Your guide to the pharmaceutical world Volume 5 Issue 1MicrobiologyIn focusComplianceApproved for successPackagingCheck the fine printMarketingHard to swallowPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingMicrobiologyIn focusComplianceApproved for successPackagingCheck the fine printMarketingHard to swallowwww.pbiforum.net01_Layout 1 08/02/2017 16:13 Page 1IMHXSPECIALITY & FINEFOOD FAIRINTERNATIONALFood&DrinkFood&Drinkwww.fdiforum.netAUGUST 2016£3.50 STERLINGLABELEXPO AMERICASThe perfectpackageThe perfectpackageFor businesses that areserious about reducing theircarbon footprintwww.blmgroup.co.ukVOLUME 3 ISSUE 4WWW.RENEWABLESANDENVIRONMENT.COMAUGUST 2016EAST MIDLANDS LEADING BUSINESS E-MAGPROFESSIONALSERVICES Alistair Wesson speaksRETAILBrexit and customer loyaltyDEVOLUTIONWhere next?www.blmgroup.co.ukWWW.EASTMIDLANDSBUSINESSLINK.CO.UKON THE RAILROAD TO SUCCESSEMBL meets Inside Out GroupON THE RAILROAD TO SUCCESSEMBL meets Inside Out GroupEMPOWERYour BusinessYour guide to the pharmaceutical world Volume 4 Issue 4MarketingBrand before allHygieneHandy hygieneDistributionDeveloping distributionProcurementProcuring contractsPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingMarketingBrand before allHygieneHandy hygieneDistributionDeveloping distributionProcurementProcuring contractswww.pbiforum.netAUGUST 2016 £3.50YORKSHIRE & LINCOLNSHIRE’S LEADING BUSINESS MAGAZINEwww.blmgroup.co.ukVOLUME 31 ISSUE 8SUPPORTINGBUSINESS GROWTH Broadband or bustENERGY &RENEWABLESWaste notHULLEverything’shappening in HullBUSINESSAS USUAL?BUSINESSAS USUAL?Often Imitated -Never Equalledwww.blmgroup.co.uk02_Layout 1 08/02/2017 16:14 Page 1@pbiforumwww.pbiforum.netcompany/pharma-business-internationalContentsVolume 5 Issue 1News4Stay up to date with the latest industry updatesfrom the global pharmaceutical technologyindustryMicrobiology8 The microbiology market has flourished in recentyears, driven by the demand from end userindustries, and providing groundbreakingsolutions to some of the biggest threats facingthe pharmaceutical and healthcare sectorsMarketing12 Mobile apps offer pharmaceutical companies awealth of information and open avenues totargeted, two-way marketing, so why aren’t morecompanies taking advantage?Procurement16 The pharmaceutical industry is facing anuncertain future with US President Trump takingaim at big pharma’s drug prices, and proposing acompetitive bidding system to replace theAffordable Care ActPackaging20 The pharmaceutical packaging industry remainsat the forefront of innovation, despite how somemay claim the look of drug packaging hasn’tchangedCompliance24 Ensuring new products meet with the approval ofgoverning bodies can be a long and frustratingprocess, but ensures greater success in the longrunTransport and logistics28 Transport is a go-to location for cutting costs, buthow much further can the industry be stretched?Events32We take a look at Pharma events happeningaround the world481232Group 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 08/02/2017 16:15 Page 14Pharma Business International www.pbiforum.netLatest newsIndena’s Madagascarproject wins Excellence inPharma: CSRIndena’s ongoing social sustainability project in Madagascar hasbeen awarded the Excellence in Pharma: Corporate SocialResponsibility during CPhl 2016 held in Barcelona, Spain. The Centella project is part of Indena’s Sustainable Sourcingprogram (SuSo) and started in October 2015 in the Alaotra Mangororegion of Madagascar, where most of Centella asiatica processed bythe company is harvested. The project, backed by the Italian NGO‘RTM – Volontari nel Mondo’, has provided more than 1,400 children and 30 teachers in 5 elementary schools with school kits andteaching materials. Moreover, Indena is putting the basis to support some renovation in schools and creation of libraries including alsotraining courses for teachers and awareness sessions for parents on the important of schooling and the inclusiveeducation of children with disabilities. Early results point to increased school attendance andimprovement in academic performance. Indena has always been committed to sustainability, and the SustainableSourcing program strengthens this commitment. Siemens & GEA partnership brings continuous manufacturing to pharma industryGEA and Siemens AG have partnered to bring continuous manufacturing to thepharmaceutical and life sciences industry by offering an integrated continuoustablet manufacturing line.The collaboration will deliver both production benefits, in terms of reducedproject execution risk, higher quality and cost-effective manufacturing andcustomer benefits in the form of seamlessly integrated technologies, expertise andsupport.Comprising GEA’s ConsiGma continuous manufacturing platform equipped witha Siemens Automation & Industrial IT solution, the combined technologies offerboth wet granulation and direct compression in a standard-setting solution forcontinuous tablet production in the pharmaceutical and life