Lifescience Industry Magazine

Issue 15 2018

DISCOVERING HEALTH TECHNOLOGY

Getting on board the NHS

NHS GREAT BRITAIN

How SMEs can get their products through the complex NHS approval system

Future Watch

Clinical Need

Going Global

People & Places

Regulatory

New technology and innovations

Meeting unmet clinical needs

Cracking international markets

Influential people and places in the industry

Updates and expert 1 advice

30 YEARS OF TURNING MEDICAL AND SCIENTIFIC IDEAS INTO COMMERCIAL REALITY

By combining science with practical design we help turn brilliant ideas into commercial reality.

Over the past thirty years we have taken an innovative

MEDICAL DEVICE PRODUCT DESIGN & VA L U E E N G I N E E R I N G

approach to medical and pharmaceutical product design and value engineering. We understand how to harness life science and biotechnology in order to develop practical, commercial products.

www.g xg ro u p.co m +44(0)1291 673437 PRODUCT DESIGN

VA L U E E N G I N E E R I N G

Patients to become their own anaesthetists

Getting on board the NHS

How SMEs can get t heir products through the complex NHS approval system

Interactive textiles to support independent living

18

NHS GREAT BRITAIN

4-5

8

Developing eye drops to treat a common sight loss condition

Welcome to the new Lifescience Industry, launched at MEDICA 2018

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Lifescience Industry is now online – visit www.lifescienceindustrynews.com for the latest news

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A message from the editor

Future Watch (pages 6-11) highlights new innovations – from digital health technology for COPD and a training programme for online mental health support, to natural pesticide alternatives and textile interfaces for assisted living.

egular readers will notice that Lifescience Industry has a new, refreshed look to reflect a wider range of regional and national network organisations across the UK. The print publication is now also supported by a brand new website.

Clinical Need (pages 14-19) features technologies with the potential to meet unmet needs, including a novel inhaler device and an innovative biopsy triaging system. Scientists are also developing an eye drop to treat age-related macular degeneration, as well as technology that would allow patients to control their own sedation during operations.

This edition begins by exploring how SMEs can access the NHS (pages 4-5), taking inspiration from a guide recently produced

by SEHTA.

Future Watch 6 Finding natural alternatives to traditional insecticides

7 Creating new digital health technology for COPD

8 Interactive textiles to support independent living

9 Home monitoring service launched

10 How to safeguard your

medtech in a competitive industry

11 Fresh thinking vital for mental health

Clinical Need

Going Global (pages 20-27) then looks at international collaborations, such as a unique partnership between the Midlands and Ohio, and a UK trade mission to Japan. In the People and Places section (pages 28-31), the spotlight is on a growing cluster of medical and healthcare excellence in Birmingham.

Finally, the Regulatory section (page 32) has expert advice from ABHI on the new Medical Device Regulation.

Going Global

14 Developing eye drops to treat a common sight loss condition

15 Final patient enrolled in MCG study

16 Biopsy triaging system for quicker results

17 Innovative inhaler for asthma sufferers

People & Places

20 ABHI expands US Innovation Hub

2012 ISSUE 4

Issue 5

28 BioHub Birmingham develops new

incubator space to meet increasing demand for biomedical facilities

22 BioPartner Delegations

Showcasing UK Life Science

23 British invention lands insit amet, Lorem ipsum dolor

Rehacare 2018adipisicing elit, sed do consectetur eiusmod tempor incididunt ut 24 Midlands Ohio collaboration labore etand dolore magna aliqua. Ut enim ad ullamcoin 24 Medilink add new exhibitions toeu

29 Cryo-Electron Microscopy Facility launched

30 Edgbaston Medical Quarter

– a community of healthcare excellence

international calendar

Jess Fisher Editor

18 Patients to become their own anaesthetists

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26 UK life sciences experts lead trade mission to Japan

19 Healthcare company wins

prestigious Queen’s Award

Sophie Davies Editor

Regulatory 32 The new MDR explained

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34 Lifescience Industry Event Calendar 2018-19

Published by Teamworks. www.teamworksdesign.com

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DISCOVERING HEALTH TECHNOLOGY

Designed by Teamworks Design & Marketing The viewsTel:expressed in this publication do not necessarily represent 029 2047 3456 Web: www.mediwales.com Contact: the opinions of individual partners unless explicitly stated.

Editor: Jess Fisher © Teamworks. 2018 jess@uklifescienceindustry.com

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Getting on board the NHS: Given its size and the opportunity to win longstanding valuable contracts, the ambition of many health technology SMEs is to sell to the NHS, but many find this difficult to achieve.

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hile operating under a single brand, the UK’s health and care systems have never been more complex. Each of the four devolved nations have independent health services, all of which have gone through incremental organisational changes since the creation of the NHS in 1948.

Innovators must understand and respond to this complexity with a value proposition that aligns the benefits and costs of their innovations for each stakeholder.

NHS treatments are based on evidence, so for a company to sell something to the NHS, there needs to be sufficient clinical evidence that it works. Increasingly in times of austerity, there also needs to be evidence that it is more costeffective than existing treatments.

In partnership with Hempsons, the South East Health Technologies Alliance (SEHTA) has produced a guide for SMEs, which provides advice on how to access the NHS in England and discusses a number of priorities to consider.

Funding your innovation Developing a new product to the stage where it will be purchased by the NHS can be a long and expensive process. The guide lists a number of important questions that the SME must ask.

l What do you want to do?

Funders of healthcare research include:

l How flexible are you?

l How long will it take? l How much resource will it take? l Who do you need to help you? l Technology Readiness Level

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Issue 15

Funders of healthcare research include: Research Councils UK, NIHR, InnovateUK, SBRI, UK Crowdfunding, Business Angels, Venture Capital, and the UK’s devolved governments.

Protecting your innovation SMEs should carry out an audit of their innovation early on to establish if there is any intellectual property (IP) that needs to be protected. Considerations will involve: n Identifying any IP and the type of IP, which may include potentially patentable inventions, new designs, databases, distinctive branding and copyright works. n Assessing the IP’s value, including defining features and the things that make the innovation more attractive or commercially viable than those of competitors. n Taking appropriate steps to protect the IP in the main geographical markets of interest, using specialist advisers to help with this. n Protecting the confidentiality of information early on, by putting in place non-disclosure agreements to safeguard innovative ideas and trade secrets. n Considering whether any third-party software or system is required to develop or commercialise the product. If so, what are the terms on which it is supplied?

Regulatory frameworks Alongside your IP strategy, a clear regulatory strategy is crucial. Contracts and leases may be renegotiated, but a failure to protect your innovation or obtain the necessary regulatory approvals from the outset can be catastrophic.

Key regulators include: n The Care Quality Commission (CQC) which is responsible for the regulation of all health and adult social care in England, both in the NHS and in the private sector. n The Medicines and Healthcare Products Regulatory Agency (MHRA) for the regulation of medicines, medical devices and blood components for transfusion in the UK. n The National Institute for Health and Care Excellence (NICE) which, although not strictly speaking a regulatory body, was established in primary legislation and is accountable to the Department of Health for the performance of its functions which have a quasi- regulatory quality. n The Human Tissue Authority (HTA) for the regulation and licensing of human tissues and cells in the UK (though Scotland has its own legislation governing certain matters). n The Human Fertilisation and Embryology Authority (HFEA) which is similar to the HTA but responsible for reproductive tissues and cells.

Any company that processes personal data must also comply with UK data protection legislation, such as GDPR which was introduced in 2018.

A guide for SMEs insight. Armed with this intelligence, you will be able to answer questions such as: What are the core functions that my product needs to offer to be an attractive business proposition for a healthcare buyer? Are there any obvious barriers to the cost savings that my idea could

Health economics No matter what level of maturity your technology is at, be it simply an idea or a commercially available product, a health economics assessment can provide valuable

For the full guide, which goes into more detail in each of these areas and more, please contact: Clare Ansett info@sehta.co.uk

Further procurement information

generate being realised in the real world? Is it possible for me to build a sustainable business on the margins between cost to produce an appealing product and possible revenue from that same product, given its cost-saving potential?

Innovation and research collaboration There are also organisations that support access to clinical expertise, facilitating the creation of collaborative research and development projects.

These include: The AHSN Network - www.ahsnnetwork.com National Institute for Health Research (NIHR) - www.nihr.ac.uk

England - www.supplychain.nhs.uk Scotland - www.nhsscotlandprocurement.scot.nhs.uk

Health and Care Research Wales - www.healthandcareresearch.gov.wales

Wales - www.nwssp.wales.nhs.uk/supply-chain

NHS Research Scotland - www.nhsresearchscotland.org.uk

Northern Ireland - www.online.hscni.net

HSC R&D Division Northern Ireland - www.research.hscni.net

NHS GREAT BRITAIN UK Health expenditure

Total Spend

£5bn

£7.3bn

£13.2bn

£122bn

Northern Ireland

Wales

Scotland

England

£147.6bn

£10.6bn

UK expenditure on medical technology

Out of total UK health expenditure £10.6bn is spent on medical technology

For daily lifescience news visit www.lifescienceindustrynews.com 5

Future watch

Finding natural alternatives to traditional insecticides Welsh biopesticide business Bionema is developing natural products to protect crops from insect damage, reducing the use of synthetic pesticides, enhancing food security and increasing crop yields.

