The Crystal City VI Workshop was indeed a wealth of information on current perspectives of how we should develop, validate and apply bioanalytical methods for the measurement of endogenous biomarkers. Good input came from drug development bioanalytical scientists, clinical laboratory scientists and the FDA regulators. I came away further informed and enthused about how we can tackle these challenging assays.
In summary, my top-10 conclusions were:
- The biology comes first … before you even decide on a biomarker assay strategy.
- Biomarker assays are not pharmacokinetic assays.
- Accuracy is an inappropriate construct for biomarker assays.
- Prescriptive acceptance criteria are inappropriate for biomarker assays.
- The FDA has an established approach to reviewing biomarker assay performance.
- Both LC/MS chromatographic and ligand binding assay (LBA) approaches have a place in biomarker bioanalysis strategies.
- Drug development bioanalysts have lessons to learn from the clinical laboratory community.
- Defining biomarker in-vivo normal levels is crucial as a reference point.
- Category 1 and Category 2 biomarker assay terminology remains relevant and in effect.
- LBA kits are convenient but … be aware of limitations and treat with care.
Full Blog Article and Podcasting
I’ve written a full article on the workshop that you can access through LCMS On-Line Training FREE membership. And announcing a very exciting development this week … we have recorded an accompanying podcast on CCVI. Please check this out and tell us what you think of our initial forays into the land of podcasts. We are very excited about this medium and hope you find it valuable.