Australia has the potential to become one of the world’s leading suppliers of cancer-fighting cell therapy treatments, but our leadership must make some bold decisions if we are to take full advantage of this opportunity.
Cell therapy involves administering live, healthy cells into a body to replace, repair damaged cells or eliminate cancer cells. Scientists have been researching cell therapy and its potential clinical applications since the 1960s, but recent advancements in technology have boosted our understanding of cell mechanisms and led to the development of effective new treatments for cancers and other diseases.
Creating cell therapies is extremely expensive. It requires extensive research to understand the disease, and even if a potential treatment is discovered, it needs to be prototyped and put into multi-phase clinical trials, which can take years and require serious investment.
It can be several additional years before a treatment passes all the regulatory hurdles and is approved for use, and even once that treatment is approved, the costs of manufacturing at scale are prohibitive.
This is why, in 2024, we still import more than 90 per cent of our medications from countries such as India and the US. But it doesn’t have to be this way. We can start by making moves on the global market for cell therapies, which is currently valued at about $9 billion but it is expected to be worth $33 billion within a few years.
Australia can become a global player in this field, and the rewards for achieving this would be enormous – but there are significant barriers in the way.
Barriers to medical sovereignty
QIMR Berghofer is at the forefront of developing cell therapies in Australia. We are a not-for-profit organisation founded in 1945 by the Queensland Government to research Northern Australia’s infectious diseases.
Since then, we have grown into one of the country’s leading medical research institutes and have developed ground-breaking T-cell and CAR-T therapies that can destroy cancer cells but also control life-threatening viral infections in vulnerable patients and treat inflammatory and autoimmune disorders and conditions.
For the past 20 years we have built the cell therapy manufacturing capability at our own Q-Gen Cell Therapeutics, housed at QIMR Berghofer. Q-Gen is a cell therapy manufacturing facility, which is approved to produce cell therapies for phase 1, 2 and 3 clinical trials.
QIMR’s strengths are our innovation in cell therapy generated by our talented scientists and laboratory teams, ability to produce high-quality therapy prototypes, conduct trials and our capability to manufacture clinical trial products for more than 20 years.
We have already attracted and partnered with international BioTech companies and institutes that value our expertise in this area and want us to manufacture their product for validation in the clinic.
T-cell and CAR-T therapies have proven their potential to kill the cancer effectively and save lives. Our treatments are designed to target cancer, but they are already expanding to other diseases that are very difficult to treat –showing promising results in treating autoimmune diseases such as systemic lupus erythematosus, idiopathic inflammatory myositis, and systemic sclerosis.
QIMR Berghofer scientists have developed novel cellular therapies for blood cancers, viral infections and autoimmune diseases. These cellular therapies have been tested in multiple clinical trials and have also been offered to critically ill patients for compassionate access.
Cell therapies manufactured at QIMR Berghofer have been offered to patients in Australia, New Zealand, US, Canada and Hong Kong.
More than 1,000 researchers, students and professional staff come through our doors every day, and although our primary task is to improve the health of Queenslanders, our impact doesn’t stop at the border.
Most health challenges in our state are aligned with those of other states, territories, and countries.
We’re continually collaborating with local, state and federal governments, organisations, hospitals and industry experts – anyone that can help drive innovation or enhance our research and help us develop new therapies.
There are numerous stakeholders, which is important as it creates a wider range of opportunities for the country.
Barriers to mass production
This vision hits a solid barrier when it comes to manufacturing these therapies at scale because the investment would be significant. We have been successful in exporting our T-cell products to the US, Canada and Hong Kong, and need to scale up the manufacturing for clinical trial products on a global scale.
QIMR is a not-for-profit organisation, but there are very good reasons why we are keen to get into the business of scaling-up manufacturing and exporting cell therapies.
We want to be able to support a growing and thriving local cell therapy and biomedical ecosystem, including providing opportunities for spinouts, small businesses, large corporations and academia to contribute to Australia becoming a leader in cell therapy manufacturing.
We are focusing on sustainability for the Institute and local suppliers, and the opportunity to create a financially viable hub will showcase a reduced reliance on government funding.
Even with government grants and subsidies, for every dollar we receive, we currently need matched funding to support the full cost of the research that we are conducting.
