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Health Sciences and Wellness Market Digital Consultant
Passionate about emerging technologies and their impact on life sciences, primarily in R&D. Developing team members. Film and theater lover. Arsenal Football Club fan. Husband and father to two girls.
This article was co-authored by James Canterbury, EY Global Life Sciences Risk & Compliance Leader.
Pharma companies have complicated supply chains and manufacturing operations that are closely regulated by health authorities such as Food and Drug Administration (FDA) and Medicines and Healthcare products Regulatory Agency (MHRA). There has recently been a significant increase in the volume of regulatory findings around data integrity issues, which can also be viewed as a lack of trust in digital records. While the lack of trust can stem from many places, it is often traced back to two primary drivers:
Blockchain offers the prospect of designing a data structure from the perspective of the product, which means that, in a single chain, all vital data about that product can be captured directly at the source of origination and maintained in an immutable audit trail.
The time-stamping function of the blockchain, in conjunction with the audit trail, provides an accurate record of who, what, where and when a product might have been changed over a given period of time. The current status or location of any given product is available by examining the current state of the block.
The real cost of data integrity and availability is the amount of effort an organization puts forth producing data they can trust. If we imagine a world where all data is trustworthy and at our fingertips, then the efforts around data would be limited to affirming that it accurately reflects our real-world transactions and processes, and in interpreting the data to make better business decisions. Any time or resources spent on trying to locate, verify and conform data is a sunken cost that yields little return.
Yet this cost is significant. In July 2016, the FDA issued a draft of their proposed Request for Quality Metrics; the Federal Register notice (80 FR 44973) gave an estimate of 667,800 hours annually to collect and respond to their 15 proposed metrics. A follow-on study conducted by the International Society for Pharmaceutical Engineering (ISPE) in June 2016 determined that the actual effort would be at least three times that amount, just to collect and prepare data on three of the metrics.
And these up-front costs are just a drop in the bucket when compared with the cost of getting it wrong. From an FDA perspective, the inability to rely on data will create major obstacles in new drug approvals and can result in warning letters, which may lead to injunctions. These trends in data integrity issues have been so obvious that in April 2016, the FDA issued a draft guidance — Data Integrity and Compliance with CGMP.
Blockchain technology is a way to structure data without the need for a central authority. A blockchain is a distributed database that hosts a continuously growing number of records. The database stores records in blocks rather than collating them in a single file.
Each block is then “chained” to the next block in linear, chronological order using a cryptographic signature; as a result, records cannot be revised, and any attempted changes are visible to all participants. This process allows blockchains to be used as ledgers, which can be shared and corroborated by anyone with the appropriate permissions.
Based on the participants, blockchains are categorized as public, private or hybrid. This is similar to comparing the public internet and a company’s intranet.
To design a blockchain that would capture the data along the life cycle of a pharma product, we would likely start at batch creation and follow it through to the smallest saleable unit. Because blockchains can refer to other blockchains (the hybrid model), companies will likely begin with blockchains that collect data from processes that are within their span of control. These may include external manufacturers or distributors. Data would be collected at the source of origination, and each block would be a combination of identifying data, status or stage data, supporting data and time-stamp information. The blockchain can be run in parallel with existing manufacturing execution system (MES), laboratory information management system (LIMS) and enterprise resource planning (ERP) systems.
Blockchain technology is still in the early stages of development and it will likely take some time before its full potential is put to use. This technology has the potential to help life sciences companies simplify complexities while providing them the ability to uphold their data integrity standards within a regulated environment. Breaking away from a database mentality may be the most challenging IT cultural or mind-set shift ever, but companies don’t need to wait until someone else has set the standard.
Breaking away from a database mentality may be the most challenging IT cultural or mind-set shift ever, but companies don’t need to wait until someone else has set the standard.
About this article
Health Sciences and Wellness Market Digital Consultant
Passionate about emerging technologies and their impact on life sciences, primarily in R&D. Developing team members. Film and theater lover. Arsenal Football Club fan. Husband and father to two girls.
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