INSPIRE Issue 35 - Industry & Commercialisation Edition

Welcome to the Industry and Commercialisation issue of INSPIRE

This issue of INSPIRE is dedicated to exploring remarkable innovations and breakthroughs taking place in health and medical research, charting their journeys through the industry pipeline, from bench, to business, to the bedside.

Australia’s health and medical research and innovation sector is in an era of exceptional progress, developing new technologies, treatments, initiatives and healthcare delivery systems to improve health and wellbeing not only nationally, but globally. With the implications of the COVID-19 pandemic, disruptions to global supply chains and recent geopolitical uncertainty, it is clearer than ever that we need a strong health and medical research and innovation future – made in Australia.

This year we have a real opportunity to imagine and lay the foundations of a new system through the recently reelected federal government and the reforms of the national health and research strategy through to the strategic examination in research and development.

This edition of INSPIRE showcases the outstanding work our members are undertaking in health and medical research and innovation, through the lens of industry and their collaborations. Each article provides unique insight into the various mechanisms that enable the translation of research into tangible outcomes. Rome wasn’t built in a day, and our readership knows all too well the time and sustained effort required to bring research into the market, and to see discoveries come to fruition in transforming health and healthcare systems.

Research translation that requires commercialisation has many challenges - gaps in policy and program investments, workforce shortages, regulatory obstacles, and funding constraints are recurring themes in this edition. But as explained by Professor Ian Alexander in his contribution, ‘it is not all doom and gloom’ and we at Research Australia are privileged to witness this – whether it was at our latest National Awards, at our April University Roundtable, or more recently through our webinar series – there are incredible stories of success despite the challenges.

In this edition, you will read about emerging health technologies like the award-winning collaboration between Telstra Health, RMIT University and the Digital Health Cooperative Research Centre (DHCRC), which exemplifies the potential of digital innovation to revolutionise outcomes not only for consumers, but also for the healthcare workforce. Discover how THerapeutic INnovations for Kids (THINK) is navigating barriers to paediatric drug development to improve the lives of children with cancer. Hear from Ms Rosemary Huxtable AO PSM as she provides a detailed update on the National Health and Medical Research Strategy, and how the Strategy is aiming to facilitate and optimise research translation and ease the pressure on our sector.

Above all, what becomes evident throughout this edition’s contributions is the remarkable perseverance, ingenuity and dedication of our sector, not only to research excellence, but to ensuring that research being undertaken will result in benefits for all Australians. Imagine what could be achieved if our eco-system and the policy landscape better enabled the collaboration of industry and commercialisation within our sector and industry and government meet each other as stronger partners to truly set Australia on the path to tomorrow’s industries with tomorrow’s skills. We encourage you to read our latest Strategic Examination of R&D submission which provides a range of recommendations to address the challenges.

We hope that by sharing the amazing work that our members are doing in the Australian healthcare and health and medical research and innovation ecosystems, we can inspire our readers to meet and overcome the many challenges that surface on the journey through the pipeline – which isn’t necessarily linear – that is from bench, to business, and to bedside.

Best wishes Nadia and your Research Australia Team

ADVISORY SERVICES

Research Australia has provided specialist consulting and advisory services for many years. Our consultancy services continue to expand each year, driven by our unique expertise, reputation for high quality work, and strong relationships to drive outcomes and influence system change.

Most recently we have worked with state and federal governments, patient groups, industry, hospitals, and aged care. Some of the consulting services Research Australia provides are:

Market scanning – detailed analysis of who is undertaking what research to inform project planning and ensure projects target the right health and medical research stakeholders.

Policy advice – on the funding streams, government policy landscape and political interests that impact your projects’ success.

Sector consultation – facilitating engagement with the health and medical research community and the consumers who can best inform approaches to health and medical research.

Grants guidance – evaluating and reviewing grants opportunities and funding programs. m +61 2 9295 8546

k admin@researchaustralia.org

CONTENTS

Australian Health & Medical Research & Innovation

Developing a National Health and Medical Research Strategy for Australia

ROSEMARY HUXTABLE AO PSM

Treating the ‘untreatable’ in the antimicrobial resistance crisis

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Art Direction

Matthew Ware p +61 403 844 763 e matt@objktive.com

For Advertising enquiries please contact the Research Australia office on p 02 9295 8546 or e admin@researchaustralia.org researchaustralia.org

INSPIRE ONLINE issuu.com/researchaustralia

INSPIRE is a publication of Research Australia Ltd

ABN 28 095 324 379 384 Victoria Street Darlinghurst NSW 2010

Developing a sustainable collaborative model for novel paediatric cancer drug discovery and commercialisation in Australia. Publisher Research Australia Ltd

Who can submit articles?

Any current member of Research Australia who would like to share a relevant story that affects their organisation including, philanthropic donations and their outcomes, research findings, and any other related health and medical research topic that affects the Australian population.

Submission guidelines & deadlines For information regarding how to submit and publishing deadlines visit the Research Australia website

Disclaimer

The opinions expressed in INSPIRE do not necessarily represent the views of Research Australia. Whilst every effort has been made to ensure accuracy, no responsibility can be accepted by Research Australia for omissions, typographical or inaccuracies that may have taken place after publication. All rights reserved.

The editorial material published in INSPIRE is copyright. No part of the editorial contents may be reproduced or copied in any form without the prior permission from Research Australia. © Research Australia 2025.

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Developing a nasal spray

CHRISTOPHE KEREBEL

My Twitter : @chriskere CHRISTOPHE KEREBEL CHRISTOPHE KEREBEL My Twitter : @chriskere

Australian Health & Medical Research & Innovation

MARLOW HAMPSHIRE

Groundbreaking research translates into better care for aged care residents

The Australian innovation revolutionising outcomes for women with breast cancer

UNIVERSITY OF WESTERN AUSTRALIA

From research idea to therapeutic impact

CHILDREN’S MEDICAL RESEARCH INSTITUTE

AI-Driven Documentation for Research and Patient Outcomes

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

TELSTRA HEALTH

WOMEN'S HEALTH ROAD

EVENTS OVERVIEW UNIVERSITY ROUNDTABLE FROM BENCH TO BUSINESS

AND BEDSIDE

On 2 April 2025, the Research Australia University Roundtable was hosted by Griffith University. It was attended by 27 representatives from 21 member universities. In addition to representatives from our university members, we were joined by representatives from the Gold Coast Health & Knoweldge Precinct, Stryker, Queensland Health and the Commonwealth Department Health and Aged Care.

We were privileged to have Ms Rosemary Huxtable AO PSM, Chair of the National Health and Medical Research Strategy attend in person and provide an update on the Strategy and engage in a stimulating discussion about participants’ priorities.

The panel discussion focused on engaging with industry in health and medical research and innovation. The diverse perspectives and experiences from panellists representing the health and medcial research and innovation pipeline demonstrated not just the complexity, but also some of the solutions for collaboration.

The Roundtable was followed by a networking lunch and an inhouse discovery tour to the Gold Coast Health & Knowledge Precinct, meeting with researchers and entrepreneurs showcasing some of the latest discoveries.

The next Roundtable will be held early July in Orange NSW, hosted by Charles Sturt University.

BUILDING CONSENSUS FOR AN AGENDA FOR AUSTRALIAN WOMEN’S HEALTH RESEARCH

Women’s health has long been under-researched and undervalued, resulting in delayed or inadequate care. To address this, Research Australia, supported by Besins Healthcare, undertook a sector-wide survey and desktop review. We convened a virtual Expert Roundtable on 20 February to bring together key stakeholders to further develop the roadmap and drive lasting change in women’s health research and outcomes. We are committed to progressing this critical work.

REFORM IN FOCUS

NATIONAL ONE STOP SHOP AND HREC STANDARDS

On 5 March, Research Australia hosted an information session about the national health and medical research agenda, including the National One Stop Shop and the Quality Standards and Accreditation Scheme for HRECs and their host institutions. The session was held by representatives from the Clinical Trials Policy Section of the Australian Government Department of Health and Aged Care, who provided expert insight into the implications of these reforms for our sector, and their role in building Australia’s capacity across the research pipeline.

Participants at the University Roundtable in person and online.

Rosemary Huxtable AO PSM & Nadia Levin

FEDERAL ELECTION POLICY WEBINAR SERIES

Research Australia hosted our Federal Election Policy Webinar Series throughout April and May. The series was focused on Research Australia’s four Priority Reforms that have been developed through extensive consultation and member engagement. These Priority Reforms are critical to our sector’s success, and include:

• A whole-of-systems approach to health and medical research and innovation

• Smarter investment in health and medical research and innovation

• A supported and diverse workforce, with a focus on EMCRs and clinician researchers

• A greater emphasis on advancing prevention policy

The Election Policy Webinar Series provided our members with a platform to further engage with each of these Priority Reforms and included analysis of the key policy frameworks for the health and medical research sector. Research Australia would also like to thank the following contributors from across our membership, Professor Kevin Pfleger, the University of Western Australia & Harry Perkins Institute of Medical Research, Dr Angus Forster from Vaxxas, Professor Sandy Middleton and Dr Nicola Straiton, Nursing Research Institute at Australian Catholic University, Dr Kiah Evans, University of Western Australia, Dr Peter Baldwin, Black Dog Institute, and Tori Brown, Lilly Australia.

PARTNERSHIP WITH MITO FOUNDATION

POWERING PROGRESS: THE FUTURE OF CLINICAL TRIALS

Research Australia partnered with Mito Foundation to host Powering Progress: The Future of Clinical Trials on 16 April. We provided attendees with an exclusive update on clinical trials for mitochondrial disease (mito), exploring recent developments in the space, and the path ahead for increasing clinical trials for mito.

The panel brought a wide range of experience, expertise and professional insights to the discussion. Notably, while over 70 potential treatments for mito are in development globally, with more than 20 having entered clinical trials, Australia has hosted trial sites for only 3 of these treatments. Without local trials, Australians are missing out on the potential to access treatments that are available elsewhere. Our panelists discussed how we can work together to increase Australian clinical trials for mito, and more broadly how we can shape the future of clinical trials to improve outcomes for Australians.

POSTBUDGET BRIEFING

Following the delivery of the Federal Budget, Research Australia once again hosted a member-only Post-Budget Briefing on 27 March to unpack the contents of this year’s Budget, and its implications for the health and medical research and innovation sector.

