Kurt Brorson, Ph.D.

Kurt has 26 years’ experience with FDA in CBER and CDER in CMC review, facility assessment & compliance (including pre-approval inspections) for BLAs, DMFs, and INDs. He also managed a highly productive and well-respected lab-based program project focused on viral safety of biotechnology medicinal products.

Work experience

Prior to joining Parexel, Kurt was a Lab Chief (GS-15) for CDER/OPQ/Office of Biotechnology Products (OBP) at the FDA. He has experience developing FDA internal policies and training, external guidances, and MaPPs. He has expert knowledge of ICH Guidelines, PHS Act, FD&C Act, 21 CFR 210, 211, 212, 314, 601 and other FDA regulations. He also assisted external organizations in conference planning and writing of technical reports on highly specialized topics germane to bioprocessing and biopharmaceuticals. He is widely considered to be a world-class expert in viral clearance during bioprocessing and viral safety of biopharmaceuticals.

Education

Kurt received his B.A. in Biology from University of Chicago (Chicago IL) in 1984 and Ph.D. in Molecular Biology from California Institute of Technology (Pasadena CA) in 1990.