Your guide to the pharmaceutical world Volume 5 Issue 5Training &DevelopmentAlways recruitingOutsourcingHandled off-siteAlzheimer’sExposéForget me notPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingTraining &DevelopmentAlways recruitingOutsourcingHandled off-siteAlzheimer’sExposéForget me notwww.pbiforum.net01_Layout 1 05/10/2017 09:07 Page 1MIXING & BLENDINGNEWSINTERNATIONALFood&DrinkFood&Drinkwww.fdiforum.netOCTOBER 2017£3.50 STERLINGLABELLING &TRACEABILITYCelebrating20 yearsCelebrating20 yearsFor businesses that areserious about reducing theircarbon footprintwww.blmgroup.co.ukVOLUME 4 ISSUE 1WWW.RENEWABLESANDENVIRONMENT.COMOCTOBER 2017EAST MIDLANDS LEADING BUSINESS E-MAGLEGALSERVICESFree justiceSUPPORTINGBUSINESS GROWTHRaising capitalCOMMERCIALPROPERTYIs demand plateauing?www.blmgroup.co.ukWWW.EASTMIDLANDSBUSINESSLINK.CO.UKWWW.EASTMIDLANDSBUSINESSLINK.CO.UKFRESHTHINKINGFRESHTHINKINGEMPOWERYour BusinessYour guide to the pharmaceutical world Volume 5 Issue 4DistributionDriving the bottom lineHardware& SoftwareThere’s an app for thatLaboratoriesWorking to standardPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingDistributionDriving the bottom lineHardware& SoftwareThere’s an app for thatLaboratoriesWorking to standardwww.pbiforum.netOCTOBER 2017 £3.50YORKSHIRE & LINCOLNSHIRE’S LEADING BUSINESS MAGAZINEwww.blmgroup.co.ukVOLUME 32 ISSUE 10WAREHOUSINGAND DISTRIBUTIONDelivering resultsIT ANDTELECOMSOn top of the gameCONFERENCE ANDHOSPITALITYSpace sellsAT THEFOREFRONTAT THEFOREFRONTOften Imitated -Never Equalledwww.blmgroup.co.uk02_Layout 1 05/10/2017 09:13 Page 1@pbiforumwww.pbiforum.netcompany/pharma-business-internationalContentsVolume 5 Issue 5News4Stay up to date with the latest industry updatesfrom the global pharmaceutical technologyindustry.Training & Development8 There’s big money in pharma, but that attractscompetition, and every company is drawing froman ever-shrinking pool of talent.Outsourcing12 Outsourcing production, research or just aboutany aspect of a pharma business is nowcommonplace, but what are the risks involved?Advanced Manufacturing16 With the 3D printing for the healthcare marketexpected to experience $1.5 billion in spendingthis year, the future really is now.Alzheimer’s Exposé20 Alzheimer’s disease ranks alongside cancer andheart disease as one of the leading causes ofdeath. So, what’s being done to tackle thedisease?Animal Health24 Increasing collaboration and thoroughlyexamining data is not just in the public interest, itis key to achieving a reduction in animal testing,as Katharine Briggs, Research Leader at LhasaLimited, explains.Ethics26 In response to America’s ongoing opioidepidemic, state and local governments are filinglawsuits against some of the biggest drugmakers, highlighting the importance of ethics inbig pharma. Events30We give a rundown of Pharma events happeningaround the world8122026Group 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. No part of this publication may be reproduced,transmitted, photocopied, recorded or otherwise without expresspermission of the copyright holder, for which application should beaddressed first to the publisher. While every reasonable care istaken, neither the publisher nor its participating agents acceptliability for loss or damage to prints, colour transparencies,negatives or other material of whatever nature submitted to thispublication. The views expressed in this publication are notnecessarily the views of those held by the publisher.This magazine is now fully recyclable. By recycling magazines, youcan help reduce waste and add to the 5.5 million tonnes of paperalready recycled by the UK paper industry each year. Before yourecycle your magazine, please ensure you remove all plasticwrapping, free gifts and samples. COVER PHOTO: © SHUTTERSTOCK / KATERYNA KON 03_Layout 1 05/10/2017 09:14 Page 14Pharma Business International www.pbiforum.netLatest newsTeva sells off globalwomen’s health portfolioin $1.38bn dealTeva Pharmaceutical Industries is selling the remainingassets of its specialty global women’s health business for$1.38 billion.It will use the proceeds from the sales – combined withthose of the recent Paragard sale – to progress