The webinar was led by Associate Professor Annette Schmiede, CEO of the Digital Health CRC and Board Director of Research Australia, who facilitated a panel discussion with leading health economists and industry representatives. Research Australia would like to extend a thank you to Professor Yuting Zhang from the Melbourne Institute of Applied Economic and Social Research, Dr Julia Norman from AbbVie’s Health and Access Policy department, and Professor Henry Cutler from the Macquarie University Centre for the Health Economy.

The panel raised that the Budget, whilst holding an important focus on health services, missed an opportunity to address the bold and ambitious reform and smarter investment that the health and medical research and innovation sector needs to thrive.

L-R Nadia Levin, Leigh Caufield, Dr Drago Bratkovic & Clare Stuart

DEVELOPING A NATIONAL HEALTH AND MEDICAL RESEARCH STRATEGY FOR AUSTRALIA

The National Strategy will deliver a plan to strengthen and leverage Australia’s worldleading research capability and deliver better health outcomes from a more productive and more efficient research system.

Australia’s first National Health and Medical Research Strategy (National Strategy) is being developed by the Department of Health, Disability and Ageing in collaboration with the National Health and Medical Research Council (NHMRC). It is a privilege for me to chair the development of the National Strategy, guiding the work of the department and the NHMRC, working closely with key experts in the field and consulting extensively with stakeholders across the health and medical research sector.

- Rosemary Huxtable AO PSM

SCOPE OF THE NATIONAL STRATEGY

The National Strategy will cover the Australian health and medical research sector in its entirety, including all levels of government, industry, philanthropy, academia and consumers. It will recognise existing strategic plans and decision-making processes across stakeholder groups and consider Australia’s global context. It will address Australia’s areas of national strength, capability gaps, and options for arrangements to foster co-investment in Australian health and medical research.

The Australian government is investing more than $14.4 billion in research and development in 2024-25. A significant proportion of that investment, drawn from government departments across the Commonwealth, goes toward research intended to improve the health of Australians, with the Health portfolio providing $1.59 billion (11% of total investment) via NHMRC and Medical Research Future Fund (MRFF) research grants.

The National Strategy recognises the significant existing funding that supports health and medical research across the country, including streams of activity managed through individual states and territories and specific initiatives to support industry involvement, translation into health practice, and commercialisation to take research outcomes to scale.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

However, the need to develop a strategy, as called for by Research Australia and other key players in the field, seeks to ensure that there is alignment and coordination in the investment in the sector, that there is opportunity to have a shared sense of priorities and a more systematic approach to disseminating and translating research outcomes into practice.

INTENDED OUTCOME

The National Strategy will provide recommendations to ensure all Australians benefit from health and medical research by producing better health outcomes for the community, aiming to:

• optimise existing money in health and medical research, encourage greater coordination and partnerships across the sector and improve efficiency and effectiveness of research efforts

• foster a strong research workforce and create the attractive investment environment necessary for a sustainable research pipeline from discovery and innovation to translation and commercialisation

• help build sustainable research pathways from discovery and innovation to translation and commercialisation.

THE ROAD SO FAR

As Chair, I am leading the consultation and engagement in developing a draft National Strategy by the middle of this year, with a final Strategy to be provided to government by the end of 2025. My aim is to ensure that the views of all those involved in, and impacted by, health and medical research in Australia are heard.

The National Strategy development team and I have been liaising with the Department of Industry, Science and Resources on their Strategic Examination of Research and Development, in addition to engaging with other research funders including the Department of Education, CSIRO and the Australian Research Council. I recognise that there are reforms already underway that will intersect with the National Strategy, such as the implementation of the Health Technology Assessment Policy and Methods Review and the work to better align administration of the Medical Research Future Fund (MRFF) and NHMRC grant programs.

I have had valuable discussions with Research Australia and other sector leaders. These discussions will be ongoing, recognising the unique place that Research Australia has at all points of the research landscape, and its capacity to bring together key players in the field.

The development of the Strategy is being supported by work to map the drivers and facilitators of health and medical research and identify ways they link together to form the health and medical research ecosystem.

The development work is considering how other countries have implemented their national health and medical research strategies and the different funding and governance approaches they have taken. In addition, an audit of the health and medical research workforce has been undertaken by the department, the results of which are available online, and an analysis of Australia’s research funding landscape is currently being finalised. Additionally, I am hearing from the community on what health and medical research means to them. Further reports on these elements will be available to consider together with the draft Strategy.

WHAT WE ARE HEARING ABOUT INDUSTRY AND RESEARCH COMMERCIALISATION

Through engagements so far, the sector is telling me that the conceptualisation of a single research pipeline does not recognise the complex range of pathways to research translation and commercialisation. For example, the commercialisation pathway for digital health can be very different to that of medical devices.

Ms Rosemary Huxtable AO PSM, Chair of the National Health and Medical Research Strategy

I am hearing that there is fragmentation and a lack of coordination leading to lack of connection between funding initiatives, including across federal and state departments and agencies.

It has also been pointed out that there is a disconnect between researchers and industry, where researchers do not readily have the capacity or capability to take the next steps toward translation of their research. This can lead to a failure to implement research into practice.

It is clear from consultations to date that the sector and broader community want to see a strong implementation plan as part of the National Strategy, with clear action plans to guide change and which:

• recognise the importance of translation and commercialisation in ensuring health and medical discoveries are able to be implemented, in order to benefit all Australians

• promote collaboration over competition, encourage data and technology sharing and minimise duplication of infrastructure costs

• provide a balance of priority-driven and blue-sky research investment; and

• guide investment through clear evaluation and success measures that reflect healthcare and community expectations as well as those of researchers.

BE INVOLVED

The first phase of consultation and engagement is nearing completion, and the development of a draft National Strategy and associated technical work is underway. The second phase of consultation will be broad, to gather as much of your feedback as possible on a draft National Strategy via written submissions, public consultations and roundtables.

Continued participation in the development of the National Strategy will reflect the key role of the whole sector in supporting the translation of great ideas into community, health system and economic benefits. I look forward to further engagement with you all.

Author: Ms Rosemary Huxtable AO PSM has been appointed Chair of the National Strategy. Ms Huxtable has a deep understanding of the complexities involved in managing large-scale initiatives such as this Strategy, developed through extensive experience in government policy, financial management, and strategic leadership. Ms Huxtable’s specific experience in health and aged care policy makes her uniquely qualified to guide the strategy’s development.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

TREATING THE ‘UNTREATABLE’ IN THE ANTIMICROBIAL RESISTANCE CRISIS

NeoXTM, a drug originating from the University of Western Australia, has potential to revolutionize treatments of antimicrobial resistance (AMR). The molecule reverses resistance and resets the clock to when antibiotics were first invented.

Artist impression of a bacterial biofilm. Stock image, licensed.

Dr Andrew Barker pictured in the Lixa R&D lab at The Marshall Centre. Photo by Jarrad Seng

Dr Maud Eijkenboom presenting at the BIO 2024 Startup Stadium

THE AMR CRISIS

By 2050, AMR is forecast to cause 39 million deaths and US$100 trillion in economic damage. Solving AMR is a topic at major global health summits, such as the G7, and is considered a systemic risk to GDP.

AMR manifests in myriad ways that may not always be recognised as AMR, including chronic or recurring ear, lung, gut and wound infections, sepsis, or even ship hull fouling, microbially-induced corrosion and contaminations in households.

AMR is a natural response from microbes to protect themselves against hostile environments or chemicals. Due to the misuse of antimicrobials, bacteria have rapidly developed the ability to evade antibiotics and biocides, thus rendering these treatments ineffective. While in the past it took 10-15 years for bacteria to become resistant to a new antibiotic, nowadays resistance is already observed while the antibiotic is still in pre-market clinical trials.

FROM CAMPUS TO CLINIC

NeoX™ originated from experiments conducted by researchers at the University of Western Australia (UWA) who identified a naturally-occurring, antibiofilm molecule that dispersed recalcitrant bacterial colonies underlying infections in cystic fibrosis patients.

Meanwhile Dr Maud Eijkenboom, a veteran in drug development, and her husband, were searching for ways to manage their youngest child’s chronic infection.

The coming together of the two passionate teams, this encouraging new science, drug feasibility and business building expertise, convinced the UWA industry engagement leadership to support the spin out of the technology, catalysing the creation of Lixa in 2021.

RESISTANCE IS FUTILE

Today, Lixa’s R&D team, headed by CSO Dr. Andrew Barker and located at The Marshall Centre for Infectious Diseases, is part of a small group of global experts working on resistance in free floating or biofilm bacteria.

‘When we began, biofilm research models didn’t accurately represent what happens in the human body. We needed to build 3D models that mimicked real life biofilms and could be quantified in real time,’ said Dr. Barker.

‘With the support of UWA and others, we built a new, high content screening capability for optimising AMR treatments.’

With this, Lixa accelerated its preclinical studies, leading to the discovery of a novel, broad-spectrum biological pathway that ‘scrambles’ the ability of bacteria to use their resistance mechanisms. When combined with an

antibiotic or biocide, previously ‘untreatable’ infections became sensitive again to low antibiotic doses.

‘We call this a resistance breaking effect’ said Lixa MD Dr Eijkenboom ‘and it’s key to what is so exciting about NeoX TM

‘If successful in its next trials, NeoX TM could offer a scalable opportunity to reinstate every antibiotic’s effectiveness. Importantly, the technology could be deployed in emerging economies and vulnerable communities where AMR strikes the hardest .’The company has become globally recognized for their biofilm research and ‘resistance breaking’ approach, having been invited to speak at the 2024 AMR World Congress, BIO 2024 and BIO 2025.

NEW HOPE FOR DRUG RESISTANT INFECTIONS

Lixa is progressing NeoX TM in a range of health and industrial applications, leading with an inhaled therapy for respiratory infections. In early 2025, the company completed a clinical safety trial in preparation for a patient trial. Lixa hopes to tackle recurring infections in bronchiectasis, followed by oral or intravenous therapies for broader resistant infections and bring back hope to patients who have run out of treatment options.

BETTER TOGETHER

NeoX TM is a moonshot to solve AMR. The ongoing relationships between UWA, Lixa, and global networks are key in driving this breakthrough technology to regulatory approval for patient care. The project has been awarded several government grants, including a recent ARC Linkage Project with UWA. Lixa engages university scientists as consultants, welcomes student interns, hires PhD graduates and supports university groups with IP and commercialisation training.

UWA Pro-Vice Chancellor of Industry and Commercial Development, Samantha Tough, says:

‘UWA is extremely proud of the progression of the research and the committed team gathering at Lixa under Maud’s leadership. The team are great to work with and continue to partner with UWA in any way they can.’

