< PreviousIMPORT & EXPORT20Pharma Business International www.pbiforum.netFor the 52 per cent of British votersthat agreed with exciting the EuropeanUnion, the referendum represented achance for the island nation to reclaimits identity and cut off its funding fromthe bloc. The fallout is a far morecomplicated affair. A year on, with adeadline set on our departure, thedebate grows ever more complicatedas trade agreements and levies arediscussed. Healthcare was fundamentalthroughout the referendum campaigntrail and remains so in the officialdivorce proceedings. Yes voters werepersuaded in part by claims thatbillions of pounds would be saved byleaving the EU and would instead beploughed into the NHS. The reality,however, was quite different. The UK’spharmaceutical and life sciencesindustries were also a key aspect in thereferendum. A manifesto issued by theAssociation of the BritishPharmaceutical Industry (ABPI) evenargued that, unless a better deal wassecured for the NHS by the newparliament, the industry body would seemajor pharma firms pull out of England. Brexit has forever altered traderelations between the UK’s lifesciences and pharmaceutical sectorsand the EU. How these tradeagreements will be regulated will be akey issue throughout negotiations overthe coming years. If the UK ends upwith a Brexit on the so-called harderend of the spectrum, British mademedicines will be treated as imports inthe EU. Moreover, the EuropeanCommission has warned that, in thiseventuality, the life sciences sectorwill be faced with a slew of newregulatory obligations. It’s a state ofaffairs seen elsewhere from theCommission. A document it issuedalongside the European MedicinesAgency stated that UK companiescould have to set up some operationsrelated to drug safety within the EU inorder to ensure their products are incompliance with Europeanrequirements. If this is the case, thedocument states, at least one memberstate’s regulatory body would have togive authorisation in order to sell a drugwithin the European Economic Area. Onewonders whether the reverse would beA bitter pill toswallow Part of Brexit negotiations will see new trade relations agreed between the UK and EU. So whatdoes this mean for Britain’s life sciences and pharmaceutical sectors?23 Á© Shutterstock / cbies20-23_Layout 1 09/06/2017 13:32 Page 1© Shutterstock / thumwadee lertworakul20-23_Layout 1 09/06/2017 13:32 Page 2IMPORT & EXPORT22Pharma Business International www.pbiforum.net© Shutterstock / Efired20-23_Layout 1 09/06/2017 13:32 Page 3Pharma Business International 23www.pbiforum.netIMPORT & EXPORTtrue, for European companies looking to trade inthe UK market. Relations between the UK and EU are alreadystrained, and are likely to bear the brunt of morepressure as negotiations develop. With this in mind,the UK could be faced with significant disruptions,something that could negatively affect all itsexporting industries. For life sciences and pharmafirms, this would mean delayed product launches inthe EU, trouble breaking into new Europeanterritories, and more red tape for exports. Addinginsult to injury, the ABPI have stated that setting upnew operations in order to satisfy and achievethese regulations could take years. The European Medicines Agency currentlyauthorises the sale of medicines across the EU,though the 27 remaining member states have, in nouncertain terms, made it clear that they will notallow the agency to remain at its current Londonbase post-Brexit. Though this is to the chagrin of Britain’s lifesciences and pharmaceutical companies, and theirfinished products, it also poses a threat tomanufacturing firms and their ingredients. If a dealcan’t be reached before the March 2019 cut-off fornegotiations, substances used in the manufactureof medicines will themselves be considered importsif they hail from the UK. If this comes to pass, it willlikely lead to companies shifting theirmanufacturing operations in hopes of avoiding anynew import tariffs. If big pharma firms are movingtheir European bases out of the UK, it leaves thenation much less competitive and in danger offalling behind. This is especially dire given Britain iscurrently one of the major biotech nexuses in theworld. Although negotiations are still very much in theirinfancy, and any advice for companies is prematureat best, it’s no exaggeration to say that the fate ofthe UK’s life sciences and pharmaceutical sectorshang in the balance. Should a beneficial deal notbe struck with our European cousins, the sectorswill likely lose much of their competiveness,attractiveness and see the spate of start-upscurtailed.20-23_Layout 1 09/06/2017 13:32 Page 4COLLABORATION24Pharma Business International www.pbiforum.netRegardless of what industry you are in, these dayssoftware – or digital content – is at the heart of bothinternal processes and driving products and services tomarket. The pharmaceutical and life sciences market ingeneral is no exception. It’s hard to imagine a medicaldevice that does not have software at its core, or a drugdelivery process that is not tightly bound up with software-driven processes.Collaboration among users is key, but professionals inthis sector are still very dependent on document-basedprocesses that do not lend themselves to the transparencyand traceability that is needed: not just for compliance, butalso to reduce wasted time, inefficiencies and associatedcosts, particularly around verification and validation stages. For instance, according to the 2016 Life SciencesProduct Development Survey of 67 per cent respondentswho are ‘document-centric’, 87 per cent rely on MicrosoftOffice (particularly Word and Excel) to document andmanage their development work items. Limitations with a document-based approachto collaborationWhile these document-centric tools are great for thepurposes for which they were designed, they do notprovide an instant view into who did what, when, how andSoftware is proving a boon to working collaboratively in thepharmaceutical and life sciences sector as Martin Kochloefl,software engineer at Seapine Software, explains. 