201208_LifescienceIndustryIssue19

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The future of the UK’s

life science industry

post COVID-19

Reimagining

life science

DISCOVERING HEALTH TECHNOLOGY

Issue 19 2020

Future Watch

Clinical Need

Regulatory

New technology

and innovations

Meeting unmet

clinical needs

Going Global

Cracking international

markets

People & Places

Influential people and

places in the industry

Updates and expert

advice

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DISCOVERING HEALTH TECHNOLOGY

Reimagining

life science

The future of

the UK’s

life science

industry post

COVID-19

4-5

42

24

13

T cell immunity

test developed

for COVID-19

Producing

next-generation

material

for PPE

Future Watch

Clinical Need

Going Global

Regulatory

47 Online Events Calendar

A message from the editor

Sophie Davies Editor

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

9 T cell immunity test

developed for COVID-19

10 TranQuality wins Innovate

UK grant to develop AI for

mental health treatment

11 Breath test for COVID-19

undergoes clinical trial

12 Consortium to develop

new system for peritonitis

detection

13 Producing next-

generation material

for PPE

14 Recruitment begins

for innovative patient

monitoring study

34 Nottingham company lands investment to

expand its share of neonatal health tech market

35 Providing technology to fight COVID-19 in

Wuhan

36 Delivering molecules for COVID-19 research in

New York

18 New approach to diagnosis

and management of epilepsy

19 Collaboration delivers

COVID-19 test kit in record

time

20 Bringing to life NHS

breakthrough innovations for

anaesthesia, airway and

critical care

21 Enhancing a COVID-19 test

with digital capabilities

22 Transforming data into

actionable insights to tackle

COVID-19

23 Restart for Cardiopulmonary

Rehabilitation services

24 Hospital Direct signs exclusive

distributor agreement for

infection control solution

38 The UKCA Mark: Prepare for 1st January 2021

39 The importance of a patient data ‘trust model‘

during 2020 and beyond

40 Clinical evidence: Seven tips to satisfy the needs

of clinicians, payers and regulators

42 An observation of COVID-19 through a

regulatory lens

Published by Teamworks. www.teamworksdesign.com

Editor: Sophie Davies, editor@lifescienceindustrynews.com

Executive Editor: Gwyn Tudor, gwyn@lifescienceindustrynews.com

Advertising Sales: sam@lifescienceindustrynews.com

Art direction: Lee Gillum.

www.lifescienceindustrynews.com

The views expressed in this publication do not necessarily represent the

opinions of individual partners unless explicitly stated. © Teamworks. 2020

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stated. © MediWales Ltd. 2012

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Issue 5

Welcome to Lifescience Industry

magazine

This edition focuses on how companies

across the UK have responded to

COVID-19, from development and

adoption of new technologies to a look

ahead at the sector’s future.

Reflecting the current landscape, this

edition of Lifescience Industry puts a

spotlight on companies which have been

peritonitis detection and

epilepsy management.

Meanwhile, regulatory

experts offer guidance on

topics such as the

UKCA mark, patient

data collection and

clinical evidence.

working on diagnostic tests, advanced

PPE, digital tools and infection control

solutions to tackle COVID-19. It also

features companies which have

adapted their businesses, formed new

partnerships and supported the global

mission to fight the pandemic.

Aside from COVID-19 stories, this

edition includes new innovations

for mental health treatment,

Hospital Direct signs

exclusive distributor

agreement for infection

control solution

An observation

of COVID-19

through a

regulatory

lens

People & Places

26 How the Midlands has

responded to COVID-19

27 Discovery and development of

new therapeutics during the

pandemic

28 Launch of personal handheld

device to help limit the spread

of COVID-19

29 Working at the forefront of

COVID-19 research

30 Celebrating the best of UK life

sciences at the Medilink UK

Healthcare business awards

32 Medilink West Midlands helps

forge new partnerships in

response to COVID crisis

33 Construction starts on the

Medicines Manufacturing

Innovation Centre

Issue 19

The future of the UK’s life science

industry post COVID-19

Health technology companies were needed

to respond to the COVID-19 challenge.

