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Article: Silos: A Barrier to Cell and Gene Therapy Commercialization

By World Courier

Is the way partnerships are managed one of the challenges to cell and gene therapy commercialization? Traditionally, purchasing teams manage vendors to guarantee the best price and service level. However, this leads to a lack of visibility within the supply chain, as vendors are unaware of who else is involved so communication is hindered and silos formed. This restricts their ability to act as technical experts and connect with other vendors to optimize the supply chain to the benefit of the patient, the developer and the payer.

At the recent ISCT conference in Montreal Sven Kili (GE), noted that the points of failure within supply chains come from transitions between operations. These operations have been described by Phil Vanek (GE), for CAR-T, as including the “collection of patient materials, delivery of those materials to the manufacturing center, wherever that may be, processing of that material, transduction to genetically modify cells, the downstream processing, fill and finish, and finally the cold chain distribution back to the point of care for re-administration”[1]. Christina Yi (Dendreon) also recounted how they had seen teams not communicating, which meant that clinical development plans did not necessarily align with process development.

Illustration of interactions enabled by the removal of silos

Traditional Silo Management  

Integrated Logistics Platform

The immediate response to this challenge is to utilise the orchestration platforms now available.  However, they cannot be the complete solution as data is only part of the challenge. These systems are incredibly powerful in creating vein-to-vein traceability and solving for supply chain interactions which can be readily described with rules, such as patient scheduling relative to manufacturing slot availability. However, they need human interaction to solve issues for which the decision making process cannot be easily articulated through a set of simple rules. They are much like the fuel warning lights in cars; the car has analysed many data points (average fuel consumption, contents of the fuel tank, etc.) to present the driver with a flashing light to say that there is a potential issue. However, it requires the driver to make a decision about where to refuel and by how much.

The impact of silos

This is where silos become an issue. If the “driver” does not know the escalation procedure or contacts of the next operation within the supply chain, they can only make decisions based on their needs and they are doing so with limited visibility of how their decisions has dependencies elsewhere. In short, they are not enabled to act with the whole system – and ultimately the patient – in mind.

Silos can occur because vendors are traditionally selected via a purchasing process that looks at capability vs price. This works well enough for simpler linear supply chains for small molecules, as an example. However, this misses the technical expertise of the vendors – and the fact that they will be called upon as the “driver” to react a blinking fuel light in the supply chain. Once on-boarded they should be seen as technical experts and allowed full visibility of the supply chain in order integrate with other vendors, to add value to the therapy and its ability to deliver patient benefit.

Enabling integration

Some vendors, like World Courier, are already creating logistics platforms[1] where the integration with orchestration platforms, shipping technologies and storage solutions is already in place. This is incredibly valuable to therapy developers as they don’t have to “re-invent the wheel” but can simply tap into already established global systems. In addition, programs like the UK’s Advanced Therapy Treatment Centres (ATTCs)[2] are bringing vendors, clinicians, the UK National Health Service NHS, and therapy developers together to identify and remove silos and create a seamless infrastructure that ensures the maximum number of patients receive the benefit of these life-changing therapies.

For therapy developers to benefit from the removal of silos they need to bring their technical experts – both in-house and external vendors – together and facilitate a discussion about how the expertise “around the table” can be used to identify risks and potential areas of optimization within the proposed supply chain. This partnership will start to remove silos and enable the creation of logistics platforms that seamlessly connect therapies to patients.

[1] Fixing the weak links in the cell therapy manufacturing chain: processes, people and partnerships.  Cell and Gene Therapy Insights, p311-318
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