MediWales Review - Spring 2006

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The Future of Clinical Trials in Wales IP at the Hub of Welsh NHS Nursing: A Critical Role in R&D

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Time for Review At the recent inaugural AGM of MediWales Ltd, it was suggested that our newsletter could evolve to provide a broader and more issuebased examination of activities in the Welsh medical sector. We’ve developed our approach accordingly, as you’ll see from the new format and content of what is now the first edition of The MediWales Review.

An essential part of our work at MediWales is to track the evolution of the sector’s development. Our features in this edition look at three key components of the R&D infrastructure emerging from the NHS, with a significant potential impact on the industry in Wales: the new Wales 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 leading academics, NHS professionals, industrialists and service providers, to explore these new developments from a number of different perspectives.

All three features deal with issues that need the input of people at the sharp end, so they are intended to stimulate debate and we are keen to hear your opinions.

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

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

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Contents F E AT U R E S The Future of Clinical Trials in Wales The wider implications of the new Wales Clinical Trials Network for stakeholders in the medical sector 4 IP at the Hub of Welsh NHS MediWales talks to the providers and potential users of the new NHS IP service in Wales 10 Nursing: A Critical Role in R&D The changing role of nurses feeds vital information into the product development process 14

PRODUCT REVIEW Online tools promote men’s health

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Handheld acne treatment gets international deal 17 Speedy benefits from fluorescence-based assays

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RESEARCH REVIEW Microneedles take away the pain

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The intention is that any patient in Wales who has an illness that is being addressed by a clinical trial, can be entered into that trial.

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Cover image reproduced by kind permission of Biostatus Ltd. www.biostatus.com

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The Future of Clinical Trials in Wales Any population that has the opportunity to take part in clinical trials gains a number of important potential advantages.

First and foremost, clinical trials offer access to the clinical benefits of new drugs, devices or therapeutic interventions. At the same time, they can generate sorely needed revenue for a cash-strapped NHS. It is also suggested that patients experience a beneficial effect from participation in trials (irrespective of the treatment) due to the close clinical scrutiny that they receive.

The delivery of clinical trials is however an increasingly competitive global marketplace. If we are to offer these advantages to the Welsh population, then Wales has to respond to the diverse needs of a range of interested parties which make up the ‘stakeholder’ profile. In this feature MediWales speaks to three such stakeholders, whose different roles inform their perspective on this important and complex issue: Professor John Williams, Director of the NHS Wales Office of Research and Development

(WORD); Richard Greville, Director of the Association of the British Pharmaceutical Industry (ABPI) Cymru Wales; and Marc Weinzweig, MD of specialist drug distribution company Biotec Distribution Wales.

Wales Clinical Trials Network WORD has been working to develop the new Wales Clinical Trials Network. The aim of this comprehensive and ambitious project is no less than, in the words of Professor Williams, ‘to ensure that any patient in Wales who has an illness or problem that is being addressed by a clinical trial, can be entered into that trial.’

PHOTO: BMARIX DRUG DEVELOPMENT

The professor went on to describe for us the principal components in the project’s infrastructure. At its core is a co-ordinating centre with a very small management unit, which will run a network of professionals in health care organisations who will support large-scale studies. It will also set up and co-ordinate a patient and carer network to contribute advice and views on R&D across the whole spectrum of activity.

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Professor Tim Maughan (Director of the Wales Cancer Trials Network) has been appointed as Director for the Cardiff-based centre. ‘This work is going to be building on what they’ve done for cancer,’ the Professor explained. ‘It’s not going to compromise the Cancer Trials Network, but I wouldn’t be at all surprised if in 10 years time we have a generic support network of professionals who are supporting both cancer and non-cancer studies.’

Two clinical trials units will offer the methodological and data

management expertise to support the work, particularly of internally generated trials. The expertise will also constitute a ‘bank’ that can be available for collaboration with industry where that is applicable.

A route for trials from inside and outside the Network Thematic networks constitute another major component in the infrastructure. These are professional/academic collaborations that bring together a full range of expert personnel, from throughout Wales and across sector boundaries, within each of nine thematic areas: mental health; learning disabilities; neurodegenerative disorders; diabetes; emergency care; epilepsy; public health; care of the elderly; and care of children.

