Lynn E. Bayless

Lynn E. Bayless joined Mustang Bio as Head of Regulatory Affairs in 2020. Ms. Bayless has over 19 years of global regulatory experience in the biopharmaceutical industry focusing solely on biologics, including gene therapies, for orphan genetic diseases. She is accomplished in the development and execution of innovative global regulatory strategies covering all stages of product development: proof-of-concept through commercialization and post-approval life cycle management. Prior to joining Mustang, Ms. Bayless was the Senior Director, Regulatory Affairs at Nightstar Therapeutics (Biogen), where she was responsible for the Phase 3 global development program for choroideremia, and the Director, Regulatory Affairs at Voyager Therapeutics, where she was responsible for the lead development programs for Parkinson’s Disease and ALS and supported the successful filing of a 510(k) application. Ms. Bayless also held multiple leadership positions over her 11 year tenure at Shire Human Genetic Therapies (Shire) where, in addition to supporting multiple global development programs, she successfully led the clinical and nonclinical regulatory strategy which resulted in the global launch of VPRIV® for the treatment of Gaucher disease and was a key contributor in obtaining global registrations for Elaprase® for Hunter syndrome. Ms. Bayless received her M.S. in Regulatory Affairs and Health Policy from Massachusetts College of Pharmacy and Health Sciences and a B.S. degree from Quinnipiac University in Laboratory Animal Technology/Pre-Veterinary Medicine and a minor in Microbiology.