Thursday, October 31, 2024

2:20 PM - 3:05 PM

Plenary Room

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Details

This session will focus on the pathway from R&D to regulated manufacture of bioconjugates for use in clinical trials in Australia, with specific examples from research institutes and SMEs highlighting the scientific and regulatory requirements to deliver clinically ready material. The session aims to highlight opportunities for the regulated manufacture of bioconjugates in Australia, including understanding the breadth of therapeutics that encompass bioconjugates, the gap between R&D and regulated manufacturing methods, including both technical and financial drivers that may address bridging that gap, and the regulatory requirements for clinically ready bioconjugates at every stage of the clinical translation pathway. The session will explore key drivers for Australian SMEs/industry to have regulated bioconjugates manufactured overseas and how to retain manufacturing in Australia. Furthermore, we will explore how to attract International SMEs/industry to rely on Australia to manufacture bioconjugates for use in Australian clinical trials.

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Speaker