Dr. Anette Karle is a seasoned expert in the immunogenicity field. She acquired her PhD in 2008 on the topic of altered antigen presentation in nitrated pollen allergens, applying the MAPPs technology. Joining Novartis in 2009, she pioneered the establishment of technologies for assessing the immunogenicity potential of compounds, thereby facilitating design and selection of candidates in drug discovery, as well as increasing the comprehension of immunogenicity determinants. As immunogenicity expert she is leading several immunogenicity-related cross-functional teams at Novartis and is member of several external consortia and expert teams.
Evaluating the immunogenicity potential of biotherapeutics is becoming increasingly important and challenging at the same time. The presentation will provide an overview over how Novartis is conducting immunogenicity potential assessment from the design space to the clinics. Categories and elements of this assessment will be presented, for example the mode of action of the drug, similarity to endogenous proteins, critical quality attributes or the immune status of the patient. The presentation will cover the immunogenicity risk assessment questionnaire as well as different types of assays which can be applied to support the selection of biotherapeutic candidates and to understand mechanistic root causes of immunogenicity.