Athena RussellGene Therapy CMC/Product Reviewer at FDA CBER Office of Therapeutic ProductsSpeaker
Profile
Athena Russell is a cell and gene therapy scientist and regulatory reviewer with 19 years of experience spanning research, product and process development, cGMP manufacturing, analytical development, and regulatory oversight. She currently serves as a CMC reviewer in the U.S. FDA’s Center for Biologics Evaluation and Research, where she reviews ex vivo gene-modified cellular therapies across the product lifecycle and advises on manufacturing, analytical characterization, assay validation, comparability, and product quality. Her prior experience includes managing product development and IND-enabling programs at the University of Pennsylvania Center for Cellular Immunotherapies and developing and manufacturing investigational cellular therapies at Mayo Clinic.