Bio Science Journal 2 by Distinctive Media Group Ltd

BioScience

BSc

JOURNAL SUMMER 2014

The Animal Testing Impasse Will the future of Anti Aging Drugs depend on it?

Premature Ageing Could damaged proteins be the key?

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Arthritis

Are genetics the answer?

MenB - RIP But to what impact?

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BIOSCIENCE JOURNAL JULY 2014

WELCOME z

Welcome

elcome to the second edition of the Bioscience Journal, one which has a number of features dedicated to the theme of ageing and which … hang on, need to stand up and walk around, spot of cramp in my left leg. That‘s better. Now where were we? Ah, yes. Ageing. Let’s start by getting something straight. We all age. Death and taxes may be the two things that are inevitable in life but I would add the fact that your knees start cracking when you stand up once you have passed fifty. Sometimes even before.

I’ll be honest. I’m coming up 53 and have arthritis in my left shoulder, a dodgy back, occasionally misbehaving blood pressure and the early onset of the respiratory condition Chronic Obstructive Pulmonary Disease (COPD) after forty years of asthma.

John Dean

Editor in chief

Am I a wreck? Do I expect sympathy? Not really - everyone I know who has passed fifty has either bad backs, bad knees, poor blood pressure, high cholesterol, concerns about… I could go on. And on.

OK, so maybe I do (my dad sure as hell looked like his father in the right light, you probably look like yours) but the trick is to be positive, don’t sit and wait for retirement then sit and wait for death like we see some people do.

And we should not rely on drugs either. We need to give life a chance. Go out and do things; keep active, join clubs, learn a new skill, play sport, walk, cycle, garden, volunteer, enjoy nights out, appreciate a good glass of wine or two, and keep healthy; eat fruit and veg, watch the fat. We still need medicines and we still need the doctors and researchers to devise regimens to let us function with our ailments. If we are lucky, someone will even come up with a cure before we get too bad but in the meantime we have to do our bit. After all, that’s life. john.dean@distinctivepublishing.co.uk

The point is this. Ageing is part of life. I heard of one doctor in my area who, when asked by a fifty-something patient who hobbled into his surgery ‘how do I stop this happening again?’, replied ‘don’t get old!’ Given that we cannot turn back the clock, the key thing is to find ways of living with life, something that the medical profession has increasingly come to acknowledge. To that end, this edition focuses not just on work being done by medical professionals and researchers all over the world to find cures for the likes of arthritis, heart disease and COPD but also to devise ways to allow people to live with them. And let’s be honest; the likes of me, the likes of most of us, hale and hearty or not, would be long dead by the time we hit fifty a century ago. We’re already up on the game. So how do we live with age? The answer is to be positive. My family sometimes complain that, when my back/knee/shoulder plays up as I drag myself up from my armchair, that I am old before my time, that I look like my dad.

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BIOSCIENCE JOURNAL JULY 2014

CONTENTS

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CONTENTS z

Contents

Introduction/foreword

6-7

Contents

9-19

UK News

21-27

World News

28-33 Arthritis

28-33

50-53

36-39 Anti ageing 40-49 Heart Disease 50-53 Meningitis 54-57 Animal testing 58-63 Asthma

Editor

John Dean john.dean@distinctivepublishing.co.uk

36-39

54-57

Design

Distinctive Publishing, Unit 6b, Floor B, Milburn House, Dean Street, Newcastle Upon Tyne NE1 1LE Tel: 0845 884 2385 www.distinctivepublishing.co.uk

Contributors

John Dean & Francis Griss john.dean@distinctivepublishing.co.uk

Advertising

Distinctive Publishing, Unit 6b, Floor B, Milburn House, Dean Street, Newcastle Upon Tyne NE1 1LE Tel: 0845 884 2343 email: john.nielson@distinctivegroup.co.uk www.distinctivepublishing.co.uk

40-49

58-63

Distinctive Publishing or BioScience Journal cannot be held responsible for any inaccuracies that may occur, individual products or services advertised or late entries. No part of this publication may be reproduced or scanned without prior written permission of the publishers and BioScience Journal.

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NEWS z

Initiative targets research into type 1 diabetes Charity JDRF and UK Prime Minister David Cameron are supporting a push for groundbreaking type 1 diabetes stem-cell research partnerships between the UK and Israel. Mr Cameron announced plans for BIRAX (the Britain Israel Research and Academic Exchange Partnership), a £10 million initiative between the Israeli government and the British Council, during a recent visit to Israel. BIRAX has already funded several medical research projects in British and Israeli universities, with the stipulation being that one research partner should reside and work in the UK and one in Israel. Now type 1 diabetes charity JDRF – along with the British Heart Foundation, Alzheimer’s Research UK and Parkinson’s UK – is supporting a new call for BIRAX funding applications from leading research scientists in the field of regenerative medicine. JDRF will exclusively support proposals from scientists focusing on type 1 diabetes stem cell research.

Israel is a world leader in stem cell technology and other areas of regenerative medicine which offer hope to better treat, prevent and cure type 1 diabetes as well as other conditions. JDRF, which has a presence in Israel and funds high quality research in the country, has been working with people with type 1 diabetes to call on the UK Government to increase funding for high quality research in the UK. Chief Executive in the UK, Karen Addington, said: “We are very pleased that the Prime Minister has given strong vocal support to the global effort to cure type 1 diabetes. The fall in government funding for type 1 research in recent years is of grave concern and we welcome this Government action to address the decline.

“We look forward to working with British government research funding bodies on this and other initiatives to maintain the UK’s position as a global leader in type 1 diabetes research.” According to NHS figures, 2.9 million people in the UK are affected by diabetes; 850,000 people are also thought to have undiagnosed diabetes. Type 1 diabetes affects 400,000 people in the UK. Of these, more than 29,000 are children. Type 2 diabetes is far more common. About 90% of adults with diabetes have type 2, and about 10% have type 1.

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z EVENTS

2014 Biomedical Awards winners

The northern biomedical sector celebrated at prestigious awards ceremony T

he best of the North of England’s biomedical companies were honoured at the 2014 Biomedical Awards, hosted by Bionow at the BALTIC Centre for Contemporary Art, on Gateshead Quays last night (24 April 2014). Sixteen companies battled it out in five award categories: Export, sponsored by CBSL; Outstanding Growth, sponsored by Sintons LLP; Innovation and Technology, sponsored by NETPark NET; Partnership/Collaboration of the Year, sponsored by Newcastle Biomedicine; and Promising Technologist of the Year, sponsored by Search Scientific, which is awarded to an exceptional individual who works for a biomedical company or research institution. The Export award was presented to Hartlepoolbased Hart Biologicals Ltd, which is engaged in the research, development, manufacture and marketing of ‘in-vitro’ diagnostic products, which are used in the detection, prevention and monitoring of a number of medical conditions relating to haemostasis and platelet function. In 2013, the company achieved over £850,000 of export sales in Germany alone, as well as adding contracts in both Europe and the USA to its manufacturing base. In the Outstanding Growth category, Middlesbrough-based WhiteWash Laboratories claimed top spot for its highly impressive

performance over the last 12 months. The company, which was launched in 2010, has developed a range of innovative teeth whitening treatments and products - its UK market share with dentists has increased significantly over the past year and the company is now achieving success within the corporate market, as well as in overseas markets through a network of distributors. The company sells its products through IBH, the biggest dental oral care supplier in the UK and they are stocked in more than 1000 dental practices. The winner of the Innovation and Technology Award was Newcastle-based Glythera, which develops next generation therapeutics through the application of its proprietary technologies, PermaLink™ and PermaCarb™. These technologies, used in the development of new or the re-positioning of current biotherapeutics, offer improved stability, bioavailability and efficiency in oncology and therapeutic applications. The company has focused the development of its PermaLink™ technology in the area of antibody drug conjugates (ADCs) and it has drawn significant interest from firms developing ADCs, resulting in national and international collaborations. In the Partnership/Collaboration of the Year category, two companies were recognised for their outstanding achievements.

Newcastle-based Keiro was honoured for its collaboration with a business – not-for-profit housing association Erimus Housing. This has seen the two firms work together to provide on-site transitional housing for clients at The Gateway, a multi-million pound facility developed by Keiro to provide services to people who have who have been discharged from hospital-based neuro, stroke and spinal units, but who need long term support. In addition, point of care diagnostics developer, QuantuMDx Group Ltd - which is headquartered at Newcastle’s International Centre for Life - received an award for its partnership with the public sector. The company’s successful collaboration with Newcastle University has supported its rapid expansion and has resulted in its recruitment of over 15 Newcastle University graduates, master’s students and post docs, as well as several large grant successes. Finally, the ceremony saw Hart Biologicals Ltd’s Keighley Campbell named Promising Technologist of the Year. Having joined Hart Biologicals Ltd in 2010 as a Research & Development Scientist, she was successful in the development of a range of coagulation reagents for use in hospital pathology laboratory testing products - these are now on sale around the world. Keighley was promoted to Research & Development Manager in

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2012 and is working on product design and development that covers Hart Biologicals’ own-label products and development activities for contract manufacturing opportunities. Geoff Davison, CEO of Bionow, said: “Congratulations must go to all the winners and those shortlisted on their achievements, and for the fantastic work they are doing to further the growth of the biomedical sector in the North of England. “The entries we received for this year’s Biomedical Awards were of an extremely high standard and confirmed the region’s standing as a powerhouse in the biomedical sector. “The winners and runners-up demonstrated just how many versatile and visionary biomedical firms we have in the North, and all of the judges were greatly impressed by their innovative approaches to research, product development and business strategy. “The biomedical sector has vast potential, and these awards showed that it has an exciting future in the North of England.” The 2014 Biomedical Awards are hosted by Bionow, the leading membership organisation for the biomedical and life sciences industry in the North of England. With over 210 subscribing members, Bionow’s membership offer focuses upon the specific needs of firms at their different stages of development, including dedicated business support programmes, shared procurement schemes with significant cost savings, exclusive insurance benefits, recruitment and training services, local and national events and access to a vibrant network of businesses. The North of England is one of the UK and Europe’s largest biomedical regions; 20% of the UK’s biomedical companies, employment and turnover are in the North. Comprising of 925 life science and healthcare companies, the sector generates a turnover of £10.9bn and employs over 38,000 people. The area is home to the N8 Research Partnership, and boasts world-leading resources in terms of investment, scientific expertise, academic research, science graduates, NHS hospitals and state of the art manufacturing facilities.

Fish oils could help babies

Potentially lethal disease in newborn babies whose bodies make too much insulin may be treatable with fish oils, according to Manchester University. The work led by the Faculty of Medical and Human Sciences and the Faculty of Life Sciences examined congenital hyperinsulinism, which means that the infant’s brain is starved of blood sugar. By giving the children purified fish oils similar to those used to treat some heart attack patients, alongside standard treatment, blood sugar levels improved.

NEWS z

Dementia organisations offered the chance to share in £900,000 fund A NEW, £900,000 fund has been launched to help those living with dementia in the North East and Cumbria.

The Northern Rock Foundation has joined forces with Comic Relief and Ballinger Charitable Trust to form the North East and Cumbria Dementia Fund and now wants to hear from projects and organisations that help people living with dementia to continue to live in and play an active part in their community. Comic Relief, Northern Rock Foundation and Ballinger Charitable Trust have a long history of working to improve the lives of disadvantaged people and are coming together to drive positive change for people affected by dementia in the North East and Cumbria. In 2010, 31,840 people were living with late onset dementia in the North East and 7,000 in Cumbria - figures predicted to rise respectively by nearly 60 per cent to 50,840 and by 85 per cent to nearly 13,000 by 2030. The North East and Cumbria Dementia Fund is looking to assist organizations to develop new ways of supporting people with dementia and their carers and to identify models of best practice that could be adopted more widely across the United Kingdom. “We want to support projects that are working with people with dementia who are living in the community either in their own homes or in sheltered accommodation and work that changes the way people with dementia are viewed and treated by society” said Programme Manager Louise Telford from Northern Rock Foundation. Comic Relief’s UK Manager, Clare Kiely, said: “Dementia is an important and growing issue that touches many people’s lives across the UK. Comic Relief is pleased to be

able to support the development of new and innovative ways to support people diagnosed with dementia and their carers to continue to live happy and fulfilling lives for as long as possible.” The North East and Cumbria Dementia Fund is also interested in supporting projects that help people with dementia who live alone, are from minority communities - including the Black and Minority Ethnic (BME) and Lesbian Gay Bisexual and Transgender (LGBT) communities - have learning disabilities or are experiencing early onset dementia. It is particularly keen to hear from projects that give people with dementia a voice, or which offer new ways of enabling them to continue to live rich and fulfilling lives in the community. The North East and Cumbria Dementia Fund has also been formed to support carers and applications are being sought from projects that either equip them with the skills to carry out their caring role or aim to challenge stigma and improve the way people with dementia are perceived. Nikki Crowther, Trustee of the Ballinger Trust said “We are delighted that Comic Relief will be working with ourselves and the Northern Rock Foundation in the North East and Cumbria to improve the lives of people affected by dementia. I think this is testament to the innovative approaches already taken here, and to the need for further support in this area. “ For further information, or to apply for funding through the North East and Cumbria Dementia Fund contact Louise Telford at Northern Rock Foundation on tel: 0191 284 8412 or email generaloffice@nr-foundation.org.uk

Need to signpost healthy eating options

Payments may aid healthy living

The researchers found that those who live or work near to outlets were almost twice as likely to be obese than those who encountered the fewest outlets.

A team at Newcastle University looked at 16 pieces of research, involving more than 30,000 participants, who were tasked with quitting smoking or taking up other healthy behaviours, such as physical activity or attending vaccination or screening sessions.

People who live and work near a high number of takeaways are more likely to be obese than people less exposed to these outlets, according to new research.

The study was carried out by the MRC Epidemiology Unit at the University of Cambridge, backed by the British Heart Foundation (BHF).

People may be more likely to adopt healthy behaviours if offered small financial incentives.

The team found that as little as £3 could make people up to 50% more likely to change their behaviour.

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z EVENTS

WhiteWash Laboratories Managing Director Tom Riley and UK Sales Director Chris McPhillips with Ashford Orthodontics Directors Graeme Winyard and Sean Thompson.

