BIOGRAPHICAL SKETCH Stephen B. Harris, PhD, ATS, FRSB, has served as President of Stephen B. Harris Group in San Diego, CA, since September 1982. He has over 50 years of professional experience in developmental and reproductive toxicology and has been an independent consultant for 40 years. He has held several appointments at San Diego State University, Stanford University, and National University, teaching developmental and reproductive toxicology throughout his career. Today, he mentors graduate students in the American College of Toxicology, Society of Toxicology, and the Society for Birth Defects Research and Prevention. Dr. Harris’s area of expertise includes (1) scientific interpretation of data from developmental and reproductive safety evaluation testing programs for the chemical, food, and pharmaceutical industries globally, (2) management and training of preclinical Contract Research Organization (CRO) personnel, especially in developmental and reproductive toxicity testing including, fetal morphological assessments in multiple species, (3) CRO testing facility design, operations, and study monitoring, (4) CRO client pre-qualification site assessments, (5) due diligence for companies interested in purchasing drugs with the intent to be repurposed for new therapeutic indications, and (6) product liability issues. He has authored many opinion papers and critiqued numerous technical reports for the chemical, food, and pharmaceutical industries to assure compliance with worldwide regulatory requirements for product approval. Dr. Harris has been invited to deliver several national and international scientific presentations and workshops and interacts with global regulatory agencies. He was formerly an editor of Food and Chemical Toxicology (2012-16), an Adjunct Associate Professor in the Graduate School of Public Health at San Diego State University (1985-2017), and an FDA Special Government Employee serving as a Consultant for the Nonprescription Drugs Advisory Committee (2015-2018). Also, Dr. Harris served as President of the Southern California Chapter of the Society of Toxicology (1996-1997), President American College of Toxicology (2006-2007), Councilor of the Teratology Society (2012-2015), and received the American College of Toxicology Service Award (2016). In 2019, a Mid-Career Scientist Award was established in his name by the Reproductive and Developmental Toxicology Specialty Section of the Society of Toxicology presented at the Annual Meeting. He is currently on the Editorial Board of the International Journal of Toxicology and a Fellow of the Academy of Toxicological Sciences and Royal Society of Biology.