Your guide to the pharmaceutical world Volume 6 Issue 1HumanresourcesPharma’s talent pipelineproblemCollaborationFostering innovationResearchSurveying the marketPharmaBUSINESS INTERNATIONALThe total packageFrom development to dispensingThe total packageFrom development to dispensingHumanresourcesPharma’s talent pipelineproblemCollaborationFostering innovationResearchSurveying the marketwww.pbiforum.net01_Layout 1 13/02/2018 09:00 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 13/02/2018 09:01 Page 1@pbiforumwww.pbiforum.netcompany/pharma-business-internationalContentsVolume 6 Issue 1News4Stay up to date with the latest industry updates fromthe global pharmaceutical technology industry.ALS Exposé8 There’s currently no known cure or effective treatmentfor amyotrophic lateral sclerosis, but innovationabounds. Pharma Business International exploressome of the exciting developments coming out theALS research & development space.M&A Round-up12 Pharma Business International checks in with theglobal M&A market, highlighting some of the biggerdeals to have taken place over the last month. Collaboration14 Collaborations bring together an immense level of skilland expertise of a number of companies, or throughlinks with academia, which can have a huge impacton the sector and the patients its serves.Traceability18 Blockchain has been dominating headlines over thelast few months with nary a conversation abouttraceability can pass without mention of thisdisruptive technology. But what can blockchain do forpharma? Packaging22 Packaging has a key role to place in battlingcounterfeit medicines, with manufacturers increasinglyrelying on track and trace systems. Human Resources26 According to the World Health Organisation (WHO),healthcare sectors around the globe are struggling toattract staff. As this critical shortage in humanresources continues, the pharmaceutical sector ispoised on a cliff edge. Despite the continualautomation witnessed across the sector, a lack ofhuman workforce could have disastrousconsequences. Research30Although clinical research and discovery in labsettings are critical to future treatments, there’sanother branch of research that pharmaceuticalcompanies must nurture. Events34We give a rundown of pharma events happeningaround the world.8141826Group 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 / ORAWAN PATTARAWIMONCHAI 03_Layout 1 13/02/2018 09:01 Page 14Pharma Business International www.pbiforum.netLatest news2018 will be‘transformative’ forJapanese pharma2018 is set to be a transformative year for Japanesepharma as the market evolves towards growth ingenerics, biosimilars and increased internalisation,according CPhI New Year report.The report has identified that demographic pressureson healthcare costs are driving a political agenda that willbenefit players with lower costs solutions.Generics are an obvious route, but Japan’s status as ahighly-developed economy with a pharma industry thatleads in innovation opens other possibilities, particularlyin the longer term for the biosimilars segment.In fact, an overwhelming 59% of domesticrespondents believe biosimilars will be the fastestgrowing sector.Crucially, as the Japanese pharma economy is in a state of transition towards greateropenness, potential rewards for early international movers were cited asanother key factor in the rapid shifts predicted in 2018.Synpromics & UCL todevelop novel therapies forblood disordersScotland’s Synpromics is collaborating with UCL Great Ormond StreetInstitute of Child Health to develop novel gene therapies for blood-baseddisorders.The new partnership is part of Synpromics’s strategy of “establishingpartnerships with leading academics in the UK to integrate its technologyinto the next generation of gene-based medicines”.This agreement will develop synthetic tissue-specific promoters for usein the specialised cells of the immune system including lymphoid, myeloid and microglia cells.The objective is to develop synthetic promoters that can be directly applied to gene-modified cell therapy, particularly where cells such as microglia orother myeloid cells can be used to deliver a therapeutic protein to the target pathologic sites.Similarly, output from the collaboration also has direct applications to further improve CAR-T therapy.Dr Michael Roberts, founder and CSO of Synpromics, said: “By embarking on this collaboration, we aim to develop a portfolio of promoters that havebroad applications in multiple disease indications.”BioCryst & Idera merge to bettercombat rare diseasesBioCryst Pharmaceuticals and Idera Pharmaceuticals are forming a new enterprisefocused on the development and commercialisation of medicines to serve morepatients suffering from rare diseases.The combined company will be renamed upon closing and will be led by Idera CEOVincent Milano who will also serve as a member of the Board.BioCryst Chairman, Robert Ingram, will be Chairman of the Board of the combinedcompany and BioCryst CEO Jon P. Stonehouse will serve as a member of the Boardof Directors.