Australia’s reputation for early phase clinical trials is making it the first choice for international pharmaceutical companies developing new drugs and therapies.

Clinical trials contribute an estimated $1.1 billion to the Australian economy each year, as well as providing the obvious benefit of bringing new therapies and treatments for diseases.

Last month, CMAX chief business development officer Zoe Harrison attended Bio-Europe Spring in Barcelona, home to one of Europe’s thriving life science clusters.

CMAX is one of Australia’s largest early phase clinical trial units and, Zoe says, there was a great deal of interest in what she and other Australian delegates were promoting, partly because of their end-to-end services.

“All the projects we run at CMAX tend to be highly collaborative, so it’s CMAX plus a CRO, plus a bioanalytical lab and data managers,” Zoe explains.

Those CROs, or contract research organisations, include ones that “act as the client’s eyes and ears on the ground”, taking on local sponsorship and legal responsibility for the trial in Australia.

“Having the relationships with all of these collaborators helps us package together a very attractive service for the international biotechs,” she says.

Australia has a strong reputation internationally for early-phase clinical trials; around 90 per cent of CMAX’s work is for sponsors (customers) overseas.

CMAX’s Zoe Harrison is a judge for this year’s 40 Under 40 awards

“Australia has become a real destination for this particular type of work. It’s about our quality, experience, speed and – critically – the research and development tax rebate that we have here,” Zoe says.

“When we go overseas, we’re finding now that venture capital funds etc are recommending that their companies go to Australia for their phase one.”

Our multicultural population is also a positive.

“The US like to see a really diverse pool of participants come through,” she says.

“While Asian biotech companies – who may ultimately want to get the drug registered with the [Food and Drug Administration] in America or the [European Medicines Agency] in Europe – work to include Caucasian data, which isn’t as readily available in their own cities.

“So, they’ll come to Australia to get that too.”

Zoe says disease is “much more complicated than we’ve always realised”.

“I find it interesting when there’s a new drug being developed and it has a completely different therapeutic action to drugs that we’ve previously seen trying to address that particular issue,” she says.

“Researchers are trying quite different approaches because the science is evolving and their appreciation of the complexity of models of disease is increasing.”

CMAX is currently doing multiple trials: in the respiratory space, trialling treatments for chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis and asthma; in the central nervous system space, with treatments for movement disorders; and in mental health, trialling drugs to address issues like anxiety and depression.

Zoe says the CMAX team is “always very excited” to trial antibiotic drugs because so few of them make it into the market due to the difficulty and expense in developing them.

“In some ways, it takes too long to get any drug to market – years and years and, they say, about a billion dollars US,” she says.

“Any efficiency is only going to benefit patients by offering additional treatment options and I think that’s something to look forward to.”

Artificial intelligence is now being used for drug discovery, and it was recently announced that Danish pharmaceutical giant Novo Nordisk will fund a Nvidia-backed AI supercomputer.

Conducting ‘virtual screening’ to analyse the structure of both the biological target and the compounds in the screening library, the AI can predict the likelihood that a molecule (drug) will interact with the target to create the desired mechanism of action. Without AI, this is a labour-intensive process.

CMAX is increasingly working with drug companies using AI for drug discovery and Zoe says AI is also used at site level in recruitment tools to identify the ideal volunteers for each clinical trial.

“We’re also starting to see more clinical trial-specific tools being developed for creating budgets and operational plans, and making sure that we have the right skill mix on clinic floor on any given day,” she says.

For those companies that manage the data coming out of the trials, the AI can also better identify anomalies in data, improve trend analysis and, ultimately, mitigate risk.

However, AI will not be an all-encompassing solution.

“We still need to be generating the science in the first place,” she says.

“There are so many new therapeutic drug classes on the horizon, it’s super exciting and really hard to know how it will play out. There’s a whole bunch of RNA therapies that we’ve studied at our clinic, gene editing technologies, new vaccine templates and so on.

“It’s not only that AI is speeding up the generation of these new molecules – there’s altogether new technologies and platforms being used. The use of things like organ on a chip are likely to also introduce some efficiency in the preclinical models that are used.”

These could have a flow-on effect, she says, with more clinical trials being undertaken, although each will likely require fewer participants.

“But that’s potentially in the future, as there’s a lot of work that needs to be done before a molecule comes to us,” she says.

“Some of it is in vitro and other work is in animals – and there’s a whole lot of efficiencies in there, which aren’t necessarily AI, but they’re new models that will probably disrupt that area and, hopefully, make it a quicker to get results.

“Our job is really in phase one – to safely transition a new drug into people for the first time.”

Zoe Harrison is a judge for InDaily and CityMag’s 40 Under 40 awards, with CMAX the sponsor of the Discovery Award. This year’s winners will be announced at a gala event at Adelaide Oval on 27 June.