THE SCIENCEENGINEERING &TECHNOLOGYMAGAZINE FORNORTH EASTENGLAND

ISSUE 6SUMMER2008

BIOTECHNOLOGY

ISSN 1753-6677

THE POWER OF THEHUMBLE HAIR FOLLICLE

SUPERBUGBREAKTHROUGH

THE RED, WHITE,GREEN AND BLUE

OF BIOTECH

This issue of NETWorks follows closely on from NETWorks Issue 5 (please visitwww.uknetpark.net to download a copy). Having explored medical devices, we nowhave a look at biotechnology, a completely different aspect of healthcare.

Although often used to refer to genetic engineering, biotechnology has a much widerrange of applications including pharmaceutical, agricultural and the latest hot buttonissue – biofuels. Many of these were debated at the inaugural NETWorks technologydebate at NETPark where we were privileged to hear the issues being discussed bysome of the most eminent business people and researchers in the North East. Thisdebate is documented on pages 5,6 and 7. We hope to make this a quarterly eventso please contact me at networks@wherebusinessgrows.com if you are interested inattending.

For this issue, the NETWorks team had a guest editor – Mike Asher, CEO of Cels, theCentre 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 interestingexperience for the team at Cels – Cels sits at the heart of the support infrastructurefor biotechnology and healthcare in the region and we hope that this issue ofNETWorks illustrates the strength and diversity of academic research and commercialenterprises in this sector. What is especially valuable in the North East is the mix ofnew and long-established companies: new companies such as Reinnervate, aCompany active in the development of 3-D scaffolds for growing stem cells, sitcomfortably alongside companies such as Immunodiagnostic Systems Limited whichhas been flourishing in the North East for many years. I am also delighted that wesecured an interview with Professor Chris Higgins, the Vice Chancellor of DurhamUniversity 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 oftesting cells, to literally “growing” energy. And perhaps the greatest testament to this isthe fact that a Cambridge biotech consultancy, Ithaka Life Sciences, chose to set upan outpost at NETPark, to take advantage of the opportunities available in this region.”

MA

Editor Catherine JohnsScientific Advisor Professor John AnsteeDeputy Editor Rob Heslop

NETWorks is published by Distinctive Publishing LtdAidan House, Sunderland Road, Gateshead, Tyne and Wear NE8 3HUTelephone 0191 298 3571

Managing Director Barrie Miller Creative Director Martin WilliamsonSales Director John Neilson

For all enquiries including editorial, subscription and advertising please contactDistinctive Publishing.

With thanks to all our contributors.

NETWorks is supported by NETPark www.uknetpark.net

Letter from the Editor

01

...we were privileged to

hear the issues being

discussed by some of the

most eminent business

people and researchers

in the North East

“ “

10

03 05

12

16 18

22 26

29 30

3432

UK BIOSCIENCEINDUSTRY FACTS

HART BIOLOGICALSNEW PARTNERSHIP

BRINGS JOBS

CELSTHE RED, WHITE,GREEN AND BLUE

OF BIOTECHNOLOGY

ABOUT NETPARK

UKTIENTREPRENEUR OFEXPORT BACKS NE

AWARDS

DURHAMUNIVERSITY

THE POWER OFTHE HUMBLE

HAIR FOLLICLE

REINNERVATEENHANCING THE

GROWTH OF CELLSIN THE

LABORATORY

UNIVERSITY OFSUNDERLAND

NE SCIENTISTSMAKE SUPERBUGBREAKTHROUGH

UNIVERSITY OFTEESSIDE

BIO SOLUTIONS FORSUSTAINABILITYAND MEDICINE

CELSHEALTHCARE

PRODUCT DESIGN& DEVELOPMENTS

DEWJO’CARCHITECTS

DESIGN OF THETIMES

08

14

20

28

31

35

ITHAKAGROWING LIFE

SCIENCEVENTURES

CELSKEEPING THE NEBIOTECH SECTOR

AHEAD OF THEFIELD

36 38NRG

FOLLOW YOURINSTINCTS...NOT

THE CROWD

DOMINIC ELSWORTHCANAWELLDRAFTED

PATENT GET YOU“MORE THAN YOU

DESERVE”?

39HIGH FORCERESEARCH

HIGH QUALITYSERVICES

CELSBUSINESS FOR LIFE

AWARDS 2008

SCIENCE CITYSCIENCE IS THE

FUTURE

ALTOMED...PROVIDING THATPERSONAL TOUCH

NHS INNOVATIONSNORTH

COMPANIES GAINAPPOINTMENTS

� UK bioscience companies have produced 42 marketed biotech drugs with a further 7 waiting for approval and atleast 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

� 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, CobraBiomanufacturing, 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 ofDNA, sequencing one-third of the human genome, monoclonal antibody production, recombinant insulin, geneticregulation 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’sscience, 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 and3.6 in Japan

CBSLNEW CONSULTANTS

BOOST CBSCOFFERING

03

Contributors

Mike Asher is CEO of Cels and has over 20 years experience in business, of which 14 have been spent running international science andhealthcare-related businesses. Mike’s experience in the health industry includes working on a consultancy basis with the NHS to develop astrategy aimed at delivering greater commercial focus to its procurement activities. Before that he ran medical diagnostics company DrewScientific Group PLC which specialised in diabetes and haematology testing systems. As Chief Executive Officer he achieved sales growthof 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 NorthernEcho. He was named North East Business Writer of the Year before joining the North East Chamber of Commerce where he wasresponsible 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 corporatemedia relations for Dow Chemicals. Andrew was editor-in-chief of Chemical Week, the world's leading chemical industry magazine for 10years before relocating back to the North East.

UK BIOSCIENCEINDUSTRY FACTS

Professor Higgins has strong links with Durham - he graduatedfrom Durham (Grey College) with a first class degree in Botanyin 1976 and a PhD in 1979. His father moved to Durham in1979 as Head of the Department of Mathematics, retiring in1991, and Chris's daughter graduated from Durham(Collingwood College) in Politics in 2005. Christopher haspublished over 200 research papers in leading journals andhas received many awards for his research. He discovered,characterized (and even named) the ABC family of membranetransporters responsible for transporting small molecules(nutrients, hormones etc) into and out of all cells. The ABCprotein family includes many proteins of medical importanceincluding the cystic fibrosis protein and the protein whichcauses resistance of cancers to chemotherapy. Christopherhas always endeavoured to ensure that his fundamentaldiscoveries are exploited - his team carried out the first clinicaltrials for cystic fibrosis gene therapy in the UK.

MP: The UK biotechnology sector is number one in Europefor research and development and second only to the US inthe world. How is Durham playing a role in this success?CH: Durham is the leading university for natural sciencesoutside the ‘Golden Triangle’. We have exceptional strengths inthe core sciences, particularly Physics, Chemistry, Biology,Engineering and Mathematics. This enables us to attract thebest students to the region from across the UK and the world,many of whom contribute to regional technology sectors afterthey graduate. Durham scientists are leading manydevelopments at NETPark working in Durham’s ownlaboratories on site, through the development and exploitationof regional facilities such as PETeC (the Plastic ElectronicsTechnology Centre), and through successful spin-outcompanies which have emerged from the University such asDurham Scientific Crystals.

MP: What opportunities exist, or will exist in the future, tohelp to build upon the reputation in this field?CH: I might, perhaps mention three key areas. In the fields ofplastic electronics and photovoltaics, combining physics andchemistry, Durham University leads the UK consortium that isadvancing science in this area - much of this work is being,and will increasingly be exploited through NETPark. TheUniversity working with CPI and NETPark provides one of thebest national, and indeed world-wide opportunities to takebasic laboratory research through to economic benefit in theprocess industries. In biology and medicine, the North EastStem Cell Institute (NESCI), a partnership between DurhamUniversity, Newcastle University Medical School, the Centre forLife and the NHS, is a UK leader in advancing regenerativemedicine.

MP: How would you sum up the role that the University ofDurham is undertaking to further science research?CH: Durham University aims to undertake the highest calibre ofresearch addressing the most significant questions of a globalnature and impact. These fundamental discoveries have had,and will continue to have, major impact nationally andinternationally. For example, Durham has, arguably, contributedas much to our understanding of the nature and the origin ofthe Universe in the last decade as any University world-wide.We are intimately involved in design and analysis ofexperiments to be carried out on the world’s largest particleaccelerator recently commissioned at CERN. Fundamental

research has many unexpected economic benefits and withoutit there would be no basis for any applied research anddevelopment. For example, the University manufactures atNETPark many of the sophisticated instruments for the biggesttelescopes around the world (and now also for space probes).Hawkeye, the worldwide technology used to monitor ballmovements in cricket, tennis snooker and other sports, wasestablished by a Durham PhD student who had beendeveloping the mathematics necessary to analyse movementof sub-atomic particles.

MP: What role does the university play in prosperingentrepreneurship in County Durham and the wider NorthEast in cutting edge fields such as biotechnology?CH: Through its international leadership in science, andapproach to learning which produces graduates that are botheducated and entrepreneurial, the University ensures some ofthe best talent from around the world is brought to the NorthEast. Our Centre for Entrepreneurial Learning, led by DinahBennett of ‘Women in the Network’ fame, aims to instilenterprise and entrepreneurship throughout the wholeUniversity. We bring many of the best scientists from aroundthe world to live and work in County Durham and the widerNorth East, which helps attract businesses. Durham Universityworks increasingly with NETPark, the Regional DevelopmentAgency One NorthEast, and the ‘Centres of Excellence’ topromote economic development and strengthen theopportunities to develop ideas in Durham, Teesside and theregion. Our input has, I believe, contributed to NETParkbecoming one of the leading science parks in the North ofEngland.

