Julie Block
About Julie Block
Julie Block serves as the Director of CMC Regulatory Compliance at Abeona Therapeutics, bringing extensive experience in clinical trial material management and pharmaceutical process manufacturing. With a background in biomedical engineering and a strong foundation in research and development, she has held various roles in the pharmaceutical industry, including positions at Medtronic and Buckman Laboratories.
Work at Abeona Therapeutics
Julie Block serves as the Director of CMC Regulatory Compliance at Abeona Therapeutics since 2020. In this role, she oversees compliance with regulatory requirements related to Chemistry, Manufacturing, and Controls (CMC) for the company’s therapeutic products. Her responsibilities include ensuring that all processes meet the standards set by regulatory authorities, which is critical for the successful development and approval of new therapies.
Education and Expertise
Julie Block earned a Bachelor of Science degree in Chemistry from Rhodes College, where she studied from 1990 to 1994. Her educational background provides a solid foundation for her expertise in Clinical Trial Material Management and Pharmaceutical Process Manufacturing. She combines her knowledge of chemistry with practical experience in the pharmaceutical industry, focusing on the development and compliance of clinical materials.
Background in Pharmaceutical Industry
Julie Block has extensive experience in the pharmaceutical industry, having worked in various roles over two decades. She began her career as a Laboratory Technician at Valvoline from 1994 to 1997. She then transitioned to Buckman Laboratories as an Analytical Chemist, where she worked for 11 years. Her tenure at Medtronic Spine & Biologics included positions as a Senior Scientist, Principal Scientist, Program Manager, and Technical Fellow, spanning from 2008 to 2018.
Experience with Regulatory Compliance
Julie Block has significant experience working with the U.S. Food and Drug Administration (FDA), which highlights her involvement in regulatory compliance within the pharmaceutical sector. Her roles have required her to ensure that products meet FDA standards, a critical aspect of the drug development process. This experience is particularly relevant to her current position at Abeona Therapeutics, where regulatory compliance is a key focus.
Achievements in Research and Development
Julie Block has a strong foundation in Research and Development (R&D), indicating her involvement in the innovation and development of new pharmaceutical products. Her expertise in Clinical Trial Material Management and Pharmaceutical Process Manufacturing supports her contributions to R&D efforts, ensuring that new therapies are developed efficiently and in compliance with regulatory standards.