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26: Forty years with stem cells – and still going strong

14: Proposals for what theEU presidency can achieve

32: She is 43, lawyer with a taste for adventure

36: Research beacons under construction

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12 the magazine about life and science in medicon Valley

Photo: Bioneer A/S

ContentsThe column - Everyone has a pet cause 3

Highlights from Medicon Valley 4

Novo Nordisk limits the use of research animals 10No more live animals will be used for pharmaceutical product control

Biomarker research facilitated by new national biobank 12Opening of a giant new biobank in March 2012

The Turning Point - Knowledge, speed and quality 13Trial Form Support has become a legend in the field of clinical research

Three proposals for what the EU presidency can 14For the next six months, Denmark will sit at the head of the table

“It’s not all bad that companies are moving jobs out of Denmark” 20Danish Minister can see a positive side to Danish companies having activities abroad

Eating your way to improved health 24We eat because we are hungry. Or at least we used to

Forty years working with stem cells as replacement therapy – and still going strong 26The desire to understand one of nature’s true wonders, keeps researchers going

How to navigate the complex world of biosimilars 30Market entry poses significant challenges and will likely generate plentyof work for legal and regulatory teams.

People - A taste for adventure 32Deep water is actually where Anne Cathrine Wilhjelm feels most at home

Research beacons under construction 36Medicon Valley Alliance and Invest in Skåne have been granted DKK 24m

Hidden gold in the science parks – IDEON 38“This is where you’ll find creative people who want to be high achievers”

The Baton - Sweden can demonstrate some of the highest survival figures in the world 40How can the cancer research cluster in the Oresund Region help tomorrow’s investors?

New Members of Medicon Valley Alliance 42

Upcoming Events by Medicon Valley Alliance 43

LifeSciences Insightno. 1 - 2012

LifeSciences Insight is distributed in Denmark and

Sweden to:

• Named decision-makers in the life science industry

• Investors

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• Hospitals

• Universities

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• Relevant MPs in Scandinavia

• Medicon Valley Alliance’s members and

• collaboration partners

In addition, the magazine is available at relevant

exhibitions and fairs in Europe, North America and

Asia.

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+45 3326 9520

info@raskmedia.com

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Partners:

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Editor in chief: Carsten Elgstrøm

Editors: Lone Frank, Malene Aadal Bo

Editorial team: Mikkel Ais Andersen, Thomas Bjørn,

Claus Clausen, Alexander Denoon, Carsten Rose,

Charlotte Strøm, Eva Tiwe, Birgitte Aabo

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Next issue: May 2012

ISSN: 1904-4755

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By Lone FrankTranslation: CLS Communication A/S

Long before Denmark took over the presidency, political commentators agreed on one thing: Calling the next half a year a success will depend on the presidency managing to set a Danish agenda. A forward-thinking agenda that extends beyond the immediate crisis.

The Danish agenda can and must be a research and innovation agenda. But is it just a question of sending more money, and if so, to whom?

Everyone has a pet cause that they think should be first in line. For instance, Ulf Wiinberg, CEO of Lundbeck, argues in this issue of LSI in favour of focusing on mental illnesses. More efficient treatment for brain diseases in particular could effectively counteract Europe’s loss of productivity and promote the relevant area of the pharmaceuticals industry. A concept like this is too narrow-minded. It is really a matter of acknowledging that entire areas of technology such as bio and nano span all sectors of society. They are not just related to our health but are the key to climate challenges, energy challenges and environmental challenges.

Technological development must drive the innovation that fuels all European industry. And this means that the overall motivation should be to break down barriers to innovation.

The barriers are evident in various areas. One example is the European patent system, which, as Henrik Vestergaard from the Danish Association of the Pharmaceutical Industry (Lif) points out, is a patchwork quilt of national systems. Naturally, this must be

made into one stop shopping as fast as possible. The Danish presidency can also appropriately fuel a reform of the research support that helps drive development.

The 8th Framework Programme has DKK 650bn from now until 2020 that needs to be negotiated and finalised, and there is a serious need to eliminate red tape. Any researcher who has tried knows that a disproportionate amount of resources are required to obtain funds from the EU’s research coffers. The almost Byzantine bureaucracy means that professional advice is required on how to even apply, and how to meet the formal requirements. An absurd amount of effort and funds are wasted, and reports establish that altogether almost as many resources are spent on applying as are ultimately granted.

At the same time, the support bears an unfortunate hallmark of regional development. Complicated rules ensure that a typical project has participants from a number of the union’s small research-intensive States as well as an appropriate representation of small companies. That sounds good on paper but in practice, unqualified groups guzzle a large share of the precious grants. Research is only about quality, and recognition of this fact needs to be built into the system.

The presidency is more than just administration and managing meetings. It is also a podium from which to begin setting a new tone and thereby changing the atmosphere, which can be as important as more money. In the midst of this almost crippling crisis, what we need is an injection of determination to want to achieve

something. Academics have to be willing to do their best, and the industry must be determined to compete against the rest of the world, and bureaucracy has to be prepared to facilitate the cooperation needed across the entire union.

The Prime Minister’s New Year speech referred to Denmark’s attempt to nudge Europe a small step in the right direction. The right direction means far more efficient and smoothly flowing innovation, so how about letting Merkel and Sarkozy deal with the euro and instead focus on giving Europe as a whole a proper boost forwards?

Everyone has a pet cause

Lone Frank is a journalist and author with a Ph.D. in neuro biology and a background in research.

As a staff writer at Denmark’s leading news paper and LifeSciences Insight, she is Denmark’s most distinguished science writer and a well-known voice in debates about science, technology and society. She is widely invited as a public speaker.

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Edited by Malene Aadal BoTranslation: CLS Communication A/S

Injection for Ethanol researchThe Swedish energy authorities are investing in ethanol and have just granted SEK 43m over four years to ethanol researchers at Lund University. At the same time, the High Technology Fund in Denmark has granted DKK 112m for a new platform that will unite Denmark’s leading players within the sustainable use of biomass. In Denmark, the purpose is especially to develop specific, sustainable solutions for producing biofuel for the global shipping fleet. In Sweden, however, it is also a matter of developing methods for creating an inexpensive and efficient means of extracting bioethanol – and preferably in a way that will not threaten global food production. “Many people are unaware that there are different types of ethanol. We are working on producing ethanol from lignocellulose, i.e. various types of wood and agricultural by-products,” says Professor Gunnar Lidén, Chemical Engineering Department, Lund University.Source: chemicalnet.se and High Technology Fund of Denmark

Minister wants Danish students to venture abroadThe chafing yoke of bureaucracy should be eased to make it possible for all Danish students to spend some time studying abroad.This is the vision according to Morten Østergaard (Social Liberals), who is the Danish Minister for Research, Innovation and Higher Education.The Minister hopes that more Danish students will gravitate to the world’s growth drivers rather than spending a semester in England, France, Germany or the USA.“We really need them to travel to parts of the world where growth will occur in the future,” says the Minister, suggesting for instance ‘tailored packages’ to tempt students off the beaten track to English-speaking destinations.Both the Confederation of Danish Industry and the Danish Chamber of Commerce are delighted with the Minister’s announcement.

“A global outlook is just about the most important gift you can give young people

today, so we could not be more positive,” says Jannik Schack

Linnemann, Head of Research Policy/Market Director at the Danish Chamber of Commerce.Source: Politiken

Photo: ScanStockPhoto

Highlights from Medicon Valley

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will form the basis for competent and development-oriented leaders in Swedish research.See the list at chemicalnet.se

Alk-Abello to invest in new graduatesGloomy prognoses for developments in qualified labour, low unemployment and high pay rises testify that highly educated labour in the life science industries could be scarce. Alk-Abello will therefore establish better ongoing contact with educational institutions so that the pharma-ceuticals Group can attract the best employees, accor-ding to Maryann Barrett, Vice President HR at Alk-Abello.“We rely heavily on our employees’ own networks when we need highly specialised labour. And we are also signalling that employees are given exciting work assignments that they can influence a great deal themselves.The last point, where we have not succeeded in making much progress, involves having a higher level of regular contact with some of the education institutions. We take in a number of individuals who are completing their dissertations but would like to do this more.”

Names and data Paula Zeilon to be Managing Director of the new Science Foresight Institute in LundDuring the summer, the European Regional Develop ment Fund granted funding to start a Life Science Foresight Institute. The Institute, under Lund University, will move to the Medicon Village in Lund in January.“The Life Science Foresight Institute will make business intelligence accessible to many more small companies and organisations than is currently possible,” says Paula Zeilon, who has 25 years of experience in business development and managing companies involved with biotechnology tools, medical devices, pharmaceuticals and diagnostics.Companies throughout Scandinavia badly need business intelligence and foresight within Life Science. The Institute will have two main focus areas, partly research on megatrends within Life Science, and partly a service function that can provide business decision support in the form of intelligence.

Niels Bohr gets top researcher from HarvardA grant of DKK 38m from the VILLUM FOUNDATION is paving the way for a brand new professorship at the University of Copenhagen. Professor Charles Marcus is the world-leading researcher in the field of quantum electronics who will be joining the Niels Bohr Institute. The grant is the first Danish instance of a private foundation funding the creation of a permanent professorship – known in the English-speaking academic world as ‘endowed chairs’. “This is a great new opportunity that the VILLUM FOUNDATION is demonstrating. It represents a new way to attract exceptionally talented researchers to Danish universities by guaranteeing researchers permanent and attractive employment conditions,” says Professor John Renner Hansen, Head of the Niels Bohr Institute.The research aims to use advanced materials to develop nanoelectronics comprising semiconducting nanowires, carbon nanotubes and superconducting systems and to develop new measurement methods. Charles Marcus and his centre will also conduct research in quantum information with systems based on electricity, i.e. electrons, instead of quantum optics, which is based on photons.

42 million for 14 junior researchersFourteen junior postdoctoral researchers returning to Sweden will receive SEK 3m from SSF’s Ingvar Carlsson Award research programme.The purpose of the programme is to give junior post -doctoral researchers the opportunity to start up research activities in Sweden on their return from abroad.“We want to retain and strengthen the country’s competitive research, which the Ingvar Carlsson Award is contributing to in an excellent manner. The promising young researchers can establish themselves in Sweden with their newly gained competence and experience from foreign institutes of higher education,” says Lars Rask, Executive Director for the Swedish Foundation for Strategic Research (SSF) in a press release. DKK 50,000 of the DKK 3m is a personal scholarship. The researchers will also have the chance to take part in a separate programme for leadership development that

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Technia invites you to the seminar

Wednesday May 9, 8:30 – 13:00 at MVA in Copenhagen

Find more info and register at www.technia.com

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The Life Science Foresight Institute will be co-financed by Lund University, Region Skåne, Malmö University and the City of Malmö. Other sponsors include Capish Knowledge and Medicon Village.

Protein researcher wins major European awardProfessor Matthias Mann has just received the prestigious Louis Jeantet Prize for Medicine for his results within fields such as cancer research. Today, we have the technology to analyse a person’s genomes very rapidly, and Professor Matthias Mann is working on advanced analysis methods that in the long term can map the entire network of associated proteins in the human organism – the proteome. Matthias Mann’s basic scientific research has facilitated the study of proteins with the efficiency previously reserved for genetic material. At one time, analysing a peptide was a major challenge – but today thousands of peptides can be examined in a very short space of time using special methods based on mass spectrometry. Professor and proteomics researcher Matthias Mann is Research Director at the Novo Nordisk Foundation Center for Protein Research at the Faculty of Health Sciences, University of Copenhagen, and Head of Department of Proteomics and Signal Transduction at the Max Planck Institute of Biochemistry in Martinsried.

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In addition to the honour, the prize consists of approx. DKK 4.3m donated by the Swiss Louis-Jeantet Foundation.

