FDA Publishes Case Studies on Biomarker Qualification

The FDA highlighted two fictional case studies it published on the role biomarker qualification plays in drug development — as part of a reorganization of the agency’s biomarker materials — to help drugmakers understand the validation studies necessary to support qualification, the collaborative efforts involved and the potential benefits.

The first mock study tracks a biomarker for drug-induced kidney injury: researchers discovered that the biomarker is measurable at low blood levels before the kidney injury, significantly increases after the injury and returns to the baseline level once the injury is resolved, suggesting it is a useful biomarker for drug development.

The second case study follows a patient advocate collaborating with researchers and regulators to qualify a biomarker for use in osteoporosis drug clinical trials. Over the course of the study, researchers learn that a protein that regulations bone cell absorption is a potential biomarker for bone turnover, information that can be used in future clinical trials. — Zack Budryk