Your guide to the pharmaceutical world Volume 5 Issue 2Clinical TrialsThe final testProcessingAutomate or expireHealth & SafetyBarrier to contaminationTrainingThe next generationPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingClinical TrialsThe final testProcessingAutomate or expireHealth & SafetyBarrier to contaminationTrainingThe next generationwww.pbiforum.net01_Layout 1 10/04/2017 11:08 Page 1THE COMPLETE PRODUCTION LINE EVENT26–28 September 2017NEC, Birmingham“A day at the show gives a year of vision”PPMA Show 2016 Visitorppmashow.co.ukSee the latest machinery in actionNetwork with industry peersGain valuable insights at seminarsOrganised byfor processing and packaging machinery, materials, robots and industrial vision02_Layout 1 10/04/2017 11:08 Page 1@pbiforumwww.pbiforum.netcompany/pharma-business-internationalContentsVolume 5 Issue 2News4Stay up to date with the latest industry updatesfrom the global pharmaceutical technologyindustryOmnicell8 Founded 24 years ago, today Omnicell is aleading provider of medication and supplymanagement solutions to the global healthcaremarket.Clinical Trials10 Clinical trials are the biggest roadblock on theroute to having a new drug created, but is theobstacle being made worse, thanks to poorpractice of pharma companies?Processing14 The pharmaceutical sector’s willingness to investin new technologies is driving growth in theglobal market and having a positive effect onindustries that are typically slower to adapt. Health & Safety18 The Ebola crisis revealed weaknesses inprotective equipment, with nurses from the USand the UK contracting the potentially deadlydisease. This live-fire test has led many to re-address their approach to PPE.Birth Control22 It’s been over fifty years since the introduction ofthe birth control pill, a contraception still mired incontroversy. Packaging26 The rise in counterfeit medicine has forcedpharmaceutical companies to rethink theirpackaging. Training & Development30 When it comes to talent, the pharmaceuticalindustry is ruthlessly demanding. The futuremight be in peril, however, with more childrenopting away from STEM subjects.Events34We take a look at Vitafoods Europe 2017 as wellas a rundown of Pharma events happeningaround the world4102234Group Editor:Steve Fisher (s.fisher@blmgroup.co.uk) Editor:Michael Fisher (m.fisher@blmgroup.co.uk) Journalist:Dominic Cuthbert(d.cuthbert@blmgroup.co.uk)Sales Director:Angie Cooper (a.cooper@blmgroup.co.uk)Sales Manager:Sam Trott (s.trott@blmgroup.co.uk)Sales:Nikki Logan (n.logan@blmgroup.co.uk)Vicky Hunt (v.hunt@blmgroup.co.uk)Tel: +44 (0) 1472 310302 Accounts & Subscriptions:Angela Sharman(a.sharman@blmgroup.co.uk)Design & Production:Gary Jorgensen,Mark Casson,(studio@blmgroup.co.uk)Editorial:Tel: +44 (0) 1472 310305, Fax: +44 (0) 1472 310317Part of BLMGroup:Armstrong House, Armstrong Street,Grimsby, N E Lincs DN31 2QE EnglandAll rights reserved. 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Before yourecycle your magazine, please ensure you remove all plasticwrapping, free gifts and samples. 03_Layout 1 10/04/2017 11:09 Page 14Pharma Business International www.pbiforum.netLatest newsNew initiative will developbetter treatments, morequicklyA ground-breaking initiative between the UK’s GSK and US-basedRegeneron could usher in a new era of drug development for a widerange of diseases.The significant undertaking will take UK Biobank samples and turnthem into important genetic data that will allow scientists to gainvaluable insight into the factors that put some people at increasedrisk of disease, or make it more difficult for them to be successfullytreated. These new genetic data will be returned to UK Biobank andwill be available to all approved researchers anywhere in the world.The sequencing focusses specifically on 1-2% of the genome,known as the exome (where the actual coding genes are contained),because it is this area that scientists believe has most relevance for drug therapy.Scientists believe this is the biggest genetics study ever. It builds on previous genetics analyses that havealready been undertaken on UK Biobank samples and which are now delivering extensive results.A better understanding of human genetics has begun to revolutionise scientificdiscovery and the development of new medicines. Potential drug candidates stem prostate and breast cancer growthScientists at the Florida campus of The Scripps Research Institute (TSRI) havedesigned two new drug candidates to target prostate and triple negative breast cancers.The research – published recently as two separate studies in ACS Central Scienceand the Journal of the American Chemical Society – demonstrates that a new class ofdrugs called small molecule RNA inhibitors can successfully target and kill specific typesof cancer.