GHP December 2015

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December 2015

www.ghp-magazine.com

Research, Translation, Commercialisation

Essentia Progress in Sterile Services and Beyond We speak to Tracy Cheung, Head of Marketing and Engagement and Anne-Marie Watts, Head of Sterile Services, to find out more about the exciting new projects the firm is working on.

Good Laboratory Standards Developed for Dealing with Infectious Diseases

Public Health England is in the final stages of creating UK SMI Q 7, which is designed to provide advice on good laboratory practice when undertaking serology assays for infectious diseases.

GS1 standards in healthcare – giving the certainty of truth

Glen Hodgson, Head of Healthcare at GS1 UK, the independent, not-for-profit standards organisation of over 29,000 members, explains how GS1 standards are seen as vital in healthcare.

Why employees need a special space away from the desk to restore psyche

editor’s note

this month’s features

Welcome to the December Issue ofghp Magazine.

As 2015 draws to a close Nooman Haque, Director of Healthcare & Life Sciences for the Silicon Valley Bank UK Branch talks us through the prevalent trends in the healthcare sector over the past year.

This issue’s foreword comes from Northern Ireland’s Health Minister, Simon Hamilton, who provides us with an insight into his department’s latest initiative, Making Life Better.

Guy’s and St Thomas’ infrastructure department also offers outsourced services to firms and other NHS trusts. We speak to Tracy Cheung, Head of Marketing and Engagement, and Anne-Marie Watts, Head of Sterile Services, to gain a fascinating insight into the firm and its work.

Mark Britnell talks us through his innovative new book, In Search of a Perfect Health System, which offers a global analysis of healthcare services from around the world and the positive and negative aspects of each.

In this issue we also explore a number of exciting new strategies from Public Health England, which could change the face of the UK health service in the long run.

We hope you enjoy this issue.

Essentia Progress in Sterile Services and Beyond We speak to Tracy Cheung, Head of Marketing and Engagement and Anne-Marie Watts, Head of Sterile Services, to find out more about the exciting new projects the firm is working on. Page 14

inside this issue 04 News 06 Philips and Massachusetts Institute of Technology Team up to Make Managing Brain Injuries Less of a Headache for Doctors and Patients 08 Canada Innovation Centre 10 Why employees need a special space away from the desk to restore psyche 12 The ECDC’s Stance on Antimicrobial Resistance 18 GS1 standards in healthcare – giving the certainty of truth 22 Good Laboratory Standards Developed for Dealing with Infectious Diseases 24 Genzyme Introduces “vs.MS,” a Global Initiative Aimed at Uncovering the Often Unspoken Challenges of MS to Drive Better Informed Care 26 Trends in Healthcare Investments and Exits – a UK Outlook 30 Tagrisso™ (Azd9291) approved by the US FDA as treatment for patients with EGFR T790m mutation-positive metastatic non-small cell lung cancer

“Treating infections due to antibiotic-resistant bacteria is a challenge: commonly used antibiotics are no longer effective and doctors must choose other antibiotics to treat infected patients.”

Dr Andrea Ammon, European Centre for Disease Prevention and Control’s Acting Director

Global Health & Pharma, 39A Birmingham Road, Blakedown, Worcestershire, DY10 3JW Tel: +44 (0) 1234 567 890 | Email: info@ghp-magazine.com | Web: www.ghp-magazine.com

news

MPs urge Government to Implement Sugar tax A group of influential MPs has urged the Government at the end of November to introduce a tax on sugar sweetened soft drinks to help combat childhood obesity. The recommendation was made in a report by the Health Select Committee, following their inquiry into childhood obesity.

The Government has come under growing pressure to include a proposal to implement the tax as part of its childhood obesity strategy, which is expected out early in 2016. In October 2015, Public Health England called on the UK Government to herald the tax in its sugar reduction report.

The Health Select Committee report also calls for limits on price promotions on unhealthy foods and restrictions on the marketing of unhealthy food to children.

Chris Askew, Diabetes UK Chief Executive, said: “Almost a third of children in the UK in their final year of primary school are overweight or obese and if nothing is changed they will be at greater risk of developing Type 2 diabetes in later life, which is a serious health condition that can lead to debilitating and life threatening complications such as amputations, heart attack and stroke. These complications are not only personally devastating to all those involved but also continue to put great pressure on an already stretched NHS. “This is why it’s essential that there is bold and far reaching action taken across a number of areas to enable people to make healthy choices. The recent launch of the NHS Diabetes Prevention Programme, aimed at those at high risk of Type 2 diabetes, is an important first step. But there is still more to be

done, which is why we want the Government, to implement the recommendations from today’s Health Select Committee report into childhood obesity.

“As the report makes clear, a package of measures is needed for reducing childhood obesity, which includes restricting marketing of junk food to children; making food and drinks healthier; and mandatory consistent front of pack colour-coded labelling to help parents make informed choices when buying food for their families. We also support calls to introduce a tax on drinks high in sugar, reducing and rebalancing the number and type of the price promotions on unhealthy foods and setting national standards for healthy foods in the public sector. The Government should also continue to invest in educating the public about healthy living and making it easier for people to be more physically active.

“If enacted together all of these measures will provide a supportive environment to enable members of the public to live long and healthy lives.”

Diabetes UK has joined a new national alliance of organisations fighting obesity. For further information, you can read the alliance’s joint statement here: https://www.diabetes.org.uk/Global/Homepage/News/FINAL_%20joint_position_childhood_ obesity_ASNov15.pdf

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Care Home Prescribing Safer through Welsh Government investment In November, the Welsh Government announced investment in new technology in pharmacies and care homes throughout Wales with the aim of reducing wasted medicines and prescribing errors as well as improving patient care

Health and Social Services Minister Mark Drakeford visited Tower Hill Residential Home, in Penarth, which is one of 30 care homes to pilot a new system, utilising innovative barcode technology generated in local pharmacies, to ensure residents receive the correct prescription medicines.

