THE SCIENCE

ENGINEERING &
TECHNOLOGY
MAGAZINE FOR
NORTH EAST
ENGLAND

ISSUE 6
SUMMER
2008
BIOTECHNOLOGY

THE POWER OF THE

HUMBLE HAIR FOLLICLE

THE RED, WHITE,

GREEN AND BLUE
OF BIOTECH

SUPERBUG
BREAKTHROUGH

ISSN 1753-6677
“
Letter from the Editor
This issue of NETWorks follows closely on from NETWorks Issue 5 (please visit
www.uknetpark.net to download a copy). Having explored medical devices, we now
have a look at biotechnology, a completely different aspect of healthcare.

...we were privileged to Although often used to refer to genetic engineering, biotechnology has a much wider

“
hear the issues being
discussed by some of the
most eminent business
people and researchers
in the North East
range of applications including pharmaceutical, agricultural and the latest hot button
issue – biofuels. Many of these were debated at the inaugural NETWorks technology
debate at NETPark where we were privileged to hear the issues being discussed by
some of the most eminent business people and researchers in the North East. This
debate is documented on pages 5,6 and 7. We hope to make this a quarterly event
so please contact me at networks@wherebusinessgrows.com if you are interested in
attending.

For this issue, the NETWorks team had a guest editor – Mike Asher, CEO of Cels, the
Centre of Excellence for Life Sciences so I now hand over the rest of the Editor’s Letter.

CJ

“Putting this issue of NETWorks together was a very worthwhile and interesting
experience for the team at Cels – Cels sits at the heart of the support infrastructure
for biotechnology and healthcare in the region and we hope that this issue of
NETWorks illustrates the strength and diversity of academic research and commercial
enterprises in this sector. What is especially valuable in the North East is the mix of
new and long-established companies: new companies such as Reinnervate, a
Company active in the development of 3-D scaffolds for growing stem cells, sit
comfortably alongside companies such as Immunodiagnostic Systems Limited which
has been flourishing in the North East for many years. I am also delighted that we
secured an interview with Professor Chris Higgins, the Vice Chancellor of Durham
University and a world-renowned researcher in the field of cell biology.

Biotechnology in the North East is highly diverse and has such an impact on our lives:
from continuing the fight against superbugs and cancer, to developing new ways of
testing cells, to literally “growing” energy. And perhaps the greatest testament to this is
the fact that a Cambridge biotech consultancy, Ithaka Life Sciences, chose to set up
an outpost at NETPark, to take advantage of the opportunities available in this region.”

MA

Editor Catherine Johns

Scientific Advisor Professor John Anstee
Deputy Editor Rob Heslop
NETWorks is published by Distinctive Publishing Ltd
Aidan House, Sunderland Road, Gateshead, Tyne and Wear NE8 3HU
Telephone 0191 298 3571
Managing Director Barrie Miller Creative Director Martin Williamson
Sales Director John Neilson
For all enquiries including editorial, subscription and advertising please contact
Distinctive Publishing.
With thanks to all our contributors.
NETWorks is supported by NETPark www.uknetpark.net
01
 03 05 08
CELS
CELS KEEPING THE NE
THE RED, WHITE, BIOTECH SECTOR
UK BIOSCIENCE GREEN AND BLUE AHEAD OF THE
INDUSTRY FACTS OF BIOTECHNOLOGY FIELD

10 12 14
DURHAM UNIVERSITY OF
UNIVERSITY TEESSIDE
THE POWER OF BIO SOLUTIONS FOR SCIENCE CITY
THE HUMBLE SUSTAINABILITY SCIENCE IS THE
HAIR FOLLICLE AND MEDICINE FUTURE

16 18 20
UNIVERSITY OF
SUNDERLAND ITHAKA
NE SCIENTISTS HART BIOLOGICALS GROWING LIFE
MAKE SUPERBUG NEW PARTNERSHIP SCIENCE
BREAKTHROUGH BRINGS JOBS VENTURES

22 26 28
REINNERVATE
ENHANCING THE
GROWTH OF CELLS CELS
IN THE BUSINESS FOR LIFE
ABOUT NETPARK LABORATORY AWARDS 2008

29 30 31
CELS DEWJO’C NHS INNOVATIONS
HEALTHCARE ARCHITECTS NORTH

UK BIOSCIENCE
PRODUCT DESIGN DESIGN OF THE COMPANIES GAIN
& DEVELOPMENTS TIMES APPOINTMENTS

32 34 35
UKTI
ENTREPRENEUR OF
EXPORT BACKS NE
AWARDS
CBSL
NEW CONSULTANTS
BOOST CBSC
OFFERING
ALTOMED
...PROVIDING THAT
PERSONAL TOUCH
INDUSTRY FACTS
■ UK bioscience companies have produced 42 marketed biotech drugs with a further 7 waiting for approval and at
least 23 are in phase III trials
36 38 39 ■ UK companies have developed 43% of the products in late-stage clinical trials in Europe

DOMINIC ELSWORTH ■ There are 331 bioscience companies in the UK, employing 22,104 people in the public sector
NRG CAN A WELL DRAFTED HIGH FORCE
FOLLOW YOUR PATENT GET YOU RESEARCH ■ At the start of 2003, there were 18 profitable bioscience companies in the UK: Amarin Corp, Acambis, Amersham,
INSTINCTS...NOT “MORE THAN YOU HIGH QUALITY
THE CROWD DESERVE”? SERVICES Biocompatibles International, BioFocus, Biotrace International, Celltech Group, Celsis International, Cobra
Biomanufacturing, Fulcrum Pharma, Galen Holdings, Genetix Group, PowderJect Pharmaceuticals, Protherics,
Shire, Theratase, Vernalis and Whatman
Contributors ■ The UK has been responsible for key breakthroughs in health research, such as the discovery of the structure of

Mike Asher is CEO of Cels and has over 20 years experience in business, of which 14 have been spent running international science and
healthcare-related businesses. Mike’s experience in the health industry includes working on a consultancy basis with the NHS to develop a
strategy aimed at delivering greater commercial focus to its procurement activities. Before that he ran medical diagnostics company Drew
Scientific Group PLC which specialised in diabetes and haematology testing systems. As Chief Executive Officer he achieved sales growth
of 400% from £2.5 to £12.5 million in just five years. Mike has also held positions with healthcare company Coulter Electronics Limited,
where he successfully developed operations and customer services internationally.
Mike Parker spent a decade in national, regional and local journalism culminating in his appointment as Business Editor of The Northern
Echo. He was named North East Business Writer of the Year before joining the North East Chamber of Commerce where he was
responsible for a threefold increase in publicity and press coverage.
DNA, sequencing one-third of the human genome, monoclonal antibody production, recombinant insulin, genetic
regulation of organ development and programmed cell death, and crystallographic electron microscopy
■ The UK has a world-class science base. With only 1% of the world’s population, the UK funds 4.5% of the world’s
science, produces 8% of the world’s scientific papers, and receives 9% of citations
■ UK researchers produce 16 research papers per $1 million of research funding, compared to 9.2 in the USA and
3.6 in Japan

Andrew Wood has lived all over the world working and writing for the process industries, including a stint as head of global corporate
media relations for Dow Chemicals. Andrew was editor-in-chief of Chemical Week, the world's leading chemical industry magazine for 10
years before relocating back to the North East. 03
 Mike Parker managed to catch up with one of the busiest men in
the North East – Professor Chris Higgins BSc, PhD, FRSE, FRSA,
FMedSci, Vice Chancellor and Warden of Durham University.
Professor Higgins has strong links with Durham - he graduated
from Durham (Grey College) with a first class degree in Botany
in 1976 and a PhD in 1979. His father moved to Durham in
1979 as Head of the Department of Mathematics, retiring in
1991, and Chris's daughter graduated from Durham
(Collingwood College) in Politics in 2005. Christopher has
published over 200 research papers in leading journals and
has received many awards for his research. He discovered,
characterized (and even named) the ABC family of membrane
transporters responsible for transporting small molecules
(nutrients, hormones etc) into and out of all cells. The ABC
protein family includes many proteins of medical importance
including the cystic fibrosis protein and the protein which
causes resistance of cancers to chemotherapy. Christopher
has always endeavoured to ensure that his fundamental
discoveries are exploited - his team carried out the first clinical
trials for cystic fibrosis gene therapy in the UK.
MP: The UK biotechnology sector is number one in Europe
for research and development and second only to the US in
the world. How is Durham playing a role in this success?
CH: Durham is the leading university for natural sciences
outside the ‘Golden Triangle’. We have exceptional strengths in
the core sciences, particularly Physics, Chemistry, Biology,
Engineering and Mathematics. This enables us to attract the
best students to the region from across the UK and the world,
many of whom contribute to regional technology sectors after
they graduate. Durham scientists are leading many
developments at NETPark working in Durham’s own
laboratories on site, through the development and exploitation
of regional facilities such as PETeC (the Plastic Electronics
Technology Centre), and through successful spin-out
companies which have emerged from the University such as
Durham Scientific Crystals.
MP: What opportunities exist, or will exist in the future, to
help to build upon the reputation in this field?
CH: I might, perhaps mention three key areas. In the fields of
plastic electronics and photovoltaics, combining physics and
chemistry, Durham University leads the UK consortium that is
advancing science in this area - much of this work is being,
and will increasingly be exploited through NETPark. The
University working with CPI and NETPark provides one of the
best national, and indeed world-wide opportunities to take
basic laboratory research through to economic benefit in the
process industries. In biology and medicine, the North East
Stem Cell Institute (NESCI), a partnership between Durham
University, Newcastle University Medical School, the Centre for
Life and the NHS, is a UK leader in advancing regenerative
medicine.
MP: How would you sum up the role that the University of
Durham is undertaking to further science research?
CH: Durham University aims to undertake the highest calibre of
research addressing the most significant questions of a global
nature and impact. These fundamental discoveries have had,
and will continue to have, major impact nationally and
internationally. For example, Durham has, arguably, contributed
as much to our understanding of the nature and the origin of
the Universe in the last decade as any University world-wide.
We are intimately involved in design and analysis of
experiments to be carried out on the world’s largest particle
accelerator recently commissioned at CERN. Fundamental
research has many unexpected economic benefits and without
it there would be no basis for any applied research and
development. For example, the University manufactures at
NETPark many of the sophisticated instruments for the biggest
telescopes around the world (and now also for space probes).
Hawkeye, the worldwide technology used to monitor ball
movements in cricket, tennis snooker and other sports, was
established by a Durham PhD student who had been
developing the mathematics necessary to analyse movement
of sub-atomic particles.
MP: What role does the university play in prospering
entrepreneurship in County Durham and the wider North
East in cutting edge fields such as biotechnology?
CH: Through its international leadership in science, and
approach to learning which produces graduates that are both
educated and entrepreneurial, the University ensures some of
the best talent from around the world is brought to the North
East. Our Centre for Entrepreneurial Learning, led by Dinah
Bennett of ‘Women in the Network’ fame, aims to instil
enterprise and entrepreneurship throughout the whole
University. We bring many of the best scientists from around
THE RED, WHITE,
the world to live and work in County Durham and the wider
North East, which helps attract businesses. Durham University
works increasingly with NETPark, the Regional Development
GREEN AND BLUE OF
BIOTECHNOLOGY
Agency One NorthEast, and the ‘Centres of Excellence’ to
promote economic development and strengthen the
opportunities to develop ideas in Durham, Teesside and the
region. Our input has, I believe, contributed to NETPark
becoming one of the leading science parks in the North of
England.
The inaugural NETPark technology debate
MP: Are there ways in which this could be further When you sip your pint of beer you are enjoying the fruits of biotechnology - the use of a biological
enhanced? If so, how? process to effect a transformation - in this case, the use of yeast to convert sugar to alcohol. It is
CH: The University’s ability to bring together scientific expertise
biotechnology that provides the stain-removing enzymes in your washing powder and the antibiotics
with social policy and humanities has made, and will continue
to make, a difference nationally and internationally. Working that fight off infection. The pace of biotech research is exploding, promising innovations ranging
together with the RDA and NETPark increasingly enables this from a cure for certain forms of blindness to molecular computing.
global excellence to benefit the North East. For example, our
Geographers have developed joint projects with ONE to help
support economic prosperity through the Boulby mine. Our
world-class research facilities, staff and talented graduates are
a critical attractor to cutting-edge companies that are looking
to locate in the area. Our network of graduates and
postgraduates in key positions around the world bring loyalty
(and business) to Durham and the North East.
MP: In global terms, how important is it for County Durham
to have such a strong university at its heart?
CH: Durham University is critical to the economy and well-
being of County Durham and beyond (don’t forget that
NETPark is half-way between our two major sites in Durham
and Stockton), both as a leading educational institution
generating new knowledge, and as a major business and
employer in its own right. Our increasing leadership in
education and enhancing aspiration in County Durham and
Teesside will also help realise home-grown potential. With its
world-wide reach the University raises the profile of the region
to economic advantage. As an example, the global reach and
influence of our students helped ensure Lech Walesa’s recent
economic visit to the UK on behalf of Poland was to Durham
instead of London or Edinburgh.
05

