Posted: 17 September 2025
With the theatrette at Melbourne Museum filled with around 150 curious and eager-to-learn attendees generating lively discussions, the second BioMelbourne Network BioSymposium of 2025, ‘Modernising clinical trials: Execution, access and impact’, brought the sector together for an extensive full-day program covering: evolving early phase outcomes, enhancing trial design, smarter industry planning, opportunities and case studies in decentralised trials, and overcoming practical boundaries with an engaging discussion on the future of the end-to-end trial journey.
In her welcome, BioMelbourne Network CEO Karen Parr set the tone for the day – framing the conversation around how now is the time to capitalise on the global opportunity to modernise how Australia designs and delivers trials so to lift execution, expand access, and increase impact for patients worldwide and the Victorian and Australian economy.
The BioSymposium’s speakers and chairs – experienced leaders and driven changemakers in their fields – spanned organisations including Bellberry, Cancer Trials Australia, CBEPure Solutions, Chimeric Therapeutics, Central Pharmacy Logistics, IQVIA Biotech, Nucleus Network, Omico, PPD (part of Thermo Fisher Scientific), PureCDM, SeerPharma, St Vincent’s Hospital Melbourne, The University of Melbourne, The University of Newcastle and TrialHub at Alfred Health.
The opening session, “Clinical trials for what outcome?” – chaired by Associate Professor Tina Soulis – focused on how early-phase design is shifting beyond safety to better capture signals of efficacy, patient relevance and commercial realities through earlier understanding of the health-system value. Speakers outlined practical levers that directly affect timelines:
- select experienced sites with relevant infrastructure and proven track records,
use feasibility questionnaires to assess capabilities,
- invest in comprehensive training and frequent communication to surface and resolve risks early,
- ‘starting at the end’, and how greater understanding of markets, from purchasers to users, can support efficiencies in trial design, and
- deploy modern data systems, and real-time monitoring, paired with robust data controls and biostatistical support to accelerate clean, reliable analysis.
Presenters also underlined the importance of early, well-prepared ethics submissions and proactive engagement – particularly for first-in-human studies – targeted recruitment using registries, digital channels and advocacy partners, flexible and decentralised visit models to support retention, and resilient investigational-product manufacturing and supply chains.
The second session, chaired by Dr Kurt Lackovic, Chief Executive Officer, Cancer Trials Australia and crafted as an industry dialogue on designing better trials, examined how to align scientific integrity with commercial reality from the outset. Discussion centred on integrating biomarker strategy, regulatory and HTA considerations, and payer expectations while mapping operational and strategic bottlenecks against commercial timelines; and strengthening collaboration between sponsors and sites to de-risk development, reduce delays and uphold patient safety and scientific rigour.
The third session – chaired by Mieke Jenkins Life Sciences Manager, A&NZ, Industry Practices, Chubb Insurance Australia, explored practical boundaries and future directions for decentralised and hybrid clinical trial models. Presenters stepped through where decentralisation adds value, where in-person oversight remains essential, and which tools, governance and ethics guardrails are required to protect quality and equity. Global data shared during the session indicated strong and rising appetite for hybrid designs, with high levels of investigator interest and clear patient appeal for mixes of home and clinic visits.
Portfolio analyses and practical examples showed that, when well-implemented, a decentralised clinical trial approach can shorten protocol-to-first-patient-in and first-to-last-patient-in timelines, lower rates of non-enrolling sites and protocol deviations, and reduce dropout by making participation easier and closer to home. This offers capital efficiencies, and makes participation easier for patients, particularly for those accessing trials outside Australia’s major cities and in rural and remote areas.
Speakers also illustrated the breadth of in-home nursing capabilities – from temperature-monitored direct-to-patient IP logistics and preparation/administration within scope, to ECGs, spirometry, point-of-care testing and structured accountability and education – highlighting where these services fit and where they do not.
The session also emphasised models that expand access for regional and rural patients, including statewide networks, tele-trial approaches and just-in-time site activation, with enabling requirements across pre-qualified networks, harmonised governance, robust supervision plans and secure platforms for telehealth and data sharing.
The closing session took an end-to-end view of the trial journey – from ethics, governance and feasibility through activation and AI – using an interactive format to prioritise immediate fixes and longer-term system improvements across Victoria and Australia. Comparisons between metropolitan and regional settings, and perspectives from payers, sponsors, sites, patients and regulators, fed into a shared agenda to overcome inefficiencies while strengthening the state and national ecosystem.
Across the day, several themes were consistent:
- Australia’s edge is real – in decentralised clinical trials, for example, Victoria has achieved several word-firsts. However, we cannot become complacent given the globally-competitive environment we operate within: streamlined pathways, skilled teams and strong infrastructure currently support early-phase leadership, yet coordination across stakeholders remains essential to preserve speed, quality and value.
- Designing for value from the start pays dividends: early alignment on endpoints, biomarkers, regulatory and payer expectations avoids costly rework and accelerates decisions later in development.
- Equity is non-negotiable: statewide and networked approaches, just-in-time activation and tele-trial models help reach patients beyond major centres and in rare and less-common conditions, reducing travel burden and broadening participation.
- Patient-centred models can also lift performance: evidence presented showed improvements in study timelines, retention and protocol adherence when care reaches people where they are – through thoughtfully governed hybrid and decentralised models that protect data integrity and safety.
The full-day event brought together health technology professionals across industry, research, hospitals, government and professional services, and was supported by the Victorian Government’s Department of Jobs, Skills, Industry and Regions, IQVIA Biotech as the Thought Leader Partner, PureCDM as Major Sponsor, and Chubb and SeerPharma as Supporting Sponsors.
BioMelbourne Network’s BioSymposium made the case that clinical research succeeds through collaboration. The volume and quality of audience questions after each session reflected a shared interest in tackling challenges and opportunities pragmatically and collaboratively across sites, CROs, labs, sponsors, regulators, payers, clinicians and patients to make trials faster, smarter and more inclusive, and to translate that momentum into better care and stronger economic outcomes for Victoria and Australia.
BioMelbourne Network is committed to championing a sustainable ecosystem enabled by supportive policy, by driving proactive advocacy. As such, it is developing a white paper to outline the State and National opportunities and barriers discussed during this BioSymposium. For more information, connect with the team.
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