PHARMA SUPPLY CHAIN INTELLIGENCE

IT FOCUS

Adam Tetz, Director Worldwide Marketing Pelican BioThermal

How are IT solutions helping to mitigate pharma supply chain risks Advanced monitoring systems and asset management software systems are increasingly utilised to collect and analyse data How new technologies advancements in GPS tracking and demand for data collection enabled by the Internet of Things IoT are driving developments in the pharma supply chain

New technologies, advanced software systems, and the integration of IT within the pharma supply chain are increasingly playing a pivotal part in protecting pharmaceutical payloads worldwide.

Maintaining end-to-end pharma supply chain integrity is critical to mitigate risks within the pharma-logistics cool chain and better ensure the safe and secure transportation of health-giving and life-saving pharmaceutical products.

The global life sciences industry faces a number of complex challenges: protecting the integrity of their temperature-sensitive high-value payloads while mitigating costs, managing and tracking the assets within a complex cold chain closed loop logistics system, meeting stringent global regulatory standards and navigating complicated global shipping lanes and unforeseen challenges.

The market for transporting temperature-sensitive materials for the healthcare market, such as pharmaceuticals, blood, tissue, and organs is a sub-segment, currently valued at approximately US$2 billion and expected to grow to approximately US$5 billion by 2026.

With the pharmaceutical companies developing ever more complex and temperature sensitive drugs, there is a growing demand to integrate IT solutions within the supply chain alongside providing improved packaging performance and efficiency within cool chain logistics. It is also vital to ensure there is a secure, compliant cool chain from deployment of shipments to last mile delivery.

In a bid to ensure good distribution practice (GDP) regulations are adhered to within cool chain logistics, innovation, IT integration and new technologies are proving paramount to the emergence and evolution of smart temperature controlled packaging protecting pharmaceutical payloads globally.

The industry is also seeing a growing trend to deploy reusable systems coupled with asset management SaaS (software as a service) and reaping the associated benefits. These systems can automatically collect and analyse data from company smart data logger outputs. These monitoring devices are increasingly being used in cold chain as they are becoming more affordable and thus more accessible to pharmaceutical companies.

A key development includes live data monitoring of payloads, smart loggers and internet of things (IoT) devices which are interconnected to the IoT, making it possible to see the condition of the payload at anywhere across its journey. Being alerted about a problem within the shipped package before it reaches destination allows preventative or corrective supply chain actions earlier than might have otherwise been possible.

Integrating the cloud-based system supports and enhances engineering expertise that is incorporated into the development and design of the sophisticated systems utilised by the life science industries.

The data retrieved and shared can help the pharmaceutical companies make more informed choices on the most appropriate packaging systems to deploy depending on specific shipping lanes and routes their payload will need to navigate.

Increasingly, passive and active bulk systems are incorporating IoT devices to track the temperature, location and other data throughout the course of the trip.

Issues can arise for the temperature in the payload area, if the parcel is opened during a customs inspection, and the IoT device can track or warn when the parcel has been opened, for how long, and if there is a risk to the payload’s temperature requirements.

Alternatively, IoT devices can be attached to a specialised container to ship a pallet of products providing an isolated monitoring option to pick up data, which can be saved to the cloud via bluetooth or radio-frequency identification (RFID).

Currently operating in the market is a range of SaaS products providing collection and analysis of brand-agnostic sensor data, as its linked to a variety of smart packaging options allowing packaging vendors to track a diversity of data including vibration, light, humidity, and more.

These software platforms can capture and monitor information throughout the course of the shipments trip.

The latest development within the pharma supply chain and packaging industry transporting pharma shipments globally is the move toward GPS devices, which provide real-time location and tracking. This is a supplemental technology, compared via Bluetooth, RFID or manually-scanned barcodes whereby pharma companies can assess data in the payload at the point it can be retrieved via a nearby mobile device, stationary gateway or manually by package.

It is predicted that advancements in GPS tracking options via an online SaaS system will soon be part of the industry. There are benefits to pharmaceutical companies knowing where their shipment is throughout its transportation trip.

If payloads are lost or get delayed en-route, the pharmaceutical company can take steps to intervene and recharge or replace coolants so the package or the bulk system gets delivered before expected temperature duration is exhausted. This presents a strong case for using IoT devices and their supporting software and technology to mitigate a temperature excursion caused by a delay.

In an ever-evolving pharmaceutical industry various drug product compounds, utilised in the sector, are developed in certain temperature control conditions or designed to be stored at specific temperatures to maintain their stability.

It’s critical when shipping pharmaceutical products between locations they remain at their storage condition temperatures to maintain their effectiveness at the point of use by patients.

