Sarah Smyth, Temperature Services Manager
Sarah Smyth graduated from Queens University Belfast with a BEd in Business Studies. After graduating, Sarah gained a wide range of experience working in the clinical diagnostics industry, especially around solutions regarding shipping temperature sensitive product in challenging climates.
Sarah joined Almac in 2016 and has worked with a large number of Pharma and Biotech companies initially in developing proposals to fulfil packaging and distribution needs, aiding in the successful delivery of a range of clinical trials. More recently, Sarah has worked closely with clients to understand the challenges they face with distributing temperature sensitive drug product and advising on the best solutions to implement for efficient management of temperature data on a global scale.
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Ten minutes with Almac’s Sarah Smyth, Temperature Services Manager
Most companies are well aware that defining a robust temperature management strategy is key to maintaining drug integrity, ensuring patient safety, driving cost efficiencies and delivering on regulatory requirements. Yet, with the biopharma industry losing approximately $35 billion annually as a result of failures in temperature-controlled logistics alone[i], it is clear that there are still some challenges in identifying and adopting effective temperature management strategies.
In order to help give some guidance to sponsors with this we’ve collated some frequently asked questions and put them to our in-house temperature management specialist, Sarah Smyth.
So, sit back, relax and take a few minutes to check out Sarah’s expert insights…
[i] https://www.aircargonews.net/sectors/pharma-logistics/failures-in-temperature-controlled-logistics-cost-biopharma-industry-billions/
How can sponsors ensure appropriate temperatures are maintained in transit?
Managing this risk requires an approach that not only thinks about how to maintain temperature during transit, but how to prove that this actually happened. This can’t be achieved without a robust distribution strategy, incorporating an approved courier network and underpinned by expert assessment of appropriate distribution models (direct to site vs. via a local depot), shipping lanes at country level, import documentation requirements and facilities at the destination.
Use of thinner, more flexible and reusable shipper solutions, designed with innovative materials and technologies is another way sponsors can safeguard the integrity of temperature-sensitive drugs in transit. More companies are moving towards shipper solutions that utilize phase change material to offer enhanced thermal protection. Placing this type of shipper into appropriate storage conditions at each point of the supply chain improves operational processing capacity and performance, ensuring that drug supplies are kept at ideal conditions for the qualified time period.
Use of a temperature monitoring device is also vital in ensuring that the temperature has been maintained during transport. The key thing here is making sure that the temperature data from the shipment gets reported and analysed in a timely manner. Without the data there is nothing to prove that there were no alarms during the shipment and this is so important for sponsors to be able to stand over their supply chain.
How can sponsors boost site compliance?
There are two aspects to consider here; getting the data back from the temperature monitor received by the site and then, the piece that a lot of sponsors really struggle with, what happens with temperature management when the drug is actually at site. And how can we make sites more compliant? Make the temperature management process as straight forward as you can!
A process that is easy to follow, without lots of paperwork and support of a dedicated team helps ensure that sites will do as they should with sponsors’ temperature data. Where possible, especially around excursion adjudication, sponsors should utilise as much technology as possible, for example, a temperature management software with automated excursion workflows.
The less we give sites to do, the more compliant they will be!
What role does data play in delivering robust temperature management?
Access to data is the core of a successful temperature management process.. It’s important that temperature data is captured effectively, in a timely manner and is visible to sponsors from product manufacture to patient administration.
Having access to this temperature data ensures that sponsors are audit ready and can stand over their supply chain.
A temperature management software helps to manage data in an efficient way, offering sponsors a single database to store, retain and analyse temperature data, effectively manage excursions and ensure product quality and patient safety.