MP: Are there ways in which this could be furtherenhanced? If so, how?CH: The University’s ability to bring together scientific expertisewith social policy and humanities has made, and will continueto make, a difference nationally and internationally. Workingtogether with the RDA and NETPark increasingly enables thisglobal excellence to benefit the North East. For example, ourGeographers have developed joint projects with ONE to helpsupport economic prosperity through the Boulby mine. Ourworld-class research facilities, staff and talented graduates area critical attractor to cutting-edge companies that are lookingto locate in the area. Our network of graduates andpostgraduates in key positions around the world bring loyalty(and business) to Durham and the North East.

MP: In global terms, how important is it for County Durhamto have such a strong university at its heart?CH: Durham University is critical to the economy and well-being of County Durham and beyond (don’t forget thatNETPark is half-way between our two major sites in Durhamand Stockton), both as a leading educational institutiongenerating new knowledge, and as a major business andemployer in its own right. Our increasing leadership ineducation and enhancing aspiration in County Durham andTeesside will also help realise home-grown potential. With itsworld-wide reach the University raises the profile of the regionto economic advantage. As an example, the global reach andinfluence of our students helped ensure Lech Walesa’s recenteconomic visit to the UK on behalf of Poland was to Durhaminstead of London or Edinburgh.

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.

When you sip your pint of beer you are enjoying the fruits of biotechnology - the use of a biologicalprocess 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 antibioticsthat fight off infection. The pace of biotech research is exploding, promising innovations ranging

from a cure for certain forms of blindness to molecular computing.

05

THE RED, WHITE,GREEN AND BLUE OFBIOTECHNOLOGY

The inaugural NETPark technology debate

But while biotechnology has been in use for thousands ofyears, it is still often poorly understood. In particular, manycutting-edge developments that involve the use of geneticengineering are causing concern about scientists“interfering with nature.”

In an effort to discuss these and other questions aboutbiotechnology, County Durham Development Companyrecently convened a panel of top regional experts atNETPark. It was the inaugural session of a quarterly seriesthat NETPark aims to organise around differenttechnology themes.

The panel, chaired by Mike Asher, CEO of Cels, theorganisation driving the growth of the North East Healthcareand Life Science sector, discussed several questions,including the definition of biotechnology, the huge number ofopportunities stemming from current research initiatives, aswell as regulatory, educational, and ethical issues. While thepotential of biotechnology is seemingly boundless, theparticipants stressed the importance of education and opendialogue with the public and the media about biotechnologyto allay any potential concerns, particularly around issuessuch as stem cell research.

“There is an exciting future for biotechnology,” Mr Ashersaid. “Developments are evolving at an ever-increasingpace. However, they come with a series of ethicalquestions, and it is important to address these with thepublic and the media.”

The other panel members were Professor John Anstee,NETPark Scientific Director; Professor Chris Hutchison ofDurham University’s School of Biological and BiomedicalSciences; Nigel Perry, CEO of the Centre for ProcessInnovation (CPI); Dr. Mike Pitkethly, Deputy CEO of CPI;and Professor Miles Whittington, Professor ofNeuroscience at Newcastle University.

Biotechnology can be most broadly defined as the use ormanipulation of a biological system to reach a particularendpoint, Professor Whittington said. However, there are anumber 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 toenhance its properties, or resist certain pests. Blue refers tomarine biotech—a relatively new field. White is used to

describe industrial uses, and red for medical applications.Perhaps the most excitement surrounds red biotech,particularly the use of modified stem cells in novel medicaltreatments. “Biotechnology is substantially improving theoutcomes of many diseases,” Professor Whittington said.“New brain stimulation devices are allowing people withParkinson’s Disease to function normally, while in the US,researchers have implanted an artificial retina that canrestore some light sensitivity in a blind patient.”

There is already considerable strength in stem cell researchin the North East, particularly embryonic stem cells atNewcastle University, and adult stem cells at DurhamUniversity. Local companies are also on the cutting edge.Avecia, based at Billingham, is developing stem cells thatgrow new skin to cure burns, Professor Hutchison said.

Professor Hutchison also pointed out that stem celltechnology has already been in use for many years inmedicine—the process of bone marrow donation to acancer patient from a relative is a transfer of stem cells.However, the use of embryonic or hybrid stem cells hasgenerated resistance among members of some religiousgroups, and the panel members stressed the need for clearcommunication about the benefits of the technology.

Professor Hutchison’s group is involved in weekend “roadshows” to educate the public about stem cell work. Thegroup also invited politicians to discuss the hybridembryos bill currently before parliament.

“The ethical considerations are manifold,” ProfessorWhittington said. “We don’t want to appear like a‘Frankenstein Laboratory.’” However, there is already a greatdeal of support from the public for healthcare applications ofbiotechnology, he said. “Public money is pouring in tocancer research, for example. People decide for themselveswhere they think the research is worthwhile.”

Opposition to genetically modified crops in Europeincreased when the companies involved did not provideenough information to the public about what they weredoing, “GM crops is one of the most importantopportunities in biotechnology, such as developing plantswith increased oil production,” Professor Hutchison said.“But these areas will only gain public support if they areexplained properly,” he said.

07

“Talking to the general public—this is one area where wehave to do better,” Professor Anstee said. “We need to letpeople know what we are doing, and what the risks andbenefits are.”

That will become ever-more important as biotechnologybecomes entwined with other areas of research. “Biotechcan be combined with information technology andnanotechnology, for example,” Dr Pitkethly commented.“Scientists are already putting cells onto silicon chips tocarry out molecular computing.”

Researchers recently implanted a biosensor into aparalyzed man that can control a cursor on a computerscreen by thought alone. Another research groupimplanted biosensors into monkeys that allow them tocontrol a robotic arm and one discovery that surprisedthe researchers was that the robotic arm was preferred toa natural arm. Professor Whittington likened suchresearch to the first, tentative steps in making “The BionicMan” a reality.

But as research successes continue at an acceleratingpace, what will be the impact on society - “Who will payfor the research? How will it be exploited? Should privatecompanies be allowed to profit from fundamental researchthat is for the good of humanity?” asked Mr Asher.

Many people disagree with the notion that the products ofnature, such as microbes or a gene sequence, should bepatented. However, the private sector will need to berewarded in some way because of the high cost ofbringing new technology to market, Mr Perry said. “Every£1 of research needs £63 to reach commercialization,” hesaid.

But it is not just new-generation products wherebiotechnology will have an impact, Mr Perry added. “A lotof biotech research is to find a way to make somethingwe already make, but more cheaply,” he said. “In the caseof chemical plants, for example, which use hightemperatures and pressures, there is often an enzymaticprocess that can do the same reaction at roomtemperature and pressure.”

With such a great deal of potential for biotechnology, thepanelists expressed concern about the number of sciencegraduates—and the ability of UK industry to attract them.“There is an increased tendency for bright bioscientists togo into the City,” Professor Anstee said. “That meansscience is losing a lot of talented people.”

“This issue has to be addressed at the secondary schoollevel,” Professor Whittington said. “Enthusiasm aboutscience is not being passed on to children,” he said. Butthere is a much broader underlying concern.

“There is a worrying issue about public understanding ofthe role of science,” Mr Perry commented. “We are usingthe products of science, but they are not wellunderstood.” However, there is evidence that if children’sminds can be “captured” young enough with excitingteaching, they will be attracted to study science andconsider it a worthwhile career.

Developments such as NETPark are an important part ofaddressing that problem, Professor Anstee said. “We canraise the aspirations of youngsters if they can actually seea place that is going to offer career opportunities intechnology businesses.”

Summing up the debate, Mike Asher commented that thepanel had been able to cover a very wide range of topicssurrounding biotechnology and there was clearly a desirefor greater understanding of science. ProfessorAnstee,echoed these comments: “It was a fascinatingdebate – it was interesting that questions from theaudience focused on the public engagement with scienceand illustrated a wish for more information about howscience affects us in our daily lives. We hope that theongoing NETPark debates will contribute to this.”

County Durham Development Company and DistinctivePublishing would like to thank all the panellists forcontributing their time, particularly Mike Asher for actingas Chair. These debates are open to the public butnumbers are strictly limited. If you would like to attendthe next one in September, please contactnetworks@wherebusinessgrows.com

The North East is a national leader in healthcare andlife sciences and Cels, the organisation charged withdriving the healthcare economy in the region, isplaying a pivotal role in this sector by promoting anddeveloping the region’s bioscience field with a strongfocus on biotechnology.

The North East bioscience sector concentrates on thestudy of diverse branches of natural science dealing withthe structure and behaviour of living organisms. Thestrength 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 carryingout groundbreaking work including creating antibodiesfor cancer therapy, vaccines for boosting the immunesystem against disease, stem cell research and genetherapy.

To support this, Cels has launched a raft of initiativesacross the region in order to drive the commercialisationof research and development. The International Centrefor Life, where Cels is based, is the UK’s first‘bioscience’ village, and is widely recognised as adynamic regional initiative that promotes research withinthe bioscience field. Another facility that supports growthis ‘Cels at Newcastle’, a unique micro-incubation facilityembedded in Newcastle University’s Medical School. It isa dynamic regional project aimed at promoting research,which was put in place to nurture biotech start upcompanies. The project has provided ongoing guidanceto businesses in the biotechnology field through theirearly stages of development as well as providing themwith a range of cutting-edge facilities. Incubatedcompanies have access to financial advice andassistance, management support, as well as theadditional benefit of the close proximity to the researchexpertise within the Medical School. Cels continues tosupport companies after they out-grow the incubator topromote their ongoing development.

