Julie Hagan is the Head of Regulatory Affairs at eGenesis and is responsible for regulatory strategy as well as regulatory operations and logistics across all programs.
Ms. Hagan brings 17 years of Regulatory Affairs experience in AAV gene therapies, autologous cell therapies, and monoclonal antibodies, and has spent the majority of her career working in the rare and orphan disease space. She has led a variety of successful IND applications and BLA filings to the US FDA at both CBER and CDER. In addition, she has written and submitted a variety or Orphan Drug Designation (ODD) Requests, Regenerative Medicine Advanced Therapy (RMAT) Applications, Annual Report (ARs), Special Protocol Assessment (SPA) requests, Fast Track Designation Requests, and Priority Review Designation Requests. Prior to eGenesis, Julie was the US Regulatory Lead for the Metachromatic Leukodystrophy (MLD) Program at Orchard Therapeutics, was the Head of the Regulatory Department at Apic Bio, Inc. for AAV gene therapies in both Amyotrophic Lateral Sclerosis (ALS) and alpha-1 antitrypsin deficiency, and was responsible for the successful filing of AAV gene therapy IND applications at REGENXBIO, Inc. for indications such as neovascular (wet) age-related macular degeneration (AMD) and Mucopolysaccharidosis Type I (MPS1).
Ms. Hagan was also a member of the Regulatory team at Human Genome Sciences (HGS) which led the filing of two successful BLAs for raxibacumab, an anthrax anti-toxin, and for BENLYSTA® (belimumab), a treatment for Systemic Lupus Erythematosus (SLE).
Ms. Hagan began her career in the biopharmaceutical industry at ICON, a large, international Contract Research Organization (CRO). Prior to her industry experience, Julie worked for 7 years at the Genetic Resources CORE Facility (GRCF), at the McKusick-Nathans Institute of Genetic Medicine, DNA Analysis Facility (DAF), at the Johns Hopkins University School of Medicine. There she performed oligonucleotide synthesis, DNA sequencing, SNP genotyping, and DNA extraction and isolation from whole blood and buccal swabs.
Ms. Hagan holds a B.A. from Gettysburg College in Gettysburg, Pennsylvania and an M.S. in Biotechnology from the Johns Hopkins University in Baltimore, Maryland.