I

t is estimated that crop pests cause more than $50 billion damage worldwide annually. Traditional chemical insecticides are environmentally damaging and can impact human health. They are increasingly subject to withdrawal on regulatory

grounds. The European Union has announced that it will ban the world’s most widely used insecticides from all fields due to the serious danger they pose to bees. Moreover, many insects are becoming resistant to these traditional insecticides. The market needs to find environmentally acceptable, safe, cost-effective solutions for tackling crop pests.

Tests on strawberry plants saw the elimination of vine weevils over a two-year programme.

A golf course in the east of England saw 80 per cent removal of its chafer grub problem in the first year with further success in year two.

The same chafer grub caused Epsom racecourse to cancel a meeting in September this year.

Bionema Ltd, a spin-out from Swansea University, is one of a number of companies that are looking at biological alternatives.

With support from Swansea University and the Development Bank of Wales, Bionema has successfully developed and brought to market a range of nematode-based products for both the professional and domestic markets, aimed at tackling some of the UK’s most damaging pests.

“At Bionema we bring together strong scientific research with the power of the natural world to develop solutions which not only show higher efficacy than other products on the market, but also protect the environment and don’t pass on any residues into the crops they protect.”

Dr Minshad Ansari Founder of Bionema

ADAS has calculated the economic cost of chafer grubs alone at up to £85 million a year for golf courses in the UK, from lost income and damage repair. The report also highlighted that on the 40 per cent of racecourses affected by the pest’s damage, lost income could amount to up to £605,000 per course.

In addition to chafer grubs and vine weevils, the current range of products tackles western flower thrips, leatherjackets, sciarid larvae and fungus gnat.

Bionema has also been awarded an Innovate UK grant to develop a fungi based solution that will revolutionise the market, both in terms of efficacy and distribution method. The company is shortly due to launch a funding round to complete the development and registration of these novel formulations.

www.bionema.co.uk

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Future watch

Creating new digital health technology for COPD Ian Bond, Founder and Chairman of Bond Digital Health, tells us about developments at the Cardiff-based company over the past year.

W

e knew 2018 was going to be a significant year in the growth of Bond Digital Health, but we didn’t realise how significant. So far, we have signed several commercial agreements with major clients, received three separate injections of funding totalling more than a quarter of a million pounds and taken on two new employees.

In terms of funding, our largest injection of money was a £200,000 private equity investment, which we used to support business growth. We were also awarded almost £70,000 in funding from Innovate UK to help us develop a revolutionary new wearable technology product that will help patients with chronic obstructive pulmonary disorder (COPD), as well as £7,500 from the Bevan Commission to help develop an electronic diary app that will help COPD patients self-manage their condition.

Bond was founded out of my personal struggle with COPD and my ambition to help fellow sufferers monitor their condition while providing more useful information to health practitioners.

Our new wearable tech product, which we describe as a ‘digital stethoscope’, is the ultimate realisation of this ambition and has the potential to transform the doctor-patient relationship.

To have financial backing from Innovate UK, whose assessors described the proposal as an

An estimated 1.2 million people in the UK are living with diagnosed COPD, with the condition accenting for one in 20 deaths. It costs the NHS an estimated £1.9 billion a year, with billions more in indirect costs to the wider economy.

“interesting and innovative concept”, is a major vote of confidence.

We are also proud to be spearheading an international collaborative project between universities and businesses that is working to develop a more accurate test for bovine tuberculosis. Our vision is to develop a new, cost-effective, accurate and rapid point of care test to enable the detection, management and control of BTB, directly supporting the Welsh and UK governments’ ambitions to eradicate the disease completely.

We are confident that our new hires will help take Bond to the next level. Edryd Sharp is our new head of product design, responsible for providing strategic direction across all elements of the creative development process.

A Cardiff Metropolitan University graduate, he joins us with more than 15 years’ experience of working in digital. Phil Cooley is our new quality assurance manager, responsible for planning and implementing a quality management system. A science graduate from Cardiff University, Phil has more than 11 years’ experience of quality control and analysis in the healthcare sector.

We have spent a lot of time this year showcasing our products and services to new customers and partners both in the UK and internationally. In May we were invited to attend the Lateral Flow Test Workshop in Zaragoza, Spain, to promote our software platform and app developments to an audience of international delegates working in the fields of lateral flow and rapid diagnostic testing. The event was a huge success, allowing us to make contacts and connections that will prove invaluable as we seek to grow our business in this competitive market.

In October we attended the Advanced Lateral Flow Course in San Diego, California, where we were again able to demonstrate to the market what Bond has to offer.

While 2018 has exceeded our expectations, we are confident 2019 will be an even bigger year for Bond Digital Health, so watch this space. www.bondhealth.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 7

Future watch

Interactive textiles to support independent living Bonnie Binary is exploring the use of e-textiles and interactive interfaces that make it easier for people to operate technology.

The challenge Not everyone is comfortable using technology. For example, many people have problems navigating multiple remotes.

Bonnie Binary’s tactile, easy-to use textile interfaces make technology more accessible for those who struggle with it. The company approached the Health Tech Hub with a proof-of-concept, but with questions regarding the best method to perform product testing. They specifically required a cost-effective, robust system to functionally test prototype e-textile resistive sensors, which are an integral part of their textile products for assisted living.

Helping to achieve solutions The Health Tech Hub assisted Bonnie Binary by: u Scoping the development work required to meet the objectives. u Researching application-specific hand force ranges to understand how this applies to Bonnie Binary’s products. u Designing and providing a test platform, including a computer interface read-out of key sensor parameters. u Advising on appropriate product quality control tests and helping to plan for future product development.

Next steps With the support of the Health Tech Hub, Bonnie Binary now has a prototype system which has been thoroughly tested. With this, the company will launch a kick-starter campaign to take their first product to market. They are reaching out to industrial manufacturers to develop new collaborations. The market will include people with early stage dementia and elderly patients, who would benefit from a simple, tactile interface.

“The Health Tech Hub helped me narrow down the tests which I should be doing in order to develop a reliable product by providing a test-bed. The test-bed enables me to choose the right materials and improve the viability of my product. The Hub helped me think in practical terms, R&D challenges and what sort of test requirements I should be looking for. I would recommend the Health Tech Hub and I would love to come back and work with the team at the next stages of product development.”

Annie Lywood Founder of Bonnie Binary

www.bonniebinary.co.uk

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www.healthtechhub.co.uk

Future watch

Home monitoring service launched Inhealthcare has collaborated with a community healthcare organisation to launch a home monitoring service for heart failure and COPD patients across Hull.

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edilink North of England member Inhealthcare, a health technology firm based in Harrogate, has partnered with community healthcare organisation City Health Care Partnership to launch a home monitoring service for long term conditions.

The service enables patients to regulate their symptoms, temperature and weight measurements from home, specifically

helping people with chronic obstructive pulmonary disease (COPD) and heart failure.

The service allows patients to record medical information, such as their temperature and blood pressure, which is then sent to clinicians via a smartphone app, an online portal or automated telephone call.

Healthcare professionals can access patient information, assess their measurements and promptly communicate any necessary action if required.

The telehealth platform was successfully launched in March, with over 100 patients with heart failure or COPD using the service to manage their conditions.

“Digital services offer much-needed support to the NHS by reducing the requirement for unnecessary visits to hospitals and GPs.�

Bryn Sage CEO of Inhealthcare

www.inhealthcare.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 9

Future watch

How to safeguard your medtech in a competitive industry Wynne Jones IP provides some top tips for protecting your new medtech innovations.

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edical technology is one of the fastest growing, and most competitive, industries in the world. With a thriving ecosystem of over 3,700 companies, 115,000 skilled workers, and a turnover of over £21 billion, the UK’s medical device market is now the third largest in Europe.

However, with innovation comes inevitable competitiveness, with the country’s top scientific minds battling to produce the latest life-changing technology. So, in a sector both dependant on, and limited by, vast innovation, how can inventors continue to create cuttingedge technology?

Jim Robertson, patent attorney and partner at leading intellectual property firm Wynne Jones IP, said: “Due to the highly competitive nature of medtech, those in the field are not only tasked with protecting their own idea against competitors, but also ensuring they have the freedom to use and develop their technology. With this in mind, the importance of intellectual property cannot be overstated, and we’d urge any potential inventors to act swiftly to protect their idea from the start.”

Here, Mr Robertson offers five expert ideas to protect medical technology and safeguard its innovation …

An effective IP strategy An IP strategy is absolutely vital to the continued development of medical technology. Implementing this from the start allows companies to identify their strengths and weaknesses, opportunities and threats, and how the IP they possess can be maximised, to ensure full protection.

