Roundtable Summary – in partnership with Citeline

As Phase I healthy volunteer trials grow more complex, biotech companies are rethinking where to run their first-in-human studies. Southern Star Research, together with Citeline, hosted a roundtable discussion on whether Australia provides the right balance of quality, speed, and predictability for early-stage research.

Moderated by Daniel Chancellor (Norstella), the session brought together experts from Axonis, ModeX Therapeutics, Southern Star Research, and Nucleus Network to discuss how shifting global expectations and regulatory uncertainty, especially in the US are influencing clinical development strategies.

The discussion highlighted Australia’s stable regulatory environment, experienced clinical teams, and supportive government policies, including the R&D Tax Incentive. With ethics committees playing a central role in trial approval, sponsors benefit from shorter timelines and a more collaborative process between sites and regulators.

Speakers highlighted that Australia’s combination of expertise, established trial sites, and cost efficiency makes it a practical option for early research. The government’s ongoing investment in training and trial infrastructure is helping expand national capacity and attract more global studies.

While some challenges remain—such as limited population size and the need for more specialist labs—the panel agreed that Australia offers strong advantages for biotechs seeking reliable, high-quality data and reduced risk in Phase I programs.

To explore the insights shared by Jennifer Burg, Kerry Culm, Daniel Evans, David Lloyd, and Graham Wood, download the full roundtable report here.