Strategic Advantages of Early-Phase Oncology Clinical Development Across Australia and the USA

Life Sciences, Clinical Trials, Pharmaceutical Regulation,
  • Monday, September 09, 2024

Webinar Preview

Discover an informative webinar that delves into the strategic benefits of conducting early-phase oncology clinical development across Australia and the USA.

Australia’s unique advantages make it an ideal starting point for early-phase oncology trials. The Therapeutic Goods Administration Clinical Trial Notification scheme offers a streamlined regulatory pathway, significantly accelerating trial initiation. Coupled with world-class research centers and a generous research and development (R&D) tax incentive — allowing biotechnology companies to reclaim up to 43.5 percent of their R&D expenditures — Australia provides a conducive environment for rapid and cost-effective early-phase development.

Read more...

Transitioning to the USA for later-stage trials, particularly Phase II, is crucial for aligning with US Food and Drug Administration (FDA) regulations and capitalizing on the diverse patient population. This diversity is especially important in oncology, where genetic variability and differing tumor biology across populations can impact treatment efficacy and safety.

Conducting trials in the USA also facilitates entry into the world’s largest pharmaceutical market, enhancing commercial prospects for oncology therapies. For this purpose, an integrated approach helps ensure a seamless transition from Australia to the USA as it helps maintain consistency in trial design, data collection and regulatory compliance while maximising the R&D rebate. It also mitigates the risks associated with navigating different regulatory landscapes.

In oncology, early-phase trials are pivotal not only for assessing safety and tolerability but also for generating early efficacy data in cancer patient populations. Designing trials that provide critical insights into a drug’s therapeutic potential, accelerating the development process and informing subsequent trial phases helps increase investor confidence and attract potential licensing partners, which in turn de-risks the program and maximizes return on investment.

Read Less...

Register for this webinar today to learn about the strategic advantages of early-phase oncology clinical development in Australia and the USA and how it helps ensure innovative cancer therapies reach the market.

Speakers

Gabriel Kremmidiotis, Chief Scientific Officer, Avance Clinical

Gabriel has 26 years’ experience in medical research and drug development. He has devoted most of his career to the biotechnology industry, managing drug development programs from early discovery to completion of phase II proof of concept clinical trials and subsequent commercial drug licensing deals.

With primary expertise in oncology, Gabriel has a diverse scientific background spanning the fields of Clinical Development, Drug Discovery, Cancer Biology, Molecular Genetics, Bioinformatics and Immunology. He has a PhD and a Bachelor of Science (Honors) from Flinders University and a Bachelor of Science from The University of Melbourne. He has published research findings in 29 international scientific papers and has several patent inventions on cancer genes and small molecule anti-cancer therapeutics. Gabriel is a member of the American Association for Cancer Research, the American Society of Clinical Oncology and ARCS Australia.

Message Presenter

Alex Kavros, Executive Vice President, Scientific & Regulatory Affairs, Avance Clinical

Before joining Avance, Alex held significant roles at Ergomed, Worldwide Clinical Trials and Vifor Pharma, where he led clinical development campaigns, spearheaded global regulatory operations and optimized business processes and workflows . His expertise encompasses a broad range of pharmaceutical products, including biologics/ATMPs, small molecules and vaccines, across various stages of development from clinical development to marketing authorization and product launch.

Alex’s academic credentials are equally impressive, with a BSc (Hons) and PhD in Chemistry from Lancaster University, UK, followed by a Post-doc in Macromolecular Engineering at Carnegie Mellon University, Pittsburgh, PA. His robust scientific background has been instrumental in his professional achievements and in shaping his approach to regulatory science.

Alex finds the integration of ‘ClinicReady’ and ‘GlobalReady’ concepts within Avance’s development strategies compelling. This approach not only enhances Avance’s domain expertise in scientific and regulatory field but promotes the development of innovative products that meet critical patient needs.

Message Presenter
John Zalcberg, Monash University

John Zalcberg, Head of the Cancer Research Program, Monash University

Prof John Zalcberg is Head of the Cancer Research Program in the School of Public Health and Preventive Medicine at Monash University, providing academic leadership to a number of clinical quality registries.

Prof Zalcberg holds the inaugural Tony Charlton Chair in Cancer Research at the Alfred Hospital and Monash University. A co-founder of the Australasian Gastrointestinal Trials Group (AGITG), he was the prior Chair of the Board of AGITG, a Co-Chair of the Cancer Drugs Alliance, past-President of the Clinical Oncological Society of Australia (COSA), and a previous board member of Cancer Trials Australia, the Cancer Institute of New South Wales, and the Australian Red Cross Blood Service.

He is a current Board member of PRAXIS and the ICON Group and a Medical consultant for Avance Clinical.

Message Presenter

Who Should Attend?

This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working within the biotech industry with the below titles:

  • Clinical affairs/R&D/research/pharmacology/operations
  • Regulatory affairs/Medical affairs
  • Site selection and start-up
  • Site management organization/Clinical study site
  • Trial management
  • Medical Director/Medical Research Scientist/Research Manager
  • Director or Manager of Regulatory Affairs/Pharmacovigilance/Scientific Affairs/Clinical Trial Operations

What You Will Learn

Attendees will learn about:

  • The benefits of conducting early-phase oncology trials in Australia and later-phase trials in the USA
  • The streamlined regulatory processes in Australia that accelerate trial initiation
  • The regulatory requirements for oncology clinical studies in the USA
  • The future impact of emerging oncology treatments on cancer care and market potential

Xtalks Partner

Avance Clinical

Avance Clinical is the largest premium full-service Australian, Asian and North American CRO delivering quality clinical trials with globally accepted data for international biotechs. The company’s clients are biotechs completing Phase I to Phase III of their drug development program that requires fast, agile, and adaptive solution-oriented clinical research services.

Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past four years, has been providing CRO services in the region for more than 26 years.

Pre-clinical through to mid to late phase
Avance Clinical offers pre-clinical consulting and regulatory services with their experienced ClinicReady team right from pre-clinical through to Phase III clinical services leveraging significant Australian Government incentive rebates of up to 43.5% and rapid start-up regulatory processes.

With experience across more than 120 indications, the CRO can deliver world-class results and high-quality internationally accepted data for TGA, FDA and EMA review.

Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, TrialHub, Certinia, Salesforce, Zelta and Medrio are just some of the technology partners.

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account