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Agnes Shanley is senior editor of Pharmaceutical Technology.
Pharmaceutical manufacturers and business partners are studying how Advanced Digital Ledger Technology might solve supply chain and other data transfer problems.
The distributed ledger technology that underpins digital currencies such as Bitcoin, offers a number of benefits for data transfer, including authenticated transactions that cannot be tampered with, and that can be distributed to different business partners.
One of its greatest strengths if the fact that it allows data to be shared within trusted networks, without requiring the development of customized interfaces.
A number of industries are looking into ways that advanced digital ledger technology (ADLT) might be used, for instance, to back up electronic currencies, or to determine provenance (ownership) of diamonds and fine art. It is also being evaluated by the music industry as a way to handle copyright recording and royalty payments, by Australia as a way to secure voting data, and , in the UK, as a way to ensure data security around nuclear facilities.
"Virtual ledger technology provides an opportunity when an organization needs to create a bridge between existing systems for internal business units, or with external service providers that do not communicate with each other," explains Darryl Glover, chief clinical officer and a co-founder of isolve, a company that is focusing on blockchain applications in pharma and healthcare.
“The advantage, especially in regulated industries, is that an ADLT bridge creates decentralized, immutable, and auditable records that regulators can examine at any time, creating transparency and trust between organizations, since they are all working from a single source of truth,” says Glover.
A blockchain does more than a database, because it allows users to store data in a linear container space that can be seen by others. The container is digitally signed, allowing anyone to verify its authenticity, although only designated users can unlock what is inside the container (1).
It seems like a natural for e-pedigree and drug traceability requirements, which require the connection of completely unrelated databases (e.g., drug manufacturers data with drug wholesaler or point-of-use data), as required by the drug supply chain security act (DSCSA). “It would allow users to track everything from when the first ingredient arrived at a manufacturing plant to when the first patient customer took the drug, says Glover, “so it can potentially track every point in the supply chain, from beginning to end.”
The financial services industry has been evaluating the technology for some time. Accenture, Goldman Sachs and a number of management consulting groups are studying it closely.
iSolve’s global asset exchange platform leverages blockchain to connect companies, investors, tech transfer offices, and service providers and record agreements, contracts, facilitate royalty payments, and handle other transactions.
Established in 2014, the company began to focus exclusively on pharma in 2015, and a pilot, the BlockRx Project, was launched in 2016 to evaluate potential applications.
But track and trace would not be the only potential application in pharma, says Glover. It could also be used in:
Currently, iSolve is working with the nonprofit Center for Supply Chain Studies, in a project that will use simulation to track a theoretical supply chain. The goal will be to see how blockchain technology might be used to help pharmaceutical companies comply with the Drug Chain Security Act. The regulation requires all trading partners in the supply chain to be able to share transaction information and, when requested, produce all related data.
Blockchain would offer a number of advantages for recording and transferring data, although Bob Celeste, head of the Center for Supply Chain Studies, notes that there are questions of how much it would cost to use for each application, who would pay, etc.
On the IT side, the technology could streamline and decentralize data management, says Glover. “IT does not require any new IT per se, and it does not replace existing IT platforms, but, rather, helps to bridge them using a ‘network in a network,’ “ he explains.
“For example, a company like McKesson would not have to maintain 500 different blockchains, only one blockchain containing information for all of its suppliers,” says Glover. In addition, blockchain technology has the virtue of being unattackable, he says. “Bitcoin has been around for 10 years and during that time it has never been hacked.” It also records a transaction permanently. “Once a transaction is placed in this ledger, it is there forever,” says Glover.
Blockchain works with large amounts of data, so it may require additional servers, but that data would be decentralized, says Glover, so, for example, Pfizer could keep all its blockchain data in one place instead of having to store it in different dedicated computers. “You can also have private blockchains, in which only computers and groups that can use the data will actually have access to it,” Glover says.
The project with the Center and iSolve is expected to result in simulated reference models, a white paper and additional educational materials. As Glover notes, there is industry interest, but pharma's familiarity with the technology is still at a very early stage.
The Center and iSolve cosponsored a webinar on September 30, 2016, that attracted over 70 companies, representing all the key stakeholders in the pharma supply chain, including contract manufacturing organizations (CMOs), says Celeste. Presentations from that webinar may be found on the Center’s web site.
A core group from those attendees will become an advisory group and task force to provide data and a reality check for the simulation. Initial findings are expected in November, and final results of this phase of the study are expected to be published in December, 2016.
A conference on blockchain technology in pharma, called the Pharma Blockchain Bootcamp, will be held on November 16, 2016 in Edison, NJ. For more information, visit www.RXBlockchainBootcamp.com.
1. W. Mougayar, Understanding the Blockchain, O’Reilly.com, January 16, 2015.