Wugen Selected for US FDA CMC Development and Readiness Pilot Program to Support Manufacturing Readiness of Soficabtagene Geleucel
“Selection for the FDA’s CDRP program enables us to streamline and seamlessly integrate clinical progress with manufacturing readiness to rapidly advance the program towards BLA filing,” said Kumar Srinivasan, Chief Executive Officer of Wugen. “Building on our recent RMAT and Breakthrough Therapy designations, we welcome the opportunity to work closely with the FDA through this highly selective program as we advance Sofi‑cel along an accelerated clinical timeline. These additional CMC interactions will strengthen our manufacturing and regulatory capabilities with the goal of bringing Sofi‑cel to patients as quickly as possible.”
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