Guidelines for Developmental and Reproductive Toxicity (DART) Testing
This webinar will provide a general overview of the regulatory guidelines required for developmental and reproductive toxicity (DART) testing. In order to initiate clinical trials for women of child-bearing potential (WOCBP), the FDA requires initiation of preclinical DART studies using mammalian research models. These regulated studies provide important information regarding the effects of drug exposures prior to and during parental mating, as well as evaluating maternal and fetal changes during gestation, and identifying any alterations in the development of the offspring following birth.
Bjorn Thorsrud, Ph.D.
Vice President of DART and Scientific Operations Frontage Laboratories
Bjorn A. Thorsrud, Ph.D. is the Vice President of DART and Scientific Operations at Frontage Laboratories (Chicago). His background includes extensive pharmaceutical expertise in contract research, having served as Director of Developmental and Reproductive Toxicology (DART) at Springborn Laboratories (now part of Charles River Laboratories). In addition, Dr. Thorsrud worked as Lead Scientist at the Dow Chemical Company with oversight over EPA and OECD regulated toxicology studies for the chemical industry. In addition, he served as Director of Infant Nutritional Sciences at MPI Research which included scientific oversight of their DART program. He received his Ph.D. from the University of Michigan, in Embryo/Fetal Toxicology and did a two-year postdoctoral fellowship in the Department of Chemistry, working on a government project with the Department of Advanced Research Projects Agency (DARPA). Dr. Thorsrud is well-published in his field and was named co-inventor on a patent for his postdoctoral research at the University of Michigan. He maintains memberships in the Society of Toxicology, American College of Toxicology and the Society for Birth Defects Research and Prevention, and he is actively involved in regional chapter activities, having served as President of the Michigan Chapter of the Society of Toxicology.
Supida Monaikul, Ph.D., D.A.B.T.
Director of Toxicology and Technical Operations Frontage Laboratories
Supida Monaikul, Ph.D., D.A.B.T. is the Director of Toxicology and Technical Operations at Frontage Laboratories (Chicago). Her background is in neuro and developmental toxicology, and includes a broad experience in pharmaceutical and nutritional contract research. She received her Ph.D. from the University of Illinois, Urbana-Champaign, in Neuroscience with a focus in brain and behavioral development, pharmacology and toxicology. She did a one-year postdoctoral fellowship at the University of Illinois, Urbana-Champaign, in the Department of Animal Science, working on an infant nutrition and brain development project using the piglet research model. For this program, she was involved with developing behavioral and cognitive testing paradigms as well as MRI mapping of brain development. Supida regularly attends conferences of the Society of Toxicology, American College of Toxicology and the Developmental Neurotoxicology and Teratology Society.
Date: Wednesday, May 25, 2022 Time: 11am ET / 8am PT Duration: 1 Hour