LifeSciences Insight no 2 - 2010

No 2 - October 2010

The Magazine about Life and Science in Medicon Valley

LifeSciences Insight

RESSURE

29: BRAND NEW EDUCATION AT DTU WILL BOOST PHARMACEUTICAL ENVIRONMENT 04: If it has to be sold, it has to be halal certified

12:

He created a SEK 3bn company

16:

Synthetic biology revolutionizes biotechnology

LifeSciences Insight no. 2, October 2010

Contents

LifeSciences Insight is distributed in Denmark and Sweden to: l Named

decision-makers in the life science industry

l Investors l

Science parks l Hospitals l Universities l Life science media l Relevant MPs in Scandinavia l Medicon Valley Alliance’s members and collaboration partners In addition, the magazine is available at several exhibitions and fairs in Europe, North America and Asia.

Circulation: 15,000 Publisher: RASK Media ApS Frydendalsvej 3 1809 Frederiksberg C +45 3326 9520 info@raskmedia.com www.raskmedia.com Partner: Medicon Valley Alliance www.mva.org Editor in chief: Carsten Elgstrøm Editorial team: Mikkel Ais Andersen, Susanne Bergstrøm, Claus Clausen, Lone Frank, Fredrik Hedlund, Anne Høybye, Anne Katrine Nørgaard, Mikkel Riis-Jørgensen, Charlotte Strøm, Jon Thunqvist, Birgitte Aaboe.

Advertising: sales@raskmedia.com +45 2887 0776 Suggestions for articles can be e-mailed to: info@raskmedia.com Cover photo: The Technical University of

Denmark (DTU) Layout and print: Zeuner Grafisk as Next issue: January 2011 ISSN: 1904-4755

3 If it has to be sold, it has to be halal certified 4 Research highlights from the universities in Medicon Valley 8 He created a SEK 3bn company 12 Synthetic biology revolutionizes biotechnology 16 Sweden and Denmark among the top 5 biotech countries 22 Commercial expansion paves the way for global development 26 Development of new antibiotics must be ensured

Brand new education at DTU will boost pharmaceutical environment

Asia Ahead – MVA’s Annual Meeting 2010 Award for outstanding collaboration in Medicon Valley Fighting Bacteria “Welcome to the revolution” Excerpt from Lone Frank’s new book

29 32 34 40

Immunologically close -Osaka University and Medicon Valley take the next step

People - Several advantages in the Danish Pharma sector

46 50

The Turning Point - Changing lanes from research into development

52 55 57

Upcomming Life Science Events Latest members of Medicon Valley Alliance

Development of new antibiotics must be ensured The development of new antibiotics must be put to national debate. Give the WHO or a similar international organisation the resources and responsibility to monitor and control the development. It is no longer a question of believing that the market forces will solve the need for new antibiotics when the financial world as well as Big Pharma have plunged into a crisis.

Let me explain what I mean. The ever increasing antibiotic resistance is indeed a growing threat to mankind. The development is heading in the wrong direction in all parts of the world and even here in the Nordic countries which have been relatively left unaffected, the problem is rising (1,2). Today, certain infections can be treated with one effective antibiotic only, and when the bacteria become resistent, there is no longer an effective cure.

Analytical experts believe that we are returning to a pre-antibiotic era with very extensive consequences (3). The more gloomy prospects include a reduction of average age by 10 years, and many operations and procedures that are performed today and taken for granted will not be performed in the future.

The solution to the problem is the introduction of new antibiotics, towards which resistance has not yet been developed, but in the global pipeline, candidates are few and far apart. In clinical research today, there are a mere 25 substances being studied, of which only six

have reached phase III (4). The vast majority of the antibiotic candidates are being developed by small biotech companies – only two of the 25 substances are being developed by Big Pharma.

This is good news and bad news.

When the large pharmaceutical companies cynically step down from clinical research because they expect low return on investments, smaller companies pick up the challenge because they can see the possibilities and potential of a project. This is good. As it turns out, the small businesses succeed in curbing costs and in developing important products at lower margins.

However, this situation is also a threat towards the entire process associated with the development of new antibiotics. The biotech world is currently going through a double crisis. Firstly, the global financial crisis has obstructed the accumulation of new risk capital invested in the early phases of clinical trials (5,6). Secondly, the more serious and long-term crisis within Big Pharma – where falling income combined with multi-billion damages payable to lost court proceedings in the US –has had an adverse impact on the major pharmaceutical companies’ will and possibility to take over clinical development of promising products when reaching phase III (7).

In other words, the biotech companies are being squeezed from both sides. When capital is low, selection becomes keen, and projects

Fredrik Hedlund, Swedish medical journalist with a degree in pharmacy from the Faculty of Pharmacy at Uppsala University

that do not have a major potential for future revenues are no longer interesting.

A future new antibiotic product is thus very much needed from a medical perspective, but not particulaly attractive from a market perspective. When a majority of the new antibiotic projects are undertaken by small biotech companies depending on risk capital and Big Pharma exits in order to gain ground within clinical use, there is a major risk that in turn, important projects will be shut down for short-term financial reasons. Products that may contribute to protecting the world’s population against lethal infections.

Therefore, extraordinary efforts are required to secure the development of such substances. The development of new antibiotics is far too important to be placed in the hands of risk capitalists.

1. The bacterial challenge: time to react. ECDC & EMA, September 2009 2. Swedres 2009. A Report on Swedish Antimicrobial Utilisation and Resistance in Human Medicine. Strama & Smittskyddsinstitutet, June 2010.

3. O Cars, L Diaz Högberg, M Murray, O Nordberg, S Sivaraman, C Stålsby Lundborg, AD So, G Tomson. Meeting the challenge of antibiotic resistance. BMJ 2008;337:726-728.

4. S Donadio, S Maffioli, P Monciardini, M Sosio, D Jabes. Antibiotic discovery in the twenty-first century: current trends and future perspectives.

The Journal of Antibiotics advance online publication, 2010-06-16; doi:10.1038/ja.2010.62.

5. Kritisk kapitalbrist bland Medicon Valleys biotechbolag. Pressmeddelande Medicon Valley Alliance 2010-01-18 6. P Birgersson. Medicindalen har blivit förkyld. Sydsvenskan 2010-05-15.

7. J Lindqvist. Fler projekt fastnar i fas II. Biotech Sweden, 2010-06-18.

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If it has to be sold, it has to be halal certified The demand for halal-certified goods is increasing rapidly on the global market.

Novozymes is among one of the companies that for some time now has adapted its products so that they can be certified.

By Birgitte Aabo

”Is it halal?”

This question is being asked by a steadily growing group of conscious Muslim consumers, and they require a clear answer. No only when doing their shopping, but also when they are vaccinated, when they study the bottle with vitamin pills or choose toothpaste in the supermarket.

The requirement for religious certification comprises a growing number of product groups in addition to food and has developed into a phenomenon which the major export companies in the Western world try to adapt to the various trades and industries all over the world.

Such companies include Novozymes headquartered in Bagsværd in Denmark and supplying, among others, enzymes for food products and animal food. The comJes Knudsen, Global Halal Coordinator, Novozymes

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pany was already awarded the first halal certifications in 2000: Jes Knudsen, who is global kosher and halal coordinator at Novozymes, says: “Earlier on, it was sufficient if we could guarantee a vendor with Muslim customers that our enzymes did not contain any alcohol or animal food. However, requirements have become stricter within the past year, particularly in South East Asia, and this has caused Novozymes to react and have almost all our food product enzymes halal-certified”.

There are many large Islamic organisations that have specialised in visiting companies all over the world and awarding production halal certification, and Novozymes uses one of the largest organisations known as IFANCA. This means that inspection visits are regularly paid to the production unit and also that sometimes, it is necessary to select other natural product vendors,

who in some cases charge a higher price: Jes Knudsen notes: “Some of our vendors don’t think it is worthwhile to pay the extra costs and carry out the extra certification formalities. However, to Novozymes there is no doubt that these expenses are beneficial to our business. A growing number of

companies require certification”.

Hair in the food Indeed it is a subject worth considering. Almost one-fourth of the world’s population are Muslims, and although far from all of them are preoccupied with the phenomenon and many do not care at all, world trade with halal products in 2006

was considered by the Canadian authorities to amount to a value of USD150bn.

Since then, demand has risen even more for products slaughtered, produced and treated in accordance with Muslim tradition, with one of the requirements being a ban of any contact with pork and alcohol. This is a market that has

Photo: ScandinavianStockPhoto

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been referred to as The Third One Billion Market next to China and India which so far have been very interesting to trade and industry as giant markets.

The history behind the increasing number of Muslims, particularly in South East Asia, starting to demand halal - Arab for allowed -is the massive food scandal in Indonesia in 2001. At the time, a spice company was caught in using an enzyme from pigs and an amino acid from horses and human hair to produce The Third Spice. The Danish anthropologist Johan Fischer, associate professor, PhD at the Department of Society and Globalisation, Roskilde University, comments on this and says that it was considered to be a fierce violation of halal and was taken so seriously that a number of the employees were sent to prison. He’s an expert on the halal wave and recently came back from a trip to Malaysia: “The major foodstuff scandal in 2001 resulted in a heavy focus on certification and the quality of it, and since then, the interest in halal products in all aspects has only grown bigger. It has been nourished by a growing Southeast Asian middleclass population who are more conscious consumers. Also there has been a kind of revival, a new interest in being a Muslim which also comprises halal products and this trend has been followed up by the producers”.

Prescribed medication exempt Johan Fischer takes it as far as to call the phenomenon an even more “intense halalisation” of the world market: “You have to be careful of how you put it, because it can easily take the wrong turn. Of course, not all Muslims area preoccupied with this - and there are many different levels of interest in halal products. In many ways it can be compared to the consciousness

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Antropologist Johan Fischer, associate professor, PhD at the Department of Society and Globalisation, Roskilde University

Scandinavian consumers’ interest in ecological foods.

There is much identity associated with being a person buying halal products. The fact is that demand for halal products is increasing and the phenomenon is spreading which means that requirements are made for all types of products, and if the producers do not comply, this may hit down hard on sales - for instance, Colgate is still running a campaign on trade fairs in Malaysia in order to gain the market shares they lost when word had it that Colgate toothpaste was not halal”.

Also vitamin pills and other kinds of dietary supplements, health products and OTC medication are available in halal versions in Malaysia and other places in Southeast Asia today: “However, the rule is that prescribed medication must not have halal certification - based on the principle that it is not a question of taking halal certified medication if the alternative is that you die. If you need heart medication, the Malaysian attitude is that you should take it, whether or not it is halal”.

Certification rivalry Even though there are exemptions to the use of halal in some cases, the fierce competition between numerous certification organisations means that they vie with each other in stipulating the strictest requirements for awarding halal certification: Johan Fischer continues: “Basically, the requirements are the same, however competition between the certification organisations is keen, and they try to outrival each other by applying the strictest rules in the market.

More and more advanced measurement devices are being developed, and they are capable of revealing the smallest trace of pork or alcohol and therefore contamination has also become a problem of increased focus”.

Contamination could, for instance, be associated with transportation - halal certification has no value to a product if the product is transported in a truck that has previously contained pigs. Therefore, Europe has got its own first halal certified harbour in Rotterdam, Holland, where halal products can be handled without being subjected to contamination.

This issue of contamination is a problem which Jes Knudsen from Novozymes has had to deal with on an increasing basis throughout the past few years: “We feel the rival policy among the certification organisations. It has been a bit turbulent for the past years when the issue of contamination has been a focus. Sometimes we see that an ingredient which has not previously been on the list requiring halal certification suddenly needs to be approved as well. For instance, glycerine, which can be produced from animal fat. Previously, we would get an approval if we could document that the ingredient did not contain animal fat; today, it has to be halal-certified.

Requirements have become stricter for the past 10 years since we were asked for the first time about halal.

Another thing is at that time, it had not been feasible for us to comply with the type of requirements we comply with today. Neither we, nor other companies were prepared for this to begin with”.

requirements have changed over time and set out an increasing number of conditions. To begin with, we weren’t required to have a certificate for foam reduction oil. We are now. Previously, our ISO9000 standard was also accepted as a quality management system for halal, but today, we are being met with requirements for an additional halal quality management system”.

On the other hand, it has given no rise to concern that Novozymes produce enzymes for beer and wine production which are not certified, nor is it a problem that the company’s employees use animal ingredients in the lab: Jes Knudsen says: “As long as there are clear boundaries, there isn’t any problem. We are very careful to inform and notify our employees regularly on how we ensure strict compliance with the standards”.

Rare in Europe Although most of the Novozymes enzymes are halal certified, applications for certification are only filed when needed. For instance, we have never had any customers who have asked for halalcertified detergent enzymes, even though halal-certified detergent enzymes are a standard product in several Muslim countries. Also, nobody seems to be interested in whether enzymes for the textile industry are halal, for which reason they are not certified. And within the pharmaceutical industry, to which Novozymes supplies enzymes to a limited extent, requirements for halal certification have not gained ground so far. Generally, enzymes are only halal certified if the customer asks for it.

This policy is followed by most of the major players on the market. The Coca Cola soft drink, for instance, is equally halal in all countries, but only halal certified if there is a demand. This is the reason why consumers in the western countries very rarely see the halal certification on foodstuffs. However, Johan Fischer who has also carried out research into the British Muslims’ attitude towards halal predicts that the requirements for halal certification will spread to an increasing number of European countries concurrently with the local Muslims earning more money - and thus become more critical and conscious consumers.

