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Common Hurdles in Cargo Monitoring Logistics for Pharmaceutical Companies – and How to Clear Them

Now more than ever, ensuring the safety, quality, and timely delivery of pharmaceutical products to their final destination is a challenging and costly endeavor. With the tight regulation of supply chain systems, and the U.S. pharmaceutical market expected to grow to a value of $550 billion by 2020, pharmaceutical companies have little room for error when it comes to balancing careful cargo monitoring with reasonable cost output.

There’s no question that these companies face a number of hurdles in maintaining and tracking both the quality and the location of their cargo as it moves through the supply chain. From route and transition connectivity to en-route product quality, time-sensitive operations to environmentally-sensitive assets, real-time monitoring of cargo along the entire supply chain is more critical than ever. Fortunately, new technologies are providing solutions for those pharmaceutical providers ready to turn their supply chain problems into drivers of business success.

The Complexities of Temperature and Timekeeping

Monitoring cargo as it transitions between land, sea, and air routes is no easy feat, but ensuring that necessary conditions are maintained is a crucial part of transportation. Moving pharmaceutical products between the warehouse, suppliers, customers, and end users requires close attention to the environment in which it is being transported.

Factors such as temperature, light, tilt, and shock can all potentially damage cargo. For example, allowing drugs such as insulin to freeze and then thaw can compromise their integrity, and direct sunlight can cause irreversible damage. Considering the fact that half of all FDA drug approvals in 2017 were cold chain products, which means their transition through the supply chain requires careful temperature management, many of the drugs being transported require constant attention. In addition to this, the industry is moving towards biopharmaceutical products, such as personalized medicines and medications with high value and low volume, which have even more specific transportation needs.

So, we shouldn’t assume that keeping all drugs cold is a one-size-fits-all solution. There are new drugs on the market, including treatments for rare diseases that must be kept at body temperature.

In addition to their own strict temperature requirements, these drugs can also have shorter lifespans. They often require a different approach altogether than cold chain products, as they can’t endure the temperature spikes that may come in ambient containers. As pharmaceuticals continue to grow ever more diverse and complex, supply chain technologies must advance at the same rate to ensure quality is kept to standard.

Planning the transport of pharmaceutical goods from courier to courier also presents issues in terms of time-sensitive operations, as many products need to reach their destination within a specific timeframe to uphold their assured quality. Transitioning from different routes and modes of transport can cause delays, especially when the owner of the assets lacks real-time updates of the cargo’s location and must instead rely on shipping reports or out-of-date tracking solutions. The downside to this scenario is clear – if something goes wrong or a shipment is delayed, there is no way to immediately act accordingly.

Dated Solutions

There are available solutions to these cargo monitoring issues, but they are largely unable to provide pharmaceutical companies with the peace of mind that their goods are being kept in top condition from the beginning to the end of their journey. For example, some old sensors provide minimum visibility of goods but aren’t equipped to provide enough insight into the quality of the cargo as it passes through the supply chain. If a product were to arrive already damaged, manufacturers would only find out as a result of negative customer feedback – far too late for meaningful action.

More recently developed sensors are leaner and focus on real-time supply chain, yet they still lack effective tracking at the unit level.

With current real-time monitoring sensors, many pharmaceutical companies aren’t able to track the quality of the individual item. In the event of a problem that cannot be addressed while the cargo is en route, such as temperature fluctuations or light exposure, the whole order must be destroyed.

This is a scenario that can be entirely avoided with the use of item level sensors as part of a fully integrated serialization and real-time tracking solution. When the same situations occur – changing temperatures or inadvertent light exposure – pallets equipped with item-level sensors enable companies to track those products that have been negatively affected and those that have not. This type of monitoring drives greater efficiency, profitability, and ROI for pharmaceutical companies.

Handling and Preventing Instances of Theft

Theft of pharmaceutical products is not a new phenomenon. However, with the increase in valuation of many drugs over recent years comes a fresh need for companies to ensure that their cargo arrives safe and secure. Increasing health insurance prices coupled with a thriving black market also contributes to pharmaceutical theft, which can be hugely profitable for thieves. This is particularly urgent for sea cargo, which is on average 3.5 million tons every year, compared with 0.5 million tons transported by air.

