GHP September 2016

ghp September 2016

www.ghp-magazine.com

Research, Translation, Commercialisation

Enhancing the Patient Experience Farrer Park Hospital, Singapore’s newest private healthcare service provider is an acute tertiary institution that represents an innovation in hospital administration, incorporating the latest technology to support better decision making for better patient outcomes and shorter hospital stays along with the beauty of nature and art to enhance the patient experience.

Lace Up with TRI Take the Lead in Your Clinical Study

A Dose of Healthy Advice

We speak to Mansoor Ahmed Director of Healthcare and Education at Colliers International in Dubai, UAE

Readership from across the world of Health and Pharma

USA/Canada 165448

Europe/UK 17981

South America 11984

Europe 43873

Asia/Pacific 10564

MENA 10606

Please subscribe to GHP Magazine for free through the webage listed below. http://www.ghp-magazine.com/home/subscribe-page-for-free/

ghp

Research, Translation, Commercialisation

editor’s note

this month’s feature

Welcome to the September edition of Global Health & Pharma, which features a whole host of news and exciting features, including the announcement of one of the first proton beam therapy cancer treatment centres to be built in England by February 2018.

04 News Health & Social Care 8 Minister Visits Swansea’s Specialist Dementia Research Centre 10 Work Begins at One of England’s First Proton Beam Therapy Centres 12 Comfort, Fairness and Value 16 Fishing for Success 18 Health is Wealth 20 A Dose of Healthy Advice 22 Aiming for Africa 24 A Case in Point 26 People with Passion

In an extended feature, Farrer Park Hospital (FPH), Singapore’s newest private healthcare service provider, provides a fascinating insight into innovation in hospital administration and incorporating the latest technology to support better decision making for better patient outcomes and shorter hospital stays.

Innovation & Technology 28 The Future of Healthcare Design: How Clever Engineering Can Help 30 The next Generation of Essential Tremor Treatment 32 New Growth Opportunities for Respiratory Protection Equipment in Western Europe 34 New E-Nose Sniffs out Rare Progressive Lung Disease 36 Is Your App a Medical Device? It’s Healthy to Know: Regulator Issues Updated Guidance 38 Genuinely Passionate About Science 42 Best Plastic Welding & Hot Air Equipment Manufacturer

Remaining topical and up-to-date, Helen Kimberley and Laura Whiting of Hogan Lovells examine some of the key issues facing the pharmaceutical industry and identify the key areas which need to be addressed as the UK progresses towards Brexit.

Looking to the future, emerging markets are the next big opportunity after the US according to Frost & Sullivan. Increased life expectancy, a growing aged population cohort, and the higher incidence of chronic lifestyle-related diseases are encouraging the use generic pharmaceuticals as governments and healthcare service providers strive to contain costs.

Ramboll’s Neil Harvey reveals that in order to meet the needs of future healthcare buildings, those who design and engineer such facilities need to think in the long term. While forecasts tell us that over the next 50 years, the number of people over 60 years of age is expected to surpass those under the age of 14, we must consider our changing needs.

I hope that you enjoy reading this packed edition.

Jonathan Miles, Editor

Comfort, Fairness and Value Farrer Park Hospital (FPH), Singapore’s newest private healthcare service provider is an acute tertiary institution that represents innovation in hospital administration, incorporating the latest technology to support better decision making for better patient outcomes and shorter hospital stays. Page 14

“Comfort, fairness and value is encapsulated in every employee and Farrer Park Hospital aims to provide a five-star hospitality experience for our guests.”

Dr Timothy Low, Farrer Park Hospital Pte Ltd

inside this issue

Regulation & Policy 44 Healthcare Recruiter Responds to Automatic UK Citizenship Recommendation 46 First Call for Help Research & Development 48 Leading Life Sciences 50 Accumulation of a Product of Cell Metabolism Found to Be Linked with Kidney Tumour Growth 52 Researchers Identify Gene Associated with Age-Related Hearing Loss 54 Reviving Accidental Hypothermic Victims with Extracorporeal Life Support 56 Kymouse™, Kymab’s Human Antibody Discovery Platform, Successfully Demonstrates Steps to Developing HIV Vaccine Translation & Commercialisation 58 Standing at the Brexit Crossroads – Considerations for Pharma Companies 60 High-Value Specialty Medicine, Biosimilars and Premium Pricing Portfolio Drive Growth in the Global Generic Pharmaceuticals Market Funding & Investment 62 Cuts to Public Health Risks Widening Health Inequalities 64 Innovative Private Insurance Models Shake up Healthcare Industry 66 Winners’ Directory 68 Deals

Global Health & Pharma, Floor 1, Suite F, The Maltsters, 1-2 Wetmore Road, Burton On Trent, Staffordshire, DE14 1LS Tel: +44 (0) 1234 567 890 | Email: info@ghp-magazine.com | Web: www.ghp-magazine.com

news

Janssen Submits Application Seeking Approval of Sirukumab in European Union for Rheumatoid Arthritis Janssen-Cilag International NV announced on 12 September the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). RA is a chronic, systemic inflammatory condition that affects approximately 6.2 million Europeans.

Newman Yeilding, MD, head of immunology development, Janssen Research & Development, LLC said: “At Janssen, we are committed to continued innovation in the field of rheumatoid arthritis through new therapeutic options, like sirukumab, that address the medical needs of people living with moderately to severely active rheumatoid arthritis. We look forward to collaborating with the European health authorities with the goal of bringing sirukumab to patients living with rheumatoid arthritis who may benefit from this new biologic therapy.”

Data from the Phase 3 SIRROUND clinical development program, which includes five studies (SIRROUND-D, SIRROUND-T, SIRROUND-H, SIRROUND-M and SIRROUND-LTE), is incorporated into the submission. Results from the SIRROUND-D study were recently presented at the Annual European Congress of Rheumatology (EULAR 2016), and results from the SIRROUND-T and SIRROUND-H studies are planned to be presented later this year.

About the SIRROUND Clinical Program The Phase 3 clinical program in patients with active RA includes five studies investigating subcutaneously administered sirukumab 50 mg every four weeks and sirukumab 100 mg every two weeks in combination with conventional disease-modifying antirheumatic drugs (DMARDs) or as monotherapy. The comprehensive development program involves more than 3,000 patients, comprising the following five studies: - SIRROUND-D study: patients who had an inadequate response to DMARDs. This study is estimated to complete in 2017.

- SIRROUND-T study: patients who had an inadequate response or were intolerant to anti-TNFα agents. This study has completed.

- SIRROUND-H study: patients with an inadequate response or who were intolerant to methotrexate (MTX) or for whom MTX was inappropriate. This study has completed.

- SIRROUND-M study: Japanese patients who had an inadequate response to MTX or sulfasalazine.

This study has completed.

-

SIRROUND-LTE study: a long-term extension study for patients completing SIRROUND-D and SIRROUND-T. This study is estimated to complete in 2020. https://clinicaltrials.gov/ct2/show/ NCT01856309.

About sirukumab Sirukumab is a human monoclonal IgG1 kappa antibody that targets the cytokine IL-6, a naturally occurring protein that is believed to play a role in autoimmune conditions like RA. It is not approved as a treatment for RA or any other indication anywhere in the world.

About the Janssen-GlaxoSmithKline (GSK) Partnership In December 2011, Janssen and GSK entered into a licensing and co-development agreement with respect to sirukumab. Under the terms, GSK has exclusive rights to commercialise sirukumab in North, Central and South America, while Janssen retains commercialisation rights in the rest of the world, including such territories as EMEA and Asia Pacific with global profit shared equally between the two companies.

Prior to the agreement, Janssen had been developing sirukumab for RA. As part of the collaboration, a Phase 3 program began in August 2012 to investigate sirukumab for the treatment of moderately to severely active RA. Janssen is responsible for the EMA regulatory file. The agreement gives both companies the option to investigate sirukumab for other indications beyond RA. About Rheumatoid Arthritis Rheumatoid arthritis is a chronic, systemic inflammatory condition that is characterised by pain, joint swelling, stiffness, joint destruction and disability. It is estimated that more than 23.5 million people worldwide are affected by the condition, for which there is no cure.1 Learn more at www.janssen.com/EMEA. Follow us on Twitter: @JanssenEMEA.

4 | ghp September 2016

Bracing for Brexit: The Impact on Regulation and Recalls Recalls may become far more complicated for businesses with potentially more risk for UK consumers in the wake of Brexit, according to the Q2 2016 ‘Recall Industry Spotlight’ Report recently released by Stericycle ExpertSOLUTIONS, the global leader in automotive and product recall solutions. he Recall Industry Spotlight, which focuses on noteworthy developments in the industry, highlights the uncertain future that UK businesses face in light of changing regulations. From pharmaceutical drugs and devices to food and automotives, British companies across industries await a resolution on future approval processes, labelling requirements and safety standards.

“Regulatory uncertainty for UK businesses will continue while the dust settles around the Brexit vote,” said Farzad Henareh, european vice president at Stericycle ExpertSOLUTIONS. “EU leaders are clearly in favour of finalising the divorce quickly in order to restore confidence in the global marketplace.

Many believe that the UK will in fact adopt EU-like regulations of its own to give UK businesses a better advantage in operating in the EU market, which makes up the UK’s largest export market. However, Stericycle’s report reveals that even if the UK’s regulatory framework remains the same the processes will inevitably change, putting additional pressure on any businesses facing product recalls in the future.

The report outlines the impact of the UK potentially being excluded from participating in the Rapid Alert System for dangerous non-food products (RAPEX) and the Rapid Alert System for Food and Feed (RASFF). Exclusion would mean that the UK could not take part in joint market surveillance actions that facilitate a coordinated, automatic approach to product safety concerns.

The UK would require its own authority to issue safety alerts and lead product recalls, which would inevitably complicate the process and cause delays. That could leave potentially dangerous products on shelves and in consumers’ homes for longer than before, put further strain on businesses’ internal resources and potentially increase recall costs.

“We’re advising UK businesses to develop their own Brexit strategies and prepare carefully for every possible scenario,” Henareh said. “Being proactive will help ensure they are in the best position when next steps are made clear.”

For more details, download the Recall Industry Spotlight at http://www.stericycleexpertsolutions.co.uk/ thought-leadership/#recall

ghp September 2016 | 5

news

Progress in Refining the Genetic Causes of Schizophrenia A recent international study led by the University of Exeter Medical School has made advances in understanding the ways in which genetic risk factors alter gene function in schizophrenia.

The study, published in Genome Biologyopens in new window and funded by the Medical Research Council, combined genetic sequence information with measures of gene regulation in schizophrenia patients and matched controls.

Schizophrenia is an inherited, neuropsychiatric disorder characterised by episodes of psychosis and altered brain function. Despite previous research successfully identifying genetic variants associated with schizophrenia, scientists remain uncertain about which genes cause the condition and how their function is regulated.

The study, which used blood samples from 1,714 individuals, is the largest of its kind. It has helped to clarify which specific genes are actually affected by the genetic variants associated with schizophrenia, and provides a blueprint for researchers to undertake similar analyses for other complex diseases.

The team included collaborators from King’s College London, University College London and the University of Aberdeen, as well as colleagues in Finland, China, Germany and the Netherlands.

The team focussed on both the underlying genetic sequence and DNA methylation - an epigenetic mark which regulates both gene expression and function.

By profiling genetic and regulatory variation in the same samples, the group found that many of the genetic variants previously found to be associated with schizophrenia have potential effects on gene regulation. The team also identified epigenetic changes in 26 of 105 regions of the genome previously implicated in schizophrenia, prioritising specific genes for further functional studies and as potential targets for novel treatments.

Professor Jonathan Mill, of the University of Exeter Medical School, who led the research, said: “This study highlights the power of integrating different types of genomic data to better understand how disease-associated DNA sequence variation actually influences the way in which genes function. Although our study focussed on schizophrenia, we’re now applying this approach to other types of complex disease.”

Dr Eilis Hannon, of the University of Exeter Medical School, was lead author of the study. She said: “It is clear that genetic studies need to look beyond simply sequencing DNA, and in this study we simultaneously profiled DNA methylation. By aligning the results from these two molecular approaches, we have generated a list of genes directly affected by schizophrenia genetic risk factors” http://www.mrc.ac.uk/

6 | ghp September 2016

Patient Satisfaction Continues to Rise Patient satisfaction with Scotland’s health service continues to rise, according to this year’s inpatient experience survey, published in late August. The Quality of Healthcare Experience National indicator has risen to 82.8 - its highest level since the survey began and a significant increase of 1.1 from the previous survey in 2014.

The 2016 survey found that 90% of patients rated their care and treatment as good or excellent, the highest rating since the survey began in 2010. Good or excellent care in A&E has increased to 88% over the same time period, while the percentage of people who thought their ward was clean has increased from 95% to 96% since the last survey in 2014.

Overall satisfaction with the hospital environment increased from 88% to 89% since the last survey, and overall satisfaction with hospital staff has remained at 91%. Health Secretary Shona Robison said: “This increase in patient satisfaction would not have been possible without the hard work of NHS staff, and I’d like to thank them for their continuing dedication.

“It is encouraging to see that satisfaction in Scotland’s hospitals continues to rise against a backdrop of increasing patient numbers. It’s especially pleasing to see even more people rating their overall care as good or excellent, including in areas like accident and emergency.

“These increasing levels of satisfaction show that our decisions to put the patient at the heart of everything we do in our NHS, and to increase workforce numbers to their current record levels, are delivering good results.

“We are determined to continue to push up standards.

This is why we are providing financial support to all health and social care partnerships in the form of £90 million over three years, specifically to reduce delays in patients leaving hospital, plus an additional £250 million for investment in social care in 2016/17.

“The funding will help support partnerships achieve the National Integration Indicators, one of which is a commitment to increase the number of people discharged within 72 hours of being ready for discharge.”

The Scottish Inpatient Experience Survey 2016 can be viewed in full at: www.gov.scot/stats/bulletins/01235

ghp September 2016 | 7

Health & Social Care

Minister Visits Swansea’s Specialist Dementia Research Centre Making Wales a dementia-friendly nation means investing in research to improve health and social care, says Minister for Social Services and Public Health, Rebecca Evans. On Monday 15 August, the Minister visited the Health and Care Research Wales Centre for Ageing and Dementia Research in Singleton Park, part of Swansea University and met with researchers to discuss their work.

Rebecca Evans said: “The Welsh Government invests £43 million annually in health and social care research, including over half a million pounds in the Centre for Ageing and Dementia Research, because we are committed to using research to improve health and social care in Wales.

“Dementia research, and using that research to shape services for Wales’ ageing population is particularly important and I am encouraged that Welsh researchers are working to create a world-class research centre here in Singleton Park.

and health; embarked on an evaluation of cARTrefu - arts in care settings; and started to develop the largest sample in the world of DNA and phenotypic questionnaire data for 4,000 people with early onset Alzheimer’s disease.

“I think that the Minister enjoyed a brief flavour of the intellectual and cultural ‘buzz’ which is a distinctive feature of the Centre.”

Web Address: http://gov.wales/

“I met some committed researchers who are working hard to tackle some of the key issues – from the environment for people living with dementia, to the genetics behind Alzheimer’s Disease. Their work will help to make a difference to health and social care and to many people affected by dementia.”

Professor Vanessa Burholt, director of Centre for Ageing and Dementia Research said: “I was delighted that the Minister visited CADR as it as it shows that the WG is committed to this vital area of research. “I am immensely proud of the progress that CADR has made in the first year, and during her visit I had the opportunity to explain to the Minister the latest developments in the Centre.

