NETWorks Magazine Summer 2008 by County Durham Development Company

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

“

hear the issues being

discussed by some of the

most eminent business

people and researchers

in the North East

Although often used to refer to genetic engineering, biotechnology has a much wider 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 Sales Director John Neilson

Creative Director Martin Williamson

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

05 12

UNIVERSITY OF TEESSIDE BIO SOLUTIONS FOR SUSTAINABILITY AND MEDICINE

DURHAM UNIVERSITY THE POWER OF THE HUMBLE HAIR FOLLICLE

ABOUT NETPARK

REINNERVATE ENHANCING THE GROWTH OF CELLS IN THE LABORATORY

CELS BUSINESS FOR LIFE AWARDS 2008

NHS INNOVATIONS NORTH COMPANIES GAIN APPOINTMENTS

CBSL NEW CONSULTANTS BOOST CBSC OFFERING

NRG FOLLOW YOUR INSTINCTS...NOT THE CROWD

DEWJO’C ARCHITECTS DESIGN OF THE TIMES

34 36

ITHAKA GROWING LIFE SCIENCE VENTURES

CELS HEALTHCARE PRODUCT DESIGN & DEVELOPMENTS

UKTI ENTREPRENEUR OF EXPORT BACKS NE AWARDS

HART BIOLOGICALS NEW PARTNERSHIP BRINGS JOBS

29 32

SCIENCE CITY SCIENCE IS THE FUTURE

UNIVERSITY OF SUNDERLAND NE SCIENTISTS MAKE SUPERBUG BREAKTHROUGH

CELS KEEPING THE NE BIOTECH SECTOR AHEAD OF THE FIELD

CELS THE RED, WHITE, GREEN AND BLUE OF BIOTECHNOLOGY

UK BIOSCIENCE INDUSTRY FACTS

ALTOMED ...PROVIDING THAT PERSONAL TOUCH

38 DOMINIC ELSWORTH CAN A WELL DRAFTED PATENT GET YOU “MORE THAN YOU DESERVE”?

UK BIOSCIENCE 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 ■ UK companies have developed 43% of the products in late-stage clinical trials in Europe ■ There are 331 bioscience companies in the UK, employing 22,104 people in the public sector

HIGH FORCE RESEARCH HIGH QUALITY SERVICES

Contributors 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. 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.

■ At the start of 2003, there were 18 profitable bioscience companies in the UK: Amarin Corp, Acambis, Amersham,

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 ■ The UK has been responsible for key breakthroughs in health research, such as the discovery of the structure of

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

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 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 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. MP: Are there ways in which this could be further enhanced? If so, how? CH: The University’s ability to bring together scientific expertise with social policy and humanities has made, and will continue to make, a difference nationally and internationally. Working together with the RDA and NETPark increasingly enables this 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.

THE RED, WHITE, GREEN AND BLUE OF BIOTECHNOLOGY The inaugural NETPark technology debate When you sip your pint of beer you are enjoying the fruits of biotechnology - the use of a biological process to effect a transformation - in this case, the use of yeast to convert sugar to alcohol. It is biotechnology that provides the stain-removing enzymes in your washing powder and the antibiotics that fight off infection. The pace of biotech research is exploding, promising innovations ranging from a cure for certain forms of blindness to molecular computing.

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 wellbeing 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

“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 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.”

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.

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

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 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.

“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.”

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

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. 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 development agency One NorthEast on inward investment, encouraging companies to relocate to the North East. This includes advice on regenerative medicine including stem cell research and biopharmaceuticals (medical drugs produced using biotechnology), addressing the growing world trends in these areas and the regional industrial and academic strengths. Another way in which Cels is driving the sector is that it proactively responded to the government’s Biotechnology Industry Growth Team (BIGT) report: Bioscience 2015, aimed at improving the health and wealth of the country as a whole, as well as that of the 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.

CASE STUDY RegeNer8, The N8 Centre for Translational Regenerative Medicine, is a collaboration between industry, clinicians and academics at the North’s eight most research-intensive universities, known as the N8, which brings together the work of the North of England’s top scientists to advance regenerative therapies to the clinic. The Centre, managed and promoted by Cels, is part of a £6m project funded by the Northern Way, the consortium of the three Northern development agencies .The N8 identified regenerative medicine as one of five key areas that would benefit from virtual and physical centres of industrially focused translational research. Currently an embryonic part of the healthcare technology sector, it has been recognised as offering major opportunities for global economic growth over the next two decades. Safety in regenerative medicine has been set as the core focus for RegeNer8 following consultations with the healthcare industry, which included representatives from bioprocessing – an application of biotechnology, pharmaceuticals, biomaterials and medical devices sectors.

