Clinical Predictive Safety: Translational Safety and Safety Biomarkers (Including Imaging)

• Modelling and simulation for predictive clinical safety – challenges and benefits

• Examples of clinical safety modelling and simulation for decision-making in drug development

• Clinical safety biomarkers – key principles, development and qualification for clinical use

• Examples of clinical safety biomarkers in drug development incl applications of imaging

             CONFIRMED SPEAKER: Magnus Nord, Global Section Director Safety Science, AstraZeneca

Exploratory Toxicology And Mechanism Based Toxicity Testing

• Incorporation of exploratory toxicology and pathology practices (e.g. target expression profiling, GEM phenotyping, integrated pharmacology, and safety biomarkers) in drug discovery & development

• Rationale, approach, and balancing resources for achieving success in investigative toxicology studies

• Proper integration of transcriptomics, biomarkers, and tissue morphology to understand mechanism based toxicity

             CONFIRMED SPEAKER: Vito Sasseville, Executive Director, Preclinical Safety: Discovery & Investigative Safety, NovartisCurrent Trends In Early Development

• Study design focusing on Adaptive Trials

• Establishing the Therapeutic Index

• Incorporating personalized ‘omics’ into early development

• Gender/ethnobridging in early drug development

             CONFIRMED SPEAKER: Pamela Garzone, Executive Director Biotechnology Clinical Research, Pfizer