Australasian Biotechnology (backfiles) AusBiotech ISSN: 1036-7128 Vol. 12, Num. 2, 2002, pp. 32-33

Australasian Biotechnology, Vol. 12 No. 2, 2002, pp. 32-33

CLINICAL STUDIES

AUSTRALIA - NOT TOO DISTANT - A VIABLE OUTSOURCING STRATEGY: Why Australian and overseas pharmaceutical companies should consider Australia for preclinical and clinical trials

Edmund Ho

Senior QA Officer, ICP Firefly Pty., Ltd., Australian Technology Park, Eveleigh, NSW. Email: edmund@icpfirefly.com.au

Code Number: au02012

With the organisational trend for reduced capital investment in laboratory facilities and related infrastructure, a more preferable and viable strategy is to access pre-existing infrastructure via outsourcing or through cooperative alliances and collaboration.

Australia now has over 225 dedicated biotechnology companies, about one half of which have been established in the last five years [1], most being startspinning off from research institutions. Local and regional biotechnology and pharmaceutical companies are developing therapeutic candidates at a much faster pace. Thus, the need for both preclinical and clinical infrastructure and expertise has increased dramatically. In response to this trend, supporting services consisting of preclinical testing laboratories and clinical trials centres have been established. These facilities meet international quality and regulatory certification standards ensuring that the data generated are acceptable to major regulatory authorities in US, Europe and Japan. Furthermore, these capabilities are bolstered with local toxicology, clinical and regulatory affairs support, ensuring NDA and IND applications are capable of meeting the requirements of international regulatory agencies.

Australian laboratories offer the full range of toxicity studies ranging from acute studies to life-span repeat-dose studies in both rodent and non-rodent species. These studies can be conducted by numerous routes including oral (gavage or diet), dermal, intravenous or inhalation routes of administration and include haematology, clinical chemistry, urinalysis, histopathology and neurobehavioural tests. Veterinary pathology expertise of high quality is available to conduct histopathology. Skin and eye irritation and skin sensitisation studies as well as genotoxicity and reproductive toxicity studies are also offered. The testing strategy and test protocols, while meeting international test guidelines, ate tailored by the toxicologists around

the specific properties of the test substance and the targeted therapeutic effect. Pharmacokinetic studies can also conducted in the animal species. In addition, animal models can be developed to mimic certain disease conditions or susceptible subpopulations. The services are available for testing of pharmaceuticals, veterinary, cosmetics, agricultural and industrial chemicals. All testing is conducted according to Good Laboratory Practice (GLP). Strict adherence to GLP is monitored by the National Association of Testing Authorities (NATA), a non-government organisation which also represents Australia in the International Laboratory Accreditation Cooperation (ILAC), the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and on the OECD Working Group on Good Laboratory Practice. In a move to bridge the gap for commercialisation of domestic innovations, the preclinical and clinical technical expertise within Australia has become increasingly coordinated where now there exist collaborative arrangements between smaller contract research organisations (CROs) and service providers focused on the overall trials process with Phase 1 and Phase II capabilities.

Domestic preclinical abilities are directed largely toward the niche startup sector, where larger CROs fail to recognise their specific needs and smaller budgets. With such a high proportion of work from start-up biotechnology companies, preclinical, clinical and regulatory exposure to novel compounds in Australia is high. This exposure places the CROs and other service providers including regulatory agents in a well-qualified position to take on novel projects based on past experience.

A noticeable trend exists where multinational pharma companies still prefer to outsource to the large CROs whilst the smaller preclinical facilities must cater for specific needs groups.

Australia's proximity to Asia and its own diverse multicultural society make it a sound option for inclusion in mutlinational clinical trials. There exists a large network of teaching hospitals providing access to skilled and qualified practitioners and a source for patient recruitment.

Strict adherence to GLP and ICH

Through collaboration between a sponsor s researchers and regulatory experts in Australia and abroad, preclinical packages may be tailored to suit the requirements of the product. The use of regulatory experts in the country of submission ensures study design and strategies are verified for compliance with GLP and ICH-GCP.

"Australia has a sophisticated regulatory regime, generally well aligned with practices elsewhere. A very clear international trend is the growing harmonisation of regulatory rules across major markets, particularly in manufacturing standards and product approvals (for example International Conferences on 1-tarmonisation of Technical Requirements of Registration of Pharmacetsticals for Human Use). This is being driven especially by the US and EU in order to hasten market entry of new products and also lower costs" [2].

Product approvals and lead times

To remain competitive in a global market the health-care service sector has reacted astutely and responsibly by recognising a sponsor's criteria for the need for faster market entry of new products and lower costs.

This has been the main driver, enhancing collaboration between small to medium CROs allowing quick response and turnaround times which also characterises the preclinical and clinical service sector within Australia. Costs are kept to a minimum as infrastructure and labour costs are limited to each service unit and convergence and harmonisation of regulatory practices at a global level ensures duplicate testing is not required.

Ethics Committees evaluate preclinical and clinical study design simultaneously with regulatory authorities, substantially reducing the lead time for projects. Approval for preclinical and clinical studies once study parameters have been finalized are usually within three to four weeks, facilitating commencement of the study.

Cost Benefits

Based on a recent benchmarking exercise by Ernst & Young and Hay [2], there was a cost advantage in performing clinical trials in Australia when comparing labour costs, occupancy costs, laboratory equipment and consumables and office equipment and operating costs.

In today's global economic climate, Australia has become an increasingly viable option with the relatively low currency exchange rate.

References

1. Thorburn, L, (2001) Australian Biotechnology a Growing Industry, Global Outsourcing Review, Vol3. No3 Autumn 2001.
2. Ernst & Young, Hay Group Strategic Industry Research Foundation (2001). Benchmarking Study of R&D Costs in Selected Segments of Australian Biotechnology.

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