Securing the Pharmaceutical supply chain is more important than ever before— a planet's health depends on it.
When pharma giants Pfizer and Moderna both announced in early November that their hastily developed Covid-19 vaccines were over 90% and 94% effective in clinical trials, the world breathed a palpable sigh of relief. After months of uncertainty and tragic headlines, finally there was some hope for a cure.
But with that relief came the public realization of a new series of equally enormous problems; how to maintain the proper scientific and safety standards in the middle of a race to develop and trial a vaccine, the fastest one to market in history; how to maintain those safety standards once the vaccines were in mass production; and most importantly, how to ensure that a functional vaccine reaches every person on the planet.
The scope and importance of these tasks are unprecedented. This is certainly one of the biggest logistical puzzles humanity has ever faced. Theoretically, 7.8 billion people need a vaccine, and the diverse and stringent requirements of the various vaccines coming to market, as well as the sheer scope of the project, could lead to deadly supply chain mistakes. What happens if a vaccine arrives too damaged to be effective? How does one know that the shot they get is in fact the genuine item and not a counterfeit that slipped into the system? How expensive will this whole operation be, including all the necessary extra costs like tracking and documenting the distribution? These are all questions that pharmaceutical companies, governments, and logistics providers around the world are now facing, and it’s a truly daunting task.
Preparing to Vaccinate a Planet
Much of the news coverage around the Moderna and Pfizer vaccines focus on their long term-storage requirements of -20°C and -80°C respectively, well below the standard capabilities of the existing cold-chain infrastructure. In actuality, however, most of the upcoming crop of vaccines will likely be transported at temperatures compatible with existing cold delivery systems.
Practically speaking, the biggest problem is not actually temperature, but scale. With a supply chain this complex, requiring accelerated processes, there are risks from counterfeiters, human error, and even natural factors. Maintaining safety and security standards, not to mention the integrity of the supply-chain, during such a massive coordinated effort will be particularly challenging for last-mile delivery, but also for trans-continental shipping. One estimate says that the number of vaccines needed would fill 8000 Boeing 747s, and global cargo shipments are already slower than usual as the lack of passenger travel means less shared hold space in commercial flights.
As the World Economic Forum has identified, the logistics alone are “the problem of a lifetime.” With 250 separate vaccines in development, each with its own transportation, storage, and administration criteria, these variables are further compounded. According to the WEF, one of the most important factors in making this all possible will be the availability of data to all the relevant parties (governments, logistics providers, and healthcare professionals). And the security of that data will be just as important as its accessibility.
So, how will these problems be solved, all this data secured and made available to the right people? These requirements are simply beyond the capabilities of manual, isolated logistics processes. Covid-19 vaccines need a supply chain that is transparent, secure, and steerable, and the only way to achieve this is through an integrated digital ecosystem.
How Modum Can Help
What Modum provides pharmaceutical and biotech brands, as well as distributors, is efficient transparency and steer-ability over the entire vaccine supply chain. By seamlessly interfacing modern sensing solutions with one integrated digital ecosystem we can provide precise awareness of a good’s location and physical condition at every point in its journey from the manufacturer to the user. Our data logger handling is not only uniquely scalable and easy to use, it’s also the most secure in the industry.
As they say, knowledge is power, and this deep integration gives our customers a holistic overview of fulfilment tracking, product quality assurance, and anti-counterfeit management simultaneously in real-time; we even have built-in compliance mechanisms! This unified approach addresses many of the challenges that come with distributing COVID-19 vaccines in one comprehensive solution.
With this integrated and scaleable approach, Modum is able to take our customers right from a world of isolated, reactive, manual processes into an easy-to-manage and proactive operating model with substantially less human effort.
Work Smart, Not Hard
How exactly is Modum able to achieve all this? By working smart. We help our customers leverage all the data that's collected in order to optimize their supply chain and automate day-to-day logistics processes, ensuring that goods arrive on time and in perfect condition at the lowest possible price. This will be particularly important as the distribution of vaccines ramps-up, and the complexity and strain on existing systems increases. Modum’s solutions help to reduce waste from error, lessen the burden of compliance monitoring and documentation, and ensure data transparency and security at every point in the vaccine’s journey, from clinical trials to local delivery. As global operations scale-up, our solutions integrate easily into existing logistics systems so that no one needs to change their proven methods. We tag along for the ride, giving customers peace-of-mind with the absolute certainty that their vaccines arrive in perfect condition, tamper-free, and on-time.
Let’s look at three specific areas of a vaccine’s journey where Modum’s solutions ensure a steerable supply chain.
For pharmaceutical companies, clinical trials are perhaps the most costly and delicate part of drug development, the make-it-or-break-it stage. All the time and effort spent developing a new medicine can go out the window if a sample is mishandled in a clinic.
Monitoring a drug kit over the clinical trial supply chain and steering the patient supply becomes a tremendous challenge at the clinic level, as reliable location and condition data is often missing. This usually introduces significant steering delays for the study managers.
