Mitch Kirkman, Novartis Pharmaceuticals Australia Pty Ltd: Australia has been a key contributor in the development of cutting edge new medicines in a huge range of therapeutic areas for Novartis.
Catherine Bourgeois, St Jude Medical: Australia has the clinical trial infrastructure that allows a trial to be established very quickly.
Mitch Kirkman, Development QA Manager, Novartis Pharmaceuticals Australia Pty Ltd
Australia has been a key location for global drug development for Novartis for over twenty years. Australia has a great track record for delivering high-quality data and for being a reliable contributor in global clinical trials.
Australia offers world-class hospital facilities as well as a rigorous ethical and regulatory system in which to conduct clinical trials. Australia also offers a strong pool of experienced and talented clinical research professionals who understand the needs of global clinical teams working to tight deadlines and high quality standards. In particular, the expertise within Australian institutions allows early phase and complex clinical trials to be undertaken, as well as offering the potential to leverage translational medicine expertise to add value to global drug development programs.
Australia has been a key contributor for cutting edge new medicines in a huge range of therapeutic areas for Novartis. These therapeutic areas include chronic myeloid leukemia (CML), multiple sclerosis, diabetes, age-related macular degeneration and chronic obstructive pulmonary disease.
Australian research centres have made significant contributions to global clinical trial programs within Novartis. A good example has been the development of an improved method of tracking response to therapy in CML. This new method looks at the clearance of the disease at the molecular level. This methodology was developed and validated at a hospital research centre in Adelaide alongside the Novartis global development program. This methodology has now become the global gold standard for tracking response to therapies for this disease and is a significant advancement over the previous approach.
Catherine Bourgeois, St Jude Medical
Australia is viewed internationally as a country that can execute high-quality trials.
This is due to a number of features of the Australian clinical trials system.
First, medical device trials require high levels of expertise. Australian researchers are highly trained not only in research procedures and the conduct of clinical trials, but also in the technology that is used in such trials. Australia has a number of very talented and recognised world experts in the field of medical device trials.
Australia’s clinical researchers are also very enthusiastic. Doctors in Australian clinical trials will often provide added feedback to companies on where products could go or what is needed.
Second, Australia has the clinical trial infrastructure that allows a trial to be established very quickly. Features such as the single ethical review process, the expertise of the ethics review committees and the standard contracts all work together to make setting up and commencing a trial straightforward, efficient and prompt.
This supportive infrastructure is particularly good for early phase trials because we can get a study up and running much faster than in many other countries. This is also a particularly important feature for medical device trials. Devices can be developed and moved into clinical testing quite quickly — perhaps four years for devices compared to 20 years for medicines. There are also often rapid iterative changes and improvements to devices, so new versions need to be tested very quickly — adherence to timelines in medical device clinical trials are critical to progress, so a short approval process obviously helps.
Third, Australia has the facilities and technology to enable the testing that is part of a medical device trial. Most hospitals already have the equipment that high-tech trials need.
Finally, Australia has an excellent patient pool. In the time I have been with St Jude Medical, we have met the recruitment targets for all our trials.
We have been involved in a range of medical device trials including pacemakers, catheters, and spinal cord stents for chronic pain. We have also been involved in deep brain stimulation. This is a new technique, which, in this trial, was being used to treat Parkinson’s disease, but I can see it is an area of research set to expand.
Most recently we were involved in an international trial for a new treatment for hypertension (high blood pressure). This was a ‘first in man’ study and was both very important as a major advance in the treatment of this condition and very challenging in its timeframes. Because of the Australian clinical trials structure, the understanding of the ethics committee, who were very experienced in such studies, and our patient pool, we were able to meet all the demands of the study including the very short timelines. We received excellent feedback from our partner for this study.