Expediting Phase I Clinical Trials in Australia

PCI Clinical Services will showcase our expertise in Phase I Clinical trials in Australia

PCI Clinical Services will showcase our expertise in Phase I Clinical trials in Australia to the stage at two new events in conjunction with the upcoming BIO 2018 International Convention in Boston next month, following our recent acquisition and integration of Melbourne-based Pharmaceutical Packaging Professionals (PPP).

The Australia drug sector invests more than AUD$1 billion every year into research and development, with investment in Phase I studies in the country alone having a conservative estimate of AUD$50 million i.

June 6, Boston: PCI’s ‘Good Morning Meeting’
(Intercontinental Boston Waterfront Hotel, 510 Atlantic Ave, Boston, 7:30am)

June 7, Cambridge: ‘Aus-Trial-Ia’ event
(Royal Sonesta, Cambridge, 4-9pm)

At both events, Craig Rogers, SVP of the Asia Pacific region, will call upon his extensive background to outline the advantages of executing studies in Australia, as well as share how to conduct early-phase Clinical studies in Australia effectively.

The events will showcase our Phase I Clinical trial capabilities and provide further information following our acquisition of PPP in March this year. During his presentations, Craig will provide an overview of the regulatory and investigational product management requirements in Australia, as a destination of choice for the conduct of early phase Clinical trials.

In his presentations, Craig will be emphasizing the specific requirements for importing, manufacturing, compounding and labelling product for Australian Clinical studies. In addition to this, he will also compare the differences between the Australian and EU/US requirements and key advantages of initiating Clinical studies in the country.

Over the last 20 years, Australia has grown to be a preferred destination for companies to undertake Phase I Clinical trials; this has been the case for a significant number of pharma companies in the US, which have identified the specific advantages of this region,” said Craig.

With Phase I Clinical trial activity in Australia recording a 17.2 per cent growth in volume from 2012-2015, compared with 1.8 per cent globally ii, our presentation will provide up-to-date information on the regulatory framework for Clinical trials in the country. In addition to this, it will also describe the various options for investigational project management, including importation, Just In Time manufacture, as well as GMP requirements for Phase I and labelling.

Craig has more than 20 years’ experience working within the pharmaceutical industry. This includes roles in Regulatory Affairs at both big pharma and emerging biotech; Scientific Affairs at IDT; and General Manager at both CMAX and Nucleus Network Phase I Clinical units. In 2008, Craig established PPP based on the opportunity available in the local Australian market to support Clinical trial manufacturing and logistics.

The recent acquisition of PPP enables us to provide wide ranging services in early phase Clinical sterile and non-sterile drug manufacture as well as establishing a PCI depot to serve the Asia Pacific market. PPP’s logistical services 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.

PCI partners Nucleus Network and Prime Financial Group AU will be presenting alongside PCI at both the Massachusetts events, with social networking and refreshments to follow.