Australia – the Launchpad for Global Clinical Development Success

Contributing authors to this blog post are Tanya Van der Wall and Nicole (Niki) Gallo.

As we prepare, yet again, for Biotech Showcase 2026, held alongside the industry-leading JP Morgan Healthcare Conference, we revisited a conversation that resonated last year around bridging continents for clinical development.

Tanya Van der Wall, Regional Managing Director JAPAC at Commercial Eyes, and Nicole (Niki) Gallo, Vice President of Regulatory Affairs at Halloran, share their insights into their global partnership under their parent company, ProductLife Group (PLG), and further highlight the opportunities in Australia’s clinical development landscape, providing recommendations and watchouts as developers look to expand.

Q: What kinds of topics are you hoping to glean, from a global development perspective, from Biotech Showcase and/or JP Morgan?

Tanya: JPM is a unique week in the global life sciences calendar as it really kicks off the year and is an interesting litmus test for market sentiment. I know that our attending clients and partners will be interested in which companies, technologies, and early-stage assets gain the attention of investors and potential partners. Will it be the same therapeutic areas, or is there a new trend? Everyone will be looking for early signs of the market picking up in 2026.

Niki: I am eager to glean perspectives and opinions on the global market status from investor and sponsor perspectives as they influence where products are developed and launched. At the Biotech Showcase and JPM, informed insights and opinions are shared and discussed. With the continuous changing of tides at the US FDA, innovation and M&A activity in China, venture capital investment strategies, and the global economy, it will be interesting to see what the crystal ball at the Biotech Showcase and JPM reveals and if it rings true in 2026.

I am also interested to know if in 2026 there will be more of the same types of innovations (i.e., peptides, mABs, ADCs, etc.) funded in the same therapeutic areas (i.e., metabolism/obesity, oncology, neurology, etc.) or charting into different product modalities and indications. Also, what are venture capitalists considering safe?

Q: There has been much enthusiasm and incentives around Australia’s clinical development ecosystem. Are you still seeing this same momentum or have dynamics shifted?

Tanya: Yes, we are still seeing strong growth in the early-phase trials, due to the streamlined regulatory processes, faster recruitment, and high standards in trial management/data collection. There are also financial benefits including the favorable exchange rate and R&D tax incentives. The market is a little more nuanced for Phase 2/3 trials, with global uncertainties adding to some of the more persistent structural barriers. Our smaller population, while diverse, can make it harder to recruit a large number of patients.

Australia is more likely to be selected as part of a larger multi-national multi-site study and particularly in oncology, neurology/rare diseases, and cardiovascular disease, rather than smaller stand-alone studies. Australia remains a relatively small market, and if post-trial access and reimbursement strategies are not favorable for market launch in Australia, we are less likely to be selected for clinical trials. So, while the later stage trials are still the largest revenue generating part of the sector, they have slowed relative to early-phase trials.  

In 2026, we expect that the vibrant clinical trial ecosystem in Australia will continue to grow, and we hope to see the implementation of the government reforms in the National One Stop Shop (NOSS) starting to remove barriers in governance and ethics approvals between states and sites.

Niki: I echo what Tanya states above. We continue to see US-based sponsors place Australia at the top of their list for conducting early-stage clinical trials, given the fast streamlined regulatory process and financial benefits. They are either solely conducting these first-in-human clinical trials in Australia or Australia is one of multiple countries in an early-phase clinical trial. In 2025, this development strategy was widely used given the uncertainties with the US FDA and US government policies and initiatives.

In 2026, I would expect this trend to continue, unless the new proposal put forward for the eighth PDUFA reauthorization becomes real, in which sponsors who conduct Phase 1 trials outside the US would have annual fees immediately following an IND submission and will have a higher PDUFA fee at the time of marketing application submission.

Q: For startups and smaller companies looking to begin their clinical trials in Australia, what advice do you have? Where should they begin?

Tanya: Startups and smaller companies really need to consider their global regulatory and commercialization strategy and seek advice as early as possible. Designing the trial will be critical to the ultimate patient population the therapy can reach and the markets where trial data will be accepted. They also need to consider their legal and financial structure, and if they can take advantage of R&D tax credits and other funding models, collecting and storing data in Australia, and safety reporting, which also must take place here. Many of these are core to our business, such as regulatory and access strategy, medical writing, and pharmacovigilance for clinical trials. And of course, we work with a network of trusted partners and experts (i.e., tax, legal, CROs, etc.) to create a wholistic plan, so early engagement is essential.