Manufacturers of products as diverse as masks

and gowns, hand sanitiser, in-vitro and point

of care diagnostics, ventilators and respiratory

products, and digital tracking and monitoring

faced unprecedented demand. The urgent need

for supplies encouraged numerous companies

new to the sector to pivot their production

facilities in an attempt to support the NHS.

They also had to meet this challenge while

keeping their own workforce safe.

Not all health technology companies

experienced unprecedented demand. Many

PPE, digital, diagnostics and respiratory

products were selling stock as fast as they could

manufacture, but other companies (those

involved in scheduled procedures that were

being cancelled and postponed across the

country) had to meet a very diferent challenge,

to ensure their businesses would be in good

health when the NHS restores normal services.

In September, Lifescience Industry held its

first Spotlight event – showcasing how the

life science and health technology sector has

worked, collaborated and persevered to meet

the challenges presented by COVID-19. The

national and regional trade associates and

networks who make up the partners behind

Lifescience Industry led the event. During the

early days of the pandemic, these organisations

provided vital contact with UK manufacturers

through daily liaison with the NHS, UK and

devolved governments, in some cases through

full-time secondment of key staf. Between

them, they coordinated thousands of ofers of

critical PPE, testing and medical technology

supplies, and brought together businesses

from across the UK to collaborate on the

development of new essential products, new

supply chains and support for companies who

were new to the health technology sector.

They provided business support, guidance

and grant support, and also delivered events

and publications to showcase the remarkable

eforts made by UK manufacturers during the

pandemic.

The Spotlight event focused on some of the

numerous examples of companies which have

delivered critical solutions at the pace required.

Sensyne Health presented their successful

As 2020 comes to an end, most of us will be glad to see the back of a totally unprecedented year. At

the start of 2020, global markets were growing and the investment market in life sciences was in good

health. Investors were backing advanced therapeutics (ATMP), precision medicine and diagnostics, digital

healthcare and AI. But even at that time, there were warning signs that COVID-19 was approaching.

Kevin Kiely,

CEO of Medilink UK

The resilience of the UK’s life sciences

manufacturing and supply chain has been

challenged during COVID-19. Governments

across the world paused the export of essential

products, leaving the UK temporarily without

key equipment and parts, as scarce resources

were directed to the highest bidder.

As many countries were chasing the same

suppliers, the UK needed to exploit its existing

manufacturing capabilities to increase its

level of self-sufficiency in the production of

strategically important products e.g. PPE,

ventilators, diagnostic test kits and vaccines. In

certain instances, this required manufacturing

companies in other sectors to repurpose their

production almost overnight.

Put simply, the UK was too reliant on a

globalised supply chain, which hampered our

response. To learn from this experience, we

need to better understand our manufacturing

and supply chain capabilities, identify potential

risks and vulnerabilities, and use these insights

to inform decision making and optimise future

investment in UK manufacturing.

Nick Rodgers,

Chair of SEHTA

The extraordinary period since March 2020

has shown that we can reset the way we use

technology in health and social care settings.

We have seen what’s possible with the clever

use of new technology, deployed at speed and

sometimes at scale. I hope that this reset is a

permanent change for the better and that,

moving forward, the NHS and Social Care will

continue to be more open to adopting our

members’ new technologies.

I am concerned that Government and the

NHS may treat the last 8 months of rapid

technology adoption to be an aberration,

and will wish to go back to old and tried ways.

But on balance, I think that there are enough

good news stories and examples of technology

delivering healthcare and cost improvements

to show the benefits of technology adoption.

So I am optimistic that the new improved

practices will continue. As a sector, Medtech

must welcome the changes with open arms

and we must work with our NHS partners to

continue the good work.