The Minister witnessed the system in action at the nearby Washington Pharmacy where he met the residents and staff. Pharmacies and care homes in Swansea, Tondu, Neath Port Talbot and Carmarthen are also participating in the pilot.

to deliver greater safety and efficiency and develop the role of the pharmacy.”

“An independent Cardiff University School of Pharmacy study of six of the care homes involved has found that as well as significant staff time spent on medicines management, on average each care home was carrying around £500 of overstocked medicines. Improved stock control in each residential home ensures that fewer medicines reach their expiry date before use and therefore have to be thrown away.”

Professor Drakeford added: “This system makes the best use of pharmacists’ time and expertise; reduces waste and improves safety for residents. It’s a great example of collaboration as well as prudent healthcare – making the best use of resources to improve the care people in Tower Hill and the other care homes taking part in this pilot receive.”

The project is sponsored by Abertawe Bro Morgannwg University Health Board. © Crown copyright

Care home staff use the new system to: • Identify the resident; • Select the right medication and; • Record its administration.

Error checking and data collection are built into the system to ensure a safer and more efficient medicines management process.

Professor Drakeford commented: “This new way of working is improving the quality and safety of care within care homes and reducing waste – not just wasted medicines but also wasted staff time.

Ordering and managing medicines in a care home can be a full-time job, which is time that could be better spent caring for residents.”

Technology company Beacon Digital was awarded £455,000 from the Welsh Government’s Health Technology and Telehealth Fund to demonstrate the effectiveness of the system in Wales. The funding was used to buy equipment, develop the supporting software and train more than 500 care home and pharmacy staff in its use.”

Professor Clive Bowman, executive chairman of Beacon Digital, said: “We are delighted to have the support of the Welsh Government to demonstrate the effectiveness of technology

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r&d

Philips and Massachusetts Institute of Technology Team up to Make Managing Brain Injuries Less of a Headache for Doctors and Patients Research project combines ultrasound technology, computer modeling & neurosurgery experts to find a better way to measure intracranial pressure from the football field to the battlefield.

Royal Philips has announced it has teamed up with the Massachusetts Institute of Technology (MIT) to research the use of Philips ultrasound technology and MIT physiological modeling as a less invasive way to measure intracranial pressure (ICP), an essential tool in managing patients with brain injuries. It could also allow doctors to use the measurement on less critical patients, who might not normally be considered for such monitoring. During the study, Philips, a diversified health and well-being company, will work with leading experts in the field of neurosurgery to test a core estimation algorithm that has been developed by the Integrative Neuro-monitoring and Critical Care Informatics Group in MIT’s Institute for Medical Engineering and Science (IMES).

Current standard ICP measurement procedures require surgical penetration of the skull or lumbar spine and insertion of a catheter into the cerebrospinal fluid space or neural tissue posing a high risk of infection and damage to vital brain structures. Due to the invasive nature of the procedure, only a small number of patients who may require ICP monitoring are typically tracked and benefit from it – often those suffering from the most severe head injuries. This trial could create the opportunity to take ICP measurements in an expanded group of patients who would not routinely be monitored because of the health risks involved with measuring ICP. “The current invasive method of measuring ICP is used only in the sickest patients, but knowledge of ICP is potentially important in a much broader population,” says Thomas Heldt, the Hermann L.F. von Helmholtz Career Development Professor at MIT’s IMES and assistant professor in MIT’s Department of Electrical Engineering and Computer Science, who is principal investigator of the study. “Our goal is to develop a noninvasive method of measuring ICP that could be used in treating a much wider range of conditions. This project gives us an exciting opportunity to test innovative hardware and modeling techniques at the bedside in real time.”

Over the next two years, Philips will work with MIT to research a fully non-invasive and calibration-free

approach to estimating ICP and thereby enable better diagnosis and triage in cases where a patient has suffered a brain injury (football field, ambulance, battlefield, and emergency room). Using Philips portable ultrasound technologies and monitoring technologies, as well as the MIT model-based estimation approach, researchers hope to get the value of ICP without penetrating the skull. Further, researchers hope to expand the use of the technology to non-traditional patients, such as those with unexplained headaches, mild and moderate traumatic brain injury, or even coma patients, who normally would not have access to this type of procedure, but who could potentially benefit from it.

Philips recently announced the opening of its new Philips Research headquarters for North America in Cambridge, Massachusetts, where it will perform these types of research projects in close collaboration with local academic and healthcare partners. Focused on understanding how medical technologies can be adapted to tackle some of society’s most pressing issues, Philips hopes that this type of research can lead to meaningful innovations that can help reduce care costs and improve patient results.

“Today it is very difficult to gauge the level of head trauma someone has sustained at the scene of an incident, because there is no quick and effective way to gauge the pressure inside the skull,” said Dr. Joseph Frassica, Chief Science Officer of Philips Research North America. “Through this research, we hope to use the same technology most people associate with the first images of their child, in a way that has the potential to help us to differentiate a concussion from a serious traumatic brain injury and everything in between. Whether you’re a high school football player, in the NFL, a soldier in the battlefield, or unfortunate enough to be injured in an auto accident – we hope that this technology will give first responders a better way to determine if you have a life-threatening brain injury and allow faster and more accurate triage and treatment. By improving access and response times, these types of solutions have the potential to really impact patient outcomes.”

