Two new clinical trials are set to begin at Griffith University’s Clinical Trial Unit (CTU) on the Gold Coast, as the Australian Government rolls out a new program to assist smaller companies and researchers to navigate complex regulations, in order to develop the next generation of medical devices, apps and therapeutic drugs.
With cold and flu season in full swing, the trials of innovative new diagnostic devices offer the promise of faster detection and treatment of bacterial and viral infections.
The trials will test in vitro diagnostic devices being commercialised by Brisbane company Ellume, and add to several drug treatment studies currently underway at the CTU, a state-of-the-art, core research facility for phase I-IV clinical trials.
Viral or bacterial?
CTU Director, Griffith University Associate Professor Evelin Tiralongo, said both Ellume trials are testing devices that may help to identify whether people are suffering from a viral or bacterial infection.
“One Ellume trial is looking to test if a device is able to accurately identify whether people with a current sore throat are suffering from a bacterial rather than viral throat infection,” Associate Professor Tiralongo said.
The other is testing to determine whether the trial device can accurately detect a Flu A and/or Flu B infection in patients with flu-like symptoms.
We are very excited to be chosen as a site for both these trials, because if proven specific and sensitive, thesedevices can be used in the future to aid doctors’ decisionson appropriate treatment choicesin real time, in this case for example, whether patients need an antibiotic or not.”
Founder and Managing Director of Ellume, Dr Sean Parsons, was motivated to develop the sophisticated, multi-layered diagnostic technology following his experience during the Swine Flu pandemic of 2009.
“I was working as a doctor in a busy emergency department where scores of people were presenting wanting to know if they had flu and, if so, what could be done to manage it,” Dr Parsons said.
Laboratory tests were taking days to return results and the available rapid tests lacked accuracy, so clinicians were forced to make treatment decisions without a reliable biological diagnosis.
Unwarranted prescribing of both antivirals and antibiotics was essentially unavoidable. There was clearly an unmet and critical need for a faster, simpler, reliable way to diagnose and manage influenza.”
The company will pass on valuable experience gained in navigating the regulatory processes required by the Therapeutic Goods Administration (TGA), which can be daunting for companies and researchers unfamiliar with the regulations, at an Ausbiotech Queensland event on Thursday 3 August.
Ausbiotech Qld committee member and representative for the Gold Coast, Dr Chris Davis, is delighted to see the increased number of health technologies being developed on the Gold Coast.
“Having begun in health technology development on the Gold Coast more than 15 years ago, I’m absolutely thrilled to see technologies like the Ellume diagnostic now being trialled here. I feel privileged to host events on the Gold Coast through Ausbiotech with the strong support of the Gold Coast Health and Knowledge Precinct office, to help foster great SE Qld health technology innovation,” Dr Davis said.
Ellume’s Head of Quality Shaun Cooper will be joined by the TGA’s Steve Dunlop, Director, Regulatory Guidance and SME Support at the event, which is set to attract small to medium biotech companies, including those developing new medical apps – a fast-emerging and potentially confusing area for regulation.
“Medical diagnostics utilising smart phone technology is a rapidly evolving field so the regulatory processes are also evolving, making assistance that smooths the process really important for companies seeking to develop such technologies,” Dr Parsons said.
“Using trusted local partners like Griffith University for our clinical trials helps smooth the process of regulatory approval and getting our technology to market.”
The SME Assist program, announced by the Turnbull Government in June, comprises multiple components — ranging from a new entry point (www.tga.gov.au/sme-assist) through to training opportunities and tools.