Niki: Tanya hit all the key elements above; however, I would double-click on the global regulatory and commercial strategy and seek health authority advice. It is crucial to seek health authority advice on proposed development plans prior to implementation to seek alignment with the health authorities in the markets in which a company plans to commercialize their product. A risk-based approach with timing and data availability will influence which health authorities to approach for advice and when. This is vital and can prevent a misstep that can cost millions of dollars.

For example, a company should weigh the risks of approaching the FDA for a Pre-IND meeting prior to conducting a Phase 1 trial in Australia or following the Phase 1 clinical trial data in Australia.

• If it is a small, rare disease population and the trial is intended to be a pivotal registrational trial, seeking advice prior to initiating the trial in Australia would be recommended if the intent is to seek commercialization in the US.
• If this is a Phase 1 healthy volunteer trial, it may be more impactful to present clinical data to the FDA in the Pre-IND meeting to inform the Phase 2 study design following the initiation of the Phase 1 trial.

Q: For companies looking to Australia as a springboard, what may be next on their global path? Any critical considerations to share as they may look to bridge continents?

Tanya: This is where our network of companies in ProductLife Group is critical. We have experts across Europe, the US, and the JAPAC region, and together, we can help to design a comprehensive plan to partner with companies throughout this entire journey.

Niki: Continue to build upon what was learned in Australia and expand globally where it makes sense to do so. The markets influence the global development strategy, but where patients and treatment centers of excellence reside are just as important and influential. So, while companies initiate development in Australia, they need to select partners, vendors, and consultants that have the global reach and regional expertise to help these companies successfully expand into regions that make sense for their product and their indication. In a roundabout way, I advise not to be shortsighted and make decisions out of the gate with the end game in mind.

As Tanya stated above, PLG has the global and regional expertise and capabilities to enable our clients to progress throughout global product development and into commercialization.

Q: What essential element on the path to product approval is often overlooked? Any advice?

Tanya: It’s really taking that holistic approach to both looking at the clinical and regulatory strategy, but not forgetting the commercial and market access strategy (where will this product find a market and who will pay?) Being able to articulate this early, clearly, and with a strong story can really make the difference in gaining the interest of investors who see thousands of pitch decks every year.

And Niki has touched on it earlier – not focusing on the distinct evidence required for different regulators is often a trap, as it can slow down time to market and add to costs if trials need to be redesigned. Taking this holistic approach prior to protocol design is a best practice, and companies that come to us at this stage can have the full benefit of our local expertise across our global network.

Niki: Remaining strong and steadfast to the holistic development approach requires tremendous strength and resilience and is an essential element towards obtaining product approval. Without being grounded or revisiting the why behind their product development, teams can get caught up in the day-to-day activities and obstacles that can cause a continuous swirl. The who, where, and why need to remain front and center.

Additionally, time and time again, companies underestimate the time, resources, and financial commitments that are required to bring a product to market. I have not encountered anyone who can stop time or make time go faster, and yet companies continually promise aggressive, everything must go right timelines that they continuously fail to meet. In drug development, when does everything go just right? I think never, and I always anticipate the unexpected happening. Having multiple mitigation strategies is key to successful product development, and in the famous words of Ross Geller from the television show Friends, you need to PIVOT as you bring products to approval. Companies also underestimate the effort it takes to complete a milestone, and there are scenarios where it does not matter how many resources or how much money is thrown into the equation. It does not help. Time needs to run its course (i.e. clinical trial recruitment).

About Commercial Eyes

Commercial Eyes, a ProductLife Group company, is a leading healthcare and life sciences consulting firm, specializing in pre and post-registration commercialization services, comprising amongst others Market and Patient Access, Regulatory and Product Development, Quality and Compliance, Patient Safety & Risk Management (PS), Medical Information (MI) and Sponsorship Services. Commercial Eyes is headquartered in Melbourne, Australia, with a strong presence in New Zealand and supporting clients in the broader JAPAC region. The company is known as one of the largest providers of commercialization services to the Pharma and MedTech sector, delivering high-quality, customer-focused results in the regulated therapeutics and healthcare industry for over 24 years. With an experienced team of over 100 consultants, the company has supported more than 1,000 clients, representing the full spectrum of health technology companies, from emerging biopharma/biotech and small to medium-sized enterprises to global multinationals. For more information, visit https://commercialeyes.com.au/

About Halloran Consulting Group

Halloran Consulting Group, a ProductLife Group company, is a US-based life-science consulting firm providing strategic development, regulatory, quality, clinical, and organizational support to industry leaders in the pharmaceutical, biotechnology, and medical device sectors. Our consultants are subject matter experts with technical and strategic expertise who deliver a tailored approach to each engagement, successfully propelling their clients to their next inflection point.