Andrew Davies,

Digital Health Lead at ABHI

The COVID-19 pandemic has accelerated the use

of remote monitoring technologies and online

tools to help support patients, whilst freeing up

healthcare capacity.

The use of technology in monitoring patients

with long-term conditions has also improved. We

have seen the creation and adoption of platforms

that support remote video consultations, with

multi-disciplinary teams if required, and virtual

tools, all linked through to the patient’s record

and data. Increasingly sophisticated, these

platforms can integrate vital sign monitoring

devices and highlight any decline in a patient’s

status, enabling clinicians to intervene early and

remotely, before a need for admission.

This use of virtual platforms is certainly one that

will endure beyond COVID-19. By providing access

to care outside of the hospital, and empowering

patients to better self-care through access to

their own results, the move will lead to fewer

unnecessary A&E visits, an improved patient

experience and a reduction in the overall cost to

the health system.

Expert opinion:

For daily lifescience news visit www.lifescienceindustrynews.com 5

work in app development, allowing patients to

self-monitor vital signs; Abingdon Health spoke

about their antibody test development and

collaboration with other businesses as part of

the UK Rapid Test Consortium; Hospital Direct

showcased new patient handling solutions,

as well as the design and development

support they were able to provide for new

manufacturers; Inspiration Healthcare Group

demonstrated the essential work they have

been doing to meet ventilator demand during

the pandemic; Somnus Scientific presented

their work in novel, real-time blood propofol

monitoring during anaesthesia; Indoor

Biotechnologies showcased their Innovate

UK funded work developing a novel cellular

immunity test for COVID-19; Aptus Clinical

demonstrated new patient wearables and AI

applications for COVID-19 patient management;

and XenoGesis presented their personal

COVID-19 journey and their eforts to provide

business continuity in exceptional times. These

examples, along with an NHS presentation from

Barts Health NHS Trust, highlighted the diversity

of projects and contributions that industry has

made and continues to make to meet

the challenge.

Looking ahead to the post COVID-19 landscape,

our partner networks and their members,

who make up the UK’s medical technology,

diagnostics, pharmaceutical and digital health

sectors, have stressed the need to retain and

build on the accelerated development and

adoption of products and digital solutions seen

during the crisis. They see a need to reshore

the lost manufacturing capability of critical

supplies back to the UK, in order to ensure the

continuity of supplies, as well as a need to build

in resilience throughout the supply chain of

critical supplies and specialist expertise. They are

unanimous in believing that the contribution

UK manufacturers can make to the continued

health of our NHS supply chain needs to be

properly recognised as part of the procurement

process. Our sector is at a crossroads. The

choice: return to pre COVID-19 practices, or

grasp the opportunities that now appear

far more achievable to accelerate product

development, trials and adoption, and

to support and nurture a strong, robust,

indigenous manufacturing base.

Cari-Anne Quinn,

CEO of Life Sciences Hub Wales

The life sciences sector can take pride in its

response to tackling the COVID-19 pandemic. The

widespread collaboration, innovative thinking

and agility has highlighted the best of what our

industry can offer.

While the outbreak has delivered unprecedented

challenges, the truth is that our health and social

care system faced pressures long before its arrival,

and these haven’t gone away. Rising patient

numbers, fiscal pressures and the complexities

brought by an ageing population. Life science

companies will continue to play a crucial role

in tackling these issues. Companies who are

working hard to develop new technologies that

will not only address the problems of today,

but also ensure that our health and social care

system is better prepared for our future needs.

The response to COVID-19 has demonstrated

that our homegrown businesses, and the

multinationals that have joined us, can innovate

with agility and pace to provide urgently needed

solutions. As well as helping improve the health

and wellbeing of people all over the world, their

innovations will be key to fuelling our economic

recovery and long term sustainability.

Issue 18

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Future watch

T cell immunity test developed for

COVID-19

Cardif-based Indoor Biotechnologies Ltd has been awarded funding from Innovate UK to develop a new type

of test for COVID-19.