The partner at Wynne Jones IP said: “Having an effective plan in place from the beginning lets

you protect your technology, and reduces the likelihood of infringing existing patents. It can also help to define the IP rights in commercial agreements with third party researchers, and could even attract further investment.”

commercially sensitive information through a patent application. In these instances, trade secret protection can help. In order for a trade secret to be effective, confidentiality must be observed by all associated parties.

Crowdfunding

Mr Robertson explained: “Those using trade secrets protection must take all precautionary steps to prevent their idea from being disclosed. This may include monitoring where information is stored, using secured passwords, and including confidentiality clauses in contracts with third parties and employees.”

With the development of medical technology requiring extensive investment, many startups may be left exploring alternative funding sources. Crowdfunding has grown in popularity thanks to its ability to pitch to an unlimited online audience of potential investors.

However, Mr Robertson warns companies to be cautious when disclosing ideas via this platform: “Disclosing ideas via crowdfunding could leave you vulnerable if they are not first protected by IP. Those seeking to raise funding should consult with an IP attorney before publicising their idea, to ensure they are afforded full intellectual property protection.”

Exclusions from patentability The law on patentability of medtech such as medical devices and diagnostics is complex and varies enormously around the world. For example, methods of diagnosis are patentable in some countries but not in others. With vast sums of money invested in the medical technology sector, it is essential that inventions are fully protected.

Patent landscaping With numerous parties vying to create the latest medicinal innovations, it is essential that inventors thoroughly research the existing patent landscape.

This can help identify risks, for example, other people who are working on closely related technology, and opportunities, such as limitations in other people’s technologies which you have overcome.

This can help prevent infringement of other people’s patents, and identify commercial opportunities.

“Exclusions can be a highly complex and confusing area for anyone seeking patent protection. To clarify this and obtain the best protection for an invention, it is crucial that inventors contact an IP attorney, who can advise them on strategy and how to protect the IP they actually possess.”

Trade secrets

Jim Robertson Wynne Jones IP

With the value of medical devices rooted in their distinguishing functions or technologies, many inventors are reluctant to disclose this www.wynne-jones.com

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Future watch

Fresh thinking vital for mental health Gerry Johnson, Online Director of XenZone, explains how a new training programme could equip young people to offer mental health support online.

Mental health is, quite rightly, in the spotlight: growing unmet demand for support should worry us all. But in addition to meeting this demand, we must also be able to meet need. And we believe, as well as helping everyone experiencing adverse mental health, we should offer preventative support as early as we can.

Early need can be met through the provision of psycho-educational material and self-help resources. A young person may want to use a goal-setting or mood-tracking tool to help them better understand and navigate their way through feelings of anxiety or depression.

Or it may be that they need counselling with a professional therapist who can offer them a variety of approaches: from talking and music, to drama or art-based therapy.

Friendship groups There are many other important components of a therapeutic environment. One is a young person’s friendship group. We know that young people are often more influenced by their friends than by their family. This is why we consider peer support to be a critical area for development.

We see increasing numbers of children and young people regularly taking part in online forums, sharing their stories and offering advice so we know that they are benefitting from peer support.

With this in mind, we recently bid for and won funding to train a new cohort of young online peer supporters through a specially developed multi-media learning portal.

The innovative project is supported

by SBRI Healthcare, an NHS England initiative, led by the Academic Health Science Networks (AHSNs), and aims to reduce the pressure on specialist services and address the stigma associated with mental health by

The new training programme will consist of four main elements, covering volunteering and participation, health and wellbeing, personal skills development and helping others. Young people will be fully supported throughout, and we’ll be talking to them and carefully monitoring the impact on their own wellbeing throughout.

helping young people offer supervised online support to peers.

We are now shaping a training and assessment programme, which will see a new cohort of young peer supporters primed and ready to offer their support to others online.

“Gamifying” We are also working hard on ways to deliver the training in a fresh and engaging way. Our aim is for the peer supporters to feel knowledgeable and supported, while closely involved with the programme. Each will choose an avatar when completing their online training, with virtual awards being given at various stages of the course. We are also ‘gamifying’ aspects of the training to appeal directly to the young people undertaking the process.

In thinking about early intervention and prevention and about a therapeutic environment for children and young people, it’s vital that we apply innovative new thinking and continue to talk to young people about what their experiences are, drawing out from them what they want from mental health support services.

The peer supporters project is seeing us work closely with around 20 young people who are co-producing the programme with us. Giving them direct influence over a new aspect of support is an incredibly positive step towards effective early help for mental health.

It is certainly not ‘the answer’, but it is a powerful element in a therapeutic environment and is grounds for continuing to focus on finding as many ways as we can to help those in need. www.xenzone.com

For daily lifescience news visit www.lifescienceindustrynews.com 11

DISCOVERING HEALTH TECHNOLOGY

Now taking ight online ...

Discover the latest life science news online from the only magazine dedicated to the life science sector.

With contributions from leading membership and support organisations working with life science businesses, academia and healthcare providers from across the UK and beyond.

www.lifescienceindustrynews.com For editorial and advertising opportunities:

+44 (0)29 20473456

info@lifescienceindustrynews.com

Written by PROMOTIONAL the sector, for the sector OPPORTUNITIES WITH LIFESCIENCE INDUSTRY www.lifescienceindustrynews.com

DECEMBER 4th 2018 CARDIFF PARK PLAZA Future watch

CONFERENCE 2018

Embrace the best of the UK’s life science sector

Join delegates to network, meet collaborative partners and build business development opportunities. Listen to a programme of valuable sector updates and gain insights and intelligence across the life science and healthcare sectors.

▲

Update on regulatory developments

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Future watch – Innovation & university showcases

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NHS market access and innovation adoption

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Support for export and international trade

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Launch of new LifeScience Industry online & print magazine

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th

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YEAR

EN

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LifeScience Academy and the skills agenda

UK

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H

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Sources of finance and funding

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UK HealthTech brings together key speakers to discuss the major strategic issues and policy developments facing the life science and health technology sector.

E TH Y

visit www.ukhealthtech.com or contact katherine.maxwell@mediwales.com +44 (0)29 2047 3456

Clinical Need

Developing eye drops to treat a common sight loss condition Scientists at the University of Birmingham are one step closer to developing an eye drop that could revolutionise treatment for age-related macular degeneration (AMD).

Macular Degeneration

Normal

A

MD is the leading cause of blindness in the developed world. Its prevalence is increasing dramatically as the population ages and it is estimated that, by 2020, there will be about 200 million people worldwide with the condition. In the UK alone, there are over 500,000 people with late stage AMD. AMD is currently treated by injections of sight-saving drugs into the eye which must be administered by medical professionals.

Scientists led by biochemist Dr Felicity de Cogan, from the University of Birmingham’s Institute of Microbiology and Infection, have invented a method of delivering these otherwise-injected drugs as eye drops.

Laboratory research showed that these eye drops have a similar therapeutic effect as the injected drug in rats. Now the Birmingham scientists have taken their research one step further by investigating the effect of the eye drops in the larger eyes of rabbits and pigs, which are more similar to human eyes. This latest study demonstrates that the eye drops can deliver a therapeutically effective amount of the drugs to the retina of the larger mammalian eye.

“Cell-penetrating peptides will drive the next generation of treatment for people with AMD. They will be transformative for patients who currently have to organise their lives around monthly clinic visits for uncomfortable intraocular injections.

In the future they will have the convenience of self-administering their medical treatment.”

Professor Robert Scott Consultant Ophthalmologist and Honorary Professor of Ophthalmology at University of Birmingham

The technology behind the eye drops is a cell-penetrating peptide that can deliver the drug to the retina (the back of the eye).

The scientists’ pending patents for the eye drops are now owned by US-based company Macregen Inc, and a team of Birmingham researchers is working with the company to develop a novel range of therapies for AMD and other eye diseases.

‘Wet’ Macular Degeneration

‘Dry’ Macular Degeneration

The combined team is now expediting proof of concept studies to confirm the validity of the therapeutic approach.

Clinical trials will be imminent once these studies are completed, and could start as early as spring 2019.

Dr de Cogan commented: “For several years, our team has focused on the challenge of delivering drugs to the back of the eye. From the outset, we realised that delivering drugs through eye drops would mean that patients can administer their treatment themselves, and this would be less costly, save time for patients and healthcare providers, and reduce the potential complications that can arise from injections.

“Now we have shown that the eye drops work in the larger mammalian eye, and we welcome the commercial investment and expertise from Macregen, so we can deliver a structured research and development programme that should bring concrete benefits to people with AMD and eye diseases.”

www.birmingham.ac.uk

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Clinical Need

Final patient enrolled in MCG study Creavo Medical Technologies (Creavo) has announced the enrolment of the last patient in a study led by the cardiology team at the South Warwickshire NHS Foundation Trust.

T

he study will assess if Creavo’s magnetocardiography (MCG) device can differentiate between the hearts of those who have previously suffered from a cardiac event, such as a myocardial infarction (MI), and the hearts of healthy, non-ischaemic patients.

