Company insight
The key issues impacting the clinical supply chain
At the GCSG 2023 US conference, Abacus Medicine Pharma Services led a presentation and discussion into the factors that continue to undermine the clinical supply chain. The company expand on their presentation for Clinical Trials Insight.
A
fter extensive research with clinical supplies professionals, Abacus Medicine Pharma Services (AMPS) believes most of the commonly reported issues with the clinical supply chain fit into four categories.
Maintaining continuity of supply Continuity of supply is the holy grail and a catch-all for supply related issues. It is no surprise that it is the most widely reported challenge by clinical supplies professionals. Practically anything can go wrong and this will ultimately impact on or will potentially threaten the continuity of supply.
Lead-time inaccuracy
Lead-time inaccuracy is also a common issue that impacts on the supply of commercial medicines into clinical trials. It is important to recognise this is often much more than just the delivery of the medicine being delayed. There are numerous dependencies along the critical path within the clinical supply chain that mean a delay in supply can have a compounded effect. A few days delay in supply could potentially add weeks or months to the product being available to patients. It is also important to recognise that the lead-time for the delivery of the drug is inextricably linked to the accuracy of lead-time of any quality documentation that is specifically required, or the lead-times associated with applications for things such as importation licenses to get the medicine from where it is located to where it is required. All these need to be accurately built into the forecast or slippage will be inevitable.
Expiry date limitations Expiry date limitations need to be recognised, as the reality of commercially
Clinical Trials Insight /
www.worldpharmaceuticals.net Delays at any stage of the clinical supply chain can be frustrating for researchers, but they are often preventable.
available expiry dates are usually very different to those promised by the SmPC or historical information. Some notable examples are omalizumab, which only has an 18-month shelf life and, therefore, an even shorter commercially available expiry date, or pembrolizumab that has a two-year shelf life, according to the SmPC, but rarely has a commercially available shelf life of greater than 12 months.
Waste concerns
When it comes to waste, it can be costly, with significant quantities of commercial medicine written off when it is not used in the trial. This does not sit well when medicines are needed for patients elsewhere. Factors such as: ■ Optimistic forecast of initial patient recruitment, resulting in too much stock being ordered and having expired before sufficient patients had been recruited.
■ Poor oversight of inventory held in individual trial centres leading to product expiring in centres where
patient recruitment had been lower than anticipated.
■ Having to deal with surplus inventory when a clinical trial has been delayed or cancelled.
These four key issues could typically result in serious consequences which could include: ■ delays to the start of the trial ■ delays to the end of the trial ■ cancellation of the trial ■ loss of patients who were recruited into the trial when no medicine was available
In addition, this can cause significant delays to the MA file submission to the regulatory authorities that could result in a delayed product launch, revenue loss, potentially being second to market and a negative impact on the market valuation of the company. ●
www.abacusmedicinepharmaservices.com 27
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