Disrupting the pharma supply chain with IoT

Born from disruption

It was during the swine flu pandemic of 2009 that Controlant’s technology first answered the pharma supply chain’s call for greater visibility. “We were born from disruption,” Herjólfsson explains in his introduction at LogiPharma. “Since then, we have been serving global pharma companies and logistics providers with real-time visibility, validated data for product release, and a cloud-based system of record.”

A decade later, COVID-19 shook up the global supply chain and triggered an unprecedented acceleration of technologies and methodologies for speeding up drug development and navigating the complexities of cold-chain logistics. It had become clear that the pharma industry’s need for real-time visibility was acute, leading to an accelerated demand for Controlant’s solution at scale.

Continuous innovation

As the industry keeps evolving, Controlant is constantly innovating. “We continue to disrupt, finding ways to help transform the pharma supply chain,” says Herjólfsson. Controlant introduced a range of new innovations at LogiPharma EU this year—from new analytics tools and a biosample monitoring solution, to a new device for cryogenic shipments—but the biggest splash was made by Controlant’s Saga Card. First introduced in 2024, this groundbreaking compact device enables unit-level tracking and facilitates product safety and integrity.

Liquito puts this transformative disruption in the context of real use cases with real benefits for patients. Controlant and Roche are long-standing partners, and the Saga Card has been piloted at Roche for the past six months.

Future proofing

“Saga Card, put simply, is an active cellular-based IoT card that has been designed with a form factor for secondary packages,” says Herjólfsson.

"The intention is to provide visibility all the way from manufacturing to the point of consumption. We wanted to look at how to solve future pharma supply chain problems."

There are strong indications of what that future will look like when we consider how the pharma product mix is changing. Over the next five years, we can already see a shift in the volumes of high-cost, high-complexity shipments. There will be a big increase in biologics and complex molecules, for example. As the composition of products changes, the logistics needs change too.

This has been on the horizon for a while, but the shift is happening now.

“We also know that over the next few years, the technological advances are going to be massive. There’s going to be different modes of transportation in the supply chain, more going directly to patients, etc.,” Herjólfsson says.

“When we started this journey, we saw immediately that if we wanted to really disrupt, we needed a team of experts from the industry­—not just from the pharma industry, but also from technology providers.” Roche is a key partner in the Saga Card innovation project with Controlant.

A Saga Card use case

“If we think about IoT, and data in general, what are we actually trying to do?” poses Liquito.

“When we looked at the challenges that we’re facing, we looked at it in two different segments: what can we control and what can we influence from a distribution channel perspective; and how can we use these real-time data insights in order to drive meaningful discussions moving forward?”

Looking at the primary distribution channel, consider areas that are possible to control or influence. Within those channels, Liquito explains, they’re looking at three primary areas of control:

Better logistics

“How we can use the data to have more meaningful discussions with our logistics service providers and, more importantly, identify trends ourselves so that we can have those discussions with the LSPs to drive better services moving forward,” he says.

Product protection

This is about making sure that products always arrive in the condition they need to be in. “We need to start leveraging that data to be more efficient in the way we’re utilizing the information available to us,” he says.

“How can we use the data to interpret the performance of our shipping solutions and then drive more informed decisions moving forward? Can we do seasonality for instance?” Liquito asks. “With the data now, we’re able to make informed decisions, so perhaps we have a summer and winter timetable, to switch up different shipping solutions.”

Process automation

“The third piece, and probably the area that we’ve had most success in so far, would be with regards to using that data to automate some of our processes from a release perspective,” Liquito says. Roche has raised the bar for quality release processes, driving efficiencies by automatically releasing products without the need for any human intervention.

Increasing influence with Saga Card

Looking at the current landscape, Roche is ahead of the curve in leveraging data to take action that moves them forward. But there’s still a portion of the landscape that remains obscured, which Liquito describes as, “our influence section”.

“The challenge is that the further you go down the supply chain, the more complex the process gets, and you start to have less and less influence as you move further and further down the distribution channel,” he says.

Roche recognized the value they could unlock by using more innovative solutions to get closer to that distribution channel. “Imagine there was some form of an outbreak,” Liquito explains. “We’ve all lived through COVID-19 recently, so how would we be able to react differently in those kinds of scenarios if we had true end-to-end visibility?”

“How powerful would those decisions be if we could really understand and influence the movement of the product within our extended supply chain and have meaningful discussions about those?”

As well as helping ensure medicines reach their destination intact, safeguarding patient safety, Saga Card is designed to help pharma companies and logistics providers automate product allocation and meet challenges like theft and the unauthorized distribution of medicines.

