Joy Cavagnaro
Regulatory Consultant
Joy Cavagnaro is the President of Access BIO, where she consults on science-based preclinical development strategies for novel drugs, 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 acting as the rapporteur for “ICH S6.” Joy was the first to advocate the “case-by-case” rational science-based approach to preclinical safety evaluation, setting a precedent in the field.
In recognition of her contributions, Joy received SOT’s Biotechnology Specialty Section First Career Achievement Award in 2011 and the Society’s Arnold J. Lehman Award in 2019, which recognizes individuals who have made significant contributions to risk assessment andthe regulation of chemical agents, including pharmaceuticals. She is Founder and past Chair of BioSafe, an expert preclinical science committee within BIO. She is also a past Chair of ASGCT’s Clinical and Regulatory Affairs Committee and Translational Science & Product Development Committee. Joy also served on the Steering Committee of the NGVL and was a member of the NTP Scientific Advisory Committee on Alternative Toxicological Methods.
Currently, Joy is an advisor and member of the Grants Working Group of the California Institute of Regenerative Medicine, Chair of the Board of the Regulatory Affairs Profession Society, and multiple Scientific Advisory Boards.
Joy 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 and authored and edited the widely-recognized “Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials,”, which is commonly referred to as the “BioBible”.
Joy holds a Ph.D. in Biochemistry from the University of North Carolina and a BS in Biology from the University of Miami.
In recognition of her contributions, Joy received SOT’s Biotechnology Specialty Section First Career Achievement Award in 2011 and the Society’s Arnold J. Lehman Award in 2019, which recognizes individuals who have made significant contributions to risk assessment andthe regulation of chemical agents, including pharmaceuticals. She is Founder and past Chair of BioSafe, an expert preclinical science committee within BIO. She is also a past Chair of ASGCT’s Clinical and Regulatory Affairs Committee and Translational Science & Product Development Committee. Joy also served on the Steering Committee of the NGVL and was a member of the NTP Scientific Advisory Committee on Alternative Toxicological Methods.
Currently, Joy is an advisor and member of the Grants Working Group of the California Institute of Regenerative Medicine, Chair of the Board of the Regulatory Affairs Profession Society, and multiple Scientific Advisory Boards.
Joy 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 and authored and edited the widely-recognized “Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials,”, which is commonly referred to as the “BioBible”.
Joy holds a Ph.D. in Biochemistry from the University of North Carolina and a BS in Biology from the University of Miami.