Feature|Articles|September 16, 2026

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

CGT commercial trajectories are set years before approval — and every development decision is an access decision.

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.

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Should There be More of a Focus on Developing Preventative Medications

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The Next Biopharma Revolution: Quantum Computing

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Shionogi’s Dr. Draica on how XOCOVA blocks viral replication between exposure and symptoms — and why it works even with prior immunity.