Transcript Document

Unlock Your Global Business Potential:
UK Regenerative Medicine and Stem Cells
By placing your business in the UK, your company can benefit from a
rich heritage in regenerative medicine and stem cells
1960
Sir Peter Brian Medawar is awarded the Nobel Prize in
Physiology or Medicine, with Sir Frank Macfarlane Burnet,
for his work on graft rejection and the discovery of
acquired immune tolerance was fundamental to the
practice of tissue and organ transplants.
1972
Sir Martin Evans, university of Cambridge (Nobel Prize
for Medicine 2007), isolated mouse embryonic stem
cells and showed that cells could be taken directly from
a mouse embryo, cultured in a dish outside the mouse’s
body, genetically manipulated, and then mixed with
normal mouse cells to form an embryo.
1978
First IVF baby born after Cambridge university
scientists: Sir Robert Edwards (Nobel Prize for Medicine
2010) and surgeon Patrick Steptoe fertilise human eggs
outside the body.
1990
Human Fertilisation and Embryology Act passed by
both Houses of Parliament. Human Fertilisation and
Embryology Authority (HFEA) designated statutory body
to enforce provisions of legislation and established in
1991.
1996
Dolly the sheep is cloned by cell nuclear replacement
(CNR) techniques at the Roslin Institute in Edinburgh,
led by Professor Sir Ian Wilmut.
2002
2002
UK Stem Cell Bank established as a repository for
stem cells derived from adult, foetal and embryonic
tissues and to be open to academics and industrialists
from the UK and abroad.
Sydney Brenner, a researcher at the Medical Research
Council Unit in Cambridge is awarded the Novel Prize
in Physiology or Medicine for his work on the genetic
regulation of organ development and programmed
cell death.
2003
2005
The UK Government sets up the UK Stem Cell
Initiative, with the aim of working with the public and
private sectors to draw up a ten-year vision for UK
stem cell research.
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Researchers at King’s College London, led by Professor
Peter Braude, generate the UK’s first embryonic stem
cell line.
The UK has led the field through ground breaking innovation as well as supportive policy and initiatives, making it easy for you to tap into world class
expertise and resources
International companies are already benefiting from working in the UK
2
By placing your business in the UK, your company can benefit from a
rich heritage in regenerative medicine and stem cells
2007
Teams of researchers at Cambridge and Oxford
universities independently discover a new type of stem
cell in mice and rats that is very similar to human
embryonic stem cells.
2008
A child suffering from gut failure was the first in the
world to receive a life-saving haematopoietic stem
cell transplant. Two hospitals in the UK now offer the
adult stem cell therapy: Great Ormond Street and Great
North Children’s.
2010
ApaTech, a spin-out from Queen Mary University of
London, and a world-leader in bone graft technologies is
sold for $330M to Baxter.
2011
ReNeuron’s PISCES study (Pilot Investigation of Stem
Cells in Stroke) is conducted in the UK and is the
world’s first fully regulated clinical trial of a neural
stem cell therapy for disabled stroke patients.
UK approved Europe’s first clinical trial using human
embryonic stem cells (hESCs). US based company
Advanced Cell Technology (ACT) received approval
from the U.K. Medicines and Healthcare products
Regulatory Agency (MHRA) to begin a trial to treat 12
patients with Stargardt's macular dystrophy.
2012
2012
the UK Regenerative Medicine Platform is
established, with funding from Research Councils UK,
to address the technical and scientific challenges
associated with translating promising scientific
discoveries in this area towards clinical impact.
The Cell Therapy Catapult is established to grow the
cell therapy industry and support the development,
delivery and commercialisation of cell therapies and
advanced therapeutics in the UK.
2011
2013
The House of Lords Science and Technology Select Committee,
under the Chairmanship of Lord Krebs, launched an inquiry into
regenerative medicine focusing on UK’s expertise in the field, the
applications of this research to treatments, the regulatory and
financial barriers to translation and commercialisation of the findings
of this research, and international comparisons.

