Joy A. Cavagnaro

Joy A. Cavagnaro, Ph.D, DABT, ATS, RAC, FRAPS is the President of Access BIO where she consults on science-based preclinical development strategies for novel drug, biologics and device combinations. She received her Ph.D in Biochemistry from the University of North Carolina at Chapel Hill. Her career spans academia, the CRO and biotechnology industries, and government. She has co-authored numerous white papers, articles, and book chapters related to various aspects of preclinical safety assessment. During her tenure at CBER/FDA she was appointed to the SBRS and served as FDA’s safety topic lead and rapporteur for “ICH S6.” advocating the “case-by-case” rational science-based approach to preclinical safety evaluation. In 2011 she received SOT’s Biotechnology Specialty Section First Career Achievement Award and in 2019 the Society’s Arnold J. Lehman Award recognizing individuals who have made significant contributions to risk assessment and/or the regulation of chemical agents, including pharmaceuticals.She is Founder and Past Chair of the leadership committee of BioSafe, an expert preclinical science committee within BIO.