For nearly two years, the Clinical Supply Blockchain Working Group (CSBWG) has been working in stealth mode, said Ben Taylor, CEO of LedgerDomain, the vendor which provided the blockchain-powered platform for the group’s recent proof-of-concept project.
The iOS-based application, KitChain, is designed to fit into the clinical trial supply chain workflow, providing an immutable digital record for inventory and event tracking. It is built on top of Hyperledger Fabric, an open-source Linux Foundation project, and enables users to securely send messages between shippers, recipients, and third parties.
“Blockchain gives everybody only the fields that they need to do their job – they are in the dark on the other topics,” Taylor told us. “As the technology vendor, we operate on a ‘lights out’ basis … we’re just making sure that all the messages are going back and forth the way they are supposed to.”
The CSBWG – made up of representatives from sponsors, CMOs, CROs, academic sites, and one courier – tested the application earlier this year in an advance ship notification (ASN) and ‘proof-of-delivery’ use case.
The group spun out of an open-invitation workshop at the Pfizer Blockchain Center of Excellence chaired by Munther Baara, head of new clinical paradigm at the NY-headquartered pharma company. Co-chairs include Chad Sklodosky, director, digital supply chain center of excellence, Pfizer, and Imran Shakur, senior manager, clinical planning and operations, Biogen.
The goal is to develop a fully interoperable, transparent, and auditable platform to track investigational drug and comparators from the point of manufacture to patient: “To create a better, more efficient, more visible process – and one that’s built on security,” Shakur told us.
“Although it seems simple on the surface, it’s still a big challenge. It’s one small piece of very extensive distributed supply chain,” explained Sklodosky.
“Over the long term, the CSBWG envisions a messaging and notification platform that supports the performance requirements of the clinical supply chain, streamlining collaboration and cementing a single version of the truth,” reads a white paper published by the group, written to spark discussion among the various supply chain stakeholders.
‘Issues across the board’: Addressing clinical trial pain points
The solution itself relies on an ecosystem, “you can’t really go it alone,” Sklodosky explained, “and that requires like-minded individuals across several different companies to come to the same conclusions and understanding about how that technology is going to provide value to their own supply chains and, ultimately, the consumers at the end.”
As Sklodosky noted, Pfizer has done more over the last five to ten years to listen to patients involved in clinical trials, as well as the sites and investigators conducting trials, and have heard the same pain points repeatedly. There is pressure on these groups to follow procedures, document things correctly, and tracking all of this, he said, has become next to impossible.
“It’s very inefficient and causes a lot of pain at the sites, which ultimately impacts patients and introduces risk, by potential medication dispensing errors, you name it,” said Sklodosky. “There’s issues across the board.”
Addressing these issues, an interoperable platform would enable clinical sites and investigators to develop their own technologies, extracting data in a uniform way, providing it back to sponsors in a uniform way, “in which they can permission to whichever sponsor they want without us worrying about risk of us inadvertently sharing data we don’t wat to share with our competition,” he explained.
“I think this is a means or a mechanism for us to finally tackle that problem that’s existed since the beginning of clinical trials,” said Sklodosky.
The work is twofold: Digitalizing the clinical trial supply chain – removing manual, paper-based processes – and improving the ability to better manage data, in a way that creates a win-win environment for all stakeholders.
Driving the discussion: More than a buzzword
While blockchain in many ways remains a ‘black hole’ – as few fully understand what it is – Shakur stressed that it is not just the latest fad, but instead a vehicle to spark conversation around digital transformation.
“Everybody can align around data standards, and blockchain is uniquely positioned to help drive that discussion in a way that I think we can all rally around,” added Sklodosky. Still, a hurdle to overcome, as with any emerging technology, is demonstrating value in a way that “hits home with the decision-makers,” he said.
“It takes a great deal of effort, a great deal of time to build up the education of what [blockchain] can do,” Shakur noted.
The problem is that the return on investment (ROI) is not immediate. Said Sklodosky, “You have to look at the long-term horizon and be willing to stay in it for that period of time and not every pharma company is going to be positioned to do that.”
It’s going to come down to a coalition of the willing, he said, “not everyone is going to be willing to pony up funding to do something that’s really for the greater good at the end of the day.”
Shakur said it will be a challenge to promote the project and give it its due platform, though the team remains committed to the vision of enhancing and digitalizing the supply chain, and is working on next steps.
“We’re trying to figure out what those next steps might be, what other use cases that we can leverage, what are the technical implementations of what that means and how that’s going to translate into the various companies,” he added.
As various proof-of-concept projects come together, providing a more holistic view of the use-cases for blockchain, Shakur said it will become easier to demonstrate its value.
“I think we need to keep asking ourselves at the end of the day, where is the patient going to derive the benefit from? That should be the guiding thought,” he added.
Exploring opportunities: Additional use cases
Examining the CSBWG’s charter, the overall vision is to create an ‘Amazon-like’ experience for the patient, in response to the growing interest in direct-to-patient clinical trials.
“The direct to patient model is a great idea, but how are you going to ensure the appropriate oversight for the folks who are delivering and administering it? You need some type of platform to give you that security, that confidence that it’s being delivered,” explained Shakur.
As for what is the right platform, that’s where blockchain comes in – and for CSBWG, the next step is to use the KitChain application in a real clinical trial under GxP regulations.
“As we learn more about the technology, what other value you can derive from, say, the regulatory reporting process, the drug accountability process at sites, the upstream tracking of the investigational product … There’s a lot of additional use cases that have the potential to build on what we’ve started as part of this first track-and-trace,” said Sklodosky.
“But the reality is, you’ve got to put at least one of these use cases into production in order to expand on that end-to-end visibility of the supply chain,” he added. “We’re still working together toward that goal, but there is still a lot more opportunity that we haven’t even realized yet.”
