At the Adents Serialization Innovation Summit in Philadelphia, Tianna Umann, Microsoft software architect, gave a talk explaining that when used within an already existing end-to-end solution, blockchain can improve communication by storing and sharing product transaction and check-point status during the manufacturing process and along supply chain in a single, fixed ledger.
Using a sequence diagram for blockchain for transparency in the pharmaceutical supply chain, Umann explained that everyone involved in the transaction would have a copy of the blockchain ledger, and as the product goes from manufacturer to carrier one, to carrier two, and so on, it is validated each time it goes through new ownership via sensors that scan for certain properties.
Individuals with access to the ledger can see the product’s location and validation status according to properties in the ledger established by the manufacturer. All carriers and trading partners will be alerted immediately if the product violates any of the parameters put into place, allowing for quicker intervention.
Pharmaceutical Processing sat down with Umann after her talk to find out more about the role of blockchain in the pharma industry.
Q: The information in the blockchain ledger is immutable. What are the pros and cons associated with that?
Umann: Usually when we talk about the pros and cons of taking data and recording a state of data or a state of a contract within a contract negotiation, the state of data is not such a problem. It’s when we’re actually coding the contracts around the blockchain that the immutable characteristic of blockchain ledgers can become a challenge.
A lot of programmers come from a .net background, where we can go in and change a mistake if one is made. But when we create the code that supports the contract logic and properties, once we commit that code to the blockchain, we can’t change it. So when there is an issue about hacker attacks around blockchain, generally, the vulnerability is somewhere in the code in the smart contract, and someone left some kind of mistake in the code that a hacker exploited in order to change data or extract currency.
However, errors around transactions are highly unlikely, and that’s what is so exciting about the blockchain ledger. If you and I want to do some kind of a transaction, I have to say I want to make this change, you have to agree, and then there may be a smart contract associated with that where we agree on the terms. We put in the information and then everyone within the network, all of the individual computers—these are not people making decisions, these are algorithms and computers making decisions—validate the logic and that the properties are within the bounds of what the entire organization says. They also validate that you’re the entity that you are and I am the entity that I am.
Not until that is validated with high confidence is it actually written into the ledger. Once it gets written into the ledger, there is actually a whole other process that occurs before the transaction is really committed to the ledger and everyone else on the ledger receives an update of the ledger. This is where the trust and the security has tremendous value. Now it’s written and that’s that.
If you want to change the terms of the contact, there are a few different strategies where new contracts can be put on the ledger that may be references the original. It’s not that different from how typical contracts amend existing contracts. But you don’t need a broker or intermediary, and this speeds up the process from weeks or months to days. You generally are reducing the amount of steps in your workflow process, removing manual processes, and removing the need to have multiple people validate.
Q: You mentioned that blockchain is not a process solution, but that it is meant to work within a process flow to improve it. How does blockchain work with the existing aspects of the manufacturing/supply chain end-to-end process in pharma specifically?
Umann: Often, when we have contract manufacturers that produce multiple products for multiple pharma companies, they have their whole serialization process in place. But once they do the reconciliation and validation that confirms that the right pills are in the right bottles from the right companies, this is where blockchain can be integrated into the existing process infrastructure.
There is a lot of data going back and forth and pushed to a centralized database. With a blockchain, not only can you push the data to a database that can be used for analytics, but the validation of those individual units can also be pushed to a blockchain ledger. It enables others within the supply chain and business ecosystem to validate the verifications so that they have a copy of this information.
We are required in pharma manufacturing to track-and-trace and continuously validate along the supply chain. As the product moves through the chain, we can use things like QR codes, tamper resistant labeling, and other serialization tools, so we know where the product is and we know if it’s been delayed, geographically diverted, and so on.
There are lots of different strategies that can be employed to validate a product throughout the entire supply chain and have the information shared and stored. But, what we now have is info being collected at the distributor or the warehouse. The risk is that anytime you have a database, regardless of how secure it is, there is always a chance that anyone who has administrative access can cha nge the data.
Also, if the pharma product is replaced with a counterfeit product and we try to go back to figure out when that happened, someone could have changed that at any point. It’s about accountability. But, when the data is recorded on an immutable document, trust and security becomes achievable.
Are pharmaceutical companies really beginning to implement blockchain?
Umann: I’m talking to a lot. When you think about supply chain, even HR recruiting, it’s a supply chain ecosystem. The mentality of industry ecosystems working together is important to almost all verticals in an industry.
In pharma, I am talking to many companies that all have this deadline, right? If you look at the DSCSA regulatory requirements, it looks like it was written for blockchain. The companies are integrating IoT and blockchain into their existing systems.
What’s very exciting is that once we start talking to companies, new business models emerge. New ways to look at their businesses and leverage their data because of the transparency. The availability of the information becomes much more accessible. Almost everyone I speak with ends up discovering new business models.
This is complicated technology, but at the end of the day, blockchain will let you take your phone and say, “I want to know where my rice came from,” and you can do a barcode scan and find out. You’ll just have an app that gives you visibility into something. Blockchain is behind it. It’s a piece of technology that improves efficiency and trust.
Q: Were there any trends you took note of at the summit. What did you think the industry is really focusing on right now in the field of serialization?
Umann: I noticed that a lot of people in the industry seem to be focused on developing a single solution for all of their customers, and I just don’t think that will work. I think that the solutions developed for track-and-trace have to be customizable and company-specific to be the most effective.