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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 l.jpg

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 l.jpg

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 l.jpg

Oncology already a key area for Asia


Iressa still a great case study for asia l.jpg

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 l.jpg

Oncology DD in Asia was metrics-driven


Oncology now full spectrum in asia l.jpg

Oncology now full spectrum in Asia


The questions have evolved l.jpg

The questions have evolved

Prehistory

AsiaDifferent

AsiaBig

AsiaGlobal

Should we?

Do what?

How toBuild?

How tooptimise?

7


Asia s important differences l.jpg

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 l.jpg

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 l.jpg

(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 l.jpg

(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 l.jpg

(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 l.jpg

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 l.jpg

What is the role of outsourcing?

Tactical

Local CRO

Do it yourself

CRO do it all

Global CRO

Strategic

14


Summary l.jpg

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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