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Over the years, Australia has established itself as an attractive early phase clinical trial destination, within a competitive global marketplace.
Its diverse and informed population, world-class research capabilities and robust regulatory framework make for a favourable environment, allowing research to be undertaken with minimal complications or protractions.
However, given that the clinical trial landscape is inherently challenging and complex, concerted efforts are required to further elevate the nation’s profile as a destination for international therapy developing companies. This will continue to be a requirement in the face of rising global competition.
In the lead up to the Bio Connections Australia 13-14 November, Melbourne conference, we spoke with US-based pharmaceutical firm, Cerebral Therapeutics, who have recently undertaken a proof of concept clinical study in Australia, using a proprietary formulation to treat refractory epilepsy.
Ahead of the conference, CEO Dan Abrams unveiled some insights into the clinical trials research, including the pros and cons of operating within Australia.
Tell us a little about your research
Our research explored the preliminary efficacy and the safety of an implanted drug and drug delivery device to treat adult patients with severe refractory epilepsy.
The direct, intracerebroventricular (ICV) formulation and infusion system administers micro-doses of medication, bypassing the blood-brain barrier – with a view to improving effectiveness, reducing systemic toxicity and improving the drug regime compliance.
Why did you choose Australia as a destination for your proof of concept?
First and foremost, we built relationships with some world-class investigators in Australia.
Most notably our Principal Investigator, Dr. Mark Cook, a Professor of Neurology in Melbourne, as well as our neurosurgical lead, Dr. Michael Murphy; a Professor of Neurosurgery. Both are clinically based at St. Vincent’s Hospital and academically at the University of Melbourne.
They are renowned leaders in the field of epilepsy and neurosurgery and were truly phenomenal to work with. They were very excited about the therapy – and that passion was reflected in the level of input and skill they showed with the patients and with the study.
Because the therapy is complex in and of itself, it really required a high level of expertise, as well as a strong collaboration. We believe Australia has been able to deliver that.
What challenges have you encountered undertaking your proof of concept in Australia and how have you overcome them?
Creating an operational system that works for a US-based company, 10,000 miles away is complex and not a trivial undertaking. In many respects, the time difference and the physical distance has been one of our greatest obstacles. We were able to work with it, but it also required that our local partners helped us bridge the time and distance divide.
We do believe we have been successful in creating an effective local operation in our partnership with St. Vincent Hospital and Neuroscience Trials Australia. Our researchers in Australia have been more than cooperative, regularly working outside of usual business hours to maximize the degree to which we can collaborate together.
There are also a number of other logistical considerations, such as setting up an Australian bank account, which can be cumbersome with the distance and time difference, but again, with our local partners we have been able to successfully execute that in Australia.
What aspects of the Australian clinical trial environment have you found particularly conducive to your work?
From a financial perspective, we have found that the Australian tax incentive scheme for clinical trials really stretches your research dollars quite a bit. Currently, the exchange rate is also pretty favorable.
From an operational perspective, Australia has significantly fewer bureaucratic hurdles than other developed countries; and fewer cultural hurdles than developing countries. We have found that Australia is pretty similar to the USA in terms of its high level and patient-centered approach in medicine and medical therapy development.
I will also reiterate that the value of the leadership we received from our investigators has been critical in helping to push the project forward at a good pace and with minimal friction.
What advice would you offer to other pharmaceutical companies who are considering Australia as a clinical trial destination?
I would say do it, pursue it, but me mindful that international collaborations take effort. As long as you are informed, prepared and have a great team. This will ensure you have fewer issues cropping up along the way and won’t need to fly over on a regular basis.
What will you be focusing on during your presentation at the Bio Connections Australia Conference?
I’ll be sharing more extensive details on how we have managed to coordinate our proof of concept within Australia, with a focus on the practical logistics, lessons learned, as well as some of the broader regulatory and financial considerations.
Dan Abrams will present his international case study at the Bio Connections Australia conference – due to take place 13-14 November in Melbourne.