But while biotechnology has been in use for thousands of
years, it is still often poorly understood. In particular, many
cutting-edge developments that involve the use of genetic
engineering are causing concern about scientists
“interfering with nature.”
In an effort to discuss these and other questions about
biotechnology, County Durham Development Company
recently convened a panel of top regional experts at
NETPark. It was the inaugural session of a quarterly series
that NETPark aims to organise around different
technology themes.
The panel, chaired by Mike Asher, CEO of Cels, the
organisation driving the growth of the North East Healthcare
and Life Science sector, discussed several questions,
including the definition of biotechnology, the huge number of
opportunities stemming from current research initiatives, as
well as regulatory, educational, and ethical issues. While the
potential of biotechnology is seemingly boundless, the
participants stressed the importance of education and open
dialogue with the public and the media about biotechnology
to allay any potential concerns, particularly around issues
such as stem cell research.
“There is an exciting future for biotechnology,” Mr Asher
said. “Developments are evolving at an ever-increasing
pace. However, they come with a series of ethical
questions, and it is important to address these with the
public and the media.”
The other panel members were Professor John Anstee,
NETPark Scientific Director; Professor Chris Hutchison of
Durham University’s School of Biological and Biomedical
Sciences; Nigel Perry, CEO of the Centre for Process
Innovation (CPI); Dr. Mike Pitkethly, Deputy CEO of CPI;
and Professor Miles Whittington, Professor of
Neuroscience at Newcastle University.
Biotechnology can be most broadly defined as the use or
manipulation of a biological system to reach a particular
endpoint, Professor Whittington said. However, there are a
number of subsectors, which are referred to by colours—
green, blue, white, and red. Green biotech involves plants,
such as the genetic engineering of a particular crop to
enhance its properties, or resist certain pests. Blue refers to
marine biotech—a relatively new field. White is used to
describe industrial uses, and red for medical applications.
Perhaps the most excitement surrounds red biotech,
particularly the use of modified stem cells in novel medical
treatments. “Biotechnology is substantially improving the
outcomes of many diseases,” Professor Whittington said.
“New brain stimulation devices are allowing people with
Parkinson’s Disease to function normally, while in the US,
researchers have implanted an artificial retina that can
restore some light sensitivity in a blind patient.”
There is already considerable strength in stem cell research
in the North East, particularly embryonic stem cells at
Newcastle University, and adult stem cells at Durham
University. Local companies are also on the cutting edge.
Avecia, based at Billingham, is developing stem cells that
grow new skin to cure burns, Professor Hutchison said.
Professor Hutchison also pointed out that stem cell
technology has already been in use for many years in
medicine—the process of bone marrow donation to a
cancer patient from a relative is a transfer of stem cells.
However, the use of embryonic or hybrid stem cells has
generated resistance among members of some religious
groups, and the panel members stressed the need for clear
communication about the benefits of the technology.
Professor Hutchison’s group is involved in weekend “road
shows” to educate the public about stem cell work. The
group also invited politicians to discuss the hybrid
embryos bill currently before parliament.
“The ethical considerations are manifold,” Professor
Whittington said. “We don’t want to appear like a
‘Frankenstein Laboratory.’” However, there is already a great
deal of support from the public for healthcare applications of
biotechnology, he said. “Public money is pouring in to
cancer research, for example. People decide for themselves
where they think the research is worthwhile.”
Opposition to genetically modified crops in Europe
increased when the companies involved did not provide
enough information to the public about what they were
doing, “GM crops is one of the most important
opportunities in biotechnology, such as developing plants
with increased oil production,” Professor Hutchison said.
“But these areas will only gain public support if they are
explained properly,” he said.
“Talking to the general public—this is one area where we
have to do better,” Professor Anstee said. “We need to let
people know what we are doing, and what the risks and
benefits are.”
That will become ever-more important as biotechnology
becomes entwined with other areas of research. “Biotech
can be combined with information technology and
nanotechnology, for example,” Dr Pitkethly commented.
“Scientists are already putting cells onto silicon chips to
carry out molecular computing.”
Researchers recently implanted a biosensor into a
paralyzed man that can control a cursor on a computer
screen by thought alone. Another research group
implanted biosensors into monkeys that allow them to
control a robotic arm and one discovery that surprised
the researchers was that the robotic arm was preferred to
a natural arm. Professor Whittington likened such
research to the first, tentative steps in making “The Bionic
Man” a reality.
But as research successes continue at an accelerating
pace, what will be the impact on society - “Who will pay
for the research? How will it be exploited? Should private
companies be allowed to profit from fundamental research
that is for the good of humanity?” asked Mr Asher.
Many people disagree with the notion that the products of
nature, such as microbes or a gene sequence, should be
patented. However, the private sector will need to be
rewarded in some way because of the high cost of
bringing new technology to market, Mr Perry said. “Every
£1 of research needs £63 to reach commercialization,” he
said.
But it is not just new-generation products where
biotechnology will have an impact, Mr Perry added. “A lot
of biotech research is to find a way to make something
we already make, but more cheaply,” he said. “In the case
of chemical plants, for example, which use high
temperatures and pressures, there is often an enzymatic
process that can do the same reaction at room
temperature and pressure.”
With such a great deal of potential for biotechnology, the
panelists expressed concern about the number of science
graduates—and the ability of UK industry to attract them.
“There is an increased tendency for bright bioscientists to
go into the City,” Professor Anstee said. “That means
science is losing a lot of talented people.”
“This issue has to be addressed at the secondary school
level,” Professor Whittington said. “Enthusiasm about
science is not being passed on to children,” he said. But
there is a much broader underlying concern.
“There is a worrying issue about public understanding of
the role of science,” Mr Perry commented. “We are using
the products of science, but they are not well
understood.” However, there is evidence that if children’s
minds can be “captured” young enough with exciting
teaching, they will be attracted to study science and
consider it a worthwhile career.
Developments such as NETPark are an important part of
addressing that problem, Professor Anstee said. “We can
raise the aspirations of youngsters if they can actually see
a place that is going to offer career opportunities in
technology businesses.”
Summing up the debate, Mike Asher commented that the
panel had been able to cover a very wide range of topics
surrounding biotechnology and there was clearly a desire
for greater understanding of science. Professor
Anstee,echoed these comments: “It was a fascinating
debate – it was interesting that questions from the
audience focused on the public engagement with science
and illustrated a wish for more information about how
science affects us in our daily lives. We hope that the
ongoing NETPark debates will contribute to this.”
County Durham Development Company and Distinctive
Publishing would like to thank all the panellists for
contributing their time, particularly Mike Asher for acting
as Chair. These debates are open to the public but
numbers are strictly limited. If you would like to attend
the next one in September, please contact
networks@wherebusinessgrows.com
07
KEEPING THE NORTH
EAST BIOTECH
SECTOR AHEAD
OF THE FIELD
The North East is a national leader in healthcare and
life sciences and Cels, the organisation charged with
driving the healthcare economy in the region, is
playing a pivotal role in this sector by promoting and
developing the region’s bioscience field with a strong
focus on biotechnology.
The North East bioscience sector concentrates on the
study of diverse branches of natural science dealing with
the structure and behaviour of living organisms. The
strength of the sector is dependent on three main areas:
■ research expertise in regional universities
■ clinical excellence in local hospitals
■ a rapidly expanding industry base.
Within the North East these organisations are carrying
out groundbreaking work including creating antibodies
for cancer therapy, vaccines for boosting the immune
system against disease, stem cell research and gene
therapy.
To support this, Cels has launched a raft of initiatives
across the region in order to drive the commercialisation
of research and development. The International Centre
for Life, where Cels is based, is the UK’s first
‘bioscience’ village, and is widely recognised as a
dynamic regional initiative that promotes research within
the bioscience field. Another facility that supports growth
is ‘Cels at Newcastle’, a unique micro-incubation facility
embedded in Newcastle University’s Medical School. It is
a dynamic regional project aimed at promoting research,
which was put in place to nurture biotech start up
companies. The project has provided ongoing guidance
to businesses in the biotechnology field through their
early stages of development as well as providing them
with a range of cutting-edge facilities. Incubated
companies have access to financial advice and
assistance, management support, as well as the
additional benefit of the close proximity to the research
expertise within the Medical School. Cels continues to
support companies after they out-grow the incubator to
promote their ongoing development.
Cels, in its role as a healthcare driver, has continually
provided a wide range of business development support
to a number of fledgling biotech companies in the region,
such as BioTransformations (anti-cancer antibodies);
Creative Gene Technology (plant biotechnology for
improved crops); ReInnervate (stem cell technology) and
BioToolomics (biopharmaceutical purification technology).
Additionally, Cels provides strategic advice to regional CASE STUDY
development agency One NorthEast on inward
investment, encouraging companies to relocate to the RegeNer8, The N8 Centre for Translational Regenerative Medicine, is a collaboration between industry,
North East. This includes advice on regenerative clinicians and academics at the North’s eight most research-intensive universities, known as the N8, which
medicine including stem cell research and brings together the work of the North of England’s top scientists to advance regenerative therapies to the clinic.
biopharmaceuticals (medical drugs produced using
The Centre, managed and promoted by Cels, is part of a £6m project funded by the Northern Way, the
biotechnology), addressing the growing world trends in
consortium of the three Northern development agencies .The N8 identified regenerative medicine as one of five
these areas and the regional industrial and academic
key areas that would benefit from virtual and physical centres of industrially focused translational research.
strengths.
Currently an embryonic part of the healthcare technology sector, it has been recognised as offering major
Another way in which Cels is driving the sector is that it
opportunities for global economic growth over the next two decades.
proactively responded to the government’s
Biotechnology Industry Growth Team (BIGT) report: Safety in regenerative medicine has been set as the core focus for RegeNer8 following consultations with the
Bioscience 2015, aimed at improving the health and
healthcare industry, which included representatives from bioprocessing – an application of biotechnology,
wealth of the country as a whole, as well as that of the
pharmaceuticals, biomaterials and medical devices sectors.
bioscience industry itself. One of the report’s key
recommendations outlined the need to set up Centres of
Excellence in Biopharmaceutical Bioprocessing. As a
result Cels has facilitated ongoing discussion in the
region to examine how such centres could help the UK
utilise and add value to its strong bioscience base.
Subsequently, Newcastle University has established a
new North East Biopharmaceutical Bioprocessing
Institute (NEBBI) designed to allow expertise in the
sector to be developed, in order to benefit local industry.
One such benefit is the establishment of a new
undergraduate degree in Biopharmaceutical
Bioprocessing at Newcastle University, the first of its kind
in the UK, which has been facilitated by Cels.
With five universities in its midst and Cels’ ongoing
support, the region has pioneered some of the world’s
most groundbreaking scientific research in medical
biotechnology over the past few years. Perhaps the most
well known is the stem cell work by scientists at
Newcastle and Durham universities which could lead to
exciting new treatments for diseases like Parkinson’s and
Alzheimer’s.
To complement this expertise, Cels has continued to
support the commercialisation of the region’s
outstanding research capabilities in subjects such as Cels is also using its commercial and bioscience Cels continues to encourage and promote the region’s
ageing, cancer and immunotherapy. The Institute for expertise to market the Newcastle University Cellular medical biotechnology field in order to maintain the North
Ageing and Health in Newcastle carries out research on Therapy GMP facility in the Bioscience Centre (ICfL). This East as a national leader in healthcare and life sciences,
ageing and age-related illnesses and has the UK’s exciting facility aims to not only assist the region to ensuring the sector continues to evolve, expand and flourish,
biggest interdisciplinary research group in this field. This develop its academic stem cell expertise but also attract bringing new jobs and wealth to the North East Region.
ranges from the fundamental research on molecular new high tech companies to the area.
mechanisms of ageing and age-related disorder, through For further information please visit www.celsatlife.com
to practical lifestyle issues, such as housing, assistive
09
 Research at Durham University is uncovering the potential of
follicle cells to aid tissue regeneration.
Professor Colin Jahoda and his team at Durham University’s School
of Biological and Biomedical Sciences are working at the cutting
edge of bioengineering to develop a fully functional artificial skin.
Skin was the first tissue engineered material to be potential makes them good candidates for future

