Assessing immunogenicity risk in biotherapeutic development

Protein therapeutics may elicit unwanted immune responses in some subjects, and this can compromise product safety. This talk will discuss some of the causes and consequences of unwanted immune responses to biologics. The talk will also review what tools, technologies and data sets may be deployed to assess immunogenicity and to enable informed decision making during biotherapeutic product and process development.
Valerie Quarmby is a Staff Scientist in the Department of BioAnalytical Sciences at Genentech. At Genentech, Dr. Quarmby has developed bioanalytical methods & strategies to enable IND, BLA and related filings for: Nutropin, Xolair, Raptiva, Rituxan, Avastin, Lucentis, Perjeta, Kadcyla and Tecentriq. She has also developed bioanalytical methods, platforms and strategies for many of the therapeutic proteins in the gRED drug development pipeline. Valerie also consults on bioanalytical and related strategies across the Roche group. She is the past Chair of the AAPS Therapeutic Protein Immunogenicity Focus Group and a member of the 2010-2015 USP Immunogenicity Testing Expert Panel. Valerie is the co-author of several AAPS sponsored industry guidance documents and many publications in peer-reviewed journals. Valerie Quarmby holds a Ph.D. in Hormone Physiology from the Imperial Cancer Research Fund and the University of London in England. Dr. Quarmby was a Postdoctoral Visiting Fellow at the US National Institutes of Health, and then joined the Laboratories for Reproductive Biology and the Department of Pediatric Endocrinology at UNC-Chapel Hill. Prior to joining Genentech, Dr. Quarmby worked in the field of clinical diagnostics at Bio-Rad Laboratories and at Endocrine Sciences/Esoterix. In 2014, in recognition of her many contributions to the pharmaceutical industry, Dr. Quarmby was awarded AAPS Fellow Status.