© Shutterstock / f11photo© Shutterstock / angellodeco© Shutterstock / Alexander Raths04-07_Layout 1 13/02/2018 09:03 Page 1Japan approves firstPARP inhibitorJapan has approved its first PARP inhibitor in Lynparza for thetreatment of advanced ovarian cancer, AstraZeneca and Merck haveconfirmed.The approval was granted on the basis of two randomised trials ofLynparza maintenance therapy for platinum-sensitive relapsed ovariancancer, SOLO-2 and Study 19.“We are proud to bring this important first-in-class treatment to womenwith platinum-sensitive relapsed ovarian cancer in Japan who currentlyhave very few treatment options,” said Dave Fredrickson, Executive VicePresident, Head of the Oncology Business Unit at AstraZeneca.“The trials show that with Lynparza maintenance therapy, women withovarian cancer can live longer without their disease worsening andLynparza is well tolerated.”This latest approval follows news that Lynparza became the first andonly PARP indicator for use beyond ovarian cancer after gaining approvalby the US FDA.Pharma Business International 5www.pbiforum.netLatest newsResearchers tout skin patch as answer to antimicrobial resistanceResearchers at Queen’s University Belfast are developing anew type of skin patch as a possible answer to the antibioticresistance crisis. The patch administers drugs directly into thebloodstream through thousands of individual “microneedles”.These “microarray patches” are a discreet, easy-to-usetechnology that contains an array of tiny projections thatpainlessly penetrate the top layer of skin to deliver a drug.The research team, led by Professor Ryan Donnelly, hope todevelop and evaluate the patch in bypassing the gut bacteriaand extend the useful lifespan of currently-available antibiotics.On the surface of the antibiotic patch will be tiny needlesthat painlessly pierce the skin, turning into a jelly-like materialthat keeps the holes open and allows delivery of antibioticsinto the skin for absorption into the bloodstream, thusbypassing the gut bacteria.Professor Donnelly said: “If we are successful, this approach will significantly extend the lifespan of existing antibiotics, allowing time for development of thenext generation of antibiotics.”Merck joins forces withCancer Research in drugdiscovery allianceMerck has partnered with Cancer Research UK and The Institute ofCancer Research in a multi-project collaboration and licensing deal todiscover and develop new anticancer drugs.It follows previous single project drug discovery collaborations anda more recent target validation collaboration between Merck andCancer Research UK’s Cancer Therapeutics Unit at The Institute ofCancer Research (ICR).The parties will collaborate on three independent research projectsspanning target hit discovery to preclinical candidate nomination.This work will progress the discovery and development of potentialcancer drugs, as well as develop biomarkers for target engagementand patient selection.As per the deal, Merck has worldwide rights to take moleculesdiscovered through the collaboration forward into clinical development.Cancer Research UK and the ICR will receive milestone paymentsbased on the achievement of research and development, regulatoryand sales goals plus royalty payments on net sales of future productsdiscovered or developed under the agreement.