repayment ofterm loan debt.The remaining assets have been sold off in two separateagreements. The first is to CVC Capital Partners Fund VI whowill acquire a portfolio of products across contraception,fertility, menopause and osteoporosis for $703 million.The second agreement involves Foundation ConsumerHealthcare acquiring Plan B One-Step and Teva’s valuebrands of emergency contraception – Take Action, Aftera and Next Choice One Dose – for $675million.Teva is also planning the divestiture of the Oncology and Pain business inEurope.VarmX publish ‘groundbreaking’study into venom derivedanticoagulantDutch biotech spin-out, VarmX, has published the results of a “groundbreaking”study into its snake venom derived therapeutic factor as an anticoagulant.The company’s flagship product – factor X – was inspired by a snake venomproduct and is currently in development.The Leiden University Medical Centre (LUMC) study explored modified humanfactor X as a safe and effective reversal agent for prevention and treatment ofbleeding in patients taking factor Xa oral anticoagulants.To avoid spontaneous stroke or deep vein thrombosis, millions of cardiacpatients worldwide take daily synthetic factor Xa anticoagulants, but there is noagent to stop the effect of these anticoagulants.This is a significant unmet medical need for the many patients experiencingsevere bleeding or requiring emergency surgery.Due to the increasing use of factor Xa inhibitors for anti-coagulation, globaldemand for a compound such as PseudoXa is growing rapidly.Destiny raises £15m to developsuperbug drugsThe UK’s Destiny Pharma has raised over £15 million to fund the development of drugs targetingantibiotic-resistant bacterial infections.The funds were raised by listing shares on London’s AIM market.With the new funds in tow, Destiny will initiate a clinical trial exploring the efficacy of its lead candidate.The company said its candidate will be tested as a preventative measure against post-surgicalinfections from superbugs such as MRSA.© Shutterstock / Julia Sudnitskaya© Shutterstock / Kateryna Kon© Shutterstock / Joe McDonald04-07_Layout 1 05/10/2017 09:18 Page 1Fosun takes 74% sliceof Gland in $1bn dealShanghai Fosun Pharma is to acquire a 74% stake in Indian drugmaker Gland Pharma for $1.1 billion.In so doing, Fosun has resurrected a deal previously blocked by theIndian government.This earlier deal saw the company attempt to acquire an 86% stakein the firm, but was rejected in August. At the time, this was thebiggest ever Chinese bid for an Indian company.However, last year saw New Delhi relax investment rules meaningforeign companies can snap up to 74% in local drugmakers withoutgovernment approval hence the revised deal. Pharma Business International 5www.pbiforum.netLatest newsUS approvesgroundbreakingCAR-T cell therapyThe US FDA has approved the first CAR-T cell therapy for patients upto 25 years suffering with B-cell precursor acute lymphoblastic leukaemia(ALL).Kymriah is a novel immunocellular therapy and a one-time treatmentthat uses a patient’s own T cells to fight cancer.To support safe patient access, maker Novartis is establishing anetwork of certified treatment centres throughout the US which will be fully trained on the use of Kymriah and appropriate patient care.There has been an urgent need for novel treatment options that improve outcomes for patients with relapsed or refractory (r/r) B-cell precursor ALL, whoseprognosis is poor.Novartis plans additional filings for Kymriah in the US and Europe later this year, including applications with the FDA and European Medicines Agency forthe treatment of adult patients with r/r diffuse large B-cell lymphoma.Additional filings beyond the US and EU are anticipated in 2018.FDA backs MDMA with‘breakthrough status’The US Food and Drug Administration has awarded MDMA with thecoveted ‘breakthrough status’ designation.With this status in tow, MDMA – more commonly known as ecstasy– will now be fast-tracked as a potential treatment for post-traumaticstress disorder (PTSD).The text steps will see the Multidisciplinary Association forPsychedelic Studies begin human trials involving 200-300 patientsfrom next year.Research has shown that PTSD sufferers can overcome theirtraumas long-term with the aid of MDMA.There are currently seven studies exploring the drug’s use forbeneficial purposes. One in particular is exploring whether MDMAcould help autistic people overcome social anxiety.