How to Maximize Your Non-GLP Toxicology Studies: A Guide for Optimal Design and Methodology

Prior to clinical studies in humans, an investigational new drug (IND) 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 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).

This webinar  will share both design and methodology guidance in Non-GLP Toxicology studies in both NHPs and rodent models. The presenters will guide you in how to design the most optimal study to provide the greatest opportunity to generate robust, high quality data, that gives maximum confidence to select new drug candidate’s and regulatory submissions.

Attendees will learn about:

• 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

Speakers

Dr. Judith Gorski, Global Director of Scientific Engagement. Crown Bioscience Inc.

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. She is an expert at establishing and validating primary, secondary and tertiary in vivo models of dyslipidemia, obesity, metabolic syndrome, and type 1 and 2 diabetes.

Dr. Gorski received her Ph.D. in Neuroscience from University of Medicine and Dentistry, New Jersey.

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