Australia has established itself as a destination for preclinical and early phase clinical research and can serve as a stepping stone to market since data generated in clinical trials in Australia is generally well received by American and European regulators. In fact, most of the early-stage trials done in Australia are for American and European companies, which repatriate the data for use in their regulatory jurisdictions. This has been observed by Asian companies, which also now increasingly choose to use this route.

Notwithstanding this trend, estimates by the Australian regulator, the Therapeutic Goods Administration, suggest that more than 60 percent of clinical trials undertaken in Australia are phase 2 or phase 3. This partly reflects the fact that Australia is considered a natural choice for incorporation into global clinical development programs due to its modern Western healthcare system, strong legal system, and robust regulatory environment.

Over the last decade there has been an explosive development in the application of high-end computing, data storage and management, computational biology, biomedical research, and genetic and molecular sciences. The convergence of these disciplines fundamentally shifts how medical research and the development of therapeutic drug and diagnostics is undertaken. Hence translational research is the continuum by which the biomedical community aims to move research discoveries from the laboratory into clinical practice to diagnose and treat patients.

In view of the above developments and the well-documented failure of the biopharmaceutical industry to bring innovative therapeutics to the market in spite of doubling its investment in R&D over the last decade, pharmaceutical companies are introducing new business models for R&D by setting up centres of excellence, externalizing R&D activities, and exploring novel financing and collaboration models separating commitments in internal resources from financial investments, and relinquishing operational control while retaining asset rights.
The early recognition of these revolutionary developments by the Queensland Government and the local industry has led to an aggressive investment in infrastructure and attracting world-class researchers since 2000. A recent example is the investment by the Queensland and Australian Governments of AUD $350 million in a new Translational Research Institute in Brisbane. As a result Queensland institutions and service providers are future-ready in terms of their R&D capabilities along the product development pipeline and can demonstrate scientific leadership, for example, as provided by Professor Ian Frazer, director of The University of Queensland Diamantina Institute and co-discoverer of Gardasil.

The presence in Queensland of expertise in a wide range of areas associated with elucidating disease mechanisms and the role of genes, identification of biomarkers, and developing therapeutic intervention supported by appropriate diagnostics, provides huge opportunities for the global biotechnology and pharmaceutical industry to establish new R&D collaborations embedded in innovative financial structures and partnership models. At the same time, Queensland-based biomedical research institutes have well-developed commercialization units ready to explore different financial arrangements and risk models.

Of course, one needs the commercial and financial skills of experienced investors to explore and propose vehicles for structuring such arrangements in ways that previously may not have been considered. Also, government support is indispensable and governments who take a strategic and long term view need to be congratulated and further encouraged to stay on course since a successful therapeutic product development can easily take up to 10 or more years. This consideration regarding the time it takes to advance a product through all the development phases, also applies to funds for life sciences R&D where there is a strong government involvement.

In addition to the modern biomedical research institutes and their commercialization units, the local Contract Research Organisation (CROs) industry can likewise be engaged as part of a product development strategy and risk management plan. The local CRO industry has been experiencing an unprecedented growth, in particular in providing preclinical and clinical research services to American, European and Japanese biotechnology and pharmaceutical companies. An overview of the service providers can be found at www.qctn.com.au

QCTN will hold 2010 Translational Research Excellence conference (TRX10) in Brisbane, 11-13 October 2010, and the conference has the theme “Collaborate to Innovate” (www.trx10.com.au). The event provides an excellent opportunity for the global biopharmaceutical industry to see what the Queensland based translational research institutes and commercial service providers have to offer in terms of new leads, R&D services and R&D capabilities – as well as the experience to translate research into outcomes.

Mario Pennisi is CEO of the Queensland Clinical Trials Network Inc.

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