THE BENEFIT OF RUNNINGCLINICAL TRIALS IN ASIA-PACIFIC FOR

BIOTECH COMPANIESRunning clinical studies in Asia-Pacific from early to late-stage trials –

why biotech companies are increasingly heading to the region

Produced by:

December 2020

2

In this whitepaper, evidence and insight from biotech industry

experts has been gathered to explore the following topics:

1) Early-phase studies with high-quality and high-speed

2) Accelerating patient recruitment for complex trials

3) An alternative to global CROs for late-stage trials:

partnership of regional specialists

4) High level of site resilience during the COVID crisis

Author: Sarah Williams, GlobalData with Novotech team

THE BENEFIT OF RUNNINGCLINICAL TRIALS IN ASIA-PACIFIC FOR

BIOTECH COMPANIES

3

Table of Contents

Introduction .................................................................................................. 4

Early phase studies with high quality and speed ................................. 5

Accelerating patient recruitment for complex trials ........................... 7

An alternative to global CROs for late stage

trials: partnership of regional specialists ............................................... 8

From Novotech’s experience, the six key criteria for

successful regional alliance are ............................................................... 9

APAC’s level of site resilience during the COVID-19 crisis ................. 10

About us ........................................................................................................ 12

4

Introduction

The benefits of outsourcing clinical trials to a contract research

organisation (CRO) have been proven time and again, with industry

research showing that biotech companies are looking to avoid the trap

of committing to inflexible contracts from large CROs. Because of this,

there is a distinct trend towards working with specialised CRO partners,

because of the deep expertise this specialisation can bring, as well as

the flexibility and affordability factors.

According to Frost & Sullivan, the CRO market is forecast to grow to

US$71.7billion by 2024 (+8% CAGR 19-24F). It also said the need for novel

therapies and cost-effective R&D will drive growth for CROs, especially

in the Asia-Pacific (APAC) region. As biopharma companies continue to

externalise R&D operations with a higher focus on the Asia-Pacific, the

CRO market in the region is forecast to grow at double the global rate, at

a compound annual rate of +15% percent between 2019 and 2024.

One of the reasons biopharma companies are turning to the Asia-Pacific

region is that running trials in traditional locations, such as North America

and Western Europe, is becoming more challenging. Increasingly a larger

data set is needed, and one that requires locations outside of these

traditional markets. This is driving a much greater focus on APAC as a

destination for clinical trials.

According to GlobalData, the median number of patients recruited in

oncology clinical trials involving sites in the Asia-Pacific region was over

40% higher than the global median (2018-2019 trials).

According to GlobalData, the median number of patients recruited in oncology clinical trials involving sites in the Asia-Pacific region was over 40% higher than the global median (2018-2019 trials).

Did you know?

5

1) Early phase studies with high quality and speed

Did you know?A US Investigational New Drug (IND) submission is not necessary to initiate first-in-human (FIH) clinical trials in Australia.

A US Investigational New Drug (IND) submission is not necessary to

initiate first-in-human (FIH) clinical trials in Australia.

Australia and Asia have become destinations of choice for biopharma

clinical trials. This is mainly because of its large patient pool, lower trial

density and so lower risk of competing trials, the high quality of medical

facilities, government financial incentives for clinical trials, lower costs,

pragmatic regulatory processes and the strategic importance of Asian

consumer markets.

In fact, between 2017 and 2019, there was a +13% rise on average each

year in clinical trials conducted in Australia.

“Biotechnology companies can initiate a clinical trial in Australia in parallel

to the preparation of a US IND submission, often commencing dosing

within a single review cycle of six-to-eight weeks from submission.”

Dr Simone Flight, principal consultant at Novotech BioDesk

There are several other reasons why early-phase studies are heading to

APAC, including:

• Increasing middle-class and aging populations, reforms and market access

• The large pool of experienced investigators: more than 2,800 Investigators in APAC have participated on a minimum of 10 trials, according to GlobalData.

6

• Favourable regulations, including ICH E17 and AFTA harmonisation

and fast-track options

• Ease of operating trials, including high data protection and low legal

barriers

One of the main advantages of choosing Australia for FIH and early-

phase studies is the very quick start-up timeline. In well over 95% of

trials run in Australia there is no requirement for a clinical trial application

dossier, which the FDA requires for an IND in the US and similarly for a

clinical trial application for the EMA.