So far, the trend is clear in the British and French major cities where there are many immigrants with a Muslim background - in France, the halal market grows by 15 per cent annually. In Paris, you can already buy many traditional French specialities such as foie gras with a halal certification.

HALAL

ISO9000 is not enough When Novozymes was certified for the first time and was given access to the halal market, this was relatively unproblematic: Jes Knudsen describes: “It was a fairly painless operation. Our good fortune is that we don’t use animal ingredients at all, and we are used to having to comply with the Jewish kosher rules, for which we have been certified for 20 years. However, the kosher requirements are very much the same, whereas the halal

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Research highlights from the universities in Medicon Valley Photo: ScandinavianStockPhoto

By Susanne Bergstrøm

Recently opened Danish centre of DNA research The Centre of Geogenetics at Copenhagen University aims at finding new solutions to the health care challenges facing the global population. As head of this new centre, Professor Eske Willerslev believes that the centre’s research

in genetic diversity could mean the development of new medicines and vaccines. The centre attracts scientists from all over the world and will boost Medicon Valley’s international position within DNA research.

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A chip can reveal viruses Scientists at Technical University of Denmark (DTU) Nanotech are working on the development of a chip that can detect viruses via saliva or a blood sample within 15 minutes.

The chip is meant to be an integral part of a portable device which will automate the process so that following a brief introduction, unskilled workers are capable of carrying out the test.

Good and bad proteins Danish bacteria scientists have identified and mapped a new group of proteins. These proteins have a disease provoking effect in diseases such as Parkinson and Alzheimer’s, and the mapping may contribute to the efforts to

counteract the development of such diseases. However, the proteins also have potentially positive perspectives within the nanotechnology development of strong materials.

Artificial situational judgement Researchers at Technical University of Denmark (DTU) are working eagerly on fitting robots with situational judgement. The aim is for the robot to get an idea of the type of user in order to adapt to current needs. One of the goals is to “socialize” today’s medical robots which at present are reported to be a nuisance to the staff, although it has taken over many heavy and routine tasks.

New findings on troubling side effects of Parkinson’s medication The standard medication used to treat Parkinson’s is Levodopa - a drug that initially has major benefits but later can produce serious side effects in the form of involuntary, jerky movements known as dyskinesias. A research group at Lund University has now found a way to study what it is in the brain that causes these side effects. In a patient with Parkinson’s disease, the nerve

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cells that produce dopamine die. The research group uses a harmless virus that introduces a small gene into the nerve cells which causes the nerve cells to stop producing dopamine, without destroying them.

The obstacles to stem cell therapy eliminated Researchers at Lund University have developed a new technique to prevent the development of tumors subsequent to stem cell transplantation. The technology consists of a unique designed virus that enables the visual distinction between mature and immature stem cells by a genetic modification. The immature stem cells can give rise to tumors, which previously was a major drawback of this type of transplantation. The results are promising with much less frequency of tumors and the right kind of surviving cells.

Medicine targeted with magnets An API incorporated in magnetic nanoparticles have successfully been targeted toward metallic implants e.g.

stents and artificial knees. The technology can be used to dissolve the thrombus with reduced risk of hemorrhage due to accumulation of the API at the stent. Various API’s can possibly be delivered this way to prevent the risk of a secondary thrombus to develop within the stent or to treat an inflammation associated with any implant.

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He created a SEK 3bn company “We were four people to begin with, and we worked hard.

We had no external investors, and we invested in the company with our own money instead of raising loans. But, it wasn’t a free ride”.

Photo: Swedish Orphan

Dr. Bo Jesper Hansen

In 1988, Swedish Orphan was founded with Dr Bo Jesper Hansen being one of the driving forces. Swedish Orphan was a pioneer within Orphan Drugs. Last year, the company was sold for SEK 3bn. This is the story of how he managed to gain success in the biotech business.

By Mikkel Ais Andersen 20 years ago, the chances of survival were almost nil if you suffered from a rare disease such as congenital and rare metabolic diseases. Today, however, the odds are much better thanks to, among others Dr Bo Jesper Hansen.

Unexplored area Having been inspired by the American model, Dr Bo Jesper Hansen has promoted the entire Orphan Drugs industry all over Scandinavia and Europe, and this has saved many lives. Orphan Drug is solely based on carrying out research in and developing drugs for the treatment of rare diseases which inherently do not result in sales figures as high as those related to the common diseases. When Swedish Orphan was founded in 1988, the company stepped into a completely unexplored area.

At that time in Scandinavia and Europe, no drugs were developed for the treatment of niche diseases, one of the reasons being that health care policy was not even formulated properly and therefore did not encourage the development of niche products. Dr Bo Jesper Hansen describes how in the US, a national health care policy urged companies to develop drugs for rare diseases. However, the road to success within this area was not always straight.

“People looked at us as if we had lost our sanity, because this kind of business wasn’t an obvious golden egg. However, I have always considered orphan drugs as a win-win-win situation to patients, companies and the society. It is expensive to society to lose newborns and young people, and we can avoid this to a certain extent when we can treat these congenital and rare diseases.

What it took for us was to believe in the project and keep going”.

To begin with, they had no products in Swedish Orphan, but they believed in the concept, which had worked in the US, and there was an obvious need that had to be fulfilled.

“We were four people to begin with, and we worked hard. We had no external investors, and we invested in the company with our own money instead of raising loans. But, it wasn’t a free ride”.

Take up business within niche areas Slowly, Swedish Orphan started to grow, and concurrently with the company’s success, profits gained were reinvested in the company. Thereby, the company did not have to borrow money, and according to Dr Bo Jesper Hansen, this is one of the reasons why Swedish Orphan starting making a profit.

“When you start a company within an area such as orphan drugs which did not exist in Scandinavia at

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the time, you have to believe in it and work hard to attain your goals.

This is why we also spent our own money on the company, and after five years, we started to see an acceptable return on our investments.”

According to Dr Bo Jesper Hansen, another ingredient for success is to follow a so-called Blue Ocean strategy, in which a company starts to operate in an unknown market and thus avoids having to deal with competitors.

“We knew that it would be tough to kick-off a completely new industry which was non-existent, but it was also an advantage, because we launched a market which we knew was there, where patients with rare diseases stood without any hope of treatment, and where we had no competitors,” Dr Bo Jesper Hansen says. His advice to entrepreneurs is to focus on unidentified areas and then seek to cover well-defined, uncovered medical needs.

“If you are to become successful within biotech, you have to dare taking up businesses within niche areas, where people are sceptical. You mustn’t dread entirely new areas, and our success is indeed a result of our Blue Ocean strategy”.

He admits that at the time, it was easier to start up a business than it is today due to the financial crisis, but he is still convinced that there is a large market with

biotech and within the development of drugs for the treatment of rare diseases. The keyword is to dare, he emphasizes.

Afraid of knowledge sharing To begin with, Swedish Orphan was a pioneer within the orphan drugs area in Scandinavia, but before the company was sold, it had 150 employees and 14 subsidiaries, and today, orphan drugs is a major industry in Europe with headquarters in Scandinavia. According to Dr Bo Jesper Hansen, there are several reasons why Medicon Valley in particular has become the centre of research.

“There are many network groups, where people meet and discuss their research, and the large knowledge sharing between Sweden and Denmark means a great deal”.

Dr Bo Jesper Hansen emphasizes the concept of knowledge sharing, which is a major asset to the industry, but he also maintains that it can be much better.

“Even though much is done to set up fora, in which research is discussed, there are many who are afraid of sharing their research and knowledge with others, keeping it to themselves as a secret, because there is an overall suspicion that people might steel one’s knowledge”.

Furthermore, he mentions two major obstacles to growth in Medicon Valley: 1. people are not willing to take a risk, and 2. access to risk capital is limited.

Photo: ScandinavianStockPhoto

S

Dr Bo Jesper Hansen’s 9 pieces of advice to success within biotech:

T

1. There must be a clear, unmet medical need. Needs cannot be invented.

2. Define a clear niche definition of the product.

3. The product must be an advantage to society.

C

4. Be attractive to talented staff.

5. The company must create a win-win-win situation for patients, the society and the company.

A

6. Have a clear mission statement.

7. Have a clear vision.

F

8. Have a clear company strategy.

9. Make sure to hire the right people to the right job functions.

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Synthetic biology revolutionizes biotechnology In a joint space between chemistry, biophysics, mathematics, computer science, molecular biology, and engineering, the discipline of synthetic biology opens up new ways in biotechnology.

By Charlotte Strøm In addition to reading DNA, researchers can now write DNA and thereby construct or program the functions of a particular cell.

Andrew Hessel is a biologist and author working to promote synthetic biology and open source biology.

understandable evolution of biological outputs ranging from single proteins to synthetic bacteria. Until the early 1970’s, biology was about classification and dissection – what might be considered reverse engineer, or taking apart things that already exist to see how

Motherboard in a computer

He advises companies on how to implement and make use of these innovative opportunities. In his mind, DNA is a programming language that scientists have been working to reverse engineering with increasing success.

“I would describe synthetic biology as a field aiming to make biology a true engineering science. Synthetic biology allows forward engineering, permitting scientists to write code de novo and allowing logical, fully

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they tick. Genetic engineering changed this. Suddenly, it became possible to think about programming life, making living things do what we wanted them to do,” Andrew Hessel says.

Biofuel and biotech Particularly within biofuel and medicine, synthetic biology has raised expectations. Andrew Hessel believes it will play an increasing role:

“The speed at which synthetic biology has become the fundament of the biofuels industry is remarkable.

The field is only about 5 years old. Biofuels is a great platform to build foundational technologies and experience. Petroleum is the world’s largest industry, yet it is unsustainable because of carbon emissions. With biofuels the carbon cycle can be closed. And the experience gained in metabolic engineering fuels can also be leveraged to make other compounds, e.g. specialty chemicals, drugs, and the like. There is really no shortage of what can be engineered with synthetic biology,” he says.

To understand the range of innovations that can be made with synthetic biology, one needs to look at the diversity of international Genetically Engineered Machines (iGEM) (http://igem.org) student projects. They range from bacteria that work as biosensors for arsenic (a water contaminant in third world countries), to vaccines for Helicobacter pylori (bacteria in the stomach causing ulcers) and cancerfighting beer.

“Some of these projects are playful, some are serious, but all are very creative. Moreover they are done in a few months on a shoestring budget compared to big pharma or a standard PhD project – all because of synthetic biology,” Andrew Hessel says.

s Visit u d n at sta 4 C2-18

DTU at iGEM From Medicon Valley, a team of students from the Technical University of Denmark (DTU) are participating in the annual iGEM competition. In 2009 the team from DTU won a gold medal for their project on genetically modifying yeast cells, enabling them to read where in the growth cycle the cells are. Yeast cells are increasingly being used for industrial production, and knowing when to start the production maximizes the output of the cells.

This year’s iGEM competition takes place in the US in November 2010 where 130 student teams from all over the world present their innovative synthetic biology projects.

Commercialization ahead The excitement on the opportunities in synthetic biology makes one scout for the commercialized projects.

“It is early days still, but the approach is so powerful that anyone that tries it is hooked, and its word is spreading fast. Genetic engineering was once very artistic, each experiment a one-off, and very slow.

Synthetic biology brings better tools to the table – chiefly the computer and the DNA synthesizer – bringing greater standardization, systemization, and speed,” says Andrew Hessel.

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Uffe Hasbro Mortensen is Associate Professor at DTU, Department of Systems Biology, and Center for Microbial Biotechnology. He agrees that the technology is developing rapidly.

“Currently, there is a lot of hype around synthetic biology in the media as well as in the scientific community. This draws attention and resources to the area and this will certainly speed up the commercial breakthrough of synthetic biology,” Uffe Hasbro Mortensen says.

He expects another five to ten years to go by before synthetic biology systems are fully implemented into industrialized projects.

Drug discovery and enzyme production Uffe Hasbro Mortensen sees synthetic biology play a role particularly within drug discovery.

“We can use this technology to detect new active molecules and test them in artificial read outs from yeast cells,” he explains.

Uffe Hasbro Mortensen continues: “Another option is artificial enzyme factories. By combining enzymes from different organisms and expressing them in a microbial cell factory, we may create chimeric enzymes that coordinate production processes effectively and inexpensively to speed up production of an interesting product. In this way, we have recently increased production efficiency of a plant product in yeast. By combining enzymes from different organisms, I expect we will be able to design entirely new products that may serve as tomorrow’s drug.”

Craig Venter, a biologist and entrepreneur, and his group of researchers in the US have recently produced

Photo: ScandinavianStockPhoto

a bacteria where the entire chromosome has been made from synthetic DNA. “This sets the stage where it is possible to design new microorganisms from scratch. By defining the properties of a microorganism yourself, it may be possible to produce the perfect cell factory for say bioethanol production in an environmental friendly way” says Uffe Hasbro Mortensen.

Changing nature?

With these new and apparently endless opportunities, it seems reasonable to ask the question: where does it end? Could one expect public resistance to scientists acting as divine creators of new organisms?

“We have in fact been doing this for many years.

The media may create a storm on gene modification, but not all public discussions are adequately informed on the facts. Genetically modified food may still give rise to some heated discussions, but so far I have not heard anybody complaining about using genetically engineered enzymes that are produced for laundry. I also do not believe that it will be a problem for the same people to accept drugs developed by using synthetic biology – if it will cure their disease or release their pain,” Uffe Hasbro Mortensen says.

