Date: September 08, 2021
Time: 8:00am (PST), 11:00am (EST)
Developing biopharmaceuticals is challenging, with safety liability remaining one of the primary reasons for failure. As such, safety assessment of host immune system has emerged as a significant and indispensable area of the preclinical drug development, especially for biologics. In routine toxicology studies regulatory guidelines recommend integration of sensitive in vitro and ex vivo immunotoxicity assays with thoughtfully designed in vivo and fit-for-purpose functional assessments in order to facilitate a comprehensive evaluation of hazard potential and to enhance patient safety. When conducting such sensitive studies with precious assay sample material, it is important to avoid unnecessary repetition of experiments due to poor reproducibility caused by research consumables and instruments. A thorough study design, therefore, must include conscientious selection of experimental tools.
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