Dose Escalation Studies: How to Deal with Variability in Vector Dose Measurements

Cell & Gene Therapy Analytics Conference Virtual Biotherapeutics Analytical Series
DATE:March 23, 2021

In this presentation, Nancy explains that pre-clinical and clinical trials involving dose escalation assume that the assigned dose values are comparable across studies. However, dose assays for vectors often have high variability. Nancy discusses how the establishment of a dose specification is linked to the assay replication strategy and show that both must take into account to reduce the risk of errant quality control decisions.