How to Maximize Your Non-GLP Toxicology Studies: A Guide for Optimal Design and Methodology
Presenters: Dr. Keefe Chng, Chief Scientific Officer and Site Head, CrownBio and Dr. Judith Gorski, Global Director of Scientific Engagement, CrownBio
Prior to clinical studies in humans, an investigational new drug (IND) application must be submitted to the FDA containing, among other things, information on any risks anticipated based on the results of pharmacologic and toxicological data collected during studies of the compound in animals.
FDA requires tests to be conducted in at least 2 animal species; this usually involves a small animal model (rodents, rabbits, guinea pigs) and a large animal model (dogs, pigs, nonhuman primates). Nonhuman primates are usually chosen as the second animal model for testing due to the close similarities in physiology shared with humans, and they naturally develop chronic diseases such as type 2 diabetes and its complications. In consequence, these studies are an integral part of the non-clinical safety assessment of new pharmaceuticals.
The studies, when designed correctly, guide selection of a safe starting dose for humans, provide an understanding of which organs may be the targets of toxicity, estimate the margin of safety between a clinical and a toxic dose, and in some cases, predict pharmacokinetic and pharmacodynamic parameters. These early tests are usually resource intensive, requiring significant investment in product synthesis, animal use, laboratory analyses, and time. Safety pharmacology studies are of special interest, and some drawbacks and pitfalls must be considered (i.e. invasive methods, difficulties related to GLP (good laboratory practices) requirements, choice of a strategy).
Watch this Webinar to Learn:
- How to optimize design of Non-GLP toxicology studies for generating robust, high-quality data
- What pitfalls to avoid in choosing a design strategy and proper methodology to give maximum confidence in study results
- Benefits of understanding which organs may be the targets of toxicity, estimating the margin of safety between a clinical and a toxic dose, and predicting pharmacokinetic and pharmacodynamic parameters
About The Presenters:
Dr. Keefe Chng has over 18 years of extensive experience in academia and industry, working with nonhuman primate models involving baboons, rhesus and cynomolgus macaques. He has developed and worked on models including: organ and bone marrow transplantation, adult mesenchymal stem cells, AAV transduction, in utero growth, neonatal development and nutrition, adult obesity, weight loss, chronic metabolic diseases, metabolic function tests, nephropathy, liver steatosis, pharmacokinetics, MRI imaging, medical devices, and brain-computer interface for motor control. He is responsible for training and establishment of NHP research programs, and has helped to develop primate facilities in Asia and in the USA.
Dr. Judith Gorski is Global Director of Scientific Engagement at Crown Bioscience Inc., and is a pharmacologist with over 18 years of experience in drug discovery and development in a large pharmaceutical environment. She has extensive experience in basic research and targeted drug discovery in the disease areas of type 1 and 2 diabetes, dyslipidemia, atherosclerosis, obesity, and metabolic syndrome. Dr. Gorski has co-authored publications in Nature, Obesity, Obesity Research, Cell Metabolism, Journal of Lipid Metabolism. Prior to joining CrownBio, Dr. Gorski's work at Merck focused on target identification/validation and small molecule and biologics identification/optimization with the aim of recommending lead candidates for clinical development.