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Dr Cavagnaro is the President of Access BIO where she consults on science-based preclinical development strategies for novel drug, biologics and device combinations. With a PhD in Biochemistry from the University of North Carolina at Chapel Hill, her career spans academia, the CRO and biotechnology industries, and government. 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.” She was the first to advocate 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. She is a Past Chair of the Clinical and Regulatory Affairs Committee and Translational Science & Product Development Committee of the ASGCT. She was a member of the NTP Scientific Advisory Committee on Alternative Toxicological Methods and is an advisor and member of the Grants Working Group of the California Institute of Regenerative Medicine. Dr Cavagnaro also serves on multiple SAB’s, including Odylia Therapeutics a non-profit corporation devoted to moving ultra-rare inherited retinal diseases ‘from science to humans’, and consults and lectures internationally on translation and risk assessment of novel therapies. She is a past chair of CRRI, an independent investigational review board and is currently a member of Advarra IRB. She has co-authored numerous white papers, articles and book chapters related to various aspects of preclinical safety assessment. The book she edited “Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials” published by John Wiley & Sons, NJ, 2008, is commonly referred to as the “BioBible”. The sequel has just published “Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals- Joy A. Cavagnaro and Mary Ellen Cosenza, eds., CRC Press, 1st Edition, 2021.