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innovation & technology

Canada Innovation Centre Launched in 2008, the Canada Excellence Research Chairs (CERC) Program awards universities in Canada up to $10 million over seven years to support world renowned researchers and their teams to establish ambitious research programs at Canadian universities. Currently six of 24 CERC chairholders are working in the health and related life sciences and technologies. Luda Diatchenko, Canada Excellence Research Chair in Human Pain Genetics, for example, is working with her team at McGill University to facilitate the development of individualized treatments and therapies for conditions related to chronic pain. Her primary objective is to better understand the genetic mechanisms at the roots of chronic pain as a basis for developing new pain-relief drugs and personalized pain therapy strategies.

In 2000, the Government of Canada created a permanent program to establish 2,000 research professorships—Canada Research Chairs—in eligible degree-granting institutions across the country. The program invests approximately $265 million per year to attract and retain some of the world’s most accomplished and promising minds to Canada. Chairholders receive funding through Canada’s three research granting agencies in the areas of natural sciences and engineering, social sciences and humanities, and health sciences. Currently, 552 researchers are being funded

by Canada’s health research funding agency, the Canadian Institutes of Health Research, for a total of $537,900,000. Canada Research Chairs have made significant advances in health research. For example, Carolyn McGregor, Canada Research Chair in Health Informatics, is a lead creator of the Artemis Project, which allows doctors to see early warning signs of infection in premature infants up to 24 hours before any symptoms show, by applying real-time online big data analytics and data-mining principles.

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health & social care

Why employees need a special space away from the desk to restore psyche Debra Ward, Managing Director for EMEA at Condeco Software Over time there has been a growing appetite for a space other the work desk. Recent research has found that UK adults spending almost an entire day a week of their working life online, this kind of work life can have detrimental effects on a workforce. In order to keep staff invigorated and boost collaboration, business leaders in the pharmaceutical industry need to create more break-out spaces..

The figures show, as according to the latest Office of National Statistics (ONS), the average adult spends more than 20 hours online a week, which includes time spent on the internet at work. Therefore, breakout spaces are vital way for businesses to help give staff a rest from the glare of their computer screen.

These areas can be described simply as a separate space, away from the normal work arena, where you can relax, eat, brainstorm, or even hold meetings. A break from the computer screen is not to be underestimated; it comes with many benefits such as helping firms comply with health and safety rules.

Firms may be under the impression that such spaces are a luxury which they cannot afford. However, decision makers must consider the benefits and positive impact on the culture of the office before ruling out creating such an area.

Forward-thinking pharmaceutical companies were quick to realise the importance of creating break-out spaces in the office. To some businesses however, it may seem like a fad and ‘agility’ and ‘flexible working’ are interpreted as just industry buzz words. That couldn’t be further from the truth. Organisations are increasingly seeing the huge benefit these spaces can yield. It improves employee engagement and over satisfaction by giving a space for staff to discuss the business with one another comfortably, creating better cross-functional relations and partnerships.

By embracing technology, decision makers can now simply use data to re-arrange their workspace. Having tangible data means that firms can make full use of their office space, which is vital when real estate is so costly. But having data goes further, it gives businesses the power and information to drive change in their workplace, efficiently and effectively.

Creating well-planned and well- thought out breakout spaces can make it easier for staff to work together, which in turn drives collaboration. The connectivity which these areas create, through innovative technology, also means that that a more engaged workforce is created, helping them pull together as a team towards business goals.

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industry insight

The ECDC’s Stance on Antimicrobial Resistance We speak to Dr Andrea Ammon, the European Centre for Disease Prevention and Control’s Acting Director, on the issue of antimicrobial resistance and the initiatives they are using to prevent it.

What is ECDC’s role in combating antimicrobial resistance?

The mandate of ECDC is to identify and assess the risks of communicable diseases for EU citizens and communicate about these risks; this includes the area of antimicrobial resistance. Management of these risks as well as of the factors that contribute to control of communicable diseases are under the responsibility of each EU Member State.

Activities related to this topic at ECDC, take place under the antimicrobial resistance and healthcare-associated infections programme. ECDC’s main areas of work include surveillance, epidemic intelligence, developing evidence-based guidance and systematic reviews, training, support to the EU Member States and, on 18 November each year since 2008, coordination of a European Antibiotic Awareness Day to raise awareness about antibiotic antimicrobial resistance and the need for prudent use of antibiotics.

Considering the global scale of the problem, how do you believe organisations, Governments and businesses can work together to combat it?

Tackling such a complex issue requires a multi-faceted ‘One Health’ approach, already laid down in 2011 in the European Commission’s action plan against the rising threats from antimicrobial resistance. This action plan contains actions for implementation by the Commission with EU Member States and identifies areas where measures are needed such as monitoring and surveillance, research and innovation, and communication, education and training, amongst others.

Partners and stakeholders must continue working on those actions and areas together. This means that everybody, including policy makers, health professionals, patients, and governmental and non-governmental organisations, has a role to play in keeping antibiotics working. Our commitment, from ECDC’s perspective, is to keep prevention and control of antimicrobial resistance as one of our priorities.

How serious is the problem of antimicrobial resistance?

Treating infections due to antibiotic-resistant bacteria is a challenge: commonly used antibiotics are no longer effective and doctors must choose other antibiotics to treat infected patients. This may delay getting the right treatment to patients and may result in complications, including sometimes death. Also, a patient may need more care as well as alternative and more expensive antibiotics, which may have more severe side effects.

