Twisted system

Tedros Adhanom Ghebreyesus is always on message. He wants to talk about ‘the basics’ of public health. We may or may not develop a silver bullet for Covid-19, but there’s an entire armoury of other measures that can help us deal with it. That’s surprisingly controversial. Claiming that WHO failed in its basic duty to be transparent, US President Donald Trump has announced his country’s intention to leave the body.

The politics of world health are usually a little subtler. When Tedros warns, as he did in July, that the virus takes advantage of the divisions between and within countries, that the greatest risk is “the lack of leadership and solidarity at the global and national levels”, and “the only way forward is together”, there are countless ways member states can choose to agree.

At May’s World Health Assembly, for instance, a dazed-looking Matt Hancock, the UK’s health secretary, smudged his country’s world-leading failures into those of the “collective”, while boasting that it was leading the way in creating “the best weapon in this fight” – a vaccine. Since then, ‘vaccine nationalism’ has become a recognisable phrase, and the world’s spies have been reassigned to pharmaceutical labs.

But the basics themselves haven’t changed. Dave Tudor, director of the UK’s Medicines Manufacturing Innovation Centre (MMIC), agrees that Covid-19 has given the UK plenty of reasons to take pride in its researchers and academics, but he’s much more willing than Hancock to discuss some of the country’s fundamental failures. “We need to take a look at where our risks have been in this crisis,” he says. “We need to ask ourselves about the supply chain.

When you’re thinking about the ability to test for this virus, when we’re looking at some of the drug shortages that have resulted... We ran out of paracetamol. Why did that happen? Is that because we were over-reliant on outsourcing that drug? We need to look at the mix of the supply chain to make sure we have the right risk-balance going forward.” Silver or otherwise, our projectiles count for nothing if we can’t fire them.

Training wheels

Tudor’s calling for a period of reflection, but if vaccine timelines are to be believed, it’s unlikely we’re going to get one. Fixing the supply chain is going to require some on-the-job learning.

“The research right now is what gets to the news,” says David Ruiz, MSD’s head of customer integration, “but in the background, pharma and the surrounding industries are working like crazy to get our capabilities up for this volume explosion.” Finally, there’s a “burning platform” for digitisation.

Given its strong vaccine manufacturing and distribution capabilities, MSD is in a better position than many of the 150-plus pharma companies developing vaccine candidates. “But the volume that we’re going to have to distribute is 100 times what we’ve distributed so far,” Ruiz continues. “We’re all very conscious that the models we have today cannot be scaled up a hundredfold directly – we cannot spend 100 times more money and hire 100 times more people to manage them. You need a digital solution to take on the transactional burden and the whole processing burden. Otherwise it’s going to be impossible to reach those levels.”

Indeed, as cases surged and borders closed in Europe and North America, the links in the pharmaceutical supply chain that didn’t snap were only held together by knots of phone lines and email threads. Internally, MSD was ready to switch to remote working long before it became a necessity, but global logistical operations don’t fit in Microsoft Teams.

“Externally speaking, we wish we had more digital capabilities with our customers,” says Ruiz. “It’s been tough for them to adjust and for us to continue the dialogue.” World and industry-wide, issues like the stock of paracetamol in a few warehouses spiralled into national shortages, and everything but the most critical projects and processes had to be paused.

Even so, says Ruiz, “old-fashioned communication” has worked surprisingly well; “but it has worked well through working a million hours”. It isn’t sustainable.

The right optimisations and workflow refinements might have shaved as much as a few 100,000 hours off Ruiz’s estimated total, but both he and Tudor are looking to make what the latter calls “ambitious, audacious step changes” – generational leaps that impact the industry’s mindset as much as its processes. “I don’t want to play the edges of technology,” stresses Tudor, who was also the former head of global manufacturing strategy at GSK. “I want to make it big and ugly, if you like, because then I get interest.”

Wacky races

A vaccine capable of ending a world-altering pandemic is a textbook example of ‘big and ugly’, and it’s not surprising that the quest to develop one is proving a distraction from Tedros’ exhortations. But whereas that project oscillates between being a worldwide race to stop the virus before it does more damage, and a race between countries to win the fruits of doing so, Tudor focuses on what he calls “pre-competitive collaboration”.

