An Introduction to Bioanalysis of Biopharmaceuticals

Seema Kumar is currently Director and senior DMPK lead at EMD Serono Inc. (a business of Merck KGaA, Germany). In her role, Dr. Kumar leads the Clinical Bioanalytical Sciences group that provides Bioanalysis (BA), Immunogenicity and DMPK support for clinical stage large molecule portfolio. Additionally as a senior DMPK lead, Dr. Kumar provides overall drug disposition support for large molecules spanning across discovery and development stages of the program. Previously, Dr. Kumar led regulated Bioanalytical group in BioMedicine Design (formerly PDM) at Pfizer. The group provided regulated (GLP/GCP) BA support including assay development, validation and sample analysis for PK and Immunogenicity (ADA and Nab) assessment of Pfizer’s large molecule portfolio. Prior to joining Pfizer, Dr. Kumar served at roles of increasing responsibility as Director of Quality Control and Director of CLIA certified Clinical Bioanalytical Lab at XBiotech USA Inc.

Dr. Kumar holds a Ph.D. from Johns Hopkins University and has published several publications in peer-reviewed journals and contributed to several book chapters. Dr. Kumar has given numerous invited talks in various national and international scientific conferences and meetings and is an active member of industry consortia (IQ, AAPS etc.)..