In episode #91 of The Weekly Bioanalysis, John and Dom return to a two-person format to tackle the "gray areas" of bioanalysis, focusing on drug discovery, biomarkers, tissues, and emerging technologies. They discuss how traditional PK assay validation is highly standardized, but areas like early-stage discovery, biomarker qualification, and tissue analysis require more nuanced, fit-for-purpose approaches. A key theme is the need for flexibility and client collaboration, particularly when defining what constitutes validation versus qualification. The hosts emphasize how evolving technologies and commercially available reagents are enabling more streamlined, context-driven assays, though terminology differences—especially between U.S. and EU practices—continue to cause confusion. They close with a discussion on tissue assay limitations, particularly the inherent variability introduced during sample homogenization.

“The Weekly Bioanalysis” is a podcast dedicated to discussing bioanalytical news, tools and services related to the pharmaceutical, biopharmaceutical and biomarker industries. Every month, KCAS Bio will bring you another 60 minutes (or so) of friendly banter between our two finest Senior Scientific Advisors as they chat over coffee and discuss what they’ve learned about the bioanalytical world the past couple of weeks. “The Weekly Bioanalysis” is brought to you by KCAS Bio.

KCAS Bio is a progressive growing contract research organization of well over 250 talented and dedicated individuals with growing operations in Kansas City, Doylestown, PA, and Lyon, France, where we are committed to serving our clients and improving health worldwide. Our experienced scientists provide stand-alone bioanalytical services to the pharmaceutical, biopharmaceutical, animal health and medical device industries.