COVID-19 has brought unprecedented focus on the Medical Technology, Biotechnology and Pharmaceutical (MTP) sector; highlighting the importance of research and development, new technologies and advancements to navigate human health challenges. This coupled, with the importance of sovereign capability and a robust supply chain to support the provision of essential MTP products. This has created unique opportunities to invigorate and invest for a stronger sector, which in 2019 supported 70,000 Australian Jobs and contributed more than $5B in Gross Value Added (GVA) to the Australian Economy.
As Australia’s growth centre for the sector, MTPConnect is responsible for delivering the $32M Researcher Exchange and Development within Industry (REDI) initiative, funded by the Medical Research Future Fund (MRFF). MTPConnect partners with research, training and industry organisations to increase skill levels and aid workforce development for the MTP sector nationally.
Skilled labour, in particular skilled in the manufacture of MTP products, namely competency in Good Manufacturing Practice (GMP), was identified as one of the key priorities, according to Jarrod Belcher, Director of the REDI Program at MTPConnect. Through a competitive process, MTPConnect selected additional industry training providers to deliver new programs addressing key skills gaps in the sector workforce.
Launched in September 2022, one of these programs is GMP Uplift developed by the Centre for Biopharmaceutical Excellence (CBE). CBE bring experience across large and small Biologics, Pharmaceuticals and Regenerative Medicine companies, both in consulting and GMP related enterprise training. CBE staff also have extensive experience in GMP operations, compliance, auditing and QMS design, a wide industry network for guest lecturers and readily available case studies.
In developing the training, CBE Director Steve Williams states, “The Federal Government took the initiative to commence this uplift program because they recognised that bringing manufacturing back into Australia was a national imperative. In order to do that, they needed to make sure that the human resources were available and were knowledgeable around compliance in GMP, to make us internationally competitive.”
CBE GMP Uplift Programs provide participants with a real-world perspective on Good Manufacturing Practice (GMP) and are designed to assist with the interpretation and application of GMP into practice, for those involved in human health products. CBE brings strong technical credentials, with experience across large and small Biologics, Pharmaceuticals and Regenerative Medicine companies, both in consulting and GMP related enterprise training. Collectively the CBE staff delivering the training; Steve Williams, Justine Mann, Maurice Parlane, Andrew Watson and Jeff Davies have over 200 years experience in GMP.
The CBE GMP Uplift training programs have been developed with the help of a consortia of associations; ARCS Australia, Translational Research Institute Australia (TRI T3 Cleanrooms), University of Technology Sydney (BIF UTS), Merck Life Sciences and CBE Pure Solutions. The program is available for entry level staff and for those with more than 12 months industry experience:
– Essential GMP Program designed for entry level employees (new starts up to 12 months). A 5-day equivalent course, designed for participant flexibility and to upskill in core GMP principles.
– Advanced GMP Program, for those working in a GMP role (12 months+) looking for an in depth understanding of the critical areas that underpin GMP compliance in practice.
Students who have taken training programs in September and October have commented favourably on the range of case studies, the depth of material, real world examples and hands on experience.
Interviews filmed at the BioProcessing Network Conference 2022, in Sydney.
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Patient family develops app for improved adherence and clinical outcomes
Darron Goralsky, a physiotherapist with over 30 years of experience, is the Clinical Director and Founder of Melbourne TMJ and Facial Pain Centre. He leads a multidisciplinary team dedicated to treating jaw pain, facial pain, and headaches. Goralsky has observed a rise in musculoskeletal issues among younger populations, largely due to increased screen time and poor posture, trends that intensified during the COVID-19 pandemic. Emphasising technology integration and patient responsibility, he believes digital health solutions play a crucial role in improving adherence and outcomes for both patients and caregivers.
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New clinical research entity first to operate across both Australia and New Zealand
Over the past 30 years, 18,000 clinical trials that have been registered in Australia, with the sector contributing $1.4 billion to Australia’s economy annually. Trials are a critical aspect of evidence-based medicine, and are essential for testing how new treatments, tests and vaccines will work. In New Zealand they contribute $146 million to the New Zealand economy.
To capitalise on this unique position and growth, a coordinated multi-site clinical research operation was missing, until now.
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Understanding extracellular vesicles in cancer therapy research
Joy Wolfram is an Associate Professor at the Australian Institute for Bioengineering and Nanotechnology and the School of Chemical Engineering at the University of Queensland in Australia. Originally from Finland, she earned both her bachelor’s and master’s degrees in biology before transitioning to engineering with a PhD in nanotechnology completed in China. Wolfram has over a decade of experience working in hospitals in the United States before joining the University of Queensland.
Her research focuses on extracellular vesicles, which are crucial for cell communication both locally within tissues and over longer distances between organs. Her lab studies the roles of these vesicles in both health and disease, particularly in cancer. They investigate the harmful messages released by cancer cells that aid in tumour growth, specifically in breast cancer, while also exploring how to harness beneficial extracellular vesicles from healthy individuals as potential therapeutics.