‘Lixa has the potential to be a generational story demonstrating the impact of research from a university.’

Authors: Dr Maud Eijkenboom, Managing Director at Lixa. Kristen Houston, Strategic Projects at Lixa. Dr Andrew Barker, Chief Scientific Officer at Lixa . University of Western Australia.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

THINK:

Developing a sustainable collaborative model for novel paediatric cancer drug discovery and commercialisation in Australia.

L-R Dr Jess Smith, Brandon Capital Partners; Dr Julia Warning, NSW Health; Prof David Ziegler, Sydney Children’s Hospital Network and A/Prof Greg Arndt, Children’s Cancer Institute, at the Luminesce Alliance Conference 2024 panel discussion

There are numerous challenges associated with discovering and developing novel drugs for paediatric cancer, but Luminesce Alliance are working to overcome them by developing robust collaborative models with sustainable funding, allowing us to find new therapeutics for kids with cancer in Australia.

Around 1,000 children and adolescents are diagnosed with cancer each year in Australia.

THerapeutic INnovations for Kids (THINK) is a drug discovery and development pipeline for generating new therapies to better treat children with cancer. THINK is funded by Luminesce Alliance and delivered by Children’s Cancer Institute, as part of Luminesce Alliance Enabling Platforms program

‘Drug discovery fascinates me,’ says Prof Ian Street, Director of THINK.

‘Even after 35 years in this field it still amazes me that we can design a ‘targeted’ molecule that, when given to a patient in tiny amounts, will seek out its target and halt its cancer-causing activity.

‘However, for many reasons completely unrelated to our ability to produce these targeted therapies, progress in drug development for children with cancer has been slow, and many parents and families discover that the treatment options available for children today have changed little to those offered 30 years ago.’

OVERCOMING KEY CHALLENGES

Historically, biotech and pharmaceutical companies that have successfully brought new therapies to adult cancer patients have been reluctant to engage in paediatric drug development, dissuaded by the prospect of low commercial returns and complex regulatory hurdles.

A review of FDA approvals between 2012-2021 revealed that only 39/341 (11.4%) approved oncology indications were for paediatric cancers.

This lack of commercial investment means that the true economic cost of children’s cancer is assumed by the public health system (government and the taxpayer) and, because of the lack of modern and more effective and less toxic treatments, these costs can continue throughout life.

Traditionally, academia has led discovery biology. Our understanding of the genomic landscape in paediatric cancers is described by academic consortia globally that have identified the key underlying biological drivers and novel drug targets.

However, this increase in knowledge has not yet translated to an increase in new drug approvals. In response,

regulatory bodies in the United States and Europe have enacted new policies to encourage drug development for paediatric cancers.

Yet, despite these commercial incentives, it is academic, government, philanthropic and not-for-profit groups that are driving the development of novel therapeutics.

Drug discovery and development is expensive and time consuming, and only through collaboration will these noncommercial groups muster the funding and resources needed to change the therapy landscape in paediatric cancer.

Further, paediatric cancer drivers are often not addressable with conventional small molecule drugs. THINK is developing a novel approach known as Small Molecule Induced Reading Frame Shift (SMIRFS) which targets RNAs not proteins, turning ‘undruggable’ targets into ‘druggable’ targets.

DEVELOPING A ROBUST AND COLLABORATIVE MODEL WITH LONGTERM SUSTAINABLE FUNDING

Successful collaborative models have been formed in the past to discover, develop and fast track novel therapeutics for approval.

In Australia, one of the most successful collaborative models was the Cancer Therapeutics (CTx) consortium which generated eight licensed clinical drug candidates in adult cancer. Importantly, the commercialisation success from these collaborative models provides the financial return to fund future projects, thus creating a long-term sustainable environment for novel drug discovery and development.

THINK aims to replicate these robust and collaborative models to generate: a virtual pharmaceutical network consisting of infrastructure, academic researchers, drug discovery biologists and chemists, and a project portfolio, funded by government, philanthropy, venture capital, and pharmaceutical companies, with the goals of finding novel clinical drug candidates for paediatric cancers first and driving these toward clinical trials, commercialisation, and novel treatments in the clinic for kids with cancer.

Authors: Professor Ian Street, Director of THINK, Children’s Cancer Institute (CCI). A/Prof Greg Arndt, Head of Drug Discovery Biology, THINK, CCI. Dr Keith Sia, Senior Drug Discovery Officer, THINK, CCI.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

A REVOLUTIONARY LEAP FOR TREATMENT OF AUTOIMMUNE DISEASES.

Taking precision immunotherapy from the lab to the market.

INNOVATIVE HORIZONS

Autoimmune diseases, where the immune system mistakenly attacks its own tissues, affect millions of people worldwide and require lifelong management. Prof. Ranjeny Thomas says ‘Our discovery is pioneering liposome-based therapies to restore immune self-tolerance, offering hope for patients with autoimmune diseases. It’s a long road from lab to market, needing iterative, team-based innovation.’

THE BURDEN OF AUTOIMMUNE DISEASE

Autoimmune diseases, such as rheumatoid arthritis and Type 1 Diabetes, are incurable chronic inflammatory conditions affecting almost 4% of the world’s population. There is ongoing disability and premature death because current drugs only partially block symptoms, cause side effects, and do not cure the underlying immune mechanism. We need a paradigm shift in our approach to the management of autoimmune diseases globally.

HOPE FOR AUTOIMMUNE DISEASE PATIENTS

At The University of Queensland (UQ), Prof. Ranjeny Thomas’s team is pioneering a breakthrough in treating autoimmune diseases using antigen-specific immune tolerance-inducing (ASITI) liposomes. This cuttingedge therapy aims to restore immune balance, for safe, prolonged remission in patients with rheumatoid arthritis and Type 1 Diabetes by targeting the immune cause and

not just suppressing the symptoms. But how does this therapy work, and what challenges did researchers face in bringing it to clinical trials? Here’s an inside look at the journey from lab to patient care.

A NOVEL APPROACH TO IMMUNE TOLERANCE

Liposomes are tiny, lipid-based vesicles acting like an envelope that delivers the letter inside to a specific immune system address. ASITI liposomes carry disease-specific peptides and vitamin D as a drug. When injected, they are specifically delivered to lymph nodes, enabling a vaccinelike action. In people with Type 1 Diabetes for example, the immune system starts to recognise pancreatic cells as something it needs to attack, and right now the only available treatment is insulin replacement.

This research takes a new approach, using a peptide from the pancreas, along with vitamin D to calm dendritic cells in the immune response.

BRIDGING THE LAB-TO-PATIENT GAP

Although the researchers had promising results with dendritic cell therapy in a clinical trial, this approach was difficult to develop into a commercial product. In response, the team developed an innovative liposome solution to co-deliver the peptide and drug. UQ filed a patent and established Dendright in 2005, a wholly owned company of UniQuest, attracting innovation funding from the Queensland and Australian Governments. However, translating research into treatments proved a very long road.

BioCatalyst. This enabled the research team to progress ASITI-201 into a Phase-1 trial for Type 1 Diabetes, which commenced in 2024.

CHALLENGES IN ADVANCING DRUG DEVELOPMENT

In 2012, Dendright attracted interest from Janssen-Cilag Pty Ltd, which provided an upfront seed grant to fund pre-clinical development of the treatment for Rheumatoid Arthritis. The partnership led to a Phase-1 trial of DEN-181 liposomes, demonstrating safety and dose-response. Fuelled by this momentum, the team attracted grants to extend research to Type 1 Diabetes from the Juvenile Diabetes Research Foundation (JDRF) and The Helmsley Charitable Trust. The Janssen partnership provided many learnings and an industry network. The team has leveraged feedback from multiple pharmaceutical companies and investment funds to hone the products and clinical approach.

The progress in lipid nanoparticle technology during the SARS-CoV-2 pandemic facilitated development of nextgeneration liposomes. The safety, effectiveness and mechanism of action were assessed in laboratory and animal studies. Innovative methods were developed, demonstrating improved liposome stability and effectiveness. Manufacturing was outsourced to a Good Manufacturing Practice-certified facility. The team nailed down where the lipids, peptide and vitamin D went after injection, and how the immune system regulated disease. They also tested samples from adults and children with autoimmune diseases to distinguish peptide-specific responses in rapidly progressing disease versus remission.

UQ spun out a new company, Liperate Therapeutics, to advance ASITI to the clinic. Backed by promising development, Liperate was awarded CUREator funding from the Commonwealth Government’s Medical Research Future Fund and biomedical investor, Brandon

Meanwhile, ASITI to prolong rheumatoid arthritis remission and cure also progressed towards Phase 1 trial-readiness, with an MRFF Frontiers Grant awarded to Prof Thomas and 13 co-investigators in 2024.

GETTING TO CLINICAL TRIALS: WHAT DOES IT TAKE?

Commercialisation is essential to bring innovations from the lab to patients. UniQuest has protected discoveries with intellectual property patents. To develop business opportunities, academic partnerships with industry or spinoff companies have required the long-term commitment of scientists and UniQuest, with the clinical endpoint in mind.

Translating a new technology to the clinic requires huge capital investment. Grants and partnerships with industry and committed philanthropy can accelerate progress and attract larger investment.

REGULATORY & MARKET ACCESS: PAVING THE WAY TO SUCCESS

Successful commercialisation and market access hinges on robust regulatory and reimbursement strategies. It is essential to collaborate with healthcare providers, patients and policymakers to establish reimbursement pathways. Consumer involvement in clinical trial design and decision-making ensures their needs are met, paving the way for successful products. A health-economic value proposition, analysing the costs and benefits of interventions, is important for market success. Partnering with pharmaceutical companies for late-stage trials and global distribution is inevitable.

With dedicated research and collaboration, ASITI is advancing towards a clinical outcome that would transform the landscape of autoimmune disease treatment options.

Authors: This article was developed by Dr. Swati Patel, at The University of Queensland and Lead researcher and inventor Prof. Ranjeny Thomas and her team. The team includes Dr. Patel supporting clinical trial readiness, Dr. Hanno Nel researching lab and animal studies to support translational research and the UniQuest team, Dr. Cecile Francis and Dr. David Markwell supporting commercialisation for ASITI and developing investment strategies for UQ’s spinout company. Prof. Thomas is a lead researcher at The University of Queensland, specializing in immunology seeking to understand autoimmune diseases and restoration of immune tolerance. Through her work, ASITI is opening new opportunities for the control and prevention of autoimmune diseases.