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The thematic networks, the coordinating centre and the clinical trials units will be further supported by a new information unit, set up to provide data derived from routinely collected hospital episode statistics.

For any particular study being generated, this will help give an indication of the feasibility of the proposed sample size across Wales, and of the likely speed of recruitment.

As part of the infrastructure development, WORD is also encouraging R&D offices in all the Trusts across Wales to work together to develop a uniform approach to research governance approval. ‘What we’re looking for,’ Professor Williams

Research arising out of one of those networks would be worked up into a protocol, with access to the clinical trials unit for any specific expertise needed. Funding, depending on the proposal, might be gained from the MRC, from Wellcome or from industry.

The study itself

would then go through the co-ordinating centre to use the all-Wales infrastructure.

‘But this is also a route for studies to travel from the outside into the network,’ said Professor Williams. ‘It may be that if a company wanted to trial a new drug for epilepsy, for example, it would come through the thematic network. If on the other hand there wasn’t a corresponding academic alliance that it wanted to engage with, it might just go straight to the co-ordinating centre, which would take the process forward if it was appropriate. So it is a gate that can open either way.’

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a single portal for companies seeking to run clinical trials, through accessing the co-ordination centre which then could, in its turn, find appropriate sites through its networks. ‘We want to make it such that the whole of Wales is effectively the trial site, with an all-Wales network of research support staff and interested clinicians,’ said the Professor. ‘We’re not doing this to generate revenue from industry, we’re doing this to work in partnership with industry. Certainly we want to nurture Wales’s indigenous industries, and we also want industries outside Wales to see us as a significant and efficient contributor. So that in terms of ‘big

pharma’ for example, we would hope that Wales in due course would become attractive to them as a source for clinical trials sites.’ explained, ‘is a situation where if a study comes in it doesn’t have to approach each organisation separately and be slowed down to the speed of the slowest, but can get a single approval that will be applicable across the whole of Wales. So we are putting funding in to enable the Trusts to achieve a common approach.’

‘We’re not doing this to create revenue from industry, but to work in partnership with industry’ From the point of view of industry, the Clinical Trials Network offers significant potential benefits. The initiative could essentially function as

For the pharmaceutical industry in Britain, the ABPI is the pre-eminent trade association, with its members supplying more than 80% of the medicines prescribed through the NHS in both England and Wales. We asked its Director, Dr. Richard Greville, how he saw Wales’s position within the UK in relation to the clinical trials work of the global pharmaceutical companies, and the possible impact of the WORD initiative.

Richard set the context by pointing out that while the UK constitutes 3% of the pharma market globally, it attracts 10% of global R&D investment. In terms of that investment therefore, the UK plays a

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knowledge and experience in developing the design of these trial protocols, in the context of good study practice.

PHOTO: BMARIX DRUG DEVELOPMENT

‘That’s what’s behind some of the initiatives being carried out at UK level at the moment – the UK Clinical Research Collaborative and the UK Clinical Research Network,’ he continued. ‘The infrastructure for clinical trials that WORD is building will feed into those groups, and this represents a real opportunity for Wales to ensure that we do have a structure to support good study practice. I think it’s a significant step

‘The UK academic knowledge base and support services are critical’ According to the ABPI’s figures on pre-clinical R&D, Wales attracts only about 2% of the industry’s investment. Why is it that Wales has historically missed out on that investment? In Richard’s view a major factor is the same one that, conversely, contributes to the UK’s 10% investment: the knowledge base.

‘The academic knowledge base and the support services that have developed in the UK are absolutely critical,’ Richard said. ‘But Wales itself doesn’t have that historical track record of conducting clinical trials. And that would probably explain why London/Cambridge/Oxford have developed into the “golden triangle”.

They continue to develop and attract the vast majority of the R&D in terms of clinical trials in the UK - even when the patient base doesn’t necessarily allow the best recruitment and doesn’t allow all clinical trials to be carried out there.

Against that factor you have to consider that the cost of clinical trials in the UK is increasing rapidly, and

Marix Drug Development, whose successful exploitation of their niche market we described in a recent case study (see MediWales Autumn 05) is a classic example of this approach.

