Your guide to the pharmaceutical world Volume 5 Issue 3Accuracy &MeasurementClinical efficiencyImport &ExportA bitter pill to swallowCollaborationThe single source of truthPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingAccuracy &MeasurementClinical efficiencyImport &ExportA bitter pill to swallowCollaborationThe single source of truthwww.pbiforum.net01_Layout 1 09/06/2017 13:28 Page 1PROCESSINGNEWSINTERNATIONALFood&DrinkFood&Drinkwww.fdiforum.netJUNE 2017£3.50 STERLINGSUSTAINABLEPACKAGINGSustainablebusinessSustainablebusinessFor businesses that areserious about reducing theircarbon footprintwww.blmgroup.co.ukVOLUME 4 ISSUE 1WWW.RENEWABLESANDENVIRONMENT.COMJUNE 2017EAST MIDLANDS LEADING BUSINESS E-MAGCYBERSECURITYTop tipsFAMILYBUSINESSGood governanceFASTEST 40All the winnerswww.blmgroup.co.ukWWW.EASTMIDLANDSBUSINESSLINK.CO.UKTHE ELECTIONISSUE-WHAT CAN BUSINESSES EXPECTFROM THE NEXT GOVERNMENT?THE ELECTIONISSUE-WHAT CAN BUSINESSES EXPECTFROM THE NEXT GOVERNMENT?WWW.EASTMIDLANDSBUSINESSLINK.CO.UKEMPOWERYour BusinessYour 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.netJUNE 2017 £3.50YORKSHIRE & LINCOLNSHIRE’S LEADING BUSINESS MAGAZINEwww.blmgroup.co.ukVOLUME 32 ISSUE 6CHRISTMAS INJUNEJingle bells?LINCOLNSHIRESHOW It’s all set to happen at the133rd Lincolnshire ShowPORTS &LOGISTICSAll changeLOOKINGAHEAD…LOOKINGAHEAD…Often Imitated -Never Equalledwww.blmgroup.co.uk02_Layout 1 09/06/2017 14:08 Page 1@pbiforumwww.pbiforum.netcompany/pharma-business-internationalContentsVolume 5 Issue 3News4Stay up to date with the latest industry updatesfrom the global pharmaceutical technologyindustry.Stamping out Fistula8 Astellas Pharma Europe is working with Action onFistula to stamp out the issue in Africa throughfunding, training and support. We sat down withProgramme Lead Jo Taylor and FistulaFoundation CEO Kate Grant to discuss thecollaboration in depth and cover the burningissues facing the pharma sector. Research & Development10 From the ‘death sentence’ of the 1980s to near-normal life expectancy, research into HIV andAIDs is making huge headway. Accuracy & Measurement14 The growing need for clinical trials to meet therequirements of regulators, deliver consistentlyhigh-quality data, and come in on budget has ledto study designs that prioritise timeliness andconvenience, yet often at the detriment of patients.Security17 Safer packaging is helping to stem the rising tideof counterfeit medicines flooding the market. Import & Export20 Part of Brexit negotiations will see new traderelations agreed between the UK and EU. Sowhat does this mean for Britain’s life sciencesand pharmaceutical sectors?Collaboration24 Software is proving a boon to workingcollaboratively in the pharmaceutical and lifesciences sector as Martin Kochloefl, softwareengineer at Seapine Software, explains. Funding28 Raising capital is crucial for pharmaceuticalcompanies and research organisations, but howdo studies and trials get funded?Events32We give a rundown of Pharma events happeningaround the world4142024Group 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: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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COVER PHOTO: © SHUTTERSTOCK / SEBASTIAN KAULITZKI03_Layout 1 09/06/2017 14:15 Page 14Pharma Business International www.pbiforum.netLatest newsCongo approves newEbola vaccineThe Democratic Republic of Congo (DRC) has approved anew Ebola vaccine to counter an outbreak in its northeast regionthat has killed four people.The vaccine – known as rVSV-ZEBOV and developed byMerck – is not currently licensed but was shown to be highlyprotective against Ebola in clinical trials published lastDecember.DRC had registered 52 total suspected cases, including twothat have been confirmed, according to a spokesperson from theWorld Health Organisation (WHO).WHO spokesperson Tarik Jasarevic said in Geneva thatvaccination would be deployed “should an EVD (Ebola virusdisease) laboratory confirmed case be identified outside alreadydefined chains of transmission”.In that case, it would be offered “to contacts and contacts ofcontacts of a confirmed EVD case, including health care workers and field laboratoryWorkers”, Jasarevic said.Innovation high in Alzheimer’s disease spaceThe level of first-in-class innovation in the Alzheimer’s disease space isexceptionally high, with 646 products currently in active development.Additionally, several first-in-class targets identified in the pipeline are also indevelopment for multiple associated indications such as