And the situation is getting worse with the emergence of new bacterial strains resistant to several antibiotics at the same time (known as multidrug-resistant bacteria). A major antibiotic resistance problem, especially in hospitals, is the emergence of bacteria that are resistant to multiple antibiotics including last-line antibiotics, which therefore severely limits treatment options for infected patients. Such bacteria may eventually become resistant to all existing antibiotics.

If this becomes the case, this would mean returning to the “pre-antibiotic era”, and organ transplants, cancer chemotherapy, intensive care and other medical procedures would no longer be possible. Bacterial diseases would spread and could no longer be treated.

What can be done to solve the problem?

ECDC has identified three main strategies to address antibiotic resistance.

• Prudent use of antibiotics is the cornerstone of preventing the emergence and spread of resistance, since antibiotic resistance being reported across Europe is directly linked to antibiotic use.

• Implementation of good infection control practices, including hand hygiene as well as the screening and isolation of infected patients in hospitals, is essential to prevent the spread of resistant bacteria.

• Promoting the development of new antibiotics with novel mechanisms of action is essential, as resistance inevitably builds over time. Proposing innovative incentives for the development of effective antibiotics has been one of the priorities of the EU-US Transatlantic Task Force on Antimicrobial Resistance (TATFAR).

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industry insight

Essentia Progress in Sterile Services and Beyond Initially an incorporated infrastructure service for Guy’s and St Thomas’ Hospital Trust, the company has now expanded and outsourced a number of departments and consultancy services for GSTT and other trusts. We speak to Tracy Cheung, Head of Marketing and Engagement and Anne-Marie Watts, Head of Sterile Services, to find out more about the exciting new projects the firm is working on.

Essentia is the in-house directorate at Guy’s and St Thomas’ Hospital Trust, covering a number of non-clinical areas. Tracy Cheung outlines those areas for us and explains why this service is so vitally important to the trust.

“Essentia is all about offering infrastructure services, which includes everything from catering and cleaning to transport and accommodation all the way through to constructing the buildings and maintenance. We also look after all the IT systems for the trust, and maintain a number of properties within our community projects.

“The organisation has been operating for many years, starting life as the Capital Estates Facilities Directorate, then gradually growing to incorporate more facilities until eventually we decided to rename it, asking staff for an appropriate name. They decided upon Essentia, because ultimately what we provide is the essential services which help the trust to keep going.”

of their work for 23 external private sector healthcare providers.

As well as sterilisation services, the department also has a manufacturing unit which makes sterile products such as flexible endoscopy scopes and dental products, as well as a medical devices unit which sterilises bulky medical devices such as commodes and wheelchairs.

Despite their vast workload, the department has continued to grow over the last few years. Anne-Marie Watts, Head of the Sterile Services department, was brought in two years ago to help commercialise and expand the department. This has led to a £5mn investment to create an additional centre and expand the department to allow for the additional commercial work which they have now incorporated, including work for Great Ormond Street Hospital.

In 2013 the trust created an offshoot of Essentia as a private limited commercial consultancy firm, owned entirely by Guy’s and St Thomas’ and seeking to offer a number of the organisation’s vital services to other NHS trusts, as well as estates looking for management support. The services offered include management consultancy, strategic development support as well as operational aspects of the organisation’s role such as sterile services.

The sterile services department was chosen to become a part of this commercial consultancy because of their exemplary work, which primarily revolves around decontaminating the medical devices throughout the trust. As GSST is the second largest NHS trust in the UK, the department cleans as many as 10 million instruments per year for the trust alone, on top

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industry insight Additionally, the site at Guy’s Hospital has now been designated a centre of excellence by one of Essentia’s partners, Johnson and Johnson. Anne-Marie explains the importance of this partnership and how it has impacted on the department.

“As part of being a centre of excellence, Johnson and Johnson bring people from around the world to our site for training, because we are seen as the best in the industry. My team, alongside J&J, train these professionals and show them how to achieve our high standards within their own environment.

“This partnership is a key example of just how much we have grown over the last few years, from one site servicing one trust to a twin site with the largest NHS run sterile services department in the Europe currently.”

Additionally, the department is a testbed for manufactures of healthcare equipment, such as the da Vinci surgical robot, which is designed in America, and therefore not compliant with EU health regulations.

Essentia’s sterile services department works with manufactures such as da Vinci and others, ensuring that their devices are compliant with cleaning and hygiene rules set out by the EU to enable them to market them to healthcare providers within Europe.

The vital nature of the sterile service department’s work means that their work is highly governed, and it their rigorous processes which have garnered them international attention.

The trust has been supportive of the growing depart.

Echoing the decision to call the overall organisation Essentia, Anne-Marie outlines her department’s importance, stating that the trust’s support highlights the vital nature of the department’s work.

“It is vital that our work is supported because without us there would be no operating theatres, and a majority of the hospitals other services would not be able to run effectively. We clean every piece of medical equipment as well the bulkier items, so without us the trust would find it very difficult to operate.

“Because of this huge weight of responsibility we have very high standards, which we endeavour to uphold at all times. We have incredibly good quality returns, with our current non-conformances at one in 3000 failures or operational faults, which none of our commercial competitors or NHS colleagues can compete with.”

The foundation of these high standards, according to Anne-Marie, is the department’s strong focus on staff training, which, moving forward, will help the department retain its high standards despite the expansion plans they have for the sterile services division.

“We rest our reputation on these high standards, and as such we dedicate a vast amount of resources to training our staff. It takes two and a half years to train a basic level technician on all of the 5000 different instruments they have to know and check throughout the process.”

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regulation & policy

GS1 standards in healthcare – giving the certainty of truth Glen Hodgson, Head of Healthcare at GS1 UK, the independent, not-for-profit standards organisation of over 29,000 members, explains how GS1 standards are seen as vital in healthcare.