Approximately 100 patients have been enrolled throughout the study (50 healthy and 50 post-cardiac event) and the results are intended to determine if MCG can detect damage in the hearts of those patients with a recently confirmed MI. Dr Roger Beadle, Consultant Cardiologist at the University of Warwick, commented: “The research team at South Warwickshire NHS Foundation are excited to be a part of this MCG project. Bringing a new technology into a hospital is a great opportunity.

“The use of MCG in the field of acute coronary syndromes is well documented but the possibilities for this technology extend far beyond that. We hope that this piece of research will be our first step in exploring this.”

“While we continue to carry out research with MCG in the emergency department, this is our initial step into how Creavo’s unique MCG technology adds value and can be utilised in the cardiology setting. The aim is to provide physicians with an accurate ischaemic condition of the heart, helping them decide on the most appropriate care pathway for the patient. We are delighted to be working alongside Dr Beadle and his team for this study and thank them for their support. We look forward to working with further patients, and to obtaining results which are expected shortly.”

Steve Parker Chief Executive Officer Creavo Medical Technologies

www.creavomedtech.com

For daily lifescience news visit www.lifescienceindustrynews.com 15

Clinical Need

Biopsy triaging system for quicker results DynamX offers a software platform of screening solutions for multiple diseases, for which screening is currently ineffective, excessively costly or simply unavailable.

T

he company was originally founded as BeamLine Diagnostics Ltd in 2015 by Dr Liberty Foreman and Dr Katherine Willetts. Initially focusing on biopsy screening for gastrointestinal tract cancers, based on work carried out during the founders’ PhDs, it soon became clear that the BeamLine algorithm could be adapted for a number of clinical problems and DynamX was born.

The core team, chaired by Dr Ian Smith MBE, includes the founders, Liberty (CEO) and Katherine (CSO), Lance Farr (CTO), Katy Burdett (clinical trials coordinator). Together they have extensive expertise in commercial technology and software development, fundraising, IP/ patents, regulatory processes (EU and US), and trial management and delivery.

All DynamX products are based on the principle of simple modular design, combining artificial intelligence, machine learning and off-the-shelf hardware, so that new screening solutions can be developed rapidly and efficiently. Commercially available infrared spectrometers are utilised, and the full array of biological sample types, including tissues, cells and biofluids, can be analysed.

One of the big problems DynamX tackles is the delay in cancer diagnoses caused by an overburdened histopathology service. The ‘gold standard’ for diagnosis of most cancers is histopathology of tissue biopsies, but the service is struggling, with demand increasing by 4.5 per cent year-on-year

requiring further testing can be returned to the routine diagnostic pathway, meaning that the system integrates seamlessly with current clinical workflows.

alongside a diminishing workforce. In September 2018, a review from the Royal College of Pathologists was published claiming that as little as 3 per cent of histopathology departments have enough staff to meet current demand. Over 50 per cent of centres are forced to outsource work to private facilities or use locums. This means both waiting times and costs are increasing.

The company is currently working with four hospital sites across the UK (UCL Hospital, Queen Alexandra Portsmouth, Manchester Royal Infirmary and Leicester Hospitals) to trial the biopsy system with over 400 patients undergoing endoscopy of the gastrointestinal tract. After receiving extremely positive initial results, this study is being expanded to 10 sites and 2,000 patients in 2019.

DynamX is developing their biopsy system, DynamX-Bx, for point-of-care biopsy triaging. Operated by a non-specialist, it allows fresh, unprocessed samples to be scanned in seconds to determine whether further histopathology analysis is needed, eliminating half of all samples from the histopathology pathway. Any samples

Other products developed by the company include DynamX-Cs (cells) and DynamX-Aq (biofluids), which offer opportunities for screening of a wide range of diseases, in addition to cancers, using sample types that can be obtained non-invasively. www.dynamxmedical.com

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Issue 15

Clinical Need

Innovative inhaler for asthma sufferers Hexa Halers has created a novel inhaler device aimed at empowering users, removing social stigma and boosting adherence.

E

very 10 seconds, someone experiences a potentially lifethreatening asthma attack. An asthma attack can leave you paralysed with fear as you struggle to breathe, speak or ask for help.

Poor self-management of asthma claims countless lives, while costing the medical services billions. Sadly, there is still an awkward stigma attached to using inhalers which urgently needs to be addressed.

Medilink North of England member Hexa Halers is committed to delivering a novel, more positive approach to inhalers which puts the user back in control and tackles the stigma. The Wirral-based company has created a new pMDI actuator brand, which

morphs into the traditional configuration to be fully functional when needed.

The Hexa Haler is the first device to encourage the formation of a positive relationship with the inhaler and offer haptic feedback. The patented polygon rotation device generates a vibration when you press it, as a form of reward, encouraging user engagement and mutual interaction.

Instead of a standard inhaler which is only used when specifically needed, the Hexa Haler becomes part of the user’s lifestyle, which boosts self-management of the condition. The device’s colour can also be personalised alongside other peripheral materials.

“Our device could be potentially lifechanging for people with asthma – it puts them in control of their condition and gives them a real sense of confidence.”

Mike Howell CEO of Hexa Halers

www.hexa-halers.com

For daily lifescience news visit www.lifescienceindustrynews.com 17

Clinical Need

Patients to become their own anaesthetists New technology in development will allow patients to control their own sedation during operations.

P

atients undergoing operations while awake will be able to control their own levels of anxiety thanks to new research. At the touch of a button, they will administer doses of intravenous sedation whenever they feel nervous on the operating table.

The aim is to allow patients to individualise their experience of surgery by putting them in control of how awake or sleepy they want to be. The technology may also allow for swifter recovery times by reducing exposure to the drug’s side effects. It would be impossible for patients to underdose or overdose themselves, as minimum and maximum limits are set. An anaesthetist would remain in the operating theatre observing the patient at all times.

Nottingham University Hospitals NHS Trust is leading the project, in collaboration with

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Issue 15

product design researchers at Nottingham Trent University. The university was awarded more than £376,000 by the National Institute for Health Research (NIHR) to develop the hardware and software for the project.

Because there is no real way of knowing how anxious a person feels, anaesthetists often err on the side of caution and have to administer larger doses to ensure that operations run smoothly. The new technology will help ensure that patients receive more suitable doses. It will also make patients feel more in control, and anaesthetists will be provided with live data on how much the patient is taking.

Ahead of the development of the technology, 25 patients at Nottingham University Hospitals NHS Trust took part in an initial study of the technique. Results

“Undergoing surgery can be a worrying experience so patients are sedated. Propofol is very effective but, like many drugs, it has side effects that can prolong recovery. By putting the control of drug delivery directly into a patient’s hand, less propofol can be used without compromising the patient’s comfort, which we expect will lead to swifter recovery times.”

Professor Philip Breedon Nottingham Trent Medical Design Research Group

showed these patients were able to choose how awake or sleepy to be for surgery and needed less propofol than if an anaesthetist alone had been in control of the sedation.

Different patients also took the drug at different points of their operation. People who felt anxious before the operation

Clinical Need

Healthcare company wins prestigious Queen’s Award Trio Healthcare, a company dedicated to evolving life enhancing healthcare solutions, has been awarded the Queen’s Award for Enterprise, the UK’s most prestigious business accolade.

M

edilink North of England member and PR client, Trio Healthcare, was presented the award under the Innovation category for its breakthrough patented silicone technology, which is improving the lives of ostomates with abdominal stomas around the world.

Abdominal stomas are surgically created intestinal openings which are used to treat conditions such as colorectal and bladder cancer, Crohn’s disease or colitis. The stoma outputs body waste such as faeces and urine, which is then collected in an odour-proof bag. Leakage can happen and discomfort is common – both of which have a dramatic impact on ostomates’ social life and psychological wellbeing.

To combat this, Trio has developed a unique, secure silicone adhesive that can be used around the stoma to provide an instant but secure adhesion to the skin.

The company’s research and development team have focused on using a nonhydrocolloid technology based on silicone polymers, which historically was viewed by the industry as ‘not suitable for ostomy applications’ due to its hydrophobic gellike chemical structure.

By modifying the chemical make-up of the silicone gel, Trio has developed a secure but comfortable solution that allows the skin to breathe normally, even perspire, whilst maintaining a secure connection. The patented formulation leaves no residue and its hydrophobic nature prevents absorption of any faeces or urine providing a complete barrier, which allows the skin to naturally heal underneath.

The Trio Healthcare team attended a reception hosted by H.R.H the Prince of Wales at Buckingham Palace to celebrate their incredible achievement alongside other worthy winners in June.

tended to use more at the start. Those who felt relaxed at the beginning tended to ask for more propofol later on. The research focused on orthopaedic operations, such as knee and hip replacements.

Dr David Hewson, Anaesthetic Registrar at Nottingham University Hospitals NHS Trust, said: “In the future, this technology could be widened out to other forms of medical or surgical procedure which require patients to be awake. It could make a huge difference to the experience patients receive while also creating efficiencies for the NHS.” www.ntu.ac.uk

www.triohealthcare.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 19

Going Global

ABHI expands US Innovation Hub ABHI has taken another important step in supporting UK HealthTech companies do business in the US.

