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Oncology CAR T-Cell Therapy: Preclinical Model Development and Adaptive Clinical Design Lead to Successful US/EU Registration

A leading cell therapy biotechnology company partnered with Labcorp Drug Development for the development of its novel autologous chimeric antigen receptor (CAR) T-cell therapy for a variety of hematologic malignancies, from preclinical studies through registrational clinical trials to assess safety and efficacy. The sponsor sought an experienced CRO partner to refine and implement the preclinical scientific strategy to screen multiple potential candidates for the ultimate selection of a lead asset to move into the clinic. Following this, the sponsor sought to advance through clinical development with a strong focus on patient safety, data integrity within operations, logistics of cell product, and adaptability to a trial program that expanded internationally and continues during a global pandemic.