2018 PharmSci 360
SEPARATE FEE AND REGISTRATION REQUIRED.
The detection, characterization and interpretation of Anti-Drug-Antibodies (ADA) formed in response to biotherapeutics are greatly influenced by the data evaluations methods used during pre-study validation and in-study sample analysis. Despite several white-paper publications and guidance documents over the past decade, there are significant gaps in the understanding and implementation of appropriate data analytic methods across the entire spectrum of Immunogenicity method development, validation, implementation and clinical impact assessments.
This short course will provide an overview of regulatory expectations and experience with data reviews, in-depth statistical guidance for a broad range of topics, case-study illustrations of some common challenges, along with a demo of some simple data analysis templates/tools.