“We have already established Join Dementia Research in Wales; obtained European funding for a Cost Action Reducing Old-Age Social Exclusion with 30 partner countries; received Catalyst funding from the Ministry of Business Innovation and Employment, New Zealand to develop a project on Ageing, housing

8 | ghp September 2016

ghp September 2016 | 9

Health & Social Care

Work Begins at One of England’s First Proton Beam Therapy Centres The creation of one of the first proton beam therapy cancer treatment centres to be built in England took a significant step forward on 23rd August, as work officially began on site. The centre, situated at the Earth Balance wellness site in Bomarsund, Northumberland, will be the second to be built by Proton Partners International in the UK and is expected to be operational by February 2018.

At the start of the year construction began at Proton Partners’ first cancer centre in Newport, Wales. The precise location of the third centre which is planned for London, is still to be announced. Each centre will be able to treat up to 500 patients every year and, in addition to proton beam therapy, will offer imaging, chemotherapy, traditional radiotherapy and well-being.

Cllr Grant Davey, leader of Northumberland County Council, said: “It is fantastic to see work getting underway on this pioneering centre being developed right here in Northumberland. “To have this facility based in the county is a real coup. It will not only make this type of treatment available to the region and beyond, but also bring more skilled jobs to Northumberland.”

Mike Moran, chief executive of Proton Partners International, said that this “marks an important step in our plans to revolutionise cancer treatment across the UK. “Northumberland is the perfect location for our second centre– it is close to well-connected transport links and opens the door to proton beam therapy to prospective patients from the North of England and Scotland.

“We have acquired the best technology available and our aim is that this area will evolve into a state of the art cancer treatment facility. The investment will also bring jobs, medical and administrative, to the area and will attract skilled individuals to the North East.”

shown that at least 10% of patients who receive traditional radiotherapy would be treated more effectively with protons.

“By offering a variety of cancer therapies, our centres will deliver a fully comprehensive level of cancer care, tailored to fit the different needs of each patient – something which is not available in the UK at the moment.”

There are currently no operational proton therapy facilities in the UK and the demand for more specialised cancer care is growing. Proton Partners are at the forefront of bringing proton beam therapy to the UK and are working with class-leading providers which will equip the new centre to the highest specification.

Proton Partners recently received £450,000 investment from regional growth fund programme, Let’s Grow North East, for its Northumberland cancer centre. All three Proton Partners centres will treat NHS patients, medically-insured private patients and self-paying patients.

For more information on Proton Partners, please visit: http://proton-int.com/ Pictured Right: L-R- David Knott, Mike Moran, Gordon Baltzer

Karol Sikora, chief medical officer of Proton Partners International, added: “There is a pressing need to bring this type of treatment to the UK as studies have

10 | ghp September 2016

ghp September 2016 | 11

Health & Social Care

1609JC14

Comfort, Fairness and Value Farrer Park Hospital (FPH), Singapore’s newest private healthcare service provider is an acute tertiary institution that represents innovation in hospital administration, incorporating the latest technology to support better decision making for better patient outcomes and shorter hospital stays.

The hospital, opened in March 2016, is sited within Singapore’s first, fully integrated healthcare and hospitality complex, called Connexion, which is Asia’s first, integrated lifestyle hub for healthcare and wellness.

Connexion houses the 220-bed Farrer Park Hospital with its more than 300-accredited specialists, 18 operating rooms, a 10-floor specialist Medical Center, along with a five-star hotel and spa.

The hospital is also a teaching site for undergraduate medical training, providing enhanced medical care, service quality and professional integrity coupled with value. Supported by approximately 600 hospital staff, specialists at Farrer Park Hospital provide a range of services, such as cardiology, oncology, orthopaedic surgery, gastroenterology and ophthalmology. A 24-hour emergency department provides for acute illnesses and the hospital has the most modern facilities for diagnostic imaging, nuclear medicine, radiotherapy and clinical laboratories.

A strong advocate for preventive care, the hospital also houses HealthConnexion, a new health screening and preventive medicine initiative which offers customizable comprehensive solutions beyond the usual health assessment where one can look forward to more in-depth health assessments, personalised dietary and fitness advice to wellness activities with link-minded individuals.

A hospital of the future Farrer Park Hospital was designed and built to be a hospital of the future, combining innovation in medical care and medical education. Integrating healthcare and hospitality under a single building, the spatial planning is unique and could be considered one of the novel designed developments around the region.

We have created a medical destination where all medical consultations, treatment and accommodation needs are well taken care of and located within the same building.

To remain competitive, we focus on our core values of providing comfort, fairness and value for our stakeholders. In terms of value, we want to ensure that patients are offered the best care and service at a reasonable fee. An example of this would be when a foreign patient is arriving for a surgical treatment; they would be admitted to the inpatient suites where nursing care and medication administered. When the patient is recuperating well, they can be discharged and opt to stay at the hotel and visit the doctor for review until they are fit to return home. This would greatly reduce the cost for the patient, provide better rehabilitation space for patients to heal and enhances the convenience of their follow up consultations.

Farrer Park Hospital embraces technology and improves medical care through state-of-the-art equip-

ment that facilities telemedicine consulting services across the world. To create a conducive environment for medical professionals, the hospital’s 18 operating rooms are linked via fiber-optic connections to various locations through the Connexion complex, including the hospital’s education center and lecture hall, teaching clinics and tutorial rooms as well as the hotel’s function rooms. Additionally, the hospital has state-of-the-art information technology which enables seamless and rapid flow of information between the admission services, inpatient areas, operating theaters, diagnostic and therapeutic centers, clinical laboratories and medical clinics.

Farrer Park Hospital is also the first private hospital to become a teaching site, with medical students from Lee Kong Chian School of Medicine at Nanyang Technological University. With a strong focus on education, service and clinical excellence, FPH will remain a strong contender for medical seekers in Singapore.

Innovation and stellar performance at Farrer Park Hospital Farrer Park Hospital is voted the ‘Best New Hospital of the Year in Asia Pacific’ by Global Health & Travel awards, and has recently received 2 more awards from Asian Hospital Management Awards 2016 recognising innovation and branding. Within a short span of six months after its opening, the hospital has already garnered seven awards which recognise the innovative and technologically advanced facilities, and humanised designs within the hospital.

Exemplary display of Farrer Park’s disruptive innovation, FPH is the first and only hospital in Singapore to integrate its medical records with the electronic meal ordering system (EMOS). Acknowledged for its improvement to overall quality, safety and efficiency for patient meal orders. EMOS empowers patients to take charge of their meal selection through an interactive tablet in their suites. This unique system actively changes the way doctors, nutritionists and hospital kitchen communicate through the use of information technology and this cannot be realised without the strong IT infrastructure and a culture of innovation across the organisation.

Integrating patient’s medical records, only meals suitable for patient’s diet will be available for selection.

This also allows food portions to be personalised through adjustments by our in-house nutritionist, under doctor’s instructions and specially prepared by five-star award winning hotel chefs. The system abolished the need for nurses to facilitate meal orders, saving 3 man hours each day (30 minutes per meal

12 | ghp September 2016

Healthcare & Pharma Leading Expert Awards

ghp September 2016 | 13

Health & Social Care for 6 meals every day) and allowing them more time to care for patients.

Compared to manual meal ordering, the new electronic system reduces the meal order errors from average 8 per month to zero. The EMOS system also provides a cost saving of around SGD $88,000 per year and looks to break even in 4 years.

Another innovation is the usage of Radio Frequency Identification (RFID) for linen management. FPH is the first hospital to adopt RFID for outsourced linen management, which empowers users the ability for real time tracking based on quantity, category and location where linen is required. This information allows users to plan and manage linen in a just-in-time manner which eliminates the need for a large laundry facility, making way for more landscapes. The system also tracks wash count and this helps to maintain the linen quality for patients. The RFID technology has helped the hospital to save more than SGD $590,000 in 2015 and a potential savings of SGD $740,000 in 2016.

The official opening of Farrer Park provided an opportunity to design a media campaign with impactful branding as well as sustainable business growth. As a new hospital, with limited resource, we had to be very effective in our communications plan. Our strategy was to highlight the key points of our organisation, differentiating them against our competitors and then consistently communicate them across all channels.

The official opening was an opportunity to design a media campaign with impactful branding as well as sustainable business growth. Prior to the opening, selected media, business and community leaders were invited to experience first-hand the unique features of the hospital that helped generate opinions.

At the official opening we expanded the group of influencer and created a sensory journey through an experiential event right at the ballroom of the official opening. Guests were able to see and touch the mock-up inpatient suite exhibits and at the brunch reception, taste inpatient meals prepared by our award winning hotel chefs. Through vigorous staff training and engagement, pre-official opening, we shaped our very own brand ambassadors for the day to guide our guests through this unique sensory journey. Our core values of comfort, fairness and value formed the

backbone of our campaign and our brand ambassadors were well versed in the consistency of messaging and experience impacting our guests. The successful media campaign brought a consistent increase in bed occupancy since the official opening.

The hospital currently sees a mixture of about 50% local and 50% foreign patients. Singapore’s medical tourism is still strong despite its high currency exchange against neighbouring countries and we are seeing an increasing number from the western countries as well. Foreign patients come from Indonesia, Malaysia, Vietnam, Bangladesh, China and as far as USA. FPH is built to serve the local population with hopes of improving the services and providing value for patients. We have seen more than nearly 5,000 surgeries to date with less than 1% mortality rate.

Challenges for the future of Farrer Park Hospital Our care philosophy extends beyond healing and the management of disease to engaging with our patients as partners in pursuit of good health and providing an oasis for healing and relaxation. Healing does not end after a successful operation. It is not just about coming to hospital for a procedure and then recuperating at home. It is about having the best and most comfortable services to get the patient on their feet.

In addition, having a family support structure close by, where relatives can stay close to the hospital is essential in the rehabilitation process. That is why, as part of Connexion, the hospital is Asia’s first, integrated lifestyle hub for healthcare and wellness that is linked to a five-star hotel and spa.

Patients are treated by an experienced team of medical and health specialists in an environment meticulously designed to maximise comfort and efficiency while promoting well-being, rest and recovery.

Throughout our facility, patients will find that attention has been given to every aspect and detail of our facility – from the comfort of our patients, to its impact on the environment, to the speed and ease of obtaining medical attention and to the maintenance of hygiene.

Though small in size our culture of innovation, allows us to grasp opportunities quickly. The seamlessness of information flow was the focus at inception and the hospital was planned to be technologically relevant for the next 20 years.

Being an institution built by healthcare practitioners has its advantages. We achieve painstaking perfection in our attention to detail. The hospital has many practical features that serve the needs of practitioners and patients while the hoteliers add details for comfort, luxury and aesthetics.

The architecture of Farrer Park Hospital and Connexion reflects the deep commitment to creating a true learning environment. Synergies between our hospital along with a closely linked hotel stimulate many innovations for improving the healthcare experience.

The concept of a hospital near a hotel is not new, however, to integrate it to the level that we have is something novel. We followed a biophilic architecture approach throughout the facility, incorporating nature and art to enhance healing. Hospitals are traditionally not the best place for recuperation. We strive to have the restful ambience of a hotel, in addition to proximity of doctors and family under the same roof, as well as using technology to enable seamless and speedy decision making; all this in support of better patient outcome and shorter stays.

You could say we are different in how we view private healthcare. A traditional hospital would not carve out 15 gardens at multiple levels throughout the facility so that patients and families can have places to feel the warmth of the sun and breathe fresh air whenever they like. The facility also hosts a private collection of over 700 commissioned Asian paintings meant to enhance the healing environment.

In land-scarce Singapore, a typical businessperson would not have fewer paid parking lots, making them one and a half times the size of a standard lot, to allow a patient on crutches to comfortably extend the car door fully to disembark. A standard project manager would not insist that contractors construct a curved sink so that surgeons will not have water dripping down his elbows after scrubbing his or her hands, or a bath bench with a cut out that allows patients to sit while washing themselves. This may seem unnecessary but these innovative approaches translate to actual benefits to people who ‘value’ them.

Everyone has the same end goal, a good experience and better patient outcome. Our strategy is simple. We take our responsibilities to patients, their families and the clinicians seriously. We attend to their needs, anticipate their wants, and find the best way to address these concerns through innovation and technology.

This ultimately brings value to patients.

Our hospital is also supported by the medical centre which provides a range of specialty services, such as cardiology, oncology, orthopaedic surgery, gastroenterology and ophthalmology, along with a 24-hour emergency clinic, providing immediate care for acute illnesses. The hospital also has the most modern facilities for diagnostic imaging, nuclear medicine, radiotherapy and clinical laboratories. There is even a holistic service which focuses on screening, preventive medicine and lifestyle enhancement.

As we are still relatively new in the market, the focus would be to build up the brand of Farrer Park. The key is to build a culture of excellence and ensure that we have an able team to assist with pushing out quality healthcare services in tandem with our core values of comfort, fairness and value to our stakeholders.

14 | ghp September 2016

With nurses being a major bulk of the workforce in Farrer Park Hospital, we believe in the continual improvement of clinical excellence and as such, FPH has since grown to be one of the top nursing training providers in both private and public healthcare in Singapore. To date, the hospital has organised more than 20 relevant courses with more than 210 course runs since Jan 2015 and these courses are approved

by Singapore Nursing Board under the CPE events that allows the allocation of CPE points for the course attendees. Many of our nurses go beyond the required number of Continuing Professional Education (CPE) points, above the annual recommended points required for recertification.

Service excellence too holds its significance in ensuring the satisfaction of our stakeholders through the Farrer Park Experience. On top of their competency skills, all our employees are required to undergo service training which helped in ensuring that our guests receive a consistent, high quality service throughout their stay.

Comfort, fairness and value is encapsulated in every employee and Farrer Park Hospital aims to provide a five-star hospitality experience for our guests.

Company: Farrer Park Hospital Pte Ltd Email: enquiries@farrerpark.com Web Address: www.farrerpark.com/hospital Address: 1 Farrer Park Station Road #02-01 Connexion, Singapore 217562 Telephone: +65 6363 1818

ghp September 2016 | 15

Health & Social Care

1609JC01

Fishing for Success Founded in 2003, Beps Biopharm S.L are widely considered as the ‘Omega-3 Specialists’ in Spain, and dedicate themselves exclusively to quality Omega-3 supplements, which they offer at very competitive prices.

With our new ‘BEPSplus’ brand we offer unique, high quality Omega-3 - in combination with other natural health extracts - enabling synergies never seen before.

As a company, we aim is to offer our customers unique formulations for a healthier life. In regards to our specialties, we focus on cardiovascular, brain function and memory, depression, chronic inflammation (including chronic liver disease), attention deficit, anti-aging and stress.

At present the company is performing well achieving continuous growth, however despite our achievements we must always try and identify the ways in which we can stand out from the crowd. With this in mind, providing a unique combination of highly concentrated omega3fatty acids with highly effective plant extracts (for example polyphenols) has been one way of dealing with competition.

In regards to innovation, our liquid omega-3 oil formulation, specially designed to increase the physical and mental performance of athletes and and overworked business men and- women has been a huge success.

The product ‘Fitness Complex’ is sold under the brand ‘BEPSplus’ and it is particularly unique as it delivers in only one teaspoon a day over 1000 mg EPA+DHA, 50% of the daily vitamin D3 requirement and 200 mg Schisandra chinensis berry extract (known for over 2000 years in traditional chinese medicine as a very potent muscle and brain function enhancer).

The staff here at Beps Biopharm S.L play a vital role in the success of the firm, moreover, our success is only possible due to the enormous effort and work invested by every single member of our company.