While air travel ensures that medical cargo can make its way quickly and safely to its final destination, the numerous handling points of this cargo make it difficult to monitor closely through the entire supply chain. “There are a lot of different stakeholders that handle the cargo. Each individual partner in the supply chain has to meet the standards,” says Glenn Abood, CEO of rfxcel. “Otherwise the quality of the supply chain can be lost.” It’s this scenario that leads to annual product losses of anywhere from $2.4 to $12.5 billion – a significant amount for a market totaling $300 to $400 billion a year.

The Role of Technology

While the hurdles facing the pharmaceutical companies in their cargo monitoring efforts are abundant, technologies exist that can help alleviate these issues – and even stop them altogether. In fact, global pharma track and trace solutions are expected to reach a value of $2.38 billion by the end of 2023. It’s clearly a market that’s in high demand, and there’s no question why. These advanced solutions allow companies to combat theft and counterfeit products, while preventing damage in the supply chain.

Perhaps the most eff ective and advanced of these solutions are those using Internet of Things (IoT) technology. IoT enables data to be sent from connected products over a virtual network, thereby streamlining logistics and keeping operations moving efficiently. IoT live monitoring can give companies valuable and abundant traceable inputs, such as the temperature, tilt, shock/vibration, humidity, speed, pressure, and motion of the vehicles and the containers they’re carrying, as they move along the supply chain. These amount to real-time updates about sensitive cargo that is accessible at any point along the supply chain, with alerts and notifications delivered to smart devices that allow for preemptive action.

Embedded sensor technologies facilitate the digitization of the pharmaceutical supply chain, meaning companies can monitor their cargo closer than ever before. By digitizing their responses, companies can manage their supply and ensure better supply chain collaboration efforts both within the company and with third party logistics partners (3PLs). Real-time monitoring, which is facilitated by IoT-based solutions, means that companies can intervene immediately if they see that there is potential for damage to the product while it is en route to its destination. No longer will cargo arrive to its final destination, only for buyers to be presented with a damaged load that they cannot use.

IoT technology can also provide companies with insights at each stage of the supply chain, granting them the ability to make data driven decisions about considerations like routes and carriers. This kind of end-to-end visibility and control means pharmaceutical companies can transform the supply chain from “a cost of doing business” and a source of regulatory risk into a true business opportunity. They’ll be able to pull predictive and prescriptive data from all parts of the supply chain, conduct innovative analytics, cut costs, comply with serialization laws, and ultimately better serve their customers.

In terms of preventing theft, the use of real-time GPS sensors that track the cargo from the manufacturer to the end-user means complete visibility. In the event that packages are taken off –route or delivered to the wrong address, the asset owner is alerted immediately and so can act quickly to protect the asset. In fact, many sensors that form part of IoT technology can offer granular data in near real time. When this is coupled with unit-level tracking, companies can see the exact location and status of their units as they are being transported. It also goes without saying that a monitoring IoT device on a particular container is a powerful deterrent to any would-be thieves.

Monitoring cargo can certainly be seen as an obstacle-ridden task for many pharmaceutical companies. But the future is bright. Innovative IoT technologies make it possible for these companies to not only overcome the many hurdles inherent to supply chain transportation, but to turn previous disadvantages in their favor. These advanced solutions allow companies to keep a closer eye than ever on their goods. This kind of visibility makes it possible to protect product quality, enjoy a strong competitive advantage, create long-lasting customer relationships, increase efficiency on operations, and ultimately boost ROI.

Author Biography

Tea Rajic is a multi-faceted professional with experience in diverse industries across North America, Europe, and Asia. With a professional history in product development, design and marketing strategy across B2B and B2C sectors, Tea has been working with rfxcel to help Life Science companies meet global regulatory requirements and bring value beyond compliance.

The digital supply chain is not just about compliance; it’s also about business value and optimization.

Implementing track and trace solutions in a dynamic environment such as India takes planning and forward-thinking precision. While the Indian government requires Indian pharmaceutical companies to comply with the Drug Authentication Verification Application (DAVA) regulation, companies are also preparing to comply with the European Union Falsified Medicines Directive (EU FMD) and the United States Drug Supply Chain Security Act (US DSCSA) for their exports. While companies are very compliance focused, it is exciting to learn about the most sophisticated technologies in the world, and how they will impact the pharmaceutical supply chain.

