Health IT, Pharma

Blockchain becomes a ‘source of truth’ for biopharma

Although blockchain faces regulatory hurdles and skepticism, its potential as a shared, yet secure ledger system to improve the pharmaceutical supply chain integrity and clinical trials is making it attractive for experimentation and investment by drugmakers.

Whatever economic role bitcoin will ultimately play, the underlying technology that powers it and other cryptocurrencies — blockchain — has attracted a lot of attention from a multitude of industries, including biotechnology and pharmaceuticals. While the the technology’s creator remains elusive, the practical applications of blockchain are emerging.

In the context of Big Pharma, those applications primarily boil down to securing the pharmaceutical supply chain and ensuring compliance in clinical trials, though other applications are being developed by smaller companies. What is particularly attractive to the industry is the idea of a shared, yet secure and incorruptible ledger system, which has potential to play a significant role in boosting data accuracy.

“I think 2019 is going to be the year of pilots – companies are going to experiment,” said Robert Chu, CEO of Embleema, a New York-based company developing a blockchain-based system that allows patients to securely control and share their medical data, in  a phone interview.

Merck is one of those Big Pharma companies testing the technology . 

Pamela Eisele, a spokeswoman for the Kenilworth, New Jersey-based company, pointed to a successful 2016 pilot test to use blockchain to provide visibility and transparency across the pharmaceutical supply chain and allow accurate, verifiable tracking of products through their life cycles. Another Merck test looked at whether it could improve the importation process. The company found that authorities could audit all products upon import without having to take and test samples. That can allow drugmakers to avoid lengthy delays that jeopardize product shelf life. The next step for Merck’s pilot test, Eisele said, is to invite other companies and organizations to join in.

In July, the Icahn School of Medicine at Mount Sinai and the Institute for Next Generation Healthcare opened the Center for Biomedical Blockchain Research, with the goal of developing partnerships with companies working to apply the technology to clinical medicine and biomedical research.

A spokesperson for Paris-based drugmaker Sanofi wrote in an email that the company is looking at the possibility of incorporating the technology into various areas of its business, pointing out that it is “definitely key” in fighting counterfeit drugs, improving clinical trials and changing the patient data relationship.

Tracking and tracing drugs is a particularly attractive application for the technology, said Mehdi Benchoufi, a researcher in the clinical epidemiology department at the Hôtel-Dieu Hospital in Paris.

“That has a lot of ramifications from the business side,” Benchoufi said in a phone interview. “I find it’s a really smooth and evident application of blockchain.”

However, even this potential application is also not without its skeptics. Currently, there are already small tags placed on medicine bottles that have an anti-cloning function, and that appears to be somewhat standard technology in the tracking of shipments, wrote David Buck, an analyst at investment bank B. Riley FBR, in an email. It is possible that blockchain offers some improvements, but that is uncertain, he added.

Indeed, large drug companies are already heavily invested in existing track-and-trace technology, which might make them reluctant to take on a new and unproven alternative like blockchain, said Hashed Health CEO John Bass in a phone interview. However, blockchain-based track-and-trace does have potential in low-resource environments where the traditional business interests and infrastructure have not taken hold Africa is one example of such a market, Bass said. Hashed Health develops blockchain products aimed at reducing the costs and administrative inefficiencies of healthcare.

One area where the technology may have a more significant effect is in the operation of clinical trials.

Trials often involve multiple centers with different institutional review boards and sources of data, which makes it difficult to handle data and consent, Bass said. Thus, blockchain could improve them by providing a “shared source of truth” rather than “a bunch of individual sources of truth” and numerous people trying to reconcile the differences. Allowing all the actors in the trial to share the same information via blockchain, including consent and even research information, would ultimately help drugs get to market faster and more efficiently, he said.

Indeed, “improving clinical trials” is on Sanofi’s list of applications the company foresees for blockchain. In particular, it could be used to ensure data are collected and shared where needed while maintaining privacy or proprietary information, reducing costs and increasing efficiency. Additionally, it could be useful in trials of rare diseases for which very few patients qualify to participate, enabling exchange of data and preservation of confidentiality, thereby reducing the time required for drug development.

“Data accuracy is incredibly important because we’re drawing conclusions in a clinical trial that are implemented in the market in terms of safety and efficacy of a drug,” Medable CEO Michelle Longmire said in a phone interview. “What’s exciting about blockchain as a single ‘source of truth’ or central ledger is that it provides a new era of data accuracy from the standpoint that you can reference it. Here’s the data point, here’s anything that happened around that, and it’s well-documented.”

The company’s product suite includes Medable Insight, which is designed to use blockchain to overcome problems in health research like scarce funding, siloed data and limited computing power.

Further, clinical trials face a number of problems such as lack of reproducibility and poor methodological quality – problems that blockchain technology has an opportunity to address, Benchoufi said. One example is patient informed consent, which is bound to clinical trial protocol revisions, meaning changes to various aspects of the trial such as dosing or how measurements are taken.

In a paper published last year in the online platform F1000 Research, Benchoufi and colleagues designed a proof-of-concept protocol whereby each step of a patient’s consent collection was timestamped using blockchain, thereby creating a transparent means of documentation. The result was a document that could not be corrupted and could be checked on any dedicated public website.

Buck wrote that this application may be of more interest to service providers partnering with drugmakers, such as contract research organizations and contract manufacturing organizations. However, Benchoufi said service providers and drugmakers alike would likely find it useful.

“We need a better-quality system because clinical trials are horribly costly,” Benchoufi said.

Bass said that a centralized server and database could achieve the same results in improving clinical trial operations as blockchain. However, that would mean relying on a centralized organization to manage that business and paying into it. Consequently, the difference is between creating a centralized entity versus creating utility across an organization via blockchain, he said.

A likely scenario is that blockchain in the context of clinical trials will become part of a hybrid of technologies – along with, for example, artificial intelligence – used to ensure ownership, access and reproducibility of data, Longmire believes.

“What’s transformational about blockchain is that the way we think about data now. Data needs to be reproducible and accessible, and patients need to own their data,” she said.

CROs would be in a good position to take advantage of blockchain, but Benchoufi foresaw the drug industry leading more on its development than the service providers. Chu of Embleema said that by 2020, it would be possible for companies to use blockchain to share data in real time with the Food and Drug Administration.

While pilots are occurring and companies are testing out the nascent technology, the successful application of blockchain industry-wide will hinge on a legal and regulatory framework governing its use.

There are certain regulations with which blockchain will have to be compliant, such as HIPAA, its equivalent in Europe and various FDA regulations, Chu said. But he added that the current regulations are suitable and even supportive of blockchain.

The FDA will need the biotechnology and pharmaceutical industries to show the way with examples and implementation, but the agency has been generally supportive regarding innovation, Longmire said.

In Europe, meanwhile, the European Commission has been supportive of blockchain’s use in healthcare, and the commission’s Innovative Medicines Initiative has explicitly called for applying blockchain technology to drug development, according to Benchoufi.

Blockchain is still a young technology in terms of applicability that faces regulatory hurdles and its share of skeptics. However, the potential for its “shared source of truth” to generate new ways to secure the pharmaceutical supply chain and improve the use of data in clinical trials mean it will likely continue to see tinkering and investment by drugmakers.

Photo: Getty Images