Pre-Clinical Risk Assessment Using Innovative Technologies

Biotherapeutics have been shown to be effective therapies which demonstrate significant target specificity and may confer multiple effector functions: for example receptor-blocking or -antagonism combined with target cell cytotoxicity of a monoclonal antibody. However, the use of biotherapeutics in the clinical setting has been complicated by the development of immunogenicity (anti-drug antibodies) against the therapy. While it is important to remember that the presence of ADA in patients often has no detrimental effect, there may be an impact upon PK, efficacy or even safety. Thus numerous pre-clinical models have been developed with the aim to better understand mechanisms involved in immunogenicity induction and to use this information to reduce the risk of immunogenicity. Technologies, including MHC-associated peptide proteomics and novel in vivo models will be compared and contrasted in this talk, with their potential uses and limitations discussed.
Heather Hinton is the head of ImmunoSafety at F. Hoffmann La Roche where, in addition to assessing and mitigating immunosafety liabilities of therapeutics, she has an interest in the immunogenicity of biotherapuetics. Heather obtained her PhD in Pharmacy and Pharmacology from the University of Bath, followed by a PostDoc at Cancer Research UK and the University of Dundee working in adaptive immunity. Following this she moved to a small biotech company specializing in therapeutic vaccines development, where her involvement in safety of therapeutics was initiated.