THE
marketed clinically. However, without skin appendages therapeutic use.
(hair follicles and sebaceous glands) this artificial skin
One of the collaborative research projects managed by
does not look or function like ‘normal’ skin tissue. Such
Professor Jahoda’s team is sponsored by the
grafts have poor success rates (50% at best) and
Technology Strategy Board, a business-led executive
repetitive skin grafting and reconstructive surgery place
non-departmental public body, established by the
a continual drain on the NHS budget (estimated at £160
government and backed by the Department for
million per annum for burn injuries alone). Moreover,

POWER
Innovation, Universities and Skills. The Board’s mission
while great strides have been made in developing
is to promote and support research into, and
lifesaving techniques that regenerate the outer layer of
development and exploitation of, technology and
the skin, the epidermis, researchers have been far less
innovation for the benefit of UK business, in order to
successful in making a replacement dermis that avoids
increase economic growth and improve the quality of
scar formation. Consequently much improvement has
life. In this case, the Durham University group is working
still to be made to improve the aesthetic properties of
in partnership with Avecia Biotechnology located in the
skin after grafting.

OF THE
Using donor human skin tissue, Professor Colin Jahoda
and his team have isolated a reservoir of specialised
dermal cells from the human hair follicle. Jahoda and
colleagues were first to show that these cells could
induce new follicles to form if transplanted into skin.
They have also shown that these cells can heal wounds,
Tees Valley. Together with the Centre for Excellence in
Life Sciences based in Newcastle and partners further
afield at Smith and Nephew and the University of
Brighton, this consortium has anticipated the clinical
market for hair follicle cell derived therapeutics that may
enhance quality of life and increase the UK’s status in
wound healing therapies.

HUMBLE
and possess regenerative properties coupled with a
By working in partnership with the Avecia scientists, led
degree of immune privilege. That is to say, they are not
by Dr Bo Kara, the Durham researchers have been able
so easily rejected as “foreign” when transplanted from
to have access to bioprocessed cells isolated from
one individual to another non-related person. These
human hair follicles. The bioprocessing involves taking a
findings underpin the basis for incorporating these hair
few thousand of the hair follicle cells, and rapidly
follicle stem cells into tissue engineered skin.
expanding cell numbers. A key part of the translation of
Researchers in Professor Jahoda’s group are now

HAIR
laboratory research to clinical cell therapies is
moving a step closer to using these cells to generate an
demonstrating that cells can still perform their required
artificial skin complete with hair follicles, advancing
roles following this type of expansion in culture. The
wound healing therapeutics to augment the treatment of
team at Brighton led by Dr Liz James are then using
burn injuries and chronic wounds such as diabetic foot
their expertise to incorporate the cells into different
ulcers. The Durham researchers have also discovered
support structures to make so called living “skin
these hair follicle cells have many other useful stem cell-
equivalents”. Working together improves understanding
like properties that make them excellent candidates for

FOLLICLE
of these adult follicle cells because functionality can be
a wider range of tissue regeneration applications. For
examined after bio-processing, an important milestone
example the follicle cells can be grown in culture
in translating the usefulness of these cells into a market
conditions that will change them into fat and bone cells,
reality.
both of which open up possible therapeutic options.
The relatively easy accessibility of the hair follicle cells www.dur.ac.uk
compared with other types of adult cells with stem cell

11
BIOTECHNOLOGICAL
SOLUTIONS FOR
SUSTAINABILITY
AND MEDICINE
Biotechnology will make major contributions to sectors such as energy,
contaminated environment management and medicine. Biotechnological based
solutions for economic and social benefit are being developed for these sectors in
the School of Science and Technology at the University of Teesside.
In contrast to fossil-derived diesel, biodiesel represents naphthalene, pyrene). Drs Komang Ralebitso-Senior and
one of the alternative biofuels that will meet our rising Helen Connolly collaborate in an area known as
energy requirements but with reduced carbon dioxide functional ecogenomics, focussing particularly on the
emission. As a consequence, the production of biofuels use of microorganisms as an environmentally friendly,
in the EU-25 has reached more than 10.29 Mega-tons cost-effective and sustainable solution for cleaning
(Mt) in 2007 from nearly 3.2 Mt in 2005. contaminated sites. They are currently working an a
University funded project which uses genechips to
Biodiesel is produced from vegetable oils and fats in the
identify and measure the presence of DNA from different
presence of methanol and a catalyst. A waste- or by-
bacterial communities that have the genes and the
product of the biodiesel process is glycerine; 1 ton of
ability to breakdown these polluting chemicals. Dr
biodiesel will make around 100 Kg of glycerine. The
Connolly implemented the Defra funded biorecycling
European biodiesel industry will release around 600
project which investigated cleaning oil polluted industrial
Ktons glycerine per year. The oversupply of glycerine,
waste by washing with biosurfactants, or biodegradable
due to increasing biodiesel production, will lead to
soaps. Dr Connolly is also leading early work on the
decreasing prices and weak markets. New outlets for
exploitation of nanoparticles to remediate polluted
the crude glycerine released by the biodiesel processes
environments, such as water and soil. A further project
are therefore urgently needed.
led by Dr Richard Lord and funded through the EU Life
Dr Pattanathu Rahman has been examining the programme has been investigating the use of crops to
possibility of using glycerine as feed for biosurfactant de-contaminate metal polluted Brownfield sites. These
production. Biosurfactants are green or environmentally- crops can then be used to generate energy.
friendly products that are similar to soap. Dr Rahman’s
Novel tools are being developed to provide biological
research has involved the production of biosurfactant
information for a variety of situations including medicine
from novel bacteria discovered recently in Teesside,
and the environment. Professor Ali is leading the
Pseudomonas teessidea and Pseudomonas clemancea.
Teesside effort on the integration of biological entities
These bugs produce the biological soap for their survival
within nano and microsystems to create smart systems
in adverse environments. Although they are tiny, they
such as laboratories on a chip. Such tools can carry out
can grow, multiply, produce and excrete biosurfactants
sophisticated biological operations and will be able to
efficiently. Amazingly these bacteria can eat tonnes of
provide large amounts of biological information in a
the waste glycerine and produce biosurfactants from a
convenient, low cost and rapid manner. The key
single cycle of overnight growth! The important and
innovations being developed include the manufacture of
basic requirements they expect during the process is
miniaturised devices, handling of fluidics within them and
favorable temperature (30 C) and some salts (minerals)
the precise positioning and manipulation of biological
in their food. The biocatalysis work is being developed
entities. Specific projects include the development of a
further through the FROPTOP group of Bioscience for
miniaturised 2D gel electrophoresis system that can be
Business cluster.
used for the separation and detection of proteins for the
Bioremediation for contaminated site restoration is diagnosis of disease conditions. This work has been
another key activity at Teesside. A negative legacy of the supported through the Bionet programme with Helena
industrial revolution has been the heavy pollution of Biosciences. Further key projects include an EPSRC
soils, sediments and ground water on key sites such as funded project with IDS Ltd on the development of a
areas surrounding town gas works plants. The Lab-on-a-chip that can perform automated
contaminated sites are often polluted with a complex immunoassay for clinical applications and a bioreactor-
mixture of chemicals which includes heavy metals, on-a-chip that can be used to screen and optimise the
cyanides, petroleum hydrocarbons (e.g. benzene, conditions for microbial growth.
toluene) and polycyclic aromatic hydrocarbons (e.g. www.tees.ac.uk