Another is Biotec Distribution, a Bridgend-based SME which supplies its drug distribution services to companies worldwide, ranging from small Welsh operations to the largest global groups such as Johnson & Johnson.

that means competition with countries such as Eastern Europe, Singapore and India. So it is important for the industry to reduce delays in trials. Globally, 80% of clinical trials are not completed on time, and it’s estimated that running a clinical trial costs about $40,000 a day.’

Feeding into good study practice Here the push for ‘good study practice’ in the UK is of paramount importance. This describes an approach where the generic processes involved in developing a clinical trial are made as smoothrunning and efficient as possible, as Richard described: ‘If industry is looking for a clinical trial involving 500 patients, a critical question is how quickly can they be recruited into the trial, and progressed safely through the trial?’

Tied in with effective recruitment is protocol design and excellent clinical data management. Every clinical trial is highly regulated and is defined within strict protocols. With the UK’s historical experience and skill base, it’s possible for protocols to be developed between clinicians and the industry which avoid some of the potential pitfalls. As Richard pointed out, it’s extremely useful for industry to be able to use a clinician’s

The company specialises in the importation, labelling and distribution

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import materials for clinical trials. In turn, it’s the QP who must verify that a given manufacturing site is working to EU standards. Biotec are licensed to undertake this process by the MHRA, and last year audited 10 different companies throughout the world for compliance with European GMP. ‘We’ve got three QPs here and a fourth being trained,’ said Marc, ‘so that’s a very high percentage in a company of 10 people. It’s a very significant factor in our success, and unless there’s a great drive from other areas of the world to get QP status, it’s going to remain that way.’

‘These are developmental groups it’s all about relationship building’ The audit requests come from the companies themselves, and this relates to another significant factor in the growth of Biotec’s business. In spite of the fact that the pharmaceutical sector is dominated by global companies, the company has developed a close network of relationships with individuals and

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contracts with these very large companies, we realised that our skill in working with people with this particular profile is very important.

We can work out what they need and support them in a way that they like.

We know their problems because of our experience in clinical trials handling - I’ve been working with biologicals and in-vitro diagnostics since the early 80s. So it’s all about relationship-building.’

In terms of effective servicing of clinical trials these kinds of niche skills can leverage the value they contribute to the process. They are part of a complex landscape typical of the health care sector, not only in Wales but across the globe. In other regions understanding this complexity and harnessing it is increasingly becoming a priority.

Wales’s size and its existing medical networks can help to boost future development. It is a situation offering much promise: for this to be translated into a competitive advantage, leading Welsh stakeholders from across the clinical trials spectrum will need to give a clear priority to working closely together.

Professor John Williams

forward for WORD to have established an overall strategic research and trials organisation in Wales, and this is increasingly being recognised by ABPI members.’

Building on indigenous knowledge, skills and infrastructure It remains to be seen whether the distance between industrial and medical perspectives can be bridged.

If it could, that would certainly be another step forward in rallying the resources of the Welsh health care system to an economical, ethical approach for delivering essential drug development. The portal function within the Wales Clinical Trials Network is already a factor encouraging that move forward.

The Network also represents an invaluable opportunity to support Wales’s delivery across the full spectrum of stakeholders in the drug development process, from patients,

PHOTO: BIOTEC DISTRIBUTION

disproportionately large role. But the position of Wales is somewhat different from that of the UK as a whole.

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clinicians, nursing professionals and regulatory bodies, to sponsors, contract research organisations, contract manufacturing organisations, and drug distribution companies – all of which exist as indigenous units in the Welsh economy. Many Welsh SMEs pursue a highly effective niche strategy in this demanding global market, both in the services they provide and the relationships they develop with their customers.

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of materials for temperaturecontrolled clinical trials. Marc Weinzweig, Biotec’s Managing Director, described how this focus has helped consolidate their position in such an intensely competitive world market. ‘We have a facility that has Good Manufacturing Practice (GMP) status here for the control of temperature,’ he explained. ‘GMP relates to the 2004 EU directive and that’s driven tremendous growth in the business.’