sciences industry.The ConsiGma continuous tableting line is a multipurpose platform that has beendesigned to transfer powder into coated tablets in development, pilot, clinical and production volumes in a single compact unit. The system can performdosing and mixing of raw materials, wet or dry granulation, drying, tableting, coating and quality control, all in one line.Simatic Sipat is a scalable and modular software solution that enables companies to extend their PAT-based quality control strategies on a step-by-stepbasis within the scope of a Quality by Design-based approach.Researchers uncover cancer cell structure,hope for drug developmentA team of researchers from Case Western Reserve University School of Medicine has helpeduncover the elusive structure of a cancer cell receptor protein that can be leveraged to fight diseaseprogression.Previous studies have showed blocking the receptor can slow tumour growth and metastasis incertain cases. However, the development of drugs has been slowed by an absence of structuralinformation on this highly unstable membrane protein.Armed with the new study, drug developers can now design molecules that nestle into the receptor’s binding sites to modulate its function or outcompetenative ligands.The research team, including Mark Chance PhD, professor and Vice Dean for research at Case Western Reserve School of Medicine, identified for the firsttime regions where the receptor interacts with other molecules, including investigational drugs. The findings (published in Nature Communications) provide thefirst complete structural model for an important class of proteins that sit in the membranes of several types of normal and cancer cells, and are criticalmediators of cell-cell communication.The techniques used by the team are helping to map other types of cancer-related cell proteins to guide drug development.04-07_Layout 1 08/02/2017 16:16 Page 1M Pharmaceutical to develop femalesexual dysfunction treatmentAs part of its planned acquisition of 40 J’s, Canada’s M Pharmaceutical’s willcontinue to advance the development of a patented drug aimed at femalesexual dysfunction (FSD).“Unlike the other two drugs approved by the US FDA to treat FSD, ourtopical drug product would focus on women with orgasm and arousaldifficulties,” said Mr Thompson, CEO of M Pharmaceutical USA. “Valeant’sAddyi, recently acquired from Sprout Pharmaceuticals, is indicated only forHSDD (desire disorder) with a number of FDA imposed prescription andmarketing restrictions.” He added: “Intrarosa, by Endoceutics, is indicated for dyspareunia (pain withintercourse) with certain prescribing restrictions. Our proposed treatment istopical, local and non-systemic, with daily and on demand use, while beingnon-hormonal and not a central nervous system drug. Based on these coreattributes, the safety profiles of the API and excipients in the drug product, thedosage and delivery form, we anticipate the product to be extremely welltolerated and highly effective for a large number of women suffering from FSDand has a great likelihood of approval by the FDA.”Pharma Business International 5www.pbiforum.netLatest newsFirst spinal muscular atrophytreatment gains US approval The US Food and Drug Administration (FDA) has approved Biogen’s Spinraza(nusinersen) under Priority Review for the treatment of spinal muscular atrophy(SMA) in paediatric and adult patients.Spinraza is the first and only treatment approved in the US for SMA, a leadinggenetic cause of death in infants and toddlers that is marked by progressive,debilitating muscle weakness.The approval was based on positive results from multiple clinical studies in morethan 170 patients. The data package included the interim analysis of Endear, aPhase 3 controlled study evaluating Spinraza in infantile-onset, as well as open-label data in pre-symptomatic and symptomatic patients with, or likely to develop,Types 1, 2 and 3 SMA.In open-label studies, some patients achieved milestones such as ability to situnassisted, stand or walk when they would otherwise be unexpected to do so and maintained milestones at ages when they would be expected to be lost.The overall findings of these studies support the effectiveness of Spinraza across the range of SMA patients, and appear to support the early initiation oftreatment.Pharma start-up ships firstUK medicines to IraqThe first consignment of British manufactured medicines has beenexported to Iraq by a Yorkshire-based pharmaceuticals wholesaler anddistributor set-up to give Iraqi people access to high-qualitytreatments.A combination of prescription and over-the-counter medicineswidely available in the UK has been sent sea freight by CurePharma,which receives support and advice from overseas trade specialist,Chamber International.CurePharma was launched by Director Mustafa Al-Shalechy,pictured left, and Business Development Manager, Ali Alshamari, toexport British pharmaceutical and healthcare products to Iraq wheremany people