CRX08: Who's who of clinical research

Queensland Clinical Trials Network Inc (QCTN) is an independent, not-for-profit, incorporated industry organisation for preclinical and clinical trials service providers, located in Queensland. The broad base of QCTN's membership clearly extends beyond clinical trials alone, with entities ranging from biotech companies, medical services and research organisations to more service-related companies like World Courier.

According to Pennisi, the overarching objective of QCTN's activity is to promote Australia as a destination for doing clinical research, "with an emphasis of course on Queensland". To achieve this, QCTN acts as the primary point of contact or link for domestic and international organisations seeking to undertake preclinical and clinical research anywhere in Australia, or simply to have a presence here.

"Basically, we help identify and connect organisations (sponsors) with appropriate research institutions, hospitals, contract research organisations (CROs) and other life sciences service providers" Pennisi says. QCTN has established strong relationships with entities in many other parts of the world including Germany, Japan, Korea, New Zealand and North America.

QCTN also facilitates education, training and accreditation for clinicians, clinical trial managers, data managers, research nurses and other sector professionals, as well as raising public awareness of the need for and value of clinical trials in different forums.

With a background in managing laboratory medicine services, Pennisi was involved in establishing the first Queensland-based 'central laboratory' in the mid-1990s to service international trials in the Asia-Pacific region. A few years later, Pennisi assisted with founding Queensland's first CRO.

"As the sector and need grew, a number of service providers then got together and formed a marketing entity called Affiliated Clinical Trials Services (ACTS) - a research organisation, laboratory, Phase I facility and a later-phase facility. It worked basically to cross-promote each other's services around the world." The idea was that by working together, everyone could save money and generally achieve more.

At the same time, Brisbane City Council (BCC) decided that clustering of like-minded businesses was a good thing, and so formed a fledgling clinical trials cluster in Brisbane. ACTS was one of the first stakeholders. "What happened then was quite interesting - suddenly hospitals on the south side of the river were talking to hospitals on the north side of the river about clinical trials and research, heaven forbid!"

About the same time, the then premier of Queensland, Peter Beattie, was rolling out his 'Smart State' policies. As part of this initiative, state government representatives started coming to the clinical trials cluster meetings, and immediately saw both the market opportunity and common sense in making it a state government activity.

According to Pennisi, Beattie announced plans for a Queensland Government-backed network of clinical trials service providers at BIO in 2004, and by the same event in 2005, Pennisi had been appointed, the funds had been allocated and the entity established. "By any measure of government activity, it was remarkably fast - and a clear sign of the Government's commitment," Pennisi says.

And because the BCC-backed cluster was already established, the marketplace and service providers were semi-organised, with a small cohort ready to deliver on the initiative. QCTN was thus born, starting with seven entities. Three years later, the membership totals 66 entities and growing, with all committed to promoting clinical and pre-clinical research in Australia.

Activities range from discovery through to marketing and cover all clinical fields and therapeutic areas - products and devices, small molecules, 'first-in-human', biologics, dermatology, oncology, cardiology, endocrinology and neutraceuticals. "We are basically a one-stop shop for people wanting to do preclinical and/or clinical research," he says

---PB--- Clinical research shines down under

"Australia is a great destination for clinical research and there is plenty of independent data to support that assertion," Pennisi says. We offer high-quality medical research and facilities in a Western health system, with stable and robust political, legal and regulatory systems. The population is ethnically heterogeneous and globally unique with its proximity to Asia.

It is also much cheaper to do trials in Australia than in many other countries - certainly compared to the US, but also compared to Japan, Singapore and Europe. This is backed by a recent benchmarking study undertaken by The Economist Intelligence Unit. It found Australia to be extremely cost competitive in conducting clinical trials when compared to the US, the UK, India, Singapore, Germany and Japan. Australia also achieves rapid start-up times for clinical trials, which aid access to US and European markets, and further decreases the overall trial costs.

