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PCI Clinical Services to Host Seminars


Topics will focus on phase I clinical trials in Australia at East Coast, U.S. locations

PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services and commercial packaging to the global biopharmaceutical industry, will share its knowledge in phase I clinical trials in Australia with a series of East Coast, U.S. seminars in June 2019. The dates are:
• June 11, Cambridge, MA
(Royal Sonesta Hotel, 4pm-9pm)
• June 12, Bridgewater, NJ
(Bridgewater Marriott, 4pm-9pm)
• June 13, Cary, NC
(Embassy Suites by Hilton Raleigh Durham Research Triangle, 3pm-8pm)
PCI says that over the last 20 years, Australia has become established as a preferred destination for the conduct of early phase clinical trials by virtue of economic advantages, speed-to-study advantages, as well as favorable regulatory pathways. Also, 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 development. Phase I Clinical Trial activity in Australia saw a 17.2 percent growth in 2012-2015, compared with just 1.8 percent globally.
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 an Asia Pacific full-service contract research organization (CRO). Nucleus Network is also an Australian CRO that specializes in the conduct of first-in-human, phase I clinical trials. Prime Financial Group provides accounting and business advisory services, offering experience in R&D financing and incentives for life sciences companies.
At each of the three events, Cameron Johnson, chief executive officer and managing director, 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 program.
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 U.S. 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,” said Mr. Fairweather. “This trend has been exemplified by the number of West Coast U.S. 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.”