Any spikes, valleys, or deviations in temperature, beyond the range-specific pharmaceutical products that are required to be stored and shipped at, could have a devastatingly detrimental effect on the payload, damaging the container’s contents and impacting on the efficacy of the products being transported for use by patients.

It is essential, therefore, that pharmaceuticals are protected throughout the supply chain as temperature excursions during transportation can even cause them to become toxic. As a result, temperature monitoring is becoming more commonplace, due to the cost of IoT devices and the capture of the data becoming both affordable and accessible.

Increasingly, pharmaceutical companies have a sophisticated understanding of the temperature stresses their products experience during shipment in certain lanes. They can better determine what is a high-risk or low risk lane and then make the appropriate packaging choice to fit that requirement. More data and predictive analytics from IoT devices and supporting SaaS solutions allow pharmaceutical manufacturers to make effective and cost-saving decisions on their cold chain logistics that are driven by data.

We are also seeing an increase in the introduction of information-centric capabilities to assist with the safe shipping of pharmaceuticals around the globe.

Packaging companies are frequently utilising advanced asset management software systems, which are in place specifically to ensure drug products are shipped to the right place, at the right time and, critically, in the right condition.

Companies deploying pharmaceutical shipments worldwide benefit from the introduction of new technological advancements and web-based asset management software solutions designed to track individual shipments around the globe.

These systems offer a range of capabilities benefiting the industry including the option to set up automatic maintenance, next shipments alerts and produce customisable reports.

Whether shipping finished products, transporting clinical trials materials, or delivering sample drugs, temperature excursions can mean the difference between success and failure, profit and loss.

Some of the latest innovations in smart packaging, serving the life sciences and pharmaceutical industries, are critical developments as ultimately the quality of pharmaceutical products being transported has a direct effect on patient safety and the efficacy of patient therapies.

Increasingly, advanced information technology is available to pharma companies, which can be utilised to track the packaging deployed in real time or capture data once the shipment reaches its destination.

Real-time monitoring could be used to know quickly if a shipment has, or may have, a temperature excursion, or will be delayed from reaching the patient. Therefore, allowing a new shipment to be sent out quickly to the patient, with the original being reclaimed or disposed of, depending on its status.

IoT solutions, GPS tracking, and temperature monitoring are gradually providing vital assistance in the global pharma supply chain enhancing the protection offered by advanced temperature controlled packaging solutions.

The use of that data and the sharing of that data with both packaging providers, logistics providers and the pharma companies themselves is an area of significant interest. It should support the development of better and more effective solutions to meet the challenges that are now better understood through that data.

With the rapid rise of biologics and biosimilars within the pharma development sector, the need for transportation temperature control is ever increasing, where any minor temperature excursion within the supply chain can have costly consequences for patients and pharmaceutical companies alike.

More complex distribution lanes, with emerging markets, geographies and increasing regulatory compliance conditions are some of the challenges when transporting these temperature-sensitive biologics/biosimilars.

Blockchain is another technology finding its place in supporting pharmaceutical manufacturing’s cold chain logistics processes. Blockchain is having a real impact on pharmaceutical shipments, from prevention of theft and counterfeiting of pharmaceuticals, to tracking root cause of a dangerous event that causes illness in a patient, to government tracking of source of origin to properly assess duties and taxes for imports.

Artificial intelligence (AI) and the predictive guidance it offers is another technology impacting how pharmaceutical manufacturers ship their drug products around the world. AI can quickly sift and sort through massive amounts of data from IoT devices and determine patterns on best packaging or process or mode to use on divergent shipping lanes.

The increased need for last-mile pharmaceutical transportation is another growing trend, as it also requires stringent compliance throughout the cold chain process to ensure the protection of high-value, temperature sensitive, pharma payload through a complex and diverse logistics path to the patient’s hands.

These additional trends are worthy of their own articles, due to the intricacies and variability of their applications to the pharmaceutical manufacturing industry and the protection of their temperature controlled shipments.

It comes down to helping pharmaceutical manufacturers better understand the true cost of impact of moving to newer technologies and what impact that can have for their operations. Ultimately, ensuring stability in the supply chain is critical within the pharmaceuticals industry where patient safety and efficacy are an absolute priority.

--PFA Issue37--

Author Bio

Adam Tetz

Adam Tetz is Director of Worldwide Marketing at Pelican BioThermal and has more than 20 years of marketing experience. He is responsible for worldwide branding, product launch and communications strategy. Prior to Pelican BioThermal, Tetz held positions in product management, marketing communications and account management across a variety of industries, including medical software, financial software and professional services.

He holds an MBA in Marketing from the University of Saint Thomas and a BA in Advertising from the University of Minnesota.

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