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Clinical development, contract & outsourcing in mena & asia pac webinar-l ajuwon_jun 2013
1. Larry Ajuwon
C l i n i c a l D e v e l o p m e n t & O u t s o u r c i n g C o n s u l t a n t
S n r . O u t s o u r c i n g M a n a g e r , G e n z y m e E u r o p e
P r e s e n t e d a t
X t a l k s e C a d e m y
E d u c a t i o n a l w e b i n a r s
1 9 J u n e 2 0 1 3
Clinical Development, Contract &
Outsourcing in MENA and Asia-Pacific
2. Agenda
1. Introduction
Emerging markets, R&D shift and drive for productivity
Overview of Global Pharmaceutical R&D
Clinical Development Process
Clinical Development Landscape
2. Asia-Pacific and Middle East + North Africa (MENA)
3. Contracting and Outsourcing (CRO Market)
4. Opportunities, Risks and Remedies
5. Notable Transactions and Relationships (3 Years) – a changing market
6. Select Growth Areas – How the future is shaping
7. Summary and Questions
Disclaimer: This webinar was made on a personal title and intended for educational purposes. The views expressed are those of the speaker and
and does not necessarily represent the views or policies of Genzyme Europe or the companies mentioned.
3. 1. Introduction and Objectives
This webinar will provide a broad overview of clinical development outsourcing in the
MENA (Middle East and North Africa) and APAC (Asia-Pacific) regions and will highlight
factors to consider when planning to outsource clinical trial in these regions
Review Motivators and drivers
Lower costs, market opportunity, large patient pool, disease prevalence, talent, health care
systems
Patent cliff, pharma R&D investments , low productivity and increasing R&D spend, pricing
pressures, restructuring of R&D departments
Maturing CRO industry and new strategic partnerships
Economic downturn, government policies
Review Hurdles and risks
IP, regulatory, legal, reimbursements, infrastructure
skills, cultural differences
Highlight practices that can enable contract and outsourcing success
Decision making, engage partners, assure quality, manage performance
6. Clinical Development Process
Activities
Clinical Research
Regulatory
Pharmacovigilance
Laboratory services
Statistics & Data Management
Site Management/Monitoring
Drug supply and logistics
16. Demography and Economics – MENA
The population of the MENA region at its least extent is about 381
million people, about 6% of the total world population. At its greatest
extent, its population is roughly 523 million.
21. Healthcare and Regulatory
Score Card - MENA
The healthcare infrastructure is
generally good but varies across
the region
Current physician to patient ratio
is 18/10,000 in most GCC
countries, with the exception of
Qatar and Bahrain which have
achieved a 27/10,000 ratio. Levant
countries (Lebanon, Syria, Jordan)
have smaller facilities, but have
advanced healthcare technology
for the conduct of clinical research
Source – Global Clinical Trials, Effective Implementation and
Management, R. Chin & M. Bairu
22. Poll Question
When outsourcing to MENA and Asia-Pac, I am most
concerned about?
1. Cultural difference
2. Quality and Approval Time*
3. Regulatory hurdles*
4. Finding the right partners
5. Patients access
* Top answers
23. Clinical Outsourcing in Asia
Providers
Global CROs present
Quintiles, Parexel, PPD,
ICON, Covance
Regional CROs
SIRO ClinPharm
WuxiAppTec
CMIC
Many local CROs
Mature market
Japan, Australia and
Singapore
Contracting models
Ad-hoc, study, program and
compound level
Functional Service Providers
Co-sourcing
Subcontracting
Risk Sharing
Contract Alliance
Joint ventures
Preferred Vendors
26. Providers
4 International and 14 Local CROs
• ClinTec
• Clinserv
• Mene Research
• ICON
Small-Mid sized CROs
Study level services
Contracting Models
In-source support
Study, program and compound
level
FSP
Co-sourcing
Subcontracting
Risk Sharing
Clinical Outsourcing in MENA
27. 4. Opportunities, Risks and Remedies
Opportunities
Closer relationships
Innovation
Patient Access
Commercial
Risks
Cultural
Fast changing environment
Legal and Compliance
Quality
Remedies
Local Teams
One Quality approach
Performance review
Face Time
Agree clear roles and
expectations
Build solid working
relationships
28. Asia-Pac
2010
• Covance and BML Japan (CLAB)
• ICON and Tigermed (Pt recruitment)
2011:
• Takeda and Covance and Quintiles
2012:
• Astellas Pharma and INC Research 3 yrs FSP
• Parexel and National Taiwan University
Hospital
2013
• RPS and Japan's Asklep (JV)
• Catalent and Chinese ShangPharma (JV)
MENA
Small -Mid-sized CROs increasing presence
No significant transaction yet
Government investment in R&D parks may
increase activity
5. Notable Transactions and Relationships
(2010-2013)
31. 7. Summary
Clinical Development takes the largest share in pharmaceutical R&D investment
Asia-Pacific and MENA regions are growth markets and R&D is shifting there
Contracting and Outsourcing of clinical activities is increasing to improve
productivity, stimulate innovation and access these markets
Outsourcing decisions and strategies guided by Clinical, Regulatory, Commercial
factors and country risks
CRO markets in Asia-Pac is seeing a lot of partnering/M&A activity between global
and local CROs, Pharmaceutical companies and Academic institutions
CRO market in MENA is small and dominated by local CROs and mid-sized
companies
Mix of contracting arrangements and multiple partners are being used
Increasing importance of strategic relationships
Future growth areas are biologics and oncology, anti-infectives, orphan drugs and
lab testing services and regulatory consulting
33. References
2012 Global R&D Funding Forecast, Battelle and R&D Magazine
Biopharma Landscape, 2012, Evaluate Pharma
Clintrial.gov
CMR International Asia Pacific Pharmaceutical R&D Factbook, 2012
Global Clinical Trials, Effective Implementation and Management, 2011
Reinventing biopharma, Strategies for an evolving marketplace, Economist Intelligence
Unit, 2012
SCRIP Insight, CRO Market Outlook to 2016, 2011
The Changing dynamics of pharma outsourcing in Asia, 2008, PwC
Trends in Asia Clinical Outsourcing, 2010, PRTM
Wikipedia