With an increasing number of life science products requiring temperature control, maintaining the temperature of products in the clinical supply chain, whether it be cold, frozen or room temperature remains a challenge. Time is probably the most critical success factor in the distribution of temperature control clinical supplies.
Running clinical trials effectively can provide a company competitive advantage and clinical supply professionals have a unique understanding of just how important it is to ensure timely dosage of patients and keep to trial timelines.
Dan Holst Jakobsen, Systems Specialist & IT Coordinator and Abhijit Bendre Business Analyst CMC Clinical Supplies from Novo Nordisk, spoke to Pharma IQ about potentially reducing risk in the clinical supply chain of temperature sensitive IMPs and materials by shortening the lead times between packaging and the patient.
They discussed the advantages of postponing packaging decisions by as long as possible, in order to have more precise information regarding demand.
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"Just in time printing and packaging would be a great way of reducing risk because you have less product in the supply chain," said Jakobsen.
The industry is currently trying to reduce the amount of overages in clinical trials, due to mounting cost pressures. In a Pharma IQ interview Steve Jacobs, President of Global BioPharm Solutions, highlighted the changes he has witnessed in the clinical supply chain in recent years, he said:
"Typically, in the past of course, we would go ahead and we’d make a huge amount of clinical supplies. We would then package a huge amount, and then we would go ahead and wind up wasting anywhere between 20% and 50% of the supply that we’d manufactured and packaged. And we’re now in the process of really moving away from that as much as humanly possible, and we are trying to come up with ways where we can go ahead and create a situation where we can deliver the clinical supplies and get the patients in and the studies done as fast as possible in also a basically cost-reasonable way."
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There are many challenges the pharmaceutical industry faces in deploying multi-use packaging solutions for European or Global distribution.
In the 11th Annual Cool Chain Logistics Europe survey, the majority of respondents 41% found effective reverse logistics networks a challenge. Followed by asset management and tracking at 25%, cleaning, reclaim or decontamination standards/methods to satisfy QA 24%, lack of clear ROI models 23%, high initial capital outlay 14%, import/export issues 8% and lack of rental or leasing options respectively.
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