GS1 standards in healthcare uniquely enable us to identify every person, every product and every place within the NHS. Their adoption and implementation helps prevent mistakes and gives certainty of truth – it allows hospital managers and clinicians to know at all times who did what to whom, when, why and where they did it and with which medical device, implant, pharmaceutical drug and dose.

In line with the Department of Health’s eProcurement strategy in 2014 – which mandates the use of GS1 standards throughout the NHS – every single one of the 154 NHS Acute Trusts in England are now GS1 UK members. Every Trust has so far achieved at least some degree of “readiness” – and in many ways the first step has been done; the benefits of GS1 standards in healthcare are now widely accepted.

How do GS1 standards help?

Using GS1 standards enables Trusts to improve the patient experience, outcomes and safety. As part of the eProcurement strategy, GS1 standards are providing the foundation for three core enablers that will improve patient safety, deliver stronger regulatory compliance and drive efficiencies.

1. Every person: identifying patients with a wristband, which includes a GS1 barcode, and staff enables accurate and consistent information to be captured and stored about the patient and the caregiver – a major driver for patient safety 2. Every product: easily accessing accurate and transparent product information for medical supplies, equipment and pharmaceuticals enables precise ordering, improved product availability and lower transaction costs 3. Every place: identifying every physical and operational location within the healthcare system enables information to be collected and stored where each event occurs

The real power comes when you link people, products and places. We’re working with the Department of Health to drive the implementation of three primary applications across Trusts: 1. Purchase-to-pay: enabling Trusts to manage their procurement processes more efficiently while providing improved product availability 2. Inventory management: ensuring Trusts keep fewer products in stock and reduce wastage, yet ensuring products are readily available where and when they’re needed 3. Patient safety recall: making it easier to identify and remove all recalled products across the Trusts or even with the patient once they have been discharged Earlier this year, in perhaps the first ever case, the Medicines and Healthcare products Regulatory Agency (MHRA) used GS1 unique identification numbers to issue a product safety recall for metal-on-metal hip replacements. This signifies the power of using a single method of coding and identification across the whole industry and sets a great example for how GS1 standards can support healthcare and lead to better patient outcomes.

Using GS1 standards allows NHS Trusts to achieve complete traceability throughout the supply chain and true interoperability between people and systems. This enhances the patient experience, makes for quicker, safer and more effective treatment and reduces processing time, cost and administration errors. It gives Trusts, and healthcare professionals, complete visibility.

The value of GS1 standards has recently been reinforced by the interim Carter Review. This states that their adoption will allow every NHS hospital in England to save an average of £3million each year – that’s £5billion across the whole NHS – while improving patient care.

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regulation &section policy Demonstrator sites At GS1 UK, we work closely with the Department of Health, the NHS in England and industry through a collaborative approach to ensure the adoption and implementation of our standards is perfectly seamless.

When the eProcurement strategy was approved, we took a real step forward for the industry by mandating the use of GS1 standards in healthcare. And with new regulations underway – Unique Device Identification (UDI) regulations in the US and expected soon in Europe, as well as the forthcoming European Falsified Medicines Directive (FMD) – we’ve got a real opportunity to drive the adoption of GS1 standards.

Six NHS Acute Trusts in England will soon become demonstrator sites of excellence. Each of these six sites – covering a range of trust sizes, services offered and complexity of treatments – will be funded by the Department of Health to show, in a real-life setting, the benefits that GS1 standards bring in healthcare. This initiative will give invaluable insight into the practical challenges and opportunities of adopting GS1 standards in a live healthcare environment and will provide a true validation of the real costs and benefits that can be achieved.

So far, a number of Trusts have made great progress against the adoption timetable – for example Portsmouth Hospitals NHS Trust and Derby Teaching Hospitals NHS Foundation Trust have both been recognised for their significant advances in healthcare, driven by GS1 standards.

What’s next?

Although there are unprecedented challenges for the NHS, through standards and investing in digital platforms, improved staff organisation and a better approach to purchasing, the certainty and transparency of information will greatly increase efficiency and productivity across the NHS, reducing paperwork and freeing up budget – and of course releasing time to care.

The industry is embracing the transformation of the NHS in England – they know that adopting GS1 standards is the right thing to do. They know that by using GS1 unique identification numbers – which can be applied to patients, medicines, surgical instruments and patient records – the industry commits to providing a common foundation that will improve confidence in care delivery.

For this change to happen, everyone must play their part – from executive boards and procurement and facilities managers to nurses and clinicians. The next step is for the industry to work together towards one shared vision: to enable England to become a global leader in the provision of digital health and care services that improve patient safety and transparency.

It’s all about what we can do and how we can move to the next step. We are ready – are you?

For more information please visit www.gs1uk.org/ healthcare

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Good Laboratory Standards Developed for Dealing with Infectious Diseases

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regulation & policy Public Health England is in the final stages of creating UK SMI Q 7, which is designed to provide advice on good laboratory practice when undertaking serology assays for infectious diseases.

Public Health England (PHE) acts as custodian of SMIs and review the documents which are in use every three to five years. They are currently in the consulting stages of developing a guide to good laboratory practice when undertaking serology assays for infectious diseases.

SMIs are algorithms and procedures for clinical microbiology, developed through consultation. Patients, public and partner organisations can comment on any open consultations, allowing them the chance to make suggestions on how the standards could be improved.

SMI Q 7: Good laboratory practice in serology assays for infectious diseases describes the essential components of a good microbial serology service. A broad definition of serology is used in this document to include both antibody and antigen tests that are performed, usually on blood samples, to detect infection or immunity.