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 ageing, cancer and immunotherapy. The Institute for Ageing and Health in Newcastle carries out research on ageing and age-related illnesses and has the UK’s biggest interdisciplinary research group in this field. This ranges from the fundamental research on molecular mechanisms of ageing and age-related disorder, through to practical lifestyle issues, such as housing, assistive

Cels is also using its commercial and bioscience expertise to market the Newcastle University Cellular Therapy GMP facility in the Bioscience Centre (ICfL). This exciting facility aims to not only assist the region to develop its academic stem cell expertise but also attract new high tech companies to the area.

Cels continues to encourage and promote the region’s medical biotechnology field in order to maintain the North East as a national leader in healthcare and life sciences, ensuring the sector continues to evolve, expand and flourish, bringing new jobs and wealth to the North East Region. For further information please visit www.celsatlife.com 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.

THE POWER OF THE HUMBLE HAIR FOLLICLE

Skin was the first tissue engineered material to be marketed clinically. However, without skin appendages (hair follicles and sebaceous glands) this artificial skin does not look or function like ‘normal’ skin tissue. Such grafts have poor success rates (50% at best) and repetitive skin grafting and reconstructive surgery place a continual drain on the NHS budget (estimated at £160 million per annum for burn injuries alone). Moreover, while great strides have been made in developing lifesaving techniques that regenerate the outer layer of the skin, the epidermis, researchers have been far less successful in making a replacement dermis that avoids scar formation. Consequently much improvement has still to be made to improve the aesthetic properties of skin after grafting. 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, and possess regenerative properties coupled with a degree of immune privilege. That is to say, they are not so easily rejected as “foreign” when transplanted from one individual to another non-related person. These findings underpin the basis for incorporating these hair follicle stem cells into tissue engineered skin. Researchers in Professor Jahoda’s group are now moving a step closer to using these cells to generate an artificial skin complete with hair follicles, advancing wound healing therapeutics to augment the treatment of burn injuries and chronic wounds such as diabetic foot ulcers. The Durham researchers have also discovered these hair follicle cells have many other useful stem celllike properties that make them excellent candidates for a wider range of tissue regeneration applications. For example the follicle cells can be grown in culture conditions that will change them into fat and bone cells, both of which open up possible therapeutic options. The relatively easy accessibility of the hair follicle cells compared with other types of adult cells with stem cell

potential makes them good candidates for future therapeutic use. One of the collaborative research projects managed by Professor Jahoda’s team is sponsored by the Technology Strategy Board, a business-led executive non-departmental public body, established by the government and backed by the Department for Innovation, Universities and Skills. The Board’s mission is to promote and support research into, and development and exploitation of, technology and innovation for the benefit of UK business, in order to increase economic growth and improve the quality of life. In this case, the Durham University group is working in partnership with Avecia Biotechnology located in the 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. By working in partnership with the Avecia scientists, led by Dr Bo Kara, the Durham researchers have been able to have access to bioprocessed cells isolated from human hair follicles. The bioprocessing involves taking a few thousand of the hair follicle cells, and rapidly expanding cell numbers. A key part of the translation of laboratory research to clinical cell therapies is demonstrating that cells can still perform their required roles following this type of expansion in culture. The team at Brighton led by Dr Liz James are then using their expertise to incorporate the cells into different support structures to make so called living “skin equivalents”. Working together improves understanding of these adult follicle cells because functionality can be examined after bio-processing, an important milestone in translating the usefulness of these cells into a market reality. www.dur.ac.uk