In regards to the healthcare sector, with our new product line BEPSplus we believe we have created the ‘next generation’ Omega3, allowing us to produce more effective supplements than any of our competitors. In addition, it will allow us to reduce the daily dose (for example number of capsules) and still achieve superior health effects, thus increasing customer compliance and satisfaction.

Looking ahead to the future, competition in the supplement field is always very tough, however, we believe through our strategy to combine the clinically proven omega3 fatty acids with highly effective plant extracts, it gives us an unlimited portfolio of synergies to be discovered in the future. As long as we stay innovative, I see no problem for Beps Biopharm S.L andhealthy continuous growth for our company Company: Beps Biopharm S.L Name: Dr. Peter Lembke Email: info@bepsbiopharm.com Web Address: http://www.beps-shop.com/en Address: Raval Santa Anna 21, 2nd, 43201 Reus (Tarrogona), Spain Telephone: +34 977 345 765

16 | ghp September 2016

Healthcare & Pharma’s Leading Experts

ghp September 2016 | 17

Health & Social Care

1609JC02

Health is Wealth RBK Nutraceuticals is an Australian TGA / GMP licensed health supplement manufacturer that has been exporting premium quality natural health supplements to over 12 countries for the past 20 years. We have thrived in the increasingly competitive health supplement market, as this article illustrates.

RBK manufactures and distributes a number of different brands, including Mother Nest, Blue Gum, True Blue & V-Plus. These products are distributed to the world’s leading retailers with its main export markets being in Asia. The product range consists of hundreds of premium natural health supplements such as omega three, propolis, multi-vitamins, colostrum, spirulina, gummy vitamins and many more. RBK also provides OEM and private label contract manufacturing services.

We specialise within the preventative health care industry by providing vitamins and supplements of high concentrations that meet RDIs to assist people to live healthy lives and be less prone to sickness and health related problems.

One of RBK’s speciality products is in high grade organic propolis, which is produced by honey bees and contains natural anti-bacterial qualities that has great healing benefits and preventative qualities for colds and flus. This product is produced in tablet, capsule and liquid forms and has thousands of loyal RBK customers all over the world enjoying its benefits.

From our experience, the natural health supplement industry has never been more competitive and RBK is always developing new products and improving existing products to keep ahead of competitors and to provide customers with the best possible products available.

In addition to product and formulation development, RBK also invests heavily on product training for all customers and partners worldwide. The objective of the ongoing educational program delivered by RBK is for sales staff to understand the products and to be able to provide genuine recommendations of suitable products for customers, not just to increase sales.

Another aspect we invest heavily in is our staff. The dedicated team at RBK is the most important factor for the ongoing success of RBK and its brands. RBK invests in ongoing personal and professional development for all staff, and takes its requirement for TGA/ GMP training very seriously and provides access to a much wider range of training for all staff in additional to the industry essentials. As such, personal and professional developing opportunities are provided to all staff and departments ranging from warehouse and logistics, operations to leadership management.

In order to maintain an ongoing high level of quality and service, all staff need not only to follow but to be part of the quality system to ensure continued improvement and development of not only the business but each employee’s personal and professional development.

These initiatives are a fundamental factor behind our continued success. At the moment, RBK is enjoying great success within existing markets especially within the highly competitive South Korean market with our best sellers continuing to outperform competitors and new products gaining in popularity. This is also due to the long-term and close partnerships that RBK has developed with key retailers and distributors.

Alongside this, RBK has also secured new and exciting markets within the past 12 months including e-commerce in China, with several flagship stores on the most popular platforms, a new partnership company in Saudi Arabia, an exclusive distributor in Myanmar and new distribution channels in Vietnam.

We have seen many successes over the past number of years and is something we wish to continue into the future. In 2015/16, RBK was featured as a case study for the Australian Government Free Trade Agreement campaign with China, Korea and Japan. RBK was identified as a suitable representative of the Australian health supplement industry to detail how FTAs can benefit Australian manufacturers within export markets. This included live seminars, and a national press, radio and television campaign.

Although the future looks very bright indeed, there are still many obstacles we will need to overcome in order to maintain the high standards we set for ourselves.

The greatest challenge that the natural health supplement industry faces are low grade health supplements flooding markets. By using lower graded and lower specification raw materials with reduced active ingredient content, cheaper low quality products are now more popular than ever.

Unfortunately, most customers have no way to know really what the product they are taking is. The Australian Government and the TGA have some of the strictest standards in the world for the manufacture and sale of health supplements to ensure product safety however work also needs to be done on overall quality of product.

18 | ghp September 2016

Over the past consecutive four years RBK has been honoured to be recognised and awarded various accolades by its peers within the industry and the business world. Most recently in 2015 RBK was awarded the State Winner of the NSW Excellence in Export Award and also Business of the Year. And of course, this recognition by GHP Magazine is a further testament to our success.

Company: RBK Nutraceuticals Name: David Mumford, sales & marketing director Email: david@rbk.com.au Web Address: rbk.com.au Address: 46 Powers Rd Seven Hills NSW 2147 Australia Telephone: +61 2 9674 3544

Healthcare & Pharma’s Leading Experts

ghp September 2016 | 19

Health & Social Care

1609JC05

A Dose of Healthy Advice Healthcare in the UAE

The Colliers Healthcare Advisory & Valuation Services team is solely focused on healthcare related business (OpCo) and real estate (PropCo), from complex medical business related operational advisory to real estate related advisory. Our professional team is attuned to the ever evolving developments in the healthcare industry and dedicated to resolving the increasingly complex business, operational and real estate needs of healthcare investors, owners, operators, landlords, tenants and developers in the MENA region.

We provide strategic advice on new healthcare concepts, expansion strategies, market and financial feasibility studies, master planning, branding, medical planning, operational performance benchmarking, business plan creation, development and operational cash flows, introduction of debt, equity and experienced operators to projects, appraisals and land, property and business valuations, PropCo / OpCo models and negotiation, management agreements and operative training and leasing and sales to property and asset management.

Colliers International is committed to accelerating the success of our healthcare clients by demonstrating a deep understanding of factors which underpin profitable healthcare businesses. Focused solely on healthcare industry, Colliers Healthcare advisors have the expertise and knowledge essential to providing forward thinking solutions to any challenging healthcare related operational and/or real estate decision where success is measured in high-quality care delivered in a cost effective way.

One word epitomises today’s healthcare marketplace – change.

As the delivery of healthcare in the Middle East and around the world continues to evolve, hospital and health system executives are grappling with many challenging new paradigms. Integrating the transition from ‘fee for service’ to ‘fee for quality’ delivery models, new compliance requirements, driving wellness and prevention, and ensuring better coordination and efficiencies are but a few of the critical initiatives hospital and health system executives face.

Trends and industry changes require investors and operators of healthcare facilities to make challenging decisions. Over the years the healthcare systems have improved across the region however the healthcare sector still continues to offer significant opportunities for investors/operators due to number of factors including.

• High population growth rate: The MENA region has one of the highest population growth rates in the world, second only to sub-Saharan Africa. The population has increased from around 100 million

•

•

•

•

•

•

20 | ghp September 2016

in 1950 to 500 million in 2010. Current projections anticipate the population to further increase to 800 million by 2050, exceeding the population of Europe by 2050.

The young population profile: The majority of the population in most of the MENA region countries falls between Generation X (1965 – 1980), Generation Y (1981 – 2000) and Generation Z (2001 – present); with approximately 33% under the age of 15 and 21% between the ages of 15 and 24 years, As the current population of the region ages there is likely to be a sharp rise in healthcare demand as almost 80% of a person’s healthcare requirements typically occurs after the age of 40 – 50 years.

The Introduction of compulsory health insurance: After compulsory health insurance was introduced in Abu Dhabi, the revenues of most of the private hospitals doubled in subsequent years, more and more countries / cities, including Dubai is also expected to follow the same pattern.

The expatriate factor in the GCC: The presence of a large number of expatriates in the GCC which is approximately 50% of the GCC population, results in demand for private healthcare provider and creates demand for operators from their native countries / region, as well as, demand for international operators from United Kingdom, USA and Asia.

The establishment of healthcare hubs in the region: The emergence of ‘satellite campuses’ by global players in the region, such as; Dubai Healthcare City in the UAE, Hamad Medical City Doha and number of other planned medical cities where established players such as Mediclinic from South Africa, Imperial College London Diabetes Centre from UK, Great Ormond Street Hospital for Children from UK, Weill Cornell Medical College in Qatar, to name a few.

High returns on healthcare sector investments: Similar to education, efficient private hospitals can make around 15% to 20% net profit margins once a hospital is stabilised, thus encouraging both investors and operators to invest in healthcare sector in the MENA region.

Heavy reliance on imported medicine and medical

equipment: This increases the cost of establishing healthcare facilities. A number of medical equipment suppliers provide medical equipment on long-term leases, and even equity investment in order to facilitate healthcare initiatives. • Supply of healthcare facilities struggles to keep pace with the burgeoning population: A situation recognised by the government that has introduced a number of initiatives in the recent past to encourage the private sector to match the shortfall and benefit from this potentially lucrative sector.

Shaping the future of the healthcare in the UAE In this era of healthcare reform, providers face unprecedented pressure from payers, employers, and consumers to deliver higher quality, more efficient care. Today, more than ever, hospitals must embrace a different type of business model, with a new set of investments and relationships to achieve success. To navigate the changing landscape, you need expert advisors with strategic insight into the healthcare industry, extensive resources, and forward-thinking solutions. Colliers Healthcare advisory & valuation services team are dedicated healthcare specialists

ghp September 2016 | 21

who truly understand the unique challenges of this industry. Colliers trusted advisors have a big picture perspective, putting in-depth knowledge of industry trends, policies and players to work for you.

Company: Colliers International Name: Mansoor Ahmed (Director MENA Region - Healthcare, Education & PPP) Email: Mansoor.Ahmed@colliers.com Web Address: www.colliers.com Address: P O Box 71591, Dubai, UAE Telephone: +971 4 453 7400

Health & Social Care

1609JC07

Aiming for Africa Atlantic International Medical Supplies Co. Ltd. (AIMS) is a highly innovative and renowned medical supplies company based in Sudan but expanding across Africa. We supply the Sudanese and broader African market with pharmaceuticals, veterinary products, bio-instruments, nutraceuticals, and medical disposables. Many people might find it very strange that a local company is seeking leadership in the Middle East and Africa region.

The firm’s initial budget was $100,000 in 1982, but reached more than $7 million in 2016. It is therefore logical that our company will surely have to seek out leadership in the region.

Since 2015, I have been appointed as the CEO with a vision to become the leading firm in Middle East and Africa in 2025. Our winning formula is: ethics + transparency + (Do it – inaction) X planning / analysis = AIMS’ success.

Since our inception, there are a number of notable achievements that help demonstrate the good work that we do. AIMS started with pharmaceuticals and we were the first company to introduce chlorpheniramine maleate ever in the Sudanese market since 1982.

Furthermore, we were the first firm to introduce probiotics in capsules and sachets in Sudan.

Moreover, AIMS were the first firm to introduce the combined calcium and vitamin D, and concluding its safe usages in patients with chronic kidney disease (CKD) providing its proper dosage for renal patients.

By the beginning of 2017 we will introduce a state-ofart oral iron range that is truly innovative.

Our goal is to make a strong foundation for our relationships which would be of mutual benefits and prosperity for both ourselves and our customers. This is a relationship based on ethics, skilfulness, everyday excitement and development and not a jungle based relationship. AIMS believe that the best policy is to make accessible and fruitful business with all Africa and Middle East countries.

Sudan is at the heart of this important geographical area, and it represents the bridge between Arab and African countries, and thus establishing a scientifically oriented and based market in Sudan is extremely convenient for expanding in the MEA region.

Essentially, AIMS is the prominent figure of supplying healthcare in our region. AIMS supply A to Z in health sector, and our fingerprint can be found in every hospital, clinic, lab, pharmacy and farm. In terms of our clientele, we supply regularly three leading NGOs, about 4000 pharmacies, 100 hospitals, more than 500 dentists, 2500 physicians in different specialities, and veterinary physicians.

Furthermore, AIMS support new researches through our partnerships with Sudanese Ministry of Health, and Sudanese Medical Universities. AIMS have successfully conducted many clinical trials in Sudan with our partners, and we successfully granted ethical clearance before each clinical trial. As such, new trends in healthcare is something AIMS strongly support with, and this clearly contributed in the development of the national healthcare sector in Sudan.

AIMS take tremendous pride in the work we do, and our hard work has made us an attractive target for many international firms. AIMS believe what has also made us a target is that we are a family company, having more than five members in pharmaceutical and medical fields. Secondly, we are located inside the heart of Khartoum, which is the capital of Sudan.

As mentioned in our formula earlier, ethics plays a huge part of our business and has made us a trusted partner for investment. Alongside this, AIMS have a systemic and unique business discipline, having our own R&D and innovation centre. Additionally, we are a growing company, now expanding to having our own offices in Kenya, Ethiopia, and Nigeria.

In these competitive times, there are a number of areas which separates us from our competitors. Innovation is our DNA and is our key to shaping the present and future of our company. Luckily enough there are very few competitors in Africa to count when it comes into innovation, and we are always maintaining our position. From a simple new indication of a generic medicine to a gene therapy we never stand still! AIMS are always looking to improve.

Our continued drive to success can be seen across the board at our company. Our staff always inspire the management with new and crazy ideas, and our working environment is a typical big family house. In every brainstorming session held, the company we end up with a brilliant new idea.

22 | ghp September 2016

At the moment, AIMS are paying most attention to genomics. I have done extensive research on gene therapy and believes it to be the ‘future of pharmacy’.

In fact, this is our primary concern for the near future so we are preparing and researching heavily on this area.

Although the work AIMS do is a reward in itself, to receive recognition from GHP magazine is simply the icing on the cake! We are very thankful to the magazine for awarding us the Healthcare & Pharma’s Leading Experts in Sudan, and we will continue working on turbo mode and our eyes into Middle East and Africa leadership.

Company: Atlantic International Medical Supplies Co. Ltd. (AIMS) Name: Dr. Mohammed Elfatih Saeed Email: drmesaeed@aimspharmagroup.com Web Address: www.aimspharmagroup.com Address: Gamhouria Avenue, Elnazir Building, Khartoum (Headquarter) Khartoum North, Square 19, AIMS’ Building (Scientific Office, Sales and Marketing) Telephone: +249 183 787846

Most Innovative Pharma Company - Sudan

ghp September 2016 | 23

Health & Social Care

A Case in Point Casenet® provides a comprehensive suite of extensible, enterprise population health and care management solutions that improve care coordination and the quality and delivery of care. In an interview with the firm’s CEO, Peter Masanotti, he lifts the lid on what his company does and why he thinks people are “at the heart of all healthcare delivery”.

How would you define your client base?

The Casenet enterprise population health and care management solution, TruCare®, supports both small clients and large enterprise customers that require tremendous scalability, have many lines of business, and require comprehensive configuration for each targeted member population. The platform flexibly manages managed care, government-sponsored, Medicaid, Medicare and commercial organizations as well as carve-outs, TPAs, ACOs and providers.

What makes you unique?

My ability to synthesize large volumes of data, find the common threads and take action on the information makes me unique.

Name: Peter Masanotti Company: Casenet Email: info@casenetllc.com Web Address: www.casenetllc.com Address: 36 Crosby Drive, Bedford, MA 01730 Telephone: +1 888 701 0886

What makes your firm unique?

Casenet delivers unmatched flexibility to coordinate and manage population health, wellness and quality programs. The ability for non-medical services, such as custodial care and transportation, to be combined with behavioral and medical services enables our clients to create a single, complete and actionable view of each patient.

