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Regardless of the bitcoin's economic role, 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 creator of the technology remains elusivepractical applications of blockchain are emerging.
In the context of Big Pharma, these applications are primarily reduced to ensuring the pharmaceutical supply chain and ensuring compliance in clinical trials, although other applications are developed by smaller companies. What is particularly interesting for industry is the idea of a shared but secure and incorruptible accounting system, which has the potential to play a significant role in increasing the accuracy of data. .
"I think 2019 will be the year of pilots – companies will experiment," said Robert Chu, CEO of Embleema, a New York-based company that develops a blockchain-based system that allows patients to control and share securely your data doctor, in a telephone interview.
Merck is one of those Big Pharma companies that test the technology.
Pamela Eisele, Kenilworth spokesperson, a company based in New Jersey, underlined a successful pilot test in 2016 to use the blockchain to provide visibility and transparency throughout the supply chain and enable accurate and verifiable tracking of products during their cycles of life. Another test Merck examined if it could improve the import process. The company found that the authorities could control all products at the time of import without having to take and test the samples. This can allow drug manufacturers to avoid long delays that jeopardize the shelf life of the product. The next step for Merck's pilot test, Eisele said, is to invite other companies and organizations to participate.
In July the Icahn School of Medicine of Mount Sinai and the Institute for Next Generation Healthcare were opened the Center for research on the biomedical blockchain, with the aim of developing partnerships with companies that work to apply technology to clinical medicine and biomedical research.
A spokesman for the Parisian pharmaceutical company Sanofi wrote in an e-mail that the company is considering incorporating the technology in various areas of its business, emphasizing that it is "certainly fundamental" in the fight against counterfeit drugs, in the improvement of clinical trials and in the change the patient's data relationship.
Tracing and tracing drugs is a particularly interesting application for technology, said Mehdi Benchoufi, a researcher in the department of clinical epidemiology of the Hôtel-Dieu hospital in Paris.
"This has many consequences on the business side," Benchoufi said in a telephone interview. "I find it a really smooth and noticeable blockchain application."
However, even this potential application is not without skeptics. Currently, there are already small tags placed on bottles of drugs that have an anti-cloning function, and that seems to be a fairly standard technology in tracking shipments, wrote David Buck, an investment bank analyst B. Riley FBR , in an e-mail. It is possible that blockchain offers some improvements, but this is uncertain, he added.
In fact, the big pharmaceutical companies are already heavily invested in the existing track-and-trace technology, which could make them reluctant to take a new and unproven alternative as the blockchain, said Hashed Health CEO John Bass in a Telephone interview. However, blockchain-based track-and-trace has potential in environments with limited resources in which commercial interests and traditional infrastructure have not taken hold. Africa is an example of this market, Bass said. Hashed Health develops blockchain products aimed at reducing costs and administrative inefficiencies of health care.
One area in which technology could have a more significant effect is the functioning of clinical trials.
Trials often involve multiple centers with different institutional review boards and data sources, which makes data and consent difficult to manage, Bass said. Thus, blockchain could improve them by providing a "shared source of truth" rather than "a group of individual sources of truth" and numerous people trying to reconcile differences. He said that allowing all actors involved in the process to share the same information via blockchain, including consent and even search information, could ultimately help drugs to market more quickly and more efficiently.
In fact, "improving clinical studies" is on the list of Sanofi applications that the company plans for the blockchain. In particular, it could be used to ensure that data is collected and shared where necessary, while maintaining privacy or proprietary information, reducing costs and increasing efficiency. It could also be useful in testing rare diseases for which very few patients are eligible to participate, allowing data exchange and preservation of confidentiality, thus reducing the time required for drug development.
"The accuracy of data is incredibly important because we are drawing conclusions in a clinical trial implemented on the market in terms of the safety and effectiveness of a drug," said Medable CEO Michelle Longmire in a telephone interview. "The exciting thing about blockchain as a single" source of truth "or central ledger is that it provides a new era of data accuracy from the point of view that you can refer to it. Here's the data point, that's all that's happened around this, and it is well documented. "
The company's suite of products includes Medable Insight, designed to use blockchain to overcome problems in health research such as poor funding, archived data and limited computing power.
In addition, clinical trials face a number of problems such as lack of reproducibility and poor methodological quality – problems that blockchain technology has the opportunity to address, said Benchoufi. An example is the informed consent of the patient, who is bound to revisions of the clinical trial protocol, which means changes to various aspects of the experiment such as the dosage or the way the measures are taken.
In a newspaper Last year, published on the online platform F1000 Research, Benchoufi and colleagues designed a proof-of-concept protocol in which each phase of the collection of a patient's consent was timestamped using blockchain, thus creating a transparent means of documentation. The result was a document that can not be damaged and could be checked on any dedicated public website.
Buck wrote that this application could be more relevant to service providers working with drug manufacturers, such as contract research organizations and contract manufacturing organizations. However, Benchoufi has stated that service providers and manufacturers of drugs will probably find it useful.
"We need a better quality system because clinical trials are horribly expensive," said Benchoufi.
Bass said that a centralized server and database could achieve the same results in improving clinical trial operations such as blockchain. However, this would mean relying on a centralized organization to manage this activity and pay for it. As a result, the difference is between creating a centralized entity and creating a utility through 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 – together with, for example, artificial intelligence – used to guarantee ownership, access and reproducibility of data, believes Longmire.
"The transformation of the blockchain is the way we think of data now – data must be reproducible and accessible, and patients need to own their data," he said.
The CROs would be well placed to take advantage of the blockchain, but Benchoufi predicted that the pharmaceutical industry was more in the lead than its development over service providers. Chu of Embleema said that by 2020 companies could use the blockchain to share data in real time with the Food and Drug Administration.
While pilots are testing and companies are testing nascent technology, successful blockchain application at the sector level will depend on a legal and regulatory framework governing its use.
There are some regulations with which blockchain will have to comply, such as HIPAA, its European equivalent and various FDA regulations, Chu said. But he added that current regulations are suitable and even favorable to blockchain.
The FDA will need the biotechnology and pharmaceutical industries to show the way with examples and implementation, but the agency has generally been conducive to innovation, said Longmire.
In Europe, meanwhile, the European Commission has supported the use of blockchain in the health sector and the Commission's explicitly innovative medicines initiative has explicitly asked to apply blockchain technology to drug development, according to Benchoufi.
Blockchain is still a young technology in terms of applicability that addresses regulatory obstacles 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 means that it will probably continue to see drug fumbling and investment.
Photo: Getty Images
