Australia – The Launchpad for Global Clinical Development Success

As we get ready for Biotech Showcase 2026, held alongside the renowned JP Morgan Healthcare Conference, we revisited a discussion that resonated last year: how organizations can effectively bridge continents to advance clinical development. 

Tanya Van der Wall, Regional Managing Director JAPAC at Commercial Eyes, and Nicole (Niki) Gallo, Vice President of Regulatory Affairs at Halloran Consulting Group, reflect on their collaboration within their parent company, ProductLife Group (PLG). They highlight opportunities in Australia’s clinical development sector and provide recommendations and considerations for organizations looking to expand. 

Q: From a global development lens, what themes are you hoping to glean from Biotech Showcase and/or JP Morgan? 

Tanya:
JPM is a prominent event in the life sciences calendar. It sets the tone for the year and provides an early view of the market outlook. I anticipate clients and partners will be closely watching which companies, technologies, and early-stage assets attract investor and partnership interest. Will established therapeutic areas continue to dominate, or will new trends emerge? Attendees will be looking for early signs of where the market may gain momentum in 2026. 

Niki:
I’m interested in gaining insights into the global market landscape from both investors and sponsors, as their perspectives influence where products are developed and launched. Biotech Showcase and JPM offer a forum for sharing informed opinions and predictions. With ongoing changes at the U.S. FDA, evolving innovation and M&A activity in China, shifting venture strategies, and broader global economic trends, it will be fascinating to see what the “crystal ball” at Biotech Showcase and JPM reveals and whether it proves accurate throughout 2026. 

I’m also curious whether 2026 brings more investment into familiar modalities (peptides, mAbs, ADCs, etc.) and established therapeutic areas (metabolic disease/obesity, oncology, neurology, etc.), or whether funding begins to broaden. What areas are considered “safe” by venture capital investors? 

Q: There’s been strong enthusiasm around Australia’s clinical development ecosystem. Is that momentum still there, or have things changed? 

Tanya:
Yes, early-phase studies continue to grow, driven by streamlined regulatory pathways, faster recruitment, and high standards in trial management/data collection. Financial incentives, including the exchange rate and R&D tax programs, also play a role. Phase 2/3 activity is more complex, however, due to global uncertainty layered over existing structural challenges. Our population, while diverse, is smaller — which can make recruiting large cohorts more difficult. 

Australia is often included as part of larger multi-national, multi-site studies, particularly in oncology, neurology and rare diseases, and cardiovascular indications, rather than being chosen for standalone trials. Since the Australian market is relatively small, when post-trial access and reimbursement prospects are unclear, we may be deprioritized. Later-stage trials still generate the most revenue overall, but their growth has slowed compared with early-phase work. 

We expect Australia’s vibrant clinical research environment to keep advancing in 2026 and hope government reforms via the National One Stop Shop help reduce governance and ethics-related barriers across states and sites. 

Niki:
I agree with Tanya. We continue to see US-based sponsors prioritize Australia for early-stage clinical trials due to its streamlined regulatory processes and attractive financial incentives. These first-in-human clinical trials are either conducted exclusively in Australia or include Australia as one of several countries in a multi-site early-phase study. In 2025, this strategy became even more popular amid uncertainty with the US FDA and broader US policy shifts. 

In 2026, I expect this trend to continue, unless the new proposal for the eighth PDUFA reauthorization is implemented. Under this proposal, sponsors conducting Phase 1 trials outside the US would face annual fees immediately after an IND submission, as well as higher PDUFA fees at the time of marketing application. 

Q: For startups and smaller companies beginning trials in Australia, where should they start? 

Tanya:
Early planning is essential. Teams should consider global regulatory and commercial strategy up front. Trial design ultimately shapes the patient population a therapy can reach, and which markets will accept the data. Companies must also assess their legal and financial structure, whether they qualify for R&D tax credits or other funding opportunities, how data will be collected and stored locally, and safety reporting — all of which need to be managed within Australia. 

Many of these areas are central to our business, including regulatory and access strategy, medical writing, and pharmacovigilance for clinical trials. We also collaborate with a network of trusted partners and experts, such as tax advisors, legal counsel, and CROs, to develop a comprehensive plan, making early engagement essential. 

Niki: 

Tanya covered all the key points above, and I would emphasize the importance of global regulatory and commercial strategy and seeking guidance from health authorities. It is critical to consult with relevant authorities on proposed development plans before implementation to ensure alignment with the regulatory expectations in the markets where the product will be commercialized. A risk-based approach, considering timing and data availability, will help determine which authorities to engage with and when. This step is essential, as overlooking it can lead to costly missteps. 

For example, a company should carefully consider whether to approach the FDA for a Pre-IND meeting before initiating a Phase 1 trial in Australia or after collecting 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 the PLG network is so valuable. With experts across Europe, the U.S., and the JAPAC region, we work together to design comprehensive plans, supporting companies throughout their entire development journey. 

Niki:
Build on the insights gained in Australia and expand globally where it makes strategic sense. While markets play a key role in shaping global development strategy, the location of patients and centers of excellence is equally important. Companies starting development in Australia should carefully select partners, vendors, and consultants who combine global reach with regional expertise to support successful expansion into the most relevant markets for their product and indication. In short, I advise against making short-term decisions early on, it’s important to keep the end game in mind from the start. 

As Tanya noted, PLG brings the regional and global capabilities needed to help clients progress from development through commercialization. 

Q: What critical steps on the road to approval are often overlooked? 

Tanya:
Taking a holistic view is essential. Clinical and regulatory strategy must be aligned with commercial and market access considerations, including who will benefit from the product and who will pay for it. Communicating this clearly and early can make a significant difference in attracting investors who review countless pitch decks. 

As Niki noted, overlooking the evidence requirements of different regulators can lead to delays and higher costs if studies need to be redesigned. Engaging with authorities before protocol finalization is considered a best practice. Companies that involve us at this stage benefit from our combination of global expertise and local insight. 

Niki:
Staying grounded in a holistic plan requires discipline and resilience, but it’s essential. Without clarity on the “why,” teams can get lost in day-to-day challenges. The who, where, and why should remain central. 

Additionally, companies often underestimate the time, resources, and financial commitments required to bring a product to market. No one can make time move faster, yet organizations frequently set overly ambitious timelines that rarely play out as planned. In drug development, when does everything go perfectly? In my experience, almost never. Unexpected challenges should always be anticipated. Having multiple mitigation strategies is essential for successful product development. As Ross Geller from Friends famously said, you need to pivot as you move toward product approval. 

Companies also tend to underestimate the effort required to achieve key milestones. In some cases, no matter how many resources or how much funding is applied, progress is limited. Time must be allowed to run its course, such as during patient recruitment for clinical trials. 

Ready to discuss your development plans? Contact us to explore how PLG can support your clinical and regulatory journey. 

Contributing authors: