“The Gene Therapy Program is paving the way for the development of innovative therapies and helping improve the lives of patients with rare diseases. Now is the time to advance these novel therapeutics using a 'Right First-Time' approach, and I couldn’t be prouder to be part of that effort.”
In his current role at the Gene Therapy Program at the University of Pennsylvania (GTP), Mike leads a team responsible for managing Quality Assurance activities that support the development and commercialization of novel genetic based therapeutics. Mike has more than 20 years of experience in the development and implementation of cGMP Quality Systems, supporting both small molecule and biologic manufacturing and testing facilities. Prior to joining GTP, Mike spent 15 years at GSK where he held a variety of senior leadership roles within Quality Assurance.
Most recently, Mike served as the Executive Director of Quality for the One Pharma Supply Chain, including R&D Operations. Mike currently serves on the PDA/FDA planning committee supporting the annual joint regulatory conference. He holds a bachelor's degree in Biology with a minor in Chemistry from Liberty University and a master's degree in QA/RA from Temple University. Mike is also an adjunct professor at Temple University's School of Pharmacy where he teaches graduate courses in Pharmaceutical Management.