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Australia the not-so-secret destination for pharma and biotech clinical trials
Supported by generous tax breaks and backed up by strong clinical research and healthcare organizations, Australia has become the not-so-secret destination for both small and large pharmaceutical and biotech companies looking to conduct early stage clinical trials. The ever-increasing cost of bringing drugs to market, the complex nature of developing and manufacturing new compounds and increased scrutiny by U.S. and European regulators, has helped spur growth of contract research organizations (CROs). According to a Frost & Sullivan report, the CRO market created $31.4 billion in revenues in 2015, and is forecast to hit the $56.4 billion mark by 2020.
To capitalize both on that growth and its available resources, the Government of Australia began offering tax incentives to attract more global drug developers to the country to conduct early stage clinical trials, as well as build on the research excellence and drug development infrastructure in the country.
“From a regulatory aspect, Australia is very well regarded in terms of the quality of data it generates,” Cameron Johnson, CEO of Nucleus Network, a leading Australian Phase 1 contract research organization, said. “What’s driving the U.S. market to come to Australia is really three key aspects: the speed, the quality, and the cost effectiveness or value.”
The speed aspect is the pathway to market under Australia’s regulatory body the Therapeutic Goods Administration (TGA), which has shortened the time required to start early-phase clinical trials by simplifying regulations. For example, unlike the U.S., instead of having to file a detailed IND before starting a Phase I trial that is reviewed by the FDA, clinical trials in Australia operate under a notification program that significantly reduces the burden of regulations from the outset. “Not only does it reduce costs, it allows for CROs to reduce the first-patient-in timeframe to four or five weeks,” said Johnson.
Under that system, known as Clinical Trial Notification (CTN), all clinical trial materials are submitted to an institutional ethics committee that reviews the scientific validity, design, safety and ethical aspects of the proposed research. The TGA is notified of a trial following site approval and, though it doesn’t review trial plans in advance, the agency can audit and investigate the management of a clinical trial.
By eliminating duplication and reducing what is seen as a cumbersome process in early trials, companies can save on costs while having assurance of appropriate governance review. In addition to the attractions of speed and quality, another major incentive for attracting trials is the cost effectiveness supported by the significant available tax breaks.
Under government incentives directed at research and development that include clinical trials, there is a 43.5% refundable R&D tax benefit for eligible organizations with annual revenues of less than $20 million in Australian dollars. Additionally, there is a 38.5% non-refundable R&D tax offset for eligible companies with total annual revenue of more than $20-million,. What can be seen as another bonus is a favorable currency exchange rate that over recent years has trimmed the cost of early-stage trials conducted in Australia by about 60% compared to those conducted in the U.S. when the tax incentives are factored in.
“With the straightforward and fast regulatory process and ethics approval, we have been able to accelerate the timeline for a Phase 1 study by six months compared to a U.S.-based program,” Bruce Montgomery, M.D., chief executive of Avalyn Pharma, said. “The studies were conducted in an expert and timely manner.”
Montgomery, who has used Nucleus Network for multiple studies for five separate companies, added that the company’s work is supported by contractors that can formulate active pharmaceutical ingredients (APIs) into clinical doses saving on time and costs associated with shipping drugs to Australia.
Underpinning the attraction of Australia as a destination for clinical trials is the infrastructure and environment in the country. Both the FDA and European Medicines Agency accept clinical trial data gathered in Australia with Nucleus Network having recent positive experience of hosting inspections from both agencies.
According to the Frost & Sullivan report, more than 1,000 research projects covering medical device, pharma and biotech have been conducted in the country in recent years that have amounted to more than $1 billion being spent on clinical trials. Nucleus themselves have conducted well over 500 early phase studies over the last 10 years with the majority of these being sponsored by overseas companies who saw the benefits of working in Australia.
Australia also boasts more than 40 universities and 50 independent medical research hospitals. Many of those hospitals have relationships with laboratory and clinical practices including Nucleus which is co-located with a number of leading universities, research institutes and the renowned Alfred Hospital as part of the AMREP precinct. There are also more than 50 clinical trial networks in Australia.
“We also have an ethnically diverse patient population from which to draw from,” Johnson said. “In terms of what’s available in Australia for clinical trials, from the tax breaks, the skills and the regulatory environment, it’s not a secret anymore.”
Nucleus Network will be attending the upcoming BIO Boston in June or can be reached by email; [email protected]