#Clinical trial startup time full#
Read the full story.Īustralia’s legal system also provides robust protection for intellectual property, encourages innovation and safeguards investment.
Results from the Australian trials fed into the global study. The trial investigated the use of Zolgensma®, a novel viral vector-based gene replacement therapy, to treat children diagnosed with Spinal Muscular Atrophy.
The Sydney Children’s Hospital Network was the only Australian site selected to participate in the global SPR1NT trial.
‘On average in Australia, the first patient into a clinical trial 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. Clinical trials undertaken in Australia do not require US FDA Investigational New Drug (IND) application approval. This ensures research does not lose momentum. Ninety-five per cent are willing for their results to be used to improve treatments for future patients.ĭata 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). Three-quarters of Australians would be willing to use genetic testing to identify the most effective drug to treat their disease. Īustralia is a particularly receptive market for the development of genomics and precision medicine. In 2019, 95,000 Australians took part in over 1,800 clinical trials. Australians are highly engaged with healthcare, which facilitates recruitment. Its excellent public and private health systems are open to trialling and adopting new technologies.Īustralia’s large, multicultural population also ensures easy access to ethnically diverse patient cohort. ‘We are pleased that Nucleus, our long-time partner, was able to accommodate our accelerated timeline.’ Strong, pro-innovation and globally recognised regulatory systemĪustralia is a highly competitive clinical trials destination, due to a streamlined approval process and a globally recognised regulatory system. ‘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. Nucleus Network recruited 200 participants for the Novavax trial over 2020. Nucleus Network had previously worked with Novavax on Phase 1 clinical trials for an Ebola treatment. Novavax engaged Australia’s Nucleus Network to conduct Phase I and II clinical trials for its COVID-19 vaccine candidate. Clinical trials for several COVID-19 vaccine candidates, including for CSL and Novavax, were conducted in Australia. The sector boasts an 8,000-strong workforce with capabilities across all life sciences.Īustralia offers clinical trials for several biologics sub-sectors, including gene therapies, cell therapies, antibody-based therapies, CAR-T therapies and RNA therapies. Many clinical trial sites are located in biomedical precincts close to universities, research institutions and private industry. Australia is world leading in this regard.’ A large and thriving clinical trials networkĪustralia has more than 50 clinical trial networks offering Phase I – IV clinical trials. ‘Approvals are happening at the local level, not at the federal government level. ‘We came to Australia because the local approval cycles are much shorter here,’ says Cyriac Roeding, Earli’s Chief Executive. The company says the speed of Australia’s approvals process shaved at least six months off its development timelines. US biotech startup Earli chose Australia to research and test its cancer detection technology at sites in Sydney, Melbourne and Adelaide. In 2020, it invested more than A$35 million on clinical trials in Australia. It has 120 staff across the country and an in-house research team. The company has over 2,000 patients at more than 300 research sites across Australia testing BeiGene’s products. Insight – Australia: A go-to destination for clinical trialsĪustralia’s world-leading clinical trials infrastructure, streamlined regulatory approval system, and grants and incentives attract both pharmaceutical giants and red-hot startups.Ĭhinese biotech giant BeiGene has enrolled thousands of patients in clinical trials in Australia since 2014. THRIVE Industry Data and Expert Analysis Working Group.THRIVE Workforce and Skills Working Group.International opportunities for Australians.Importance of Foreign Direct Investment.Grants and support for tourism businesses.
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