“This is like designing a scalpel to precisely seek out and destroy a cancer – but witha pill and without surgery,” said TSRI Professor Matthew Disney, senior author of bothstudies.RNAs are molecules that translate our genetic code into proteins. RNA defects canlead to cancers, amyotrophic lateral sclerosis (ALS), myotonic dystrophy and many otherdiseases.In their ACS Central Science study, Disney and his colleagues used DNA sequencingto evaluate thousands of small molecules as potential drug candidates. The researcherswere on the lookout for molecules that could bind precisely with defective RNAs – like keys fitting in the right locks.Allergan forms alliance to develop eyedisease medicines The parent company of Allergan Pharmaceuticals Intonation has entered into a strategic researchand development alliance with genome editing specialist, Editas Medicine.Through the alliance, Allergan will receive exclusive access and the option to license up to five ofEditas’ genome-editing ocular programs, including its lead program for Leber Congenital Amaurosis(LCA10), which is currently in pre-clinical development.The agreement covers early stage, first-in-class ocular programs targeting serious diseases based on Editas’ CRISPR genome editing platform.Editas’ lead program is being developed for the potential treatment of LCA10, a rare, inherited retinal degenerative disease that appears in childhood andleads to blindness.“The CRISPR genome editing platform holds the potential to transform the treatment of many genetic and non-genetically derived diseases, includingdiseases and conditions of the eye,” said David Nicholson, Chief Research and Development Officer, Allergan.CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a versatile tool that can be programmed to target specific stretches of genetic codeand edit DNA at precise locations in the human genome. © Shutterstock / kentoh© Shutterstock / Ramona Heim© Shutterstock / Tyler Olson04-07_Layout 1 10/04/2017 11:10 Page 1Scottish universities collaborateto accelerate drug discoveryResearch teams at the Universities of Dundee and Edinburgh are looking topartner with the pharmaceutical industry to better understand the biologicalprocesses that could allow the development of new drugs to support tissueregeneration or repair.The National Phenotypic Screening Centre (NPSC) at the University ofDundee and the Medical Research Council (MRC) Centre for RegenerativeMedicine (CRM) at the University of Edinburgh have signed a memorandum ofunderstanding that commits them to work more closely together as they striveto translate novel biological discoveries into new stem cell therapies.Close collaboration between the two centres, which together representgovernment investment amounting to around £35 million, will allow novelbiological discoveries from CRM to benefit from the expertise and industrialdrug screening infrastructure provided by the NPSC, leading to the start-pointsfor new therapies.An in-depth understanding of cell and tissue function will facilitate the searchto find molecules that improve key tissue regeneration processes that couldeventually be used as drugs for regenerative repair.Pharma Business International 5www.pbiforum.netLatest newsCharity-academia tie-up launchesvirtual biotech companyParkinson’s UK and the University of Sheffield in Yorkshire have launched a £1million virtual biotech company to create new treatments for Parkinson’s.In a first-of-its-kind partnership, Keapstone Therapeutics will combine researchfrom the University with funding and expertise from the charity to develop newtreatments.Oxidative stress happens when there are too many damaging molecules calledfree radicals inside our bodies. It causes damage to our cells and tissues and isbelieved to play a key role in the death of brain cells in Parkinson’s.Researchers have pinpointed a way to trigger a possible in-built defence systemthat helps protect brain cells from oxidative stress.Dr Richard Mead at the University of Sheffield