2012
Sir John Gurdon, of the Gurdon Institute in Cambridge,
together with Shinya Yamanaka, is awarded the Nobel
Prize for the discovery that mature cells can be
converted to stem cells.
Recognising the challenges facing the application of regenerative medicine, the UK continues to invest in, and develop this sector, supporting worldfirst clinical trials and financially supporting innovative new companies with non-dilutive funding
3
The UK recognises the need to support industry deliver patient benefit
and achieve commercial viability
4
Collaborate and work in the UK to access world class resources that
are delivering results
1
Pfizer Regenerative Medicine opened a facility in
Cambridge, UK, in 2010 to lead its move into the stem
cell industry. In 2011, the operation embarked on a
landmark collaboration with University College London
(UCL) to develop a treatment for certain forms of
blindness using stem cell therapy.
The UK holds a leading position in the science and commercial
translation of regenerative medicine. Resulting in world class
resources that your company can tap into:
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Cutting edge, well funded, research in cell therapy and stem
cells, tissue engineering, biomaterials, medical technologies
and nanotechnology
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Connectivity through specialised networks: connecting you to
the research, clinical and industry base and creating
opportunities for collaboration
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Talent and expertise: highly skilled researchers and clinicians
and regenerative medicine experts
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World-class cell and tissue banking facilities available for
industry
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Funding for UK based companies through government
initiatives
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Leveraged funding through collaboration with academia
Pfizer noted that “locating the new laboratory in the
area will give us access to one of Europe's strongest
biotech hubs”.
5
Comprehensive supply chain and logistics allow you to deliver on time
and cost effectively
2
Roslin Cells and the Cell Therapy Catapult partner to
establish a source of clinical grade induced pluripotent
stem cells (iPS) banked according to Good
Manufacturing Practice (GMP) in the UK. The
establishment of the cell bank with an initial £2m
investment provides the UK with an important source
of iPS cells acceptable to the regulatory authorities.
These iPS cell lines will be available for clinical
research in both academia and industry, with the initial
six expected to be available by the end of 2014.
You can tap into an established and accessible commercial
supply chain that is evolving and adapting to support
regenerative medicine activities:
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Ease of access to numerous specialist suppliers, and logistics
providers, helping you deliver in a timely, cost effective
manner
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Access to storage solutions and established cold chain
logistics experts
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A well connected, efficient transport network connecting you
nationally and internationally
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Established expertise, accessible to industry, through the
NHS Blood and Transplant (NHSBT) and Scottish National
Blood and Transfusion Services (SNBTS) in cell and tissue
collection and logistics
6
Access existing manufacturing capabilities with proven ability to deliver
3
Companies can work with established manufacturing facilities
experienced in delivering for clinical trials
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A large number of manufacturing and bioprocessing facilities
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Established Good Manufacturing Practice (GMP) facilities
with experience in working with industry
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Advanced Therapy Medicinal Product (ATMP) manufacturing
The UK is also leading the innovative manufacturing revolution
with investment into centres of excellence actively collaborating
with and supporting industry activities to develop processes and
techniques for cost-effective scale up and manufacturing
ReNeuron is the first commercial customer for Roslin
Cells’ new GMP Cellular Therapy Manufacturing
Facility in Edinburgh. Under the contract, Roslin Cells
will manufacture clinical-grade cell banks of
ReNeuron’s CTX cell product, the basis of its ReN001
stem cell therapy for stroke and its ReN009 cell
therapy for critical limb ischaemia. The work will be
undertaken in Roslin Cells’ Edinburgh facility which
secured its licence from UK authorities earlier this
year.
