LifeSciences Insight no 2 - 2012

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20: ESS wILL booSt futurE r&D IN mEDIcoN vaLLEy

3: Give inventions back to the inventors

24: IPR – potential and pitfalls

42: New vaccine construct opens up exciting new vistas

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the magazine about Life and Science in medicon valley

Raw materials. Service. Expertise.The fine art of pharmaceutical composition.It takes outstanding raw materials and great skills to create something unique. Which is what Merck Millipore does for you: by striking the balance between innovation and supply chain security, with services like EMPROVE® and extensive regulatory support. It’s how we find solutions together with you that contribute to the big picture: your success.

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BIOTECH & MEDTECHBUSINESS PLAN COMPETITION

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26: FORTY YEARS WITH STEM CELLS

– AND STILL GOING STRONG 14: Proposals for what the

EU presidency can achieve 32: She is 43, lawyer

with a taste for adventure36: Research beacons

under construction

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The Magazine about Life and Science in Medicon Valley

Photo: Bioneer A/SMedicon Valley Alliance and RASK Media 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 TeamLifeSciences Insight is a high-quality magazine that weights 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, the latest trends and conditions in the market.

DistributionIn 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, Sweeden and Norway to:

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.

Looking for Exposure?

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• Named decision-makers in the life sciences industry• Investors• Science parks• Hospitals• Universities• Life science media

• 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

Would you like to know more?

Please contact: RASK Media Sales Department Phone: +45 28 87 07 76 E-mail: [email protected] www.raskmedia.com

10: She iS inveSting 1,4 billion in biotech ‒ Meet Mette KirStine Agger

7: Research and business highlights from Medicon Valley

20: Targeted medicine - how far have we come?

28: How to out-source clinical trials

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12 the Magazine about life and Science in Medicon valley

ContentsThe column 3- One step back and two steps forwards

Highlights from Medicon Valley 4

Spot on a New Technology 6The wonders of combining chemotherapy with electricity

Portrait Mette Kirstine Agger 10She’s been called a leading light within biotech and is said to write so fast on her keyboard that it sounds like a machine gun. Meet Mette Kirstine Agger.

Business profiles 16We take a closer look at CLS Communication and Bioneer

Theme: uncovering the secret of life 20Scientists are struggling to understand the human heritage. How far have they come and what can we do with it?

Pharmacogenomics 22

Scandinavian genome projects 25

Consumer Genetics 26

Guide 28How to deal with legal issues when outsourcing clinical trials

The Baton 30Hospital Medical Director Jannik Hilsted on Life science in the Øresund Region - Fact of Fiction?

Hidden gold in the science parks 32Medicon Village is booming

New Members of Medicon Valley Alliance 34

Upcoming Events by Medicon Valley Alliance 35

LifeSciences Insightno. 2 - 2012

LifeSciences Insight is distributed in Denmark and

Sweden to:

• Named decision-makers in the life science industry

• Investors

• Science parks

• Hospitals

• Universities

• Life science media

• Relevant MPs in Scandinavia

• Medicon Valley Alliance’s members and

• collaboration partners

In addition, the magazine is available at relevant

exhibitions and fairs in Europe, North America and

Asia.

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Editor in chief: Malene Aadal Bo

Editors: Lone Frank, Carsten Elgstrøm

Editorial team: Mikkel Ais Andersen, Claus Clausen,

Fredrik Hedlund, Jannik Hilsted, Kristian Holte, Jannie

Schjødt Kold, Charlotte Strøm, Linda Viberg

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Fredrik Hedlund is a medical journalist with qualifications as both a pharmacist from Uppsala University and as a journalist from Stockholm University.

After having been editor-in-chief of the journal Läkemedelsvärlden and medical reporter for Sweden’s leading daily, Dagens Nyheter, he is now a freelance based in Malmö. He contributes regularly to journals such as Läkartidningen, Tandläkartidningen, Medicinsk Vetenskap, Läkemedelsvärlden and Life Science Insight.

By Fredrik Hedlund

AstraVeneca’s decision to close its research facility in Södertälje, Sweden, is a heavy blow for neuroscience research throughout Scandinavia. However, it may also mean the emergence of a brand new research model and increased political interest in life science.