Everyone wants to learn from Henrik and RenéThe Department of Thoracic Surgery, Copenhagen University Hospital, is where you’ll find two of the world’s leading experts on minimally invasive surgery, which involves removing tumours using keyhole surgery, and foreign surgeons are flocking to the department to learn their techniques.The two chief consultants are Henrik Jessen and René Petersen. Henrik Jessen is the surgeon who intro duced advanced keyhole surgery in Denmark, and as early as in 1999 carried out his first minimally invasive lung operation. “A number of scientific articles have shown that the survival rate is at least as high as with open surgery. Meanwhile, the period of bed confinement is significantly shorter and patients are in better condition after the operation. That means they cope better with the subsequent chemotherapy,” says Henrik Jessen. At the moment, a number of centres across Europe are beginning to adopt this kind of operation. Consequently, the surgeons in Copenhagen receive visits from about 15-20 teams of foreign surgeons a year from countries such as Switzerland, Germany, France, England and the Scandinavian countries. Source: Dagens Medicin

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Technology nEws

10-year head start on Alzheimer’sResearchers from Lund University, with Physician Oskar Hansson at the helm, have found a particular combination of biomarkers that can predict Alzheimer’s ten years before a diagnosis could otherwise be made. The research team studied 140 people with mild memory impairment, paying particular attention to those with low levels of the substance beta-amyloid and high levels of the substance tau. As many as 91 percent of subjects with this pattern of biomarkers went on to develop Alzheimer’s within a ten-year period whereas those who had normal values for the markers did not run a higher risk of developing the disease. “Drugs have previously proved to be largely ineffective – probably because the disease has not been discovered until it has already caused major brain damage,” says Oskar Hansson to the Archives of General Psychiatry medical journal (www.archpsyc.ama-assn.org).

Electricity makes calcium a cancer killerElectricity and calcium together make a powerful combination that forces cancer cells to work so hard that they die. This has been shown by researchers from Herlev Hospital and Aarhus University in a new study recently published as a Priority Report in the Cancer Research medical journal. In the study, which is based on cells and animal trials, researchers injected calcium around diseased cells and subsequently applied an electrical current. Because calcium acts as a signal molecule in the cells, they prefer a low calcium content. However the electrical current opens the cell membranes and permits the calcium to flow in. The cell attempts to pump the calcium out again while disruptions occur in e.g. the potassium and sodium

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developing prostate cancer than men who have at least one child.Yasir Ruhayel, PhD student at Lund University, and doctors at Skåne University Hospital have completed research that shows the correlation between prostate cancer and fertility is higher than the correlation between prostate cancer and, e.g., diet, smoking, alcohol and various other diseases. Yasir Ruhayel has closely studied a number of previously known genetic explanations concerning why some men have problems with reproduction. In his thesis, he has investigated whether they also reduce or otherwise affect the risk of suffering from prostate cancer.If future research can more safely identify the genes that reduce the risk of prostate cancer, new opportunities for developing drugs and preventive measures will open up. Source: Lund University

Bio-chip to lead to the medicine of tomorrowThe human body composes its molecules of life from just 20 different amino acids that resemble a string of pearls. The cookery book of life features individual recipes consisting of descriptions of the composition of amino acids. The number of potential combinations is infinite. And for researchers attempting to understand the proteins and use this knowledge to develop new medicines, this is an almost impossible mission. However, a team of Danish researchers and biotech companies are about to change that. With an EU grant of approx. DKK 35.5m, the team will further develop a technology that can produce mini-laboratories on a chip. The project is called hiPAD and will be led by Professor Søren Buus from the University of Copenhagen. It is hoped that the technology can help promote a more personal and effective approach to health and medicine. The project is a further development of the EU PepChipOmics project, which focused on developing the chip itself. Source: University of Copenhagen The brain is smarter than we thoughtCalcium is vital for all brain functions. However, now researchers at the University of Copenhagen have discovered that the otherwise very important substance does not – as previously presumed – affect the brain cells’ energy metabolism. This discovery brings researchers closer to understanding brain diseases such as migraines, autism and Parkinson’s Disease and provides important knowledge about what occurs in brains during the aging process. The discovery has just been published in the renowned Journal of Neuroscience. “We have stumbled across the surprising finding that the way in which neurons, i.e. nerve cells, create and use energy is smarter than previous in vitro research involving tissue and biochemistry has

balance, and the work is so energy-intensive for the cell that it ultimately dies. The results showed that 89% of the tumours disappeared after a single treatment with calcium and an electrical current. At the Department of Oncology at Herlev Hospital, Julie Gehl is already preparing similar trials on humans.

On the trail of the fly larvae’s secretA team of Danish researchers has revealed part of the secret of the fly larvae’s unique ability to clean and heal chronic wounds, for instance in patients with diabetes. The discovery sparks hope that in the long term a plaster inspired by fly larvae can be made that can replace the live fly larvae in hospital wards.Fly larvae do two things. They produce antimicrobial substances that can kill bacteria such as streptococci and staphylococci, and they produce a cocktail of digestive enzymes that they quite literally vomit into the wound.“Once inside the wound, the digestive enzymes dissect the dead tissue into small pieces and the fly larvae then ingest this soup of dead tissue. When the larvae have finished eating, only healthy tissue remains in the wound. At the same time, the antimicrobial substances ensure that the amount of pathogenic bacteria in the wound is reduced,” says Anders Schou Andersen, who has managed to isolate and mass produce an antimicrobial substance and a digestive enzyme from fly larvae. In addition to healing wounds, the antimicrobial substance is also a potential answer to the global demand for antibiotics that can wipe out multiresistant bacteria. Source: Experimentarium

Halved risk of prostate cancer in infertile menThere is a clear correlation between men who have trouble having children and a lower risk of prostate cancer. According to a new thesis from Lund University, these men have about a 50 percent lower risk of

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Meanwhile, other stem cell researchers have managed to partially restore the sight of blind women. The experiment was carried out by researchers from a company called Advanced Cell Technology USA and other organisations. The researchers manipulated the embryonic stem cells into becoming retina cells which they then transplanted into the eyes of two female patients. Both subsequently found they could differentiate letters and see the contours of their fingers. This is the first time that a study involving embryonic stem cells has had such positive and measurable results. It is also the first time the method has actually been used on humans. The research is so sensational that it has been published in the medical journal. The researchers explain that while the treatment is promising, it is also demanding for the individual patient because the immune system must be suppressed, just like with organ transplants. The researchers are therefore reluctant to make any assurances that further treatment can be avoided. Source: Dagens Medicin and Berlingske.dk

indicated. The smarter and simpler regulation of the brain’s energy production is an advantage for the brain, which can function as required and does not depend on complex biochemical signalling,” says postdoctoral researcher Claus Mathiesen from the Center for Healthy Aging, Faculty of Health Sciences, University of Copenhagen. “ This knowledge can help us reveal the causes of brain diseases that occur when some parts of the brain cells suddenly die or begin working incorrectly and inappropriately, as with migraines or Parkinson’s Disease,” says Claus Mathiesen. New pathfinder for stem cells Danish researchers have joined forces with Coloplast to create ‘scaffolds’ – a microparticle – consisting of biodegradable polymer materials that support stem cells and make them grow as desired. The results have been published in the Journal of Controlled Release.Stem cells can revive dead tissue but only if the cells can locate the site in the body where they will be useful. This works best with a helping hand - in the form of the scaffolds constructed by the research team.The experiments were carried out with ‘adult stem cells’.

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Novo Nordisklimits the use of research animals

350,000 research animals a year

The use of research animals in Denmark has remained stable at about 350,000 a year for some years – while research activity has increased. This means that fewer research animals are used for each study, according to a report published in The Journal of the Danish Medical Association in 2009.

Approximately 220,000 of the research animals are used for medical research. Most are used for research into nerve and mental disorders, and by far the majority are rodents – including mice, which comprise over half of the animals. Other research animals include pigs and rabbits.

No more live animals will be used for pharmaceutical product control at Novo Nordisk, which previously used about 13,000 animals a year for this purpose.

By Birgitte AaboTranslation: CLS Communication A/S

After a good ten years of hard work, Novo Nordisk has now definitively stopped using research animals for pharmaceutical product control. Many of the trials can be discontinued because they are unnecessary, and the rest have been replaced by other types of tests using cells from e.g. laboratory rodents.

“Using animals as a means for gaining new knowledge and testing medicine is an ethical dilemma, and in 1999 we made the decision to try to find other methods than animal trials, regardless of the cost. Now we have managed to completely stop using live animals for testing the quality of medicines from the production lines,” says Lise Holst, the company’s director of bioethics.

She explains that the driving

force was not money but rather a conviction among the employees that the animal trials were either unnecessary or could be replaced by new laboratory tests.

Extensive data collection Novo Nordisk used research animals to meet the requirements set by the health authorities when individual products entered the market. The extensive collection of data reviewed in close cooperation with authorities worldwide has now revealed that most of the research animals can retire.

“We collected data from years of production and compared the results of tests on animals with other tests that do not involve live animals. This gave us the scientific proof we needed to convince the authorities that our theory was

correct: testing on live research animals was often unnecessary. In cases where research animals were not unnecessary, we developed brand new laboratory methods,” she says.

In order to obtain regulatory approval for replacing animal trials with laboratory trials, it was once again necessary to collect scientific data from comparison studies that showed the new tests were at least as good or better in terms of assuring quality and patient safety.

In the light of this comprehensive work, Novo Nordisk was permitted to drop many of its animal trials in product control, while the rest have been replaced by newly developed testing methods that require only cells from animals. At the same time, an

internal procedure was introduced to ensure that no future products would require the use of live research animals.

A milestone was therefore reached when Novo Nordisk carried out virus control in November and could call it “the very last time they would use research animals for product control”.

Further reductionIn the 1990s, the company used more than 13,000 mice, rats, guinea pigs, hamsters and rabbits for its biological product control, but the figure gradually dropped over the years – to 772 animals in 2010.

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Although animal trials are no longer used for product control, Novo Nordisk uses about 62,000 research animals a year for other purposes and expects to maintain this level, even though research activities are increasing by about 15 percent annually. Using research animals when researching and developing new medicines is, as yet, unavoidable, and animal trials are also required to meet health authority requirements concerning testing on animals before conducting trials on humans. But Novo Nordisk will continue to work on minimising the use of research animals, according to Lise Holst.

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information stored in the biobank will be accessible by everyone.

“The good news is that this is truly for the common good,” he says and he welcomes public and private researchers into collaborations with SSI and on the storage of samples.

This includes the pharmaceutical and biotechnological industry, which will have a unique opportunity to dig into the concept of individualised medicine to an extent that has never previously been seen.

The biobank is funded by a grant from the Novo Nordisk Foundation and the Lundbeck Foundation and will be one of the largest of its kind in the world.

FACtSBiomarkers may be relevant in a wide range of chronic diseases within oncology, neurology, immunology and endocrinology. Biomarkers may be relevant to:• Early disease detection• Testing the efficacy

of medicines when prospectively justified

• Disease classification of subgroups

• Prognosis

A state-of-the-art, computer-controlled and robot-operated biobank building, run by SSI, is ready to open in early spring 2012. The biobank has the capacity to store 15 million human blood and tissue samples. With improved registration and categorisation of samples in a bioregistry, the

capability to conduct very detailed searches, e.g., in specific age groups, a certain disease or certain phenotypes, will be strengthened considerably. Combined with Denmark’s unique central person registration and Cause of Death registry, Danish researchers will have advanced tools at their disposal in the search for biomarkers for a number of serious diseases.

Samples are to be collected at hospitals all over Denmark and, initially, the biobank will hold the six million samples that SSI has collected over the years.

Great expectationsProfessor Mads Melbye is in charge of the new biobank and he has great expectations.

“We have unique possibilities to combine the information with registry data. This will allow an intensified search for relevant biomarkers for different diseases and, furthermore, will improve the search for effective medicines,” he says.

Mads Melbye stresses that the

Biomarker research facilitated by new national biobankThe Statens Serum Institut’s (SSI) opening of a giant new biobank in March 2012 marks a competitive advantage for Danish researchers in the search for biomarkers for a wide range of diseases.

