Pharma 4.0 can improve product safety. Here is how.

Ask healthcare and biopharma industry leaders about the highest impact risks facing their global supply chain in the coming decade and they will invariably highlight one priority above all – product safety. Safety is the beating heart of the entire value chain in healthcare.

Product recalls and safety concerns are not only propelling pharma manufacturing onto the public stage, they are also bringing the pharma supply chain that supports biologics-based manufacturing into sharp focus.

This spotlight on quality and compliance is also due to changing biopharma trends that affect cold chain logistics.  

For instance, we are seeing a shift from transporting chemical based active pharmaceutical ingredients (APIs) to biologics. An increasingly complex, time-consuming and expensive drug creation process.  Rising demand for cold chain freight shipping solutions from suppliers to manufacturing plants due to the complexity and high cost of new APIs. All this is escalating production and completion, putting more cost pressures on companies.

Yet many medical and life science products are still being transported the same way they were 25 years ago. The industry as a whole has to deal with theft, damage, spoilage, wastage, expiration and often weak monitoring of pharma cargo. Falsified, substandard, contaminated or even counterfeit drugs. Multiple players and countries – with every step in the cold chain shipping of chemical and biologic based ingredients presenting challenges that can make or break the integrity of the cold chain logistics.

The growth of biopharma brings added urgency to improve safety, with global biopharma cold chain logistics estimated to grow from $15.7 bn in 2019[1] to almost $17 bn by 2020[2].

So the burning question is: how can we leverage technology possibilities and digital transformation to build a safety-first, quality control-obsessed supply chain? In addition, in doing so, how can we future-proof Asia’s growing role in global pharma manufacturing in the 4.0 era?

Intelligence will power the next generation, safety-first supply chain

Like all industry trends, the 4.0 industrial revolution has come to mean different things for different industries. Critical drivers include connectivity, intelligence and advanced analytics along with robotics and flexible automation[3].

For pharma and biopharma manufacturing – one of the most complex and non-linear supply chains of any sector, with distribution often requiring significant temperature controls and specialized packaging – the largest driving force is now intelligence.

By changing how we combine the physical supply chain with digital technology such as AI, big data analytics and the Internet of things, we can create a new, connected culture of supply chain safety, with logistics and transport as the key enabler of enhanced operational efficiency.

The core value proposition is to protect the integrity of biologics and chemical compounds by tracking and monitoring the ingredients from supplier to factory – measuring temperature, time and the location to deliver reliable data and a clear line of sight at every stage.

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The benefits of this end-to-end visibility are clear and numerous.

It will help contribute to a reduction in the $35 bn[4] annual bill of healthcare products rendered worthless or harmful due primarily to temperature deviation.

It will pinpoint the exact location of any deviation or waste. Help determine how long freight takes to arrive at its destination. Identify and solve potential risks along a complex supply chain that is far from straight.

Never has the need been higher, particularly for intra-Asia biologics. For instance, we ship biologics for a research-based global pharma company from Singapore to their production facility in Japan. The APIs are heat sensitive and contamination prone and particularly susceptible to the rigors of cross-border shipping, making full custodial control not just optional but imperative.

The big picture? Implementing a robust supply chain with independent and reliable information on the flow of ingredients, with knowledge of all contact points, timing and temperature issues, making it possible to reduce and trace any issues or pain points that emerge between the supplier, vendor, factory and other stakeholders.  We are building a future where innovation equals automatic compliance. Where full visibility becomes standard. Where knowledge and trust is empowered and speed is continually enhanced. And costs are lowered – but not at the detriment of compliance.

Next generation sensors – the path to full visibility  

Future innovation and reliability is perhaps best illustrated by the next generation of sensors.

Sensors are not new – pharma and healthcare have been using the likes of our SenseAware shipment monitor to track data on temperature, humidity or exposure for close to a decade. Yet what is remarkable is the growing number of sensor-enabled devices and their transformational impact on a digital supply network[5].

