Development of an early stage biomarker within discovery: Considerations for assay requirements
Early-stage biomarker assay development and validation plays an increasingly important role in drug discovery and development. But as ever-changing regulatory guidelines push pharmacodynamics (PD) and safety endpoint data requirements to new degrees of sensitivity, the demand for developing fit-for-purpose biomarker assays presents new challenges to drug developers and regulators alike.
In this webinar, Adrian Freeman, Head of Biomarkers Bioanalysis and Clinical Services, shares a story of how Envigo developed a novel biomarker assay that takes assay endpoint requirements into consideration in his presentation ‘Development of an early stage biomarker within discovery: Considerations for assay requirements.’
This insightful webinar will provide a behind-the-scenes perspective into the bioassay development as well as:
• Examine the biology and measurement of thyroid hormones
• Discuss the considerations and parameters used for the development of a biomarker assay
• Discover the positive outcome of collaboration among CROs, regulators and instrument / kit manufacturers