Under that Directive, a company must employ at least one Qualified Person (QP) in order to be licensed to

small groups within the sector that exerts a powerful influence.

‘Even if you’re working with a massive company,’ said Marc, ‘you’re working with a small group inside that company. These are developmental groups, research-type people, involved with drug development and sometimes manufacture. And the majority of them, irrespective of whether they’re working for a virtual company or a global corporation, work in small units. At J&J for example we deal with 6-8 people.

When we analysed how we get our

Professor John Williams Director, Wales Office of Research & Development 4th Floor, Welsh Assembly Government Cardiff CF10 3NQ Tel: 029 2082 5252 Fax: 029 2082 3997 Email: word@wales.gsi.gov.uk Web: www.word.wales.gov.uk Dr Richard Greville Director ABPI Cymru Wales Caspian Point 2 Cardiff CF10 4DQ Tel: 029 2045 4297 Fax: 029 2045 4298 Biotec Distribution Wales Ltd Unit 17, St Theodore’s Way Brynmenyn Industrial Estate Bridend CF32 9TZ Tel: 01656 722256 Fax: 01656 720003 Email: marc@biotec-uk.com Web: www.biotec-uk.com

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IP at the hub of Welsh NHS Last August saw the longawaited establishment of a dedicated facility for the exploitation of NHS IP in Wales.

Across the UK, IP hubs were starting to be introduced as far back as 1999 through the NHS Innovations initiative. Largely funded through the DTI’s Public Sector Research Exploitation (PSRE) fund, the remit of the innovation hubs is to provide services helping NHS organisations to identify, protect and exploit NHS intellectual property.

There are now nine regional NHS IP hubs in England, and one in Scotland.

Wales did not receive PSRE funding on two previous occasions, so we are coming late to the game. The Welsh Assembly Government has now been able through WORD to provide some funding for its own IP exploitation programme in the Welsh NHS. In August, Angle plc were formally contracted to operate Welsh Innovations in Health Care (WIsH).

Operating throughout the UK, Angle plc won the contract in partnership with TrusTECH, who run the NHS IP hub for the North West of England and will bring their experience of NHS operations and culture to WIsH. The in situ part of the WIsH operation has been set up at Aberystwyth under Innovations Manager Dr. Nic Shilton. who will be running a small team. Specialised support from the Angle and TrusTECH consulting teams is fed into the local team, as and when needed by their projects.

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For Wish’s project director, Shane Booth, active identification of IP possibilities is the priority at this stage. So the focus is on visits out in the field, supplemented by training and awareness-raising events to raise the service’s profile. ‘Another approach’, said Shane, ‘is a surgery, where say at a particular hospital we’ll be available through a morning to discuss ideas and queries as a drop-in service. From our

experience with technology incubators we know that the surgery approach is a good way to encourage people to come and ask for assistance.’

WIsH have standard audit procedures for both service and technology innovation projects. ‘We will sit down with the people involved,’ explained Nic, ‘and audit the idea, and then we would do a background search and give them that feedback.

If the results are positive, then we carry on. If we find it’s already being done or just doesn’t have legs, we wouldn’t continue – but we would make sure people know why it is or isn’t being taken forward.’

Potential for service innovation Part of the WIsH remit is to identify, secure and roll out service innovation, finding opportunities for practical improvements related both to patient care, and to operational management and efficiency. ‘There’s a cultural expectation that innovation is solely about IP exploitation, but I think that’s misguided,’ said Shane.

‘What they’ve found in North West England is that there are far more opportunities – something like a ratio of 4:1 – in service innovation.’

One such project involved TrusTECH in the publication of a speech therapy pack for children with speaking difficulties. The tools and techniques had been developed by a speech therapist for her Trust, and while rising referrals indicated her success, they also indicated that such problems needed to be more skilfully tackled at an earlier stage in schools. In consultation with TrusTECH, the therapist worked to develop her materials specifically for use in schools.

TrusTECH found a medical publisher, and established copyright as lying with the NHS Trust as the therapist’s employer. The License agreement was then set up return a royalty to the Trust for every copy of the pack sold. ‘TrusTECH’s skill in this,’ said Shane, ‘was in dealing with the issue of the most effective way to disseminate this pack, and to return a proper reward to the NHS Trust, while improving the delivery of care.’

