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CAR-T
A NEW FRONTIER
Science Background
CAR-T
Cell and Gene Therapy (CGT) is a new frontier in medicine. It is science defined by extracting cells, proteins, or genetic materials from a patient or donor, altering them, then re-injecting them back into the patient.
Of significant promise are CAR-T treatments, a form of immunotherapy that uses patient T cells to fight cancer. It offers patients a new treatment option beyond traditional chemotherapy, surgery, and radiation. Instead, treatments are individualized to address the specific cancer in a specific patient using the patient’s own cells. T cells, the cells responsible for immune system responses, are separated from a patient’s blood via apheresis (separating plasma from cells) and are modified in a lab by adding synthetic receptors called chimeric antigen receptors, or CAR. The combined CAR-T cells are then expanded into the hundreds of millions and ultimately infused back into a patient where they will further multiply as they recognize and kill cancer cells.
Ship
Modify
Extract
Infuse
Ship
CAR-T
Process Background
Apheresis separates and extracts patients’ white blood cells from the rest of their blood over the course of a 2-to-3-hour procedure. The white blood cells are then sent off to a laboratory for testing where they are reviewed against defined CAR-T requirements.
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The patient specimen (i.e., the bag of blood cells) must be properly managed according to each treatment’s guideline, most requiring cryopreservation. The preparation, validation, packaging, order placement, shipping and receiving, scheduling, and testing are managed by hospital administrators and clinical staff.
The manufacturing process (i.e., adding the CAR and growing the cells) is managed by pharmaceutical companies, the specific company, and requirements dependent upon each treatment.
CAR-T
Challenge
The oddity of CAR-T is that the patient’s blood is both the input and the output of a circuitous exchange of custody between for-profit and non-profit organizations, clinical and non-clinical individuals. Every step requires an exchange of information and/or physical action to manage ‘change of custody’ ‘chain of identity’ and ‘change of form.’ There is no consensus view of the process because there are no standards. Managing the process is virtually impossible without extensive manual intervention, making it labor intensive and highly specialized.
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Clinicians bear the burden of managing the extensive operational processes that start from the point of patient blood collection through to infusion back into the patient. Procedures span pharmaceutical companies, blood banks, laboratories, and medical centers, each with their own requirements and processes.
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Coordinating the continuum of care requires virtually every organizational level and functional role within the hospital setting. Current management practices consist of paper-based data collection transcribed to spreadsheets, emails, and disparate software solutions.