What are the major challenges facing your business at present?

Our biggest challenge is managing our success. With success comes rapid growth and growth needs to be managed carefully to ensure solution quality, client satisfaction and company values are maintained.

Looking ahead, what is the main objective for your business?

People are at the heart of all healthcare delivery; both those receiving care and those providing care. Casenet was founded to improve the experiences of all people giving and receiving care, and to deliver on the promise that better coordination of care will lead to better health outcomes.

24 | ghp September 2016

ghp September 2016 | 25

Health & Social Care

People with Passion The Yes Yes Company pioneers the use of plant polymer technology to complement human intimate chemistry, providing an innovative solution for vaginal dryness. In 2006 following three years of research, they developed and launched a range of certified organic intimate products including water and oil based personal lubricants and vaginal moisturisers, offering an alternative to the standard ‘old style’ lubricants.

YES WB water based lubricant and YES VM Vaginal Moisturiser have been formulated to be iso-osmotic and pH balanced. They are free from ingredients which have the potential to irritate mucosal tissue and YES OB is a Plant-oil based lubricant, with a long-lasting natural alternative to silicone lubricants. YES Baby is a Fertility Friendly lubricant system for couples trying to conceive. Our products have three international patents and are Class IIa Medical Devices.

Looking ahead, what is the main objective for your business?

The Yes Yes Company Ltd’s main objective is for YES to be the worldwide ‘first choice’ brand within the category of intimate products, both for health professionals and consumers. Our products provide global life-changing benefits, and we want all women to experience natural relief from the symptoms of vaginal dryness.

How would you define your client base?

Our client base is anyone who values the importance of certified organic, non-irritating intimate products, and includes cancer patients, menopausal and post-menopausal women and couples who wish to enhance their sexual health and pleasure.

What business or business person do you most admire and why?

Steve Jobs - partly for the simplicity, innovation and effectiveness of Apple Products but his quote “We’re here to put a dent in the universe. Otherwise why else even be here?” sums up his philosophy perfectly, and corresponds with the The Yes Yes Company’s mission ‘To change the world from the inside’.

What makes your firm unique?

The Yes Yes Company Ltd is the only firm, with a certified organic intimate moisturiser available on the NHS. Our products are formulated without glycerine, glycols, or parabens and have been designed to be side-effect free. We are passionate about intimate health and serious about sexual pleasure.

What are the major challenges facing your business at present?

The major challenge is to raise awareness of the unique benefits of our products on a global scale with limited resources for marketing and public relations.

Name: Sarah Brooks & Susi Lennox – Joint CEOs Company: The Yes Yes Company Ltd Email: sarah@yesyesyes.org; susi@yesyesyes.org Web Address: www.yesyesyes.org Address: Trademark House, Ramshill, Petersfield, Hampshire GU31 4AT Telephone: 01730 261224

26 | ghp September 2016

ghp September 2016 | 27

Innovation & Technology

The Future of Healthcare Design: How Clever Engineering Can Help In meeting the needs of future healthcare buildings, those who design and engineer the facilities need to think long term. With forecasts that tell us that over the next 50 years the number of people over 60 years of age is expected to surpass those under the age of 14, we must consider our changing needs.

Priorities in healthcare are shifting from transferable to non-transferable diseases, including cancers, diabetes and heart disease, as well as injuries. Pre-empting and building in flexibility for future needs is crucial, although can be extremely difficult whilst balancing budgeting limitations. This poses a key challenge in the future design of our hospitals and healthcare facilities.

areas as medical technologies change. Mechanical and electrical systems which support diagnosis and treatment are located on a support accommodation tramline between ‘on-stage’ and ‘off-stage’ areas of the hospital. In this way, the ‘on stage’ patient treatment areas of the building, which are likely to modify during the building’s life span, can be adapted with no disruption to other areas of the building.

Considering the wider needs of the population and adopting different strategies aid development of new models of efficient patient care. In some parts of the world such as Scandinavia, large scale consolidation programmes are underway, while here in the UK we are seeing the opening of specialist units, such as Cramlington - the first dedicated emergency hospital in the UK.

Hospital running costs significantly outweigh the construction costs, with the capital outlay often matched in year two or three. Incredible effort is therefore needed to maximise efficiencies through adjacencies of departments, care givers, patient pathways and the reduction of building energy consumption.

For the upper two in-patient floors, a pre-fabricated module construction principle has been adopted as these individual rooms can be designed at a more cost effective domestic level of construction. Pre-fabrication processes have improved significantly in recent times with increased use in hotel and student accommodation buildings. We are able to take this pre-fabrication innovation and apply it to in-patient accommodation, providing hotel quality bedwards at a much reduced cost compared to traditional construction. Pre-fabrication allows us to ‘beta-test’ the patient rooms (and their technology) to provide a high quality known end product. Innovative building materials such as cross laminated timber are becoming an increasingly proven option for pre-fabrication. These known modern materials and construction methods are vital to helping us overcome the key challenge of building in flexibility whilst reducing construction time.

Papworth heart and lung research institute is another example of a hospital designed for the future, with its direct tunnel link to the high dependency unit enabling a significant increase in basic and clinical research capacity, resulting in 40% new recruitment.

Designs for major hospitals are also advancing with Pembury being the first hospital in the UK to be built with single bedrooms for all patients. In the diverse hospital environment, no one model has proven to be the ‘best solution’, but each facility has its own particular advantages.

For the New North Zealand Hospital (NHN) project which we are working on in Denmark, the architectural plan pushes together four central cores which carry patients vertically through the building, allowing immediate access to diagnosis, treatment and rehabilitation departments. This reduces patient treatment time but equally allows for more to be treated in a given period for the same building operational cost.

The NHN is being designed to comply with challenging energy consumption targets for buildings built in 2020. This 115,000m2 building is at the lowest current UK hospital energy consumption level, as the ‘marginal gains’ theory has been used by the designers to explore energy consumption. All elements have been rigorously challenged, from underground aquifers used as a seasonal energy store (saving 40% of the running costs of conventional cooling systems), through to varying ventilation rates for individual bedrooms as the sun moves around the building and varying light colour temperature and illumination levels.

At this Danish site two construction methodologies are adopted in parallel, based on functional need and future adaption. The lower two diagnosis and treatment floors are constructed using a conventional in-situ concrete frame, providing long spans and regular column grids which aid future adaption of clinical

At an operational level, new hospitals are also embracing automation as a means to manage the delivery and removal of supplies. At NHN, automatic goods vehicles (AGV’s) transfer goods from the central logistics building, via an underground tunnel network and dedicated lifts. Waste is removed via dedicated waste chutes local to each department – with the AGV’s taking the waste back to the logistics building on their return journey.

New hospitals are now required to incorporate a robust and flexible IT infrastructure – systems such as pneumatic tube systems, laboratory conveyor testing systems and da Vinci robotic surgery must be provided for. Additionally mobile phone platform technology will allow hospital communication and control systems to become more closely integrated.

28 | ghp September 2016

With new hospital buildings designed for a sixty year operational life span – and considering how medical treatment has changed in the last sixty years – we cannot with any confidence predict the way the hospital of the future will function. Engineers of new hospital buildings need to strike a careful balance between total building flexibility (and the consequent cost and inefficiency) and bespoke design (and the resulting inflexibility for adaption).

Understanding the healthcare environment, drawing on what others have done across the world and close stakeholder collaboration are all absolutely vital to maximising hospital efficiencies, where minimising a hospitals running costs is a key driver to delivering facilities that can focus on patient care.

Company: Ramboll Name: Neil Harvey Email: neil.harvey@ramboll.co.uk Web Address: www.ramboll.co.uk Address: Christchurch House, 30 Waterloo Street, Victoria Square, Birmingham B2 5TJ United Kingdom Telephone: +44 121 230 1650

ghp September 2016 | 29

Innovation & Technology

The next Generation of Essential Tremor Treatment Essential tremor is the most common movement disorder, affecting around one million people in the United Kingdom, and millions more worldwide. The most common symptom is hand tremor, but tremors can also affect the head, arms, voice, legs and torso. There is no definitive cure for essential tremor and for most patients the severity of the tremor will increase over time. This can cause patients to experience difficulty performing everyday tasks such as eating, dressing, writing, holding objects and even speaking.

While medication may be used to control the symptoms, only around 50% of patients have received satisfactory benefits from the drugs currently available.

Procedures such as Deep Brain Stimulation (DBS) are available and involve placing electrodes in the brain as well as fitting a pacemaker-like device into the patient’s chest. This requires additional surgeries every few years to replace the batteries powering the pacemaker or to perform other maintenance. While providing a significant reduction of the tremor, many patients are deterred by the level of invasiveness of this treatment option.

However for over 30 years, ultrasound waves have been safely used in diagnostic imaging devices and more recently the technology is being harnessed as an alternative to surgery, providing non-invasive therapy for a number of clinical indications in neurosurgery, oncology and gynaecology. MR-guided Focused Ultrasound (MRgFUS) is currently being used to treat neurological conditions such as essential tremor and last month the FDA approved the Exablate Neuro system as the first focused ultrasound device to treat such a condition. MRgFUS uses MRI imaging to plan the treatment, identify the target area and monitor the procedure in real-time whilst ultrasound waves ablate tissue deep within the brain, minimising damage to adjacent healthy tissue – with no incisions.

What is MRgFUS and how does it treat essential tremor?

By using more than a thousand beams and higher energy levels, ultrasound waves can be focused to generate enough heat to cause thermal ablation, which destroys cells. MRgFUS treatment involves focusing ultrasound waves on a target deep within the brain. The beams pass through the brain tissue and only at the focal point where they converge there is an

increase in temperature. For patients with essential tremor the beams converge at the Vim nucleus of the thalamus, the tiny part of the brain that is involved in causing tremors.

How does the procedure work?

During the MRgFUS procedure, the patient lies down on the treatment bed in the MRI scanner with their head in a helmet which contains transducers that deliver ultrasound beams. The physician identifies and verifies the correct target for treatment and then gradual heats the target tissue. MRI provides continuous real-time thermal feedback of the temperature changes at the target tissue, contributing to a high safety profile.

Due to its non-invasive nature the Exablate Neuro system carries very minimal risk of infection, bleeding and other surgical complications. It’s performed as a single outpatient procedure and patients experience immediate tremor improvement.

Benefits to healthcare professionals Throughout this single outpatient procedure, the patient is awake and able to interact with the treatment team, providing the physician with the ability to identify any potential side effects. The treatment takes between 3-4 hours and data from a multi-centre clinical study showed that patients generally experience an immediate and significant reduction in their tremor following the completion of the procedure – which is sustained after one year post-procedure. Since there are no incisions, recovery time is rapid with virtually no risk of infection or other complications associated with surgery and patients are able to return to their normal routine within 24-48 hours which reduces the need for hospitalisation.

30 | ghp September 2016

Currently MRgFUS has already been adopted and used by world recognised physicians in more than 120 leading medical facilities around the world. The treatment offers access to new and untapped segments of patients and holds the promise for a range of neurosurgical procedures. Exablate Neuro already holds a CE mark for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain, but as the treatment becomes more widespread it presents an opportunity for physicians to research new applications and provide patients with new non-invasive treatment options.

Name: Rick Schallhorn Web Address: www.insightec.com

ghp September 2016 | 31

Innovation & Technology

New Growth Opportunities for Respiratory Protection Equipment in Western Europe Strict enforcement of work safety standards across Western Europe is driving investment and innovation in the region’s respiratory protection equipment market. With International Organization for Standardization (ISO) standards likely to be introduced before 2020, employers will be keen to ensure compliance and invest in personal protective equipment (PPE).

Among the major end-user industries, construction will experience a surge in employment in countries such as the United Kingdom (UK), Ireland, Finland, Luxembourg, Netherlands, Portugal and Sweden, translating to higher sales of respiratory protection equipment. Another important industry, manufacturing, will witness fast growth in the wood, metal, chemicals and electronics segments, brightening the prospects of equipment vendors.

New analysis from Frost & Sullivan, Analysis of the Western European Respiratory Protection Market (http://www.frost.com/sublib/display-report. do?id=MC1E-01-00-00-00&src=PR), finds that the market earned revenues of €646.6 million in 2015 and estimates this to reach €712.8 million in 2020.

Disposable respirators were the biggest revenue generator, followed by non-disposable respirators and self-contained breathing apparatus (SCBA). Powered air-purifying apparatus (PAPR) is a growing segment, while airline and escape respirators are relatively small segments.

“Resurgent economies and improving awareness of the potential risks of inhaling contaminated air have opened up further application opportunities in the chemical industry, machine operations, asbestos removal in the construction industry, agriculture, spray paints, and firefighting,” said Frost & Sullivan visionary science research analyst Sanjana Prabhakar “Low exposure limits in countries like the UK, France, Germany and Scandinavia will augment both volume and prices of respiratory protection equipment.”

However, the slowdown in the mining, oil and gas industries, low-cost imports, and lack of streamlined regulations can rein in the market’s potential in the short term. The inadequate scope for innovation will also cause the market to compete on price in the lower-end segments such as disposable masks.

In advanced segments (PAPRs, SCBAs), wearables and sensors will enjoy higher uptake, if the cost differential is minimal. The added ease offered by PAPR through the elimination of fit-testing and seal, while using loose fitting equipment is attracting customer away from the disposable and non-disposable segments. The greater use of complex respirators will entail regular servicing and maintenance, which is an important source of recurring revenues.

Going forward, manufacturers will start offering multi-functional products that can be easily integrated with other PPE such as above. Manufacturers may also incorporate electronics in their products to make respirators smarter.

“Increasing emphasis on customer service and training will fuel new business opportunities, particularly for companies that tie in training services with products,” noted Sanjana Prabhakar. “Continued partnerships with customers and strong focus on understanding local market needs will help manufacturers stand out in the intensely competitive market.”

Web Address: www.frost.com

32 | ghp September 2016

ghp September 2016 | 33

Innovation & Technology

New E-Nose Sniffs out Rare Progressive Lung Disease An e-nose used to detect cancer has been adapted for early detection of Pulmonary Arterial Hypertension (PAH), a rare form of high blood pressure, by Université Paris-Saclay in partnership with the Technion Israel Institute of Technology. The artificial nose can sniff out PAH on a person’s breath as the disease alters its signature.

As cases are often diagnosed late, patients suffering from PAH have just a five-year life expectancy after diagnosis. It causes cells to obstruct small pulmonary arteries that pump blood from the heart to the lungs, impairing blood flow and increasing blood pressure within the lungs. Symptoms include shortness of breath, chest pain, dizziness and eventually right-sided heart failure.

But the disease can be managed with the right diagnosis. The earlier, the better. A team at the Technion, working in nanotechnology and headed by Professor Hossam Haick, initially invented the e-nose to diagnose cancer. Doctor Sylvia Cohen-Kaminsky from Université Paris-Saclay contacted Haick to apply his technology to PAH – which has some similar characteristics to cancer. They are setting up a device dedicated to the diagnosis of the devastating disease.

They created an international associated lab between Inserm, the Technion, and Université Paris-Sud, made and published the proof of concept of the detection of PAH using the e-nose. It’s built from gold nanoparticles coupled with chemical modules.

A large clinical trial sponsored by the public hospital system in Paris, Assistance Publique Hopitaux de Paris, and headed by Professor Marc Humbert from Université Paris-Sud, renowned expert in pulmonary hypertension, is now ongoing in PAH for validation.

“The gold standard for the diagnosis of PAH is right heart catheterism, which can make the right diagnosis, but it is invasive, risky and unsuitable for widespread screening,” says Cohen-Kaminsky. “The e-nose is a non-invasive and safe detection method that means general screening of PAH could eventually be made available.”