Deal helps two North East firms gain a bigger bite of the market. North East teeth whitening company WhiteWash Laboratories has signed a deal with one of the UK’s largest dental labs, Ashford Orthodontics Ltd, in an agreement that could be worth up to £100,000 a year. WhiteWash, which manufactures and distributes premium tooth whitening products to more than 1,000 dentists across the UK, has teamed up with the Sunderlandbased lab, which will manufacture trays for the whitening gel that have been specially designed to maximise the effects for customers. The deal between the two North East dental firms could help both companies to gain a bigger bite of the market. Middlesbrough-based WhiteWash, which was founded by school friends Tom Riley, Matthew Lloyd and Chris McPhillips whose first joint venture was selling sweets in the playground to classmates, has developed a closely-guarded secret formula with British dentists, which

maximises the whitening effects whilst caring for teeth. The growing company, which turns over about £1m, is already exporting to more than 20 companies around the globe, and is hoping to expand into new markets. Ashford Orthodontics Ltd was founded eight years ago by Directors Craig Stevens, Sean Thomson and Graeme Winyard. Now employing 17 people, the lab has a specialist in-house two-year training programme, which all technicians undergo. Tom Riley, Managing Director of WhiteWash Laboratories, said: “We’re very pleased to be working with Ashford Orthodontics. They are one of the UK’s largest specialist orthodontics

labs and have an excellent reputation for this type of work – and they are also based in the North East, which is a great plus for us. The deal means that customers will be getting a high-quality, British-made tray which has been specially designed to maximise the effects of our products. We’re very much looking forward to working with Ashford Orthodontics.” Craig Stevens, Director at Ashford Orthodontics Ltd, said: “WhiteWash is a really progressive, interesting and innovative company, and we were delighted to be working in partnership with them. They have a network of more than 1,000 UK dentists, which could really open up potential new markets for us – and it’s a bonus to us that it’s a fellow North East firm that we’re doing business with.”

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The Alexander Graham Bell Centre for Digital Health @ Moray College The new ÂŁ6.5 million building in the heart of Elgin City Centre will support ground breaking work already being carried out by researchers, including experts from NHS Grampian who are showing how IT can revolutionise health services in remote the rural areas. The range of facilities including the Research and Commercialisation rooms available for rent will provide access to a community of expertise, networking and events together with business development support from the public and private sectors.

The centre has been designed to assist business in developing new ideas, thinking and products and services by bringing together the necessary disciplines under one roof. There is a wealth of pioneering innovation, research and commercialisation activity evident in the Moray region, where the digital health and life science communities are highly networked and collaborative.

To find out more about this innovative and exciting development please contact: Hilda Puskas, Moray College UHI on (01343) 576475 or accommodation.moray@uhi.ac.uk www.moray.uhi.ac.uk/business-and-community/the-alexander-graham-bell-centre-moray-life-science-centre

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z NEWS

‘Rethink needed on radiotherapy’

Women whose breast cancer has spread to just a few lymph nodes under the arm could benefit from radiotherapy treatment following mastectomy, according to UK scientists. Current NHS guidelines say that women should be offered radiotherapy if their breast cancer has spread to four or more underarm lymph nodes.

Scarlet fever rash

High levels of scarlet fever remain across England Public Health England (PHE) has reported a continuation of the high levels of scarlet fever across the country with 405 new cases reported in the last week (from 21 to 27 April). A total of 8,305 new cases have now been reported since the season began in September 2013. While data from recent weeks suggest a decline in incidence, close monitoring continues to assess the impact of children returning to school after the Easter break.

“We strongly urge people to remain vigilant and to go to their GP if they develop symptoms which suggest scarlet fever such as a sore throat, fever, headache and rash.”

Scarlet fever is a seasonal disease and this is the time of year when we would expect to see a decline in the number of cases. Given the unusual rise in incidence seen this year, this seasonal pattern may not be observed.

Whilst scarlet fever is usually a mild illness it should be treated with antibiotics to reduce the risk of further complications. It is mainly a childhood disease, most common between the ages of two and eight years, although adults can also develop scarlet fever.

PHE will continue working closely with healthcare professionals to assess the impact of the high levels of scarlet fever on the number of complications reported. Investigations also continue across the country to assess whether a new strain may have emerged. Dr Theresa Lamagni, PHE’s head of streptococcal infection surveillance, said: “We are still observing exceptionally high numbers of cases and will continue to monitor the situation closely to see if there is a sustained fall over the coming weeks.

But the new study, funded by Cancer Research UK, shows that radiotherapy may improve survival for women whose cancer has spread to between one and three lymph nodes and help prevent their disease from returning. Until now, there has been uncertainty over the benefits of radiotherapy in these women, said Dr Paul McGale, senior statistician at the Clinical Trial Service Unit in Oxford and an author on the study. The researchers, who analysed results from 3,786 women from 14 trials conducted over 18 years, say that their findings offer hope for sufferers. Martin Ledwick, Cancer Research UK’s head information nurse, said: “This study suggests that more women than previously thought could potentially benefit from radiotherapy following a mastectomy. “Radiotherapy is becoming more sophisticated, and 40 per cent of cancer patients who are cured now receive it as part of their treatment.” The study was funded by Cancer Research UK, the British Heart Foundation, and the UK Medical Research Council.

Schools, nurseries and childcare settings should embed good hand hygiene practice within daily routines for pupils and staff and alert local PHE Health Protection Teams if an outbreak of scarlet fever is suspected. Children and adults should be encouraged to cover their mouth and nose with a tissue when they cough and sneeze and to wash their hands after using or disposing of tissues.

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NEWS z

Artists impression of lung cancer cells

Alarming rise in lung cancer cases Lung cancer rates in women have risen by 73 per cent over the past forty years according to new Cancer Research UK figures. Dr Harpal Kumar, Cancer Research UK’s chief executive, said: “These figures provide a stark reminder that lung cancer remains one of the biggest challenges in cancer research. The disease kills more than twice as many people as the second most common cancer killer – bowel cancer – and this looks set to continue unless we all do more.” While the rate for women has continued to climb, the figures show lung cancer rates have fallen by nearly half (47 per cent) in men over the same period and by 20 per cent for people overall. About 87 per cent of lung cancers are caused by tobacco, with the remaining 13 per cent of cases not related to tobacco; the figures mirror changes in smoking rates. Rates in men have been falling since the 1950s but for women this didn’t happen until the 1970s. The lung cancer rate in women is now 41 per 100,000, up from 23 in 1975. For men, it is now 59 per 100,000, down from 112 in 1975. The latest figures show there was about 43,500 cases in the UK in 2011 – 23,800 men and 19,700 women. There were also 35,200 deaths from lung cancer, 19,600 men and 15,600 women. Lung cancer is the second most common cancer in the UK but the biggest cancer killer and Cancer Research UK says that advances in treatment have been limited and public awareness of the disease has been low.

Relatively few people survive lung cancer. More than two-thirds of patients are diagnosed at a stage when it’s too late for them to be offered treatment that could cure them.

Fewer than 10 per cent of people diagnosed with lung cancer survive for at least five years after diagnosis. Sara Hiom, Cancer Research UK’s director of early diagnosis, said: “We need to improve awareness of the possible signs and symptoms of lung cancer and urge people – especially those at increased risk – to go to their doctor without delay if they spot any symptoms. “We know that if people go to their GP as soon as they’re aware of symptoms it can make all the difference and save lives. “Look out for feeling more breathless than usual or for much of the time, a cough that has lasted longer than three weeks, an existing cough that has changed or got worse or coughing up blood. If you notice any of these or have worries about unusual changes, make an appointment to see your doctor.” Cancer Research UK believes that other key priorities include creating a research environment that speeds up the understanding of the disease and leads to better, kinder treatments. Dr Kumar said: “These figures provide a stark reminder that lung cancer remains one of the biggest challenges in cancer research. The disease kills more than twice as many people as the second most common cancer killer – bowel cancer – and this looks set to continue

unless we all do more. The attitude that a lung cancer diagnosis is a death sentence must change. “Cancer Research UK wants to make the UK a leader in lung cancer research. We’re determined to build a community of the world’s best researchers to help improve treatments and beat lung cancer sooner.”

Laboratory Innovations 2014

Lab Innovations provides a forum for laboratory buyers and laboratory suppliers to meet and do business. Now in its third year, the event has established itself as THE industry event for visitors to see the latest technology providing cost-cutting solutions, increasing productivity and higher ROI for their business. A visit to Lab Innovations 2014 will give you the chance to source innovative new products from leading suppliers, to network with your industry peers and to gain new skills and knowledge by attending free seminars on the show floor. The theatre programmes will again be compiled by industry experts Campden BRI and the Royal Society of Chemistry. To find out more, visit: www.lab-innovations.com

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NEWS

Research offers insight into the ‘silent killer’

UK scientists have discovered where the life-threatening hidden fat surrounding our vital organs comes from. The new insight into this ‘bad’ (visceral) fat may have important implications for future understanding and treatment of obesity and its health consequences. The research, led by scientists in the Medical Research Council (MRC) Human Genetics Unit at the University of Edinburgh, was published in the journal Nature Cell Biology. There are two main types of fat in the body: subcutaneous fat, which sits directly beneath the skin and provides energy, cushioning and insulation and visceral fat, which forms in six depots around the heart, intestines and other vital organs. Studies have shown that having a lot of visceral fat increases the risk of cancer, type 2 diabetes, cardiovascular disease and Alzheimer’s disease, while subcutaneous fat is thought to be protective. Using genetically modified mice, the researchers showed that up to 80 per cent of visceral fat in the body can be traced back to a single type of cell in the developing embryo. These fat precursor cells, which express a gene called Wt1, are not found in subcutaneous fat, suggesting that ‘good’ and ‘bad’ fat come from different sources. Cells expressing Wt1 were also found in the visceral fat of adult mice, where they continue to make more fat cells throughout their lifetime, in a similar way to stem cells. The highest number of these cells were found in the fat depots around the heart and stomach, which are known to be the riskiest places to carry excess fat.

Research to improve ultrasound Researchers at King’s College London have been awarded £10 million from the Wellcome Trust and the Engineering and Physical Sciences Research Council to develop advanced ultrasound imaging technology to improve the detection of birth defects in unborn babies. Prenatal diagnosis of birth defects is important because it has a direct impact on how the new-born is managed, enabling medical practitioners to make preparations such as arranging to deliver the baby in a specialist unit.

Lead author of the study Dr You-Ying Chau, from the MRC Human Genetics Unit at the University of Edinburgh, said: “Determining the origins of good and bad fat has been one of the big unanswered questions in obesity research. We’ve now shown that most bad fat comes from cells expressing the Wt1 gene in the later stages of pregnancy. “We also found that cells expressing Wt1 continue to act as a source of visceral fat into adulthood where they may be influenced by external factors such as diet. If we could find a way to control the regulation of these cells, we might be able to stop the body laying down any more bad fat around the organs. However, it will take many more years of research before we get there.” The team also discovered that visceral fat, like the organs it surrounds, has its own protective membrane called a mesothelium. This also contains Wt1-expressing cells and can act as a source of visceral fat. Professor Nick Hastie, leader of the research team and Director of the MRC Human Genetics Unit, part of the MRC Institute of Genetics and Molecular Medicine, at the University of Edinburgh, said: “We found strong evidence for the existence of a mesothelium, which was a big surprise because nobody thought this membrane existed in fat. “It seems that not only does the mesothelium help produce the cells that make the fat, it also surrounds the fat, making it into a neat little organ. In a way this makes sense because, otherwise, how would your body know to form fat and to package it around your heart or kidneys?”

Breathing support for premature babies could lead to better lung function A new study led by researchers at King’s College London has found that premature babies supported immediately after birth by high-frequency oscillation - a type of breathing support - had better lung function as adolescents than those who received conventional ventilation. Children ventilated with the high frequency method also showed higher academic achievement in three of eight school subjects.

Professor Stephen Hill, Chair of the MRC’s Molecular and Cellular Medicine Board which funded the work, said: “Visceral fat can be a silent killer because it’s possible to have a lot of it without looking fat on the outside. Studies like this one are important because they help us to understand how our genes and other biological factors are involved in regulating visceral fat, so that in future we can devise new ways to prevent or treat the devastating consequences of obesity.”

Seaweed health benefits explored Scientists at Newcastle University have identified the seaweeds which are most effective at preventing people from absorbing fat. Alginates are already used in foods, such as stabilisers in jam and to maintain the head on a pint of beer. New research funded by BBSRC has identified the chemical properties of alginates which prevent fat from being digested, which has allowed scientists to produce a league table of the most effective seaweeds.

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NEWS

New hope for Huntington disease sufferers A group of researchers has identified a major new pathway thought to be involved in the development of Huntington disease. The findings, published in the Proceedings of the National Academy of Sciences journal, could eventually lead to new treatments for the disease, which currently has no cure. Scientists at the BC Cancer Agency Research Centre and the MRC Toxicology Unit in

Leicester, UK, working with the Centre for Molecular Medicine and Therapeutics in Vancouver, Canada, studied mice and human tissue and found that the HACE1 gene is essential for mopping up toxic molecules during periods when harmful ‘reactive oxygen species’ build up in the cell. Lead author Dr Barak Rotblat, of the MRC Toxicology Unit, said: “Our evidence points towards a previously unknown role of HACE1 in Huntington disease and possibly other forms of neurodegeneration. It’s very early days, but if we were able to find a way to boost this pathway, we might be able to develop a treatment that halts, or even reverses progression of Huntington disease.”

Dr Poul Sorensen, the senior author of the work from the BC Cancer Agency Research Centre and a Professor at the University of British Columbia, said: “This is a glowing example of how work in one field, namely childhood cancers, where we first identified the HACE1 gene, has applications to a completely different disease, Huntington disease”. The research was funded by the International Human Frontier Science Program Organization and the Canadian Institutes of Health Research.

Elekta Confirms £4.2 Million Crawley Land Investment Elekta Ltd, the world-leading manufacturer of treatment solutions for cancer and brain disorders, has purchased the Gateway site in Crawley. This landmark site is adjacent to Elekta’s UK head office on Fleming Way, and overlooks the roundabout at the junction of Fleming Way and London Road. The two hectare (five acre) site is about three miles North of the centre of Crawley. It was bought in a £4.2 million deal handled by property adviser Vail Williams from

owner-manager and developer of industrial property company Segro.

“We are delighted to be making this massive investment in the local economy,” says Bill Yaeger, executive vice president Elekta Oncology. “We have specific and significant plans for further investment in the site which will effectively future proof Elekta’s commitment to Crawley and the South East for many years to come.”

the Queen’s Award for Enterprise 2013 for International Trade. In March, Elekta won the the award for Supply Chain Excellence at the prestigious annual Gatwick Diamond Business Awards 2014 in recognition of its engagement supporting local industry. Elekta also won the Made in the South East awards and an Institute of Export award. Elekta will reveal further plans for the site in the coming months.

In September last year Elekta - an employer of over 800 people in Crawley - received

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NEWS

Guidelines seek to minimise identification risk

Research funders have outlined the steps they will take to reduce the risk of anonymised individual research subjects in the UK being re-identified. Cancer Research UK, the Economic and Social Research Council, the Medical Research Council and the Wellcome Trust issued a response to a statement from the Expert Advisory Group on Data Access (EAGDA). EAGDA set out recommendations to reduce the risk, including regularly reviewing the risk of re-identification through linking with other data.