Mads Melbye, Professor, Executive Vice

President.

By Charlotte Strøm, MD, PhD, journalist

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Illustration of the new Biobank, Statens Serum Institute

the turning Point

By Eva TiweTranslation: CLS Communication A/S

“We want to develop the Nordic countries into an attractive region for clinical research,” he explains.

What has made this company such a success, with a current turnover of EUR 40 million?

“First off, it’s the entrepreneurial spirit of Daniel Spasic, coupled with the fact that we’ve continuously succeeded in bringing in good people, which has been the most important key to success. If you have the right employees in the right place and with the right attitude and knowledge, then that’s an excellent recipe for success,” says Jan Hellqvist, TFS’s Regional Manager for Northern Europe.

In addition, he lists willpower, a strong customer focus, speed and guaranteed quality as success factors that have helped create the Trial Form Support we see today.

“Speed and flexibility are important to many customers. We can fulfil a contract in just two days. We’ve heard of examples where large American CROs (Contract Research Organisations) take months to do the same thing. And we can adapt completely to the wishes and goals of the customer while remaining compliant with the demands of GCP (Good Clinical Practice),” says Hellqvist.

The company is capable of completing just about any task within clinical research using its own staff. The focus is on four business areas: • TFS Explore, which conducts early-stage research

and development, initially centring on phase I studies. These are conducted in clinics or at the phase I centres at Karolinska University Hospital, in Stockholm, and Skåne University Hospital, in Lund.

• TFS Develop, which conducts clinical research from phase II to phase IV.

• TFS People, which hires out clinical research staff for shorter or longer periods.

• TFS Academy, which focuses on providing training and education.

“We take complete responsibility from the production of the synopsis right up until the finished report, and we have all the necessary resources within the company to be able to accomplish this,” says Hellqvist.

Today, TFS is the largest private-sector company

of its kind in Europe, but it is still only mid-size when compared to the giants in the industry – the 12th largest when seen from a global perspective.

“This is a size which more and more customers find attractive,” explains Hellqvist.

“Many mid-size companies have attempted to work with large CROs without receiving the value and attention they were expecting. On the other hand, merely working with small local units does not sit well with companies that want to work internationally.”

“We don’t want to become too large and, above all, we want to retain our local focus, which, all things considered, is a definite plus.”

“We’re more flexible, have better prices, and everything happens faster with us than with the giants in the industry.”

This results in happy customers, and, according to Hellqvist, TFS has a repeat business level of more than 90 percent, with new customers coming in all the time, especially from the fields of biotechnology, functional foods and cosmetics.

Knowledge, speed and qualityTrial Form Support, or TFS, has become a legend in the field of clinical research. The company

was founded in 1996 as a one-man enterprise by Daniel Spasic. Since then it has expanded

considerably, and now Spasic heads a corporation with around 500 employees and is on his

way to establishing TFS in the USA as well.

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Jan Hellqvist, Regional Manager for Northern Europe.

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By Mikkel Ais AndersenTranslation: CLS Communication A/S

For the next six months, Denmark will sit at the head of the table at EU Council of Ministers meetings, and last month when Helle Thorning Schmidt (Social Democrats) presented the programme for the EU Presidency, Europe at work, she had this to say:

“We are taking over the presidency at a historically difficult period. Like the Polish presidency, our presidency will be defined by

the crisis. But that makes it no less important that the necessary decisions be made.”

This means that issues such as research, innovation and health have found their way onto the programme of the Danish presidency even though the all-encompassing financial crisis that is affecting the whole of Europe requires a great deal of attention. And if Denmark understands how to exploit the potential, the EU presidency will be a unique opportunity to train the political

spotlight and support Danish positions of strength, thereby boosting growth and funding in the Danish welfare system.

We asked Ulf Wiinberg, from Lundbeck, Henrik Vestergaard, from the Danish Association of the Pharmaceutical Industry (Lif), and Antje Marquardsen, from the professional organisation Pharmadanmark, how the industry can benefit most from the EU presidency.

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Three proposals for what the EU presidency can achieveDenmark has the EU presidency in 2012 and this will provide unique opportunities. We have proposals from three industry heavyweights concerning how we can benefit from the EU presidency.

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Lundbeck’s CEO, Ulf Wiinberg.“The EU presidency will enable us to direct the European political spotlight at areas where we are strong and can help the EU to deal with the challenges the union is facing. We will then be helping ourselves by paving the way for better framework and growth conditions for important Danish export industries. For example, medicine is Denmark’s most important export group with a 10 per cent share of the total exports,” he says. Ulf Wiinberg describes how the most important condition for stabilising the economy and restoring growth in Europe is basically a matter of European companies having a healthy and productive workforce. The healthcare sector therefore plays

a vital role. Consequently, it is necessary to focus on research and innovation.

“The right investments and initiatives can be key factors in increasing productivity and growth in society. For example, the loss of productivity in the EU as a result of mental illnesses in 2007, alone, totalled a staggering EUR 136.3 billion. A clearer political focus on timely and effective efforts to combat mental illnesses is a prime example of how Denmark can help the EU while helping an important Danish industry. It can also strengthen the European pharmaceuticals industry as a whole,” he explains, concluding: “The relationship between people’s health and society’s growth and productivity is evident and reflects two sides of the same coin, and

Denmark can use the EU presidency to blaze a trail.” Ulf Wiinberg may fear that the economic investments in innovation and research will be neglected in an effort to get the economy back on track, but according to him, that would be going too far. “Only a constant research effort can pave the way for the improved medicines that will alleviate future challenges in terms of health. This can create a breeding ground for economic growth. The presidency should emphasise the importance of this matter,” he believes.

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Denmark is responsible for showing the way

Ulf Wiinberg, CEO Lundbeck Pharma A/S

research and growth results proliferate,” she says.

Antje Marquardsen is not only striving to create an environment that encourages more knowledge sharing and projects between Danish MedTech companies, but also to create frameworks within the EU that encourage cooperation across Europe between companies and universities to promote joint competitive advantages.

“We should encourage a debate about openness and patents that can result in everyone recognising the benefits of sharing know -ledge.”

more competitive on the global stage, where we are about to be overtaken. She points out that Denmark needs to make its voice heard at Council of Minister meetings and facilitate discussions on how we can establish better frameworks for pharma and biotech companies.

“At the moment we are not exactly up to our ears in new medicines. The ideas are there, but getting them translated into research projects is a task companies cannot handle alone. To promote this process, we need more efficient knowledge sharing between companies and universities. Companies are probably cautious about sharing their knowledge because they’re afraid it will be stolen, but that is the only way we can create an innovative environment where

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Although Denmark is small, it is streets ahead in the pharma and biotech industry, and we need to use the EU presidency to advertise this fact. This is the opinion of the Chairwoman of Pharmadanmark, Antje Marquardsen, who says it is one of the best showcases anyone could hope to have.

“Many States are not very familiar with Danish biotech, and we can do something about that through the EU presidency. The challenge is to put biotech on the agenda and thereby highlight Denmark’s innovative strengths within pharmaceuticals, biotech and medical equipment. In this way, we can make Denmark more attractive for new investors - as they are scarce at the moment,” she says.

Antje Marquardsen also addresses the need to make Europe and secondarily Denmark

Drag people to the showcase – and help each other to keep it stocked

Antje Marquardsen, President,

Pharmadanmark

Like Ulf Wiinberg, Henrik Vester-gaard, Deputy Director at Lif, is con-vinced of the importance of Denmarkusing the presidency to put inno-vation and research on the agenda.

“It’s good that the government’s innovation initiative Smart Health – Better Life focuses on the pharma and biotech industry, but we must be aware that the perspectives for innovation in this industry are very long-term. It is important that the allocated financial resources are focused, preferably on pharma and biotech, because this is where a lot of EU research resources need to be injected,” he says, referring to the formulation of the 8th framework programme, which determines how EU research funds are to be allocated.

Horizon 2020 is the title of the proposal presented by the Commission for the 8th framework

programme and it will be the Danish presidency’s task to negotiate and finalise the programme. The Commis-sion proposes that between now and 2020, DKK 650bn should be spent on research, and Henrik Vestergaard is very pleased with that.

He highlights that the EU presidency is a golden opportunity to create growth within innovation and research but that unless adequate funds are earmarked for biotech, for example, the opportunity will be lost.The other major challenge Denmark is facing in connection with the EU presidency is of a more bureaucratic nature, according to Henrik Vestergaard from Lif. The overall structure needs to be adjusted to make it easier for companies to operate in the European market.“The European market is also

heavily influenced by being a Europe comprised of Nation States, and each country therefore still has its own patents and patent courts. This means patents must be filed in 27 different places to obtain a European patent whereas the US has just one system. We need a unified European patent court system, so companies can more easily defend themselves against patent violations. Generally speaking, we need to move away from the separates systems that operate differently from one State to another,” says Henrik Vestergaard.

Unitary patent system and looser the purse strings

Henrik Vestergaard, Deputy Director, LIF

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Business Profile

Text: Mikkel Ais AndersenTranslation: CLS Communication A/S

The pharma industry has met major financial obstacles in the past five years. Weak pipelines, uncontrolled expansion and sky-high drug prices are just some of the explanations given for the recent decline. But the real story behind the decline is the loss of income from the pharmaceutical blockbuster products that have lost their patent protection – such as Lipitor (Pfizer), Plavix (Sanofi Aventis), Avandia (GlaxoSmithKline) and Zyprexa ( Lilly).

Based on recent investments and market prognoses, the blockbuster products are expected to deliver only

Proven business transformation solution can boost pharma and biotech

Over the past five years, the pharma industry has been held to ransom by its own entrenched business models. The market has changed – especially due to the abrogation of patents for several pharmaceuticals – and the models are no longer up to date.For decades, PLM has been speeding up business transformation in other industries, and a number of pharma companies have successfully begun implementing it. The solution can be an important differentiator to steer medium sized pharma away from the pharma industry’s financial slowdown

a 5 per cent return on investments. Only one in six new drug candidates is likely to produce any return and be attractive to investors.

The loss of patent protection on popular products is almost always accompanied by development, and this is when generic versions of the drugs begin to germinate. The Hatch Waxman Act permits generic producers to begin developing generic versions of the branded products as early as five years before the

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Business Profile

patent expires, enabling generic producers to develop and acquire regulatory approval for their products well before the patent expiry date. So they must act quickly to achieve success with the generic version of the drug, but sadly many pharma companies are not at all geared for this.

Follow the product’s cycleWhile the business climate for pharma companies has changed drastically over the past five years, the pharma business model has not kept up, and major parts of the industry are now suffering as a consequence. A brand new approach and business model are required for the pharma companies that are hoping to grow – especially within the generic products that currently have golden opportunities due precisely to the abrogation of patent protection – if they are agile to make the right move. This is the view of Petter Sahlin, sales director for Technia, the leading consulting company in the Nordic region, which works with product lifecycle management (PLM) solutions for life science. When implementing their solution for drug development, focus is on the product launch process. In a nutshell, the PLM solution creates one cross-functional real-time view on product definition with change control – sales, supply chain, regulatory submissions, packaging and labelling. “Many pharma companies must become stay agile while being more structured, especially those developing generic drugs” says Petter Sahlin, mentioning examples of success stories within pharma: Meda, Actavis, Orion Pharma, and Teva.

Learning from other industries: From Audi and BMW to pharma and biotechPetter Sahlin explains how the competitive edge in generic products is driven mainly by rapid but cost-effective access to new markets, and that the PLM model can be a useful tool.

