The Future of Clinical Trials in Wales

Nursing: A Critical Role in R&D

IP at the Hub of Welsh NHS

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Time for Review

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The intention is thatany patient in Waleswho has an illness thatis being addressed by aclinical trial, can beentered into that trial.

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ContentsFE AT U R E S

The Future of Clinical Trials inWales The wider implications ofthe new Wales Clinical TrialsNetwork for stakeholders in themedical sector 4

IP at the Hub of Welsh NHSMediWales talks to the providersand potential users of the newNHS IP service in Wales 10

Nursing: A Critical Role in R&DThe changing role of nurses feedsvital information into the productdevelopment process 14

PR O D U CT RE V I E W

Online tools promote men’s health 16

Handheld acne treatment getsinternational deal 17

Speedy benefits fromfluorescence-based assays 17

RE S E A R C H RE V I E W

Microneedles take away the pain 19

Cover image reproduced by kindpermission of Biostatus Ltd.

www.biostatus.com

At the recent inaugural AGM ofMediWales Ltd, it was suggestedthat our newsletter could evolve toprovide a broader and more issue-based examination of activities inthe Welsh medical sector. We’vedeveloped our approachaccordingly, as you’ll see from thenew format and content of what isnow the first edition of TheMediWales Review.

An essential part of our work atMediWales is to track theevolution of the sector’sdevelopment. Our features inthis edition look at three keycomponents of the R&D infrastructure emerging fromthe NHS, with a significant potential impact on the industry in Wales: the newWales Clinical Trials Network; the recently established Welsh NHS IP hub;and the impact on R&D of nursing professionals.

We’ve talked to a range of people in pivotal roles, including leadingacademics, NHS professionals, industrialists and service providers, toexplore these new developments from a number of different perspectives.All three features deal with issues that need the input of people at the sharpend, so they are intended to stimulate debate and we are keen to hear youropinions.

The Review will be built around original features on specific issues ofconcern to our membership. We’ll also continue to include in-depth casestudies, as well as running regular digests of material in the medical andscientific press about products, research, and sector activities. We areparticularly keen to receive contributions from our member companies,including ideas for topics you would like to see covered, press releases, andhigh quality photography.

Meanwhile we’d like to remind members that Gwyn Tudor, our ForumManager, is currently elected Chairman of Medilink UK until July 31st. Thisrole increases opportunities for MediWales members to extend their networkactivity beyond Wales, and to make the most of links with academic,industrial and clinical groups throughout the UK.

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Any population that has theopportunity to take part inclinical trials gains a number

of important potential advantages.First and foremost, clinical trials offeraccess to the clinical benefits of newdrugs, devices or therapeuticinterventions. At the same time, theycan generate sorely needed revenuefor a cash-strapped NHS. It is alsosuggested that patients experience abeneficial effect from participation intrials (irrespective of the treatment)due to the close clinical scrutiny thatthey receive.

The delivery of clinical trials ishowever an increasingly competitiveglobal marketplace. If we are tooffer these advantages to the Welshpopulation, then Wales has torespond to the diverse needs of arange of interested parties whichmake up the ‘stakeholder’ profile. Inthis feature MediWales speaks tothree such stakeholders, whosedifferent roles inform theirperspective on this important andcomplex issue: Professor JohnWilliams, Director of the NHS WalesOffice of Research and Development

(WORD); Richard Greville, Director ofthe Association of the BritishPharmaceutical Industry (ABPI)Cymru Wales; and Marc Weinzweig,MD of specialist drug distributioncompany Biotec Distribution Wales.

Wales Clinical Trials NetworkWORD has been working to developthe new Wales Clinical TrialsNetwork. The aim of thiscomprehensive and ambitiousproject is no less than, in the wordsof Professor Williams, ‘to ensurethat any patient in Wales who has anillness or problem that is beingaddressed by a clinical trial, can beentered into that trial.’

The professor went on to describefor us the principal components inthe project’s infrastructure. At itscore is a co-ordinating centre with avery small management unit, whichwill run a network of professionals inhealth care organisations who willsupport large-scale studies. It willalso set up and co-ordinate a patientand carer network to contributeadvice and views on R&D across thewhole spectrum of activity.

Professor Tim Maughan (Director ofthe Wales Cancer Trials Network)has been appointed as Director forthe Cardiff-based centre. ‘This workis going to be building on whatthey’ve done for cancer,’ theProfessor explained. ‘It’s not goingto compromise the Cancer TrialsNetwork, but I wouldn’t be at allsurprised if in 10 years time we havea generic support network ofprofessionals who are supportingboth cancer and non-cancerstudies.’Two clinical trials units will offer themethodological and data

management expertise to supportthe work, particularly of internallygenerated trials. The expertise willalso constitute a ‘bank’ that can beavailable for collaboration withindustry where that is applicable.

A route for trials from inside andoutside the Network

Thematic networks constituteanother major component in theinfrastructure. These areprofessional/academiccollaborations that bring together afull range of expert personnel, fromthroughout Wales and across sectorboundaries, within each of ninethematic areas: mental health;learning disabilities; neuro-degenerative disorders; diabetes;emergency care; epilepsy; publichealth; care of the elderly; and careof children.

Research arising out of one ofthose networks wouldbe worked up into aprotocol, with access tothe clinical trials unit forany specific expertiseneeded. Funding, depending onthe proposal, might begained from the MRC,from Wellcome orfrom industry.Thestudyitself

wouldthen gothrough the co-ordinating centre touse the all-Wales infrastructure.

‘But this is also a route for studies totravel from the outside into thenetwork,’ said Professor Williams. ‘Itmay be that if a company wanted totrial a new drug for epilepsy, forexample, it would come through thethematic network. If on the otherhand there wasn’t a correspondingacademic alliance that it wanted toengage with, it might just go straightto the co-ordinating centre, whichwould take the process forward if itwas appropriate. So it is a gate thatcan open either way.’

The thematic networks, the co-ordinating centre and the clinicaltrials units will be further supportedby a new information unit, set up toprovide data derived from routinelycollected hospital episode statistics.For any particular study beinggenerated, this will help give anindication of the feasibility of theproposed sample size across Wales,and of the likely speed ofrecruitment.

As part of the infrastructuredevelopment, WORD is alsoencouraging R&D offices in all theTrusts across Wales to worktogether to develop a uniformapproach to research governanceapproval. ‘What we’re lookingfor,’ ProfessorWilliams

explained, ‘is asituation where if a study comes in

it doesn’t have to approach eachorganisation separately and beslowed down to the speed of theslowest, but can get a singleapproval that will be applicableacross the whole of Wales. So weare putting funding in to enable theTrusts to achieve a commonapproach.’

‘We’re not doing this to createrevenue from industry, but to work

in partnership with industry’From the point of view of industry,the Clinical Trials Network offerssignificant potential benefits. Theinitiative could essentially function as

a single portal for companiesseeking to run clinical trials, throughaccessing the co-ordination centrewhich then could, in its turn, findappropriate sites through itsnetworks. ‘We want to make it suchthat the whole of Wales is effectivelythe trial site, with an all-Walesnetwork of research support staffand interested clinicians,’ said theProfessor. ‘We’re not doing this togenerate revenue from industry,we’re doing this to work inpartnership with industry. Certainlywe want to nurture Wales’sindigenous industries, and we alsowant industries outside Wales to seeus as a significant and efficientcontributor. So that in terms of ‘big

pharma’for example,

we would hopethat Wales in due

course would becomeattractive to them as a source for

clinical trials sites.’For the pharmaceutical industry inBritain, the ABPI is the pre-eminenttrade association, with its memberssupplying more than 80% of themedicines prescribed through theNHS in both England and Wales. Weasked its Director, Dr. RichardGreville, how he saw Wales’s positionwithin the UK in relation to theclinical trials work of the globalpharmaceutical companies, and thepossible impact of the WORDinitiative.Richard set the context by pointingout that while the UK constitutes 3%of the pharma market globally, itattracts 10% of global R&Dinvestment. In terms of thatinvestment therefore, the UK plays aP

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disproportionately large role. But theposition of Wales is somewhatdifferent from that of the UK as awhole.

‘The UK academic knowledge baseand support services are critical’

According to the ABPI’s figures onpre-clinical R&D, Wales attracts onlyabout 2% of the industry’sinvestment. Why is it that Wales hashistorically missed out on thatinvestment? In Richard’s view amajor factor is the same one that,conversely, contributes to the UK’s10% investment: the knowledge base.