F

ollowing its launch six months ago, ABHI’s Innovation Hub has proven to be of significant benefit to UK companies. As a result, the Hub will now be expanded to accommodate double the number of organisations.

With access to Dell’s world-class faculty, the Hub allows companies to take

The Hub is a unique partnership between ABHI and the Dell Medical School at the University of Texas in Austin, offering UK companies a base within the State of Texas to grow their business.

advantage of a network of clinical contacts, hospital systems, investors, and key business groups. “The adoption and use of innovative technologies is the greatest enabler for delivering population health and valuebased care. We are therefore delighted to be working with ABHI and the Innovation Hub members to deliver this”, said Ruben Rathnasingham, Assistant Dean for Health Product Innovation at Dell Medical School.

He continued: “It is particularly pleasing to see just how successful this initiative has been, and I look forward to supporting more UK companies across Austin and the wider State.”

The Innovation Hub is a critical part of ABHI’s US Accelerator Programme, which also gives companies complete access to ABHI’s Texas trade missions, designed to forge and develop partnerships across the State with leading clinical communities.

In addition, inclusion in the Innovation Hub allows companies to participate in the ‘Texas Health Catalyst,’ a programme designed by the Dell Medical School to foster health research and advance innovation.

Speaking about the partnership, ABHI International Director, Paul Benton said: “We have had so much momentum with the Innovation Hub that we have decided to expand the scheme to enable more companies to benefit from it. Not only are we offering physical space and connections, but the support offered through our network of US-based mentors allows companies to tap into advice and expertise from a group of in-market specialists. It is a great opportunity and we are looking forward to welcoming more UK companies into the Hub over the coming months.”

www.abhi.org.uk

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Issue 15

6TH INTERNATIONAL CO NFERENCE O N

16 - 19 JUNE

BIO-SENSING TECHNOLOGY

2019 | RENAISSANCE KUALA LUMPUR HOTEL, KUALA LUMPUR, MALAYSIA

Following the success of the first five conferences, the 6th International Conference on Bio-Sensing Technology will continue to bring together leaders from industry and academia to exchange and share their experiences, present research results, explore collaborations and to spark new ideas, with the aim of developing new projects and exploiting new technology for bio-sensing applications.

This year the conference will have one theme dedicated to bio-sensing technology for the internet-of-things and a post conference meeting with a particular focus on applications addressing challenges in telehealth and diagnostics.

Networking and partnering event Building on the success of the partnering event at the 5th international conference, we are again able to offer this exciting opportunity to delegates who can meet with companies and research organisations on Wednesday afternoon, following the conference, with a focus on the application of bio-sensing technology in telehealth.

This will provide an opportunity for companies and academics to share ideas and needs to explore future exploitation of innovation in telehealth and point-ofcare diagnostics.

The conference will include: l

Presentations from leading specialists highlighting new opportunities in biosensing technologies

l

An opportunity to share best practice in the integration of technologies for bio-sensing

l

An exhibition of leading-edge, commercial technology

l

A poster forum for unveiling new research ideas and concepts

l

Networking opportunities

l

A strong industry focus with companies presenting their technologies

Bio-sensing technologies are of growing importance in healthcare, agri-food, environmental and security sectors, and this is reflected in the continued growth of global markets for such technologies.

Connectivity with the wider-world through the internet and the demand for data to drive big-data applications are other important drivers of bio-sensing technology development. This conference will provide a forum for accessing the most up-to-date and authoritative knowledge from both commercial and academic worlds, sharing best practice in the field as well as learning about case studies of successfully integrated bio-sensing technologies.

Abstract Submission Deadline: 4th January 2019

IBST IBST www.elsevier.com/events/conferences/international-conference-on-bio-sensing-technology

Going Global

BioPartner UK Delegations Showcasing UK Life Science BioPartner UK Delegations promote the UK presence at international conferences. We work with conference organisers, in-country agencies and overseas networks to provide the best discounts and business opportunities for UK companies travelling with the Delegation.

We have negotiated exceptional discounts to some of the world’s highest quality biopharma partnering events. In partnership with United Life Sciences, we manage the UK presence at key overseas conferences.

Register by the early bird date of 1st January 2019 for reduced rates.

BioFIT 2018 4-5 December Lille, France

UK delegation and discounts available

BIO-Europe 2018

5-7 November Copenhagen, Denmark UK Delegation and discounts available

BIO-Europe Spring 2019

25-27 March Vienna, Austria

UK Delegation and discounts available

Biotech Showcase 2019

7-9 January San Francisco, USA UK Delegation and discounts available

See our website for details of these and other opportunities. Join the BioPartner Programme and be kept up to date! www.biopartner.co.uk/events.php

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Issue 15

Going Global

British invention lands in Rehacare 2018 A British company has showcased its innovative eFOLDi Scooter and eFOLDi Power Chair at the leading trade fair for rehabilitation, inclusion and care, Rehacare, in Düsseldorf.

S

unTech UK Ltd, founded by a father and daughter duo, created the eFOLDi in a bid to improve convenience, efficiency and quality of life for individuals with limited mobility.

Since SunTech UK Ltd launched the product in 2009, the eFOLDi Scooter has won

The eFOLDi Scooter is the world’s first compact, lightweight and versatile personal electric vehicle (PeV) and folds easily from a wheeled suitcase to a comfortable chair to a mobility scooter – giving freedom and flexibility to its users.

numerous awards including the British Invention of the Year, the Scottish Edge Enterprise, gold at the 2015 Beijing Invention Competition and a final spot in the Virgin Voom Awards. It has also been dubbed a “fantastic invention and simply brilliant” by Sir Richard Branson.

The eFOLDi is the brain child of inventor Jianmin Wang who “sketched up” the idea from his hospital bed after badly breaking his leg and becoming disabled. The product was born out of the frustrations suffered

by Mr Wang, who has over 600 inventions to his name, and his determination not to become housebound. Frustrated with shopping for mobility scooters that were either too heavy, too clunky or too old-fashioned, he created a product that incorporated

freedom, fashion and fun into the world of mobility scooters.

Now ten years old, SunTech UK Ltd is receiving praise from across the industry for their pioneering products. Earlier this year they raised nearly £1m from 746 investors through a crowdfunding campaign on Crowdcube, which allowed them to further refine the design of the eFOLDi Scooter to meet the needs of their growing customer base.

They have also developed an eFOLDi Power Chair which folds automatically at the touch of a remote-control button and, like the scooter, vastly improves the life of those with limited mobility.

www.efoldi.com

For daily lifescience news visit www.lifescienceindustrynews.com 23

Going Global

Midlands and Ohio collaboration Medilink Midlands and the City of Mentor are collaborating to promote bilateral trade and investment between the Midlands region of the UK and Northeast Ohio.

The City of Mentor is located in Northeast Ohio, a 20-minute drive from downtown Cleveland, and is part of a cluster of life science and biomedical companies that have grown up around the Cleveland Clinic, one of the world’s leading hospitals. There are over 700 medical and bioscience companies in Northeast Ohio and the cluster includes world-leading companies such as General Electric, Siemens, Philips, Toshiba, Hitachi, and STERIS. Medilink Midlands is a strategic collaboration between Medilink East Midlands and Medilink West Midlands to support and promote the life sciences sector in the Midlands region of the UK. Medilink Midlands brings the collective expertise of the two organisations together to support over 1,700 life sciences organisations within the region.

The UK has the third largest medical

technology sector in Europe, and the Midlands has the largest regional cluster in this sector in Europe.

The recent launch of Medilink Midlands follows the announcement of the UK’s Industrial Strategy: government’s longterm plan to boost the productivity and earning power of people throughout the

country. One of the five core foundations of the strategy is ‘places: prosperous communities across the UK’. Working alongside the Midlands Engine and other strategic alliances, Medilink Midlands’ sole aim is to help stimulate additional and value-added growth of the Midlands as a prosperous community for Life Sciences.

“The collaboration between the City of Mentor, and Northeast Ohio, is the first international relationship announced by Medilink Midlands since it was launched.

North Eastern Ohio is an attractive strategic location for Midlands companies looking to establish a low-cost foothold in the largest medical and life sciences market in the world. The State of Ohio is an important manufacturing region in the USA and has considerable potential synergies with the Midlands Region – the UK’s leading manufacturing region. Medilink Midlands looks forward to encouraging a broader collaboration between the two regions through its partnership with Midlands Engine.”

Dr Darren Clark Director of Medilink Midlands

Medilink add new exhibitions to international calendar Medilink’s International Team have announced they have added two of the world’s leading supply chain exhibitions, MD&M West and Medtec LIVE, to their 2019 international calendar.

MD&M West takes place 5-7 February in Anaheim, California. It is America’s largest annual MedTech event, attracting 20,000 visitors and connecting thousands of advanced design and manufacturing professionals with a large collection of global MedTech suppliers for three days of industry immersion. The MD&M West Expo is attended by engineers, executives, manufacturing and operations personnel, and R&D experts looking for suppliers, new technologies and inspiration.

