1、06/1 0/2022INDEPENDEN T P U B L I C AT I O N BY#0836R AC O N T EU R.NE TLife Sciences Superpower:Growing the leading global hub in the UKRead the latest report on the potential for life sciences to create health and wealth for the UK.FUTURE OFPHARMACEUTICALSHOW GLASGOWS R&D HUB CAN AID THE NHSBREAKI

2、NG THE IRON GRIP OF EROOMS LAW0403COULD 3D PRINTING TRANSFORM PHARMA?10R A C O N T E U R.N E TF U T U R E O F P H A R M A C E U T I C A L S0302pioneering new R&D facility,to be officially opened shortly,is set to streamline pharmaceutical production in the UK.Experts in the field believe that the wo

3、rk of the 56m Medicines Manufacturing Innovation Centre(MMIC)has the potential to save the economy hundreds of millions of pounds a year.The centre,located by Glasgow Airport,is the outcome of a public private collaboration involving founding industry partners GSK and AstraZeneca,Scottish Enterprise

4、,UK Research and Innovation,the Centre for Process Innovation and the University of Strathclyde.Professor Clive Badman,executive director at the university and former head of precompetitive collaboration at GSK,has played a leading role in the centres creation.He explains that one of the main reason

5、s for its existence is to find a more efficient alternative to whats been the industrys standard procedure for the past 100 years:multistep batch manufacturing.The stopstart nature of this approach means that the entire production process can take as long as two years.If producers were to adopt soca

6、lled continuous manufacturing on a large scale instead,it should enable them to cut the time down to six months at most.Batch manufacturing is notoriously inefficient.In a research report last year,PwC noted that,15 years ago,“it was estimated that$50bn was lost as waste each year in the US alone du

7、e to inefficiencies of batch production.Since then,very little has changed.”Continuous manufacturing has been shown to reduce capital costs by up to half,downstream waste by 60%and greenhouse gas emissions by as much as 80%.Crucially,continuous manufacturing could make the UK more selfreliant and he

8、lp to restore the fortunes of its pharma sector.According to the Association of the British Pharmaceutical Industry,the sectors exports fell so drastically in 201020 that its trade balance sank from an 8.9bn surplus to a 920m deficit over that period.More than 75%of gen eric(off patent)drugs prescri

9、bed on the NHS are estimated to contain at least one component made in India or China,while many others are wholly manufactured abroad.Generics account for 90%of British prescriptions.Although these imports from China and India are tested by the UK Medicines and Healthcare Products Regulatory Agency

10、,many in the industry are still concerned about their quality.They are also worried about the prospect of China weaponising drugs,just as Russia has been weaponising energy.But the problems dont stop there,as Badman explains.“Disruptions from Brexit and the pandemic have meant that,despite having he

11、ld contingency stocks,we have been running short of critical drugs.This has led to the prescription of second or even thirdline choices.”The NHS has reported that 1,700 medicinal products have been in short supply since the start of the pandemic.Last October,for example,the NHS Cambridgeshire and Pe

12、terborough Clinical Commissioning Group alerted local healthcare professionals to shortages of more than 30 drugs,including vital ones such as the painkiller diamorphine and the antidepressant fluoxetine.This supply crisis has been widely attributed to the markets haphazard,freeforall nature.Costs a

13、re set by the socalled drug tariff price the amount the NHS pays pharmacies for prescription generics.“Pharmacists are encouraged to buy generic drugs at a cost below the tariff price to give them a profit,”says Professor Mike Hannay,a member of the Royal Pharmaceutical Societys governing assembly.“

14、This is great for the NHS it keeps driving down prices.”More than a billion generic prescriptions are written each year,saving the NHS more than 13bn annually,according to the British Generic Manufacturers Association.Newer branded products are far more expensive.Its not unusual for the cost of deve

15、loping one drug to run into billions,but in the high stakes of pharmaceutical roulette,nearly 90%of medicines in development socalled candidate drugs never reach the market.The cost savings that the NHS achieves with generics enable it to prescribe innovative new drugs.Last year,for instance,fivemon

16、thold Arthur Morgan became the first NHS patient to receive a oneoff gene therapy medication for spinal muscular atrophy(SMA).Untreated SMA is the leading genetic cause of childhood death.The drug in question,Zolgensma,has a list price of nearly 1.8m per dose.The NHS has not disclosed how much it pa

17、id for his treatment.There is a conundrum dominating the debate about how to pay forNHS drugs:pricecutting by the suppliers of generics has been pushing manufacturers out of the UK.“This is what happens in a commodity market its supply and demand,”Hannay says.“Prices get so low that one manufacturer

18、 after another leaves the market until there is only one left.At that point,the prices of generics go through the roof.”In 2020,The Pharmaceutical Journal reported that the NHSs medications bill had increased by an estimated 76m in only two years because of drug tariff price hyperinflation.For insta

19、nce,the drug tariff price of risperidone,a widely used generic antipsychotic,had leapt by 1,736%since 2018.Extreme price volatility has become a feature of this market,notes Hannay,who adds:“We buy medicines at a spot price on the day.No other industry would do this.”But Badman is confident that the

20、 MMIC can address the problem through its work to transform how drugs are made in the UK.The efficiency improvements promised by the development of continuous manufacturing techniques“should enable British companies to produce generic medicines at a comparable cost to that incurred by Indian and Chi