“Use of the PLM model in the pharma industry is relatively new, but other industries have achieved cost-effective design transfer using PLM – among others GE, Johnson & Johnson, Audi, BMW, Boeing, Airbus, H&M, Scania, Ericsson, ABB and Siemens. The main objectives

of introducing PLM to improve pharma’s business-related launch of products are to reduce time-to-market and give exact status reports. At the same time, it creates a transparent cross-functional view of the product’s maturity in legislative processes while safeguarding launch dates and quality. The essence is to give one version of the truth about the product’s status to everyone in the company at all times during the drug launch,” says Petter Sahlin before concluding:

“Pharmaceutical companies need new business models to restore sound financial results. This is a strategy that the pharmaceutical industry can use to react far quicker and more flexibly to business opportunities than they do now. PLM gives a company the opportunity to exploit market changes, grow and ultimately maximise profit.”

8 per cent progress in one yearTechnia implements mainly PLM in medium-sized and large companies working with medical technology (such as GE Healthcare, Elekta, Mölnlycke Healthcare, Philips Digital Mammography, Oticon) and in medium-sized pharma companies, such as Orion Pharma, in Finland. Among other achievements, the PLM model has increased the companies’ ability to enter new markets and register their products.

Orion Pharma is an innovative R&D-based pharma company specialising in developing medical treatments and diagnostic tests for the global market. With pharmaceutical R&D focused on the nervous system, cancer and intensive care units, in 2011 the company generated EUR 918 million, which was 8 per cent progress compared with 2010.

“Why reinvent the wheel?”Though still in the first phase of implementing the PLM model, Orion Pharma is part of the first wave of pharma companies that have chosen to optimise their business through PLM. Minna-Liisa Siltala, who is PLM project manager at Orion, explains about the deliberations underlying implementation of a new business model like this.

“There were very few public PLM references in the pharmaceutical industry. But PLM has been rolled out from industry to industry for the past 20 years so we thought: ‘Why reinvent the wheel?’ We wanted something that had best practices built into it from the beginning. So instead of a customised solution for a medium pharma company like ours, we opted for out-of-the-box functionalities that had a proven track record in other industries,” she says.

Streamlined processes reduce costsMinna-Liisa Siltala explains that there were various reasons for choosing Technia’s ENOVIA PLM system in particular.

“We appreciated that ENOVIA was a proven and out-of-the-box (yet customisable) solution for many P

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other industries and that Technia could do the whole implementation. PLM for us is about managing the complexity of our business in the most cost-efficient way.”

The PLM solutions Orion chose will serve more than 600 users. It will also enable the company to shorten the product introduction process and reduce the critical time to market for new drugs. Legislative policy requirements will also be met.

As in any industry, Orion wants to reduce its time to market by streamlining its processes to increase revenue and cut costs.

Out of the sandboxSome of the most important processes used by Orion and that will benefit from PLM include marketing authorisation and lifecycle management, which are currently handled using a homemade system. Another process involves packaging and how drugs are labelled – including patient information leaflets.

“All these processes are closely related to each other and are key essentials in the new product introduction process,” explains Siltala. “Handling the final stages prior to a launch, and this is where we often have external partners, is where PLM comes in. We can no longer be in our own sandbox and with our own tools. We need transparency and data consistency from the beginning.”

Focus on product launchesPetter Sahlin from Technia encourages pharma

companies to face reality. You simply have to radically optimise your business models, and especially medium-sized companies like Orion Pharma, which conduct research in and develop generic drugs, can benefit from the PLM model.

“The value of introducing PLM for launching products is particularly useful for generics, specialty pharma and OTC. But it is relevant for all pharmaceutical companies that need to reduce time-to-market and improve their launch process. Big Pharma often has similar but older, not integrated solutions in place, which often leads to islands of information, and comprehensive data duplication.”

He concludes that PLM is an important tool within biotech and pharma, but this far it has only proven its strength in optimising product launches.

“Launch performance is important for most organisations that are developing drugs, but it is just one of the many success factors which will create the future winners in our industry. If, for example, you focus exclusively on research, PLM is less interesting, but in a business context, the right PLM model can be a means for maximising profit.”

Minna-Liisa Siltala from Orion Pharma concludes very simply:

“PLM for us is about managing the complexity of our business in the most cost-efficient way.”

Business Profile

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By Birgitte AaboTranslation: CLS Communication A/S

“Of course, it’s a challenge when companies move jobs out of Denmark. But on the other hand, it also means that we can create global companies in Denmark that may have a need to establish activities and production companies in other countries. Therefore I don’t see it as unconditionally negative,” says Ole Sohn (Socialist People’s Party), who in October was appointed Minister of Economic and Business Affairs in the Danish the government, which is a coalition of the Social Democrats, Social Liberals and Socialist People’s Party.

“It’s not all bad that companies are moving jobs out of Denmark”

Even though the Danish Minister of Economic and Business Affairs Ole Sohn (Socialist People’s Party) can see a positive side to Danish companies having activities abroad, he intends to work to keep them in Denmark, partly by involving players from the biotech industry in a new growth team.

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Even though he can see positive aspects about what is time after time described as a pressing problem for the Danish business community – not least for the life science industry, where major companies are increasingly relocating activities abroad – he is busy making an effort for Danish competitiveness:

“Our competitiveness has declined over the past ten years. We must do something about that,” he says, explaining that the government’s business policy will have two main elements. Partly by creating good general frameworks,

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and partly through targeted efforts in areas with the potential for development.”

Growth team under wayThe same is apparent in the government’s programme, which mentions biotech several times as one of the promising areas that deserve special attention and development opportunities – together with green technology, food production and shipping, for example. As part of this targeted part of the business policy, a committee has been set up with participants from 13 ministries.

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BlUE BooKole Christian liep Sohn

Born in 1954 in Torsted in West Germany, and raised in Egebjerg near Horsens, Denmark. His father was a shop steward and radical party member, his mother a teacher, and politics were discussed frequently at home. At the age of 14, he chose to join the Communist Party. On leaving school he became a boy labourer and ship’s cook before taking a Higher Preparatory course at Gedved Teacher Training College until 1973, where he was spokesman for the students on his course. He also played the role of national spokesman for the privates in the supply troops while enlisted.

He then worked as a builder’s labourer and became a member of the management of the General Union of Workers (SID Horsens), followed by chairman and member of the executive committee. From 1981, he was a member of the central committee of Denmark’s Communist Party and was chairman from 1987 until 1991. He was also a member of the executive committee of the Popular Movement Against the EEC and the Red-Green Alliance, before becoming a candidate for the Socialist People’s Party in the Danish parliament in 1992. Elected into parliament in 1998, he became chairman of the parliamentary group of the Socialist People’s Party from 2005. Appointed Minister of Economic and Business Affairs in October 2011.

Besides his political career, he has been a lecturer, author and publisher with Sohn ApS. However, he stepped down as director of his company three days before being appointed minister.

Ole Sohn lives in Rødovre, is married to Inger Sohn, who is a teacher, and together they have two grown children.

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have had trouble identifying specific initiatives that indicate that the government is actually prepared to focus on biotech as a growth area. On the contrary, the government has been accused of introducing stumbling blocks for industry in the guise of new tax initiatives. Two are particularly resented by the industry –those limiting the opportunity to apply tax losses from previous years, and higher tax on royalty income from abroad. Both parts have assumed great importance for the industry since the financial crisis set in and it has become harder to obtain venture capital.

Ole Sohn is not surprised. He

with representatives from biotech and others together with the Minister of Health. A meeting that gave plenty of good input for welfare and health.

“There are major challenges in some areas and there’s much to be done, but the union lacks funding and we therefore need to find smarter and more intelligent solutions – solutions that biotech has a stake in.”

Stumbling block or supportIn the life science industry, however, the statements made by the government to date have not been met with undiluted praise. The representatives of the industry

“A multiministerial committee is a new way of working together that ensures we don’t simply make decisions in our own core areas. First, the committee will address the green sector and then the health and welfare sector,” says Ole Sohn.

When the committee has identified the areas where increasing global demand and Denmark’s strengths match, operative growth teams will be established. These will involve companies and other relevant players. Biotech will be able to propose action plans in this connection.

Ole Sohn held his first meeting

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points out that this is the Tax Minister’s territory, but defends the decision nevertheless:

“In relation to royalties, the decision was made because we didn’t want to risk being left in a situation where setting off foreign tax against patents is so extensive that it ultimately results in a loss for the Danish state. In terms of deferred tax, it is really a matter of adapting to the rules that apply in Germany,” he says, drawing attention to other government initiatives.

For instance it is generally easier for small companies to get a start-up loan. And he also mentions the Danish wage scales, which are actually one of the most important aspects in relation to large companies moving jobs out of Denmark – the Danish wage scale, for which the industry itself bears considerable responsibility according to the Minister.

“In Denmark, wages have increased more than elsewhere in the past ten years and it is largely up to the parties in the labour market to agree on this area,” he says.

But the Minister is prepared to discuss possible barriers to growth in the individual industries in connection with identifying and expanding Danish strengths.

“Perhaps some barriers can be

softened and there are things that can be changed, but we don’t have a big bag of money to hand out. You can’t invent employment. The cornerstone of the industry is that it can continue to develop itself through research and education and that is where we are injecting considerable funds – it’s also an expression that biotech is an area we will continue to prioritise.”

There are major challenges in some areas and there’s much to be done, but the union lacks funding and we therefore need to find smarter and more intelligent solutions – solutions that biotech has a stake in.

“

Market expectations – health-promoting foods:• An annual growth of 5% is expected in Europe by 2013 • The expected market growth of health promoting foods is three times higher than the growth for food and drinks• Market value in 2013 · USD 37 billion in the USA · USD 10 billion in Europe Source: Business Insights

Danish manufacturers of health-promoting food ingredients • Chr. Hansen (2,300 employees globally) · Probiotics, dairy cultures and natural colours• Novozymes (5,800 employees globally)• Market value in 2013 · Enzymes• DuPont, formerly Danisco (67,000 employees globally)• Market value in 2013 · Enzymes, emulsifiers and dairy cultures

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By Charlotte Strøm, MD, PhD, journalist

We eat because we are hungry. Or at least we used to. Today an increasing focus on health drives us towards foods with a health claim and food products which claim to offer more than just satiety or a means to silencing the belly. The global market for functional foods and fortified foods is growing.

Fortified or functionalWhat is the difference between fortified and functional foods? Fortified food items have been enriched with health-promoting additives, like vitamin-enriched products. Functional foods, on the other hand, claim a health-promoting effect beyond the nutritional value of

the food component, e.g. certain types of high-molecular fibres that can have a positive effect on gastrointestinal health.

“The distinction between the two is based on legislation. Where functional foods have documentation to substantiate health claims, fortified foods are not subject to the same scrutiny, except that the amount of additive in the food item may not exceed limits that put people at risk upon consumption,” explains Professor Lars Ove Dragsted, from the Department of Human Nutrition, Faculty of Life Sciences at the University of Copenhagen.

Raising the bar on documentationThe health-promoting effects of food components are evaluated by the European Food and Safety Authority (EFSA). The status and health claims of functional foods must have been given a positive opinion by the EFSA and the EU must approve the health claims. The EFSA evaluates on an ongoing basis the documentation upon which the food component manufacturers base their health claims. Examples of functional foods which have been given a positive opinion on health claims by the EFSA include plant sterols in margarine, anti-carcinogenic effect in chewing gum, and calcium and vitamin D. However, Professor Lars Ove Dragsted acknowledges that calcium and vitamins fall a bit outside the definition of functional foods, and believes that their use as additives comes down to actual deficiencies in parts of Europe.

“Traditionally, the intake of calcium and vitamin D is rather low in Europe. However, as the effect of calcium and vitamin D on bone health is undisputed, the positive opinion on the health claims of these substances could be perceived as a nutrition policy move by the EFSA,” he says.

Currently the documentation on, e.g., omega 3 and probiotics is being re-evaluated by the EFSA, and the demands for scientific substantiation of a claim are quite high. Lars Ove Dragsted welcomes strong documentation of health claims in foods but realises that it can be difficult to fulfil the demands of the authorities.