Andrew Hessel agrees that the area of synthetic 27165 oxoid_pharma advert:1

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biology and particularly the genetic engineering is somewhat controversial: “Right now, many people fear genetic engineering.

They do not see it as creative, but as the potential to be destructive. At one time, many people viewed computers and robotics that way, too. It will take time to change attitudes. But the regions that create policies working to stimulate development in this area and speed the path to market will do better than those that try to shut it down. This is my message to all governments today: Missing this boat will hurt your country economically and scientifically.”

Without further ado it seems timely to let the future begin.

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A head start in clinical development

By Charlotte Strøm

Phase One Unit is a research group providing services to pharmaceutical and biotech companies within clinical research, pharmacokinetic, and pharmacodynamic studies. The clinic has great experience in sponsor initiated trials.

“It’s been some twenty five years now since we conducted our first sponsor initiated clinical trial. Since then we have developed our research group considerably into a dedicated phase I and II unit,” says Ulf Malmqvist, MD, PhD, Head of Department at Phase One Unit.

The clinic has 12 beds and is located at Skåne University hospital. Phase One Unit employs two physicians full time, three research nurses, a biomedical scientist, an orderly, and a study coordinator. The clinic is owned by the County of Skåne.

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The unit offers 24 hours surveillance and has access to emergency crash teams, and the hospital’s medical, cardiac, and surgical intensive care units.

“Safety is the main priority when conducting firstin-man trials. There are no short cuts and Phase One Unit has the highest standard available, always putting safety first,” says Ulf Malmqvist.

Follow up with healthy volunteers in early clinical development is equally important. For this purpose the easy access to digital data within the Swedish health care system facilitates the patient or subject follow-up months and even years after the trial.

The roots of Phase One Unit are academic as the research institution is closely connected to and physically located at Skåne University Hospital in Lund. The close connection between Phase One Unit and the university hospital allows interaction between pre-clinical and clinical research units.

“This is a major advantage. We have access to specialized hospital equipment and advanced medical diagnostic procedures. Furthermore we collaborate closely with the specialists at Skåne University hospital, expanding our expertise into a wide range of therapeutic areas,” Ulf Malmqvist says.

Skåne University Hospital has physicians with expertise covering all clinical specialities. It is a large academic institution counting 1750 beds, and it is responsible for highly specialized medical care in the south region of Sweden. Lund University Hospital was established in 1768, which makes it the oldest university hospital in the country.

Phase One Unit and Skåne University Hospital is located at the Swedish side of Medicon Valley. It is however, easily accessible from south Sweden as well as from Copenhagen where an international airport is located.

Flexibility Phase One Unit has expertise in investigating different routes of drug administration, of physiological, and biochemical measurements. Furthermore they have experience in studies on testing novel medical devices in Phase I. They count a track record of more than a hundred sponsor initiated clinical investigations particularly within respiratory and cardiovascular medicine.

“We cover all therapeutic areas for Phase II studies with both full time and part time experts at hand.

Hence, we have a high degree of flexibility and adapt easily to the sponsor’s special needs,” Ulf Malmqvist points out.

Standard Operating Procedures (SOPs) describing the trial conduct assure quality of all trials at Phase One Unit. The quality assurance is controlled by yearly audits from an independent auditor, and in addition pharmaceutical companies routinely audit the clinic.

“GCP adherence, compliance with the EU clinical trial directive, and with the Swedish federal guidelines for clinical research is obviously the backbone of our work,” says Ulf Malmqvist about the quality assurance of Phase One Unit. And it is more than just words, as the unit has been inspected by the FDA (Food and Drug Administration, US) and the MPA (Medical Products Agency, Sweden). The clinic is certified by the MPA to fulfil all medical and GCP requirement for doing any type of phase one studies.

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Sweden and Denmark among the top 5 biotech countries Sweden and Denmark are in the top league in terms of biotech research according to a study made by the magazine the Scientific American. However, it is important that the two countries maintain momentum in order to hold their positions. Competition between countries is keen.

By Frederik Hedlund The science magazine, the Scientific American, has pulled out a so-called ”Worldview Score Card” within biotech by comparing a number of important parameters in different countries. The result is that Sweden and Denmark

rank among the top five countries in the world, in which to carry our biotech research. According to the magazine, important parameters for the biotechnological climate in a country include patent laws and the pos-

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sibility to protect one’s inventions, the biotechnological intensity in the country, support to new enterprises and the entry of risk capitalists, educational level of manpower and the entrepreneurial level in the country. Each of the two countries had a value of between 0 and 10 on each of the five target areas, which subsequently were summarised into one total biotech score.

On a whole, Sweden ranks no. 4 with 28 points and Denmark follows immediately after as no. 5 with 27 points. The only countries that receive higher points are the US, Singapore and Canada.

- These figures most likely reflect that relative to the size of their populations, Sweden as well as Denmark are rather focused on biotech research, according to Hans Möller, VD for Ideon Science Park, Lund, an entity accommodating around 40 Swedish biotech companies

and completing between five and six biotech start-ups every year.

And he is supported by Morten Mølgaard Jensen, CEO of the relatively newly started Copenhagen Bio Science Park, COBIS, with approximately 25 companies working with – or for - biotechnology.

“Denmark as well as Sweden has had a continuous focus on creating a strong biotech sector. Originating from a historical background, the two countries have built strong biotech businesses based on collaborations between industry and universities, and this has formed the basis of the entire Medicon Valley area”, he says.

- Naturally, it is inspiring that we manage to hold top 5 positions in this competitive environment.

However, Morten Mølgaard Jensen predicts that it will be difficult to maintain the positioning and that it re-

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quires continued hard work and perhaps difficult political decisions.

“I see heavily increasing competition. It is no longer unique to create favourable conditions to start a biotech business. Denmark and Sweden has somewhat of a head start compared to other biotech regions in Europe, but other countries are catching up fast.

To stay amongst the leading nations , we must continue to develop and innovate our biotech sector as well as be prepared to address the structural requirements such as taxation and labour market policy, which are areas where there is room for improvement, at least in Denmark.

According to Hans Möller, the business climate in Sweden is good for the new biotech companies. Governmental agencies such as Vinnova and the semi-governmental institution Innovationsbron grant entrepreneurs subsidies to start their own business. And help is provided at several different levels.

What makes a difference for newly started businesses is to have access to good and efficient lab rooms, which the companies can use together. Another important issue is business consulting, ie types of business models

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Top 5 biotech countries in the world 1. USA 2. Singapore 3. Canada 4. Sweden 5. Denmark

37 points 31 points 29 points 28 points 27 points

Source: Scientific American.

to apply, how to prioritize various activities and how to acquire seed capital.

And the capital part is exactly what Hans Möller considers to be the challenge to the Swedish biotech business.

There is a downside to Swedish risk capital, at least in round two and three when a business needs to acquire amounts in the region of SEK50-100million. The number of private risk capital enterprises in Sweden is too low, which means that many businesses are forced to seek capital abroad, often in the US, and then the geographical distance becomes a barrier”, he says.

Denmark has similar subsidy schemes, but they are not quite as structured as in Sweden, according to Morten Mølgaard Jensen.

“The government, local and regional entities have been instrumental in launching a large number of various projects, the goals of which are to improve the framework for Danish biotech businesses. Proof-of-concept funding, technology transfer offices, pre-seed capital sources and smaller growth programmes are among the most important. However, there is a clear flaw in the coordination between all these initiatives. What I miss is a focus on creating a major critical mass. Denmark is a small country, and if we wish to maintain a strong academic position and to be among the best to commercialize biotech research, it is essential that we manage to cooperate and coordinate our activities. Useful advice on to how to structure your business or how to apply for seed capital is not available in a structural context in Denmark.

Indeed, there are many organisations, network players and trade organisations that perform very well and provide some assistance. However, if you are a new scientist with a new idea and wish to engage in a more entrepreneurial universe, it may be difficult to know, who to approach”, he says.

Sweden as well as Denmark are given rather poor ratings in terms of the educational level of the labour force – only around 2.3 out of 10 possible points. These figures include leading CEOs of biotech companies who have written a doctor’s thesis as well as a brain gain/ brain drain factor: the attractiveness of a country to foreign doctors relative to the number of local doctors going abroad.

Hans Möller does not find that the educational level is generally low in the Nordic countries, but his guess

is that the low educational value is based on other factors.

- In Sweden, it is possible to become a VD for a biotech company without having a doctor’s title, which is not the case in all countries. And Swedish youth is very flexible in terms of travelling today, and they do not mind going to other countries to write their doctor’s thesis, he says. According to Morten Mølgaard Jensen, even Danish students go abroad with the same focus, but this does not necessarily mean a brain drain. At least not in the long term.

Morten Mølgaard Jensen says: “I think it is a positive trend for Denmark that a doctor’s degree is acquired elsewhere in the world, as this gives cultural inspiration. The young people bring home new ideas and techniques which countries such as Denmark and Sweden are

too small to develop themselves. In addition, young people going abroad may meet experts within specific areas which are not immediately available in Sweden or Denmark. The challenge is then to make it attractive for them to come back. And with regards to the brain gain part, there is really much we can do.

If we take an objective view on how competition looks on these markets, it is no longer necessary to travel much further than to Ireland or the UK in order to find much better tax conditions. And if you go to Canada, you can apply for the so-called ”tax holidays” for the first two years of operations as a foreign company. This is a fantastic competitive parameter.

What we need to understand is that people who are willing to migrate from their homes in India, Pakistan, China or the US will seek countries

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where they gain maximum benefits.

They might be interested in working for Novo Nordisk, but why should they go to Denmark where personal tax rates are around 60 per cent when they can go to Singapore where tax rates are as low as 25 per cent? We need to realise that this is how their minds work.”

Morten Mølgaard Jensen continues: ”Of course, the financial aspect is not the dominant one, other aspects are the value of the specific job, general living conditions etc., but I think we kid ourselves if we think that all we need to do is arrange for free drinks every Friday, and they will be at our doorstep. People aren’t that ignorant.”

Note: Denmark’s fifth ranking is shared with Finland and Israel who have received 27 points as well.

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Commercial expansion paves the way for global development

By Charlotte Strøm As a spin-off from the pharmaceutical company Pharmacosmos A/S, a new contract research organization, Pharmacosmos CRO has recently been established.

Pharmacosmos CRO will assist small and mid size European pharmaceutical companies in global drug development projects.

“Once we decided to develop Pharmacosmos into a fully integrated pharmaceutical company it had a tremendous impact on our organization. We focused carefully on building an efficient global development model by bringing the best people on board and making alliances with strategic partners in order to take on the challenge of developing the products in our pipeline to meet global regulatory requirements,” says Lars Christensen, MD, President & CEO.

From production facility to pharma business Pharmacosmos is the manufacturer of dextran and iron containing products for anemia. Pharmacosmos started primarily as a production facility, but a change in strategic focus turned the company into a drug development company. After driving global drug development projects successfully for their own products, it seemed only

natural to share the experience with companies facing similar challenges.

“It is expensive and challenging to conduct drug development in a global setting. A key element is to build your organization to handle the projects adequately and efficiently which will inevitably include a significant degree of outsourcing,” says Claes Christian Strøm, Vice President at Pharmacosmos CRO. He carries on: “For most small and midsize biotech and pharmaceutical companies it rarely makes sense to build a full internal team of drug development experts. In Pharmacosmos CRO we have a proven track record of conducting drug development and obtaining regulatory approval with our own medicinal products. This year MonoFer® – a new treatment for iron deficiency anemia – has been registered in more than twenty European countries and CosmoFer® in registered in more than fifty countries globally”.

Combining sites in three continents In the clinical part of development Pharmacosmos CRO is combining sites in Europe and the US with sites in India.

Pharmacosmos CRO is based in Holbæk, a forty minutes drive from Copenhagen, where the mother company Pharmacosmos and the production facility is also situated. Conveniently close to the highway the company is located in the picturesque countryside of West Sealand.

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“Sites in Europe and the US are fundamental to support the important key opinion leader interaction. Furthermore the dialogue with the regulatory bodies, the FDA (Food and Drug Administration) and EMA (European Medicinal Agency) is crucial for a drug development company. However, financial constraints and limited duration of patents, calls for new approaches with access to a high number of patients at a low cost. This is where India adds well to the picture.

The combination of sites in these three continents is attractive to small and mid size pharmaceutical companies,” says Claes Christian Strøm.

The costs of conducting clinical trials are considerably lower in India compared to the Western World and with access to large patient populations including treatment naïve patients; India is rather attractive to invest in when it comes to clinical development.

Claes Christian Strøm is a medical doctor and PhD with commercial flair and a degree in finance (HD). Claes Christian Strøm has more than thirteen years of clinical and commercial experience working as a physician, from the pharmaceutical industry, and CRO business. He joined Pharmacosmos CRO as Vice President in May 2010.

Pitfalls What are the pitfalls of conducting clinical trials in India?

“A new – and to you unknown – partner in India introduces a major risk in your clinical development project. When setting foot in India you can rest assured that hundreds of CRO’s stand ready to embrace you.

The question is how to find that particular CRO, which will deliver timely, quality data, and who will live up to the required standards,” Claes Christian Strøm says.

He explains that the CRO business is a fairly young industry in India and not all companies have demonstrated thorough understanding of Good Clinical Practice. This comes down to the details as e.g. understanding how to handle source documentation, understanding the importance of asking patients about side effects, understanding the impact of strictly following in- and exclusion criteria. Albeit being details they are fundamental for data quality.

