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We would like to share the Australian value proposition to small biotech's and virtual's due to the positive impact Australia has on clinical trials.
Some of the compelling benefits are;
1. Speed - There is a favorable regulatory pathway- you can have FPI in about 5-6 weeks and you do not need an IND to commence your phase 1. Many sponsors come to Australia, then file their IND with data in hand. This saves time and money.
2. Quality - Data generated in Australia is accepted by the US FDA and EMA. You can do the early clinical development in Australia then to the US/EU for Phase 2/3.
3. Cost - There is a government tax Incentive policy in place that provides a significant 41% Cash Rebate for all work completed there. This includes manafacturing, lab PK/PD, shipping fees, all clinical work. Due to the lower cost in general in Australia, you can expect to save approximately 60% of the cost if the same study was conducted in the United States.