Recent publication: "Considerations for drug development biomarker assays in the clinical laboratory"

I'm pleased to share that a Commentary, co-authored with John Allinson and Steven Piccoli, has been published ahead of print in Bioanalysis, "Considerations for drug development biomarker assays in the clinical laboratory” (link). In it, we consider the differences between FDA BMV and clinical laboratory biomarker regulations and the reliability of the data. Specifically, the challenges clinical laboratory biomarker data used to support safety and efficacy endpoints in regulatory filings face due to their operational practices that differ than those recommended in the BMV, while being accepted for medical decision in patient care.

I have to acknowledge Erica Troksa, who challenged me to think about this issue several years ago and change my perspective; ultimately leading to this publication. 

Here is the first paragraph:

"Of late, the phrase 'context of use' (COU) has become widely used to describe the performance characteristics required in a biomarker assay used in drug development programs.  In clinical laboratories, including those supporting clinical trials, biomarker assays have been established to support the medical community in the diagnosis, treatment and monitoring of patients with various diseases.  Advances in therapeutic modalities has expanded the number of diseases for which therapies are being developed. Frequently, clinical laboratories have biomarker assays used in disease treatment that are now being evaluated for use in clinical trials to demonstrate the safety and efficacy of new therapies, and in some cases the biomarkers act as a number of different study endpoints, including predictive and prognostic, while some aspire to be surrogate endpoints. The introduction of the term COU has raised a number of questions in the scientific and regulatory communities due to the shift from one regulatory environment (medical practice) to another (new therapy approval).  In this article, we will review the issues, similarities and differences in the expectations and approaches between these two regulatory perspectives on measuring biomarkers; in particular looking at the question of why pivotal biomarker assay data from clinical laboratories used for medical decisions is not, in some cases, perceived as acceptable by health authorities when considering the approval of new drug therapeutics."