From a MediWales point of view, the introduction of the Welsh hub is a step towards supporting the routes

for effective technology transfer which benefit both Welsh NHS patients and Welsh companies in the medical sector. Professor Williams, WORD Director, gave us his perspective on the role of industry in this new initiative.

‘WIsH is there to capitalise on intellectual property in the NHS,’ he said. ‘Some of that will be translated into commercial developments through spin-out companies, but not all: some will need to go through existing companies. The remit is partly to protect IP so that the NHS gets some return for its innovation, but also to facilitate the realisation of developments based on that. And some of that will be through the established private sector. So we see this very much as being in partnership with industry.’

Call for dialogue between industry and NHS Greg Baily, MediWales Chairman, sees the early involvement of industry in the process as key to the success of the WIsH project. ‘When I speak to some people,’ he said, ‘there is this tendency to think that the be-all and end-all is having the idea. But that is really just the beginning you’re only taking the first step down the path. There’s an awful lot to come with all the regulatory hurdles, the route to market, the complexities, and in the medical sector particularly that path is quite a tortuous one’.

In Greg’s view, the proper evaluation of NHS IP – assessing it technically, clinically, and in terms of its market – calls for a consistent dialogue between industry and the NHS. Early-stage partnership and evaluation can increase the likelihood of a successful product for both patients and commerce, and also reduce its time to market. ‘Neither clinicians nor manufacturers have the luxury of time or money to develop an indepth understanding of each other’s expertise,’ he pointed out. So that’s part of what an IP hub needs to offer.’

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Aside from the exploitation of IP from within the NHS, Greg also sees significant opportunities in supporting the movement of innovation from outside, into the NHS. ‘A good example of that,’ he said, ‘is the Lean manufacturing process at OCD that’s being applied to the laboratory at the Royal Glamorgan Hospital [see MediWales Autumn 05]. There you have a practice adopted in a company in Wales, being applied in a Welsh NHS Trust, and ultimately enabling them to become much more efficient in that particular area - meaning not just cost savings but better service.

Greg sees other potential opportunities such as partnering between NHS and industry and academia, and management of IP generated out of that. ‘But I also recognise that the WIsH project has limited resources compared to the English IP hubs for example‘. he

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said ’Some of those have a very wide range of activities, he continued, but I think WIsH is going to need to focus more tightly. And they’re going to need to work with people like us in industry who are focused on innovation.’

Guiding products to market Although WIsH is a small unit, MediWales has consistently lobbied for a Welsh IP Hub. We welcome its arrival and want to see it succeed.

To do so we see it as essential for a strong industrial relationship to be built into the project. Regardless of how clinically useful a new product or process may be, unless it is financially and technically feasible it will not be able to meet the aspirations of its inventor or deliver the desired improvements for patients. Through our work across the Welsh medical sector, MediWales can help to deliver the industrial participants able to evaluate and guide projects to market and mass production.

Dr Nic Shilton, Innovations Manager Welsh Innovations in Health Care (WIsH) Technium Aberystwyth Aberystwyth SY23 1AS Mobile: 07917 649278 Tel: 01970 613425 Fax: 01970 613 244 Email:n.shilton@wishnhswales.org.uk Web: www.wishnhswales.org.uk

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Nursing: a critical role in R&D Over the past year MediWales has been closely involved with a substantial study into the significance of the R&D role in the nursing professions.

Professor Joyce Kenkre, a MediWales Board member from the University of Glamorgan School of Care Sciences, has been working on secondment to the office of the Chief Nurse at the Welsh Assembly Government to develop a research strategy for nurses, health visitors and midwives in Wales.

A report produced by Professor Kenkre in collaboration with clinicians, academics and industry, details some of the most important issues to be addressed.

Modernisation of the NHS has intensified the need for nursing professionals to keep pace with the speed and range of changes within it, whether in the form of advances in technology, innovative developments in clinical practice, or new structural approaches to the delivery of services to patients.

