Belfast Health and Social Care Trust has licensed a new rapid meningitis diagnostic test for worldwide exclusive marketing rights.

The new test, developed by scientists at the Royal Victoria Hospital and commercialised by Irish start-up company HiberGene Diagnostics, uses an emerging molecular method known as loop-mediated isothermal amplification (LAMP), that can to provide reliable diagnosis within an hour.

Meningitis is a difficult disease to diagnose as symptoms are typically flu-like. Standard laboratory tests take at least 24 hours to process, and there is a need for rapid and accurate results to allow earlier confirmation to enable earlier treatment.

Brendan Farrell, CEO of HiberGene Diagnostics said: “We are particularly pleased to have secured exclusive rights to the meningitis test from the Belfast Trust. Clinical validation of the test has shown a sensitivity of 100% and a specificity of 99.7% which is excellent.”

Consultant Paediatrician Professor Mike Shields, who led the research, said: “Meningitis presents a clinical challenge for the emergency department doctor because the patient's symptoms can be non-specific.

“No doctor wants to send a seriously sick child home, which is why this new diagnostic test holds such promise. When this test is available it will have the potential to save many lives.”

HiberGene Diagnostics Ltd is a start-up client company of NovaUCD, the Innovation and Technology Transfer Centre at the University College Dublin.

The company plans to market the test in the first half of 2012 and is in discussions with potential distribution partners in the US and Europe.

Keeping hold of key members of staff has always been an issue for successful organisations. To avoid head-hunters, Anton Franckeiss explains valuable measures to increase employee retention and satisfaction.

Although the pharmaceutical industry is one that consumers tend to depend on to provide instant cures or magical remedies to our all too human frailties, it actually operates to a longer timeframe. Any new treatment for our remedies may take only seconds to swallow, but will have been in development for many years, and possibly even decades. But despite its foundation in long-term projects, the industry also experiences higher than average staff turnover rates – a circumstance that the industry shares with IT and financial services. While the requirement for specialist knowledge and professional skills is a common factor across all three of these sectors that should not be ignored, human resource (HR) professionals within the industry should resist the temptation to believe that there is a single cure that can be prescribed and administered.

Although the analogy may be a simplistic one, especially in the industry context, adopting a holistic view that sees retention rates as one of the vital signs of the ‘patient’ (ie the workforce of each pharmaceutical company) may be helpful. Recent surveys, both by Pharmaceutical Field and by the Chartered Institute of Personnel and Development, have shown a slowing of staff turnover rates in the industry. Yet the reasons may be at least partly a reflection of the broader labour market and economy.

In an era of slow economic growth after a sharp recession, employees are seeing redundancies elsewhere – or even closer to home – and may have drawn the conclusion that the metaphorical frying pan might be a happier place to be for the medium-term than the unknown quantity of the metaphorical fire. There is, however, no room for complacency here. If the factors at play are limiting turnover rather than actively encouraging retention, the ‘condition’ could flare up again at short notice depending on movements in the broader economy: a chronic condition, after all, requires monitoring and management to ensure that any chances of it becoming acute are minimised.

Road to recovery

The analogy of a chronic condition, however, should be challenged. A continuing situation of poor retention does not imply that this either must simply be lived with or will inevitably get worse. There is no reason that the prognosis should be gloomy, although a combination therapy approach will be required and the regime will need to be maintained for some time before improvements in the underlying condition are secured. The key to success lies in the depth of understanding that the doctor – in this case the HR functions of companies in the industries – can acquire about their patient.

Without research, dialogue and communication, companies can too easily assume that they understand the retention factor priorities of their workforce, while the employees actually see the outlook rather differently. A 2006 survey by Talent Drain, for example, showed that employees rank ‘cooperation’ as the second most important factor, while employers listed this in ninth place.