21、nese exporters”,he says.If the MMIC succeeds,it should improve the NHSs security of supply,help the domestic pharma industry and boost both the local and national economy a shot in the arm with no adverse side effects.Generic re-engineering:how an R&D hub can aid the NHSFUTURE OF PHARMATEUCITCALSWit

22、h a mission to develop advanced drug production techniques,a newly built innovation centre in Glasgow offers solutions to several problems facing the service and the UK pharma industryDistributed inJohn IllmanPublished in association withAlthough this publication is funded through advertising and sp

23、onsorship,all editorial is without bias and sponsored features are clearly labelled.For an upcoming schedule,partnership inquiries or feedback,please call+44(0)20 3877 3800 or email Raconteur is a leading publisher of special-interest content and research.Its publications and articles cover a wide r

24、ange of topics,including business,finance,sustainability,healthcare,lifestyle and technology.Raconteur special reports are published exclusively in The Times and The Sunday Times as well as online at The information contained in this publication has been obtained from sources the Proprietors believe

25、 to be correct.However,no legal liability can be accepted for any errors.No part of this publication may be reproduced without the prior consent of the Publisher.Raconteur MediaKarolina Grabowska via PexelsThe Centre for Process Innovation,2021Advertise with Raconteur in The Times and reach more sen

26、ior business decision makers than any other national title.Email to learn more about our calendar of over 80 reports in The Times.If youre looking at this advert,then your prospects are too.R E S E A RC H A N D D E V E L O P M E N TNick EasenAn awardwinning writerand broadcaster who covers science,t

27、echnology,economics and business.He has produced content for Time,CNN and BBC World News.John IllmanAn awardwinning writer and former newspaper health editor.He has written numerous books including The Body Machine,with pioneering hearttransplant surgeon Christiaan Barnard.Emma PerryA lab technician

28、 by day and freelance journalist by night.With a PhD in materials science from Oxford,she has a passion for new technologies andwhat they can do for future generations.ContributorsAraconteurraconteur.storiesraconteur-media/future-pharmaceuticals-EditorSarah VizardSub-editorChristina RyderChief sub-e

29、ditorNeil ColeCommercial content editorsLaura BithellBrittany GolobReports editorIan DeeringDeputy reports editorJames SuttonDesign/production assistant Louis NassDesignHarry Lewis-IrlamColm McDermottSamuele MottaSean Wyatt-LivesleyDesign directorTim WhitlockIllustrationKellie JerrardCelina LuceyCam

30、paign managerNarinder HayerHead of productionJustyna OConnellAssociate commercial editorPhoebe BorwellCONTINUOUS MANUFACTURING COULD RESULT IN70%a reduction in facility size of50%a reduction in manufacturing costs of69%a reduction in energy consumption ofR A C O N T E U R.N E TF U T U R E O F P H A

31、R M A C E U T I C A L S0504For big pharma in particular,the drugdiscovery process is a notoriously protracted and profligate exercise.Does it really have to be this way?espite incredible advances in science,we still find it hard to bring new pharmaceutical products to market cost effectively.Its why

32、 Erooms law was coined 10 years ago.This states that the real cost of developing a new drug roughly doubles every nine years.Its so named because its the reverse of Moores law an observation that the semiconductor industry has managed to double the number of transistors it can cram on to a microchip

33、 about every two years.There has been a slight improvement in pharma productivity since 2010,but this pales in comparison with the preceding slump.And there is a chance that Erooms law could again exhaust resources and push costs back up.It retains a seemingly inexorable gravitational pull on the se

34、ctors efforts to improve its R&D efficiency.Professor Chris Molloy is CEO of the Medicines Discovery Catapult,a governmentbacked notforprofit innovation centre.He points out that“competition between firms targeting the same new biology has led to 4,400 ongoing clinical trials assessing certain antib

35、odies for cancer cells.There is neither the breadth of biology nor the market capacity to support the outputs of these trials.Erooms law was kept true by a cohort of increasingly large and complex companies competing over similar approaches to similar biological problems.There have also been decades

36、long inefficiencies in clinical trials,which still account for more than 60%of total R&D costs.”Eroom for improvementNick EasenD R U G D I S C O V E RY intellectual effort to evaluating disease models before we invest in drugs.There is a lot of mileage in techniques that tell us more about disease i

37、n people,with insights that can be translated back into tools that are used in R&D.”Scannell continues:“We are short of good decisionmaking tools,whether its animal and invitro models or human experimental medicine methods that tell us if candidate drugs will be useful or not.The financial incentive

38、s are also wrong.They push investment towards novel chemistry,which generally isnt the bottleneck.”The fact is that novel chemistry is the most investable form of pharmaceutical innovation,because it can be protected more easily by strong patents.The key to finding better drugs in the lab will requi

39、re a deeper understanding of disease biology and more effective methods of modelling the effects of diseases.This could be aided by better R&D collaboration that encompasses big pharma,biotech companies,academics,regulators,policy makers and pat ient groups.Dr Jennifer Harris,director of research at

40、 the Association of the British Pharmaceutical Industry,is a firm believer in the benefits of pooling resources and cooperating more closely on research.“This is fundamental to the discovery and early development of new medicines,”she says.“Its vital to create a dynamic ecosystem that inspires innov

41、ation through collaboration across disciplines,sectors and borders.”Big pharma can also learn from observing practices in fields with a demonstrably strong focus on efficiency the hitech sector,for instance.Recruiting people from such industries could help as well.“There is too much inefficiency in