“It remains much less demanding to document effect and safety for functional foods than it is for medicines,

Eating your way to improved healthFunctional foods or fortified foods represent a growing market globally. As consumers gradually acknowledge various food components to a greater extent for their effects beyond nutritional value, manufacturers are challenged by the authorities on the documentation justifying health claims.

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but the EFSA is certainly raising the bar,” he says, continuing:

“Some of the food components in question may very well have health-promoting effects. Many others could have beneficial effects too, e.g. components in fruits and vegetables. Whole grain is an example of a food component that may be even healthier than previously anticipated. The point is that it’s a laborious process to define each component properly and furthermore to document the effect in clinical studies,” says Lars Ove Dragsted.

ProbioticsProbiotics are live microorganisms believed to be beneficial to the host organism. Lactic acid bacteria such as Lactobacillus and Bifidobacteria are the most common types of microbes used as probiotics. Probiotics are commonly consumed as part of fermented foods with specially added active live cultures, such as yoghurt or dietary supplements.

Medicon Valley-based Chr. Hansen is a global bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries. The production of probiotics is one of the core competences of the company. Sarita Bairoliya, Global Marketing Manager of Probiotics at Chr. Hansen, welcomes the challenge from the EFSA and explains why:

“The EFSA is currently updating the documentation guidelines, which is likely to differentiate more clearly between the many strains of probiotics available on the market. Chr. Hansen has a strong tradition of documenting our probiotic food ingredients with clinical studies, and we have more than a hundred clinical studies to show for it. We are running clinical studies, even as we speak.”

Cultural differences At the Department of Human Nutrition, Professor Lars Ove Dragsted is studying the bioactive components in food that have the ability to prevent or alter the risk of lifestyle disease. He agrees that there is a trend towards increasing awareness of how to alter or prevent diseases and promote health through foods. However, this has

not always been the case. Cultural differences between northern and southern Europe have traditionally been characterised by opposing approaches to the related area of food fortification.

“In Scandinavia we have traditionally been reluctant to accept artificial additions to foods, be they additives, vitamins or functional compounds. For instance, people here generally find it much more acceptable to take a vitamin tablet than to have food fortification. The situation is reversed in southern Europe, where there is a much higher acceptance of vitamins or health promoting additives in foods and rejection or reluctance towards vitamin supplements, such as tablets,” Lars Ove Dragsted explains.

Most health-promoting factors are added as ingredients and not as additives, which could make a major difference, at least in northern Europe.

Sarita Bairoliya at Chr. Hansen recognises the historical geographic and cultural patterns in the consumer acceptance of probiotics.

“Yoghurt fortified with probiotics was introduced in France in the 80s and a few years later, these products were successfully introduced to Scandinavian markets,” she says.

Future foodsSarita Bairoliya points to two major changes to look out for in the future:

“First of all, the trend is definitely an increasing awareness of how to promote health via foods. This goes not only for digestive health but also for weight management and bone health. Thus we will increasingly see health-promoting effects becoming the primary reason for purchasing many food items,” she says, and adds:

“Second, we see many consumers favouring foods and ingredients with a natural origin, where the perception is that components from nature are better per se than components that can be chemically produced. Although consumers are more focused on the healthy aspects of foods, they remain preoccupied with taste and texture. If a product does not taste good or feels strange or different in the mouth, it is unlikely to be a success.”

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By Charlotte Strøm, MD, PhD, journalist

StEM CELL tHERAPY Stem cells have been used as a treatment principle for more than forty years. Patients suffering from leukaemia can receive bone marrow transplants, exploiting the capability of the stem cells in the donor marrow to repopulate the recipient with healthy bone marrow that can produce new blood cells.

the pioneersThe use of bone-marrow-derived stem cells was pioneered the 1970s by a team at the Fred Hutchinson Cancer Research Center in Seattle, USA. The work was led by Dr. E. Donnall Thomas, who was later awarded the Nobel Prize in Physiology or Medicine. The work demonstrated that bone marrow cells infused intravenously could repopulate a patient’s bone marrow and produce new blood cells.

Research into stem cells grew out of findings by Ernest A. McCulloch and James E. Till at the University of Toronto in the 1960s.

Since then, the search for improved treatments of chronic and/or malignant diseases using stem cells has been a major drive for researchers and clinicians in a range of therapeutic areas, from oncology and haematology to ophthalmology, cardiology, endocrinology and neurology.

Stem cell replacement therapyToday adult stem cells are routinely used medically as replacement therapy, for example in bone marrow transplants.

Furthermore the technology for artificially growing and differentiating stem cells into specialised cell

types with characteristics consistent with cells of various tissues is readily available. Hence, muscle, bone and cartilage can be grown through cell cultures. The protocol for growing connective tissue from stem cells is well-described and clinical trials in cartilage and bone injuries are currently ongoing.

Experimental replacement stem cell therapiesOther forms of replacement therapies based on stem cell technology include the regeneration of nerve cells in patients with spinal cord injuries, replacement of dopamine-producing cells in patients with Parkinson’s disease, and stem cells induced for insulin production. However, these projects share the common fate of facing serious obstacles. So far the insulin stem cells project has revealed major difficulties in obtaining a stable phenotype and is still in the pre-clinical testing phase.

Clinical trials in Age-related Macular Degeneration (AMD), a chronic disease characterised by loss of pigment epithelial cells in the retina, have been promising. A phase I trial was recently (January 2012) reported in The Lancet. In addition to showing no adverse safety issues, structural evidence confirmed that the human embryonic stem cell-derived cells (hESC) survived and continued to persist during the study period reported. It has been over a decade since the discovery of the hESC, and this first report of hESC-derived cells transplanted into patients, with encouraging safety results and engraftment data, demonstrates that stem cell research and development is still going strong.

Forty years working with stem cells as replacement therapy – and still going strong

The search for spectacular medical stem cell interventions has been going on for decades. And there are many hurdles to overcome. Still, the desire to uncover and understand one of nature’s true wonders, the stem cell, keeps researchers going.

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The basics on stem cells Embryonic and adult stem cells • Stem cells are biological cells present in all multicellular organisms that can divide (through mitosis) and

differentiate into diverse specialised cell types• Stem cells can self-renew to produce more stem cells• In mammals, there are two types of stem cells:

- Embryonic stem cells, deriving from blastocysts (the fertilised egg)- Adult stem cells, which are found in various tissues throughout childhood and in adults

• In adult organisms, stem cells act as a repair system for the body, replenishing adult tissues• In a developing embryo, stem cells can differentiate into all the specialised cells/tissue – and are therefore

called pluripotent stem cells• Adult stem cells maintain the normal turnover of regenerative organs, such as blood, skin, or intestinal

tissues

Stem cell sourcesHuman stem cells are, in principle, available from all kinds of sources. However they are most often are harvested from three major sources:• Bone marrow, extracted by harvesting from the iliac crest, • Adipose tissue or lipid cells, extracted by liposuction, and • Extracted from peripheral blood. Stem cells can also be taken from umbilical cord blood.

Autologous versus allogenic stem cells • Of all stem cell types, autologous use involves the least risk to the recipient • Autologous stem cells are harvested from the patient’s own body • Allogenic stem cells derive from a donor that may or may not be related to the stem cell recipient

- In cases of transplant of haematopoietic stem cells, the HLA tissue types of donor and recipient must be compatible to a certain degree in order to minimise the risk of rejection

SOLUTIONS FOR BIOTECH

Protein Production Bacterial and mammalian production - from process development to purified product.

From Active Compound To Administration Drug characterization, analysis, and formulation development.

Immune Models In vitro models for prediction of immuneregulatory effects of compounds.

Biomarkers Identification, validation and documentation of disease relevantbiomarkers.

Molecular Histology Service In situ detection of microRNA. Image analysis - quantitative ISH. Combined IHC and ISH service.

Stem Cell Technology Adult – and pluripotent stem cell characterization. Stem cell models for regenerative medicine. Cell (stem) motility models.

Bioneer A/S Kogle Allé 2 DK- 2970 Hørsholm

t +45 45 16 04 44 f +45 45 16 04 55

e info@bioneer.dk w www.bioneer.dk

By Charlotte Strøm, MD, PhD, journalist

tISSUE REGENERAtION After a stroke or myocardial infarction some of the ensuring tissue damage is irreversible. Or is it?

Scientists from Odense University Hospital, University of Southern Denmark, are seriously challenging this medical paradigm and currently investigating how stem cells can be useful in tissue regeneration.

Ready to use universal stem cell therapy“We are looking to develop a universal allogenic stem cell therapy that is ready to use off the shelf when the patient enters the hospital and acute treatment is needed,” says Moustapha Kassem, Professor, MD, MSc, PhD, at the Department of Endocrinology, Odense University Hospital.

He explains how the shortcomings of autologous stem cell therapy come down to its inability to be truly helpful in the treatment of acute events.

“In the long run it is unrealistic that we all have stem cells in the bank – so to speak – that can be withdrawn to treat potentially acute injuries that may happen to us in the future,” he says.

Potential new role for adult stem cells as tissue regeneratorsStem cell therapy as a universal allogenic therapy that is ready-to-use after acute stroke –

this may be wishful thinking, and yet investigations are currently ongoing into using stem cells

as tissue regenerators and immune modulators in order to minimise tissue damage.

MVA-based major research and development project on stem cells Large-scale stem cell research project with a number of different contributors from the public and private-sector biotech and pharma community are ongoing. Here are some highlights:

Up-scaling haematopoietic stem cells in a bioreactorThe StemXpand project is a collaboration between Bioneer and the biotech companies Stemcare (Denmark) and Vabrema (Netherlands). Christian Clausen, MSc, MD, PhD and Head of Department at Bioneer, is managing the development at Bioneer. Cord blood only holds a small amount of haematopoietic stem cells. Consequently, it is necessary to harvest several portions to obtain the required amount for use in the treatment of adult patients with, e.g., leukaemia. “Many researchers are working on the expansion of haematopoietic stem cells, but the strategy in the StemXpand project involves testing a method for significant up-scaling. We will draw on our experience with producing large quantities of cells in a so-called bioreactor system,” says Christian Clausen, who points to the potential of producing haematopoietic stem cells for research purposes as well as for clinical use.

Advanced disease models use stem cells to test new drugs for Alzheimer’sA research consortium consisting of researchers from Bioneer, the Faculty of Life Sciences at the University of Copenhagen, Copenhagen University Hospital – Rigshospitalet, Aarhus University, Lundbeck and Pixiegene aim to develop a stem cell model by which new drugs for the treatment of serious neurologic diseases can be identified. Skin cells taken from Alzheimer’s patients are ‘reset’ back into stem cells which can subsequently specialise into nerve cells and be used to test various drugs for the treatment of Alzheimer’s disease. What makes this set-up unique is that every stem cell model will be patient specific. The nerve cells deriving from skin cells in AD patients are used solely for research purposes and are not returned to the patient as treatment. The project received a grant of DKK 14 million in October 2011 from the Danish National Advanced Technology Foundation.

Enhancer of tissue regenerationTogether with a German research group based in Frankfurt Moustapha Kassem and the scientists at Odense University Hospital are investigating how to minimise cell damage after a stroke.

In the study, patients receive injections with adult stem cells into the brain.

“The technologies around this are extremely refined,” Moustapha Kassem explains and he is proud that his scientists have been able to reduce the immunogenicity of allogenic stem cells considerably.

Trials of allogenic stem cell therapy as an enhancer of tissue regeneration in patients with stroke are currently ongoing. Eleven patients have been studied and followed for six months in this phase I clinical trial designed to study the safety of the procedure.

Future stem cell therapies“Most of the stem cell concepts that are being pushed forward today are really revolutionising our thinking and opening up new doors for novel medical therapies. In several animal models proof of concept studies have been carried out,” says Moustapha Kassem.

“What remains is the huge challenge of transferring these technologies to day-to-day clinical medicine.”

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Quantum leap in early drug discoveryInduced Pluripotent Stem Cells, iPS, is a revolutionising technology for targeted early drug discovery. Based on human biopsies or blood samples iPS technology provides patient specific disease models and opens up a new era within the concept of personalised medicine.

