About SBH Group
Stephen B. Harris, PhD, FATS, FRSB has served as President of Stephen B. Harris Group in San Diego, CA. since 1982. He has over 40 years of professional experience in developmental and reproductive toxicology and has been an independent consultant for over 30 years. Through the course of his career, he has held several teaching appointments at San Diego State University, Stanford University, and National University in the areas of developmental and reproductive toxicology. Today, he continues to mentor graduate students as an Adjunct Associate Professor in the Graduate School of Public Health at San Diego State University. Dr. Harris's area of expertise includes: (1) scientific interpretation of data from developmental and reproductive safety evaluation testing programs for the pharmaceutical and chemical industries globally, (2) management and training of Contract Research Organization (CRO) personnel especially in developmental and reprodcutive toxicity testing including fetal morphological assessments in multiple species, (3) CRO operations, study monitoring, and testing facility design, (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.
Dr. Harris has successfully authored many opinion papers and critiqued numerous technical reports for the pharmaceutical, chemical and food industries to assure compliance with worldwide regulatory requirements for product approval. He has been invited to deliver several national and international scientific presentations and workshops and interacts with global regulatory agencies. Dr. Harris was formerly Editor for Food and Chemical Toxicology and on the Editorial Board of the International Journal of Toxicology. In addition, Dr. Harris served as President of the American College of Toxicology (2006-2007) and a Councilor of of the Teratology Society (2012-2015). Currently, he is a FDA Special Government Employee serving as a Consultant for the Nonprescription Drugs Advisory Committee and a Fellow of the Academy of Toxicological Sciences and Royal Society of Biology.