anxiety and depression,highlighting shared pathophysiological processes. Notably, G-protein coupled receptorsignalling was the most prevalent signalling pathway identified among first-in-classtargets for Alzheimer’s disease and its associated indications.Fiona Chisholm, Analyst for GBI Research, said: “Although the Alzheimer’s diseasespace is a challenging one due to an extremely high clinical trial failure rate, itmaintains a strong level of innovation, with many pipeline products specificallytargeting proteins widely considered to be underlying factors in disease progression.”While established targets such as amyloid beta and microtubule-associated proteintau account for a sizeable proportion of the first-in-class pipeline, there are moreinnovative targets, such as those implicated in lipid metabolism and the inflammatoryaspects of Alzheimer’s disease pathology.Report champions EU-UK medical researchpartnershipsPartnerships between UK and EU medical researchers have increased the value of research andbenefitted patients across Europe, according to a new report.The report – commissioned by eight UK medical organisations – highlights how the UK’scontribution to research throughout the EU has fostered and strengthened scientific cooperation.As negotiations begin on a new relationship between the UK and the EU, it’s vital that they resultin the best possible outcome for science and patients across the EU.Clinical trials have benefitted hugely from UK and EU researchers working together, especiallythose for rarer diseases where the UK leads the highest number of trials.As the number of patients with rarer conditions is low in each country, it’s only possible to recruit enough patients for clinical trials by carrying out trialsacross countries.The leadership role played by the researchers in the UK in Europe is reflected through their extensive membership of influential scientific committees andpanels.© Shutterstock / jaddingt© Shutterstock / nito© Shutterstock / Orawan Pattarawimonchai 04-07_Layout 1 09/06/2017 14:09 Page 1Takeda establishes drugdiscovery subsidiaryTakeda has entered into an agreement for an absorption-type company splitwith Succeeding Company, its wholly-owned subsidiary, with the aim oftransferring part of its R&D businesses.It is currently implementing steps to accelerate its R&D transformation byfocusing on three key therapeutic areas – oncology, gastroenterology andcentral nervous system (plus vaccines and concentrating R&D activities inJapan and the US).The transformation will provide the company with the necessaryorganisational and financial flexibility to drive innovation, enhance partnerships,and improve R&D productivity for long-term, sustainable growth.Takeda will transfer some of its research businesses to SucceedingCompany, enabling its R&D organisation to optimise organisational efficiencywith the aim to generate true innovation.Succeeding Company will provide integrated research support including drugdiscovery consulting for a broad range of diseases.With deep drug discovery expertise across these value-added services,Succeeding Company aims to contribute to the innovation in Japan as well asoutside of Japan.Pharma Business International 5www.pbiforum.netLatest news‘A’ grade for Loma’s InsightPharmaceutical Metal DetectorFollowing the expansion of its solid dose operations, contractmanufacturer AAA Pharmaceuticals has recently installed customised InsightPharmaceutical (PH) Metal Detectors from Illinois-based contaminantinspection equipment specialist, Loma Systems.Produced from polished stainless steel for hygiene and wash downbenefits, Loma’s Insight PH Metal Detector’s compact design allows it to belocated on virtually any production or packaging line without disrupting theplant layout. The tablet presses at AAA Pharmaceutical are located in close proximityso Loma set up the frequencies on the metal detectors to avoid interference. Jeff Biggs from AAA Pharmaceuticals said: “We conducted an across the board comparison between six metal detector companies and even requesteddemonstration units so that we could properly assess both functionality and specifications. “Loma was the first to respond to our request for a trial machine and it quickly became evident that their Insight PH model rated highly for performance andfeatures.