Employers also typically overstate the impact of pay and financial rewards, while underestimating the importance to employees of opportunities for personal growth. What appears as a mission critical role contribution through one end of the telescope looks more like one component of an on-going personal biography from the other. In an industry that embraces great diversity of roles – from sales to scientific specialists – there is likely to be a similar diversity of outlook – the intelligent response is to seek understanding rather than to assume that a single remedy can be applied in all cases. Feedback to HR from line management in different operational areas could be helpful here, so keep lines of dialogue open.

The right prescription

Employee motivation and engagement requires similar treatment; although recent surveys say suggest turnover is reduced, they also suggest what an earlier Pharmaceutical Field article, called The Fear Factor, highlighted. Pro-actively seeking to increase engagement will enhance the chances of turning a cure into a preventative approach. The highly engaged will be less easily tempted away when external economic factors change. Again, an appreciation of potential complexity will be helpful. Scientific staff may be balancing a need to supervise and manage others and commercial encouragement from the organisation to develop their leadership skills with their personal commitment to their professional discipline. Acknowledging such a potential conflict of factors will be a far more productive way of identifying motivational approaches than failing to address it.

There are also industry-specific challenges to address, one of which was highlighted in an interview between the BBC’s Evan Davis and GSK Chief Executive Andrew Witty in the former’s recent book, Made in Britain: “One of the things we say to our scientists is that you have to be comfortable with failure. [There are] great scientists in this company who will never succeed in their entire career … Of 10,000 new molecules that we might synthesise, so that we might create 10,000 possible new drugs, probably one will be a drug.”

Strategies that promote innovation – the use of multi-disciplinary project teams where each can make their own distinct contribution and gain inspiration from other – can help here in other ways. But also allow staff with specialist skills to receive peer, as well as line management, feedback on the value of their contribution. It was a point by Alistair Flaister in a People Management article, Organisational learning: The social network, when he made the important point that: “The real engine of creativity and organisational success is to be found in internal networks of friendship and collaboration.”

Line managers have other contributions to make, not least in listening acutely and in building a supportive and encouraging team culture. It’s a point underlined in the 2010 Work Foundation report, Exceeding Expectations: the principles of outstanding leadership, which identified two elements common to the approaches of outstanding leaders in creating a working environment:

The first is the need to develop an open and supportive atmosphere to create the conditions for trust and respect, and the second is to ensure the workplace enabled success and satisfaction.

Part of the latter element may require support from HR in terms of fresh thinking. Depending on the severity of the case, HR might also ponder the benefits of making a referral to a specialist consultant. Helping specialist staff to make the transition to a leadership role is not simply a progression or promotion through a series of levels of leadership. It requires them to make a fundamental transition from development of a professional discipline to that of a broader organisational and commercial role. It also requires the transfer and application of new behaviours that challenge and enhance their performance and contribution. Two other factors that The Work Foundation found as common to outstanding leaders is a willingness to be flexible in their approach to process, and a willingness to adapt roles to give individuals the maximum opportunity to achieve personal growth and job satisfaction. An organisational willingness to be similarly flexible in role definition and organisational design can support good leaders within the company to deploy this approach successfully.

Never say no

Think of a talented individual that the company should seek to retain, and then imagine how they might feel if they heard the words “I’d love to be more flexible, but I’ve spoken to HR and they said …” It’s also helpful to remain mindful that disengagement is unlikely to be a proactive personal choice – employees are more likely to become disengaged as a reaction.

Ultimately, employee retention is not so much a condition as a symptom. An indicator that employee engagement is low, that opportunities to satisfy personal motivations are too limited, that opportunities for progression are overly limited or unclear, or that employees are not receiving positive feedback on their performance and/or contribution when praise is due. The answer is not to treat the isolated symptom, but to investigate the underlying condition and develop a comprehensive talent management strategy that will systematically improve organisational health. Even in an industry where specialist skills are a key requirement in many roles, an employee value proposition and a recruitment strategy that identifies employees with a strong cultural fit are still important requirements. Any industry dependent on innovation and intellectual property should appreciate that human resources are its critical input. And most employees – who will, after all, have chosen to make an application to join the organisation and done so in good faith – are ultimately looking for something relatively straightforward: regular reminders of several good reasons to stay. That, of course, is easy to say, but there’s something positive to be said for making it easy to do.

