Former Senior Biomedical Research Service Scientist at CBER/FDA and FDA safety topic lead and rapporteur for ICH S6.
International expert in preclinical development and translational safety evaluation of biopharmaceuticals. She pioneered the science-based “case-by-case” framework that underlies modern nonclinical safety assessment. Her leadership spans key roles in major regulatory and gene and cell therapy organizations, including Founder and Past Chair of BioSafe within BIO, Past Chair of RAPS, and senior positions within ASGCT. She serves on national and international advisory bodies and chairs Chesapeake Research Review, an independent IRB. Dr. Cavagnaro is a widely published author and editor of Preclinical Safety Evaluation of Biopharmaceuticals, regarded as the “BioBible.”