The Future of Oncology Drug Development | Dr. Lakshmi Amaravadi

Oncology drug development is becoming more complex, and bioanalysis can no longer be treated as simple drug measurement.

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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