Conventionally, microbiology and virology laboratories perform microbial serology assays. In an increasing number of laboratories some tests are performed using analysers on automated blood sciences tracks. It is important to recognise those critical pre-analytical, analytical and post-analytical steps and procedures which are essential to the delivery of a high quality service.

The principles described in this new document are also relevant to nucleic acid amplification tests (NAATs) performed on blood samples, especially where microbial serology and NAATs are available for the same infection and may be listed together in order entry systems. In these circumstances there should be an experienced assessment of the appropriateness of performing serology tests or NAATs as part of a unified process that may include changing the request from a NAAT to a serology test, or vice versa.

Good laboratory practice, which is what this SMI documents outline within the field of serology assays for infectious diseases, is referred to as “a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived”. The aim of good laboratory practice is to promote the development of quality test data as well as to provide a tool to ensure a sound approach to the management of laboratory testing, including conduct, reporting and archiving.

Public Health England develop these standards together with partner organisations, Public Health Wales, representatives from Scotland and Northern Ireland, NHS and the Royal College of Pathologists which display their logos on the SMIs. An organisation’s logo in an SMI indicates the society participated in equal partnership and support for the objectives and process of preparing SMIs. Nominees of professional societies are members of the steering committee and working groups that develop SMIs. The nominees participate in the development of the SMIs although their views cannot be rigorously

representative of the members of the partner organisation nor the corporate view of the organisation, with nominees also acting as conduits for two way reporting and dialogue.

Each of the devolved administrations endorses SMIs. Public Health Wales bases its own All-Wales SOPs on the SMIs. The Welsh Microbiological Association, the Scottish Microbiology and Virology Network, the Scottish Microbiology Association and the Northern Ireland Microbiology Forum and Audit Group also endorse the standards.

UK Standards for Microbiology Investigations include: • syndromic algorithms, that are the overarching framework that connect other SMIs, and describe the investigations chosen at the pre-analytical (clinical syndrome) stage • recommended investigations for microbiology • minimum testing algorithms for virology (analytical and post analytical) • clinical guidance that covers the clinical background, differential diagnosis, and appropriate investigation of particular clinical conditions • quality guidance that describes laboratory methodologies to ensure quality, like assay validation, quality assurance and understanding uncertainty of measurement.

There are three groups of users who find SMIs relevant to their work, the first being practicing laboratory medicine professionals in the UK who use the SMIs as a general resource.

Additionally, clinicians use SMIs to learn about the standard of laboratory services they can expect for their patients. SMIs can help them order the appropriate tests electronically from hospital wards.

The final principal user of SMIs is commissioners of healthcare services, who use SMIs to find the standard of microbiology investigations they can seek as part of the clinical and public health care package for their population.

Within the consulting process for SMIs, members of any of these three groups are able to add their views on the document and how it could be improved. All SMIs are developed, reviewed and updated through this consultation process.

The standards unit updates and reviews SMIs by consultation using the opinions of many other stakeholders, including members of the public, partners and specialist groups. This includes microbiology professionals and doctors. The resulting documents reflect the majority view of contributors, which insures that the document is democratically produced and reflects the needs of everyone who will be affected by the document.

The full consultation, which is open until 2nd November 2015, is available to view here.

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translation & commercialisation

Genzyme Introduces “vs.MS,” a Global Initiative Aimed at Uncovering the Often Unspoken Challenges of MS to Drive Better Informed Care Initial Findings from Global Survey of People Living with Relapsing Multiple Sclerosis (RMS) and Care Partners to be Shared at ECTRIMS. Genzyme, a Sanofi company, has announced a new global initiative, vs.MS, that is designed to raise awareness of the often unspoken emotional and physical burden of relapsing multiple sclerosis (RMS) on people living with the disease and their care partners.

To better understand the full burden associated with RMS, Genzyme, which has been pioneering the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years, fielded a global survey among more than 1,500 people living with RMS and their care partners across seven countries. An initial set of data from the vs.MS global survey has been shared for the first time at the 31st Congress of the European Committee on the Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, October 7-10.

“As part of our ongoing commitment to help improve the lives of people living with MS, we are proud to introduce this new global initiative in collaboration with patients and caregivers,” said Darlene Jody, Head of MS Medical Affairs at Genzyme. “At Genzyme, we believe that when we know more, we can do more.

The experiences uncovered through the vs.MS survey will help shed light on the physical and emotional toll RMS can have, and we look forward to developing a program that may help drive a more open exchange for better informed care.”

While at ECTRIMS, Genzyme is bringing together thought leaders from across the MS Community representing people living with MS, healthcare providers specializing in the disease, and advocacy groups to review the full vs.MS survey findings and begin developing a program that will be rolled out to the community.

To unveil the initial vs.MS survey results at ECTRIMS, Genzyme is hosting an interactive digital experience at their booth, as well as sharing the findings via the @ GenzymeCorp Twitter handle. For each individual who participates in the interactive digital experience and for every retweet that includes the campaign hashtag #vsMS, Genzyme will donate 5 Euros to the Multiple Sclerosis International Federation (MSIF) in support of the organization’s research efforts.

Data from the vs.MS global survey will provide a glimpse into the impact the disease may have on various aspects of day-to-day life for people living with RMS. For example, half of respondents feel their ability to progress in their career has changed for the worse since they were diagnosed with RMS, and 40 percent are concerned about being able to keep their job.

The vs.MS survey also reveals the effect of RMS on the emotional well-being of those living with the disease and their care partners. For example, more than half of respondents living with RMS feel lonely or isolated because of their MS, while more than half of care partners do not discuss their fear of MS progressing to avoid upsetting the person they care for.

