Paul Chamberlain, Advisory Board member and NDA Group Biopharmaceuticals Expert, has been invited to present at the eight annual Immunogenicity & Bioassay Summit, taking place October 26 – 28, 2016 in Baltimore, MD.
Paul’s presentation will reflect on how the extent of the evaluation of relative immunogenicity of closely related therapeutic proteins is strongly dependent on the nature of the product and the regulatory purpose. Directly comparative clinical evaluation is normally required for biosimilars, whereas a requirement for clinical data is exceptional in the case of manufacturing process changes for authorized products. The importance of minimization of bioanalytical bias, sensitivity of the clinical population, and duration of interventional monitoring for building an effective strategy will be highlighted.
To learn more about the event click here.
Advisory Board Member