© Shutterstock / Viacheslav Lopatin© Shutterstock / Castleski Photo: Queen’s University BelfastProfessor RyanDonnelly04-07_Layout 1 13/02/2018 09:03 Page 26Pharma Business International www.pbiforum.netLatest newsTakeda’s Zika vaccinefast tracked in USTakeda has picked up picked up Fast Track designation in the USfor TAK-426, its whole Zika virus vaccine candidate.The process allows more frequent interactions with the FDA, rollingreviews of the Biologic License Application, and eligibility for apriority review if relevant criteria are met.Zika can cause congenital Zika syndrome, including microcephalyand other congenital brain abnormalities, in infants born to mothersinfected during pregnancy.The virus has also been associated with neurologicalcomplications, including Guillain-Barre Syndrome, in the generalpopulation. It has spread in recent years to more than 84 countries,territories or subnational areas, including the US.There is currently no vaccine or medicine for Zika.Takeda’s Zika vaccine candidate is currently being studied in a Phase 1 trial (ZIK-101) under a USInvestigational New Drug application. If initial data from ZIK-101 are supportive, Takeda will workto progress into Phase 2 development as soon as possible.Effects of anti-cancer drugs observed inblood vessel-on-a-chipResearchers at the Institute of Industrial Science, the University of Tokyo, CNRS and INSERM,have unveiled a new organ-on-a-chip technology for the study of blood vessel formation anddrugs targeting this event.The technology – detailed in a study in EBioMedicine– recreates a human bloodvessel and shows how new capillaries grow from a single vessel (parent vessel) inresponse to proper biochemical signalling cues.It can further be used to develop drugs targeting this growth as a therapeuticapproach to treat cancer and blood-vessel-related diseases.Angiogenesis describes a specific process of blood vessel formation from pre-existing blood vessels. Dr Yukiko Matsunaga, lecturer at the IIS, the University ofTokyo, has been working in the SMMIL-E project, a joint French-Japanese projectagainst cancer by using tissue engineering and organ-on-a-chip technology to study various biological phenomena including angiogenesis.Her new technology provides a simple setting to study angiogenesis other effects such as the dynamics of blood vessel permeability.Partnership launched to improveclinical trials for Parkinson’s patientsThe National Institutes of Health is teaming with government, biopharma, lifescience and non-profits to increase success for advancing promisingtreatments for Parkinson’s disease (PD).Part of the NIH Accelerating Medicines Partnership (AMP), AMP PD will focuson identifying and validating promising markers of disease called biomarkersthat may be useful in tracking the progression of PD and could serve asbiological targets for the development of new drugs.AMP PD partners include Celgene, GlaxoSmithKline, The Michael J. FoxFoundation for Parkinson’s Research and Pfizer, among others.These organisations will invest a combined total of $12 million over five yearsthrough the Foundation for the National Institutes of Health which will managethe project.NIH’s National Institute of Neurological Disorders and Stroke will match the private sector funds with an additional $12 million contribution, pendingavailability of funds. The US Food and Drug Administration will also be a critical partner in providing regulatory guidance.© Shutterstock / sfam_photo© Shutterstock / O2creationz© Shutterstock / Kateryna Kon04-07_Layout 1 13/02/2018 09:03 Page 3UK has strongest R&Dpipeline in EuropeThe UK has the strongest clinical and preclinical pipeline in Europe,according to a new report from the BioIndustry Association (BIA) andInforma Pharma Intelligence.The report shows that more UK biotech companies are maturing andmoving through the financing life cycle, with UK biotech company IPOsraising more than twice as much money in 2017 than in 2016.“The UK’s impressive preclinical and clinical pipeline shows the strengthand capability of the UK biotech ecosystem to produce fantastic sciencethat attracts talent and funding from across the globe,” said BIA CEOSteve Bates.UK biotech also raised more on the public markets than in venturecapital as UK companies matured and progressed through the funding lifecycle with £515 million raised in venture capital, £234 million raised in IPOs and£452 million raised in follow on funding.Pharma Business International 7www.pbiforum.netLatest newsUL researchers to ‘transform’the pharma marketScientists at University of Limerick (UL) are teaming up withEnterprise Ireland (EI) to commercialise continuousnanomanufacturing technology which, they claim, will “transform thepharmaceutical market”.The project aims to tackle the biggest challenge facing thepharmaceutical industry today.While pharmaceutical companies are continually developing newdrugs, seven out of ten of those drugs never reach the patient. This isnot because they are ineffective at treating disease but because theyare not soluble enough to be absorbed in the body.Dr Luis Padrela, lecturer in