Clinical trials open up treatment options for patients

Dr Tina Soulis, CEO of Neuroscience Trials Australia, sheds light upon a sector where business and science meet, aiming to affect the lives of families affected by brain diseases

A Mobile Stroke Unit started operating in Melbourne this week. Equipped with a CT scanner capable of imaging a patient’s brain, telemedicine equipment and a mobile laboratory, the purpose-built, 5.3-tonne trial stroke ambulance was introduced by Victorian Premier Daniel Andrews, whose government has invested $7.5 million into the trial as part of its plan to improve ambulance response times.

“This Australian first stroke unit will save hundreds of lives, and we’re proud to be delivering it.”

Dr Tina Soulis also feels proud of this achievement as the trial is one of the projects that she manages as CEO of Neuroscience Trials Australia (NTA), a not-for-profit research organisation specialising in clinical research, operating as part of Florey Institute of Neuroscience and Mental Health. “I am passionate about the work that my team and I do right here in Melbourne,” she says. “More importantly, I would like to educate our community about clinical research.” This is what Neurotrials Australia does.

“It is is a unique business,” she says.

“There is no-one like us in the world. There are other contract research organisations, but they all do lots of things – we specialise in neuroscience, which means everything to do with the brain, with diseases like strokes, Alzheimer’s, Parkinson’s, epilepsy, all these things that affect many people in Australia – and globally, as well. About 80 per cent of our projects are from companies who come from the US and Europe to do their trial. So we’re bringing projects into the country, for Australian patients, to create Australian jobs, and also for the doctors who are interested in doing the job.”

What is it that makes Australia attractive for clinical trials? “One of the reasons Australia is looked upon as favourable is because we create good data,” she says.

“We also have good quality health care system and our patients are fully engaged. In our public healthcare system, there is a real shift towards educating patients about being involved in a clinical trial as also a treatment option. So if someone goes into a hospital and they are diagnosed with Alzheimer’s disease or early stages of dementia, they may be offered one of the two treatments available, or to enter one of the half a dozen clinical trials.
“All of a sudden, it opens up patient treatment options, and that is the whole point of us doing these projects, to make more treatment options available to the patients.
“Our regulations make it very simple to come and do a trial in Australia, we have a lot of international interest, particularly from the US; because they can come here, open up their trial fairly simply because our ethics committees do all of the review; our regulator, the Therapeutic Goods Administration (TGA), doesn’t review the clinical trial; it’s done by the hospital ethics committee, whereas in the US they can’t do a clinical trial until there’s been a review of the FDA,” she says.

“Also, our government has a fabulous tax incentive which means small companies can come to Australia, do their clinical trials or clinical research, manufacture the study drug or device, and claim back 43.5 per cent of what they spend. So it also makes us an attractive business proposition.
“We have engaged patients, we have doctors who are leaders in their field, we have a regulatory framework that makes doing clinical trials pretty straightforward; we have tax incentives and capabilities.”

Speaking of capabilities, NTA has several projects under way; Dr Soulis can’t hide her excitement talking about them: “There is a project that we are doing with epilepsy; it is a device that is inserted into the brain, a pump where they put in an anti-epileptic drug, designed for people who can’t tolerate drugs. It’s the first time this has been done and it’s working really well. We’re also doing some of the first stem cell trials in Parkinson’s disease; the technology we use has never been used anywhere in the world,” she says proudly.

Their main focus at the moment is research on Alzheimer’s disease.

“We are involved in over 30 projects, indirectly and directly, working in 22 sites across Australia and New Zealand,” she says.

“It’s fair to say that our priorities are where unmet needs are and with Alzheimer’s, we’re talking about a disease that is going to affect over a million people, and for years, there has been nothing to treat it.”

This is changing, largely thanks to the work being done at the Florey Institute, where Professor Ashley Bush has been working on an iron-reduction treatment for people in early stages of the disease. “With Alzheimer’s disease, we are learning more and more,” she says. “While we might not have all the answers today, all this work is hopefully leading to a breakthrough. If you looked at the big pharmaceutical companies five years ago, they were all in late-stage development of clinical trials, and they had spectacular clinical trial failures.

“They spent a lot of money and they were treating people with moderate to severe Alzheimer’s way down the line. What they found is that the drugs didn’t help people at that stage of the disease but they had a trend to be beneficial to people who had just been diagnosed with dementia.”

Professor Bush’s work involves a protein, beta-amyloid, which is crucial for the development of Alzheimer’s.

“We will know more about this particular disease in the future because of that work,” says Dr Soulis.

“The other unmet need is Motor Neurone Disease (MND); we’re working very closely with (footy veteran and philanthropist) Neale Daniher and a young haematologist, Dr Ian Davis, who have successfully raised over $20 million for the MND Foundation. Right now there are about 2,500 people with MND at any time in Australia. If you had asked someone five years ago what is MND they wouldn’t have heard of it – myself included. There were zero clinical trials and now there are six; we are running most of them.
“All I can say is that we’re passionate to bring these projects to Australia. Whilst we are a commercial business, whatever profit we make at the end of the year goes back to support academic research.”

What would she say to a family affected by a disease, considering to enter a clinical trial?

“I always say ‘speak to your doctor. What I like to tell them is that as a clinical trial patient you are seen more often by your doctor, you’re looked after by your doctor, and everything is recorded. Whatever they give you has to be approved by an ethics committee. Everything is being done to strict regulations that have been checked by us.”

As for her personal journey into the field, it began with her setting out to study dentistry.

“Then I realised I couldn’t spend my life looking into people’s mouths,” she laughs and explains how she switched from dentistry to science, before she decided to pursue a PhD in medicine.

“I always loved science, I always loved questions, so I did my PhD in diabetes which is also a huge issue and that’s where I became interested in clinical trials, which were at their infancy in Australia at that time. So I finished my PhD and I’ve been involved in seeing all this being developed around the world.”

And how has her Greek backround affected her work? “I don’t know if it’s Greek or not, but my parents have always given me a good work ethic. My dad urged me and my sister to study; he told us, ‘you have to become your own person, so no matter what happens in your life, you can survive’.

“I think that’s the best advice he ever gave us. He taught us to be fighters and that might come from a Greek mentality, the underdog thing. Being Greek to me means to be very proud of my heritage, everybody who works with me can tell you that. There are many scientists of Greek heritage in Australia. No matter what is thrown at us, we continue to be leaders at whatever field we choose.”