Ireland is now well established as one of the world’s leading life sciences hubs with 13 of the top 15 medical technologies companies having international operations. All of the top 10 global pharmaceutical companies have operations in this country too. But the sector now faces unprecedented challenges as a result of the fallout from the Covid-19 pandemic.
“The current crisis is a Black Swan event, the likes of which has never been seen before,” says Accenture Life Sciences managing director Barry Heavey. “It is completely reshaping supply chains with the industry experiencing an unprecedented increase in demand for certain products. These include diagnostics and their components, like reagents and disposable equipment used in sterile manufacturing processes.”
There is also a spike in demand for potential Covid-19 treatments. “For example, Regeneron in Limerick manufactures Kevzara which could be used to treat some symptoms of Covid-19,” Heavey notes. “As doctors are trying things, you see spikes in demand for certain products like that. In other cases, reports have found that old drugs such as corticosteroids can alleviate symptoms and have seen a huge increase in demand. No one could have predicted these spikes.”
On the flipside of the coin, there has been a significant drop in demand for specialty care products which are normally delivered in hospitals or other clinical settings. “Good examples would be treatments for cancer, ulcerative colitis, and rheumatoid arthritis,” Heavey explains.
“Another example is a vaccine for shingles. It has been an extremely successful product, growing sales very quickly but prescriptions dropped 84 per cent between February and April of this year because potential recipients were cocooning at home. The manufacturer had been struggling to keep up with demand before this, but has now experienced this sudden drop.”
Challenging times
The situation is set to become even more challenging with at least 20 Covid-19 vaccine or treatment candidates in advanced stages of development. “Some of these might progress further and get approved. The question then will be if the industry has the capacity to manufacture them or if companies might end up with excess capacity if another more promising, or apparently superior vaccine comes along, or indeed if there are safety concerns like we’ve seen with the Oxford trials earlier this month,” he says.
Covid-19 itself is a further complicating factor. “Many companies are trying to cut their on-site workforces to about 30 to 40 per cent of normal levels due to safety concerns,” Heavey points out. “Manufacturing facilities must have some people on the factory floor and laboratories, but they need to be physically distanced in order to avoid the problems encountered in some other contexts such as meat factories.”
When combined with the uncertainty on the supply and demand sides this is creating a lot of stress for the life sciences industry, and the people who work in it.
Fundamental changes to the nature of the pharmaceutical industry and the products it manufactures are adding to that stress. “The old way of balancing supply and demand on paper and spreadsheets is no longer sustainable,” Heavey says.
“Ten years ago, the world’s best-selling drug was Lipitor. It was manufactured here in Ireland and contained 33 components. Today’s highly complex large molecule biologics drugs can have 6,000 components. On average it takes six to nine months to make one batch of these drugs – in one case we know of it takes 20 months to make a batch. That makes it very difficult to respond to sudden changes in supply and demand.”
It also means a lot more can go wrong in the process. “Because there are more variables in the process it takes longer to check and double check,” he continues. “Quality control labs have to test batches throughout the process to make sure that all 6,000 components are present and correct. These lab tests can often take longer than the manufacturing process.”
The inherent uncertainties of a testing process involving such complex products adds further pressure to the system. “Those working in the supply chain want to know when a batch will be ready to ship. The challenge is the manufacturing side doesn’t know how long it will take to test as the quality control teams struggle to predict timeframes due to constantly changing priorities for sample testing. There is a lack of visibility up and down the supply chain with only a vague sense of what’s happening in different areas. Accenture is trying to help these different groups to join the dots and respond to the challenges presented by sudden rises and falls in demand,” he says.
In dealing with these challenges, Heavey advises companies to put their people first. “These people have patients’ lives in their hands, and they are very stressed at the moment. They need support from leaders and there is a need for everyone to empathise and communicate better with each other.”
The next step is to leverage data to improve visibility within the process. “You need to know what’s going on in every area as there are so many variables to deal with. Good data leads to better decisions.”
A focus on priority areas is also important. “You can’t focus on everything all the time,” says Heavey. “You need to look at the high-risk areas and prioritise those for attention. Lower risk areas can be dealt with by planning by exception.
He advises companies to form cross-functional SWAT teams to undertake interventions and orchestrate responses effectively when the need arises. The multi-disciplinary nature of these teams is crucially important, he stresses.
“The pharma industry is so big and so highly regulated it tends to be made up of highly specialised groups whose members have to be deep subject matter experts. These can tend to become siloed but there is a need to bring people together in a crisis. There is a need to have the supply chain, manufacturing, quality and sales teams all working together to make better decisions faster.”