Stigma could lead to under-use of hearing aids

Research ‘must be allowed to thrive’ The Parkinson’s Disease Society has embarked on a new drive to ensure that research into the illness, and other conditions, continues to be supported across Europe. As part of the campaign, which is hosted by the Association of Medical Research Charities, the society has teamed up with other organisations including Cancer Research UK and the Academy of Medical Sciences.

• ensure research findings are used to make European citizens healthier by maintaining the role of the European Chief Scientific Adviser and reporting and publishing the results of all research

The campaign sets out to encourage potential new Members of European Parliament (MEPs) to champion medical research.

Steve Ford, Chief Executive of the Parkinson‘s Disease Society, said: “Without support from the highest levels, medical research across Europe will flounder.

MEP candidates will receive pledge cards developed by Parkinson’s society and the other organisations involved. The pledge includes calls to: • encourage investment in medical research • make Europe a place where research can flourish by considering the implications of European legislation for medical research, including current proposals for a new Data Protection Regulation • ensure people can access effective therapies faster by boosting cross-border research collaboration and making it easier for promising therapies to navigate the licensing system

“Proposed changes to the new EU Data Protection Regulation regarding gaining specific consent could stop the world’s largest ever in-depth study into people with Parkinson’s in its tracks. “To have a situation where the future of pioneering medical research projects remains uncertain is simply unacceptable.

Only a fifth of people experiencing hearing problems wear a hearing aid, according to the University of Manchester.

The study examined 160,000 people in the UK. Professor Kevin Munro, Ewing Professor of Audiology, School of Psychological Sciences, who also worked on the study, said: “There still seems to be a stigma attached to wearing a hearing aid, where as there is little stigma now associated with vision loss and wearing spectacles.”

Supply Chain Group Formed

A new group has been launched to address supply chain challenges facing medical companies in the UK. The Supply Chain Special Interest Group (SIG) is a collaboration between Medilink East Midlands and specialist medical supply chain consultancy Lime Associates. Steve Langron, Supply Chain Director, Lime Associates, said: “The SIG is a great platform for the industry to share best practice on how to control risk and enhance the customer’s experience.”

“We strongly call on all MEPs to lend their support to this new campaign to ensure that medical research can continue to thrive across Europe.” Steve Langron

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ADVERTORIAL

Mind the Gap Efforts to attract women and more young people generally into science will be boosted this summer with a string of new initiatives. There are six times more men than women working in the science-using industries, so it stands to reason that there aren’t as many female role models available to young women considering entering the scientific professions. Yet, if we look back through the history books there are many key breakthroughs in science where women have led the way; notably Rosalind Franklin who played a key role in unearthing the molecular structure of DNA—to Nancy Wexler who dedicated her entire career to finding a cure for Huntington’s Disease. Today science has a pressing talent problem. As well as trying to address the gender imbalance, we also need more young people choosing to study science at school and pursue a sciencebased career. We all agree that we need more women in science; diversity of thought and experiences have been shown to improve our ability to solve problems, and that’s what science is all about, solving a problem. The challenge has been around for a while. A tremendous effort has been made by STEM (science, technology, engineering and mathematics) organisations across the country.

And this Government and the previous administration recognised the scale of the challenge of making science more attractive, so we can’t blame the skills gap on a lack of investment. But Rome wasn’t built in a day and changing perceptions takes time. Now all of this hard work is beginning to bear fruit. Findings from a national survey conducted by Cambridge Occupational Analysts (COA), identified subjects where the level of interest increased more among women than men included chemistry and biochemistry. The seven year study also found that subjects gaining most in popularity included combined sciences and physics, biochemistry, and chemistry. On the way down is art, hospitality and planning. We are seeing that science is gaining in popularity amongst both sexes and in some cases is more popular with women. Yet despite the encouraging signs more can be done and more will be done through the proposed employer-led Science Industry Partnership.

EDUCATION INTO EMPLOYMENT

Through the Science Industry Partnership (SIP), Cogent on behalf of leading science organisations will roll out new skills and learning programmes in a two-year project

which will give employers better control over government investment in skills and training. If deemed successful at the end of the twoyear pilot phase it could change the way that organisations commission the delivery of education and training in the future, with the Government linking more directly with employers. One of the programmes in the SIP is a STEM-based initiative, Pathways to Work, a programme which will see closer links between employers with schools and colleges to open up the world of work. The SIP will collaborate with other skills bodies to co-ordinate the quality and reach of science and STEM careers information. The aim is to inspire, inform and support young people into STEM-based careers. The SIP will work with the best STEM career models to introduce the world of work and routes to fulfilling careers through both vocational and academic routes. Experience gained from our own initiatives has taught us that if you want to inspire young people to pursue a career in science they need to be given a hands-on experience.

A Scientific Approach to New Talent We believe that recruiting young people is one of the best ways to grow your business. If you would like to find out how and understand more about the support available please contact Cogent.

Apprenticeships Industry Placements Graduates Recruitment Mentoring

0845 257 0007 www.cogent-ssc.com

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Scientists excited about cancer research findings

Scientists from Weill Cornell Medical College in New York, working with not-for-profit health organisation Houston Methodist, have cast new light on a deadly form of breast cancer. The team have found that a gene not previously associated with breast cancer plays a pivotal role in the growth and progression of the triple negative form of the disease. About 42,000 new cases of triple negative breast cancer (TNBC) are diagnosed in the United States each year, 20 per cent of all breast cancer diagnoses. Patients typically relapse within one to three years of being treated. Senior author Dr. Laurie H. Glimcher, the Stephen and Suzanne Weiss Dean of Weill Cornell Medical College, wanted to know if the gene was important to cancer’s ability to adapt and thrive in the oxygen- and nutrientdeprived environments inside tumours.

The group, which included investigators from nine institutions, examined several types of breast cancer cell lines. They found that XBP1 was particularly active in basal- like breast cancer cells cultivated in the lab and in triple negative breast cancer cells from patients. When they suppressed the activity of the gene in laboratory cell cultures and animal models, the researchers were able to dramatically reduce the size of tumours and the likelihood of relapse, especially when the approach was used in conjunction with the chemotherapy drugs doxorubicin or paclitexel. The finding suggests that XBP1 controls behaviours associated with tumour-initiating cells in a number of cancers, say the team.

Using cells taken from patients’ tumours and transplanted into mice, Dr. Glimcher’s team found that the gene, XBP1, is especially active in triple negative breast cancer, particularly in the progression of malignant cells and their resurgence after treatment.

They also found that interactions between XBP1 and another transcriptional regulator, HIF1-alpha, spurs cancer-driving proteins. Silencing XBP1 in the TNBC cell lines reduced the tumour cells’ growth and other behaviours typical of metastasis.

Dr. Glimcher, who is also a professor of medicine at Weill Cornell, said: “Patients with the triple negative form of breast cancer are those who most desperately need new approaches to treat their disease.

Lead author Dr. Xi Chen, a postdoctoral associate at Weill Cornell, said: “This starts to demonstrate how cancer cells co-opt the endoplasmic reticulum stress response pathway to allow tumours to grow and survive when they are deprived of nutrients and oxygen.

“This pathway was activated in about twothirds of patients with this type of breast cancer. Now that we better understand how this gene helps tumours proliferate and then return after a patient’s initial treatment, we believe we can develop more effective therapies to shrink their growth and delay relapse.”

“It shows the interaction between two critical pathways to make the cells better able to deal with a hostile microenvironment and in that way offers new strategies to target triple negative breast cancer.”

Scientists still need to study how those strategies would help women with the disease. Co- author Dr. Jenny Chang, professor of medicine at Weill Cornell and director of the Houston Methodist Cancer Center, said: “Obviously, we need to know now whether what our group saw in models is what we’ll see in patients. “We are very excited about the prospect of moving this research forward as soon as possible for the benefit of patients.” The study was funded by the National Institutes of Health and the Leukemia and Lymphoma Society.

Dr Laurie H Glimcher

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z WORLD NEWS

TIDieR’s development was supported by the Wellcome Trust, says: “This is a major problem for clinicians, researchers and, most of all, patients. Often key features, such as how long the treatment lasts, the way it is delivered, and how progress is monitored, are missing or poorly described.” The 12 items on the TIDieR checklist include the name of the intervention, the way it works, what materials and procedures were used, who provided the intervention, how, where and when it took place, how much in terms of duration and number of sessions, how well it was planned, how well it was delivered and modifications that were necessary.

Guide ‘will make research papers easier to understand’ A group of healthcare experts drawn from institutions around the world have developed a guide to improve the way interventions are described in research papers. The guide will address the problem that many interventions, ranging from surgery to rehabilitation, are so poorly described in the medical literature that they are difficult for clinicians to use in practice. The Template for Intervention Description and Replication (TIDieR) checklist and guide identifies 12 criteria to improve the reporting in research papers. It was developed by a 16-member panel from leading universities in Australia, France, Canada and the UK.

Associate Professor Tammy Hoffmann of Bond University, Australia, who along with her colleague Professor Paul Glasziou was one of the lead authors, said: “The evaluation of interventions to help patients is a major research activity yet the quality of descriptions in publications remains remarkably poor.” In previous research, the two authors found that only 39% of the 137 interventions they reviewed were properly described either in the research paper or in any references, appendices or websites. When researchers were asked to provide missing details, they were often unable to do so.

Professor Glasziou said: “Unlike the secret remedies of the 19th Century - when clinicians and consumers were kept in the dark about what ingredients were used - the current incomplete descriptions of interventions are more likely to arise due to poor communication and lack of awareness of the matter among authors and lack of attention by reviewers and editors. “It was clear that comprehensive guidance was needed, along with robust ways to implement the guidance. TIDieR is designed to be used to improve how interventions are reported in journals and make it easier for authors to provide an account of their intervention, for reviewers and editors to assess the descriptions, and for readers to use the information.” Associate Professor Hoffmann said: “TIDieR should be the researchers’ guide, the editor’s checklist, and the readers’ friend. Most of all, it will help patients to receive interventions that have been tried and tested and shown to work.”

Co-author Professor Mary Dixon-Woods of the University of Leicester’s Department of Health Sciences in the UK, whose contribution to

Genome breakthrough

Research pledge

American firm Sangamo BioSciences, Inc. published a clinical study of its proprietary zinc finger nuclease-based genome editing technology in humans.

EU countries and South Africa have agreed to step up collaboration in global health research, earth observation and research infrastructures.

Data demonstrates that the T-cell genome can mimic a natural mutation that provides resistance to HIV infection.

The 12th Joint Science and Technology Cooperation Committee meeting welcomed broader African participation in the second programme of the European and Developing Countries’ Clinical Trials Partnership.

Edward Lanphier, president and chief executive officer, said: “Our goal is to use this powerful technology to engineer genetic cures for diseases that have thus far been treated as chronic conditions, including HIV and a wide range of monogenic diseases.“

Recognising that tight word limits in academic journals often restrict reporting of interventions, TIDieR encourages authors to use multiple formats, such as websites and videos linked to the papers, to fully describe the intervention and provide details of additional resources.

The parties decided also to continue to support work through respective funding programmes of the Global Alliance for Chronic Diseases.

Study produces encouraging results Bristol-Myers Squibb Company and Pfizer Inc. have announced results of analysis of the anticoagulant drug Eliquis in relation to patient age. Lead author Dr. Sigrun Halvorsen, Department of Cardiology, Oslo University Hospital, Norway, said: “Eliquis has demonstrated superiority versus warfarin for reducing the risk of stroke and all-cause mortality with fewer major bleeding events in patients with NVAF with consistency across age groups, including patients 75 and older and the very elderly over the age of 80.”

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Scientists shed light on drug resistance

Scientists from the Florida campus of The Scripps Research Institute uncovered a mechanism of drug resistance which could have an impact on development of new antibiotics. The study centred around Streptomyces platensis, which secretes anti-bacterial substances. Ben Shen, the professor who led the study, said: “Now, because we know the resistance mechanism, we can design elements to minimise the emergence of resistance as promising new drug candidates are developed.”

Device allows doctors to learn about strokes

New blood markers could diagnose dementia before any symptoms A set of ten molecules in blood could be used to predict with 90 per cent accuracy whether people are at greater risk of developing dementia, according to researchers at Georgetown University Medical Center, USA. The study, published in Nature Medicine, is the first to show differences in the blood between people with pre-clinical Alzheimer’s disease before symptoms appear and those who will not develop the condition. The team took 525 healthy participants aged 70 and over and observed them for five years. By measuring the presence of ten compounds – known as phospholipids - in the blood the researchers could predict with 90% accuracy people that would go on to develop Mild Cognitive Impairment or Alzheimer’s Disease within that time frame.

Dr Doug Brown, Director of Research and Development, at the UK-based Alzheimer’s Society, said: “Right now we do not have a blood test that is currently available to predict the risk of someone getting dementia. Having such a test would be an interesting development but it also throws up ethical considerations. If this does develop in the future people must be given a choice about whether they would want to know, and fully understand the implications. ‘This research could also give clues on how Alzheimer’s Disease occurs and warrants further study, but as such a small number of people showed dementia symptoms there need to be larger studies with different populations before it could be turned into a blood test for Alzheimer’s Disease.“

A monitoring device designed by the University of Pennsylvania in America is helping doctors to monitor cerebral blood flow (CBF) in stroke patients.

Researchers from Penn Medicine and the Department of Physics & Astronomy in Penn Arts and Sciences say that the technique, called diffuse correlation spectroscopy, uses a probe on the head to measure the fluctuations of nearinfrared light caused by moving red blood cells in tissue.

Brain games

American firm Quincy Bioscience, makers of leading brain health supplement Prevagen®, has launched a games website to promote brain health. The site offers free and unlimited brain games to boost cognitive performance. Each game has been created to improve a specific brain function. Mark Underwood, President and cofounder of Quincy Bioscience, said: “We believe that keeping the brain stimulated with games designed to exercise the mind can be beneficial and fun.” You can play the brain games at www.prevagengames.com

Over the course of the study, 28 people who started without cognitive symptoms went on to develop either Mild Cognitive Impairment or Alzheimer’s disease within an average of two to three years.

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z WORLD NEWS

Expert calls for re-evaluation of ‘cosmetic’ surgery A leading health expert has said that cosmetic surgery isn’t just about vanity any more but has important health benefits. Professor Laurence Kirwan, who has clinics in New York, Connecticut, United States, and also in London, said: “One of the procedures I carry out most often is breast reduction. The procedure removes excess breast tissue, which causes health problems for some women.”

Unfortunately, many women suffering from the physical strain of overly large breasts are too embarrassed to consult their general practitioners in case they are dismissed as wanting the surgery for vanity’s sake, Prof Kirwan said.

He said that weight reduction of as little as 250 grams from each breast, combined with a breast lift, has been shown to produce measurable benefits.

He said: “Forget the issues of self-esteem and body image – the women I see who are desperate for breast reduction are in a great deal of discomfort.”

