Pharmaceutical Technology - November 2018

Pharmaceutical Technology - eBook

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Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 27 traceability and security of data—integrity. Data integ- rity is a fundamental traceability requirement in any pharma/biotech. Companies must assess if the data are trustworthy and if they can make business-critical de- cisions based on it. The gap with internal systems is that they are just that: internal. Exposing them to CROs is possible, but what happens when the CRO has their own systems, which the CRO staff knows and readily uses? Essen- tially, there is a problem of exchanging the audit log for a piece of data between parties. New technologies are being considered to solve this problem, such as blockchain, which aim to provide a full history of what has happened to something over time. Current systems, however, do not use blockchain in this fash- ion. While there are many blockchain companies and platform providers, there currently are no real proven providers of blockchain networks specifically for this purpose. Data quality The final data-centric aspect that needs considering is quality. This is also a barrier to sharing data, as quality is subjective. To remove the subjective nature of what the measure of quality is, the context for a piece of data is needed. All things that could impact the data point need to be known: what instrument it was run on, what software was used to analyze it, what standards were used to run the experiment, what conditions were like in the lab (metrology); what other instru- ments were used to prepare buffers and media and were they calibrated properly, was the scientist trained, did they make the buffer solution properly? The list goes on. So, if this "context" is not present with the data, then the quality of the data cannot be assessed, and decisions made on it may be flawed. This is the routine question every sponsor organization asks of its CRO and proving it in a systematic, easy manner is difficult, as much of the data exists in different soft- ware systems. From an industry perspective, sponsors would love a CRO to use their systems, but this is not always possible or easy to set up due to enterprise sys- tem security policies. The utopian view would be a network of software solutions—an ecosystem—that all work seamlessly together to deliver the data collaboration services re- quired. The reality is that the industry is not there yet, but there are emerging endeavours to help address this, such as the Allotrope Foundation, who are looking to "revolutionize the way [they] acquire, share, and gain insights from scientific data, through a community and the framework for standardization and linked data" (2) and the Pistoia Alliance, which supports and funds projects that transform R&D innovation through pre-competitive collaboration (3). Each effort is focused on breaking down the barriers to data and process sharing in pharma and biotech. CROs are a necessary part of the small-molecule and biologics drug development lifecycle, but increasingly, customer expectations go beyond a simple PDF report as a deliverable. Getting the right data solution in place that allows safe, secure, and direct collaboration should be a critical objective with the data from the entire life- cycle of a drug being available at the sponsor scientist's fingertips. The industry is some way from the utopian state at the moment, and the business model aspects of this requirement need to be worked out and not just the core software and technical data sharing aspects. References 1. FDA, NDA and BLA Applications,, velopmentapprovalprocess/howdrugsaredevelopedandapproved/ drugandbiologicapprovalreports/ndaandblaapprovalreports/default. htm, accessed Aug. 10, 2018. 2. Data Standard, Allotrope Foundation, (2018), online, www.allo-, accessed Oct. 3, 2018. 3. N. Lynch and D. Proudlock, Home–Pistoia Alliance, online, Pis-, (2018), accessed Oct., 3 2018. PT

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