“With the help of the Loma team, the metal detectors were installed quickly and have proved easy to use, clean and maintain.”New Alliance to tackleantimicrobial resistanceIn a bid to stymie antimicrobial resistance, the AMR IndustryAlliance has been launched as a hand out to the life-sciences industry.It is estimated that unless action is taken, the burden of deaths fromantimicrobial resistance could be as high as 10 million lives each yearby 2050.In an unprecedented effort, over 100 companies and tradeassociations signed the Industry Declaration on AMR at the WorldEconomic Forum in Davos in 2016, followed by the adoption of aRoadmap by a number of pharmaceutical companies at the UN High-Level Meeting on later that year.They set out a common set of principles for global action that focuson reducing the development of antimicrobial resistance, invest in R&Dto meet public health needs and improve access to antibiotics,vaccines and diagnostics.The AMR Industry Alliance will ensure that signatories collectivelydeliver on the specific commitments made in the Declaration and theRoadmap and will measure progress made in the fight againstantimicrobial resistance.© Shutterstock / ESB Professional© Shutterstock / Orawan Pattarawimonchai 04-07_Layout 1 09/06/2017 14:09 Page 26Pharma Business International www.pbiforum.netLatest news‘Encouraging early results’for ALS candidateNew research from scientists at the University of Sheffield into a drugcandidate which could help to delay the onset of motor neurone diseasehas shown encouraging early results.The candidate was discovered by the British artificial intelligencecompany BenevolentAI.The study, led by Dr Richard Mead and Dr Laura Ferraiuolo from theUniversity’s Sheffield Institute of Translational Neuroscience (SITraN),found significant and reproducible indications that the drug prevents thedeath of motor neurones in patient cell models and delayed the onset ofthe disease in the gold standard of models.Motor neurone disease, also known as Amyotrophic Lateral Sclerosis(ALS), is a progressive neurodegenerative disease that causes muscleweakness, paralysis and ultimately, respiratory failure.Life expectancy following diagnosis is approximately two to five years.SITraN are now moving to the next phase of their research, advancing the existing study and assessingthe suitability and potential for clinical development.First-in-class innovation key forpharma companiesFewer than two in ten medicines exceed the average pharma R&D costrequired to bring a drug to market when the risks of failure to reach marketapproval are factored in.A GBI Research report found that, across the pharmaceutical industry, aproduct entering into clinical development has a 72% likelihood of failing toreach the market across any of the indications for which it is in development.On top of this, it is widely understood that bringing drugs to market isbecoming increasingly expensive.Dominic Trewartha, Managing Analyst for GBI Research, said: “Overall, thesehigher costs appear to stem from an increased clinical failure rate and emphasison proving superiority over comparator drugs in healthcare technologyassessments, as well as an increasing level of sophistication from payers when assessing the cost-effectiveness of drugs.“The additional trials needed to provide adequate evidence of a drug’s efficacy have significantly added to the cost of development.”UK on track to build world’s thirdglobal biotech clusterA new report from the UK BioIndustry Association (BIA) shows that the UKmaintained its strong leadership position in European biotech funding last year andhas the strongest pipeline in Europe for future drug development.‘Building something great: UK’s Global Bioscience Cluster 2016’ showed that theUK is in a strong position to close the gap on the leading life sciences clusters inBoston and San Francisco and maintain its lead in Europe, providing currentmomentum can be maintained.Despite a challenging year of financial uncertainty with Brexit and the US electionleading to markets cooling across the globe in 2016, UK companies worked harderthan ever to secure the funding that they needed.A total of £1.13 billion was raised by UK-based biotech companies from private and public sources in 2016.Moreover, the UK is better placed to realise the value of its science-base. Companies own their technology for longer which means that they are able toscale up.