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Companies and Organisations

Challenges for biotechs include attracting capital investment, meeting milestones in a timely fashion, and deciding on the best point at which to license a potential new drug. Having clinical data adds a lot of value to licensing deals, but there are commercial risks if clinical trials are delayed or prolonged.

We currently have a promising new cancer therapy in a phase 1 clinical trial that is being conducted by Cancer Trials Australia. Within 3 months of getting the green light to proceed with our ‘first in humans’ study, CTA had recruited our first patient. This is remarkable progress and, although we are a small to medium-sized company, this is comparable with what large companies can achieve and helps Bionomics compete in a tough market.

CTA not only appreciate our time frames, but are also an extremely valuable service provider in that they enable us to access a number of highly regarded centres for patient recruitment and facilitate all approvals needed. They are essentially a one-stop shop. We will definitely be working with CTA again in the future as we progress our lead compound and bring other potential new therapies through the trial process.

Dr Deborah Rathjen, CEO Bionomics, Sept 08

Amgen have been conducting clinical trials in oncology for more than twenty years and have been involved with CTA since its inception as the CDCT . We have progressed more than 10 lead compounds through CTA. Several early phase trials with these compounds have been performed at CTA member institutions including some first in human studies.

CTA have changed in a number of ways over the years and are going from strength to strength. They are now a one-stop shop in the sense that they oversee the budgets and handle all the ethics requirements in a centralised manner. This is a huge plus and saves companies like us a lot of hassle, particularly when the trial is being conducted across a number of separate sites. The CTA network has grown significantly, is an extremely valuable resource, and contains many excellent investigators and other research personnel who are adept at recruiting and managing trial patients.

Despite Australia’s population size, more than their fair share of new oncology medicines has been tested here. This is, in part, due to the unique regulatory system as the CTN process is a lot quicker than the bureaucratic procedures in many other countries. From a company’s point of view, speed, recruitment and quality are of utmost importance and we get all of that here.

Brian Cohen, Senior Manager Clinical Operations Amgen, Oct 08


Member Representatives

In the last two years I have been involved in international clinical trials and have been the principal investigator (PI) for four of them. If new anti-cancer drugs show promise early on, a suite of clinical trials can rapidly ensue. However, with each trial there is a huge amount of organisation and paperwork. Dealing with the regulatory and legal documents can take up a lot of our time. Moreover, PIs may not have the experience to deal with some of the legal agreements.
This is where CTA comes in: CTA can ensure that realistic responsibilities are assigned to the investigative team; take out much of the legwork of running a clinical trial; and save time, not just for PIs, but for other clinical trial staff. For example, excellent research nurses are important and we like them to be able to stay focused on their real role.
In comparison with even a few yeas ago, we now also have the situation where most hospital departments need to recover costs, thus there is also a lot of complex interdepartmental paperwork for reimbursements, so for us the value of involving CTA increases even more.
CTA have a lot to offer and are an experienced and professional organisation. Now, even when companies approach PIs directly, we turn to CTA. That way we too have more to offer and the companies get a better product.

Dr Clare Scott, Researcher Walter and Eliza Hall Institute of Medical Research, Medical Oncologist Royal Melbourne Hospital, October 08


Clinical Trial Advisory Groups

Over the past decade Australian children with cancer have had little access to investigational compounds. To remedy this situation, all the paediatric oncology centre directors got together in 2007 to create a new entity called Australian Children's Cancer Trials (ACCT) Rather than recreate the systems and procedures needed to conduct paediatric clinical trials, we chose to work with Cancer Trials Australia who have all the necessary structures in place.

CTA provides ACCT with the research governance systems and resources, including designated staff members, to conduct paediatric clinical trials. Their experience and expertise is of great value to ACCT. Additionally, CTA has well-established links with industry and through these relationships are able to help us connect with potential sponsors. We have already benefited from opportunities to show companies some of the scientific research results from our labs and this has led to us receiving funding to run a new clinical trial. Because it costs so much to get an early phase trial underway (in the order of $20m+), it would not happen without industry sponsors.

CTA is user-friendly and efficient and can protect the interests of the investigators involved, ensuring each is getting a particular level of funding. Financially, it’s actually better for both the institutes and industry to work through CTA. For us, the greatest reward is knowing that ACCT can play a significant role in the development of new therapeutics for children’s cancer and that Australian children will be among the first to potentially benefit.

Associate Professor David Ashley
Director, The Royal Children's Hospital Children's Cancer Centre (Melbourne)
Chair, ACCT


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