‘What we need in prep for these are content pieces that relate to each market. Think thought leadership pieces that we can use to drive traffic to website and the platforms to book meetings.’
‘For Singapore, the article should be something along the lines of Singapore & Australia: East meets West as the clinical trial gateway into Asia”. US and EU sponsors will gravitate towards Singapore & AU as the hub to enter into Asia so we need to be pushing accelerated AU timelines, FDA acceptable data and strong IP protection in both regions. I believe that Lisa will be attending a Gov session on the Friday after the conference in Singapore so this content piece needs to have a bit of a Gov spin to it.’
East meets West as the clinical trial gateway into Asia
The Asia-pacific region leads the world in the clinical trials market, due to the many advantages offered to biotech and pharmaceutical companies.
As of 2022, APAC accounts for 57% of Phase I trials worldwide.
Within the APAC region, Australia us leading the way to reduce the costs of conducting clinical trials.
Home to world-class research institutions, hospitals, and clinical trial facilities, the Australian government is actively supporting research and development through various funding schemes and grants – this investment encourages pharmaceutical and biotechnology companies to conduct clinical trials in Australia, driving economic growth and fostering scientific breakthroughs.
“With these incentives and other factors, in Australia, the total cost of running a clinical trial is about 30%-40% less than in the U.S.” stated Brad Miller, Clinical Operations Director for Biosceptre International.
APAC posted a growth in clinical trials of around 10%, between 2017 and 2022, outstripping growth in other major regions including the US, Europe and RoW. APAC’s growth far exceeded the overall average figure of 5.3% per year.
But what makes Australia such an attractive location for companies looking to conduct clinical research?
The geographic advantage is one reason – Australia’s location in the Asia-Pacific region offers strategic advantages for multinational clinical trials. Its close proximity to Asia provides access to emerging markets and facilitates the recruitment of large patient cohorts, especially those requiring ethnically diverse cohorts.
Australia has more than 50 clinical trial networks, offering Phase I – IV clinical trials and Australia’s leading state, NSW, is also home to Australia’s largest city, Sydney, with an Asian population of around 28%.
And Sydney’s leading Phase I research facility is Scientia Clinical Research.
Located within the prestigious Prince of Wales Hospital grounds, within a major research precinct, alongside The Lowy Cancer Research Centre, Sydney Children’s Hospital, Sydney and the Royal Hospital for Women, Scientia Clinical Research has led the way for Phase 1 research in NSW.
Scientia continues to support clinical trials from a mainly international audience, comprising of sponsors and CRO’s from Europe, China, Japan, Korea, the UK and the USA, all who utilise our facility and our capability to support 900 clinical beds every month.
Australians are also highly engaged with healthcare, which facilitates recruitment – in 2019, 95,000 Australians took part in over 1,800 clinical trials. And since 2017 Scientia Clinical Research has successfully recruited participants for other 140 studies, with almost 100% being achieved from our in-house Recruitment Team.
Regulatory
Firstly, Australia’s regulatory scheme is geared towards providing benefits and opportunities for sponsors: R&D tax incentives offer tax offsets for eligible R&D expenditure – up to a 43.5% R&D cash rebate on clinical trials investment.
Scientia submits research proposals directly the Human Research Ethics Committees (HREC’s) with a turnaround time of between 4 to 6 weeks from submission to approval.
US Biotech company Earli stated that the speed of Australia’s approval process shaved at least 6 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.’
Data from clinical trials conducted in Australia is also accepted by key jurisdictions, including the US Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA) – this ensures that the momentum of research is maintained. Clinical trials undertaken in Australia do not require US FDA Investigational New Drug (IND) application approval.
IP Protection
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.
Regulatory Environment: Australia boasts a robust regulatory environment governed by the Therapeutic Goods Administration (TGA) and the National Health and Medical Research Council (NHMRC). These bodies ensure that clinical research adheres to strict ethical and safety standards, providing assurance to sponsors, researchers, and participants alike.
Conducting clinical studies in Sydney, Australia offers numerous advantages, including a supportive regulatory environment, access to diverse patient populations, world-class research infrastructure, government investment in research and development, streamlined approval processes, access to key opinion leaders, geographic advantages, and adherence to high-quality data and reporting standards. These factors contribute to Australia’s position as a leading destination for clinical research, driving growth, innovation, and advancements in healthcare.
To find out more about Scientia Clinical Research can help you, simply drop us a message using the form below and we will be in touch.
