Regenerative Medicine: Today and Tomorrow
During this year’s AusBiotech conference, held in October in Brisbane, MTPConnect released the report, Regenerative Medicine: Opportunities for Australia, in collaboration with the AusBiotech Regenerative Medicine Advisory Group and other key stakeholders, including the Centre for Commercialisation of Regenerative Medicine (CCRM) Australia. The report, a culmination of surveys, interviews and workshops with more than 60 key members and bodies in the sector, analyses the current state of regenerative medicine (RM) in Australia, its strengths and weaknesses, and provides a roadmap for advancing the sector to successfully compete on the global stage. While the document has a commercialisation and industry focus, it does emphasise the strength, importance and necessity of discovery research in RM.
Why is there such an intense interest in RM and stem cell technology? The report states that RM is “a new paradigm in science.” As such, there is an excellent potential for RM to form the foundation of curative treatments for a spectrum of diseases, illnesses and conditions, including retinal disease, diabetes, cardiovascular disease, neurodegenerative, orthopaedic and immune disorders. It is this powerful potential that has led to the growth of this area of research and given rise to a new industry.
At the heart of this potential is discovery science research, for which Australia has a strong track record, with its rich history of medical research excellence, discovery and innovation. Our world-class research institutes and universities have a reputation for producing high-quality research, evidenced by the volume of scientific publications and fostering talent, from both Australia and abroad. In the RM space, Australia ranks 10th in global publications (and 2nd when adjusted for population) and has contributed to many significant breakthroughs, including conducting some of the world’s first human stem cell trials.
To look at the numbers, a quarter of Australia’s 42 universities and almost two-thirds of the country’s 70 medical research institutes have a strong focus on RM. There are over 300 groups, comprising of approximately 1,200 researchers, that undertake RM research in some form. Driving this has been the support from the Australian government, particularly with funding from the Australian Research Council (ARC) and the National Health and Medical Research Council (NHMRC), and other specific grants. Since 2016, RM research has been receiving $AUD32 million in NHMRC funding annually. Monash University, as the home of ARMI, is unsurprisingly one of the largest recipients of funding support, with $AUD150 million of grants for stem cell research alone since 2001. Overall, the RM field accounts for approximately 10% of Australia’s medical researchers today.
However, translating discoveries from lab bench to bedside requires more than just an active basic science research arm. A robust industry, with knowledge and experience in commercialisation, is vital to this journey. This report outlines the rise of the RM industry in Australia and around the world within the last decade. With 37 therapies having obtained approval and marketed for clinical use, it is expected that this will increase markedly within the next five years, especially in the areas of immunotherapy and cell therapy. Currently, there are more than 30 companies in Australia developing RM products. Industry experts project that the global RM market will be worth $AUS120 billion by the year 2035.
To be competitive and to make an impact in this burgeoning field, there are a number of barriers the Australian industry needs to address. This ranges from regulation reform to ensuring funding and investment is maintained. For academia, one of the most pertinent hurdles is collaboration. The report calls for expanding and deepening the linkages between academia and industry to accelerate commercialisation, which is an issue that permeates all areas of medical research. With many potential new treatments falling into the ‘valley of death’ (the time between a basic science discovery, usually within academia, and the decision to commit resources to develop the idea into a tangible product, almost always by industry), the imperative to improve academia-industry relationships has been recognised. However, the immaturity of the RM ecosystem exacerbates this issue for the field; there are few organisations with experience in taking products to market that are able to collaborate with and guide research teams. While the severity of this issue will lessen over time as the industry expands, organisations such as Stem Cells Australia and CCRM Australia, have taken the initiative to address this issue as early as possible. ARMI is also one such organisation, with the establishment of the Industry Advisory Committee and with programs such as the Industry Mentoring Program.
Australia is in a strong position to become a leader in RM, in both academia and industry. As the report outlines, while there are barriers that Australia will need to overcome before creating a “sustainable local industry that is successful at commercialising local research” and creating novel RM therapies for patients around the world, these are not insurmountable. Undoubtedly, the quality and quantity of RM research in academia is one of the country’s greatest strengths and is of paramount importance to building a strong RM sector, as early-stage research is what feeds the “innovation pipelines.”
Read the report on the MTPConnect website.