Cels, in its role as a healthcare driver, has continuallyprovided a wide range of business development supportto a number of fledgling biotech companies in the region,such as BioTransformations (anti-cancer antibodies);Creative Gene Technology (plant biotechnology forimproved crops); ReInnervate (stem cell technology) and

BioToolomics (biopharmaceutical purification technology).Additionally, Cels provides strategic advice to regionaldevelopment agency One NorthEast on inwardinvestment, encouraging companies to relocate to theNorth East. This includes advice on regenerativemedicine including stem cell research andbiopharmaceuticals (medical drugs produced usingbiotechnology), addressing the growing world trends inthese areas and the regional industrial and academicstrengths.

Another way in which Cels is driving the sector is that itproactively responded to the government’sBiotechnology Industry Growth Team (BIGT) report:Bioscience 2015, aimed at improving the health andwealth of the country as a whole, as well as that of thebioscience industry itself. One of the report’s keyrecommendations outlined the need to set up Centres ofExcellence in Biopharmaceutical Bioprocessing. As aresult Cels has facilitated ongoing discussion in theregion to examine how such centres could help the UKutilise and add value to its strong bioscience base.Subsequently, Newcastle University has established anew North East Biopharmaceutical BioprocessingInstitute (NEBBI) designed to allow expertise in thesector to be developed, in order to benefit local industry.One such benefit is the establishment of a newundergraduate degree in BiopharmaceuticalBioprocessing at Newcastle University, the first of its kindin the UK, which has been facilitated by Cels.

With five universities in its midst and Cels’ ongoingsupport, the region has pioneered some of the world’smost groundbreaking scientific research in medicalbiotechnology over the past few years. Perhaps the mostwell known is the stem cell work by scientists atNewcastle and Durham universities which could lead toexciting new treatments for diseases like Parkinson’s andAlzheimer’s.

To complement this expertise, Cels has continued tosupport the commercialisation of the region’soutstanding research capabilities in subjects such asageing, cancer and immunotherapy. The Institute forAgeing and Health in Newcastle carries out research onageing and age-related illnesses and has the UK’sbiggest interdisciplinary research group in this field. Thisranges from the fundamental research on molecularmechanisms of ageing and age-related disorder, throughto practical lifestyle issues, such as housing, assistive

KEEPING THENORTHEAST BIOTECHSECTOR AHEADOF THE FIELD

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, whichbrings 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, theconsortium of the three Northern development agencies .The N8 identified regenerative medicine as one of fivekey 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 majoropportunities 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 thehealthcare industry, which included representatives from bioprocessing – an application of biotechnology,pharmaceuticals, biomaterials and medical devices sectors.

CASE STUDY

Cels is also using its commercial and bioscienceexpertise to market the Newcastle University CellularTherapy GMP facility in the Bioscience Centre (ICfL). Thisexciting facility aims to not only assist the region todevelop its academic stem cell expertise but also attractnew high tech companies to the area.

Cels continues to encourage and promote the region’smedical biotechnology field in order to maintain the NorthEast 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

THEPOWEROF THE

HUMBLEHAIR

FOLLICLE

Skin was the first tissue engineered material to bemarketed clinically. However, without skin appendages(hair follicles and sebaceous glands) this artificial skindoes not look or function like ‘normal’ skin tissue. Suchgrafts have poor success rates (50% at best) andrepetitive skin grafting and reconstructive surgery placea continual drain on the NHS budget (estimated at £160million per annum for burn injuries alone). Moreover,while great strides have been made in developinglifesaving techniques that regenerate the outer layer ofthe skin, the epidermis, researchers have been far lesssuccessful in making a replacement dermis that avoidsscar formation. Consequently much improvement hasstill to be made to improve the aesthetic properties ofskin after grafting.

Using donor human skin tissue, Professor Colin Jahodaand his team have isolated a reservoir of specialiseddermal cells from the human hair follicle. Jahoda andcolleagues were first to show that these cells couldinduce new follicles to form if transplanted into skin.They have also shown that these cells can heal wounds,and possess regenerative properties coupled with adegree of immune privilege. That is to say, they are notso easily rejected as “foreign” when transplanted fromone individual to another non-related person. Thesefindings underpin the basis for incorporating these hairfollicle stem cells into tissue engineered skin.Researchers in Professor Jahoda’s group are nowmoving a step closer to using these cells to generate anartificial skin complete with hair follicles, advancingwound healing therapeutics to augment the treatment ofburn injuries and chronic wounds such as diabetic footulcers. The Durham researchers have also discoveredthese hair follicle cells have many other useful stem cell-like properties that make them excellent candidates fora wider range of tissue regeneration applications. Forexample the follicle cells can be grown in cultureconditions 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 cellscompared with other types of adult cells with stem cell

potential makes them good candidates for futuretherapeutic use.

One of the collaborative research projects managed byProfessor Jahoda’s team is sponsored by theTechnology Strategy Board, a business-led executivenon-departmental public body, established by thegovernment and backed by the Department forInnovation, Universities and Skills. The Board’s missionis to promote and support research into, anddevelopment and exploitation of, technology andinnovation for the benefit of UK business, in order toincrease economic growth and improve the quality oflife. In this case, the Durham University group is workingin partnership with Avecia Biotechnology located in theTees Valley. Together with the Centre for Excellence inLife Sciences based in Newcastle and partners furtherafield at Smith and Nephew and the University ofBrighton, this consortium has anticipated the clinicalmarket for hair follicle cell derived therapeutics that mayenhance quality of life and increase the UK’s status inwound healing therapies.

By working in partnership with the Avecia scientists, ledby Dr Bo Kara, the Durham researchers have been ableto have access to bioprocessed cells isolated fromhuman hair follicles. The bioprocessing involves taking afew thousand of the hair follicle cells, and rapidlyexpanding cell numbers. A key part of the translation oflaboratory research to clinical cell therapies isdemonstrating that cells can still perform their requiredroles following this type of expansion in culture. Theteam at Brighton led by Dr Liz James are then usingtheir expertise to incorporate the cells into differentsupport structures to make so called living “skinequivalents”. Working together improves understandingof these adult follicle cells because functionality can beexamined after bio-processing, an important milestonein translating the usefulness of these cells into a marketreality.

www.dur.ac.uk

Research at Durham University is uncovering the potential offollicle cells to aid tissue regeneration.

Professor Colin Jahoda and his team at Durham University’s Schoolof Biological and Biomedical Sciences are working at the cuttingedge of bioengineering to develop a fully functional artificial skin.

11

13

In contrast to fossil-derived diesel, biodiesel representsone of the alternative biofuels that will meet our risingenergy requirements but with reduced carbon dioxideemission. As a consequence, the production of biofuelsin 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 thepresence of methanol and a catalyst. A waste- or by-product of the biodiesel process is glycerine; 1 ton ofbiodiesel will make around 100 Kg of glycerine. TheEuropean biodiesel industry will release around 600Ktons glycerine per year. The oversupply of glycerine,due to increasing biodiesel production, will lead todecreasing prices and weak markets. New outlets forthe crude glycerine released by the biodiesel processesare therefore urgently needed.

Dr Pattanathu Rahman has been examining thepossibility of using glycerine as feed for biosurfactantproduction. Biosurfactants are green or environmentally-friendly products that are similar to soap. Dr Rahman’sresearch has involved the production of biosurfactantfrom novel bacteria discovered recently in Teesside,Pseudomonas teessidea and Pseudomonas clemancea.These bugs produce the biological soap for their survivalin adverse environments. Although they are tiny, theycan grow, multiply, produce and excrete biosurfactantsefficiently. Amazingly these bacteria can eat tonnes ofthe waste glycerine and produce biosurfactants from asingle cycle of overnight growth! The important andbasic requirements they expect during the process isfavorable temperature (30 C) and some salts (minerals)in their food. The biocatalysis work is being developedfurther through the FROPTOP group of Bioscience forBusiness cluster.

Bioremediation for contaminated site restoration isanother key activity at Teesside. A negative legacy of theindustrial revolution has been the heavy pollution ofsoils, sediments and ground water on key sites such asareas surrounding town gas works plants. Thecontaminated sites are often polluted with a complexmixture 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 andHelen Connolly collaborate in an area known asfunctional ecogenomics, focussing particularly on theuse of microorganisms as an environmentally friendly,cost-effective and sustainable solution for cleaningcontaminated sites. They are currently working an aUniversity funded project which uses genechips toidentify and measure the presence of DNA from differentbacterial communities that have the genes and theability to breakdown these polluting chemicals. DrConnolly implemented the Defra funded biorecyclingproject which investigated cleaning oil polluted industrialwaste by washing with biosurfactants, or biodegradablesoaps. Dr Connolly is also leading early work on theexploitation of nanoparticles to remediate pollutedenvironments, such as water and soil. A further projectled by Dr Richard Lord and funded through the EU Lifeprogramme has been investigating the use of crops tode-contaminate metal polluted Brownfield sites. Thesecrops can then be used to generate energy.

