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Australia's medical reputation continues to grow

21 March, 2006

Australia has a strong and well supported research sector, a culture of innovation and world class science and medical infrastructure. Australia is also rapidly gaining international recognition in the pharmaceutical and biotechnology industries as an attractive environment for conducting clinical trials.

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Australia has a solid record of attracting and conducting international clinical trials with around 700 clinical trials performed in more than 2000 sites around Australia annually.

According to the First Australian Clinical Trial Survey (FACTS), produced by medical communications group ProScribe in 2004, Australia is a top performer in meeting recruitment timelines and targets with approximately a third of Australian affiliates ranked among the top 10 per cent of international affiliates.

Australia's regulatory process is comparatively swift - 99 per cent of clinical trials currently use the Clinical Trial Notification scheme where companies can notify and receive acknowledgement from the Australian Therapeutic Goods Administration (TGA) and start clinical trials in a week. The TGA stringently oversees all clinical trials. Its rulings are recognised and upheld by counterpart organisations world-wide. The TGA accepts data submitted from clinical trials conducted overseas as long as they follow Good Clinical Practice. Studies conducted in Australia routinely meet international regulatory requirements, including those of the US Food and Drug Administration and the International Conference on Harmonisation (ICH).

Australia is cost competitive with investigator fees per patient half those in the US and Canada. Australia's relative cost advantage holds up in all phases and therapeutic areas. In fact, Australia's costs for conducting clinical trials are comparable to those in Eastern Europe. By involving Australian affiliates of international pharma companies in international clinical trials experienced clinical staff can be accessed at a very competitive rate.

Australia also has several geographic and social factors in its favour: close proximity to the Asia-Pacific countries, a reverse seasonality to the Northern Hemisphere, the existence of ethnic sub-populations and an increasing incidence of western lifestyle diseases. Further, Australians have demonstrated a willingness to participate in clinical trials suggesting a sophisticated public approach to science and health.

A number of well-known, multi-national pharmaceutical companies have recognised Australia's impressive capability to conduct clinical research and have chosen to base some of their trials here. The list includes GlaxoSmithKline (GSK), Eli Lilly, Roche, Pfizer and Servier.

GSK conducts early stage trials at its facility in Sydney. The James Lance GlaxoSmithKline Medicines Research Unit is a dedicated Clinical Pharmacology unit located within the Prince of Wales Hospital. The Sydney Unit is one of only a few Phase I facilities the company supports world-wide. At any one time, GSK is conducting approximately 80 clinical trials in Australia involving approximately 250 investigating clinicians and 10,000 patients.

Eli Lilly, Roche and Pfizer have also established specialised, biometric centres in Australia drawing on the excellence of local researchers, clinical staff and data managers.

In 2004 the Murdoch Children's Research Institute (MCRI) in Melbourne entered into an alliance with the Royal Children's Hospital and international clinical trials organisation, Quintiles. The alliance will bring international paediatric clinical trials to the Institute's clinical trials group, the Australian Paediatric Pharmacology Research Unit (APPRU). As a result of the alliance the APPRU will see an increase in clinical trial activity.

The landmark, multi-centre PROGRESS hypertension trial was independently designed and led by the Sydney-based Institute for International Health in conjunction with French pharmaceutical company Servier. This trial involved 172 clinical centres and more than 6,000 patients in ten countries world-wide. The study is now complete and the main results show that study treatment reduced the risk of stroke by a quarter. The results have direct clinical implications for more than 50 million individuals with cerebrovascular disease worldwide.

Australia is home to numerous centres of clinical trial expertise and international best practice. These centres further expand Australia's capabilities by offering scope and choice of operational models when determining the most appropriate venue for specific trials. Following are some examples of the breadth of Australia's clinical trial capability and expertise:

Since its inception in 1993, Cancer Trials Australia (CTA) has grown to be one of the premier early phase trial groups in Australia focusing exclusively on cancer therapeutics having been selected by the then Pharmacia as one of its preferred centres worldwide for early phase testing of oncology drugs. The organisation has unique capabilities offered by its combination of clinical and research skills, access to platform technologies and centralised administration of clinical trials.
CTA uses as its underlying model a multi-site, coordinated and collaborative approach involving expert personnel in medicine, science, nursing and data management. Strengths of this model are its capability to take research findings from the laboratory to the clinic and its complement of skilled personnel.

