Blockchain in Drug Discovery and Development

In the previous blog, ’Disruptive Innovation of Blockchain and Evolution of Pharmaceutical Ecosystem in Data Integrity and Transparency’, we explored how blockchain can address present age data integrity and security aspects in the pharmaceutical ecosystem with efficient and effective collaboration.

Let us now explore some blockchain uses that can be applied for drug discovery and development.

Patents and Intellectual Property (IP)

The IP is arguably the most significant aspect of any new drug, as the core, and most critical part of a patent is its Composition of Matter. In the patent office, proving a patent requires four aspects:

  • Proof of creator
  • When was it created
  • What was included on the date of creation
  • Proof that the content was not altered

Use of blockchain, in this case, will assist in proving the IP assets, origin, and proof of ownership, without any disclosure of data! Here is how blockchain will work.

Figure 1: Illustration of the use of blockchain in IP assets and patents

The researcher will initiate blockchain upload of IP documents through a dedicated interface. Here, the blockchain system will locally encrypt the document, and locally create an encrypted document and upload it to a secured document storage system of the user’s choice or an enterprise document storage system to a create a record. The encryption key generated in this process is shared on the blockchain system, and a blockchain certificate is issued and allocated to the researcher.

Thus, confidentiality, security, trust and legally accepted record, proof of origin, timestamp and ownership can be achieved all at once [1].

Licensing and Royalty

At present, the pharmaceutical drug research and development ecosystem is under tremendous pressure to deliver new drugs due to depleting patent lifecycle and dwindling drug pipeline. Add to this the volatile market dynamics and frequent mergers and acquisitions, and the pressure multiplies many times. The only effective and efficient solution is collaboration among different stakeholders, combined with mutual benefit contracts.

Each enterprise has complementary strengths and pooling their respective talents could achieve a breakthrough molecular design while lowering risk. However, the collaborating parties may not trust each other and may be worried about being shortchanged during splitting royalties and ownership of IP. It is possible to envision a smart contract of royalties that coordinates this arrangement, with ownership in eventual molecules being fairly divided between the firms.

When regulators approve the drug, the stipulated royalties can be triggered by using blockchain smart contracts. Further, the Byzantine fault tolerance of the network can defend against corporate malfeasance if one of the firms attempts to cheat [2].

Research Literature Referencing and Authenticity

In research, various pieces of literature are referenced frequently. With the ever-increasing amount of publishers and research papers available for access over the internet, the trustworthiness, as well as the authenticity, of literature is often put under scrutiny in the scientific community. In such cases, blockchain can aid the scientific community in establishing the authenticity and trustworthiness of the literature.

Here is a use case:

A scientist crafts a unique assay protocol. The details of the assay protocol and associated work material is uploaded in a secured document storage system enabled by blockchain. The blockchain-enabled system will encrypt the document and generate a hash. The same hash is published in the public-facing blockchain, along with the research paper, on publisher’s website. When the community wants to verify the trustworthiness and authenticity of the assay file provided in the scientific literature, they only need to perform a simple matching of hash published in the assay.

Clinical Trials

Clinical trials are generally outsourced to CRO’s for faster execution and potential patient outreach. Similarly, testing is outsourced to central laboratories for mass-level laboratory testing under GLP conditions. In this scenario, the trustworthiness of data being shared among stakeholders becomes a crucial question. With the recent exposure of laboratory data tampering (e.g., lab data from analytical instruments like HPLC, GC, Mass Spectrometer, NMR), drug regulators around the world have started questioning the authenticity of data being produced for regulatory approvals.

With the use of blockchain technology, data can be securely recorded in chronological order and stakeholders can prove the identity, trustworthiness, proof of content, and timestamp at any time in point.

Blockchain technology can also be used in maintaining patient data integrity in clinical trials, where patients may contribute their data for research purposes using smart contracts mechanism.

Another use case within the clinical trial industry can be the entire planning and execution of clinical trial on blockchain using smart contracts. Smart contracts will drive how someone will read, write, download, print, and share data. The statistical team will only have access to eCRF raw datasets, along with aggregated and analyzed data, to perform exploratory and multidimensional analysis of data. The CDM team will not have access to datasets generated by the statistical unit. Similarly, the Supply Chain Management team will have only have access to the patient identifier, its drug dispensation reports, and site kits inventory, so that they can replenish the kits and for drugs in advance [3].

There can be multiple other use cases in pharmaceutical ecosystem across data capture, Informed consents, IRT, and so on.

In subsequent blogs, we will explore how blockchain can aid pharmaceutical manufacturing and supply chain sector.

References

[1] B. Clark and B. McKenzie, “Blockchain and IP law: a match made in crypto heaven?,” February 2018. [Online]. Available: http://www.wipo.int/wipo_magazine/en/2018/01/article_0005.html. [Accessed 10 03 2018].

[2] B. Ramsundar, “Why Blockchain Could (One Day) Topple Google,” [Online]. Available: http://rbharath.github.io/why-blockchain-could-one-day-topple-google/.

[3] M. Benchoufi and P. Ravaud, “Blockchain technology for improving clinical research quality,” Trials, 2017.

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About Tushar Sinkar

mmTushar is a clinical solutions consultant with more than 8 years of experience in implementing cutting-edge solutions in the Life Science and Healthcare domain. His areas of expertise include enabling pharmaceutical companies and independent software vendors in conceptualizing, designing, and implementing clinical trial and real world evidence (RWE) solutions that are driven by semantics and are interoperable, secured, and GxP and HIPAA compliant.


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