Streamlining Early Phase Development
Co-Locating Clinical Trials and Manufacturing in Australia
Sponsors are increasingly off-shoring Phase 1 trials due to opportunities for cost reduction, improved timeline, increased trial quality, and additional market entry opportunities.
There are many key decisions to make when deciding where to place an early phase trial, all which can impact the speed, cost and quality of the trial. Sponsors are increasingly off-shoring Phase 1 trials due to opportunities for cost reduction, improved timeline, increased trial quality, and additional market entry opportunities.
Understanding the regulatory differences and advantages between countries is therefore vital in determining which location offers the sponsor the most desirable path to start their first-in-human trial. Furthermore, there is an increasing trend for development of the Investigational Product (IP) being trialed to be managed by sponsor companies who are seeking to streamline early phase development to establish proof of concept quickly. As such, in addition to coordinating regulatory oversight and associated timelines, an important consideration is aligning availability of the IP with the recruitment and trial preparation schedule.
The USA and Australia are two of the leading destinations for off-shored Phase 1 clinical trials worldwide, in addition to being two of the largest markets in the world for pharmaceutical sales. This paper outlines the regulatory differences between the regulatory bodies in three countries – the USA’s FDA, Australia’s TGA and the UK’s MHRA – and more deeply explores the speed, quality and cost benefits of conducting a clinical trial in Australia paired with manufacturing the IP in the same region.
Who should read this:
Biotech and Pharma researchers responsible for moving from pre-clinical to Phase 1 clinical trials.
What you’ll take away:
- Understand the differences in regulatory oversight when choosing a location for your Phase 1 trial.
- The advantages of speed and why Australia is one of the leading destinations for early phase trials.
- What to consider when selecting the means for generating and supplying Investigational Medicinal Product.
- Meeting first-in-patient dates: Should you supply IP from overseas or manufacture onsite?
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Read More on How to Fast-Track Your First-In-Human Trial
For a more in-depth explanation on the regulations, costs and timelines associated with early phase trials governed by the FDA (USA) and TGA (Australia), read our white paper “Fast-Tracking Your Phase 1 Clinical Trial in 2022”, which explores the differences in the regulatory bodies overseeing Phase 1 trials in four countries: The USA, Canada, Australia and the UK.