Kurt Brorson, Ph.D.
Parexel International
Vice President, Technical
Regulatory and Access
Kurt Brorson, Ph.D. is Vice President, Technical at Parexel International in the Regulatory Consulting Services group (RCS). At Parexel, Kurt provides a full range of consulting services for the quality of biopharmaceuticals, with specific expertise in biomanufacturing, biotech product quality and risk-mitigation, biosimilars, transition products and viral safety/viral clearance. He also acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined. Strategist known for inspirational leadership and successful oversight of cross-functional teams engaged in consulting, regulatory services and compliance improvement initiatives. Engaged in constant industry standards ideation and creation, technical report building, and program development that educated the whole industry.
Prior to joining Parexel, Dr. Brorson was a Lab Chief in CDER/OPQ/Office of Biotechnology Products (OBP) at the FDA, with 26 years in the Agency. At the FDA, he was a reviewer, inspector and laboratory scientist, running a mission-focused research program project widely considered to be world-class in virus retentive filtration and viral safety of biotech products. Dr. Brorson received his B.A. in Biology from the University of Chicago (Chicago, IL) in 1984 and his Ph.D. in Molecular Biology from the California Institute of Technology (Pasadena, CA) in 1990.
Regulatory and Access
Kurt Brorson, Ph.D. is Vice President, Technical at Parexel International in the Regulatory Consulting Services group (RCS). At Parexel, Kurt provides a full range of consulting services for the quality of biopharmaceuticals, with specific expertise in biomanufacturing, biotech product quality and risk-mitigation, biosimilars, transition products and viral safety/viral clearance. He also acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined. Strategist known for inspirational leadership and successful oversight of cross-functional teams engaged in consulting, regulatory services and compliance improvement initiatives. Engaged in constant industry standards ideation and creation, technical report building, and program development that educated the whole industry.
Prior to joining Parexel, Dr. Brorson was a Lab Chief in CDER/OPQ/Office of Biotechnology Products (OBP) at the FDA, with 26 years in the Agency. At the FDA, he was a reviewer, inspector and laboratory scientist, running a mission-focused research program project widely considered to be world-class in virus retentive filtration and viral safety of biotech products. Dr. Brorson received his B.A. in Biology from the University of Chicago (Chicago, IL) in 1984 and his Ph.D. in Molecular Biology from the California Institute of Technology (Pasadena, CA) in 1990.