42、the costs of drug development and there is not enough focus on lean teams,virtual companies and outsourcing,”says Chris Garabedian,CEO of Xontogeny,a biotech accelerator.“When a preclinical stage biotech company has 50plus employees,as well as 10 senior executives,inefficiency is likely.At least 80%

43、of a programmes budget should be going towards advancing R&D and no more than 20%to nonresearch activities.This is not always the case.”Molloy notes that some successful smaller players in drug discovery have defied Erooms law recently.“Their costs of capital and appetites for risk contrast with tho

44、se of big pharma,which is running only 20%of the worlds clinical trials.Risktakers such as Moderna and BioNTech,which cracked the Covid pandemic,should be fresh in our memories,”he says.Realworld research also offers considerable potential.This involves collecting data arising from the DLike many ot

45、her industries,pharma has great hopes for artificial intelligence.Indeed,the first drugs designed mainly by AI systems are already being investigated in clinical trials.In genomics,where vast swathes of genetic data are becoming available,machine learning is starting to play a significant role in ch

46、oosing drugtargets.Funding for AI technology,particularly in drug discovery,has also boomed in recent years.Machine-learning systems,for instance,are helping to map disease pathways,mine literature and analyse data.But all the hype surrounding AIs potential can be distracting,according to Jack Scann

47、ell.He argues that it“shouldnt blind us to the fact that disciplines that have fallen under the AI rubric have been useful for decades.Computational chemistry,chemo-informatics,structural biology,computational genetics long part of the mainstream in the drug and biotech industries are being branded

48、as AI.”The biggest factor limiting the effectiveness of AI in pharma isthe amount of biological datathats available to crunch.Generating better data will help to train the algorithms,but this is costly and takes time.“A lack of high-quality healthcare and biomedical research data thats accessible an

49、d mineable is limiting the potential of AI,”says Dr Martin-Immanuel Bittner,CEO of drug discovery firm Actoris.“Any drug discovery programme is a series of decisions.We can make better ones with better data.If I could change one thing about current practice,I would want it to be based on the best po

50、ssible data,generated reproducibly at scale in a physiologically meaningful way.”There are some areas in which AI is aiding significant advances.They include drug chemistry,protein structures and predictive modelling,yet these arent typically the rate-limiting steps in the R&D process.“AI systems ar

51、e well suited to recognising patterns in data.They have unprecedented capacity and scalability,”says Chris Molloy.“The skill is to feed them with interconnected,multifaceted data.British companies such as Exscientia,BenevolentAI,PhoreMost and Healx have trained their systems to analyse decades of st

52、ructured chemistry,biology and literature data to help them obtain otherwise improbable insights,which will guide their R&D decisions.”AI can certainly be an extremely powerful R&D tool,but its clear that the industry isstill learning the extent of these powers and where best toapply them.How AI can

53、 aid drug discoveryWhen a pre-clinical stage biotech company has 50-plus employees,as well as 10 senior executives,inefficiency is likelyIts vital to create a dynamic ecosystem that inspires innovationthrough collaboration acrossdisciplines,sectors and bordersDeloitte,2021THE STEADY RISE OF DRUG DEV

54、ELOPMENT COSTSAverage R&D cost among 12 global biopharma companies to develop a pharmaceutical compound from discovery to launch($bn)2010201220142016201820201.51.02.02.53.0routine delivery of healthcare services,rather than controlled experiments.Interest in this information has proliferated in rece

55、nt years.It has the potential to both enrich and expedite the R&D process.This approach was used effectively during the early stages of the Covid crisis.The rapid rollout of vaccines and other treatments would have been impossible without the aid of realworld data.Harris notes that“the ability to co

56、llate such data,analyse it and learn from it is central to our ability to develop new medicines and improve patient outcomes.Bringing health data together from different sources will be key to better understanding human biology and drug responses.”For all the productivity problems the drug discovery

57、 sector faces,its more able than it ever has been to determine what its real bottlenecks are.The next few years will see whether it can overcome these.What are the components ofsustainability in the pharmaceutical industry?In a broad sense,were looking at the environmental impact of the research,man

58、ufacturing,distribution and disposal of medicines.The industry is committed to minimising its impact on the planet.We have been involved in environmental initiatives since the early 1990s.Companies are investing in the R&D of greener products,as well as more sustainable manufacturing and distributio

59、n practices.The goal is to deliver medical innovation to patients in ways that protect the environment as well.Companies are also working on initiatives to cut carbon emissions across their own operations,as well as those of their suppliers.But sustainability isnt only about minimising greenhouse ga

60、s emissions.Initiatives to recycle,reduce waste,save water and minimise the impact on the environment from the normal use of the medicine are all vital.All companies that are members of the International Federation of Pharmaceutical Manufacturers&Associations have sustainability commitments.Many hav

61、e set theirs using the Science Based Targets initiative or other widely recognised standards.Some are further ahead than others,but every firm takes environmental action seriously.How can the sector best address such challenges?The industry needs to look at its wider footprint.Its not only about kno

62、wing the direct impact we have on the environment;its also about understanding the effects our suppliers have as they work for us and the effects our patients have as they use our medicines.We must reimagine our entire value chain.Without the ambition,commitment and investment to do that,well never

