Crystal City VI (CCVI), adds to the series of workshops held jointly by the FDA and AAPS. These workshops have historically helped pave the way for regulatory guidelines in bioanalysis. Following Crystal City V and the reference to biomarkers in the FDA draft Guidance on Bioanalytical Method Validation (BMV), this recent workshop set out to discuss the unique challenges that biomarkers present to the bioanalyst. The two day workshop covered discussions around large and small molecule biomarkers using chromatographic LC/MS approaches and ligand binding assay (LBA) strategies. As well as the FDA and drug development industry representatives, the clinical chemistry laboratory community was invited to the discussion. As such some robust debates and discussions around case examples and practical scenarios of biomarker bioanalysis were had.
In this podcast we hear Dr. Steve Lowes perspective on the key elements of the workshop and where we go from here. Take a listen to this 30 minute discussion between Steve and Dr. Jack Henion then take a look at further information on Steve’s blog article and join the conversation.