By Charlotte Strøm, MD, PhD, journalist

DRUG DISCOVERY Induced Pluripotent Stem Cells (iPS) is a novel testing tool for pharmaceutical and biotech companies that will shorten the early drug discovery phase considerably. The extraordinary thing about iPS technology is that it will provide patient-specific disease models.

“iPS technology is a shooting star, and I’m confident that it will revolutionise the whole process of early drug discovery and make the search for drug candidates much more efficient,” says Christian Clausen, MSc, MD and Head of Department at Bioneer.

Christian Clausen is heading the group of experts at Bioneer who act as contract manufacturers of iPS cell lines. Bioneer is so far the only company to provide the technology for commercial use in Denmark, while a few Danish university research centres have the capacity to produce iPS cell lines, albeit for research purposes only.

Bringing a cell back to the embryonic stateiPS technology is based on cells from a human biopsy (e.g. skin, fat or blood). The cells are multiplied and subsequently brought back to a state resembling embryonic stem cells. As these stem cells are pluripotent, they have the capacity to develop into any kind of human cell type. Uniquely, this allows testing of drug candidates for effects against a specific disease in a range of different disease relevant cell types simultaneously.

Christian Clausen is excited about the possibilities that the technology presents.

“I have been working with stem cells for a decade now, and iPS technology is truly a quantum leap within this research area,” he says, continuing

“iPS cell lines are patient specific, so knowledge about specific disease subtypes, phenotypes etc will make the search for drug candidates much more targeted.” Furthermore, disease mechanisms can be identified and elucidated.

Big pharmaceutical companies or major biotech enterprises with significant research resources and large facilities may want to take the iPS cell lines home to their own laboratories. However, Bioneer has the capacity to run the drug testing on iPS cell lines and to store them for clients with less research capacity in-house.

Infinite supply of patient-matched cellsOnce the iPS cell lines have been produced, the self-renewal capacity of iPS cell lines yields an infinite supply of patient-matched cells for drug screening.

iPS technology in short: Cells from a human biopsy (e.g. skin, fat or blood) are

multiplied and transferred back to embryonic stem cells. A stem cell is pluripotent

and thus has the capacity to become any human tissue (nerve, bone, liver cells etc).

As the cell line originates from a patient with a specific disease a drug candidate can

subsequently be tested on cells in a range of different tissues simultaneously.

The iPS cell lines are patient specific and efficient disease models for improving

highly targeted early drug discovery. The self-renewal of iPS cell lines yields an

infinite supply of patient-matched cells.

Patient

Blopsy or bloodsample from patient

Estabelish cell culture

Reprogramming process(transcription factor

activation)

3-4 weeks of induction in culture

self-renewalcapacity

Induced pluripotentstem cells (iPs cells)

Ectoderm

skin

Brain

nerve

Mesoderm

Blood

Heart

Muscle

Bone

Liver

Pancreas

Intestine

Lung

stomach

Gra

phic

s: B

ioneers

A/S

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By: Thomas Bjorn, Solicitor, Miller Rosenfalck LLP, London and Alexander Denoon, Solicitor, Lawford Davies Denoon, London

With the cost of treatment for a single patient often exceeding $100,000 a year, biopharmaceuticals are attractive targets for generics companies as the patents protecting the original products expire. Even established pharmaceutical companies have expressed interest, as evidenced by Pfizer’s announcement in October 2010 of a joint venture with Biocon (India’s largest biotech company) to bring biosimilar insulin treatments to market. Merck US moved into the sector in 2008, and also traditional generics firms (including Sandoz, Cipla, Teva and Desani Pharma) are pursuing opportunities in this field.

Market entry hurdlesThere are, however, numerous barriers to market entry.

First, the scientific and technical challenges to manufacturing biosimilars are significant in comparison with conventional generics. Estimates included in a recent article in the Economist suggest that while “a typical generic drug may cost a few million dollars to develop ... a biosimilar version could cost perhaps $100m-150m.1”

second, many people are predicting that the elaborate process for the approval of biosimilars

is likely to be a significant battleground between innovator and generic companies. Innovators will want to defend their market and protect patients from products with different characteristics even after expiry of the patents, while generic companies will need to recoup their investments in such complex systems.

It is, for these very reasons, difficult to convince a regulator to approve a biosimilar product.

Third, in most cases biosimilars will be prescription-only products, which will require a sophisticated sales force and experience in dealing with reimbursement and regulatory requirements.

Generic vs BiosimilarGiven the complexity of the products, a separate regulatory approval regime has been established for

How to navigate the complex world of BIOsIMILARs

As the life sciences sector faces unprecedented challenges, the market for “generic” biopharmaceuticals is looking to be one of the few attractive targets. However, market entry poses significant challenges and will likely generate plenty of work for legal and regulatory teams. Here is how to go about it.

1: “Attack of the biosimilars: Biotechnology drugs are the next target for cheaper versions”, The Economist, 21 October 2010, New York: http://www.economist.com/node/17316667.

Biocon Biopharmaceuticals, India.

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A biopharmaceutical is usually a protein (such as a monoclonal antibody) that has been manufactured using genetically engineered microbial, mammalian or plant cells. In contrast, small molecule pharmaceuticals are normally chemically synthesised. Due to the complexity of the biopharmaceutical protein and the fact that the protein may be extremely sensitive to minor changes in the manufacturing process, biopharmaceuticals are usually significantly more complicated and expensive to produce than conventional pharmaceuticals.

Many of the current crop of “blockbuster” medicines are biopharmaceuticals. Biopharmaceuticals currently make up more than 20% of global medicine sales, and they are projected to grow at double-digit rates as sales of many conventional medicines decline.

requirements will also extend to the exciting field of advanced therapy medicinal products (such as stem cell therapies).

A manufacturer wishing to develop a biosimilar product and having identified the relevant RMP must therefore carry out such studies as may be required to establish the necessary data to support the equivalence.

Applicants should ensure that there is a clear path to approval. The EMEA has issued guidelines and Q&A’s regarding biosimilars and the scientific data necessary to support a claim of biosimilarity. Competent authorities adopt a helpful approach to guidance on the requirements for biosimilar applications.

Regulatory matters are no longer administrative issues. These are now considered strategic issues for biopharmaceutical companies. As a result, regulatory and intellectual property teams should devise coordinated strategies for market entry and prepare for market entry by competitors.

ConclusionWhile competent authorities enjoy a high degree of discretion in complex assessments2, given the enormous value at stake, there is significant prospect for challenging a decision by a competent authority to approve or reject an application for a biosimilar (whether on grounds related to quality, safety or efficacy). The most common basis for challenge is likely to be unreasonableness (including improper considerations and irrationality), but challenges based on procedural fairness and legitimate expectation will also be considered.

biosimilars. Here are the most important things you need to know, before entering the field:

While traditional generic medicines merely need to establish their bioequivalence to the original reference product and therefore do not usually need to undergo clinical trials in humans, biosimilars must undergo, at least abbreviated, trials.

In Europe the rules regarding the approval of generic medicines and biosimilars are set out in Article 10 of the Medicinal Products Directive 2001/83/EC, which provides that a generic medicinal product will be compared with a reference medicinal product (RMP), which already holds a marketing authorisation.

It is worth bearing in mind that a generic (or a biosimilar) can only be placed on the market after the expiry of the applicable data exclusivity period. In most cases, this will be ten years after the grant of the marketing authorisation for the RMP (see Article 10 of the Directive).

A generic medicinal product can be granted a marketing authorisation without the need for new clinical trials if:• It has the same qualitative and quantitative

composition in active substances as the RMP• It has the same pharmaceutical form as the RMP• Bioequivalence of the generic and the RMP can be

shown through bioavailability studies

However, if a biological does not meet the definition of a generic (e.g. differences regarding manufacturing processes, such as the use of a different expression system), the results of appropriate pre-clinical tests and clinical trials relating to these conditions must be provided. By way of example, this may require the manufacturer to conduct trials on 100 patients rather than on 1,000 patients for a conventional phase III clinical trial. The type and quantity of supplementary data must comply with relevant criteria in the Annex to the Directive and related detailed guidelines issued by the various competent authorities. These 2: HLH Warenvertriebe [2005] ECR I 0000.

A taste foradventure

She is 43, a qualified lawyer and last year became a partner at SEED Capital, Denmark’s largest

venture fund with a biotech focus. Anne Cathrine Wilhelm now has her dream job, building the

legal foundation for all the venture fund’s investments in biotech. The route to her

success has involved hard work and the courage to always follow her

heart.

By Mikkel Ais AndersenTranslation: CLS Communication A/S

Back in 2000, Anne Cathrine Wilhjelm was sitting in her office in DONG s legal department. She was 32, had been a qualified lawyer for five years and now had a safe position with a secure foundation in life. She had landed an attractive job at an early age that kept her life on an even keel. And yet she wasn’t satisfied. She needed to turn her life upside down and do something that

would leave her in deep water. Because deep water is actually

where Anne Cathrine Wilhjelm feels most at home.

A valuable lesson The decision that would change her life – one that would have caused most people’s hands to shake. Not Anne Cathrine

Wilhjelm. “When I’m absolutely certain that I’m well

prepared, there’s no reason to be afraid of

Photo

: Lars

Kaae

People

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going under,” she says as if it’s the most natural thing in the world.

Eight years earlier, she became a law graduate and immediately got a job as a solicitor’s clerk at KromannMünter, now KromannReumert. She spent the next six years there and became a lawyer. It’s a time she remembers fondly.

“In terms of work, it was a hard time but it toughened me up and taught me that success does not come from cutting corners. Lawyer Erling Borcher, a partner at KromannMünter, taught me the ropes, and passed on the importance of double-checking everything. So you know that you have things under control. It takes time but it has been a valuable lesson for me.”

She emphasises that she would not have the courage, humility and self-insight she has today if it had not been for her time in training.

Something at stakeAnne Cathrine Wilhjelm learned that hard work pays off. She loved her job – especially when something was at stake. She enjoyed creating success and liked responsibility – both in good times and bad.

“I’m very happy working with commercial law. This is where decisions must be made and a legal foundation formed to ensure that good, innovative and creative

business ideas can take off. If I haven’t done my work properly, these ideas will fall flat in a business context. That’s why I also have a passion for innovation and entrepreneurship,” she explains eagerly.

Plenty of actionThe six years that Anne Cathrine Wilhjelm spent with KromannMünter gave her a solid background in commercial law. She had fought legal battles, proved her worth and enjoyed working with intellectual property

when I’m absolutely certain that I’m well prepared, there’s no reason to be afraid of going under.

People

“

BLUE BOOkAnne Cathrine Wilhjelm

• Anne Cathrine Wilhjelm is 43

• She gained her law degree at the University of Copenhagen in 1992 and that same year was employed as a trainee at the EU Commission office in Copenhagen

• Immediately after finishing her university education she was employed as a solicitor’s clerk at KromannMünter (now KromannReumert) where she became a qualified lawyer

• Anne Cathrine took an LLM in International and Comparative Law at Vrije University in Brussels, 1995-1996

• After six years at the lawyer’s office, Anne Cathrine was employed in DONG’s legal department

• In 2000, Anne Cathrine took the plunge and became the chief legal officer for an e-commerce company – HABURI.com

• Anne Cathrine became affiliated with DTU Symbion Innovation, an innovation environment, in 2003 as a lawyer and helped to establish the SEED Capital venture fund the following year

• In 2011, Anne Cathrine became a partner at SEED Capital

• Anne Cathrine is married to Lars and they live with their three children on a farm in Northwest Falster, Denmark

• Anne Cathrine prefers spending her spare time with her family, exploring the countryside, skiing and reading a good book

34

and competition law, which sounds like a sport when she describes it.

“If you do your homework, you minimise the risk of losing.”

