Yes, it is true! The workshop report from AAPS Crystal City VI is finally here. I know those of us that participated in the 2015 workshop—in which we focused for two days on how to deal with ligand binding assay (LBA) and LCMS biomarker validation and sample analysis—have been wondering what the outcome was of that 2-day discussion. We certainly heard very different views and practices between the presenters on day one versus those on day two about who is right and who is wrong: the clinical chemistry folks, the PK folks doing biomarker work, or the followers of the original Jean Lee paper. I have to say that I am very pleased with the great job that the 4 authors of this report have done, hearing everyone out and stating in the paper that all the possible approaches that are actually practical and doable, considering some of the limitations that we as scientists have to deal with when working on such biomarker assays.
In the report, the authors have explained the importance of parallelism, relative accuracy, and the consideration for the biology and intended use. One statement that resonated so well with me, and in fact put a smile on my face as I was reading it, was this one discussing parallelism: “When parallelism is achieved, […] the assay is measuring what it is intended to, but it does not mean they are identical. While this concept is increasingly well understood and there is agreement that these are critical validation experiments, its application can be complex, requires scientiﬁc judgment, and does not lend itself to a simple rule set.”
As I read this, I realized that this statement on parallelism can actually apply to almost all the other parameters that we evaluate in LBA biomarker validation. Kudos to the authors of this report for creating such a great summary of the Crystal City VI workshop discussions, and giving us a strong basis to build on as we continue working together in smaller sub teams. Also, my hat’s off to everyone that participated in the workshop and who agreed, as well as disagreed, with my comments. The outcome has been a great paper and a solid platform to move forward and build out in more detail, hopefully in a harmonized manner.
I look forward to see what comes out of future discussions and sub teams regarding bioanalytical method validation for biomarkers, as I believe these are extremely important conversations that have the potential to make a powerful impact in our industry and beyond. Let us not forget that at end of the day, all of these efforts are to help those patients that are in need of better drugs for better quality of life and / or survival.