‘The academic knowledge base andthe support services that havedeveloped in the UK are absolutelycritical,’ Richard said. ‘But Walesitself doesn’t have that historicaltrack record of conducting clinicaltrials. And that would probablyexplain whyLondon/Cambridge/Oxford havedeveloped into the “golden triangle”.They continue to develop and attractthe vast majority of the R&D in termsof clinical trials in the UK - evenwhen the patient base doesn’tnecessarily allow the bestrecruitment and doesn’t allow allclinical trials to be carried out there. Against that factor you have toconsider that the cost of clinical trialsin the UK is increasing rapidly, and

that means competition withcountries such as Eastern Europe,Singapore and India. So it isimportant for the industry to reducedelays in trials. Globally, 80% ofclinical trials are not completed ontime, and it’s estimated that runninga clinical trial costs about $40,000 aday.’

Feeding into good study practice

Here the push for ‘good studypractice’ in the UK is of paramountimportance. This describes anapproach where the genericprocesses involved in developing aclinical trial are made as smooth-running and efficient as possible, asRichard described: ‘If industry islooking for a clinical trial involving500 patients, a critical question is -how quickly can they be recruited intothe trial, and progressed safelythrough the trial?’

Tied in with effective recruitment isprotocol design and excellent clinicaldata management. Every clinicaltrial is highly regulated and is definedwithin strict protocols. With the UK’shistorical experience and skill base,it’s possible for protocols to bedeveloped between clinicians and theindustry which avoid some of thepotential pitfalls. As Richard pointedout, it’s extremely useful for industryto be able to use a clinician’s

knowledge and experience indeveloping the design of these trialprotocols, in the context of good studypractice.

‘That’s what’s behind some of theinitiatives being carried out at UKlevel at the moment – the UK ClinicalResearch Collaborative and the UKClinical Research Network,’ hecontinued. ‘The infrastructure forclinical trials that WORD is buildingwill feed into those groups, and thisrepresents a real opportunity forWales to ensure that we do have astructure to support good studypractice. I think it’s a significant step

forward for WORD to have establishedan overall strategic research andtrials organisation in Wales, and thisis increasingly being recognised byABPI members.’

Building on indigenous knowledge,skills and infrastructure

It remains to be seen whether thedistance between industrial andmedical perspectives can be bridged.If it could, that would certainly beanother step forward in rallying theresources of the Welsh health caresystem to an economical, ethicalapproach for delivering essential drugdevelopment. The portal functionwithin the Wales Clinical TrialsNetwork is already a factorencouraging that move forward.

The Network also represents aninvaluable opportunity to supportWales’s delivery across the fullspectrum of stakeholders in the drugdevelopment process, from patients,

clinicians, nursing professionals andregulatory bodies, to sponsors,contract research organisations,contract manufacturingorganisations, and drug distributioncompanies – all of which exist asindigenous units in the Welsheconomy. Many Welsh SMEs pursuea highly effective niche strategy inthis demanding global market, bothin the services they provide and therelationships they develop with theircustomers.

Marix Drug Development, whosesuccessful exploitation of their nichemarket we described in a recent casestudy (see MediWales Autumn 05) isa classic example of this approach.Another is Biotec Distribution, aBridgend-based SME which suppliesits drug distribution services tocompanies worldwide, ranging fromsmall Welsh operations to the largestglobal groups such as Johnson &Johnson.

The company specialises in theimportation, labelling and distribution

of materials for temperature-controlled clinical trials. MarcWeinzweig, Biotec’s ManagingDirector, described how this focushas helped consolidate their positionin such an intensely competitiveworld market. ‘We have a facility thathas Good Manufacturing Practice(GMP) status here for the control oftemperature,’ he explained. ‘GMPrelates to the 2004 EU directive andthat’s driven tremendous growth inthe business.’

Under that Directive, a companymust employ at least one QualifiedPerson (QP) in order to be licensed to

import materials for clinical trials. Inturn, it’s the QP who must verify thata given manufacturing site is workingto EU standards. Biotec are licensedto undertake this process by theMHRA, and last year audited 10different companies throughout theworld for compliance with EuropeanGMP.

‘We’ve got three QPs here and afourth being trained,’ said Marc, ‘sothat’s a very high percentage in acompany of 10 people. It’s a verysignificant factor in our success, andunless there’s a great drive fromother areas of the world to get QPstatus, it’s going to remain that way.’

‘These are developmental groups -it’s all about relationship building’

The audit requests come from thecompanies themselves, and thisrelates to another significant factor inthe growth of Biotec’s business. Inspite of the fact that thepharmaceutical sector is dominatedby global companies, the companyhas developed a close network ofrelationships with individuals and

small groups within the sector thatexerts a powerful influence.

