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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

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
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

iressa still a great case study 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

the questions have evolved
The questions have evolved

Prehistory

AsiaDifferent

AsiaBig

AsiaGlobal

Should we?

Do what?

How toBuild?

How tooptimise?

7

asia s important differences
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
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
(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
(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
(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
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
What is the role of outsourcing?

Tactical

Local CRO

Do it yourself

CRO do it all

Global CRO

Strategic

14

summary
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