Prof. Ranjeny Thomas in lab.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

DEVELOPING A NASAL SPRAY TO PREVENT CHILDHOOD EAR INFECTIONS

Researchers at the Wesfarmers Centre of Vaccines and Infectious Diseases, based at The Kids Research Institute Australia, have developed a preventative therapy in the form of a nasal spray that aims to cut the rate of ear infections by half and significantly reduce the healthcare and economic burden in Australia.

Wesfarmers Centre of Vaccines and Infectious Diseases researchers

Associate Professor Lea-Ann Kirkham and Dr Elke Seppanen

TAKING ADVANTAGE OF ‘FRIENDLY’ BACTERIA

Many families are familiar with the pain of childhood ear infections – not just the physical pain suffered by the child, but the frustration around ongoing medical visits, antibiotic prescriptions, hearing loss and speech delays, and often long hospital waitlists and repeat surgeries for recurrent infections. Each year, more than 700 million middle ear infections are experienced worldwide, with treatment in Australia coming at an annual cost of $500 million.

Researchers at the Wesfarmers Centre of Vaccines and Infectious Diseases, based at The Kids Research Institute Australia in Perth, have come up with a novel way to tackle this problem head on - developing a nasal spray therapy that uses ‘friendly bacteria’ to guard the ear from infection.

Called Spritz-OM, this innovative treatment was coinvented by Associate Professor Lea-Ann Kirkham and Professor Peter Richmond. As the scientific lead, it was Associate Professor Kirkham’s research in the laboratory that helped to pinpoint how to fight off the key pathogen responsible for over 50 per cent of the world’s ear infections.

‘We discovered that children with recurrent ear infections rarely had a certain species of “friendly” bacteria in their nose, and when exploring this further in the laboratory, we found that these bacteria had the ability to prevent ear infections,’ Associate Professor Kirkham said.

‘Further work by our team demonstrated that a spray containing the ‘friendly’ bacteria was effective in preventing ear infections in mice, paving the way for securing patents on this discovery and publishing our research in The Journal of Infectious Diseases.

‘From this, we were able to obtain significant funding to work with industry experts to manufacture Spritz-OM and progress to clinical trials,’ Associate Professor Kirkham said.

CONNECTING WITH INDUSTRY

In 2023, the team were chosen to further develop the exciting potential of this break-through by participating in the CSIRO ON Accelerate program designed to help entrepreneurial researchers reach their goals through market validation, capital-raising and connections with industry partners and networks.

‘Participating in ON Accelerate really opened the doors for engaging with the biotech industry, as well as pressuretesting our team and encouraging us to focus on the path to market. We learnt the importance of strong science and excellent communication, as well as a deep knowledge in both business and product development,’ Associate Professor Kirkham said.

‘Since then, we have attracted key industry experts to

help accelerate Spritz-OM development, and we are now manufacturing clinical grade material in preparation for a world-first clinical trial here in Australia.

‘We are really excited for the future of Spritz-OM as we strive towards prevention of ear infections for happier healthier kids,’ Associate Professor Kirkham said.

PHASE 1 TRIALS SET TO BEGIN

Professor Peter Richmond’s expertise will be at the forefront as the clinical trial gets underway. Head of the Wesfarmers Centre’s Vaccine Trials Group, Professor Richmond has led over 50 clinical trials to test the safety and efficacy of new vaccines and therapies.

‘Our first clinical trial for Spritz-OM will involve healthy adults, and this will provide key safety data to then progress into studies in children,’ Professor Richmond said.

‘If the trials are successful, Spritz-OM can significantly improve health and educational outcomes on a global scale. For kids, it means less pain, reduced hospital visits and improved hearing and learning – and for parents, it also means more sleep!

‘But for me, one of the most impactful effects of a therapy like Spritz-OM is the massive potential to reduce antibiotic use, which has a huge impact on bacterial resistance.

‘Childhood ear infections are the main reason children are prescribed antibiotics world-wide, and throughout our studies, we found that some children were prescribed more than ten courses of antibiotics over a two-to-threeyear period.

‘By cutting the rate of ear infections in half, Spritz OM could be a solution to curbing the alarming rise in antimicrobial resistance throughout the world’ Professor Richmond said.

The Spritz OM team are currently at the Investigational New Drug (IND) enabling phase, with the first clinical trial expected to commence in 2026.

Authors: The Spritz-OM development team is based in Perth, Western Australia and is led by Associate Professor Lea-Ann Kirkham, a Research Microbiologist and inventor of Spritz-OM. Consultant paediatrician and Immunologist Professor Peter Richmond is coinventor of Spritz-OM and clinical advisor on the team. They are supported by an excellent team with experience in vaccine development, drug manufacture, clinical trials, research translation, and commercialisation to guide the development path for this exciting discovery.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

KEEPING AUSTRALIAN VACCINATION TECHNOLOGY ON HOME SOIL

VACCINATING THE POPULATION

Post pandemic we’ve seen a decline in vaccination rates in Australia and globally. Misinformation about vaccines, vaccine complacency and needle phobia are all contributing factors to an increase in vaccine hesitancy, which has the potential to put entire communities at risk of vaccine preventable diseases.

Threats of future pandemics, the arrival of vector-borne diseases in our region, and the related health and economic impacts of these events, are reasons why more than ever, it is important to be looking at ways we can improve vaccination rates and build sovereign capabilities to respond quickly and effectively to existing and new threats.

Over the past decade, there have been significant advances in the research and development of Microarray Patch (MAP) technology and its transformative potential as an efficient and cost-effective way of delivering vaccines. Market research is also indicating that given a choice, people would prefer MAPs for vaccination over traditional needle-and-syringe.

Vaxxas is an Australian-based company leading the way in MAP technology with its easy-to-use, high-density microarray patch (HD-MAP) that delivers vaccines to the dense population of immune cells in the skin.

OPPORTUNITIES

One of the biggest challenges of current intramuscular (IM) delivered vaccines is the requirement to maintain vaccines at refrigerated temperatures. The World Health Organisation estimates that up to 50 percent of vaccines are wasted each year largely due to the failure of cold chain during storage and last mile logistics. The COVID-19 pandemic showed us that for mRNA-based vaccines in particular this was challenging.

Australia has invested heavily in its vaccine supply and manufacturing capability post-pandemic. This investment is compromised if we don’t find a more effective way of delivering vaccines for vaccination.

Vaxxas is one of several companies globally working closely with organisations such as CEPI (the Coalition for Epidemic Preparedness Innovations), Wellcome and the Gates Foundation on ways to overcome cold-chain challenges by stabilising mRNA-LNPs and other vaccine types with MAP technology.

Vaxxas has demonstrated stability of some influenza vaccines at 40°C for 12 months and 25°C for mRNA-LNPs for at least 12 months on its HD-MAP which could help to reduce the costs and inconvenience of cold chain storage and distribution.

GROWING EVIDENCE FOR CHANGE

The case for using MAPs as an alternative to needle injection is growing. In addition to thermostability benefits, MAPs also offer ease of use ( potentially selfadministration), patient preference, and the potential to induce a comparable or event superior immune response to needle and syringe with as little as one-sixth of the dose

AUSTRALIAN TECHNOLOGY FOR GLOBAL IMPACT

Based on technology originating from The University of Queensland, Vaxxas is an example of the potential for ground-level innovation to make a significant impact to global health. However, all too often Australian technology has to move offshore to obtain the scale and investment needed to produce a global product. Vaxxas is making significant investment to keep its HD-MAP technology onshore, as evidenced by its state-of-the-art facility in Brisbane and 170 strong team.

The company has benefited from funding by both the state and federal governments focused on growing

advanced manufacturing onshore. Continued support from Australian government and industry for companies like Vaxxas, will ensure Australians have direct access to life-changing medical advancements when they are needed, rather than “getting in line” behind other countries when the next crisis arises.

The need for a sovereign supply and comprehensive vaccine strategy was clear after the public health and economic impacts of the COVID-19 pandemic; and is even more apparent now given the rapidly changing geopolitical and economic environment.

SOVEREIGN AND REGIONAL SUPPORT

Like any disruptive technology, the transition to HD-MAP delivery will require a commitment on multiple fronts. Clinicians and healthcare providers will require training, and the broader population education. High-volume manufacturing infrastructure and updated distribution channels will need to be established.

It is important Vaxxas can develop both commercially attractive vaccines for the private market, and supply governments with affordable solutions to prepare and respond to healthcare emergencies.

The benefits of such investment extends far beyond sovereign healthcare to creating a sustainable global biomedical hub supported by a highly-skilled workforce, robust foreign investment and significant export potential. This type of capability also creates the ability to play a significant leadership role in the region providing access to life-saving vaccines for our South Pacific neighbours.

While much progress is being made, success is only achieved when the first commercial products appear on shelves and, most importantly, are helping to improve the lives and livelihoods of many around the world. This is an opportunity to show the world what we can achieve by realising the full potential of Australian innovation at home.

Vaxxas is grateful for support from the Australian and Queensland Governments in commercialising its highdensity microarray patch (HD-MAP) technology for vaccine delivery through programs such as the Modern Manufacturing Initiative and construction of its first biomedical facility in Brisbane.

Author: Michael Junger, Director – Industry & Government Relations, Vaxxas

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

MORE THAN BAGS OF BLOOD:

HOW LIFEBLOOD IS ESSENTIAL TO THE HEALTH OF ALL AUSTRALIANS.

Blood, plasma, platelets, breast milk, even poo. Donors generously give these biological substances for Lifeblood to turn into safe, reliable materials that save lives.

Australian Red Cross Lifeblood researchers are constantly on the lookout for innovative ways to do more with what is donated.

PROTECTING BABIES FROM BLOOD GROUP INCOMPATIBILITIES

You might’ve heard of anti-D. It’s a special product that can protect an unborn child from inadvertent attack by their mother’s immune system. By immunising an Rhnegative mother with anti-D, their immune system won’t recognise their child’s Rh-positive blood as a foreign body, or antigen. Lifeblood screens all at risk women at no charge to see if they’ll need anti-D.

Lifeblood also screens high-risk pregnancies for seven other blood incompatibilities in five separate tests. Now, advances in genomics mean we’re developing one test

that will span at least 17 antigens. Lifeblood’s researchers are ensuring that the expanded testing reflects the most common antigens seen in Australian women and that we continue to protect the next generation from harm.

ASSURING QUALITY AND EXTENDING SHELF LIVES

With a constant eye to the future of Australia’s blood supplies, Lifeblood researchers investigate the long-term stability of all donated blood components.

