalized MedicineLondon Genetics – Quintiles, Personalized Medicine
2011
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
Lower labour rates Highly educated
research talent “Sea Turtles”
Recruitment - Relatively small 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
Elements Supportin
g Strategy
To be addressed
INFRASTRUCTURE
Governments prioritizing research in key therapeutic areas
Regulatory agencies adopting more global standards
Growing acceptance of and adherence to ICH-GCP guidelines
Motivated investigators
Data quality and integrity
Intellectual property protection
Regulatory harmonization
Access to patients in rural areas
Informed consent Investigator training
Elements Supportin
g Strategy
Growth Opportunitie
s
SCIENCE, INNOVATION AND TECHNOLOGY
Supply chain management
EDC capabilities Drug discovery
Elements Supportin
g Strategy
Growth Opportunitie
s
Development of R&D biocentres, campuses, and facilities
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)
Source: Primary research with CROs and sponsors, Frost & Sullivan, 2009
2009 India China S Korea Taiwan Singapore
Thailand
Philippines
Tot market size
433 255 65 100 128.4 8.6 45.1
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
GLOBAL COMPANY OPERATING IN JAPAN
Source: PRTM, “Trends in Asia: Clinical Outsourcing,” 2010
CORE R&D FACILITIES IN ASIA10 PHARMA COMPANIES
Source: “Evolving R&D for Emerging Markets,” Drug Discovery, 9:417-420, 2010
CORE R&D FACILITIES IN ASIA10 PHARMA COMPANIES (CONT’D)
COMPETITIVENESS OF ASIAN COUNTRIESFOR BIOTECH IPOS
Source: Frost & Sullivan, 2009