Queensland has even more of an edge in this area, according to Pennisi, and that is having QCTN to actively promote and link the services and providers available. No other such organisation exists elsewhere in Australia. "We will help a company or venture capital-backed entity to identify who to go to in Australia for regulatory advice on clinical trials, who can monitor the study, find the site, who can help with logistics. More then half of our work comes from the US, and most of it is from VC-backed or small cap entities - and usually early phase, although not all."

QCTN is currently focussing on markets like Japan, Korea and Taiwan. These countries have quite sophisticated regulatory environments and thus understand the reasons for ethics review, intellectual property protection and so on when undertaking clinical research, making these issues easier to deal with in Australia.

Australia has already demonstrated its ability to deliver - and is also seen as a more legitimate and efficient stepping stone to Western markets and FDA approval. "Even American companies now come to Australia to do their early-phase, first-in-man studies, and then take the data back to the US, and this has also given other countries the confidence to use Australia," he says.

---PB--- Q for quality

Pennisi estimates that only about half of the possible entities in Queensland are members of QCTN, giving it plenty of room to grow and work to do. The organisation is also keen to engage with the Federal Government as a backer and move the model into the national arena. In fact, it would be feasible to roll out almost immediately as there is already significant interest, and all the basic infrastructure and functionality is already in place.

"There will be some subtle branding changes - we would change the first word to 'quality' - and as an industry in Australia, we are quite proud of the quality of product that we provide and the cost-effectiveness or value of that quality, and it is this that makes us the vibrant industry that we are."

The other big focus for QCTN is promotion in overseas markets, such as BIO in the US and equivalent events in many other countries like Japan and Korea. "We go to those events in our own right, but we also encourage members to come with us for a fee, to help us underwrite our exposure, and provide them with a visibility platform in the big markets for a fraction of the cost of doing it on their own."

QCTN also works very closely with and values the network of Queensland Trade Commissioners overseas, particularly those in North America, Japan, Korea, Taiwan, China, India and Europe.

Staff at QCTN comprises 3.8 full-time positions, including that of Pennisi. "We concentrate on spending our money (from State Government grants and membership fees) to improve the services and opportunities for our members rather than increasing our staff numbers." Pennisi says QCTN can operate with such a small number of staff because it works closely with those trade offices.

QCTN has a focus on looking north - "let's face it, we are a Western population living in Asia. That, along with our high quality clinical and regulatory environment and our cost effective offerings means we have something that America, Europe and the rest of Asia wants - a Caucasian population and Western medical system in an Asian time zone.

"These are countries that we are very familiar and comfortable with, we have good trading relationships, and we deal with them every day - and therefore we have an extensive and comprehensive network of trade offices we can leverage. So not only are we are stepping stone for these guys to get into Western markets; we are also a stepping stone for Americans and Europeans to get into the Asian environment. Building these bridges has been really important for us and is a growing part of what we do."

QCTN also capitalises on any opportunities it sees to further efforts in the Asian markets. For instance, it recently placed a young cadet in the Tokyo Trade Office of the Queensland Government under a state-sponsored scheme available to any Queensland company. The cadet works for QCTN under the direction and umbrella of the Trade Commissioner in that market for six months.

"It is a great scheme for the industry sector in Queensland - fantastic for the cadet, for us and for our members, who could not afford such a strong presence in that market by themselves," he says. Pennisi is delighted with the results so far. "Our cadet is already building on relationships we established previously in Japan, and her presence there will culminate in us taking a commission to BIO Japan in October to promote Japanese companies doing work in Australia."

As part of its sector commitment, QCTN will continue to play a big role in events such as CRX08, which will alternate between Brisbane and Melbourne for the next few years. With the involvement of the NHMRC and some of Australia's leading clinical researchers - and following Queensland Premier Anna Bligh's recent Smart State III launch, in which she indicated 'we are now going to focus on brains not bricks' - Pennisi sees this particular meeting becoming the pre-eminent event for anyone involved in clinical research.

"It is fast becoming the forum for the who's who of clinical research in this country. We currently have quality people, undertaking quality research in Australia, and by organising these types of events, we want to build and reinforce that quality position. It is what makes Australian research valuable - it is high quality and we want to protect that."