Mechanisms And Mitigation Strategies For Drug-Induced Liver Injury (DILI)

Why Should You Attend:

Are you and others in your organization aware of the many mechanisms known to cause Drug-Induced Liver Injury (DILI)? This webinar will highlight the most commonly known DILI mechanisms and describe mitigation strategies.

Historical safety assessment approaches have been poor predictors of the manifestation of clinical DILI. Thus, new methods are needed to better identify and mitigate risks prior to human clinical trials. This webinar will describe the known mechanisms associated with DILI and will inform modern methods used to identify and assess risks. The webinar will dig deep into the most common strategies used by drug hunters and will describe the relevant assays and models used to characterize and mitigate DILI risks. This will include physico-chemical property-based approaches, as well as multivariate approaches that combine several DILI-related endpoints, both in vitro and in vivo.

While the focus is on medicinal chemistry methods, this webinar will benefit all scientists who participate in the cross functional execution of drug discovery programs.

Areas Covered in the Webinar:

• Types of DILI
• DILI symptomology, Liver Function Tests, Hy's Law
• Common DILI Mechanisms
• Liver transporter inhibition
• Reactive metabolite formation
• Mitochondrial dysfunction
• Reactive Oxygen Species (ROS)
• Immunological mechanisms
• DILI Prediction methods
• Physico-chemical properties
• Transporter inhibition assays
• Multivariate approaches
• Cyctotoxicity assays (2D and 3D)
• Microfluidic deivices (Liver-on-a-chip)
• Medicinal chemistry mitigation 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.

Industries:

• Pharma, Biotech

Free Materials:

• Reference documents
• Rule documents or guidance
• Checklist
• SOP template
• Easy fill in forms
• Articles

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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