If we were able to mass produce cell treatments domestically, using our own IP and others’ from both locally and international biotech companies, in our own state-of-the-art facility, the cost of those treatments for Australians would fall significantly. In due course, we would create opportunity for Australian made cell therapy products to seize a billion-dollar export market share.
Secondly, we believe it’s important for Australia to become self-sufficient in this area. Imported cell therapy drugs are extremely expensive – a single infusion for a single patient can cost as much as $600,000, and there is no way our health budget could support that.
Australia learned many valuable lessons from the COVID pandemic: we discovered major vulnerabilities in our supply chains and realised we were dependent on overseas suppliers for treatments to protect our citizens.
We believe the government should be more proactive in this area and empower Australia’s medical capabilities to ensure we have better options in the future.
ROI enables change
We see an opportunity right now to increase the amount of research and innovation conducted in this area, and for Australia to become an international hub for developing and manufacturing cell therapies.
QIMR envisions a future where Australia could be a net exporter of cell therapy treatments. But before that is possible, we need to build on our expertise and experience to create a cell therapy manufacturing hub that fully embraces technologies, cost effective production, talent development and manufacturing cutting edge treatments in collaboration with local and global partners.
Scaling up production requires us to consider emerging sophisticated end-to-end automation and robotics, which would improve standardisation of production, minimise costs and maximise the return on investment.
We have also been addressing this internally by completely transforming our culture from a more traditional research environment to one where researchers are partnered with a member of our business team, so they both learn to work differently.
Researchers at QIMR set about to achieve milestones and receive tranche payments from internal QIMR R&D commercialisation funds or similar external support programs depending on progress.
Our researchers understand the importance of the impact of their research which leads to a treatment that is in demand.
It’s a completely different way of working, but to me it seems as though we have many people here in Queensland with experience from the US pharmaceutical and biotech industries – and we’re all speaking the same language.
Queensland has a long history and leadership in promoting a culture of entrepreneurship and at QIMR we take that seriously, and we’re also extremely careful about nurturing for success.
QIMR has a strong capabilities and teams that work hard to qualify which treatments have the elements that justify spinning out to create a new company, and which treatments are more suitable to licence.
It really depends on the profile of the product. We recently spun-out a company called Cyteph – that is developing an off-the-shelf cell therapy that harnesses the immune system to target and fight brain and other solid cancers
Business could be booming
These types of therapies are effective and the world is embracing them, which is causing the demand for cell therapy products to increase exponentially.
The government needs to recognise that this isn’t just another academic institution asking for more public money, it’s an opportunity for the country to become a leader in this field.
QIMR’s products are effective and in-demand, we’re not interested in handouts. We want to provide the Government, and the citizens of Australia, a return on investment, and sovereign authority over a wide range of effective treatments – for cancer and a wide range of other ailments.
Our vision proposes to re-inject some of these revenues back into research and the production of affordable cell therapy products.
The vision is not limited to QIMR, it is a broad collaborative idea which proposes to support the broader Australian research, innovation and industry community with an end-to-end development to manufacture ecosystem, thus, fast-tracking home-grown innovation to the clinic and commercialisation.
By investing in a state-of-the-art manufacturing facility, Australia could offer extremely attractive rates for international clients to not only prototype and trail their therapies, but also manufacture them on a large scale.
Imagine people coming from all over the world to study for specialist medical or bespoke biomanufacturing degrees that could be offered exclusively at universities in Queensland, the associated beneficiaries of this idea.
Unfortunately, it’s going to take some bold policy decisions for the public sector to take advantage of this opportunity. It will only happen if the government policy is focused on the long term not just on the next election cycle, and takes the visionary steps, supports the local capabilities to make Australia a global leader in cell therapies.
We need politicians that will make decisions in favour of being selfless for the good of Australia and the Australian people. Countries that have been successful in creating a vibrant biomedical industry sector have done so through long-term investments from government.
Taking this step could have a defining and profound impact on our wellbeing and inject a massive boost to the economy. It would also provide Australia the resilience of having sovereign capability to better deal any medical emergencies that may arise in the future.
Professor Fabienne Mackay, Director and CEO, QIMR Berghofer Medical Research Institute. Professor Mackay’s groundbreaking work on the role of BAFF in autoimmune diseases led to the development of belimumab (Benlysta™), the first new treatment for Systemic Lupus Erythematosus (SLE) in over 50 years. With over 184 publications and 18,500 citations, she is internationally recognised for her contributions to immunology and translational research.
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