for clinical trials - austrade

Partnering with Australia on Clinical Trials | 1

for Clinical Trials

WhyAustralia


Why Australia

01

Quality

02

Speed

03

Cost-effective


Sophisticated health and medical research environment

Rapid approvals and robust regulatory framework

An ethnically diverse patient population

Quality transferable data

Cost-efficient

Australiais an ideal location for conductingclinical trials

Quality. Speed. Cost.



Clinical trials are part of a robust and diverse health and medical research ecosystem in Australia

Clinical trials

of the global industry sponsored clinical trials5%

Australia hosts

>95,000clinical trial participants

each year1,880 trials conducted in Australia each year

AUD $1.4 billionspent on clinical trials in Australia in 2019

8,000people

employedin the sector

Source: MTPConnect. (2021). Australia’s Clinical Trials Sector. mtpconnect.org.au*Health Care Index (2020)

Australia’s healthcare system is world class,

ranking 9th globally*


Whole-of-government support for clinical trials

Clinical trials

Strong governmentcommitment

and national action to ensure an efficient, high-quality and vibrant clinical trials environment

A $20 billion endowment fund

Medical Research Future Fund (MRFF) supports translational research and commercialisation

National Mutual Acceptance (NMA)a system for mutual acceptance of scientific and ethical review for multi-centre clinical trials conducted across multiple states


Whole-of-government support for clinical trials

Clinical trials

The Australian Government is promoting clinical trials among consumers and healthcare providers, making it easier to engage.

National consumer campaigns to promote participation in clinical trials

Copyright: © Commonwealth of Australia 2014

A searchable clinical trials registry accessible to the public.www.anzctr.org.au/TrialSearch

https://www.anzctr.org.au/TrialSearch.aspx

Partnering with Australia on Clinical Trials | 7Australian Trade and Investment Commission | 7

Quality01.



Quality

A sophisticated health and medical research environment

medical technology and pharmaceutical companies

1,278 ASX-listed life sciences companies

160world-class medical research institutes

>55

clinical trial networks

>50biobanks

>50 people employed in research and MTP sector

68,000universities focusing on clinical research

>40


Quality

Quality data from Australian clinical trials is accepted in key jurisdictions

Data from studies conducted in Australia can be used to support international regulatory applications, including the US FDA and the European Medicines Agency (EMA)


Clinical trials conducted in Australia do not require US FDA Investigational New Drug (IND) application approval


Speed02.



Clinical trial process allows flexibility without compromising quality


Streamlined approval system, including the CTN and CTA schemes

Simplification of clinical trial delivery by removing tariffs on clinical trial kits and placebos

World leading intellectual property (IP) system

Speed

Rapid approvals and robust regulatory framework


Approval by human research ethics

committee

Notify regulatory authority (Therapeutic Goods Administration)

Four-page template form submitted electronically

Notification acknowledgement.

Trial begins

Submission for ethical review

Study documents including protocol, investigator brochure, informed consent

Submission for site governance review

Legal documents including clinical trial agreement, indemnity agreement and insurance coverage

Speed

Streamlined clinical trials notification scheme

1 DAY 5 - 7 DAYSAPPROX 4 – 6 WEEKS


Cost-effective03.



Cost-effective

Reports show Australia is

28% cheaper than the US before tax incentives, and

60% cheaper after tax incentives, for early-phase clinical trials

Source:Frost & Sullivan, Australia: Preferred destination for early phase clinical trials, 2016


Cost-effective

Favourable exchange rate and a generous R&D tax incentive boosts Australia’s attractiveness


Companies with an annual aggregated turnover of less than A$20 million receivea 43.5% refundable tax offset, uncapped

Companies with an annual aggregated turnover of more than A$20 million and all other eligible entities receive a 38.5% non-refundable tax offset*

*Entities may be able to carry forward unused offset amounts to future income years

Partnering with Australia on Clinical Trials | 16Partnering with Australia on Clinical Trials | 16

Clinical trials

Australia is an ideal location

Strong economic & cultural ties with Asia supported by Free Trade Agreements

Seasonal differences

Investigators, clinical networks and trial facilities of a global standing

Globally recognised key opinion leaders in major therapeutic areas

Use of digital expertise and analytics in patient recruitment

Contract manufacturing capabilities to support clinical trials

An ethnically diverse population


Clinical Trials

Clinical trials started in Australia 2015-19

8,4097% growth in clinical trials started in Australia in CY2015-19

14.5% pa growth Phase I activity Clinical trial by phase started in Australia in CY2015-19*

*with clinical phase reported

482 434 538 606 601

971 11071159

1235 1276

2 0 1 5 2 0 1 6 2 0 1 7 2 0 1 8 2 0 1 9

Industry Sponsored Non-Industry Sponsored

115 134 164 171 198

196 184209 261 253

229 214229

265 22484 8274

83 80170 157208

177 202

2015 2016 2017 2018 2019

Phase I Phase II Phase III Phase IV Device

Note: *with clinical phase reportedSource: MTPConnect. (2021). Australia’s Clinical Trials Sector. mtpconnect.org.au


Clinical Trials

Clinical trials by therapy area in Australia CY2015-19

Number of clinical trials started

4.6%

7.7%

4.9%

6.9%

10.7%

9.6%

9.5%

3.2%

14.1%

14.6%

CAGR%(CY2015-19)

Note: *Select therapy areas shownSource: MTPConnect. (2021). Australia’s Clinical Trials Sector. mtpconnect.org.au

0

50

100

150

200

250

300

350

400

2015 2016 2017 2018 2019

Oncology

Public Health

Mental Health

Cardiovascular

Musculoskeletal

Metabolic and Endocrine

Oral and Gastrointestinal

Respiratory

Neurological

Ophthalmology


Clinical Trials

Australia’s R&D response to COVID-19 global pandemic

Australia involved in the clinical trial activity of many COVID vaccine candidates

Hundreds of Covid-related research studies being conducted throughout Australia

Clinical trial activity resumed mid 2020,thanks to Australian governments and MTP sector COVID response

The Australian Institute of Infectious Disease (a $650 million project) will be the largest centre of excellence in the Southern hemisphere

Breakthrough and Innovation Funds by State and Federal governments

The Australian Government invested over $350 million to support vaccine research and development


Find out more

Australian Clinical Trial Handbook

tga.gov.au/publication/australian-clinical-trial-handbook

Australian Clinical Trials

australianclinicaltrials.gov.au

Medical Research Future Fund

beta.health.gov.au/initiatives-and-programs/medical-research-future-fund

MTPConnect

mtpconnect.org.au/Australia’s Clinical Trials Sector (2021)

Medicines Australia

medicinesaustralia.com.au

AusBiotech

ausbiotech.org

https://www.tga.gov.au/publication/australian-clinical-trial-handbook

http://www.australianclinicaltrials.gov.au/

https://beta.health.gov.au/initiatives-and-programs/medical-research-future-fund

https://www.mtpconnect.org.au/

https://www.mtpconnect.org.au/images/MTPConnect_Australia's%20Clinical%20Trials%20Sector%20report%202021.pdf

https://medicinesaustralia.com.au/

https://www.ausbiotech.org/


How Austrade can help

Our assistance includes

Austradeaustrade.gov.au/contact

Providing insight on Australian capabilities

Identifying potential Australian service providers

Helping international companies identify potential investigators and sites


for more information

www.austrade.gov.au

Contact us

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