Prof Kirwan said: “My most famous patient, who has been very open about it, is Swedishborn television presenter Ulrika Jonsson. Her large breasts caused her a great deal of back pain so in 2009 we reduced her bust from 32E to 32C.” He said that damage to the body caused by overly large breasts can include slipped discs, nerve damage and curvature of the spine. Overly large breasts also can hinder the ability to exercise so patients who want to improve their health might find breast reduction the stimulus necessary to begin losing weight, Prof Kirwan said. Studies have shown that patients who had breast reduction surgery were more physically active, had better glucose control and reduced their risk of diabetes and other conditions.

Forget the issues of selfesteem and body image – the women I see who are desperate for breast reduction are in a great deal of discomfort.

According to American and Scandinavian studies, breast reduction surgery’s benefits are similar to those of other surgeries more recognised as beneficial for health, such as hip replacements. Researchers estimate that overly large breasts can shorten a woman’s lifespan by up to five years due to the cumulative damage to the body. They can cause women to ‘stoop over’ earlier, damaging nerves and discs in their backs. Breast reduction surgery prevents this damage, prolonging the spine’s long-term health, Prof Kirwan said. Liposuction is another procedure that can help people avoid health problems. Developed to remove fat cells around the belly button, outer thighs and upper arms that were resistant to diet and exercise, liposuction never was meant to be considered an alternative to weight loss, Prof Kirwan said. Prof Kirwan said; “Excess fat in these areas secretes enzymes that cause inflammation in blood vessels and can lead to heart disease. These chemicals also may cause diabetes, a disease that affects the health of the eyes, kidneys, heart, nerves and feet.” Numerous studies have concluded that reducing the body’s fat load means the pancreas, which controls glucose levels in the bloodstream, is not overworked.

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ADVERTORIAL z

Making the most of this value requires not only the development of exceptional technology, but also the availability of intellectual property (IP) protection that will provide companies with a return on their investments made. Unfortunately the news in this area has been less positive over the last few years, and the legal systems governing patent law in the US and Europe have made a number of changes that have potential to cause significant difficulties in the bioscience field. In the US, recent focus has concentrated on the question of what constitutes patentable subject matter in the biosciences field in light of recent US Supreme Court decisions and the way in which the US Patent and Trademark Office (USPTO) has decided to change its’ practice as a result of these.

Iain Armstrong

It’s an exciting time in biosciences, as we see increasing numbers of technological advances make the move from the laboratory to clinical context, offering new hope for patients and rewards for both scientists and investors. Bioscience start ups are increasingly being asked to play a vital role in ensuring that the pipeline for new drug development remains full. Several of the major pharmaceutical originator companies each face lost sales of multiple billion dollars as patents, that had ensured market exclusivity for key drugs, expire. The need to make good this shortfall means that the value of bioscience start ups to big pharma has arguably never been higher. This has been seen in an increased interest in acquisition of independent companies, as well as in performance of bioscience shares in the stock market.

The Supreme Court’s decisions in the “Myriad” and “Prometheus” cases had been widely interpreted as potentially causing problems in the fields of gene testing and diagnostics – areas vital to the development of personalised medicine that is expected to re-shape the future of patient therapy. However, the recent guidance issued by the USPTO as to how it intends to implement the points raised by the Court suggests that this may have a much broader reach, impacting not only on personalised medicine, but also upon a wide range of treatments based on the use of the body’s own naturally occurring proteins. In Europe, the arrival of the Unitary Patent and Unified Patents Court will provide a new centralised route for patent prosecution and litigation across the European Union as a whole. However, uncertainties regarding the costs associated with these systems, the approaches that will be taken by judges, and the extent to which they will protect patent proprietors as opposed to “patent trolls”, have lead to questions over how widely they will be adopted in practice.

Overall, the prospects for technological advances in bioscience research look as bright as they have for a long time.

Overall, the prospects for technological advances in bioscience research look as bright as they have for a long time. However an active approach in response to the current IP challenges, by the bioscience industry as a whole, as well as by individual companies, will play a major role in determining whether patients and investors alike ever see the full benefits that these advances potentially offer. Iain Armstrong IP Director iarmstrong@hgf.com at HGF Ltd www.hgf.com

HGF 25

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z WORLD NEWS

Bioline launches new products for epigenetics research Bioline, an American wholly-owned subsidiary of Meridian Bioscience, Inc. has entered the rapidly growing epigenetics field, with the launch of the first kits in the EPIK™ product range. The kits have been developed to meet the needs of researchers employing PCR and realtime PCR analysis in epigenetics, by delivering increased reliability and sensitivity.

“The EPIKTM range is a further demonstration of our commitment to our life science customers and to bringing innovation and quality products to the research laboratory, clinical diagnostic laboratories, and biotechnology companies.”

Marco Calzavara, President of Bioline, said, “Epigenetic changes alter the physical structure of DNA and can turn genes on or off. “Strong links have been identified between epigenetics, aging and cancer. Consequently, there is a lot of active research in this rapidly growing field. “Our customers have told us that reliability is a major issue in epigenetic analysis, and with the launch of these new kits, we will bring new levels of reproducibility and sensitivity to this field.” Richard L. Eberly, President of Meridian Life Science, Inc., said: “We are delighted with the launch of this new product range. Researchers world-wide will now have greater confidence in their results, as they push the boundaries of epigenetics understanding.

Collaboration is announced

Genocea Biosciences, Inc has announced a joint research collaboration with DanaFarber Cancer Institute and Harvard Medical School to characterise antitumour T cell responses in melanoma patients. Chip Clark, president and chief executive officer of US-based Genocea, said: “We believe this collaboration speaks to the promise of our ATLAS™ technology to discover a subset of antigens relevant to positive anti-tumour T cell responses in melanoma patients, which might form the basis for an effective immunotherapeutic.”

Fig. 1 EPIK Amplification Kit offers unrivalled performance from bisulfitemodified DNA templates. Primers were designed for bisulfitemodified sequences of the ELK1 gene (323bp, 600bp, 810bp, 1kb and 1.5kb). PCR was performed with 1) EPIK Amplification Kit and kits from suppliers 2) Z, 3) Q and 4) I according to the manufacturers’ recommended conditions. The results illustrate that only EPIK was able to amplify all five fragments successfully and so offers significantly improved performance with bisulfite-modified DNA. Marker - HyperLadder™ 100bp Plus (M)

Fig. 2 EPIK Amplification Kit delivers extremely sensitive and highly specific amplification even from low amounts of DNA template. A two-fold serial dilution from 35ng bisulfitemodified DNA (lanes 1-12) was used to amplify a 474bp fragment of the ELK1 gene with EPIK Amplification Kit and enzyme from supplier Z, using the recommended conditions. The results illustrate the unrivalled sensitivity of EPIK compared to supplier Z, even with low template concentrations. Marker HyperLadder™ 100bp (M).

Equipment to support research

Dutch research centre is expanded

The centre is the university’s premier facility for research and advancement of industry in medical, pharmaceutical and natural sciences.

The company works within the bioenergy, bio-based chemical, biopharmaceutical and industrial enzyme industries.

Imaging solutions company MILabs is working with Kanazawa University in Japan to install a system to enhance molecular imaging capabilities at the Advanced Science Research Center.

The VECTor+/CT system has been evaluated as the most suitable system for the research due to its ultra-high resolution, sensitivity and scanning speed for micro-SPECT imaging while providing .

Dyadic International, Inc. a global biotechnology company focused on the discovery, development, manufacture and sale of enzymes and other proteins, has completed the expansion of its research laboratory in The Netherlands.

Floor space at Dyadic Netherlands in Wageningen has significantly increased, allowing for the installation of a wide range of research equipment. The expansion will house scientists hired for new projects.

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WORLD NEWS z

German company scoops prize German biopharmaceutical company CureVac GmbH has won the EU’s first innovation inducement prize. The company received the prize for progress towards a novel technology to bring lifesaving vaccines to people across the planet in safe and affordable ways. The European Commission offered the £2 million prize to encourage inventors to overcome one of the biggest barriers to using vaccines in developing countries, the need to keep them stable at any ambient temperature.

It would be possible to rapidly produce these vaccines against almost any infectious disease, and deliver these to the most remote areas of the world. CureVac is currently running a number of clinical trials with these vaccines. Two other proposals, ‘Surechill’ (The Sure Chill Company Ltd, United Kingdom) and ‘Freshwest’ (Freshpoint Quality Assurance Ltd., Israel and West Pharmaceutical Services Deutschland GmbH & Co. KG, Germany) were congratulated by the jury for their applications.

Máire Geoghegan-Quinn, European Commissioner for Research, Innovation and Science, said: “CureVac‘s success opens up the possibility of a real European breakthrough in the delivery of vaccines to areas where they are needed most. This technology could save lives – exactly the type of innovation an EU inducement prize should support.” CureVac’s RNActive® vaccine technology is based on messenger RNA (mRNA) molecules that stimulate the immune system. It has the potential to allow the production of vaccines that are protected against both elevated temperature and inadvertent freezing.

Robert-Jan Smits, Director-General for Research and Innovation, presents the vaccine prize at the Innovation Convention 2014

Antitope and Synthon announce collaboration

Cambridge, UK and Nijmegen, the Netherlands, 2 July 2014 – Antitope Limited (“Antitope”), an Abzena company, today announced that it will collaborate with Synthon Biopharmaceuticals BV (“Synthon”), a global pharmaceutical company with expertise in the development of complex small molecule and biosimilar drugs and new biopharmaceuticals, including antibody drug conjugates (“ADC”), to assess the potential immunogenicity of candidate antibodies for Synthon’s ADC programmes. Antitope will use its EpiScreen™ technology, a highly accurate and sensitive ex vivo human T cell assay to determine the potential immunogenicity of the antibodies provided by Synthon. The EpiScreen™ technology correlates with published clinical anti-drug antibody immunogenicity data which supports selection of lead product candidates with low immunogenicity during preclinical development. “We are confident that Antitope’s EpiScreen™ technology will strongly help reduce the risk that Synthon’s antibody based development candidates will induce immunogenic responses in patient populations,” said Marco Timmers, CSO of Synthon Biopharmaceuticals. Matthew Baker, CSO of the Abzena group and co-founder of Antitope, commented:

Siemens at ESC 2014

Sustainable cardiovascular care means delivering more than quality outcomes. It means delivering them affordably. Again and again. For everyone.  Find out how Siemens helps to safeguard your position as a leading cardiovascular care provider at this year’s ESC Congress.   See how we help to push back clinical boundaries and pull down operational barriers. Visit our website to find out more about our presence at the ESC Congress 2014.

“We are very pleased to be working with a company that, like Abzena, has scientific innovation at the heart of its business and look forward to collaborating with Synthon to help it build its biopharmaceuticals pipeline.”

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z FEATURE

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FEATURE z

Are genetics the key to

arthritis treatment? New international studies have revealed how genetics could explain why different environmental exposures can trigger the onset of different forms of rheumatoid arthritis.

s our joints succumb to wear and tear, chronic pain becomes more of an issue for people in their later years, restricting movement, sparking depression and disrupting sleep. That is why researchers are increasingly focusing not just on finding medical therapies and cures for the various forms of the condition but also on ways to help people better live with the symptoms. Much of the medical research focuses on what triggers the condition, as a way of helping the development of medical treatments, and researchers are continually making encouraging breakthroughs.

genetic distinction between the two disease subtypes seropositive and seronegative rheumatoid arthritis and established that different genetic variants of a protein that plays a vital role in how the body’s immune system fights infection are associated with the two forms of rheumatoid arthritis. This provides clues to the theory that exposure to different infectious agents, such as bacteria or viruses, trigger the different forms of rheumatoid arthritis in some people. Dr Steve Eyre, from the genetics and genomics centre, said: “We recognise that rheumatoid arthritis is a complex disease that can have variable presentation and outcomes for different people, in particular in

Take some recent announcements. For example, a new international study has revealed how genetics could explain why different environmental exposures can trigger the onset of different forms of rheumatoid arthritis.

These findings add to our ability to genetically The team at the Arthritis Research UK Centre for Genetics and Genomics at define subtypes of The University of Manchester, part of an international consortium rheumatoid arthritis involving scientists from 15 academic institutions, which is an important believe their findings step towards selecting the could have important implication for the way that rheumatoid arthritis best treatment for each is diagnosed and treated. patient.

They say that more accurate clinical testing is now needed to better identify the less-well understood type of rheumatoid Genetics and Genomics Centre arthritis to prevent it being misdiagnosed. Rheumatoid arthritis the way they respond to treatment. is a serious inflammatory form of arthritis, affecting almost 400,000 people “These findings add to our ability to genetically define subtypes of rheumatoid in the UK alone, causing painful, swollen arthritis which is an important step towards joints, and in severe cases, considerable selecting the best treatment for each patient.” disability.

Dr Steve Eyre

The condition is known to have strong genetic and environmental components and it was already known that a proportion of rheumatoid arthritis patients test positive for autoantibodies, while 30% remain seronegative. The researchers have now better defined the

Centre director Professor Jane Worthington said: “Now that we have established a genetic basis for these two types of rheumatoid arthritis, we hope it will lead to patients receiving a swifter, accurate diagnosis and more appropriate, targeted treatment. These findings have opened the door to a better understanding of seronegative rheumatoid

arthritis.” Elsewhere, a new clinical trial has underlined the benefits of a promising new therapy option for patients with rheumatoid arthritis. The two-part phase II study was led by the Medical University of Vienna in Austria to assess the safety and efficacy of sirukumab - an anti-interleukin-6 monoclonal antibody - among patients affected by active rheumatoid arthritis despite prior methotrexate therapy. In the first part of the trial, 36 patients received either sirukumab or a placebo every fortnight for ten weeks. Part two saw 151 subjects receive either sirukumab for a full 24 weeks, or be given a placebo for ten weeks before switching to sirukumab for the remainder of the study. Results published in the Annals of the Rheumatic Diseases revealed that 26.7 per cent of sirukumab patients were able to meet the study’s primary response rate goal, in terms of improvement in tender or swollen joints and symptoms including pain and disability. This compared to 3.3 per cent of those in the control group. Greater improvements in disease activity levels were seen at week 12 with sirukumab across both parts of the trial, while adverse events were shown to be similar for sirukumab-treated and placebo-treated patients across the entire trial, underlining its safety. Arthritis Research UK said it would be interesting to see how the drug performed in a phase III trial, which would involve a considerably larger number of patients. Sirukumab is being developed by GlaxoSmithKline and Janssen.government residential home beds and establishing Management Centres responsible for guidance and monitoring care providers in each region.

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COULD FOOTBALL HELP IN THE BATTLE AGAINST ARTHRITIS?

