BioPharm

28 BioPharm International eBook October 2018 www.biopharminternational.com fundamental traceability require- me nt i n a ny pha r ma/ biote c h. Companies must assess if the data are trustworthy and if they can make business-critical decisions based on it. The gap with internal systems is that they are just that: inter- nal. Exposing them to CROs is possible, but what happens when the CRO has their own systems, which the CRO staff knows and read ily uses? Essent ia lly, t here i s a p r o b l e m o f e x c h a n g i n g the audit log for a piece of data between parties. New technolo- gies are being considered to solve this problem, such as blockchain, which aim to provide a full his- tor y of what has happened to something over time. Current sys- tems, however, do not use block- chain in this fashion. While there are many blockchain companies and platform providers, there cur- rently are no real proven providers of blockchain net works specifi- cally 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 mea- sure 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 instru- ment it was run on, what software was used to analyze it, what stan- dards were used to run the experi- ment, what conditions were like in the lab (metrology); what other instruments were used to prepare buffers and media and were they calibrated properly, was the scien- tist trained, did they make the buf- fer solution properly? The list goes on. So, if this "context" is not pres- ent with the data, then the qual- ity 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 system- atic, easy manner is difficult, as much of the data exists in different software 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 system secu- rity policies. The utopian view would be a network of software solutions— a n e c o s y s t e m — t h at a l l wo r k sea m lessly toget her to del iver the data collaboration ser v ices required. 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 "revolut ion i z e t he way [t hey] acquire, share, and gain insights from scientific data, through a communit y 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 collabora- tion (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 increas- ingly, 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 lifecycle of a drug being available at the sponsor scientist's fingertips. The industr y 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, FDA.gov, www.fda.gov/drugs/ developmentapprovalprocess/ howdrugsaredevelopedandapproved/ drugandbiologicapprovalreports/ ndaandblaapprovalreports/default.htm, accessed Aug. 10, 2018. 2. Data Standard, Allotrope Foundation, (2018), online, www.allotrope.org, accessed Oct. 3, 2018. 3. N. Lynch and D. Proudlock, Home–Pistoia Alliance, online, Pistoiaalliance.org, (2018), accessed Oct., 3 2018. BP Biopharma Laboratory Best Practices Outsourcing The utopian view would be a network of software solutions— an ecosystem—that all work seamlessly together to deliver the data collaboration services required. Ad Index Company Page AB SCIE X 2 LEE INDUSTRIES INC 9 W YAT T TECHNOLOGY CORP 5

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