In early-February, Astrazeneca announced that they would close down all neuroscience research operations in Södertälje, just south of Stockholm, Sweden. It is to be replaced by a ‘virtual research team’ in the USA and the UK, consisting of 40-50 researchers, compared with the 1,100-1,200 jobs disappearing from Södertälje.

This is naturally a death blow for Swedish and Scandinavian research in the field of neuroscience. However, it has also kick-started political interest in the innovative life science field.

Wake-up call for the politiciansJust two weeks after Astrazeneca’s announcement, the Swedish Minister for Enterprise, Annie Lööf, presented a three-year financial initiative worth SEK 100 million for life science incubators. This means fresh new money to finance life science start-ups.

A few weeks later a new injection of money was presented by Annie Lööf, worth SEK 31 million over three years for which small and medium-sized innovative companies can apply to start the development of specific innovative work.

In early-April The Swedish Minister for Education, Jan Björklund, presented the Sweden Science for Life Laboratory, which will be a world-leading research institute with an estimated annual turnover of SEK 1 billion. It will focus on genetic research to map the structure and effects of proteins in the human body. The main financiers, in addition to the State, are the Knut and Alice Wallenberg Foundation and Astrazeneca itself.

It is clear that the issue of support for innovative companies is very high on the political agenda at present, and this is very good news. Even though the initiatives so far have been somewhat Stockholm-oriented, I believe that the most important thing is that the issue of the innovation climate in the field of life science has seriously come to the attention of the most senior politicians. This will make it so much easier to increase interest in the Øresund region.

A new research model is taking shapeAstrazeneca’s new strategy to switch to a small ‘virtual research team’ should not be seen as a retreat in the field of neuroscience. Instead it is the clearest example to date of how Big Pharma is reorganising its research in the future.

The biggest problem for pharmaceutical companies in the past five to ten years has been that they have produced far too few new pharmaceuticals. I believe that Astrazeneca’s closure is a clear signal that the companies’ large, heavy internal research departments are on the way out. The pharmaceutical companies are instead building a new organisation with a small research management organisation which will outsource research to independent research companies and academic researchers.

For example, companies such as Sanofi, Pfizer, and also the Danish company Lundbeck have recently reduced the size of their R&D organisations to achieve “greater flexibility in the use of external and internal capabilities”, as they put it. Without doubt, this will create a new, more dynamic market for life science companies that are able to sell entire research projects and conduct advanced contract research with the big companies.

Brighter days aheadThere are other signs that the life

science sector is moving towards brighter days. A survey of 150 small and large companies in the health care sector conducted recently by the Swedish Trade Council shows that nearly 40% of the companies surveyed expect increases in exports of over 50% in the next three years. The same optimism can also be seen on the Swedish stock market, where 17 life science companies were listed in April this year or are planning to be listed in 2012. Throughout 2011, only ten life science companies entered the stock exchange.

Therefore, even though Astrazeneca’s decision to close darkened the skies of neuroscience research in the spring, and the researchers in Södertälje who have been given their notice probably see things differently at present, I think that we can say that developments still seem to have taken one step backwards and two steps forwards.

One step backwards and two steps forwards

Translation: CLS Communication A/S

Technology news

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Highlights from Medicon Valley

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Danish researchers to sew new tissue out of nanofibreTissue such as nerve cells and the tissue in women’s wombs is difficult to regenerate once it has been destroyed. A new Danish research project being carried out in cooperation between Coloplast and the iNano research centre at Aarhus University will study how the structure in the electrospun nanofibre can be used. “The structure of electrospun nanofibre resembles that of tissue, so we want to find out if our nanofibre can imitate the physical tissue. Once we know that, we will expand the process by adding bioactive drugs such as medicine or active growth substances such as stem cells or proteins,” says Menglin Chen, a postdoctoral researcher at iNano.

Initially, the project will focus on the structure of pelvic tissues. The paper-like substance which is a result of electrospinning, could be inserted through a simple surgical incision. The nanofibres would then disappear as the new tissue forms or the medicine is released. Source: Ingeniøren.dk

New stem cell found in the brainResearchers at Lund University have found a new stem cell in the adult brain. The results show that these cells can propagate and create several different cell types. But even more important is the fact that they can create new brain cells. Researchers are now hoping to be able to make use of these findings to develop methods that can remedy disease and repair damage in the brain.