© Shutterstock / Sebastian Kaulitzki© Shutterstock / Pressmaster© Shutterstock / Plufflyman04-07_Layout 1 09/06/2017 14:09 Page 3Huge step forward for Irishhaemophiliacs Every person with haemophilia B requiring factor replacement therapy in Irelandwill now have access to the latest extended half-life (EHL) therapy after thesigning of a new national contract with the Board of St James’ Hospital in Dublin.This signals the first change in clotting factor concentrate availability for almost20 years and puts Ireland as the only country in the world to offer all people withhaemophilia B the opportunity to move onto a commercially supplied EHLtherapy.The Haemophilia Product Selection and Monitoring Advisory Board (HPSMAB),working on behalf of the National Centre for Haemophilia and CoagulationDisorders (NCHCD) at St James’ Hospital, conducted an open tender competitionfor supply of recombinant Factor IX therapies.The supply offer from Sobi (Swedish Orphan Biovitrum) was judged to offer the best value for Irish patients and so has been awarded the contract to supplyits recombinant clotting factor therapy Alprolix (rFIXFc) for a minimum of two years.Pharma Business International 7www.pbiforum.netLatest newsReNeuron secures £1.8m celltherapy manufacturing grantReNeuron Group, the UK-based stem cell therapy developmentcompany, has scooped a £1.8 million grant from Innovate UK tofurther advance its next-gen manufacturing capabilities.The grant comes as part of Innovate UK’s ‘Cell & Gene TherapiesIndustrial Manufacture’ scheme. It will fund a collaborativeprogramme of work to be undertaken by ReNeuron, as leadparticipant, and its collaborators, the Cell & Gene Therapy Catapult.The funding will facilitate key process development activitiesrelating to up-scaled commercial manufacture of the company’s celltherapy candidates.These include the development of robust manufacturing processesutilising next generation technology and techniques that will enablethe production of its therapeutic candidates at a commercial scale.Sharon Grimster, General Manager Waves at ReNeuron, said: “Thegrant award will assist ReNueron in the execution of its strategy toultimately bring the manufacture of its cell therapy candidates in-house to meet demand following market approval.”Scientists to pit brain tumoursagainst Zika virus in‘revolutionary first’Scientists funded by Cancer Research UK are to test whether the Zika viruscan destroy brain tumour cells.In what has been described as a “revolutionary first”, the experiment couldpotentially lead to new treatments for one of the hardest to treat cancers.Dr Harry Bulstrode at the University of Cambridge has received a CancerResearch UK Pioneer Award to test the effect of the Zika virus on glioblastoma –the most common and aggressive form of brain tumour. The research, using tumour cells in the laboratory and in mice, will see if thevirus can destroy cancer cells.Each year around 2,300 people are diagnosed with glioblastoma in England.Fewer than 5% of patients survive their disease for five years or more.Existing treatments are limited by their ability to cross the blood-brain barrier,and doses must be kept low to avoid damage to healthy tissue.The Zika virus can cross the blood-brain barrier, and could target cancer cells,sparing normal adult brain tissue and opening a potential new way to attack thedisease.© Shutterstock / wacomka© Shutterstock / science photo© Shutterstock / Kateryna Kon04-07_Layout 1 09/06/2017 14:09 Page 4STAMPING OUT FISTULA8Pharma Business International www.pbiforum.netPharma Business International:Astellas is supporting the secondphase of Action on Fistula with agrant. To what extent do you thinkpharmaceutical companies are duty-bound to make a positive difference?Jo Taylor:Our reason for supportingAction on Fistula is simple. As a pharmacompany focused on addressing unmetpatient needs and with cultural valuesfocused on transparency and integrity,we recognise we are in a strong positionto make a positive difference to society. Astellas Pharma Europe chose tosupport Fistula Foundation becauseobstetric fistula was identified as asignificant unmet health need where wefelt Astellas would be able to make atangible difference to people’s lives whilealso supporting with capacity-building inthe affected countries.We’re delighted the programme hasbeen an unprecedented success: over2,500 women with fistula have receivedlife-changing reconstructive surgery andit’s doubled the capacity to conductfistula surgeries in Kenya. Our employeesare also incredibly engaged with theprogramme and active in fundraising,helping contribute to its ongoingsuccess. PBI:The Action on Fistula plan haslaid out its aims for the next threeyears – including providing surgeriesto an additional 2,000 women andtraining more surgeons and nurses –what does the future hold beyond thatdate?JT:The