Informatics
Continued from page 54 Centralised (A) Centralised-decentralised-distributed models
his/her/their original whitepaper30 is the concept of disintermediation or the enablement of “multiple parties who do not fully trust each other to safely and directly share a single database without requir- ing a trusted intermediary”11a. If, in that quotation you replace the words “a single database” by any of the following: data, results, information or know- how, then you have the basis for a system that can support more effective collaboration between par- ties who would otherwise be very nervous or suspi- cious about working together. Current drug discov- ery R&D is now increasingly being done by a net- work of organisations, often in a classic, centralised customer-supplier relationship, but increasingly in a more collaborative, peer-to-peer, decentralised ecosystem where information, data and results are shared more or less openly31. Blockchain technology, probably with off-chain storage, which is needed because current block size in most blockchains is not sufficiently big to allow full datasets to be stored on-chain, could enable this more collaborative, distributed mode of prod- uct (not just drug) discovery to become the stan- dard research model, so superseding the historical centralised mode. DLT-enabled or merely blockchain-connected ELNs, LIMS and SDMSs as predicted above could facilitate and de-risk this research revolution without compromising critical company IP. True, global collaborative drug dis- covery could finally be fully enabled by the blockchain.
Drug Discovery World Fall 2017 5. Clinical Trials
Use-cases around blockchain support for the area of clinical trials and the supply chain comprising Pharma-Physician-Patient-Data have been the sub- ject of several recent articles32. The exact mecha- nisms for how DLT could positively impact clinical trials’ support are still being hotly debated. Indeed, a recent, heavily-publicised paper describing how “blockchain-timestamped clinical trials protocols could improve the trustworthiness of medical sci- ence” has recently been retracted33. Nevertheless, blockchain technology and its four primary facets of ITCI could most definitely smooth and facilitate the undeniably complex transactional space that is the clinical trial. DLT could have a significant impact, from patient recruitment, supply of trial medicine (or placebo), to protocol and results securing; and from billing, to more easily allowing individual physicians to run different trials for multiple Pharma. DLT may even lead to the situa- tion where physicians are disintermediated from the clinical trials process altogether!
6. Licensing
In use-case #4 above, I discuss how DLT could help secure the newer, decentralised, more collaborative form of drug discovery. An additional arm of effec- tive medicines’ discovery that has become more and more popular over the last 20 or more years has been the cross-licensing and joint development of clinical candidates. Two good examples from
Decentralised (B) Distributed (C)
11 (a)
http://www.multichain. com/blog/2016/05/four- genuine-blockchain-use-cases/; (b)
https://bravenewcoin.com/ news/moodys-new-report- identifies-25-top-blockchain- use-cases-from-a-list-of-120/; (c)
https://everisnext.com/ 2016/05/31/blockchain- disruptive-use-cases/; (d)
https://www.coindesk.com/four -quadrants-dividing- conquering-crypto-universe. 12
http://curlewresearch.com/ curlew-blockchain-workshop- bioit-2017/. 13
https://www.slideshare.net/ RichardShute1/an-introduction- to-blockchain-in-healthcare/. 14
http://unixwiz.net/techtips/
iguide-crypto-hashes.html. 15 There are many hashing algorithms available and many online sites that can take files and generate the relevant hash. See for example
http://hash.online-convert.com/ sha256-generator which calculates the SHA256 hash for any given inputted file. 16 https://proofofexistence. com/about. 17
http://accelrys.com/micro/ notebook/documents/eln-legal- issues-sandercock.pdf. 18 I use the term ‘compound’ in this article to cover small molecules, the traditional drugs of Pharma, as well as the more modern large molecule therapeutics including biomolecules, antibodies, RNA- derived materials (eg siRNA), proteins, etc. 19
https://en.wikipedia.org/ wiki/First_to_file_and_first_to_ invent. 20 (a)
http://www.nature.com/ news/technology-the-1-000- genome-1.14901; (b)
http://www.bio-itworld.com/ 2016/3/28/how-veritas- genetics-plans-make-999-
whole-genome-stick.html. 21
https://www.slideshare.net/ RichardShute1/securing- personal-genomic-data-res. 22
https://www.forbes.com/ sites/patricklin/2017/05/08/bloc kchain-the-missing-link- between-genomics-and-privacy. 23
http://www.encrypgen.com.
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