Informatics
of this is the concept of digital identity42. The use of blockchain technology to support a higher level of security and immutability to next generation digital identity, and to allow individuals to take back a higher degree of control over their own identity, has become one of the biggest areas of DLT exploration over the last few years43. Numerous start-up companies44 and several initia- tives have been established to look at DLT and dig- ital identity, eg the Decentralised Identity Foundation (DIF)45. Many of the more significant global technology players have also become involved in such ventures46.
In drug discovery R&D digital signatures are used, inter alia:
l In ELNs, to confirm that an experiment has been performed by an individual and that it is under- standable to a second individual who is “knowl- edgeable in the art’. l In documentation that will form part of any later regulatory submission. l In contracts. l In Good Laboratory, Manufacturing or Clinical Practise (GLP/GMP/GCP) documents.
Digital signatures are in fact used right across the R&D domain. Any technology that can make digital signing and identity confirmation more secure and certain, and so make fraud and identity misappropriation less likely, will make the discov- ery and marketing of the drugs that are prescribed to patients more trustworthy and more trusted. While preliminary descriptions of the use of DLT in digital signatures have been described47, it will probably be digital identity initiatives such as DIF that will more likely produce the new industry- standard signatures that future blockchain-enabled ELNs and document management systems will use across the R&D space, again, not just in healthcare but in many other industries.
Conclusion
In this article on blockchain technology in drug discovery, I have focused on potential use-cases in R&D. They all build upon four fundamental facets of DLT: Identity, Timestamping, Content and Immutability (ITCI). Many are supported by observations and suggestions put forward by oth- ers, both online and in the literature. Taken alto- gether, it is clear that DLT is going to be a major technological player in healthcare and drug discov- ery in the future. Furthermore, that future is not too far away, according to a survey of 120 senior pharmaceutical and life science leaders conducted
Drug Discovery World Fall 2017
in June 2017 by The Pistoia Alliance48. This survey concluded that “interest in blockchain is high with a significant 83% expecting blockchain to be adopted in under five years.”49 When polled on the single most significant hurdle or perceived lim- itation that blockchain must overcome before it is adopted widely in healthcare, “the leaders identi- fied the biggest hurdle as regulatory issues (45%), followed by concerns over data privacy (26%).” A more focused question on the specific areas where blockchain tech will have the greatest impact sug- gested that manufacturing and the medicines’ sup- ply chain (68%) followed by the health records area, including genomic data (60%) were the areas likely to be most affected by DLT.
These observations suggest that blockchain tech- nology may have its biggest impact post-R&D. I contend, however, that DLT will also disrupt the pre-submission, R&D space. Some suggestions about how and where that disruption might occur along the medicines discovery value chain are described above. Time will tell whether any of these lead to successful blockchain-based products, services or businesses, or whether some other cur- rently unknown use-case will appear that becomes the killer app for blockchain just as email was for the internet50. Rest assured, blockchain technology is here to stay and medicines discovery will be changed by it.
Acknowledgement
I should like to thank Dr Nick Lynch of Curlew Research for his help, advice and support in the writing of this article.
DDW
Continued from page 56
Dr Richard Shute is an experienced medicinal chemist and informatics IS/IT manager. His PhD was on -lactam antibiotics from Nottingham University. Richard worked for more than 25 years in Big Pharma at ICI, Zeneca and AstraZeneca; half that time in chemistry, the other half in infor- matics. Richard has worked for Curlew Research as a consultant since 2015.
40 If one considers a car to be a ‘high-tech instrument’ then the use of blockchain technology to manage and keep track of the usage of self- driving cars is another (albeit non-healthcare) use-case that has been seriously proposed for the future: http://www.
coindesk.com/blockchain- move-self-driving-cars-fast- lane/. 41
http://coinmarketcap.com/ currencies/ethereum/. 42 (a)
https://www.techopedia. com/definition/23915/digital- identity; b) https://www.
adelaide.edu.au/press/titles/digi tal-identity/Digital_Identity_ Ebook.pdf. 43 (a) https://mydigitalblock
chain.com/2016/04/06/how- the-blockchain-could-become- the-next-e-signature/; (b)
http://www.coindesk.com/docu sign-founder-sees-blockchain- tech-potential-identity- management/. 44 https://letstalkpayments. com/22-companies-leveraging- blockchain-for-identity- management-and- authentication/. 45 https://decentralised-
identity.github.io/. 46 (a)
https://www.ibm.com/ blockchain/identity/; (b)
http://www.coindesk.com/bloc kchain-consortium-draws- enterprise-giants-to- revolutionize-digital-identity/. 47
https://blog.signatura.co/ using-the-blockchain-as-a- digital-signature-scheme- f584278ae826. 48 http://www.pistoiaalliance. org. 49 http://www.drugdiscovery
today.com/view/46077/83-of- life-science-leaders-believe- blockchain-will-be-adopted- within-five-years-finds-survey- from-the-pistoia-alliance/. 50
http://radar.oreilly.com/ 2013/12/email-the-internets-
first-and-last-killer-app.html.
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