Why More Biotechs Are Starting Trials In Australia

Recently, Elena Sinclair and I launched a new webinar series called Trials Without Borders. The idea came directly from Elena, who works as a consultant and often fields the same question from small biotechs: Should we start our clinical trial in the U.S., or are there advantages to looking abroad? She suggested we bring together experts who could provide real-world answers, and the response has been stronger than we expected.

A Streamlined Regulatory Path

The TGA does not re-review the protocol or investigator brochure; it merely acknowledges the HREC approval. By regulation, that acknowledgement must happen within two weeks, though Robertson and Soulis both noted it typically comes much sooner. For a small subset of studies—usually cell or gene therapy products that have never been in humans and lack prior FDA or EMA review—the more complex Clinical Trial Application (CTA) pathway is required. Soulis described it as “a mini IND,” with product-level rather than protocol-level oversight.

That streamlined CTN process often shocks U.S. sponsors. “People often say to us, ‘Are you sure that’s all we need to do?’” Soulis said. “We are sure, and that is all you need to do.”

Timelines and Incentives

Once the HREC submission is underway, the path to study start is measured in months, not years. Robertson noted her credentialed HREC meets twice monthly, returns comments within 48 hours, and can approve Phase 2-4 studies in about 30 days. First-in-human trials can take slightly longer, but most projects move from final protocol to first patient in two to three months.

Local governance reviews occur in parallel and are largely administrative thanks to a standardized national contract template developed by Medicines Australia. That eliminates much of the legal wrangling U.S. sponsors are accustomed to. Contracting delays are more likely to come from site budgeting than from the agreement itself.

The economics of running a trial in Australia are equally attractive. Sponsors benefit from the exchange rate, which immediately delivers a 30%-40% cost advantage. On top of that, the country offers a generous R&D tax incentive, refunding up to 43.5% of eligible R&D spend, and in some cases nearly 48%. The credit applies broadly, from preclinical work to clinical operations, though the work must be performed in Australia to qualify. (We dig into all of this in more detail in episode 3.)

How Sites and Patients Are Managed

For many companies, the real test is whether patients can be enrolled efficiently. Here, too, Australia has built-in advantages.

Robertson emphasized the importance of linking with KOLs who often act as conduits into national clinical trial networks. Australia has dozens of these groups in oncology, neurology, and rare diseases, and they function as collaborative ecosystems. A sponsor may connect with one rheumatologist, for example, only to be directed to the two or three national experts who see the majority of Sjögren’s syndrome patients.

That collegiality extends to trial feasibility. Unlike in some countries, Australian sites will decline a study if they doubt their ability to recruit. “They’re blunt, but fair,” Soulis said. “They’ll often connect you to another investigator who can help, rather than sign up and fail to enroll.”

Both panelists pointed out that patient access extends well beyond major metropolitan hospitals. Telehealth, regional satellites, and hospital-at-home programs, once rare, are now common. Clinical trial nurses routinely visit participants at home, investigational products can be shipped directly, and routine assessments can be handled at local depots. COVID accelerated these practices, but they have since become standard.

The episode’s Q&A revealed frequent questions around participant reimbursement. Soulis explained that Phase I healthy volunteers are well compensated, particularly if inpatient stays are required. By contrast, Phase II and later patients are generally reimbursed only for meals, travel, or occasional overnight stays. HRECs set reimbursement guidelines, typically around AUD $100 per visit, and the payments are not considered taxable income.

Recruitment strategies also differ from the U.S. in one notable way: clinical trial advertising cannot name the investigational product. Sponsors can describe the disease area and type of agent but cannot use a drug name in any public-facing materials. Hospitals, advocacy groups, and specialized recruitment firms often step in to bridge that gap, using social media and physician networks to raise awareness.

Global Data and Specialized Therapies

Sponsors often ask whether FDA and EMA will accept Australian data. The precedent is clear: Robertson pointed out that over two-thirds of drugs approved by the FDA in recent years included Australian trial data in their submission packages.

Still, sponsors must pay attention to details. For FIH studies, Australia allows the use of GMP-like product rather than strictly GMP-compliant material. While this is acceptable locally, it may create friction when submitting data abroad. “That’s the only loophole,” Soulis noted. “Otherwise the data is fully aligned.”

In terms of quality, Australia adheres to ICH GCP standards and is in the process of training sites to the E6 R3 revision. Patient-facing documents require some adaptation to Australian English, metric measurements, and local consent formats, but protocols and investigator brochures are generally accepted as written.

When it comes to cell and gene therapies, both experts stressed that manufacturing and validation capabilities exist in-country, though many sponsors choose to bring partially manufactured or frozen products from overseas. Logistics matter: ensuring viability and timing of cellular products requires specialized facilities, but Australia has built a solid ecosystem to support these trials. One caution for sponsors eyeing the tax incentive is that overseas manufacturing or data management will not qualify for the credit. The actual work must occur within Australia, not simply through an Australian CRO.

The Bottom Line

Australia offers something rare in clinical research: regulatory simplicity, financial incentives, and a highly collaborative site culture. U.S. biotechs gain a cost advantage, a rapid path to first patient, and data that regulators will accept globally.

For Robertson and Soulis, the proof is in the repeat business. Once companies have navigated their first study, they tend to return. “Many sponsors come back again because they get used to the process,” Robertson said. “It’s straightforward.”

Soulis put it even more directly: “In two to three months, we can take you from protocol to first patient. That’s the value proposition, and that’s why Australia keeps winning trials.”