13
15
NORTH EAST
SCIENTISTS MAKE
BREAKTHROUGH IN THE
FIGHT AGAINST DEADLY
SUPERBUG
A research team led by University of Sunderland
scientists has made a major breakthrough in the fight
against a deadly hospital infection which kills tens of
thousands of people every year.
Experts have discovered a technique for the early
detection of the superbug pseudomonas aeruginosa
which particularly infects patients with cystic fibrosis.
70,000 people worldwide are affected by cystic fibrosis
and, on average, around 50% of those will be infected
with the superbug – 50% of those infected will die.
Although the research concentrated on the superbug’s
relation to cystic fibrosis, pseudomonas aeruginosa also
attacks patients with localized and systemic immune
defects, such as those suffering with burns, patients with
AIDS and cancer.
According to the Centre for Disease Control and
Prevention in the USA, pseudomonas aeruginosa
accounts for 10% of all hospital infections.
While the superbug is very difficult to cure, as it is highly
resistant to antibiotics, early detection makes a huge
difference to a patient’s chances of survival.
Now for the first time, the University of Sunderland–led
team has discovered a technique that can identify the
superbug within 24-48 hours of infection, greatly
increasing a patient’s chances of survival.
The team is led by Professor Paul Groundwater and
Dr Roz Anderson at the University of Sunderland, in
collaboration with colleagues Professor John Perry,
Freeman Hospital, Newcastle, Professor Arthur James,
Northumbria University, and Dr Sylvain Orenga,
bioMérieux, France.
Prof Groundwater says: “This superbug has a massive
impact on people who are immunocompromised.
“It is calculated that 28% of people who have undergone
transplant surgery are infected by pseudomonas
aeruginosa. We hope our research will make a big
difference in the survival rate of many thousands of
vulnerable people throughout the world.
“The bacteria infect the fluid on the lungs of cystic fibrosis
sufferers. It also infects patients in intensive care units. It is
really difficult to treat, and hospital staff need to know very
quickly if someone has been infected by it.
“In our new diagnostic method, a non-coloured compound
reacts with an enzyme present in pseudomonas
aeruginosa and produces a very distinctive purple colour
which indicates the presence of the bacteria. This
technique works on 99% of the strains of this superbug.”
The research has been sponsored by the multinational
biotechnology company bioMérieux. The company, based
in France, designs, develops, and produces a wide range
of diagnosis systems for medicine and industry.
“bioMérieux is very proud to have participated in and
supported this research that will help in the fight against
healthcare associated infections - a strategic focus for our
company,” says Dr. Peter Kaspar, bioMérieux corporate
vice-president of research and development. “This
discovery will enable bioMérieux to bring additional high-
medical value tests to clinicians and positively impact
patients’ treatment and their follow-up care.”
Cystic fibrosis is an inherited chronic disease that affects
the lungs and digestive system. A defective gene and its
protein product cause the body to produce unusually thick,
sticky mucus that clogs the lungs and leads to life-
threatening lung infections, obstructs the pancreas and
stops natural enzymes from helping the body break down
and absorb food.
Pseudomonas aeruginosa is a major cause of infection
among patients with immune defects. It is tolerant to many
detergents, disinfectants and antimicrobial compounds and
is difficult to control in hospitals and institutional
environments. It causes urinary tract infections, respiratory
system infections, dermatitis, soft tissue infections,
bacteremia, bone and joint infections, gastrointestinal
infections and a variety of systemic infections, particularly in
patients with severe burns and in cancer and AIDS patients
who are immunosuppressed. Pseudomonas aeruginosa
infection is a serious problem in patients hospitalized with
cancer, cystic fibrosis, and burns.
bioMérieux has been a world leader in the field of in vitro
diagnostics for 45 years. bioMérieux are based in France,
but have subsidiaries in more than 150 countries. In 2007,
revenues reached e1.063 billion with 84% of sales outside
of France. bioMérieux provides diagnostic solutions which
determine the source of disease and contamination to
improve patient health and ensure consumer safety. For
more information, visit www.biomerieux.com.
www.sunderland.ac.uk
17
NEW
PARTNERSHIP
BRINGS JOBS
Hart Biologicals Ltd began life selling blood testing
reagents – chemicals which are mixed with patients’
blood samples to test how quickly it clots. Clinicians
need this vital information to ensure they prescribe the
right doses of blood thinning drugs. Too little, and the
blood won’t clot and kick-start the healing process; not
enough of the right drugs can lead to life-threatening
clots.
Supplying diagnostic reagents led to a partnership with
two German companies manufacturing blood testing
machinery – Dynabyte Medical and Pentapharm. The
machines are proving so popular with UK hospitals,
Pentapharm is now building premises in Hartlepool to
work specifically with Hart.
And all this is happening after just winning the National
Medilink Award for Export Achievement. Medilink is a
national network of regionally-based independent
organisations which aims to raise the profile of healthcare
technology.
“I’m going to Vienna at dawn tomorrow morning to meet
with Pentapharm. It’s crazy, but in a good way because
our family business is moving forward,” says Alby Pattison,
MD, from his office on the Newburn Bridge Industrial
Estate. “We have established new markets in Germany,
the USA and Spain, which has increased turnover by 47%
and Pentapharm has started recruiting.
“Hart Biologicals’ products have the potential to save the
National Health Service many thousands of pounds,” says
Alby. “The reagents halve the time needed for laboratory
analysis saving two hours of nurse time per sample.”
Dynabyte’s Multiplate Platelet Function Analyser and
ROTEM, made by Pentapharm, give quick results which
benefit patients and, again, saves the NHS money. Peri-
Medilink Award (L to R) Matt Newman, UK
Trade & Investment; Malcolm Pattison, Hart
Biologicals; Kevin Kiely, Chairman Medilink UK.
and post-operative bleeding can lead to complications
and the need for expensive blood products and because
blood only remains stable for a short time, the quick
measurement of clotting potential facilitates specific,
evidence based therapy rather than a general solution.
The Multiplate Platelet Function Analyser was trialled at
the Freeman Hospital in Newcastle for the study of
bypass surgery. The hospital has now bought one for
cardiac patients, as have hospitals in Sussex and
Manchester. The Edinburgh Royal and St Mary’s Hospital
in London, famous for celebrity patients, both have the
machines for general surgery.
Says Alby:” This instrument is now in constant use at the
Great Ormond Street Hospital for Children. It only needs
0.3 ml of blood per test to see how platelets are
functioning so it’s very useful for small, seriously ill children.
“I showed the machine to the haematology laboratory
there. They had a three-year-old girl with a Berlin heart
(an artificial external pump) who was on the transplant list
and they needed to monitor blood clotting around it for
the weeks leading up to her successful transplant. On the
back of that they bought the instrument.”
The ROTEM, currently on trial at the Chelsea and
Westminster Hospital, near the Houses of Parliament, has
two key advantages. It can conduct four tests
simultaneously on one sample and it can be used at the
point of care, not just in a laboratory. Whittington Hospital
in London has just obtained one and, as a result, Hart
Biologicals is now supporting a charity project in
Tanzania, supplying free blood plasma products and
other testing equipment: “They asked us. I couldn’t say
no,” says Alby.
www.hartbio.com