Cryoprecipitate is a plasma-derived product often given to people who are critically bleeding. It lasts for a year when kept at -25°C, but only six hours once it’s been thawed for use. Enter the research team. They’ve found that thawed cryoprecipitate can be stored for up to three days if kept in a fridge, without compromising quality. Lifeblood is

Eva (above) receives weekly plasma treatments to treat her immune disease.

now working with the Australian & New Zealand Society of Blood Transfusion to incorporate our findings into future guidelines and potentially reduce wastage.

OPTIMISING STORAGE TO STABILISE SUPPLY

Platelets are a key blood component that can prevent or stop bleeding. They excel at both tasks but there’s a catch – they can only be stored for seven days, making maintaining an adequate supply a constant challenge. This is particularly true for hospitals that don’t have high demand for platelets, like those in remote and regional areas. Short storage timeframes can lead to wastage before the hospital has a patient in need of platelets.

Lifeblood researchers have developed techniques for platelet cryopreservation (deep freezing) for up to four years, or fridge storage for up to three weeks. Both techniques make the platelets take on a more activated form, which might be particularly useful for treating active bleeding. The options are being thoroughly investigated in Phase III clinical trials, with results expected in late 2025.

New platelet storage options may help Lifeblood to strategically manage our national supply, where the future may see platelets stored at three different temperatures depending on needs and trial results. If Lifeblood did introduce cold-stored platelets, this may see more hospitals able to hold platelets, leading to less frequent orders and improved national availability of this critical blood component.

TURNING PLATELET COMPONENTS INTO BIOENGINEERED SKIN

Platelets don’t just stop bleeding. They’re also full of growth factors that are perfect for wound repair. Lifeblood researchers have developed a process to make two new, growth factor rich, materials from platelets, and we’ve been collaborating with researchers from The Alfred Hospital to make them into bioengineered skin. This product might replace existing skin grafts, which require removing healthy skin from elsewhere on the patient’s body to repair the damaged area.

At Lifeblood’s Good Manufacturing Practice certified facilities, we prepare human platelet lysate and platelet precipitate. The platelet precipitate is a key building block for a hydrogel scaffold to grow skin cells upon. Alongside this physical support, the precipitate and lysate provide growth factors to enhance skin cell development. The eventual bioengineered skin product is now being tested in a Phase I clinical trial, to see if it can replace traditional skin graft treatments in patients with severe burns.

MORE THAN BLOOD: DONATED BREAST MILK

Did you know that over 4,000 litres of breast milk was donated to Lifeblood last year? When babies born very prematurely can’t receive their mother’s breast milk, feeding with donated breast milk (instead of infant formula) approximately halves their risk of a serious gut disease called necrotising enterocolitis.

Lifeblood is preparing to pool milk from multiple donors. Why? Our researchers found that the nutritional content in breast milk naturally varies based on factors like how long it’s been since giving birth. By combining donations, we can reduce variability and help doctors ensure our tiny recipients are getting what they need to grow and thrive.

MORE THAN BLOOD: FAECAL MICROBIOTA

Your gut contains millions of tiny living organisms and bacteria, called your microbiota. A third group of generous donors contribute microbiota for us to turn into a lifesaving product for people suffering from debilitating gut infections.

Our faecal microbiota products were first supplied in a bottle, but clinicians told us they could be tricky to handle, messy and slow. Back at the drawing board, extensive optimisation saw us launch new syringes in December 2024 that connect directly to the treatment instrument. Clinicians are loving how easy they are to use!

Stay tuned for more, as the team are also working on a microbiota capsule – a potentially easier way to treat those in need.

WHAT’S NEXT FOR LIFEBLOOD?

We rely on donors across the country to generously give their time and part of themselves. Lifeblood researchers are working hard to find new ways to do more and ensure Lifeblood remains essential to health for all Australians.

Whether it’s blood, plasma, platelets, breast milk or faecal microbiota, there’s always a reason to give life. What’s yours?

• Milk donation: https://www.lifeblood.com.au/milk

• Faecal microbiota donation: https://www.lifeblood. com.au/microbiome

• The journey of plasma: https://www.youtube.com/ watch?v=nRUWnA6SV9Y

Authors: Dr Patrick Capon and Dr Alison Gould, Australian Red Cross Lifeblood on behalf of Lifeblood’s research and development staff and postgraduate students.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

ADDRESSING THE PEOPLE MANAGEMENT SIDE OF THE EARLY RESEARCH COMMERCIALISATION STAGE

For the past decade, Larry Marlow has been working to optimise the professional development of scientific, technical and clinical leaders in universities, medical research institutes, hospitals, medtech/biotech and life science organisations across Australia.

Multiple challenges face the successful researcher or scientist as their career or group grows and they take responsibility for leading a team. Founders of spin-out companies may find themselves wearing multiple hats, juggling various accountabilities with limited resources and infrastructure.

The step to commercialise research requires significant time, resources and expertise, diverting further attention from core research activities and academic pursuits including developing the value proposition, taking steps to protect I.P., choosing a particular commercialisation path, scaling the business model and building the team.

Recruiting and developing a team that can complement a founder’s skills and expertise as well as share the vision and passion is often seen as a mechanical process rather than requiring a set of well managed and skilled leadership activities.

THE IMPORTANCE OF ADDRESSING PEOPLE MANAGEMENT IN COMMERCIALISATION

However, failure to address the challenges associated with the dynamics of the people management side of early research commercialisation may lead to an invisible ‘phantom workload’ – creating additional and unnecessary demands on time and energy and slowing project completion.

Not uncommonly at an early stage of commercial transition a dedicated ‘human resource’ officer role charged with people management support functions cannot be justified. Scientific team members are not uncommonly thrust into these positions without formal training.

The challenges identified here are twofold. For the Founder, what set of skills and capabilities can assist individuals with a strong technical or scientific background to transition from a focus on personal achievement - a necessary early career focus - to a different mind and skill set to help successfully grow, manage and lead a scientific team? For the Team Member charged with people management accountabilities, how can these individuals be helped to skilfully fulfil their important complementary role to achieve and maintain a high performing team?

WHAT DOES EFFECTIVE PEOPLE MANAGEMENT LOOK LIKE IN EARLY RESEARCH COMMERCIALISATION?

The people management side of the early research commercialisation stage should include consideration of building such skill areas as:

• Understanding of the success factors for scientific and technical team leadership

• Communicating ideas and plans in a way that engages others

• Enhanced self-awareness and awareness of impact on others

• Increased ability to influence and communicate effectively with different audiences

• Understanding of the factors to inspire and motivate others

• Creating a positive lab and team culture

• Identifying and resolving conflicts in the workplace

• Effective use of team decision making and facilitation skills and processes

• to generate a climate of high team performance

• Identifying, interviewing, hiring and inducting the best people for your team

• Giving feedback, managing performance, and developing team members

• Developing and maintaining a high level of team creativity and engagement

• Dealing with difficult people and situations in a scientific/technical setting

• Leading productive meetings for scientific and technical teams

• Understanding of how to better manage time and competing demands

• Building a healthy team climate, supporting work-life balance.

HOW MARLOW HAMPSHIRE IS MAKING A DIFFERENCE

For the past decade Marlow Hampshire has been assisting the professional development of scientific, technical and clinical leaders in universities, medical research institutes, hospitals, medtech/biotech and life science organisations across Australia through a comprehensive two-day training program facilitated by Adjunct Professor Larry Marlow. The program, consistently highly rated by participants, addresses the issues described above and provides practical knowledge, skills and conceptual frameworks that can be readily applied back in the workplace or lab.

This includes opportunity for self-assessment against a model of excellence as a technical or research leader, diagnostic instruments for assessing high team performance, employee work motivations, team meetings, personal resilience, and leadership style; strategies for enhancing influence and presentation skills, hiring high performers and networking as well as opportunity to interact with participants from other organisations at similar career stages.

Author: Larry Marlow is the CEO and Principal of Marlow Hampshire.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

GROUNDBREAKING RESEARCH TRANSLATES INTO BETTER CARE FOR AGED CARE RESIDENTS

The team receiving the Digital & Data Health Innovation award from Research Australia. (l-r) Clare Russell (RMIT), Professor Karin Verspoor (RMIT), Dr Jennifer Beer (Telstra Health), Professor Nick Fisk (Research Australia), Isobel Frean (DHCRC)

L-R: Alex Luongo and Hui Mathews (DHCRC), Dr Tabinda Sarwar (RMIT), Vickie Irving (Telstra Health), Joycelyn Ling, Clare Morgan and Judith Ngai (DHCRC)

Telstra Health’s Chief Health and Risk Officer, Dr Monica Trujillo, shares how an award-winning research collaboration created a groundbreaking risk-prediction tool that will assist to improve care for Australians in residential aged care.

The Commonwealth Government’s Aged Care Data and Digital Strategy 2024-2029 sets a clear vision: to deliver the highest quality person-centred care while fostering a sustainable and productive care economy through the power of data and digital innovation.

With Australia’s ageing population set to double by 2050, the demand for residential aged care services to address complex health needs continues to rise. At the same time, it is expected the aged care sector will need an additional 100,000 workers by 2050 to meet the growing demand.

At Telstra Health, aged care represents one of our core areas of focus and we are continually looking at how digital innovation can help deliver on the Federal Government’s aged care strategy as well as support an increasingly stretched care workforce.

Our award-winning collaboration with RMIT University and the Digital Health Cooperative Research Centre (DHCRC) is one example of how a research-led innovation can deliver a commercial outcome that benefits carers and residents alike.

ADDRESSING A REAL NEED IN AGED CARE

Detecting health deterioration in frail residents is notoriously difficult: early signs are often subtle and involve a complex mix of physical, mental, and functional factors that conventional tools used in hospital settings can overlook. This challenge is a key driver behind the strengthened standards introduced as part of aged care reforms, emphasising the need for improved identification of deterioration.

Workforce shortages further challenge aged care facilities’ ability to consistently monitor for these signs, resulting in nearly 40% of aged care residents being transferred to hospitals each year. Research suggests that up to 40% of these transfers could be prevented through early detection and intervention.

To address this gap in the safety and quality of aged care, this joint research initiative pioneered the development of the first deterioration detection tool in aged care.

The tool has the capacity to automatically monitor both structured and free-text electronic patient records to detect deterioration in frail aged care residents across 36 evidence-based indicators.

It represents the introduction of clinical decision support software to predict deterioration – already used in acute care settings – into aged care. This type of innovation,

which has been standard practice for so long in hospital settings, is long overdue in the residential aged care sector and has enormous potential to uplift the safety and quality of care provided to residents.

