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Informatics


To help provide some more insight to those use- cases that might be more beneficial and compelling within the healthcare industry and more specifical- ly in drug discovery, in May 2017 Curlew Research facilitated a workshop at BioIT’s World Expo in Boston on Blockchain Technology12. One session of the workshop13 used the knowledge of the near- ly 30 attendees, many of whom had Pharma and Biotech expertise, and some of whom already had blockchain experience, to try to identify some of the more compelling business processes or capabil- ities in the medicines and healthcare value chain from target to patient where DLT might be benefi- cial. In this article I expand on the suggestions and insights which came out of that workshop, focus- ing on potential use-cases in drug discovery R&D, from target identification up to regulatory submis- sion, review and approval.


In a subsequent piece I will look at the post- R&D space from regulatory submission, via man- ufacturing, to the patient themselves.


Blockchain use-cases in drug discovery R&D


In the drug discovery R&D domain (defined for the purposes of this article as from Target ID to the end of Phase III clinical), there were a number of important use-cases identified by the attendees. These clustered into seven higher level areas:


1. Patents and Intellectual Property (IP) 2. Genomic data management 3. Raw and refined research data 4. Collaboration 5. Clinical trials 6. Licensing


7. Electronic signatures


1. Patents and Intellectual Property (IP) A critical part of R&D is the generation of intellec- tual property (IP), usually (but not exclusively) through the production of patents such as ‘compo-


Drug Discovery World Fall 2017


sition of matter’ linked to utility. One of the earli- est clear use-cases for DLT was its ability to times- tamp unalterably a file or document, through stor- age of the hash of the file14,15 on the blockchain. Such a file timestamping service is already avail- able through sites such as Proofofexistence.com16. Currently IP is handled pre-clinically by most organisations through the use of electronic lab notebooks (ELNs). These electronic record (ER) systems are now well-accepted legally for the cap- turing of IP17, as they are able to provide proof of who created the ER (ie Identity), when it was cre- ated (ie Timestamping) and what it contained on the date of creation (ie proof of Content). One additional, ideal facet would be the ability to prove that the ER has not been altered since it was creat- ed (ie Immutability). These four, critical properties: Identity, Timestamping, proof of Content (via hashing) and Immutability – what I term ITCI – are four of the fundamental use-cases provided by blockchain technology. In the area of patents, IP and ELNs, it therefore seems likely that highly secure, blockchain-enabled ELNs will be with us in the not too distant future. DLT could also enable a more fine-grained approach to patenting which could advantageously support the increasing trend towards pre-clinical drug discovery patents being filed later and with fewer compounds18 – some- times with only the one compound of real interest. If the ITCI data on that compound and its relevant bioactivity have been captured on a blockchain, then there is a clear, unarguable ‘stake in the ground’ for when that material has been first gen- erated. We will have to wait and see how, or whether, this might affect ‘first to file’19, the patenting approach now adopted pretty much everywhere in research/discovery based industries.


2. Genomic data management


Genomic data plays an important role in the early stages of drug discovery R&D as part of the feed- back from the clinic to target identification and val-


The drug discovery value chain. Estimates of timings and resources based on classical small molecule drug discovery. Source: https://steveblank.files. wordpress.com/2013/08/drug- discovery-pipeline.jpg


References 1 (a) “Blockchain Revolution”, Don Tapscott & Alex Tapscott, Portfolio/Penguin 2016, ISBN: 978-0-141-23785-4; (b) http://www.telegraph.co.uk/tec hnology/news/10881213/The- coming-digital-anarchy.html; (c) https://www.theguardian.com/ world/2016/jul/07/blockchain- answer-life-universe- everything-bitcoin-technology; (d) https://www.economist. com/news/world-if/21724906- trust-business-little-noticed- huge-startups-deploying- blockchain-technology- threaten. 2 (a) https://hbr.org/2017/ 01/the-truth-about-blockchain; (b) https://www.forbes.com/ sites/forbestechcouncil/2017/0 2/16/how-blockchain-will- evolve-in-2017/# 306322876343; (c) https:// www.wired.com/2017/03/forge t-bitcoin-blockchain-reveal- whats-true-today-tomorrow/; (d) http://www.coindesk.com/ information/; (e) http://www. coindesk.com/research/state- blockchain-q1-2017/. 3 https://www.linkedin.com/ pulse/8-lessons-blockchain- you-wont-read-anywhere-else- jiri-kram.


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