What is the importance of data-driven processes in pharmaceuticals manufacturing, storage and distribution?
For an industry with R&D at its core, it’s no surprise that pharmaceutical companies are harnessing the power of data to improve the efficiency and success of clinical trials, and the approvals process.
Clinicians have long been able to access vast databases of molecular structures, alongside existing research and trial results – yet there were obvious limitations because clinical trial environments tended to be ‘traditional [and] tightly-controlled’.1
As with almost every other industry, the widescale adoption of big data has transformed pharmaceuticals almost beyond recognition. Its scope is enormous but in recent years, we’ve seen it being used to optimise workflows, promote shared learning, develop new and more complex treatments faster, comply with regulations, meet commercial targets and, ultimately, improve patient outcomes.
Now we are on the cusp of discovering how powerful artificial intelligence (AI), virtual reality (VR) and augmented reality (AR) might become in aiding research. Janssen Research & Development, for instance, is working with university experts to develop algorithms that would help clinicians predict how different cells will react to the same compound, so new studies can get off the ground quicker. 2
“Pockets of the pharmaceutical industry have still yet to realise the full potential of digital technology”
Another leader in the field is Pfizer, which has joined forces with pharmaceutical tech company XtalPi to create what has been described as ‘a hybrid physics and AI-powered software platform for accurate molecular modelling of drug-like small molecules.’3
But the excitement surrounding new technologies such as these is somewhat tempered by the fact that pockets of the pharmaceutical industry have yet to realise the full potential of digital technology.
The changing face of pharma supply chains
One such area is supply chain management, where manual processes, legacy IT systems and a lack of integration make it difficult for manufacturing and distribution companies to drive efficiencies, prove traceability and compliance, and reduce time-to-market. It certainly seems absurd that so much money is invested in speeding up R&D, only for operational inefficiencies further along the supply chain to delay release, increase wastage and/or push up costs.
That’s not to say that the majority of pharmaceutical manufacturers and distribution specialists are completely without tech; indeed, when we start working with them, they are often on their third or fourth piece of software.
The problem is they tend to adopt what I term ‘vanilla ERP’ solutions – essentially, a glorified accounting and inventory management system that provides limited actionable insights. Some also rely on users updating information retrospectively, rather than it being readily-available at the start of every task.
In pharmaceutical warehousing, for example, real-time data contained in warehouse management systems (WMS) gives managers full visibility over every process, enabling them to prioritise tasks, monitor progress and identify SLOB (slow-moving and obsolete) stock. It’s about driving action, rather than simply reporting.
Achieving all this is important for businesses in all sectors, though it is especially critical in pharmaceuticals where treatments have expiry dates and/or must be kept in a temperature-controlled environment. It might be possible, albeit difficult, to shift
dead stock if you sell clothes or books – but not when the effectiveness and safety of medical treatments are compromised.
A WMS is also extremely valuable if an issue, such as a temperature fluctuation, occurs in the warehouse because it shows the precise location of stock at the time. Using data from other systems, managers can therefore identify any affected batches and write them off. What’s more, since tasks are driven by customer demand, linked to sales orders, teams are able to pick several items off the shelves at once, rather than responding to them one-by-one.
Real-time data can also be used to track stock as it moves through the warehouse to alert teams when it is reaching its expiry date, putting it on hold so it can be destroyed safely and securely. When you consider the potential for human error when performing such tasks, there is a compelling case for automating them.
Without a standardised WMS, it is also near-impossible to prove compliance and traceability from production to end-user and no company – whether manufacturer, distributor or retailer – can afford to be the ‘weak link’ that compromises the integrity of a treatment.
The prevalence, and inherent risks, of counterfeit drugs and medical devices, for example, has placed fresh demands on manufacturers and distributors. Under the EU Falsified Medicines Directive, the final part of which comes into force in February, every batch must ‘display a 2D data matrix code and human readable information’ capable of being scanned at different stages of the supply chain.4
Barcode scanning, for instance, is a feature of any good WMS and helps to ensure accuracy and compliance. Rather than manually keying in information when goods arrive on site, and risking error, workers scan them, with data stored in a central location that can be accessed at any time.
Improving production processes
Logistics is, of course, just one part of the pharmaceutical supply chain; another is mission-critical planning and scheduling in pharmaceuticals production. Our team worked on a project involving a major US pharma company, which had been tasked with proving that a planned facility could deliver an influenza vaccine for half the US population should a pandemic break out.
Using production data from previous batch runs, the team was able to develop a capacity model for an entirely new plant. Simply feeding this information into a spreadsheet would not have delivered the detailed results – and confidence – stakeholders needed for the facility to get the go-ahead. As an example, the software enabled those working on the project to identify a bottleneck in the bioreactor and solve the issue.
Once production had begun, employees at the facility used the software to ensure resources are used optimally to keep every task on track. Furthermore, different tiers within the company are able to access data to support better decision-making, from those using shop floor data capture to manage day-to-day production, to senior managers working at a strategic level.
The pharmaceuticals sector is characterised by its commitment to new technologies, but it’s worth remembering that, for some companies at least, this doesn’t mean VR headsets or robotics.
A good warehouse management system and/or scheduling system will even integrate with legacy software, so companies don’t need to go through the upheaval of replacing everything.
As we have seen, platforms that use data and present it in a way that drives the right behaviour in manufacturing and distribution are just as important as the ones being developed within cutting-edge research teams.
Rob Hodgson is Warehouse Management and Supply Chain Specialist at the Access Group. Go to www.theaccessgroup.com/supply-chain-management