AusBiotech will lead a consortium of seven partners as the Australian regenerative medicine (RM) industry prepares to thrive and drive benefits to Australia’s economy and the health of its people, after it received funding through MTPConnect’s Project Fund Program.
The project will identify and establish a national RM sector ‘catalyst’ collaboration body, and address priority action areas including: workforce capabilities, collaboration, funding, regulation and policy infrastructure, and Australian manufacturing capability.
The seven consortium partners hold extensive insight and experience in the life science and regenerative medicines landscape in Australia: AusBiotech, Medicines Australia, Cell Therapies Pty Ltd, Novartis Pharmaceuticals Australia Pty Ltd, Biointelect Pty Ltd, Research Strategies Australia, and MTPConnect. The partners will match the funding from MTPConnect to deliver the project.
The 12-month project will build on Australia’s expertise and achievements in the RM industry – an emerging area of health technology that targets the body’s own regenerative capabilities. RM includes gene therapies, cell therapies (such as CAR-T), and tissue-engineered products intended to regenerate or replace injured, diseased, or defective cells, tissues, or organs to restore or establish function and structure.
Australia has a strong and active RM industry eco-system with internationally-recognised basic and translational research, clinical trials framework and clinical centres, with more than 30 companies in Australia developing products and more than 30 clinical trials in progress.
Globally, the sector has more than 1,000 clinical trials in progress, and attracted USD $9.8billion in financing in 2019 alone. Global therapeutics companies are turning their attention to the RM sector and we are seeing more gene and cell therapies being brought to Australia for patient access.
The significance and need for this project was highlighted in a national, sector-wide report that assessed the current state of the Australian RM sector and made recommendations on the priorities and goals, see Regenerative medicine: Opportunities for Australia (MTPConnect, LEK, 2018).
Major outcomes of the project include:
- A researched, strategic roadmap for the RM sector’s development in Australia, including sub-reports on skill and talent specific to the sector; determining a plan to attract patient venture capital investment and the role of Australian biotech companies partnering with global companies; and case studies;
- Determining a sustainable funding and model structure for an RM sector ‘catalyst’ collaboration body;
- A regulatory white paper;
- Establishing annual data points and information resources to: map/benchmark GMP manufacturing capability and capacity; establish a model for an annual clinical trial database; and capture investments in Australian RM;
- Mapping the pathway for a typical product from early research to market, and patients receiving a therapy; and
- Mapping the global pipeline of gene and cell therapy products on the horizon.
The new consortium project will receive $300,000 funding through MTPConnect’s Growth Centre Project Fund Program, an Australian Government initiative supported by the Department of Industry, Science, Energy and Resources. Consortia members are providing $300,000 in matched funding. It is a competitive matched funding program that aims to invest in ideas to boost the innovation, productivity and competitiveness of Australia’s MTP sector.
– QUOTES FROM CONSORTIUM –
AusBiotech CEO, Lorraine Chiroiu said: “AusBiotech is delighted to be joining with a high-quality consortium of organisations to further build the foundations for regenerative medicine in Australia.
“The potential health benefits of a surging regenerative medicine sector, were until quite recently more likely to be considered science fiction than reality, but the evidence is mounting; the outcomes stunning – and the excitement for the sector’s future is too good to ignore.
“However, Australia is underprepared to capitalise on the opportunities gene and cell therapies can deliver. This project will bring together, for the first time, the entire ecosystem, and focus our efforts for best effect. From SME to multinational, investor to manufacturer, patient to employee, this project will prepare us for the road ahead.”
Biointelect Managing Director, Jennifer Herz, said, “Biointelect is committed to the commercialisation of cell and gene therapies in Australia. In our day-to-day work with promising researchers and companies in early stage development, we see a real need to support commercialisation locally. We also work with late stage biopharma companies and see a broad range of challenges in supply chain, logistics, health service implementation, funding and reimbursement ahead. Biointelect is excited to be involved in the Catalyst Project as the foundation for a world-leading Australian regenerative medicine industry, helping to ensure that Australians patients have access to cutting edge therapies.”
Cell Therapies Pty Ltd CEO, Dawn Driscoll, said, “Australia’s regenerative medicine ecosystem has so many positive attributes and so much going for it: from excellent basic research through to an innovative commercial scene, and underpinned by a robust and rational regulatory framework. Now is absolutely the right time for AusBiotech to oversee a Consortium to move this industry forward and maximize the many opportunities regenerative medicine presents. I am thrilled to be part of it, and look forward to contributing to the further expansion of an industry that can do so much for so many patients in need.”
Medicines Australia CEO, Elizabeth de Somer, said, “Medicines Australia is pleased to be a member of the consortium, as we consider it is vital to modernise regulatory and reimbursement pathways to keep pace with the rapid advancements in therapies such as cell and gene therapies.
“There are around 360 novel cell and gene therapies in early to late stages of clinical development and one third of these are in development for rare diseases. These therapies have the potential to revolutionise treatment options. It will be necessary to ensure the regulatory and reimbursement processes in Australia allow Australian patients to benefit from them as quickly and efficiently as possible.”
MTPConnect Managing Director and CEO Dr Dan Grant said, “MTPConnect’s Growth Centre funding awarded to AusBiotech and consortia members over the next twelve months will help to deliver this important growth initiative for the regenerative medicine sector in Australia.
