Innovative biotechnology companies are basing their product development and services on recently evolved developments in biochemistry, genetics, molecular biology, immunology, cellular biology and other biological techniques.

Australia’s current biomedical capabilities encompass:

• diagnostics
• medical devices
• pre-clinical and clinical trials
• therapeutics
• vaccines
• emerging capabilities

The largest product area within biomedicine is therapeutics, with 49 per cent of core biotech companies focused in this area. Areas of significant capability include immunology, oncology, infectious diseases (eg. HIV, Hepatitis B), metabolics and diabetes, allergy and respiratory diseases, stem cell research, inflammatory diseases, cardiovascular diseases, infertility, neurology and pain, nutraceuticals, urology, and tropical health and medicine.

While therapeutics (and, specifically, oncology therapeutics) is a focus for the largest group of listed biotech companies in Australia, capabilities in diagnostics, vaccines and medical devices are evidenced by substantial company activity in these areas.

There is also significant biodiscovery focus through institutions such as the Australian Institute of Marine Science (AIMS).

Natural biodiversity is seen as a key factor underpinning biomedicine. Australia is one of the world’s 17 mega-diverse countries, and is well placed to capture new chemical entities from its natural products research.

AIMS possesses one of the world’s largest publicly owned collections of biotic extracts for bioactive chemical discovery, covering some 20,000 marine macroscopic and microscopic organisms from around Australia. The Bioactive Molecule team uses samples from this library to identify novel chemicals of interest, and is playing a key role in the global race to find new treatments and alternatives in the fight against cancer.

Biomedical devices and technology

Areas of strength include Ventricular Assist Devices (Heart Assist Technologies, Sunshine Heart Company, Ventracor), Hearing devices (Cochlear, Vast Audio), Hip and Knee implants (Australian Surgical Design Manufacturers, Portland Orthopaedics), sleep apnoea devices (Resmed), Diagnostic Kits (Cellabs, Enterix), Implantable drug delivery (Sirtex Medical) and retractable syringes.

Emerging capabilities

Oncology is the focus of the majority of listed biotech companies in Australia. There are also a growing number of public biotech companies that highlight Australia’s emerging capabilities in cell and tissue engineering, with the emergence of companies with research interests in stem cells, cell-based vaccines (eg. dendritic cell vaccines), tissue replacement and repair or regeneration of organs.

Drug delivery technology is another emerging area for Australia, with opportunities in marketing through international collaborations. A range of capabilities in which major changes are forecast over the next five to 10 years are noted below, under the phases of the value chain.

Discovery stage

Australia’s biomedical sub-sector is developing capabilities in research into microbial resistance. This research is particularly important not only in biomedical applications, but also across other areas of biotechnology. For example, research into resistance to antibiotics for bacterial infections and resistance against anti-fungal products is not only applicable to human health, but also in the agriculture and environmental sectors.

In the 2007-08 Federal Budget, the Australian Government allocated A$100 million to Princess Alexandra Hospital and University of Queensland to support a research and development facility for the development, testing and small-scale production of life-saving biopharmaceuticals.

The Australian Government is also providing a A$10 million grant to assist in the establishment of a small-scale mammalian cell production facility. This will bridge the infrastructure gap in the national biotechnology manufacturing chain by providing the capacity to produce recombinant proteins using mammalian cells. The facility will allow drug developers access to small quantities of complex biological material for studies ranging from preclinical research to Phase III clinical trials.

In medical devices, discovery capabilities in biomaterials science are beginning to translate into the establishment of new companies. Australia is likely to develop further in the area of personalised medicine with biomarker discovery, and build on research capabilities in stem cells.

Development stage

The Australian Synchrotron in Melbourne was officially opened in July 2007, and provides infrastructure for advanced technology, with particular benefits expected across discovery and development of biomedical products and in the areas of nanotechnology, disease mechanisms and microbiology.

There are strong prospects for the formation of more internationally competitive cancer research consortia, particularly for breast, colon, ovarian, prostate cancers and leukaemia.

More specifically, emerging capabilities in the development phase include tissue engineering (eg. autologous primary cell cultures for tissue repair), niche areas of protein discovery techniques and prophylactic and therapeutic vaccine development (eg. novel combinations or single shot vaccines and DNA based vaccines for autoimmunity, chronic infections and anti-biowarfare).

Preclinical stage

Building on existing capabilities in the preclinical phase, there is increasing sophistication and infrastructure in animal and other preclinical facilities, including transgenics, in Australia. For example TetraQ is the first contract research organisation in Australia to provide integrated preclinical services to the global pharmaceutical and biotechnology industries.

A further example of how Australia is building on existing capabilities in this area is the use of GM technology to produce an internationally competitive product, including supply through companies such as Ozgene.

Clinical trials stage

Emerging capabilities in clinical trials include:

• the use of applied stem cell therapy and cell therapy in tissue repair
• wound healing for diabetes treatment
• connective tissue engineering
• neurodegenerative disease
• some cosmetic applications

The ARC Research Network for Tissue Engineering has been established to coordinate research into tissue engineering which will help build capabilities. Further fostering of these capabilities is likely as governments, industry and relevant agencies look to a more national approach to streamlining approval of clinical trials. This should assist in highlighting the key issues and developing specific strategies and solutions as required.

Australia has multiple advantages as a venue for clinical trials. It has an exemplary record for meeting timelines and recruitment targets for drug trials. Each year there are around 700 clinical trials conducted across 2000 centres in Australia. Multinational companies such as Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Pfizer, Quintiles, Roche and Servier have chosen to base clinical trials in Australia.

Major clinical trial centres in Australia include Cancer Trials Australia, Nucleus Network and the Queensland Clinical Trials Network.