An important measure of success of any clinical supply chain strategy is whether or not clinical sites have the necessary study medications at the ready when needed to avoid delays in new patient starts or continuance of therapy. The complex nature of some clinical trials can create challenges which can place considerable stress on the supply chain. The difficulty in ensuring the continuity of supply increases as variables are introduced into the mix. These variables can include blinded studies, those with multiple arms or dynamic designs such as adaptive studies, fluctuations in patient recruitment, insufficient or interrupted supply of the IMP or comparator drugs, and more.
Forecasting and demand simulations are useful for anticipating when and where stock is likely to be needed to formulate a kit production and distribution strategy. Additional stock over and above the forecasted amount needed is commonly added to create a generous buffer inventory to help manage any deviations and hopefully avoid supply disruptions or shortages. However, even with forecasting and building out a sizeable buffer inventory, clinical sites may still not always have the appropriate kits on hand to dispense to patients. Why?
The answer is surprisingly simple. Nearly all clinical supply models in use today are linear and rely upon the advance production of finished or partially-finished patient kits prior to the study start. Depending upon the supply strategy employed, large initial lots of finished kits and periodic resupply shipments may be sent to clinical sites based upon anticipated demand or partially-finished kits may receive final labeling and be shipped to clinical sites on an as-needed basis. In either scenario, drug product must be committed (e.g., packed into) a patient kit before it is actually needed. And therein lies the crux of the problem – a linear supply chain lacks the flexibility to effectively address unforeseen inconsistencies between supply and demand.
In order to create a supply chain that is flexible and responsive, it must first be broken. By splitting the supply chain into two independent stages the root cause of supply delays and shortages can be eliminated instead of just managed and the focus can shift from managing inventory to managing demand. By using a demand led approach the supply chain becomes much more flexible and responsive and requires a significantly smaller buffer stock.
Stage 1: Advance Preparation of Bright Stock
Prior to the start of the study the investigational medical product and any comparator drugs are processed up to the point of primary packaging. These primary packaged drugs are uniquely numbered but remain unlabeled. And because the drugs are not packaged into patient kits at this stage, they can be pooled for use across multiple protocols if applicable. Once released by Quality, they are tracked in a central inventory management system as bright stock, but are physically distributed to regional GMP clinical packaging facilities closer to the clinical sites.
Stage 2: Secondary Packaging and Distribution
Once clinical sites indicate the need for a small supply of seed stock or there is an actual patient demand, the appropriate regional packaging facility picks the required bright stock from its inventory and performs secondary packaging and labeling to produce only the type and quantity of patient kits requested. The finished kits are released, packed and shipped out to the clinical site in a matter of days.
Not only does the demand led approach mean that clinical sites receive the kits they need quickly, it greatly reduces the risk of treatment delays due to insufficient inventory. In addition, slower recruiting clinical sites are not faced with the challenge of storing an overabundance of inventory or potentially returning or updating the labeling on expiring inventory. Delayed commitment of the study drugs greatly reduces the amount of buffer stock needed from upwards of 200% or more common in today’s linear supply models to less than 20%.
By interrupting the traditionally linear supply chain at the primary packaging stage instead of the secondary packaging stage, the supply chain under a demand led approach is transformed into one that is flexible, efficient and most importantly, able to get study drugs to clinical sites quickly.
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