Clinical Trials Victoria unveils new name, CEO

Nucleus Network, the new umbrella name for Clinical Trials Victoria (CTV), the Centre for Clinical Studies (CCS) and its member alliances, was launched today at the organisation's facility, located adjacent to Melbourne's Alfred Hospital -- three hours after a 12-patient clinical trial finished in the same room.

Victorian innovation minister John Brumby launched the network, describing it as "a compelling illustration of the ability of academics, research institutions and business to work together to create a single platform for clinical research and improve outcomes for patients."

Speaking at the launch, Graham Macdonald, Merck Sharp & Dohme's external licensing coordinator, said that while Nucleus Network's major customers would be large pharmaceutical companies, he hopes that it would diversify quickly.

Macdonald noted that clinical trial industry was extremely competitive, with Australia competing with other countries in Asia and Eastern Europe. However, collaboration in some specialty areas "is the best way to make us competitive in an external sense".

Centralised organisations such as the Nucleus Network also make it easier to achieve standardisation and harmonisation of procedures, particularly in the areas of ethics approval and informed consent documentation, he said.

Early clinical trials have posed somewhat of a 'bottleneck' for biotech companies in their attempts to bring products to investment readiness, he said.

In an area where time to market is "the critical issue", Macdonald said he hoped the Nucleus Network would help to unblock the bottleneck and allow more biotech products to reach phase II, so that companies could attract partnerships or perhaps internal capital in order to complete the late stage clinical trials themselves.

"Being involved in clinical trials is something very satisfying for most patients," said Macdonald, and the network could provide an avenue to look at the "nuts of bolts" of how physicians deal with patients.

How it works

The Nucleus Network comprises more than 40 industry relationships and research alliances. As a single point of contact, it is intended to provide a 'bench to bedside' approach, with access to expertise ranging from phase I clinical trials to the point where new drugs and treatments are being prescribed to patients.

Brumby said that the "important and distinct roles" of CTV and CCS would remain "but they'll operate under the Nucleus Network banner."

CCS will continue to provide clinical research consulting to industry while the clinical trials themselves will be conducted through the newly badged Clinical Trials Consulting.

CTV and the CCS were established in 2002 with $8 million in seed funding from a Victorian government Science Technology and Innovation grant.

Since then, CTV has conducted numerous clinical trials at its 24-bed facility for multi-national pharmaceutical companies and national and international biotechnology companies. Medical interventions have been tested in a wide range of therapeutic areas including heart disease, dermatology, diabetes, hepatitis, menopause, cancer and rheumatology. "To date, this project has been a great investment for the state," said Brumby.

Biotechnology and pharmaceutical companies from Sweden, Germany, France, USA, Singapore, China, Taiwan, Japan, India and Malaysia have expressed interest in bringing their clinical trial work to Australia through the newly branded organisation.

CEO named

Andrew Giddy will be taking up the position of Nucleus Network CEO from October 2005. Giddy has worked for the Boston Consulting Group and headed Roche Switzerland's clinical operations group until July 2000. "We're delighted to welcome him to the team," said Nucleus Network chairman Gary Jennings, who is also director of the Baker Medical Research Institute.

The importance of the team over and above the facility itself was also stressed by Nucleus Network medical director Prof Henry Krum at the launch, who said: "Well-conducted clinical research is not about the surroundings but the dedication and teamwork of people conducting the studies."