Bioanalytics – Chemical

Symposium

Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices

Speaker(s)

• 

  Afshin Safavi, PhD

  Founder and Global Chief Scientific Officer
  BioAgilytix
  Chapel Hill, North Carolina
• 

  Steven Piccoli, PhD

  Head, Clinical Biomarkers, Experimental Medicine
  GlaxoSmithKline
  Collegeville, Pennsylvania

The goal of this presentation is to define the latest scientific and regulatory considerations for the analytical validation of assays for fluid-based (any protein, peptide, nucleic acid, lipid or other chemical entity soluble in plasma, urine, saliva, etc.) biomarkers used in the qualification of Drug Development Tools. This presentation will also address the latest industry practices for exploratory biomarkers. The topics to be discussed include considerations for assay design and technology selection, optimization of pre-analytical factors, core assay performance expectations, and setting minimally acceptable assay performance criteria. Technology areas covered include singleplex ligand binding and immunometric assays, singleplex and multiplex mass spectrometry assays, and enzyme-based assays.

Learning Objectives:

• Review and discuss the latest scientific and regulatory considerations for the analytical validation of assays for fluid-based biomarkers used in the qualification of Drug Development Tools.
• Review and discuss the latest industry practices for exploratory biomarkers. The topics to be discussed include considerations for assay design and technology selection, optimization of pre-analytical factors, core assay performance expectations, and setting minimally acceptable assay performance criteria.
• Biomarker areas covered include singleplex ligand binding and immunometric assays, singleplex and multiplex mass spectrometry assays, and enzyme-based assays.