GROWING LIFE
SCIENCE
VENTURES
Ithaka Life Sciences is a biotech consultancy with offices at NETPark, Cambridge, Manchester
and Oxford. NETWorks spoke to Dr Paul Rodgers, Ithaka’s CEO about the company’s success.
Building businesses in the life sciences sector requires
strong but flexible leadership as a venture moves from
start-up to trading profitably and potentially through to
exit. Inputs into the process from outsourced experts
require great sensitivity and skill – with scientific depth,
commercial acumen and staying power to make it
happen.
It is Dr Paul Rodgers’ opinion that founders most likely to
succeed take those critical first steps in the company of
those who have taken that road before them.
Ithaka Life Sciences is all about making it happen. Their
aim is to share knowledge and know-how with their
clients as early as possible to eliminate risk and to prepare
a venture for the journey ahead.
Paul Rodgers is an entrepreneur who is widely
acknowledged within the life sciences market for his work
with young companies. Not only for his scientific,
corporate governance and ‘investment readiness’
expertise; but also for his strong leadership skills, his
ability to work across disciplines, and the insightful way he
builds appropriately skilled teams.
And he has taken the same approach to building Ithaka
Life Sciences – a company he set up in 2000 – that has
quickly built a reputation as one of the UK’s leading
consultancy and interim management service providers,
specialising in the nurture and development of new and
growing life science businesses.
Ithaka has built a team of experts who draw on real
experience in taking science into the commercial market
and share his principles and ideals. It employs 10
commercially and technically astute scientists,
management consultants and business leaders who, prior
to joining Ithaka and since then, have founded 20 life
science companies and raised more than £50 million in
investment finance for early stage ventures.
Companies include: Hydron- Pantherix-Cambridge Drug
Discovery-Xention Discovery- Axis Genetics – Pestax –
Smart Holograms – Pysnova Neurotech.
The team’s specialist knowledge includes: founding
company directors, investment finance; specialist
recruiters; IP strategists; pharmaceutical industry
facilitators and management buyouts experts.
Market expertise includes: pharmaceutical R&D, medical
devices, diagnostics and sensors, agriculture and food
biotechnology. This diverse range of expertise means they
can supply services at each transitioning stage associated
with the company’s growth through to exit.
Ithaka Life Sciences can provide the essential focused
leadership and practical set up and operational management
services at pre-start-up through to exit. The team works
alongside company founders to develop a compelling
investment proposition that fits with their own goals and
ambitions both for the business and for themselves. As the
new venture evolves, they can help source the skills to take it
to the next level.
Dr Paul Rodgers: ‘This is where the Ithaka Team excels. We
remain focused not only on immediate technical and
commercial goals, but on the road ahead. It means obstacles
can be planned for well in advance and pitfalls avoided.’
Ithaka’s services are not just about imparting knowledge; as
well as being strategic, the support is practical and tactical.
This critical hands-on experience means that Ithaka Life
Sciences is well-placed to guide and deliver technical and
commercial strategic planning services for public sector
champions and private investors too. In the North East, they
have worked closely with One NorthEast and the Centre of
Excellence for Life Sciences.
Under Paul’s leadership, the Ithaka Life Science Team has
undertaken more than 100 assignments for over 60 clients; a
high proportion of which is repeat business. And, wherever
you are in the commercial process, Ithaka’s services are
delivered with the same depth and level of commitment
whether you are close to market or just exploring the
commercial opportunities.
Engaging with Ithaka Life Sciences means you gain access
to a much broader spectrum of knowledge both within the
company and via its personal network of more than 800
contacts.
The company has offices in Cambridge, Manchester and
Oxford and, recognising the strength of the North East’s
biotechnology sector, set up an office at NETPark in 2004
providing a centre of expertise and access to a wider
community for the region.
www.ithaka.co.uk
EXAMPLES OF ITHAKA LIFE SCIENCES’ WORK
Strategic Planning Services
■ 2007: Ithaka appointed by One NorthEast to undertake a major regional and wide ranging review of the
types of activity being undertaken within healthcare projects.
Result: Recommendations from Ithaka are now being implemented by One NorthEast.
■ 2006: Ithaka delivered market research to develop a business case for a Positron Emission Tomography
(PET) scanner facility to provide screening services to the NHS and private healthcare service providers,
and to provide drug development services to the pharmaceutical industry.
Result: Investment in the scanner facility is now being implemented.
■ 2005: Ithaka appointed by Cels to develop strategies for the exploitation of two specific stem cell
technologies.
■ 2004: Ithaka appointed to work alongside Cels to develop a strategy and roadmap for commercial
exploitation of embryonic and adult stem cell research at Durham and Newcastle Universities, the Centre
for Life and in local NHS Trusts.
■ 2004: Ithaka delivered market research on the commercial applications of stem cells and obtained
information from over 40 pharmaceutical and biotechnology companies with interests in stem cells.
Examples of Commercial New Venture Development
■ Creative Gene Technology Ltd (CGT) - Durham
2003: Ithaka appointed to undertake a commercial assessment of Durham University spin out plant
genomic and proteomic technologies company, Creative Gene Technology (CGT).
Following the assessment, Paul Rodgers was appointed as a non-executive director of CGT in 2004.
Ithaka Life Sciences has led the development of a commercial strategy and production of the current
business plan.
Results: A total of about £400,000 in funding has been secured from regional investment funds. A £2.5
million funding round is currently in progress.
Paul Rodgers is currently acting Chairman
■ Smart Holograms
Interim management and strategic direction for Smart Holograms. During the establishment of the
business Paul Rodgers was initially the CEO and subsequently Chairman of the Board. Currently Paul is a
non-executive director with particular responsibility for the company’s IP portfolio.
Results: To date, the Company’s technology has attracted venture capital, government grants and
industry funding of over £18 million in its core science base and business. Assignment of patents and an
intellectual property pipeline agreement negotiated with the University
Full time CEO and Chairman recruited for next phase of company development.
First product scheduled for launch in 2008.
■ Pysnova Neurotech
The establishment and early fundraising for Cambridge University new start-up Psynova Neurotech.
Results: Ithaka drafted the business plan and assisted with the setting up of the company. Ithaka is
providing on-going management services to the company.
Paul Rodgers steered the Company through its first funding round as Chairman of the Board. The
Company is now operational and has attracted £2.25 million from venture capital sources.
21
ABOUT NETPARK... NETPark is North East England’s science, engineering
and technology park for the commercialisation of
cutting edge R&D. Companies thrive at NETPark
because of:
■ State of the art facilities and room to grow on a
prestige site
■ Low operating costs
■ Excellent transport links
■ A skilled workforce

Companies at NETPark have access to cutting edge

The first building, the NETPark Research
Institute was opened in 2004. 2200 sq m
specifically designed for R&D and low
volume complex equipment prototyping
and manufacture. Leased to Durham
University for two world-class research
groups: the Centre for Advanced
From green fields to dynamic
Instrumentation and the Semiconductor
science park in next to no time
Crystal Growth and Ceramics Group.
Phase 1 of the NETPark
Incubator followed a year later.
1600 sq m of office, work and
laboratory space and meeting
rooms. Already 100% full
including 2 regional centres of
excellence.
research from 5 universities within 30 minutes drive and
tailored business support that enables them to achieve
their potential. They are part of a like-minded
community that enables each company to flourish,
grow and compete with the best in the world.
NETPark’s focus is on the physical sciences,
particularly plastic electronics, microelectronics,
photonics, nanotechnology, and their application in the
fields of energy, defence, and medical-related
technologies.
13 hectares (Phase 1) are already fully serviced and
another 3 hectare area is in the process of being made
available.
NETPark is developed by a partnership led by Durham
County Council including Sedgefield Borough Council,
One NorthEast and all 5 regional universities.
Management and promotion of NETPark is in the hands
of County Durham Development Company, Durham
County Council’s inward investment arm. Helios City
is the preferred developer for Phase 1.
For more information, visit www.uknetpark.net or
email netpark@wherebusinessgrows.com