These pressures have placed a premium on making best use of the R&D component in the roles of nursing professionals. The report illustrates ways in which attention to R&D in these disciplines can support the NHS, through generating an evidence base and sharing best practice, so that improvements to patient care could be incorporated speedily and consistently.

The role of Sue Bale, Associate Nursing Director R&D at Gwent Healthcare Trust, places her at the centre of many of these changes.

‘The nursing profession is maturing,’ Sue pointed out, ‘so you expect diversity and specialisation. But the new ‘design for life’ model of care, and the modernisation of roles in the

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health service generally, have opened up a lot of opportunities for working across professional boundaries.’

The core role of Registered Nurse has therefore developed in its range and level of activity, and there are new nursing posts reflecting this that emphasise the research component.

Two significant such posts are those of the Nurse Consultant and the Advanced Nursing Practitioner.

Nurse consultants - a strong strategic role in researching Nurse Consultants are not found in every medical area, and their appointment will depend on the profile of patient need within each Trust. There are five Nurse Consultants at Gwent, covering the areas of child and adolescent mental health; personality disorders; midwifery; continence; and cardiac disease. These Nurse Consultants have a clinical caseload and an area of expertise that is on par with a medical consultant.

They also have a strong strategic role in looking at how their particular area of service can be developed. As part of that role they are expected to

contribute to research in their specialist area, as well as make a professional input in to give their professional input to the education and development of other nurses, and to the education and development of other nurses. ‘This is about what’s happening out there in the world,’ Sue explained. ‘These people are presenting at international conferences and are leaders in their field.’

The role of Advanced Nurse Practitioners also incorporates research as part of a range of highly developed skills. One of Gwent’s Advanced Nurse Practitioners, Maureen Dobbins, has been working with UWIC Business School to look at developing a device for patients whose cancer necessitates the removal of both their tongue and larynx.

‘Although these patients will be fitted with a false larynx at a later stage, for the post-operative period they’re without anything and that causes great frustration,’ Sue explained.

The first step was to carry out exploratory research, to establish not

Changes in Procurement Strategy Sue Bale observed that where supply is concerned, within Gwent Healthcare Trust the move is increasingly is to seek an integrated ‘package’ that supports everything needed for delivery. ‘Where we’re going as an organisation,’ she explained, ‘is in having service level agreements with our providers.

‘Our mattress contract with Huntleigh is an example of that. They give us all the technical support that we need, education and training of the people using it, they maintain their products and replace those broken, they take responsibility for being part of our delivery system. ‘That means we don’t have the problems of dealing with

manpower, the training, covering leave, technical support. And that last point is important, because there are not enough of our own medical technicians and engineers.’ So if, for example, a company has a medical product which they consider would be of benefit to patients, they should bear in mind that the Trust would be looking for a company to supply the device, any training needed, and the servicing and technical support demanded. ‘It’s this kind of integrated service we’re looking for, because from a risk management perspective we’re getting the best possible service for the patient,’ Sue concluded.

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just the professionals’ but the patients’ view of what they needed.

Sue worked with Maureen to enable her to successfully carry out that research (which subsequently won an award in the Nursing Journal).

Meanwhile, Gwent’s contact in UWIC is now working on getting the device developed.

‘SME’s often make ad hoc use of contracts in the nursing professions’ The design of the research for this project reflects the particular capabilities of nursing professionals as hubs for contacts with every level of patient care. Maureen’s project canvassed not only patients, medical consultants and nurses, but also physiotherapists, occupational therapists and cleaners. From an industry perspective, the ‘front-line’ Registered Nurse’s core role is as vital a conduit as more specialised nursing roles for R&D information relating to patient care. The full spectrum of experience can then feed into the product development process.

This view is also confirmed by MediWales’s own contact with companies in the medical sector. We are often approached by SMEs who have made substantial use of ad hoc contacts such as family members or friends in the nursing professions, because of their valued input both as to the source of a particular problem and/or possible means of tackling it.

The systematic development of nursing professionals’ R&D capability also offers clear benefits to larger companies. Huntleigh Healthcare, for example, are contracted not only to supply specialised mattresses to Gwent but also to deliver training in their use.

