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Profile: Auckland Clinical Studies

Auckland Clinical Studies (ASC) performs early-phase clinical trials in New Zealand, mostly for major international pharmaceutical companies. Maurice Wilkins Centre Director Professor Rod Dunbar this year offered laboratory support to ACS, helping it to secure two new contracts worth around $2 million, both with top-fifteen pharmaceutical companies (“sponsors”).

A positive experience

“Both companies were extremely positive about the collaboration with Rod and his team. The data was what the companies wanted – it was of very high quality – and their communication was great,” says ACS Operations Director Dr Christian Schwabe. High-quality laboratory tests (“assays”) are critical for clinical trials, providing information about how a new drug behaves in the body and how people respond to it, so pharmaceutical companies have very exacting standards.

The scientists successfully translated their academic expertise into the industrial setting. Dr Anna Brooks who, along with fellow team-member Dr Vaughan Feisst did much of the work, says it was a great experience doing industry-level research and meeting the sponsors’ stringent specifications.

Dr Schwabe says the success of the trials the scientists contributed to has increased the likelihood of ACS securing further contracts with the sponsors in future. “In this business it’s a lot about trust and relationships – it’s word of mouth, more than anything, that gets us work."

Understanding industry needs

The researchers’ mind-set was an important contributor to the successful relationship. “What [the Centre] presented was very much a ‘can do’ attitude and a willingness to respond to the sponsors’ needs. The companies we work with could choose to do their studies anywhere in the world – at the end of the day we provide a service to them, and we need to have the mentality that goes with that.”

Dr Schwabe says that’s exactly what the Maurice Wilkins Centre team provided, along with the flexibility to respond to the often changing needs of the sponsor companies.

Rod and his team repurposed their laboratory to provide the kind of information the companies required. “There was a willingness to invest the time to set up the assays and to do the validation work. Their interest was in getting the data right, to deliver the quality, and everything else was secondary.”

The scientists also came up with solutions when tweaks to the laboratory protocols were required, providing the kind of expertise ACS required. “I need to be confident that the lab knows what they are doing, and I am very confident with Rod and his team,” says Dr Schwabe.

And they adjusted their own research programmes to fit around the very precise timing of the trials. A protocol may require, for instance, that blood samples are taken exactly five minutes after study participants receive a drug, and precise intervals thereafter, with each sample processed within half an hour of being drawn.

Dr Schwabe says Maurice Wilkins Centre team members were waiting at the laboratory door to receive hand-delivered samples from ACS’s clinical trial facility, and worked weekends and public holidays, to process them within exacting timeframes like these.

How the relationship developed

The Centre’s relationship with ACS began after a conference presentation by one of the company directors, in which he noted it was difficult to find collaborating scientists to provide innovative new laboratory tests for their trials. “After that presentation Rod, who was in the audience, approached [our director] and said that that’s exactly what he would like to provide,” says Dr Schwabe.

It was fortunate timing. “We had two sponsors who were interested in conducting healthy volunteer studies in New Zealand, and both of those studies required flow cytometry for the establishment of new assays.” Dr Anna Brooks, who runs a flow cytometry facility in Rod’s laboratory, had just the expertise to help establish the new tests.

Benefits for New Zealand

“New Zealand is developing a strong reputation as a trustworthy place for high-quality clinical trials,” says Rod. That means New Zealanders are helping in the development of new drugs. They’re providing scientific expertise, and taking part in trials as volunteers and patients (who may derive clinical benefit, especially if the drug continues to later-phase testing here).

The trials are also bringing in significant export income for the country, through companies like ACS. And taking part in the ACS studies has also provided financial support for scientists in Rod’s laboratory. “It’s a great avenue of bringing in income,” says Dr Brooks who, like Dr Feist, has helped to fund her own salary by taking part in the research.

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