Joy Cavagnaro, PhD, DABT, Fellow ATS

Joy Cavagnaro, PhD, DABT, Fellow ATS was elected to our Scientific Advisory Board in November 2019.

Dr. Cavagnaro is the President of Access BIO where she consults on science-based preclinical development strategies for novel drug, biologics and device combinations. 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 was the 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 which recognizes 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 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 served on the Steering Committee of the NGVL. She was a member of the NTP Scientific Advisory Committee on Alternative Toxicological Methods and is currently an advisor and member of the Grants Working Group of the California Institute of Regenerative Medicine. She also served as Chair of the Board of the Regulatory Affairs Profession Society. She currently serves on multiple SAB’s. Dr. Cavagnaro consults and lectures internationally on translation and risk assessment of novel therapies. She has co-authored numerous white papers and chapters related to various aspects of preclinical safety assessment. Dr. Cavagnaro was an author and edited “Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials” published by John Wiley & Sons, NJ, 2008, which is commonly referred to as the “BioBible”.

Dr. Cavagnaro holds a PhD in Biochemistry from the University of North Carolina, and a BS in Biology from the University of Miami.