Novel tools are being developed to provide biologicalinformation for a variety of situations including medicineand the environment. Professor Ali is leading theTeesside effort on the integration of biological entitieswithin nano and microsystems to create smart systemssuch as laboratories on a chip. Such tools can carry outsophisticated biological operations and will be able toprovide large amounts of biological information in aconvenient, low cost and rapid manner. The keyinnovations being developed include the manufacture ofminiaturised devices, handling of fluidics within them andthe precise positioning and manipulation of biologicalentities. Specific projects include the development of aminiaturised 2D gel electrophoresis system that can beused for the separation and detection of proteins for thediagnosis of disease conditions. This work has beensupported through the Bionet programme with HelenaBiosciences. Further key projects include an EPSRCfunded project with IDS Ltd on the development of aLab-on-a-chip that can perform automatedimmunoassay for clinical applications and a bioreactor-on-a-chip that can be used to screen and optimise theconditions for microbial growth.www.tees.ac.uk

BIOTECHNOLOGICALSOLUTIONS FORSUSTAINABILITYAND MEDICINE

Biotechnology will make major contributions to sectors such as energy,contaminated environment management and medicine. Biotechnological basedsolutions for economic and social benefit are being developed for these sectors inthe School of Science and Technology at the University of Teesside.

15

17

NORTH EASTSCIENTISTS MAKEBREAKTHROUGH IN THEFIGHT AGAINST DEADLYSUPERBUGA research team led by University of Sunderlandscientists has made a major breakthrough in the fightagainst a deadly hospital infection which kills tens ofthousands of people every year.

Experts have discovered a technique for the earlydetection of the superbug pseudomonas aeruginosawhich particularly infects patients with cystic fibrosis.

70,000 people worldwide are affected by cystic fibrosisand, on average, around 50% of those will be infectedwith the superbug – 50% of those infected will die.

Although the research concentrated on the superbug’srelation to cystic fibrosis, pseudomonas aeruginosa alsoattacks patients with localized and systemic immunedefects, such as those suffering with burns, patients withAIDS and cancer.

According to the Centre for Disease Control andPrevention in the USA, pseudomonas aeruginosaaccounts for 10% of all hospital infections.

While the superbug is very difficult to cure, as it is highlyresistant to antibiotics, early detection makes a hugedifference to a patient’s chances of survival.

Now for the first time, the University of Sunderland–ledteam has discovered a technique that can identify thesuperbug within 24-48 hours of infection, greatlyincreasing a patient’s chances of survival.

The team is led by Professor Paul Groundwater andDr Roz Anderson at the University of Sunderland, incollaboration 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 massiveimpact on people who are immunocompromised.

“It is calculated that 28% of people who have undergonetransplant surgery are infected by pseudomonasaeruginosa. We hope our research will make a bigdifference in the survival rate of many thousands ofvulnerable people throughout the world.

“The bacteria infect the fluid on the lungs of cystic fibrosissufferers. It also infects patients in intensive care units. It isreally difficult to treat, and hospital staff need to know veryquickly if someone has been infected by it.

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

reacts with an enzyme present in pseudomonasaeruginosa and produces a very distinctive purple colourwhich indicates the presence of the bacteria. Thistechnique works on 99% of the strains of this superbug.”

The research has been sponsored by the multinationalbiotechnology company bioMérieux. The company, basedin France, designs, develops, and produces a wide rangeof diagnosis systems for medicine and industry.

“bioMérieux is very proud to have participated in andsupported this research that will help in the fight againsthealthcare associated infections - a strategic focus for ourcompany,” says Dr. Peter Kaspar, bioMérieux corporatevice-president of research and development. “Thisdiscovery will enable bioMérieux to bring additional high-medical value tests to clinicians and positively impactpatients’ treatment and their follow-up care.”

Cystic fibrosis is an inherited chronic disease that affectsthe lungs and digestive system. A defective gene and itsprotein product cause the body to produce unusually thick,sticky mucus that clogs the lungs and leads to life-threatening lung infections, obstructs the pancreas andstops natural enzymes from helping the body break downand absorb food.

Pseudomonas aeruginosa is a major cause of infectionamong patients with immune defects. It is tolerant to manydetergents, disinfectants and antimicrobial compounds andis difficult to control in hospitals and institutionalenvironments. It causes urinary tract infections, respiratorysystem infections, dermatitis, soft tissue infections,bacteremia, bone and joint infections, gastrointestinalinfections and a variety of systemic infections, particularly inpatients with severe burns and in cancer and AIDS patientswho are immunosuppressed. Pseudomonas aeruginosainfection is a serious problem in patients hospitalized withcancer, cystic fibrosis, and burns.

bioMérieux has been a world leader in the field of in vitrodiagnostics 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 outsideof France. bioMérieux provides diagnostic solutions whichdetermine the source of disease and contamination toimprove patient health and ensure consumer safety. Formore information, visit www.biomerieux.com.

www.sunderland.ac.uk

NEWPARTNERSHIPBRINGS JOBS

Hart Biologicals Ltd began life selling blood testingreagents – chemicals which are mixed with patients’blood samples to test how quickly it clots. Cliniciansneed this vital information to ensure they prescribe theright doses of blood thinning drugs. Too little, and theblood won’t clot and kick-start the healing process; notenough of the right drugs can lead to life-threateningclots.

Supplying diagnostic reagents led to a partnership withtwo German companies manufacturing blood testingmachinery – Dynabyte Medical and Pentapharm. Themachines are proving so popular with UK hospitals,Pentapharm is now building premises in Hartlepool towork specifically with Hart.

And all this is happening after just winning the NationalMedilink Award for Export Achievement. Medilink is anational network of regionally-based independentorganisations which aims to raise the profile of healthcaretechnology.

“I’m going to Vienna at dawn tomorrow morning to meetwith Pentapharm. It’s crazy, but in a good way becauseour family business is moving forward,” says Alby Pattison,MD, from his office on the Newburn Bridge IndustrialEstate. “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 theNational Health Service many thousands of pounds,” saysAlby. “The reagents halve the time needed for laboratoryanalysis saving two hours of nurse time per sample.”

Dynabyte’s Multiplate Platelet Function Analyser andROTEM, made by Pentapharm, give quick results whichbenefit patients and, again, saves the NHS money. Peri-

and post-operative bleeding can lead to complicationsand the need for expensive blood products and becauseblood only remains stable for a short time, the quickmeasurement of clotting potential facilitates specific,evidence based therapy rather than a general solution.

The Multiplate Platelet Function Analyser was trialled atthe Freeman Hospital in Newcastle for the study ofbypass surgery. The hospital has now bought one forcardiac patients, as have hospitals in Sussex andManchester. The Edinburgh Royal and St Mary’s Hospitalin London, famous for celebrity patients, both have themachines for general surgery.

Says Alby:” This instrument is now in constant use at theGreat Ormond Street Hospital for Children. It only needs0.3 ml of blood per test to see how platelets arefunctioning so it’s very useful for small, seriously ill children.

“I showed the machine to the haematology laboratorythere. They had a three-year-old girl with a Berlin heart(an artificial external pump) who was on the transplant listand they needed to monitor blood clotting around it forthe weeks leading up to her successful transplant. On theback of that they bought the instrument.”

The ROTEM, currently on trial at the Chelsea andWestminster Hospital, near the Houses of Parliament, hastwo key advantages. It can conduct four testssimultaneously on one sample and it can be used at thepoint of care, not just in a laboratory. Whittington Hospitalin London has just obtained one and, as a result, HartBiologicals is now supporting a charity project inTanzania, supplying free blood plasma products andother testing equipment: “They asked us. I couldn’t sayno,” says Alby.

www.hartbio.com

Medilink Award (L to R) Matt Newman, UKTrade & Investment; Malcolm Pattison, HartBiologicals; Kevin Kiely, Chairman Medilink UK.

21

Building businesses in the life sciences sector requiresstrong but flexible leadership as a venture moves fromstart-up to trading profitably and potentially through toexit. Inputs into the process from outsourced expertsrequire great sensitivity and skill – with scientific depth,commercial acumen and staying power to make ithappen.

It is Dr Paul Rodgers’ opinion that founders most likely tosucceed take those critical first steps in the company ofthose who have taken that road before them.

Ithaka Life Sciences is all about making it happen. Theiraim is to share knowledge and know-how with theirclients as early as possible to eliminate risk and to preparea venture for the journey ahead.

Paul Rodgers is an entrepreneur who is widelyacknowledged within the life sciences market for his workwith young companies. Not only for his scientific,corporate governance and ‘investment readiness’expertise; but also for his strong leadership skills, hisability to work across disciplines, and the insightful way hebuilds appropriately skilled teams.

And he has taken the same approach to building IthakaLife Sciences – a company he set up in 2000 – that hasquickly built a reputation as one of the UK’s leadingconsultancy and interim management service providers,specialising in the nurture and development of new andgrowing life science businesses.

Ithaka has built a team of experts who draw on realexperience in taking science into the commercial marketand share his principles and ideals. It employs 10commercially and technically astute scientists,management consultants and business leaders who, priorto joining Ithaka and since then, have founded 20 lifescience companies and raised more than £50 million ininvestment finance for early stage ventures.

Companies include: Hydron- Pantherix-Cambridge DrugDiscovery-Xention Discovery- Axis Genetics – Pestax –Smart Holograms – Pysnova Neurotech.

The team’s specialist knowledge includes: foundingcompany directors, investment finance; specialistrecruiters; IP strategists; pharmaceutical industryfacilitators and management buyouts experts.

