< PreviousCLINICAL TRIALS10Pharma Business International www.pbiforum.netPHOTO: SHUTTERSTOCK.COM/MINERVA STUDIO10-13_Layout 1 10/04/2017 11:11 Page 1Pharma Business International 11www.pbiforum.netCLINICAL TRIALSClinical trials often make or break anew product, with much of the futuresuccess of huge investments beingdetermined on how the product interactswith humans. While there is always vastamounts of tests that should – and will –have been undertaken on the product,there is always the disastrous possibilitythat there will be an adverse reactionwhen it is introduced to volunteers in theclinical trials.Clinical trials only come into play oncethe preclinical and testing procedureshave been completed, and in most casescan only be undertaken after receivingapproval by an authorised body such asthe FDA. Figures suggest that it can takeup to ten years on average, and cost anincredible $2.6 billion for a drug to makeit through all the stages of clinical trials.And less than 12% of new medicines evenmake it past FDA screening, and intophase 1 of clinical trials.And it is a multi-phase process, ofcourse. In most cases it will first be testedon a small number of volunteers, with theresults of such being monitored before itis then tested on hundreds – andeventually thousands of volunteers.A single problem at any stage of theprocess can set back the product foryears – perhaps even kill it outright.Recent media scandals have shown assuch, with a Portuguese painkiller clinicaltrial resulting in one death and multiplepatients suffering severe injuries. The case12 ÁTHE FINALTESTClinical trials are the biggest roadblock on the route to having a new drugcreated, but is the obstacle being made worse, thanks to poor practice of pharmacompanies?10-13_Layout 1 10/04/2017 11:11 Page 2took place in Rennes, France – and hitinternational news after the disastrousresults resulted in a casualty. Numerousafter-case tests have suggested thatcomplications occurred because thedrug interacted with parts of the brain itwas not intended to – especially whentaken in larger doses. The casualty, alongwith those who suffered the worst injurieswere all patients who had received ahigher dosage as part of the trial. Apart from bad reactions however, oneof the biggest issues faced bycompanies undertaking clinical trials isthat of the high dropout rate ofvolunteers. In cases where results needto be monitored over time, this can be ahuge issue. The average dropout rate oftrials comes in at around 30%, which isbad enough before it’s taken intoaccount that this causes 80% of trials tonot finish on time. While an obviouscontributor to this is individuals havingpoor – but not critical – reactions to thedrugs, and thus being taken off theroster; the biggest reason for dropouts islisted as poor patient engagementbetween the pharmaceutical companyand the volunteers.This can be due to multiple aspects,including a lack of feedback, difficulty inallowing people to understand or followstudy protocols or simple motivation.There are so many do’s and don’ts forpeople in these trials, that poorlyprovided material and lists on what theycan and cannot do are likely to frustrateand cause people to dropout. In thedigital age we are in now, there is littleexcuse for this. Apps and social mediashould enable companies to interact withpatients at a moment’s notice, yet theyare not being utilised. Many companiesseem to have the attitude that the peoplein this process somehow matter lessthan the end customer. This is not thecase, as many of these people willbecome consumers in time, but evenbeyond that, they determine how long ittakes to get to that stage!Tools like apps could remind patientswhen they need to visit clinics, helparrange appointments or simply measurehow much exercise they do – to seewhat effect this has on results. The toolsare already there to take advantage of –yet companies are allowing theopportunities to pass them by.When it already can cost up to $2billion to reach this stage, it seemsfoolish to consider that sponsors are notdoing everything they can to improve onpatient engagement. CLINICAL TRIALS12Pharma Business International www.pbiforum.netPHOTO: SHUTTERSTOCK.COM/IMAGE POINT FR10-13_Layout 1 10/04/2017 11:11 Page 3PHOTO: SHUTTERSTOCK.COM/TYLER OLSON10-13_Layout 1 10/04/2017 11:11 Page 4PROCESSINGThe global pharmaceutical market is a complex anddynamic industry, vulnerable and beholden to avariety of key influences. The greatest stimulus in thisregard is economics, with the increase ingenerics offering a cheaper alternative toexpensive medicines and treatments, and therise of developing nations and the lowerclasses. With access to medicines continuingto advance, and patient care improving allround, new revenue streams are being madeavailable to the market year on year. As withalmost every other industry reliant on complexmanufacturing, technology is the elephant inthe room, making human workers feel,ironically, like the mammoth (read: extinct).The pharmaceutical supply chain hasalways been one of the most complex andforward thinking, given the nature of theproducts that move through it. Althoughmany of the same machines used in theprocessing and production ofpharmaceuticals can be found in foodfactories (much to the delight of machinesuppliers), medicines present a uniquequandary. With complex, sensitive andsometimes volatile ingredients beinghandled and processed, a similar level ofintuitive and multifaceted machines areneeded. The human condition invitesaccident and error, and with the best will inthe world, a flesh and blood worker isfallible and prone to physical fatigue and awhole spectrum of emotional andpsychological issues. A robot workershares none of these concerns and,maintenance, cleaning and servicing aside,can run indefinitely. Though automation is a familiar sight ina typical pharmaceutical processing plant,14Pharma Business International www.pbiforum.netThe pharmaceutical sector’s willingness to invest in newtechnologies is driving growth in the global market and having apositive effect on industries that are typically slower to adapt. 