The Strength of Australia & Asia Pac in the

Clinical Trial Market Space: Is it the Next Big

Bang? (Podium)

Kevin Wightman, PPD

Zoe Armstrong, MSD

Jacalyn Kent, Lilly

Julie Rikard-Bell, INC

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Faculty Disclosure

In compliance with ANCC Guidelines, I/We hereby declare:

I/We do not have financial or other relationships with the manufacturer(s) of any commercial service(s) discussed in this educational activity.

Kevin Wightman, PPD Zoe Armstrong, MSD

Jackie Kent, Lilly Julie Rikard-Bell, INC

Introduction

• Panel

• Kevin Wightman - Exec Director, ASEANZ Area Head, PPD

• Zoe Armstrong – Exec Director, ANZ and SEAsia, MSD

• Jackie Kent – Senior Director, Eli Lilly

• Julie Rikard-Bell – Senior Director, INC Research

• Session overview

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Audience participation…

• Who has attended management training and done a SWOT

analysis?

• Who considers that we (Australia and NZ) are part of Asia?

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ANZ SWOT

Experienced sites

Phase I /Early Dev

Quality

English speaking

Healthcare

infrastructure/Standard

of Care

Patient diversity

Cost

Governance delays

Population/patient numbers

Recruitment reliability

Timezone

Talent shortage – eg. CRAs and

Site staff

Ability to access good healthcare

ASIA/US/EUR Hub/Facilitator

Early Dev Centre of Excellence

Innovation leadership

(early adoptor)

Closer site/industry collaboration

(incl career opportunities)

Japan/India Korea/China…etc…

ANZ in the “too hard” basket

Parochial/Complacent/arrogant

(quality/speed/innovation

/adoption)

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Asia SWOT

N Sites ▲

Experienced sites

Phase I /Early Dev

N Patients ▲

$ Cost ▼

Govt/industry investment ▲

Recruitment reliability

Variable Start-up pathways &

timelines ▲▼

Perceived quality/risk ▲

Timezone/cultural/Language

barriers

Importation, etc, complexity▲

Technology/communication ▲▼

Innovation leadership

(early adoptors + first follower)

China/Japan/Asia market driving

global R&D agenda

Site/Industry collaboration

Quality risks for naiive sites▲

Blocked by established markets

Value vs Cost arguments

Cost advantage erosion

Unpredictable Reg changes

Asia Pacific (ANZ + Asia = Synergy)

• A unique combination of cultures, experience, sites,

patients, talent, challenges and opportunities

• Sites (site relationships and site performance) are the key

interface between researchers (sponsors) and patients

• As a part of Asia Pacific Australia and NZ can SHARE AND

LEARN many best practices in spirit of collaboration (or co-

opertition!)

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The view from the Pharma telescope

• Rising R&D costs – searching for efficiencies

• Strategic relationships – Sites and partners

• Greater Pharma collaboration –Transcelerate

• Complex protocols – adaptive designs & high Reg hurdles

• Increase in Digital technologies and digital demand.

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So what does that mean for sites in Asia

Pacific and ANZ?

• Centres of excellence

• More patients per site with fewer countries involved.

• Quality and speed at the same time.

• Access to $$ comparators – More pressure on pharmacies

• Pharma to Pharma efficiencies - less rework hopefully.

• Better more trusted relationships as we all race to bring novel medicines

to patients.

• Digital access for everything!

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the next big bang….or are we discovering

life on other planets?

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APAC in the eyes of Global CRO HQ

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The Great Promise

60% of the world’s population

1/3 of the global economy

23% of the global revenue

moving to 33% by 2018

The Challenges of APAC

Communication, culture & understanding

Talent

Diversity

Compliance

Patient access and recruitment

Why APAC?

• 60% of the world’s population

• High recruitment and lower patient costs

(excluding Japan, Korea, ANZ)

• The importance of ethnicity/genetic differences in

drug development

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Patient access, recruitment and retention

are important to the success of clinical trials

The Importance of Sites in APAC

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Over the last 15 years, 86% of

studies failed to recruit on time

74-80% of global sites perform

one clinical trial and never

perform another

In 2014, 65% of sites surveyed

had less than

3 months operating cash

Most prevailing reasons enrollment fails from the sites perspective = protocol

The ability to recruit and retain motivated, informed,

protocol-eligible patients starts with sites

85%

I/E Criteria

54%

Study Design

33%

Amendments

after we agree

Summary and Panel discussion

• If not the The “Big Bang” Theory then what next for ANZ and APAC...?

– Evolution and Survival of the Fittest…competitive ecosystem for Talent, R&D and

Commercial

– Adapt to survive in rapidly evolving new digital environment

– Collaboration and symbiosis between industry, sites, government will provide the

synergies needed to grow and thrive

• Working together we can make major impacts on development and

delivery of better healthcare in our region and globally

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