Clinical Trials in Australia

WALK INS WELCOME AT THE EVENT

The Australian Federal Government’s R&D Tax Incentive Program, arguably one of the most generous tax incentives globally, is surprisingly easily available to US-based Life Science companies, once they have established a legal presence in Australia.

There is a significant alignment with Australia’s regulatory approval body, the Therapeutics Goods Administration (TGA) with America’s FDA.

There are many companies making use of this arrangement to conduct their early-stage clinical trials in Australia, then using that data, seamlessly transferring that over to the US, where additional/later-stage trials are conducted, in order to achieve FDA approval.

Come and learn more about the all the benefits including:

• Fast start-up times – IRB (HREC), site governance approval and CTN scheme in 2 to 4 months depending on size of site.
• Focus on recruitment and open environment to conduct decentralized trials
• Data generated, can be held in Australia or transferred to the US parent.
• High quality data from clinical trials conducted to GCP and accepted in the USA as Early Feasibility Data.
• International recognition for quality research (substantiation studies)
• Collaborative research industry with partnerships and networks working together to provide quality service to deliver trials on-time and on-budget.
• Australia has more than 40 globally recognized tertiary institutions, published researchers, respected key opinion leaders (KOLs) and Principal Investigators (PIs), dedicated and purpose-built facilities, and associated support staff.
• Generous R&D Tax Incentives: Companies are able to undertake some of their research (including clinical trials) in Australia, and will be eligible to claim back a refundable 43.5% back through their annual tax returns. For some aspects of the research that cannot be conducted in Australia for legitimate logistical reasons, a submission can be made for “Overseas Activities”. If approved, those activities and associated expenses, are also claimable at the 43.5% refundable tax rate.

Agenda:

5:30 pm – 6:00 pm: Networking and light refreshments

6:00 pm – 6:10 pm: Introductions

6:10 pm – 7:00 pm: Presentation

7:00 pm – 7:30 pm: Q & A

Cost: FREE but please register in advance

About the Presenters:

Pavel Reddy, PhD Founder and Director, Global R & D Pty Ltd

Dr Pavel Reddy comes with 15+ years of R&D Tax expertise, having worked for a Big Four firm, as well as another local respected R&D Tax advisory firm. With a Doctorate in Biology and a 20-year academic career in the Sciences, Pavel is well-placed to identify and understand the technology that underpins R&D Tax Incentive claims across several sectors.

Pavel has also met the requirements for R&D Tax Agent registration and is currently registered with the Australian Government’s Tax Practitioners Board.

Global R&D is in regular contact with the regulatory bodies, the Australian Taxation Office and AusIndustry. This enables the business to keep abreast with relevant information relating to the R&D Tax Incentive program, which is shared with our clients.

George Zafris MBA Director, Molecules2Market, Inc

George is a founding Director of M2M INC the role he has served for the last year. George has an MBA in Management and an BSc with a focus in Hematology and Pharmacology. George's responsibilities have included acting as the customer's primary contact during study conduct, trial budget and financial management, trial document management, electronic data capture, site feasibility, as well as the co-ordination and/or management of multiple service lines including 3rd party vendor management. George has been involved in all aspects of a study from start up to close out. He has been involved in global study management across North America, Latin America, Europe, and Asia/Pacific and Phases I, II and III with considerable experience managing and coordinating multi center global clinical projects and project teams.

George has experience working in the Central Nervous System and Peripheral Nervous System therapeutic areas including migraine, depression, agitation in Alzheimer's, and narcolepsy. George also has experience in managing oncology, pediatric, infectious disease, allergy and orthopedic trials. Most of George’s 22 years in the industry has been based in small, medium and large CROs.  The balance of his career was spent working for himself as a contractor or for small US and Australian Biotech companies. During his time as a contractor, George was approached to undertake a local AUS Director role for a small New York biotech company, a role which he still serves to this day.