CTA has enlisted a consortium of hospitals and research institutes to undertake Phase II and III clinical trials on potential therapies for cancer, including newly diagnosed chronic myeloid leukaemia and cancers of the prostate, lungs and skin. The consortium includes the Ludwig Institute for Cancer Research, the Peter MacCallum Cancer Centre and the Walter and Eliza Hall Institute of Medical Research and two major public hospitals.

A similar model has been adopted by Clinical Trials Victoria (CTV), whose members include the CTA, the Baker Heart Research Institute, The Alfred Hospital, Monash University and the Neurosciences Victoria consortium.
This diverse and expert membership places CTV in an ideal position to conduct clinical trials for a range of conditions including cancer, cardiovascular disease and neurological disorders.

The Institute of Drug Technology Australia Limited (IDT) specialises in the development, scale-up and manufacture of active pharmaceutical ingredients (APIs), in compliance with international standards and regulations. It has completed many projects on behalf of multinational clients, demonstrating its expertise and skill in every stage of the process, including the development of APIs for phase I and phase II clinical trials, and the provision of long-term commercial supply.

IDT's portfolio includes anti-cancer drugs (specialising in cytotoxics), anti-psychotics, antibiotics, narcotics and anti-inflammatory drugs, and it has built and validated new 'state-of-the-art' cGMP manufacturing facilities to accommodate this product range. IDT also offers a full pharmacy service that includes drug randomisation, labelling and packaging, and the manufacture of active and placebo components.

CMAX Pty Ltd is a division of IDT, located in the Royal Adelaide Hospital, CMAX is FDA audited and consists of a 42-bed, self-contained clinical trial unit, offering a range of Phase I through to Phase IV studies. The clinical unit also has the flexibility to conduct out-patient style studies. In conjunction with the clinical unit CMAX's analytical laboratory provides a wide range of bioanalytical services.

CMAX provides clinical research services to multinational organisations worldwide. CMAX has conducted trials at all clinical trial phases in a wide range of therapeutic areas such as cancer, HIV/AIDS, cardiovascular disease and endocrine and immunological disorders.

CMAX is equipped to provide a full range of services, from identifying appropriate sites for different trials and designing protocols, to the preparation of full reports and documentation required by the TGA and ethics committees.

 - The National Health and Medical Research Council's (NHMRC) Clinical Trials Centre (CTC) is the largest facility of its kind in New South Wales. Affiliated with the University of Sydney, the CTC conducts and coordinates large multicentre trials, takes part in trials of national and international collaborative trial groups, and contributes expertise to trials run by others. It is especially interested in cancer and cardiovascular trials. The CTC receives core funding from the NHMRC and additional income from various external bodies including government, public and private institutions and the pharmaceutical industry.

 - Q-Pharm Pty Ltd is a contract research organisation, established as a joint venture between the Queensland Institute of Medical Research and the University of Queensland. Q-Pharm specialises in Phase I trials on the safety and tolerability of new drug candidates, bioequivalence studies and drug analysis. Q-Pharm draws on its network of clinical associates to service the needs of clients from the pharmaceutical and biotechnology industries, both locally and overseas. The company has conducted trials in therapeutic areas including bacterial and viral infection, neurological disorders, and acute and chronic pain.

 - Neurosciences Victoria Ltd offers a range of products and services to neuroscience research and commercial entities. Some of the services include: neuroscience product pipeline and intellectual property management through the research and development pipeline from basic science, through pre-clinical and clinical trials, to market release as a targeted commercial entity; access to leading-edge platform technology and to world-class neuroscientific and technical expertise.

- Novotech (Australia) Pty Ltd, through their UK subsidiary, is able to offer locally based services to European clients. In addition, through key external partnerships and strategic alliances they offer worldwide reach to clients, particularly in the North American market. Novotech is contracted to manage both large global multicentre studies and local clinical trials. The range of therapeutic areas in which trials have been conducted include: CNS, anti-infectives, oncology and medical devices for cardiovascular and respiratory.

As a result of its overseas alliances and focus on service quality, Novotech was named one of Australia's fastest growing companies in the technology sector in the 2003 Deloitte Technology Fast 50, achieving three-year revenue growth of 291 per cent.

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