To explore next generation cell processing techniques to advance Australian cell based therapeutics

The average human life expectancy has increased exponentially in the past 60 years, however tissues and organs in our bodies are just like parts in a machine and are not meant to last forever and are prone to break down over time. With this increase in lifespan we have seen a parallel rise in the rate of chronic disease such as osteoarthritis, cardiovascular disease, diabetes and cancer. In Australia 1-in-2 people are affected by at least one chronic disease and 73 per cent of deaths in Australia can be attributed either directly or indirectly to chronic diseases Cell therapies represents a paradigm shift in the way we treat chronic diseases. Cellular therapies can be used for a variety of applications ranging from reprogramming immune cells to fight cancer to replacing whole organs and tissues. Cell-based products are a different therapeutic treatment option as they are ‘living drugs’. Whilst the technology holds enormous promise, if appropriate protocols are not in place to ensure the quality and standardization of isolated cell based products and if an appropriate regulatory framework is not in place to facilitate safe and effective routes to market, then we will never be able to realize the full potential of this technology. My Churchill Fellowship focused on studying next generation processes for cell isolation/manipulation and the relevant regulatory framework in Europe that govern the translation of this research into the health sector. The major recommendations from my report are as follows: 1. Several of the cell isolation and modifications mentioned in this report hold enormous potential for the field of cell based therapies, however further work is needed to transition techniques from the lab to the clinic. Automatisation and development of high throughput systems can help overcome these technical limitations, ensure standardisation of cell therapy products, reduce the rate of human errors and decrease manufacturing costs. Researchers need to start branching outside the field of biology and facilitate networks and collaborations with experts from other disciplines, such as information technology, business process management and engineering. 2. Regulators need to be more actively engaged with academia to close the gap between academia and industry. This can possibly be achieved through public outreach, engaging scientists earlier (i.e. undergraduate science curriculum) or tying grant funding for applied cell based research projects to regulatory and technical feasibility. 3. Increasing government funding and the creation of targeted research calls to study the safety and efficacy of existing and emerging cell isolation and modification techniques.