For such companies, the R&D focus on building up systems in Trusts for sharing evidence-based practice among nursing professionals, including the dissemination of training materials and technical data, would make the most of their training input and minimise wastage through repetition or information shortfall.

The data furnished through Prof.

Kenkre’s scoping exercise clearly demonstrates the value of R&D input from nursing professionals. Any

moves to develop a consistent strategy for its support would therefore be heartily welcomed by companies in the Welsh medical sector. MediWales would next like to see the establishment of a clear working mechanism for companies Prof Joyce Kenkre Professor Primary Care School of Care Sciences University of Glamorgan Pontypridd CF37 1DL Tel: 01443 483170 Fax: 01443 483140 Web: www.glam.ac.uk

to access nursing expertise at all levels. This would encourage collaborative research that is both ethically and economically sound, and could substantially contribute to the improvement of patient care.

Professor Sue Bale Associate Nurse Director R&D Gwent Healthcare NHS Trust Grange House Llanfrechfa Grange Cwmbran NP44 8YN Tel: 01633 623802 Fax: 01633 623836 Web: www.gwent-tr.wales.nhs.uk

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Products

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Review

South Wales company Dermastar Ltd has signed an agreement to distribute AcneStar, its acne treatment device, to the South East Asia market with potential sales of around £2 million.

AcneStar employs light emitting diodes (LED’s) to produce blue light at a specific wavelength within the electromagnetic spectrum. Acne bacteria produce a chemical, porphyrin, which changes its molecular structure on exposure to this light. The company claims that these changes in the porphyrin molecule metabolically disrupt and so destroy the acne bacteria, helping to calming inflammation and clear the acne.

One of the reasons diagnosing prostate cancer can be difficult is the reluctance to take tests. But a new interactive website, www.prosdex.org.uk, aims to help men overcome their worries and advise them as to whether they need to do a test for prostate cancer or not.

This is what the new website – developed by Cardiff University, the NHS Cancer Screening Programme, Cancer Research UK and Oxford University – is designed to do. As it is an interactive site, users can keep a record of their attitude to testing as they examine the information available, and can alter their

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The NHS Cancer Screening Programme reports that increasing numbers of men are requesting the test and has welcomed the Prosdex site’s role in helping men to make an informed decision.

The online approach is also being adopted by the Institute of Cancer Research. The Everyman Centre, set up by the ICR as Europe’s only dedicated male cancer research centre, is teaming up with Butlins to incorporate advice on checking for testicular cancer into the holiday

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Acne treatment to new international markets

Recent research has shown how men tend to be poor at monitoring their own health, and at seeking health care when needed. This becomes a particularly significant factor in cancer treatment, where a high proportion of men access care too late to benefit from early detection. The Royal College of Nursing in Wales is calling for innovative ways of working with men and boys to address the problem.

Now two new website initiatives are helping to encourage men to be more active in checking for prostate and testicular cancers.

response as they progress. It also includes video clips of men discussing their own experiences, to help users consider the issues that may affect their own decision on taking the test.

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Men’s health online

The test enables the detection of the prostate-specific antigen (PSA). PSA is produced in the prostate gland and naturally enters the bloodstream. A high level of the antigen can be an indicator of prostate cancer. But this indicator is not absolute: two out of three men who have a higher PSA level are diagnosed as not having prostate cancer. This makes it all the more important that men are given the knowledge to make an informed decision about being tested.

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group’s online bingo website, www.butlinsbingo.com. One in eight men in Wales diagnosed with the disease will die each year, but early detection through simple checks encouraged by the website can increase chances of recovery to 99%.

Prof Glyn Elwyn Centre for Health Sciences Research Cardiff University CF10 3AT Tel: 029 2087 0090 Email: elwyng@cardiff.ac.uk Web: www.prosdex.org.uk

Source: Advances Wales 49; Western Mail 24.4.06

The Company’s AcneStar product embeds the technology in a unique hand-held device the size of a mobile phone. This allows sufferers to administer the treatment themselves, instead of having to receive it at a clinic.

Dermastar Ltd have recently won a WDA grant approval for further independent studies to take place on AcneStar.