has already identified small ‘drug-like’ molecules that can activate these defences.Now, Keapstone Therapeutics will further develop these molecules, which could eventually become new drugs that can slow or stop the progression ofParkinson’s.The new company is part of the charity’s Parkinson’s Virtual Biotech venture, formed to rapidly develop and test treatments with the potential to transformlife for people with Parkinson’s.FDA okays first treatment forfrequent urination at nightNoctiva has become the first treatment approved by the US Foodand Drug Administration to treat frequent urination at night.The treatment - desmopressin acetate – is now approved for adultswho awaken at least two times per night to urinate due to a conditionknown as nocturnal polyuria. Nocturia (wakening at night to urinate) is a symptom that can becaused by a wide variety of conditions, such as congestive heartfailure, poorly controlled diabetes mellitus, medications, or diseases ofthe bladder or prostate.The treatment is taken daily via a nasal spray approximately 30minutes before going to bed. It works by increasing the absorption ofwater through the kidneys, which leads to less urine production.Noctiva’s efficacy was established in two 12-week, randomised,placebo-controlled trials in 1,045 patients 50 years of age and olderwith nocturia due to nocturnal polyuria. Although these trials showed asmall reduction in the average number of night-time urinations withNoctiva compared to placebo, more patients treated with Noctivawere able to at least halve their number of night-time urinations, andpatients treated with Noctiva had more nights with one or fewer night-time urinations.© Shutterstock / Andrey_Popov© Shutterstock / Elena Pavlovich© Shutterstock / sfam_photo04-07_Layout 1 10/04/2017 11:10 Page 26Pharma Business International www.pbiforum.netLatest newsPfizer launch novel antibioticin the UKPfizer has launched its combination antibiotic Zavicefta in the UK to helpmeet the urgent need for new treatments. Zavicefta (Ceftazidime-avibactam) is approved for the treatment of adultpatients hospitalised with serious infections due to aerobic Gram-negativebacteria.It has been designed to manage difficult-to-treat infections that arebecoming increasingly resistant to current standards of care, and representsan important treatment advance, especially in patients where theconsequences of antibiotic treatment failure due to resistance can bedevastating.Ceftazidime-avibactam combines the beta-lactam antibiotic ceftazidime with the novel beta-lactamase inhibitor, avibactam.Dr Matthew Dryden, Consultant Microbiologist at NHS Hampshire Hospitals, said: “The need to tackle multi-drug resistantpathogens is pressing and will require a lot of ingenuity.” Antimicrobial resistance, the ability of microbes to resist the effects of medication previously used totreat them, is one of the most significant healthcare issues facing the world today. Dawn of new era in precisionmedicine for pancreatic cancerThe development of new treatments for pancreatic cancer is set to be transformedby a network of clinical trials, aiming to find the right trial for the right patient, after a£10 million investment from Cancer Research UK.The investment will support the ‘PRECISION Panc’ project which aims to developpersonalised treatments for patients, improving the options and outcomes for adisease where survival rates have remained low.Professor Andrew Biankin at the University of Glasgow, who has pioneered theproject along with researchers across the UK, aims to speed up recruitment andenrolment of pancreatic cancer patients to clinical trials that are right for theindividual patient.The researchers will use the molecular profile of each individual cancer to offer patients and their doctor a menu of trials that might benefit them.The first wave of research will establish the best way to collect and profile patient tissue samples. Each patient will have up to five samples taken from theirtumour at diagnosis for analysis at the University of Glasgow.Cypralis explores novel Alzheimer’streatment with ADDF fundingThe Alzheimer’s Drug Discovery Foundation (ADDF) has awarded $524,000 toCambridge life sciences company Cypralis. The funding will augment the existing Johnson & Johnson Innovation facilitatedcollaboration between Cypralis and Janssen Pharmaceuticals, which aims to developnew cyclophilin