aim of Action on Fistula is tocreate a legacy in Kenya that will allowmore women to be treated once theprogramme draws to a close. This is whywe have invested in the training of fistulasurgeons and nurses, alongside thebuilding of the Fistula Treatment Networkand awareness-raising programmes.These measures will allow more womento be identified and offered treatmentlong beyond the end of the programme. PBI:Price gouging controversieshave rocked consumer faith in bigpharma. Do you think initiatives suchDefeatingfistulaAstellas Pharma Europe is working with Action on Fistula to stamp out theissue in Africa through funding, training and support. We sat down withProgramme Lead Jo Taylor and Fistula Foundation CEO Kate Grant todiscuss the collaboration in depth and cover the burning issues facing thepharma sector. Jo TaylorProgramme Leadat Astellas 08-09_Layout 1 09/06/2017 13:30 Page 1Pharma Business International 9www.pbiforum.netSTAMPING OUT FISTULAas these can help get the public backon side? JT:For Astellas, investing inprogrammes like Action on Fistula isabout giving back to society and being aresponsible business. We support theprogramme because we want to helpend the suffering of women with fistula inKenya. One woman in the programmetreated had waited a staggering 50 yearsfor help – we are supporting the FistulaFoundation to work towards endingfistula so that no more women have toendure the physical and psychologicaltrauma of this devastating condition. PBI:Partnering with Astellas hasenabled the Fistula Foundation totransform the treatment landscape inKenya. Are there plans to work withany other pharmaceutical companies?Kate Grant:I am so grateful toAstellas for enabling us to launch Actionon Fistula in Kenya. Astellas enabled usto truly transform the fistula landscape,building a true network for fistulatreatment in Kenya that we believe willmean that more women receive life-changing fistula repair surgery for yearsto come. Thanks to Astellas there are now sixhospitals in Kenya treating women 12months of the year, and 43 of 47counties have had successful outreachprograms to encourage women to gettreatment. Astellas will remain our onlypartner in Kenya. However, we havelearned a great deal in building thisprogram in Kenya that we have begun toapply this model in Zambia.Support from Johnson & Johnsonenabled our Zambia program to launchearlier this year and we are already seeingexciting progress that reinforces ourconfidence that this model is the wayforward. We hope more companies willstep forward to partner with us in othercountries where fistula is prevalent, wherewe can apply this treatment model.PBI:Fistula is rare in the westernworld but, as the programme proves,is chronic in developing economies.Do you think the issue is ignored inthe west, or is the public simplyunaware?KG:Most people are simply unaware,because fistula is a rare injury in theindustrialised world. But fistula used tobe common in places like the UK and theUS, when women did not have access toemergency obstetric care. In fact, wherethe Waldorf Astoria in NYC sits todayused to be the site of a fistula hospital.That hospital closed when access toemergency obstetric care became morecommon and fistula cases droppeddramatically. So, the fact that fistula israre and that it happens to poor womenliving half a world away certainlycontributes to the lack of awarenessglobally about this heartbreaking buttreatable injury.PBI:To what extent would you saythat the thousands of women sufferingfrom fistula is a product of misogyny?And do you think if this was an issuefrom which men suffered, would havebeen treated more readily? KG:Actually, the number of womenwith fistula is at least one million. Weknow that the root cause of fistula ispoverty, not misogyny. That said, we alsoknow that girls and women are often morenegatively impacted by poverty than menand boys. We know that too little moneygoes into maternal health care generallyand fistula treatment specifically. Also, inso many of the countries where we work –places like Afghanistan and Somaliland –a woman often needs a man’s permissionto seek care, for instance. Most of thewomen we help are poor, and too oftenpowerless, with husbands who often havecontrol over money and access tocommunication, making it more difficultfor women to get the care they need.With the important caveat that we do hearmany stories of men staying by theirwives’ side when she develops obstetricfistula. Kate Grant, FistulaFoundation CEO08-09_Layout 1 09/06/2017 13:30 Page 2Next >