Clinical supplies & logistics
products, particularly biologics, are very sensitive to temperatures, a famous example being the smallpox vaccine, where temperatures above 10°C render the vaccine inert,” he says. “Then there are procurement issues. The clinical supply chain also accounts for the inputs into the manufacturing process and the material that accompanies the clinical product. This means that material shortages can completely derail the entire supply chain.”
The location of a clinical trial, whether it’s on-site or the products are administered in the patient’s home, can change the required supply chain strategy.
implemented, allowing the tracking from the manufacturer down to exact product information given to a patient,” adds Williamson.
Planning moves into the spotlight The current bubble in the number of clinical trials underway is partly due to the delays caused by the pandemic. By July 2020, around 200 companies had put clinical trials on hold, or cancelled them altogether.
“If I were leading a regulatory body, I would encourage pharma to harmonise study design to bring the best quality of trial, and data.”
Extended delays along the supply chain meant inventory buffers of key supplies were exhausted quickly. Every problem, however, is an opportunity to learn and improve. Extended disruptions highlighted the need for closer relationships between suppliers and couriers, and threw the spotlight firmly on planning, which now has to incorporate the likelihood of factors that were previously considered outliers – pandemics, cyberattacks, natural disasters and even war.
35,050
The number of new trials launched in 2022, as of 28 November.
Clinicaltrials.gov 24
There is no simple way to optimise supply chains for all kinds of study while accounting for a broader range of risks. Falling back on best practice in areas such as business continuity planning in the face of an unexpected disaster, or diversification of the supplier network to ensure that there is back up in times of crisis, is as good a place to start as any. For Williamson, there are three common challenges that clinical supply management can be expected to control. The first is temperature deviation. “Certain
There have been many instances when products could not be manufactured, or the syringes used to administer the product could not be supplied. For instance, in 2018 hurricane Maria devastated Puerto Rico, home to Baxter’s manufacturing plant. Baxter supplied 50% of US hospitals, and many more worldwide, with saline. The temporary closure had a huge impact on clinical supply chains worldwide. “Clinical supply managers were then expected to find other procurement routes from different suppliers and even countries, to ensure clinics and patients could receive the saline that was needed,” says Williamson. He further points to quantity forecasting as a key pillar of the planning process. Accurately forecasting demand plays a crucial role in clinical supply management and the overall need for clinical product must be calculated based on clinical study plans and patient projections, so that the forecast can be used for manufacturing and procurement activities to ensure enough product is available for the clinical trials.
“Should the clinical trial significantly change – perhaps the number of patients doubles – then there is an immediate impact on the demand for that product and if that was not previously incorporated into a potential scenario in the demand forecast, the result could be a lack of product for patients,” Williamson continues. Having worked on both the clinical sponsor side and the outsourced partner side, Williamson is nevertheless satisfied that the industry is generally well-prepared to tackle the demands of more complex supply chains, provided the relevant expertise are in place.
“Being able to understand the intricacies of the activities which they are outsourcing is important for a sponsor, so I believe that even small pharma companies should have a clinical supply chain expert to ensure adequate oversight,” he remarks. Just like in study design, Williamson sees controlling as many variables as possible within the supply chain as the key to ensuring the best possible outcomes are met. “If I were leading a regulatory body, I would encourage pharma to harmonise study design to bring the best quality of trial, and data,” he concludes. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Reenya/
Shutterstock.com
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