34 | ghp September 2016

ghp September 2016 | 35

Innovation & Technology

Is Your App a Medical Device? It’s Healthy to Know: Regulator Issues Updated Guidance Updated guidance issued to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe. From counting steps to helping healthcare professionals prescribe treatment for burns injuries, healthcare apps and stand-alone software are a part of everyday life.

You might not realise depending on an unregulated app to provide a diagnosis or recommend treatment could have potentially life-threatening consequences.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued updated guidance today to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe.

John Wilkinson, MHRA’s director of medical devices said: We live in an increasingly digital world, both healthcare professionals, patients and the public are using software and stand-alone apps to aid diagnosis and monitor health.

The guidance is presented as a step-by-step interactive PDF. App users can use this guidance to check if their health app is a medical device, and what to look for to make sure the app is safe and works.

Where apps or stand-alone software make a diagnosis or recommend a treatment, people should check for CE-marking before using their apps and developers should make sure they are complying with the appropriate medical device regulations.

Software and app developers can use the guidance to identify if their product is a medical device. It will aid developers in navigating the regulatory system so they are aware what procedures they need to have in place to get a CE mark which indicates acceptable safety standards and performance, and what their reporting responsibilities are when things change or go wrong.

Patient safety is our priority. We continue to encourage people to report any safety or performance issues involving medical devices, including apps, to MHRA via our Yellow Card Scheme online.

Web Address: www.gov.uk

Many apps and pieces of stand-alone software currently on the market are classified as medical devices.

These are apps which gather data from the person or a diagnostic device, such as diet, heartbeat, or blood glucose levels and then analyse and interpret the data to make a diagnosis, prescribe a medicine, or recommend treatment.

It is important that apps which are medical devices comply with medical device regulation and work as expected. Apps that give incorrect diagnoses or prescribe inappropriate treatments may have severe, potentially life-threatening consequences.

36 | ghp September 2016

ghp September 2016 | 37

Innovation & Technology

Genuinely Passionate About Science kdm communications is a full service, business-to-business marketing agency with international reach, specialising in the life science, medical and technical sectors. They provide a full spectrum of marketing services, helping their clients to choose the right tools for what they are aiming to achieve.

The kdm team includes an eclectic mix of marketing experts and PhD scientists, who together offer a unique combination of strategic planning, marketing expertise and technical knowledge. The firm’s Annabel Sedgwick reveals more about the firm who are “genuinely passionate about science and feel privileged to have worked across this sector for over 30 years”.

How would you define your client base? kdm communications surround ourselves with clients who excel at all things technical, medical, mechanical, scientific, industrial and digital. We are just as happy to work with small start-ups or huge multinationals and, because we are a team of scientists, we don’t get lost in technical language. We understand our clients’ products and their markets, and know exactly what their current and prospective customers want to hear.

What makes your firm unique?

The firm are genuinely passionate about science and feel privileged to have worked across this sector for over 30 years. We keep things simple and do not overcomplicate what needs to be done. We have remained a relatively small core team – backed by a larger group of well-established specialists to call upon for specific project expertise. This allows us to really concentrate on delivering sound marketing strategies and implementing highly targeted campaigns which position our clients as thought leaders, as well as promoting their products and services. I think the key to our continued success is that we all really love what we do.

What are the major challenges facing your business at present? kdm communications have built a superb team over the last 10 years, with an incredibly low staff turnover.

This means we are now in a strong position to grow the agency and expand the team, without losing the formula that has made us successful – a shared sense of pride in what we do and how we do it.

Looking ahead, what is the main objective for your business?

The world as a whole has changed extensively over the last 10 years and we are now living in a digital age, where the internet and social media permeate every aspect of modern life. This has effectively revolutionised marketing for our clients and their markets, and now a significant amount of our work is to create content for digital channels. The key to success in this virtual world is quality – the better and more widely shared content you generate, the more inbound leads it creates – and so helping our clients to keep up with the continuous demand for new material is now essential.

What business or business person do you most admire and why?

There are so many examples out there of entrepreneurs who have gained success through having a clear vision and the determination to see it to fruition.

For example, I was recently impressed by Arthur Kay, founder and CEO of bio-bean®. His fast-growing company is the first in the world to industrialise the process of recycling waste coffee grounds into advanced biofuels and biochemicals. It is people like this – who see an everyday problem as an opportunity to develop a unique solution – who really inspire me.

Company: kdm communications Name: Annabel Sedgwick Email: annabel@kdm-communications.com Web Address: www.kdm-communications.com Address: Cressner House, Suite 3, 12 Huntingdon Street, St Neots, Cambridgeshire, PE19 1BG Telephone: 01480 405333

38 | ghp September 2016

ghp September 2016 | 39

Lace up with TRI. Take the lead in your clinical study.

TRI expedites your clinical study start-up to minimize costs and avoid delays.

LI160032

Visit www.tech-res.com or call 301.897.1724 for more information.

LI160034

LIVING WITH DIABETES? WE DELIVER: NO CODING EASY TO USE

Large LCD display. Large buttons with simple functions.

SMALL SAMPLE SIZE Tiny 0.6 uL blood sample size.

ACCURATE

Clinically proven. Exceeds new ISO 15197:2013 accuracy standards.

QUICK RESULTS Results in six seconds or less.

Stores 960 test results.

FREE METER AND FREE BOX OF 100 LANCETS With your f irst purchase of 100 MediSure test strips.

PRECISION

QUALITY

1-855-MDI-SURE (855-634-7873)

VALUE

www.medisure.ca

42 | ghp September 2016

Innovation & Technology

LI160009

Best Plastic Welding & Hot Air Equipment Manufacturer Leister Technologies LLC is the US based subsidiary of Leister Technologies AG and specialises in plastic welding and additional plastic processing techniques. We profile this innovative company and explore the solutions it offers.

For over 60 years, Leister has been a world leader in plastics processing with hot-air, hot-wedge and extrusion welder technology. To assure customers can always rely on the renowned Leister quality, the company develops and produces all products and accessory parts in Switzerland in compliance with the strict ISO 9001 standard.

The classic product portfolio of the Leister Group is subject to continuous development and has been extended by high-tech machines and components involving laser and micro-technology. Leister Laser Plastic Welding produces powerful and cutting edge laser welding systems for plastics. Axetris AG develops and produces laser gas detectors, micro-optics, mass flow rate sensors and infrared sources for industry.

Frequent application areas for medical engineering products include doctor’s offices and hospitals. Consequently, the area of hospital care involves a large number of products that are partially made of plastic and are also laser welded.

Ultimately, the entire Leister group is committed to the highest possible standards, placing a priority on seamless, transparent quality management since the very beginning. Going forward this will continue to be the firm’s focus as it aims to achieve greater success in the years to come.

Company: Leister Technologies, LLC Email: leister@leister.com Website: https://www.leister.com/

The award winning Leister Technologies LLC offers decades of experience in the processing of plastics and industrial processes. The firm offers over 40 specialists from the fields of process engineering, mechanical engineering, electrical engineering, and product design all of whom are developing the technology of the future. They constantly drive continuous innovation, and their achievements have been honored by expert juries many times over. The results are products that stand out because their design is suitable for construction sites and industry.

Within the medical industry, there are many different areas of medical engineering that involve the use of plastics. Laser plastic welding has been an established part of certain applications for years. The medical devices market is a prime example of an area where products containing laser-welded components have been introduced. Microfluidics and chips for analytics are particularly worthy of mention in this regard. In many applications, these kinds of components also take the form of disposables, which can be found in various areas of medical engineering. Other products or devices have assemblies welded onto them. These usually have to be joined in such a way that they are sealed off tightly from the environment.

ghp September 2016 | 43

Regulation & Policy

Healthcare Recruiter Responds to Automatic UK Citizenship Recommendation Following a report from the Institute of Public Policy Research (IPPR), which recommends that EU nationals who work as doctors, nurses and physiotherapists should be granted automatic rights to British citizenship, specialist healthcare recruiter, MSI Group, has voiced its support.

The suggestion is designed to prevent a post-Brexit ‘brain drain’ from the NHS, with the IPPR warning that the cost and complexity of the current process deters both low-skilled workers and high earners who want a quicker and more efficient system.

Commenting on the recommendation, Nick Simpson, CEO of MSI Group, said: “As an organisation which is on the front line of recruitment into the NHS, we are already witnessing chronic talent shortages. Many of the Trusts that we work with have already found that recruiting the appropriate number of staff is becoming increasingly challenging.”

“Historic cuts to nursing training places, the recent abolition of bursaries for student nurses, changes to Tier 2 visa requirements, and last year’s caps on agency pay have all contributed to damaging talent pipelines. Without EU workers the NHS would simply fall over.”

“With this in mind, we fully support the IPPR’s recommendation. The NHS has been built through the

support of hard working immigrants, not least those from the EU. Waiving the £1,200 citizenship fee and fast-tracking valuable NHS workers who have lived in the UK for more than five years, as recommended by the IPPR, would not only help safeguard our National Health Service from potentially disastrous levels of staff attrition, it would also serve as a gesture of thanks to the healthcare professionals who help maintain safe staffing levels and keep the wheels in motion.”

“There was a 14% spike in applications for British citizenship by European Union nationals living in the UK in the run-up to the EU referendum and immigration experts have predicted that the Home Office would need to process the equivalent of 140 years’ worth of visa applications in 12 months if the 3.5 million EU nationals currently working in the UK decide to seek residency rights if free movement is restricted post Article 50. The truth is that the bureaucracy, cost, and waiting times associated with the process may prompt many healthcare professionals to seek careers elsewhere – and this is a risk that we simply cannot afford to take if we are to maintain patient safety levels.”

44 | ghp September 2016

ghp September 2016 | 45

Regulation & Policy

LI160015

First Call for Help Frestedt Incorporated serves their clients as their ‘First call for help’, whenever they need clinical, regulatory, quality or biomedical engineering support. From running, monitoring or auditing a clinical trial, to negotiating difficult regulatory discussions within a company or with regulatory authorities around the world, they provide detailed and highly technical responses to meet specific needs.

Frestedt Incorporated works for companies of all sizes including drug, device and food companies. They are known for their quick response times and low costs. As a small group of professionals with a large network of more than 70 consultants, they can address most problems quickly and efficiently.

The firm’s CEO and President Dr. Joy Frestedt reveals more, including her thoughts on negotiating difficult regulatory decisions, running clinical trials for food companies and how significant changes are on the horizon for all facets of research and development in the biomedical sector.

How would you define your client base?

Frestedt Incorporated’s clients include some of the largest and smallest companies in the world. The firm’s client mix changes from month to month.

Pharmaceutical companies enjoy having Frestedt Incorporated team members writing their investigator brochures or integrated safety summaries. Due to the firm’s deep experience and extensive knowledge, device companies call on Frestedt Incorporated staff frequently to author, develop and provide training on Clinical Evaluation Reports (CERs) and food companies call for help on the claim substantiation records.

While Notified Body positions on CE marking and CERs are constantly evolving, Frestedt Incorporated helps clients become more tactical by providing the most current, pragmatic solutions to meet Notified Body inspections with confidence. The firm also has a wholly owned subsidiary, Alimentix, with a special focus on running clinical trials for food companies (including those with new dietary ingredients or dietary supplements). Alimentix has convened GRAS (Generally Recognized as Safe) panels which are responsive to the changing US FDA regulations (a new Final Rule was just released in August 2016).

Frestedt Incorporated expanded operations in 2016 and the firm has begun assisting clients with test method validations and risk management assessments to support biomedical engineering efforts.

What makes your firm unique?

Frestedt Incorporated is unique due to the skill level of the team and the ability to meet tight timelines and budgets, with a focus on training the firm’s clients to do the work on their own, if they wish. Frestedt

Incorporated staff members do not fear collaboration and sharing knowledge, indeed, the team focuses on working with good people on good projects using good processes. Frestedt Incorporated believes in building a stronger science community and working hard to help exactly as needed. The firm specializes in addressing the obvious as well as the not so obvious problems in real time.

What are the major challenges facing your business at present?

Significant change is underway globally for all facets of the research and development functions in every biomedical sector. Staying on top of the new information and knowing how to implement change within companies is not easy. From new international standards to changing regulations in most parts of the world, Frestedt Incorporated team members face these challenges together with their clients. The firm’s clients come back over and over as change and the need for expert, efficient technical support do not seem to slow down.

Looking ahead, what is the main objective for your business?

Frestedt Incorporated’s main objective is to serve the firm’s clients with the best possible science and to grow slowly while addressing this main objective. The firm will • Design and run a clinical trial; • Monitor or audit clinical trials run by others; • Develop a regulatory strategy to get a product to market; • Create regulatory documents to support product development” and • “Develop or expand a client Quality Management System to meet enterprise needs

46 | ghp September 2016

• Provide scientific substantiation for a food claim; • Respond to biomedical engineering issues and; • Many other tasks, as needed.

Frestedt Incorporated and Alimentix teams look ahead and continue to see significant quality improvement initiatives which require companies to look both internally and externally to find the right resources to meet their needs. The firm’s objective is to serve more clients while providing the best quality in the market.

What business or business person do you most admire and why?

The team at Frestedt Incorporated admires each and every one of the firm’s clients. Whether starting a business for the first time and taking a great idea from the drawing board to the market or striving to get a team full of both local and global workers with individual needs to align on a goal within a large corporation, the team members at Frestedt Incorporated learn quickly and take the most admirable traits to heart as well as to the workplace every single day.

Name: Joy Frestedt, PhD, CPI, RAC, FRAPS Company: Frestedt Incorporated Email: jf@frestedt.com Web Address: www.frestedt.com and www.alimentix.com Address: 9445 Minnetonka Boulevard, Saint Louis Park, MN 55426 Telephone: 001 952 426 1747

ghp September 2016 | 47

Research & Development

1609JC10

Leading Life Sciences One Nucleus is an international membership organisation for companies working within the life science and healthcare industry. We caught up with Harriet Fear, Chief Executive at One Nucleus, to find out more about what they do and how they are one of the leading life sciences and healthcare organisations in Europe.

To start things off, could you give us an overview of your organisation and what you do.

Based in Cambridge in the UK, One Nucleus is the largest membership organisation for the life science and healthcare sector in Europe and provide practical support to our members. Importantly, we are not-forprofit and have 500 organisations as members. About 80% of our members are based in the Cambridge/London corridor, an area that is home to at least 60% of the UK’s life science industry base and is at the heart of Europe’s largest life science and healthcare cluster.

Our members range from large corporates such as MedImmune, AstraZeneca and Amgen through to tiny start-ups, and everything in between! Our mission is to help our members maximise their global competitiveness and we have a deep international focus.

How does it feel to have received two GHP Awards?

Here at One Nucleus the team and I are thrilled to have won two GHP Awards, especially because they are peer reviewed by the international community: • Best Global Life Sciences Membership Organisation and; • European Life Sciences & Healthcare NPO of the Year 2016.

The commitment and innovation of our fantastic membership drives me and the team to do our very best for and with them. For One Nucleus to have been recognised as the Best Global Life Sciences Membership Organisation in particular, against stiff competition, is hugely motivational for us and we look forward to continuing to serve our members to the very best of our ability and highest standards possible.

What healthcare areas do you specialise in?

We focus across the life science and healthcare space as that is what our members are broadly involved in.

In terms of our work, we support our science and technology based members being global leaders in the research, development and commercialisation of healthcare innovations that radically improve the quality of people’s lives around the world. For our business and professional services members, it means us helping them to deliver exceptional services that significantly enhance the business performance of their clients.

