Associate Director Regeneron Pharmacuticals TARRYTOWN, New York
This talk will cover how we overcame challenges and unique considerations for developing robust assays to measure the concentration of a reversal agent in the presence of its target therapeutic. It will also address how we mitigated the signal from the therapeutic mAb in the immunogenicity assay. A core theme of this presentation will be the focus on reagent selection and bioanalytical assay strategy.
Learning Objectives:
Describe challenges associated with developing Pharmacokinetic and Immunogenicity assays for reversal agents to therapeutic compounds.
Discuss strategies for developing robust PK and ADA assays for reversal agents to therapeutic compounds.
Consider bioanalytical assay challenges for co-administered molecules.
