Immunogenicity & researc Summit 2014 (Optimizing Bioassays for Biologics )

In biologics drug development, a reliable bioassay is crucial to the approval of the final product. However, when developing new drugs, a lack of data on the relevant mechanism-of-action can slow progress. This can become especially complex with new biologic modalities such as bispecifics and antibody drug conjugates. At Cambridge Healthtech Institute’s Second Annual Optimizing Bioassays for Biologics conference, industry leaders will showcase strategies for assay selection, validation, transfer, and maintenance with an emphasis on molecules with multiple mechanisms. Health authorities will weigh in on new guidelines as well as provide insight into what they consider a well-characterized biologic. Finally, new technologies and bioassay formats will be presented along with recommendations for implementation to ensure a steady drug development pipeline.