A blockchain-based initiative known as PharmaLedger has won support from prominent companies like Pfizer, Novartis, Merck & Co., Bayer and AstraZeneca.
In 2019, the FDA launched a pilot program supporting the Drug Supply Chain Security Act with the support of IBM, KPMG, Merck & Co. and Walmart.
The pandemic’s disruption of the pharmaceutical supply chain further spurred industry interest in exploring blockchain to improve logistics networks, as the Harvard Business Review observed.
Overall adoption of blockchain in pharma or the enterprise at large, however, remains at a nascent stage.
Blockchain in the enterprise “kind of died with the bear market,” said Nitin Kumar, co-founder of the blockchain startup Zbyte (San Francisco), referring to the short-lived financial malaise in 2020. Many blockchain vendors active around then didn’t survive.
The startup Zbyte believes blockchain could transform data management in clinical trials and quality management in the pharmaceutical industry.
Addressing core challenges
Several hurdles, however, have held back adoption. For one thing, integration between blockchain-based and legacy IT systems has been a headache.
“So we’re hand-holding the non-blockchain world into blockchain,” said Saurabh Radhakrishnan, co-founder of the company.
The company aims to do that by eliminating the need for developers to use low-level languages such as Solidity, Haskell or Rust by creating a low/no-code interface for enterprise developers to create blockchain applications.
“Bridging that gap becomes super important because it becomes very expensive for an enterprise to build a blockchain-based application because it has to hire an entirely new team,” Radhakrishnan said.
Furthermore, to interact with a blockchain, you need to create and maintain a blockchain wallet along with various cryptocurrencies. Managing a blockchain wallet while having cryptocurrencies on an enterprise balance sheet can present further complications. “It is not convenient,” Radhakrishnan said. “The Web 2.0 UX has not hit the Web 3.0 world yet,” he added, referring to terms involving the post-dotcom internet and the potential decentralized internet based on public blockchains.
“That connection is missing,” agreed Nitin Kumar, Zbyte co-founder. So one of the things the company is doing is facilitating the link between systems relying on legacy Web 2.0 software and the blockchain-enabled Web 3.0 systems.
Zbyte is working to make it possible to use single sign-on as a way to interact with blockchain “without actually having to do all of that complex wallet management and creation process,” Radhakrishnan said. Instead, users could log in via software such as Google Workspace or Microsoft Office 365 while bringing in data from existing databases from Microsoft Dynamics, Oracle, or SAP.
In addition, Zbyte also enables enterprise companies to operate only in fiat, with all the complexity of cryptocurrency management to pay the blockchain occurring under the hood.
Why blockchain still matters
One of the core values of blockchain is its immutability. “Blockchain is a database that cannot be changed,” Radhakrishnan said. Adding a piece of data to the blockchain requires approval from all those participating in this database, and once added, it cannot be altered or removed. This ensures the reliability and accuracy of the data without a central entity changing the data to suit their needs.
While making an existing database into an immutable ledger remains possible, it would be challenging to create a system where consensus comes from multiple individuals, Radhakrishnan said. “You could do that, but that’s like creating blockchain from scratch. That’s like saying I could build my own cloud system.”
Zbyte believes using blockchain supports scalability from a price standpoint.
The company supports a multichain ecosystem to maximize user flexibility. “When you are creating a decentralized application on our platform, you can deploy in either a single chain or multiple chains, choosing between the lowest fees or the highest security, Radhakrishnan said. “You can pick and choose different blockchains for the use case you are looking at.”
Reassessing blockchain’s potential in pharma
Blockchain technology promises to make clinical trials more transparent and could safeguard against misconduct and errors in clinical research. One proof of concept study published in JMIR Medical Informatics found that blockchain has the potential to address common threats to clinical trial data integrity. That paper concluded that more technical work is required to develop “optimal models for participation in the system by its various stakeholders.”
There often is considerable paperwork to fill out and load into clinical management systems used by principal investigators in traditional clinical trials. For example, each patient encounter could require a new document to log efficacy, safety data, and other parameters. Ultimately, if the clinical trial is successful, such reports are provided to regulatory authorities.
The process is “very intransparent and inefficient,” Radhakrishnan said.
Blockchain-based systems could help drug companies record each data point in a clinical trial and get validation from a regulator reviewing an ultimate submission.
Similarly, blockchain could help compliance with quality requirements in drug manufacturing.
In the production process, every piece of equipment involved in drug manufacturing must work according to a set of predefined criteria approved by the FDA. Such data collection information on how a piece of equipment has been maintained and how it operates to ensure a drug production process meets quality standards.
“Traditionally, all of that is done on paper or in expensive quality management software that is often hard to navigate,” Radhakrishnan said.
The FDA can review the data from such systems if there is a concern related to a recall or an audit. “Everything is recorded, even when the janitors clean the floors because, if they didn’t clean a certain day, that could change the quality standards for that batch process for that specific drug,” Radhakrishnan said.
Looking toward the future
While the pharmaceutical industry may have a budding interest blockchain, Radhakrishnan it remains uncertain whether the industry will favor a private or public blockchain. A private blockchain is controlled by a limited number of participants and can be more prone to security threats and requires more trust than a public blockchain, according to the Blockchain Council.
“Public blockchain is what zbyte is enabling to ensure that any information that the enterprises are willing to share to gain stakeholder trust can be viewed at any time by anyone without them having to worry about all the complexity that accompanies it,” Radhakrishnan said.
The industry observers should keep an eye on how blockchain evolves as the barriers to deploy the technology steadily reduce, Radhakrishnan said. “While blockchain offers the benefits of increased efficiency via automation, increased trust via the immutability, and the increase transparency to the entire ecosystem, from pharma companies to clinical trials to regulatory bodies to end consumers, it will be interesting to see how adoption moves forward,” he concluded.
Filed Under: clinical trials, Data science, Drug Discovery