‘Even if you’re working with amassive company,’ said Marc, ‘you’reworking with a small group insidethat company. These aredevelopmental groups, research-typepeople, involved with drugdevelopment and sometimesmanufacture. And the majority ofthem, irrespective of whether they’reworking for a virtual company or aglobal corporation, work in smallunits. At J&J for example we dealwith 6-8 people. When we analysed how we get our

contracts with these very largecompanies, we realised that our skillin working with people with thisparticular profile is very important.We can work out what they need andsupport them in a way that they like.We know their problems because ofour experience in clinical trialshandling - I’ve been working withbiologicals and in-vitro diagnosticssince the early 80s. So it’s all aboutrelationship-building.’

In terms of effective servicing ofclinical trials these kinds of nicheskills can leverage the value theycontribute to the process. They arepart of a complex landscape typical ofthe health care sector, not only inWales but across the globe. In otherregions understanding thiscomplexity and harnessing it isincreasingly becoming a priority.Wales’s size and its existing medicalnetworks can help to boost futuredevelopment. It is a situation offeringmuch promise: for this to betranslated into a competitiveadvantage, leading Welshstakeholders from across the clinicaltrials spectrum will need to give aclear priority to working closelytogether.

Professor John WilliamsDirector, Wales Office of Research & Development4th Floor, Welsh AssemblyGovernmentCardiff CF10 3NQTel: 029 2082 5252Fax: 029 2082 3997Email: word@wales.gsi.gov.ukWeb: www.word.wales.gov.uk

Dr Richard GrevilleDirector ABPI Cymru WalesCaspian Point 2Cardiff CF10 4DQTel: 029 2045 4297Fax: 029 2045 4298

Biotec Distribution Wales LtdUnit 17, St Theodore’s WayBrynmenyn Industrial EstateBridend CF32 9TZTel: 01656 722256Fax: 01656 720003Email: marc@biotec-uk.comWeb: www.biotec-uk.com

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Professor John Williams

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Last August saw the long-awaited establishment of adedicated facility for the

exploitation of NHS IP in Wales.Across the UK, IP hubs were startingto be introduced as far back as 1999through the NHS Innovationsinitiative. Largely funded through theDTI’s Public Sector ResearchExploitation (PSRE) fund, the remit ofthe innovation hubs is to provideservices helping NHS organisationsto identify, protect andexploit NHS intellectualproperty.

There are now nineregional NHS IP hubs inEngland, and one inScotland. Wales did not receivePSRE funding on twoprevious occasions, sowe are coming late to thegame. The WelshAssembly Governmenthas now been ablethrough WORD to providesome funding for its ownIP exploitationprogramme in the WelshNHS. In August, Angleplc were formally contracted tooperate Welsh Innovations in HealthCare (WIsH).

Operating throughout the UK, Angleplc won the contract in partnershipwith TrusTECH, who run the NHS IPhub for the North West of Englandand will bring their experience ofNHS operations and culture to WIsH.The in situ part of the WIsHoperation has been set up atAberystwyth under InnovationsManager Dr. Nic Shilton. who will berunning a small team. Specialisedsupport from the Angle andTrusTECH consulting teams is fedinto the local team, as and whenneeded by their projects.

For Wish’s project director, ShaneBooth, active identification of IPpossibilities is the priority at thisstage. So the focus is on visits out inthe field, supplemented by trainingand awareness-raising events toraise the service’s profile. ‘Anotherapproach’, said Shane, ‘is a surgery,where say at a particular hospitalwe’ll be available through a morningto discuss ideas and queries as adrop-in service. From our

experience with technologyincubators we know that the surgeryapproach is a good way to encouragepeople to come and ask forassistance.’

WIsH have standard audit proceduresfor both service and technologyinnovation projects. ‘We will sitdown with the people involved,’explained Nic, ‘and audit the idea,and then we would do a backgroundsearch and give them that feedback.If the results are positive, then wecarry on. If we find it’s already beingdone or just doesn’t have legs, wewouldn’t continue – but we wouldmake sure people know why it is orisn’t being taken forward.’

Potential for service innovation

Part of the WIsH remit is to identify,secure and roll out serviceinnovation, finding opportunities forpractical improvements related bothto patient care, and to operationalmanagement and efficiency. ‘There’sa cultural expectation that innovationis solely about IP exploitation, but Ithink that’s misguided,’ said Shane.‘What they’ve found in North West

England is that there are farmore opportunities –something like a ratio of 4:1 –in service innovation.’

