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Developing and Applying Biomarkers in Early Phase Clinical Trials

As the pharmaceutical industry embraces the concept of personalised medicine, there is an increased interest in the application of biomarkers earlier in the drug development pipeline. This can pose significant challenges for both Pharma and diagnostics companies.

Almac has significant experience in the discovery of single target and multivariable signature based biomarker assays in a pre-clinical setting from both cell line and xenograft models and translating them into analytically validated clinical tests that can be used to enrich clinical trials from as early as phase I.

This webinar presents an overview of some of the key components involved in developing such products including:

  • Platform selection
  • Optimising tests for FFPE tissue
  • Assay migration (tissue type and/or platform)
  • Determination of assay analytical parameters to CLIA standards
  • Biomarker clinical trial design and management
  • Clinical assay delivery
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