The MMIC brings companies, academics and regulators together on a neutral site and helps them understand where their objectives align so they can collaborate on specific ‘Grand Challenges’. Swap in countries and it might sound a lot like WHO. Either way, once it has engaged the right UK-based experts and drawn investment from enough companies (matched in part by the UK government), the MMIC takes charge of developing and approving a commercial technology for them all to share. Not only are companies’ R&D costs minimised, but the issues that come from attempting to protect such large investments by treating widely applicable technologies as intellectual property are completely sidestepped. The UK grows its treasured life sciences sector, too. “No single company puts its head above the parapet,” explains Tudor. “MMIC will take all the difficult questions from the regulators to get it approved, and once it’s approved, the industry can replicate.”

The first two of the MMIC’s ‘Grand Challenges’ have already found success using digital technologies to stop manufacturers and supply chains from thinking in terms of inflexible product batches. Grand Challenge Two, in particular, aims to replace the fixed production methods used for clinical supply chains – which aren’t adapted to the different requirements of multicentre trials – with a modular, automated robotics system that can be integrated into manufacturing platforms to produce and release material entirely as required. The value of the control and transparency that such technology can bring to the supply chain is hard to overstate.

Impressive as that is, there’s nothing bigger or uglier than the topic on Ruiz’s mind: blockchain. “It’s still very green,” he says, “but we’re starting to see where we can utilise it to jump generations.”

Presently, the customer integration Ruiz is paid to achieve is limited by the fact that every single connection between different companies’ computer systems requires the creation of a unique interface. MSD has thousands of customers around the world, so that adds up to a lot of labour, expense and waste. Moreover, customers or vendors would likely need to run parallel interfaces to work with other pharmaceutical manufacturers. Before too long, there would be as much interface bloat as pertinent system data. “We’re thinking,” explains Ruiz, “of using blockchain as a hub for connections that replaces the thousands of system-to-system connections, with just one interface to the blockchain – which would be the hub for all the industry to connect. Then the cost of the deployment just becomes much more affordable for everybody.”

He talks through the potential for such a system by returning to the issue of product shortages. Upon identifying that there’s a risk of a drug running out, MSD starts an allocation process to ensure it’s only distributed as required and protect patients from any supply interruption. “In our current world, we have a limited view on how much stock there is in the wholesalers and in the pharmacies, so that allocation becomes a matter of phone calls,” he explains. When a pharmacy runs low on a product, its staff have to make the first in the longer or shorter series of phone calls necessary to prime the supply chain to direct its allocation procedures. Unfortunately, each of those phone calls increases the potential for mistakes and miscommunications. Even when there’s stock to spare, drugs still run out.

By contrast, in a digital world, when the entire supply chain shares real-time stock information through a secure blockchain portal, there would be no need for suppliers or manufacturers to wait for a phone call at all. “You would know that one pharmacy is running lower than the others, so you could prioritise where the product goes in a much smarter and more efficient way,” says Ruiz, before pausing, as if for emphasis. It’s not his emphasis. The phone line has cut.

Unblock the chain

It’s unlikely that blockchain is going to make a telling difference to the distribution of Covid-19 vaccines over the next couple of years, but that doesn’t have to be the point. In Tudor’s terms, it’s big and ugly enough to have an impact without being implemented.

“This perhaps would be my key message,” continues Ruiz, on a new line. “We need to use consortiums to agree on standards across the industry, or we will never be able to scale up digitisation. We haven’t found blockchain to resolve specific problems yet, but we’re using it to trigger a consortium mentality.”

Covid-19 is having a similar effect, not least because of all the uncertainty around which vaccines – and vaccine technologies – will actually require the manufacturing capacity. Companies acting alone and making the wrong brick-and-mortar investments could cost themselves hundreds of millions of dollars.

Inherently scalable, digitisation will make it possible for supply chains to duplicate or multiply their capacity for marginal extra costs, so long as companies give up a little control. Blockchain’s ‘trustless’ technology is not foolproof, but nor are any other ways of reaching accords. There’s a lesson for states in there somewhere.

“Yes, there’s a lot of competition between players,” admits Ruiz, “but our biggest competitor is really the affordability of the product and the availability of resources within a nation to pay for medicines.” That’s as basic as it gets.