Date: February 1, 2022
Duration: 47 Minutes
For successful biomarker-driven clinical development, proactive planning to fully integrate clinical design and execution with a clear biomarker-informed development plan is required. Preclinical data are both a valuable and essential part of biomarker discovery, validation, and proof of concept, and a strong preclinical biomarker approach will contribute to trial success.
Addressing how to generate the biomarker data needed to progress therapeutic development is, therefore, crucial. Additionally, maintaining engagement between discovery and clinical biomarker and operations teams is necessary to ensure that preclinical biomarker assays are effectively translated into clinical assays.
This webinar will discuss key considerations when transitioning preclinical biomarker assays into the reality of the clinical development setting – including both practical and regulatory considerations.
Topics covered:
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Preclinical biospecimen sourcing for assay development and biomarker point-of-care for a more successful transition into clinical settings
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Choice of analytes and platforms and selecting the right technologies for generating useful data
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Clinical sample strategies and the considerations for the format, integrity, management, and logistics of the samples
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Regulatory requirements for biomarker assay validation for clinical trial assays
