Joy Cavagnaro, PhD, DABT, Fellow ATS, RAC, RAPS Fellow
Joy Cavagnaro is the President of Access BIO where she consults on development strategies and therapeutic safety 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 Senior Biomedical Research Service and served as FDA’s safety topic lead and rapporteur for “ICH S6.” She was the first to advocate the “case-by-case” science based approach to preclinical safety evaluation which is consistent with traditional principles but embraces new practices, is questions-based, data driven and targeted based on product attributes. The approach is designed to obtain maximum information with judicious animal use. Prior to joining FDA, Dr. Cavagnaro was principal study director for biotechnology products at Covance (formerly Hazleton Labs).
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. She is Founder, Past Chair and current ex officio member of the leadership committee of BioSafe, an expert preclinical science committee within BIO. She is Past North American Chair of DIA’s Biotech SIAC and current Research and Development SIAC Liaison to the ACNA Executive Committee. Dr Cavagnaro was the US BIO representative to the 2006 ABPI/BIA Early Stage Clinical Trials Taskforce. She is Past Chair and current member of the Clinical and Regulatory Affairs Committee and Translational Science & Product Development Committee of the ASGCT. She is also currently a member of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) and a reviewer and advisor to the California Institute of Regenerative Medicine. Dr. Cavagnaro is a Chair of CRRI, 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 is commonly referred to as the “BioBible”.
During her tenure at CBER/FDA she was appointed to the Senior Biomedical Research Service and served as FDA’s safety topic lead and rapporteur for “ICH S6.” She was the first to advocate the “case-by-case” science based approach to preclinical safety evaluation which is consistent with traditional principles but embraces new practices, is questions-based, data driven and targeted based on product attributes. The approach is designed to obtain maximum information with judicious animal use. Prior to joining FDA, Dr. Cavagnaro was principal study director for biotechnology products at Covance (formerly Hazleton Labs).
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. She is Founder, Past Chair and current ex officio member of the leadership committee of BioSafe, an expert preclinical science committee within BIO. She is Past North American Chair of DIA’s Biotech SIAC and current Research and Development SIAC Liaison to the ACNA Executive Committee. Dr Cavagnaro was the US BIO representative to the 2006 ABPI/BIA Early Stage Clinical Trials Taskforce. She is Past Chair and current member of the Clinical and Regulatory Affairs Committee and Translational Science & Product Development Committee of the ASGCT. She is also currently a member of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) and a reviewer and advisor to the California Institute of Regenerative Medicine. Dr. Cavagnaro is a Chair of CRRI, 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 is commonly referred to as the “BioBible”.