“The choice you make on your Indian partner is crucial to the success of your clinical development project. Having our track record in India minimizes that risk considerably,” Claes Christian Strøm from Pharmacosmos CRO says.

Max Neeman International Ltd is the strategic partner of Pharmacosmos CRO in India. It is a leading CRO in India, and this is the CRO that successfully is participating in the continued clinical development of MonoFer® in collaboration with Pharmacosmos.

The head office is located in New Delhi and on top of the CRO business the company is running a chain of private hospitals throughout India.

Matching partners The obvious conclusion from the experience of Pharmacosmos and their endeavors in India would be for any pharmaceutical business to copy that model. If they cannot build the organization to handle the trials far away surely more and larger CRO’s offer these services. But Pharmacosmos CRO is not afraid of competion.

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“Large CRO’s like Quintiles and ICON may offer similar services in India. However, a small or mid size company suffer from lower priority compared to big pharma in these massive organizations. If you are twenty people you may have a hard time finding your way around in a CRO counting thousands,” he says and adds, “The smaller local CRO’s most often do not have the international track record.”

Global presence Thinking and acting global is truly the credo of Pharmacosmos as they are selling their medicinal products for treatment of iron deficiency anemia in fifty five countries worldwide. So they have proven that global presence can be done even for a small pharmaceutical company, which counts only approximately a hundred people.

“From Pharmacosmos we have the regulatory, medical, and commercial expertise to support successful drug development to meet international requirements with the regulatory authorities. In addition we have a proven track record in commercializing products in all corners of the world,” Claes Christian Strøm ends.

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Brand new education at DTU will boost pharmaceutical environment A new pharmaceutical education at the Technical University of Denmark (DTU) is in the pipeline. Starting this autumn, the Masters Degree aims at education pharmaceutical engeneers.

By Mikkel Riis-Jørgensen

An entirely new Masters Programme in Pharmaceutical Technology at DTU is planned to kick off this autumn.

The education responds to a growing need of educating pharmacists in the Medicon Valley area that can be an asset to pharmaceutical businesses from day one after their final exam.

Pharmaceutical engineers working with high profile enterprises The master’s degree is quite revolutionary in its outlook as it aims at educating pharmaceutical engineers. The

programme focuses specifically on technology-based research on pharmaceutical drugs – from drug discovery or device idea through design to production. Furthermore, the students will find themselves working in close collaboration with companies such as Novo Nordisk, Novozymes and LEO Pharma. Instead of theoretical assignments designed by DTU-lecturers the students will be working with real-life cases supplied by pharmaceutical enterprises. This can provide them with a head start in the business when they have earned their master’s degree.

Photo: ScandinavianStockPhoto

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“The graduates will be able to support the development of pharmaceutical drugs and devices with an integrating role, as they have achieved great insight in the development process from the initial drug discovery or device idea to the finished product”, elaborates Kristoffer Almdal, Professor and Section leader at DTU Nanotech.

Cross-disciplinary educational teamwork A wide range of students with various educational backgrounds can gain entry to the Master Programme. This will create an environment of cross-disciplinary teamwork which will make the students understand the various parts of the engineering process in a different light as they can draw on inputs from students with different scientific backgrounds.

“The students will build on their academic profile from their various Bachelor degrees and achieve a core competence within a sub-section of the pharmaceutical field, in addition to achieving an overview of the whole engineering process”, explains Kristoffer Almdal and continues: “This point of departure will make the graduates

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clearly distinguishable from graduates from comparable programmes”.

An education targeted pharmaceutical companies The special engineering approach to the pharmaceutical field means that the future graduates are not destined for pharmacies across Denmark. Instead they are ideal candidates for prosperous careers in the pharmaceutical industry.

“The programme will strive to resemble the working process in an actual pharmaceutical company. Thus, the students will have gained solid experience at relating to concrete issues of relevance to the pharmaceutical industry by the time they graduate. When they receive their diploma, they are already well prepared for real-life cases”, says Kristoffer Almdal.

“There is therefore good reason to believe that DTU’s new generation of pharmaceutical engineers is just what the pharmaceutical companies’ demand”, Kristoffer Almdal predicts.

In addition, he anticipates that the innovative educational profile can contribute to attract and maintain skilled students, researchers and scientists in the Medicon Valley region, and thus boost the region’s international profil.

Q&A’s to the new Masters Degree What are the admission requirements?

A Bachelor’s degree in general chemistry (analytical and physical chemistry), organic chemistry, biochemistry, mathematics or molecular biology. Bachelors from DTU, other Danish universities and international students with a relevant background can be admitted to the programme.

How many can be admitted?

There is a maximum level of 30 students on the programme each year.

When does it start?

The master’s degree is offered for the first time in the fall term 2010.

What degree do you earn?

Cand.polyt. or cand.scient.tech. in Pharmaceutical Technology.

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Award for outstanding collaboration in Medicon Valley

28 October

The fastmoving markets of Asia is the topic for the Annual Meeting at Medicon Valley Alliance.

Asia Ahead – Focusing on the Eastern Markets The progressive Asian Economies has survived the financial crisis in good shape. While the market in the US and Europe is nervous about a double dip there is an atmosphere of optimism and confidence in Asia. Forecasts, that are subject to consensus among economists, predict that the huge region of Asia will obtain a growth this year at 8,6 percent, when Japan is not included. In that case this will be the highest rate of growth in twenty years.

But how big are the pharmaceutical, biotech and medtech markets of Asia? What are the key strongholds of Japan, South Korea, China and India? How do you conduct clinical trials and how do you handle Regulatory Authorities in Asia? These are some of the key issues that will be addressed on Medicon Valley Alliance’ Annual Meeting 2010 – Asia Ahead.

Speakers at the meeting will among others be Claus Eilersen, Senior Vice President, Novo Nordisk Pharma; Marie Carlholm, Clinical Project Coordinating Director & Team Leader, AstraZeneca and Thomas Jonsson, Life Science Ambassador, Japan/Korea, Medicon Valley Alliance.

Moderator will be Jan Wifstrand, Chairman of the Board, The Annual Meeting will take place in Copenhagen on the 28 October.

Please visit www.mva.org/annualmeeting2010 to read more.

For the second time, the Medicon Valley Cross-Border Award is to be given to a successful cross-border collaboration in the Medicon Valley area.

The prize is given to a collaboration with one or several partners from both sides of Oresund, that has successfully enhanced one or several of the following: Research findings, business opportunities, customers services, patient benefit or international recognition.

Professor at Copenhagen University, Nils Brünner won the award last year based on his ground-breaking cancer research and collaboration with Swedish scientists from Lund, Malmö and Uppsala universities.

The award will be presented at Medicon Valley Alliance’s Annual Meeting on 28 October 2010. Members of Medicon Valley Alliance can nominate a candidate. Please visit www.mva.org/ cross_board to read more.

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Fighting bacteria 54-year-old Birgit Kjældgaard Giwercman has spent half of her working life on conducting research in bacterial resistance in a university environment.

Today, she has transferred this knowledge to her own biotech company.

By Birgitte Aabo Birgit Kjældgaard Giwercman was given an offer she couldn’t refuse. Although she was the single mother of five children aged 5-19 years and had to consider the offer carefully, she was ready to leave her job at the University of Copenhagen and start as a business woman when in 1999 she was asked to fill a managerial position at the new biotechnological company Pantheco.

Birgit Kjeldgaard Giwercman says: “I enjoyed working as an associate professor at the Department of Medical Microbiology and Immunology at the University. However, I couldn’t help sometimes thinking that

I had spent half of my working life studying bacteria and their ability to develop resistance. I felt an urge to utilise this knowledge in a company aiming at making new antibiotics, and I was looking for challenges from a scientific and a managerial perspective”. Today, she runs her own biotechnological company, BKG Pharma.

To begin with, she took 2 years’ leave from the University, but she has never been tempted to return to her old job. Instead, the thought of becoming selfemployed slowly gained ground.

Birgit Kjældgaard Giwercman says: “It was a fantastic experience to move from the University to

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Birgit Kjældgaard Giwercman, founder and CEO og BKG Pharma. Photo: BKG Pharma

Pantheco. At once, I felt at home. Although I enjoyed my many years at the University, I didn’t expect to stay there forever, and I was glad that I didn’t have to submit an application almost every time I needed a box of clips. Suddenly, everything was possible and I could start implementing my visions”, says Birgit Kjældgaard Giwercman who then could not help being slightly an-

noyed at not having changed career track before the age of 43 years.

More responsibility Having focused on the development of new antibiotics, Pantheco got off to a good start and rose within a few years to employ approximately 50 people. Birgit

35

Personal data: Birgit Kjældgaard Giwercman, 54 years.

1984: Graduated with a degree in medicine from the University of Copenhagen.

1985-89: Doctor within, among others, dermatology and clinical microbiology.

1989-94: Senior resident, Statens Lægevidenskabelige Forskningsråd. Research into development of bacterial resistance, resistance mechanisms, immunology and biofilm research.

1994-99: Assistant professor and later associate professor at the Department of Medical Microbiology and Immunolgy, University of Copenhagen.

1999: Head and later Director of microbiology at Pantheco A/S. 2001: Director of Development, Member of Management, Cureon A/S. 2004: Starts as an inventor, founder and director of BKG Pharma.

Mother of five children, married to Allan Koch, Master of Science (MSc) in Economics and Management, residing in Charlottenlund, Denmark.

Birgit Kjældgaard Giwercman, founder and CEO og BKG Pharma. Photo: BKG Pharma

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Kjældgaard Giwercman started to climb up the career ladder and was offered even more managerial responsibility if she were willing to follow her boss to Cureon A/S, a company working on medicine against cancer.

“That decision was not difficult, because I would like to have more responsibility and more experience in getting the overall picture of a company - this was real change management and very challenging and interesting. I had some fantastic years and thought that I had ended my long war against bacteria resistant antibiotics”.

It turned out differently. Birgit Kjældgaard Giwercman made her own observations in the two biotech companies and she became increasingly aware of the fact that this could be done in an alternative manner: “I saw how growing ambitions led to an increasing number of employees, larger and larger domiciles and an increase in expenditure, followed by problems of raising new capital. Through outsourcing it had to be possible to construct a much cheaper and much more effective model, under which various experts were only used when needed”.

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In 2003, the two companies, in which Birgit Kjældgaard Giwercman had been working, merged into Santaris Pharma whose primary focus is medicine against cancer and rare diseases, and she chose to resign before the merger.

“At that time, I had told many people that my ambition was to become self-employed one day. But was this the time? I wasn’t quite sure. Should I choose to work as a consultant, or should I try life as a selfemployed person? I had just been married, and I had to be sure that he backed the idea, because I knew, that it would probably mean more work”.

Her husband supported her decision, and she then started a life of month long studies in the evening and at night next to job assignments as a consultant. “The aim was to provide well-founded research on the idea she had nurtured: “The laboratories of both companies, I had worked in, had found many effective drugs, which were subsequently given up as they turned out to be toxic to the human body. In order to avoid this, my plan was to find effective molecules that had already been approved for human use in another context”.

No porridge The molecules were found and the optimism rose higher after lab tests. BIrgit Kjældgaard Giwercman acquired start-up funds from DTU Innovation to begin with and later via her networks and among friends and acquaintances.

“This means that it was possible to carry out a controlled start-up”, she says and emphasizes that she does not see it as a problem that friends and acquaintances are financially involved in the project.

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Birgit Kjældgaard Giwercman, founder and CEO og BKG Pharma. Photo: BKG Pharma

“I didn’t care if it were my old mother or professionals who had made investments in my company, I would still feel the same obligation. It makes no difference.

Also, investments have been divided into small portions, so nobody risks having to eat porridge if they lose their investment”.

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38

Laboratory for red wine In order to succeed with her company, Birgit Kjældgaard Giwercman has used her network diligently. This is how it became possible for her to rent a laboratory at Statens Serum Institute. She also made use of her network connections when together with others in Symbion Science Park, where she is presently domiciled, she arranged a fully equipped laboratory: “By giving away 120 bottles of red wine, we managed to set up a laboratory with equipment amounting to several million DKK in value. There were laboratories that shut down here and there, and we contacted them and received feedback along the lines of: “Yes, we have some equipment here. Come and get it. Yes, we wouldn’t mind a few bottles of red wine”. So now we have a very fine laboratory”.

Today, the preliminary work has been completed. It took a little longer to get there than BIrgit Kjældgaard Giwercman had predicted: “There have been various challenges in the process, and the financial crisis has also had an impact and made everything proceed more slowly. However, the exit phase is over, and we are trying to find a buyer so that the project can be carried out in clinical trials. The drugs involved are two completely new classes of antibiotics which are very different from what has been

used before. And they are extremely effective against multi-resistant bacteria”, she promises.

Always at the back of her mind As she predicted herself, being self-employed carries more work, but also more satisfaction from working: “It may be a cliché, but to me my work is also a hobby.

I become so engulfed in it that I forget the time of day. Since I became self-employed, I don’t believe I have ever really turned out the lights - BKG Pharma is always at the back of my mind, even when I taking the dog for a walk along the beach. However, I never look at it as a problem, and I have come up with many ideas on these walks”, she says.

Even though she has escalated her work as the owner of a company, she has always been dedicated to her working life and allowed it to make up a great deal of her personal life. How she has managed to raise five children - even being alone with them for a number of years? A strong family network.

