Cell and gene therapies is an exciting and emerging field with massive potential to revolutionise how we treat many diseases, particularly cancers, with many clinical trials in progress or having been completed in Australia. Moreover, recent announcements regarding reimbursement for Kymriah® CAR-T therapy for acute lymphoblastic leukaemia further highlights the promising therapeutic potential of cell and gene therapies.
However, the translational pathway is long and expensive due to enormous challenges encountered at various stages along the pipeline, ranging from discovery and development to the regulation of the therapies. There are a variety of unmet needs ranging from co-ordinated storage, national GMP-standard production capacity and a lack of highly trained staff to meet the demands of manufacturing at scale.
There is already a rapidly growing clinical demand for cancer fighting cell therapies and it is anticipated that these therapies will extend beyond leukemia and lymphoma as the focus shifts to other malignancies. Patients are already being referred overseas for access to CAR T-cell therapy at considerable expense to patients and their health. Patient access can be improved and health system costs reduced if more manufacturing of cell and gene therapies can take place in Australia.
To address this and other issues, TIA will invest a total of $8.8M over the next four years in a group of five leading cell and gene therapy development and manufacturing facilities in Australia. This investment is part of the Australian Department of Education and Training’s National Collaborative Research Infrastructure Strategy (NCRIS) program, that supports national research infrastructure across a range of scientific disciplines, including therapeutic development.
The facilities to be supported are (in alphabetical order):
• Cell and Molecular Therapies (Royal Prince Alfred Hospital)
• Cell and Tissue Therapies WA (Royal Perth Hospital)
• Centre for Cellular Immunotherapy (Peter MacCallum Cancer Centre)
• Q-Gen Cell Therapeutics (QIMR Berghofer Medical Research Institute)
• Sydney Cell and Gene Therapy (Westmead Precinct)
This investment will support key operational and technical staff at each of these key centres, further enabling access by external researchers and SMEs to a range of high-quality services, offered on a collaborative or fee-for-service basis. These facilities already work closely together, however this additional investment will provide the resources to build and maintain a vibrant product development pipeline for the cell and gene therapy community.
TIA’s support for these leading national cell and gene therapy facilities will contribute to transforming Australia’s ability to both develop and deliver cutting-edge cell and gene therapies directly to Australian patients and put Australia at the global forefront of development of new biological therapies that offer such great promise to patients worldwide.
Stuart Newman, the CEO of TIA, said:
“TIA is delighted to announce these investments in these key national centres of excellence offering cell and gene therapy services here at the International Society for Cell & Gene Therapy. We are confident that this increased capacity will enable and encourage researchers and SMEs to engage with these world-class providers and fill the Australian therapeutic development pipeline, ultimately leading to new and more accessible cell and gene therapies.”
Professor John Rasko AO, Founding Director, Cell & Molecular Therapies Royal Prince Alfred Hospital and President of International Society of Cell and Gene Therapy, said:
“Having been active in this field for over two decades, I’m thrilled to see this substantial investment in Australian cell and gene therapy announced at the conference of the world's largest society devoted to this sector, the International Society for Cell & Gene Therapy. We are hosting over 1500 world experts, physicians, regulators and scientists here in Melbourne for our annual international meeting.
With national co-ordinated funding initiatives such as the TIA NCRIS investment, Australia is now well placed on the map to attract investors, clinical trialists and the biotechnology sector for the benefit of patients and their families.”
Therapeutic Innovation Australia (TIA) is a leading not-for-profit research infrastructure organisation that hasreceived funding under the Australian Department of Education and Training’s National Collaborative Research Infrastructure Strategy (NCRIS) since 2008. TIA manages investment in hard and soft infrastructure to enableexternal access to key translational research capabilities, thereby enabling and accelerating translation of research discoveries towards clinical testing. To do this, TIA invests NCRIS funds in a consortium of capabilitiesthat provide the translational benefits via state-of-the-art laboratory equipment and highly trained and experienced technical staff.
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