Cross-Functional Planning Is the Competitive Differentiator in CGT: Q&A with Chris Learn

In June of this year, Pharmaceutical Executive published a piece authored by Sean Werner, CTO of Cell Processing at BioLife Solutions. In it, Werner discusses the high rate of complete response letters (CRLS) issued for cell and gene therapy (CGT) submissions. According to Werner, many of these CRLs are issued due to issues connected with clinical effectiveness, CMC issues, and regulatory concerns and are often issued late in the development cycle.