Arthritis Research UK has awarded funding to a team at the University Nottingham to find out why so many professional footballers develop osteoarthritis. The five-year study, the first of its kind, aims to establish how common the condition is among ex-players compared to the general population. The findings could have implications far beyond the world of professional football and lead to greater awareness of how to avoid and prevent injuries for people who play sport at whatever level. The study, ’Osteoarthritis Risk of Professional Footballers’, is one of the biggest projects being carried out by a team at the Arthritis Research UK Centre for Sport, Exercise and Osteoarthritis at The University of Nottingham. It is part funded by FIFA, Spire Healthcare and footballers’ charity Xpro, and supported by the FA and the PFA. Based at the University of Nottingham, the research is led by a team of researchers within the Division of Rheumatology, Orthopaedics and Dermatology, including the study manager Dr Gwen Fernandes in the department of academic rheumatology. Dr Ferandes said: “Professional footballers appear especially prone to arthritis due to the intensity of the sport they play and the injuries sustained during their playing careers. “They seem more likely to develop early onset osteoarthritis of their knee joints, for example. The results of our study will establish the prevalence of osteoarthritis among professional footballers compared to the normal male population and hopefully identify the specific risk factors for knee osteoarthritis in footballers.” The study has the backing of former England player Sir Trevor Brooking, who said: “A few years ago I had a knee replacement for my left knee and have benefited enormously from that successful operation in my daily work commitments. There’s very little research on this important topic, and the study will be of immense benefit to the current football community, and will help to direct the game for future generations of footballers.”

As part of the first phase of the study, the research team will work with football associations to recruit at least 18,000 exprofessional footballers over the age of 40 and ask them to fill in a questionnaire. Questions will include how many games they played, how many hours they spent training, how long they played and at what level, whether they were injured, and whether they now have osteoarthritis and so on, enabling researchers to build up a detailed picture of their playing careers.

In the second phase of the study, 900 of the players who responded to the questionnaire will then have their knees x-rayed by Spire Healthcare’s research arm, Spire Perform, based at FA headquarters at St George’s Park, which will provide evidence of structural changes in their knees. The results of the questionnaires and the x-rays will then be compared against a control arm of 500 men recruited from the general population of Nottingham.

Professional footballers appear especially prone to arthritis due to the intensity of the sport they play and the injuries sustained during their playing careers. They seem more likely to develop early onset osteoarthritis of their knee joints, for example. The results of our study will establish the prevalence of osteoarthritis among professional footballers compared to the normal male population and hopefully identify the specific risk factors for knee osteoarthritis in footballers. Dr Gwen Fernandes

Study Manager, department of academic rheumatology.

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The extent of pain experienced by sufferers of arthritis has always been thought to result from the direct consequences of joint destruction. However, the extent of pain is often poorly related to the amount of damage and can spread to nearby regions of the body where there is no evidence of arthritic disease. We wanted to look at what might be causing this. Professor Anthony Jones

The University of Manchester’s Human Pain Group, Salford Royal NHS Foundation Trust

LIVING WITH ARTHRITIS KEY FOCUS FOR RESEARCHERS Just as important as the search for a cure to many researchers is work to help sufferers live with the condition. In the UK, Arthritis Research UK-funded scientists have shown for the first time that the abnormalities in the way the brain experiences pain may be to blame for the chronic pain suffered by osteoarthritis patients. The findings by researchers at The University of Manchester suggest the need for new therapies to target brain mechanisms to enable the brain to cope more effectively with chronic pain, including talking therapies. Chronic pain can affect up to 30% of the population at any one time – with most complaints relating to arthritis. Professor Anthony Jones, from The University of Manchester’s Human Pain Group based at Salford Royal NHS Foundation Trust, said: “The extent of pain experienced by sufferers of arthritis has always been thought to result from the direct consequences of joint destruction. However, the extent of pain is often poorly related to the amount of damage and can spread to nearby regions of the body where there is no evidence of arthritic disease. We wanted to look at what might be causing this.” “Currently it is not understood why patients with arthritis have such variability in how much pain they experience but, in spite of this, we continue to spend large sums of money using potentially damaging antiinflammatory drugs.” Researchers thought that the spreading and intensification of pain in arthritis may be similar to that experienced by sufferers of fibromyalgia, a widespread chronic pain condition associated with psychological distress and sleep disturbance where there is currently no consensus about the cause of the pain. Earlier research had suggested that patients with fibromyalgia have abnormalities in the way in which the brain deals with pain so the Manchester team looked at the overlaps in how pain is processed in the brain, between osteoarthritis and fibromyalgia to help them understand why some sufferers of arthritis can

experience much worse pain than others.

pain responses in other areas of the brain.”

The study, published in the European Journal of Neuroscience, measured brain waves in response to short painful laser pulses to the skin in patients with osteoarthritic or fibromyalgic pain and those with no pain. They found that while anticipating the painful pulse a brain area called the insula cortex increased its activity and this predicted the extent and intensity of the patients’ own chronic pain.

The study suggests there are common abnormalities in the way the brain expects pain in fibromyalgia and osteoarthritis –

Dr Christopher Brown, honorary research associate in the Human Pain Research Group, at The University of Manchester, said: “Increased activity in this brain area has been linked to a number of phenomena, including body perception and emotional processing, which might explain the greater pain perception in some patients. “Interestingly, responses during pain anticipation were reduced in an area at the front of the brain called the dorsolateral prefrontal cortex. These reduced responses corresponded to less ability to develop positive ways of coping with the pain in both groups of patients. “We think that boosting activity either directly or indirectly in this area of the brain is likely to result in better coping and better control of CONTINUED ON PAGE 36

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which can be considered potential common brain mechanisms for these conditions. Professor Wael El-Deredy, from The University of Manchester, said: “More research is needed but this suggests we should be putting more resources into a common approach to developing new therapies that target these potential brain mechanisms. “Our previous work has shown that brain responses to pain expectation can be altered by relatively short and inexpensive mindfulness-based talking therapies in patients with different types of chronic pain. Our current findings therefore provide both a new target for development of new therapies and some optimism for simple interventions to improve the brain’s control of chronic suffering endured by many patients with chronic pain conditions.” Professor Alan Silman, medical director of Arthritis Research UK, which funded the research, said: “This research provides a fascinating insight into the way the brain processes the pain of osteoarthritis and goes some way to explaining why so many people with osteoarthritis with similar levels of joint damage experience such varying degrees of pain. “Focusing research on targeting abnormal brain mechanisms rather than more conventional approaches looking at joint damage could be a major step forward, that could reduce people’s dependency on antiinflammatories and painkillers.” In France, researchers discovered that electrical brain stimulation could aid fibromyalgia sufferers. Conducted by a team at Aix-Marseille University, the research used a technique known as transcranial magnetic stimulation among a group of 38 female patients who suffered from persistent fibromyalgia pain for more than six months. Results reveal that patients who received the brain stimulation experienced a greater improvement in quality of life than those on placebo, experiencing a better emotional state. No direct cause-and-effect correlation was proved by the study but lead researcher Dr Eric Guedj of Aix-Marseille University and

the National Centre for Scientific Research said: “This improvement is associated with an increase in brain metabolism, which argues for a physical cause for this disorder and for the possibility of changes in areas of the brain to improve the symptoms.”

ADDRESSING THE DEVASTATING EFFECTS OF BACK PAIN

The way that back pain is assessed and treated needs to change to take into account its impact on the social lives of sufferers, according to a new Arthritis Research UK-funded study. A team of researchers led by Warwick Medical School in Coventry found that that low back pain often led to damaged relationships and people becoming isolated and depressed. The team reviewed 49 research papers describing 42 studies and lead researcher Dr Rob Froud said; “Patients with low back pain seek diagnosis, treatment and cure, but also reassurance about lack of a cause of their pain. “They also want to be believed as having their experiences as someone ‘doing battle’ with pain validated. Some people struggle to meet social expectations and obligations – but when they do they fear their credibility of the pain and disability can be jeopardised. Others withdraw, fearful of disapproval, or unable or unwilling to meet social demands.

with emphasis on what is important to patients.” Professor Alan Silman, medical director of Arthritis Research UK, said: “Chronic back pain is one of the most significant causes of morbidity in the UK, causing pain, distress and loss of function for millions. One of the issues is its persistence over in many patients several years or even decades. “This research shows that the consequence is not just in terms of the physical problems but the impact it has on people’s lives and social functioning, and highlights the need to consider this as both a pressing health as well as a wider societal problem.” Low back pain is the most common form of chronic pain, with approximately 4 per cent of the UK population taking time off work because of it, equating to 900 million working days lost every year. While 90 per cent patients who consult their GP for low back pain stop seeing their GP after three months, most still have low back pain and related disability a year later, suggesting that they feel that there is limited help is available or that further consultation would not be worthwhile.

“Pain and disability are the most commonly measured outcomes in trials of back pain treatments, but the development of the next generation of outcomes for research and clinical use needs to take a broader perspective,

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REVIEWING SUCCESS OF KNEE REPLACEMENT

An Oxford surgeon is investigating a popularly used type of knee replacement to find out how to improve its longevity. Alex Liddle from the University of Oxford has been awarded a one-year surgical fellowship of £61,000 by Arthritis Research UK to examine unicompartmental knee replacement surgery, which accounts for up to 10 ten per cent of all knee replacement operations in the UK. Unicompartmental, or partial knee replacement surgery, has many advantages over a total knee replacement. It uses a smaller incision and preserves the normal structures within the knee joint, so patients recover more quickly and have better function following surgery than they do after total knee replacement. It also has a lower rate of

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serious complications such as infection, and is significantly cheaper for the NHS. However, patients with partial knee replacements are up to three times more likely to undergo revision surgery than patients with total knee replacements. This is often because the bond between the implant and the bone becomes loose. Mr Liddle, who is based at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford, aims to find out why the unicompartmental implant needs to be revised, and what can be done to reduce the revision rate. He said: “We know that unicompartmental knee replacement surgery is technically demanding, and that orthopaedic centres who perform a high volume of this type of surgery

have very few failures through loosening, so one factor could be the experience of the surgeons. “Another factor could be selecting the right patient, as this type of operation may be more suitable for some people than others. Also the actual design of the implant may be a factor. Most are fixed to the bone with cement, which may be the weak link in their design so we’re also looking at the effectiveness of a new design of uncemented implant.” As part of his research, Mr Liddle will examine data from the National Joint Registry on 550,000 patients who have undergone either unicompartmental or total knee replacement surgery, as well as conducting clinical and scientific studies of the new, cementless implant.

We know that unicompartmental knee replacement surgery is technically demanding, and that orthopaedic centres who perform a high volume of this type of surgery have very few failures through loosening, so one factor could be the experience of the surgeons. Alex Liddle

Surgeon, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford CONTINUED ON PAGE 38

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Patent Valuation

Patricia Barclay of Bonaccord discusses Patent Valuation with Bioscience Journal: Patent valuation was the subject of a recent European Patent Office conference in Athens to which I was privileged to be invited to contribute. Speakers identified three common approaches: n The cost approach – the historic costs in developing the technology to the point of patenting and the associated patent costs up to the date of valuation n The market approach – what someone is willing to pay for the patent, usually calculated by looking at the price paid for a similar patent n The income approach – the potential earnings from the patent discounted to the net present value In my experience the vast majority of businesses prefer the third method although Martin Bader of BGW, management consultants in Switzerland, felt that was more reflective of accounting departments and that he had found general management preferred the certainties of the cost approach. The cost approach however is unreliable as some very valuable technologies such as cats’ eyes may incur relatively little development cost while other inventions may indeed have been developed and patented at great cost but are

essentially worthless if there is no market for the subsequent technology. The cost approach can nonetheless often be useful in calculating the value of the copyright in software as generally the effort can be repeated by a competitor to achieve a similar outcome. The market approach is also problematic as it can be difficult to identify comparators and the price paid. Even if the price can be ascertained there will generally be other assets or rights included in the deal making it difficult to calculate the portion ascribable to the patent whereas identifying an appropriate royalty rate is usually much simpler and this can act as a starting point for the income method. In the early days of a company’s existence however there tends to be more focus on the cost of obtaining and maintaining the patent. This may lead to a different approach in calculating the value of a particular patent to the business. Malte Kollner of Dennemeyer, patent agents in Germany, addressed some of these issues in the context of discounting from an idealised value to reality. Points a business might like to consider include:

n What is the scope of the patent and how easily could it be circumvented? n Could the patent be enforced? n What extra profit could be derived from a patent? n How core is this technology to the long term of goals of the business? More established businesses could also benefit from a regular, systematic review of their patent estate but few do this. A survey conducted by Dr Bader’s company and PWC amongst the top 500 applicants to the EPO ( he did not specify the number responding) found a substantial number of patents - perhaps amounting to the majority - were neither used by the company for their own business or as blocking mechanisms against competitors. Clearly there are substantial savings to be made.

n Can you access the other assets required to commercialise the patent such as manufacture, market, other technologies, finance?

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Mighty Mitochondria Damaged protein could be one of the keys to premature ageing

cientists have found that the condition of key proteins in the mitochondria -the batteries of cellscould be used to predict, and eventually treat, premature ageing. And restricting diet could be one way of making this happen. The researchers from Newcastle University in North East England used interventions, like calorie restriction, a system whereby the cells are deprived of nutrients and which in previous studies has been shown to cause mice to live longer than normal.

These interventions also resulted in more efficient assembly of important mitochondrial proteins into complexes. In a complex state, proteins work together more effectively, while on their own they generate toxic free radicals, which in turn cause cells to age more rapidly. If a similar mechanism is found in people it could lead to treatments, such as new drugs to improve protein assembly. In a paper published recently in the journal Nature Communications the team describe their findings.

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Thomas von Zglinicki, Professor of Cellular Gerontology at the Institute for Ageing and Health, Newcastle University, said: “Free radicals have long been linked with the ageing process. Mitochondria generate the energy required to keep our bodies going but they also generate free radicals. How exactly they are involved in ageing is still controversial. Our data shows that quite minor differences can explain large variations in healthy lifespan. Essentially what we have found is that the ageing process goes slower than normal in mice that managed to form mitochondrial protein complexes more efficiently, and that we actually could help them to do so.” A complex of 96 proteins is at the heart of the mitochondrial power station. Comparing the protein composition in mitochondria from mice that had more or less propensity

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to long life, the team found the mitochondria from long-lived animals surprisingly had less of these proteins and thus seemed less well suited for energy production than the shorterliving mice. However, further research showed that assembly of the protein complex was the key: If individual components were more scarce, assembly was perfect, but became more sloppy if more material was around. This then led to less efficient energy production and more release of oxygen free radicals, toxic byproducts of mitochondrial metabolism. Dr Satomi Miwa, joint lead researcher on the team and a specialist on mitochondrial function, said: “These data go a long way to explain how calorie restriction can improve mitochondrial function, extend lifespan and reduce or postpone many age-associated diseases.” Professor Thomas von Zglinicki added: “We have shown here that complex assembly efficiency correlates to longevity differences in mice that correspond to one or two decades of healthy life in humans. We have also shown that human cells age faster if we corrupt complex assembly. What we now need to do is to see how we can improve the quality of these protein complexes in humans and whether this would extend healthy life.”