Swiftly followed by Phase 2 of
the NETPark Incubator. Total
projected size 2252 sq m, funded
by Durham County Council, One
NorthEast and ERDF.
This year NETPark will be the fastest-growing science park in the UK.
Construction of the Plastic Electronic Technology Centre (PETeC) will be complete this year.
A 3,000 sq m national flagship facility for the development and exploitation of direct write
technologies and flexible functional materials (FFM); revolutionary technology that
The Innovation Village will also be completed
independent forecasts predict will be a £16 billion industry by 2015. Managed by CPI, the
this year. 5 bespoke R&D pods for growing
centre is 1 of only 4 currently being built in the world.
and/or investing companies, developed by
Helios City. The total size will be 2500 sq m -
units in multiples of 250 sq m
23
25
ENHANCING THE
GROWTH OF
CELLS IN THE
LABORATORY
Cell culture techniques help researchers test drugs, learn
about how cells behave, and can even reduce the use of
animals in research. But examining cells in a Petri dish is
very different from looking at how they behave in a living
body. Reinnervate, a Durham University 'spin out'
established in 2002, specialises in the development of
enabling technologies to help overcome the limitations of
current cell culture techniques. Dr Stefan Przyborski is
Director and Chief Scientific Officer of Reinnervate and
spoke to NETWorks about how its proprietary
technologies facilitate research into cell growth and
function in vitro.
Reinnervate has 3 primary areas of interest:
■ the development of more favourable growth conditions
for cells in vitro;
■ the design and synthesis of small molecules that control
cell differentiation;
■ the development of new strategies in neural stem cell
research.
Culturing mammalian cells in the laboratory enables
biotechnologists to investigate the activity of cells, test
drugs and allow the development of new therapeutic
approaches. This technology is used worldwide in
academic institutions and in the healthcare, biotechnology
and pharmaceutical industries.
As biotechnologists look to develop new ways of using cells
in the laboratory and reduce the numbers of animals used
in research, the use of cell culture techniques is predicted
to increase to a billion dollar industry (Global Industry
Analysts Inc. 2006). The market for Reinnervate’s products
is huge.
Cell cultures are used for a broad variety of applications and
the technology has given rise to many important findings
over the years. However, it has to be recognised that when
cells are grown outside the body they’re exposed to
different environmental pressures that influence their
structure and ability to function. Recreation of the in vivo
environment in a Petri dish, multi-well plate or culture flask
is therefore critical to ensure that cultured cells behave in a
manner representative of their counterparts in vivo.
Traditionally cells cultured in Petri dishes in the laboratory
grow on flat two-dimensional (2-D) plastic which is highly
synthetic compared to the three-dimensional (3-D)
environment in the body. As a consequence, cells grown in
the laboratory don’t always function in a realistic fashion
and cell culture assays can provide inaccurate and possibly
misleading data.
This has major repercussions for scientists in biomedical
research and drug development who rely on such data from
cell culture experiments to determine the future direction of
their research programme and product development. So,
there’s enormous demand to create cell-based testing
methods that enable cells to grow more like their native
counterparts and hence produce more accurate data on
cell behaviour and function.
To address this issue, Reinnervate has developed a novel
3-D cell culture system - in brief, scientists at Durham
University have re-engineered the configuration of
polystyrene (the growth substrate material that’s currently
used for the majority of existing cell culture applications)
into a 3-D scaffold that has subsequently been adapted for
cell culture applications. The scaffold is inert and can be
supplied pre-fabricated, sterile and ready to use. This offers
several advantages to the user, including an inexpensive
simple un-wrap and use consumable technology, enabling
reproducibility during routine use, robustness, stability and
less preparation time.
The porosity of the polystyrene scaffold is specially
customized to within narrow tolerances during its
manufacture. This is an important feature to create a
consistent and suitable environment for 3-D cell growth.
Engineering the scaffold into a thin membrane (e.g. 200µm
thick) enables the entry of cells into the interior of its
structure (and out again for cell retrieval) and it’s of suitable
thickness to allow cells sufficient exchange of gases and
Figure 1: Histological section through the polystyrene scaffold (in
white) showing the growth of epidermal skin cells throughout the
structure of the material. Reducing the level of the culture medium to
create an air/liquid interface near the surface of the culture induces
cell stratification (top) mimicking the behaviour of cells within the
epidermis. Specimen embedded in resin, sectioned and stained with
Toluidine Blue. (Image courtesy of Dr R Carnachan).
Cell culture work using this material has shown that the
scaffold provides vertical space to support the growth of
cells to form complex 3-D interactions with their
neighbours, in a way resembling the structure of real
tissues. Optimisation of the growth medium and cell
seeding density results in the growth of cells throughout the
scaffold forming a 3-D block of tissue in vitro (see Figure 1).
Cell viability is maintained at high levels in these cultures
and cells are not exposed to the un-natural geometric
stresses experienced in cells grown on flat surfaces. A
further benefit is that cells grown within polystyrene
scaffolds show enhanced ability to differentiate and respond
to biochemical agents in a manner resembling the activity of
their native counterparts in vivo.
A major challenge in stem cell biology is the ability to
control the development of cells and tissues in a predicable
way. Biotechnologists require molecules that induce reliable
and reproducible biological activity resulting in consistent
modes of cell differentiation. Reinnervate has established a
pipeline for small molecule design and production. This
process involves molecular modelling and design, synthesis,
chemical testing and biological evaluation to generate a
‘tool box’ of well defined compounds for use in cell biology.
For example, retinoids are naturally occurring derivatives of
vitamin A, which play a major role in mammalian
development, and are commonly used to induce the
differentiation of cultured stem cells in the laboratory.
However, such molecules, including the commonly used all-
trans form of retinoic acid, degrade readily. This degradation
is difficult to avoid during the routine use of these molecules
in cell culture and results in the formation of isomers that
effect cell differentiation in alternative ways compared to the
intact parent molecule. This in turn introduces a potential
source of variation in the control of cell differentiation.
To address this problem, Reinnervate has designed and
synthesised a small collection of well-defined synthetic
analogues of retinoic acid that have significantly improved
chemical and physical stability and mimic the biological activity
Figure 2: Fluorescence micrograph showing the expression of the
neural protein NF-200 in populations of neurons derived from human
pluripotent stem cells in response to our lead synthetic retinoid,
EC23. (Image courtesy of Dr V. Christie).
of retinoid derivatives currently used to induce cell differentiation.
The reagents Reinnervate has produced so far possess the
ability to modulate the differentiation of stem cells to form
populations of mature neurons in a robust and reproducible
manner (see Figure 2). With the benefit of improved stability,
the use of these reagents will reduce cellular heterogeneity
in cultures of differentiating cells. Stable, synthetic
modulators of cell differentiation offer distinct advantages
over existing technologies and will be of significant
commercial value. This programme of research is ongoing
and will produce a range of well characterised small
molecules that have proven ability to regulate cell behaviour
in vitro.
Our research, focussed on the identification and
development of biomarkers and cell growth supplements, is
a long term programme which is still in its infancy.
Nevertheless, we’ve already developed a promising in vitro
system to identify neurotrophic factors produced by adult
stem cells that will lead to the production of defined growth
supplements which we believe could be commercialised in
the medium term.
Reinnervate is talking to commercial partners who may wish
to exploit our growth supplements for drug discovery and
development purposes and, longer term, in the
development of clinical applications. Reinnervate has
established a world class academic R&D group at Durham
University in state-of-the-art laboratories and has achieved
great success scientifically. This arrangement has enabled
us to rapidly develop projects from the idea stage to a
tangible technology within a relatively short period of time.
We’re currently preparing to raise significant capital to maintain
our research programme in collaboration with the University
and in the future establish independent premises at NETPark
for our product development and administrative activities.
Dr Stefan Przyborski
www.reinnervate.com
27
 BUSINESS FOR LIFE
AWARDS 2008 SUMMER HEALTHCARE
LAUNCH PARTY PRODUCT DESIGN
Where: Beamish Hall
When:Thursday 3rd July
& DEVELOPMENT
Cost: Free “The Cels InSTeP programme brings together a unique InSTeP is having a real impact on North East Companies
collaboration of regional healthcare, engineering, developing new products in the healthcare sector.
Following the success of the Business for Life Awards 2007, Cels Healthcare Network is pleased to announce the Business product development and design professionals to offer Working across a wide range of technologies including
for Life Awards 2008 will take place on Thursday 4th December 2008 at the prestigious Newcastle Gateshead Hilton. companies the opportunity to ‘fast-track’ the biotechnology columns, diagnostic devices and novel
The awards celebrate the achievements of North East England’s Healthcare Industry. North East England has a successful development of healthcare products, services and wheelchair concepts, Instep is enabling innovative ideas
and thriving healthcare and life sciences economy, featuring world class leaders in biologics manufacturing such as Avecia technology,” explains Dr Mark Jarvis, Programme to become truly market-led products that will make a
Life Sciences and rich subclusters of companies in fields such as medical devices, assistive technology and health informatics. Manager at Cels. significant contribution to the growth of the regional
economy. One company which has benefited from the
“User focused design is of central importance to maximise
help of InSTeP is UK Haptics (see below).
The awards consist of 5 categories: the market potential of medical and healthcare products.
Instep provides a complete programme, providing a clear The delivery of InSTeP client projects is led by
Innovation Award and practical route for the transfer of state-of-the-art Northumbria University’s Centre for Design Research and
Export Achievement Award applied research towards a market-ready product through brings in other regional partners including C2M (UK) Ltd,
Start-up Award expertise including research, concept design, product INEX, Kinneir Dufort, NHS Innovations and Newcastle
Outstanding Growth Award development, user testing, and rapid prototyping.” University’s Resource Centre for Innovation & Design.
Partnership with the NHS Award
“We provide a complete, integrated service If you have any idea that you think InSTeP could help you
to develop, please contact Dr Mark Jarvis on
to small or medium size companies wishing
Each award winner will receive automatic entry into the Medilink UK National Awards, an event which recognises the UK’s 0191 211 2560 or email mark.jarvis@celsatlife.com.
to develop new products or processes, or
most innovative healthcare companies. This year Cels celebrated the region’s success as three out of the five winners of the
national awards hailed from the North East. improve existing ones.”
- Dr Mark Jarvis, InSTeP project delivery manager, Cels
The companies saw their hard work pay off picking up awards recognising achievements across ‘Partnership with the NHS’,
awarded to Peacocks Medical Group Ltd, ‘Growth in sector’, awarded to ImmunoDiagnostic Systems (IDS) Ltd and ‘Export Gary Todd MD UK Haptics
Achievement’, which was awarded to Hart Biologicals Ltd.
This year’s competition will be launched at the Business for Life Awards 2008 Launch Party being held Thursday 3rd July
2008 at Beamish Hall – this is a free event. To book your place, go to www.hcnetnee.com/summerlaunch08. The judging CASE STUDY : UK HAPTICS
will take place in November with the winners being announced at the high profile awards ceremony in December.
The Brief
InSTeP was approached by UK Haptics to develop a medical
instrument adaptor for a new medical training and evaluation tool
enabling users wearing 3D glasses to manipulate a ‘Haptic Pen’ in
the real world, whilst seeing this as a medical tool or piece of
equipment in the virtual environment. Users can practise and be
assessed on performing clinical procedures, with the ‘Haptic Arm’
providing real physical feedback to give the sensation of true
interaction with the virtual environment.

The Project
InSTeP worked with UK Haptics to develop an adaptor, which
would allow the user to hold and manipulate real medical tools
whilst performing the virtual procedure. Though initially focused on
the attachment of cannular needles, the design was ‘future-
proofed’ to enable the attachment of as-yet-unspecified devices.
InSTeP liaised with partners to produce a rapid prototype of the
solution, enabling evaluation in the context of UK Haptics’ current
system.

The Outcome
The speed of development and the provision of a physical
prototype enabled UK Haptics to progress distribution talks with
potential international partners whilst attending a leading US-based
haptic conference. The system has now been sold to a number of
commercial and research clients, while the adaptor prototype is
For further information on the event including currently undergoing user and safety testing.

sponsorship opportunities, please contact Dion Griffith 29

on 0191 211 2568 or dion.griffith@celsatlife.com.