Market expertise includes: pharmaceutical R&D, medicaldevices, diagnostics and sensors, agriculture and foodbiotechnology. This diverse range of expertise means theycan supply services at each transitioning stage associatedwith the company’s growth through to exit.

Ithaka Life Sciences can provide the essential focusedleadership and practical set up and operational managementservices at pre-start-up through to exit. The team worksalongside company founders to develop a compellinginvestment proposition that fits with their own goals andambitions both for the business and for themselves. As thenew venture evolves, they can help source the skills to take itto the next level.

Dr Paul Rodgers: ‘This is where the Ithaka Team excels. Weremain focused not only on immediate technical andcommercial goals, but on the road ahead. It means obstaclescan be planned for well in advance and pitfalls avoided.’

Ithaka’s services are not just about imparting knowledge; aswell as being strategic, the support is practical and tactical.This critical hands-on experience means that Ithaka LifeSciences is well-placed to guide and deliver technical andcommercial strategic planning services for public sectorchampions and private investors too. In the North East, theyhave worked closely with One NorthEast and the Centre ofExcellence for Life Sciences.

Under Paul’s leadership, the Ithaka Life Science Team hasundertaken more than 100 assignments for over 60 clients; ahigh proportion of which is repeat business. And, whereveryou are in the commercial process, Ithaka’s services aredelivered with the same depth and level of commitmentwhether you are close to market or just exploring thecommercial opportunities.

Engaging with Ithaka Life Sciences means you gain accessto a much broader spectrum of knowledge both within thecompany and via its personal network of more than 800contacts.

The company has offices in Cambridge, Manchester andOxford and, recognising the strength of the North East’sbiotechnology sector, set up an office at NETPark in 2004providing a centre of expertise and access to a widercommunity for the region.

www.ithaka.co.uk

GROWING LIFESCIENCEVENTURES

Strategic Planning Services

� 2007: Ithaka appointed by One NorthEast to undertake a major regional and wide ranging review of thetypes 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 celltechnologies.

� 2004: Ithaka appointed to work alongside Cels to develop a strategy and roadmap for commercialexploitation of embryonic and adult stem cell research at Durham and Newcastle Universities, the Centrefor Life and in local NHS Trusts.

� 2004: Ithaka delivered market research on the commercial applications of stem cells and obtainedinformation from over 40 pharmaceutical and biotechnology companies with interests in stem cells.

Examples of Commercial New Venture Development

� Creative Gene Technology Ltd (CGT) - Durham2003: Ithaka appointed to undertake a commercial assessment of Durham University spin out plantgenomic 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 currentbusiness plan.

Results: A total of about £400,000 in funding has been secured from regional investment funds. A £2.5million funding round is currently in progress.

Paul Rodgers is currently acting Chairman

� Smart HologramsInterim management and strategic direction for Smart Holograms. During the establishment of thebusiness Paul Rodgers was initially the CEO and subsequently Chairman of the Board. Currently Paul is anon-executive director with particular responsibility for the company’s IP portfolio.

Results: To date, the Company’s technology has attracted venture capital, government grants andindustry funding of over £18 million in its core science base and business. Assignment of patents and anintellectual 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 NeurotechThe 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 isproviding on-going management services to the company.

Paul Rodgers steered the Company through its first funding round as Chairman of the Board. TheCompany is now operational and has attracted £2.25 million from venture capital sources.

EXAMPLES OF ITHAKA LIFE SCIENCES’ WORK

Ithaka Life Sciences is a biotech consultancy with offices at NETPark, Cambridge, Manchesterand Oxford. NETWorks spoke to Dr Paul Rodgers, Ithaka’s CEO about the company’s success.

From green fields to dynamicscience park in next to no time

The first building, the NETPark ResearchInstitute was opened in 2004. 2200 sq mspecifically designed for R&D and lowvolume complex equipment prototypingand manufacture. Leased to DurhamUniversity for two world-class researchgroups: the Centre for AdvancedInstrumentation and the SemiconductorCrystal Growth and Ceramics Group.

The Innovation Village will also be completedthis year. 5 bespoke R&D pods for growingand/or investing companies, developed byHelios City. The total size will be 2500 sq m -units in multiples of 250 sq m

Swiftly followed by Phase 2 ofthe NETPark Incubator. Totalprojected size 2252 sq m, fundedby Durham County Council, OneNorthEast and ERDF.

Phase 1 of the NETParkIncubator followed a year later.

1600 sq m of office, work andlaboratory space and meetingrooms. Already 100% fullincluding 2 regional centres ofexcellence.

This year NETPark will be the fastest-growing science park in the UK.

Construction of the Plastic Electronic Technology Centre (PETeC) will be complete this year.

A 3,000 sq m national flagship facility for the development and exploitation of direct writetechnologies and flexible functional materials (FFM); revolutionary technology thatindependent forecasts predict will be a £16 billion industry by 2015. Managed by CPI, thecentre is 1 of only 4 currently being built in the world.

NETPark is North East England’s science, engineeringand technology park for the commercialisation ofcutting edge R&D. Companies thrive at NETParkbecause of:� State of the art facilities and room to grow on aprestige site� Low operating costs� Excellent transport links� A skilled workforce

Companies at NETPark have access to cutting edgeresearch from 5 universities within 30 minutes drive andtailored business support that enables them to achievetheir potential. They are part of a like-mindedcommunity 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 thefields of energy, defence, and medical-relatedtechnologies.

13 hectares (Phase 1) are already fully serviced andanother 3 hectare area is in the process of being madeavailable.

NETPark is developed by a partnership led by DurhamCounty Council including Sedgefield Borough Council,One NorthEast and all 5 regional universities.Management and promotion of NETPark is in the handsof County Durham Development Company, DurhamCounty Council’s inward investment arm. Helios Cityis the preferred developer for Phase 1.

For more information, visit www.uknetpark.net oremail netpark@wherebusinessgrows.com

ABOUT NETPARK...

23

25

ENHANCING THEGROWTH OFCELLS IN THELABORATORY

27

Cell culture work using this material has shown that thescaffold provides vertical space to support the growth ofcells to form complex 3-D interactions with theirneighbours, in a way resembling the structure of realtissues. Optimisation of the growth medium and cellseeding density results in the growth of cells throughout thescaffold forming a 3-D block of tissue in vitro (see Figure 1).

Cell viability is maintained at high levels in these culturesand cells are not exposed to the un-natural geometricstresses experienced in cells grown on flat surfaces. Afurther benefit is that cells grown within polystyrenescaffolds show enhanced ability to differentiate and respondto biochemical agents in a manner resembling the activity oftheir native counterparts in vivo.

A major challenge in stem cell biology is the ability tocontrol the development of cells and tissues in a predicableway. Biotechnologists require molecules that induce reliableand reproducible biological activity resulting in consistentmodes of cell differentiation. Reinnervate has established apipeline for small molecule design and production. Thisprocess 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 ofvitamin A, which play a major role in mammaliandevelopment, and are commonly used to induce thedifferentiation of cultured stem cells in the laboratory.However, such molecules, including the commonly used all-trans form of retinoic acid, degrade readily. This degradationis difficult to avoid during the routine use of these moleculesin cell culture and results in the formation of isomers thateffect cell differentiation in alternative ways compared to theintact parent molecule. This in turn introduces a potentialsource of variation in the control of cell differentiation.

To address this problem, Reinnervate has designed andsynthesised a small collection of well-defined syntheticanalogues of retinoic acid that have significantly improvedchemical 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 theability to modulate the differentiation of stem cells to formpopulations of mature neurons in a robust and reproduciblemanner (see Figure 2). With the benefit of improved stability,the use of these reagents will reduce cellular heterogeneityin cultures of differentiating cells. Stable, syntheticmodulators of cell differentiation offer distinct advantagesover existing technologies and will be of significantcommercial value. This programme of research is ongoingand will produce a range of well characterised smallmolecules that have proven ability to regulate cell behaviourin vitro.

Our research, focussed on the identification anddevelopment of biomarkers and cell growth supplements, isa long term programme which is still in its infancy.Nevertheless, we’ve already developed a promising in vitrosystem to identify neurotrophic factors produced by adultstem cells that will lead to the production of defined growthsupplements which we believe could be commercialised inthe medium term.

Reinnervate is talking to commercial partners who may wishto exploit our growth supplements for drug discovery anddevelopment purposes and, longer term, in thedevelopment of clinical applications. Reinnervate hasestablished a world class academic R&D group at DurhamUniversity in state-of-the-art laboratories and has achievedgreat success scientifically. This arrangement has enabledus to rapidly develop projects from the idea stage to atangible technology within a relatively short period of time.

We’re currently preparing to raise significant capital to maintainour research programme in collaboration with the Universityand in the future establish independent premises at NETParkfor our product development and administrative activities.

Dr Stefan Przyborski

www.reinnervate.com

Cell culture techniques help researchers test drugs, learnabout how cells behave, and can even reduce the use ofanimals in research. But examining cells in a Petri dish isvery different from looking at how they behave in a livingbody. Reinnervate, a Durham University 'spin out'established in 2002, specialises in the development ofenabling technologies to help overcome the limitations ofcurrent cell culture techniques. Dr Stefan Przyborski isDirector and Chief Scientific Officer of Reinnervate andspoke to NETWorks about how its proprietarytechnologies facilitate research into cell growth andfunction in vitro.

Reinnervate has 3 primary areas of interest:� the development of more favourable growth conditions

for cells in vitro;� the design and synthesis of small molecules that control

cell differentiation;� the development of new strategies in neural stem cell

research.

