Cloud-based temperature-monitoring solutions offer big benefits to pharmaceutical operators, but they’re not easy systems to implement. Elly Earls meets Doug Meyer, associate director of clinical drug supply at Biogen; and clinical supply consultant Philip Chou to find out why they’re worth the hassle.

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Ensuring drugs are stored at the right temperature during transit is crucial throughout the entire pharmaceutical supply chain; an excursion from the prescribed temperature range can compromise product efficacy and, therefore, patient safety. But nowhere is this more important than during the clinical supply process – to ensure the safety of trial participants, and guarantee consistency of results between and within batches of drugs.

Temperature monitoring solutions – the devices themselves and the software they link to – are key to achieving this and, thanks to rapid advances over recent years, the latest cloud-based systems are not only ensuring operators meet the minimum regulatory standards but bringing important business benefits too.

Ahead in the cloud

When it comes to the temperature recorders themselves, the biggest advancements have been in battery life – the devices can now last for months – and the communications technology that is used to transmit temperature data back to operators. While even up to just a few years ago, the radio transmitters in these devices were only powerful enough to be short range, today, mobile-phone radios can be incorporated into them, allowing each recorder to communicate directly with the cellular network. Not only does this give operators flexibility when it comes to choosing vendors but it also means the infrastructure around temperature monitoring is a lot less costly to develop.

Alongside this, temperature-monitoring software has also advanced hugely. The latest cloud-based solutions offer real-time tracking, so the clinical supply team can see the temperature of a shipment as it moves through the supply chain, as well as allowing operators to visualise their entire temperature-controlled supply chain in one place, giving them important insights into where things are working and where they aren’t.

When combined, these advances mean operators that invest in the latest temperature-monitoring solutions get two key benefits: the ability to act fast if something does go wrong and the opportunity to make better decisions based on a comprehensive database of consolidated temperature information.

“Our system has been fully operational for about six months now, and we’re already seeing that there’s a wealth of information we can capture, which means we can make decisions based on how our shippers are performing, how our shipments across different shipping lanes are being tracked and how our carriers are performing too,” says Doug Meyer, associate director of clinical drug supply at Biogen.

It hasn’t been a simple task to get to this point, however. The selection of the right system for the company’s particular supply chain operation offered the first challenge.

“It’s important to have a set of requirements at a high level that you’re looking for and see how each of the different providers meets those requirements,” Meyer says.

“You also need to look at how the new system is going to impact the company’s processes and all the different parties involved in those processes, whether they’re the shipping parties or the receiving parties. Do they need access or permissions? Do they need to install software at their location? What kind of training and support will they need to implement the system?”

Each company also needs to ask whether they want a specific system for the clinical supply chain or a solution that covers the clinical and commercial sides of the business. In Biogen’s case, the latter made more sense.

The power of one

“We have a lot of shared processes between us and the commercial supply chain, and some shared resources, especially in our quality organisation, so there was a lot of drive to have a single solution that could work across clinical and commercial,” Meyer says. “If you look at some of the larger pharmaceutical organisations with supply chains that are much more separated, though, I think a different solution might be more justified.”

Finally, any system selected has an easy-to-use interface, which all the different parties involved can work with, whether they’re uploading data, entering shipments or reviewing the status of shipments. “Simplicity is key,” Meyer stresses. “Look at how you’re going to use these solutions to make your operation more efficient and effective.”

The next question, of course, is ‘How much is all of this going to cost?’ And it’s one that needs to be asked not only in relation to the software itself, but also the time and resources that will be required to implement an entirely new system, as well as any extra charges that could be incurred by third-party shippers that have to switch to that new system.

“The cost is the cost to implement the solution,” Meyer emphasises. “It’s the investment in getting it up and running, and having a big project team together to do that. Of course, there’s a cost to the software, which can vary, and once you’re in the maintenance mode, it will depend on the number of users and devices associated with it. Overall, we didn’t see a big difference in the cost of the devices; the biggest piece was the implementation.”

Meyer and his team decided that the costs were more than justified. “We looked at what time and resources we would save compared with our current processes, which involved spending a lot of time tracking data and manually reviewing printouts of temperature charts. Having ways to automate that was huge, as was having timely access to the data,” he says.

“Previously, it could take us days or weeks to get data after there was an issue with a shipment so, in the meantime, we would ship more product because we didn’t know whether the previous shipment was usable or not.

“Often, the product ends up being usable, but we didn’t know that in time, so we’d end up incurring extra costs to expedite the new shipment and the site would receive twice as much material.”

Another compelling reason for Biogen to invest was compliance. “Having all your data in one place and validated is a huge benefit from a compliance perspective,” Meyer says, although he does admit that this side of things is harder to quantify.

This is a dilemma that many pharmaceutical companies face, says Philip Chou, principal at Philip Chou Consulting, a clinical supply chain consultancy providing solutions in global clinical supply chain. Having consolidated shipping records means it’s easier and quicker for operators to bring up the temperature data required by regulators, but how much money is this going to save them?

We looked at what time and resources we would save compared with our current processes, which involved spending a lot of time tracking data and manually reviewing printouts of temperature charts.

“I can do it in ten minutes with these systems rather than going to the clinical site and going through individual protocols, but how much does that cost? What’s the return on investment? It’s hard to quantify,” says Chou, who isn’t seeing many operators taking the plunge to invest in the latest cloud-based systems at present, largely because it’s tricky to put a figure on the return on investment they offer.

Regulatory pressure in this area, however, could be the push operators need. “All it would take is a company to go through an audit and have to go through a lot of pain to try to retrieve this data for the regulatory inspector. Once that happens, I think they’ll be much more motivated,” says Chou.

Current EU GDP guidelines, which came into effect in 2013, state that “customers should be provided with information to demonstrate that products have complied with the temperature storage conditions”, and inspections have been more frequent in recent years.

“What I have experienced – at my previous company and also hearing from my peers – is an increase in requests from regulators inspecting clinical sites for the sites to provide proof that the drug temperature during shipment was within the acceptable range,” Chou says. “Sites that don’t have their own copies of the temperature recorder data will ask the study sponsor for records, and those requests end up with the clinical supply chain group. Having a cloud-based system would allow us to provide the proof a lot more easily.”

Once a solution has been chosen and the costs justified, the final – and for Meyer, most challenging – step is how to implement and integrate it across the entire supply chain network, ensuring that the process works just as well for internal sites and external partners.

Finding harmony

“We had to ask how we were going to roll this out to our different supply chain partners, who have different experiences and capabilities,” he says. “We had to think about the required training and controls, and having a harmonised process that would work across internal and external distribution sites.

“It’s really important to get that alignment in how you programme the devices and how the software is configured. It is a challenge we continue to face, and takes a lot of time and effort on the external sites.”

Having all parties involved from the outset means it hasn’t been insurmountable. “The thing that was very helpful to us is that we spent a lot of time on the planning piece, more than we anticipated, to ensure that we got our internal and external partners involved in the process,” Meyer says. “They were involved even while we were still doing the vendor selection. Having that early involvement was a key enabler for us to have success down the road.”

Not only are temperature monitoring tools themselves set to continue to evolve but it should also become easier to integrate them with other tools across drugs’ life cycles. “The big, exciting thing down the road is looking at how we can better monitor products across the whole life cycle – from the manufacturing site to the patient’s home,” Meyer says. “That’s going to take a while, but it’s a very exciting prospect.”