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Issue 15

To enquire about booking an exhibition stand with Medilink, contact Medilink’s International Team via email on international@medilink.co.uk or 0114 232 9292

New medical technology event Medtec LIVE will be held in Nürnberg on the 21-23 May. Medtec Europe and MT Connect have merged together to create Medtec LIVE 2019 – a fantastic opportunity, which combines the strengths of both the existing events. The event is expecting 600 national and international exhibitors and 8,000 visitors including R&D personnel, engineers, buyers and product managers.

Going Global '%&- &hi 9ZXZbWZg " EgdYjXi BVcV\ZbZci IgV^c^c\

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MEDILINK WEST MIDLANDS

ENTRIES NOW OPEN 2018 Medilink WM Medical and Healthcare Business Awards EMAIL: VANESSAB@MEDILINKWM.CO.UK | WWW.MEDILINKWM.CO.UK

Ad 136 x 190 mm.indd 1

09/10/2018 12:56:12

For daily lifescience news visit www.lifescienceindustrynews.com 25

Going Global

UK life sciences experts lead trade mission to Japan Prominent UK life sciences experts from industry and academia travelled to Asia in October to encourage collaboration and investment between the UK and Japan and Korea.

M

edCity, the life sciences cluster organisation for the greater south east of England, joined up with the Northern Health Science Alliance to lead a 50-strong delegation to showcase the UK’s excellence in health science.

The group was made up of scientific academics from leading universities and research institutes and innovative companies from across the UK. Their five-day trade mission included a UK Life Sciences symposium in Tokyo, the annual

biotech partnering conference BioJapan, in Yokohama, and culminated in a visit to Samsung Biologics in Seoul.

The focal point of the mission, BioJapan, took place from October 10-12, and has played an important role in facilitating interaction between Japanese and global organisations to stimulate new business opportunities for almost two decades.

As the second largest pharmaceutical market in the world and a global leader

in cell and gene therapies, Japan is seeking to adopt cutting-edge technologies to further improve and advance the sector. The visit provided a platform for companies and scientists, including Genomics England, Imperial College London, the Milner Therapeutics Institute, Random42 and Richmond Pharmacology, to build international networks and create long-lasting partnerships.

We spoke to the delegation ahead of the mission and they explained why this is an important date in the calendar.

”

26

Sarah Haywood, Chief Executive Officer at MedCity: “We are back in Japan for a fourth year to showcase the UK’s ecosystem of innovative life sciences companies and academic research. With over 5,000 companies, and a turnover of over £70bn, our thriving life sciences sector makes the UK an ideal destination for collaborative research and commercialisation. We’ll be there to foster partnerships between Japan and the greater south east of England, which is home to four of the world’s top 10 universities, 19 of the top 20 pharma companies, and worldleading research institutes.”

Issue 15

”

Suzanne Ali-Hassan, Head of Corporate Affairs at the NHSA: “This delegation provides the ideal opportunity to highlight the forwardthinking research and innovative technologies being developed in the North of England. The North is a hotbed of progressive and dynamic life sciences companies and world-leading academics. We’re looking forward to showcasing what we have to offer on an international scale and letting the world know that we’re open for investment, research and business.”

”

Joanne Hackett, Chief Commercial Officer, Genomics England, spoke about their ground-breaking project to sequence 100,000 whole genomes, targeting patients with rare diseases and cancers: “This visit comes after a landmark week for the 100,000 Genomes Project, as whole genome sequencing becomes an NHS service for the first time, transforming patient care. Japan has one of the most innovative science sectors in the world and BioJapan is an ideal platform to demonstrate the capabilities of the UK genomics industry to an international audience.”

Going Global

In recent years, Japan and the UK has established a number of collaborations including: l Takeda Pharmaceutical

acquired Shire Plc for almost £46bn.

l The Medical Research Council

and the Japan Agency for Medical Research and Development (AMED) signed a Memorandum of Cooperation to advance UK-Japan partnership in medical research and development.

l The Cell and Gene Therapy

Catapult signed a memorandum of understanding with Japan’s Forum for Innovative Regenerative Medicine to accelerate research and commercialisation of regenerative medicine.

”

Yoshiaki Tsukamoto, Executive Director, Japan Bioindustry Association, the organisers of BioJapan: “We have a long history of scientific collaborations with the UK, as we face similar health issues and having a natural affinity to get science out of the lab and to patients as quickly as possible. We are pleased to welcome the UK delegation back to Japan to promote their expertise in areas such as ageing and artificial intelligence and look forward to seeing the partnerships that arise as a result.”

l University College London and

Takeda Pharmaceutical formed a new research collaboration to identify and validate novel target genes for the treatment of neurodegenerative diseases.

”

Rebecca Wilson, Head of Corporate Partnerships for the Faculty of Natural Sciences, Imperial College London, who are returning for the second year: “This trade mission is an important event in Imperial’s calendar. There are enormous benefits to being able to touch base faceto-face with existing partners and introduce our world-class research in areas such as antimicrobial resistance, regenerative medicine and drug discovery to new global audiences. Collaborating across borders is a key component of our strategy to accelerate technology transfer. We look forward to further deepening our relationship with Japanese companies and institutions, which already includes over 1,000 publications co-authored with Japanese academics and individual industrial relationships that span over three decades.”

l Astellas Pharma acquired

Quethera, a Cambridge-based advanced therapies company, for £85m.

l The London School of Hygiene &

Tropical Medicine and Nagasaki University started a joined PhD programme in Global Health.

l The UK and Japanese

governments have worked together to promote dementiafriendly communities in 34 countries.

Delegates: Imperial College London University College London King’s College London Queen Mary University, London The Milner Therapeutics Institute National Phenome Centre Imperial Thinkspace The University of Sheffield Connected Health Cities The University of Manchester Richmond Pharmacology Random42 Fusion Antibodies Mitt GripAble Plasticell Londoneast-uk Colliers Phastar JLL www.medcityhq.com

For daily lifescience news visit www.lifescienceindustrynews.com 27

People and Places

BioHub Birmingham develops new incubator space to meet increasing demand for biomedical facilities The BioHub Birmingham is constructing 5,000sqft of self-contained laboratory and office suites to meet an increasing demand for biomedical incubator space.

T

he BioHub opened in 2015 and its shared facilities on the ground floor are now operating at capacity. It is managed by University of Birmingham Enterprise and located at the Birmingham Research Park, which provides incubation services and facilities, as well as commercial office space for biomedical and hi-tech companies.

The Birmingham Research Park is on the University campus, and the University has invested significantly to create a formidable landscape for medical innovation. In the last year alone, the University has opened: the Healthcare Technologies Institute, where experts in chemical engineering, biomedical science, computer science, applied mathematics, chemistry and physics

The BioHub Birmingham hosts a thriving community of researchers and early stage life science companies including Abingdon Health, Linear Diagnostics, Nonacus, Future Genetics, Gifford Bioscience, Aliksir, Cernotas and Hairclone.

work collaboratively on translational projects; the Centre for Custom Medical Devices, which works in collaboration with Renishaw and uses additive manufacturing (3D printing) to speed up development in the medical devices supply chain; and the Medical Devices Testing and Evaluation Centre, which helps remove the regulatory blockages encountered by small to medium sized enterprises (SMEs).

The University ranks fourth in the UK for the production of Intellectual Property (patents) and much of its medical innovation comes from interdisciplinary research, where scientists who apply engineering or chemistry know-how to solve problems in medicine. This collaborative landscape has attracted increasing attention from international business, and the University currently has over 200 industrial partners, spanning all business sectors, who use its facilities and research expertise.

The BioHub is one part of this landscape, and its current tenants include diagnostics, precision medicine, and biotechnology companies, who share laboratory and office space.

The new development will create laboratory and office suites with sizes starting at 600sqft/55m2. The enquiry list for the new suites is now open, so for further details or a tour of the facilities contact Angie Reynolds, Birmingham Research Park Manager, a.reynolds.1@bham.ac.uk

www.thebiohub.co.uk

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People and Places

Cryo-Electron Microscopy Facility launched A state-of-the-art Cryo-EM facility, which will advance the understanding of the processes of life, has been opened at the University of Leicester.

T

he new facility was opened by Dr Richard Henderson, from the MRC Laboratory of Molecular Biology in Cambridge, who was one of three scientists to win the 2017 Nobel Prize in Chemistry “for developing cryo-electron microscopy for the high-resolution structure determination of biomolecules in solution.”

The Cryo-EM facility, hosted at the Leicester Institute of Structural and Chemical Biology, brings cutting-edge research technologies to the Midlands and represents another successful collaboration within the Midlands Innovation partnership. The University of Leicester led the successful bid, in collaboration with the Universities of Warwick, Nottingham and Birmingham, to establish the facility. The total investment exceeds £6M with £3.7M from the Medical Research Council (MRC). The four partner universities provided the remaining funds with a major contribution from the University of Leicester (£1.8M).

