“In today's world, data is the new gold for us, the new economy,” says Barry Moore, Head of Clinical Supply Chain Solutions, Glaxo SmithKline (GSK).
GSK and like-minded pharma companies – as well as some CDMOs such as Almac – are currently sifting through the river of blockchain to determine whether they might find those golden data nuggets within that technology.
One way of doing this is via the Clinical Supply Blockchain Working Group (CSBWG), an organization originated two years ago with individuals at Pfizer and Biogen, and where today Moore serves as chairman. This summer the group released an initial white paper readers can access here.
Since its formation, the CSBWG has moved from defining the “core message format, data flow, and sharing functionality requirements for a secure and streamlined solution,” to the specific challenges of supply chain complexity and management.
For some readers, first thoughts of blockchain will still begin with the “why and how” it will benefit elaborate supply-chain and management systems already in place.
Moore answers with a much-practiced delivery.
“We're keen to get complete access, and full visibility, to our supply chain. Much more than we have now. Everything from the genealogy of our medicine, and regardless of the manufacturer or whether it is our medicine or a competitor’s we're purchasing.
“That means understanding the disposition of all inventory around the world, and getting that data brought to us in near real-time, so we can run our analytics and algorithms against it.
“This will in fact,” he says, “give us that desired end-to-end supply-chain transparency. It will improve the quality of so many of our decisions.”
Like Mailing A Letter?
Still, much remains to be done to reach that lofty vantage point.
How, for example, will CDMOs keep separate the data from various customers flowing through a single blockchain – a network of various customers and suppliers?
In reply, Moore switches our metaphor from rivers to safety boxes.
“In the local post office, you can put your letter into a safety security box,” he says, perhaps employing an analogy indicative of the many years of his career – and perfect at least for the age group of this interlocutor.
“We're all [biopharma customers] putting our data into that same building [blockchain network], but we all have personal, protected ‘lockers,’ where only trusted parties are given the keys to open them.”
I added the emphasis to “trusted parties.”
With the implementation of a blockchain, the aspirational topic du jour of our drug development and manufacturing outsourcing industry – CDMO as trusted partners – takes on additional dimensions.
This fundamental trusting of course starts with the blockchain backbone for the actual communication; “use cases” and blockchain prototyping are underway throughout our industry.
Some organizations are testing for sheer speed of interaction, others ease of use – but all must determine “trust” on these two levels: at the partner organization per se, and the security of the connecting network.
“If our data is in the blockchain, everybody may know it’s there, but nobody can decrypt it unless I've shared that public key,” Moore says.
“Pfizer, Biogen, Merck, or anybody using that blockchain can also communicate with the same CDMO – Vendor A – using a ‘smart contract,’ or same data shipping ‘use case.’ Vendor A can pick up all of those messages destined for them only because they have those specific keys.”
But while the content of those ‘letters’ will vary in what they direct Vendor A to do for each sender, “the format of the communication must be the same – that is, machine readable.”
“Internally, GSK may have one ERP system, Biogen another, and Merck something else. That’s why setting standards at this point in time is critical work for us to accomplish.
“We are putting a single agent in the middle – the blockchain network – and we believe this will remove a lot of the friction in our drug supply chains today.”
One blockchain vendor CSBWG is currently working with on this frictionless supply-chain network is GS1.
“There are others, but we are currently working with them to come up with industry standards for data interchange for clinical supply chains,” Moore explains. “They have decades of experience working with industries such as energy, various manufacturing, and retail.
“Finally, we are also attempting to get some standardization on interchange messages between all the pharma, CDMO, IOT vendors, couriers, and healthcare networks.”
“UCLA, North Carolina State … any other big hospital groups have their own pharmacy systems, so they would now receive these data messages we put into the blockchain for them as well,” says Moore.
“That is the fuller vision of the length of the blockchain.”
And so Moore iterates the importance for CSBWG to attempt to build a proof of concept.
“It seems to work for industries – IBM and many others,” he says. “There are even blockchains for small farmers. If it works for small farmers, you'd think it would work for billion-dollar pharmaceutical companies. We intend to find out.”
Unchaining The Top
Moore speaks openly about IT challenges – “hosting” of the blockchain with a company like Amazon Web Services (AWS), for example, as well as decisions needed to be made for any industrywide rollout.
However, he says, “Among these, I think the technical challenges are easier than the organizational and political ones.”
“I believe if something comes along to trip us up a bit, it'll be either political in nature, or a lack of a fuller understanding at senior management levels.
“Our industry still finds it difficult to convey what a blockchain is, to the point where I almost don't talk about it anymore. I focus on supply-chain visibility and interoperability.”
Moore says the “business case,” and overall strategies, have to be thoroughly worked out and explained to convince senior management this is now “well worth investing in, and it is in fact time to set up collaborations.”
Pertinent to Outsourced Pharma readers and regarding those external supply-chain partners, should a “go” decision be made by an existing or potential bio or pharma customer, CDMOs will have a binary choice:
Join in or be left out.
However, as per above, only those “trusted partners” will be invited to make that decision. How this works itself out will be of interest to both sides.
Moore is both optimistic and well-grounded.
“At the minimum, I believe we'll move the industry forward with standards. We’ll add to a clearer understanding that the interoperability of our current supply-chain interfaces is difficult, challenging, and suboptimal across the industry. It’s holding us back.
“So we are looking at this potential solution. It is not going to be easy, but that is the aspiration.”