In addition to this, the Australian government also offers up to a 43.5%

refund on R&D spend. Qualifying companies with less than $20M in

annual revenue receive a cash refund at the end of the fiscal year. The

rebate includes any activity (provided it’s conducted in Australia) that is

either directly related to, or in support of, core clinical trial activity. That

includes database management, clinical trial insurance, bio-statistical

analysis and recruitment costs. It helps to make Australia an optimal trial

location for biopharma companies looking to accelerate their clinical

development at a reasonable cost.

“We’ve actually done four phase 1 studies in Australia, and about to

start-up number five, six and seven. But we went originally into Australia

because of the tax credit, and then recognized both the speed and the

quality of data generated from the sites and from the CROs, so we’ve

continued to run most of our phase 1 studies in Australia. The reason

we keep going back is the high quality. We would not continue to do

that if we weren’t really impressed with the quality of the data.”

Chief Medical Officer at US biopharma

7

2) Accelerating patient recruitment for complex trials

As study protocols and designs become increasingly complex, so does

patient recruitment. Asia, with its large treatment-naïve population

pool and low trial concentration has become a preferred destination to

accelerate subject recruitment for the most complex clinical trials. While

Australia and New Zealand are preferred locations to run early-phase

trials, sponsors often look to Asia for large, late-phase clinical studies.

According to GlobalData, about half of all oncology studies initiated

worldwide in 2019 involved sites in the Asia-Pacific and the number of

oncology clinical trials in the region grew by +13% each year on average

between 2017 and 2019.

Moreover, most Asian countries lack systematic reimbursement of standard

of care which means clinical trials are often the only channel that patients

can access novel treatments. This ultimately stimulates recruitment rates

and encourages patient adherence to research therapies.

Case study: Fast recruitment for complex trials in Asia-Pacific

A US-based biopharma company

specialized in the development of novel

Immuno-Oncology protein therapeutics

Running a Phase Ia solid tumor

study in Australia and South Korea

Involving sites in Australia allowed

the sponsor to quickly initiate the

trial and take advantage of the

R&D cash refund scheme…

…while the activation of sites in

South Korea helped accelerate

the recruitment of patients.

1

0

5

10

15

20

25

30

35

40

OctNovDecJanFebMarAprMayJun Ju

lAugSepOctNovDecJanFebMarApr

# patients

Cumulative patient recruitment over time for a Phase Ia solid tumor study

Activation of 5 additional sites in South Korea

Oct 15th : First SIV (Australia sites)Nov 14th : First patient in

Cumulative patient recruitment over time for a Phase la solid tumor study

8

“I think the biggest difference between the APAC and, say US sites, again is really

that strong engagement by the investigators and the sites in terms of enrolling

the right patients for your drug based on the proposed mechanism of action”

Executive Vice President and Chief Medical

Officer at US West Coast Biopharma

3) An alternative to global CROs for late stage

trials: partnership of regional specialists

According to GlobalData, phase II and III trials represent approximately

85% of sites activated in biotech-sponsored trials. About 30% of the

phase III trials are being managed across two or more geographic

regions.

In an outsourced CRO model, working with a local, regional team can be

the key to success. A regional CRO provides the local expertise which

supports sponsors’ ability to quickly activate sites and get patients

enrolled. A flat team structure also facilitates communication between

the CRO and the sponsor as well as decision-making, and to accelerate

the escalation of issue if they arise.

Also, having staff located near the study site, and understanding the

culture and language makes a huge difference in terms of a study’s

success rate.

Regional teams offer sponsors:• Direct cultural understanding and ease

of local environment navigation

• Better patient uptake and involvement

• Direct access to senior management

• Faster timelines because of this

• Lower costs because of faster timelines

9

From Novotech’s experience, the six key criteria for successful

regional alliance are:

1. The CROs and biotech have a successful history of working

together

2. The CROs have transparency and the flexibility to work with a

range of programme management and communications models

3. The CROs have a willingness and experience in dividing services

to ensure the sponsor has access to “best of its kind capabilities”

and eliminate fragmentation of core central services

4. A governance structure is established, including senior participants

from the sponsor, and all CROs to ensure that milestones are on

track and that key issues can be quickly resolved

5. The CROs adopt a single set of SOPs and operational instructions

6. Use of single IT systems (for example CTMS, eTMF, safety DB)

10

4) APAC’s level of site resilience during the COVID-19 crisis

According to the Cancer Research Institute’s information, 60% of oncology

trials in APAC reported that they were able to continue enrolment and

recruitment normally during the peak of the pandemic – as compared to

20% in the USA. This shows the high level of site resilience in the region,

and also the safety and high quality medical response to a pandemic

where many have considered Western countries (including the US and

UK) have not managed the crisis as well.

