Australia at the Forefront: Powering a Harmonised APAC Cell and Gene Therapy Ecosystem

Through regulatory alignment across regions, improving patient access, and clinical innovation, the Australia-Pacific regionis emerging as a global leader in cell and gene therapy development.

Among the many discussions that shaped AusBiotech International Conference 2025, CEO Greg Plunkett represented Accelagen in a panel session focused on the future of cell and gene therapy(CGT) across the Australia-Pacific region (APAC). The panel discussed how the region is positioning itself as a key leader in CGT through a focus on regulatory harmonisation and the importance of patient access in bringing novel therapies to market.

Regulatory Harmonisation Across APAC

“We are seeing further developments on harmonisation in the way each country may view and regulate cell and gene therapy products,” Greg noted. Countries across the APAC region are beginning to recognise that closer alignment creates better conditions for development and opportunities for global collaboration.

Australia’s position at the forefront was a focal point of the panel, with a validated framework of operation and a successful history of clinical data being used globally. As a testament to the progress in the region, clinical data from APAC countries are regularly accepted by international regulators such as the FDA and EMA. Many countries across APAC already use Australia as a reference point because of its strong development capabilities and dependable regulatory standards.

Australia’s Leadership in CGT Development

“The APAC region yields a significant amount of data used in global submissions, and this reinforces the region’s credibility,” Greg explained. “Australia really is at the forefront of a lot of these areas. Not only in the ability to develop and support the development of cell and gene therapies, but also the manufacture and supply, which has always been a big challenge in this type of technology.”.

The panel also discussed how government support in clinical research has contributed to Australia’s position as a leader in the region. The new SMART CRC was highlighted as an example of how collaborative frameworks allow government, industry, and academia to work together and accelerate progress in the development of CGTs.

The Role of Collaboration and CRO Expertise 

The importance of regulatory harmonisation was central to the panel discussion, as it becomes increasingly clear that alignment across jurisdictions is essential for efficient product development.When companies must rework products and development pipelines to meet local criteria, it reduces efficiency and limits the viability of providing access in smaller markets. CROs with regional knowledge like Accelagen play an important role in aligning programs and guiding sponsors through complex development pathways.

“Having a harmonised regulatory environment means that development and product realisation becomes more time and cost effective, and therefore technologies are reaching patients earlier,” Greg explained. “If we want to account for multiple countries, let’s build and design a programme that suits all those jurisdictions at once.”

Progress Toward a Unified Regulatory Landscape

Progress in regulatory harmonisation acrossAPAC has been seen in countries such as Australia, Hong Kong, Malaysia, andKorea, with China also likely to adopt similar standards. As alignment progresses, APAC is emerging as a more cohesive and predictable environment forCGT development.

For APAC, there is still work to be done in reframing how governments view and fund projects, as traditional funding models struggle to align with CGTs. “There is still a lot of movement needed,” Greg noted. “Typical funding models don’t quite extend to this type of technology.”

Patient Access as a Priority

Looking beyond, maximising patient access toCGTs also requires development. Greg added, “It's the most important component of supply, and without it the true benefit of these products can’t be realised.”

The APAC region is positioned to play an instrumental role in global CGT development over the next decade. The capability and quality of its research, facilities, and clinical experience are all strengths which have continued to grow.

Accelagen’s Commitment to Regional Growth

For Accelagen, the focus is on how to create meaningful differences for patients and improve access both within APAC and across the globe. Accelagen is contributing to the development of the region by helping move key technologies forward, expanding supply into the region, and building experience and a client base that supports development and international connectivity.

Harmonisation, patient access, and strong data outputs will continue to shape the APAC region’s role in the global clinical research sector. As regional cooperation strengthens, Accelagen will play an important role in collaboration and alignment with global partners, with the goal of bringing meaningful therapies to patients who need them.