Insights that empower customers

“From a patient perspective, how powerful would it be to be able to provide patients with insights into not only how the products are moving through the distribution channel, but whether they move through the validated and approved distribution channel, not impacting the efficacy of the product,” says Liquito.

“Then there’s the power of the dataset itself—because it all revolves around data.” You need to be able to use the available data effectively and influence the channel with it.

“How would we position ourselves differently, from a supply chain perspective, to not only be able to improve our own operational efficiency, but to provide customers with insights to take better and more informed decisions moving forward?”

The goal Roche set themselves was not just to utilize the data, “but to really transform the way we’re engaging with the end customers or patients, and provide insights that they otherwise wouldn’t have access to.”

Navigating complexity

Extending visibility down to consumer packages is new territory, and raises questions about scalability and sustainability, and about compliance and data privacy. For this project, Liquito identifies two main complexities: the feasibility of embedding these components at scale, and the concept of ‘big pharma is watching’.

Liquito points out that simply entering a packaging facility is a very complicated process, involving anti-contamination measures, such as putting on protective suits—“I disinfect my hands 12 times!” —and considering how strictly they need to control the environment, it’s clear that preparing to implement this new capability onto the lines is no small feat.

“In that respect, we’ve made a lot of progress to understand how to embed these devices onto a packaging line within the GMP environment, to enable the automated insertion of the product,” Liquito says.

“One critical element we have to overcome is: if we’re speaking about millions of units going out the door, we need to be able to automatically insert these into a validated line and have it run efficiently.”

The perception that big pharma is watching is another complexity, and one that could be detrimental to the approach, and even to the ongoing uptake of the technology throughout the extended pharma distribution network. “We’ve already started engaging with health authorities and regulatory bodies to not only help them bridge that gap between what we are doing and how we are doing that, but also the value this brings,” says Liquito.

Ironically, one way to mitigate this challenge is to offer everyone, including end-users, the same high level of transparency. As Liquito puts it,

"We need to start democratizing data."

“We need to make data available to a wider network and not restrict that, and have the extended network also benefit from the information that’s collected, and contribute towards things like serialization, track ‘n trace—all the buzzwords that we’re all working towards, trying to facilitate and embed within our distribution channels.”

Data overload?

The ball is already rolling with Saga Card at Roche, but if we look ahead to when millions or tens of millions of units are being monitored, that adds up to a huge amount of data. Is there enough value in that data to warrant the massive undertaking?

“How do you really judge value? Is the value of someone’s life and making sure the product itself, its efficacy, is maintained throughout the distribution channel, enough to warrant what we deem as value?” asks Liquito. “Yes, we seem to think so.”

"The technology is really making sure end consumers, and whoever's getting these drugs put into their veins or consuming them in any form, are protected as much as possible."

The illegal distribution of products is another case in point. “One product gets sold into a market and finds its way into another market—how do we ensure that the efficacy of the product is maintained in those kinds of scenarios?”

To do that, you need technologies like the Saga Card.

“These kinds of technologies bring light and enable us to have different discussions with, for instance, law enforcement to prevent the illegal distribution or movement of products from happening in the first place,” says Liquito.

Extracting value from data with AI

The ability to have these sorts of discussions will be greatly enhanced as the pharma supply chain becomes more AI-enabled—a hot topic throughout LogiPharma EU this year. Today, AI is less a buzzword and more a fixed part of any technology provider’s roadmap. In essence, AI is improving how humans interact with data. When data is more manageable, the value is easier to extract.

The use of generative AI for interpreting data greatly depends on the quality and type of data available. There’s no point organizing data into categories of shipments, temperatures, locations etc., if that data is not accurate, validated, and comprehensive. The Saga Card is key here, enabling the collection of GxP-validated data across the life sciences supply chain, from end to end.

Co-innovation is the only way

For this project, the task at hand was essentially to provide all the global connectivity and availability of data you have in a cell phone, squeezed into the size of a credit card.

"We knew we needed to push the technology to a boundary where it doesn’t exist today."

“Having a battery that could go into a credit card size, but still fuel an IoT module globally, and then run for two years plus for the lifetime of the product,” says Herjólfsson.

“The key is co-innovation,” he says, with wide-ranging and deep expertise coming from several technology partners. “There’s no way that the two of us [Controlant and Roche] could have done it alone.”

The Saga Card is a product of Controlant and their partners, as innovators and disrupters. It helps reduce supply chain complexity and solve future supply chain problems, so pharma companies and logistics providers can focus on their core business and be confident in the ongoing resilience of their supply chain.