Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex. Once efficacy and safety is demonstrated, the focus of advanced therapy developers moves to controlling cost. However, the biggest cost within the supply chain is caused by its complexity. In this blog we will share why the advanced therapy supply chain is so complex and how this complexity correlates to cost.
The complexity comes partly from the strict shipping metrics (temperature management, delivery time/shelf life) but mainly from the fact that there are multiple transactions throughout the chain of custody between donor and patient. These occur throughout the supply chain and are compounded by the number of clinical sites and different geographies, where differing regulations and languages pose an additional challenge. This is mainly driven by the number of transactions between organizations, which are then magnified by the number of clinics involved and their global locations. This complexity adds cost and needs to be actively managed.
Therefore, if therapy developers can reduce complexity, they can reduce cost.
If a therapy is to be successful there is little that can be done to manage the number of clinical sites, as this will be determined by market demand and clinical capability. However, complexity is reduced when there is control over chain of custody transactions. This can be realized through having centralized control of the vein-to-vein supply chain and ensuring that responsibility sits in a single, well-defined location.
Complexity is driven by the fact that the therapeutic product is moving between organizations and every movement, although mitigated by SOPs, is a change of location, quality system, and personnel.
This constant change of responsibility is the biggest risk in any supply chain.
Within an early clinical trial, this complexity can be managed by in-house teams, often created from a mix of clinical, manufacturing, and administration personnel that are supported with CRO/CMO input. However, this hands-on approach becomes impossible as patient numbers grow and the therapy moves closer to commercialization. Indeed, once the therapy completes its clinical trials, one of the critical support systems, the CRO, disappears. Therefore, for advanced therapies, it is essential that a scalable control system is implemented for their supply chains.
As the advanced therapy industry grows complexity is likely to grow with it, therefore therapy developers have two choices. They can either build in-house teams that are suitably resourced and experienced enough to manage the product integrity throughout the different geographies, regulatory structures, ports of entry requirements, storage locations, and kitting requirements, or they can outsource to groups with the established expertise to ensure that therapies get to patients efficiently.
Both in clinical development and commercialization, the therapy developer will always retain ownership of the product. However, by clearly defining shipping parameters, much like manufacturing SOPs, and delegating responsibility to an external organization, the therapy developer can ensure optimal management of the supply chain.
Are you currently involved in an advanced therapy clinical trial? If so, I’d like to share a case study we developed recently regarding how a company saw 55% cost savings across its distribution system, and increased visibility of its supply chain through meaningful data. Download your free copy of our case study Reducing Cost within Advanced Therapy Clinical Trials by selecting the icon below.