From The Stage

Outsourcing Clinical Biomarkers: Challenges and Opportunities

Posted by / / Biomarkers

Outsourcing complex bioanalysis has not always been a common course of action for pharmaceutical research and development divisions. In the past, companies generally only outsourced more routine projects, often for cost cutting reasons. But today organizations have begun to view outsourcing of more complicated assays in a different light, as a way to not only cut costs, but to take advantage of specialized expertise that drives efficiency in drug development processes, and frees up internal R&D functions to focus on the company’s core competencies. Clinical biomarkers have come into focus…

Considerations to Set ADA Cut Points

Posted by / / BioAgilytix Insight, Immunogenicity

Cut points are the threshold values for the distinction of positive and negative results in immunogenicity assays. Establishing appropriate cut points is crucial to ensuring acceptable assay sensitivity, and, although there are assay-specific characteristics to be considered when setting the cut point, some fundamental aspects should be considered when setting cut points in immunogenicity assays. 1. Statistical Methods Cut points should be calculated applying newest statistical tools using samples from treatment-naïve subjects to obtain robust numbers and take the variability of the assays into account. The cut point should be…

The Challenges of Standardizing Commercial Kits for Biomarker Quantification, Part 3: Ensuring the Right-Fit Kit

Posted by / / BioAgilytix Insight, Biomarkers

If you’ve been following the other posts in this series, you know that the use of commercial biomarker assay kits is on the rise as a lower cost, less resource-intensive option to support drug development programs. But commercially available immunoassay kits are created for a larger market, so even when procured from the optimal vendor, it is unlikely that a kit in its purchased state will be a perfect fit for the needs of your study. That being said, it is still important to be critical and thorough during kit…