FEB 03, 2016 3:00 PM PST

The Future of Preclinical Animal Models in Pharmaceutical Discovery and Development: How the Scientific 3Rs of Relevance, Robustness and Reproducibility are Critical

Speaker
  • Director of Comparative Biology and Medicine, GlaxoSmithKline, Adjunct Professor of Pathology, Duke University School of Medicine
    Biography
      Jeff Everitt received his DVM from Cornell University and then completed a residency in comparative pathology at the University of Pennsylvania and a postdoctoral research appointment at the University of Illinois. Dr. Everitt served for 17 years on the senior scientific staff of the CIIT Centers for Health Research where he attained Senior Scientist status. At CIIT he led the animal care and use program as well as a multidisciplinary research program that examined the health effects of inhaled fibrous particulate. He currently serves as a Director of Comparative Biology and Medicine at GlaxoSmithKline and as an Adjunct Professor of Pathology at Duke University School of Medicine in Durham, NC. Dr. Everitt is board certified in anatomic pathology (ACVP) and in laboratory animal medicine (ACLAM) and is a Fellow in the International Academy of Toxicologic Pathologists (FIATP). He has served in leadership positions in multiple professional organizations in laboratory animal science, pathology and toxicology during the past twenty years. Dr. Everitt has lectured and published widely on best practices for the control of variability and bias in the conduct of in vivo studies.

    Abstract

    Animal models have provided an important tool to help make the decision to take potential therapies from preclinical studies to humans. In the past several years, the strong reliance of the pharmaceutical discovery and development process on the use of animal models has come under increasing scrutiny for ethical and scientific reasons. There have been several prominent papers that have reported limited concordance of animal experiments with subsequent human clinical trials. Recent assessments of the quality of animal studies have suggested that this translational failure may be due in part to shortcomings in the planning, conduct and reporting of in vivo studies. This talk will emphasize methods to assure best practice rigor in animal study methods and reporting. It will introduce the so-called “scientific 3Rs” of Relevance, Robustness, and Reproducibility to the In vivo study approach, and will review important new trends in the pharmaceutical discovery and development communities.


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