DESIGN
OF THE TIMES
Award winning Sedgefield architects Dewjo’c, which
specialises in highly technical design to create
research and laboratory environments combined with
office space, is bringing its experience to bear on a
series of buildings at NETPark.
Dewjo’c Architects was founded in Middlesbrough in 1900
and from this beginning it has built a thriving architectural
practice with offices in Teesside, Newcastle and London.
Having cut its teeth initially in industrial design for the
growing chemical giant ICI and its many subsidiaries, in
the 1980s Dewjo’c capitalised on its expertise and broke
into the pharmaceutical and research sector.
Dewjo’c is now one of only a few practices in the world
uniting expertise from the disciplines of architecture,
engineering and pharmaceutical process design. Its client
list includes GlaxoSmithKline, MSD, Cardinal Health and
Sanofi-Aventis and it has worked on projects both
nationally and internationally in Poland, China, Germany,
Egypt and Ireland.
Closer to home, Dewjo’c has developed links with the
region’s major higher education establishments, with
successful research projects for Newcastle, Durham and
Teesside universities.
It has effectively completed major projects across most
scientific research disciplines and is currently developing
a fourth major building on Newcastle University’s Campus
for Ageing and Vitality. It recently completed the design of
two stem cells units, one at Cels in Newcastle and the
other at Durham University.
Dewjo’c designed the first building on NETPark – the
Research Institute – for Durham University’s Centre for
Advanced Instrumentation and has gone on to design
the Incubator Building (and its extension, which is
currently under construction) and the PETeC Building
(Plastic Electronics Technology Centre) which is due for
completion later this year.
Through its work in the pharmaceutical sector Dewjo’c
has also completed major projects for biotech companies
including Avecia’s Biologic centre in Billingham, Genzyme
in Suffolk, Lonza Biologics in Slough and Lundbeck on
Seal Sands.
Dewjo’c is also investing heavily in research into
sustainable design. With a number of prestigious awards
in this field, it sees environmental responsibility as a major
influence on 21st Century design.
The practice’s expertise resides in its human resources –
from highly skilled and experienced directors to innovative
architects and an enthusiastic team of technologists.
Dewjo’c recognises the value of close multi-disciplinary
working, particularly in the field of designing specialist
environments and highly complex facilities for research
and manufacturing. It works closely with engineering
colleagues to produce fully co-ordinated solutions with a
depth of understanding unsurpassed in this field.
Dewjo’c has gained an enviable reputation in this sector
for delivering projects which are innovative and
imaginative whilst fulfilling the client’s brief, project
deadlines and budget.
Director Steve Agar, said: “Being involved in the design of
these types of building is always stimulating as specialist
facilities require bespoke solutions. Often, they are a one-
off, focusing on unique technologies or products and this
encourages us to push the boundaries of design to
create something that is as aesthetic as it is practical.
“We bring with us great understanding of what a building
of this nature requires. We have brought that experience
to bear at NETPark, with buildings that deliver both
practically and aesthetically.”
For more information on Dewjo’c Architects contact Steve
Agar on 01740 632 100 or visit
www.dewjoc.com
Far left: (L-R) Chris Ferguson
of Dewjo’c Architects, Kevin
Drew of Whelan and Dave
Wallace of Dewjo’c Architects
on site at the new PETeC
building.
Left: The stunning Dewjo’c
designed Research Institute
building at NETPark.
COMPANIES GAIN
APPOINTMENT WITH NHS
INNOVATIONS TEAM
Biochemistry companies developing new products can Technologies, providing IP advice and support in
now access free support from a team specialising in exploiting the technology in healthcare markets.
the commercialisation of healthcare related intellectual
The point of care tests are a further application of
property (IP).
electronic diagnostic technology being developed by
NHS Innovations North - the NHS Intellectual Property Orla in collaboration with the Japan Radio Company
Management Hub for the North East - has a proven (JRC).
track record in managing the commercialisation of new
The Surface Acoustic Wave (SAW) device allows
ideas and research in the North East, offering assistance
detection of specific disease markers in a blood sample.
to businesses as well as staff employed in the region’s
The markers bind to the surface and alter the acoustic
Trusts.
wave passing across the device.
Specialising in IP assessment, patent searching, market
The breakthrough tests will be able to be carried out at a
research and due diligence, the team also provide
patient’s bedside before being transmitted wirelessly to a
consultancy for businesses looking for support in
laboratory and will result in earlier and more effective
research and development funding applications.
treatment for patients, while providing savings for
Offering a high quality service that includes prior art healthcare providers.
exploration, market assessment and the
The NHS Innovations North team is made up of
commercialisation of new healthcare technology,
consultants with a science and engineering background
consultants have recently assisted a local based
and can offer small and medium sized businesses a
company providing support research into
detailed insight in to healthcare markets and selling
groundbreaking diagnostics devices.
innovation into the NHS.
Newcastle based company, Orla Protein Technologies,
Established in 2002, NHS Innovations North is one of a
has developed an innovation that incorporates protein
national network of regional hubs set up to protect and
assembly and antibody research into wireless electronic
commercialise intellectual property generated within the
devices which can be used at a patients bedside to
UK’s NHS Trusts.
accurately detect markers of disease.
The team has worked on a range of innovative projects
The platform technology can be developed for use in the
including mediums which test for resistance to MRSA
early detection at point of care of a range of illnesses
drugs, speaking aids for patients who have had throat
such as cardiac and arthritis, and also respiratory viruses
cancer and handheld devices used to test for brain
including Respiratory Synchytial Virus (RSV) - a major
injury.
cause of respiratory illness in young children causing
infection of the lungs and breathing passages - and the For more information about NHS Innovations North and
influenza virus, which can lead to serious complications to search for healthcare technologies available for licence
in vulnerable groups. visit www.nhsinnovationsnorth.org.uk or contact the
team on 0191 516 4400.
The NHS Innovations North team at RTC North will
provide management support to Orla Protein
31
ENTREPRENEUR
OF EXPORT BACKS
NORTH EAST
AWARDS
An award-winning export entrepreneur is urging other
firms in the region to take advantage of the opportunities
presented by the North East Exporters Awards 2008.
The awards, sponsored by UK Trade & Investment,
One NorthEast and the North East Chamber of
Commerce (NECC), recognise the efforts of
individuals who have helped their companies boost
their international sales performance.
And one of last year’s winners – Alan Timothy – has
thrown down the gauntlet to others across the region
to send in their nominations.
Alan Timothy, Chief Executive Officer and founder of
Profile Analysis Ltd, which specialises in helping firms to
manage field sales data in order to maximise sales and
sales team performance, was winner of the Innovation
in Export Award in last year’s North East Exporters
Awards.
Profile Analysis is the holding company for Rocket
Science and i-snapshot, which operate in the UK and
overseas. The company has i-snapshot subsidiaries in
the UK, USA and Germany and distribution agreements
covering Australia, Holland, Canada and South Africa.
The company has taken advantage of the full spectrum
of support offered by UK Trade & Investment to help
develop overseas sales of its innovative i-snapshot tool.
The company joined UK Trade & Investment’s flagship
Passport to Export scheme to help develop a workable
and achievable export strategy for the market.
In addition, UK Trade & Investment has provided
information and feedback on sales prospects in the
German market through its Overseas Market
Introduction Service (OMIS). Profile Analysis intends to
fully exploit the value of this market research by using
UK Trade & Investment’s Virtual Export Manager
service.
Alan said: “Winning the award has helped raise the
profile and importance of our overseas activities within
Profile Analysis and was seen by our overseas partners
as reinforcement of our commitment to their markets. I
would encourage all those engaged in export to share
their successes through the awards.”
The winners of the North East Exporters Awards 2008
will be announced at a special gala dinner to be
attended by Lord Digby Jones, Minister for Trade and
Investment, at The Hilton, Gateshead on Thursday, 17
July when leading figures from the world of business
will gather to celebrate the region’s international trade
success. The event is also sponsored by The Royal
Bank of Scotland, Barclays and Emirates.
Entries are now sought for the awards in each of the
five categories: New Exporter Award, Export Award,
Innovation in Export Award, Export Communicator
Award and Passport to Export Award.
The awards will go to those who, in the judges’
opinion, achieved the most for their companies in
pursuit of export business. Each of the winners will
receive a special trophy and £1,000. NE EXPORTERS AWARDS 2007
David Coppock, UK Trade & Investment’s International New Exporter Award: John Aitchison of Comesys Europe with Brian Shaw of UKTI
Trade Director, said: “Alan was a worthy winner and we
Innovation In Export Achievement Award: Alan Timothy of Profile Analysis (Rocket
are delighted to have his support for this year’s awards”. Science) with Roger Stainforth of NECC
For details of how to enter the awards or to purchase Export Communicator Award: David Patrick Bennett of Bison Bede with Zelie Guerin of
tickets, price £55 each or £500 per table, for the North Regional Language Network
East Exporters Dinner on Thursday, 17 July at The Passport To Export Award: Nicki Berriman, wife of winner Chris Berriman of Merit
Hilton, Gateshead, contact the North East Regional Merrell Technology, with Tania Cooper (Chair of North East Regional Trade Office)
International Trade Hotline on 0845 05 05 054 or log
Award For Export Achievement: Darren Jobling of Eutechnyx with Russ Grazier (RBS)
onto www.exportersawards.co.uk. Deadline for
entries is 18th June. The Group Winners are photographed with host Wendy Gibson and Roger Black
33
STOP PRESS!! STOP PRESS!! STOP PRESS!!

NEW CONSULTANTS ALTOMED...PROVIDING

BOOST CBSL
OFFERING
CBSL, the wholly owned subsidiary of Cels, has
expanded its team of consultants by appointing Philip
Aldridge and Andy Copland.
CBSL provides a comprehensive range of business
consultancy, marketing, project management,
investment and innovation management services to a
variety of industry sectors, with a particularly strong
track record in the healthcare and life science markets.
Both Philip and Andy have joined CBSL from Cels and
will be involved in providing a broad range of
consultancy services.
Philip Aldridge, who has been appointed as Senior
Consultant, joined Cels in November 2003 and brought
to the team his expertise in GMP manufacturing. Philip
has process development experience in fermentation,
biotransformation and ultrafiltration operations. He also
has extensive GMP manufacturing experience with bulk
antibiotics and biopharmaceuticals. His experience also
covers the fields of biopharmaceutical drug
development and business development; the latter
LEFT: Philip Aldridge
MIDDLE: Andy Copland
gained in the position of Biotechnology Business
Development Manager for both Synpac and ACS
Dobfar (UK) Ltd. In addition, Philip has GMP
biopharmaceutical facility design experience. He is also
a current member of the BIA’s Manufacturing Advisory
Committee, MAC.
Andy Copland, who has been appointed as Business
Consultant, has over 15 years in operational and
strategic management many of which have been spent
working within the NHS. Andy has been an operational
manager, in primary, community and secondary care.
He has worked as a business manager in medicine and
surgery as well as a planner and commissioner of
mental health and acute services. Andy was also a PFI
Project Board member, leading the service and
functional reviews for a £24m community hospital build
in the east of England. In recent years Andy has been
working in the private sector supporting businesses to
develop and identify new markets and has been leading
a special procurement project for Cels.
THAT PERSONAL
TOUCH
Nestling in a business park in South Tyneside is a firm
which has, over thirty years, been building strong
business relationships with almost every hospital in the
United Kingdom. The activities of Altomed Limited are
almost entirely focused on supplying surgical
instruments and disposables used in eye operations.
Originally in Gateshead and now based at Boldon
Business Park, Altomed remains a privately owned
company, and is run by its three directors including
husband and wife team Peter and Karen Myers. It is
now the UK market leader in supplying ophthalmic
surgical instrumentation to NHS and private hospitals and
employs twenty people.
The product range is wide. It includes stainless steel and
titanium instruments for use in all of the ophthalmological
sub-specialities including cataract, retinal, keratoplasty
and oculo-plastic procedures. In the UK, as well as
supplying Altomed branded instruments, the company
also acts as official importers & distributors for many US
and EU based specialist manufacturers.
Peter Myers, Managing Director, believes that the solid
reputation and profitability the firm has achieved is based
on high levels of personal service which many
multinationals cannot match. “The big players in our
industry, many of them US-based, are excellent at
developing innovative surgical tools, implants and capital
items, but due to their size, they tend to lack the flexibility
to deliver true personal service to end-users in the
hospitals.”
“Our competitors, large and small, are mainly based in
the south-east. We have found that the personalities who
work at Altomed, particularly in customer service roles,
are a vital part of our business. These largely non-
graduate personnel, with local roots, are often highly
praised by our customers, who tend to be operating
theatre staff and surgeons. It’s important that we retain
and reward our excellent people.”
Although many aspects of the firms business involve
high-tech and high-spec products, old fashioned service,
approachability and product knowledge will remain
essential components for challenges ahead.
www.altomed.com

RIGHT: Chad Zhang of

BioToolomics with Philip Aldridge
of CBSL and Eddie Hutchinson,
former chairman of DIDA.

