Cellular therapy is a new form of treatment with a set of clinical, operational, quality, and regulatory standards that differ from those in the pharmaceutical industry.
The complexity of cellular therapy is present at all levels:
- Clinical: It requires very specific knowledge of adverse reactions that almost exclusively occur in cellular therapy.
- Operational: The complexity in the manufacturing process, including cell collection, shipping cells for genetic engineering, etc. requires a team of people with specific training for each of these steps and a high level of communication and coordination that requires training and time. Therapy is very time-sensitive, as the patients who receive the treatment often have cancers that require timely intervention. Failure in any of these steps can result in the loss of the cellular product and with that, the life of a patient.
- Quality: All processes in cellular therapy, from the patient to the lab, and back to the patient, must follow the highest quality standards to ensure that the treatment is delivered to the patient safely. This requires very specific expertise that can only be acquired over years of experience
- Regulatory: The regulatory structure for cellular therapy is evolving rapidly and is another area of high complexity and specific expertise.
- Financial: Reimbursement of services related to cellular therapy is also evolving and has been limited the academic centers.
by the nerds of MetaTech