Mitch Kirkman, Development QA Manager, Novartis Pharmaceuticals Australia Pty Ltd

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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.