Drug Discovery and Development
This session focuses on the comprehensive process of drug discovery and development, from early target identification to clinical application, with an emphasis on integrating clinical pharmacology and toxicology to improve success rates and patient safety. It will explore the biological rationale behind drug target selection, mechanism of action studies, and lead optimization, highlighting how pharmacokinetic, pharmacodynamic, and toxicological data guide decision-making throughout the development pipeline. The session will address preclinical evaluation strategies, including in vitro and in vivo models used to assess efficacy, safety, and potential side effects before first-in-human studies. Discussions will also cover translational approaches that bridge laboratory findings with clinical outcomes, ensuring that biological information is effectively used to predict human response. Challenges such as drug attrition, unexpected toxicity, and variability in therapeutic response will be examined, along with innovative solutions such as model-informed drug development, biomarker-driven strategies, and adaptive trial designs. Regulatory expectations, ethical considerations, and risk–benefit assessment during development will also be highlighted. By emphasizing the integration of pharmacology and toxicology across all stages, this session aims to provide insights into developing safer, more effective medicines while reducing development timelines and costs, ultimately benefiting patients and healthcare systems worldwide.