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 one of the alternative biofuels that will meet our rising energy requirements but with reduced carbon dioxide emission. As a consequence, the production of biofuels in the EU-25 has reached more than 10.29 Mega-tons (Mt) in 2007 from nearly 3.2 Mt in 2005. Biodiesel is produced from vegetable oils and fats in the presence of methanol and a catalyst. A waste- or byproduct of the biodiesel process is glycerine; 1 ton of biodiesel will make around 100 Kg of glycerine. The European biodiesel industry will release around 600 Ktons glycerine per year. The oversupply of glycerine, due to increasing biodiesel production, will lead to decreasing prices and weak markets. New outlets for the crude glycerine released by the biodiesel processes are therefore urgently needed. Dr Pattanathu Rahman has been examining the possibility of using glycerine as feed for biosurfactant production. Biosurfactants are green or environmentallyfriendly products that are similar to soap. Dr Rahmanâ&#x20AC;&#x2122;s research has involved the production of biosurfactant from novel bacteria discovered recently in Teesside, Pseudomonas teessidea and Pseudomonas clemancea. These bugs produce the biological soap for their survival in adverse environments. Although they are tiny, they can grow, multiply, produce and excrete biosurfactants efficiently. Amazingly these bacteria can eat tonnes of the waste glycerine and produce biosurfactants from a single cycle of overnight growth! The important and basic requirements they expect during the process is favorable temperature (30 C) and some salts (minerals) in their food. The biocatalysis work is being developed further through the FROPTOP group of Bioscience for Business cluster. Bioremediation for contaminated site restoration is another key activity at Teesside. A negative legacy of the industrial revolution has been the heavy pollution of soils, sediments and ground water on key sites such as areas surrounding town gas works plants. The contaminated sites are often polluted with a complex mixture of chemicals which includes heavy metals, cyanides, petroleum hydrocarbons (e.g. benzene, toluene) and polycyclic aromatic hydrocarbons (e.g.

naphthalene, pyrene). Drs Komang Ralebitso-Senior and Helen Connolly collaborate in an area known as functional ecogenomics, focussing particularly on the use of microorganisms as an environmentally friendly, cost-effective and sustainable solution for cleaning contaminated sites. They are currently working an a University funded project which uses genechips to identify and measure the presence of DNA from different bacterial communities that have the genes and the ability to breakdown these polluting chemicals. Dr Connolly implemented the Defra funded biorecycling project which investigated cleaning oil polluted industrial waste by washing with biosurfactants, or biodegradable soaps. Dr Connolly is also leading early work on the exploitation of nanoparticles to remediate polluted environments, such as water and soil. A further project led by Dr Richard Lord and funded through the EU Life programme has been investigating the use of crops to de-contaminate metal polluted Brownfield sites. These crops can then be used to generate energy. Novel tools are being developed to provide biological information for a variety of situations including medicine and the environment. Professor Ali is leading the Teesside effort on the integration of biological entities within nano and microsystems to create smart systems such as laboratories on a chip. Such tools can carry out sophisticated biological operations and will be able to provide large amounts of biological information in a convenient, low cost and rapid manner. The key innovations being developed include the manufacture of miniaturised devices, handling of fluidics within them and the precise positioning and manipulation of biological entities. Specific projects include the development of a miniaturised 2D gel electrophoresis system that can be used for the separation and detection of proteins for the diagnosis of disease conditions. This work has been supported through the Bionet programme with Helena Biosciences. Further key projects include an EPSRC funded project with IDS Ltd on the development of a Lab-on-a-chip that can perform automated immunoassay for clinical applications and a bioreactoron-a-chip that can be used to screen and optimise the conditions for microbial growth. www.tees.ac.uk 13

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.

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.”

Experts have discovered a technique for the early detection of the superbug pseudomonas aeruginosa which particularly infects patients with cystic fibrosis.

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.

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.

“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 highmedical 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 lifethreatening 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

“In our new diagnostic method, a non-coloured compound 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. PeriMedilink 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

EXAMPLES OF ITHAKA LIFE SCIENCES’ WORK

GROWING LIFE SCIENCE VENTURES

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.

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.

■ 2004: Ithaka appointed to work alongside Cels to develop a strategy and roadmap for commercial

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.

■ 2004: Ithaka delivered market research on the commercial applications of stem cells and obtained

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.

exploitation of embryonic and adult stem cell research at Durham and Newcastle Universities, the Centre for Life and in local NHS Trusts. 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.

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 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 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.

From green fields to dynamic science park in next to no time

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 Instrumentation and the Semiconductor 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.

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

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.

Swiftly followed by Phase 2 of the NETPark Incubator. Total projected size 2252 sq m, funded by Durham County Council, One NorthEast and ERDF.

The Innovation Village will also be completed this year. 5 bespoke R&D pods for growing and/or investing companies, developed by Helios City. The total size will be 2500 sq m units in multiples of 250 sq m

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 independent forecasts predict will be a £16 billion industry by 2015. Managed by CPI, the centre is 1 of only 4 currently being built in the world.

