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...
Agenda
1. Introduction
 Emerging markets, R&D shift and drive for productivity
 Overview of Global Pharmaceutical R&D
 ...
1. Introduction and Objectives
 This webinar will provide a broad overview of clinical development outsourcing in the
MEN...
Overview of Global R&D 2010
R&D Outsourcing Overview
Clinical Development Process
 Activities
 Clinical Research
 Regulatory
 Pharmacovigilance
 Laboratory services
 Sta...
Pharmaceutical R&D Budget, 2011
Clinical Development Timelines, 2011
2. Overview of Clinical Trials and Demography
of Asia-Pac and MENA
Active Clinical Trials
Source: Clintrial.gov, June, 2013
 Total = 46,210
Active Industry Sponsored
Clinical Trials
 Total= 11,496
 Asia-Pac = 3,588
Active Industry Clinical Trials - MENA
 Total = 788
 MENA + Asia-Pac represents
38% of all active trials
NME Launch- Asia-Pac
Clinical Development Opportunities and
Challenges - Asia
Demography and Economics
Asia-Pac
Demography and Economics – MENA
 The population of the MENA region at its least extent is about 381
million people, about...
3. CRO Market – Asia-Pac and MENA
CRO Market By Drug Phase
CRO Market by region (2010)
Clinical Performance Score Card – Asia-Pac
Healthcare and Regulatory
Score Card - MENA
 The healthcare infrastructure is
generally good but varies across
the region...
Poll Question
When outsourcing to MENA and Asia-Pac, I am most
concerned about?
1. Cultural difference
2. Quality and Appr...
Clinical Outsourcing in Asia
 Providers
 Global CROs present
 Quintiles, Parexel, PPD,
ICON, Covance
 Regional CROs
 ...
CRO Market -India
CRO Market - China
 > 200 CROs
Providers
 4 International and 14 Local CROs
• ClinTec
• Clinserv
• Mene Research
• ICON
 Small-Mid sized CROs
 Study l...
4. Opportunities, Risks and Remedies
 Opportunities
 Closer relationships
 Innovation
 Patient Access
 Commercial
 R...
Asia-Pac
2010
• Covance and BML Japan (CLAB)
• ICON and Tigermed (Pt recruitment)
2011:
• Takeda and Covance and Quintiles...
6. Select Growth Areas
Therapeutic Area
 Oncology
 Anti-infective
 CNS
Services
 Orphan Drugs
Capabilities and Service...
BioPharma Landscape
Nasdaq Biotech Index Analysis (Evaluate Pharma, May 2013)
7. Summary
 Clinical Development takes the largest share in pharmaceutical R&D investment
 Asia-Pacific and MENA regions...
Thank you
Questions?
References
 2012 Global R&D Funding Forecast, Battelle and R&D Magazine
 Biopharma Landscape, 2012, Evaluate Pharma
 Cl...
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Clinical development, contract & outsourcing in mena & asia pac webinar-l ajuwon_jun 2013

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Clinical development, contract & outsourcing in mena & asia pac webinar-l ajuwon_jun 2013

  1. 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. 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. 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. 4. Overview of Global R&D 2010
  5. 5. R&D Outsourcing Overview
  6. 6. Clinical Development Process  Activities  Clinical Research  Regulatory  Pharmacovigilance  Laboratory services  Statistics & Data Management  Site Management/Monitoring  Drug supply and logistics
  7. 7. Pharmaceutical R&D Budget, 2011
  8. 8. Clinical Development Timelines, 2011
  9. 9. 2. Overview of Clinical Trials and Demography of Asia-Pac and MENA
  10. 10. Active Clinical Trials Source: Clintrial.gov, June, 2013  Total = 46,210
  11. 11. Active Industry Sponsored Clinical Trials  Total= 11,496  Asia-Pac = 3,588
  12. 12. Active Industry Clinical Trials - MENA  Total = 788  MENA + Asia-Pac represents 38% of all active trials
  13. 13. NME Launch- Asia-Pac
  14. 14. Clinical Development Opportunities and Challenges - Asia
  15. 15. Demography and Economics Asia-Pac
  16. 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. 17. 3. CRO Market – Asia-Pac and MENA
  18. 18. CRO Market By Drug Phase
  19. 19. CRO Market by region (2010)
  20. 20. Clinical Performance Score Card – Asia-Pac
  21. 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. 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. 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. 24. CRO Market -India
  25. 25. CRO Market - China  > 200 CROs
  26. 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. 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. 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. 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. 30. BioPharma Landscape Nasdaq Biotech Index Analysis (Evaluate Pharma, May 2013)
  31. 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. 32. Thank you Questions?
  33. 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

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