Joy A. Cavagnaro, PhD, DABT, Fellow ATS

Joy Cavagnaro is the President of Access BIO where she consults on science-based 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 rapporteur for “ICH S6.” She was the first to advocate the “case-by-case” rational science-based approach to preclinical safety evaluation. Dr. Cavagnaro is Past Chair of RAPS and the National Capital Area Chapter of SOT. In 2011 she received SOT’s Biotechnology Specialty Section First Career Achievement Award and in 2019 the Arnold J. Lehman Award. She is Founder, Past Chair and 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 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.

Dr. Cavagnaro is currently a member of Advarra, an independent IRB. She serves on multiple SAB’s and 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. 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”. “Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals” CRC Press/Taylor&Francis Group publisher is anticipated late 2021.