“Australia has a strong and active regenerative medicine industry eco-system and if we get this right, success could be worth $6 billion in annual revenue and 6,000 new jobs for Australia by 2035. Setting up Australia’s first Regenerative Medicine Catalyst body will now make this a possibility, helping to elevate and drive growth of this emerging industry sector in Australia. Congratulations to AusBiotech and consortia members on securing this funding.”
Novartis Oncology, Australia and New Zealand General Manager, Cheryl Maley, said “More than one year after the first Australian patient received government funded Kymriah®, and with over 100 patients infused since the first local trial patient, we continue to strive to bring innovative cell and gene therapies to Australian patients. Novartis is excited to join this Regenerative Medicines (RM) consortium as we hope that by sharing some of our experiences, and share our successes we can help map the path for local RM companies to bring their developments to Australian patients in a similar way.”
About Kymriah® (tisagenlecleucel)
Kymriah is an immunocellular therapy, a one-time treatment manufactured individually for each patient using their own T cells, genetically reengineered and programmed to recognise and destroy cancer cells. More information about Kymriah can be found at https://www.novartis.com.au/products/consumer-information/products. Healthcare professionals should see approved Product Information before prescribing. Approved Product Information available on request. For the most up to date Product Information go to https://www.novartis.com.au/products/healthcare-professionals
Warning: Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving KYMRIAH. Do not administer KYMRIAH to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab as per the CRS management algorithm.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Cytokine release syndrome; Neurological events; Infections and febrile neutropenia; Prolonged cytopenias; Secondary malignancies; Hypogammaglobulinemia; Live vaccines; Tumour lysis syndrome; Blood, organ, tissue and cell donation; Active central nervous system (CNS) leukaemia or lymphoma; Concomitant disease such as patients with a history of active CNS disorder or inadequate renal, pulmonary or cardiac function; Prior bone marrow transplant; HIV, Hepatitis B, Hepatitis C and viral reactivation; Prior treatment with an anti-CD19 therapy; Effects on laboratory tests; Use in the elderly and paediatric use; Reasons to delay treatment such as Unresolved serious adverse reactions, Active uncontrolled infection; active chronic GVHD, Significant clinical worsening of leukaemia burden or rapid progression of lymphoma with unstable clinical presentation following lymphodepleting chemotherapy; Patient information regarding adverse event symptoms.
Research Strategies Australia Managing Director, Tim Cahill said, “Research Strategies Australia is very excited to be part of this project which aligns with our mission to maximise the benefits of publicly funded research. Developing a body to catalyse and grow the regenerative medicine industry in Australia is needed to translate our excellent health and medical research capability into improved health outcomes for Australians and those living across our region. By linking the different parts of the regenerative medicine value chain we can speed up the pathway from benchtop to bedside and grow the benefits from our public investment in research.”
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Media enquiries: Karen Parr, Director, Communications, AusBiotech,
kparr@ausbiotech.org / P: +61 (0) 3 9828 1405 / M: +61 (0) 420 729 123
About AusBiotech
AusBiotech is Australia’s biotechnology organisation, working on behalf of members for more than 30 years to provide representation and services to promote the global growth of Australian biotechnology. AusBiotech is the voice of a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural sectors.
About Biointelect
Biointelect provides a range of services for biopharmaceutical and medical device companies seeking to commercialise new technologies globally. We conduct detailed market evaluations and we define optimum clinical, regulatory, reimbursement and market-entry strategies.
About Cell Therapies
Cell Therapies Pty Ltd (CTPL) is an Australian-based, globally-active commercial contract development and manufacturing company, specialising in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products. A leader in this groundbreaking field, our expert team and world-class facilities have been developing and manufacturing cutting edge treatments for cancer and rare diseases on behalf of local and international clients for more than 15 years.
About Medicines Australia
Medicines Australia represents the discovery‐driven pharmaceutical industry in Australia. Our member companies invent, manufacture and supply innovative medicines and vaccines to the Australian community, which keeps Australians out of hospitals, prevents disease and play a pivotal role in ensuring a productive and healthy community. Medicines Australia’s mission is to drive the creation and development of a predictable environment for the continued, sustainable growth of the innovative and researchbased prescription medicines industry.
About MTPConnect
MTPConnect was formed in December 2015 as part of the Federal Government’s Industry Growth Centres Initiative. It aims to accelerate the rate of growth of the medical technologies, biotechnologies and pharmaceuticals sector to increase commercialisation, collaboration and establish Australia as an Asia-Pacific hub for MTP companies.
About Novartis Australia and New Zealand
Novartis is the largest Australian medicines company improving the lives of more than 2.8 million patients across Australia and New Zealand. From generics to gene therapy, we are committed to accelerating patient access to life saving treatments. We are reimagining medicine by using innovative science and technology to address challenging healthcare issues and our rich pipeline has 200+ projects in development and an industry leading clinical trial footprint in Australia. Our unbossed, curious and inspired culture unites our 700 employees, it is what unleashes the power of our people and is at the heart of the work we do each day.
About Research Strategies Australia
Research Strategies Australia is a consulting firm with the mission of maximising the benefits of publicly funded research. We work with government, universities non-profits and the private sector to plan, manage and monitor research investments.