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Accelerating Oncology Clinical Development in Asia. Pharma Trials Asia 2010, Singapore 18th March. Dr. Ross Horsburgh, VP Asia/Pacific, Kendle International. What’s happened so far. Prehistory. Asia Different. Asia Big. Asia Global. Pre 1990 Ad-hoc Investigator-interest trials.

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Accelerating Oncology Clinical Development in Asia


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    1. Accelerating Oncology Clinical Development in Asia Pharma Trials Asia 2010, Singapore 18th March Dr. Ross Horsburgh, VP Asia/Pacific, Kendle International

    2. What’s happened so far Prehistory AsiaDifferent AsiaBig AsiaGlobal Pre 1990 Ad-hoc Investigator-interest trials Early 90’s Asia specific diseases or questions Late 90’s Large scale trials Rescue studies NOW Inclusion in global development

    3. Oncology already a key area for Asia

    4. IRESSA still a great case study for Asia ISEL trial: -5 Asian markets (Taiwan, Thailand, Singapore, Malaysia, Philippines) - 342 Asian patients of total 1692 globally Overall no difference in survival Iressa vs. placebo However pre-planned sub-group analysis of Asian patient cohort showed significant benefit

    5. Oncology DD in Asia was metrics-driven

    6. Oncology now full spectrum in Asia

    7. The questions have evolved Prehistory AsiaDifferent AsiaBig AsiaGlobal Should we? Do what? How toBuild? How tooptimise? 7

    8. Asia’s important differences Large population Lower costs (espec. Procedures) Fast execution Focus on science & education Lack of legacy systems / mindset Rapid growth High rate of change(sites / personnel / CRO’s / newco’s / regulations)

    9. Ensure you think “strategic opportunities” not “operational issues” No unique operational challenges Asia wont follow EU / USA “if it looks like they did is it the best approach?” Winners will best exploit the differences Asia’s greatest contribution will be innovation - process - science / products

    10. (1) Drive Efficiencies Large population Lower costs (espec. Procedures) Fast execution Focus on science & education Lack of legacy systems / mindset Rapid growth High rate of change(sites / personnel / CRO’s / newco’s / regulations) 10

    11. (2) Leverage the science & innovation Large population Lower costs (espec. Procedures) Fast execution Focus on science & education Lack of legacy systems / mindset Rapid growth High rate of change(sites / personnel / CRO’s / newco’s / regulations) 11

    12. (3) Maximise Market Access returns Large population Lower costs (espec. Procedures) Fast execution Focus on science & education Lack of legacy systems / mindset Rapid growth High rate of change(sites / personnel / CRO’s / newco’s / regulations) 12

    13. Where are the best centres for oncology? KOREA‘R’ as well as ‘D’ CHINAToughest, but biggest market access upside TAIWAN-long pedigree in Oncology INDIA Great metricsGreat innovation PHILIPPINES- consistent performer SINGAPORE - fast to start, predictable regulatory, Ph1 & Translational

    14. What is the role of outsourcing? Tactical Local CRO Do it yourself CRO do it all Global CRO Strategic 14

    15. Summary Asia is already a key region for Oncology DD Asia is different- Think strategic +ve not operational –ve Open mind on what / how / how much / where to outsource and maximise the CRO’s added value