Article: Per Dose Impact of Logistics on Advanced Therapies

The impact of logistics on the ability of advanced therapies to treat patients reinforces the message that therapy developers need to think about their entire supply chain and ‘Logistics by Design’.

A recent paper published in Cytotherapy[1] identified the impact of logistics on the ability of advanced therapies to treat patients. The paper aimed to understand how the cost of goods sold (COGS) is affected when the Manufacturing Platform for North American patients is located in Latin America, along with a Logistics Platform transporting critical shipments to support production.

The outcome was that it’s preferable to keep manufacturing in North America. However, the key learnings came from subsequent insights generated from the data behind the paper, developed by World Courier.

These are as follows:

1. Failure within logistics has the same impact as failure within manufacturing

Source: https://www.celltherapyjournal.org/article/S1465-3249(19)30003-9/abstract 

All 28 steps of the supply chain identified in the paper have the potential to prevent patients being treated, as well as data generated within clinical trials, or reimbursement at commercial scale. Of these 28 steps, nearly 10% involve logistics, implying that at least 10% of a company’s development and planning should revolve around creating a robust logistics platform.

In essence, if a therapy cannot be delivered, either as a raw material into manufacturing or as a final therapy to the patient, then its efficacy, COGS, quality control (QC) and reimbursement strategy is irrelevant as the patients receive no benefit.

2. Per dose cost impact of logistics is analogous to facilities and staffing

Source: https://www.celltherapyjournal.org/article/S1465-3249(19)30003-9/abstract  

The biggest cost drivers are consumables, QC analysis and challenges within ‘fill & finish’. Yet it is interesting to see the similarity, per dose, between facility, staffing and logistics costs.

There are dedicated conferences to addressing the issues around manufacturing facilities (e.g. reducing COGS, closing and automating processes). There are also national programs developing the staff needed to produce advanced therapies at scale (e.g. Catapult & Advanced Therapies Apprenticeship Community[1]). However, there is currently not the same focus on logistics.

In order for advanced therapies to continue developing into a viable industry, there is a need to look at these challenges in parallel, otherwise there is the risk of an efficacious therapy failing to treat patients, as it can’t be delivered effectively.

These data points reinforce the concept behind ‘Logistics by Design’, which lays out the need for Manufacturing, Clinical and Logistics Platforms to be developed together. The fundamental message being that therapy developers need to think about their entire supply chain, including logistics, when developing their therapy to ensure that they can treat patients at both clinical and commercial scale.

[1] Chimeric antigen receptor – T cell therapy manufacturing: modelling the effect of offshore production on aggregate cost of goods (https://www.celltherapyjournal.org/article/S1465-3249(19)30003-9/abstract)

[2] https://www.advancedtherapiesapprenticeships.co.uk/