MDC Connects is a series of informative webinars covering the drug discovery process, from our own experts and experts at our CRO network partners.
Safety plays a huge part during preclinical development, and any drug must be extensively tested to regulatory standards before approval to test in humans. Safety-related hazards can arise from target-mediated risk, off-target activity, pharmacodynamic effects on the major body systems such as cardiovascular, central nervous and respiratory systems, as well as gross behaviour and pathological changes in animals. Comprehensive testing strategies, combining in vitro and in vivo safety studies enable liabilities of a new molecule to be identified and assessed in line with the clinical patient setting and can significantly influence compound selection, ensure the safety of clinical trial candidates and increase the chances of success.
In this webinar, Richard Knight from Apconix highlights the importance of thinking about safety early in the drug discovery programme; considering target, mechanistic and compound related safety. Pauline Garner from Sequani provides a practical guide to the design of safety studies and considerations of formulation, toxicokinetics, species selection and regulatory requirements. Finally, Malcolm Haddrick from MDC discusses the challenges and opportunities of using complex cell models in early de-risking strategies and toxicity testing.
Recording
Slides
Making safety part of drug design at Apconix
How to get your molecule into humans: A practical guide for the present and a look to the future at Sequani
Challenges and opportunities of complex cell models in toxicity testing at MDC