OVERCOMING THE DATA BARRIERS

Access, use and sharing of data remains a challenge across Australia’s health system. Although electronic records in residential aged care contain valuable information for detecting deterioration, over 90% is in the form of unstructured text, posing technical and privacy challenges to using this valuable insight.

In response to these challenges, the project team developed and validated cutting-edge, data-driven tools using natural language programming (NLP) and machine learning to extract, de-identify and structure unstructured and free-text electronic record data.

Researchers were then able to create a solution with the capacity to automatically monitor both structured and free-text electronic patient records for 36 evidence-based indicators of deterioration, making it a highly reliable tool.

Incorporating electronic record data from 44 aged care facilities, the tool underwent extensive clinical validation and usability studies by nursing staff from multiple aged care facilities to ensure it is fit for purpose in real-world settings.

This data is now able to be presented to aged care staff in a user-friendly, visual way. Each resident is categorised with a frailty index, offering alerts for risks of falls, depression, and mortality, with data displayed on a dashboard for staff to view at individual or cohort levels.

The innovative approach to data transformation and industry collaboration has seen the project recognised across the sector, being awarded the 2024 Research Australia Digital & Data Health Innovation Award and the Award for Impact from Cooperative Research Australia.

Now our attention turns to commercialisation and expanding access to this groundbreaking initiative for aged care facilities across Australia. This tool has the potential to benefit more than 60,000 elderly aged care residents. Providing access to this innovation, will be crucial in ongoing efforts to enhance safety and quality standards in residential aged care.

Author: Dr Monica Trujillo is the Chief Health and Risk Officer at Telstra Health

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

ELORATM

THE AUSTRALIAN INNOVATION REVOLUTIONISING OUTCOMES

FOR WOMEN WITH BREAST CANCER

In a healthcare landscape where life-changing medical innovations frequently move offshore for production, Perthbased OncoRes Medical is taking a different approach.

The company is pioneering revolutionary technology to dramatically improve breast cancer surgery outcomes for patients, while purposefully building manufacturing capabilities within Australia.

In Australia, breast cancer remains the most commonly diagnosed cancer in women, with one in seven at risk of being diagnosed in their lifetime. A diagnosis marks the

beginning of a challenging and emotional journey, where women are suddenly required to make swift decisions about their treatment options, often setting them on a path of multiple interventions with far-reaching physical and emotional impacts.

According to OncoRes Medical CEO and MD, Dr Katharine Giles, new treatment approaches are urgently needed.

‘Up to one in three women undergoing breast-conserving surgery face the physical and psychological burden of repeat operations due to missed cancerous tissue,’ she explains.

This statistic represents thousands of women annually who experience the distress of learning cancerous tissue remains after what they hoped would be their final surgery. Beyond the emotional toll, these repeat procedures increase healthcare costs and delay critical follow-up treatments.

OncoRes’ solution is Elora™, a pioneering handheld imaging system that enables surgeons to identify and remove all cancerous tissue in a single operation. The innovative device combines high-resolution optical imaging with sensitive micro-elastography to detect subtle differences between cancerous and healthy tissue during

OncoRes is pioneering revolutionary technology to drastically improve breast cancer surgery outcomes for women.

surgery. By providing real-time assessment of the tumour cavity and margins, Elora gives surgeons immediate feedback on whether cancer remains present at the surgical site, allowing them to remove additional tissue if needed while the patient is still in the operating room. This microscopic-level precision helps surgeons achieve clear margins in the initial procedure, significantly reducing the need for follow-up surgeries.

Clinicians often explain this device as extending their sense of touch, allowing them to more clearly identify the cancerous tissue, in situ.

THE POWER OF COLLABORATION

The novel imaging technology powering Elora emerged through a longstanding collaboration between researchers, surgeons and pathologists at the University of Western Australia, the Western Australian Department of Health, and Harry Perkins Institute of Medical Research. This collaborative foundation remains integral to the Company’s ongoing advancement, with OncoRes maintaining strong research ties to the University of Western Australia that continue to fuel innovation and refinement of their technology.

‘Multidisciplinary collaboration has been critical to our success,’ says Dr Giles. ‘Having clinicians, scientists and engineers working together from the beginning ensured we were developing a solution that would actually work in the operating room. Each discipline brought crucial perspectives that shaped both the technology and its practical implementation.’This tight-knit ecosystem of Western Australian medical innovation has provided OncoRes with unique advantages in translating laboratory concepts into commercial-ready technology.

BUILDING LOCAL MANUFACTURING CAPABILITIES

In an age where offshoring manufacturing is common practice, OncoRes has made a deliberate choice to establish manufacturing capabilities in Western Australia. This decision stands out in the medical technology sector, where overseas production is typically viewed as the costeffective option.

‘By manufacturing in Australia, we reduce supply chain risk, reduce the cost of goods, increase the intellectual property we develop and hold in-house, and create jobs,” Dr Giles explains. “Counter to popular belief, this approach actually gives us strategic advantages.’

The company has already manufactured over 1,000 specialised disposable components for their technology at their Western Australian facility. These precision-engineered parts require tight tolerances and specialised materials to ensure accurate tissue assessment during surgical procedures. By controlling the production process locally, OncoRes maintains direct oversight of quality control, can rapidly iterate on designs, and significantly reduces the lead time from engineering improvements to implementation.

DIVERSE THINKING DRIVES INNOVATION

OncoRes isn’t just innovative in its technology and manufacturing approach—the company has curated a team with diverse professional backgrounds and perspectives to tackle complex challenges. This deliberate approach to team-building has created an environment where crosspollination of ideas drives creative problem-solving.

‘Diversity of thought improves problem-solving, and we’re solving one massive problem, a small problem at a time,’ Dr Giles explains. The Company has assembled a multidisciplinary workforce drawing expertise from aeronautics, defence, automotive, oil and gas and mining industries – sectors not traditionally associated with medical technology development.

‘When we bring together people with different professional experiences, educational backgrounds, and perspectives, we find solutions that might never emerge from a more homogeneous team,’ explains Dr Giles.

THE PATH AHEAD

With support from government programs and key investors, OncoRes is now advancing toward late stage clinical trials and commercial deployment of Elora. The technology has the potential to significantly improve outcomes for breast cancer patients worldwide while positioning Western Australia as a hub for medical innovation.

‘Every woman deserves the best possible outcome from breast cancer surgery - to leave the operating room knowing all cancer has been removed, without the anxiety of waiting to hear if they’ll need another operation. We’re all bound together by a really strong purpose. We’re transforming experiences for breast cancer patients while proving that Australian innovation can lead the world in medical technology.’

Author: Dr Katharine Giles is the CEO of OncoRes Medical. OncoRes is funded by the Medical Research Commercialisation Fund and collaborates with leading researchers at the University of Western Australia, the Harry Perkins Institute of Medical Research and breast cancer surgeons and pathologists from the Western Australian Department of Health.

Dr Katharine Giles

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

FROM CONVERSATION TO CARE:

AI-DRIVEN DOCUMENTATION FOR RESEARCH AND PATIENT OUTCOMES

In women’s health care, where time is precious and patient complexity is high, artificial intelligence (AI) is emerging as a game-changer - streamlining documentation, enhancing collaboration, and ensuring every patient receives comprehensive, evidencebased care.

Artificial intelligence (AI) is revolutionising women’s health care by reducing administrative burdens, supporting clinical decision-making, and facilitating collaboration across multidisciplinary teams.

At Women’s Health Road (WHR), we have been using the AI scribe tool ‘ Heidi’ for over a year, acting as a virtual ‘resident,’ transcribing consultations in real-time. More recently, it has been seamlessly integrated into our cloud-based practice management system (PMS). By standardising documentation through AI-powered templates, clinicians can dedicate more time to patient care while enabling real-time data collection that supports research and healthcare innovation.

BRIDGING INNOVATION, MULTIDISCIPLINARY CARE, AND PATIENT OUTCOMES

Inconsistent medical documentation often leads to fragmented care and inefficiencies. At Women’s

Sarah Yeomans

Health Road, AI-powered templates ensure key clinical elements are consistently recorded, facilitating seamless collaboration among gynaecologists, GPs, and allied health professionals. These structured templates enhance diagnostic precision, improve continuity of care, and support real-time decision-making, ultimately leading to better patient outcomes and high-value healthcare.

Beyond optimising patient care, AI-driven documentation promotes sustainable healthcare delivery. By reducing administrative workload, clinicians can focus on meaningful patient interactions and clinical decisionmaking. For healthcare providers and industry stakeholders, standardised documentation enhances compliance, improves resource allocation, and facilitates data-driven funding applications, ensuring innovative, high-quality care remains accessible and cost-effective.

With guidance from clinicians, I have developed WHR’s templates for initial consultations, follow-ups, and in-clinic procedures, specifically for patients with heavy menstrual bleeding (HMB). These templates capture essential details, such as those related to iron deficiency anaemia, and incorporate the Heavy Menstrual Bleeding Clinical Care Standard (2024). Additionally, the FIGO Abnormal Uterine Bleeding (AUB) parameters are embedded, ensuring AI transcription standardises patient descriptions of menstrual symptoms - enhancing both clinical care and research capabilities (Figure 1, Figure 2).

These AI-powered templates also assist with patient coding, ensuring accurate classification of conditions and treatments. This improves the ability to track patient outcomes, supports healthcare funding applications, and enhances data collection for research on menstrual disorders and gynaecological health.

When creating the AI templates, I consulted with Dr. Talat Uppal, our gynaecologist, to determine what elements were most valuable in consultation notes. She emphasised the importance of capturing a patient’s social history—details about their home, work, or school life, as well as social and economic factors that may impact their health. As Dr. Uppal often states, ‘If it is important enough for the patient to share with me, then it is important enough to include in their notes.’ This patient-centred approach was fundamental in shaping the templates, ensuring they capture comprehensive patient concerns while maintaining relevance to the primary reason for consultation.

I have since developed a bank of consultation templates that are now used by our entire multidisciplinary team at Women’s Health Road. These include:

• HMB/AUB Consult

• IUD Insertion/HMB Consult

• Colposcopy/AUB

• Unscheduled PV Bleeding on Hormone Medication

• Postmenopausal Bleeding

• Sleep Coach Initial Consult

• Urogynae Consult

• Surgical Note Templates for procedures including hysteroscopy, IUD insertion, ablation, biopsy, and laparoscopy.

