Dr. Joy A. Cavagnaro has been awarded the 2019 SOT Arnold J. Lehman Award as a testament to her position at the leading edge of the field of safety evaluation of biotherapeutics.
Dr. Cavagnaro is a graduate of the University of North Carolina at Chapel Hill, where she earned her PhD in biochemistry. She has had a prestigious career at a variety of scientific entities, including the US Food and Drug Administration (US FDA) and Covance Inc. (previously Hazelton Laboratories America, Inc.). Currently, Dr. Cavagnaro is the president of Access BIO, L.C., a consultancy she founded that focuses on product development via science-based approaches.
Dr. Cavagnaro’s early contributions to the field of biopharmaceutical safety assessment formed the basis for all subsequent testing in this area. In the 1990s, when existing International Conference on Harmonization (ICH) Safety Guidelines proved insufficient to apply to biotechnology-derived therapeutics, Dr. Cavagnaro’s work was instrumental in the development of the ICH S6 guidance, “Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.” Indeed, at the US FDA, Dr. Cavagnaro had already executed a vision for how to carry out safety characterization for biotechnology-derived therapeutics through science-based, case-by-case evaluation of each new entity, a concept that became the foundation of ICH S6. This guideline was unique in its emphasis on the science as the driver for the appropriate safety assessment, and Dr. Cavagnaro served as the rapporteur for this guidance. The principles of ICH S6 have supported the progression and evolution of biotherapeutics as a field, including the translation of novel cell and gene-based therapies into the clinic, while advocating for the concept of pharmacologic relevance and consequently furthering the 3Rs principle of animal welfare. She is the founder and currently an ex officio member of BioSafe, an international group of biotechnology experts that advise other scientists in industry and regulatory agencies, which highlights Dr. Cavagnaro’s unceasing energy to advance the field that was shaped so heavily by her early efforts.
Dr. Cavagnaro’s work on the preclinical safety of and development strategies for biopharmaceuticals has been widely published, in the form of peer-reviewed articles and book chapters. She also was the editor of this subject’s foremost book, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials. She has been a member of SOT since 1986 and was the first individual to receive the SOT Biotechnology Specialty Section Career Achievement Award.