cannot get access (or afford) adequate treatment formany chronic illnesses.The initial consignment, sourced through a UK pharmaceuticalscompany, included several different medicines including antiplatelets,used to prevent cardiovascular disease and the common pain reliever,paracetamol.The medicines, worth around £50,000 in current prescription andretail values, were sent to a large pharmaceutical distributor in Baghdad,and will now be delivered to hospitals, clinics and pharmacies.PHOTO: BIOGEN04-07_Layout 1 08/02/2017 16:16 Page 26Pharma Business International www.pbiforum.netLatest newsNovo Nordisk & Oxford Universitylaunch landmark £115m researchcentre Novo Nordisk and the University of Oxford have together launched a landmark researchcollaboration focused on type 2 diabetes. The partnership will enable scientists from Novo Nordisk and University of Oxford to collaborateand discover innovative approaches for treating type 2 diabetes. As part of the collaboration, NovoNordisk is also investing in a new research centre on the premises of the University of Oxford.Based in an Oxford University research centre, The Novo Nordisk Research Centre Oxford willemploy up to 100 researchers. The total investment from Novo Nordisk is expected to be around 1billion Danish kroner (£115 million) over a period of 10 years. The centre will focus on innovation within early stage research that haspotential to substantially impact future treatment of type 2 diabetes and its complications.The collaboration will actively seek to encourage cross-fertilisation of ideas between academic researchers from theUniversity of Oxford and researchers employed by Novo Nordisk with funds to sponsor the collaborative research.James D. Johnson, Professor, PhD, has been appointed head of the Novo Nordisk Research CentreOxford. Pharmaceutical growth continuesto set technology paceWhile food and beverage remain the largest sectors in terms of packaging machineryneeds, no market can keep pace with the pharmaceutical growth forecast through 2020,according to the 2016 State of the Industry US Packaging Machinery Report.Produced by PMMI, the report – ‘The Association for Processing and PackagingTechnologies’ – projects pharmaceuticals to grow at a CAGR of 2.8% through 2020,surpassing $700 million for the first time.The greatest influence on growth in the pharmaceutical industry is general economicdevelopment. As more people can afford access to drugs, this will, in turn, drive growthin packaging and packaging equipment for pharmaceuticals. And, as the US population becomes more health conscious and adopts healthier lifestyles, lifeexpectancy is increasing and creating a greater demand for medicines for the elderly.Another factor driving a rise in the market is the pharmaceutical industry’s willingness to investigate and adopt new technologies. One of the recentdevelopments in this sector is packaging machinery without electrical cabinets or cabinet-less machinery. Ariad at epicentre of 2017’s firstmulti-billion pharma M&A dealJapan’s Takeda is acquiring Ariad Pharmaceuticals in a deal worth $5.2 billion - thefirst multi-billion pharmaceutical M&A deal of the year.Paris Panayiotopoulos, President and CEO of Ariad, said: “We are very pleased tocombine with Takeda, which will allow us to not only accelerate our mission to discover,develop and deliver precision therapies to patients with rare cancers, but also delivermeaningful value to our shareholders through a substantial cash premium.”Alexander J. Denner, Ph.D., Chairman of the ARIAD Board of Directors, added: “Thistransaction is a great outcome for Ariad shareholders and brings hope to improve thelives of many cancer patients. It has been a pleasure to work with our outstandingmanagement team and, on behalf of the board of directors, I extend our deepest gratitude to everyone at Ariad for their unrelenting dedication.”The transaction is expected to close by the end of February 2017. Takeda Pharmaceuticals USA, a wholly owned subsidiary of Takeda, has established KikuMerger Co. to effect the transaction.04-07_Layout 1 08/02/2017 16:16 Page 3Pharma Business International 7www.pbiforum.netLatest newsTop pharma companies formnew industry standards groupVeeva Systems and six of the top 25 largest global pharmaceuticalcompanies have together formed Align Biopharma, a new groupdedicated to setting technology standards that will make it faster andeasier for healthcare professionals (HCPs) to connect with the lifesciences industry.Founding members, along with industry input, will develop openstandards and solutions for companies to streamline how HCPs getthe drug and treatment information they need to deliver improvedcare to patients.The rise of specialty drugs to treat complex diseases is creating agreater need for HCPs to have more timely and tailored information.As the number of new drugs increases so does the amount ofinformation healthcare professionals require facilitating patientengagement. There