With MODsense, Modum provides clinical trial supply coordinators with unprecedented real-time feedback throughout the clinical trials process, from transport to the clinic, in-clinic fridge monitoring, and eventually quality assurance release management. All of this monitoring is taken care of by MODsense with the help of cost-efficient kit-level data loggers and MODsense Gateways. These small access points only need a power connection to gather data from nearby MODsense loggers and then send alerts and data to our cloud platform via the cellular network. Because this system is closed-loop, there’s no need to integrate with the clinic’s IT platform. For accelerated trials like those that Covid-19 vaccines are going through, the margin of error is razor-thin and our monitoring solutions ensure that there aren’t any delays or unpleasant surprises from auditors throughout the trials process.
For more information on Modum’s solutions for real-time monitoring and quality assurance during clinical trials, click here.
Counterfeit Protection & Warehouse to Warehouse Monitoring
When the stakes are this high, and the potential holes in the system this big, the primary distribution stage, the first few stops on the vaccine’s journey from manufacturer to local distributor, are where the scale of this whole operation starts to hit home. This primary delivery stage will only become more important as the global operation ramps up over 2021. To cope, logistics providers like UPS and DHL are building massive cold storage facilities in the US and Europe, so as the first few vaccines reach the market, hundreds of millions of doses will be moved between storage warehouses as they are divided up by region.
During this process, Modum’s Warehouse-to-Warehouse monitoring solutions ensure clear and transparent quality-assurance data at set gateways, or continuously in real-time, depending on budget and needs. Our solutions have the flexibility to work as standalone products or, with multiple interface options, can easily integrate with logistics providers when needed. Modum’s approach to real-time tracking is automated and risk-based, helping companies exceed their monitoring requirements while simultaneously reducing costs thanks to automated workflows and smart integration. Our system is so efficient that it can cut primary distribution monitoring costs by a factor of five or more when compared to traditional USB data loggers and PDF-based documentation processes.
The primary distribution stage is also where vaccines are the most vulnerable to criminals and counterfeiters. Interpol has gone so far as to call vaccines “liquid gold” to organized crime, as thousands of doses sit vulnerable in warehouses. For pharmaceutical companies, as well as local governments and healthcare providers, this is a nightmare scenario.
Modum tackles this issue on two fronts, first ensuring that there is a steady stream of real-time data to guarantee the status of the vaccines and detect lane deviations, and then securing that data so that it cannot be faked. This is accomplished by creating an immutable link between our MODsense data loggers, the shipment ID, and the shipment's quality requirements. All this is stored on the device itself, bringing multi-factor authentication back into the physical supply chain. In short, our customers can be certain that only authorized personnel are able to interface with our sensors, and will know if the shipment is tampered with at any point.
For more information on how Modum can lower QA costs and keep vaccines out of the hands of criminals during the primary distribution phase, get in touch with us.
National and Last Mile Distribution
The ‘last-mile’ typically presents the biggest distribution challenges, as this is where the variables become more numerous and more unpredictable. Factors like infrastructure, staff training, weather, even traffic play a far more disruptive role here than in hub-to-hub transport, so it’s here that a well-controlled supply chain really earns its keep. Being able to prevent errors and optimize these final stages, particularly when the vaccines must be kept at a degree-specific temperature to be effective and save lives, is an absolute must. But many distributors rely on active or passive cooling of their goods on a stage-by-stage basis and check the temperature of sporadic qualification shipments, rather than continuously monitoring each one. It takes enormous effort to manually piece these individual measurements together into something resembling a complete picture, in particular , and there is serious risk of human error or even the loss of vital vaccines.
With MODsense, we can solve all of this. As our system enables wireless pairing between the order ID and the associated device and works with role-based permissions to interact with the system, the overhead of tracking and tracing shipped vaccines is greatly reduced. This way, our easy-to-use solution improves visibility, security, and efficiency, all while creating a GxP compliant audit trail and delivering up to date monitoring data to help customers steer their distribution.
Modum’s MODsight AI system can even predict the payload temperature of a transportation box based on a combination of past MODsense T logger data and weather forecast info. These projections are accurate enough to make real-time recommendations to shippers for selecting the most cost-effective insulation packaging that still ensures the temperature requirements of the individual shipment. In our experience, this smart optimization means a major reduction in packaging costs, up to 40%.
Modum is a Swiss company filling a highly specialized niche. We provide secure digital supply chain steering data at scale for drug companies and logistics providers, a role that has suddenly become more important than ever during this Covid-19 vaccine rollout. We also help pharmaceutical and biotech brands uphold their reputations by providing actionable visibility, guaranteeing the quality and authenticity of the delivered medicines while ensuring timely sales fulfilment. Our seamless combination of smart data loggers and modern data management software tools ensures there are no surprises anywhere along the supply chain.
In essence, we serve as an independent data manager and audit trail provider, keeping brands appraised of their products, helping them reduce monitoring and QA costs, and ensuring transparency from logistics providers. We can achieve all this by providing an interface between the physical and digital worlds, bringing together modern technologies to create one scaleable, steerable, end-to-end supply chain monitoring and tracking solution.
As countries around the world ramp up their Covid-19 vaccination, the modularity of our system allows you to start at the scale that is most useful for your organization and grow from there. Reach out to us to learn more about how we can with Covid-19 vaccine distribution.