Highlighting CAR-T as an Important Modality (PDA/FDA Joint Regulatory Conference 2023)

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the importance of CAR-T as a modality and other highlights from his part of the session, "Process Validation for CAR-T Products: A Continuous Journey."

Gayed: Sure, I'd like to just echo the CAR-T is a very important new modality that's able to use the patient's own cells, patient own immune system to be able to treat disease, mostly cancer today. But it's a very, very important element for the industry that we have been learning a lot about in the last few years. And I think it will be a lot of interest in coming years. We talked about the continuous journey for validation and add into that our ability to communicate and share the learnings among each other, not just within the same company or across the industry. That's, I think it's a very unique time for this modality and being in a setting like the FDA/PDA conference, we need to be able to share the knowledge, communicate, and hope to fast forward these learnings across.

Gayed: I think it's, it's very important to think about the time we enter this modality and how young it is and draw parallel to maybe biologics and 30 years ago or so, and see how fast we can make an improvement and more advancement in technology today, than 30 years ago. I think we can really really make an impact much faster and we can really take this modality and the benefit that it will bring for treatments or really serious disease for patients in need.