On the whole, our entire focus is on providing practical and tangible services for our members. We run major conferences in the UK (including the much

appreciated Genesis Conference in December every year in London for 800 delegates), smaller networking events, therapy focused events (for example focusing on oncology; respiratory; vaccines; personalised healthcare; CNS and many more besides – bringing communities together).

What role do your staff play in the successes of your firm?

Our team is absolutely key to our success. We have a very clear vision and mission and a trajectory that all the team support and work to deliver to. Most of the team has a strong creative background and we all take great pleasure in working with and for our members.

We also run a large training programme both for specialists and non-specialists in the sector, manage a major Purchasing Consortium (which sees many of our members making significant financial savings on supplies) and a host of other activities – including digging deep into thorny issues with our ON Insights initiative – a series of intentionally small workshops with key members to debate and get under the skin of matters affecting members which we then profile to our 10,000 plus strong database.

What do you see as an activity that has had national or international impact at One Nucleus?

In 2014, I was approached by the office of the British Prime Minister and asked if I would like to be a Business Ambassador for the UK. This is a voluntary role and sees me promoting the UK life science and healthcare sector internationally. There are only four Business Ambassadors in the UK for No 10 so it was a huge honour to be asked to undertake this important role.

What do you hold the success of your organisation down to?

We are an incredibly collaborative organisation – where that collaboration will be of benefit to our members – remembering that mission all the time! One of our core objectives is not to duplicate what others do well and we publicly support a range of other organisations in the UK who are working in the sector.

My activities so far (I have just accepted to extend in the role for a further two years) have included leading a trade mission to India, briefing numerous visiting international dignitaries and supporting the British Government with their trade and investment strategy.

I genuinely believe I was asked to undertake this role because of the strength of the One Nucleus membership – after all, we would not exist without them!

In terms of how we differentiate ourselves – this is something of which I am especially proud – I would wager that our international focus makes us stand out.

One Nucleus thinks like its members do – globally. Most of what we do has an international focus to it – whether it be us having signed relationship agreements with the four major US membership organisations for the sector (including MassBIO), or hosting a steady stream of visiting groups of companies from other parts of the world to meet with and collaborate with our members. My background as a British Diplomat for 21 years comes into play here often – I was pretty much born global myself and this runs through the One Nucleus team.

What role have you and your company played in shaping the future of the healthcare sector?

The future protection of the sector is of course vital.

Our Genesis conference regularly takes the future as its theme and we are fortunate to have incredible Key Opinion Leaders speak at the Conference (http://www. genesisconference.com/), discussing, unearthing and unleashing the matters of importance to the sector in terms of remaining robust into the future.

How is your organisation performing at present?

We absolutely love what we do and are fortunate to have had the same team for many years now which is great testament to the company in my view. There have been five babies born in that time and three of the team have returned from maternity leave into roles back in the company – which is fantastic for us as we keep the team members expertise and enthusiasm.

Our membership continues to grow and our international recognition never ceases to surprise and please me. We clearly are doing something right!

48 | ghp September 2016

What events does your organisation have in the pipeline?

Our second major conference is our ON Helix (translational research conference) that we host in Cambridge each Summer. The early stage translational research phase is an area that many of our members excel in and we are keen to promote that on the world stage. This year we were incredibly fortunate to have some fantastic keynote speakers including: Dr Susan Windham-Bannister, the ex-President of the Mass Life Sciences Center (responsible for the Governor of Mass’s $1 billion life sciences programme). We also had Sir John Savill, CEO of the MRC, Professor David Roblin, COO of the Crick Institute, Jane Osbourn, site leader of MedImmune and Nick Lemoine of NIHR.

Last year’s event was an astounding success, with many complimentary comments from those attended.

Among those was Sir Mike Rawlins, ex Chair of Eastern AHSN, President of the Royal Society of Medicine now Chair of MHRA, who said: “ON Helix is THE translational event in the UK where all participants can expect to network at the highest level with each other and learn an incredible amount all in the one day. It’s terrific!”

In a similar vein, Sir William Castell, (at the time the Chair of the Wellcome Trust) commented: “ON Helix was a great day, very well attended and with a fantastic speakers’ line-up. It shows the importance of addressing translational research topics amongst the life sciences community. Importantly it is a great showcase for the strength of biomedical innovation in the southeast of England. “ Looking ahead, what challenges does you face in the future, in terms of the company you work for, and the industry you work in?

Whilst it is likely fair to say that we are currently seeing a ‘Golden age’ of biotech, it is never good to rest on one’s laurels. There are challenges continuously for the sector but from what the team and I have witnessed, it has never been easy for life science and healthcare companies! The sector is jam packed with highly entrepreneurial, strong, intellectual people who want to make a difference in the world and who are ready to face the challenges head on and that will, I hope, never change.

Thank you so much for your time. Is there anything else you would like to add?

In June this year I was delighted to be honoured with an MBE in the Queen’s Birthday Honours List for my services to the healthcare and life sciences sector.

As I made clear at the time, I firmly believe I would not be or have been on any award radar without the strength and brilliant global importance and impact of our membership.

Company: One Nucleus Limited Name: Harriet Fear Email: harriet@onenucleus.com Web Address: www.onenucleus.com Address: One Nucleus, the Portway, Granta Park, Cambridge, UK, CB21 6GS Telephone: 01223 896 454

ghp September 2016 | 49

Research & Development

Accumulation of a Product of Cell Metabolism Found to Be Linked with Kidney Tumour Growth Researchers funded by the Medical Research Council (MRC) have shown that when the metabolite fumarate accumulates in a hereditary form of renal cancer it leads to an epigenetic reprogramming that drives cancer, according to a study published in Natureopens in new window. The tumour growth mechanism seen here could be similar in other cancers, such as lung and bowel cancer, where the enzyme that breaks down fumarate is not present or not fully functional.

Fumarate is found naturally in fruits and vegetables. It is also produced artificially for use as a food additive to act as an acidity regulator and flavouring agent. It usually acts as an intermediately product during the citric acid cycle, which the cells use to produce energy.

Hereditary leiomyomatosis and renal cell cancer (HLRC) is a rare form of cancer that results in skin tumours and can lead to kidney cancer. It was already known that the disease was related to a mutation in the gene that codes for the enzyme fumarate hydratase (FH), found in the mitochondria, but until now it was unclear how this leads to tumour growth.

Researchers from the MRC Cancer Unit at Cambridge University used a combination of RNA sequencing and metabolomics, the study of small molecules resulting from metabolism, to find out what was causing tumour growth.

The team found that the excess fumarate that results from the loss of FH led to epigenetic changes to a micro RNA. This caused the micro RNA to be suppressed, which functions in the prevention of metastasis. These epigenetic changes resulted in the expression of genes that initiated epithelial to mesenchymal transition. This is the process whereby normal cells become cancerous and metastasise, spreading around the body

Now that the mechanism of tumour growth related to FH loss is known, future work can focus on how fumarate is involved in other cancers. For instance, it has been shown that FH is lost in other types of tumours, including non-hereditary renal cancer, neuroblastoma, and tumours of the adrenal gland. Given that metastasis is the primary cause of death in cancer patients, understanding how to block metastasis caused by fumarate could be a key strategy for cancer therapy.

Future work would also need to be done to further understand the action of fumarate in normal conditions.

Lead researcher, Dr Christian Frezza from the MRC Cancer Unit, says: “The findings of our study suggest that the disruption of FH and the resulting fumarate accumulation have roles in this type of kidney cancer.

This could also be a feature of other tumour types where FH loss has been reported, including neuroblastoma, colorectal and lung cancer.”

Dr Nathan Richardson, head of molecular and cellular medicine at the MRC, says: “The results of this research give us a clearer insight into how fumarate is involved in this form of renal cancer. It now gives us the opportunity to see if this also applies to other common forms of cancer and also how metabolism is related to the progression of the disease.”

Web Address: www.mrc.ac.uk

50 | ghp September 2016

ghp September 2016 | 51

Research & Development

Researchers Identify Gene Associated with Age-Related Hearing Loss A large screening programme has identified several genes associated with age-related conditions including hearing loss, retinal degeneration and osteoarthritis. The animal study, published in Nature Communications opens in new window, may lead to studies of the equivalent human gene and help develop screening programmes to identify the risk of developing an age-related condition many years before symptoms appear.

Age is a risk factor for many conditions, including diabetes, cardiovascular disease, hearing loss, dementia and others, but the genes that we carry also influence whether we are more or less susceptible to these. Not much is known about which genes influence age-related conditions, or how they do so.

Lead researcher, Dr Paul Potter of MRC Harwell, said: “Our study is an important springboard for a better understanding of which genes in humans are involved in age-related conditions, and how changes in those genes influence this. This is a first and vital step in developing new therapies.”

To explore this further, researchers from MRC Harwell, a research facility based in Oxfordshire, introduced new mutations at random positions in the genes of mice before they were born, and then monitored their health as they aged. If an age-related condition developed, the researchers investigated which particular gene in that mouse had been mutated. One gene identified in this way was Slc4a10. This was already known to be needed for eye function, but this new study linked defective Slc4a10 to age-related hearing loss for the first time.

Dr Lindsay Wilson, programme manager for genetics and genomics at the MRC, said: “As we get older, we have an increased risk of developing many conditions, including diabetes, cardiovascular disease, hearing loss and dementia. The genes that we carry can influence this, but it is hard to know which do, or how.

This study increases our understanding of the genes related to ageing and ill-health and may ultimately help us to identify new treatments.”

Web Address: www.har.mrc.ac.uk

Identifying this gene and others related to late-onset conditions in mice could now prompt investigation of the same genes in humans to ask if naturally-occurring mutations in them cause similar effects. In future, screening people for defects in the genes identified could help to predict their chances of developing a particular condition, and the findings may one day inform treatment development or timing of interventions.

52 | ghp September 2016

ghp September 2016 | 53

Research & Development

Reviving Accidental Hypothermic Victims with Extracorporeal Life Support Dr Beat Walpoth, director of cardiovascular research at the University Hospital of Geneva, Switzerland, is a leading surgeon and expert on rewarming victims of hypothermia using extracorporeal life support (ECLS).

The technique has been adapted from cardiac surgery as early as the 60’s and 70’s when patients were cooled down to core temperatures around 20°C in order to perform complex cardiac surgical repairs in a state of deep hypothermic cardiac arrest with good survival after rewarming to normothermia.

Dr Beat Walpoth said that, “such operations would be impossible in normothermia because the brain has a tolerance to anoxia – not being perfused by blood – of about three minutes. However, when you cool the body to 20˚C, the brain’s tolerance is extended to around 30 minutes.”

“After the first successful rewarming of a patient in cardiac arrest with accidental hypothermia by Professor Ulrich Althaus, I joined the team at the University Hospital of Bern, Switzerland and we developed the method much further. This pioneering research has shown that it is possible to revive a victim in deep hypothermia with cardiac arrest by rewarming the body with ECLS (cardio-pulmonary bypass, or ECMO) and to give him a chance for a sequela-free long-term survival (published by our group in the New England Journal of Medicine in 1997). Prior to this event such patients would have been declared dead.”

But could this technique be advanced to the point at which humans could lie dormant for years at a time?

Suspended animation is the concept that lowering a person’s core temperature dramatically can enter them into a dormant state, waiting to be reanimated years later. It is a theme that is often revisited in science fiction and is regularly proposed as a way of dealing with the long timescales of interstellar travel, but how realistic is the possibility of cryonic suspension?

Dr Walpoth continues, “It has always been the dream of many scientists and writers. At the moment I’m not convinced that it will be possible for the whole body to be ‘frozen’ (cryo-preserved). As you may know, it is possible for cells; you can freeze certain types of cells for 20 years or even longer and they will still carry all of their capacity when thawed.”

“There is work in progress to try to apply this technology not only to isolated cells but to whole organs. So

far, some organs have the potential to be cryo-preserved at -196°C and thawed; you can, for instance, do that with simple organs such as heart valves, which function quite well after thawing. But from there, to go to ‘freezing’ a whole body is an enormous step. I don’t want to be overly optimistic or pessimistic but time will tell – my expectation is that these technologies will not be available in the near future.”

The pioneering cardiovascular surgeon is the founder of the International Hypothermia Registry, which gathers patient data and collates peer-reviewed analysis to improve the treatment of accidental hypothermia victims.

Dr Walpoth will be speaking at the World Extreme Medicine Conference and Expo at Dynamic Earth, Edinburgh, EH8 8AS on 19 November 2016. The Extreme Medicine Exposition brings together leading experts from around the globe to share learnings on prehospital care, expedition and wilderness medicine, sport, endurance, humanitarian and disaster medicine.

Mark Hannaford, founder of conference organisers World Extreme Medicine, said, “Dr Walpoth’s great experience is relevant and poignant for a lot of doctors working in expedition and wilderness medicine, as hypothermia is a great danger to all mountaineers and polar explorers. “Improving the efficacy of the treatment of accidental hypothermia is hugely important to safety in these extreme environments, and Dr Walpoth is at the very forefront of that research.

“World Extreme Medicine was founded around a campfire in Namibia, and we coined the phrase ‘World Extreme Medicine’ as an umbrella term for all practices of medicine outside of a clinical environment, whether it is prehospital, disaster and humanitarian, endurance, sport, expedition or wilderness medicine.

“Our message is that there is a great diversity of careers in medicine, and that traditional hospital environments are not the only option for a fulfilling career.

To put it into a layperson’s terms, there’s never been a more exciting time to work in medicine.”

For further information about the Extreme Medicine Expo, which takes place 18 – 21 November 2016, please

54 | ghp September 2016

visit: http://www.extrememedicineexpo.com/events/event/ extreme-medicine-conference-expo-2016-early/ University Hospital of Geneva: http://www.hug-ge.ch/ Professor Ulrich Althaus: http://www.ctsnet.org/home/ualthaus University Hospital of Bern: http://www.insel.ch/en/ International Hypothermia Registry: https://www.hypothermia-registry.org/ World Extreme Medicine Conference and Expo: http://www.extrememedicineexpo.com/ World Extreme Medicine Conference Info: http:// www.extrememedicineexpo.com/events/event/extreme-medicine-conference-expo-2016-early/ Glossary Cardio-pulmonary bypass: Cardiopulmonary bypass (CPB) is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body. The CPB pump itself is often referred to as a heart–lung machine or “the pump”.

Cryo-preserved: Cryopreservation is a process where cells, whole tissues, or any other substances susceptible to damage caused by chemical reactivity or time are preserved by cooling to sub-zero temperatures.

ECLS: Extracorporeal life support (ECLS) is a variation of cardiopulmonary bypass. Whereas cardiopulmonary bypass facilitates open heart surgery for a number of hours, extracorporeal life support maintains tissue oxygenation for days to weeks in patients with life threatening respiratory or cardiac failure (or both).

ECMO: Extracorporeal membrane oxygenation (ECMO) works by removing blood from the person’s body and artificially removing the carbon dioxide and oxygenating red blood cells. Generally, it is only used in the later treatment of a person with heart or lung failure as it is solely a life-sustaining intervention.

Normothermia: A normal state of temperature.

Sequela-Free: Living without a condition which is the consequence of a previous disease or injury.

Web Address: www.hug-ge.ch

ghp September 2016 | 55

Research & Development

Kymouse™, Kymab’s Human Antibody Discovery Platform, Successfully Demonstrates Steps to Developing HIV Vaccine Kymab, the Cambridge-based antibodies-to-medicines company, recently announced a publication of a new approach to developing a human vaccine against HIV in the internationally renowned scientific journal Science.

