About this episode

Dr. Lakshmi Amaravadi discusses the complexities of oncology drug development and the importance of biomarker validation.

Oncology drug development is becoming more complex, and bioanalysis can no longer be treated as simple drug measurement. Sponsored by Leucentra, https://leucentra.com/ Inspired by science, empowered by IT. Leucentra helps life science and healthcare organizations evaluate, implement, and get more value from technology that supports innovation. In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe speak with Dr. Lakshmi Amaravadi, Head of Oncology Bioanalysis at AstraZeneca, live from AAPS PharmSci 360 in San Antonio. Dr. Amaravadi unpacks why biomarker validation is not one-size-fits-all, how context of use should guide scientific decision making, and why fit-for-purpose validation matters in modern oncology drug development. The conversation explores: 00:00 Why oncology bioanalysis is becoming more complex 02:12 FDA biomarker validation guidance and industry response 04:27 What “fit for purpose” means in practice 06:38 PK assay validation vs biomarker assay validation 07:52 What drives Dr. Amaravadi’s work in translational science 10:48 Why validation is not a checkbox exercise 12:19 Advice for young scientists entering bioanalysis 15:12 Why oncology drug…

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Leucentra

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