Tracie Fradet
Team Lead, Cytogenomics, Astellas
Tracie Fradet is a skilled professional in regenerative medicine with over two decades of experience in Cytogenomics, assay development, and quality control. Since 2016, she has been a key contributor at the Astellas Institute for Regenerative Medicine (AIRM). As Team Lead of Cytogenomics, she leads genetic stability assessments for cell therapy products. Previously, as Senior Assay Development Scientist, she developed crucial assays for the Retinal Pigment Epithelial (RPE) cell therapy program. Her work directly supports innovation, regulatory filings, and the safe translation of regenerative medicine therapies to patients. In 2023, Tracie earned her MS in Regulatory Affairs, deepening her expertise in compliance and enhancing her ability to navigate the regulatory landscape for cell therapy submissions to global agencies.