April 12, 2019 | Like any new technology, blockchain must find its place. Richard Shute believes that one of those places is in the life sciences, where it can benefit researchers and drug companies while protecting patients. Blockchain has great potential within the clinical arena to support enhanced data management at nearly every level, he said.
Shute is a project manager & consultant for The Pistoia Alliance, a global not-for-profit consortium of life science, pharma, technology, and academic organizations working to overcome barriers to R&D through collaboration. Shute has over 25 years of experience in Big Pharma, having worked at ICI, Zeneca, and AstraZeneca, and since 2015 he has been a consultant at Curlew Research and has been an advocate of blockchain technology.
On behalf of Bio-IT World, Hannah Loss spoke with Richard Shute about how and where blockchain technology can benefit the life sciences.
Editor’s note: Hannah Loss, a Conference Producer at Cambridge Healthtech Institute, is helping plan a track dedicated to Blockchain in Pharma, R&D, and Healthcare at the upcoming Bio-IT World Conference & Expo in Boston, April 16-18. Shute is chairing and will be speaking on the program, as well as moderating a panel discussion focusing on the application of blockchain in pharma, R&D, and healthcare. Their conversation has been edited for length and clarity.
Bio-IT World: Is there anything you want to clarify about blockchain as we start?
Richard Shute: I’d like to go into a bit of terminology. People talk a lot about this “thing” called blockchain but there is another term that is used frequently, sometimes synonymously, in this area, yet there is a subtle difference between the two concepts. That other term is Distributed Ledger Technology (DLT). The key thing to remember is that all blockchains are DLTs, but not all DLTs are blockchains. That’s just a little bit of subtle terminology that’s worth stressing.
Can blockchain be used for everything?
It’s important to identify good use cases for blockchain. Blockchain technology is not a panacea! There are five facets I believe are key to determining if the technology matches the use. These are 1) transparency, 2) disintermediation, 3) trust, 4) auditability, and 5) immutability. All participants in a blockchain can view that chain and anything that is added, so it is considered transparent. It is the single source of truth. Trust is one of the big selling points of blockchain; in fact blockchain is often referred to as the “trust protocol”. Blockchains connect data blocks, distributing validation, establishing trust between participants and viewers of the blockchain. Enabled by transparency and trust, disintermediation is the removal of third-parties. Disintermediation is one of the central aspects of blockchain. The removal of middle-men reduces costs and time. The final two, auditability and immutability, are interlinked. Immutability means the data in a blockchain cannot be changed. Once the data has been set, or mined into the block, as it is called, it is unchangeable. It can be audited or inspected into perpetuity. This creates an exhaustive and everlasting means of record-keeping. These five areas help shape what a good use case is because, as I said, blockchain is not for everything.
Which aspect of drug discovery will benefit first from blockchain?
An area that shows promise as a good fit for blockchain technology is getting medications from manufacturer to patients, the medicines’ supply chain. This sector has been riddled with issues from counterfeiting and corruption to bad practice. I believe this area will reap the benefits of blockchain technology first. By aiding drug serialization challenges, and in particular, fostering adherence to the Drug Supply Chain Security Act in the US, blockchain technology can play a pivotal role in securing the provenance of those medications. It’s a rich area for blockchain use case investigation.
Why do you think this area will benefit first?
My belief that this area will benefit first is based heavily on the amount of research that has already gone into blockchain use in the supply chains of so many industries. From tuna and coffee to the diamond industry (tracking diamonds from the mine to the jewelry shop), each of these diverse industries is using blockchain technology to help manage their supply chain. Even Louis Vuitton Enterprises is exploring blockchain technology to protect and prove the authenticity of their high-end luxury goods. For many people around the world, medicines can be considered a luxury good, a valuable asset which pharma companies don’t want counterfeited or corrupted; blockchain technology provides a way to trace and manage that product.
What aspect of drug discovery will benefit the most from blockchain?
Within the clinical arena is a wide array of potential areas that could benefit from blockchain technology. Blockchain can support enhanced data management at nearly every level. It enables more secure and better transactioning of clinical data. Greater confidence in data exchange also leads to increased collaboration, another big benefit. One specific aspect of clinical data management where blockchain technology could play a big role is consent management. The choices a patient makes regarding the future of any personal data that may come out of a clinical trial, what they consent to, are important and valuable—to that patient, to future researchers, and to pharmaceutical companies. At a recent Pistoia Alliance workshop looking at potential use cases for blockchain technology, consent management came out as a high priority with several pharmaceutical companies showing a lot of interest. Another area that is still somewhat new and an area with substantial room for improvement and innovation is electronic health records (EHRs). Blockchain technology could impact millions of healthcare providers through DLT-enabled EHRs. DLT can also reduce cost in the clinical space through the so-called “smart contract” capabilities inherent in the technology. I believe the greatest benefit will be in the clinical area because here it can impact for the better the most people.
I anticipate both the medicines’ supply chain and the clinical area benefiting from blockchain. The Pistoia Alliance surveys conducted over the last two years are in accordance.
What are the barriers to its use in the life sciences?
Barriers to blockchain adoption in the life sciences have been identified by the Pistoia Alliance, as well as others. The Pistoia Alliance conducted a survey in September 2018. A selection of life science professionals was asked what the greatest barrier to adoption was. Fifty-five percent reported it was lack of access to skilled blockchain personnel. Understanding the technology itself was second; 16% rated that the greatest challenge. A similar survey in 2017 showed people thinking differently. The two top barriers in that survey were regulatory issues, at 45%, and concerns over data privacy, at 26%. There is evidence of evolution in the results of those two surveys. In the short time between September 2017 and a few months ago, the focus has changed from broad areas to specific topics. When the Pistoia Alliance conducted the September 2018 survey, 60% of pharmaceutical or life science professionals were currently using or experimenting with blockchain. That was an almost three-fold increase from 2017. One year later, and the life science industry had experienced significant blockchain growth. That’s exciting.
What challenges remain for blockchain in the pre-clinical R&D space?
The biggest challenge for blockchain technology remains one of credibility. For many people blockchain equals Bitcoin. People have to get past this association with nebulous and sometimes difficult-to-understand cryptocurrencies and their association with the dark net and nefarious organizations. Once people get past that, I think they will appreciate what the technology can do for them. What works best is to show people the use cases; then DLT and blockchain technology will certainly become more widely accepted. The increasing availability of blockchain and DLT platforms, such as Ethereum, Multichain, and Hyperledger, is really helping the technology progress and become much more widely accepted across multiple industries, not just life science.