CASE STUDY - BIOTOOLOMICS LTD

Chad Zhang (PhD) founder and Managing Director of
BioToolomics, based in Consett, has extensive academic and
industrial experience of chromatography systems used in the
purification of biopharmaceuticals. When he decided to set
up his company to exploit his novel ideas, he commissioned
CBSL to provide expert guidance and support.
CBSL has worked with Dr Zhang in a number of areas
starting with intellectual property management.
Subsequently CBSL has leveraged finance from both
public and private sources. Initially this was in the form of
grants and proof of concept funds required to prove and
exemplify his technology. Latterly it has been to access
significant funds to facilitate major product launches. In
addition, CBSL has provided access to specialist design
services to further enhance his products.
Philip commented: “Working with Dr Zhang, CBSL has
defined the markets, and route to market, to successfully
exploit his novel technology. We have also enhanced the
business planning process so that his ideas are captured
in a way that has proven attractive to investors.”
“CBSL has given BioToolomics tremendous help across a
range of business development areas. Their strong vision,
broad range of expertise and good networks in the
bioprocessing sector, have really added value to my
company.”
Chad Zhang, Managing Director, BioToolomics Ltd.
For further information on CBSL, contact Mike Hartley,
General Manager on 0191 211 2560.
37
CAN A WELL DRAFTED
PATENT GET YOU “MORE
THAN YOU DESERVE”?
According to a recent Court of Appeal ruling it can.
This is good news for biotech and pharmaceutical
companies who invest in developing new products and
want the broadest possible monopoly on their inventions.
The claims of a patent define the extent of the monopoly
granted to a patentee. Claims may be directed to a
product or to a process (or method). A claim to a product
itself will have the effect of granting to the patentee a
monopoly over all ways of making the product. It may also
give the patentee a monopoly over all uses of the patented
product, including uses he never even thought of!
Consider a patent for new glue, in which a claim covers its
chemical composition.
If, at some time after the patent is filed, the substance turns out
to be useful for a different purpose, e.g. as a plasticiser, the
patentee will have a monopoly over that as well. Even though
the patentee had not thought of using the glue as a plasticiser,
his claim covers the substance itself, so his monopoly extends
to more than he invented – “more than he deserves”.
This was the example given in a recent decision by the Court
of Appeal in H Lundbeck A/S v Generics (UK) Ltd and others.
The case relates to a patent owned by the small research-
based pharmaceutical company Lundbeck. Lundbeck is
based in Denmark and specialises in diseases of the central
nervous system. In 1989 it launched an antidepressant drug
called Citalopram. Citalopram is a racemate consisting of
equal numbers of molecules called enantiomers.
Enantiomers are conventionally designated (+) or (-) and
are molecules with similar physical properties but differing
in shape such that they are mirror images that cannot be
completely superimposed on each other.
Researchers at Lundbeck found a way to separate the
Citalopram racemate into its enantiomers and
discovered that the antidepressant effect was caused entirely
by the (+) enantiomer. Through this research, Lundbeck
developed a new antidepressant drug called Escitalopram,
sold under the brand name Cipralex®. Escitalopram is
essentially the pure (+) enantiomer of Citalopram.
Cipralex® (Escitalopram) became the world’s top selling
branded antidepressant and accounted for 60% of
Lundbeck’s turnover.
Fortunately, Lundbeck had taken steps to protect its
intellectual property rights by filing a new patent to cover
the (+) enantiomer. The patent was drafted to obtain the
broadest possible monopoly on Escitalopram and included
the following claims:
■ Claim 1 - A “product” claim to the (+) enantiomer itself.
■ Claim 3 – A “product” claim to a pharmaceutical
composition comprising the compound.
■ Claim 6 – A “process” (or “method”) claim to a method
of preparing the compound.
When Lundbeck’s patents covering their earlier product
(Citalopram) expired, generics manufacturers were able to
sell generic versions of Citalopram, but they were
prevented from producing Escitalopram. Consequently,
three generics manufacturers attacked the Escitalopram
patent on the grounds of lack of novelty, lack of inventive
step and insufficiency.
“Insufficiency” relates to the requirement that a patent
claim must not be broader than what has been disclosed
in the patent specification.
In 2007, the judge concluded “The first person to find a
way of achieving an obviously desirable goal is not
permitted to monopolise every other way of doing so.
Claims 1 and 3 are too broad. They extend beyond any
technical contribution made by Lundbeck. Claims 1 and 3
of the Patent are invalid for Insufficiency.”
The judge believed that the invention lay in the particular
way of making the (+) enantiomer and that a patentee
should not have a monopoly for “more than he deserves”.
This decision left Lundbeck with only a valid Claim 6 and a
monopoly on its particular method of making the (+)
enantiomer. Without Claims 1 and 3 they could not prevent
generics companies from finding other ways of producing it
and selling generic versions.
Lundbeck appealed the decision and last month, received
a more favourable ruling from the Court of Appeal. This
time, it was stated that the concept that a patentee
“should not have more than he deserves” does not form
part of the statutory test for sufficiency of patent claims.
Claims 1, 3 and 6 of Lundberg’s Escitalopram patent have
therefore been upheld.
This decision is good news for Lundbeck and for other
research-based companies who invent products by
providing new methods of making useful compounds. For
Lundbeck, it means that its twenty year monopoly on
Escitalopram will not be cut short by generics
manufacturers finding other ways of making it.
Through a well drafted patent application, it is possible for a
patentee to get “more than he deserves” and in cases such
as the above, where a single product is key to the success
of a company, strong patent protection is invaluable.
Hargreaves Elsworth Patent Attorneys are currently offering
free “IP Clinics” to local companies who are interested in
discussing ways to protect their inventions or to monitor
competitor patent activity.
For more information please contact Dominic Elsworth on
0191 211 1974.
Author: Juliet Scullion
HIGH QUALITY SERVICES
FOR LIFE SCIENCES
& FINE CHEMICALS
High Force Research Ltd (HFR) offers confidential, environmental impact and economics. Later we offer
high quality services for outsourced synthesis and support in technology transfer to commercial production.
R&D from the scale of grams to kilos for
Laboratory Facilities
pharmaceuticals, life sciences and fine chemicals. Our
HFR, originally based at the Mountjoy Research Centre,
team of chemists has wide experience of multi-step
Durham, relocated in 1996 to purpose built laboratories
organic synthesis, particularly of heterocyclic
in nearby Bowburn, expanded in 2001 to 11,000 sq. ft.
chemistry, catalytic hydrogenation, nucleoside and
Facilities comprise 30 fume hoods and include a Class
amino acid chemistry, fluorination and chiral chemistry.
100,000 clean room suite for cGMP operations. We
A partner for proof-of-concept studies operate in glassware up to 30 litres, with stainless steel
HFR collaborates with discovery groups, start-ups and autoclaves up to 7.5 litres for hydrogenation and
spin-offs from academia and industry in synthesising pressure reactions. Other specialised facilities include
new materials for proof-of-concept studies and in laboratories for electrochemistry, cosmetics formulation
process development on the route to market. We offer a development and a segregated laboratory for handling
fast response and flexible service to customers and corrosive materials including aqueous HF.
partners and can operate on “fee for service”,
Analytical instruments include 270MHz Bruker nmr,
collaborative research or joint venture basis, depending
Agilent 1100 hplcs, Shimadzu glc with headspace
on project and business requirements.
analysis, Jasco ftir, polarimeter and Karl Fischer
cGMP synthesis of APIs autotitrator.
MHRA audited cGMP facilities comprise two segregated
Quality Systems
laboratories, in which we produce from grams to multi-
We recognise that the quality of products and services
kilos of Active Pharmaceutical Ingredients and their
offered to customers and clients is the key to future
intermediates to cGMP standards for pre-clinical studies
growth. Our quality system has separate quality
and Phase 1 clinical trials. One laboratory is dedicated to
assurance and quality control functions to which we
products for oncology, the second to materials for other
have added the capabilities to undertake analytical
therapeutic areas and drug delivery systems.
development and method validation.
Reagents for Diagnostics, Electronics
Ownership/ Contact details
and Reference Materials
HFR was founded in 1988 and is wholly owned by its
We undertake multi-step synthesis of nucleosides and
Directors: Roy Valentine (Research Director), Stuart
other reagents incorporating chromophores for
Penny (Operations Director) and Bob Redfern (Managing
application in novel diagnostic technologies. We also
Director). For further details, contact:
carry out synthesis of pharmaceutical reference
materials, metabolites and impurities as well as High Force Research Ltd
specialised materials for electronics. Bowburn North Industrial Estate, Bowburn, Durham
DH6 5PF, United Kingdom.
Process R&D and Scale–up
We have the capability to devise synthetic routes to new Telephone + 44 (0)191 377 9098
molecules or to identify and evaluate alternatives which Fax + 44 (0)191 377 9099
may avoid hazardous or costly materials. Working at Email: enquiries@highforceresearch.com
both bench-top and kilo-lab scale, we can then develop www.highforceresearch.com
processes to meet targets of yield, specification, safety,
39
Final word
Now and again biotechnology tends to belie the maxim that ‘all
publicity is good publicity’. Sometimes it gets a bad press, as
Andrew Wood has explored in his piece for this issue of
NETWorks.

No one would deny that there are significant moral and ethical
issues, but it’s all a question of balance. Reading about the
innovative work happening here in the region shows that, at its
best, biotechnology is both positive and life-enhancing.

And it builds on a long history of scientific enquiry and innovation.

We humans have been manipulating cells ever since we became
domesticated enough to indulge in cultivating crops and breeding
animals.

The ancient Egyptians understood enough about microbiological

processes to successfully utilise fermentation in their production
of wine and bread. Voyages of discovery introduced corn and
potatoes to the western world, and the western world adapted
them to grow in different conditions.

As far back as the mid-1800s, Gregor Mendel was cross-breeding

traits – one step in a march of human enquiry that led through
Walter Sutton’s suggestion in 1902 that paired chromosomes
might be the carriers of heredity, right up to Watson and Crick
determining the molecular structure of DNA in the early 1950s.

Biotechnology has important applications in the medical,

pharmaceutical, food and environmental services industries –
affecting every aspect of our lives.

And it’s an enormously important sector for the North East – with
Healthcare & Innovation as one of the Three Pillars of the
economic strategy for a region boasting thriving companies and
world-class research. Research that includes the unique
interdisciplinary collaboration that has made the region a focal
point for stem cell research – research founded on producing
cost-effective and ethically-robust health solutions.

Stewart Watkins
Managing Director
County Durham Development Company