According to Frost & Sullivan, less than 8% of clinical trials running in

Asia-Pacific faced disruption because of the COVID-19 crisis, while this

ratio was two to three times higher in Europe and North America.

Sites across the APAC region have quickly changed how they manage

trials, and most are able to deliver the clinical trial services their clients need.

Key Actions Taken by Local Authorities to mitigate the spread Each location across Asia-Pacific used a range of different actions to effectively

reduce the spread

Australia

South Korea Thailand Malaysia Singapore

New Zealand Taiwan Hong Kong• Adoption of a national cabinet• High testing frequency• Mandated distancing• Rapid border closure

• Border closure

• High testing frequency • Strict social distancing rules with evening curfew in place

• Strict border controls

Cumulative cases and keys actions taken per location

• Strict movement control order in place

• Pre-pandemic preparednesss

• Rapid implementation of testing

• Delays addressing immigrant worker population explains recent trend

• High testing frequency• High tech tracing• Effective Healthcare System• Hygiene barriers and wearing

of masks widely accepted

• Pre-pandemic preparedness • Pre-pandemic preparedness (from SARS)

• High tech tracing• Wearing of masks widely accepted• Border closure

• Wearing of masks widely accepted• Strict lockdown measures quickly implement

11

The swift pandemic response and now low infection rates in the region

is evidence of the high quality medical and healthcare network.

As this whitepaper has made clear, the data – both statistical and

anecdotal – shows that the APAC region is in demand for clinical studies

because it has both the depth of quality and the breadth of capabilities

to deliver trial results efficiently and safely with a real focus on quality

control.

APAC’s Covid-19 experienceAlong with the whole region, Novotech’s Asia team had some painful experiences with SARS and MERS in 2003 and 2015. Based on lessons learned from these experiences, Asian governments acted faster and stronger than others when COVID-19 hit. The public’s awareness of the impact of this disease is good, which is why acceptance of government actions was positive. More importantly, the region’s medical and social infrastructure is good, which includes comprehensive insurance coverage (the testing fee was low or a test was free for those with symptoms). South Korea also has one of the highest densities of hospital beds in the world at 115 per 10,000 people (according to WHO data), four times higher than in the US.

1

Source Frost & Sullivan

Clinical Trial % Disruption by Region

23%

19%

8%

13%

0

0.05

0.1

0.15

0.2

0.25

NorthAmerica

Europe APAC ROW

Clinical Trial % Disruption by Region

12

About us

About Novotech

Novotech is internationally recognized as the leading regional full-service

contract research organization (CRO) in Asia-Pacific. Novotech has been

instrumental in the success of over a thousand Phase I - IV clinical trials

for biotechnology companies.

Novotech was established in 1996, with offices in 11 locations across the

region, and site partnerships with major health institutions.

Novotech provides clinical development services across all clinical trial

phases and therapeutic areas including: feasibility assessments; ethics

committee and regulatory submissions, data management, statistical

analysis, medical monitoring, safety services, central lab services, report

write-up to ICH requirements, project and vendor management. Novotech

obtained the ISO 27001 certification which is the best-known standard

in the ISO family providing requirements for an Information Security

Management System. Together with the ISO 9001 Quality Management

system, Novotech aims at the highest IT security and quality standards

for patients and biotechnology companies.

About the Author

Sarah Williams is a journalist and editor with more than 12 years’ experience

across business and consumer titles, from fintech to lifestyle. Originally

hailing from Los Angeles, she has worked in Qatar, the UAE and the UK

and has been published in titles as diverse as Bloomberg Businessweek,

The New Arab and La Femme magazine. Sarah is based in Manchester

and has been with Verdict Media and the New Statesman Group since

early 2019.

https://novotech-cro.com