The publication presents new findings from a collaboration between researchers at Kymab, The Scripps Research Institute (TSRI) of San Diego, California, and the International AIDS Vaccine Initiative (IAVI). HIV is one of the most intransigent targets for vaccine development, and no effective vaccine has been developed in thirty years of global research. The paper is entitled “Priming HIV-1 broadly neutralizing antibody precursors in human Ig loci transgenic mice”.

The research, which tested the first step in an approach to develop effective vaccines against the range of HIV variants existing worldwide, was published in Science on Thursday 8 September 2016, and was supported by funding from the International AIDS Vaccine Initiative and the US National Institutes of Health.

The results show that Kymouse, which is a mouse that has been modified to mimic human antibody responses, is an effective platform for discovering and testing possible vaccines and suggest ways in which testing of vaccine candidates can be improved.

“We increasingly recognise that traditional vaccine strategies will not be successful against all viruses, especially not HIV. Together with the Kymab team, we have taken a novel approach in which we have induced human antibodies in Kymouse that are at the beginning of the pathway to protective antibodies and which is a huge boost to our mission to develop a HIV vaccine.” says Dennis Burton, chair of the TSRI Department of Immunology and Microbial Science and scientific director of the International AIDS Vaccine Initiative (IAVI) Neutralizing Antibody Center (NAC) at TSRI and the National Institutes of Health (NIH) Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID).

The work is based on the observation that a fraction of people who become infected by HIV develop broadly

neutralising antibodies against diverse HIV strains.

Such antibodies would be ideal to protect against or possibly treat HIV infection — if a vaccine could be made to elicit them.

However, these antibodies originate from a limited number of precursor antibody-producing cells in the body and acquire their unusual and protective properties only during a long course of infection. Moreover, although these cells have been activated when immunising certain biased animal models, this is the first time it has been achieved through immunisation of an immune system, as in the Kymouse, that resembles the human.

The researchers injected Kymouse strains with a nanoparticle formed of 60 copies of a small protein that mimics HIV and was designed to bind and stimulate the specific precursor cells for one class of broadly neutralising antibody. They expected to find just one such precursor cell (among tens of millions of such cells) in each immunised mouse.

The research team then looked to see whether or not the mice had mounted an antibody response to this injection. Given the combined challenges of a complex immunogen structure and the rarity of the right antibodies, an effective response against the HIV immunogen was elicited remarkably efficiently.

“Our phenomenal results with the teams at TSRI and IAVI came from work at the boundaries of protein engineering, immunology and vaccine technology,” explains Professor Allan Bradley, chief technical officer at Kymab and director emeritus of the Wellcome Trust Sanger Institute, who developed the Kymouse platform. “Using Kymouse, we show how an advanced vaccine candidate can search out the one cell among tens of million antibody-producing cells and make it proliferate.

56 | ghp September 2016

“Kymouse can deliver antibody responses that we need to build effective HIV vaccines.” The team validated their antibody response by sequencing genes from more than 10,000 cell samples, and showed that genes from responding mice had the expected sequence for precursors to broadly neutralising antibodies against the HIV target.

“It is a big step forward in this branch of HIV vaccine development,” says William Schief, TSRI professor and director of vaccine design for the IAVI Neutralizing Antibody Center at TSRI, in whose lab the vaccine nanoparticle was developed. “We have the first proof of principle that this HIV vaccine strategy and our vaccine candidate can work in a human immune system and trigger the first step in the pathway to developing broadly neutralising and protective antibodies against the virus. “It is the very sort of response we’d want to see as we test components of a future vaccine.”

HIV has proved an extremely difficult challenge in vaccine development. The new research shows that Kymouse can produce antibodies of the type that could evolve to confer protection, suggests ways in which the immunisation regime can be improved and indicates that Kymab’s technologies will support and accelerate the search for other, rarer and perhaps even more effective antibodies.

“About 35 million people have died of HIV/AIDS and 36 million are currently infected. Although a vaccine is the most likely way to stem this loss, no successful vaccine has been found in more than thirty years of HIV research,” says Professor Paul Kellam, vice president of infectious diseases and vaccines at Kymab.

“This is a pressing need and these results show that our Kymouse technologies can serve a vital part in the search for effective vaccines that help to protect against this most challenging disease.”

“This dramatic proof of concept gives us hope we can find better broadly effective vaccines for HIV and, indeed, for other infections, using the human immune system to help guide us along the best path.”

Kymab has raised more than $120m in equity funding from partners including Bill & Melinda Gates Foundation, the Wellcome Trust, Malin Corporation plc and the Woodford Patient Capital Trust plc to fund its unique antibody development platform in therapeutic development and vaccine discovery. Kymab is building a rich pipeline of assets in four main therapeutic spaces: infectious disease, such as HIV and malaria, as well as immuno-oncology, inflammation and haematology.

For more details, please visit: http://www.kymab.com http://www.scripps.edu/ www.iavi.org

ghp September 2016 | 57

Translation & Commercialisation

Standing at the Brexit Crossroads – Considerations for Pharma Companies Following the June EU referendum in the UK, pharmaceutical businesses around the world are assessing what impact Brexit may have on their operations and business relationships in the UK, the EU, and internationally.

The most obvious issue affecting pharmaceutical businesses, post-Brexit, is what will happen to existing and future marketing authorisations in the UK and the EU, but other important considerations include the potential impact of Brexit on data exclusivity periods, orphan products, supplementary protection certificates (SPCs), and clinical trials. This article looks at some of the key issues facing the pharmaceutical industry and identifies the key areas which need to be addressed as the UK progresses towards Brexit.

EU legislation and Brexit models Much of the legislation and regulation governing the sale of medicines in the UK at present comes from the EU (either as Directives, which have been implemented into national laws, or Regulations which are directly effective in all EU Member States and therefore do not require domestic implementation). In many cases where the UK decides to continue to implement EU legislation post-Brexit, it will need to agree with the EU some form of mutual recognition or equivalence regime in order to continue to be given access to rights set out in the EU legislation and for the EU to continue to recognise UK regulatory decisions.

Various models of Brexit have been proposed - from ‘Brexit-lite’ in which the UK remains part of the single market (either via the EEA or otherwise) and retains legal provisions derived from relevant EU Regulations and Directives, all the way to a total separation, which would require significant repatriation of EU laws or alternatively the drafting of new national UK provisions.

Dealing with existing and future approvals Depending on the terms of the UK’s withdrawal from the EU, Brexit may require companies to: • Transfer existing marketing authorisations (MAs) which rely on an establishment in the UK to an entity established in another EU Member State (whether to a new establishment of the same company, a group company, or a third party); • Change their approach to MA filings for new products that will be launched in the UK and the rest of the EU (including considering the impact of Brexit on M&A deal structures where the transfer of MAs is required) and; • Undergo new good manufacturing practice (GMP) inspections for their manufacturing sites in the UK

Clinical trials The Clinical Trials Regulation, which entered into force on 16 June 2014, is expected to apply across the EU before Brexit takes effect. The UK will need to decide whether to implement equivalent legislation in the UK post-Brexit. It would also need an agreement with the EU to continue to fully benefit from new Regulations, such as the multi-centre approval process.

Activities performed in all clinical trials (and health technology assessments (HTAs) were exempted from patent infringement in the UK by the amendment of the UK’s ‘Bolar’ provision in 2014. Since this provision is fully implemented into UK law (and heavily consulted on recently), the authors would not expect further changes to it, given the importance of being able to attract clinical trials to the UK. Businesses will also need to consider the wider validity of clinical trial data generated in the UK, post-Brexit, and analyse the use of, and ability to transfer, personal data to the UK which has been obtained through clinical trials in the EU. Data/market exclusivity The period of data/market exclusivity which applies once a new product has been authorised (the ‘8+2+1 rule’) derives from EU law and has been implemented in UK law. It seems likely that the UK will continue to protect developers of innovative medicines in this way, as part of ensuring the UK remains equally as attractive as the remaining EU Member States. The UK may even see this as an opportunity to set itself apart from the rest of the EU by providing longer protection for innovators.

However, this would need to be balanced against the NHS’s need to reduce the overall drug spend (which relies in part on generic entrants following the expiry of data/market exclusivity). UK legislators may also adopt a nuanced approach on issues such as exclusivity periods for new combinations, or indications, which may, in time, diverge from the EU’s approach.

Specific EU legislation also applies to orphan drugs, which is designed to stimulate research and development of medicinal products for rare diseases only affecting a small percentage of the population (no more than 5 in 10,000 people within the EU).

This orphan market exclusivity applies by virtue of a

58 | ghp September 2016

Regulation and the UK would need to actively ‘opt-in’ to reflect this legislation in national law, post-Brexit.

Such an ‘opt-in’ would indicate the UK’s commitment to rewarding research into rare diseases.

SPCs Like orphan market exclusivity, supplementary protection certificates (SPCs) exist by virtue of an EU Regulation. Carrying a maximum of five years’ additional exclusivity at the end of the life of the basic patent, SPCs are considered to be hugely important by innovator companies, but equally are subject to frequent challenges from the generics industry who can access the market earlier if the SPC on a product can be knocked out.

SPCs compensate the originator for the R&D time involved in getting a new drug to market, which take up a significant amount of the ordinary 20 years’ patent monopoly period. If the UK wishes to maintain its commitment to rewarding pharmaceutical research and innovation, it is to be expected that a parallel SPC system would be retained. However, this is not a foregone conclusion and innovators should ensure that their government affairs teams are fully apprised of the significance of SPCs to their business.

Assuming that UK SPCs continue in parallel to the EU system, will the numerous existing European Court (CJEU) decisions in this heavily litigated area continue to apply? Whilst those references from the UK are embedded in the national case law, the fate of references from other countries, and pending references is unclear. We envisage that, until the national courts diverge, they will see the existing CJEU cases as of useful (but not precedential) value. This undoubtedly provides an opportunity for the UK courts to impose some clarity on an area where the CJEU has at times generated confusion.

The path forward…

Whilst the UK’s preferred Brexit model remains unknown (and Article 50 has not been triggered) a definitive assessment of the impact on the pharmaceutical industry is, as in many other industries, unclear. However, whilst the status quo prevails, businesses can prepare by ensuring that their key areas of interest are raised with the UK government. Whilst divergence from Europe in many areas (such as clinical trials) is not desirable due to the international nature of the pharmaceutical industry, Brexit may provide the opportunity to simplify other areas, in particular around SPCs, and the provision for additional data exclusivity periods. Even if, ultimately, the outcome of Brexit is a re-negotiated EU membership or an EEA arrangement (Brexit-lite), increased engagement with government stakeholders can only improve the relationship between the pharma industry and those who regulate it.

Company: Hogan Lovells Name: Helen Kimberley and Laura Whiting Email: helen.kimberley@hoganlovells.com laura.whiting@hoganlovells.com Web Address: www.hoganlovells.com Telephone: +44 20 7296 5306

ghp September 2016 | 59

Translation & Commercialisation

High-Value Specialty Medicine, Biosimilars and Premium Pricing Portfolio Drive Growth in the Global Generic Pharmaceuticals Market Emerging markets are the next big opportunity after the US, says Frost & Sullivan. Increased life expectancy, a growing aged population cohort, and the higher incidence of chronic lifestyle-related diseases are encouraging the use generic pharmaceuticals as governments and healthcare service providers strive to contain costs. Impending patent expiries of key drugs and a promising pipeline of next-gen high value-added biosimilars too will sustain double digit growth for generics.

On the flip side, increasing global competition, downward pricing pressure, and tightening regulations will challenge market participants. Further, professionals and patients often prefer branded drugs over generics. Using innovative production platforms to develop lower cost biosimilars as well as a premium priced portfolio can offer greater mileage to generics companies.

Recent analysis from Frost & Sullivan, Global Generic Pharmaceuticals Market, finds that generic drugs earned revenues of $330.87 billion in 2015, with a 37% share of the global pharmaceutical market. This is expected to reach $557.37 billion by the end of 2020. In fact, the generics segment is growing at a compound annual growth rate of 11% for this period, while the global pharmaceutical market is growing at a lower CAGR of 9.8%. By 2020, speciality and biosimilars will account for up to 70 % share of generics.

“Patent expiration and increased usage of traditional generic drugs are curbing the cost of drugs, compelling the industry to invest in specialty medicines,” said Frost & Sullivan Transformational Health Industry Manager Sanjeev Kumar. “With innovation and technology, generics can be enhanced to deliver additional benefits. Furthermore, to beat the competition, several generics companies in developed countries are transforming themselves from low-margin formulation to high-margin formulation manufacturers.”

The US remains the largest generic pharmaceuticals market, characterised by high profit margins, high levels of generic prescription by doctors, strong intellectual property legislations, retailers’ purchasing price, and pricing levels determined by demand.

Europe may emerge as a game changer with the early adoption of biosimilar drugs.

“The next big opportunity, however, lies in emerging markets,” noted Kumar. “The availability of cheap labour, inexpensive production methods, skilled personnel, and sound infrastructure make India and China the most sought after destinations for import of generics by developed markets.”

While the economic boom and healthcare reforms make China lucrative, India is a major market for consumption as well as manufacturing of generics. The country targets exports of more than 40 % to the US each year. Dominated by branded generics, the Indian market will see higher demand after the implementation of universal health coverage.

Web Address: www.frost.com

60 | ghp September 2016

ghp September 2016 | 61

Funding & Investment

Cuts to Public Health Risks Widening Health Inequalities After taking on responsibility for public health, local authorities were dealt an in-year cut of £200 million last year and now face further real terms cuts to public health budgets. Cuts to public health and the front line services they deliver are a false economy as they not only add to the future costs of health and social care but risk widening health inequalities, says the health committee in its report on public health post-2013.

In her first speech as Prime Minister, Theresa May put reducing health inequalities at the top of her list for action, highlighting the ‘burning injustice’ that if you are poor you will die on average nine years earlier than if you are rich.

The government must recognise that tackling health inequalities and improving public health will not primarily happen in hospitals, even though hospitals receive the lion’s share of health funding. Rather, it requires a whole life course approach, tackling the wider determinants of health in local communities, effective action on prevention and early intervention, and through joined-up policy making at a national level.

There is a growing mismatch between spending on public health and the significance attached to prevention in the NHS 5 Year Forward View.

Call for bold and brave action To support this agenda at a national level, the committee wants to see a Cabinet Office minister given specific responsibility for embedding health across all areas of Government policy at national level.

The report concludes that while there is evidence of progress locally, there is less evidence of such an approach becoming embedded across Government departments. It calls for the Government to take bold and brave action through its life chances and childhood obesity strategies in order to improve public health and reduce health inequalities.

Chair’s comments health committee Chair, Dr Sarah Wollaston adds: “The disappointing watering down of the childhood obesity strategy, published in August, demonstrates the gap in joined-up evidence-based policy to improve health and wellbeing. Government must match the rhetoric on reducing health inequality with a resolve to take on big industry interests and will need to be prepared to go further if it is serious about achieving its stated aims.”

Public health does not primarily take place in hospitals but within local communities and the committee heard general but not universal support for the move of public health to local authorities but also concerns about the resulting fragmentation of some services and issues that have arisen over the transition.

Government policy The committee urges the Government to make good on its commitment to health in all policies by enshrining health as a material consideration in planning and licensing law. The committee heard evidence that this would help local government to directly improve the health of their local communities and reduce health inequalities. Local authorities need the levers to be able to take effective action to protect local communities and this is especially important given the cuts to their budgets.

Public health system progress The committee found that in some local authority’s good progress has been made, with modest positive impact on public health outcomes already being seen, but in others, less headway has been made. The new public health system is designed to be locally driven, and therefore a degree of variation between areas is to be expected. However, the committee is concerned that robust systems to address unacceptable variation are not yet in place.

