BIO profile: Nucleus network: networking clinical trials

The international market for testing new drugs and drug targets is already enormous and it continues to grow exponentially, but dear old Australia still sits way down the list in terms of activity, conducting a very small percentage of global clinical trials.

This is despite an independent report in The Economist in 2005, which ranked Australia as the best place to do clinical trials in seven surveyed countries, ahead of the US, UK, Germany, Japan, Singapore and India. It achieved this due to three main factors: low cost, the large number of recognised trial sites, and the high percentage of trials completed on time.

For Nucleus Network's marketing manager Maria Chiam, the report did not surprise her company. "Australia is gaining a reputation as a collaborative network to work in," she says. "It makes life easier, the trials more efficient, with less hold-ups, and provides a synergy of expertise and facilities. In the end, this all means better, faster and cheaper clinical trials."

A participant at the BIO International Convention since 2003, Victorian-based Nucleus Network is looking forward to BIO 2007 in Boston in May. The group's objective is to promote Australia as a destination for clinical trials, and marketing manager Maria Chiam is optimistic about the success of the Australian presence again at the world's largest biotechnology forum.

"The game is all about getting the product to market ... fastest and with the least cost," Chiam says. "Every day lost in a trial is dollars lost in potential sales."

Nucleus Network is unique in being a not-for-profit business that re-invests earnings in developing the clinical research profession in Australia.

It was put together by a group of clinicians and researchers in Victoria who wanted to foster collaboration between Australian academic and research institutions, government and industry.

Their aim was twofold - to increase opportunities for attracting clinical trials to local facilities, and for doing better clinical research that was really useful on a global scale.

The network acts as a one-stop shop for conducting clinical trials in Australia. It directly undertakes early-phase trials over a range of therapeutic areas, including cardiovascular, rheumatology, infectious disease, dermatology, respiratory disease and oncology, as well as trials for medical devices and biologicals such as vaccines. It is one of four dedicated, purpose-built, early-phase clinical trial units in Australia specialising in Phase I-II trials.

Willing participants

Australia, and Melbourne in particular, are well positioned for early-phase trials due to a number of factors, not least of which is the availability of concentrated groups of different ethnicity, Chiam says. "Australia can easily recruit the right demographics for well-orchestrated early-phase trials."

Volunteers are generally plentiful, especially with the closely located student base and many self-employed people, a good and willing source of appropriate cohorts for phase I and II testing of new compounds.

Chiam says another big plus for Australian trials is the collaborative and frank attitude of Australian clinicians. "Australians clinical researchers are valued for this. They are generally not afraid to give an educated opinion on the progress of a trial or to make a clinical decision."

Nucleus Network gained its impetus in July 2004, when a world-class purpose-built clinical trial facility and offices was opened for operation in the Burnet tower in Melbourne.

2004 and early 2005 saw the new venture becoming established to bring clinical research investments to Victoria and nationwide through the establishment of over 40 alliance partnerships within Australia to deliver a full range of drug development services.

These alliance members comprise not-for-profit and independently owned clinical research organisations, academia, research institutes and health-care research organisations. Following consolidation and some changes to the stakeholders in 2005, Nucleus Network was officially launched as an independent entity in June last year.

Nucleus Network currently comprises three business units -- the Centre for Clinical Studies conducts the clinical trials, Clinical Trials Consulting looks after clinical research consulting and regulatory affairs, and Nucleus Network Education provides education and training in Good Clinical Practice (GCP).

The alliance partners contribute across all three areas of business, particularly in conducting formal education and certification of clinical trial professionals (using the internationally recognised ACRP certification program in GCP), which is increasingly demanded by the international field.

This sharing of resources and expertise means costs saving for all and greater accessibility for Australians to world-class clinical research facilities and the latest technology.

Facilities

Early-phase trials are conducted at the Centre for Clinical Studies unit next to the Alfred Hospital in Melbourne. This 24-bed state-of-the-art facility is positioned within a large and vibrant biotechnology research and hospital precinct, including a major teaching hospital.

This ensures easy access to a range of clinical and allied services such as nuclear medicine, pathology and cardiology, as well as leading specialists and investigators in the relevant therapeutics areas, who are available to fulfil principal investigator roles.

Besides the purely clinical facilities, the unit boasts two recreation rooms, a fully equipped laboratory, pharmacy access with five dedicated clinical trial pharmacists, proximity to 24/7 emergency care, and a full-time participant recruitment service with access to diverse patient and volunteer populations.

The unit has a regular staff of over 40, comprising medical, scientific, nursing personnel and clinicians with experience in clinical trial management and industry-standard clinical research.

"Nucleus Network can also provide full commercial sponsorship for international companies without a corporate presence in Australia, and that all clinical trial data generated in Australia are acceptable to the FDA and EMEA," Chiam says.

Collaboration such as this is seen as a big plus by international drug companies, and may be the vital advantage for people such as Chiam to succeed in her job of selling Australia to the clinical trials market in preference to Europe, North America or Asia.

She identified India and China as becoming stronger in this area and the next 'big' competitors for us. Fortunately for Chiam, Australia is already positioned well, with a solid reputation in conducting trials and for the quality of its medical and clinical research.

With close to 60 per cent of Nucleus Network's business coming from the US, Chiam is based in San Francisco for most of the year, making her journey to BIO 2007 much shorter than most of the Australian contingent. She hopes to return to the West Coast with several new clinical trials locked in.

According to Chiam, BIO is also a great environment for learning about the international biotech market, and for forming networks and sharing ideas with other Australians. "It is a great chance to get together and is often the start of working together," she says.

Nucleus Network is exhibiting as part of the Australian Pavilion at BIO 2007.