These data go a long way to explain how calorie restriction can improve mitochondrial function, extend lifespan and reduce or postpone many ageassociated diseases

Dr Satomi Miwa

Joint Lead Researcher, Institute for Ageing and Health, Newcastle University

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One Heart two fronts

The battle against heart disease, the world’s number one killer and one of the major illnesses associated with ageing, is increasingly becoming a global one fought on two fronts- prevention and cure.

esearchers around the planet are working to devise both new treatments and better understand lifestyle choices which will reduce the frightening death toll associated with the disease. Indeed, the World Heart Foundation (WHF) is running a year-long, worldwide effort as part of its Champion Advocates Programme, which aims to reduce premature mortality from cardiovascular disease (CVD) by at least 25 percent by 2025 and highlight the importance of prevention. One recent event was in Washington DC, America, when leaders from the World Heart Federation, the American Heart Association, the U.S. Department of Health and Human Services and the American College of Cardiology came together to highlight the pressing need to cut premature mortality from cardiovascular disease. Johanna Ralston, chief executive officer of the World Heart Federation, said: “Heart disease knows no boundaries, which is why the World Heart Federation’s Champion Advocates Programme is travelling around the world to reach different communities and populations and work together to inform change through long-lasting policies and programmes. “With every panel, we come closer to achieving our goal of reducing premature mortality from cardiovascular disease.”

The need is pressing. About 600,000 people die of heart disease in the United States every year, one in every four deaths. Heart disease is the leading cause of death for both men and women and every year about 720,000 Americans have a heart attack. Of these, 515,000 are a first heart attack. Coronary heart disease also costs the United States $108.9 billion each year, including the cost of health care services, medications, and lost productivity Nancy Brown, chief executive officer of the American Heart Association, said: “Heart disease can touch anyone, no matter where you live. It will take the collective efforts of everyone from community leaders to healthcare professionals, educators and business leaders to stop this No. 1 killer at the national and global level. By working together we can hopefully make this often fatal condition a distant memory for future generations.” During the past year, the WHF has hosted similar briefings in a number of countries, from China to Spain, to promote the goal of addressing the global burden of cardiovascular disease.

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Firefighters study casts light on role of diet in prevention

One of the main thrusts of the campaign is prevention because there is a lot that people can do to ward off the onset of cardiovascular disease. Healthy eating is one of the big focuses for researchers, who argue that it makes sense to take the right steps early in life. That is why new research conducted in Boston, in America, is so interesting because it showed that, among a large group of Midwestern firefighters, greater adherence to a Mediterranean-style diet was associated with lower risk factors for cardiovascular disease. The study, led by researchers from Harvard School of Public Health (HSPH) and Cambridge Health Alliance (CHA), was the first to assess the effects of Mediterranean-style diet among a group of young, working U.S. adults. Stefanos Kales, associate professor in the Department of Environmental Health at HSPH and chief of occupational and environmental medicine at CHA, said: “Our study adds more evidence showing the health benefits of a Mediterranean diet, even after adjusting for exercise and body weight,” U.S. firefighters are known to have a high prevalence of obesity and risk factors for CVD but a Mediterranean diet, rich in fish, nuts, vegetables, and fruits, has been shown in previous studies to lower the risk. However, those studies have primarily been conducted among older people, those with existing health conditions and among Mediterranean populations. The researchers analysed medical and lifestyle data, including dietary habits, from an existing cohort of 780 male firefighters in the Midwest. They developed a modified Mediterranean diet score (mMDS) to assess the participants’ dietary patterns. The firefighter group with greatest adherence to Mediterranean-style diet showed a 35 per cent

decreased risk in metabolic syndrome, a condition with risk factors that include a large waistline, high triglyceride level, low HDL (“good”) cholesterol level, high blood pressure, and high blood sugar. The group with the highest mMDS also had a 43 per cent lower risk of weight gain compared with the lowest mMDS group. Additionally, greater adherence to a Mediterranean-style diet was significantly associated with higher HDL cholesterol and lower LDL (“bad”) cholesterol. Consistent with previous investigations, obese participants in the firefighter study reported a higher intake of both fast foods and sugary drinks. “The logical next steps from our investigation are studies using the workplace to specifically promote Mediterranean dietary habits among firefighters and other U.S. workers,” said Justin Yang, lead author of the study and a postdoctoral fellow at HSPH.

Depression and heart disease

A recently-published report has highlighted the possible link between behaviour connected to mental health and incidences of heart disease.

The findings, from the Whitehall II study of more than 10,000 civil servants in the UK and published in the European Journal of Preventive Cardiology, provided evidence that the symptoms of depressive disorder are causally associated with the risk of coronary heart disease, and as such should be considered a potentially modifiable risk factor. The Whitehall II study began in 1985-88 when the health of 10,308 civil servants working in 20 London-based departments was assessed by clinical examination and a questionnaire. Subsequent assessments were made every two-to-three years, with exposure to depression measured on six occasions over the 20-year study period. All participants were followed for major heart disease events and stroke. Results over the five-year observation showed that there was no added risk of coronary heart disease (CHD) among those who showed evidence of depressive symptoms during one or two of the questionnaire assessments but a 100% increase in risk in those who reported symptoms at three or four of the assessments. CONTINUED ON PAGE 44

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The parachute goes inside the heart and blocks off non-functioning areas, so the heart won’t have to work as hard to pump blood.

New drug offers hope for heart failure sufferers

Investigator Dr Eric Brunner from the Department of Epidemiology and Public Health, University College London, said: “European prevention guidelines refer to depression as a coronary risk factor, and in our study repeated episodes of depressive symptoms accounted for 10 per cent of all CHD events in the study population. “However, this figure relies on the strong assumption of a direct causal mechanism. Whether or not the association is causal, supporting individuals to recover from chronic or repeated episodes of depression has merit, particularly if the individual is then better able to reduce any vascular risk, for example by quitting smoking.” Some of the funding for the study came from the Stroke Association, the UK’s Stroke charity, whose spokesperson, Dr Madina Kara, said: “Whilst depression has been identified as a risk factor for coronary heart disease, the findings of this study showed no such link between depression and stroke. However, this research does reveal that stroke survivors are twice as likely to develop depressive symptoms.”

New device ‘ increases chance of survival’

As well as prevention, researchers are hard at work on new treatments. For example, Saint Luke’s Mid America Heart Institute cardiologists are taking part in a clinical trial investigating a new minimally invasive cardiac implant which may offer new hope to patients with severe heart failure, for whom open heart surgery may previously have been their only option. The trial is focused on heart attack survivors with severe heart failure. Following a heart attack, the left ventricle of the heart (the main pumping chamber) may become enlarged leading to symptoms such as fatigue and

shortness of breath. Eventually, the damaged heart muscle converts to stiff scar tissue, which results in pooling of blood in the tip of the heart. This leads to significant pressure build up inside the heart and causes significant strain on the remaining healthy tissue. As part of the PARACHUTE-HF trial, Saint Luke’s interventional cardiologists implant the Parachute Ventricular Partitioning Device(pictured above) in the left ventricle, where the device closes off the non-functional portion of the heart from the healthy, functioning portion. The device, which looks like a small inverted umbrella in structure, is ultimately covered by the body’s own tissue and becomes a permanent implant. The clinical trial will seek to determine if the device can slow the progression of heart failure, decrease repeat hospitalisations, and improve survival and quality of life. Andrew Kao, M.D., heart failure and transplant cardiologist and principal investigator of the PARACHUTE-HF trial, said: “The Parachute device is an exciting new option for patients who develop heart failure after a heart attack.

Swiss drug company Novartis recently announced that the Data Monitoring Committee (DMC) unanimously recommended early closure of the PARADIGM-HF study after results suggested that its heart failure pill LCZ696 may prove an affective treatment for heart failure. The trial indicated that patients with chronic heart failure with reduced ejection fraction (HF-REF), who received LCZ696, lived longer without being hospitalised for heart failure than those who received standard care with ACE-inhibitor enalapril. The trial was closed after analyses showed the safety profile of LCZ696 was acceptable and Tim Wright, Global Head of Development, Novartis Pharmaceuticals, said: “Novartis recognizes the huge global need for treatments that extend and improve the lives of people with heart failure and we believe LCZ696’s unique mechanism of action could be transformative. “This result is a demonstration of our commitment to developing innovative medicines that have an impact on the most important outcomes like cardiovascular mortality.” Dr. Milton Packer, Professor and Chair for the Department of Clinical Sciences at

“In the past, this type of treatment would have been possible only through open heart surgery. To be able to offer patients a minimally invasive treatment which takes less than 75 minutes to complete as opposed to major surgery is a significant advance.” Adnan Chhatriwalla, M.D., interventional cardiologist and medical director of the Structural Heart Disease Program at Saint Luke’s Mid America Heart Institute, said: “Access to these potentially groundbreaking treatments and clinical trials is a tremendous benefit for our ischemic heart failure patients, especially for severe heart failure patients who are not ideal surgical candidates. This procedure offers a treatment option where previously there was none.”

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Positron Emission Tomography (PET) is a non-invasive molecular imaging technique that produces 3 dimensional images of functional/biochemical processes in the body

University of Texas Southwestern Medical Center, Texas, USA and one of the two Principal Investigators, said: “The results of PARADIGM-HF are truly impressive. The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure.” Novartis is in discussions with global health authorities regarding approval for marketing. LCZ696, a twice a day pill for heart failure, is a first in class medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms. . Known as an ARNI (Angiotensin Receptor Neprilysin Inhibitor), LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover. LCZ696 is the second treatment being developed by Novartis for patients with heart failure, along with RLX030 (serelaxin) for acute heart failure. Chronic heart failure is a progressive, debilitating disease where the heart is unable to pump enough blood throughout the body. Symptoms such as breathlessness, fatigue and fluid retention can appear slowly and worsen over time, significantly impacting quality of life. Approximately half of patients have the reduced ejection fraction form of the disease. Heart failure is a significant and growing public health concern with more 20 million people living with the disease across Europe and the US alone.

Imaging techniques explore heart disease

New imaging techniques that can pinpoint the severity of a patient’s heart disease are being researched by a team at King’s College London thanks to a grant from Heart Research UK. It is hoped that the research will lead to more accurate detection of areas of the heart with poor blood supply or damage, allowing specialists to assess the severity of coronary artery disease so that patients can benefit more quickly from treatment. The team based in the Cardiovascular and Imaging Sciences & Biomedical Engineering Divisions at King’s, led by Dr Richard Siow, has been awarded £190,877 from Heart Research UK for a two-year project. About 20 per cent of the air we breathe is oxygen, whilst levels in blood supplying the heart are between three and six per cent, but in coronary artery disease, where the blood supply to the heart becomes restricted, levels of oxygen may be as low as one to three per cent. This causes changes within the tissue and the build-up of damaging by-products such as free radicals which can lead to cardiovascular disease such as atherosclerosis, heart attack and stroke. Dr Siow said: “Doctors are keen to develop new ways of imaging the human heart without the need for invasive medical tests. Our project involves an advanced imaging technique which produces detailed three-dimensional pictures showing how tissues and organs are working. “The aim of our research is to come up with a more accurate way of detecting damage to the heart so that interventions can happen quicker – and give a better outcome for the patient.” The project involves an advanced imaging technique called positron emission tomography (PET) which produces detailed three-dimensional pictures showing how tissues and organs are working. The team will develop new tracer molecules which they will use to image human heart and blood vessel cells grown in culture. The multidisciplinary King’s team, which includes Professor Giovanni Mann and Professor Philip Blower, will study

how the probes accumulate in the cells, and how this is affected by oxidative stress such as occurs in heart disease. Professor Ajay Shah, Director of the King’s College London’s BHF Centre of Research Excellence, within which the project will be conducted, said: “The development of novel imaging approaches to assess heart disease is an important aim of our Centre and this project fits very well within this theme.” Heart Research UK National Director Barbara Harpham said: “Anything that gives doctors a more accurate diagnosis of a patient’s condition has to be a positive step forward, and the King’s team’s work will develop state of the art imaging that will help to do this.”

Doctors are keen to develop new ways of imaging the human heart without the need for invasive medical tests. Our project involves an advanced imaging technique which produces detailed threedimensional pictures showing how tissues and organs are working. Dr Richard Siow

Cardiovascular and Imaging Sciences & Biomedical Engineering, King’s College London

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Coenzyme Q10 and cardiovascular disease: an overview Dr D. Mantle FRSC FRCPath Medical adviser, Pharma Nord (UK) Ltd

Introduction

Coenzyme Q10 (CoQ10) is a naturally occurring vitamin-like substance, first characterised in 1957 by Prof Fred Crane at the University of Wisconsin. CoQ10 is also known as ubiquinone, because of its ubiquitous distribution in all body tissues. Coenzyme quinones occur in several chemical forms, with CoQ10 being the only form found in human tissues. CoQ10 plays a key role in the biochemical mechanism supplying cells with energy, acting in conjunction with enzymes (hence the name CoQ10) to convert sugars and fat into energy. The action of CoQ10 is of particular importance in tissues with a high energy requirement, such as cardiac muscle. CoQ10 is also important as an antioxidant within the body. The objective of this article is therefore to provide an overview of the pharmacology of CoQ10, and its role in the prevention and treatment of disease, particularly cardiovascular disorders.

FUNCTIONS OF COQ10

CoQ10 is an essential cofactor of enzymes involved in the process which supplies all cells with energy (cellular respiration). CoQ10 is stored in mitochondria, the specialised structures found within cells responsible for the generation of energy. Specifically, CoQ10 is an intermediate in the electron transport system that generates energy in the chemical form of adenosine triphosphate (ATP), shuttling electrons from complexes I and II to complex III of the mitochondrial respiratory chain. Tissues with a high energy requirement, especially the heart and skeletal muscles, contain higher numbers of mitochondria within their cells, and are particularly reliant on maintaining adequate tissue CoQ10 levels for their normal functioning. For example, the heart and skeletal muscles typically contain about 1000mg of CoQ10, out of a total body pool of 1500-2000mg. CoQ10 is also important within the body as a major fat-soluble antioxidant, protecting cell membranes (particularly those of the mitochondria) from the damaging effects of free radicals. Free radicals are generated continually within the body as an unwanted by-product of normal cellular metabolism, particularly cellular respiration. CoQ10 is the only lipid soluble antioxidant produced within the body. Most recently, gene expression profiling has shown that CoQ10 influences the expression of several hundred genes. In particular, studies in cell culture, animal models and human subjects have shown that CoQ10 can directly regulate gene expression relevant to inflammation and fat metabolism (Schmelzer et al, 2008; Yubero-Serrano et al 2012). In addition, CoQ10 supplementation has been reported to decrease levels of inflammatory markers in patients with coronary artery disease (Lee et al, 2012). CoQ10 occurs in cells in two closely related forms, oxidised (ubiquinone) and reduced (ubiquinol). The inter-conversion between these two forms is essential for the normal functioning of CoQ10.