After her dynamic time with KromannMünter, Anne Cathrine Wilhjelm was employed in DONG s legal department. She had counted on continuing to specialise in competition law but that was not in the cards. As it happened, her work involved almost exclusively a new gas law, and that didn’t capture her imagination.

“I’m used to plenty of action legal decisions that have a real impact. Ten years ago, DONG was a well-established company and at that time no new business ideas were being launched.”

100 percent dedication – a necessityOnce Anne Cathrine Wilhjelm had begun to doubt where her work with DONG would lead in the business community, she was also compelled to address the issue and respond to her doubts. She explains this with a matter-of-course attitude that shows she is a person who lives according to her ideals. Anne Cathrine Wilhjelm does not work with anything unless she can dedicate herself to it 100 percent. And personally she believes this is one of the keys to her success.

“My grandfather said to me that you should never start anything in a half-hearted manner. Then you may

as well not bother at all. I’ve tried to follow that advice all my life – both at work and in private. I try to be honest with myself and when I commit to something I always do my best.”

Anne Cathrine Wilhjelm stepped down from her position with DONG in favour of an insecure future with a start-up company, HABURI.com, that sold fashion wear on the internet. And her indomitable optimism overshadowed her nerves and concerns.

“I’ve always focused on constantly improving my skills. I’ve gained knowledge and new competences and in that way tried to make myself an asset. It’s a matter of filling your baggage throughout your life and always updating

I’ve found the perfect niche in life. I love my job and my colleagues, and I couldn’t imagine doing anything else.

People

“

35

yourself. I’m convinced that makes you attractive to the job market. So being made redundant hasn’t worried me too much,” she says.

Venturing onto thin iceAnne Cathrine Wilhjelm’s wish came true and she began working with entrepreneurs and more insecure adventures that involved seizing chances and helping to create success stories. The internet company needed a skilled lawyer and its vast potential appealed directly to Anne Cathrine Wilhjelm. She took the plunge and became chief legal officer for the new company. But then things went wrong. Before Anne Cathrine Wilhjelm was hired, major legal contracts had been signed that were like millstones around the company’s neck.

“It was hard for the company because it was bound by a number of contracts that were not very favourable, and they couldn’t be changed. It was frustrating not to have been involved from the beginning.”

HABURI.com had trouble financing its operations and was acquired by a German company. Anne Cathrine Wilhjelm had left a good position at DONG to realise her passion for entrepreneurship and there she was on maternity leave with her second child and no job – a situation that cannot be described as rosy, but she

didn’t throw in the towel. She stuck to her guns and remained convinced that her dream job would turn up.

the right nicheAt that time, one of the founders of HABURI.com, Ulla Brockenhuus-Schack, was CEO of DTU Symbion Innovation A/S, an innovation environment. She needed legal assistance and got Anne Cathrine Wilhjelm involved as a lawyer, and just one year later the SEED Capital venture fund was established.

Anne Cathrine Wilhjelm was now exactly where she had always wanted to be – setting off on a new commercial adventure, and she was involved from the very start. The company grew and Anne Cathrine Wilhjelm could see that the seeds she had helped sow were thriving. For eight years now she has worked with all the legal aspects of the venture fund. She ensures the legal platform provides scope for investing in biotech. She’s like a fish in water, and last year became a partner at SEED Capital with responsibility for the entire legal foundation.

“I’ve found the perfect niche in life. I love my job and my colleagues, and I couldn’t imagine doing anything else. I’m happy that I’ve always dared to follow my heart on adventures and not put up with doing things that don’t make me happy. Otherwise I wouldn’t be where I am today,” she concludes.

People

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By Birgitte AaboTranslation: CLS Communication A/S

Medicon Valley wants to top the bill with global decision makers looking for unique life science competences. We need eye-catching ‘research beacons’ to direct attention towards the Danish-Swedish region, and the EU has recently granted DKK 24m to the initial phase of the process.

“The money will be used to map areas where we already have or can achieve high-calibre international status and on which we choose to focus. Then, we will organise a structure for the research beacons that are selected,” explains Stig Jørgensen, CEO of Medicon Valley Alliance.

The quest for research beacons has already begun and employees at Invest in Skåne and Medicon Valley Alliance are mapping the region’s specialist competences. A pilot project has involved studying

how drugs are administered using various methods - called drug delivery. Medicon Valley has a number of players with special talents within the administration of biological medicines in particular insulin, antibodies and vaccines:

“We have everything needed to create a tempting drug delivery showcase to present to the world. We have the technology, companies and research,” points out Stig Jørgensen.

Countering developmentsThe research beacons are to weapon against the increasing competition facing Medicon Valley’s life science sector. The region competes with about 250 other cluster organisations around the world and is under heavy global pressure. This is evident as the numbers of small companies that have disappeared and the many others that are fighting to survive:

“It is a challenge for Denmark and Sweden to keep the

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Research beacons under construction

Medicon Valley Alliance and Invest in Skåne have been granted DKK 24m for the preliminary work on ‘research beacons’ that are to give the region a powerful global image. Initially, the focus will be on drug delivery and cancer.

Interreg – EU funds for crossing the borderInvest in Skåne and Medicon Valley have been granted Interreg funding for the identification of research beacons – a total of DKK 24m over three years. Interreg is a contraction of ‘inter-regional’, and the main purpose of this EU programme is to increase development and integration across national borders, as these aspects often comprise both administrative and cultural barriers to constructive cooperation.

The research beacons The objective is to make Medicon Valley more attractive and increase the park’s competitive edge while establishing the region as one of the world’s leading life science regions. This will be achieved through: 1) Establishing and promoting a common vision for Medicon Valley through a new marketing and communication strategy 2) Developing international partnerships and attracting foreign investments

The ambassador programme When the research beacons become a reality, thanks to the Medicon Valley Alliance’s ambassador programme they will have spokesmen supporting them in various locations around the world. The programme creates relationships and partnerships with other cluster organisations in North America, Europe and Asia and will form the basis for new international alliances. This will be achieved partly through Medicon Valley Alliance posting ambassadors with foreign cluster organisations for a period of three years – and in return welcoming guests from other clusters.

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major companies’ activities in the region. Novo, Lundbeck and other major global companies are moving more and more of their activities out because they are being offered better terms elsewhere and want to be close to the large new markets such as India and Brazil. So what can the region do?” asks Stig Jørgensen.

Clear benefitsStig Jørgensen points out that the research beacon initiative closely matches statements coming from the Danish government on a clearer focus in the business community:

“We agree that you can’t be a world champion at everything. We need to focus on select areas and market them more intensely. If we can join forces and create a powerful Danish-Swedish research and business environment, I think we have a real chance to compete with countries such as China. They are not as good as our region at complex tasks and public-private partnerships.”

“When we began making contact to mobilise the players in drug delivery, not everyone understood why they should take part. Major companies only get involved if they can see commercial benefits. That’s how it is. Gradually however, understanding and faith in the project has been established – and appreciation for the fact that everyone would benefit from a physical centre where companies can join forces and show the world their combined talents,” says Stig Jørgensen.

Strong faithTore Duvold, Senior Vice President, New Product Discovery at LEO Pharma and board member of Medicon Valley Alliance, is among those who have faith in the research beacons.

“It is interesting for us as a global, research-based company to be part of promoting the region’s profile and establishing it as a region with world-class specialists and unique competences in a range of areas. It requires innovative thinking and cooperation between the players associated with each research beacon to reach that point, but getting the process started is the first step and we are glad to be part of it.”

On the Swedish side, advocates of the project include the rector of Lund University, Anders Axelsson, who points out, however, that getting the university environment and companies to think in the same way won’t be easy.

“Companies have other deadlines and more financial considerations to take into account, but a common language has already been established in some areas where people are working well together. This is the case, for example, within drug delivery – we understand each other in that area so it’s a good place to start.”

Setting up the scaffoldingIt is too early to say how much ‘mental scaffolding’ will be needed to accommodate the research beacons in

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Medicon Valley, however Stig Jørgensen estimates there will be four or five beacons. In addition to drug delivery, mapping is already under way concerning what the region as a whole can contribute to the fight against cancer.

“We have begun the warm-up to mapping the resources within cancer. Treatments are becoming more tailored to individual patients and, in this context, Denmark and Sweden are well-equipped, not least due to the vast pool of genetic data we have collected from the populations. But we are currently missing out on the synergies because the countries don’t cooperate enough,” says the CEO.

Once the structure of the research beacons has taken shape, funding will be needed to establish them, and Stig Jørgensen’s employees are currently preparing applications to be sent to major private funds to the tune of over DKK 1 bn. Minister of Economic and Business Affairs, Ole Sohn, whose interview is published elsewhere in this magazine, hopes they are successful.

“The beacon project is certainly a good initiative. I sincerely hope the beacons can attract financial support from the funds,” he says.

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By Eva TiweTranslation: CLS Communication A/S

Ideon has grown significantly since its inception in 1983. It is now home to more than 250 companies, each with a varying number of employees. The median number is five to six individuals per company, but you will find everything from one-man enterprises to companies with more than a thousand employees.

“This is where you’ll find creative people who want to be high

achievers.” This is how Hans Möller, the enthusiastic CEO, describes

the activities in Ideon Science Park in the Swedish city of Lund.

Hidden gold in the science parks

Ideon was founded in 1983 in some barracks in Lund.

Ownership is divided equally between Wihlborgs and Ikano.

About 250 companies are based on the park, employing anywhere from one person to more than 1,000.

Hans Möller is the company’s CEO and Maria Sätherström the Marketing Director.

Hans Möller

Maria Sätherström

IDEoN It all sounds pretty idyllic, and it does not seem as though the CEO perceives any major problems with the enterprise. He simply feels that it is great that the companies are doing so well.

Nevertheless, there are a number of weaknesses.

“While many of the companies are doing very well, quite a few get stuck at around five employees. These are often companies with research-intensive ideas, which are run by the founders themselves.

“However, more than 700 enterprises have passed through Ideon, and over 28 years of operation, we have a survival rate of more than 70 percent.”

The park affords excellent support for commissioning companies, and there is a close network between Ideon companies and the business world. There are four “incubators”, which nurture and assist new arrivals on their way to a positive start. Rickard Mosell is the CEO of one of these, Ideon Innovation, which has a turnover of SEK 10 million and five employees.

“It’s a dynamic environment, and right now we have 27 companies. We have a continuous intake and accept about 10 per cent of the roughly 100 companies that come to us every year.”

These companies are knowledge-intensive and are given a bridge to business via Ideon Science Park.

“Our credibility with businesses is high, which provides a reduced risk and added velocity,” says Mosell.

Incubators offer business development assistance, and Ideon business consultants have the longest track record in Sweden, providing advice via their contacts with economists, lawyers, engineers and accountants.

“The name Ideon is enough to open doors.”

“We have an unparalleled network and can provide solutions for problems large and small considerably faster than companies could on their own. The companies in the incubator are all in the same boat, have the same problems and

“In addition to the fact that we were the first science park in Scandinavia, our strength lies in having several pillars, including IT, telecoms and life sciences.” The Park works closely with the University of Lund in the fields of medicine, technology and economics, and everything is located within walking distance.

“Our advantages will become even more apparent when the synchrotron MAX IV radiation facility and the ESS super microscope come online in 2015 and 2020, respectively,” says Hans Möller.

The Ideon Gateway, which towers over the park’s skyline, is not only home to development companies. There is also a hotel with 180 rooms, a restaurant and a bar, as well as a bank and divisions of the Technical Research Institute of Sweden.

“We have a stimulating environment, which favours company growth.”

And growth is often quick: QlikTech, an IT company set up by two individuals in 1993, now has 1,100 employees worldwide and develops business intelligence software. Another large company is Axis Communication, which first came to the park back in 1984. The company left Ideon in the mid-1990s, but has now returned and has about a thousand employees.

“The function of Ideon is to bring research to the marketplace. These are the companies of tomorrow – knowledge-intensive companies working in a global market. Here, companies assist one another and become part of the industrial transformation that is taking place,” says Möller, who became CEO of Ideon in August 2003.

