Presentation Description: Several risk factors are implicated in development of immune response in clinic and mitigation approaches are available. An adoption of Quality by Design strategies has led to substantial improvements in quality The genetic variability of the patient population can explain why some individuals, racial and/or ethnic groups or other subpopulations develop inhibitory antibodies at a higher frequency than others. Hence, the immunogenicity risk can be personalized using HLA of a subject. The genomic association with immunogenicity risk can reduce the uncertainty around impact of immunogenicity. We obtained HLA information from naïve subjects and their immune cell functional outputs when challenged with therapeutic proteins with known T cell epitope content. An algorithm based analysis was performed on the sequence to correlate to the functional assay outputs and HLA. This information from preclinical assessment can drive the stratification of subjects when impact of immunogenicity on PK and PD is performed in clinic.
Learn how to use the algorithms and preclinical immune assays to understand risk of pharmacogenomic markers like HLA on immune response
The participant will be able to learn how to collect HLA information in clinical trials
Associate the pharmacogenomics information with disposition for immune mediated adverse events