Isabella Palazzolo

Dr. Isabella Palazzolo is a Senior Director of Regulatory Affairs CMC at Intellia Therapeutics, where she serves as the CMC strategy lead for NTLA-2002 (lonvoguran ziclumeran) — the first ever in vivo CRISPR-based genome editing therapy to reach marketing application stage. She has lead the program from Phase 1 to now, through multiple agency interactions and milestones including the opening of the IND, and global clinical amendments. She led Intellia's participation in FDA's CBER CMC Development and Readiness Pilot (CDRP) program, driving an unprecedented series of three CMC-focused Type B meetings with senior FDA reviewers in a single calendar year in preparation for the company's first-ever BLA submission. Dr. Palazzolo brings almost 15 years of industry experience spanning genome editing, AAV-based gene therapy, biologics, and combination products, complemented by 8 years of academic research in neuroscience, cell biology, and molecular biology. Prior to Intellia, she held progressive regulatory CMC roles at Biogen and Eli Lilly and Company. She is an active contributor to regulatory policy and industry forums, currently serving as Associate Director to CASSS, and has previously participated in BPOG regulatory workstreams, ARM CMC Task Force initiatives, and served as a roundtable facilitator and session chair at major industry conferences. Dr. Palazzolo holds a Ph.D. in Endocrinology and Metabolism from the University of Milan in partnership with the National Institutes of Health (NIH), Bethesda, and a M.S. in Pharmaceutical Biotechnologies from the University of Milan.