Joy Cavagnaro, PhD, DABT

Joy Cavagnaro, PhD, DABT

Joy Cavagnaro, PhD, Diplomate of the American Board of Toxicology (DABT), Fellow of the Academy of Toxicological Sciences (ATS),  Regulatory Affairs Certification (RAC) Fellow of the Regulatory Affairs Professionals Society (RAPS) is the President of Access BIO.

Her career spans academia, the Contract Research Organization (CRO) and biotechnology industries, and government. During her tenure at the Center for Biologics Evaluation at the Food & Drug Administration (CBER/FDA) she was appointed to the Senior Biomedical Research Service (SBRS), served as FDA’s  International Council for Harmonisation (ICH) safety topic lead and rapporteur for Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals ( ICH S6).  Before joining the FDA, Dr. Cavagnaro was principal study director for biotechnology products at Covance.  Prior to founding Access BIO, Dr. Cavagnaro was Vice President of Regulatory Affairs and Quality Assurance at Human Genome Sciences.

Dr. Cavagnaro is Past Chair of Regulatory Affairs Professionals Society (RAPS) and the National Capital Area Chapter of Society of Toxicology (SOT).  She is a past councilor of the Biotechnology Specialty Section of the SOT, where she was recipient of the section's first Career Achievement Award.  She is Founder, Past Chair and ex-officio member of the leadership committee of BioSafe, an expert preclinical science committee within the  Biotechnology Innovation Organization (BIO). She is Past North American Chair of the Drug Information Association (DIA)’s Biotech Community and Research and Development Liaison to the Atlanta Center for Nutrient Analysis (ACNA) Executive Committee.  She is Past Chair and current member of the Clinical and Regulatory Affairs Committee and past member of the Translational Science & Product Development Committee of the  American Society of Gene & Cell Therapy (ASGCT). She was the BIO representative to the 2006 Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) Early Stage Clinical Trials Taskforce.  

Dr Cavagnaro is currently a Chair of Chesapeake Research Review, Inc. (CRRI), an independent Institutional Review Board (IRB). Dr. Cavagnaro serves on many scientific advisory boards and consults and lectures internationally. She has also edited and authored chapters in 'the BioBible'Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials published by John Wiley & Sons, NJ.


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