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Support for product developers in manufacturing innovation
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Expertise in Scaffold design, fabrication and analysis
7
Access a strong clinical research infrastructure allowing you to deliver
clinical trials efficiently
4
The UK is committed to delivering efficient clinical translation.
Companies can access a strong health research infrastructure to
deliver high quality clinical trials quickly and cost effectively
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An ongoing phase II trial to compare Autologous
Chondrocytes Implantation (ACI) versus existing
techniques for knee cartilage repair is being
carried out over 27 UK sites (and 2 sites in
Norway) with 400 patients recruited. The trial is
sponsored by Keele University and is hosted by
Jones & Agnes Hunt Orthopaedic Hospital NHS
Trust.
Access an infrastructure that can help you deliver
–
The UK is Investing £500 million annually in health research
infrastructure
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Support through the National Institute for Health Research
(NIHR) Clinical Research Network (CRN) enabling over 25
clinical studies in regenerative medicine to take place within
the NHS at the current time
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Access to a single healthcare system that treats 60 million
patients, generating vast volumes of structured real world data.
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Access to specialist clinical expertise – Clinician led translation
from bench to patient
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Streamlined approvals for clinical research (Health Research
Authority)
 Simplified access for industry through the NIHR Office for Clinical
Research Infrastructure (NOCRI), NHS Research Scotland (NRS)
Permissions Coordinating Centre and Health Research Wales
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The UK provides commercial support for all your activities
5
The Cell Therapy Catapult and ReNeuron are
collaborating on new cell therapy manufacturing
technologies and assays, focusing on the
development and optimisation of the processes
required to scale up manufacture of the CTX cell
line. The Catapult will contribute £1.3 million into the
collaboration - in the form of expert knowledge, plus
state-of-the-art laboratories, equipment and
services, while ReNeuron will also provide facilities
staff and relevant expertise.
The Cell Therapy Catapult has been established to accelerate
delivery of therapies to the patient and will work with industry by:
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Taking products into clinical trial, de-risking them for further
investment
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Providing clinical expertise and access to NHS clinical partners
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Providing technical expertise and infrastructure to ensure
products can be made to GMP and delivered cost effectively
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Providing regulatory expertise to ensure that products can get
to the clinic safely in the shortest time
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Providing opportunities for collaboration, nationally and globally
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Providing access to business expertise networks and finance
opportunities so that commercially viable products are
progressed and investable propositions are generated
The UK hosts numerous experienced commercial and business
advisors and consultancies
The UK regenerative medicine Industry has a united voice through
the BioIndustry Association’s (BIA) Cell Therapy and RegenMed
Advisory Committee
9
The UK is your gateway to Europe and the global markets
6
Accessing the UK market, and the National Health Service (NHS),
is of strategic importance, increasing the probability of successful
entry into the European market as evidenced by the number of
European Headquarters in the UK:
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A clear, well established regulatory framework making the UK a
recognised route into the European market
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Regulatory advice and support through the Medicines and
Healthcare products Regulatory Agency (MHRA) and other
organisations
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In April 2013, the MHRA approved Athersys’
application to expand its ongoing Phase 2 study
evaluating the administration of MultiStem® therapy to
patients who have suffered an ischemic stroke. Ethics
Committee review was been successfully completed in
August, 2013, and enrolment at multiple United
Kingdom sites will commence following the completion
of final preparations at participating clinical centres.
