Centre for Commercialisation of Regenerative Medicine Australia (CCRM)

6 7 BUSINESS VIEW OCEANIA VOLUME 4, ISSUE 7 BUSINESS VIEW OCEANIA VOLUME 4, ISSUE 7 CCRM Tessara Therapeutics breaks barriers in neurology by enabling the pharmaceutical and CRO industries to discover and develop safer and more effective drugs to treat debilitating neurological diseases. Regulatory agencies worldwide recognise that the current drug development model is broken with its reliance on non-predictive animal tests to determine the safety and efficacy of new drug candidates, leading to a 95% failure rate in human clinical trials. Regulators in major markets worldwide are driving the paradigm shift away from traditional animal-based drug testing methods, including in both the EU (Resolution 2021/2784) and USA (FDA Modernization Act 2021). These directives accelerate the shift towards accurate, high-throughput in vitro test systems based on human cell-based tissue constructs. Tessara’s RealBrain® Drug Screening Platform is exactly such a system. Our Drug Screening Platform is based on human 3-dimensional brain micro- tissues, featuring fully functional neural networks embedded in their own, cell-secreted support matrix. The platform is highly reflective of human neurophysiology, and reproducible at scale for use in the pharmaceutical industry. Tessara is an innovator in tissue engineering that converges neuroscience, material science and industrial engineering. RealBrain® Technology offers a unique combination of features to lead the market in the upcoming paradigm shift away from animal testing. ...... For more information, please visit our website www.tessaratherapeutics.com CCRM Australia is involved in several training and development programmes and campaigns that seek to identify technologies, support collaborative efforts, and bring funding from investors into the sector. They include the Regenerative Medicine Industry Interface (a technology evaluation program), business units including Attract (regulatory and business support) and Clarity Unit (a consulting unit), interactive Workshop and Roundtable programs, and the annual CCRM Australia Business of Regenerative Medicine Asia Pacific symposia. The lean team of four aims to increase their numbers over time to match CCRM Canada’s 200-strong specialist staff as Australia’s sector steadily grows. Mr Tiziani explains that two significant challenges working against CCRM Australia are currently being addressed. “The first issue is the difficulty of introducing a model such as ours to the Australian market. It’s very important that we get our message out there and maintain our presence across a large network. Raising awareness of our mission and the services we provide is something we have to continuously Your Lead Site Solution SVMH is a tertiary university-affiliated health service providing a wide range of services, including acute medical and surgical services, comprehensive cancer care, rehabilitation, mental health, palliative care and residential care. Research is embedded in clinical care at SVHM with almost 600 interventional clinical trials at any time from Phase1-4, including drugs, diagnostics, devices and digital solutions. To support all levels of clinical trials, SVHM also offers the sector-leading Research Valet™ Service, which streamlines human research ethics submissions. This unique initiative provides fast-facilitated Human Research Ethics Committee (HREC) submissions preparation and liaison throughout the HREC approval process with targeted results within 30 days of HREC meeting. This combined approach provides researchers a smooth study start-up, providing St Vincent’s a competitive edge on the global market for clinical trials. For more information, please visit www.researchvalet.com.au Research Valet ™