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 accelerates the development process and in subsequent trial phases helps increase investor confidence and attract potential licensing partners, which in turn de-risks the program and maximizes return on investment.
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.
Join experts from Avance Clinical, Gabriel Kremmidiotis, Chief Scientific Officer; and Alex Kavros, Executive Vice President, Scientific & Regulatory Affairs, for the live webinar on Monday, September 9, 2024, at 10am PDT (1pm EDT).
For more information, or to register for this event, visit Strategic Advantages of Early-Phase Oncology Clinical Development Across Australia and the USA.
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