London is the HQ for the EMA and the MHRA, making
the UK a convenient base for interactions with regulators
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Guidance and recommendations by the National Institute for
Health and Care Excellence (NICE) are respected Europewide. (The Scottish Medicines Consortium (SMC), in Scotland)
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The NHS allows you to deliver robust clinical trial data to
support market access
•
NHS England has developed innovative commissioning
approaches including Commissioning through Evaluation.
•
As the largest public health service in the world, the NHS
is an ideal resource for recruiting for and conducting
clinical trials; and commercialisation of innovative
therapies.
10
The UK business environment has changed; new fiscal incentives
have been created to support life sciences and innovation
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The UK government has introduced fiscal measures to stimulate innovation and growth for companies
There has never been a better time to develop and grow a commercial footprint in the UK in this sector
TSB
R&D tax credits
for SMEs worth
approximately 25p
on every £1 (7p
for large
companies)
Funding of industry
activities from the
Technology Strategy
Board
23%
Corporation
tax will drop
further to
20%
Low corporation tax rate currently
standing at 23 per cent decreasing further
to 20 per cent by April 2015.
£180m
Patent
Box
Patent box: 10%
corporation tax on
qualifying profits
£300m
To stimulate R&D
partnerships between
universities
businesses &
charities
Biomedical
Catalyst = £180m
programme of
public funding for
growth
11
Clinical success: the UK is one of the leading European countries
developing Advanced Therapy Medicinal Products
You can work with leading clinicians and clinical centres to deliver your clinical trials easily, efficiently and to a high
quality.
Figure 1: Clinical trials, in the UK, by therapeutic area
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34 cell therapy clinical trials and 37 cell therapy
pre-clinical studies (Cell Therapy Catapult)
Expertise in numerous therapeutic indications
The UK is in the top three leading European
countries developing Advanced Therapy Medicinal
Products (ATMPs) in Europe
Bone and
cartilage
9%
Diabetes
9%
Ophthalmology
9%
Gastroenterolgy
9%
Trials by stage:
Phase III
Neurological
12%
1
Phase II
12
Phase 1/II
17
Phase I
2
0
Blood
14%
Cardiovascular
12%
Trial in the UK by therapeutic area
2
Phase II/III
Oncology
26%
5
10
15
Oncology
9
Blood
5
Cardiovascular
4
Neurological
4
Gastroenterology
3
Ophtalmology
3
Diabetes
3
Bone and Cartilage
3
20
Data from Cell Therapy Catapult report
12
Multi-disciplinary clinical successes in regenerative medicine from
voice box reconstruction to tendon repair
You can work with leading clinicians and clinical centres to deliver your clinical trials easily, efficiently and to a high
quality.
Stroke
Voice-box Reconstruction
Huntington Disease
Multiple Sclerosis
Rheumatoid Arthritis
Ophthalmology
Tendon repair
Cardiovascular
Cartilage repair
Diabetes
Immunotherapy
Digestive Tract
Oncology
Liver cirrhosis
13
Your competition is already benefiting from the UK Offer in
Regenerative Medicine
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Ease of doing business: a supportive business environment coupled with
Government commitment to support the sector
– Business incentives such as year on year reductions in corporation tax,
R&D tax credits and the Patent Box, culminating in an improved business
environment in the UK.
– Increased funding into the sector from Government as well as UK charities
Rich and Diverse Ecosystem to tap into
– World class researchers, centres of excellence and research infrastructure
– A strong and growing supply chain
– Established manufacturing facilities
– Innovative manufacturing approaches
– A single healthcare system that treats 60 million patients, generating vast
volumes of structured real world data.
– Unrivalled access to cell and tissue samples to enable discovery and
development.
– A Cell Therapy Catapult to support your activities from business models,
manufacturing to clinical and regulatory expertise
Market Access: the UK, European and global markets
– Clear, well established regulatory framework, harmonised for Europe
– New commissioning models available for specialised products and
services allowing direct access to the whole of the NHS
– Strategy being developed for NHS readiness and action plan to facilitate
adoption of regenerative medicine products
A track record of successful collaboration with industry
– The NHS and research base working closely with industry
– Available support and funding for UK based companies
14
Find out how UK Trade & Investment (UKTI) can help your business
Our practical help and advice is free and confidential

