Preclinical Safety Assessment and Mitigation Strategies in Drug Discovery

Date: 19 March - 20 March 2019

Location: Boston, MA, USA

Tutors: Dr Bryan H. Norman

New Course for 2019

The discovery of new therapeutic agents is met with significant challenges in preclinical discovery and development.  Both efficacy and safety endpoints must be adequately assessed prior to testing a new investigational agent in humans.  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 properly design and execute experiments that can best assess and discharge risks prior to first human dose (FHD), in the context of anticipated human drug exposures.

This course begins with a description of the finish line for preclinical drug hunters–the successful filing of an Investigational New Drug (IND) application to regulatory agencies, such as the FDA or EMA.  From there, it explores the current best practices and methods used to identify, understand and mitigate common preclinical safety risks from both a strategic and tactical perspective.  Importantly, the course also describes proactive approaches that can help scientists avoid many safety issues and deliver safe small molecule drug candidates in the shortest time possible.  While the course has a strong emphasis on mitigation strategies achieved through medicinal chemistry, the content describes methods that are valuable to all disciplines within a cross functional drug discovery team.

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Course Outline

  • Principles of toxicology and safety assessment.
  • The Investigational New Drug (IND) application.
  • Target assessment, predictive toxicology and in silico methods.
  • Preferred drug properties to minimize toxicological risks.
  • Common off-target safety concerns and mitigation.
  • Managing on-target safety concerns.
  • Pharmacokinetics in preclinical safety assessment.
  • Drug metabolism and bioactivation.
  • Toxicophores and Structure Alerts.
  • Mechanisms and mitigation strategies for Drug-Induced Liver Injury (DILI).
  • Preclinical safety biomarkers and translation to the clinic.
  • Safety assessment and flow scheme design in lead optimization.
  • Clinical candidate selection and FHD enablement.


Who Should Attend

Medicinal chemists, toxicologists, biologists, pharmacologists, pharmacokineticists and program managers will all gain valuable insights into modern preclinical safety assessment strategies.  The participation of multiple disciplines encourages cross functional learning through interactive team sessions.

What's Included

  • Refreshments & lunch daily
  • The comprehensive Course Manual
  • Course Certificate