Andrea Mislak, Ph.D.

Senior Director, Analytical and Formulation Sciences at KBI Biopharma

Speaker

Andrea Mislak is a Senior Director of Analytical and Formulation Sciences at KBI Biopharma where she leads a multidisciplinary team supporting formulation development, the design and execution of ICH-compliant method qualifications, validations, and transfers, biophysical characterization and comparability studies, and QC release and stability testing in support of Phase I through Commercial large-molecule manufacturing campaigns. With nearly 20 years of experience in the pharmaceutical industry, Andrea brings deep expertise spanning small molecule drug discovery and development, drug metabolism and pharmacokinetics, and novel modality biologics development and testing. Prior to KBI, Andrea was a research chemist in Drug Metabolism and Pharmacokinetics at Merck Research Laboratories in Boston, where she conducted small molecule analysis using LC-MS/MS in biological matrices to support in vivo PK/PD studies and in vitro ADME assays. Andrea joined KBI Biopharma in 2016 after completing her Ph.D. at Yale University in Pharmacology with a certificate in Regulatory Affairs. She also holds a Batchelor’s degree in Biochemistry and Molecular Biology from Boston University.