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

4. Overview of Global R&D 2010

5. R&D Outsourcing Overview

6. Clinical Development Process
 Activities
 Clinical Research
 Regulatory
 Pharmacovigilance
 Laboratory services
 Statistics & Data Management
 Site Management/Monitoring
 Drug supply and logistics

7. Pharmaceutical R&D Budget, 2011

8. Clinical Development Timelines, 2011

9. 2. Overview of Clinical Trials and Demography
of Asia-Pac and MENA

10. Active Clinical Trials
Source: Clintrial.gov, June, 2013
 Total = 46,210

11. Active Industry Sponsored
Clinical Trials
 Total= 11,496
 Asia-Pac = 3,588

12. Active Industry Clinical Trials - MENA
 Total = 788
 MENA + Asia-Pac represents
38% of all active trials

13. NME Launch- Asia-Pac

14. Clinical Development Opportunities and
Challenges - Asia

15. Demography and Economics
Asia-Pac

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.

17. 3. CRO Market – Asia-Pac and MENA

18. CRO Market By Drug Phase

19. CRO Market by region (2010)

20. Clinical Performance Score Card – Asia-Pac

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

24. CRO Market -India

25. CRO Market - China
 > 200 CROs

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)

29. 6. Select Growth Areas
Therapeutic Area
 Oncology
 Anti-infective
 CNS
Services
 Orphan Drugs
Capabilities and Services
 Biologics
 Regulatory
 Clinical Analytics
 Diagnostics & Lab services
 Clinical Operations

30. BioPharma Landscape
Nasdaq Biotech Index Analysis (Evaluate Pharma, May 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

32. Thank you
Questions?

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