Amy Fix

Ms. Fix is ILiAD’s Chief Regulatory Officer with responsibility for regulatory strategy and interactions with global regulatory agencies. Ms. Fix has over 25 years of experience in Regulatory Affairs and drug development. Since 2021, Ms. Fix led ILiAD’s regulatory strategy for BPZE1 as a consultant. Prior to joining ILiAD full-time, Ms. Fix was Chief Regulatory Officer at Vaxxinity from April 2021 through December 2023, where she led the regulatory strategy for their chronic disease vaccine portfolio and led the marketing application submissions for their COVID-19 vaccine. Before joining Vaxxinity, Ms. Fix was Senior Vice President of Regulatory Affairs and Quality at Arcellx and a Principal Regulatory Consultant for Scendea. Prior to joining Arcellx in September 2019, Ms. Fix was Senior Vice President of Regulatory Affairs and a member of the Senior Management team at Novavax, leading the development of multiple late-stage vaccine development programs, including a Phase 3 global maternal immunization clinical trial being conducted in 11 countries, and two Phase 3 older adult programs for the RSV and influenza franchises. Prior to joining Novavax in April 2013, she held positions of increasing responsibilities at Human Genome Sciences, Shire, MedImmune and Baxter and Emergent Biosolutions. During Ms. Fix’s career, she has successfully conducted numerous global regulatory meetings, and has been responsible for multiple INDs, BLAs, NDAs, and post-marketing programs, has been a key member of business development/due diligence teams, has worked with the World Health Organization on global health initiatives, and has built successful Regulatory departments from the ground up. Ms. Fix received her Bachelor of Science degree in Biology from the University of Illinois, her Master of Science degree in Molecular Biology from the University of Virginia’s Biotechnology program, and her Master of Business Administration degree in Management from Johns Hopkins University.

Copyright 2013-2024 ILiAD Biotechnologies