The current system of sector-led improvement needs to be more clearly linked to comparable, comprehensible and transparent information on local priorities and performance on public health. Changes to local government funding, especially the removal of ring-fencing of the public health grant, must be managed so as not to further disadvantage areas with high deprivation and poor health outcomes.

Health protection Health protection—encompassing prevention, preparedness and response to outbreaks and other

62 | ghp September 2016

health threats—is a critical public health function.

Despite several sets of guidance on responsibilities the committee heard that confusion, duplication and lack of clarity persist in some local areas.

Public Health England must ensure that local areas are clear about their responsibilities and equipped to deliver a seamless and effective response to outbreaks and other health protection incidents.

Web Address: www.parliament.uk

ghp September 2016 | 63

Funding & Investment

Innovative Private Insurance Models Shake up Healthcare Industry New analysis from Frost & Sullivan, Transformations in Global Private Health Insurance Models (http://frost.ly/q9), finds that North America is the largest private health insurance market, accounting for more than two-thirds of the global private insurance premium revenues, or $1.07 trillion in 2015. Europe came in a distant second with $189.54 billion, followed by Asia-Pacific with $124.07 billion, Latin America with $30.78 billion and Africa with $1.43 billion.

“Several models of innovations for health insurance and adjunct sectors have emerged in different regions of the world, while some areas experience few innovations,” states Frost & Sullivan transformational health research analyst Siddharth Shah. “Developing regions are increasing insurance familiarity and coverage with disease-specific insurance products and insurance as add-ons. The developed regions are incentivizing healthy behaviours with freebies and are rolling out e-Commerce initiatives.”

The healthcare delivery space is witnessing numerous changes with the integration of care delivery, while insurers are keeping pace with these revolutions by engaging the services of some of the start-ups targeting the health insurance sector. Significantly, adjunct insurance sectors are turning to community and crowdsourced insurance, adding a fresh dynamic to the global market.

“Health insurance innovations are aimed more at operations that save costs and improve efficiencies, rather than at product customizations or market awareness and access,” noted Shah. “Due to market disparities, the developed markets emphasize cost reduction, while the others focus on expanding coverage.”

In the long term, most global health insurers are expected to harness the power of Big Data analytics to eliminate inefficiencies, make insight-backed decisions and design new products and services that can be profitable. Wearables, telehealth, mobile payments, data-security and other cutting-edge technologies too will play a huge role in the global insurer market.

Web Address: www.frost.com

These large-scale transformations are forcing the health insurance industry to evaluate all aspects of its business models, policy holder engagement and plan structures. The major disruptions in private insurance relate to consumerism, big data and analytics, chronic disease prevention management, mHealth tools and transition to value-based compensation. Among these, the most important changes are consumerism and transition to value-based compensation, as they compel insurers to alter their operational methods.

64 | ghp September 2016

ghp September 2016 | 65

Winners’ Directory

Most Innovative in Biotech and Medical R&D Company: MedSource Name: Matthew Wagener Email: mwagener@medsource.com Web Address: www.medsource.com Address: 16902 El Camino Real, Suite 1A, Houston, TX, 77058 Telephone: 281-286-2003 Most Innovative in Biotech and Medical R&D Company: TREK, INC. Name: Brian Carmer Email: sales@trekinc.com Web Address: www.trekinc.com Address: 190 Walnut Street, Lockport, NY 14094 USA Telephone: +1-716-438-7555

66 | ghp September 2016

Regulatory Heights Inc. We are the Solution to all your regulatory compliance needs!

Do you have a pharmaceutical, generic, biologic, biosimilar, OTC drug, medical device, natural health product, herbal medicine, dietary supplement, veterinary drug, cosmetic or food product? Do you need regulatory applications for clinical investigations, product licensing or post market amendments filed with international regulatory authorities (for example in North America, EU, China, Japan, Australia, NZ)? Do you need clinical trial documents designed or safety reports filed with regulatory authorities that are good clinical practice (GCP) or good vigilance practice (GVP) compliant?

Do you have a facility for animal studies and need good laboratory practice (GLP) certification? Do you have a facility for the manufacturing, packaging, testing, labeling, import, distribution or wholesale of the above products or their active ingredients? Perhaps you need these facilities to be good manufacturing practice (GMP) compliant and licensed, as stipulated by the regulatory authority in your region of business? Or perhaps you have a pharmacy that needs licensing as an outsourcing facility with US FDA?

www.regulatoryheights.com

LI160015

Canadian based Regulatory Heights Inc. is headed by CEO & President, Rachelle D’Souza, who has effectively serviced several multi-national and start-up companies in the above industries and has successfully licensed various medical products and facilities with international regulatory authorities. At Regulatory Heights Inc., we constantly monitor the current regulatory environment and utilise regulatory strategies to help our clients facilitate their market approvals, cut costs, mitigate risks and further product innovation. Articles and webinars by our CEO on the latest international regulatory developments are published on-line by professional regulatory associations, webinar hosting platforms and industry magazines around the world. Regulatory Heights Inc. is the recipient of industry awards for its service. We believe in providing quality service at an affordable price!

Deals

MSI Recruitment Wins Major NHS Master Vend Contract Following an evaluation of CCS Allied Health Professional suppliers, and in a bid to reduce agency staffing costs, Leicestershire Partnership NHS Trust (LPT) on 19 August selected MSI Recruitment to become its Master Vend supplier of Allied Health professionals (AHPs).

With over 150 sites across Leicester, Leicestershire and Rutland, Leicestershire Partnership NHS Trust provides high quality integrated mental health, learning disability and community health services for a population of over one million people. The trust employs over 5,500 individuals.

MSI recruitment will, through its bespoke technology platform i-Engage, now manage the recruitment of this vital group of agency professionals to ensure that pay is in line with NHS Improvement caps, reduce expenditure and manage non-compliant off-framework suppliers. MSI Recruitment’s focus will be on the provision of community services. i-Engage is a managed service platform which was commissioned by, and built exclusively for, MSI Recruitment to facilitate communication with NHS Trusts and its supply chain of agencies. The platform is a full procure-to-pay system that gives NHS organisations control over the booking process, creating increased transparency and giving trusts greater budgetary control.

Commenting on the win, Michael Johnson-Ellis, director of business development at MSI Group, comments: “I am honoured that MSI Recruitment has been selected to work with Leicestershire Partnership NHS Trust. Its decision was no doubt influenced by our reputation for great service, the quality of candidates that we provide, and our demonstrable ability to assist Trusts in managing agency spend. This win is

testament to not only our fantastic and knowledgeable team but also the capabilities of our i-Engage platform.

We look forward to a long and successful relationship with Leicestershire Partnership NHS Trust.”

Debbie McKenzie, senior divisional manager, AHP/ HSS Division, at MSI Recruitment, comments: “The size and remit of this Trust means that it has historically faced challenges in managing workforces both strategically and on budget. However, I am confident that with MSI Recruitment as Master Vendor, Leicestershire Partnership NHS Trust will soon be reaping the organisational and economic benefits of efficient and compliant agency AHP supply.”

Commenting on the procurement exercise, Sarah Holliehead, head of procurement at Leicestershire Partnership NHS Trust Comments, “LPT have had a relationship with MSI for a number of years mainly through the provision of nurses. In 2015, LPT undertook a tender exercise to source a Master Vendor provider for Nursing. MSI were in our top 3 during evaluation but didn’t succeed in winning the contract.

Since then, LPT have been amazed and significantly impressed by the journey MSI have taken between then and now and thoroughly deserve this contract.

We very much look forward to working with them as a partnership over the next 4 years.”

The new partnership will commence from the 17th October 2016 following a 12-week implementation period.

68 | ghp September 2016

Chronos Therapeutics Strengthens Management Team with New Appointments Chronos Therapeutics Ltd (Chronos), the private biotech company focused on ageing diseases, brain and nervous system disorders on 4th August announced the appointment of Dr Fraser Murray and Dr Timothy Schulz-Utermoehl, as Vice Presidents of Pre-Clinical Development.

Fraser and Timothy join Chronos from Polleo Pharma, a UK biotech start-up company they co-founded. Both have substantial scientific management expertise acquired in large pharmaceutical companies and previously held senior positions at Shire, AstraZeneca and Merck.

Fraser and Timothy will be responsible for three pre-clinical research programmes recently acquired

by Chronos. These include a dopamine active transporter inhibitor programme in MS fatigue and the Company’s orexin 1 antagonist programme in addictive behaviours. A third, undisclosed programme has potential in post-traumatic stress disorder (PTSD).

Chronos’ commercial evaluations reveal significant unmet medical needs in these target indications and very substantial commercial potential.

Dr Huw Jones, CEO of Chronos Therapeutics, commented: “We are delighted to welcome Fraser and Timothy to Chronos at a time of significant expansion of our research portfolio. They bring substantial pre-clinical development expertise to our organization and are synergistic to our recent acquisition. In particular, their experience as co-founders of Polleo will be invaluable as we advance our behavioural brain disease portfolio.”

Fraser Murray Dr Murray brings more than 20 years’ of drug discovery and early development experience across

a range of therapeutic areas, including neurodegeneration, psychiatry, inflammation and dermatology.

He has held leadership roles at Shire, AstraZeneca and Merck. Prior to co-founding Polleo Pharma and raising investment to fund the portfolio, Dr Murray was Senior Director and Head of Discovery Biology for Shire Speciality Pharmaceuticals, focused on CNS and GI disorders. Dr Murray holds a PhD from The School of Pharmacy UCL, a BSc from the University of Strathclyde and an MBA from Alliance Manchester Business School.

Timothy Schulz-Utermoehl Dr Schulz-Utermoehl has over 17 years’ experience in the pharmaceutical industry, spanning early and late-stage discovery research and preclinical development. He has held senior roles at Shire, AstraZeneca and Merck. Prior to co-founding Polleo Pharma, Dr Schulz-Utermoehl was a Director within the Exploratory Projects Department for Shire Speciality Pharmaceuticals in the UK. Dr Schulz-Utermoehl carried out post-doctoral research at Novo Nordisk A/S, holds a PhD in Biochemistry from Imperial College London, an MSc in Toxicology from the Royal Postgraduate Medical School, London and a BSc in Pharmacology/ Physiology from the University of Leeds.

For additional information, please visit: www.chronostherapeutics.com

ghp September 2016 | 69

Deals

Canadian Medical Technology Company LABORIE to Become New Subsidiary Patricia Industries, a part of Investor AB, has signed an agreement with Audax Private Equity to acquire the Canadian medical technology company LABORIE, which focuses on the diagnosis and treatment of urologic and gastrointestinal disorders that affect the daily lives of millions.

LABORIE was founded in 1967 and has grown organically and through acquisitions from a leading manufacturer of capital equipment for urodynamic testing into a fully-integrated medical device company with a market-leading position in urology and a rapidly growing gastroenterology business. LABORIE has an attractive, asset-light business model with a high share of its revenue derived from recurring sales of proprietary consumables.

LABORIE’s global manufacturing, development and commercialization capabilities create a solid platform for growth through organic and non-organic expansion in core and adjacent markets, new geographies and further expansion beyond diagnostics into therapeutic products. LABORIE will continue to be run by its current management team, which will remain part-owners of the company.

LABORIE will be the most recent addition to the Patricia Industries portfolio of high-quality growth companies, whose other healthcare holdings include Mölnlycke Health Care, Permobil, Aleris and BraunAbility.

Fiscal year 2016 (ending March) sales were USD 117 m. with strong profitability. Additional financial information about LABORIE, including the acquisition price, will be disclosed upon completion of the acquisition.

“LABORIE will be a strong addition to Patricia Industries and marks another step in our strategy to continue to build our portfolio of wholly-owned subsidiaries in the Nordics and in North America”, comments Investor CEO Johan Forssell.

improve their daily lives, and its culture and values fit very well with those of Patricia Industries and Investor.

Drawing from our experience and global network within healthcare products and services, we believe that Patricia Industries is well-positioned to support LABORIE in its continued progress in a number of areas. We look forward to working together with LABORIE’s dedicated management and employees to advance the company’s position further, to the benefit of its customers, employees and owners”, comments Börje Ekholm, CEO of Patricia Industries.

“We are excited to partner with Patricia Industries for the next phase of our growth”, comments LABORIE President and CEO Brian Ellacott. “LABORIE is the global leader in improving quality of life for patients suffering from urologic and gastroenterology disorders.

This investment will allow us to continue to expand our global footprint as well as develop and bring to market innovative new products that will improve outcomes for patients.”

The acquisition is subject to approval by the relevant competition authorities. Closing is expected during the third quarter 2016.

Patricia Industries, a part of Investor AB, makes control investments in best-in-class companies with strong market positions, brands and corporate cultures within industries positioned for secular growth.

Our ambition is to be the sole owner of our companies, together with strong management teams and boards. We invest with an indefinite holding period, and focus on building durable value and capturing organic and non-organic growth opportunities.

The acquisition of LABORIE is Patricia Industries’ first Canadian acquisition and the second in North America since the inception of Patricia Industries in 2015.

LABORIE will be a new subsidiary managed out of the New York office.

LABORIE is an industry-leading manufacturer and supplier of pelvic health and gastrointestinal equipment and consumables. Since its founding in 1967, LABORIE has been committed to delivering innovative, complete solutions that provide better diagnostics and treatment outcomes to patients worldwide. LABORIE is a portfolio company of Audax Private Equity.

“LABORIE has successfully developed into a high-quality and highly regarded provider of diagnostics products that help a vast number of people

For more information, visit www.audaxgroup.com

70 | ghp September 2016

Yukon Supports Revelstoke’s Investment in Fast pace Urgent Care Yukon Partners, a provider of mezzanine capital for middle market private equity transactions, announced on 25th August that it has partnered with Revelstoke Capital Partners in its investment in Fast Pace Urgent Care.

Fast Pace Urgent Care, headquartered in Brentwood, Tennessee, is a leading regional manager of urgent care clinics across rural Tennessee and Kentucky. The company’s nurse practitioner model with physician oversight increases rural patient access to healthcare while delivering high quality outcomes and improving patient satisfaction. Due to the rural focus of the Company’s current operations, many of the patients utilize the company’s urgent care clinics as their primary care solution allowing the company to function as an integral healthcare provider in the community.

Revelstoke sponsored the transaction in which it, Yukon, and other institutional co-investors made an investment in Fast Pace. Yukon also provided mezzanine capital, and Ally Corporate Finance and NXT Capital underwrote the senior credit facility. Schiff Hardin LLP served as legal counsel to Yukon.

“Fast Pace has developed a differentiated and successful rural market model which provides access to high quality, affordable healthcare centred on the patient. The company’s focus on improving the health

and quality of life for individuals and their communities, increasing access to care, and lowering costs for patients and payors addresses healthcare’s triple aim and presents a compelling value proposition for all participants,” said Simon Bachleda, managing partner and co-founder of Revelstoke. “We are enthusiastic about partnering with such a passionate and experienced management team.”

“Revelstoke’s healthcare expertise and emphasis on strategic growth initiatives will be invaluable assets as we continue to expand our reach to more communities,” remarked Stan Bevis, founder and CEO of Fast Pace.

“We are excited to support Revelstoke and the Fast Pace management team as they continue to execute their value-added strategy of providing high-quality and affordable healthcare to rural populations,” said Michael Hall, managing partner of Yukon. “We are confident Revelstoke’s expansive healthcare experience will complement the Fast Pace management team in furthering the company’s impressive track record of growth.”

ghp September 2016 | 71

LI160011