63、have an accurate picture of the footprint were reducing.The scale of the challenge means we need to collaborate with others.A good example is the Energize initiative,where 12 pharmaceutical companies are working with energy suppliers to accelerate the adoption of renewable electricity and reduce gre

64、enhouse gas emissions in the pharmaceutical value chain.We fully support the NHS pledge to reach net zero with its suppliers by 2045.Pharmaceuticals have been estimated to account for between 12.5%and 25%of its carbon emissions in England,with 5%attributed to certain asthma inhalers and anaesthetic

65、gases.Several firms are already making lowercarbon inhalers and are investing heavily in researching and trialling alternative types of gas for inhalers that make them much better for the environment.Thats the type of innovation that needs to be encouraged.What role should industry regulators be pla

66、ying here?Its important that companies can work with the authorities globally to solve the environmental challenges we face.Weve seen during the pandemic that the industry can bring real benefits to the table,working with the government,the NHS,academia and other parties.Addressing the global climat

67、e crisis will take a similar kind of collaboration,maybe on an even greater scale.Forums like the upcoming COP27 meeting will play a key role in enabling such work.One area where further collaboration would help is regulation.The pharmaceutical industry is highly regulated in areas ranging from pati

68、ent safety to environmental sustainability.If a company makes changes to a medicine or its packaging for environmental reasons,we need to see various regulators coordinate their policies so that we can generate the data they require to demonstrate that the product continues to meet the highest stand

69、ards.Only by working with regulators,governments and global health systems can we go further and faster in meeting our environmental goals.The scale of the challenge means we need to collaborateI N S I G H TPinder SahotaPresident,The Association of the British Pharmaceutical IndustryPinder Sahota,pr

70、esident of the Association of the British Pharmaceutical Industry and general manager at Novo Nordisk UK,on the sectors quest for sustainabilityDefying Erooms law requires a“multifaceted approach,not just a focus on R&D costs”,says James Barlow,professor of technology and innovation management at Im

71、perial College Business School.“We need to look at the overall drug delivery pipeline and the processes supporting this.”The growing number of cheap generic medicines coming to market not only raises the bar for new pricier drugs;it also deters investment in therapy areas where generics exist.Why sp

72、end heavily on developing an expensive super drug when lowercost alternatives are already available and doing an adequate job?Yet,if drug discovery were a more productive process,gains could be achieved.The failings of drug discovery are complex.They do not depend on one sector,group of companies or

73、 processes.Inefficiencies occur all the way along the value chain.Empowered by new data,AI technologies such as machine learning could help here(see panel,opposite page),but the availability or lack thereof of the biological data these systems require to work properly is a limiting factor.Professor

74、Jack Scannell is an industry consultant who led the team of academics that proposed Erooms law in a paper published by Nature in 2012.He argues that“the biggest challenge is that we often make the wrong decisions before clinical development starts.We need to devote much more Myriam Zilles via Unspla

75、shR A C O N T E U R.N E TF U T U R E O F P H A R M A C E U T I C A L S0706Although most revenue in the pharmaceutical industry is generated by major branded medicines and products,sales of generic drugs have continued to grow.Indeed,in some European countries,generics account for a significant share

76、 of the prescription drugs market.While there are many reasons to be thankful for the innovation in big pharma,generics have been proving invaluable in terms of both affordability and availabilityMARKET SHAREMarket share of generics in selected European countries in 2020Total cost saving achieved in

77、 the US healthcare system by using generics and biosimilars in 2020$338.4bnAssociation for Accessible Medicines,2021Projected value of the global market for generic drugs by 2025$497bnKPMG,202037%of global medicine spending is expected to be on drugs other than original brands by 2026IQVIA,2021GENER

78、IC REVENUESActual and forecast global sales of generic prescription drugs in 2012-26Evaluate,2020201220162023201420212018202520132020201720242015202220192026$70bn$76bn$78bn$81bn$82bn$74bn$74bn$74bn$82bn$85bn$89bn$92bn$96bn$99bn$67bn$100bn$90bn$80bn$70bn2010No data503060407067.6%Italy58%Poland36.8%Hu

79、ngary39%23.2%13.7%39.6%Serbia CroatiaSloveniaSwitzerland49%Austria31.6%Russia23.4%Sweden22.5%Norway22.2%Spain19.5%France23%Finland23%Germany28.8%Turkey26%Greece44%20.9%LatviaEstonia22.9%35.5%PortugalDenmark22.5%Netherlands16.6%Belgium17.2%Ireland28%UK24%Lithuania37%Bulgaria21%Romania26%19.2%Czech Re

80、publicSlovakiaEuropean Federation of Pharmaceutical Industries and Associations,2022PATENT PROTECTIONNumber of patents for drugs expiring worldwide in 2020-262020202320212024202220252026Total small-molecule drugsBlockbuster drugsKPMG,20201902192912542553183831135567OPPORTUNITIES FOR GENERICSPotentia

81、l for manufacturers to produce generics,based on percentage of patent expirations by therapeutic area in 2020-26MARKET GROWTHActual and forecast compound annual growth rate of the generics marketKPMG,2020KPMG,2020OncologyCentral nervous systemSystemic anti-infectivesGastrointestinalCardiovascularMus

82、culoskeletalOthers19.6%18.7%11%7.2%5.4%5.4%30.1%5.7%2014-195.4%2019-25R A C O N T E U R.N E TF U T U R E O F P H A R M A C E U T I C A L S0908Commercial featureCommercial featureI know how hard it is for patients.One less trip to hospital could be considered progressExtending the role of big pharma

