How do I create a cost structure for cellular therapy laboratory services supporting clinical trials?

Abstract Background The rapid growth of FDA‐licensed and clinical trial cell and gene therapy products is causing significant growing pains for laboratories onboarding and processing these products for clinical use. While clinical programs have traditional and supplemental reimbursement models, many services provided by the laboratories are not directly reimbursed. Compounding this issue is the increasing diversity and complexity of products with unique processing requirements leading to resource‐intensive workflows. Study Design and Methods Our institution developed a three‐tiered cost structure for services provided by the cellular therapy laboratory billed to industry‐sponsored, externally manufactured clinical trials based on the level of start‐up and per product handling complexity. A list of tasks and time required to complete the tasks was recorded to account for the complexity of the specific trial. This data was used to determine the total cost billed to onboard and carry out cell processing and handling tasks by the cellular therapy laboratory to the principal investigator of the clinical trial. Results Our tiered fee structure enabled a more accurate accounting of laboratory personnel time based on the complexity of the clinical trial products, enabling our laboratory to recoup necessary costs. Conclusion A tiered fee structure corresponding to higher levels of onboarding and administrative complexities can more accurately estimate costs to enable cell processing laboratories to remain financially sustainable and continue to deliver cell and gene therapy products to patients.