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can assist one another. It’s a real melting-pot,” says Mosell.

“If we look back five years, we find a survival rate of 80 percent for those companies, which have left Ideon Innovation, and one company out of 15-20 has become truly huge.”

One of the drawbacks in being associated with a knowledge-intensive university is that it can sometimes impede contact with established companies, which have been around for decades and have failed to consider new technologies in recent years.

Another drawback, which can

actually be an advantage as well, is the park’s geographical location. On the one hand, Ideon is located some distance away from the centre of Lund, whilst on the other it is within walking distance of most of its academic contacts.

The construction company Wihlborgs owns 50 per cent of Ideon, with the other half being owned by Ikano. When the park opened in 1983, Ingvar Kamprad invested SEK 100 million . State support, as well as support from Skåne Regional Council, helps finance the running of the incubators.

Ideon has an annual turnover of about SEK 400 million in service and rental income, and Hans Möller sees the company as profitable for tenants as well as from a societal perspective – it is all about the SEK 2 billion, which the state recuperates through taxes.

The park was born in a couple of barracks in Lund, which were named “The Incubator”, and new business areas are still being developed, such as environmental technology and material flow analysis. Read more about Ideon’s activities at www.ideon.se.

A selection of the companies at Ideon:

ST Ericsson – develops hardware for mobile phones

BioInvent – a biotech company which develops medicines

Scalado – develops software for, among other things, mobile phones

Baton with Points of View

“the Baton” is a point of View feature about life science in Medicon Valley. It is written by business people, researchers, politicans ans opinion-shapers with a personal and extensive commitment to Medicon Valley. the holder of the Baton passes it on to a new person along with one or more questions related to life science in Medicon Valley.

Carsten Rose gives the relay baton to Jannik Hilsted, Medical Director, Rigshospitalet, Denmark.the question that Carsten Rose will pose to Jannik Hilsted is: “Life Science in the Øresund Region: Fact or Fiction?”

40

the Baton

In the year 2030, one in two Swedes will get cancer during their lifetime. The main reason is that we are living longer, but a number of bad health habits also take their toll. Smoking, poor diet, too much alcohol and too little exercise interplay with socio-economic factors leading to a higher incidence among unemployed people with low income and little education.

The challenge is therefore a strong focus on prevention, and the good message is that around 30 per cent of all new cancer cases can be prevented, provided that we have the political will to change our attitudes profoundly regarding the above-mentioned lifestyle factors.

Swedish cancer care is among the very best. Regardless of cancer type, Sweden can demonstrate some of the highest survival figures in the world. However, in recent years the rate of improvement in survival has decreased in Sweden compared to other western countries. Until around ten years ago, Swedish cancer research, both clinical and experimental, ranked in the top five, regardless of how quality was estimated. Unfortunately, we have begun losing ground, especially in the field of clinical cancer research.

How can the cancer research cluster in the Oresund Region help tomorrow’s investors?

In the realisation of these facts, a new national strategy for Swedish cancer care and research has been formulated. Central to this strategy is the creation of six regional cancer centres in Sweden with full responsibility for all aspects of the cancer problem from prevention, diagnosis, primary and secondary therapy to rehabilitation, palliation, research and education. With a strong focus on patient needs a large number of cancer diagnoses are now described in a process-oriented manner not only to achieve rapid diagnosis and optimal therapy but also to ensure each patient’s possibilities for rehabilitation and participation in clinical studies.

The regional cancer centre for southern Sweden (Region Skaane, Region Halland, the Municipality of Kronoberg and the Municipality of Blekinge) was the first-founded Regional Cancer Centre in Sweden

Carsten Rose, Head of Division, Professor Oncology, RCC

South, Sweden

41

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the Baton

and has since been the major player in the formulation of an overall strategy to optimise survival figures for Swedish cancer patients and reinstitute a strong focus on translational and clinical cancer research.

A number of important infrastructural improvements have greatly enhanced the chances for success in the fulfilment of the goals of RCC South. Important examples are the creation of an outstanding regional bio bank closely connected to the Cancer Register and the Registry for Quality Assurance for the various cancer diagnoses in the catchment area for RCC South. A modern radiation therapy unit is under construction at Skaane University Hospital with a future close collaboration with the MAX Lab IV (synchrotron radiation) and European Spallation Source (neutron radiation). This will create possibilities for developing new insights into radiotherapy which have probably never been seen before.

Another very important achievement has been the foundation of the IMV (Ideon Medicon Village). Situated only a ten-minute walk from Skaane University Hospital, access to top-notch laboratory facilities has allowed RCC South to argue for and, in collaboration with the Faculty of Medicine at Lund University, concentrate the international competitive experimental cancer research laboratories from both Malmö and Lund in close proximity with the Cancer Register and Quality Assurance Unit of RCC South and the Skaane Regional Biobank at IMV.

On both the Danish and the Swedish sides of the Øresund there has been a long tradition for great achievements in the field of clinical cancer research, as exemplified by the internationally recognised results in the area of breast cancer.

For a number of reasons, this leading position has been weakened over the years, and the current situation is unsatisfactory – for our patients, health-care providers, the scientific community and the medical industry. The strategy for RCC South is therefore to focus, stimulate and facilitate the execution of clinical research in connection with the high-quality, population-based registers and the experimental cancer researchers. One practical example is a new agreement between Copenhagen University Hospital – Rigshospitalet and Skaane University Hospital regarding collaboration on phase I-II studies in cancer and haematology. By accepting the referral of patients between the two independent phase I-II units, these types of studies will be able to recruit from a patient catchment area of around four million people in connection with easy access to global characterisation of patient tumour tissue and serum samples. Not only will this approach be an advantage to major medical companies, it will also give small biotech

companies, in particular, access to easier testing of innovative new molecules.

The Øresund Region seems to have the potential to be one of the strongest and most innovative regions in Europe in all

aspects of life science. Connected by the bridge, there is a strong political will in both Denmark and Sweden to greatly improve and optimise cancer care and cancer

research. Unique facilities for biobanking in connection with highly recognised

population-based registers allow safe and swift transition of new

achievements in laboratories to clinical and practical testing before new inventions can be

internationally marketed. Continuous improvement and education of both clinicians and researchers as well as improvement in our fundraising ability should make the region even more attractive to young talents, thereby ensuring collaboration, growth and competitiveness.

The Kite is a symbol for RCC South, Sweden.

42

CLS Communication A/Swww.cls-communication.com CLS Communication is one of the largest language providers in the world. Offices in Europe, Asia and North America give CLS a strong global presence, providing 24-hour service to its clients. The company’s core business is translation, writing and editing in life sciences, banking and finance, insurance, telecommunications and legal sectors. Over 600 in-house and 3,000 external language experts write, edit and translate texts in any language. At CLS, the latest technology ensures the highest levels of security and confidentiality.

LiPlasome Pharma ApSwww.liplasome.comLiPlasome Pharma A/S is a biotechnology company developing and commercialising a novel lipid based prodrug and drug delivery platform usable for targeted transport of anticancer drugs. The company has successfully concluded a part of its pre-clinical development programme and demonstrated proof of principle in animal studies of the novel tumour activated prodrug and drug delivery platform. LiPlasome Pharma is currently searching for partners interested in developing and exploiting the drug delivery platform in or outside cancer therapy.

International Personnel Management (Scandinavia) ApSwww.ipmglobalmobility.comIPM specialises in managing global mobility programmes for internationally based companies. That means managing all the complexities associated with visas, salary packages, tax, social security, currency, accommodation and schooling.We do all that is required to ensure a successful outcome for both employer and employee. We are currently managing international assignments in more than 50 home and 60 host countries around the world. Established in 1995, we pride ourselves on delivering a high touch, quick response service.

truly translational Sweden ABwww.trulytranslational.comIncrease the value of your projects. Truly Translational Sweden AB provides expertise and lab services within translational science to support the life science industry. The mission is to translate preclinical project ideas into efficient development plans delivering successful clinical trials. Truly Translational is founded on solid scientific expertise and more than 50 years experience with drug research & development in both large pharma and biotech. Experiences from pre-clinical project idea generation to phase I and II clinical trials for both small and large molecules.

Expand your network:Latest members of Medicon Valley Alliance

MARkEN Ltdwww.marken.comMarken is the leading global clinical supply chain service provider dedicated 100% to the pharmaceutical and life sciences industries, supporting over 6,000 investigator sites in more than 100 countries. Marken integrates Depot and Logistics services into solutions that extend the reach of clinical trials to even the most remote treatment naïve geographies.

kLAR Advokater P/Swww.klaradvokater.dkKLAR Advokater is a Danish law firm specializing in solving the legal issues of technology companies, including life science companies.Our areas of expertise includes:- Regulatory issues concerning

medical devices and pharmaceuticals

- Establishing and maintaining contractual relationships of life science companies

- Intellectual property rights with a special emphasis on patent rights and trademark rights

- Investment of venture capital, seed capital and other forms of capital

- Mergers and aquisitions of life science companies

- Prevention & resolution of conflicts

new members

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FEBRUARY 2012February 27Boost Seminar: Compound De-risking with 3D-cell-culture Systems, ØrestadThis workshop offers you an excel-lent way to get fully updated with the latest information on 3D-cell-culture technologies for toxicological and efficacy studies, and gives you the opportunity to exchange views with academic and industry peers who are active and interested in the field of 3D cell culture.Venue: Arne Jacobsens Allé 15-17, 2300 Copenhagen S, Denmark time: 8.30-13.00www.mva.org/content/us/initiatives

February 28De-risking Drug Development from Candidate Selection through to Clinical PoCDe-risking Drug Devel-opment from Candidate Selection through to Clinical PoCThis seminar will address several of today’s key challenges in drug devel-opment leading up to clinical proof of concept. The agenda brings together a panel of speakers from academia, phar-maceutical companies and solution providers to discuss key issues from formulation design right through to effective clinical trial planning. Venue: Arne Jacobsens Allé 15-17, 2300 Copenhagen S, Denmarktime: 9.30-15.30www.mva.org/content/us/initiatives

MARCH 2012March 22Introductory Meeting to Medicon Valley AllianceAt this meeting we welcome both members and non-members who would like to know more about how to benefit from a membership of Medicon Valley Alliance. If you are considering membership and would like to get more details, this is also an excellent oppor-tunity to find out more and discuss the various opportunities with us.Venue: Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmarktime: 15.00-18.00www.mva.org/calendar

APRIL 2012April 25, 2011Ordinary General MeetingMembers of Medicon Valley Alliance are hereby invited to attend the Or-dinary General Meeting 2012.Venue: Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmarktime: 16.00-18.00www.mva.org/calendar

MAY 2012May 25, 2011Medicon Valley Golf Championship 2012Medicon Valley Alliance presents the Medicon Valley Golf Championship for CEO’s and Executives in Medicon Val-ley. Besides offering an outstanding golf and nature experience, you will have the opportunity of meeting and networking with peers from the re-gion’s life science sector in a relaxed setting.Venue: Bokskogen Golf Club in Skåne,Sweden – New Coursetime: 7.30-17.00www.mva.org/content/us/initiatives

Upcoming Events

Medicologic A/Swww.medicologic.dkMedicologic is a Danish design and engineering company specializing in industrial design, product innovation and mechanical construction. The present CEO Michael Funder, an engineer and toolmaker, founded Medicologic in 1995 under the name DanCad. Over the years we have spent thousands of hours serving our customers, and today we are proud to count some of Denmark’s finest industrial companies among our clients.

Arena Instrumentation Denmark ApSwww.arena-instrumentation.comArena Instrumentation is a laboratory equipment maintenance service providor for the pharmaceutical, healthcare and Biotech companies within Denmark and Sweden. Would you like to save money on your current laboratory equipment maintenance?Arena Instrumentation would like to get to know your business and to build a close relationship to ensure you get the service you want and require.

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Events by Medicon Valley Alliance

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