Professor John Schwabe, Director of the Leicester Institute of Structural and Chemical Biology, led the region-wide bid to the Wellcome Trust-MRC initiative to establish

the new facility at Leicester. He commented: “There is currently a revolution in using CryoEM for research in structural biology. It is very exciting to be opening this facility which will keep the Leicester Institute of Structural and Chemical Biology at the forefront of the field.”

The revolution in Cryo-Electron Microscopy has been driven by developments in the microscopes themselves, the camera systems, and in the computational methods used to process the images. This has allowed the latest generation of Cryo-EMs, such as the one in Leicester, to generate 3-dimensional structures of bio-molecules in exquisite detail. It enables scientists to understand the mechanisms through which molecular machines in our cells perform the key functions of life fit. This can lead to understanding disease processes and how best to address them.

The facility is centred around a state-of-theart 300kV cryo-electron microscope, with the latest generation of direct electrondetecting cameras. Alongside this is the High Performance Image Processing Facility which boasts the computational infrastructure (based around powerful GPU’s) necessary to process

the very large (>1TB /day) amounts of data generated by these instruments. A second “feeder” microscope is based at the University of Warwick.

This regional facility will establish a Midlands Cryo-EM ‘ecosystem’ that will enable the sharing of equipment and expertise, and will help to strengthen existing and establish new scientific collaborations across the region.

Over the past four decades, European researchers – including MRC-funded researchers in the UK – have played a pivotal role in developing increasingly sophisticated and super-powerful cryo-electron microscopes. This microscope is one of several that was announced in July 2017, as part of £11.3m government funding to boost structural and cell biology research.

www.le.ac.uk

For daily lifescience news visit www.lifescienceindustrynews.com 29

People and Places

Edgbaston Medical Quarter – a community of healthcare excellence Located in the heart of the UK, Edgbaston Medical Quarter (EMQ) in Birmingham is a growing cluster of medical and healthcare excellence.

I

t is just over 80 minutes from London by train with direct international flights to all major global destinations. EMQ sits largely on the 640-hectare Calthorpe Estate, which is managed by Calthorpe Estates, a family-owned investor, developer and landowner dedicated to creating thriving communities and best places to live and work.

Mark Lee, Chief Executive of Calthorpe Estates, said: “EMQ is at the centre of a medical and life sciences revolution which is taking place in the West Midlands. It boasts 64 per cent of the city’s healthcare economy and offers a high cluster of assets. As well as offering patients cutting-edge medical treatments, it is also a leader in health innovation – helping to make tomorrow’s innovations become reality, today.”

Internationally renowned EMQ’s flourishing healthcare and life sciences community is supported by internationally renowned training and educational facilities.

The area has attracted leading practitioners and offers some of the best places to be treated in the UK; providing faster access to treatments and helping to save lives. Some of the medical facilities and specialist care centres located in the area include Cure

30

Issue 15

Leukaemia, Birmingham Centre for Clinical Trials, The Centre for Defence Healthcare Engagement, The Centre of Excellence in Interdisciplinary Mental Health and The Institute of Translational Medicine.

Mark said: “We are honoured to have patients from all over the UK, and increasingly from other countries, come to Birmingham for private treatment at our leading hospitals and clinics. Patients choose Edgbaston, Birmingham, for their treatment because of its healthcare excellence, ease of access, value and the fact Birmingham’s medical facilities sit alongside thriving leisure and lifestyle communities.

Friends and family can enjoy award-winning places to eat and a host of arts, cultural, leisure and sports facilities. It is also one of the top shopping locations in the UK, coupled with being a culturally diverse and welcoming city, with beautiful green open spaces which are the perfect place to relax and recover.”

27 life sciences specialisms EMQ boasts over 180 medical organisations, 80 hospitals and specialist care centres, 44 GP clinics and routine care facilities, and 23 training facilities, many of which are within walking distance of one another. It is home to 27 life sciences specialisms with active research programmes and is Europe’s largest clinical trials centre and the ‘go to’ destination for more cost-effective and rapid clinical trials.

Cure Leukaemia and the Centre for Clinical Haematology, which are at the forefront of developing pioneering drug treatments and personalised medicine, have located in Birmingham because of these clinical trial capabilities. Specialist care centres include oncology, mental health, diabetes, addiction, fertility and trauma. EMQ is home to a wide range of other medical specialisms including cardiovascular, dentistry, osteopathy, plastic surgery, aesthetics, orthopaedics, ophthalmics and physiotherapy.

People and Places

Cutting edge medical facilities available within Edgbaston Medical Quarter Numerous collaborations The presence of so much knowledge and a wellconnected community within a small area has enabled various bodies to unite on numerous collaborations, notably the relationship between the University of Birmingham NHS Foundation Trust with the West Midlands Genomic Medicine Centre and University of Birmingham on the ‘100,000 Genome Project’.

“As a region we are looking to grow our healthcare and life sciences sector, and support collaboration between industry, academia and the healthcare system. Working together our ultimate aim is to attract further investment into Edgbaston Medical Quarter, Birmingham and the wider West Midlands region and see it go from strength to strength.”

Mark Lee Chief Executive Calthorpe Estates

As well as offering cutting edge patient facilities, the West Midlands has also capitalised on its position as the UK’s largest medical devices cluster. There are 550 medical technology companies based in the area, more than any other region across the UK. Being based in Birmingham means companies can connect with practitioners and students from internationally renowned medical facilities including the University of Birmingham, Queen Elizabeth Hospital Birmingham, Birmingham’s Women’s Hospital and Birmingham Children’s Hospital. There is also a lot of dedicated support available from a range of healthcare partners including West Midlands Academic Health Science Network (WMAHSN), Medilink West Midlands, the Birmingham Health Partners and the Institute for Translational Medicine.

Three state-of-the-art medical opportunities located within Edgbaston are available for pioneering life sciences and medical businesses or clinics looking to relocate to Birmingham.

Edgbaston Medical Quarter (EMQ), managed by Calthorpe Estates, is continually developing the area to enhance its appeal as an optimum investment destination.

The area offers space to grow and is the ideal location to open up a new hospital, healthcare clinic or consulting rooms through to research & development or office space.

It offers the opportunity to gain access to the UK national public and private healthcare markets and associated interests, as well as research, development and personalised healthcare projects.

The opportunities that are currently available within EMQ include Building 4 at Pebble Mill - a 27-acre medical development, which is being built on the site of the former BBC Studios.

Outline planning permission has been granted to transform Building 4 into a 9,000 sq m (96,875 sq ft) world-class healthcare facility. The proposed building, which has 150 on-site car parking spaces, will be positioned between Circle Health’s new private hospital and rehabilitation centre and the Birmingham Dental Hospital and School of Dentistry.

Also available is 30 Highfield Road – outline planning has been granted for a unique grade A office or medical centre of over 2,788 sq m (30,000 sq ft). The building has structural and service specifications that meet all medical standards, including the creation of an operating theatre. It also has an open-plan efficient floor space, on-site car parking and is set within Edgbaston Village, a thriving leisure and retail location.

The third opportunity is Regency House – a self-contained 2,069 sq m (24,973 sq ft) building. The landmark property combines a classic period property with contemporary medical space.

A range of other sites in and around the Life Science economic area are available – ranging from new build sites to incubator units.

For further details about Edgbaston Medical Quarter opportunities, contact Matt Long, Portfolio Development Director, at Calthorpe Estates on +44 (0)121 248 7676 or visit our website.

To find out more information about Edgbaston Medical Quarter please contact Calthorpe Estates on +44 (0)121 248 7676 or visit our website. www.edgbastonmedicalquarter.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 31

Regulatory

The new MDR explained Phil Brown, ABHI Director, Technical & Regulatory, explains the ins and outs of the new Medical Device Regulation.

F

or a product to be placed on the European market, it must meet the requirements outlined in the relevant regulation and be affixed with a CE Mark. The current EU regulation for health technologies is undergoing change, with the existing Medical Device Directive (MDD) being replaced by the new Medical Device Regulation (MDR), first published in 2017.

The culmination of eight years’ work, the MDR will ensure that European regulation for devices is considered the ‘gold standard’ globally. For our industry, this new regulation modernises the original MDD rules, bringing together best practices from existing Commission guidance whilst covering newer technologies such as nano-materials and human tissue derivatives.

The updated requirements demand a more robust compliance with elements of quality management, risk management, distribution control, transparency, post-marketing surveillance and training. These elements are now ingrained within the business process, ensuring that CE Marking has a more holistic feel.

This all sounds reasonable and logical of course, but there are caveats and nuances that impact on these timeframes and that will influence company strategies surrounding their product portfolio. For example, a notified body that will certify ‘conformity assessment’ of a product or quality system must apply to be accredited under the new scheme.

Only accredited bodies can issue certificates against the new MDR. This application and accreditation period is underway, with the first notified body accreditation expected towards the beginning of 2019 at the earliest. This does not leave a great deal of time for companies to organise certification and CE Marking against the MDR and requires early dialogue with their notified body.