Starting with compliance

Many regulatory agencies, like DAVA and FMD, require manufactured prescription drugs to be serialized and uploaded into a national medicines database. India is one of the largest providers of drugs globally. Therefore, it is critical that Indian pharma meet statutory deadlines like the November 26, 2018, DSCSA and the February 9, 2019, FMD. Fail to meet these requirements and Indian pharma economy will likely suffer.

Early adoption often leads to a gain in market share. Furthermore, serialization and traceability can provide companies with the ability to know every distinct entity within their supply chain, what each product is, and its make-up. Serialization paired with innovative technologies, like Internet of Things (IoT) technology, can offer additional value beyond that of traditional track and trace software. With the help of IoT, companies can pinpoint in real-time the exact location of a product, the temperature, the various routes and handoffs, and where the product ultimately ends up. Such on-demand end-to-end visibility has critical high-value implications.

The future with Blockchain, Artificial Intelligence, and Machine Learning

Traceability companies are unlocking the benefits of technologies like blockchain, artificial intelligence (AI), and machine learning (ML) to digitize the supply chain operations.

One of the most exciting innovations in supply chain at the moment is blockchain. Traceability companies, such as rfxcel, are actively working to pilot blockchain efforts. We believe that track and trace systems provide the perfect environment to experiment with blockchain. Because blockchain is a secure immutable technology that operates through a peer-to-peer network, our solutions have established ecosystems to allow only credentialed trading partners to participate in the medicines supply chain. While the data is currently being passed via web services with AS2 or EPCIS, these regulatory ecosystems have demonstrated that there can be a trusted partner environment with clear handoffs. Once regulations are fully implemented, and the trading partner ecosystems are connected and collaborating, blockchain technology will start maturing for the pharmaceutical supply chain.

Digital supply chain is also being affected by artificial intelligence and machine learning.  Track and trace and compliance efforts have led to enormous amounts of data, too much for humans to decipher and make decisions. We’re actively working with our customers to help them implement artificial intelligence to use their data predict issues.  Paired with machine learning, systems will correct issues by making decisions without human intervention. Pharma companies will see faster and fully optimized operations, including demand forecasting, intelligent logistics, course corrections, anticipatory ordering.

Compliance – everything to gain and nothing to lose

We encourage the industry to view compliance as the key to unlocking enumerable supply chain benefits. The future beyond DAVA, DSCSA, and FMD compliance is exciting, but companies must first achieve compliance before they can get to the good stuff.  And selecting the right solution provider is the key.

 

Vikash Pushpraj is the Senior Vice President in charge for Professional Services, Cloud Operations, and Customer Success of rfxcel. Before joining rfxcel in 2017, Vikash spent many years successfully leading departments of product development and customer success at a number of Fortune 500 software companies, such as PTC and Autodesk, where he was responsible for a product portfolio that generated $600+ million annual revenue. Vikash also has entrepreneurial experience from a number of successful start-ups and brings a renewed sense of vigor at rfxcel, often stressing the importance of time management and urgency in providing overall customer success.

About rfxcel:

Founded in 2003, rfxcel is one of the first companies to focus on the safety of the pharmaceutical supply chain and bring advanced track and trace software to manufacturers, repackagers, wholesalers, distributors, and dispensers. rfxcel’s mission is to be the thought leader in traceability technology for Life Science, Food and Beverage and other industries.  rfxcel enables customers to better manage their business today and deliver value tomorrow. For more information, visit 

IoT Is the Key to Supply Chain Continuity, Visibility, and Productivity

As the global logistics and supply chain industry continues to grow — it is expected to reach $15.5 trillion by 2023 — pharmaceutical companies are facing more hurdles than ever to monitor their cargo as it passes through the supply chain.

Critical priorities include maintaining precise environmental conditions, monitoring for damage or delays, and preventing counterfeit and theft. It should come as no surprise that managing these challenges on such a massive scale requires the latest technology.

Fortunately, the Internet of Things (IoT) has the power to alleviate a lot of these supply chain issues. And the market isn’t going to slow down any time soon: Global pharma track and trace solutions are expected to reach a value of $2.38 billion by the end of 2023.

Essentially, IoT enables data to be sent in real time from connected products over a virtual network, streamlining logistics and keeping operations moving efficiently. These solutions allow companies to prevent damage and delays all along the supply chain, and combat theft and counterfeit products.

Let’s take a deeper look into why it’s in the interest of every modern pharma company to get on board with IoT technology if they want to ensure continuity, visibility, and productivity in their supply chain, and, by extension, patient safety.

