Strategies to Mitigate Preclinical Safety Risks in Drug Discovery

Why Should You Attend:

Are you and others in your organization aware of the current best practices in preclinical safety assessment and mitigation? Best practices in drug discovery research change as technology improves and new approaches are validated. This is especially true in preclinical drug safety assessment, as new methods are generally assessed and validated with retrospective clinical safety data. Lack of awareness of established and emerging best practices in safety assessment can leave drug discovery researchers vulnerable to costly delays and/or terminations that may have been avoided prior to first human dose. Many safety risks can be identified earlier and mitigated. This webinar will increase the awareness of risks and mitigation strategies that have potential to improve clinical success rates.

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. Successful drug discovery teams will design and execute experiments that can best assess and discharge risks prior to first human dose (FHD). This webinar also describes proactive approaches that can help drug hunters avoid many safety issues and deliver safer small molecule drug candidates.

Areas Covered in the Webinar:

• Principles of Toxicology and Drug Safety.
• The Investigational New Drug (IND) Application.
• Predictive Toxicology.
• Preferred Drug Properties to Minimize Risks.
• On-Target vs. Off-Target Safety Concerns.
• Drug Metabolism and Drug-Drug Interactions.
• Toxicophores, Structure Alerts and Reactive Metabolites
• Drug-Induced Liver Injury (DILI).
• Preclinical Safety Biomarkers--From Lab to Clinic.

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.
Instructor Profile:



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.

Follow us :