Culturing mammalian cells in the laboratory enablesbiotechnologists to investigate the activity of cells, testdrugs and allow the development of new therapeuticapproaches. This technology is used worldwide inacademic institutions and in the healthcare, biotechnologyand pharmaceutical industries.

As biotechnologists look to develop new ways of using cellsin the laboratory and reduce the numbers of animals usedin research, the use of cell culture techniques is predictedto increase to a billion dollar industry (Global IndustryAnalysts Inc. 2006). The market for Reinnervate’s productsis huge.

Cell cultures are used for a broad variety of applications andthe technology has given rise to many important findingsover the years. However, it has to be recognised that whencells are grown outside the body they’re exposed todifferent environmental pressures that influence theirstructure and ability to function. Recreation of the in vivo

environment in a Petri dish, multi-well plate or culture flaskis therefore critical to ensure that cultured cells behave in amanner representative of their counterparts in vivo.

Traditionally cells cultured in Petri dishes in the laboratorygrow on flat two-dimensional (2-D) plastic which is highlysynthetic compared to the three-dimensional (3-D)environment in the body. As a consequence, cells grown inthe laboratory don’t always function in a realistic fashionand cell culture assays can provide inaccurate and possiblymisleading data.

This has major repercussions for scientists in biomedicalresearch and drug development who rely on such data fromcell culture experiments to determine the future direction oftheir research programme and product development. So,there’s enormous demand to create cell-based testingmethods that enable cells to grow more like their nativecounterparts and hence produce more accurate data oncell behaviour and function.

To address this issue, Reinnervate has developed a novel3-D cell culture system - in brief, scientists at DurhamUniversity have re-engineered the configuration ofpolystyrene (the growth substrate material that’s currentlyused for the majority of existing cell culture applications)into a 3-D scaffold that has subsequently been adapted forcell culture applications. The scaffold is inert and can besupplied pre-fabricated, sterile and ready to use. This offersseveral advantages to the user, including an inexpensivesimple un-wrap and use consumable technology, enablingreproducibility during routine use, robustness, stability andless preparation time.

The porosity of the polystyrene scaffold is speciallycustomized to within narrow tolerances during itsmanufacture. This is an important feature to create aconsistent and suitable environment for 3-D cell growth.Engineering the scaffold into a thin membrane (e.g. 200µmthick) enables the entry of cells into the interior of itsstructure (and out again for cell retrieval) and it’s of suitablethickness to allow cells sufficient exchange of gases and

Figure 1: Histological section through the polystyrene scaffold (inwhite) showing the growth of epidermal skin cells throughout thestructure of the material. Reducing the level of the culture medium tocreate an air/liquid interface near the surface of the culture inducescell stratification (top) mimicking the behaviour of cells within theepidermis. Specimen embedded in resin, sectioned and stained withToluidine Blue. (Image courtesy of Dr R Carnachan).

Figure 2: Fluorescence micrograph showing the expression of theneural protein NF-200 in populations of neurons derived from humanpluripotent stem cells in response to our lead synthetic retinoid,EC23. (Image courtesy of Dr V. Christie).

HEALTHCAREPRODUCT DESIGN& DEVELOPMENT

“The Cels InSTeP programme brings together a uniquecollaboration of regional healthcare, engineering,product development and design professionals to offercompanies the opportunity to ‘fast-track’ thedevelopment of healthcare products, services andtechnology,” explains Dr Mark Jarvis, ProgrammeManager at Cels.

“User focused design is of central importance to maximisethe market potential of medical and healthcare products.Instep provides a complete programme, providing a clearand practical route for the transfer of state-of-the-artapplied research towards a market-ready product throughexpertise including research, concept design, productdevelopment, user testing, and rapid prototyping.”

“We provide a complete, integrated serviceto small or medium size companies wishingto develop new products or processes, orimprove existing ones.”- Dr Mark Jarvis, InSTeP project delivery manager, Cels

InSTeP is having a real impact on North East Companiesdeveloping new products in the healthcare sector.Working across a wide range of technologies includingbiotechnology columns, diagnostic devices and novelwheelchair concepts, Instep is enabling innovative ideasto become truly market-led products that will make asignificant contribution to the growth of the regionaleconomy. One company which has benefited from thehelp of InSTeP is UK Haptics (see below).

The delivery of InSTeP client projects is led byNorthumbria University’s Centre for Design Research andbrings in other regional partners including C2M (UK) Ltd,INEX, Kinneir Dufort, NHS Innovations and NewcastleUniversity’s Resource Centre for Innovation & Design.

If you have any idea that you think InSTeP could help youto develop, please contact Dr Mark Jarvis on0191 211 2560 or email mark.jarvis@celsatlife.com.

The BriefInSTeP was approached by UK Haptics to develop a medicalinstrument adaptor for a new medical training and evaluation toolenabling users wearing 3D glasses to manipulate a ‘Haptic Pen’ inthe real world, whilst seeing this as a medical tool or piece ofequipment in the virtual environment. Users can practise and beassessed on performing clinical procedures, with the ‘Haptic Arm’providing real physical feedback to give the sensation of trueinteraction with the virtual environment.

The ProjectInSTeP worked with UK Haptics to develop an adaptor, whichwould allow the user to hold and manipulate real medical toolswhilst performing the virtual procedure. Though initially focused onthe attachment of cannular needles, the design was ‘future-proofed’ to enable the attachment of as-yet-unspecified devices.InSTeP liaised with partners to produce a rapid prototype of thesolution, enabling evaluation in the context of UK Haptics’ currentsystem.

The OutcomeThe speed of development and the provision of a physicalprototype enabled UK Haptics to progress distribution talks withpotential international partners whilst attending a leading US-basedhaptic conference. The system has now been sold to a number ofcommercial and research clients, while the adaptor prototype iscurrently undergoing user and safety testing.

CASE STUDY : UK HAPTICS

29

Where: Beamish HallWhen:Thursday 3rd July

Cost: FreeFollowing the success of the Business for Life Awards 2007, Cels Healthcare Network is pleased to announce the Businessfor 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 successfuland 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 AwardStart-up Award

Outstanding Growth AwardPartnership with the NHS Award

Each award winner will receive automatic entry into the Medilink UK National Awards, an event which recognises the UK’smost 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 July2008 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.

BUSINESS FOR LIFEAWARDS 2008 SUMMER

LAUNCH PARTY

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

Gary Todd MD UK Haptics

Award winning Sedgefield architects Dewjo’c, whichspecialises in highly technical design to createresearch and laboratory environments combined withoffice space, is bringing its experience to bear on aseries of buildings at NETPark.

Dewjo’c Architects was founded in Middlesbrough in 1900and from this beginning it has built a thriving architecturalpractice with offices in Teesside, Newcastle and London.

Having cut its teeth initially in industrial design for thegrowing chemical giant ICI and its many subsidiaries, inthe 1980s Dewjo’c capitalised on its expertise and brokeinto the pharmaceutical and research sector.

Dewjo’c is now one of only a few practices in the worlduniting expertise from the disciplines of architecture,engineering and pharmaceutical process design. Its clientlist includes GlaxoSmithKline, MSD, Cardinal Health andSanofi-Aventis and it has worked on projects bothnationally and internationally in Poland, China, Germany,Egypt and Ireland.

Closer to home, Dewjo’c has developed links with theregion’s major higher education establishments, withsuccessful research projects for Newcastle, Durham andTeesside universities.

It has effectively completed major projects across mostscientific research disciplines and is currently developinga fourth major building on Newcastle University’s Campusfor Ageing and Vitality. It recently completed the design oftwo stem cells units, one at Cels in Newcastle and theother at Durham University.

Dewjo’c designed the first building on NETPark – theResearch Institute – for Durham University’s Centre forAdvanced Instrumentation and has gone on to designthe Incubator Building (and its extension, which iscurrently under construction) and the PETeC Building(Plastic Electronics Technology Centre) which is due forcompletion later this year.

Through its work in the pharmaceutical sector Dewjo’chas also completed major projects for biotech companiesincluding Avecia’s Biologic centre in Billingham, Genzymein Suffolk, Lonza Biologics in Slough and Lundbeck onSeal Sands.

Dewjo’c is also investing heavily in research intosustainable design. With a number of prestigious awardsin this field, it sees environmental responsibility as a majorinfluence on 21st Century design.

The practice’s expertise resides in its human resources –from highly skilled and experienced directors to innovativearchitects and an enthusiastic team of technologists.Dewjo’c recognises the value of close multi-disciplinaryworking, particularly in the field of designing specialistenvironments and highly complex facilities for researchand manufacturing. It works closely with engineeringcolleagues to produce fully co-ordinated solutions with adepth of understanding unsurpassed in this field.

Dewjo’c has gained an enviable reputation in this sectorfor delivering projects which are innovative andimaginative whilst fulfilling the client’s brief, projectdeadlines and budget.

Director Steve Agar, said: “Being involved in the design ofthese types of building is always stimulating as specialistfacilities require bespoke solutions. Often, they are a one-off, focusing on unique technologies or products and thisencourages us to push the boundaries of design tocreate something that is as aesthetic as it is practical.

“We bring with us great understanding of what a buildingof this nature requires. We have brought that experienceto bear at NETPark, with buildings that deliver bothpractically and aesthetically.”

