Robin Walsh is currently a Sr. Principal Toxicologist in the Toxicology Department at Eli Lilly and Company. She received her Master of Science in Molecular Biology and Biochemistry from Northeastern Illinois University. At Lilly, she is responsible for the development of and testing the CD4 T cell proliferation assay for the preclinical immunogenicity risk assessment of therapeutic antibodies. She is part of a team responsible for the preclinical immunogenicity risk assessment at Lilly. Robin is certified by the ASCP in Flow Cytometry and is an active member of AAPS. She serves as a Secretary of the AAPS Immunogenicity Risk Assessment and Mitigation Working Group within the Therapeutic Product Immunogenicity Focus AAPS Community, where she also serves as the Education Liaison
Understanding immunogenicity of biologics is a key part of preclinical development. The performance of an immunogenicity risk assessment at the earliest stages of product development can be beneficial for early decision making. CD4 T cell assays can be used to interrogate biologics for potential clinical immunogenicity. In this presentation, we will talk about how CD4 T cell assays can be an integral part in an weight of evidence approach for immunogenicity risk assessment.