SYNTHESIS AND DEFICIENCY OF COQ10

Although some CoQ10 (approx 25% of requirement) is obtained from the normal

diet, most is manufactured within the body, particularly by the liver. It has been estimated that the population of Denmark, for example, obtain only 3-5mg of CoQ10 per day from their normal dietary sources (Weber et al, 1997). The synthesis of CoQ10 is a complex process requiring a number of amino acid, vitamin and trace element precursors and cofactors; a deficiency in any of these can adversely affect the normal production of CoQ10. It is of note that CoQ10 shares a common synthetic pathway with cholesterol. As people age, the capacity of the body to produce CoQ10 decreases; optimal production occurs around the mid-twenties, with a continual decrease thereafter. CoQ10 levels can also be depleted by intense exercise, certain types of prescription medicines, and by illness. Dietary supplementation with coenzyme CoQ10 therefore provides a mechanism to maintain adequate levels within the body. However, it is important to note that the pharmaceutical quality and bioavailability of coenzyme supplements from different manufacturers may vary widely. Deficiency of CoQ10 has been linked with increased risk of a number of disorders, including cardiovascular disease, neurodegenerative disease, immune disorders, periodontal disease and male infertility. Tissues with that are metabolically most active, and have the highest energy/CoQ10 requirements (e.g. cardiac and skeletal muscles, immune response cells, gingiva), are the most susceptible to deficiency. Most cases of deficiency result from factors such as aging or the effects of drugs such as statins (secondary deficiency). Primary deficiency results from defects in the genes responsible for the various steps in the bodyâ&#x20AC;&#x2122;s synthesis of CoQ10; these are rare and can be successfully treated by supplementation if identified in infancy.

BIOAVAILABILITY OF SUPPLEMENTAL COQ10

Bioavailability is defined as the proportion of an orally administered substance that reaches the systemic circulation. CoQ10 is a fat soluble substance. Following emulsification and micelle formation, CoQ10 is absorbed by mucosal cells of the small intestine, as for any other dietary fat. CoQ10 is then transported via chylomicrons

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SAFETY OF COQ10

CoQ10 is generally well tolerated, with no serious adverse effects reported in long term use. Very rarely, individuals may experience mild gastrointestinal disturbance. There are no known toxic effects, and CoQ10 cannot be overdosed. CoQ10 is well tolerated in healthy adults at an intake of 900mg/day, and in rats at a dose of up to 1200mg/Kg/day (Ikematsu et al, 2006). CoQ10 is not recommended for pregnant or lactating women, in whom the effects of CoQ10 have not been extensively studied. Several case studies have suggested that CoQ10 may interfere with the action of warfarin; however a randomised controlled clinical trial showed CoQ10 supplementation at 100mg/day had no effect on the clinical action of warfarin (Engelsen et al, 2003).

CONCLUSIONS

To date there are more than 600 articles published in the peer-reviewed medical literature (including some 60 randomised controlled clinical trial studies) relating to CoQ10 and cardiovascular disease, listed on Medline (the database of the US National Library of Medicine). However, many healthcare professionals remain unfamiliar with the potential role of CoQ10 in the prevention or management of cardiovascular disease. Of course not every one of the above articles has reported positive findings with regard to CoQ10 and cardiovascular disease, however the balance of published evidence supports a beneficial role for CoQ10 in the prevention and management of cardiovascular disease, as outlined in the article above. None of the clinical trial studies have reported any significant adverse effects following oral supplementation with CoQ10.

Coenzyme Q10 Key Points

n CoQ10 is a naturally occurring vitamin-like substance that plays a key role in the metabolic process supplying cells with energy. n CoQ10 is of particular importance in tissues with a high energy requirement, such as the heart. n CoQ10 levels are reduced by aging, illness and certain drug types, such as statins. n Deficiency of CoQ10 has been linked with a number of disorders, including cardiovascular disease. n Clinical studies have demonstrated that oral supplementation with CoQ10 can be of benefit in the prevention or treatment of a variety of cardiovascular and other disorders. n None of the clinical trial studies using CoQ10 have reported significant adverse effects.

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MenB - RIP The UK Department of Health has announced that it will work to introduce the meningococcal B (MenB) vaccine into the childhood vaccination programme – But to what impact? Officials made the announcement following independent advice from the Joint Committee on Vaccination and Immunisation (JCVI). The JCVI, the Government’s vaccine experts, says evidence shows that the Bexsero® vaccine is effective in preventing MenB in infants and should be rolled out, subject to it being made available by the manufacturer at a costeffective price. The Department of Health will start negotiations with Novartis, which produces the only licensed vaccine, as soon as possible. JCVI experts have recommended adding the vaccination to the primary childhood programme meaning that, if plans progress, infants will be immunised starting at two months of age. Deputy Chief Medical Officer Professor John Watson said: Infants under one year of age are most at risk of MenB and the number of cases peak at around five or six months of age. With early diagnosis and antibiotic treatment, most make a full recovery. But it is fatal in about one in ten cases and can lead to long-term health problems such as amputation, deafness, epilepsy and learning difficulties. “We will now be working closely with Novartis in the coming months and if negotiations are successful, we hope to work with the other

UK health departments to introduce a vaccine to prevent MenB as quickly as possible. This would make the UK the first country in the world to implement a nationwide vaccination programme.” Professor Andrew Pollard, chairman of the Joint Committee on Vaccination and Immunisation (JCVI) and Professor of Paediatric Infection and Immunity at the University of Oxford said: MenB disproportionately affects babies and young children and can be devastating. After very careful consideration, JCVI concluded that use of the new vaccine would reduce cases of meningococcal meningitis and septicaemia and lead to a reduction in deaths, limb amputations and brain injury caused by the disease. “The JCVI published its recommendation to the UK health departments that if the new vaccine can be purchased at a low price and is therefore cost effective for the NHS, it should be used in the routine immunisation programme for babies in the UK to prevent disease.” Christopher Head, Chief Executive of Meningitis Research Foundation said: “We are delighted that the JCVI have recommended vaccinating all babies against this most feared and deadly disease.

We will now be working closely with Novartis in the coming months and if negotiations are successful, we hope to work with the other UK health departments to introduce a vaccine to prevent MenB as quickly as possible. This would make the UK the first country in the world to implement a nationwide vaccination programme

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It’s a wonderful outcome which will save lives and spare countless families the trauma of seeing a loved one seriously disabled by the devastating after effects of MenB. We pay tribute to the people who have suffered from this illness, whose bitter experience has helped demonstrate the compelling case for prevention.” Meningitis Now, the UK’s largest meningitis charity, and its supporters welcomed the news after months of lobbying, and desperately hope negotiations will be swift. The charity’s latest figures suggest that 675 Meningitis B cases in the UK could have been prevented since the vaccine was licensed for use in January 2013. Meningitis Now founder Steve Dayman MBE, who launched the UK’s meningitis movement after losing his baby Spencer to Meningitis B in 1982, said: “This is the most monumental announcement in the fight against the disease in the 31 years I have campaigned to eradicate meningitis. “It is the decision we’ve pushed for, to have the Meningitis B vaccine given free to all infants. There is no doubt that it will save thousands of

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lives and spare survivors and their families the pain of living with life-changing after-effects.

Bexsero is the first Meningitis B vaccine and babies will need three doses.

“We thank our supporters for their determined campaigning and the JCVI for listening to our arguments on the true burden of this disease.”

It was created using a new process ‘reverse vaccinology’ and will cover up to 88 per cent of strains.

The UK has one of the highest Meningitis B incidence rates in the world – affecting an average of 1,870 people each year and kills in hours.

The EU licensed Bexsero for use in Europe in January 2013 and has been available to buy privately since December costing up to £600. A recent Meningitis Now and Mumsnet survey revealed two in three parents could not afford to immunise their child.

Anyone can get the strain, with one in 10 people affected dying and one in three survivors suffering life-long after-effects. It kills more children under five than any other infectious disease in the UK. Meningitis Now chief executive Sue Davie said: “We are thrilled the JCVI listened to our arguments, including the disease’s impact on the whole family, survivors’ quality of life and true burden of after-effects.

There are still several deadly forms of meningitis such as Group B Streptococcal, which do not have vaccines. Meningitis Now’s Beat it Now! campaign to bring in the vaccine saw a 36,500-name petition calling for the vaccine on the NHS, delivered to the Department of Health.

“While this is a fantastic leap forward, there is still much work to do because there still aren’t vaccines for all forms of meningitis. “We all must remain vigilant to the disease’s symptoms and those affected must get the support they need.”

It is the decision we’ve pushed for, to have the Meningitis B vaccine given free to all infants. There is no doubt that it will save thousands of lives and spare survivors and their families the pain of living with life-changing after-effects. Steve Dayman MBE Founder, Meningitis Now

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The Animal

Impasse Must anti aging drugs rely on animal testing? The use of animals in scientific research, including in the development of cosmetics and medicine, has long been a matter of contention.

According to the politicians, the key challenge is to balance the need of researchers with much public belief that the use of animals in research must reduce.

Researchers argue that the developments of products to tackle both the effects of ageing or treat a wide range of illnesses must rely on animals in the laboratory.

In the foreword to the latest Government guidance, published in Spring 2014, David Willetts MP, Minister for Universities and Science, Lord Taylor of Holbeach CBE Lords Minister and Minister for Criminal Information and the Rt Hon Earl Howe Minister for Quality in the Department of Health, say: “The Programme for Government commitment to work to reduce the use of animals in research brings together the UK’s long tradition of support for animal welfare alongside its strength in science and innovation.

Animal rights campaigners, on the other hand, contend that such practices are cruel and unnecessary. Now, the UK Government is stepping up its efforts to reduce the use of animals, replacing them with other methods wherever possible. Working through the Home Office Animals in Science Regulation Unit, the Department for Business, Innovation and Skills and Government Office for Science, Whitehall has issued guidance that aims to tighten up the use of animals. Additional input has come from other government departments including the Department of Health, and government agencies including Public Health England, the Medicines and the Healthcare Products Regulatory Agency. The National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) also made a major contribution as did the Government Chief Scientific Adviser and departmental Chief Scientific Advisers, as well as experts from academia, research councils and government advisory committees.

“This document provides more detail on how we will continue to deliver our commitment while maintaining and reinforcing our position at the forefront of global science and innovation. “In this plan, we bring together new and existing initiatives for promoting the widespread adoption of scientific and technological advances which present significant opportunities to replace animal use, to reduce the number of animals used and to refine the procedures involved so as to find additional ways to minimise suffering.

and others with relevant animal research and welfare interests. “The UK is seen as a leader, globally, in the adoption of the 3Rs. This gives us a real opportunity to accelerate the international uptake of scientifically valid alternatives in research and safety testing. This work is very challenging and often involves agreement at intergovernmental level. However, the reward is to effect reductions in the volume of animal experiments on a scale well above what can be achieved by domestic action alone. “It will also benefit the UK Life Sciences sector (a key component of the Government’s Industrial Strategy) by ensuring that strict application of UK regulations does not simply export experiments abroad. Similarly, harmonising standards internationally will ensure that UK companies with high welfare standards are not shut out of large developing economies which may currently demand additional animal testing not required by most states. “Transparency and openness about the use of animals in research, and why their continued use remains necessary, helps to improve our overall understanding about the issue, enables an informed public dialogue and can help to mitigate anxieties and misunderstandings.”

“Delivery of this plan is not simply a challenge for the Government and its agencies. If we are to be successful we need to enhance our partnerships with a wide range of stakeholders, including the research community in both academia and industry

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‘ANIMALS STILL A VITAL TOOL’

According to the report, the use of animals in scientific research remains a vital tool in improving our understanding of how biological systems work both in health and disease. Such use, it says, is crucial for the development of new medicines and medical technologies for both humans and animals. The report says that the National Health Service is one of the primary beneficiaries of research and testing that uses animals through the licensing of new medicines, the development of new and safe vaccines and for the detection and control of infectious diseases. For example, the development of monoclonal antibody therapies over the past 20 years has transformed our ability to treat diseases including breast and other cancers, rheumatoid arthritis and multiple sclerosis. The development of this technology would not have been possible without the use of animals. The report also says that the research supports the UK’s world-class research base in environmental, agricultural, medical and other life sciences, supporting highly skilled jobs with the life sciences sector contributing more than £50bn a year to the UK economy. It says the UK policy is that animal research and testing is carried out only where no practicable alternative exists, and under controls which keep suffering to a minimum. This is achieved through the 3Rs, the principles first advocated in the UK more than 50 years ago, which state: * In every research proposal, animals are replaced with non-animal alternatives wherever possible * That the number of animals used is reduced to the minimum needed to achieve the results sought * That, for those animals which must be used, procedures are refined as much as possible to minimise their suffering. The report states: “The scientific imperative for developing new approaches to research and development is very strong. Although the use of animals forms a major part of much scientific and medical research, success seen in animal studies has not always translated in the clinic. “Many potential drugs fail due to lack of efficacy in humans or concerns about their safety. Methods are needed to screen these failures out as early as possible and to select, with further research and development, those approaches most likely to succeed. ”Similarly, there are concerns about the utility of animal studies for testing environmental chemicals. For example, animals are invariably exposed to much higher doses than typical human exposures making interpretation difficult. A number of international science organisations have called for the development of mechanism-based assays that are more predictive of human biology. “Increasingly attention has focused on nonanimal technologies for solutions. These

include tissue engineering, stem cells, and mathematical modelling – areas in which the UK science base is at the forefront. “There is an opportunity to both minimise the use of animals and address major challenges faced by society, such as problems associated with ageing. By tapping into the UK’s strong science base it is possible to derive economic benefits from the development of new models and tools which replace, reduce or refine the use of animals in research.”

MAKING IT HAPPEN

The Delivery Plan sets out the Government’s strategic priorities in delivering the commitment by putting the 3Rs at the heart of a science-led programme: n advancing the use of the 3Rs within the UK n using international leadership to influence the uptake and adoption of 3Rs approaches globally and n promoting an understanding and awareness about the use of animals where no alternatives exist. According to the report: “We have set out our aim to make the UK the location of choice for pioneering research and development together with investment in the related manufacturing. “This Delivery Plan shows how implementing the 3Rs makes a real contribution to this strategy, realising significant benefits for humans, animals and the environment and sustained economic growth. “A consequence of the commitment in the Coalition Agreement to work to reduce the use of animals in scientific research has been, and will continue to be, to accelerate uptake of the 3Rs both domestically and internationally.

