Mike Labruto MS University of Pennsylvania/Gene Therapy Program

Michael LaBruto (Mike) is Quality Executive Director for the Gene Therapy Program at the University of Pennsylvania. Mike is responsible for the Quality Assurance organization supporting GXPs in the discovery, development and commercialization of genetic based therapeutics. Prior to his role at the Gene Therapy Program(GTP), Mike has worked for GSK Pharma, GSK Biopharmaceuticals, GSK-Vaccines, Elan Pharmaceuticals and Amersham Health in Quality Assurance, Quality Control, Analytical Chemistry, and GMP manufacturing departments. He has been directly responsible for development of cGMP Quality Systems, including Risk Management and Deviation investigation systems in both small molecule, biologics, and Cell & Gene Therapy pharmaceutical facilities. He has also been responsible for managing numerous regulatory inspections, writing and developing local and global policies, authoring CMC sections of regulatory submissions, and the successful launch of new drug and biological products. Mike is also an adjunct professor at Temple University School of Pharmacy teaching graduate courses in Pharmaceutical Management. He holds a BS degree in Biology (minor in Chemistry) from Liberty University and a MS degree in QA/RA from Temple University.