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Accelerating Oncology Clinical Development in Asia PowerPoint PPT Presentation


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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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

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


Oncology already a key area for Asia


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


Oncology DD in Asia was metrics-driven


Oncology now full spectrum in Asia


The questions have evolved

Prehistory

AsiaDifferent

AsiaBig

AsiaGlobal

Should we?

Do what?

How toBuild?

How tooptimise?

7


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)


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


(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


(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


(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


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


What is the role of outsourcing?

Tactical

Local CRO

Do it yourself

CRO do it all

Global CRO

Strategic

14


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


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