The other step he advises is to evaluate supply chain scenarios. “Look at what might happen if demand for a particular product spikes or if raw materials or disposable equipment are in short supply, what if a laboratory is capacity constrained and becomes a major bottleneck in product release. You are better prepared and better able to anticipate events when you play out scenarios in advance. You can assess how good your data-driven predictive models are if you compare what you predicted in your scenario planning, versus what actually happened when some of these scenarios play out.”
Accenture’s role in the industry
Unsurprisingly given the critical role played by quality control in the manufacturing process, the laboratory has become one of fastest growing sub-sectors for employment in the industry in this country. “At Accenture we are helping to make this aspect of the industry one of the best in the world,” Heavey adds.
Accenture Scientific Informatics Services (ASIS) is playing a central role in that. The global business, acquired by Accenture in 2017, established its EU hub in Dublin recently where it provides digital solutions that harness the power of data and transform scientific laboratories.
“Across Ireland, we’re helping Pharmaceutical Quality Control Labs manage data regarding the safety and efficacy of their drugs. Our job is to help scientists provide product quality data back to the manufacturing and supply chain teams so that they can get the products to patients as quickly as possible,” says ASIS senior manager Don Rainville.
In many cases, our Irish practice is the lighthouse for new technologies in Accenture globally
“Within these labs, there are incredibly expensive instruments collecting information, and that information needs to go somewhere. We focus on the digital lab and getting data into a digitised format from the lab to the decision makers.”
Digitising the lab offers real time insights into what’s happening during the manufacturing process. “There are multiple points during manufacturing when you have to test samples taken from a batch,” says Rainville.
“It’s all about reducing the overall amount of time that the sample spends in the lab. There is a lot of talk about curve flattening at the moment, avoiding lots of people coming to hospital in a short space of time. We are trying to sharpen the curve in this case – getting batches out the door at a quick and consistent pace. We want to speed up and give consistency in the time taken for testing, by connecting the lab through the internet of lab things (IoLT), providing an end-to-end data strategy, enhancing the human experience, and enabling a network of labs to communicate. We can achieve a significant reduction in cycle time by simply applying digital lean principles to improve scheduling and capacity planning.”
This application of lean principles is more than simply about reducing waste, according to Heavey. “The more sophisticated view of lean is to use it to address volatility and overburden. It can be used to make a process more predictable and reduce overburden on people and the knock-on stress effect. If a lab has to test hundreds of samples in a period and manufacturing is ramped up, it may not have the staff or capacity to cope. Digitising the process will help to deal with issues like that.
“The digitally enabled lab gets from instruments to insights as fast as possible,” he adds. “It’s not just about digital. It’s about having the best process possible and the best working experience possible,” Heavey adds.
But digitising and collecting data is only part of the story. “Having lots of data is kind of useless if it’s not correlated with other aspects of the process,” he explains. “You need to be able to correlate lab results with what happened in the manufacturing process. You don’t have the full picture without that.”
Another recent Accenture acquisition, Enterprise System Partners (ESP), is playing a key role in that area. The Irish company, headquartered in Cork, recently joined ASIS at the facility in Dublin, where it specialises in systems which digitally track and document the production process, providing the groundwork for more automated and analytics-driven manufacturing and supply chains. It also enables digital tracking of products from the packaging line all the way to the patient.
This technology has particular applications for qualified persons who are legally responsible for certifying that each batch of a medicinal product is suitable for release for sale or for use in a clinical trial. “The documentation record for a batch can run to up to 3,000 pages,” says ESP managing director Liam O’Brien. “ESP can gather all the data on what happened to the batch and compile an electronic batch record. This allows the qualified person to spend less time checking stuff which has already been verified and spend their time better. That results in less stress, and less time to release the batch.”
This also provides a basis for ongoing process improvements. “You can start to see trends in batches and the conditions which give rise to issues. We are now getting to a situation where regulators want to get information from qualified persons in an electronic format which is transparent and immutable.”
Ireland is quite advanced in this area, as it is in many other aspects of pharmaceutical manufacturing, according to Heavey. “In many cases, our Irish practice is the lighthouse for new technologies in Accenture globally. That’s good for attracting further investment to Ireland. From an Accenture point of view, we are now helping to roll out these technologies to other pharma sites around the world. Ireland is not only exporting pharmaceuticals globally, it is exporting pharmaceutical manufacturing support services around the world as well.”