ENHANCING THE GROWTH OF CELLS IN THE LABORATORY

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 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.

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).

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 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).

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 alltrans 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

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 LAUNCH PARTY Where: Beamish Hall When:Thursday 3rd July Cost: Free Following the success of the Business for Life Awards 2007, Cels Healthcare Network is pleased to announce the Business for Life Awards 2008 will take place on Thursday 4th December 2008 at the prestigious Newcastle Gateshead Hilton. The awards celebrate the achievements of North East England’s Healthcare Industry. North East England has a successful and thriving healthcare and life sciences economy, featuring world class leaders in biologics manufacturing such as Avecia Life Sciences and rich subclusters of companies in fields such as medical devices, assistive technology and health informatics. The awards consist of 5 categories:

Innovation Award Export Achievement Award Start-up Award Outstanding Growth Award Partnership with the NHS Award Each award winner will receive automatic entry into the Medilink UK National Awards, an event which recognises the UK’s 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. 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 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 will take place in November with the winners being announced at the high profile awards ceremony in December.

HEALTHCARE PRODUCT DESIGN & DEVELOPMENT “The Cels InSTeP programme brings together a unique collaboration of regional healthcare, engineering, product development and design professionals to offer companies the opportunity to ‘fast-track’ the development of healthcare products, services and technology,” explains Dr Mark Jarvis, Programme Manager at Cels. “User focused design is of central importance to maximise the market potential of medical and healthcare products. Instep provides a complete programme, providing a clear and practical route for the transfer of state-of-the-art applied research towards a market-ready product through expertise including research, concept design, product development, user testing, and rapid prototyping.”

“We provide a complete, integrated service to small or medium size companies wishing to develop new products or processes, or improve existing ones.”

InSTeP is having a real impact on North East Companies developing new products in the healthcare sector. Working across a wide range of technologies including biotechnology columns, diagnostic devices and novel wheelchair concepts, Instep is enabling innovative ideas to become truly market-led products that will make a significant contribution to the growth of the regional economy. One company which has benefited from the help of InSTeP is UK Haptics (see below). The delivery of InSTeP client projects is led by Northumbria University’s Centre for Design Research and brings in other regional partners including C2M (UK) Ltd, INEX, Kinneir Dufort, NHS Innovations and Newcastle University’s Resource Centre for Innovation & Design. If you have any idea that you think InSTeP could help you to develop, please contact Dr Mark Jarvis on 0191 211 2560 or email mark.jarvis@celsatlife.com.

- Dr Mark Jarvis, InSTeP project delivery manager, Cels Gary Todd MD UK Haptics

CASE STUDY : UK HAPTICS 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 ‘futureproofed’ 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.

For further information on the event including sponsorship opportunities, please contact Dion Griffith on 0191 211 2568 or dion.griffith@celsatlife.com.

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 currently undergoing user and safety testing.

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.

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 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.

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.

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.

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 oneoff, 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

COMPANIES GAIN APPOINTMENT WITH NHS INNOVATIONS TEAM Biochemistry companies developing new products can now access free support from a team specialising in the commercialisation of healthcare related intellectual property (IP). NHS Innovations North - the NHS Intellectual Property Management Hub for the North East - has a proven track record in managing the commercialisation of new ideas and research in the North East, offering assistance to businesses as well as staff employed in the region’s Trusts. Specialising in IP assessment, patent searching, market research and due diligence, the team also provide consultancy for businesses looking for support in research and development funding applications. Offering a high quality service that includes prior art exploration, market assessment and the commercialisation of new healthcare technology, consultants have recently assisted a local based company providing support research into groundbreaking diagnostics devices. Newcastle based company, Orla Protein Technologies, has developed an innovation that incorporates protein assembly and antibody research into wireless electronic devices which can be used at a patients bedside to accurately detect markers of disease.

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.