inhibitors for neurodegenerative diseases.Cyclophilin inhibitors on the market or in development are non-selective between thefour commonly screened cyclophilin isoforms A, B, C and D.Cypralis and Janssen are currently undertaking a joint research programme togenerate a new class of CNS penetrant, selective inhibitors of cyclophilin D applicableto targeting degenerative diseases including CNS degeneration.The funding will enable Cypralis to extend ‘hit-to-lead’ medicinal chemistry and broaden its library of novel brain-penetrant cyclophilin inhibitors, whilstcontinuing to participate in the joint research programme with Janssen.Dr Howard Fillit, CSO of the ADDF, said: “With ADDF funding, Cypralis will use its extensive knowledge of cyclophilin inhibitors to explore their potential as atreatment for Alzheimer’s and other neurogenerative diseases.”© Shutterstock / Joe Besure© Shutterstock / sfam_photo© Shutterstock / Cherries04-07_Layout 1 10/04/2017 11:10 Page 3Pharma Business International 7www.pbiforum.netLatest newsNICE to fast-track moredrug approvalsUK patients will benefit from access to the most cost-effectivetreatments nearly 5 months faster after changes to the NICE drugevaluation process were approved.The changes will see the introduction of a new fast-track option forappraising treatments which offer value for money. The aim is forthem to be available to patients a month after they are licensed.The fast track appraisals, which will be rolled out to more drugs intime, are part of several changes to NICE processes approved by theBoard in March this year.Several changes have been made to the proposals following apublic consultation launched in October 2016.Sir Andrew Dillon, NICE Chief Executive, said: “We’ve listenedcarefully to what stakeholders have been telling us throughout thisconsultation and made some important changes, as well as addingdetail to our proposals.”The fast track appraisals will apply to drugs with a likely cost perextra year of quality-adjusted life of under £10,000, offeringexceptional value for money. Duchesnay adds VVA treatment to women’s health portfolio Duchesnay, a Canadian pharma company committed to women’s health, has acquired exclusive US andCanadian rights to market and distribute Osphena from Japan’s Shionogi.Osphena (ospemifene) is the only oral, non-hormonal prescription medication indicated for thetreatment of moderate to severe dyspareunia (painful intercourse), a symptom of vulvar and vaginalatrophy (VVA) due to menopause.The acquisition enables Duchesnay to develop, manufacture and commercialise ospemifene-basedproducts in the United States and Canada.It is estimated that 50% of postmenopausal women experience VVA symptoms and that 40% of these womenalso suffer from dyspareunia. A survey of women with VVA undergoing therapy found that approximately 35% hadconcerns about hormone exposure.With the acquisition Duchesnay can now offer these women a non-hormonal oraltreatment option. The addition of Osphena is also expected to enhance the company’srelationship with the leading healthcare professionals by providing them with anadditional resource to address their postmenopausal patients’ health needs.Shionogi will continue to retain its rights to ospemifene in all other countries of theworld.Fosun makes Chinese pharma’s‘largest overseas acquisition’China’s Fosun Pharmaceutical has agreed to acquire a majority stake in Indian-based Gland Pharma for $1.2 billion in what is (to date) the largest overseasacquisition of a Chinese pharmaceutical company.The deal includes a maximum $50 million contingent consideration for GlandPharma’s Enoxaparin sales in the US.Enoxaparin is used for “preventing blood clots in patients who have certainillnesses or who will be having certain types of surgery”.Fosun said the acquisition will promote its development upgradingpharmaceutical manufacturing, speeding up internationalisation progress andincreasing market share in injectables field.The company would also be able to further explore the international market byleveraging Gland’s research capability and India’s preferential policies upongeneric drugs.“The deal will greatly strengthen Fosun Pharma’s global presence andaccelerate our speed of internationalisation. It will enable us to provide more highquality products and services to our patients worldwide.”Following the closing of the transaction, Gland Pharma will remainheadquartered in Hyderabad. P.V.N.