She says: “I have never had to think about rushing home and getting the meat balls ready. I have been able to draw on a very closely spun network, and this has been crucial to me. I had my first three children while I was studying and when later on, I had the next

two children, the older siblings were helpful in taking care of them and picking them up from institutions.

Sometimes I have taken the children with me. For instance, they have been running on roller skates near the University, while I finished the day’s work. And I am a woman - women are capable of multitasking!”

The women are coming!

Birgit Kjældgaard Giwercman has never experienced that her gender nor her many children have been an obstacle in relation to her career. On the contrary, she has been met with the awareness that women are needed - also in the management of the biotech companies. Still, the industry is male dominated and only 8 per cent of the board members in the Danish, privately owned biotech companies are women. However, she thinks this is about to change: “The women are on their way! I meet many hardworking, clever and ambitious young women in the business, and I’m quite sure that we will be seeing a larger number of women - in boards as well as among entrepreneurs - within biotech in the years to come. It is indeed a question about it taking time and changing traditions”.

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Welcome to the revolution - when all of us become guinea pigs Lone Frank A journalist and author with a Ph.D. in neurobiology and a background in research.

As a staff writer at Weekendavisen, one of Denmark’s leading newspapers, 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.

Lone Frank has written for leading international publications such as Science and Nature Biotechnology and regularly appears as a commentator on Danish radio and television.

In 2007 and 2008, she presented and co-produced two series of television programmes on controversial science for the Danish National Broadcasting Corporation, DR. At present, Lone Frank has published three books: • The New Life (Gyldendal, 2004) • Cloned Tigers (Gyldendal, 2005) • Mindfield (Oneworld, 2009), all of which have been bestsellers in Denmark and won critical acclaim. Currently only Mindfield is available in English.

Lone Frank has won several awards for her writing. She lives in Copenhagen and has just finished her fourth book.

The new book: Mit smukke Genom (My Beautiful Genome) will be published on 24 September 2010. From Chapter 4 of the book, LifeSciences Insight brings an excerpt in agreement with the author and the publishing house Gyldendal. The book will be published in the UK and USA.

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Excerpt from Lone Frank’s new book

Welcome to the revolution - when all of us become guinea pigs We are in the month of June, and it is hot in Boston. However, inside the Hynes Convention Center, it is cold. I have gone to Boston to attend the first international conference on consumer genetics.

The atmosphere is tense, as if we are all looking at the birth of something new and revolutionary.

The young entrepreneur John Boyce sayse: “Here you will see consumer genetics from all imaginable perspectives”. Sorenson Genetics is here to tell us about the Americans’ increasing use of genetic paternity tests which can be purchased by mail order or in the local pharmacy. It goes without saying that de CODEme is represented at the conference as well. Their stand is located next to the companies sequencing the consumer’s entire genome and not just testing a few million SNPs. Be it the future business models or the possibilities of sharing one’s genetic information with everybody else, all of it is covered in the speak sessions scheduled at the conference .

However, there are also snakes in the grass. Inside this freezing conference room, a panel of experts are discussing how forces try to restrict the otherwise very free market. An example is the German authorities. They do not find that it is safe or desirable to market advanced genetic tests directly to innocent consumers. They argue that not everybody is capable of understanding what they are getting involved in or how to react on the genetic information, and they maintain that genetic tests of any kind in future must be prescribed by a doctor.

“The Germans are an interesting group of people”, the speaker says. The speaker is Kári Stefánssson and apparently, he

is in a sarcastic mood. “They will cheerfully sell you tobacco and alcohol and fast cars, which they are certain are lethal, but you are not allowed to buy information about your own health risk. I find that a trifle odd”.

The person next to me whispers loud enough for half the row of seats to hear: “Arrogant bastard”. A few listeners agree, while Stefánsson continues his tirade from the podium.

“All in all, the criticism of direct marketing to consumers is interesting”. We know already that patients use the internet and are often better informed than their GP. People are interested in their health, and to me, the question is if we are not responsible for conveying to them our knowledge on genetics and the research conducted within the field?”

Stefánsson also takes the opportunity to tell us that his own researchers happen to have found new genetic markers that indicate the risk of atrial fibrillation.

“Here you will see consumer genetics from all imaginable perspectives” It has turned out that variants of the ZFHX3 gene located on chromosome 16 increase the risk of atrial fibrillation drastically and as a result also the most common type of brain haemorrhage1. Minor brain haemorraghes which individually may not always be fatal to the patient, but which when accumulated will gradually destroy so much brain tissue that they lead to dementia.

“In the half per cent of the population who are at risk of suffering from brain haemorrhaging, se can see that the gene variants make up a 75 per cent risk. And at the same time, they provide much better predictions than the traditional cholesterol measurements. This kind of

knowledge can be used to initiate preventive treatment. However, nevertheless, many doctors and geneticists remain firm in their scepticism - why is this?”

“Arrogant bastard”. A few listeners agree, while Stefánsson continues his tirade from the podium.

I am seated on the fifth row and am slightly shocked. Not to hear about medical resistance or the German scepticism for that matter, that was what we could expect, but to note that this ZFHX3 gene is totally new to me. This has happened since I went to Iceland only a few months ago and illustrates very clearly just how fast things develop.

As soon as the new markers have been publicisized and appear in scientific literature, they will be included in the gene profiles from deCODEme, and I will be able to check my own situation on their website. And this is what will happen in the future. Every time an arbitrary group of researchers discover a new connection between SNP and a biological property, I and everybody with a genetic profile can retrieve our raw data and check our personal status. This could be new data concerning the risk of depression one day and susceptibility to athlete’s foot the next. If you think about it, it is a fascinating way to be directly connected to cutting-edge research. ”’Stop!”

A young man seated two rows in front of me asks Stefánsson if he really thinks that he and his colleagues are good enough to tell people that state-of-the-art knowledge changes rapidly and drastically.

“Those who buy your genetic profile assessment this year and who are told that their risk of developing a disease of some kind is low, may be told next year that the risk of developing that same disease

41

Excerpt from Lone Frank’s new book

is high. Because research has made new discoveries and the prelminary genetic studies have been led into new avenues. The fact is that there are major uncertainties on the results provided by you, and I don’t think the average user is aware of this”.

The young man sounds a bit agitated, but Stefánsson appears unaffected.

“That’s the name of the game.

Nobody can predict the future, and we must at all times act on what we know today”.

He reminds me of Bert Vogelstein from John Hopkins University who said something along the same lines to Nature.

“People are good at taking a small portion of knowledge and turning it into something very beneficial. It is important that we do not wait until we understand everything, because this is going to take a long time.”2 And isn’t it true that we are impatient? A population concerned about its health will not accept having to wait until everything has been fully explained and resolved.

However, the young man has a point there. It is indeed striking how many different messages that can be extracted from the same genome. Not because our genes change, but because tests as well as interpretations do. It has only been mentioned in passing at the conference, but the fact is that there are problems with interpreting the risk associated with the genetic profiles, because the vendors use different genetic chips in their analyses. They simply don’t check all the same variants.

And then there are the updates. Discoveries of new significant SNPs incorporate those already known and thus give a new risk assessment of the same genome. In 2009, the magazine New Scientist had a Dutch group of scientists look into how the risk assessment of Type 2 diabetes had developed at deCODEme,

42

and much had happened in only 2 years. The Dutch did not perform tests on live subjects, but made computer simulations on almost 6,000 genomes with different combinations of SNPs related to diabetes. When deCODEme launched their genetic profile during the autumn of 2007, eight genes were included in the TCFL2 gene risk calculation, but already one year after, a total of eleven genes were included, and in 2009, the number had gone up to fifteen. These changes resulted in four out of ten computer-simulated individuals changing risk category once, whereas one out of ten changed risk category as much as twice.

Does this mean anything?

It doesn’t mean so much if the risk is associated with a disease, for which there is no immediate preventive treatment. However, if we are talking about a condition where

preventive medical treatment is recommended for one risk category, but not for another, it suddenly has very specific consequences.

Another thing, of course, is consumer confidence. Cecile Janssen from the Erasmus University in Amsterdam and

head of the study is concerned about it. When the results appear to change over time without users having any influence on the outcome, they easily lose motivation to react at all. As when the national boards of health recommend one way of living to avoid cancer, and then withdraw this recommendation shortly after.

The message seems to be: Wait - we still have a long way to go.

And as some people maintain about consumer genetics - it isn’t quite ready for prime time. Others may contradict this. They would maintain that genetic risk assessment needs to be explored in order to become fully useable, and it is important that this is done publicly.

The message seems to be: Wait - we still have a long way to go The consumers must be fully informed that it is an area of uncertainty and that it is the fundamental principle. We have to realise and get used to the fact that science does not give us all the answers, but it is a never-ending process which will constantly change our understanding of the world.

Robert Cook Deegan, head of Genome Ethics, Law and Policy at the Duke University, says from the podium: “”No matter what kind of problems we are facing now, it is a fact that our way of thinking within this area has changed fundamentally. We do have access to personal genetic information, and this information is becoming cheaper and better all the time. ” His comment on the new German act is quite simple: “Pure idiocy”.

“Wanting to protect people against consumer genetics is like shutting down the internet to protect weaker souls from the porn available out there on various websites. This is what the Germans

Excerpt from Lone Frank’s new book

are doing. They do it out of fear and without knowing the potential they are missing”.

All in all, we see an interesting turn of the tide. For many years now, words such as “problematic knowledge” and the “right to be uninformed” have been voiced regularly. The predominant attitude has been that by all means, “people” should be protected from any knowledge that may cause them to feel insecure, because as experts they were in no position to understand the consequences. The positive interpretation of this is a kind of caring guardianship. Another one could be a “we-know-better” attitude.

“We do have access to personal genetic information, and this information is becoming cheaper and better all the time.”

So far, nobody has really known how people react to genetic information, but the first studies on this have started to surface. And it appears that the average consumer is very good at handling the more toxic messages.

At the Boston University, Robert Green has been studying Alzheimer’s disease for years and tested relatives of Alzheimer patients for the ApoE4 variant which increases the risk of developing the disease tenfold. And what happens? Those who test positive for the - perhaps - fatal variant show surprisingly that they do not have higher stress levels and are not concerned more about the future than those who are not tested and therefore do not know about their risk.3 Although, the first six weeks after having received the information, the carriers of ApoE4 were clearly more stressed than those not knowing for sure, but six months to one year later when the

researchers talked to them again, psychological well-being was no different within the two groups.

However, a large number of those who knew they were carriers of the ApoE4 variant were much more conscious about their lifestyle and planning their time than those who might have the same Alzheimer risk, but who had chosen to remain in the dark as regards their health status.

Another interesting survey has looked into the correlation between smokers and lung cancer.

Researchers from the National Institutes of Health have examined smokers who are related to patients with lung cancer and offered them a test involving a genetic variant which is known to increase the risk of lung cancer for those who smoke.

The hypothesis is that people who are told that they are do not have a risk of suffering a given disease, but perhaps even a lower risk than the average person, will react with indifference. When lung cancer is involved, these people will boldly continue to smoke, and if it is a cardiovascular disease, they couldn’t dream of abstaining from fat fastfood.

To the concerned ethicist, this may sound plausible, but it appears to be wrong.

In this study which was headed by Colleen McBride, there was not traceable difference in the motivation to stop smoking in those tested, whether or not they carried the risk-increasing mutation. McBride summarised the two studies as follows: “The findings might help us realise that we need to put a lid on our concerns that we have to protect people against this type of information”. (...)

“Are you here too?”

George Church, professor at Harvard Univeristy, appears to be mildly surprised to see me at another conference in Boston. A short while ago, during the meeting on consumer genetics, I exchanged a few polite words with him, and here we are with each our name tag around our necks and a cop of coffee in our hands. This time, the conference is being held in Microsoft’s impressive building in Cambridge, and the whole scenery is very exclusive. In fact, the entrance fee is USD1,000 - twice the price of the market’s cheapest SNP profile - unless you belong to the Press.

The revolving point is Church’s own, very special version of consumer genetics - the Personal Genome Project.

PGP as it is also referred to, is not only a very personal project it is also extremely ambitious. The vision is to enroll 100,000 volunteers who for free will have their entire genetic material mapped in return for publicising their genome and a wide variety of their health data on the internet. An enormous data reservoir rendering it possible to look for the correlation between genes, environmental factors and human qualities. Data Photo: Robin Skjoldborg

Another interesting survey has looked into the correlation between smokers and lung cancer

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Excerpt from Lone Frank’s new book

accompanied by names and images of participants and available to everybody who might want to have a peek.

Church says: “I’m inspired by the Wikipedia model”, while eating a bagel. To him, the project is an attempt to create a biological parallel to the computer world’s open source movement, where software is free, and where everbody has a saying in making improvements and increasing the overall knowledge on a voluntary basis. The innovative part of it is to give room to amateurs.

“We are dealing with very valuable data, and it would be crazy to keep these data within companies or to academics. The fact is that we cannot know who will make up tomorrow’s innovators. Technology is sufficiently cheap in order for everybody to participate, and the next Bill Gates or Steve Jobs could easily be a 15-year-old boy who gets a brilliant idea by looking into our database at home in his room”.

An enormous data reservoir rendering it possible to look for the correlation between genes, environmental factors and human qualities.

Church was one of those who started his career by building computers in his room. Now, many years and many inventions later, he has been appointed one of the “10 hottest nerds in the world” by TIME Magazine. To one of my American colleagues, the journalist Carl Zimmer, he “might be the most intelligent and most influential biologist, you have ever heard about”. Right now, Church is finishing his bagel and looks like a friendly lumberjack with his naturally waved hair and large beard. I tell him in a flattering manner that his visionary project makes 23andMe and their

44

research revolution look like 1 May on a rainy day.