WORKFLOW CHANGES: A MORE EFFICIENT MODEL OF CARE

Since integrating the AI scribe, our workflow has become more streamlined. While appointment durations have not significantly shortened, the AI scribe has freed up more time for holistic care, allowing clinicians to focus on meaningful patient interactions rather than administrative tasks. Medical students and observers have also expressed that AI scribes enhance training by reducing the manual burden of notetaking while improving overall accuracy.

A key advantage of Heidi Health AI is its multilingual functionality (currently supporting 26 languages), which has been invaluable in our multicultural patient community. This feature enhances accessibility and supports better communication for patients with diverse linguistic backgrounds.

Furthermore, we integrate both private services and charity-based work for patients with abnormal uterine bleeding. Investing in a digitally sophisticated ecosystem has enabled us to expand capacity and care for more vulnerable patients. AI scribes do operate in a rapidly evolving space, presenting unique ethical and logistical challenges. To ensure safety, we adhere to strict clinical governance structures, including continuous monitoring and quality improvement initiatives. All AI-generated notes undergo human oversight, with clinicians reviewing each entry to ensure accuracy.

SCALABILITY AND FUTURE APPLICATIONS

The AI-driven documentation model at WHR demonstrates the potential for expansion across other areas of women’s health and beyond. With continued industry collaboration, these templates can be adapted for conditions such as endometriosis, menopause management, and reproductive health care. Future advancements could include predictive analytics and AI-assisted clinical decision support, further optimising healthcare delivery and patient outcomes.

By integrating AI into women’s health documentation, we are setting a new benchmark for multidisciplinary care - one that enhances collaboration, efficiency, and patient-centred outcomes while bridging the gap between research, innovation, and clinical practice.

Author: Sarah Yeomans BClinSci, MSciMed (SRH(PH), medical practice assistant, Women’s Health Road

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

NEXT-GEN HEALTH INNOVATION

AI and the Future of Motor Competence

Motor competence (MC) is not just about running or jumping – it’s at the core of how children grow and thrive. MC, which includes the ability to move, coordinate, and balance, plays a huge role in their health and well-being.

Studies have shown that developing these skills early can even help improve brain function and cognitive abilities, leading to better learning and performance in school. Unfortunately, motor skills aren’t where they should be for many kids worldwide, and this can have long-term consequences.

Thankfully, there’s a growing effort to change this, especially in schools and junior sports programs, which are key environments for children to develop their movement skills. But to make a real difference, we need better tools to assess and inform programs to support each child’s motor development. The challenge, however, is that teachers and coaches often lack the resources, support or time to thoroughly assess these skills in a way that’s both accurate and easy to manage.

One solution is the use of technology. While wearable sensors show promise in tracking motor skills, they often come with challenges like where to place the sensors and how to calibrate them. A more accessible alternative? Video-based machine learning, which offers a simple, effective way to analyse motor skills. And this is where an innovative new tool comes in: Moving the Next Generation (MNG).

A SMARTER WAY TO ASSESS MOTOR SKILLS

MNG is a cutting-edge web platform that uses videobased machine learning to automatically assess and report on how children perform various skills like hopping, skipping, throwing, and catching. It was developed to make it easier for teachers and coaches to pinpoint specific areas that need improvement and inform targeted programs.

In a recent study, over 1,000 children performed seven different motor skills while being recorded on video. These recordings were analysed by experts who assessed each

child’s performance using a well-established method called the Test of Gross Motor Development. From there, machine learning models were trained to assess the same skills automatically by analysing the joint movements in the videos.

The system works in two stages: first, it uses a 2D pose estimation model to detect the child’s movements, and then it builds a 3D picture of the movement for deeper analysis (Fig 1 and 2). This technology looks at how joints and limbs interact over time, breaking down the motions to assess performance in fine detail. With the help of machine learning, it becomes possible to provide accurate results quickly and consistently.

MAKING IT SIMPLE FOR EVERYONE

The best part? MNG is designed to be super user-friendly. Teachers and coaches don’t need to be tech experts to use it. The cloud-based platform allows users to record performances, received real-time automated results, track and monitor progress on any device – whether it’s a phone, tablet, or computer. No more complicated setups or expensive equipment. Plus, the platform helps save time by automating the assessment process, so teachers and coaches can focus on what really matters: helping kids improve (Fig 3). The platform also makes sure data is stored securely, with features like face blurring and encryption, all while being compatible with physical

education curriculums to support effective teaching strategies.

A TOOL FOR THE FUTURE WITH RESULTS YOU CAN TRUST

In the study, the platform achieved an impressive performance accuracy rate of over 85% on average across the seven skills. Which is better than human assessment!

What makes MNG especially powerful is that it’s accessible to anyone, anywhere. Whether a coach is in a rural school or a city sports program, they can use this platform to track and support motor skill development, giving children everywhere the opportunity to develop the foundational skills they need to thrive.

While technology won’t replace human connection, it can certainly help make the job easier and more effective. By using MNG, we can ensure that more children get the attention and support they need to develop essential movement skills. And as we continue to fine-tune and expand this technology, the possibilities are limitless –opening doors for a healthier, more active future for kids everywhere.

Author: Associate Professor Natalie Lander and Dr Yuxin Zhang are members of Deakin University’s Institute for Physical Activity and Nutrition, as well as the School of Exercise and Nutrition Sciences. Dr Tao Zhou is a member of the Institute for Intelligent Systems Research and Innovation at Deakin University.

Figure 1: The Architecture of the Framework

Figure 2: The Graph Model of the 17-joint Human Skeleton

Figure 3: MNG In action: Lowther Hall Principal Elisabeth Rhodes, Director of Sport Vicki Hoban, PE Teacher Matthew Cromarty, and Year 7 Students

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

PIONEERING METHODS TO MEASURE AND VALUE QUALITY OF LIFE

Health economic tools developed in Australia have transformed how governments globally make decisions on reimbursing medical technologies.

It’s important that governments making decisions about what medical technologies to fund understand what matters most to patients, especially when resources are scarce.

For example, should they reimburse a new cancer drug that has been shown in clinical trials to extend progression-free survival if its side effects are so severe that patients’ lives become unbearable?

What matters to patients is not necessarily the health outcomes or extra length of life offered by a drug or medical device, but rather outcomes such as mobility, ability to undertake usual activities, absence of pain and mental health.

INNOVATION AND QUALITY OF LIFE

Brendan Mulhern, Professor of Health Economics and Outcomes Research at the University of Technology Sydney (UTS), develops health economic tools that measure the trade-offs between extending life and supporting its quality.

‘There is international recognition that not all interventions aim only to improve clinical or physiological outcomes, but that broader outcomes are also important,’ he says.

‘It’s about measuring the trade-off between length of life and quality of life and over what period.’

Quality of life has become a critical outcome for health reimbursement decision makers, but measuring it in a standardised way is not straightforward. It requires instruments that include both a descriptive system (what questions to ask a person so their answers describe their quality of life) and a scoring system (a value set).

Australia is at the forefront of research in both these areas. Australian ‘value sets’ (a standardised scoring system based on the health preferences of the general population) for the two most widely used instruments recommended in international guidelines, the EQ-5D-5L and SF-6Dv2, were both developed by Australian researchers from UTS.

Associate Professor Mulhern and his team at the UTS Centre for Health Economics Research and Evaluation (CHERE) are world leaders in Australian health-related quality of life research, and are involved in nearly every major initiative in this field in Australia and around the world.

THE IMPACT SO FAR

Whenever a new drug or a medical device is funded, governments use their tools to take into account people’s quality of life, as reported by patients.

Their tools are routinely used by the Australian Pharmaceutical Benefits Advisory Committee (PBAC) and the UK National Institute for Health and Care Excellence (NICE) to make health resourcing allocation decisions at the population level. The use of these measures is written into the guidelines around reimbursement.

The team recently published the new EQ-5D-5L value set for Australia, adapting a standardised measure of health status that has been used routinely internationally since the 1990s.

To develop a value set for the EQ-5D-5L for Australia, researchers asked more than 4,000 Australian adults what they valued most in health outcomes.

Industry uses these tools to capture evidence of the impact of treatments, and this information supports funding submissions to regulators.

For example, in the last five years, the EQ-5D-5L has been licensed for use in Australia almost 1,600 times. About 5% of these licences were for commercial use by the domestic pharmaceutical and medical device industry.

The second most widely used preference-based measure internationally, the SF-6Dv2 health classification system, was also led by Associate Professor Mulhern. Developed from widely used generic measures of health-related quality of life, it has been licensed 249 times since 2022 by the international pharmaceutical and medical device industry.

‘What these tools mean is that the patient voice is heard in decision making, using questions that are standardised and can be used across different settings and across different conditions and populations,’ Associate Professor Mulhern says.

As populations age, other outcome measures will become increasingly important in decision making, such as patient wellbeing, control, hope and social connection.

A BETTER PATH FORWARD

CHERE continues to lead the way in this research. A tool to measure quality of life in paediatric medicine has recently been licensed for use by industry, and research is ongoing into measures of wellbeing for First Nations Australians.

Associate Professor Mulhern’s work has also been influential in improving the quality of life evidence collected in cancer clinical trials, via the Cancer Australia Quality of Life technical service he leads.

‘Improving this evidence has direct impacts on the assessment of the efficacy and effectiveness of new cancer treatments, therefore directly improving outcomes for Australians affected by cancer,’ he says.

‘This research will continue to have a significant impact by enabling decision makers to maximise outcomes across the health and social care system in resource constrained environments.’

Author: Brendan Mulhern is a Professor of Health Economics and Outcomes Research with the Centre for Health Economics Research and Evaluation (CHERE), University of Technology Sydney.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

FROM RESEARCH IDEA TO THERAPEUTIC IMPACT

The growing necessity of commercial engagement

As an ageing physician-scientist in the twilight of his career, I have never been more excited about the near-term prospects for the betterment of human health offered by biomedical research.

This is largely the consequence of the ongoing revolution in genetics and genomics that is transforming the face of modern medicine. The most immediate impact has been an explosion of knowledge about the molecular basis of human disease. This knowledge is in turn being rapidly translated into diagnostic power and providing fuel for the development of advanced therapeutic interventions for the many problematic conditions that lie beyond the reach of contemporary medicine.

Frustratingly, however, development of diagnostic power is outpacing advances in therapeutic power. The consequence is that healthcare professionals are increasingly able to tell patients and their families exactly what’s wrong, but then frequently have little further to offer. In my view, closing this gap is one of the most pressing challenges confronting the global biomedical research community.