83、in search of easier treatmentPharmaceutical companies such as Accord Healthcare have become far more than medicine manufacturers,in recognition that the effectiveness of a medicine may be determined by how it is delivered-as an injection or pill,for example.Patient advisory groups are advising on wh

84、at are known as drug delivery systemsistory has shown repeatedly that crises,such as pandem-ics and war,accelerate the pace of scientifi c progress.So it has been with Covid-19.It can take 10 years or more to develop a vaccine.It took less than a year to develop successful Covid-19 vaccines thanks t

85、o unprece-dented international cooperation.But innovations have not been restricted to new developments to restrict or treat Covid-19.The pan-demic has acted as a catalyst for excit-ing developments in remote and digi-tal care for patients who struggled or were anxious about attending clinic appoint

86、ments during lockdowns.This has extended the role of com-panies like Accord Healthcare,one of Europes fastest growing pharmaceuti-cal companies.Accounting for a third of all injectable chemotherapy for cancer in Europe,it is researching innovative drug delivery systems to maximise the effi ciency of

87、 chemotherapy and sup-porting to minimise symptons.This is a huge challenge because chemotherapy has extensive side effects,which can include extreme fatigue,nausea,hair loss and increased vulnerability to infection.The many types of drug delivery systems include capsules,tablets,injections and infu

88、-sions(injections administered over a long period,sometimes hours).Enabling patients to self-adminis-ter drugs at home became critically important during the pandemic.Self-administration can be more convenient,potentially reducing pressure on over-stretched hospital and GP practices.This is why Acco

89、rd is collaborat-ing with healthcare professionals and patient groups to try and make self-ad-ministration as easy as possible.Many cancer treatments require injections or infusions.The company,which has 500 research scientists,is looking for ways to reduce infusion time,make injec-tions easier to g

90、ive and receive and reformulate injections into tablets.This could not only help patients,but may also save the NHS time and resources reducing the need in some cases for hospital or GP visits.There are already Research prioritiesProstate cancer is among Accords current focuses,particularly because

91、it is the most common cancer among men in the UK.Moreover,more men are developing the disease as the pop-ulation gets older.Prostate cancer is another example where Accord sees its role as being far more than just a med-icine manufacturer.While recent campaigns have increased awareness of the signs

92、and symptoms of prostate cancer and encouraged more open debate,pros-tate cancer still remains a sensitive and often stigmatised topic.This,in turn,can discourage men from going to the doctor.The invasive nature of tests for prostate cancer,and fears over the impact of surgery,radiotherapy and hormo

93、nal treatment,including dis-ruption of sexual performance and libido,can be very concerning for patients.Reduced energy levels,insomnia and challenges with urinary and bowel function can also impact productivity and patients ability to engage in social activities.speciality brands at Accord,says:“I

94、know how hard it is for patients.Some patients may struggle sitting in infusion chairs for hours.I dont think that we will eliminate the need for infusion,but we can try and make some incremental gains.For example,one less trip to hospital for a patient could be considered progress.”Collaborating wi

95、th patient groups is key.Dunford notes:“These groups do astonishing work in raising awareness about cancer,alerting people to possi-ble threatening symptoms and encour-aging them to fl ag up any concerns they have to their doctors.“They are also there for patients who have just had a cancer diagnosi

96、s.People may need both psychological and practical support,and someone to lean on during what may be a very frightening,lonely time.”Newly diagnosed cancer patients can experience sadness,anxiety,anger and sometimes a sense of helplessness.And,of course,it is not only the individual patient who is a

97、ffected.Family members may also go through turbulent,emotional ups and downs.poor dexterity or needle phobia and so on.This was a big problem during the pandemic for patients who were immunocompromised or frail and were unable to visit hospitals or GPs.Infusions,administered in clinics,can be especi

98、ally challenging for patients.Joseph Dunford,vice-president,some injections patients can adminis-ter themselves.Accords collaboration with health-care professionals and patient groups has led to investments in a range of innovative options to help patients who fi nd self-administration of injections

99、 very diffi cult;for example,those with All of these things underline a great challenge for the pharmaceutical industry,academic researchers and patients and their families.Pharmaceutical innovationAccords pipeline encompasses treat-ments for prevalent tumour types,including breast cancer,in additio

100、n to haematological and cancer supportive care therapies.The company has 20 treatments scheduled for launch over the next fi ve years.It is also at the forefront of the development of so-called biosimilars.These medicines are clinically equiv-alent to biological medicines derived from living cells.T

101、here has been increasing interest in biosimilars over the last few years as biologic origina-tor medicines have come off patent.Biological medicines have provided transformative treatments for infl am-matory and autoimmune diseases and hormone defi ciencies.The use of cost-saving biosimilars has sav

102、ed the NHS hundreds of millions of pounds,while giving ever increas-ing numbers of patients access to state-of-the-art medicines.Providing value for money is an integral part of the Accord philosophy and perhaps explains why the company has become one of Europes fastest growing phar-maceutical compa

103、nies.For more information please visit accord-HAQCan you put into perspective the scale of the cancer challenge?The patient is at the centre of everything we do.We are driven by the knowledge that cancer is the second biggest cause of death in Europe 1.9 million deaths annually,plus 3.7 million new