“This success is based upon the premise that the 3Rs provide opportunities for high standards of animal welfare alongside better science, faster science, and more cost-effective science.” Supporting the argument that sometimes animal use is unavoidable, the report says that issues such as microbial resistance, and an increasingly ageing world population present challenges which must be met even if that involves animals. It also says that improved research models will be required in dealing with the prevalence of conditions such as pandemic flu, drugresistant TB, dementia and the increased burden of obesity and related conditions such as diabetes, stroke and heart disease. Animal research will play a vital role in delivering these challenges, it says. The report adds: “As a consequence, the UK requires the use of a significant number of animals in scientific experiments or procedures each year. In 2012, more than million procedures were commenced, significantly lower than the volumes in the 1970s and early 1980s, but higher than the figures in the 1990s and 2000s.” The report also considers the use of genetically altered animals, saying: “As the research potential offered by genetically altered rodents and fish has increased, so the number used has risen significantly and this is reflected in total numbers between 1995 and the present. “However, the trend for many other species – for example dogs, cats and non-human primates – has generally declined over the same period since much work previously done in these species can now be done on species of perceived lower sentience such as mice or fish. “Scientists are required to use the species of the lowest perceived sentience which is

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appropriate to their research. However, this may lead to an increase in the overall numbers used. For example, neuroscience studies in a small number of non-human primates may be replaced by a genetically altered mouse model in which significantly greater numbers of animals need to be used. “Advances in genetics and understanding the genome are likely to lead to a continued increase in the use of genetically modified animals (mainly mice and fish) as scientists seek to better understand gene functions and interactions. This research will be essential to finding potential new targets for treating diseases such as dementia and type 2 diabetes. It will also underpin the development of stratified or personalised medicines.” There are also examples of replacing nonhuman primates with transgenic mice, which have been used to replace non-human primates in oral polio vaccine safety tests. Non-human primates possess virus receptors similar to those found in humans. However, mice have now been genetically modified to express human polio receptors. This mouse model has now been validated and formally adopted by the European Pharmacopoeia. The report says: “It is no simple task to either predict or contain the number of animals which will be used in future years. On the one hand global economic and scientific trends, with demands for even better medicines and environmental management, may lead to upward pressure. On the other hand implementing the 3Rs through new technologies which enable scientists to use better, faster and cheaper non-animal approaches will lead to downward pressure. “In this context, a key priority for the Government is to ensure that we continue to maintain our high standards through rigorous regulation of the use of animals in research, and we avoid exporting work overseas to countries where welfare standards may be lower.”

HOW ANIMAL USE IS BEING REDUCED

The UK plays a leading role globally in supporting the development and adoption of techniques to replace, and refine, the use of animals in research including: * The NC3Rs, the body which oversees implementation of the 3Rs, champions animal welfare and high standards in animal research. It has funded research to improve the assessment and alleviation of pain in laboratory animals, and to ensure that rats and mice are killed as humanely as possible at the end of studies * The NC3Rs supports the training and development of early career scientists so that the 3Rs are embedded in mindset and practices of the next generation of research leaders. This includes a PhD studentship scheme which is dedicated to the 3Rs and a scheme for early career post-doctoral scientists (the David Sainsbury fellowship) which supports the transition to independent researcher. To date the NC3Rs has funded 37 PhD studentships and six David Sainsbury fellowships

The report points to the significant impact of scientific progress, including; * Increasingly, scientists are using both nonanimal (in vitro) methods and animal-based (in vivo) methods in a sequential manner. This approach realises the benefits of the faster and more cost-effective progress which in vitro methods can often deliver whilst also addressing the complexity which only an appropriate whole animal in vivo model can offer. * Recent advances in genetic manipulation and generation of clinically relevant cell lines for drug testing and disease modelling have significantly impacted on the use of animals in research. * The Government has been providing funding to the NC3Rs since it was established in 2005 and the level of that funding has significantly increased since 2010 based upon their record of success. The Government’s research funding bodies (e.g. the Medical Research Council) have funded major initiatives, often in partnership with charities such as the Wellcome Trust, to ensure the UK gives leadership in data sharing to avoid duplication occurring and to help improve understanding about the pathways and causes of disease * A number of government departments and agencies have, in recent years, worked collaboratively to develop and validate new technologies which can replace animal use in safety testing and help reduce risks to the public, the environment, pets and farm animals. Examples include progress in the field of induced pluripotent stem cell (iPSC) biology has led to the generation of patient matched cell lines for use in diagnosis, treatment and study of disease in vitro. For example, iPSC lines have been generated from patients suffering from congenital liver disease. They have then been genetically manipulated to correct the mutation and effectively cure the disease in the cells

There is a move to facilitate resource and data sharing and collaboration across industry and academia and to ensure that the 3Rs are at the heart of all relevant science including the training of research leaders of the future. The report concludes; “Whilst significant efforts are being made by government, academia, industry, research funders and animal welfare bodies to advance the 3Rs, there are also challenges to making rapid progress. “Many of these relate to the need for as yet undiscovered technologies, but others may relate to conservatism and a risk- averse approach to adopting change. In developing this Delivery Plan, we have confronted these challenges head on to set out ways to address them. We take the opportunity to set out how research involving animals can also bring benefits for all of us and we aim to improve understanding of why this is the case. “A challenge for academia is conservatism on the part of journal editors and peer-review panels to accept publications based on nonanimal techniques in lieu of the ‘traditional’ animal models. “Everyone has a part to play. Government can provide support and leadership to help to minimise the use of animals in research and help to make the case for why animals need to be used when no alternative exists. We can therefore improve public understanding of why we need to use those animals.”

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No time to

breathe easy the battle against asthma intensifies

Asthma is one of those conditions that can strike the very young and stay with them as they head into old age, often developing over many years into the more serious illness Chronic Obstructive Pulmonary Disease (COPD). Incurable at the moment, asthma is the ultimate example of an illness that sufferers must learn to live with, relying heavily on drug regimes, with the ageing process presenting distinctive challenges often caused by prolonged exposure to asthma which permanently narrows the airwaves. For many people, however, the story starts long before middle and old age and charity Asthma UK is among those organisations concerned that not enough is being done to help young asthma sufferers. It is concerned that hospital admissions for children across England have increased by 15 per cent, according to data released from

the Child and Maternal (CHiMat) Health Intelligence Network. The organisation says that this is of particular concern given that reducing child hospitalisation rates is one of the priorities set by the Government. Kay Boycott, Chief Executive of Asthma UK, said: “It is extremely worrying that the number of children being admitted to hospital because of asthma has risen. “These figures make it abundantly clear that we urgently need to see renewed commitment to improve basic asthma care across the NHS. We desperately need a full and systematic NHS asthma audit to pinpoint specific improvements that need to be made to stop

children with asthma ending up in hospital.” About 200 people of all ages are hospitalised in the UK because of their asthma every day and three will die and, against that backdrop, much of the research being conducted into the illness focuses on prevention rather than cure.

PREVENTION A BIG FOCUS FOR RESEARCHERS

For example, scientists at the University of Edinburgh, led by Senior Asthma UK Research Fellow Dr Henry McSorley, have discovered that parasites could protect against asthma, potentially leading to new treatments.

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IT’S A DOG’S LIFE AS RESEARCH RAISES INTRIGUING POSSIBILITIES

Across the Pond, similar work carried out in America has suggested that exposure to dust (a major trigger of asthma attacks) from homes with dogs may alter the immune response to allergens and other asthma triggers by affecting the composition of the gut microbiome—the community of microbes that naturally colonize the digestive tract. The findings help demonstrate how environmental exposures may protect against airway allergens and asthma, according to the team. The study, led by researchers at the University of California, San Francisco, the University of Michigan, Henry Ford Health System in Detroit and Georgia Regents University in Augusta, was supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Previously, the researchers found that infants who live in homes with dogs are less likely to develop childhood allergies. They then showed that dust collected from homes with dogs contains a wider range of bacteria types than dust gathered from homes without pets. In the current study, they show that dogassociated house dust can play a key role in preventing allergic inflammation. Feeding young mice dust from a home with a dog protected the animals against airway inflammation triggered by cockroach allergen. Compared to mice fed dust from a pet-free home or those not exposed to dust, mice exposed to dog-associated dust had fewer of the cells and immune-modulating chemicals involved in allergic responses. The researchers obtained similar results when they exposed dust-fed mice to a different allergen. In addition, the investigators found that exposing mice to dog-associated dust altered the composition of the mouse gut micro biome. Dr McSorley and his colleagues found that in a mouse model of asthma, secretions of a parasitic worm called H. polygyrus can suppress the release of a chemical called interleukin 33 (IL-33), resulting in a smaller immune response to allergens and less damage to the lungs. IL-33 is an important chemical in asthma. Belonging to a family of messengers called cytokines, IL-33 is rapidly released in response to allergens or damage in the lungs and ‘raises the alarm’ in the immune system. High levels of IL-33 have also been found in the lungs of people with severe and steroid-resistant asthma, potentially making it an important target for asthma therapy. Dr McSorley said: “In populations where parasitic worm infection is common, the rate of asthma is low; in contrast, in the developed world over the last 100 years, parasitic infection has become rare, and over the same time asthma has become far more common.

parasitic infections protect against asthma, and in their absence, we are predisposed to it.This is the first example of a secretion that can suppress this pathway in asthma and we hope to further dissect the molecules and mechanisms involved in this suppression, with the aim of identifying new medicines that will help people with the condition.” Dr Samantha Walker, Deputy Chief Executive of Asthma UK, who funded the study, said; “Previous studies have looked at infecting asthma patients with parasites such as hookworms to test whether this might ease their symptoms. If we can find a way of isolating the product that leads to this protective effect and use this to develop new medicines – in a similar way that salicylic acid was isolated from willow bark to use as aspirin – this would be far better. This is a major achievement for Dr McSorley and we look forward to seeing how his research progresses.”

The animals’ lower intestines contained high levels of the bacterium Lactobacillus johnsonii. Feeding mice live L. johnsonii reduced inflammation triggered by cockroach allergen or infection with respiratory syncytial virus, two risk factors for childhood asthma. These results, say the team, suggest potential new strategies to prevent and treat certain allergic diseases and lung infections.

COPD - WHY IT’S GOOD TO TALK

Also concerning health professionals is the prevalence of COPD, which can afflict longterm asthma sufferers. COPD, which in 2010 surpassed stroke to become the third leading cause of death in the United States, is a serious lung disease which over time makes it harder to breathe. It most often occurs in people age 40 and older with a history of smoking but as many as one in six people with COPD have never smoked. COPD also can occur in people with a genetic

“This has led researchers to propose that

CONTINUED ON PAGE 61

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BIOSCIENCE JOURNAL JULY 2014

FEATURE z

condition known as alpha-1 antitrypsin deficiency or through long-term exposure to substances that can irritate the lungs, such as dust or fumes.

A good conversation between patients and providers about COPD can make a real difference for disease sufferers.

The illness is diagnosed with a simple test called spirometry, which can be conducted in a doctor’s office. The test involves breathing out as hard and fast as possible into a tube connected to a machine that measures lung function. It affects an estimated 24 million Americans but as many as half of those affected remain undiagnosed and researchers who conducted a recent survey believe that is down to lack of willingness among sufferers to discuss their condition. The researchers who conducted the web-based survey released by the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health found that a reluctance among patients to talk about COPD was a major barrier to diagnosis of the disease. They believe that this is partly because symptoms of the disease – such as shortness of breath, chronic coughing or wheezing, production of excess sputum, or a feeling of being unable to take a deep breath – come on slowly and worsen over time, leaving many to dismiss their symptoms and delay seeking diagnosis and treatment until the disease is advanced.

James Kiley, Ph.D., director of the NHLBI Division of Lung Diseases, said: “A good conversation between patients and providers about COPD can make a real difference for disease sufferers. It’s no secret that early diagnosis and treatment can improve daily living for those who have COPD but you can’t get there without an open line of dialogue in the exam room. “That’s why patients and providers need to be aware of COPD, its risk factors and symptoms, how it affects daily life and what can be done to help get them back to doing the things they love.” The survey did, however, find a dramatic increase in the numbers of current smokers, a key COPD risk group, who had discussed their symptoms with their doctors - from 42 per cent in 2009 to 67 per cent in 2013. Overall, 26 percent of adults who reported experiencing these symptoms stated they had not discussed these symptoms with their doctor or health care provider. Researchers say that physicians also missed opportunities; 82 percent of current smokers who reported symptoms had a conversation with their doctor about their smoking history, but only 37 per cent of former smokers, who are also at risk, reported a similar conversation. According to the survey, COPD awareness issues contribute to the problem; three of the top reasons cited by people with COPD CONTINUED ON PAGE 62

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UK ASTHMA FACTFILE

n Asthma is the most common longterm condition affecting all age groups. What was once thought to be a uniform disease triggered by one type of immune cell now appears to be a much more complex condition. n In the UK, 5.4 million people are currently receiving treatment for asthma: 1.1 million children (1 in 11) and 4.3 million adults (1 in 12). n The UK still has some of the highest asthma prevalence rates in Europe and on average three people a day die from asthma. n There were 1,242 deaths from asthma in the UK in 2011 (18 of these were children aged 14 and under). n An estimated 75% of hospital admissions for asthma are avoidable and the majority of deaths from asthma are preventable. n The NHS spends more than £1 billion a year treating and caring for people with asthma. n In 2008/09 up to 1.1 million working days were lost due to breathing or lung problems.

THE COSTS OF ASTHMA

n The NHS spends more than £1 billion a year treating and caring for people with asthma. n In 2008/09 up to 1.1 million working days were lost due to breathing or lung problems. Source: Asthma UK

symptoms who did not talk to a doctor were ‘I did not think of it‘, ’I’ve had these problems for years‘ and ‘these problems will just go way in time.’ Only 18 per cent of symptomatic people who discussed their symptoms heard their provider mention COPD.

There are hopeful signs, though. Recently, the U.S. Food and Drug Administration approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, longterm maintenance treatment of airflow obstruction in patients with COPD.

affects the muscles around the large airways and stops the muscles from tightening, and vilanterol, a long-acting beta2-adrenergic agonist (LABA) that improves breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs.

James Kiley said: “Regardless of positive developments, the challenge remains that more than one in three Americans do not know what COPD is or how it affects them – and less than half understand that COPD can be treated.

Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said: “Anoro Ellipta works by helping the muscles around the airways of the lungs stay relaxed to increase airflow in patients with COPD. The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”

The safety and efficacy of Anoro Ellipta were evaluated in more than 2,400 patients with a diagnosis of COPD. Those treated showed improved lung function compared to placebo. However, the FDA approved Anoro Ellipta with a patient medication guide that includes information about potentially serious side effects in some cases.

“COPD is the only major chronic disease where deaths are not decreasing. It is critical for people to understand whether they may be at risk and recognise their symptoms as early as possible.”

Anoro Ellipta is a combination of umeclidinium, an inhaled anticholinergic that

Anoro Ellipta is manufactured by GlaxoSmithKline, Research Triangle Park, N.C.

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