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Abstract
Choosing the optimal time to develop a companion diagnostic alongside therapeutic products can feel like aiming at a moving target. To hit the bull’s eye, one must select the appropriate assay platform for the early validation of predictive biomarkers.
This requirement and several related challenges will be discussed at CHI’s conference on “Clinical Biomarker Assay Development.” Besides taking up the issue of choice of assay platform, presenters will discuss analytical validation strategies, reimbursement requirements, and regulatory compliance issues.
Many pharmaceutical and biotechnology companies employ biomarker analysis for pharmacokinetic/pharmacodynamic (PK/PD) modeling. Often, companies do such evaluation utilizing commercially available assay kits. “The problem is, whether they use home-brewed or commercial kits, groups must be aware of and plan for controlling lot-to-lot kit or assay component variability. This is critical for accurate bioanalysis in support of both preclinical and clinical studies,” says Afshin Safavi, Ph.D., svp of bioanalytical operations and founder, BioAgilytix Labs…