104、cases,according to the World Health Organization.The pandemic has created an additional major problem.The charity Macmillan Cancer Support,with whom we collab-orate,has estimated that there were around 50,000 missing diagnoses across the UK meaning that com-pared to a similar timeframe in the previo

105、us 12 months,there had been 50,000 fewer cancer diagnoses.AQPatients are generally speaking far better informed these days.How signifi cant is this in terms of their physical and mental health?It is well established that empowering patients with knowledge about their condition may help to support th

106、em through the ini-tial stage of their illness.But it has to be reliable knowledge.Where do we all turn for knowledge?Often we start with a Google search.Unfortunately,the quality of information on the inter-net is very variable.This became hor-ribly clear during the pandemic,when appointments were

107、postponed and patients were afraid to attend hospital out-patient appointments.Patients need reliable informa-tion at all times you cannot get an appointment with an oncologist(cancer specialist)at 3am when you are having a sleepless night arising from worry and fear.That is why in September 2021,Ac

108、cord contributed to the launch of an oncology patient support app Unify Health.It was developed with experts from the Royal Marsden NHS Foundation Trust,Care Across(a dig-ital startup focusing on cancer),and Macmillan Cancer Support and the wider cancer community.It offers sup-port and advice to pat

109、ients to aid their physical and mental wellbeing while undergoing cancer treatment.Macmillan Cancer Support is one of Britains largest charities.It provides information about symptoms,care,wellbeing and other support to people affected by cancer;looks at the emo-tional and practical impact of cancer

110、;campaigns for better care;and runs an online cancer forum for 90,000 people.What we were looking to achieve with the app was a holistic support system for patients from the time of diagnosis.We wanted to enable them to down-load relevant information that also linked them to their local pharmacist,a

111、nother critical source of support.We know there is more work to do,but again,it is worth stressing that we realised during the pandemic that our support doesnt have to stop at chemotherapy medicines.We can support patients through their jour-ney using tools that are accessible 24/7 and that are tail

112、ored to their needs and preferences.AQCan you say more about pharmacists?There is a view that their skills and expertise are often under-appreciated.Absolutely.A report published by the independent think-tank The Kings Fund in March con-cluded that pharmacists working in primary care networks in Eng

113、land were under-appreciated by GPs and often given tasks below their compe-tency level.Again,working in collaboration with the Royal Marsden NHS Foundation Trust,we have developed a separate app for pharmacists.Oncodemia pro-vides a practical,bite-size training cur-riculum for community pharmacists

114、who wish to help champion cancer care in the community.It provides advice on how to talk to and assist cancer patients,particularly around managing symptoms and worries.We felt that pharmacists,just like patients,needed supporting during the recent lockdowns.They were one of a number of vital indust

115、ries,including supermarkets,who just had to keep going.They were already under-resourced and overstretched and even more in demand as health-care needs soared.Our support doesnt have to stop at chemotherapyQ&AJoseph Dunford,vice-president,speciality brands at Accord Healthcare highlights the company

116、s commitment to patients and the critical lessons of Covid-19THE IMPACT OF COVID ON CANCER CARE50,0001millionThe estimated number of missing cancer diagnoses in the UKcancer patients across Europe could have been undiagnosedMacmillan Cancer Support,2020European Cancer Organisation,2022UKEuropeAccord

117、 Healthcare Provides a fi fth of the UKs generic prescriptions(medicines out of patent)Accounts for a third of all injectable cancer chemotherapy in Europe Distributes nearly 1,000medicines in the UK Supplies approximately 20 million packets of medicine a month in the UK Manufactures and distributes

118、 medicines in 85 countries Has 2,000 employees,including 500 research scientistsLaunched only 14 years ago,Accord is a privately-owned company which is developing a major research and development centre in Harrow,north London,due to open in 2023.Cancer will be one of its major focus areas.The compan

119、ys portfolio spans oncology,cardiology,neurology,psychiatry,diabetes,pain management and gastroenterology.We know that there is more work to do,but again,it is worth stressing:we realised during the pandemic that our support doesnt have to just stop at chemotherapy medicinesmen in Europe will develo

120、p prostate cancer before the age of 851 in 7European Association of Urology,2020This article has been paid for by Accord Healthcare50%of cancer services globally were disrupted because of the pandemicGloballyUnited Nations,2021R A C O N T E U R.N E TF U T U R E O F P H A R M A C E U T I C A L S1110T

121、HREE-DIMENSIONAL EXPANSION FROM 2020 TO 2026Forecast growth of global market for 3D printing products and servicesmagine a future in which one of the crunchy little loops in your bowl of breakfast cereal is your medication,produced by the local pharmacy using a 3D printer and tailored to your taste,

122、your dosage needs and even your genetic makeup.UKbased research indicates that 90%of drugs work on only 30%to 50%of the population and that adverse reactions account for 7%of hospital admissions.Personalised medicines could increase the efficiency of treatments and reduce the incidence of serious si

123、de effects.Their potential is clear to Deepak Kalaskar,professor of bioengineering at University College London and honorary researcher at the Royal National Orthopaedic Hospital NHS Trust.“If we can reduce theside effects of a dosage,this will improve the patient experience significantly,”he says.M

124、anufacturing such bespoke drugs tends to require numerous ingredients and production processes,which is where 3D printing comes into its own.With the ability to handle a range of materials,it enables layerbylayer fabrication and can produce small batches relatively economically on demand.The technol