THE PROMISE OF GENE THERAPY

While multiple approaches will inevitably be required to address this challenge, gene and gene-modified cell therapies are set to have a profound impact. Indeed, we are already seeing previously unimaginable success in the treatment of devastating genetic diseases of childhood,

such as spinal muscular atrophy and genetic forms of blindness and deafness.

Gene therapy is also making in-roads into the treatment of acquired diseases, such as cancer most notably through the genetic reprogramming of T lymphocytes to re-direct them to the destruction of cancer cells. Even the development of viral vector and mRNA-based vaccines, that were so rapidly deployed during the global Covid-19 pandemic, can be attributed to technologies developed by researchers in the gene therapy field. And all this is just the beginning.

For most of my research career, stretching back over 30 years, the possibility of treating human disease by gene therapy was largely a dream, with most conditions lying beyond the reach of available technology. This has changed dramatically over the last decade such that there are now multiple gene therapies, all developed internationally, that have successfully traversed the entire translational pathway from idea at the laboratory bench, to human clinical trials and on to regulatory approval and market-scale availability. Currently there are close to 70 gene therapy products approved globally, inclusive of RNA therapies, and greater than 3000 in various stages of development.

A CHANGING RESEARCH LANDSCAPE

This dramatic change in the translational landscape within the gene therapy field is confronting academic researchers, such as myself, with a new and largely unfamiliar reality. Formerly, when undertaking laboratory research towards the development of novel genetic therapies, the horizon was peer-reviewed publications in a high impact biomedical research journals and the successful winning of competitive grants to sustain laboratory research activity.

There was always the thought that one day our research might change the lives of patients and their families if we could surmount the formidable biological and technological challenges involved. Relatively suddenly this possibility has become a pressing near-term reality. We now have the biological knowledge and genetic technologies that put many difficult or impossible to treat conditions within immediate therapeutic reach. The new imperative is to vigorously engage the daunting challenge of clinical translation, getting experimental therapies out of the laboratory, into early phase human clinical trials and beyond. But how?

THE CHALLENGES OF RESEARCH TRANSLATION IN AUSTRALIA

Australia is internationally recognised for the excellence of its biomedical research community and as an attractive destination for global clinical trials, but we underperform at multiple steps in the intervening translational pathway. Not the least of the challenges involved is immense cost, and for gene and gene-modified cell therapies access

to the necessary biomanufacturing capabilities. It is now increasingly difficult to reach early phase clinical trials in an academic context with competitive grant funding.

Early commercial engagement is almost inescapable. For academics with translation-ready research programs, options include partnering with or sublicensing to existing commercial entities or participating in the creation of a new start-up or spin-out commercial entity. The latter lies well beyond the comfort zone of most academics in Australia and the challenge is further complicated by our relatively nascent and risk averse venture capital sector.

THE ROAD AHEAD

But it is not all doom and gloom. The environment for clinical translation in Australia is improving. With the disruption of global supply chains during the pandemic and ongoing geopolitical instability, State and Federal governments have universally recognised the need for a future made in Australia. We are seeing significant investment in biomanufacturing capability for both RNA and recombinant viral vector-based products that will bolster the local translational pathway and an increasing recognition of the need for commercialization training programs. Looking to the future, biomedical researchers in the academic sector hoping to translate their research through to health impacts have real reason for optimism and with tenacity, entrepreneurial spirit and early commercial engagement have genuine prospects of success.

Author: Professor Ian Alexander is Head, Gene Therapy Research Unit, Sydney Children’s Hospitals Network and Children’s Medical Research Institute, Chief Medical Officer, VVMF Pty Ltd and  Senior Staff Specialist, The Children’s Hospital at Westmead. He was also Research Australia’s Peter Wills Medal recipient in 2022.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

VCCC ALLIANCE

OUR STORY

Established in 2009, the VCCC Alliance is a powerful partnership of leading research, academic and clinical institutions working together to accelerate and amplify leading-edge cancer research, knowledge and expertise to benefit the national and international community. Through innovation and collaboration, the alliance is leading the development of integrated, research-driven, consumer-informed and equitable cancer research, education, and models of patient care, to fundamentally change the way we tackle cancer.

MEMBERS/ASSOCIATE MEMBERS:

• Peter MacCallum Cancer Centre

• The Royal Melbourne Hospital

• WEHI

• University of Melbourne

• The Royal Women’s Hospital

• The Royal Children’s Hospital

• Western Health

• St Vincent’s Hospital Melbourne

• Murdoch Children’s Research Institute

• Austin Health

• Albury Wodonga Health

STRATEGIC GOALS 2024-2029

Collaborative Research – Bring the best minds together

The Clinical Translational Network brings together the best and brightest clinician/academics through funded and honorary positions within the alliance to address the most important challenges impacting cancer patients, accelerating research translation through multiple partner collaboration.

Data and Technology – Drive better sharing of data and knowledge

Developed by the alliance with The University of Melbourne, Data Connect has enabled data from general practice, cancer registries and hospitals to

be linked for research purposes, for the first time in cancer research in Australia.

Equitable Care and Outcomes – Ensure all patients have access to optimal care

Equity underpins all of the alliance’s work, while specific programs aim to improve outcomes by supporting those disadvantaged by current system structures – including a focus on Aboriginal and Torres Strait Islander peoples, culturally diverse and regional communities, all underpinned by a Cancer Equity Framework.

Patient-powered – Integrate diverse consumer perspectives to improve research and care

Consumers are involved in all we do. We’re developing a diverse network of consumer leaders across Victoria, and utilising a system-wide approach, aiming for cancer care that is patient-centred and valuebased.

Leadership and Learning – Upskill, support and inspire the cancer workforce

The Centre for Cancer Education provides world-class training across all oncology disciplines, informed by leading cancer experts and underpinned by the latest research. Through a bespoke digital platform, the CCE develops, facilitates, and delivers highquality, evidence-based education to support the cancer workforce locally, nationally, and globally. This platform offers tailored learning modules, live event recordings, resource hubs, private training, and webinars, ensuring broad access to cutting-edge knowledge, research translation, and professional development opportunities.

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL

THE LAST WORD

INDUSTRY IN HEALTH AND MEDICAL RESEARCH INNOVATION

From Bench to Business to Bedside-the triple B

The mantra of “bench to bedside” has long been synonymous with the aspiration to translate medical research into clinical care—even though this process can take decades. The addition of the “B” for business into this phrase may raise concerns for some: fears that it could dilute the altruism often associated with medical research, or that it might extend the already lengthy timeframe even further.

However, I would argue that the value of quality research lies in its scalable application to health service delivery—and that commercialisation is about more than just money. It’s the pathway by which products are made available to those who need them—patients, caregivers, clinicians—and its success can be measured in both commercial and non-commercial terms. The right industry partner can in fact accelerate, not hinder, the process of delivering research to the bedside— or wherever care is provided. In Australia, though, we need to create an environment in which this can occur routinely, in order to fully realise the talent and potential of our researchers and clinicians.

CONTEXT MATTERS: AUSTRALIA’S UNIQUE CHALLENGE

When considering the “bench to business to bedside” model in Australia, context is everything—and the preconditions here differ significantly from many other countries.

First, Australia’s health and medical research ecosystem is complex, with distributed leadership and governance structures that make it challenging for researchers, universities, health services, governments, and industry to navigate. On top of that, the competitive nature of research funding can turn researchers and states into rivals, rather than collaborators—as seen post-COVID, when every state and territory pushed for its own mRNA facility rather than working together nationally.

HOW DO WE UNLOCK THE LABYRINTH?

Federal and state governments have made substantial investments in research infrastructure to catalyse collaboration and innovation. But governance programs and strategic planning must ensure these benefits are fully realised.

One key initiative is the National Critical Research Infrastructure program, which aims to boost Australia’s capacity in health and medical research through streams like innovation enablers, healthcare digitisation, co-investment partnerships, and mRNA technology platforms.

Another encouraging step is the Industry, Philanthropy, and Commercialisation Committee, a collaborative initiative between the NHMRC and the MRFF. This committee brings industry and philanthropic perspectives to the table and advises on research translation, funding support, and innovation strategies—critical work that helps turn discoveries into both clinical and commercial applications, ultimately improving the health and wellbeing of Australians.

BUILDING ON WHAT WORKS—BUT BRIDGING GAPS

Australia now has health and medical research precincts in most states and territories, and many are moving toward the Triple Mission Model, which integrates clinical care, medical education, and research. However, industry engagement within these precincts is uneven. While some demonstrate strong business partnerships that accelerate the Triple B model, others remain in the early stages of formal industry collaboration.

What may not be popular in some circles is the recognition that failure is part of doing business. This applies not only to individual research projects but also to institutes that continue to operate without measurable impact.

INVESTING IN PEOPLE, NOT JUST PROJECTS

Building capacity to succeed in the Triple B model is essential. While there are exchange programs between research organisations and industry, these rarely lead to true integration. Staff often remain siloed, aligned to one organisation or the other. We need to reimagine new workforces, but we should look to lessons from other sectors – what works and what doesn’t. For example, what have been the experiences of clinician researchers, who hold joint appointments across hospitals and universities—and consider whether this model could be adapted for industry–research partnerships.

A TOUGH ROAD—BUT A CRITICAL ONE

Commercialising medical research is difficult. It involves long timelines, high costs, regulatory hurdles, IP and

viability issues, and challenges in achieving adoption within conservative health systems. There’s also the “valley of death” in translation, where promising research fails to progress due to lack of support or commercial traction.

Australia faces additional hurdles: a smaller population, fewer large-scale investors, and a less mature venture capital ecosystem. We don’t have the deal volume or investment pipelines of larger countries. That means our leaders—across government, academia, and industry— must work even harder to land strong local deals, remove systemic barriers, and actively support in-country innovation.

But despite these hurdles, Australia has no shortage of research talent, entrepreneurial spirit, or medical need. What we often lack is the connective tissue between discovery and innovation, which commercialisation is one aspect. The Triple B—Bench, Business, Bedside—isn’t just a catchphrase. It’s a roadmap for a better system. By embracing business not as an intrusion but as a catalyst, we can shorten the distance between the lab and the clinic. We can turn ideas into innovations, and innovations into outcomes. And most importantly, we can ensure that the incredible work done by Australian researchers doesn’t just stay on paper.

Elizabeth Koff AM, Managing Director of Telstra Health

Author:

Elizabeth Koff AM

CHRISTOPHE KEREBEL

CHRISTOPHE KEREBEL