by Bijoylaxmi Ghosh
Blockchain is a distributed ledger or database on a peer-to-peer network of personal computers known as nodes, where records are stored in digital blocks. These blocks collectively form a ‘blockchain’ which is distributed on several storage devices. As the database is distributed without a central authority, no entity can make a transaction without the knowledge of the other participants. All participants need to agree before any changes in information can be introduced in the form of new blocks. Unlike traditional databases which can be edited after information is stored in the central authority, records incorporated in a blockchain cannot be altered, so there will be no data tampering. This makes blockchains immutable, permanent and secure (Figure 1).
Applications of blockchain in drug discovery and development
Since its first use in managing digital fund transactions, blockchain technology has been extrapolated to many other industries, with the potential to transform the global economy by changing the way business is done. A forecast by Statista revealed that global investment in blockchain technology is estimated to reach $11.7 billion by 2022 (1). De-centralised distribution of information makes blockchain an attractive technology which can reshape businesses by offering trust, streamlining processes, lowering operational costs, removing fraud and duplicity, as well as enabling data integration in a sharing-based economy.
With these features, blockchain is poised to be a game changer in the drug discovery and development industry. Starting from target identification to being available in the market for public use, a drug undergoes multiple complex, expensive and time-consuming processes that require transparency and trust among the stakeholders involved in various steps. Blockchain can be applied to several aspects of the drug discovery and development lifecycle, namely data management, clinical trials, intellectual property (IP), royalties and licensing, ensuring drug authenticity and supply chain compliance (Figure 2).
Data management during literature review and research
The journey of a prospective new drug starts from research laboratories which generate raw (output files from the instruments) and refined (human readable and interpretable) data that are used as proofs of experimental findings. Careful review of the literature and citation of relevant data are important for drug discovery. Blockchain can ensure the authenticity of published data and help protect the integrity of scientific information. Each block of information on the blockchain is given a unique identifying code known as a ‘hash’, which is linked to the previous block in the chain, making it extremely difficult for the content of the block to be changed. The authenticity of the data can be verified by matching the hash provided in the published paper with the hash stored originally in the public blockchain, together with the time when the data was stored, known as the timestamp (2).
Large amounts of genomic data for target identification and validation are generated during the early stages of drug discovery. By only allowing relevant parties to access the data, blockchain technology can play a significant role in maintaining data confidentiality. Data sharing on the blockchain can also significantly accelerate the drug development process by avoiding duplication of work.
The possibility of secured sharing of authentic data among various stakeholders through blockchain makes it an attractive tool which can simplify clinical trial operations. After a new drug is developed, clinical trials are conducted to test its efficacy. Clinical trials are lengthy processes that involve complex interactions between various sources of data and multiple regulatory review boards from different locations. Confidentiality and proprietary information must be maintained while collecting and sharing clinical trial data. However, it is challenging to accurately and efficiently manage clinical data from multiple sources of information. Blockchain can help improve the quality of clinical trial outcomes by offering a single sharing platform for all stakeholders. Recently, Boehringer Ingelheim and IBM Canada have announced a partnership to explore blockchain technology in clinical trials (3).
Clinical trials require informed consent from participants about each step in the trial process. Transparency of clinical trial consent for protocols is of utmost importance for participating individuals and other stakeholders. However, the process of receiving informed consent is complex and often cannot be achieved satisfactorily. According to a Food and Drug Administration (FDA) report, in 2012, almost 10% of the clinical trials monitored by the FDA faced issues related to informed consent such as unapproved documents, invalid consent forms, absence of written consent forms, failure to collect re-consent of revised protocols, absence of Institutional Review Board approval of protocol changes and fraud documentation (4). Blockchain can ensure transparency of informed consent documents, authentic timestamping, secured storing and tracking of the consent forms, as well as real-time sharing of the information among all authorized parties. Exochain is an example of a blockchain startup working on secure storage of patient data (5). Collecting re-consent to revised protocols can be achieved through creating ‘smart contracts’ that would be bound to any changes in protocol revisions (6). Written in computer code, a smart contract is a self-executing agreement that functions under certain conditions and can be built into the blockchain to verify, facilitate or negotiate the contract agreements. Terms of a smart contract are automatically executed when the conditions of the contract are fulfilled, without requiring a middleman.
