PCI Pharma Services (PCI), full-service provider of specialist outsourced drug manufacturing, clinical trial services and commercial packaging to the global biopharmaceutical industry, will showcase its expertise in Phase I clinical trials in Australia with a series of East Coast, US seminars in June 2019.
Over the last 20 years, Australia has become established as a preferred destination for the conduct of early phase clinical trials by virtue of significant economic advantages, speed-to-study advantages, as well as favourable regulatory pathways. The proven excellence and performance of the country’s clinical trial institutions are supported by a highly favourable regulatory and business environment. The Australian Government’s commitment to the clinical trial sector is demonstrable, with significant incentives to help ensure success for early phase studies.
Within the Asia-Pacific region, Australia is now one of the more mature markets for conducting clinical trials, with more than AUD$1 billion sector investment for research and development1. Phase I clinical trial activity in Australia saw a 17.2% growth in 2012-2015, compared with just 1.8% globally2.
The three East Coast seminars will be hosted by PCI in partnership with Novotech, Nucleus Network and Prime Financial Group AU.
Headquartered in Australia, Novotech is internationally recognised as a leading Asia Pacific full-service contract research organisation (CRO). Nucleus Network is Australia’s industry-leading contract research organisation specialising in the conduct of First-in-Human, Phase I clinical trials. Prime Financial Group provides accounting and business advisory services, offering significant experience in R&D financing and incentives for life sciences companies.
At each of the three events, Cameron Johnson, CEO and Managing Director of Nucleus Network, will discuss "Phase I clinical trials in Australia", covering trial set-up and design to support applications and facilitate rapid approval.
"Australia’s Simplified Regulatory Environment as Gateway to Asia" will be the subject of Novotech’s presentation, delivered by Alyce King, Business Development Manager. Alyce will help delegates learn more about how Australia provides a comprehensive environment for early phase clinical trials, with cost, speed and quality advantages.
During his presentation, Brendan Brown, Partner at Prime Accounting and Business Advisory Services, will explore "The Cost of your Trial in Australia". He will take a specific focus on eligibility requirements for Australia’s attractive R&D tax incentive programme.
PCI’s Jon Fairweather, Business Development/Technical Services Executive, Australia, will provide an overview of the investigational product management and regulatory requirements for Phase 1 studies in Australia. Jon will give up-to-date information on the regulatory framework, comparing Australian requirements with those of the EU and US markets. Jon will also set out the various options available for investigational product management, including importing, just in time manufacture and GMP requirements for Phase I labeling.
“Australia has established a significant presence in the global clinical trials sector over the past 20 years as a preferred destination for companies undertaking Phase I studies. This trend has been exemplified by the number of West Coast US pharma names which have identified the specific advantages of the region. PCI is delighted to partner with Novotech, Nucelus Network and Prime for these seminars to share our respective experience and expertise,” commented Jon.
Last year, PCI acquired Melbourne-based Pharmaceutical Packaging Professionals (PPP), which enabled the global pharmaceutical provider to deliver a wide range of services in early phase clinical sterile and non-sterile drug manufacture as well as establishing a PCI depot in Australia to serve the Asia Pacific market. Logistical services at PCI’s Melbourne facility include storage capability across a range of temperature conditions including Controlled Room Temperature, 2-8˚C, -20˚C, and -80˚C environments, which expand PCI’s existing capabilities in storing, packaging and shipping Cold Chain products.
References1. https://australianclinicaltrials.com/the-australian-tour-phase-i-clinical-trial-units/
2. https://www.austrade.gov.au/.../2814/Clincal-Trials-Capability-Report.pdf.aspx