UKTI’s professional trade and industry advisers operate in the UK alongside a network of experts based in all
British diplomatic offices overseas.
UKTI can:

Provide tailored information on the UK offer and capabilities that match your business needs

Support your business journey to invest in and grow in the UK
UKTI’s Life Science Investment Organisation (LSIO)

The LSIO is here to help your business navigate the opportunity to partner with and invest in the UK and to
connect you to the wider UK life science community
For further details on the LSIO and the UK life sciences offer for industry,
visit: www.ukti.gov.uk/lifesciences
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16
Acronyms

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AHSC – Academic Health Science Centre
AHSN – Academic Health Science Network
ARUK – Arthritis Research UK
ATMP – Advanced Therapy Medicinal Product
BBSRC - Biotechnology and Biological Sciences
Research Council
BRC – Biomedical Research Centre
BRU – Biomedical Research Unit
CPRD – Clinical Practice Research Datalink
CtE – Commissioning through Evaluation
EMA - European Medicines Agency
EPSRC – Engineering and Physical Sciences
Research Council
KTN – Knowledge Transfer Network
LRMN – London Regenerative Medicine Network
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LSIO – Life Science Investment Organisation
MRC – Medical Research Council
MHRA – Medicines and Healthcare products
Regulatory Agency
NHSBT – NHS Blood and Transplant
NHS – National Health Service
NICE – National Institute for Health and Care
Excellence
NIHR – National Institute for Health Research
NISCHR - National Institute for Social Care and
Health Research
NOCRI – NIHR Office for Clinical Research
Infrastructure
OSCI – Oxford Stem Cell Institute
SNBTS – Scottish National Blood and Transfusion
Services
TSB – Technology Strategy Board
UKTI – UK Trade and Investment
UKRMP – UK Regenerative Medicine Platform
WT – the Wellcome Trust
17
Appendix: Success Stories
18
How the UK environment helped ReNeuron be a leader in the field
ReNeuron
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ReNeuron is a leading, clinical-stage stem cell business. The
company’s primary objective is the development of novel stem
cell therapies targeting areas of significant unmet or poorly met
medical need.
ReNeuron’s clinical trials in disabled stroke patients: The
PISCES study (Pilot Investigation of Stem Cells in Stroke) is the
world’s first fully regulated clinical trial of a neural stem cell
therapy for disabled stroke patients. The trial is being conducted
in Scotland at the Institute of Neurological Sciences, Southern
General Hospital, Greater Glasgow and Clyde NHS Board.
Phase II of the stroke trial is starting with support of a £1.5
million grant from the Technology Strategy Board (TSB)
Also received regulatory and ethical approvals to commence a
Phase I clinical trial in the UK with its ReN009 stem cell therapy
programme critical limb ischaemia (CLI). The trial will be
undertaken through NHS Tayside at Ninewells Hospital and
Medical School, Dundee, Scotland.
Cell manufacturing for the trial will be carried out by Roslin Cells
Completed significant £33 million fundraising, with £7.8 million
from the Welsh Government, to continue development and build
a new manufacturing facility.
19
How the UK environment helped Cell Medica succeed
Cell Medica

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
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Founded in 2006 by Gregg Sando. Funded by the Wellcome
Trust and Imperial Innovations
Three Technology Strategy Board (TSB) grants to develop
and progress novel cell therapy to treat infections in children
following bone marrow transplant. Partner: Great Ormond
Street Hospital (GOSH)
Two other TSB grants to support manufacturing and
reimbursement models
Currently running early phase trial at GOSH – with support
from TSB.
Company has grown to 41 employees with offices and
laboratories in London, Berlin and Houston. Three
development projects – global clinical trials.
“Fortunately for us the Government had identified areas of important
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20
Intercytex: using a Progressive Translation approach to take
product to market
Intercytex

Intercytex is a regenerative medicine product and services company focused on
developing its lead product to treat a variety of skin related problems. These
treatments are being brought to patients through Intercytex’s innovative Progressive
Translation system which is available to third party clients through their Cell2Therapy
CMO service
Intercytex operates a fully licensed GMP manufacturing facility and has experience in
producing a variety of autologous and allogeneic 2D and 3D cell therapy products. Its
current product Vavelta/ICX-RHY, an injectable allogeneic fibroblast suspension, is a
good example of Intercytex applying the Progressive Translation approach:

Progressive licensing:
Focus on unmet medical need
and orphan products in order to
allow access to the current
legislative frameworks already in
place of conditional approvals.
Progressive development:
A close partnership between
client, contract developer and
hospital allowing iterative
development of new treatments


