Beyond context of use: smarter LC–MS strategies for biomarker success
Tuesday 9th June, 2026
07:00 [PST] 10:00 [EST] 15:00 [BST]
Alternative time zones
Gain insight into building robust, flexible LC–MS workflows that support biomarker decision-making across discovery, translational and clinical phases with real-world examples and case-based discussion.
Liquid chromatography–mass spectrometry (LC–MS) has become an essential tool for biomarker quantification, offering high specificity, sensitivity and multiplexing capabilities across diverse therapeutic areas. However, successful implementation requires thoughtful alignment of analytical strategy with the intended application. In this webinar, we will explore key considerations for developing and deploying LC–MS–based biomarker assays within a fit-for-purpose framework, and how this differs from a strict context-of-use approach. We will discuss practical strategies for surrogate matrix selection when authentic matrices are limited or variable, and address critical aspects of clinical sample handling that can significantly impact data integrity. Additional topics will include approaches for qualifying endogenous quality controls, evaluating biomarker stability across collection and storage conditions, and designing streamlined, personalized method validation plans that balance scientific rigor with program timelines.
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What will you learn?
- Considerations for developing LC–MS biomarker assays within a fit-for-purpose framework
- Differences from context-of-use approaches
- Strategies for surrogate matrix selection
- Clinical sample handling for data integrity
- Approaches for qualifying endogenous quality controls
- Approaches for evaluating biomarker stability across different conditions
- Streamlined and personalized method validation plans
Who this may interest?
- Translational medicine and biomarker strategy teams
- Bioanalytical and analytical development scientists
- Experts in clinical development and clinical pharmacology
- Precision/personalized medicine groups
- Those involved in regulatory and development strategy functions
Speakers
Niki Gonzalez
Bioanalytical Scientist
Aliri Bioanalysis
Niki Gonzalez started working on macromolecules (DNA, proteins) during her PhD, mostly focused on chromatin dynamics, structure and interactions with other protein complexes. She graduated from Ohio State University (OH, USA) with a PhD in Chemistry (Physical Chemistry) and started applying her knowledge in an industry setting working in bioanalytical chemistry using LC–MS/MS to develop methods for detection and quantitation of challenging molecules. Niki specializes in large molecule bioanalysis including proteins, biomarkers and antibodies.
Shane Karnik
Sr. Laboratory Director
Aliri Bioanalysis
Shane Karnik joined Aliri Bioanalysis in 2003 and currently serves as Senior Laboratory Director. In this role, he leads a team of scientists executing bioanalytical programs that support pharmaceutical drug development across both non-GLP and regulated (GLP/GCP) preclinical and clinical studies. His work spans a wide range of analytical platforms, including nominal and high-resolution mass spectrometry, advanced chromatographic techniques, and automated sample preparation systems. Shane has extensive experience in the extraction and quantitation of small molecule drugs, therapeutic peptides, biologics and oligonucleotide-based therapeutics. In addition to his scientific leadership, he plays a key role in ensuring technical rigor and regulatory compliance across all projects at Aliri. Prior to joining Aliri, Shane Karnik earned a Master of Science in Chemistry from the University of Colorado (CO, USA) in 2000 while working full-time in research and development at a medical device company. He remains actively engaged in the scientific community as a member of the Bioanalytical CRO Council, contributor to AAPS bioanalytical focus groups, and member of the American Society for Mass Spectrometry.
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