“The results of this global survey offer a unique look into the realities of relapsing MS, including the challenges that people living with MS and their care partners deal with on a daily basis,” said Dr. Barry Singer, MD, Director of The MS Center for Innovations in Care at Missouri Baptist Medical Center in St. Louis, MO, and a vs.MS steering committee member.

“We are hopeful that insight into the daily struggles of those living with MS will result in better disease management.”

The vs.MS survey was fielded among more than 1,500 people across seven countries, including people living with RMS and RMS care partners. Developed with input and guidance from a steering committee of leading global neurologists specializing in MS, the online survey addressed topics such as progression and disability; cognitive challenges; relationship and intimacy issues; emotional burden; fatigue and sensitivity; bladder and bowel challenges; and impact of MS on careers.

In the coming months, Genzyme will reveal the full vs.MS data set and partner with the MS Community to encourage behavior and attitude shifts in an effort to drive better outcomes for those affected by the disease.

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industry insight

Trends in Healthcare Investments and Exits – a UK Outlook Nooman Haque, Director of Healthcare & Life Sciences, Silicon Valley Bank UK Branch.

As we move through the final quarter of the year, 2015 is shaping up to be a pivotal year in the life science investment market. Volatility seems to have returned with a vengeance and this, coupled with the normal uncertainties surrounding the 2016 US presidential election, means it’s worth contemplating what the future may hold.

The first half of the year seemed to go according to the script: a healthy pipeline of crossover funded IPO candidates that indeed went public and continued to have positive price performance. The financial performance was in turn supported by some important clinical milestones particularly in oncology such as Novartis’ data on its CTL019 study in non-Hodgkin lymphoma and multiple myeloma. It’s this kind of positive research news that continues to excite investors.

The importance of crossover investors has been clear for some time. Silicon Valley Bank’s 2014 summary concluded that businesses attracting these investors enjoy higher valuations, quicker listings and superior post-IPO price performance. Bagging a crossover syndicate has, in the last few years, been almost a mark of approval and an inflection point in itself.

The availability of crossover money and its importance in driving capital markets interest has also helped sustain fundraising at the VC level. Limited partners, who invest in VC funds, need to be sure the investment partners can engineer a good exit or listing so that capital can be returned to them. Proving that the old adage, a return of capital is as important as return on capital, is true. Positive VC fundraising activity in 2014, up a staggering 56% on the previous year, means these firms have plenty of dry powder to deploy on new deals. The strong IPO market has also helped fuel the M&A market with upfront payments creeping up and again providing liquidity to the investors.

That pattern continued into the first half of 2015 as five of the six US biopharma IPOs that raised more than $100 million were backed by crossover investors.

Overall, nearly half of the 24 biopharma IPOs in the first half of 2015 had crossover interest. Furthermore, this optionality of allowing businesses to go public encouraged the M&A market, particularly for early stage assets. Of the 11 deals struck in the first half of the year, six were pre-clinical or phase 1. In comparison, around 40% of the IPO biopharma candidates were pre-clinical.

Medical device businesses, notable for their absence in the IPO scene, have also returned with the added bonus that two of the seven device IPOs in the first half of 2015 featured crossover investors. Overall, 2015 should top 2014’s 10 device IPOs. As a further benefit to the sector Medtronic, hampered earlier in the year by its merger with Covidien, returned as a buyer and concluded two deals.

If further proof were needed that positivity knows no bounds, Europe’s capital markets seem to have responded, albeit with more caution. Direct comparisons are harder because Europe’s more fragmented capital markets can be a weakness and a strength. It certainly appears to limit the scale of large biopharma IPOs which need specialist investment coverage. However, smaller businesses can find a happy home if they have a good story and willing investors. In the first half of 2015, 14 European businesses went public with 11 making their primary listing on a European exchange, compared to seven in the first half of 2014; although the total amount raised by the 11 businesses was slightly down at €400 million with an average raise of €36 million. In the pipeline for a London listing are two late stage biopharma businesses, Acacia and Shield, who are looking to raise enough money to propel them towards commercialisation.

That’s a good point to pick up the story now. Both Acacia and Shield made their announcements towards the end of Q3 and the financial markets were undergoing turmoil with negative news on China, ambiguous data from the US economy and to cap it all off biotech had its own focus of attention with Turing Pharmaceuticals making the headlines for all the wrong reasons.

When Turing Pharmaceuticals announced it was raising the price of Daraprim – a treatment for toxoplamosis – by 5,000% it drew the ire of the industry.

More importantly, in an environment when presidential candidates are working hard to connect with a somewhat sceptical constituency, it was kept in the news by Hilary Clinton and nightly news pundits. This brought into sharp relief the economic and moral issues around expensive treatments and called into question their necessity and the process of how drugs are brought to market. The ensuing volatility has seen the NASDAQ biotech dip 25% from its peak and has seemingly caused consternation amongst potential IPO candidates. More so, when one considers that the shares of big pharma have not responded in the same way.

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industry section insight Few doubt that genuinely innovative treatments should command prices to reflect their innovation and risk – at least within the patent system we have now – and there is little to think why the valuations of many biotech businesses who are involved in cutting edge areas should be affected by a business whose only drug came off-patent decades ago. That would be the rational response, but markets do not always respond rationally. In the face of potentially value-impacting measures like price controls, one would expect the valuation of narrow-focused biotech businesses with long development timescales to differ wildly from a diversified and mature big pharma business.

Whilst pre-election threats of impending price controls are likely to be hot air in the long run, the general turmoil has certainly caused some investors to retreat from the market and that is likely a good thing.

