New Horizons in Predictive Toxicology (eBook)

Alan G. E. Wilson, PhD, ATS, is currently Vice President of Drug Metabolism, Pharmacokinetics, and Toxicology and Pathology at Lexicon Pharmaceuticals. He is internationally-recognized in drug metabolism, pharmacokinetics and toxicology and has over 25 years of experience working on product discovery and development for both small molecules and biotherapeutics. He has significant hands-on experience with the regulatory and GLP requirements for the conduct of ADME, PK and safety assessment studies to support regulatory submissions and clinical studies. Prior to joining Lexicon, Dr. Wilson held senior management and leadership positions with major international pharmaceutical and life science companies. He has been involved with the approval and registration of several successful marketed products and has extensive experience working with regulatory agencies in the United States, Europe and Asia Pacific. Dr. Wilson has Board of Director and Scientific Advisory experience with several companies. He is Board Certified in Toxicology and has produced more than 120 publications. Dr. Wilson has been an invited speaker and presenter at international conferences.

Introduction and overview; computational modeling approaches: in silico tools for toxicity prediction, development of an evaluation support system for estimating repeated dose toxicity of chemicals based on chemical structure, towards a common regulatory framework for computational toxicology: current status and future perspectives, information, informatics and modeling in predictive toxicology; in vitro approaches in predicting toxicity: cellular stress and in vitro predictive toxicology, in vitro genotoxicity, cardiac toxicity prediction: to simplify, or to integrate, that is the question, in vitro approaches for determining liver specific toxicity of new drug candidates, human-based in vitro experimental systems for the assessment of human-specific adverse drug effects: scientific concepts, current applications and promising approaches, models of organ injury,mitochondrial toxicity; in vivo approaches in predicting toxicity: nonclinical models for the evaluation of mechanisms of toxicity,in vivo genetic toxicology: application to cancer risk assessment, predicting hepatic toxicity in vivo, immunotoxicity testing,reproductive toxicity,toxicity biomarkers,renal toxicity, integrative approaches to toxicity prediction, metabolism-based toxicity prediction,impact of drug transporters in the pharmacological and adverse reactions of drugs,toxicokinetics, the role of computational systems biology models in toxicity testing in the 21st century: an example with predictive multi-scale models of the liver, animal models