Australia’s vaccine clinical trial superhighway
25 May 2020
Quality and speed consistently bring global biotech and pharma down under to conduct clinical trials. With one of the world’s lowest rates of COVID-19, Australia’s clinical trials industry is booming as international sponsors look for COVID-clean environments ensuring uninterrupted development.
Already well regarded for its advanced healthcare and research infrastructure, skilled workforce, reliable participation rates, and competitive research and development tax incentives – Australia's epidemiology is now giving its trial status an extra boost. In a webinar for the 2020 World Vaccine Congress, leading representatives of Australia’s clinical trials industry shared their experience of the expanding industry landscape and why Australia is the premier destination for vaccine clinical trials.
COVID and clinical trials in Australia
Seven months into the global COVID-19 pandemic, many clinical trial destinations around the world are struggling to comply with physical distancing requirements, manufacturing challenges, adaptation to teletrial and remote management technologies whilst maintaining participation rates. Many of the major global trial site clusters have reported significant and sustained interruptions to trial initiation, a slow down in recruitment or even halting of trials – but not Australia.
Australian scientists have played a key role in COVID-19 research; the Doherty Institute was the first laboratory outside of China to culture the virus. They transferred the live virus to Melbourne-based 360Biolabs in February to support early vaccine work, including the CEPI-backed COVID pharmaceuticals trial.
Fiona Mackay, senior business development manager with Novotech, noted an impact in two areas. “We’ve seen a lot of COVID studies opening up in Australia, but the region is also rescuing clinical studies and programs from global recruitment issues caused by the pandemic,” she said.
Melbourne-based Nucleus Network, Australia’s largest Phase 1 clinical research organisation, is about to start their fourth vaccine study. Principal Investigator, Dr Paul Griffin, said; demand is high for a safe, quality environment. “Our high-quality clinical trials are bolstered by a very supportive regulatory system – and almost real-time approvals.”
COVID-clean environment sparks growth
A relatively COVID-clean environment in Australia has ensured continued growth in trials starting up, attraction of inbound investment and new business supported by strong vocal support for participation from the Australian population, sparking renewed calls for continued investment in the clinical trials sector.
We’ve seen a 14% increase in beds across Australian commercial Phase 1 units
Max Rossetto, general manager of business development with Luina Bio reinforced Australia’s value proposition, highlighting the world-class quality of the research workforce and local regulatory processes. “The science in Australia is second to none, and the regulatory pathway is pragmatic without sacrificing safety,” he said.
“The Therapeutic Goods Administration and our quality systems are recognised by major international regulatory bodies, including the US FDA, EMA and Japanese authorities, as a reliable and safe trial location.”
Speed, stability, and the southern hemisphere advantage
Time is of the essence as the race to deliver COVID-19 vaccines and therapeutics intensifies with political, economic and social pressure. With proven ability to deliver on those fronts, the case for initiating vaccine clinical trials in Australia is compelling.
Angela Luttick is executive vice president of business development for 360Biolabs, a specialty laboratory services organisation for therapeutic, vaccine, and diagnostics development. She said speed and value for money are regarded as significant advantages in initiating vaccine trials. Operational efficiency is an area that Australia has focused upon improving for some years, supported by responsive regulation and harmonisation.
You don’t need to open an IND in Australia to move into Phase 1 – that alone puts you weeks to months ahead
“For smaller biotech companies, in general, Australia is 30% cheaper than a clinical trial in the US. When you add the R&D tax incentive, we’re around 60% cheaper.”
Angela added that seasonal differences are a drawcard for vaccine development in Australia. “A lot of our clients doing northern hemisphere clinical trials swap straight down to southern hemisphere trials as seasons change. It can save six months and considerable costs,” she said.
Come for the incentive and stay for the workforce
People are the industry’s most precious resource; 7000-8000 skilled staff work across the Australian clinical trials sector.
Max from Luina Bio pointed out that while prospective clients start interested in the R&D tax incentive, they stay because of the expertise, reliability, the relationship and the quality of the work Australians deliver.
“After they (sponsors) start working with us and see our capability, the tax rebate becomes secondary. They’re interested in our workforce – 80% of our people are postgrads – and how fast we can work to deliver drug substance that can be used in trials recognised by their regulatory authorities.”
Australia’s willing population
Trials cannot run without participants; they are the critical and time sensitive ingredient. Australia’s ethnically diverse population has traditionally shown a willingness to take part in clinical trials. During COVID-19, Australians have continued to step up – encouraged by a strong media focus and political narrative on the importance of clinical trials and playing our part in global vaccine development.
Nucleus Network has strategies in place to call upon participant support for Phase 1 trials
Dr. Paul Griffin says Nucleus Network has strategies in place to call upon participant support for their Phase 1 trials. “We’ve had thousands of people register for our vaccine studies and other important clinical trials. Despite being in the midst of a global pandemic, Australians realise how important it is advance medical research for vaccines and other life-saving drugs,” Paul said.
A top 5 world ranking down under
Australia is a world leader in discovering infectious diseases and vaccine development opportunities. We have a rich research and development history that is celebrated and enthusiastically invested in at both a public and private level.
With research institutions, major teaching hospitals and life science research-intensive universities and an AUD$170bn local biotech industry spread around the country, it is not surprising that Australia is ranked top 5 globally for biotech by Scientific American (2018).
A stable political, social and economic environment bolsters the country's pathway out of COVID.
The Australian government frequently highlights the medical research and clinical trials industry as key success stories in the country’s innovation agenda. Our stable political and social environment, and more than three decades of steady economic growth positions Australia as a leader in the road to recovery from COVID-19.
The infrastructure is world-class, from manufacturing, logistics, reliable supply chains, a highly educated and skilled national workforce at sites coupled with a pragmatic regulatory and data management systems, supported by a diverse population who are invested in playing our part in vaccine development – Australia is a very compelling vaccine trial destination.