Besides good surf and BBQ, what can Australia offer your clinical program ?

I have been running clinical trials in Australia for the better part of 15-years and there are numerous potential benefits in running clinical trials there - particularly early phase trials. There are also reasons that it may not make sense for a given clinical program or strategy.

One of the benefits is that their regulatory scheme often allows a therapy to enter into human trials months or years ahead of doing so in the US. This isn’t to say it is a free-for-all there as they have updated both their drug and device regulations over the past 3-5 years and continue to do so but there often is a pathway to be able to run first-in-man and feasibility trials much earlier than in the US or Europe. This allows for early clinical data to support investing, critical pathway and development decisions, and data to support later phase trial design and FDA submissions.

Another reason that it can be beneficial to run clinical trials in Australia is that there currently is a rebate scheme that allows for upwards of 40% of all dollars spent on research being conducted in Australia to be refunded on an annual basis. There are a number of criteria and stipulations that define eligibility and the amount of the rebate and there have been times that it did not make sense to pursue this. However, more often than not, it is a great form of reduction of cost particularly for a start-up biotech.

As with all clinical strategies there may be reasons that going to Australia does not make sense. For some organizations the travel distance, time zone differences, etc are logistically too difficult to manage. It might be that the patient population required for the study is not in Australia either in numbers or required demographics. While not an issue I have run into, shipping of product may be logistically restrictive. Other reasons could certainly exist and careful consideration of the benefits and risks is required before making the leap to running a study in Australia.

A final benefit might be that there are geographies such as Israel that once a study is approved in one country, approval there is quick opening the door for more sites. But that is a discussion for another post.

As always, if you would like to discuss this potential strategy reach out and we can have a discussion.