I

dentifying people who have already

been infected with the virus and

become immune could have huge

benefits for enabling society to safely

return to normality. However, since the

symptoms of COVID-19 can vary from

person to person, and some people

display no symptoms at all, reliable

testing methods for prior infection and

subsequent immunity are vital.

One way of determining whether someone

has been infected with the virus is by

looking for specific antibodies in blood

samples. Numerous antibody tests exist,

but doubts remain about their reliability in

determining whether a person has gained

immunity, as well as more recent concerns

about their longevity post infection.

Long-term protection against viruses comes

not only from antibodies, but also from

cells of the immune system including T cells,

which play a critical role in controlling and

eradicating viral infections. The new test

developed by Indoor Biotechnologies Ltd is

a diferent type of immunity test, focusing

on T cells rather than antibodies. The simple

cellular immunity test can identify the

presence of T cells that respond to the virus

which causes COVID-19 from a single tube of

blood, within 24 hours.

The test is designed so that it can be easily

used by labs across the world, enabling

mass testing of COVID-19 T cell immunity

to be performed. It also has the potential

to be more sensitive and more reliable at

determining immunity than antibody testing.

In addition to assessing immunity status,

the test may also be valuable during

vaccine development to help identify

whether an adequate immune response

has been generated to protect people

from COVID-19, and for testing how long

that immune response remains.

www.indoorbiotech.co.uk

10

Issue 19

Future watch

TranQuality wins Innovate

UK grant to develop AI for

mental health treatment

oor mental health is the single

largest cause of disability in

the UK and one in six people

experience a mental health problem

each year. The total economic costs of

mental illness through lost productivity

has been estimated at £105.2 billion

each year and treatment accounts for

more than 10 per cent of the annual

NHS spend.

TranQuality provides mental health

assessment and treatment programmes

for the NHS and private patients with

clinical depression and anxiety as well

as companies. For patients, it uses EEG

to identify specific areas for treatment

using Transcranial Magnetic Stimulation

(TMS). TMS stimulates neurons in the

brain through an electromagnetic field

that reduces or reverses an individual’s

symptoms.

TMS is often used when conventional drug

and talking therapies are not working

efectively or have stopped working

completely. The treatment is approved by

the National Institute for Health and Care

Excellence (NICE) and is non-invasive, pain-

free and has no known side efects.

The standard TMS approach requires

around 20 to 30 sessions, and costs

between £4,000-£8,000 per patient, which

is limiting its adoption as a mainstream

treatment. TranQuality has reduced

the cost and number of sessions by

targeting the TMS using a patient’s EEG.

An AI support tool could further reduce

treatment length and cost.

TranQuality is a key partner of the

Beingwell Group, a family of wellness

companies providing solutions across

mental health, cognitive fitness and sleep.

It opened its newest clinic in the North of

England in January 2020. The company

has wider clinics in Humberside and has an

online platform that enables individuals to

check and monitor their mental health at

regular intervals to maintain good mental

wellbeing and to better understand their

mental health.

TranQuality has been awarded an Innovate UK grant to develop AI capable of

identifying depression and anxiety in brain activity. Currently, the company

uses cognitive neuroscientists to analyse brain activity captured by an Electro

Encephalogram (EEG), but they believe that AI could take on a significant

amount of that work in the future.

“This Innovate UK funding will allow us

to explore and implement AI technology,

which has seen a significant interest in

healthcare. This could be a step towards

a more personalised treatment of mental

health conditions, addressing the mental

wellness of each patient individually,

which is important as everyone deals

with it so differently. Our mission is to

support clinician analysis and treatment

to reduce its cost to below £1,000 per

patient. AI development has started well,

and a successful solution would help

an EEG targeted TMS become more

affordable and accessible across the UK

and globally.”

Bernard McMahon

Chairman

TranQuality Solutions Ltd

www.tranquality.com

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