Early De-Risking: In Vitro Safety Strategies for Pre-IND Success скачать в хорошем качестве

Early De-Risking: In Vitro Safety Strategies for Pre-IND Success

Safety data is no longer just a regulatory checkbox – it’s a strategic advantage. Discover how in vitro and computational tools reduce the reliance on animal testing and support smarter, earlier decision-making in drug discovery. As regulatory expectations evolve, so must the strategies for early drug safety assessment. The 2024 EU amendment and the FDA Modernization Act mark a clear shift toward reducing animal testing and promoting more ethical, human-relevant science. These developments are accelerating the adoption of New Approach Methodologies (NAMs) – particularly in vitro and computational models that better reflect human biology and improve early risk assessment. A key focus of these methods is the early identification of off-target activity, which is more important than ever. Such unintended interactions are often linked to adverse effects and clinical failures, making early safety profiling a critical step in de-risking drug candidates and increasing the chances of development success. In this webinar, hear from Dr. Emilie Desfosses, Preclinical Safety Director at Eurofins Discovery, as she shares practical approaches for integrating secondary pharmacology data into early-stage risk assessment. The session will cover: • How to interpret hit profiles from binding and functional assays • Strategies for identifying organ systems at risk based on target activity modulation • How to use visualization tools to assess safety margins and compare compound profiles • Approaches for prioritizing follow-up studies and refining risk mitigation strategies Attendees will gain insights into how in vitro and in silico methods can support more informed, human-relevant safety decisions -especially as ethical and regulatory changes continue to reshape preclinical research. Whether you’re evaluating lead candidates or refining your de-risking strategy, this session offers valuable guidance on improving predictivity and reducing reliance on animal testing. Key learning points: • Understand recent trends in secondary pharmacology and how they’re shaping safer, earlier drug development strategies • Explore new visualization and interpretation tools that support earlier integration of safety data • Gain insight into the latest IQ-DruSafe recommendations for in vitro secondary pharmacology and what they mean for current practice • Learn how functional and binding safety panels contribute to early risk assessment and better compound selection