Description

For the past decades, pharmacokinetic (PK) assays have been the main focus of the bioanalytical community. Multiple guidelines were written and updated over the years to define the design of validation experiments and assay acceptance criteria for small molecule PK assays. Later, immunogenicity assessments and large molecule PK gained attention an came into scope. In recent years, the important role of biomarkers can play in drug development became evident. The analysis of biomarker samples and the validation of biomarker assays were typically based on the existing guidelines and best practices for PK assays. The bioanalytical scientists that were setting up these methods often had background and experience developing PK assays. The bioanalytical industry has understood that there are different considerations for biomarkers when defining best platforms, how assays need to be characterized or when run acceptance criteria must be set. Fit-for-purpose validations were introduced, and followed by the concept of Context of Use (CoU).

In this webinar, PRA scientists will summarize some recent developments in the way the bioanalytical community feels about measurement of biomarker samples. The concepts of CoU, assessment of parallelism, longitudinal monitoring of assay performance and other validation parameters will be discussed. We will use some case studies with examples of challenging biomarker assays and how these can be overcome. Finally, we will provide insight in the process of biomarker outsourcing and important aspects Sponsors should consider.

Learning Objectives:

• Why biomarker assays are different than PK assays
• Summary of current best practices for biomarker assay design and set-up
• Understand how to successfully outsources of biomarker assay