Speedy benefits for drug testing Fluorescence imaging techniques used for drug testing by new Cardiff company AssayMetrics can help to improve productivity in drug discovery. Providing robust assaying results, and reducing the number of both false negatives and false positives, the technique should increase the reliability of highthroughput screening and help to speed up drug trials.

Fluorescence-based assays have already proven their value in drug testing. The dyes used in the technology emit a variable fluorescent light according to the degree that a drug affects the activity of the biological target. But one difficulty attending the process is in discriminating ‘true’ hits – because many of the compounds being screened (and some of the

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components of the equipment) also emit fluorescent light. On a high thoughput screen analysis, the result of this ‘background’ light emission means that effective compounds are missed, or time is spent on compounds that are false hits for the targets.

AssayMetric’s technology works effectively to restore the necessary contrast so as to clarify true hits.

The company has identified a number of dyes that fluoresce for longer than those currently in use, thus producing signals that are very different from the ‘background’ light

Dermastar Ltd 23 Frogmore Street Abergavenny NP7 5AH Tel: 01873 851555 Fax: 01873 851566 E-mail: info@acnestar.co.uk Web: www.dermastar.co.uk

emission. ‘Assays based on our fluorescence dyes are far more robust, and therefore more reliable,’ said Dr Pierre Graves, founder and President of AssayMetrics.

Clients can buy the dyes to develop their own assay, and AssayMetrics also provides an assay development service. Last year the company received Welsh Development Agency help to support the development of off-the-shelf assays based on the dyes.

‘Our software simulations have shown that our technologies could potentially dramatically improve the way new drugs are discovered,’ said Dr Graves.

‘The WDA assistance is helping us turn these ideas into new products for drug screening and diagnostics.’

AssayMetrics Ltd 22 Angelica Way, Cardiff CF14 9FJ Tel: 05511 4004731 Email: sales@assaymetrics.com www.assaymetrics.com

Source: Advances 50

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Research Micro-needles: taking the pain out of injections

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The micro-needles measure up to 150-300 microns (0.15mm-0.3mm) in length and are prepared by the Cardiff School of Engineering, and Tyndall National Institute at Cork in Ireland. Tests carried out using a tiny plate containing up to 400 needles, applied to the surface of the skin, have been shown to be painless. The medicament or vaccine is introduced into the skin either by subsequently applying it as a solution or gel; by coating it onto the needles; or by injecting it through hollow micro-needles.

Dr James Birchall, head of the School’s Gene Delivery Research Group, said: ‘The micro-needles need to be able to penetrate the external barrier to medicine delivery – the stratum corneum layer of the skin – without impinging on the underlying pain receptors or blood vessels. At the Welsh School of Pharmacy, we’ve specifically used micro-needle designs to show that DNA is able to express its gene product in the viable skin layers.

Our next step is to use the microneedles to deliver DNA vaccines to human skin.’

Potential applications include a broad range of conventional drugs, proteins, DNA and vaccines such as hepatitis B and influenza. ‘We see a real need for developing pain-free and efficient vaccines,’ said Dr Birchall. ‘Delivering vaccine into the skin provides an opportunity to

PHOTO: WELSH SCHOOL OF PHARMACY

Innovative work by scientists in South Wales could see the end of painful conventional needles and the fear they sometimes induce. A team at Cardiff University’s Welsh School of Pharmacy is researching the application tiny micro-needles for the delivery of vaccines and genes.

generate an efficient and prolonged immune response without the requirement of a clinician to administer the vaccine.’

The micro-needles the team has been working with are made of silicon but further advances in the technology could mean the development of biodegradable micro-needles that dissolve in the skin. ‘Micro-needles don’t cause bleeding and may be designed to biodegrade,’ said Dr Birchall, ‘and therefore would not carry the risk of infection associated with the inappropriate or accidental re-use of conventional needles.’ He estimates that, if research and trials are successful, the micro-needles could be in use in hospitals and surgeries in around five years.

Dr James Birchall Welsh School of Pharmacy Cardiff University, Redwood Building Cardiff CF1 3XF Tel: 029 2087 5815 Email: birchalljc@cf.ac.uk Web: www.cf.ac.uk/phrmy

Source: Advances Wales 49

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