The platform technology can be developed for use in the early detection at point of care of a range of illnesses such as cardiac and arthritis, and also respiratory viruses including Respiratory Synchytial Virus (RSV) - a major cause of respiratory illness in young children causing infection of the lungs and breathing passages - and the influenza virus, which can lead to serious complications in vulnerable groups. The NHS Innovations North team at RTC North will provide management support to Orla Protein

Technologies, providing IP advice and support in exploiting the technology in healthcare markets. The point of care tests are a further application of electronic diagnostic technology being developed by Orla in collaboration with the Japan Radio Company (JRC). The Surface Acoustic Wave (SAW) device allows detection of specific disease markers in a blood sample. The markers bind to the surface and alter the acoustic wave passing across the device. The breakthrough tests will be able to be carried out at a patient’s bedside before being transmitted wirelessly to a laboratory and will result in earlier and more effective treatment for patients, while providing savings for healthcare providers. The NHS Innovations North team is made up of consultants with a science and engineering background and can offer small and medium sized businesses a detailed insight in to healthcare markets and selling innovation into the NHS. Established in 2002, NHS Innovations North is one of a national network of regional hubs set up to protect and commercialise intellectual property generated within the UK’s NHS Trusts. The team has worked on a range of innovative projects including mediums which test for resistance to MRSA drugs, speaking aids for patients who have had throat cancer and handheld devices used to test for brain injury. For more information about NHS Innovations North and to search for healthcare technologies available for licence visit www.nhsinnovationsnorth.org.uk or contact the team on 0191 516 4400.

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. David Coppock, UK Trade & Investment’s International Trade Director, said: “Alan was a worthy winner and we are delighted to have his support for this year’s awards”. For details of how to enter the awards or to purchase tickets, price £55 each or £500 per table, for the North East Exporters Dinner on Thursday, 17 July at The Hilton, Gateshead, contact the North East Regional International Trade Hotline on 0845 05 05 054 or log onto www.exportersawards.co.uk. Deadline for entries is 18th June.

NE EXPORTERS AWARDS 2007 New Exporter Award: John Aitchison of Comesys Europe with Brian Shaw of UKTI Innovation In Export Achievement Award: Alan Timothy of Profile Analysis (Rocket Science) with Roger Stainforth of NECC Export Communicator Award: David Patrick Bennett of Bison Bede with Zelie Guerin of Regional Language Network Passport To Export Award: Nicki Berriman, wife of winner Chris Berriman of Merit Merrell Technology, with Tania Cooper (Chair of North East Regional Trade Office) Award For Export Achievement: Darren Jobling of Eutechnyx with Russ Grazier (RBS) The Group Winners are photographed with host Wendy Gibson and Roger Black 33

STOP PRESS!! STOP PRESS!! STOP PRESS!!

NEW CONSULTANTS 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

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.

LEFT: Philip Aldridge MIDDLE: Andy Copland 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.

ALTOMED...PROVIDING 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 nongraduate 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

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.

■ 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 If, at some time after the patent is filed, the substance turns out permitted to monopolise every other way of doing so. to be useful for a different purpose, e.g. as a plasticiser, the Claims 1 and 3 are too broad. They extend beyond any patentee will have a monopoly over that as well. Even though technical contribution made by Lundbeck. Claims 1 and 3 the patentee had not thought of using the glue as a plasticiser, of the Patent are invalid for Insufficiency.” his claim covers the substance itself, so his monopoly extends to more than he invented – “more than he deserves”. The judge believed that the invention lay in the particular way of making the (+) enantiomer and that a patentee This was the example given in a recent decision by the Court should not have a monopoly for “more than he deserves”. of Appeal in H Lundbeck A/S v Generics (UK) Ltd and others. This decision left Lundbeck with only a valid Claim 6 and a The case relates to a patent owned by the small researchmonopoly on its particular method of making the (+) based pharmaceutical company Lundbeck. Lundbeck is enantiomer. Without Claims 1 and 3 they could not prevent based in Denmark and specialises in diseases of the central generics companies from finding other ways of producing it nervous system. In 1989 it launched an antidepressant drug and selling generic versions. called Citalopram. Citalopram is a racemate consisting of equal numbers of molecules called enantiomers. Lundbeck appealed the decision and last month, received a more favourable ruling from the Court of Appeal. This Enantiomers are conventionally designated (+) or (-) and time, it was stated that the concept that a patentee are molecules with similar physical properties but differing “should not have more than he deserves” does not form in shape such that they are mirror images that cannot be part of the statutory test for sufficiency of patent claims. completely superimposed on each other. Claims 1, 3 and 6 of Lundberg’s Escitalopram patent have Researchers at Lundbeck found a way to separate the therefore been upheld. Citalopram racemate into its enantiomers and This decision is good news for Lundbeck and for other discovered that the antidepressant effect was caused entirely research-based companies who invent products by by the (+) enantiomer. Through this research, Lundbeck providing new methods of making useful compounds. For developed a new antidepressant drug called Escitalopram, Lundbeck, it means that its twenty year monopoly on sold under the brand name Cipralex®. Escitalopram is Escitalopram will not be cut short by generics essentially the pure (+) enantiomer of Citalopram. manufacturers finding other ways of making it. Cipralex® (Escitalopram) became the world’s top selling Through a well drafted patent application, it is possible for a branded antidepressant and accounted for 60% of patentee to get “more than he deserves” and in cases such Lundbeck’s turnover. as the above, where a single product is key to the success Fortunately, Lundbeck had taken steps to protect its of a company, strong patent protection is invaluable. intellectual property rights by filing a new patent to cover Hargreaves Elsworth Patent Attorneys are currently offering the (+) enantiomer. The patent was drafted to obtain the free “IP Clinics” to local companies who are interested in broadest possible monopoly on Escitalopram and included discussing ways to protect their inventions or to monitor the following claims: competitor patent activity. ■ Claim 1 - A “product” claim to the (+) enantiomer itself. For more information please contact Dominic Elsworth on ■ Claim 3 – A “product” claim to a pharmaceutical 0191 211 1974. composition comprising the compound.

