Current challenges in assessing immunogenicity

Biography Gopi Shankar is a Vice President at Janssen BioTherapeutics, the biotechnology discovery and development unit of Janssen Research & Development, LLC (one of the Pharmaceutical Companies of Johnson & Johnson). His department of approximately 150 scientists is responsible for characterizing biophysical and pharmacological parameters of biologic molecules for discovery and for developing preclinical projects through first-in-human trials by determining pharmacokinetics, toxicokinetics, target pharmacodynamics, starting dose and projected efficacious dose recommendations. The department also provides analytical and bioanalytical results for Janssen's clinical trials of biologics. Throughout his entire career, Dr Shankar has focused on the development of innovative solutions to scientific hurdles, developed consensus and harmonized scientific practices. A renowned expert in the field of immunogenicity and a Fellow of the American Association of Pharmaceutical Scientists (AAPS), Dr Shankar has led or contributed to several highly impactful scientific advances in immunogenicity; his research, consensus-building efforts and best-practice publications have transformed the thinking and tactical processes related to clinical immunogenicity.