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Recent Developments in Analytical Support of Biomarkers

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

Contributors

  • Radboud van Trigt, Ph.D., PRA Health Services

    Radboud van Trigt started his career in bioanalysis in the early 2000s as a study director for small molecule LC-MS/MS analysis at a CRO. A couple of years later he joined Astellas, a large pharmaceutical company, as a bioanalytical scientist. Over the years he got involved in other types of analytical studies supporting drug development including large molecule PK using LBAs, qPCR, flow cytometry, microbiology and biomarkers. Radboud gained a lot of experience in validation of assays and sample analysis in clinical trials of all phases. Currently, Radboud is a science director for biomarkers at PRA Health Sciences and in that role responsible for the global biomarker science and strategy for the bioanalytical laboratories.

  • Amanda Hays, Ph.D.

    Dr. Amanda L. Hays offers more than a decade of lab experience in multiple fields, including pharmacology, drug metabolism, immunoassays, immunogenicity, biomarkers and flow cytometry. She has particular expertise leading clients from pre-clinical through phase III clinical trials and post-marketing studies. Prior to joining BioAgilytix, she served as Director of Bioanalytical Science at PRA Health Sciences, where she provided global scientific leadership and technical guidance for PRA’s large molecule bioanalytical laboratory. Dr. Hays is the Vice Chair of the AAPS Biomarkers and Precision Medicine Community and has held several volunteer leadership positions through the AAPS in the last several years. She earned her Ph.D. in Pharmacology from the University of Kansas Medical Center in Kansas City, KS.

November 9, 2020
Mon 12:30 PM EST

Duration 1H 30M

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