125、ogy should give healthcare professionals and patients a wider range of treatments to choose from.It could improve drug performance and the patient experience in other ways too.For example,it may be possible to add“further functionalities to final dosage forms”,according to Dr Thomas Kipping,head of

126、drug carriers at Merck Group.He adds:“By embedding a drug substance in an amphiphilic polymer,you can obtain solubility enhancement and supersaturation effects,which can improve your bodys uptake of that drug.This can drastically lower the doses needed and so avert unwanted side effects.”The printin

127、g process also enables a single tablet to deliver regulated doses of a drug over time,as inert has already completed a consultation exercise on such matters.It is looking to“extend the current regulatory framework to enable the manufacture of medicinal products at point of care,including with newer

128、manufacturing methods such as 3D printing”.Only one 3Dprinted medicine has been approved and commercialised to date:epilepsy treatment Spiritam(levetiracetam).Nonetheless,this pioneering product has“demonstrated that the pathway is there for 3Dprinted drugs”,according to OConnor.Kipping believes tha

129、t focusing initially on more straightforward treatments would be a good way to ensure safety and quality.“I imagine that we could roll out simpler formulations in the short to medium term,with automated feedback loops that dont require such dedicated controlling,”he says,but adds that,in the longer

130、term,“patient safety has to be really assured”before the sector goes much further down this path.potentially,rules from industry regulators on standards of quality and safety.In the US,the Food and Drug Administration(FDA)has completed its analysis of the regulatory challenges created by pointofcare

131、 manufacturing.Dr Thomas OConnor,deputy director of the FDAs office of testing and research,says:“We hope to be able to share our thoughts in a paper later this year to solicit feedback from multiple stakeholders.”The UK Medicines and Healthcare Products Regulatory Authority layers can be alternated

132、 with those containing the active ingredients.A report published by BlueWeave Consulting in September has highlighted a rapid expansion in the amount of R&D activity focused on 3Dprinted drugs.The firm expects this market to grow from$347m(326m)in 2021 to$966m in 2028.Drug development is another fie

133、ld that could benefit from advancements in 3D printing,especially when it comes to cost control.As Kipping points out:“Some drug substances might be a few thousand euros per milligram.”The technology enables both smaller and more complex formulations,he says,“and you may even cut formulation times b

134、y half if systems can be optimised”.The facility to print on demand could even help to make pharmaceutical supply chains more sustainable.Traditional production methods can produce a lot of waste,notes Adedamola Olayanju,principal scientist at Manchester Biogel.“What 3D printing can do is reduce thi

135、s by avoiding excess production.By printing on demand instead of producing to forecast,we may no longer have unused drugs being left to expire,”he says.The biggest challenge is to ensure the quality and safety of printed medicines.For example,printing systems would need to be cleaned thoroughly betw

136、een production runs to ensure that there is no crosscontamination.The pharmaceutical sector could learn from industries such as car manufacturing,where feedback loops using advanced imaging systems are being applied to provide a layerbylayer analysis during print runs.“We could adopt many of these s

137、ystems to provide safety,”Kipping says.“But discussions will be needed with regulatory bodies and machine designers to come up with good solutions.”Pharmas adoption of 3D printing will necessitate new guidance and,zoranm via iStockHubs,Industry Today,2021Emma PerrySome day,your prints will comeSince

138、 the first 3D-printed medicine was approved in 2015,no other drug made using this method has entered the market.But the situation could soon be about to change in a big wayB E S P O K E D R U G SICommercial featureSupplement absorption levels boosted by unique technologyA technique pioneered to help

139、 target cancer therapy has been developed to maximise the positive impact of minerals,vitamins and plant extracts on healthhe nutritional-supplements market is one of the fastest growing sectors in the world economy with the public searching for ways to boost their immune system and optimise lifesty

140、les.The huge interest in good health,generated by the Covid pandemic,has remained.The supplement market,currently valued at$358.8bn,is expected to grow by an annual rate of 6.3%every year to 2030.The sprint for supplements has been boosted by revolutionary technol-ogy that ensures the active ingredi

141、-ents from minerals,vitamins and plant extracts,reach their targets and fulfi l their potential.Traditional ingredients formulated as pills,powders and gummies have varying degrees of success with the bodys natural defence mechanisms and digestive systems neutralising them to the point that,in some

142、cases,less than 1%reaches the bloodstream.Liposomal delivery,which was pio-neered for targeted cancer treatments,encapsulates the active ingredient in a water-based solution to supercharge its potential to be absorbed by the body known as bioavailability and have a positive impact on health.“Liposom

143、al delivery is a game changer when it comes to distribut-ing all kinds of active ingredients.Our uniqueness is that we have adapted the technology so it can be applied to mass-market products,”says Jan Braband,founder and chief executive offi cer of PlantaCorp,which is a global leader in contract li

144、posomal supple-ment production.“Liposomes are incredibly effi cient at transporting the ingredient and getting it into the bloodstream so that it can do what it is supposed to.It allows them to get to work.We have levels of 90%bio-availability,which contrasts sharply to other delivery processes that

145、 are at 1%and less.Effective delivery“The issue with those processes is that the vast majority of the product does not get absorbed and is secreted out by the body,having had minimal effect.Basically,what you pop into your body travels through it and out with waste products with almost no impact.”St

146、udies have shown that iron sup-plements delivered with PlantaCorps patent-pending system achieved 398-times greater bioavailability than a non-liposomal method while curcumin was 47-times more effective than com-parative products.The ability of liposomal systems to deliver active ingredients to spec