One such project involvedTrusTECH in the publication ofa speech therapy pack forchildren with speakingdifficulties. The tools andtechniques had beendeveloped by a speechtherapist for her Trust, andwhile rising referrals indicatedher success, they alsoindicated that such problemsneeded to be more skilfullytackled at an earlier stage inschools. In consultation withTrusTECH, the therapistworked to develop her

materials specifically for use inschools.

TrusTECH found a medical publisher,and established copyright as lyingwith the NHS Trust as the therapist’semployer. The License agreementwas then set up return a royalty tothe Trust for every copy of the packsold. ‘TrusTECH’s skill in this,’ saidShane, ‘was in dealing with the issueof the most effective way todisseminate this pack, and to returna proper reward to the NHS Trust,while improving the delivery of care.’

From a MediWales point of view, theintroduction of the Welsh hub is astep towards supporting the routes

for effective technology transferwhich benefit both Welsh NHSpatients and Welsh companies in themedical sector. Professor Williams,WORD Director, gave us hisperspective on the role of industry inthis new initiative.

‘WIsH is there to capitalise onintellectual property in the NHS,’ hesaid. ‘Some of that will betranslated into commercialdevelopments through spin-outcompanies, but not all: some willneed to go through existingcompanies. The remit is partly toprotect IP so that the NHS getssome return for its innovation, butalso to facilitate the realisation ofdevelopments based on that. Andsome of that will be through theestablished private sector. So wesee this very much as being inpartnership with industry.’

Call for dialogue between industryand NHS

Greg Baily, MediWales Chairman,sees the early involvement ofindustry in the process as key to thesuccess of the WIsH project. ‘WhenI speak to some people,’ he said,‘there is this tendency to thinkthat the be-all and end-all ishaving the idea. But that isreally just the beginning -you’re only taking the firststep down the path. There’san awful lot to come with allthe regulatory hurdles, theroute to market, thecomplexities, and in themedical sectorparticularly that path isquite a tortuous one’.

In Greg’s view, theproper evaluation of NHS IP –assessing it technically, clinically,and in terms of its market – callsfor a consistent dialogue betweenindustry and the NHS. Early-stagepartnership and evaluation canincrease the likelihood of asuccessful product for both patientsand commerce, and also reduce itstime to market. ‘Neither cliniciansnor manufacturers have the luxury oftime or money to develop an in-depth understanding of each other’sexpertise,’ he pointed out. So that’spart of what an IP hub needs tooffer.’

Aside from the exploitation of IP fromwithin the NHS, Greg also seessignificant opportunities insupporting the movement ofinnovation from outside, into theNHS. ‘A good example of that,’ hesaid, ‘is the Lean manufacturingprocess at OCD that’s being appliedto the laboratory at the RoyalGlamorgan Hospital [see MediWalesAutumn 05]. There you have apractice adopted in a company inWales, being applied in a Welsh NHSTrust, and ultimately enabling themto become much more efficient inthat particular area - meaning notjust cost savings but better service.

Greg sees other potentialopportunities such as partneringbetween NHS and industry andacademia, and management of IPgenerated out of that. ‘But I alsorecognise that the WIsH project haslimited resources compared to theEnglish IP hubs forexample‘. he

said ’Some of those have a very widerange of activities, he continued, but Ithink WIsH is going to need to focusmore tightly. And they’re going toneed to work with people like us inindustry who are focused oninnovation.’

Guiding products to market

Although WIsH is a small unit,MediWales has consistently lobbiedfor a Welsh IP Hub. We welcome itsarrival and want to see it succeed.To do so we see it as essential for astrong industrial relationship to bebuilt into the project. Regardless ofhow clinically useful a new productor process may be, unless it isfinancially and technically feasible itwill not be able to meet theaspirations of its inventor or deliverthe desired improvements forpatients. Through our work acrossthe Welsh medical sector, MediWalescan help to deliver the industrialparticipants able to evaluate and

guide projects to market andmass production.

IP at the hub of Welsh NHS

Dr Nic Shilton, Innovations ManagerWelsh Innovations in Health Care (WIsH)Technium AberystwythAberystwyth SY23 1ASMobile: 07917 649278Tel: 01970 613425Fax: 01970 613 244Email:n.shilton@wishnhswales.org.ukWeb: www.wishnhswales.org.uk 11

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Over the past yearMediWales has been closelyinvolved with a substantial

study into the significance of theR&D role in the nursing professions.Professor Joyce Kenkre, aMediWales Board member from theUniversity of Glamorgan School ofCare Sciences, has been working onsecondment to the office of the ChiefNurse at the Welsh AssemblyGovernment to develop a researchstrategy for nurses, health visitorsand midwives in Wales.