17 ÁPHOTO: SHUTTERSTOCK.COMHYWIT DIMYADIAutomate orexpire14-17_Layout 1 10/04/2017 11:12 Page 1PHOTO: SHUTTERSTOCK.COM/DMITRY KALINOVSKY14-17_Layout 1 10/04/2017 11:12 Page 2PHOTO: SHUTTERSTOCK.COM/ESB PROFESSIONAL14-17_Layout 1 10/04/2017 11:12 Page 3Pharma Business International 17www.pbiforum.netPROCESSINGhuman workers, for now, are stillnecessary. The times, though, are achanging. A number of reports haveindicated that tens of thousands (in somecases hundreds of thousands) of workerswill lose their jobs to robots andautomation in the coming decades. Thelack of a definitive answer shows thatnothing is sacrosanct and we’re stillrunning on assumption, yet the fact ofthe matter is that the robots are coming.Far from the doom-mongering tabloidswould have us believe, the influx ofautomation is the great next greatindustrial leap forward. Leveraging thisshift could usher in greater benefits forworkers, as well as opening an entirelynew sector in the design, manufactureand maintenance of these automatedsystems. Until we reach the technologicalsingularity – which Google’s Director ofEngineering places at 2045 – robots willstill be reliant on fertile human minds topropagate. Although Governments in theUK, US and elsewhere are pondering theethical dilemma posed by robot workers,whether they should be taxed or areentitled to the same rights as theirhuman counterparts, there’s still decadesto adjust the industrial status quo. With its acceptance of newtechnologies, the pharmaceuticalindustry is considered a leader. Alongsidethe influx of new markets and greaternumbers of previously untappedconsumers, the global pharma market isbeing driven by its willingness toinvestigate new technologies. Key to thisgrowth is companies putting their moneywhere their proverbial mouth is andinvest in new technologies. Some of themost recent developments are takingplace in packaging machinery, wheremachines without electrical cabinets – orentirely cabinet-less – are becoming amore common fixture on the productionline. The servo modules within thecontrol architecture for robots,significantly reduces the number ofelectronic parts, eliminating the need forsome cabinets. Benefits of this includelower maintenance costs (due to reducedelectronics), greater efficiency and theavailability and use of identical systemparts. With the industry’s position as a leader,if these technologies and moredemonstrate adequate aptitude in thepharmaceutical sector, other marketsthat are typically slower to adopt newtech may embrace it also. Thoughpolitical posturing, price hikes andcorporate greed might suggestotherwise, pharma’s first port of call is toits patients. By the sector’s very nature,patients are (by and large) at the heart ofeverything it does. It makes sense that itis also benefiting society by divingtechnological growth in other areas, be itfood or other consumer products.Automation is here to stay and for thepharmaceutical industry, that’s awelcomed state of affairs.PHOTO: SHUTTERSTOCK.COM/DMITRY KALINOVSKY14-17_Layout 1 10/04/2017 11:12 Page 4PHOTO: DMITRY KALINOVSKY / SHUTTERSTOCK.COM18-21_Layout 1 10/04/2017 12:24 Page 1The Ebola crisis revealed weaknesses in protective equipment,with nurses from the US and the UK contracting the potentiallydeadly disease. This live-fire test has led many to re-addresstheir approach to PPE.Pharma Business International 19www.pbiforum.netHEALTH & SAFETYThe pharmaceutical industry cameinto the spotlight a few years backdue to the Ebola crisis in WesternAfrica, and particularly the health andsafety procedures in the industrywere harshly scrutinised byGovernments and associatedorganisations. With two Dallas nursescontracting Ebola from the first USvictim, potentially due to a failure intheir PPE, there is great focus onensuring the same does not happenin the event of the next big outbreak. Personal protective equipment isthe final barrier that preventscontamination of health workers towhat is a particularly fatal virus, and itis perhaps unsurprising then, thatthose industries who focus on PPEspecifically for that virus have donequite well for themselves. LakelandIndustries, a US company whoproduces hazmat suits against Ebolasaw their shares rise from just over$8 to $21 in a single week, whileother companies in the industry sawsimilar, if not as impressive, leaps. The problem does not come aboutin laboratories, or with largepharmaceutical companiesemployees failing in their safetyprocedures – in fact many of thesepeople are so used to PPEprocedures that they can adequatelyprotect themselves with minimaleffort. It is instead a breakdown inthe healthcare sector, particularlywith the instructions provided tonurses and other healthcare workersthat can be confusing and at times,contradictory. The Centers for Disease andControl (CDC) have released newguidelines that call for full-body garband hoods that protect workers’necks, as well as stricter rules on theremoval of equipment anddisinfection of gloved hands.However, these are ultimatelyBarrier tocontamination20 Á18-21_Layout 1 10/04/2017 12:24 Page 2Next >