Biomarker assay development: qualification vs validation debate
Wednesday 9 October 2024
07:00 [PDT] 10:00 [EDT] 15:00 [BST]
Alternative time zones
Bioanalytical considerations when developing biomarker assays: qualification vs validation debate.
Biomarkers are a critical aspect of bioanalytical testing by providing a vast amount of information, from the effects of a drug on the subject, to determining the drug’s mechanism of action and the correct dose for a patient. When developing a biomarker, it is important to understand the context of use to determine the level of development required. The level of development can be as simple as kit implementation or as in-depth as a fit-for-purpose validation. Understanding a study’s needs will help guide the level of development and determine the appropriate platform and assay.
What will you learn?
- What a pharmacodynamic (PD) marker is
- Bioanalytical considerations of biomarker development depending on the context of use
- The difference between the level of development in terms of qualification and validation
- Types of methods/platforms in the LBA space and considerations for sample type and size requirements, and availability of critical reagents/kits
- What off-the-shelf biomarker assays are and how they are used
Who this may interest?
- Individuals interested in learning more about biomarkers
- Individuals who are looking to outsource bioanalytical studies
- Individuals who develop and validate biomarker assays
Speaker
Lindsay Rutherford
Scientific Advisor
KCAS Bio (KS, USA)
Lindsay is currently a Scientific Advisor at KCAS Bio, supporting ligand-binding assay services. Lindsay has over 15 years of experience in assay development and previously worked at ICON (KS, USA) overseeing the Large Molecule Method development team. Prior to her CRO work, Lindsay spent 10 years in the diagnostic and drug development space. She received her PhD in Chemistry at the University of Arkansas (AR, USA) and works out of the Kansas City area.
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