Intellectual Property (IP)
As the newly developed drug molecule is the prime source of revenue generation for pharma companies, IP is a critical asset in drug development. The process of protecting intellectual property through filing patents is expensive and time consuming. Global monitoring and facilitation of IP protection processes are complex and challenging. Loss of crucial data may cause huge losses of investments on the new drug (7). Blockchain can help significantly in proving the creation of IP assets, while also protecting the confidentiality of the data. Blockchain-enabled Electronic Laboratory Note (ELN) – a digital notebook for systematic, safe and efficient storage and sharing of laboratory data – ensures security and allow late filing of fewer new therapeutic compounds of real interest. IP documents uploaded to blockchain by the researchers are encrypted to prevent unauthorized access, and a record is created on the ledger. The encryption key generated upon uploading the document can be shared on the blockchain system, allowing a blockchain certificate to be issued to the researcher. Thus, there will be no conflict regarding who created the material and when, while maintaining confidentiality, legality, security and trust at the same time (2).
Royalties and licensing
Royalty payments from licencing deals are a crucial source of income for drug manufacturing companies. Considering the huge costs and resources required for a drug to reach the market from the laboratory, pharma companies need to partner with other organisations to share the risk of drug development. Depletion of patent lifecycles, limited number of new drugs, unstable market dynamics, frequent mergers and acquisitions pose tremendous challenges. Generation of breakthrough therapeutic molecules relies on effective collaboration among various stakeholders of the pharma ecosystem. However, lack of trust between the collaborating parties poses significant challenges. Fear of splitting royalty and loss of IP ownership constrain the collaboration of organizations, lowering the chance of potential discovery and development of new molecules. A possible solution to this problem is to create smart contracts of royalties, which can ensure fair distribution of ownership between collaborating enterprises.
Ensuring drug authenticity
Drug manufacturing and distribution partners of the pharma ecosystem are spread across different countries, making drug tracking and tracing difficult for pharma companies. In this complex system, many cases of fraud go undetected, negatively impacting manufacturers and patients and causing loss of revenues for the drug companies. According to PWC, in 2015, fake drugs with a market value between $163 to $217 billion were introduced into the supply chain (8). The World Health Organisation reported that approximately 10% of medical products in developing regions are substandard or falsified (9). By tracking every transaction going through the supply chain, blockchain can be an effective solution in preventing counterfeiting. With ongoing real-time records on the blockchain, it will be extremely difficult for unauthorized agents to introduce counterfeit products into the supply chain. The FDA has recently launched a pilot programme with Merck, IBM, KPMG and Walmart to evaluate blockchain technology in improving tracing and tracking of prescription drugs, increasing accurate data sharing among stakeholders and ensuring the integrity of products across the supply chain (10). The Mediledger project is aimed at finding blockchain solutions for tracking and tracing prescription medicines and preventing entry of counterfeit medicines into the pharma supply chain (11).
Blockchain can also ensure the authenticity of excess drugs procured by wholesalers before they are re-sold. Currently, without a method to verify drug authenticity, these drugs are returned to the manufacturing companies which destroy them, resulting in a waste of resources. By recording the serial number of the products into the distributed ledger, wholesalers and customers can verify that the un-sold drugs are authentic and suitable for re-sale.
Supply chain compliance
A drug may be transported thousands of kilometres from the manufacturing site before it reaches customers. During the journey through the supply chain, the drug must be monitored by logistics companies to ensure that it is maintained at the optimal handling, transport and storage conditions. Failing to maintain the right conditions can negatively affect the efficacy of the products. Currently, the specific conditions required for a drug are monitored through smart devices such as Internet of Things (IoT) throughout the entire supply chain. As various participants of the supply chain such as manufacturers, logistics companies, stores and pharmacies use their own ledgers in IoT, tracking becomes complicated. Blockchain can bring all stakeholders of the supply chain onto the same ledger and facilitate tracking by introducing compliance and governance throughout the supply chain. The inherent transparency, immutability and de-centralised features of blockchain ensure adherence to all guidelines by any participating authority. Any deviations from the compliance conditions can be managed by creating smart contracts that will alert relevant stakeholders in the supply chain. Novartis is experimenting with blockchain technology by running several proofs of concepts for tracking and tracing of products as well as integrating IoT sensors to monitor optimum temperature and humidity conditions throughout the supply chain (12).