Anton Franckeiss is the Managing Director of ASK Europe.

Leicester University has developed a new ‘Star Trek-style’ medical suite to help diagnose hospital patients with potentially serious diseases.

The £1 million ‘sick bay’ aims to assess patients more quickly, reducing the number of time-consuming and uncomfortable blood tests.

Professor Paul Monks, who helped develop the new facility, said: “We want to free doctors to actually treat patients and this technology enhances that ability.”

The medical bed assimilates the “ultimate non-invasive diagnostics”, which Star Trek fans will recognise, said Professor Monks.

“Dr McCoy in Star Trek had a tricorder that he waved over the patients to help diagnose diseases.”

Professor Tim Coats, a consultant at the hospital, said that the non-invasive technology uses one group of instruments to analyse the patient's breath, while a second group uses imaging originally intended for exploring the surface of Mars, while a third looks inside the body to measure blood flow.

The new high-tech facility has taken three years to develop, and promises to improve detection of serious diseases such as cancer, heart failure and infections. Professor Monks said: “We’ve shown that it can detect lung cancer quite early.”

Leicester Royal Infirmary plans to use the new equipment within two weeks in its Accident and Emergency department.

For the first time in a century, new guidelines outlining how to diagnose and treat blood pressure has been issued by NICE.

The document, developed in corporation with the British Hypertension Society (BHS), features the major recommendation that blood pressure should be monitored over the course of 24 hours using ambulatory methods, which confirms draft guidelines published in February.

Professor Bryan Williams, from the University of Leicester, chaired the guidelines and estimates that up to 25% of people diagnosed with high blood pressure using the current method of attending routine check-ups with a GP, may not be hypertensive and may not require treatment.

Professor Williams commented: “This new guideline is going to change the way blood pressure is diagnosed and treated for millions of people in the UK and around the world.

“It means that we will be more accurate in treating those who need treatment and in avoiding treating those who don't”.

The new devices cost a heft £1,000-£2,000, but the guidelines note that “by improving the speed and accuracy of diagnosis, we will actually save money by only targeting treatment at those who need and will benefit from treatment”, stated Professor Williams.

“I am under no illusions about the challenges to implement this but I believe this guideline will be well received by both doctors and patients not just in England and Wales, but worldwide”.

As well as claiming that the new approach is highly cost-effective, the guidelines also simplify the treatment strategy for high blood pressure, giving focus to the most effective treatments. The document also contains specific advice on the treatment of blood pressure in young adults and the very elderly.

The official guidelines can be read here.

The FDA has appointed Dr Stephen Spielberg to the new post of Deputy Commissioner for Medical Products and Tobacco.

The appointment comes as part of a reorganisation of the Agency’s management structure, in a bid to ease agency-industry relations following Joshua Sharfstein’s exit of the FDA in January.

Peter Pitts, former FDA associate commissioner for external relations, commented that the reshuffle will bring “a stronger voice in agency policy development”.

Dr Spielberg’s post will oversee the centres for drugs, biologics, medical devices and tobacco products, as well as heading special medical programmes.

He currently works as Director of the Centre for Personalised Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City and has previously worked at Merck and Johnson & Johnson.

Record prescription drug shortages in the US will soon reach crisis point, say pharmacists and doctors, who spend hours each day searching for medication.

FDA recalls, production difficulties and corporate decisions to discontinue certain medications are cited as the main causes of the drug insufficiency.

Michelle Taymuree, Clinical Pharmacy Manager at Diablo Valley Oncology, California, said: “When we go to order, it's more common to see drugs in limited quantity, on back order or completely unavailable than it is to see drugs that are completely available”.

A growing number of patients in the US are reporting both delays and disruptions in their treatments. Some patients eventually receive their medications but others have had to switch regimens, and the health impact of these changes is unknown.