HIGH QUALITY SERVICES FOR LIFE SCIENCES & FINE CHEMICALS High Force Research Ltd (HFR) offers confidential, high quality services for outsourced synthesis and R&D from the scale of grams to kilos for pharmaceuticals, life sciences and fine chemicals. Our team of chemists has wide experience of multi-step organic synthesis, particularly of heterocyclic chemistry, catalytic hydrogenation, nucleoside and amino acid chemistry, fluorination and chiral chemistry. A partner for proof-of-concept studies HFR collaborates with discovery groups, start-ups and spin-offs from academia and industry in synthesising new materials for proof-of-concept studies and in process development on the route to market. We offer a fast response and flexible service to customers and partners and can operate on “fee for service”, collaborative research or joint venture basis, depending on project and business requirements. cGMP synthesis of APIs MHRA audited cGMP facilities comprise two segregated laboratories, in which we produce from grams to multikilos of Active Pharmaceutical Ingredients and their intermediates to cGMP standards for pre-clinical studies and Phase 1 clinical trials. One laboratory is dedicated to products for oncology, the second to materials for other therapeutic areas and drug delivery systems. Reagents for Diagnostics, Electronics and Reference Materials We undertake multi-step synthesis of nucleosides and other reagents incorporating chromophores for application in novel diagnostic technologies. We also carry out synthesis of pharmaceutical reference materials, metabolites and impurities as well as specialised materials for electronics. Process R&D and Scale–up We have the capability to devise synthetic routes to new molecules or to identify and evaluate alternatives which may avoid hazardous or costly materials. Working at both bench-top and kilo-lab scale, we can then develop processes to meet targets of yield, specification, safety,

environmental impact and economics. Later we offer support in technology transfer to commercial production. Laboratory Facilities HFR, originally based at the Mountjoy Research Centre, Durham, relocated in 1996 to purpose built laboratories in nearby Bowburn, expanded in 2001 to 11,000 sq. ft. Facilities comprise 30 fume hoods and include a Class 100,000 clean room suite for cGMP operations. We operate in glassware up to 30 litres, with stainless steel autoclaves up to 7.5 litres for hydrogenation and pressure reactions. Other specialised facilities include laboratories for electrochemistry, cosmetics formulation development and a segregated laboratory for handling corrosive materials including aqueous HF. Analytical instruments include 270MHz Bruker nmr, Agilent 1100 hplcs, Shimadzu glc with headspace analysis, Jasco ftir, polarimeter and Karl Fischer autotitrator. Quality Systems We recognise that the quality of products and services offered to customers and clients is the key to future growth. Our quality system has separate quality assurance and quality control functions to which we have added the capabilities to undertake analytical development and method validation. Ownership/ Contact details HFR was founded in 1988 and is wholly owned by its Directors: Roy Valentine (Research Director), Stuart Penny (Operations Director) and Bob Redfern (Managing Director). For further details, contact: High Force Research Ltd Bowburn North Industrial Estate, Bowburn, Durham DH6 5PF, United Kingdom. Telephone + 44 (0)191 377 9098 Fax + 44 (0)191 377 9099 Email: enquiries@highforceresearch.com www.highforceresearch.com

Author: Juliet Scullion 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