Extending the Financial Runway
One of the most significant advantages for US biotech companies conducting clinical trials in Australia is the ability to extend their cash runway. Australia’s Research and Development (R&D) Tax Incentive provides up to 43.5% cashback on eligible R&D expenditures. This incentive enables companies to fund more research and development activities, thereby advancing their projects without the immediate pressure of additional fundraising.
Yvonne Lungershausen, Avance Clinical CEO, explains, “Australia’s R&D Tax Incentive is a game-changer for US biotech firms. It significantly reduces the financial pressure of early-stage clinical development and allows companies to do more research with less budget.”
Unsurprisingly this Australian incentive is often considered almost too good to be true and so there can be some confusion around the process. However, as the largest Australian headquartered CRO, Avance Clinical has more than three decades of guiding sponsors so they get the full benefits of the program.
“It’s quite a simple process and we have partnered with R&D rebate specialists who arrange everything so our clients can claim all eligible research activities,” said Lungershausen.
Accelerating Timelines
Time is a crucial factor for Early Phase biotechs. Conducting clinical trials in Australia can significantly accelerate timelines due to streamlined regulatory processes and a supportive medical research infrastructure of site networks and phase 1 units. Unlike the United States, Australia does not require an Investigational New Drug (IND) application for clinical trials, which can save several months of preparatory work.
Gabriel Kremmidiotis, Avance Clinical Chief Scientific Officer, emphasizes, “The no IND requirement in Australia means that biotech companies can initiate trials much faster. This efficiency is invaluable, especially when time-to-market can determine a product’s success”.
Do you have any estimates or examples of how fast it can be? Or how much faster?
Alex Kavros, Avance Clinical Executive Vice President, Global Scientific & Regulatory Affairs, notes, “Australia’s regulatory environment is designed to facilitate swift trial commencement. For US biotechs, this means getting to the clinical phase faster and with fewer regulatory burdens, allowing for a more efficient use of resources”.
