Larimartx
Spring House
Dr. Shankar 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 executive MBA from Drexel University.
Following a brief post-doctoral tenure, he managed Quality Control & Immune Monitoring at Northwest Biotherapeutics (Seattle, WA) from 1999 to 2002. He then joined Centocor (Malvern, PA) as a Senior Research
Scientist overseeing clinical immunogenicity and methods development. Subsequently he assumed progressively greater responsibilities for immunogenicity and the bioanalytical laboratory (including PK, target
engagement, and immunogenicity bioanalysis) supporting biologics development at Janssen (Spring House, PA) - from preclinical through post-market studies. In his most recent position (2018-2022) he was Vice
President and Head of Biologics Development Sciences within Janssen BioTherapeutics, Johnson & Johnson’s biotechnology division. He led a global department of about 175 scientists who contributed to scientific and
operational deliverables associated with discovery and preclinical development such as analytical characterization, developability, translational PK/PD, bioanalytical sciences and GLP compliance.
Dr. Shankar is a globally recognized subject matter expert in the field of immunogenicity and has published in the areas of basic immunological research, 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 entire career, he has focused on the development of fit-for-purpose solutions to scientific problems, operational inefficiencies, and regulatory gaps. He has built consensus for and harmonized scientific practices within drug development, many of which have been adopted by regulatory agencies in their 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, analysis, and labeling for clinical immunogenicity. His research, consensus-building efforts and best-practice publications, both independently and via the American
Association of Pharmaceutical Scientists (AAPS), have transformed the thinking and tactical processes related to immunogenicity around the globe. He is also an Adjunct Professor at the University of Tennessee Health Sciences Center. For his contributions to pharmaceutical science, he was conferred AAPS Fellow status in 2015. Dr. Shankar is now the President-Elect and shall serve as President for the 2023-2024 term in AAPS (an end-to-end pharmaceutical sciences society with 7000+ members).
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Tuesday, May 14, 2024
3:30 PM – 4:30 PM PT