industrial biochemistry in UL’s BernalInstitute, aims to change that. The key, according to Padrela, lies innanotechnology.The team are developing continuous scalable methods of drugmanufacture at the nano-level. Their research has attracted bothnational and international attention. Success in this area would mark asignificant advance in the treatment and prevention of global ill-health.The commercialisation project starts this month and will run fortwo years. Cancer Drugs Fund torelease £140m for the NHSThe new Cancer Drugs Fund is expected to release at least £140 million intothe NHS over the next five years, helping cancer patients get access to new andinnovative treatments.Since the new Cancer Drugs Fund (CDF) opened in July 2016, nearly 15,700patients have benefited from the 52 drugs treating 81 different types of cancer. Ofthese patients, around 5,000 have received treatment sooner than they wouldhave under the previous system.NHS England has also secured discounts on eight of the treatments previouslyfunded via the old CDF which will generate savings for the NHS of around £140million over the next five years.The new system means the National Institute for Health and Care Excellence(NICE) appraisal process now starts much earlier for newly referred drugs, withthe aim of publishing draft guidance before drugs receive their licence, and thenfinal guidance to be issued within 90 days of that.© Shutterstock / the goatman© Shutterstock / Dmitry Kalinovsky© Shutterstock / Marbury04-07_Layout 1 13/02/2018 09:03 Page 4ALS EXPOSÉ8Pharma Business International www.pbiforum.netOver the last eighty years, amyotrophiclateral sclerosis (ALS) has gone from relativeobscurity to one of the most challenging andrecognisable diseases due to a number ofhigh profile patients and recent charitycampaigns. ALS – a rare neurological conditionotherwise known as motor neurone disease –came into the public consciousness in thethirties after US baseball player Lou Gehrigwas diagnosed with the illness for which it isnow commonly known as Lou Gehrig’sdisease. However, it was the diagnosis ofphysicist Stephen Hawking in the earlysixties that has fixed the image of ALS in thepublic eye. Hawking is one of the rare casesof a long life in the face of the disease,whose sufferers live on average betweenthree and five years following diagnosis.Despite an almost entire loss of mobility,speech and breathing difficulties, Hawkinghas managed to survive these past fivedecades. But the majority of sufferers aren’tso lucky.ALS is caused by a gradual degenerationand eventual death of motor neurones – thenerve cells that stretch from the brain to thespinal cord and to muscles throughout thebody. These cells initiate and provide vitallinks between the brain and voluntarymuscles. When they die, so does a person’sability to control these muscles, leading tosufferers getting trapped inside their ownbodies. Movement, speech, swallowing andbreathing are all affected. For the social media generation, thedisease was given a high profile boost in theform of viral Ice Bucket Challenge. In short,celebrities would tip ice cold water overthemselves to mimic the sensation of ALSand nominate others to follow. The aim was toraise funds to help advance ourunderstanding. The campaign eventuallyraised $115 million. The latest iteration is theALS Pepper Challenge which, as one mightexpect, involves celebrities eating chillies toraise funds. Getting a diagnosis for the disease canoften be a challenge unto itself, one whichcan eat into whatever precious time a patienthas left. This is because the onset of ALS issubtle, with symptoms often beingmisdiagnosed or even overlooked. Yet thesesigns will inevitably develop into moreobvious weakness and atrophy which adoctor is able to pick up on and diagnose.One of the most common warning signs is inthe hand or arm as sufferers begin toexperience difficulty with simple tasks. Othercases might see the disease first manifest in aleg, with people then noticing awkwardnesswhen they walk or run. In any case, there isno reversing the progression of the disease,so symptoms will only get worse. Findinga cureThere’s currently no known cure or effective treatment for amyotrophic lateralsclerosis, but innovation abounds. Pharma Business International explores some ofthe exciting developments coming out the ALS research & development space. 10 Á08-11_Layout 1 13/02/2018 09:06 Page 1© Shutterstock / Marcos Mesa Sam Wordley08-11_Layout 1 13/02/2018 09:06 Page 2Next >