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BLOCKCHAIN TECHNOLOGY A


few years ago, blockchain came on to the scene and into the public eye, made famous due to bitcoin’s rapid rise in


value. Bitcoin is a ledger containing financial data blocks chained together, and each block is authenticated by ‘miners’ using the proof-of- work algorithm. Once validated, a block of new data is then added to a pre-existing serial chain of ledgers. It’s stored in a decentralised fashion, has embedded trust and can’t be altered. It’s therefore immutable to hacking. Over the years, the number-one question has been: “Why should the drug-development industry care about using blockchain to drive drug development when what we’ve got is already working?” An example is a working pilot programme that was started a couple of years ago between government and leading industry partners, designed to use blockchain in clinical trials. As blockchain provides multiple solutions and enhanced data management, and can produce trustworthy data that is immutable in real time, it is highly desirable for drug development. The Drug Supply Chain Safety Act (DSCSA) was authorised in 2013, with the single purpose of allowing pharmaceutical ecosystem stakeholders and trading partners to team up on improving the safety and security of drugs. The DSCSA lays out vital steps to build an electronic, interoperable system by the end of 2023, where participants of the pharmaceutical supply chain are called to verify, track as well as trace prescription drugs as they are distributed in the US. To conform to the new federal law in a timely


manner, there is a substantial requirement to enhance transparency and establish a progressively coordinated pharmaceutical supply chain. The urgency is self-evident, as half of the US population is taking prescription medicines for numerous diseases, and a rise in the number of ageing Americans is projected to nearly double from 52 million in 2018 to 95 million within the next four decades. Today, the existing notification system is


extremely hands-on and laborious due to its fragmented nature, and fails to take advantage of currently available advanced technologies. Blockchain data infrastructure not only provides a trustworthy immutable data architecture, it also reduces the time to broadcast shareable information among stakeholders and to patients in the event of a product recall.


32 | Outsourcing in Clinical Trials Handbook


By using blockchain technology, one can quickly identify troubled lots and alert supply chain partners in an automated fashion, through the use of built-in smart contracts with conditional executions based on predetermined tasks. This methodology does away with unnecessary communication and leads to a lot less pharmaceutical material waste. To this end, multiple pharmaceutical


stakeholders as well as the federal government collaborated to ensure medicines are risk-free and reliable – and that the medically active ingredients used are authentic and up to medical standard. This continuous analytical rigour improved manufacturing, supply flow, environmental control, and technological methods through tracking and recording. Making use of a consistent data gathering methodology, the security of the supply chain can quickly be enhanced by removing replica drugs, excluding inefficient components and additionally safeguarding drug products.


In response to the preliminary purpose of linking varied systems, the pilot programme efficiently incorporated an organization system from a manufacturer with post-serialization item information to a personal-permissioned blockchain and develop a comprehensive oversight of product activity. This enabled the second objective of visibility to be attained, by enabling the use of the blockchain to confirm serial information of the medication prior to it being administered. An interoperable solution will certainly track along with creating a map of pharmaceutical items between trading partners as an essential element to consider prior to its administration. In order to rigorously analyse whether


blockchain would be an excellent innovation to handle the demands of the pharmaceutical supply chain, the pilot programme had two


“In order to adopt blockchain to power drug developments and trials, an egalitarian, comprehensive, open- sourced commercial solution of uniformed blockchain capability is required.”


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