For more information on Dewjo’c Architects contact SteveAgar on 01740 632 100 or visitwww.dewjoc.com

DESIGNOF THE TIMES

Far left: (L-R) Chris Fergusonof Dewjo’c Architects, KevinDrew of Whelan and DaveWallace of Dewjo’c Architectson site at the new PETeCbuilding.

Left: The stunning Dewjo’cdesigned Research Institutebuilding at NETPark.

Biochemistry companies developing new products cannow access free support from a team specialising inthe commercialisation of healthcare related intellectualproperty (IP).

NHS Innovations North - the NHS Intellectual PropertyManagement Hub for the North East - has a proventrack record in managing the commercialisation of newideas and research in the North East, offering assistanceto businesses as well as staff employed in the region’sTrusts.

Specialising in IP assessment, patent searching, marketresearch and due diligence, the team also provideconsultancy for businesses looking for support inresearch and development funding applications.

Offering a high quality service that includes prior artexploration, market assessment and thecommercialisation of new healthcare technology,consultants have recently assisted a local basedcompany providing support research intogroundbreaking diagnostics devices.

Newcastle based company, Orla Protein Technologies,has developed an innovation that incorporates proteinassembly and antibody research into wireless electronicdevices which can be used at a patients bedside toaccurately detect markers of disease.

The platform technology can be developed for use in theearly detection at point of care of a range of illnessessuch as cardiac and arthritis, and also respiratory virusesincluding Respiratory Synchytial Virus (RSV) - a majorcause of respiratory illness in young children causinginfection of the lungs and breathing passages - and theinfluenza virus, which can lead to serious complicationsin vulnerable groups.

The NHS Innovations North team at RTC North willprovide management support to Orla Protein

Technologies, providing IP advice and support inexploiting the technology in healthcare markets.

The point of care tests are a further application ofelectronic diagnostic technology being developed byOrla in collaboration with the Japan Radio Company(JRC).

The Surface Acoustic Wave (SAW) device allowsdetection of specific disease markers in a blood sample.The markers bind to the surface and alter the acousticwave passing across the device.

The breakthrough tests will be able to be carried out at apatient’s bedside before being transmitted wirelessly to alaboratory and will result in earlier and more effectivetreatment for patients, while providing savings forhealthcare providers.

The NHS Innovations North team is made up ofconsultants with a science and engineering backgroundand can offer small and medium sized businesses adetailed insight in to healthcare markets and sellinginnovation into the NHS.

Established in 2002, NHS Innovations North is one of anational network of regional hubs set up to protect andcommercialise intellectual property generated within theUK’s NHS Trusts.

The team has worked on a range of innovative projectsincluding mediums which test for resistance to MRSAdrugs, speaking aids for patients who have had throatcancer and handheld devices used to test for braininjury.

For more information about NHS Innovations North andto search for healthcare technologies available for licencevisit www.nhsinnovationsnorth.org.uk or contact theteam on 0191 516 4400.

COMPANIES GAINAPPOINTMENT WITH NHSINNOVATIONS TEAM

31

33

The awards, sponsored by UK Trade & Investment,One NorthEast and the North East Chamber ofCommerce (NECC), recognise the efforts ofindividuals who have helped their companies boosttheir international sales performance.

And one of last year’s winners – Alan Timothy – hasthrown down the gauntlet to others across the regionto send in their nominations.

Alan Timothy, Chief Executive Officer and founder ofProfile Analysis Ltd, which specialises in helping firms tomanage field sales data in order to maximise sales andsales team performance, was winner of the Innovationin Export Award in last year’s North East ExportersAwards.

Profile Analysis is the holding company for RocketScience and i-snapshot, which operate in the UK andoverseas. The company has i-snapshot subsidiaries inthe UK, USA and Germany and distribution agreementscovering Australia, Holland, Canada and South Africa.

The company has taken advantage of the full spectrumof support offered by UK Trade & Investment to helpdevelop overseas sales of its innovative i-snapshot tool.The company joined UK Trade & Investment’s flagshipPassport to Export scheme to help develop a workableand achievable export strategy for the market.

In addition, UK Trade & Investment has providedinformation and feedback on sales prospects in theGerman market through its Overseas MarketIntroduction Service (OMIS). Profile Analysis intends tofully exploit the value of this market research by usingUK Trade & Investment’s Virtual Export Managerservice.

Alan said: “Winning the award has helped raise theprofile and importance of our overseas activities withinProfile Analysis and was seen by our overseas partnersas reinforcement of our commitment to their markets. Iwould encourage all those engaged in export to sharetheir successes through the awards.”

The winners of the North East Exporters Awards 2008will be announced at a special gala dinner to beattended by Lord Digby Jones, Minister for Trade andInvestment, at The Hilton, Gateshead on Thursday, 17July when leading figures from the world of businesswill gather to celebrate the region’s international tradesuccess. The event is also sponsored by The RoyalBank of Scotland, Barclays and Emirates.

Entries are now sought for the awards in each of thefive categories: New Exporter Award, Export Award,Innovation in Export Award, Export CommunicatorAward and Passport to Export Award.

The awards will go to those who, in the judges’opinion, achieved the most for their companies inpursuit of export business. Each of the winners willreceive a special trophy and £1,000.

David Coppock, UK Trade & Investment’s InternationalTrade Director, said: “Alan was a worthy winner and weare delighted to have his support for this year’s awards”.

For details of how to enter the awards or to purchasetickets, price £55 each or £500 per table, for the NorthEast Exporters Dinner on Thursday, 17 July at TheHilton, Gateshead, contact the North East RegionalInternational Trade Hotline on 0845 05 05 054 or logonto www.exportersawards.co.uk. Deadline forentries is 18th June.

ENTREPRENEUROF EXPORT BACKSNORTH EASTAWARDSAn award-winning export entrepreneur is urging otherfirms in the region to take advantage of the opportunitiespresented by the North East Exporters Awards 2008.

New Exporter Award: John Aitchison of Comesys Europe with Brian Shaw of UKTI

Innovation In Export Achievement Award: Alan Timothy of Profile Analysis (RocketScience) with Roger Stainforth of NECC

Export Communicator Award: David Patrick Bennett of Bison Bede with Zelie Guerin ofRegional Language Network

Passport To Export Award: Nicki Berriman, wife of winner Chris Berriman of MeritMerrell 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

NE EXPORTERS AWARDS 2007

ALTOMED...PROVIDINGTHAT PERSONALTOUCH

Nestling in a business park in South Tyneside is a firmwhich has, over thirty years, been building strongbusiness relationships with almost every hospital in theUnited Kingdom. The activities of Altomed Limited arealmost entirely focused on supplying surgicalinstruments and disposables used in eye operations.

Originally in Gateshead and now based at BoldonBusiness Park, Altomed remains a privately ownedcompany, and is run by its three directors includinghusband and wife team Peter and Karen Myers. It isnow the UK market leader in supplying ophthalmicsurgical instrumentation to NHS and private hospitals andemploys twenty people.

The product range is wide. It includes stainless steel andtitanium instruments for use in all of the ophthalmologicalsub-specialities including cataract, retinal, keratoplastyand oculo-plastic procedures. In the UK, as well assupplying Altomed branded instruments, the companyalso acts as official importers & distributors for many USand EU based specialist manufacturers.

Peter Myers, Managing Director, believes that the solidreputation and profitability the firm has achieved is based

on high levels of personal service which manymultinationals cannot match. “The big players in ourindustry, many of them US-based, are excellent atdeveloping innovative surgical tools, implants and capitalitems, but due to their size, they tend to lack the flexibilityto deliver true personal service to end-users in thehospitals.”

“Our competitors, large and small, are mainly based inthe south-east. We have found that the personalities whowork at Altomed, particularly in customer service roles,are a vital part of our business. These largely non-graduate personnel, with local roots, are often highlypraised by our customers, who tend to be operatingtheatre staff and surgeons. It’s important that we retainand reward our excellent people.”

Although many aspects of the firms business involvehigh-tech and high-spec products, old fashioned service,approachability and product knowledge will remainessential components for challenges ahead.

www.altomed.com

NEW CONSULTANTSBOOST CBSLOFFERING

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

CBSL, the wholly owned subsidiary of Cels, hasexpanded its team of consultants by appointing PhilipAldridge and Andy Copland.

CBSL provides a comprehensive range of businessconsultancy, marketing, project management,investment and innovation management services to avariety of industry sectors, with a particularly strongtrack record in the healthcare and life science markets.Both Philip and Andy have joined CBSL from Cels andwill be involved in providing a broad range ofconsultancy services.

Philip Aldridge, who has been appointed as SeniorConsultant, joined Cels in November 2003 and broughtto the team his expertise in GMP manufacturing. Philiphas process development experience in fermentation,biotransformation and ultrafiltration operations. He alsohas extensive GMP manufacturing experience with bulkantibiotics and biopharmaceuticals. His experience alsocovers the fields of biopharmaceutical drugdevelopment and business development; the latter

gained in the position of Biotechnology BusinessDevelopment Manager for both Synpac and ACSDobfar (UK) Ltd. In addition, Philip has GMPbiopharmaceutical facility design experience. He is alsoa current member of the BIA’s Manufacturing AdvisoryCommittee, MAC.

Andy Copland, who has been appointed as BusinessConsultant, has over 15 years in operational andstrategic management many of which have been spentworking within the NHS. Andy has been an operationalmanager, in primary, community and secondary care.He has worked as a business manager in medicine andsurgery as well as a planner and commissioner ofmental health and acute services. Andy was also a PFIProject Board member, leading the service andfunctional reviews for a £24m community hospital buildin the east of England. In recent years Andy has beenworking in the private sector supporting businesses todevelop and identify new markets and has been leadinga special procurement project for Cels.

