Navigating analytical and regulatory hurdles in early-phase clinical cell therapy development

“Patient safety and regulatory compliance remain the ultimate priorities in my work.”

Abi Pinchbeck, Editor, Cell & Gene Therapy Insights, speaks to Vaibhav Patel, Director of Quality Assurance and Regulatory Affairs at the University of Minnesota, about the analytical and regulatory challenges of cell and gene therapies, particularly in early phase development. This includes the adaptation of analytical methodologies from early phase into commercial manufacturing and the increasing emphasis on post-marketing surveillance data as well as other regulatory hurdles.

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