147、ifi c targets in the body has been long estab-lished but their manufacture is com-plex and expensive.Germany-based PlantaCorps sector R&D expertise enabled it to engineer a cost-effec-tive version for the mass market which is proving a perfect vehicle to deliver the required concentrations of active

148、 ingredients across nutritional products.The companys innovative encapsu-lation technology works by combin-ing the active ingredient with oil-free phospholipids and water and the solu-tion is then subjected to high-energy ultrasonic waves and high gravitational forces.The process can be adapted to m

149、aximise the potential of a range of ingredients and targets within the body.“It allows the product to work and we have seen clients growing their busi-ness alongside ours because of its suc-cess,”adds Braband,whose company serves operations in 28 countries and has expanded to a new hi-tech manu-fact

150、uring facility in Hamburg.“It is very rewarding to see customers enjoying success.Bioavailability is a huge chal-lenge but liposomal formulations are the answer.”The liposomal drug delivery market is booming and has a projected market value of$40bn in 2024 and PlantaCorp,which started in 2015 and al

151、so operates in the UK,is enjoying huge success with production volume growth estimated at 34.5%for 2021 to 2022 with a 27.8%increase in client base.Rising demand for supplementsDemand for dietary supplements increased massively during the pan-demic and interest in their ability to boost immune syste

152、ms is still strong.A report showed that supplement use jumped from 29.5%to 71.9%in Asia,from 40.6%to 75.7%in America and went from 30.8%to 68.7%in Europe.Research conducted by PlantaCorp revealed a trend of strong sales of vitamins and minerals to strengthen immune system with sales of pure vita-min

153、 C leaping by 94%,Zinc supple-ments up by 42%and vitamins A and D sales increased by 35%in the fi rst quarter of 2020.High demand levels have remained as the public continues to seek to improve general health and boost their immune systems.PlantaCorp has welded its success to a strong ethos of susta

154、inability with its liposomal formulations made from water and GMO-free sunfl ower phos-pholipids and sea buckthorn extract is being used instead of chemical pre-servatives.Glass bottles are the pre-ferred packaging option and its pro-duction processes are powered by regionally produced wind energy.“

155、It is very good to know that our product works and is successful for our clients but I also want to be able to look myself in the mirror and know it is a good product,”adds Braband.“We try not to use chemical pre-servatives and we are constantly updating our processes to enhance our naturalness.“Lip

156、osomal systems have made such a difference to delivering ingredients successfully.The difference between achieving 1%to 10%bioavailability up to 90%is a complete game changer.“There is so much more that can be achieved and I think we have opened up a door to a new world of possibilities for ingredie

157、nts and for better health.”1.Grand View Research,Nutritional supplements market size report,20222.Oxford Academic,Current developments in nutrition,2021For more information please visit TUnlocking the potential of active ingredientsLiposomal technology is making huge advances in boosting the bioavai

158、lability from plant extracts which traditionally struggle to get absorbed by the body.Botanicals,which are preparations made from plants,algae,fungi or lichens,can provide nutritional benefi ts but they need a carrier to get them into the bloodstream to be effective.Liposomal delivery allows extract

159、s such as curcumin and quercetin,which have antioxidant,anti-infl ammatory and immunoprotective properties,to reach their supplementation potential.The systems success is signifi cant as the World Health Organisation(WHO)estimates that 80%of countries use medicinal plants as part of their healthcare

160、.1“We are constantly looking at ways to improve our technology so that we can bring more benefi t from supplements and plant extracts,”adds PlantaCorp founder Jan Braband.“Millions and millions of people around the world want to protect and enhance their health and immune systems and our mission is

161、to help them by refi ning liposomal delivery technology to get the best from the products they take.“We are committed to R&D and we believe that we will be able to deliver more and new products over the next decade.”1.WHO Global Centre for Traditional Medicine,2022BIOAVAILABILITY STUDY-IRON SUPPLEME

162、NTSerum ferritin levels(blood protein containing iron)after single dose of liposomal vs.non-liposomal iron supplements measured over 12 hoursPlantaCorp,2021406080100Liposomal iron,15mgNon-liposomal iron,15mgTime(hours)24681012Serum ferritin level(ng/mL)Non-liposomal iron,40mg12020By printing on dema

163、nd instead of producing to forecast,we may no longer have unused drugs being left to expire$12.6bn12.6bn$17.4bn$24.9bn$37.2bn2020202220242026As the technology matures,it may even be possible to print medicines personalised to each consumers genome.To ensure that these work,researchers are bioprintin

164、g human tissue on which to test them.The way it reacts to a drug in the laboratory should indicate how it will react in the body.“This is a huge step forward,particularly in areas such as osteoporosis,where our best understanding of the condition used to bebased on the results of tests on mice,”Kala

165、skar says.If the 3D printing of drugs is to be rolled out on a large scale,there are several practical considerations left to address.Not all printers can handle the same materials and manufacture products in the same volumes,for instance,while it would be unviable for a hospital to be operating hun

166、dreds of different printers.The technology is clearly still far from mature,yet it is“moving from concept to industrial stage”,Kipping says.“And it is exciting to be part of this evolution.”in GDP added to the UK economyfrom increased investment in cutting-edge R&D.6 8Over the next 30 yearswe could seeRead the latest report on the potential for life sciences to create health and wealth for the UK.bn