Company insight
Clinical trials and the commercial supply chain
Ian Hoban, Business development director, Abacus Medicine Pharma Services introduces his latest feature: “My previous article focused on four key issues affecting the clinical supply chain: maintaining continuity of supply; lead-time inaccuracy, expiry date limitations and waste. But before products enter the clinical supply chain, they have to run the gauntlet of the commercial supply chain. This article looks at some of the underlying factors that make it difficult to avoid hitting issues governed by the commercial supply chain.”
anufacturer lead-times can vary by manufacturer, product, sourcing markets and the stage that the brand is at in its life cycle. So, it is critical to have a handle on this from an early stage … and yes, they do change so maintain regular surveillance.
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Manufacturer commercial strategy Has far-reaching implications on the availability of the commercial medicines you are looking to source and varies greatly between manufacturers. Some watchouts include supply policy, global pricing policy and loss of exclusivity strategy.
Competition for patients Take into account your patient profile. If they are being targeted by numerous sponsors’ trials, this can result in lower-than-forecasted patient recruitment and large quantities of stock having to be destroyed.
Competition for medicines Likewise, competition can happen when the same commercial medicine is being sourced for similar clinical trials for standard of care or comparator products. If this is not carefully considered an unachievable sourcing plan will be adopted.
Loss of exclusivity status (LOE) LOE of a commercial medicine you are planning to source might mean lower acquisition prices becoming available. However, this may also result in lower availability as manufacturers will typically reduce forecast demand, resulting in lower levels of inventory in the post-LOE period. Subsequent reduced demand results in fewer batch releases and shorter expiries.
National policies and regulations This involves understanding and keeping up to date with individual customs
requirements or being aware of markets where key brands are frequently subjected to unilateral export bans.
Market variations
One obvious variation between markets is the population and sourcing large quantities of commercial medicines from small markets can potentially lead to local shortages. When this happens the manufacturer often puts controls in place which means bad news when you come to look at re-supply. Ensure that your sourcing strategy is sustainable when targeting smaller markets with favourable acquisition costs or availability of key quality documentation.
Balancing the risk of supply shortages against wastage To de-risk potential outages, it may be necessary to add more buffer stock than necessary, leading to costly write-off costs, but this may well be the right thing to do on the balance of risk.
Protocol and regulatory design with inflexibility ‘baked-in’ Build in sufficient “alternative” commercial medicine options into the trial design so that you can pivot rapidly if there is a shortage with the primary choice.
API issues
API sources for your selected commercial medicines can run out causing downstream shortages later. Monitoring this as a good potential indicator of imminent supply chain issues can buy precious time to react before the commercial supply chain is impacted.●
Abacus Medicine has developed a unique analytical and purchasing platform to help manage this risk. Clinical Trials Insight /
www.worldpharmaceuticals.net
www.abacusmedicinepharmaservices.com 27
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