Speakers

A senior professional with extensive experience and expertise in biotechnological drug development. Cultivates a pro-active “can-do” mentality and entrepreneurial spirit. Able to liaise with many different groups and customers as well as work towards a common company goal/strategy. Gained significant experience through interactions with health authorities and preparation of source and submission documents for clinical trial and license application. Excellent understanding of enhanced development approaches aligning on ICH Q8 to upcoming ICH Q12.

Presentation Title: Deploying Appropriate Spending on Analytical Testing To Avoid Wasting Resources?

Abstract: Molecule and process characterisation are key enables for defining a robust and lean commercial control strategy. Having the risk of an attribute to patient safety and molecule efficacy in focus, a balance needs to be found between success rate of the therapy to make it to the market and phase appropriate investment in analytical method development to gain sufficient molecule and process understanding.

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