Representatives of the Australian clinical companies in Adelaide answer questions from Chinese biotech companies.
For Chinese biotech companies keen to take their innovation abroad, South Australia seems an ideal starting point for R&D thanks to the vibrant clinical ecosystem, extensive resources and generous incentives there.
A case in point is Adelaide, which is home to various laboratories, CROs, hospitals, private phase I units, ethics approval and R&D tax consultants, and other service providers. Representatives of these players offered their insights to Chinese biotech companies at the South Australia ∙ Clinical Trials Ecosystem – China Event Series zoom webinar on Sep. 13.
Avoid contacting PIs through multiple CROs
“It is important to reach out to the site principal investigators early on to help with the study design, and to understand the current standard of care in Australia for various diseases,” said Ganessan Kichenadasse, Medical oncologist and Principal investigator at The Southern Oncology Clinical Research Unit.
He added that some drugs that are available in Australia to treat cancers could be leveraged as an add-on therapy to the sponsors’ products, and immunotherapy complications are also mostly covered under Medicare resources. Medicare is Australia's universal health insurance scheme.
Kichenadasse also suggested against using multiple CROs for the same study to avoid having multiple feasibilities for the same trial or questions such as the number of patients seen every month for a particular cancer type.
A 43.5% rebate for R&D costs
Chinese biotech may set up subsidiaries in Australia to be eligible for the R&D incentives, according to Mike Burfield, Managing Director at Bentleys R&D Tax Incentives. Their intellectual property (IP) generated from the R&D can be either Australian or foreign-owned.
Companies that have a group turnover of less than AUD$20 million (RMB100 million or $14.7 million) may opt for a 43.5% rebate. “When an Australian entity has spent AUD$1 million on eligible R&D, it could be entitled to a cash rebate of up to AUD$435,000,” Burfield explained.
And those with a group turnover of over AUD$20 million could enjoy a 16.5% non-refundable offset as an additional tax deduction, he said. The parent company and the Australian subsidiary can both claim a tax deduction.
Adaptive design and thorough assessment of CROs
Adaptive design, which allows healthy volunteer and patient components under one protocol, is what Australia is adept at, said Yvonne Lungershausen, CEO of CRO firm Avance Clinical.
And since a lot of studies require more than one site, she said South Australia “could be a gateway to the rest of Australia and even New Zealand.”
She also gave tips on selecting sites and CROs.
“It is very important to ensure that the sites that you engage are able to work for the timeline expected,” she said.
She added that sponsors should do a thorough assessment of their CROs and have confidence in them. This way, sponsors can ask the CROs “to do a single good quality feasibility rather than do 10 feasibilities through multiple CROs.”
Streamlined ethics review
“What Australia offers is fast start-up. We have a very streamlined and efficient ethics review process under our clinical trial notification scheme,” said Lungershausen.
To get an ethics approval in Australia, sponsors must have the investigator brochure and clinical study protocol ready, along with the patient consent form. CROs like Avance can help translate such documents from Chinese to English and conduct a gap analysis to ensure compliance.
There are also ethics review specialists to speed this process. One of them is Bellberry, which provides human research ethics reviews and allows for electronic submissions.
“Across all phases and types of research that Bellberry review, we average a turnaround of 21 business days with an application residing with the committee from the time of submission to the time that the decision outcome is provided,” said the firm’s CEO Kylie Sproston.
Seek local partners
Chinese sponsors may make use of the expertise and resources of local partners to facilitate their clinical trials.
CAMX Clinical Research is an early phase clinical trial specialist. It conducts studies ranging from ascending dose studies, drug interaction studies, to bioequivalence and bioavailability studies and proof-of-concept studies.
“When selecting a site for your study in Australia, we really recommend engaging with the science principal investigator team to get feedback on your planned study, and then to identify anything that might be able to improve the study in the clinic,” said CAMX’s CEO Jane Kelly.
Agilex Biolabs, on the other hand, is specialized in bioanalysis. Its work covers pre-clinical toxicology, PK assays, gene therapy assays and so forth.
“Once you have identified that you want to come to Australia to conduct a clinical trial, it's important to engage all of the different players within the ecosystem, from the CRO to the bioanalytical laboratory early on in the process, and to ensure that there is no limitation in getting the clinical trial set up in its entirety,” said Kurt Sales, Director of Immunoassay at Agilex.