Quality management One standard of the ‘new legislative framework’ is EN ISO 13485, which controls the quality management system of a manufacturer. Quality management considers all aspects of the manufacturer’s activities, from product conformity to management responsibilities and actions. Unlike the MDD, the new regulation includes aspects of quality management within its legal text.

The regulation demands details of quality objectives, organisation of the business, design and development, as well as details on postmarketing plans and activities.

Declaration of conformity In conjunction with the transition timelines, there are several aspects that companies need to address to allow for the future CE Marking of their products. However, until May 2020, either the new MDR or the old MDD can be applied to medical devices being placed on the European market. Beyond May 2020, all new products must comply with the new MDR.

The ‘declaration of conformity’ therefore, which is the legal document stating that a given product is compliant with the regulation, demands that aspects of management review and business practice are carried out, and that these aspects are audited by the notified body.

The signatory to the ‘declaration’ must be cognisant of such processes to be assured that compliance requirements are met.

Distribution network The MDR also requires manufacturers to have greater control over the distribution of their products. All ‘economic operators’, which includes the manufacturer, authorised representative, warehouses, importers and distributors, have defined roles and responsibilities. Indeed, all have a responsibility for ensuring that only products that are MDR compliant are placed on the EU market.

Manufacturers must have complete transparency of their distribution network, including sub-distributors. In addition, the authorised representatives must have a ‘person responsible for regulatory compliance’, who effectively releases only conforming products onto the EU market.

Continual monitoring Post marketing surveillance is considered as both reactive and pro-active, in that it covers vigilance and adverse effects, as well as continual monitoring of products in use. Both are critical to understanding how a product performs and how product ‘risk’ changes.

The MDR requires that these processes are audited by the notified body, as they form part of the legal text rather than part of European guidelines. A company must also have plans for conducting post-marketing clinical follow-ups either to verify or enhance product performance.

These activities are then used to update risk management documentation, drive product development processes and determine lifecycle needs.

In addition, the MDR mandates the development of a database called EUDAMED, which when fully implemented will house data on vigilance, clinical performance, clinical investigations and product literature. Certain parts of this data will have to be made publicly available, which will certainly help to debunk the mystery of medical devices!

Key points of emphasis for the new MDR

Global Gold Standard

Quality Management

Declaration of Conformity

Distribution Control

Continual monitoring

EUDAMED Database

www.www.abhi.org.uk

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Issue 15

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DISCOVERING HEALTH TECHNOLOGY

Now taking ight online ...

November

5-7online Discover the latest life science news from the only magazine dedicated to the 2018 life science sector.

With contributions from leading membership and support organisations working with life science businesses, academia and healthcare providers from across the UK and beyond.

December UK HealthTech Cardiff, UK

4

2018

MediWales Innovation Awards Dinner Cardiff, UK

December

4

2018

December

4

2018

Bio-Europe Copenhagen, Denmark

November

8

Advanced Therapies Network Launch London, UK

2018

MedTech Connects: SMEs to Multinationals Smith & Nephew Workshop London, UK

December

12

EU Medical Device & IVD Regulations Workshop London, UK

2018

www.lifescienceindustrynews.com February

For editorial and advertising opportunities: February February MD&M West HIMSS 2019

MedTech Connects: Social Care info@lifescienceindustrynews.com Dementia Challenge London, UK

5-7+44 (0)29 2047345611-15 California, USA

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2019 2019 2019 Written

by PROMOTIONAL the sector, for the sector OPPORTUNITIES WITH LIFESCIENCE INDUSTRY www.lifescienceindustrynews.com

March

25-27 2019

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Bio-Europe Spring Vienna, Austria

March

27-29 2019

Issue 15

Asia Health Singapore

April

2-4 2019

Gulf Health Mishref, Kuwait

February

13

Medilink North of England Awards Leeds, UK

2019

May

9 2019

Anglonordic Life Science Conference London, UK

Event calendar 2018

2019

November

12-15

Medica Dusseldorf, Germany

2018

December

13

14

One Nucleus: Genesis London, UK

14-17 2019

January

7-9

Biotech Showcase San Francisco, USA

2019

Innovation for Health Rotterdam, The Netherlands

2019

May

20-22

BIA 15th Annual bioProcessUK Conference Edinburgh, UK

2018

2018

February

November

February

21-23

May

15-16 2019

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BIA Gala Dinner London, UK

2019

MedFair India New Delhi

2019

China Medical Equipment Fair (CMEF) Shanghai, China

January

March

14

May

21-23 2019

28-31

Arab Health Dubai, UAE

2019

2019 MedTech London Conference & Awards London, UK

2019

Med-Tech Innovation Expo Birmingham, UK

January

March

14-17

KIMES 2019 Seoul, South Korea

2019

Medtec Live Nürnberg, Germany

May

28-30

Africa Health Johannesburg, South Africa

2019

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EVENT PARTNERS 37

We innovate healthcare At Roche our aim is to improve the health, quality of life and well-being of people around the world by providing an innovative range of diagnostic solutions and medicines. Roche is a global, research-focused healthcare company with Group Headquarters in Basel, Switzerland.

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Personalised Healthcare We combine our strengths in pharmaceuticals and diagnostics to better fit treatments to patients. When genetic differences can be identified, the efficacy and safety of medicines can be improved enormously. To this end we have a companion diagnostic strategy for every molecule we develop.

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Tel: +44 (0)1444 256000 www.roche.co.uk At Roche we focus on developing medicines and diagnostics that will help patients live longer, better lives

PUBLIC RELATIONS AND COMMUNICATION SERVICES MEDILINK’S WHAT WE DO PR EXPERTS • Strategic PR/Communications have the sector specific knowledge and experience to support your organisation’s growth, using cutting edge communication tools including traditional, digital and social media.

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If you’d like to see how Medilink’s PR Team can support your organisation’s growth, contact pr@medilink.co.uk or call 0114 232 9292 38

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Our vision is to make Wales the place of choice for health, care and wellbeing innovation

Ein gweledigaeth yw i wneud Cymru y le o ddewis ar gyfer arloesedd ym meysydd iechyd, gofal a llesiant

Our mission is to accelerate the development and adoption of innovative solutions for better health and wellbeing.

Ein cenhadaeth yw cyflymu datblygiad a’r defnydd o atebion arloesol ar gyfer iechyd a llesiant gwell.

We inspire collaboration to drive innovative healthcare solutions. We support the life sciences industry, working with partners in health and social care, industry and academia, to identify, nurture and grow ways to make a positive difference to the wellbeing of patients.

Rydym yn ysbrydoli cydweithrediad er mwyn llywio atebion gofal iechyd arloesol. Rydym yn cefnogi’r diwydiant gwyddorau bywyd, ac yn gweithio gyda’n partneriaid ym meysydd iechyd a gofal cymdeithasol, diwydiant a’r byd academaidd, i nodi, meithrin a datblygu ffyrdd o wneud gwahaniaeth cadarnhaol i lesiant cleifion.

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Mae ein hunaniaeth Gymreig a’n cydwybod gymdeithasol gyffredin wrth wraidd pobeth a wnawn.

Am fwy o wybodaeth, ewch i: www.lshubwales.com/cy Ffôn: (029) 2046 7030 E-bost: hello@lshubwales.com 39

Partnership is the key to a flourishing Lifescience Industry

DISCOVERING HEALTH TECHNOLOGY

Written by the sector, for the sector. In print and online, Lifescience Industry magazine is supported by some of the UK’s most respected medical organisations.

Partner organisations Medilink UK Partners Medilink East Midlands BioCity Nottingham Pennyfoot Street Nottingham NG1 1GF Tel: +44 (0)115 822 3154 www.medilinkem.com Medilink North of England 3 Smithy Wood Drive Sheffield S35 1QN Tel: +44 (0)114 232 9292 www.medilink.co.uk Workplace Churchgate House 56 Oxford Street Manchester M16EU Tel: +44 (0)7734 383 407

40

Medilink South West c/o Institute of Bio-Sensing Technology University of the West of England Coldharbour Lane Bristol BS16 1QY www.medilinksw.co.uk

South East Health Technologies Alliance Lancaster’s West End Lane Henfield West Sussex BN5 9RB Tel: +44 (0)7905 201857 www.sehta.co.uk

Medilink West Midlands 4 Greenfield Crescent Edgbaston Birmingham B15 3BE Tel: +44 (0)121 452 5630 www.medilinkwm.co.uk

National & Regional Partners

MediWales The Bonded Warehouse Atlantic Wharf Cardiff CF10 4HF Tel: +44 (0)29 2047 3456 www.mediwales.com

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Edgbaston Medical Quarter Calthorpe Estates 76 Hagley Road Edgbaston Birmingham B16 8LU Tel: +44 (0)121 248 7676 www.emq.org.uk Life Sciences Hub Wales 3 Assembly Square, Cardiff CF10 4PL Tel: +44 (0)29 2046 7030 www.lshubwales.com MedCity 4 Christopher St London EC2A 2BS Tel: +44 (0)20 3179 8100 www.medcityhq.com