A report produced by ProfessorKenkre in collaboration withclinicians, academics and industry,details some of the most importantissues to be addressed.Modernisation of the NHS hasintensified the need for nursingprofessionals to keep pace with thespeed and range of changes withinit, whether in the form of advances intechnology, innovative developmentsin clinical practice, or new structuralapproaches to the delivery ofservices to patients.

These pressures have placed apremium on making best use of theR&D component in the roles ofnursing professionals. The reportillustrates ways in which attention toR&D in these disciplines can supportthe NHS, through generating anevidence base and sharing bestpractice, so that improvements topatient care could be incorporatedspeedily and consistently.

The role of Sue Bale, AssociateNursing Director R&D at GwentHealthcare Trust, places her at thecentre of many of these changes.‘The nursing profession is maturing,’Sue pointed out, ‘so you expectdiversity and specialisation. But thenew ‘design for life’ model of care,and the modernisation of roles in the

health service generally, have openedup a lot of opportunities for workingacross professional boundaries.’ The core role of Registered Nursehas therefore developed in its rangeand level of activity, and there arenew nursing posts reflecting this thatemphasise the research component.Two significant such posts are thoseof the Nurse Consultant and theAdvanced Nursing Practitioner.

Nurse consultants - a strongstrategic role in researching

Nurse Consultants are not found inevery medical area, and theirappointment will depend on theprofile of patient need within eachTrust. There are five NurseConsultants at Gwent, covering theareas of child and adolescent mentalhealth; personality disorders;midwifery; continence; and cardiacdisease. These Nurse Consultantshave a clinical caseload and an areaof expertise that is on par with amedical consultant. They also have a strong strategic rolein looking at how their particulararea of service can be developed. Aspart of that role they are expected to

contribute to research in theirspecialist area, as well as make aprofessional input in to give theirprofessional input to the educationand development of other nurses, andto the education and development ofother nurses. ‘This is about what’shappening out there in the world,’ Sueexplained. ‘These people arepresenting at internationalconferences and are leaders in theirfield.’

The role of Advanced NursePractitioners also incorporatesresearch as part of a range of highlydeveloped skills. One of Gwent’sAdvanced Nurse Practitioners,Maureen Dobbins, has been workingwith UWIC Business School to look atdeveloping a device for patients whosecancer necessitates the removal ofboth their tongue and larynx.‘Although these patients will be fittedwith a false larynx at a later stage, forthe post-operative period they’rewithout anything and that causesgreat frustration,’ Sue explained. The first step was to carry outexploratory research, to establish not

Sue Bale observed that where supply isconcerned, within Gwent HealthcareTrust the move is increasingly is to seekan integrated ‘package’ that supportseverything needed for delivery. ‘Wherewe’re going as an organisation,’ sheexplained, ‘is in having service levelagreements with our providers.

‘Our mattress contract with Huntleigh isan example of that. They give us all thetechnical support that we need,education and training of the peopleusing it, they maintain their products andreplace those broken, they takeresponsibility for being part of ourdelivery system. ‘That means we don’thave the problems of dealing with

manpower, the training, covering leave,technical support. And that last point isimportant, because there are not enoughof our own medical technicians andengineers.’ So if, for example, acompany has a medical product whichthey consider would be of benefit topatients, they should bear in mind thatthe Trust would be looking for a companyto supply the device, any training needed,and the servicing and technical supportdemanded. ‘It’s this kind of integratedservice we’re looking for, because from arisk management perspective we’regetting the best possible service for thepatient,’ Sue concluded.

Changes in Procurement Strategy

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just the professionals’ but thepatients’ view of what they needed.Sue worked with Maureen to enableher to successfully carry out thatresearch (which subsequently wonan award in the Nursing Journal).Meanwhile, Gwent’s contact in UWICis now working on getting the devicedeveloped.

‘SME’s often make ad hoc use ofcontracts in the nursing

professions’

The design of the research for thisproject reflects the particularcapabilities of nursing professionalsas hubs for contacts with every levelof patient care. Maureen’s projectcanvassed not only patients, medicalconsultants and nurses, but alsophysiotherapists, occupationaltherapists and cleaners. From anindustry perspective, the ‘front-line’Registered Nurse’s core role is asvital a conduit as more specialisednursing roles for R&D informationrelating to patient care. The fullspectrum of experience can thenfeed into the product developmentprocess.

