Ever since blockchain burst onto the scene a decade ago as a technology primarily designed for use in the financial services industry, people have continually found new—and sometimes odd—applications for the technology. Blockchain has been applied to everything from “buying” time (sic!) to renting a supercomputer, yet when it comes to the life sciences, a lack of practical applications has resulted in blockchain being considered a “hammer in search of a nail.”
Over that same time, life science organizations have been attempting to cope with an ever-increasing flood of information, arriving from many hundreds of sources in varied formats, with stringent governance and compliance requirements for how data is used. For several years, The Pistoia Alliance has been working with members as part of our Blockchain Project to investigate the link between these two issues and look at how blockchain might be applied to solve a number of problems for pharmaceutical researchers.
This has included exploring the various potential uses of blockchain and other distributed ledger technologies (DLTs) in life sciences through hackathons, boot camps, and webinars hosted across the globe. Most recently, the Alliance hosted a blockchain Use Case Analysis Workshop in London, and participated in a panel discussion during the Blockchain Track at Bio-IT World Conference & Expo 2019 in Boston. At both events, there was great discussion among attendees around some of the use cases that life science organizations should be looking at, as well as some of the barriers to blockchain adoption, and what can be done to address these issues.
Protecting patients and proving provenance
At the London event—a workshop attended by members from around the world to assess the viability of blockchain use cases—the two highest priority areas with the potential to drive meaningful innovation in the industry were identified as:
- Consent management: As more of our personal healthcare data becomes digitized, the issue of what information patients are willing to share becomes increasingly complex. Patients may only consent to parts of their medical history being shared and want to feel confident their privacy isn’t being violated without their knowledge. By using “smart contracts” built on blockchain to manage patient consent forms and the permissions they contain, organizations can know exactly what patients are eligible, and what data are and aren’t permissible for inclusion in clinical or medical trials.
- Manufacturing API: If the production of the active pharmaceutical ingredient (API) in a given drug isn’t properly tracked and quality-managed, it can have horrific consequences, including potentially death, for unsuspecting patients. Whilst the likelihood of this happening is vanishingly small because of global “Good Manufacturing Practice” (GMP) regulations, there is still potential to improve the integrity and cost-effectiveness of the API manufacturing supply chain. The immutable and transparent nature of blockchain makes it an ideal tool for managing the provenance of all component materials not just in the production of the API, but across the whole pharmaceutical manufacturing supply chain.
Both of these ideas are built on attributes which make blockchain useful, i.e. it enables total transparency and traceability for any type of information, whether that be a patient’s medical record or supply chain documentation, especially where trust is an issue. However, these are far from the only use cases the life sciences industry should be looking at. The broader challenge of DLT use-cases in life science was discussed further at the Bio-IT World panel in April on the application of blockchain in pharma, R&D, and healthcare.
Bio-IT World always brings together key stakeholders from the life sciences world, and is an event keenly anticipated each year. 2019 was no different, and we had some very interesting discussions with attendees on the next steps when it comes to blockchain. One of the key takeaways was that blockchain is potentially applicable in any scenario where data needs to be both shared and secured. The panel discussion was wide-ranging and looked at how distributed ledger technology could theoretically be used across a host of different areas within healthcare and life sciences. These included electronic medical records, collection of clinical data from clinical trials, protection of IP, increased use of smart contracts, supply chain, and drug serialization.
Drug trials are a particular area of high interest. If we think about how trials are conducted, there are substantial data management problems—such as accurate reproduction of results, privacy concerns, and patient enrollment strategies—all of which are driving up the cost of conducting trials and making them less efficient than they could be. Opposite patient enrollment, blockchain technology could address this by allowing patients themselves to upload their data to the blockchain anonymously and, when they meet the criteria researchers are looking for, they could be considered for relevant trials. DLT could also enable the entire trial “packet” to be presented to regulators with assured provenance, so simplifying and speeding up approvals. This could not only help improve efficiency and reduce the cost of conducting trials, but crucially, it’s a better way of helping patients discover and get the best chance to access potentially life-changing new therapies.
The Bio-IT World panel also discussed the way in which blockchain technology could be used to improve consent management, echoing our London group, but this time with a focus on genomic data and allowing patients to monetize their data as they wish. There is huge demand from scientists and organizations wanting to access genomic data for research purposes. By having patients store their data on a blockchain, it not only enables researchers easily to find the data they need but also gives patients the power to grant or deny permission as they wish. Nor is this a theoretical application—we’re already seeing blockchain-based genomic data markets develop to meet this emerging market.
The blockers to blockchain
However, the panel at the Blockchain Track at Bio-IT World Conference & Expo 2019 also showed that while there are exciting opportunities for blockchain, there are still significant barriers preventing wide-spread adoption. 43% of attendees in a poll conducted during the panel cited a lack of skilled personnel as a key issue that needs to be addressed, while just over a third (36%) cited unacceptably high energy consumption levels. A fifth (21%) said the technology was too difficult to understand. Some of these issues are more easily overcome than others, but all of them require far greater collaboration between all players in the industry—including researchers, technologists, and regulators, among others—along with deeper understanding of the technology, if we are to see significant progress.
For example, since a lack of skilled personnel is one of the biggest concerns, it will be important for organizations to coalesce around educational programs and courses to improve the skill level of life sciences professionals across the board. To this end, The Pistoia Alliance has run blockchain introductions and a boot camps
and Bio-IT World Expo has run workshops to help increase familiarity with key blockchain concepts such as distributed ledger structure and architecture, best practices, and how to develop smart contracts. On top of this, there are steps—such as embracing universal data standards and formats—which would make blockchain adoption easier for every organization.
An Industry-Wide Solution
It can be easy to forget just how new blockchain is. The first block on the chain, the Genesis block, was created as recently as 2009. As with any newly invented technology, we are only just beginning to understand the scope of potential blockchain applications. Recent Pistoia Alliance and Bio-IT World Expo events have shown just how far-ranging an impact DLT could have on the life sciences industry, revolutionizing the way firms deal with a host of problematic data issues, including consent, clinical trial management, and authenticity.
However, if blockchain is to realize its potential as a transformative technology, we need to figure out how to overcome some very real hurdles, not least the fact that many people simply do not understand the fundamental nature of blockchain technology. We need far better education around blockchain and the ways in which it can be applied, and this is only going to happen if there is greater collaboration among life sciences organizations. We’re keen to help this happen, and we look forward to working with the readers of Bio-IT World to take steps towards broader blockchain adoption, to get drugs to patients faster, safer and more securely.
Dr. Richard Shute is a consultant for Curlew Research and The Pistoia Alliance.To find out more about The Pistoia Alliance’s work with blockchain, please visit: https://ip3.pistoiaalliance.org/subdomain/main/end/node/1841