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Gopi Shankar, M.B.A., Ph.D.



Gopi Shankar, M.S., Ph.D., MBA, FAAPS, is Vice President and Head of Biologics Development Sciences (BDS) within Janssen BioTherapeutics (JBIO), Janssen Research & Development (JRD). He leads a global team of scientists who contribute to scientific and operational deliverables across the areas of biophysics, translational pharmacology and model-guided drug design, and bioanalytical sciences. He is based in Spring House, PA. 

Gopi earned an M.S. in Molecular Biology from Oklahoma State University, a Ph.D. in Immunology from University of Kentucky, a Certificate in Biomedical Regulatory Affairs from the University of Washington, and an MBA in Leadership and General Management from Drexel University. Following a post-doctoral tenure, he managed Quality Control & Immune Monitoring at Northwest Biotherapeutics (Seattle, WA) from 1999 to 2002. He then joined Centocor as a Senior Research Scientist overseeing clinical immunogenicity. Subsequently he assumed progressively greater responsibilities for immunogenicity and the bioanalytical laboratory, supporting biologics development at JRD – from preclinical through post-market studies.

A world-renowned expert in the field of immunogenicity, Gopi has published in the areas of basic immunological research and technical, strategic and regulatory best practices. He has led or contributed to several highly cited articles on immunogenicity, including 6 industry whitepapers and a chapter in the United States Pharmacopeia.

During his career, Gopi has focused on the development of fit-for-purpose solutions to scientific problems. He has also built consensus for and harmonized scientific practices within drug development, many of which have been adopted by regulatory agencies in their public scientific guidance documents. These approaches include anti-drug antibody detection methods development and validation, resolution of assay interferences to improve accuracy, quality control of bioanalytical reagents, and the establishment of terminology and analytical approaches for clinical immunogenicity. His research, consensus-building efforts and best-practice publications, both independently and via AAPS, have transformed the thinking and tactical processes related to immunogenicity around the globe.

For his contributions to pharmaceutical science, the American Association of Pharmaceutical Scientists (AAPS) conferred Fellow status to him in 2015. In 2019, he was elected as a Member-at-Large to serve on the AAPS Board of Directors