By placing sensors in everything, we accumulate data about biopharma distribution practices – bringing end-to-end visibility to suppliers, distributors and customers. For our next generation of sensor technology, we are investing in a new Bluetooth-enabled low-energy tracking sensor, which is bringing intelligent package tracking to the Internet of Things.

What’s also clear is that smart sensor computing capabilities are strengthening substantially – improving the business case while ensuring barriers to smart sensor adoption continue to fall[6].

As sensor-enabled devices grow and become mainstream, the day is coming where each consignment of freight is likely to include small tracking devices – transforming traditional signals into true digital insights for immediate decision making using data and analytics.  

Tomorrow’s digitally enabled supply chain enhances safety and security

This results in an increasingly connected logistics platform – yielding real-time, automated insights and analytics that identify patterns and gaps in safety and in turn, efficiency, revenue and competitive advantage.

While most of the data generated today is around performance, location and availability, data sets will increasingly be used to make pre-emptive decision-making around safety, spoilage and damage mitigation, as well as optimizing delivery routes in real time. 

AI in particular has the potential to transform the biopharma supply chain by crunching huge amounts of real-time data and making intelligent recommendations that incorporates weather, traffic conditions and so on, empowering businesses to react sooner rather than later.

There are already signs that near real-time assessments of the safety and quality of pharma ingredients is providing myriad benefits – particularly in matching information flow to physical flow.

For instance, we move large numbers of active containers to transport APIs from North America to a factory in Japan in a safe and secure manner. We use a 24 x 7 global control tower and state-of-the art technology to monitor shipment progress and conditions throughout the journey to avoid any surprises. In-house regulatory and quality assurance expertise together with a global network of cold chain facilities ensures correct product handling.  In case of unforeseen delays, robust contingency plans kick in to protect shipment integrity.  

Having this end-to-end control engenders trust in the process, and is key to safety.

The future – Prevention is Still Far Better than Cure

Making the best use of all the information available and using AI to streamline processes and increase scalability and reliability will drastically change the healthcare landscape.

We can look ahead to the day where healthcare could become more affordable by simplifying complex distribution channels and delivering treatment directly to the point of primary care.

“The first step is to acknowledge the problem, and then you can move on to risk management and analysis”

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We will see more innovative therapy involving biologics and genomic therapy, which in turn will feed into the main goal – better patient care and improved health outcomes.

Whatever the future, logistics services – once considered a tactical aspect of supply chain – are rapidly evolving due to the power of intelligence and data analytics.

At the same time, pharma and biopharma companies are restructuring to make better use of AI, for instance to reduce wastage and effort in the development of new drugs[7].

What is more, they are increasingly embracing the digital era by appointing chief digital officers[8], to make pharma and biologics smarter and faster and more efficient, with safety and integrity of valuable shipments a clear priority.

Knowledge and information is not just good to know, it is actually good for you.

For if there’s one thing medical science has taught us, it’s that prevention is still far better than cure.

Learn more about FedEx healthcare solutions.

[1] https://pharmaceuticalcommerce.com/cold-chain-focus/global-biopharma-cold-chain-logistics-will-hit-15-7-billion-in-2019/

[2] https://www.statista.com/statistics/725474/global-biopharma-cold-chain-logistics-spending/  ($16.9 billion by 2020)

[3] McKinsey, 2019 as reported by multiple media sources in relation to Davos and 4.0 manufacturing including “lighthouse” manufacturers

[4] https://www.iata.org/whatwedo/cargo/pharma/Documents/ceiv-pharma-specifications.pdf

[5] Deloitte, Using Smart Sensors to Drive Supply Chain innovation report, 2019

[6] Deloitte, Using Smart Sensors to Drive Supply Chain innovation report, 2019

[7] https://www.cphi.com/europe/visit/news-and-updates/pharma-outlook-12-trends-watch-2019

[8] https://www.fiercepharma.com/marketing/chief-digital-officers-land-at-big-pharma-cue-tech-transformations-test-innovations-and