Aus-Trial-Ia Phase I Clinical Trials Down Under – Cambridge
Tuesday 11th June – Cambridge, MA
Join PCI Clinical Services and our partners at one of our East Coast seminars to learn more about the advantages of conducting your clinical trials in Australia.
We will be joined by our partners Nucleus Network, Prime Financial Group AU and Novotech.
Topics will include:
- Phase I Unit Overview
- Australian Regulatory Landscape
- Phase I Manufacturing Overview
- Financial Benefits of Working In Australia
Be sure to stay for our social networking event!
3:00pm – 4:00pm: Registration
4:00pm – 4:10pm: Welcome and Introduction
4:10pm – 4:40pm: Phase I Clinical Trials in Australia
Cameron Johnson, Chief Executive Officer and Managing Director, Nucleus Network Ltd
Cameron Johnson joined Nucleus Network in August 2013 as the Chief Operating Officer before moving into the position of Managing Director. Prior to joining Nucleus Network, Cameron held the position of Chief Executive Officer at a Phase 1 Clinical Trials Organisation and was also the inaugural CEO of the company. Cameron has worked in early phase clinical trials organisations across Australia and Europe since 2001.
Australia continues to be a preferred destination for companies to undertake their Phase I clinical Trials. Rapid ethics approval and a simple notification to the Therapeutic Goods Administrations means that from submission to FPFD will only take on average 6 weeks. Further to this the clinical trial application only requires the IB, Protocol and PICF with no need to prepare an IMPD or IND application. To facilitate rapid approval there are specific considerations in trial design, these will be described in the presentation along with relevant trial set up considerations. The data from the Australian study can then be used to support your IND or IMPD application allowing companies to speed up their drug development process.
4:40pm – 5:10pm: Australia’s Simplified Regulatory Environment as Gateway to Asia
Alyce King, Business Development Manager, Novotech CRO
Originally from Melbourne, Australia, Alyce King is a Boston based Business Development Manager with over 8 years’ experience in the life sciences space. She currently works for Novotech, a clinical research organization headquartered in Sydney, Australia with a presence across 3 continents. Alyce’s previous roles in the pharmaceutical and medical consumable industry has provided her with expert understanding of business development from both a business to business and direct to patient perspective. Along her strong passion for enabling clients to conduct clinical trials in the Asia Pacific region. She has a Bachelor of Science, majoring in Chemistry and Human Physiology from Monash University.
Learn how Australia provides a comprehensive environment for early phase clinical trials, with cost, speed, and quality advantages. Alongside this, learn about benefits of running clinical trials in Asia.
5:10pm – 5:40pm: Phase 1 – Investigational Product Management and Regulatory
Craig Rogers, SVP of Asia Pacific , PCI Clinical Services
Craig has over 20 years of experience working within the pharmaceutical industry. This included roles in Regulatory Affairs at big pharma and local 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 his gap analysis of the services available in the local market to support clinical trial manufacturing and logistics. Craig is a registered pharmacist, toxicologist and lawyer.
Australia over the last 20 years has grown to become a destination of choice for the conduct of early phase clinical trials. This has been particularly the case of West Coast US pharma who have identified the specific advantages of this region. This presentation will provide an overview of the regulatory and investigational product management requirements in Australia. It will provide up to date information on the regulatory framework for clinical trials in Australia and compare and contrast this with the EU/US requirements. It will also describe the various options for investigational product management, including importing, just in time manufacture, GMP requirements for Phase I and labelling. Attendees should leave with a good understanding of the regulatory and investigational product requirements for Australia.
5:40pm – 6:10pm: The Cost of your Trial in Australia
Brendan Brown, Partner, Prime Accounting and Business Advisory Services
Brendan has over 20 years experience in the accounting profession and is a Partner of Prime Accounting and Business Advisory. He has provided specialist R&D tax services to his clients for the past 13 years and has also acted as the accountant, tax agent, CFO and/or company secretary for a range of successful Australian life science companies. In recent years, Brendan has assisted a large number of Overseas life science companies setup in Australia to successfully conduct their clinical trial activities and potentially access the R&D tax incentive.
Australia’s R&D tax incentive program has made Australia one of the most attractive locations in the world for companies to undertake their R&D activities. Foreign owned companies can now access the program and claim cash for amounts spent on R&D in both Australia and overseas. The R&D tax incentive refund can provide eligible applicants with a cash refund of up to 43.5% of the amount spent annually on eligible R&D activities. This presentation will explore the eligibility requirements of this program.
6:15pm – 9:00pm: Close out and Networking Event
To register for this event, please click here:
Date & Time
11 Jun 2019 - 3:00 pm - 8:00 pm
Royal Sonesta Hotel
40 Edwin H Land Blvd