There is growing recognition, among both industry and regulators, that patients are experts in their own illnesses, that they are increasingly well-educated about treatments, and that they want to have a say in how investigative therapies are studied. The concept of patient centricity is very much at the forefront in autologous CAR T-cell therapies because these novel therapeutics blur the boundaries that typically separate the patient, the manufacturing process, and the product. With these therapies, the patient is not just the recipient of a drug product—the patient is the product.
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