Progressive reimbursement:
Obtain early reimbursement
from a variety of sources that
will both help development
finances as well as providing
marketing information
Biocatalyst grant to
 Developed costing models
Improve shelf life and
for current system and scale
logistics to enable
up options
 Phase II clinical trial
pharmacy supply
completed
 Obtained full hospital
 Working with Cell Therapy
reimbursement to treat first
 Specials license obtained
Catapult to produce less
patients under Specials
for Intercytex
painful injection system
manufacturing facility
 Created a partnership with
 Working with charities to
“Fortunately for us the Government
identified
areasexamine
of important
University had
Hospital
of
reimbursement
South Manchester to
possibilities
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therapy
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one
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involvement,
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Street
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GMP
“The UK provides a unique
mix ofand the opportunity facility
onto the
London,
to exchange
ideas with other organisations
Manchester Airport City
highly networked world-class
scientists,
working
in the same field’. Karen
Hodgkin,
Senior Vice President of
Enterprise
Zone
a globally respected andClinical
helpful Development
 Working with suppliers on
scale-up options
Orphan designation
obtained in EU and US
regulatory system, a National Health
service and a succession of supportive
Governments”, Dr Paul Kemp, Chief
Executive and Chief Scientific Officer
21
Neusentis: working in partnership with academic researchers
in Cambridge and across the UK
Neusentis
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Neusentis is a Cambridge-based Pfizer research unit that
delivers 'new science therapeutics', with a particular focus on
pain and sensory disorders. It works in partnership with
academic researchers in Cambridge and across the UK.
Within regenerative medicine, Neusentis is developing cell
based therapies for ulcerative colitis, age related macular
degeneration and a drug to regenerate neural circuit function in
stroke patients.
A key partnership case study is the work being done on Cell
Replacement Therapy for Age Related Macular Degeneration in
the ‘London Project’. ‘The London Project’ was formed by
Professor Pete Coffey (Institute of Ophthalmology, UCL) and
Lyndon da Cruz (Moorfields Eye Hospital) to produce a cell
replacement therapy for AMD. In 2008 The London Project
teamed up with Pfizer to help move the project into the clinic so
as to determine whether this cell replacement therapy was safe
and whether it lead to an increase in vision in patients with AMD.
The work has pulled in expertise from across the whole Pfizer
organisation and the team have received approval from the
authorities to proceed with the trial.
GE Healthcare Life Sciences chooses Wales for its new state
of the art laboratories for cell therapy and cell bioprocessing
GE Healthcare
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In 2012, GE Healthcare Life Sciences, a business unit of GE
Healthcare, opened its new £3 million cell science laboratories in
Cardiff , Wales. The state-of-the-art investment at the company’s
Maynard Centre creates is a world-class facility for research and
technology innovation in cell science, to help advance the rapidly
emerging fields of cell therapy and cell bioprocessing, and to support
the development of new, more effective and safer medicines.
The laboratories will focus on the development of novel technologies
for the rapidly emerging field of cell therapy and on advancing new
cellular based tools to help pharmaceutical companies develop better
and safer medicines at lower cost. The facility is equipped with the
latest technologies for cell bioprocessing and cell imaging, as well as
an industry-leading clean-room manufacturing facility. In addition,
GE’s customers and scientific collaborators will benefit from an
advanced technical training centre.
“Cellular research has an extraordinary potential to address some of
the world’s biggest healthcare challenges. Our investment in these
new laboratories is a great milestone and demonstrates our
commitment to innovation and excellence in cellular science. Here in
Cardiff we have established an outstanding team of scientists, many of
whom are leaders in their field, and these new facilities will allow us to
greatly expand our work.”
UK Approves Europe's First Embryonic Stem Cell Clinical Trial
Advanced Cell Technology
Moorfields Eye Hospital

Advanced Cell Technology, a US-based company received
permission, in 2011, by the UK Medicines and Healthcare products
Regulatory Agency (MHRA) to start Europe's first clinical trial involving
human embryonic stem (hES) cells.

The ongoing trial aims to treat 12 patients with Stargardt's macular
dystrophy. The disease strikes people between the ages of 10 and 20,
causing progressive vision loss. There is currently no treatment.