Continuity
Many pharmaceutical products must reach their destination within a specific time frame to assure their integrity. Transitioning from different routes and modes of transportation can cause delays, especially if the owner of the assets lacks real-time updates of the cargo’s location and must instead rely on shipping reports from other parties or obsolete tracking solutions. The owner is forced to entrust their products to a variety of couriers, with no real way to verify the status of the shipment until it arrives at its final destination.

The implementation of IoT technology provides pharma companies with insights at each stage of the supply chain, enabling them to make real-time, data-driven decisions about routes, carriers, and other vital considerations. This allows, for example, the “smartening” of warehouses and optimization of routes.

Furthermore, IoT technology allows companies to pull predictive and prescriptive data from all parts of the supply chain, conduct innovative analytics, cut costs, ensure meeting compliance requirements, assure patient safety, and ultimately better serve their customers. Companies will enjoy greater continuity with their products arriving consistently on time and intact, resulting in satisfied buyers and an improved reputation for the sellers.

Visibility
Unit-level visibility is more essential than ever. Temperature, light, tilt, shock, and other transport variables can damage cargo. For example, light detection inside containers is an indication of product tampering or alteration, products such as insulin need to be kept at a certain temperature and out of direct sunlight, and certain cold chain shipping containers require batteries that will be compromised if they’re not kept level. In fact, nearly all 2017 FDA drug approvals were cold chain products, which require careful temperature management throughout the entire supply chain process. Many of these are treatments for new diseases, making it even more important that they are well cared for.

Not all current monitoring sensors and data loggers can track the quality of individual items in real time, meaning many pharma companies aren’t able to truly safeguard their products during shipment. In the event of a problem that cannot be addressed while the cargo is en route, such as temperature fluctuations or light exposure, the whole order must be destroyed.

However, IoT live monitoring gives companies valuable and abundant traceable inputs, such as the temperature, tilt, shock/vibration, humidity, speed, pressure, and motion of the vehicles and the containers they’re carrying as they flow through the supply chain. This means, for example, if there is a temperature excursion or inadvertent light exposure on pallets equipped with item-level sensors, companies can track those individual products that have been affected. This type of monitoring drives greater efficiency, profitability, and return on investment.

Companies utilizing IoT technology get real-time updates on the status of their cargo, including location and environmental conditions, from anywhere in the world. Accessing these updates from the comfort of a smart device, a lead technician can diagnose a problem and send the requisite information to proactively fix it, regardless of how far they might be from the shipment.

Productivity
Theft of cargo remains a major criminal undertaking and, with millions of dollars’ worth of pharmaceutical supplies being stolen each year, it’s delivering a major blow to productivity and revenues. Not only does it disrupt the supply chain, it causes huge financial losses and can affect team morale. So, with the increase in valuation of many drugs in recent years comes a fresh need for companies to ensure their cargo arrives safe, intact, and secure.

IoT technology allows companies to exercise vigilance over their assets, with enabled sensors sending advanced data in real time. Couple this with unit-level tracking, and companies can see the exact location and status of their units as they are being transported. Live GPS tracks location and can verify if drivers are doing unauthorized pickups, raising flags for potential theft activity and identifying trends on carriers and routes. If anything, unusual happens, the owner of the asset is notified and can respond in a timely manner. With the implementation of IoT technology and the resulting drop in cargo theft, pharma companies enjoy greatly increased productivity.

The often-vast distances between “Point A” and “Point B” present challenges to effectively managing cargo. For industries as large and complex as pharmaceuticals — where time, care, and security could cost millions of dollars — efficiency is key. Advanced solutions made possible by IoT technologies allow companies to keep a closer eye than ever on their products, protecting quality, creating long-lasting customer relationships, and ultimately boosting their return on investment.

Author: Glenn Abood

Glenn Abood is the Founder and CEO of rfxcel. Glenn is known for his steadfast and thoughtful approach to building rfxcel, along with being able to motivate and build relationships with everyone, leading to company success and the establishment of key partnerships and alliances in the industry. For more than 15 years, Glenn’s focus has been on creating an agile company capable of developing reliable, leading-edge traceability, which has grown to be one of the most reliable and recognizable traceability companies in North America, Asia, Europe and Latin America.

Company: rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. rfxcel is headquartered in the USA and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

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