Description: This presentation outlines molecular assay design considerations to support cell and gene therapies. A forward-thinking approach leads to several gained efficiencies missed in early study design or due to segmented pre-clinical and clinical teams. The key is defining the context of use when planning these studies for the end goal, clinical translation. Successful programs leverage building methods for both pre-clinical and clinical use. Here, we highlight assay differences in cell versus gene therapies and lessons learned.
Learning Objectives:
Considerations for packaging/building methods for both pre-clinical and clinical use
Assay Context of Use – qPCR versus ddPCR platforms and other design modalities
Leveraging expertise and capabilities to better prepare for the end goal – Clinical Translation
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