31 May 2022

Australia: A go-to destination for clinical trials

Australia’s world-leading clinical trials infrastructure, streamlined regulatory approval system, and grants and incentives attract both pharmaceutical giants and red-hot startups.

Chinese biotech giant BeiGene has enrolled thousands of patients in clinical trials in Australia since 2014. The company has over 2,000 patients at more than 300 research sites across Australia testing BeiGene’s products. It has 120 staff across the country and an in-house research team. In 2020, it invested more than A$35 million on clinical trials in Australia.[1]

US biotech startup Earli chose Australia to research and test its cancer detection technology at sites in Sydney, Melbourne and Adelaide. The company says the speed of Australia’s approvals process shaved at least six months off its development timelines.

‘We came to Australia because the local approval cycles are much shorter here,’ says Cyriac Roeding, Earli’s Chief Executive. ‘Approvals are happening at the local level, not at the federal government level. Australia is world leading in this regard.’[2]

A large and thriving clinical trials network

Australia has more than 50 clinical trial networks offering Phase I – IV clinical trials. Many clinical trial sites are located in biomedical precincts close to universities, research institutions and private industry. The sector boasts an 8,000-strong workforce with capabilities across all life sciences.

Australia offers clinical trials for several biologics sub-sectors, including gene therapies, cell therapies, antibody-based therapies, CAR-T therapies and RNA therapies. Clinical trials for several COVID-19 vaccine candidates, including for CSL and Novavax, were conducted in Australia.

Novavax engaged Australia’s Nucleus Network to conduct Phase I and II clinical trials for its COVID-19 vaccine candidate. Nucleus Network had previously worked with Novavax on Phase 1 clinical trials for an Ebola treatment. Nucleus Network recruited 200 participants for the Novavax trial over 2020.

‘The urgent global race to develop a vaccine against the COVID-19 pandemic drove our rapid identification and selection of an optimal, highly immunogenic vaccine candidate,’ says Stanley C. Erck, President and CEO of Novavax. ‘We are pleased that Nucleus, our long-time partner, was able to accommodate our accelerated timeline.’[3]

Strong, pro-innovation and globally recognised regulatory system

Australia is a highly competitive clinical trials destination, due to a streamlined approval process and a globally recognised regulatory system. Its excellent public and private health systems are open to trialling and adopting new technologies.

Australia’s large, multicultural population also ensures easy access to ethnically diverse patient cohort. Australians are highly engaged with healthcare, which facilitates recruitment. In 2019, 95,000 Australians took part in over 1,800 clinical trials.[4]

Australia is a particularly receptive market for the development of genomics and precision medicine. Three-quarters of Australians would be willing to use genetic testing to identify the most effective drug to treat their disease. Ninety-five per cent are willing for their results to be used to improve treatments for future patients.

Data from clinical trials conducted in Australia is accepted by key jurisdictions, including the US Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA). This ensures research does not lose momentum. Clinical trials undertaken in Australia do not require US FDA Investigational New Drug (IND) application approval.

‘On average in Australia, the first patient into a clinical trial [after approvals] is about three months, whereas in the US or the EU, it’s six to nine months — it’s efficient,’ says BeiGene’s commercial vice president and head of APAC, Adam Roach.[5]

The Sydney Children’s Hospital Network was the only Australian site selected to participate in the global SPR1NT trial. The trial investigated the use of Zolgensma®, a novel viral vector-based gene replacement therapy, to treat children diagnosed with Spinal Muscular Atrophy. Results from the Australian trials fed into the global study.

Australia’s legal system also provides robust protection for intellectual property, encourages innovation and safeguards investment. Australia’s IP regime consistently ranks in the top tier of international IP systems, and is aligned with international standards.

Thriving research and industry ecosystem

Australia’s large research and industry ecosystem offers opportunities to partner with Australian companies and institutions on clinical trials. Australia has over 1,200 pharmaceutical and medical technology companies, 55 medical research institutes and 40 universities focused on clinical research.

UK company Gyroscope Therapeutics is partnering with the Centre for Eye Research Australia (CERA) to deliver Australia’s first experimental gene therapy for dry aged-related macular degeneration. The Phase II trials are testing the safety and effectiveness of Gyroscope’s experimental gene therapy. CERA performed the first surgeries to deliver the therapy in 2021.

Singapore-based biopharmaceutical company Cerecin chose Australia to conduct Phase II clinical trials for an experimental migraine prevention drug. The study was conducted exclusively in Australia at 9 sites across the country. Cerecin worked with a specialist neurologist from the Department of Neuroscience at Monash University as lead investigator.

R&D grants and incentives

Australia offers grants and incentives that can help reduce clinical trial costs. The National Health Medical Research Council Fund is the largest single source of direct government funding for clinical trials in Australia. It provides around A$100 million in funding annually through a wide range of programs.

Australia’s grants and incentives for R&D activities include:

  • The R&D Tax Incentive offers tax offsets for eligible R&D expenditure, reducing the cost to businesses of undertaking R&D activities
  • The Patent Box is a proposed A$206 million scheme to reduce taxes on income from Australian medical and biotech patents. It aims to encourage businesses to undertake their R&D in Australia and keep patents here
  • The Medical Research Future Fund includes A$750 million over 10 years from 2022–23 for Clinical Trials Activity
  • The mRNA Clinical Trials Enabling Infrastructure Grant Opportunity supports medical research and medical innovation projects that use emerging technologies, platforms, equipment and infrastructure to conduct clinical trials of mRNA-based vaccines and therapeutics
  • The Biomedical Translation Fund is a A$500 million fund for promising biomedical discoveries sponsored by the government and matched by private sector investors.

[1] Sydney Morning Herald, Cancer-fighting firm BeiGene expands operations in Australia (smh.com.au), 3 May 2022
[2] Sydney Morning Herald, Cancer detection: Australia’s ‘high quality’ clinical trials lures Silicon Valley cancer fighter (smh.com.au), 5 April 2022
[3] Nucleus Network (May 2020), Novavax to commence COVID-19 vaccine trial with Nucleus Network, media release
[4] MTPConnect (2021), Australia’s clinical trials sector.
[5] Sydney Morning Herald, Cancer-fighting firm BeiGene expands operations in Australia (smh.com.au), 3 May 2022

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