Medical professionals have no choice but to scramble for little supplies available or in some cases to delay potentially lifesaving treatments.

Maria Serpa, President of the California Society of Health-System Pharmacists, stated: “Pharmacists have worked diligently to keep this from impacting physicians and patients. Patients shouldn't have to be the ones to pay”.

Alternative treatments have blunted the impact in some cases, but it’s only a matter of time before those options will diminish too.

The number of drugs in short supply currently lies at 190, compared to 70 drugs in 2006, according to the University of Utah Drug Information Service.

More than 90% of US hospitals reported a drug shortage in the past six months, and nearly 45% claimed at least 21 shortages during that time, reported the American Hospital Association in June.

Most medications in short supply are those used in hospitals, including generic injectables, cancer drugs, anaesthesia, electrolytes, vitamins and minerals.

Click here to read other statistics relating to the drug shortages.

The development of a new computer software programme allows patients with type 2 diabetes to manage their condition through the use of their mobile phones.

According to a study by the University of Maryland School of Medicine, the amount of haemoglobin A1c in a person’s blood was lowered by 1.9% over a period of a year in patients using the mobile health software.

Dr Charlene C. Quinn, Assistant Professor of Epidemiology and Public Health at the University of Maryland School of Medicine, stated that the results were encouraging, and that “previous randomised clinical trials have suggested that just a 1% decrease in A1c will prevent complications of diabetes, including heart disease, stroke, blindness and kidney failure.”

The study indicates that the use of modern technology may be able to help patients and their physicians manage more health conditions in the future.

Dr Quinn commented: “Mobile health has the potential to help patients better self-manage any chronic disease, not just diabetes. This is one of the first large, reported, randomized clinical studies examining the mobile health industry, which is rapidly growing.”

The software sends the patient's blood sugar results wirelessly from a blood glucose monitor to the mobile phone. If the level is too low or too high, the software prompts the patient to rectify the reading. The system can also send logbooks and suggested treatment plans to the patient’s doctor.

The FDA has released draft guidance on how it intends to regulate the field.

The amendments in the Health Bill to the commissioning landscape may have
been small but they are significant for pharma. David Round (pictured) outlines the
implications of these changes to the care pathway and the new opportunities
for joint working.

The dust is beginning to settle on the amendments to the Health and Social Care Bill and it is now time to assess just what the changes in commissioning structure will mean in practice. How will the renamed Clinical Commissioning Groups (CCG) approach the creation of care pathways? Will there be much change from the model used by the previous Primary Care Trust (PCT), or will these new organisations opt for a ‘business as
usual’ approach where possible in order to simply get commissioning processes up and running in a timely fashion?

And what opportunities does the increasingly local focus on commissioning provide pharmaceutical companies to deliver added value services over and above drug products
that are increasingly viewed as a commodity across the NHS?

For pharmaceutical companies the good news is that the changes to the Bill, following the ‘pause and listen’ process, are not overwhelming. The coalition Government has accepted
many of the recommendations of the NHS Future Forum but the essence of the shift towards greater local commissioning remains the same.

The newly created GP Commissioning Consortia (GPCC) remain in place – albeit under the new name of CCG to reflect the inclusion of nursing and hospital consultants on the main board. The pressure is also off CCGs to be ready for the 2013 deadline – although those that are ready will be able to proceed with their commissioning plans sooner. In areas where CCGs are not ready to undertake commissioning duties, the National Commissioning Board will take over from the PCT Clusters for an interim period.

There is also a move towards greater local accountability, with CCGs now required to consult with a raft of new local bodies, including Clinical Senates – responsible for ensuring
CCG clinical plans are robust and meet local requirements – local NHS Commissioning Boards, and Health and Well Being Boards.

New constellations

All of these groups will have an influence on the evolution of the care pathway and must, therefore, be considered within the pharmaceutical market access strategy. Clinical Senates will work alongside the existing clinical networks – such as cancer networks – to ensure CCGs take local and disease specific requirements into consideration. If the Clinical Senate believes that care pathway plans are not good enough it can recommend the NHS Commissioning Board steps in before the CCG is authorised to act as a commissioning group.