26 ÁThe singlesourceof truth24-27_Layout 1 09/06/2017 13:33 Page 1Pharma Business International 25www.pbiforum.netCOLLABORATION© Shutterstock / alice-photo24-27_Layout 1 09/06/2017 13:33 Page 2COLLABORATION26Pharma Business International www.pbiforum.netwhy, nor what impact that action had on otherelements of the project. For example, a taskanother team is working on. The survey resultssupport this: among Office users, 30 per centreported frustrations with versioning andchange management.This matters for several reasons. First, if theUS Food and Drug Administration (FDA) oranother regulatory body asks to audit acompany, tracking all the relevant informationcould take weeks, if not months, taking upvaluable employee time. This information willtypically be stored in lots of different locationsand formats, making collation of that contentdifficult. Second, regardless of an external audit, it isvery hard to have visibility of all the elementswithin a project if information about them isstored in documents and different places. Inparticular, validation processes becomeextremely unwieldy, typically involving astream of emails being sent between amanager and a developer. Third, there is the sheer amount of time thatpeople can spend documenting – and thenlooking for – the right document or content.Validation processes typically take up a thirdof the time associated with each step in adevelopment project. In the survey, 67 percent of respondents who used document-driven processes to record and managedevelopment said that documenting work wasone of their top three time-consuming tasks.72 per cent put reviewing documentation intheir top three time-consumers. A single source of truth is theanswerThe answer is to create what is oftenreferred to as ‘a single source of truth’,something which an increasing number oforganisations worldwide are adopting. Thereare various ways to achieve this, but thefundamental idea is to use a software tool tocreate a single place where all the digital‘assets’ associated with a productdevelopment project are stored, with visibilityand tracking across all files and users,regardless of location or the tools they areusing as individuals or teams. Every single24-27_Layout 1 09/06/2017 13:33 Page 3COLLABORATIONPharma Business International 27www.pbiforum.netchange by every user is recorded and ideallythis should be immutable. In other words, itcreates a record that cannot be changed. This approach makes traceability a loteasier, because in the pharmaceutical and lifesciences market, everything associated withrisk, requirements and validation processesare in one place. Rather than beingdetermined by documents and user activity,the process is driven by the ‘single source oftruth’ tool. Since everything is traced together,an organisation can have the confidence thatall the information the FDA or anotherregulatory body might need is in the rightplace. This not only saves time and effort, butgives organisations the confidence they willpass an audit.Furthermore, the risks of losing a vital digitalasset or working from the wrong version areeliminated, because users cannotinadvertently over-write versions of someoneelse’s work, plus if there is an issue to resolve,it should be possible to roll back to a previousversion (depending on the ‘single source oftruth’ tool being used).‘Single source of truth’ approaches vary, butthere are a few best-practice steps toconsider, including: the ability to support lotsof different file formats, integration with othersystems, technology and process-agnostic (sothat people don’t need to change the way theywork), support for remote users and externalthird parties, capacity to scale regardless offile volume, complexity and users. Another attribute to look for is a ‘singlesource of truth’ that covers the entire lifecycleof a digital asset, so that it can encompassmaintenance, response to customer feedbackand future enhancements. Pre-definedworkflows are worth considering because theymake it very clear if a step in a process hasbeen missed. Also look for FDA-approvedelectronic signature features integrated withinthe tool. For pharmaceutical and life sciencescompanies, a ‘single source of truth’ meanseverything in one tool, rather than beingstored in documents, with the confidence thatdata is secure, available, correctly logged,presentable and complete. © Shutterstock / angellodeco24-27_Layout 1 09/06/2017 13:33 Page 4FUNDING28Pharma Business International www.pbiforum.netThe price gouging scandals that haveshocked patients, decimated public faithand painted big pharma as antagonists,have had their day in court. Many ofthose on the opposite end of the public’scollective pitch fork, justified bumping uptheir price tags as a means of fundingresearch. The aim, they argued, was thatby increasing costs now, profits could beploughed back into research, makingmore effective and affordable medicinesin the future. Pharmaceutical companies andresearch organisations have a number ofmeans of raising capital in order to fundresearch and grease the wheels ofThe costs ofinnovation Raising capital is crucial for pharmaceutical companies and research organisations,but how do studies and trials get funded?© Shutterstock / Pixelbliss30 Á28-31_Layout 1 09/06/2017 13:34 Page 1© Shutterstock / funnyangel28-31_Layout 1 09/06/2017 13:34 Page 2Next >