“Yes, I must admit that we are different from all other projects”, he says. The project is not only characterised by its enormous number of participants, but also by the thoroughness by which each participant is measured and assessed. The Personal Genome Project does not only incorporate the health data of the volunteers - their various diseases as well as their consumption of medicines and dietary supplements - but also carries out own tests. For instance, people are subjected to a brain scan in order to gain an insight into the structure and functional ability of the organ. Another element is the individual’s immune system and how the person in question reacts to various infections. And finally, a small skin biopsy is aspired and changed into immortal stem cells that are stored in a biobank, from which everybody with a good research project can order a batch. (...)

The British author H.G. Wells once said: “Civilisation is a race between education and disaster”.

And is this not were we stand right now?

The race is on. There are technologies that, apart from moving ahead full speed, are cheap, easily accessible to a wide selection of the population. These are forceful technologies. They uncover hitherto hidden information. which for the first time in the history of mankind comes to light. And nobody, not even this elite of top scientists and tycoons, knows how technology and information can be used and exploited within only a few years.

Nevertheless, they wish to give us all an insight into the consequences of good - or bad - ideas. (...)

Behind all the juicy examples, we are faced with the major underlying and conceptual issues such as rights to genetic privacy.

Throughout the years, we have had debates about all kinds of different information, but we still need to consider and take a stance on what it means to have genetic information lying and floating around in public space. What kind of rights do we have as individuals - is it the right to keep genetic information a secret, or is it a right to make sure that the information is not exploited? (...)

“Civilisation is a race between education and disaster”.

And how will we react to genetic information in relation to the technological development and the national debate? All in all, we are looking at rather heavy changes.

We will be instrumental in launching research projects and we need to upload our inner biology to the joint cyperspace. This might be the end of the former idea of DNA as being something exceptional. And maybe we will be talking about a kind of social transformation. A leap to a new way of thinking, where we no longer consider our genetic information and for that matter cells retrieved from our bodies as us. Where instead, we talk about tools that can be used by us and which are made available to others.

This way of thinking is very much in contrast with today’s ideas which are expressed in all the stories on DNA piracy.

An interesting example is being debated vehemently in the American media while we are standing here and discussing visions for the future. A group of Indians from Arizona, the Havasupai tribe, has been paid exorbitant damages after researchers have used DNA from tribe members for research without obtaining informed consent.

Back in 1990, a number of Havasupai voluntarily donated their DNA in order for researchers at

Excerpt from Lone Frank’s new book

Arizona State University to look into the genetic reasons for the tribe’s high diabetes incidence rates.

They found no diabetes genes, but later on, they included the material in other projects without having obtained specific consent. This work has resulted in more than 20 scientific articles, including theories including genetic causes for schizophrenia to the origin of Indian populations.

This way of thinking is very much in contrast with today’s ideas…

More specifically, the genetic research carried out in recent years is what has caused the Havasupai to react. Not surprisingly, genetic analyses demonstrate that similar to other original US populations, the tribe migrated from Central Asia.

However, the Havasupaia, who live in

Near

at the bottom of the Grand Canyon and make a living from tourism, refer to their own myths of origin which say that they simply originated from this piece of land.

Newspapers and blogs support the Havasupai. And are very firm on stating that researchers must not touch a DNA sequence without obtaining the donor’s consent on everything they do. However, apart from this concept not being practical from a research perspective, is it at all reasonable? Is our DNA actually ours. Is it possible that the information contained in the double spirals is part of our joint human inheritance? And that therefore, we are not entitled to stop it from being used to help other people?

1.

2.

3.

(...)

So far, personal genetics have primarily been sold and served as something that involves health. Of course, it is important, but when all is said and done, our illnesses and weaknesses are not the most interesting things about being a human being. The physical aspect is more a basis for keeping everything in order. It doesn’t leave a mark as such.

What makes it really interesting is the intersecting point between the physical human being, the frame, and the individual.

This is where genuine enthusiasm appears. Because how do we move from genes to what we used to call a soul?

Gudbjartsson et al. 2009, Nature Genetics, Aug;41(8):876-8. Epub 2009 Jul 13 Check Hayden, E., 2010, Nature, vol. 464, 1. April, pp. 664-667 Green et al., 2009 New England Journal of Medicine, vol. 361, pp.245-254

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Immunologically close – Osaka University and Medicon Valley take the next step

By Jon Thunqvist It could probably be said that it all started back in March this year when a delegation of prominent Japanese researchers visited Medicon Valley within the Life Science Ambassador Programme.

However, both entities were of course well aware of each others existence long before that.

“By being present in the foreign markets, we can quickly identify potential products and see to it that they are thoroughly explored”, says Thomas Jonsson, Medicon Valley’s Life Science Ambassador in Japan and Korea.

Photo: Agnete Schlichtkrull

Medicon Valley researchers have made it a priority to keep an open research environment, one which welcomes cooperation and partnerships with other global players in these fields.

What happened June this year was that the collaboration were formalized into a so-called Memorandum of Understanding (MoU). The outspoken purpose of the MoU is to mutually exchange information and actively work to establish Academic and Business collaborations, mainly, but not limited to, the area of Immunology. For Medicon Valley this partnership is especially interesting for big pharma, biotech and the universities in the region.

It is no surprise that Osaka University is involved from the Japanese side. The university is a frontrunner among Japanese institutions when it comes to international collaboration. Situated in the Kansai area in Western Japan, Osaka has for centuries been Japans center for medical research and manufacturing.

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the Medicon Valley region believes the partnership holds great promises.

“IFReC comprises a broad range of expertises in the fields of immunology and vaccine development. ALK-Abello has a strong track record in allergy research, and we are always open for collaborations with leading academic institutions offering specialities that complement our own in-house knowhow and skills,”

Danish ALK-Abello visited Osaka University in late August of this year and was impressed by the cutting-edge scientific level and the researchers they met.

From left to right: Kiyoji Hanasaki, Professor - International Relations, Office for University-Industry Collaboration, Osaka University; Peter Adler Wurtzen, Ph.D., Research Scientist, Experimental Immunology, ALK-Abello; Carola Rask, Ph.D., Research Scientist, Experimental Immunology, ALK-Abello; Kaare Lund, Ph.D., Manager, Experimental Immunology, ALK-Abello; Ken J. Ishii, MD/Ph.D., Adjunct Professor, Principal Investigator, Laboratory of Vaccine Science, IFReC, Osaka University; Hachiro Senoo, Ph,D., Professor - International Relations, Office for University-Industry Collaboration, Osaka University

Immunology Frontier Research Center With its new international Immunology Frontier Research Center (IFReC), there is no exaggeration to say that Osaka University has further emphasized its position as one of the world leaders in this field. IFReC was launced in 2007 as part of the World Premier International (WPI) Research Center Program by the Japanese national government, and has many top-level achievements in the field of immunology. What makes IFReC stand out even more is that has managed to turn itself into an international research institute – truly a rare bird in Japan.

Some 40 % of IFReCs researchers are foreigners.

Professor Kiyoji Hanasaki, International Relations, Office for University-Industry Collaboration, Osaka University, points out, that the cooperation between Medicon Valley and Osaka University is a win-win situation.

- Companies in Medicon Valley have opportunities of effective access to the cutting-edge technologies invented by researchers at IFReC in the nature of the cooperation. And it helps us to find right partners for researchers of IFReC or other faculties and institutes of Osaka University for facilitating their basic researches turn into commercialization, says Professor Hanasaki.

ALK-Abello impressed Much like professor Hanasaki and his colleagues at IFReC are intrigued by the possibilities that the cooperation with Medicon Valley offers, researchers and investors in

says Mr. Kaare Lund of Danish ALK-Abello, a world leader in the allergy treatment.

Mr. Lund had a chance to visit Osaka in late August of this year and was impressed by the cutting-edge scientific level and the researchers he met.

“Immunological research in Japan has developed tremendously in recent years and is now characterized by the presence of a vibrant and ambitious scientific community, also in the field of allergy. These characteristics match our internal values at ALK well.

In addition, an organization like IFReC seems to be dedicated to provide the funding and the infrastructure needed to push for toplevel research,“ he says.

Regarding the mid- to long-term outlook, Mr. Lund believes that the cooperation has the potential of developing into a mutually beneficial long-standing relationship between the two entities.

A long-term perspective is of course of great importance as pharmaceutical research takes time and tenacity if it is to meet with success. A fact that the people involved readily point out.

The cooperation is expected to evolve into concrete partnerships and research collaboration between companies in Medicon Valley and Osaka University in areas of mutual interest based on win-win situation for both parties. The collaboration may include companies’ expertise in applied technologies to support basic researches by researchers of Osaka University or vice versa, says Prof Hanasaki.

Neck-breaking speed In the pharmaceutical field, such as in any other competitive industry, innovation and development comes at a neck-breaking speed. The Medicon Valley Alliance with its network of Life Science Ambassadors also has an Ambassador posted on the ground in Japan. Mr. Thomas Jonsson, Life Science Ambassador in Japan and Korea

47

points to early warnings as one of the big advantages of the Ambassador Programme.

“By being present in the foreign markets, we can quickly identify potential products and see to it that they are thoroughly explored”, he says.

There has been some worries that the Osaka was losing out to Tokyo in both production and research, but recent developments, such as the government-led National Institute of Biomedical Innovation (NIBIO) that was set up in 2005 seem to have alleviated the situation somewhat.

A few of the last years great scientific breakthroughs have actually come in the Kansai area, most notably perhaps is the research by Prof. Shinji Yamanaka of Kyoto University into so-called induced pluripotent stem cells (iPS).

NIBIO has a yearly budget of JPY 13 billion (USD 140 million) to spend on research into fields such as bioninformatics, proteomics and immunological regulatory mechanisms.

One of the renowned researchers with a base in Kansai is the very successful immunologist Prof Tadamitsu Kishimoto. A trailblazer with numerous patents to his name and now eager to see his alma mater produce further scientifically breakthroughs.

With the proceeds from his patents, Prof Kishimoto has set up a foundation for young researchers. In a recent interview with Nature magazine he spoke of his pet projects. “I want to support immunological sciences in Osaka”, he said.

Potential for business Mr. Thomas Jonsson, Medicon Valley’s Life Science Ambassador in Japan and Korea applauds the recent development in the Japanese pharmaceutical field. “There is great potential for business here. The region has a combination of strong pharmaceutical companies and excellent research facilities. The Medicon Valley back in Scandinavia is built along the same premises. This makes us very optimistic for the future. “ On a second note, and one that is sometime overlooked when it comes to crossborder collobarations, the fact of the matter is that Scandinavians and Japan seem to have an innate understanding for each other.

Culturally and mentally, the people of Northern Europe and the Land of the Rising Sun find it very easy to get along.

“Distances are far, but our values are very similar,” concludes Mr. Jonsson.

Contact Kjeld Birch, MD Managing partner +45 4054 2440

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49

PEOPLE

Several advantages in the Danish pharma sector Dr. David Solomon, CEO of Zealand Pharma moved with his family to Denmark almost two years ago and hasn’t regretted the decision to relocate.

David Solomon enjoys the successful Danish pharma sector, the Danish public structure and Denmark in general and has no plans of returning to his home land or any other country any time soon.

By Anne Høybye When Dr. David Solomon, originally Canadian, but with residence in New York, was recruited through a search firm to Medicon Valley-based Zealand Pharma, he didn’t have any hesitations about moving to Denmark.

“Canadians are used to being internationalist like Danes,

and Canada is a lot like Denmark in terms of the social quality of the culture and social structures. So having lived 25 years in New York and having the opportunity to come to Denmark, was a natural one for me” says David Solomon, who besides Canada, US and Denmark also has lived in Korea and Thailand.

Advantages in the Danish pharma sector

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Another reason why David Solomon enjoys Denmark is that he sees several advantages in the Danish pharma sector compared to other countries.

“The important advantage is that there are more PhD’s in life science in Denmark per capita than in any other country in the world and as a result, Denmark hosts some of the large pharmaceutical companies in the world like Novo Nordisk, Lundbeck and Leo Pharma in spite of being just five million people. Canada has 35 million people and has no big pharmaceutical businesses. So Denmark has a culture of large successful companies which trickles downwards to a culture of small pharmaceutical entrepreneurial companies” says David Solomon.

David Solomon also refers to the fact that the large pharmaceutical companies are owned by foundations and therefore cannot be bought by companies abroad as a contributing factor to the successful Danish pharma sector. David Solomon sees the Danish work ethics also as a great strength as well as a contributing factor to the success of the Danish pharma sector and a contributing factor to the success of his company Zealand Pharma.

“The culture here is that everyone is working on a common goal which means that in a company like Zealand you can get more done on time on budget with excellent people than I could ever get done in the US or in Canada.

Zealand Pharma is among the most successful biotech companies in the country, and, I think, it is because of the Danish structure which is inherent in the Danish society and Danish healthcare” says David Solomon.

Transparency and deference The Danish work culture was new to David Solomon which meant he also had to make some adjustments in his leadership. He explains: “In the States, you have the phenomenon of too many Chiefs and not enough Indians. In Denmark there is still a formality – a deference for the administrating directors and the CEO which means that you can take a certain position if you are a good leader, set the rudder straight on the boat, offer hope to everybody and make a pact and a plan going forward, and people will follow you if they believe you are credible”.