This view is also confirmed byMediWales’s own contact withcompanies in the medical sector. Weare often approached by SMEs whohave made substantial use of ad hoccontacts such as family members orfriends in the nursing professions,because of their valued input both asto the source of a particular problemand/or possible means of tackling it.The systematic development ofnursing professionals’ R&Dcapability also offers clear benefitsto larger companies. HuntleighHealthcare, for example, arecontracted not only to supplyspecialised mattresses to Gwent butalso to deliver training in their use.For such companies, the R&D focuson building up systems in Trusts forsharing evidence-based practiceamong nursing professionals,including the dissemination oftraining materials and technicaldata, would make the most of theirtraining input and minimise wastagethrough repetition or informationshortfall.

The data furnished through Prof.Kenkre’s scoping exercise clearlydemonstrates the value of R&D inputfrom nursing professionals. Any

moves to develop a consistentstrategy for its support wouldtherefore be heartily welcomed bycompanies in the Welsh medicalsector. MediWales would next like tosee the establishment of a clearworking mechanism for companies

to access nursing expertise at alllevels. This would encouragecollaborative research that is bothethically and economically sound, andcould substantially contribute to theimprovement of patient care.

Nursing: a criticalrole in R&D

Prof Joyce KenkreProfessor Primary CareSchool of Care SciencesUniversity of GlamorganPontypridd CF37 1DLTel: 01443 483170Fax: 01443 483140Web: www.glam.ac.uk

Professor Sue Bale Associate Nurse Director R&D Gwent Healthcare NHS Trust Grange HouseLlanfrechfa GrangeCwmbran NP44 8YNTel: 01633 623802Fax: 01633 623836Web: www.gwent-tr.wales.nhs.uk

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Speedybenefits for drug testingFluorescence imaging techniquesused for drug testing by new Cardiffcompany AssayMetrics can help toimprove productivity in drugdiscovery. Providing robust assayingresults, and reducing the number ofboth false negatives and falsepositives, the technique shouldincrease the reliability of high-throughput screening and help tospeed up drug trials.Fluorescence-based assays havealready proven their value in drugtesting. The dyes used in thetechnology emit a variablefluorescent light according to thedegree that a drug affects the activityof the biological target. But onedifficulty attending the process is indiscriminating ‘true’ hits – becausemany of the compounds beingscreened (and some of the

components of the equipment) alsoemit fluorescent light. On a highthoughput screen analysis, the resultof this ‘background’ light emissionmeans that effective compounds aremissed, or time is spent oncompounds that are false hits for thetargets.AssayMetric’s technology workseffectively to restore the necessarycontrast so as to clarify true hits.The company has identified anumber of dyes that fluoresce forlonger than those currently in use,thus producing signals that are verydifferent from the ‘background’ light

The Company’s AcneStar productembeds the technology in a uniquehand-held device the size of a mobilephone. This allows sufferers toadminister the treatment themselves,instead of having to receive it at aclinic. Dermastar Ltd have recently won aWDA grant approval for furtherindependent studies to take place onAcneStar.

Dermastar Ltd23 Frogmore StreetAbergavenny NP7 5AHTel: 01873 851555 Fax: 01873 851566 E-mail: info@acnestar.co.uk Web: www.dermastar.co.uk

emission. ‘Assays based on ourfluorescence dyes are far morerobust, and therefore more reliable,’said Dr Pierre Graves, founder andPresident of AssayMetrics.Clients can buy the dyes to developtheir own assay, and AssayMetricsalso provides an assay developmentservice. Last year the companyreceived Welsh Development Agencyhelp to support the development ofoff-the-shelf assays based on thedyes.‘Our software simulations have shownthat our technologies could potentiallydramatically improve the way newdrugs are discovered,’ said Dr Graves.‘The WDA assistance is helping usturn these ideas into new products fordrug screening and diagnostics.’

Source: Advances 50

AssayMetrics Ltd22 Angelica Way, Cardiff CF14 9FJTel: 05511 4004731Email: sales@assaymetrics.comwww.assaymetrics.com

Men’s healthonlineRecent research has shown howmen tend to be poor at monitoringtheir own health, and at seekinghealth care when needed. Thisbecomes a particularly significantfactor in cancer treatment, where ahigh proportion of men access caretoo late to benefit from earlydetection. The Royal College ofNursing in Wales is calling forinnovative ways of working with menand boys to address the problem.Now two new website initiatives arehelping to encourage men to bemore active in checking for prostateand testicular cancers.