Momentum should not drive valuation and volatility reminds everyone that risk does and should scare away investors who, on reflection, don’t understand what they’re getting into and whose investment approach is predicated on nothing more than a greater fool investment strategy. Sensible prices are required for a sustainable capital markets and wild optimism is as bad as pervasive negativity.

It’s encouraging that, as of yet, the crossover investors who have come to anchor the market in recent years show little sign of abandoning the sector. Whilst paper valuation gains certainly help their NAV calculations and thus the fees they obtain from managing money, many crossover investors understand the longer term potential of these businesses and are buying accordingly. Thus being a leading indicator on the ability of a business to attract funding.

The corollary is that if crossover investors do start to withdraw, it will likely herald a reversal in the market and make it more difficult for many businesses to go public. This will place pressure on VC investors to play more of the traditional anchoring role in supporting an IPO and in turn this is likely to impact valuations at private and IPO rounds. Many VCs have continued to raise funds which they can deploy and use as leverage to drive favourable valuations and these experienced investors know how to get businesses onto the market or sold. In short, even in the absence of crossover investors one shouldn’t expect a dramatic tightening, but instead a more discerning and lower priced market. If this undermines the ability of VC funds to raise money then it could become a serious problem while, on the other hand, if not enough businesses are able to raise public money there appears to be little downside should the market got a touch more selective.

Nooman Haque, Director of Healthcare & Life Sciences, Silicon Valley Bank UK Branch Nooman Haque is the Director of Healthcare & Life Sciences with Silicon Valley Bank’s UK Branch. He leads a team dedicated to supporting early, growthstage and established businesses in all sectors of life sciences. Nooman is responsible for developing new relationships, identifying lending opportunities and working with the global life sciences team to support companies with all aspects of their business. He is actively involved within the sector, sitting on the BIA’s Finance and Tax Committee and is a frequent participant on panel and seminars.

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Tagrisso™ (Azd9291) approved by the US FDA as treatment for patients with EGFR T790m mutation-positive metastatic non-small cell lung cancer

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translation & commercialisation One of fastest development programmes – from start of clinical trials to approval in just over two and a half years to meet unmet patient need.

Ongoing Accelerated Assessment in the EU and Priority Review in Japan.

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved TAGRISSO™ (AZD9291) 80mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

AZD9291 is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer. This indication is approved under the FDA’s accelerated approval process based on tumour response rate and duration of response (DoR).

AZD9291 is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the activating, sensitising mutations (EGFRm), and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance. Nearly two-thirds of NSCLC patients who are EGFR mutation-positive and experience disease progression after being treated with an EGFR-TKI develop the T790M resistance mutation, for which there have been limited treatment options.

Pasi A Jänne M.D., PhD, Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, Scientific Director, Belfer Center for Applied Cancer Science and Professor of Medicine, Harvard Medical School said: “In the AURA clinical studies, AZD9291 has demonstrated compelling early efficacy and tolerability in patients with EGFRm T790M metastatic non-small cell lung cancer. This treatment has the potential to become the standard of care for patients living with EGFRm T790M non-small cell lung cancer.

The accelerated approval of AZD9291 highlights its clinical promise for a targeted group of patients and gives healthcare providers an important new option.”

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “The FDA approval of TAGRISSO marks an important milestone for lung cancer patients who urgently need new treatment options. We have built on our heritage in this area and acted on the breakthrough clinical evidence to ensure this next-generation medicine reaches patients in record time. As we advance our comprehensive lung cancer portfolio, we have the opportunity to treat greater numbers of patients across all stages of this disease through precision medicines, immunotherapies and novel combinations.”

AstraZeneca has collaborated with Roche to develop the cobas® EGFR Mutation Test v2 as the companion diagnostics for AZD9291. The cobas® EGFR Mutation Test v2 is intended to identify a range of EGFR

mutations in patients with non-small cell lung cancer, including T790M. AZD9291 was granted Fast Track, Breakthrough Therapy, Priority Review and Accelerated Approval status by the FDA. In Europe and Japan, AZD9291 was granted Accelerated Assessment and Priority Review status respectively. Interactions with regulatory authorities in the rest of the world are ongoing.

The FDA approval of AZD9291 is based on data from the two AURA Phase II studies (AURA extension and AURA2) which demonstrated efficacy in 411 EGFRm T790M NSCLC patients that had progressed on or after an EGFR TKI. In those trials, overall objective response rate ((ORR) a measurement of tumour shrinkage) was 59% (95% CI: 54% to 64%). In a supportive Phase I study in 63 patients, ORR was 51% and median duration of response was 12.4 months.

The AZD9291 tolerability profile showed that no individual severe grade 3+ adverse events occurred at ≥ 3.5%.The most common adverse events were generally mild to moderate and included diarrhoea (42% all grades; 1.0% Grade 3/4), rash (41% all grades; 0.5% Grade 3/4), dry skin (31% all grades; 0% Grade 3/4), and nail toxicity (25% all grades; 0% Grade 3/4). There are no contraindications for AZD9291.

Warnings and precautions include interstitial lung disease, QT interval prolongation, cardiomyopathy and embryofetal toxicity.

AZD9291 Development Programme AZD9291 is being studied in the confirmatory trial, AURA3, an open label, randomised Phase III study designed to assess the efficacy and safety of AZD9291 versus platinum-based doublet chemotherapy in patients with EGFR T790M positive, locally advanced, or metastatic NSCLC who have progressed following prior therapy with an EGFR-TKI. AZD9291 is also being investigated in the adjuvant setting and in the metastatic first-line setting, including in patients with brain metastases, as well as in combination with other compounds.

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