While ambitious plans are in the pipeline, blockchain applications in the drug discovery process are still in their infancy. Powerful incumbents, ideological pushback, privacy concerns, off-chain transactions and lack of faith are some of the hurdles that may delay blockchain implementation in drug discovery and development. Lack of blockchain knowledge and skillsets also pose significant challenges that may be overcome through providing relevant and adequate training. In addition, the public nature of the blockchain ledger poses issues concerning privacy and data security, arising from a lack of clear understanding of the complex blockchain technology. This leads to fear of losing proprietary data and trade secrets. Doubts concerning the ownership and access of blockchain data can be resolved by establishing consensus protocols through thorough understanding of the technology in meeting privacy and data security.
Given the potential of blockchain applications throughout the drug discovery and development value chain, the pharma industry is likely to benefit from the technology when existing barriers to implementation have been overcome. Success of the ongoing pilot programmes will determine further investments in blockchain by pharma companies. Time will tell whether the technology lives up to its hype of revolutionizing the pharma industry. With the rapid growth of blockchain technology and increasing interest of industry players, it will be interesting to watch how the technology shapes the drug discovery and development process in the years to come.
1. Blockchain – Statistics & Facts. Retrieved on 18 August 2019, from https://www.statista.com/topics/5122/blockchain/
2. Blockchain Technology in Drug Discovery: Use-Cases in R&D. Retrieved on 18 August 2019, from https://www.ddw-online.com/informatics/p320746-blockchain-technology-in-drug-discovery:-use-cases-in-r&d.html
3. Boehringer Ingelheim and IBM Canada Announce First of its Kind Collaboration to Integrate Blockchain Technology into Clinical Trials. Retrieved on 18 August 2019, from https://www.pharmaadvancement.com/drug-development/clinical-trials/boehringer-ingelheim-and-ibm-canada-announce-first-of-its-kind-collaboration-to-integrate-blockchain-technology-into-clinical-trials/
4. Blockchain protocols in clinical trials: Transparency and traceability of consent. [version 5; peer review: 1 approved, 2 approved with reservations, 2 not approved]. Retrieved on 18 August 2019, from https://f1000research.com/articles/6-66/v5
5. Top 5 Blockchain Use Cases in Pharma and Healthcare — that you should know about! Retrieved on 18 August 2019, from https://medium.com/blockchainbistro/top-5-use-cases-of-blockchain-in-pharma-and-healthcare-that-you-should-know-about-77ccdd76369b
6. Smart Contracts. Retrieved on 18 August 2019, fromhttps://www.investopedia.com/terms/s/smart-contracts.asp
8. 2 GSK scientists indicted in secrets case involving China. Retrieved on 18 August 2019, from https://www.pwc.com/us/en/industries/health-industries/library/blockchain-could-help-secure-the-pharmaceutical-supply-chain.html
9. 1 in 10 medical products in developing countries is substandard or falsified. Retrieved on 18 August 2019, from https://www.who.int/news-room/detail/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified
10. Merck, IBM, KPMG and Walmart Selected for FDA Blockchain Pilot. Retrieved on 18 August 2019, from https://www.raps.org/news-and-articles/news-articles/2019/6/merck-ibm-kpmg-and-walmart-selected-for-fda-bloc
11. The MediLedger Project. Retrieved on 18 August 2019, from https://www.mediledger.com/
12. Momentum for blockchain in healthcare is growing in Basel. Retrieved on 18 August 2019, from https://www.baselarea.swiss/baselarea-swiss/channels/innovation-report/2018/12/Momentum-for-blockchain-in-healthcare-is-growing-in-Basel.html