One of the main reasons for drug candidates to be terminated from development is preclinical toxicity and clinical safety. Efforts have been made to identify such liabilities earlier in the drug discovery process. Comprehensive in vitro/in silico approaches have been established for generating “on and off target” profiles for our drug candidates; however, translatability still remains to be an enigma. Early pharmacology and efficacy studies coupled with exposure response models allow a unique insight into compound attrition/selection criteria as well as clinical translatability. These studies often entail substantial dose escalations and can be effectively leveraged to understand the early changes with not only tissue histology but also biomarkers without compromise to study endpoints.

Speakers:

TBA

With a faculty of distinguished speakers who are highly regarded experts and key opinion leaders on this topic, this workshop intends to discuss:

• Basic concepts of drug safety
• In vitro tools for candidate selection in discovery and to predict/design in vivo preclinical studies
• Novel approaches to the assessment of target organ toxicity
• A series of case studies on drug safety
• Biomarkers for safety