is significant potential for biopharmaceuticalcompanies to use digital technology to inform HCPs on new or morecomplex treatments.Initially, Align Biopharma will focus on developing two newstandards to facilitate seamless digital engagement and simplify theHCP experience with a mix of identity management and consent &communication preferences.Gates Foundation awards Abcelleragrant to fight tuberculosisCanada’s AbCellera has received a grant from the Bill & Melinda Gates Foundation to discovermonoclonal antibodies against Mycobacterium tuberculosis (Mtb).The project will use AbCellera’s antibody discovery platform to generate panels of high- affinitymonoclonal antibodies against 10 tuberculosis targets. These antibodies will be used for thedevelopment of new diagnostic tests for disease caused by Mtb.Tuberculosis is one of the leading causes of death worldwide, with an estimated nine million newcases annually. Conventional diagnostic methods used in the developing world fail to identifyindividuals with disease caused by Mtb in more than half of all cases, and access to more sensitivetests that require specialised laboratory equipment is limited in many high-burden countries.The development of low-cost, point-of-care tests with greater specificity and sensitivity would havemajor impact on curtailing the spread of the disease in low- to middle-income countries that accountfor over 90% of tuberculosis cases.AbCellera has established a microfluidic single-cell platform that enables the screening of millions ofimmune cells in a single day. FDA approves Teva’s anti-abusepainkillerTeva Pharmaceutical’s Vantrelatm ER, an opioid formulated with its proprietaryabuse deterrence technology, has been approved by the US Food and DrugAdministration (FDA).Vantrelatm ER (hydrocodone bitartrate) extended-release tablets are indicatedfor the management of pain severe enough to require daily, around-the-clock,long-term opioid treatment and for which alternative treatment options areinadequate.The product’s approval is supported by a clinical program that evaluated thesafety and efficacy of Vantrelatm ER, as well as its abuse potential in laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies, andclinical abuse potential (CAP) studies.As an opioid, Vantrelatm ER is associated with serious risks and the PIcontains a boxed warning that includes addiction, abuse and misuse, which canlead to overdose and death, as well as serious, life-threatening, or fatalrespiratory depression.Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officerat Teva, said: “While no technology can completely eliminate abuse, Teva’sproprietary abuse deterrence technology is an important step forward. We arecommitted to furthering responsible pain management.”04-07_Layout 1 08/02/2017 16:16 Page 4MICROBIOLOGY8Pharma Business International www.pbiforum.netIn studying microorganisms, we see our own world reflectedin miniature, and make some of the most significant leapsforward on a stage invisible to the naked eye. Few symbolsare as emblematic of the sciences, and thus the greaterunderstanding of the world around us, then the microscope.It’s fitting, then, that microbiology is a key and critical branchof the pharmaceutical and healthcare sectors. To put it inperspective, the global market was worth $4.78 billion in2015, with a projected figure of $6.78 billion by 2021, basedon a report from A to Z Research.Put simply, microorganisms make up some of the world’ssmallest life forms, seen only with the aid of a microscope.Their size alone makes working on a single microorganismpractically impossible, leaving researchers reliant on culturemedia to help grow thousands, millions and sometimes evenbillions of microorganisms. Some microbial cultures arecomprised of only a single kind of microorganism, irrespectiveof the other individuals. This is referred to as a ‘pure culture’,while a ‘mixed culture’ refers to two or more species ofmicroorganism growing together in culture media. The applications of this science in medicine and healthcarerange from diagnosis, to research and development. Perhapsthe biggest scientific breakthrough of the year – and even asearly as February it’s already up against some stiffcompetition – saw the world’s first three person baby bornusing a new method of Three Person IVF. It would be animpossible breakthrough without our understanding ofmicrobiology being what it is. Indeed, the very evolution of ourspecies is working in tandem with these scientific discoveries.Where once ‘test tube’ babies and IVF were medicalbreakthroughs, they have become commonplace, and whereIn focusThe microbiology market has flourished in recent years, drivenby the demand from end user industries, and providinggroundbreaking solutions to some of the biggest threats facingthe pharmaceutical and healthcare sectors. 10 Á08-11_Layout 1 08/02/2017 16:16 Page 1Pharma Business International 9www.pbiforum.netMICROBIOLOGY08-11_Layout 1 08/02/2017 16:16 Page 2Next >