Chad Zhang (PhD) founder and Managing Director ofBioToolomics, based in Consett, has extensive academic andindustrial experience of chromatography systems used in thepurification of biopharmaceuticals. When he decided to setup his company to exploit his novel ideas, he commissionedCBSL to provide expert guidance and support.

CBSL has worked with Dr Zhang in a number of areasstarting with intellectual property management.Subsequently CBSL has leveraged finance from bothpublic and private sources. Initially this was in the form ofgrants and proof of concept funds required to prove andexemplify his technology. Latterly it has been to accesssignificant funds to facilitate major product launches. Inaddition, CBSL has provided access to specialist designservices to further enhance his products.

Philip commented: “Working with Dr Zhang, CBSL hasdefined the markets, and route to market, to successfullyexploit his novel technology. We have also enhanced thebusiness planning process so that his ideas are capturedin a way that has proven attractive to investors.”

“CBSL has given BioToolomics tremendous help across arange of business development areas. Their strong vision,broad range of expertise and good networks in thebioprocessing sector, have really added value to mycompany.”

Chad Zhang, Managing Director, BioToolomics Ltd.

For further information on CBSL, contact Mike Hartley,General Manager on 0191 211 2560.

CASE STUDY - BIOTOOLOMICS LTD

LEFT: Philip Aldridge

MIDDLE: Andy Copland

RIGHT: Chad Zhang ofBioToolomics with Philip Aldridgeof CBSL and Eddie Hutchinson,former chairman of DIDA.

37

High Force Research Ltd (HFR) offers confidential,high quality services for outsourced synthesis andR&D from the scale of grams to kilos forpharmaceuticals, life sciences and fine chemicals. Ourteam of chemists has wide experience of multi-steporganic synthesis, particularly of heterocyclicchemistry, catalytic hydrogenation, nucleoside andamino acid chemistry, fluorination and chiral chemistry.

A partner for proof-of-concept studiesHFR collaborates with discovery groups, start-ups andspin-offs from academia and industry in synthesisingnew materials for proof-of-concept studies and inprocess development on the route to market. We offer afast response and flexible service to customers andpartners and can operate on “fee for service”,collaborative research or joint venture basis, dependingon project and business requirements.

cGMP synthesis of APIsMHRA audited cGMP facilities comprise two segregatedlaboratories, in which we produce from grams to multi-kilos of Active Pharmaceutical Ingredients and theirintermediates to cGMP standards for pre-clinical studiesand Phase 1 clinical trials. One laboratory is dedicated toproducts for oncology, the second to materials for othertherapeutic areas and drug delivery systems.

Reagents for Diagnostics, Electronicsand Reference MaterialsWe undertake multi-step synthesis of nucleosides andother reagents incorporating chromophores forapplication in novel diagnostic technologies. We alsocarry out synthesis of pharmaceutical referencematerials, metabolites and impurities as well asspecialised materials for electronics.

Process R&D and Scale–upWe have the capability to devise synthetic routes to newmolecules or to identify and evaluate alternatives whichmay avoid hazardous or costly materials. Working atboth bench-top and kilo-lab scale, we can then developprocesses to meet targets of yield, specification, safety,

environmental impact and economics. Later we offersupport in technology transfer to commercial production.

Laboratory FacilitiesHFR, originally based at the Mountjoy Research Centre,Durham, relocated in 1996 to purpose built laboratoriesin nearby Bowburn, expanded in 2001 to 11,000 sq. ft.Facilities comprise 30 fume hoods and include a Class100,000 clean room suite for cGMP operations. Weoperate in glassware up to 30 litres, with stainless steelautoclaves up to 7.5 litres for hydrogenation andpressure reactions. Other specialised facilities includelaboratories for electrochemistry, cosmetics formulationdevelopment and a segregated laboratory for handlingcorrosive materials including aqueous HF.

Analytical instruments include 270MHz Bruker nmr,Agilent 1100 hplcs, Shimadzu glc with headspaceanalysis, Jasco ftir, polarimeter and Karl Fischerautotitrator.

Quality SystemsWe recognise that the quality of products and servicesoffered to customers and clients is the key to futuregrowth. Our quality system has separate qualityassurance and quality control functions to which wehave added the capabilities to undertake analyticaldevelopment and method validation.

Ownership/ Contact detailsHFR was founded in 1988 and is wholly owned by itsDirectors: Roy Valentine (Research Director), StuartPenny (Operations Director) and Bob Redfern (ManagingDirector). For further details, contact:

High Force Research LtdBowburn North Industrial Estate, Bowburn, DurhamDH6 5PF, United Kingdom.

Telephone + 44 (0)191 377 9098Fax + 44 (0)191 377 9099Email: enquiries@highforceresearch.comwww.highforceresearch.com

HIGH QUALITY SERVICESFOR LIFE SCIENCES& FINE CHEMICALS

CAN A WELL DRAFTEDPATENT GET YOU “MORETHAN YOU DESERVE”?

According to a recent Court of Appeal ruling it can.

This is good news for biotech and pharmaceuticalcompanies who invest in developing new products andwant the broadest possible monopoly on their inventions.

The claims of a patent define the extent of the monopolygranted to a patentee. Claims may be directed to aproduct or to a process (or method). A claim to a productitself will have the effect of granting to the patentee amonopoly over all ways of making the product. It may alsogive the patentee a monopoly over all uses of the patentedproduct, including uses he never even thought of!

Consider a patent for new glue, in which a claim covers itschemical composition.

If, at some time after the patent is filed, the substance turns outto be useful for a different purpose, e.g. as a plasticiser, thepatentee will have a monopoly over that as well. Even thoughthe patentee had not thought of using the glue as a plasticiser,his claim covers the substance itself, so his monopoly extendsto more than he invented – “more than he deserves”.

This was the example given in a recent decision by the Courtof Appeal in H Lundbeck A/S v Generics (UK) Ltd and others.

The case relates to a patent owned by the small research-based pharmaceutical company Lundbeck. Lundbeck isbased in Denmark and specialises in diseases of the centralnervous system. In 1989 it launched an antidepressant drugcalled Citalopram. Citalopram is a racemate consisting ofequal numbers of molecules called enantiomers.

Enantiomers are conventionally designated (+) or (-) andare molecules with similar physical properties but differingin shape such that they are mirror images that cannot becompletely superimposed on each other.

Researchers at Lundbeck found a way to separate theCitalopram racemate into its enantiomers anddiscovered that the antidepressant effect was caused entirelyby the (+) enantiomer. Through this research, Lundbeckdeveloped a new antidepressant drug called Escitalopram,sold under the brand name Cipralex®. Escitalopram isessentially the pure (+) enantiomer of Citalopram.

Cipralex® (Escitalopram) became the world’s top sellingbranded antidepressant and accounted for 60% ofLundbeck’s turnover.

Fortunately, Lundbeck had taken steps to protect itsintellectual property rights by filing a new patent to coverthe (+) enantiomer. The patent was drafted to obtain thebroadest possible monopoly on Escitalopram and includedthe following claims:

� Claim 1 - A “product” claim to the (+) enantiomer itself.� Claim 3 – A “product” claim to a pharmaceutical

composition comprising the compound.

� Claim 6 – A “process” (or “method”) claim to a methodof preparing the compound.

When Lundbeck’s patents covering their earlier product(Citalopram) expired, generics manufacturers were able tosell generic versions of Citalopram, but they wereprevented from producing Escitalopram. Consequently,three generics manufacturers attacked the Escitaloprampatent on the grounds of lack of novelty, lack of inventivestep and insufficiency.

“Insufficiency” relates to the requirement that a patentclaim must not be broader than what has been disclosedin the patent specification.

In 2007, the judge concluded “The first person to find away of achieving an obviously desirable goal is notpermitted to monopolise every other way of doing so.Claims 1 and 3 are too broad. They extend beyond anytechnical contribution made by Lundbeck. Claims 1 and 3of the Patent are invalid for Insufficiency.”

The judge believed that the invention lay in the particularway of making the (+) enantiomer and that a patenteeshould not have a monopoly for “more than he deserves”.

This decision left Lundbeck with only a valid Claim 6 and amonopoly on its particular method of making the (+)enantiomer. Without Claims 1 and 3 they could not preventgenerics companies from finding other ways of producing itand selling generic versions.

Lundbeck appealed the decision and last month, receiveda more favourable ruling from the Court of Appeal. Thistime, it was stated that the concept that a patentee“should not have more than he deserves” does not formpart of the statutory test for sufficiency of patent claims.Claims 1, 3 and 6 of Lundberg’s Escitalopram patent havetherefore been upheld.

This decision is good news for Lundbeck and for otherresearch-based companies who invent products byproviding new methods of making useful compounds. ForLundbeck, it means that its twenty year monopoly onEscitalopram will not be cut short by genericsmanufacturers finding other ways of making it.

Through a well drafted patent application, it is possible for apatentee to get “more than he deserves” and in cases suchas the above, where a single product is key to the successof a company, strong patent protection is invaluable.

Hargreaves Elsworth Patent Attorneys are currently offeringfree “IP Clinics” to local companies who are interested indiscussing ways to protect their inventions or to monitorcompetitor patent activity.

For more information please contact Dominic Elsworth on0191 211 1974.

39Author: Juliet Scullion

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 WatkinsManaging DirectorCounty Durham Development Company

Final word