Joann Parker BS, MS

Parker has Extensive experience in the regulatory CMC area involving biological products including gene therapy, cell based therapies, devices and small molecules for global development for investigational through registration products. Successful prosecution and development of strategies to guide CMC development resulting in investigational, commercial registrations and technical files. Managerial responsibilities for multiple staff including for remote colleagues. Direct health authority interactions including scientific advice, pre-submission and pre-approval inspections.