One of the reasons diagnosingprostate cancer can be difficult isthe reluctance to take tests. But anew interactive website,www.prosdex.org.uk, aims to helpmen overcome their worries andadvise them as to whether they needto do a test for prostate cancer ornot.

The test enables the detection of theprostate-specific antigen (PSA). PSAis produced in the prostate glandand naturally enters thebloodstream. A high level of theantigen can be an indicator ofprostate cancer. But this indicator isnot absolute: two out of three menwho have a higher PSA level arediagnosed as not having prostatecancer. This makes it all the moreimportant that men are given theknowledge to make an informeddecision about being tested.

This is what the new website –developed by Cardiff University, theNHS Cancer Screening Programme,Cancer Research UK and OxfordUniversity – is designed to do. As itis an interactive site, users can keepa record of their attitude to testingas they examine the informationavailable, and can alter their

response as they progress. It alsoincludes video clips of mendiscussing their own experiences, tohelp users consider the issues thatmay affect their own decision ontaking the test.

The NHS Cancer ScreeningProgramme reports that increasingnumbers of men are requesting thetest and has welcomed the Prosdexsite’s role in helping men to make aninformed decision.

The online approach is also beingadopted by the Institute of CancerResearch. The Everyman Centre,set up by the ICR as Europe’s onlydedicated male cancer researchcentre, is teaming up with Butlins toincorporate advice on checking fortesticular cancer into the holiday

group’s online bingo website,www.butlinsbingo.com. One ineight men in Wales diagnosed withthe disease will die each year, butearly detection through simplechecks encouraged by the websitecan increase chances of recovery to99%.

Source: Advances Wales 49; Western Mail 24.4.06

Prof Glyn ElwynCentre for Health SciencesResearchCardiff University CF10 3ATTel: 029 2087 0090Email: elwyng@cardiff.ac.ukWeb: www.prosdex.org.uk

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Micro-needles:taking the painout ofinjectionsInnovative work by scientists inSouth Wales could see the end ofpainful conventional needles and thefear they sometimes induce. A teamat Cardiff University’s Welsh Schoolof Pharmacy is researching theapplication tiny micro-needles forthe delivery of vaccines and genes.

The micro-needles measure up to150-300 microns (0.15mm-0.3mm)in length and are prepared by theCardiff School of Engineering, andTyndall National Institute at Cork inIreland. Tests carried out using atiny plate containing up to 400needles, applied to the surface ofthe skin, have been shown to bepainless. The medicament orvaccine is introduced into the skineither by subsequently applying it asa solution or gel; by coating it ontothe needles; or by injecting itthrough hollow micro-needles.

Dr James Birchall, head of theSchool’s Gene Delivery ResearchGroup, said: ‘The micro-needlesneed to be able to penetrate theexternal barrier to medicine delivery– the stratum corneum layer of theskin – without impinging on theunderlying pain receptors or bloodvessels. At the Welsh School ofPharmacy, we’ve specifically usedmicro-needle designs to show thatDNA is able to express its geneproduct in the viable skin layers.Our next step is to use the micro-needles to deliver DNA vaccines tohuman skin.’

Potential applications include abroad range of conventional drugs,proteins, DNA and vaccines such ashepatitis B and influenza. ‘We see areal need for developing pain-freeand efficient vaccines,’ said DrBirchall. ‘Delivering vaccine into theskin provides an opportunity to

generate an efficient and prolongedimmune response without therequirement of a clinician toadminister the vaccine.’The micro-needles the team hasbeen working with are made ofsilicon but further advances in thetechnology could mean thedevelopment of biodegradablemicro-needles that dissolve in theskin. ‘Micro-needles don’t causebleeding and may be designed tobiodegrade,’ said Dr Birchall, ‘andtherefore would not carry the risk ofinfection associated with theinappropriate or accidental re-use ofconventional needles.’ He estimatesthat, if research and trials aresuccessful, the micro-needles couldbe in use in hospitals and surgeriesin around five years.

Dr James BirchallWelsh School of PharmacyCardiff University, RedwoodBuildingCardiff CF1 3XFTel: 029 2087 5815Email: birchalljc@cf.ac.ukWeb: www.cf.ac.uk/phrmy

Source: Advances Wales 49

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