Target Assessment, Predictive Toxicology and In Silico Methods In Preclinical Safety Assessment

Why Should You Attend:

Are you and others in your organization aware of the current best practices in predicting and avoiding safety issues in drug discovery? The causes of drug candidate terminations due to safety used to feel like a black box for drug hunters. However, in recent years, new methodologies have been introduced, some of which have demonstrated higher predictability and greater alignment with retrospective clinical safety data. This webinar will highlight many of the examples, both experimental and in silico, that may help drug discovery researchers understand the most valuable approaches to assess (and improve) the safety of drug candidates.

The identification of potential new therapeutic agents is met with significant challenges in preclinical discovery and development. Perhaps the most challenging part of drug discovery is the mitigation of safety risks that arise during most drug discovery optimization efforts. This webinar explores the current best practices and methods used to assess drug targets and design appropriate mitigation strategies. Predicting toxicological findings is an inexact science. However, promising new experimental and in silico methods have been developed and pressure tested against clinical safety data. This webinar will describe some of the recent advances in the methodologies used to predict and avoid clinical safety issues prior to FHD.

Areas Covered in the Webinar:

• How to assess potential drug targets prior to experimental investment.
• How target pharmacology, therapeutic area and patient population inform a safety testing strategy.
• Predictive toxicology vs. retrospective toxicology.
• What are in silico methods? How and when to use them.
• New technologies, such as high content assays and "organs-on-chip".
• Approaches to predict drug-induced:
• Cardiotoxicity
• Hepatotoxicity
• Genotoxicity
• How do compound structure and properties relate to safety risks?
• Multivariate safety testing strategies

Who Will Benefit:

• Medicinal chemists, toxicologists, biologists, pharmacologists, pharmacokineticists and program managers will all gain valuable insights into modern preclinical safety assessment and mitigation strategies.
• Educational levels: B.S., M.S., Ph.D.
• Best suited for drug discovery researchers in early to mid career.

From Pharma, Biotech, University and Research Institute Drug Discovery Programs

Bryan Norman
President, Norman Drug Discovery Training and Consulting LLC

Bryan H. Norman received his Ph.D. in Organic Chemistry at Emory University and was an NIH Postdoctoral Fellow at Penn State University. After three years at Monsanto/Searle, Bryan joined Eli Lilly and Company in 1993, where he led multiple cross functional drug discovery efforts, many of which culminated in clinical candidates for oncology, endocrine and pain indications. In addition to his expertise in medicinal chemistry, Bryan has significant cross functional drug discovery experience and expertise in additional disciplines, such as biomarkers, pharmacokinetic/pharmacodynamic (PK/PD) relationships, mechanisms of drug metabolism and toxicology. He has specific expertise in the mechanisms and mitigation strategies to avoid drug-induced liver injury (DILI). The breadth of his background has led to his service on many Due Diligence teams to assess potential in-license opportunities. In addition to drug discovery training and consulting activities, Bryan is currently an Adjunct Professor at the Indiana University School of Medicine, where he teaches multiple drug discovery topics. He is a Volume Editor and serves on the Editorial Board of Burger’s Medicinal Chemistry, Drug Discovery and Development. Bryan is currently on the Board of Directors of the Medicinal and Bioorganic Chemistry Foundation and serves on various grant review committees. He has published over 45 papers in peer-reviewed scientific journals, been named an inventor on over 30 U.S. patents and given many invited lectures at scientific conferences and universities. His most recent research interests have focused on the identification of mechanisms associated with drug-induced liver injury and the discovery of novel analgesic agents for use in chronic pain.

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