David Solomon was also surprised by the level of transparency that employees requested in Denmark. He admits not being as transparent as he could be in the beginning before he learned to explain and spend more time on providing guidance.

“I say for a CEO it is like being a basket ball coach. You cannot score any baskets. You can only motivate the players on the court to score more baskets, but you can’t yourself score baskets. Your job is to have a plan, provide the right structure, the right community, the right safety and the right resources to people so they can do their job well and happily and with the right productivity” says David Solomon.

Taxes, day care and health care For Zealand Pharma’s CEO, it hasn’t only been a cultural change at work but also in his private life and for his family. David Solomon moved to Denmark with his wife and their three year old daughter, Juliet. And what he soon learned was that Danes have a higher barrier for letting people into their lives. David Solomon gives an example.

“If we go to a playground in the US, and Juliet starts to play with another child, immediately the parent will come over and start talking and 20 minutes later you would be invited to their house for play dates and for dinner the next day. In Denmark, kids might play together on the playground, but the other parent doesn’t come over and talk, and you have to make a huge effort. It can take one or even two months before there is a play date, let alone an invitation for dinner”.

On the other hand, David Solomon applauds the structure of the Danish public kindergarten and tells that the equivalent structure in the US would cost more than 20.000 Euros a year for the equivalent type and quality of day care for kids that you would find in Copenhagen. David Solomon thinks Danes worry too much about the tax base instead of recognizing the considerable products and services they receive instead.

“In the US, we are just celebrating a structure – a bad structure, but finally a structure that means that the 40 million people - eight times as many as the Danish population – that have no health insurance will have a sort of a way where some of them can get some coverage. The fact that we all have health care in Denmark is a good thing. I think it is a human right”, David Solomon declares.

Dr. David Solomon, CEO of Zealand Pharma Photo: Zealand Pharma

Keep an open mind!

It is obvious that David Solomon has fallen for Denmark, but it isn’t just Denmark that keeps him and his family here. “ I hope I can be at Zealand Pharma as long as the ownership at Zealand thinks I add value because this for me is a wonderful opportunity to expand a durable company to a larger scale. And Denmark is a wonderful place to advance a company to the highest level. Denmark has a lot to offer right now because of a combination of technology, financial and human resources. You can’t do the same in the US or Canada right now”, David Solomon says.

For others who are considering relocating, David Solomon has only one piece of advice.

“Keep an open mind! Until you really experience life in a new setting, you don’t know what it is really about. If you are open and ready to learn and ready to accept new values and new challenges there can be a huge amount of growth potential, a huge amount of positive surprises and a huge amount of pleasure from the experience that you can’t anticipate before making the move”.

For David Solomon the rewards of relocating from one country to another was so positive and the challenges much smaller that he wouldn’t hesitate doing it all over again. But he doesn’t expect to relocate again any time soon.

“Each country has things to offer, but right now I love Denmark”, David Solomon concludes.

51

> The Turning Point In this new series of portraits of upcoming biotech and medtech companies in Medicon Valley, LifeSciences Insight focuses on the companie’s Turning Point. We ask founders and CEO´s about their experience of the major changes imposed on the company during their development from idea to business. What crucial crossroads have they seen? How would they define climax? And what decisions have been most important for their success?

Changing lanes from research into development Taking the research experience from the laboratory into real life for testing in humans marked a turning point for biotech company NsGene.

By Charlotte Strøm In 2008, NsGene had the first clinical trial application approved. This marked the moment when the twenty five employees located in Ballerup, Denmark, started redefining their working place from being solely a research company to being an actual drug development company.

“Mentally, it was a major milestone for us to get to this point. We felt good and proud of moving one of our drug candidates and our technology platform out of the lab and into the hospital for clinical testing,” says Teit E. Johansen, PhD, Chief Executive Officer & President at NsGene.

Clinical trial results This year the employees reached yet another milestone when they had the results from the first clinical trial.

The drug NsG0202, NGF (Nerve Growth Factor) delivered using the technology platform EC Biodelivery™ (Encapsulated Cell) , has been tested in a group of six patients with Alzheimer’s disease.

“We are encouraged and feeling very optimistic by the results.

The technology has been assessed clini-

Teit Johansen, CEO Photo: NsGene A/S

52

cally, and we have demonstrated that direct and local delivery of a regenerative substance into the central nervous system is feasible in a patient friendly and safe way,” says Teit E. Johansen, referring to the open label clinical trial for NsG0202 that took place at Karolinska University Hospital in Sweden.

Additionally, the study results support a positive trend on efficacy.

“This is obviously a safety study, and we are very excited to get the safety of the device confirmed. Moreover, it appears that improvements in cognitive testing correlated positively with the results from the objective PET scans,” says Teit E. Johansen and continues, “From animal studies NGF has demonstrated pharmacologic, restorative, and neuroprotective effects. With a longer duration of the study, the more evident the combination of these different therapeutic mechanisms of NsG0202 becomes apparent.”

An original paper on the study results is currently under review and Teit E. Johansen expects the results to be published in a peer-reviewed scientific journal later this year.

NeuroSearch spin off NsGene is an almost eleven year old spin off from NeuroSearch, where Teit E. Johansen used to work as Head of Molecular Pharmacology. At that time he was the driving force behind the discovery and patenting of Neublastin, a novel therapeutic protein. As NeuroSearch was focusing more on small molecules, NsGene was spun out to take on biological substances for the treatment of neurological diseases.

Photo: NsGene A/S

Neublastin was later licensed by Biogen Idec that is developing the drug further for the treatment of neuropathic pain. Recently Biogen Idec acquired the rights to develop Neublastin for all indications. This was always part of the plan for NsGene.

“For our license strategy we have proactively been looking for a partner that can explore the full potential of our pipeline opportunities, and this is also what has happened with Neublastin,” says Bent U. Frandsen, Vice President Business Development & Finance at NsGene.

The agreement on Neublastin with Biogen Idec obviously gave the company a financial lift that allows further activities in the time to come.

“The last couple of years have been tough for NsGene.

Like any other biotech company, it has suffered from the financial crisis and the reluctance on making investments at mid or long term. The fact is that it takes time to develop drugs – and it indeed is a costly business,” Bent U. Frandsen says.

Passing the barrier with local, direct, and controlled delivery

tem (CNS). It occurs along all capillaries and consists of tight junctions around the capillaries that do not exist in normal circulation. Endothelial cells restrict the diffusion of microscopic objects (e.g. bacteria) and large or hydrophilic molecules while allowing the diffusion of small hydrophobic molecules (O2, hormones, CO2). Cells of the barrier actively transport metabolic products such as glucose across the barrier with specific proteins. Hence the blood-brain barrier protects the CNS. Large molecules cannot cross the blood-brain barrier and access the CNS albeit there are potential benefits in some neurotrophic growth factors in neurodegenerative diseases of the CNS like Alzheimer’s. The EC Biodelivery™ platform bypasses the obstacles of passing the bloodbrain-barrier by allowing a direct and local delivery of substance into the brain through a catheter with a semi permeable membrane. Behind the membrane a cell line is genetically modified to deliver therapeutic substances in a controlled manner directly and locally into the affected part of the brain.

Perfect match

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This technology platform takes its starting point in the well-established neurosurgical procedure called stereotactic surgery. With this technique, the surgeon

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Lars Vahlberg, CEO Photo: NsGene A/S

can place probes or electrodes in precise areas of the brain using imaging and other three dimensional techniques.

MD, PhD, Executive Vice President & Chief Operating Officer at NsGene, Lars U. Wahlberg is the brain behind the technique as a specialist in neurosurgery. While working at Brown University in Providence, USA he and co-workers in the late 1980’s invented and patented fibers for direct and local drug delivery inside the brain.

“Since the time of the prototype of the technology, the device has undergone great refinement and adjustments,” Lars U. Wahlberg says.

He presented the technique at several scientific and partnering events in the mid 1990´s and he and Teit E. Johansen soon realized that they were both looking to find treatments of diseases in the CNS for which no options were available.

“I know how to discover relevant biological substances.

But it is really of no use to invent biological drugs for the treatment of neurodegenerative diseases, if we are unable to administer them appropriately for an effect in the brain. This is the main reason for our partnership, and we are in fact a perfect match,” Teit E. Johansen says.

first clinical trial. On the other hand, we have also suffered set-backs and disappointments from time to time.

However, they are often related to the biotech business and financial environment rather than a read out of your actual success as an R&D company,” he says.

Teit E. Johansen carries on: “You need loyal investors, enabling you to focus your energy on demonstrating progress on a continuous basis.”

Tether Semi-permeable hollow fiber membrane Genetically modified cells

Nutrients Proteins/medicin

Ups and downs According to the people at NsGene, it takes a certain kind of psychology to be in the biotech business.

“You have to roll with the punches,” Lars U. Wahlberg says with a smile.

Teit E. Johansen looks back at the past decade and concurs with his partner on this viewpoint: “I feel a tremendous joy to see our projects move forward. Surely, it was a great feeling finally starting our

54

More to come The track record of NsGene demonstrates the capability of discovering and delivering proteins with therapeutic potential in neurological diseases.

In the years to come, drug candidates for the treatment of Parkinson’s and Huntington’s diseases will move forward from animal models into humans using EC Biodelivery™. Furthermore a neuropeptide is being investigated for the treatment of epilepsy.

Teit E. Johansen is particularly proud of the fact that after the success of Neublastin, NsGene has invented yet another biological substance for the treatment of neuropathic pain.

“The mechanism of NsG33 is different from Neublastin, but the in vivo data look very promising. Considering the huge unmet need with patients, there is an enormous market potential,” Teit E. Johansen says and ends: “This means that NsGene is the originator of two of the most promising biological substances for the treatment of neuropathic pain. Admittedly, this brings a smile to my face.”

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Venue: Yokohama, Japan More information: www.jba.or.jp/english/bio/index.html

OCTOBER 2010 October 5 CPhI Worldwide 2010 This pharma event offers opportunities for buyers, manufacturers, suppliers and users to exchange ideas, form alliances and do business with over 25,000 of their industry peers.

Venue: Paris, France More information: www.cphi.com October 5 - 6 9th Annual BIO Investor Forum Bio Investor Forum is an international investor conference focused on private and emerging publich biotech companies.

The conference presents a broad view of investment opportunities as well as therapeutic workshops with latest information on pipeline innovation.

Venue: San Francisco, CA / USA More information: www.bio.org/investorforum October 10 – 12 BioPartnering Europe BioPartnering Europe (BPE) 2010 is looking to be one of the top business development meetings of the year. The people who are transforming pharma business today will be attending BPE and will be discussing strategies that could prove very valuable to you and your company.

Venue: London, UK More information: www.biopartnering.com October 6 - 7 BioContact Quebec Biopharmaceutical partnership symposium with company presentations from Canada, the US, Asia and Europe. The companies will be presenting in different sectors of activities (diagnostics, therapeutics and services) and disciplines such as cancer, cardiology, drug delivery systems, metabolism, genomics, immunology, medical technologies and others.

Venue: Quebec, Canada More information: www.biocontact.qc.ca

NOVEMBER 2010 November 15 – 17 BIO-Europe 2010 BIO-Europe is Europe’s largest partnering conference, serving the global biotechnology industry. The conference annually attracts leading dealmakers from biotech, pharma and finance along with exciting emerging companies.

Venue: Munich, Germany More information: www.ebdgroup.com/bioeurope

NOVEMBER 2010 November 15 - 17 Medica - World Forum of Medicine Medica is the world’s largest event for the medical sector. The international trade fair and congress deals with the entire range of inpatient and outpatient care as well as technical and medical innovations. Medica hosts exhibitors from about 70 countries and is the meeting point for medical experts from appx. 115 countries around the world.

Venue: Düsseldorf, Germany More information: www.medica.de November 15 – 17 NanoBioTech-Montreux This conference is at the frontiers of both micro- and nanotechnologies, with a special emphasis on biological, chemical and medical applications. The format includes plenary talks, lectures, presentations and an exhibition.

Venue: Montreux, Switzerland More information: www.nanotech-montreux.com

DECEMBER 2010 December 5 – 7 Regenerative Medicine & Stem Cell RMSC offers a platform for promoting international exchanges and strengthening cooperation in science and technology involved in regenerative medicine and stem cell.

Venue: Shanghi, China More information: www.bitlifesciences.com December 5 - 7 BioPartnering China 2010 BioPartnering China (BPC) is your opportunity to access the innovation and partnering opportunities represented in China’s rapidly-growing life science industry. BPC brings together the leaders of the Chinese life science industry to network with decision-makers from around the world.

Venue: Shanghai, China More information: www.biopartnering.com

December 28 – 30 International Conference on Nanotechnology and Biosensors 2010 ICNB 2010 aims to bring together researchers, scientists, engineers, and scholar students to exchange and share their experiences, new ideas, and research results about all aspects of Nanotechnology and Biosensors.

Venue: Hong Kong, China More information: www.icnb.org

JANUARY 2011 January 10 - 12 JP Morgan’s Healthcare Conference J.P. Morgan’s Healthcare Conference is the world’s largest annual life science investor conference. The conference features company presentations from both public and private companies over three days of simultaneous sessions. There will be several keynote luncheon presentations as well as lots of opportunities for individual meetings and networking.

Venue: San Francisco, USA More information: www.jpmorgan.com January 10 – 12 Biotech Showcase 2011 Biotech Showcase provides private and public life science companies the opportunity to present to an audience of investors and business development executives during the course of the largest annual healthcare investor conference.