As yet, the makeup of these Clinical Senates and local NHS Commissioning Boards is not clear. However, with the continuing exodus from PCTs, there is no doubt that some familiar names will reappear in these new roles.

It is also clear that there is a fast developing gap between the most advanced CCGs and the rest. Some, indeed, have already set their clinical priorities and are looking at care pathways. Within this process, these CCGs will have taken into account the views and concerns of local clinicians and local clinical requirements. The difference now is that there will be formal bodies in place to undertake that local clinical accountability.

For pharmaceutical companies the message remains consistent: market access strategy success will depend upon gaining an in depth insight into not only the CCGs and the speed
with which they are progressing and embarking towards clinical decision making, but also understanding the new influencers within the Clinical Senates and local NHS Commissioning
Boards.

Understanding the mission

However, there is one change to the Bill that also presents significant opportunities to pharmaceutical companies – the decision to place medical research at the centre of the
NHS mission. Under the amended proposals, ­The Secretary of State for Health will be given a statutory duty to promote research, while the new CCGs will be actively required to encourage research, innovation and the use of scientific evidence through their decisions.

This move is fundamental, and addresses criticism that the original Bill did not encourage doctors to make use of improved therapies or the latest evidence on clinical best practice.

For pharmaceutical companies, this shift in emphasis opens the door towards more innovative, cooperative working; and for embarking on joint working initiatives with CCGs. It also ensures doctors and pharmacists will continue to be involved in research projects, from clinical research to patient care, patient outcomes and procedures.

Indeed, some of the CCGs are already actively seeking more opportunities to get involved in programmes and projects that can deliver better patient outcomes by reconfiguring patient services. These leading groups want to work with pharmaceutical companies on research projects that could, if successful, be rolled out across a number of CCGs and allow them to deliver care pathways that meet budgetary constraints.

One big leap

For pharmaceutical companies this will necessitate a new approach. It may require a shift in budget towards a significant up-front investment in developing a new service within a
CCG with a view to recouping that investment further down the line when the service is successful. Fortunately, with companies no longer able or willing to spend money on certain promotional items and activities due to ABPI code changes and the new Bribery Act, there are opportunities to redirect funds towards such programmes.

Key to the success of such joint working is openness: both pharmaceutical companies and the NHS need to clearly understand the benefits to both sides of the venture. ­The  pharmaceutical company cannot simply put in a new service in order to improve product sales; that will not work in today’s NHS. The emphasis must be on implementing a service
that raises the profile of the disease area, which in turn leads to an increase in the whole market – generating additional sales – but reduces the overall burden of the disease on the
local health economy. For the NHS, there will be an investment in resource that effectively identifies certain types of disease earlier, enabling cost savings through improved preventative care.

There is a valid concern amongst smaller and medium-sized pharmaceutical companies that they simply cannot fund joint initiatives on this scale. Feedback from the NHS suggests that companies will be encouraged, even expected, to band together to create a joint working partnership.

Looking into outer space these changes are significant. But they are also taking place within an environment of increasing financial constraint. It is essential that pharmaceutical companies understand the genesis of change; to identify the changes in care pathway and patient pathway that are occurring as a result of natural budgetary restraint and those that
are a direct result of the shift in commissioning structure.

Armed with this insight, companies can ensure messaging remains valid and effectively targeted and reflects the changes that can and are being made by CCGs. Messaging must
reflect the huge pressure on CCGs to reduce costs whilst also improving patient outcomes. And it must recognise the fact that many of these organisations are and will be looking
for partners that can offer innovative solutions and services – from specific procedures to drugs or devices – proven to meet these objectives.

It is those organisations that can take that messaging, that can identify and engage with the CCG vanguard and, where appropriate, embark upon joint initiatives that can be extended over time that will be well placed to meet the needs of increasingly local
commissioning policies.

David Round is the UK General Manager of Cegedim Relationship Management.