Eye surgeon James Bainbridge of Moorfields Eye Hospital and
University College London leads the UK trial.
24
MHRA Authorizes Athersys to Expand Ongoing Phase 2 Clinical
Trial of MultiStem Cell Therapy in Ischemic Stroke
Athersys
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Athersys (Cleveland, OH, US) is a clinical stage biotechnology company
engaged in the discovery and development of therapeutic product
candidates designed to extend and enhance the quality of human life. The
Company is developing its MultiStem® cell therapy product, a patented,
adult-derived "off-the-shelf" stem cell product platform for disease indications
in the cardiovascular, neurological, inflammatory and immune disease
areas.
In April 2013, the Medicines and Healthcare products Regulatory Agency
(MHRA) approved Athersys’ application to expand its ongoing Phase 2 study
evaluating the administration of MultiStem® therapy to patients who have
suffered an ischemic stroke. Ethics Committee review was been successfully
completed in August, 2013, and enrolment at multiple United Kingdom sites
will commence following the completion of final preparations at participating
clinical centres.
The study is expected to enrol approximately 136 patients in total and is
currently being conducted at multiple centres throughout the United States.
Athersys is working with the Newcastle Cell Therapies Facility for production
of cells for the trials
"The MHRA authorization will enable us to bring several leading United Kingdom
stroke centres into the study, which will help us to speed the completion of the stroke
clinical trial. The authorization is also noteworthy as it marks the initiation of MultiStem
clinical development activity in the United Kingdom.”
Dr. Gil Van Bokkelen, Chairman and Chief Executive Officer of Athersys
25
EPSRC Centre for Innovative Manufacturing in Regenerative
Medicine collaborating with industry
The EPSRC Centre for innovative
manufacturing in regenerative
medicine
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The EPSRC Centre for Innovative Manufacturing in Regenerative Medicine
provides an integrated platform of fundamental and translational research as
a ‘go-to’ resource for the regenerative medicine product developer.
It is one of the few centres in the world providing academic and industrial
translational research in regulated regenerative medicine manufacturing, in
order to grow the industry, deliver benefit to patients, and develop the UK
research community.
It is a partnership of Loughborough, Keele and Nottingham Universities and
industry, with currently around 20 industry and clinical partners. Centre
institutions participate in three of the UK Regenerative Medicine Platform
hubs.
The Centre places an emphasis on cost-effective, robust manufacturing
system and process design with a focus on both regulatory compliance and
informing the regulators, in particular with respect to the implementation and
principles of good manufacturing practice.
An example of the collaborative work carried out at the centre is the
collaboration with Ruskinn Technology Ltd -one of the world’s leading
suppliers and manufacturers of anaerobic and modified atmosphere
workstations. Ruskinn was recently acquired by The Baker Company, USA around the development of HypoxyCOOLTM. Ruskinn
“The EPSRC project has provided the essential proof of principle for HypoxyCOOLTM,
and through such support has better ensured positive outcomes both in terms of the
application of autologous cell production and adding value to the Ruskinn business.”
Huw David Thomas, UK Commercial/Sales Manager, Ruskinn Technology Ltd
A University of Swansea spin-out joins efforts with Biotec
Services International to form TrakCel
TrakCel

TrakCel is an orchestration platform to safeguard patients being
treated with regenerative therapies. The platform ensures that the
right patient receives the right therapy at the right time and location.
Efficiently tracking, tracing and documenting the movement and
handling of multiple regenerative therapies with minimal resources
required, using state of art technologies including biometrics, Radio
Frequency Identification (RFID) and Global Positioning.

TrakCel’s was formed as a joint venture between AwenID (a university
of Swansea spin-out) and Biotec Services International (storage and
distribution of unlicensed, temperature-sensitive medicinal products
for use in clinical trials).

The company’s technology platform is going to be assessed by GSK
in Q1 2014. As part of a Department of Business Innovation and
Skills, Advanced Manufacturing Supply Chain Initiative (AMSCI) the
company has received financial assistance to develop its technology
for gene therapy applications.
How the UK environment supported Tissue Regenix
Tissue Regenix

Tissue Regenix is a medical technology company which uses a
proprietary technology platform, dCELL ®, which removes cells and
DNA to make replacement body parts from biological (animal)
materials.

The three priority markets for the application of the technology are:
Vascular; Cardiac; and Orthopaedics

A Technology Strategy Board (TSB) quality systems project led to
Tissue Regenix’s dCELL® vascular patch achieving European
certification in August 2010.

The dCELL® technology, which reduces the immunological response
so negating the need for immunosuppressants, is already benefitting
patients worlwide.

Vital translation projects such as this can be difficult for an SME to
fund privately. Further support, for Tissue Regenix’s knee meniscus
material, allowed the company to successfully raise £6m through an
AIM listing.

Tissue Regenix is founded on IP developed solely at the University of
Leeds and they continue to work with those researchers to develop
future products within the portfolio. The collaboration has also helped
Tissue Regenix develop quality control methodologies for their
products.
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