© Shutterstock / Romariolen© Shutterstock / joesayhello Photo: Novartis04-07_Layout 1 05/10/2017 09:18 Page 26Pharma Business International www.pbiforum.netLatest newsGenoskin introduce animaltesting alternative to USGenoskin is expanding into the US with the launch of itsbleeding-edge alternative to animal testing.The French biotech firm keeps donated human skin alive intesting wells, offering a scalable and competitive answer to animaltesting.It has now established an office in the biotechnology hub ofBoston with a local production unit slated for the first quarter of2018.The skin is donated by patients after common plastic surgeryprocedures. At the end of these procedures, any excess skin isgenerally disposed of by the hospital. The Genoskin team nowrecycles this skin into a patented testing model for cosmetic,pharmaceutical and chemical companies and research institutions.The retrieved skin is placed in a testing well that contains a special biological matrix to keep the skin alive for severaldays.CEO Pascal Descargues said: “Our skin models help academic institutions, pharma, cosmetic andchemical companies obtain more predictive results in order to lower R&D costs.”Patient death haltsCellectis trialCellectis has been forced to halt the clinical trial of a groundbreaking CAR-T therapy following a patient death.The French cell therapy company is working alongside the US Food andDrug Administration to resume trials with a lower dose of UCART123.It is designed to help patients with acute myeloid leukaemia and blasticplasmacytoid dendritic cell neoplasm.The first patient treated in the study, a 78-year-old man, died afterexperiencing cytokine release (CRS) syndrome.The first patient treated in the AML trial, a 58-year-old woman, alsoexperienced CRS and other symptoms but recovered.There is a chance, analysts claim, that these adverse effects could bealleviated by lowering the dose and treating symptoms more aggressively.However, more information is needed to access the treatments prospects.PrEP deemed safe for gay andbisexual adolescent boysDespite being first approved by the US FDA back in 2012, there was littleevidence on the use of PrEP among gay and bisexual adolescent males.For this pivotal study, researchers enrolled 78 gay and bisexual youngmen – aged 15 to 17 – from six US cities.Participants all tested negative for HIV at the start of the study, but wereat high risk for an infection.They received daily doses of PrEP for the next 48 weeks. In total, 47participants completed the study. Three young men did become infected with HIV, but blood samplessuggest they were taking less than two doses of PrEP each week at thetime of infection.The rate of HIV infection in the study was 6.4 cases per 100 people per year – twice as high as the rate seen among men ages 18 to 22 years.Researchers are now calling on the FDA to approve PrEP for use among adolescents.© Shutterstock / Marc Bruxelle© Shutterstock / science photoPhoto: Genoskin04-07_Layout 1 05/10/2017 09:19 Page 3Gilead acquires Kitefor $11.9bnGilead Sciences is to acquire fellow Californian company Kite Pharmain a deal valued at $11.9 billion.The deal has been unanimously approved by the boards of bothcompanies and is expected to close in the fourth quarter of 2017.“The acquisition of Kite establishes Gilead as a leader in cellulartherapy and provides a foundation from which to drive continuedinnovation for people with advanced cancers,” said John F. Milligan,Gilead’s President and CEO.Kite’s research and development and commercialisation operationswill remain based in Santa Monica, with product manufacturing remaining in El Segundo, California.Pharma Business International 7www.pbiforum.netLatest newsGates Foundation invests$40m in ImmunocoreThe Bill & Melinda Gates Foundation has invested $40 million inImmunocore’s soluble TRC-based therapeutics for infectiousdiseases.The investment will support development of Immunocore’s