Venue: San Francisco, USA More information: www.ebdgroup.com/bts January 19 - 21 International Medical Distributor Meeting IMDM is a leading international medical technology partnering conference, offering new collaborative opportunities to innovative medical technology providers and professional medical device distributors.

Venue: Budapest, Hungary More information: www.imdmeeting.org

FEBRUARY 2011 February 1 - 2 Conference on 6th Annual Drug Delivery Systems This Conference showcases the basics and latest developments for inhaled drugs, RNAi based therapies and protein and peptide methods. The interactive discussions ranges from drug delivery technologies to advancement and manufacturing of formulations.

Venue: London, UK More information: www.visiongain.com

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Upcoming Life Science Events EVENTS BY MEDICON VALLEY ALLIANCE October 5, 2010 Introductory Meeting to Medicon Valley Alliance Do you want to know more about Medicon Valley Alliance and our projects? Do you know how to make use of our international network? Do you know of all the opportunities we offer for sponsorships and news coverage? This meeting is open for members and non-members who want to know more about how to benefit from a membership of Medicon Valley Alliance.

Venue: Medicon Valley Alliance, Ørestad, Denmark Time: 15.00-18.00 More information: www.mva.org October 26, 2010 Meet the Ambassadors Day The Life Science Ambassador Programme invites companies and universities to attend 1-hour meetings with the Life Science Ambassadors from Japan, South Korea and Canada.

A personal meeting with a Life Science Ambassador is the best starting point for discussing specific research or business opportunities in Japan, South Korea or Canada. The meetings are free of charge.

Venue: Medicon Valley Alliance, Ørestad, Denmark Time: 15.00-18.00 More information: www.ambassadorprogramme.com

October 28, 2010 Annual Meeting 2010: Asia Ahead - Focusing on the Eastern Markets Get the latest information on the Asian markets and how to access them, while networking in a relaxed setting with key life science stakeholders in Medicon Valley. Medicon Valley Alliance’s Annual Meeting will address topics like key strongholds of Japan, South Korea, China and India, how to conduct clinical trials in Asia, and how to handle regulatory authorities in Asia.

Seats are limited and only for members of Medicon Valley Alliance.

Venue: Medicon Valley Alliance, Ørestad, Denmark Time: 14.00-19.30 More information: www.mva.org

For a complete overview of life science events and courses in Medicon Valley, please view www.mva.org/calendar

COM MITMENT

S I M P L I C I TY

We are inspired by technology and law. We are inspired by clients and associates.

We strive to inspire you.

We are committed to defending our clients’ interests.

We are committed to successful prosecution.

Our approach is thorough, yet prompt. We aim to keep things simple.

Copenhagen and Aarhus · www.inspicos.com · T +45 7070 2422

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www.faeno.dk 4454-0210

I N S P I R AT I O N

Expand your network:

Latest members of Medicon Valley Alliance Aproxi ApS www.aproxi.dk Aproxi focuses on improving the quality of dental composite restorations in general and contact area quality towards the adjacent tooth particularly.

The product family comprises of the Proxi Former (an anatomically shaped, prepolymerised insert available in various sizes to ensure the correct contact area), Proxi Inserter (a tool to deliver the Former in the surrounding composite filling), Proxi Sizer (to measure the size of Former needed) and Proxi Trainer (a clinically very realistic training system). Aproxi’s products are patented, CE certified and FDA approved.

Clinical Laserthermia Systems AB www.clinicallaser.se CLS has developed a system for lasermediated heat treatment of solid cancer tumours: Immunostimulating Laser Thermotherapy (ILT). The method gives an improved immune defence against treated and untreated tumour, reduced tumour growth and prolonged survival in experimental animals with liver cancer, as compared to surgical resection. The company has demonstrated corresponding results in patients with cancer. Thus, the method not only kills cancers in solid organs, it is much less traumatic for the patient than standard surgery and elicits an immunologic defence, which translates into an improved effect on the cancer disease. derma veris derma veris www.dermaveris.com derma veris is a Contract Research Organization focusing on dermatological product development for the pharmaceutical, herbal and cosmetic market.

The company manages a broad range of dermatological formulation principles combined with an extensive knowledge of documentation requirements. derma veris develops dermatological pharmaceuticals for preclinical and clinical testing and herbals and skin care products with a special emphasis on the guidelines of the EU directive, labeling and certificates. derma veris offers both laboratory requiring activities as well as consulting services.

Exova Metech A/S www.exovametech.dk Exova METECH A/S is a Danish company with 85 employees, which provides DANAK-accredited calibration and solu-

tions for metrological tasks specifically targeted towards the pharmaceutical area. The company is based in Taastrup and is therefore close to its customers in Medicon Valley. Exova METECH also provides hire of technical staff for calibration and other metrological tasks for shorter or longer periods of time.

Calibrations can be performed using Exova METECH’s measuring equipment and procedures, or using the customer’s own measuring equipment and instructions. Exova METECH is accredited for validation.

Grete Lundbeck European Brain Research Foundation www.thebrainprize.org The Grete Lundbeck European Brain Research Foundation is a Danish, charitable, non-profit organisation. The purpose of the Foundation is to promote interest in brain research and its results and to encourage and reward outstanding brain research. The Brain Prize - € 1 million - will be awarded for the first time in spring 2011 to one or more scientists who have distinguished themselves through outstanding contributions to European brain research and who are likely to remain active researchers for at least 10 more years.

Awards will be followed by an extensive outreach programme organised together with the major Danish universities.

IMS Health Danmark www.imshealth.com IMS is the world’s leading provider of consulting solutions and market intelligence to the pharmaceutical and healthcare industries. IMS helps to strengthen portfolios, optimize product launches, mount superior marketing efforts, forge more productive alliances and optimize sales force structure and deployment. The IMS Consulting and Services team includes thought leaders with expertise in industry issues, business processes, and therapies. With a presence in more than 100 countries and over 55 years of experience, IMS provides Evidence-Based Consulting with immediate client impact.

Inpac Pharma www.inpacpharma.com Inpac Pharma is the Nordic-focused CDMO with capabilities ranging from product development and pilot production to full scale commercial manufacturing and packaging. In addition,

the company provides expertise and capabilities in secondary packaging and distribution of both commercial products and products for clinical trials in cold-chain as well as in ambient environment. The goal of Inpac Pharma is to strengthen the customer’s competitive edge. The integration of expertise and production equipment enables Inpac Pharma to achieve this goal, driven by precision, passion and creativity.

JGConsult www.JGConsult.dk JGConsult is a Contract Research Organization specialised in the statistical analysis of clinical trials in compliance with regulatory guidelines and standards. JGConsult produces statistical analysis reports comprising userfriendly end-of-text material easily included in clinical study reports while maintaining full traceability to source data. The JGConsult SOP System has been audited by clients. JGConsult represents more than 20 years of biostatistical experience within the pharmaceutical and device industry.

Medpace Sweden AB www.medpace.com Medpace is a global full-service research organization providing Phase I-IV core development services for drug, biologic, and device programs. With Medical and regulatory expertise in multiple therapeutic specialties, Medpace has assembled much industry experience and therapeutically focused teams to execute at every level of the company operation, thus providing multiple drug development services.

CLAUSON-KAAS AS

Niels Clauson-Kaas A/S www.clauson-kaas.dk NCK was founded in 1956 to conduct research and development in synthetic organic chemistry on a contract basis.

NCK has worked for more than 170 customers world-wide. Most of the products which NCK develop are APIs for pre-clinical or clinical studies and are produced in accordance with cGMP. NCK routinely develops and validates analytical methods for release testing of APIs. Focus on timely delivery, quality and communication.

CHEMICAL RESEARCH LABORATORY www.clauson-kaas.com

OrgCRO Medchem & Science AB www.orgcro.se OrgCRO is a service company in the field of organic and medicinal chem-

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Expand your network:

Latest members of Medicon Valley Alliance istry with experienced scientists and access to fully equipped laboratories.

The company offers efficient service in scale-up, synthetic methodology, and library synthesis for medicinal chemistry projects. OrgCRO scientists can translate scientific documents to and from German, French, English, Swedish, and Chinese. Furthermore, OrgCRO can provide its expertise as a consultant for each customer according to their specific needs.

Pharmacosmos CRO A/S www.Pharmacosmos-CRO.com Pharmacosmos CRO is a development CRO supporting the development needs of European biotech and pharma companies by offering access to optimised, global development services. The CRO is a spin-off from Pharmacosmos, a Danish-based specialty pharma com-

pany with products in over 50 countries globally. Pharmacosmos has established an efficient development model based on an internal core group of development experts supported by a global partner network, which has resulted in faster and more efficient development.

This proven development model is now being offered through Pharmacosmos CRO. SYSteam Malmö AB www.systeam.se SYSteam is a turnkey-solution IT supplier with a leading position among IT consultant companies in the Nordic region.

Their business concept is to “actively support the customer’s business development using effective information systems”. They have extensive knowledge of customer’s operations and an overall view of information systems and information technology. Their work method is

result-oriented with long-term, active cooperation with their customers. They follow their customers throughout the entire business process.

Valea AB www.valea.se Valea AB is one of Europe’s leading consulting agencies within the field of intellectual property law. Valea’s staff of approximately 90 employees includes authorised European patent attorneys, trademark attorneys, design attorneys and lawyers. Valea’s consultants combine specialist knowledge in patents and law with specific proficiency in all technical fields and a sound business understanding of both the short and long term commercial value of IP for its clients.

View the 300 members of Medicon Valley Alliance at: www.mediconvalleyonline.com

S T O C K H O L M

O S L O

C O P E N H A G E N

H E L S I N K I

Are you looking for the right expertise to manage your clinical study in the Nordic region?

Stop looking – we are here!      clinical research organisation with offices in all Nordic countries. Our experienced and dedicated staff manages clinical studies in all development phases and covers a wide range of therapeutic areas. We offer in-depth knowledge of clinical development and management of all aspects of clinical research including:

project management, monitoring, medical writing, applications to authorities, data management, data processing, statistics and pharmacovigilance.

We look forward to assist you in managing your clinical study, please contact us to schedule an individual meeting.

Sweden: +46 58 8 791 66 40 · Norway: +47 90 14 02 93 · Denmark: +45 45 79 01 02 · Finland: +358 9 8520 2700 · info@irwcro.com · www.irwcro.com

Looking for Exposure?

Medicon Valley Alliance and RASKmedia cooperate to publish the magazine LifeSciences Insight.

LifeSciences Insight will be the primary mouthpiece for the Medicon Valley region’s many companies and organisations within biotech, medtech and pharma as well as companies who have this segment as their customers or suppliers.

A STRONG TEAM LifeSciences Insight is a high-quality magazine that weighs validity and thoroughness highly. Therefore, we have joined forces with a strong group of people. Life science journalists Lone Frank (DK) and Fredrik Hedlund (SE) will take turns writing a column for the magazine. Lone Frank is also a part of LifeScienses Insight editorial team. The exclusive and close cooperation with Medicon Valley Alliance ensures that LifeSciences Insight constantly has an in-depth knowledge of the life sciences industry and the latest trends and conditions in the market.

DISTRIBUTION In addition to interesting and updated articles about the conditions of the industry, LifeSciences Insight gives companies in the region a unique opportunity to brand themselves both nationally and internationally. With its thoroughly selected distribution network, LifeSciences Insight is the ultimate and optimum opportunity to present one’s company.

LifeSciences Insight is distributed in Denmark and Sweden to: • • • • •

Named decision-makers in the life sciences industry Investors Science parks Hospitals Universities

• Relevant MPs in Scandinavia • Medicon Valley Alliance’s members and collaboration partners • Relevant national and international trade fairs, conferences and exhibitions in Europe, North America and Asia

• Life science media

There will be at least four editions a year, in total 60,000 copies. LifeSciences Insight gives its readers a thorough knowledge of and an updated insight into the industry and the conditions the industry is facing right now.

No 1 - July 2010

The Magazine

about Life and

Science in Medi

con Valley

LifeSciences

CONTACT/SALES

Insight

Would you like to know more?

Please contact: Sales Manager Mads Elgstrøm E-mail: mel@raskmedia.com Direct phone: +45 2887 0776 Cell phone: +45 3171 4597 08: CLINICAL UNDER PRESRESEARCH SURE 17: The saga of Victoza

www.RASKmedia.com Denmark

Sweden

Norway

Finland

USA

Germany

30: South Kore fast on life scie a moving nces

38: Focus on HR in Medicon Valle y

Biotech Companies

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We have received a new shipment of Werkswagen cars from the star dome in Stuttgart. We’ll be the first to admit these are not cars for everyone. But then again, the finer things in life rarely are. In case you’ve been too busy to be familiar with the Werkswagen concept, here’s the executive summary: Werkswagen cars are used company cars, driven by the top level management of the Daimler corporation. These cars leave nothing to be desired in terms of equipment, yet they have only been in use for a very short time.

Vejle tlf. 7211 6000 Hørsholm tlf. 4516 5959 Ishøj tlf. 4012 8918 Aalborg tlf. 7211 5200

A Werkswagen car comes with a complete service history, and it’s been tended to by staff from the factory. Also, these cars are rare models, where the first, large write-off is already accounted for. However, they are also sold by Starmark. So we’ve given them an overhaul of our own as well. Just to make sure they’re as immaculate as you’d expect them to be.

See the available cars on www.starmark.dk, or swing by the dealership nearest to you.

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An executive privilege