© Shutterstock / Ruslan Guzov© Shutterstock / Sisacorn© Shutterstock / dibrova04-07_Layout 1 10/04/2017 11:10 Page 4Industry PartnerIncrease your pharmacy’s revenue and decrease your expenses:Free up staff time and reduce operating expensesProcess 35-40 sealed and audited cards per hourAssemble more packs with less resourceBenefits for you and your patients:Improved accuracy and reduced checking timeAbility to track and trace each medication packedTried and tested solution developed over the past 10 yearsBOOK YOUR FREE DEMO TODAY BY CALLING 0161 413 5333 or EMAILING enquiriesUK@omnicell.comSee the Omnicell VBM 200F in action at www.omnicell.co.uk/medication-adherence/technologyIntroducing the new Omnicell filling machineenueuce ients:yearsG IMPROVE ADHERENCE AND YOUR PATIENT’S OUTCOMES TODAYThe Omnicell VBM 200F ensures pharmacies have the competitive advantage to easily scale their business to improve adherence and patient outcomes today.08-09_Layout 1 10/04/2017 11:10 Page 1Pharma Business International 9www.pbiforum.netOMNICELLOmnicell UK & Ireland have introduceda new automated pharmacy packagingand filling solution, Omnicell VBM 200F. Itwill reinforce the company’s reputation asa world-leading provider of automatedhealthcare solutions and medicationadherence packaging. The newautomated filling machine will helpcommunity pharmacy to drive efficienciesin the face of major funding cuts. This is the only automated pharmacysolution that accurately fills and checksSureMed by Omnicell multi-medicationadherence packs, and is able to processup to 40 sealed and audited cards perhour. This allows the pharmacy to free upstaff time, reduce operating hours andreduce costs so they can assemble morepacks with less resource. It uses unparalleled vision-checkingtechnology to identify and validatemedication being packed based on size,shape, colour and imprint, significantlyreducing the risk of human error andimproving patient safety. The drug anddose information is printed onto acoloured consolidated label on the insidecover of each card, which includes drugimages. The system improves accuracyand reduces checking time with theability to track and trace each medicationpacked. The packed medication imagesand patient data are visually recordedand stored securely so that the dataremains easily accessible to thepharmacy for reporting and futurereference.The automated fillingsystem allowsOmnicell tocontinue topushboundaries byusing smart medicationtrays which are equippedwith barcoding and RFIDtechnology that makessure each pack isaudited throughout theentire packing process.While one pack is beingfilled by the system, asecond pack is stagedready to be filled, improvingefficiency, reducing operating expensesand freeing up staff time. The systemstores 200 different medications withinthe machine and countless cassetteswhich can be exchanged on the systemwhile it is running. Each drug specificcassette contains RFID chips to makeidentification easy. Additional medication which is notstored in the cassettes can still be stagedin the machine to be filled manually at thesame time as cassette medication,ensuring all medicine is checked via thevision system before being placed in thepack. Guided light manual fill trays useon screen and guided filling technology todirect the operator to the correct drugand correct location within the manual fillstation, further reducing the risk of humanerror within pharmacies. The system has an ergonomic design,is easily accessible for cleaning andmaintenance and has an easy to useinterface. Omnicell prides itself in offeringpharmacies everything needed tosmoothly integrate the system and offer24/7 unparalleled technical support andafter-care service. The company arecommitted to constantly developing oursystems to ensure its customers arealways at the forefront of stockmanagement, clinical governance, andpatient safety.Founded 24 years ago, today Omnicell is a leading provider ofmedication and supply management solutions to the globalhealthcare market. The company specialises in improving themedication and supply distribution process from hospital andpharmacy to home.Omnicell introduce new automatedpharmacy filling solution For more information, visit www.omnicell.co.uk,email enquiriesuk@omnicell.com or call +44(0) 161 413 5333.08-09_Layout 1 10/04/2017 11:10 Page 2Next >