ImmTAV(Immune mobilising monoclonal TCRs Against Virus) and ImmTAB(Immune mobilising monoclonal TCRs Against Bacteria) therapeuticsfor the treatment of tuberculosis and HIV where the TCR-basedtherapeutics have the potential to reduce treatment timelines andimprove patient outcomes.Immunocore will also continue expanding its platform technologyto enable therapeutics with broad coverage of the affected diseasepopulation.The investment was made as part of the Foundation’s programme-related investments strategy which aims to stimulate private sector-driven innovation, encourage market-driven efficiencies and attractexternal capital to priority global health and development initiatives.This new collaboration is part of a larger initiative withinImmunocore to apply its soluble TCR-based therapeutics to areasoutside of oncology, including infectious diseases and autoimmunediseases.Chemo pain assuaged withjet lag drug, study findsA new study published in Pineal Research has shown that painful side effectsfrom cancer medicine could be mitigated with a drug that eases the effects of jetlag.In studies undertaken by the Universities of Edinburgh and Aberdeen, jet lagdrug melatonin appeared to prevent pain caused by chemotherapy damage tonerves.Experts say the findings could help scientists understand more about ways tolimit painful side effects of chemotherapy.Chemotherapy-induced neuropathic pain (CINP) causes tingling and painsensation to touch and cold temperatures that can be severe enough to causepatients to limit their chemotherapy treatment.It affects almost 70% of patients undergoing chemotherapy and can havesevere impact on quality of life.The study showed that melatonin given prior to chemotherapy limited thedamaging effect on nerve cells and the development of pain symptoms.© Shutterstock / Marian Weyo© Shutterstock / JStone© Shutterstock / Blue Planet Earth04-07_Layout 1 05/10/2017 09:19 Page 4TRAINING AND DEVELOPMENT8Pharma Business International www.pbiforum.netAlways recruitingThere’s big money in pharma, but that attracts competition,and every company is drawing from an ever-shrinking poolof talent 08-11_Layout 1 05/10/2017 09:20 Page 1Pharma Business International 9www.pbiforum.netTRAINING AND DEVELOPMENTPharmaceutical companies have alwaysreached for high standards, but their customersnow often expect them to go above andbeyond their legal requirements to ensureabsolute quality before they award contracts.This means manufacturers need to ensure theirequipment and procedures are absolutelyexceptional.Although the investment in training andtechnology requires some short termexpenditure, the long term results can behugely impressive, with companies able tocompete at the very top level and be well-placed to land major contracts. The mostsuccessful companies in the pharmaceuticalssector are those which have benefited frominnovation and investment in a high qualityinfrastructure.The pharmaceutical industry, like most othermanufacturing sectors, is constantly in need ofa steady stream of new talent, both to replacethose who are lost to the industry throughretirement and to ensure employees are wellequipped with up to date knowledge of theirroles and the industry as a whole. Initiativessuch as the See Inside Manufacturing schemein the UK helps achieve this by raising theprofile of manufacturing and providing anexcellent opportunity to identify new recruits –as well as developing existing employees whoget the opportunity to pass on their skills.There are plenty of examples of how strongerlinks between businesses and educationalestablishments are reaping the rewards foremployers and employees alike. Many areworking together as part of Industrial CASEStudentships, to support cutting-edge researchinto some of the current pressing medical andbiological challenges.The studentships fund four-year collaborativePhD projects supervised jointly by a member ofacademic staff and an industrial partner.Studentships are principally based at theacademic partner, with a mandatory placementat the non-academic partner for a minimum ofthree and up to eighteen months. The© Shutterstock / anyaivanova10 Á08-11_Layout 1 05/10/2017 09:20 Page 2Next >