The newly-discovered cell is located around the small blood vessels in the brain. A similar cell type has previously been identified in several other organs where it gives rise to the reconstruction of muscles, bone, cartilage and fatty tissue. By analysing brain tissue from biopsies and brain sections, the researchers have now found a brain stem cell for the first time.

“Our findings have shown over time that the capacity of the cells is much higher than we first thought. These cells are extremely versatile. It is most interesting that they have the ability to create nerve cells and yet can also develop into other cell types,” says Gesine Paul-Visse, one of the authors of the study.

The report “The Adult Human Brain Harbors Multipotent Perivascular Mesenchymal Stem Cells” has been published in the journal PLoS ONE. Source: www.med.lu.se

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Breakthrough in Humidity Monitoring Monitoring humidity in connection with controlled room temperature monitoring is becoming a new focus area in of the pharmaceutical industry and EU regulators, particularly on sea freight transports and in small storage facilities. ELPRO is ready with a new and handy concept for producing the necessary reports. It is called Libero PDF Logger and unifies secure cold chain monitoring with the advantages of Adobe’s PDF file format, thus removing the need to install and qualify specific software at destination. LIBERO automatically evaluates alarm criteria and creates a PDF/A report as soon as it is plugged into the USB port of any PC. It is designed for measuring and recording relative humidity from 10% to 100% RH and temperatures from -25°C to +70°CRead more on www.pdf-datalogger.com

Protein researchers unravel the molecular dance of DNA repairScientists at the Novo Nordisk Foundation Center for Protein Research at the University of Copenhagen and their international collaborators have successfully obtained so-called molecular snapshots of tens of thousands of the processes involved in DNA damage repair. The results of this study will help unravel exactly how cells repair their broken DNA, how chemotherapy affects cells’ workings and will assist in the discovery of new drugs with fewer side effects.

“DNA repair is vital in keeping cells healthy. So unravelling the molecular details of how a cell communicates when its DNA is broken will help us understand how cells protect their genomes,” says Associate Professor Chunaram Choudhary from the Novo Nordisk Foundation Center for Protein Research. He believes that identification of proteins which are crucial for repairing broken DNA may help find new drug targets, and by using such very specific drugs it may also be possible

to minimise the side effects which occur when a drug hits too broadly in the body. The team first damaged the DNA of cells using radiation or chemical drugs and then used a technique called mass

spectrometry, which is a way of precisely determining the identity of proteins and their chemical modifications. This allowed them to follow thousands of protein modifications that took place in the process of DNA repair. Read more here: www.cell.com/molecular-cellSource: Novo Nordisk Foundation Center for Protein Research

New LEO Pharma chemical entity is approvedEvery year, only 20-25 new chemical entities, or active substances, are approved by the US Food and Drug Administration. Now the Danish pharmaceuticals company LEO Pharma has been added to the exclusive list of approved New Chemical Entities (NCE).

The entity that now has FDA approval is called ingenol mebutat. After 13 years of researching and developing ingenol mebutat – first by the Australian-American biotech company Peplin Inc., and then by LEO Pharma – LEO Pharma has now finished developing the medicine Picato® gel. In the US, the product has been approved for treating solar keratosis (also called actinic keratosis), which can develop into skin cancer. Source: Leo Pharma

Copenhagen University Hospital behind new test for testicular cancerNow doctors in countries near Denmark can benefit from a test developed by researchers at Copenhagen University Hospital. They have worked out a way of identifying the precursor cells for testicular cancer in a sperm sample and have automated the process. This renders biopsies – which require an operation –unnecessary.

With support from the Danish National Advanced Technology Foundation, Copenhagen University Hospital has joined forces with Visiopharm, among others, to develop an automated process that replaces the existing labour-intensive process involving studying sperm samples to find precursor cells. The sperm sample is dyed immuncytologically to make the precursor cells visible. Microscopic scanners are then used to scan the sperm samples into a large photo file, after which the photo files are checked via a computer and a special algorithm. Kristian Almstrup, senior researcher from the Department of Growth and Reproduction at Copenhagen University Hospital, believes Copenhagen University Hospital will be able to sell the test to other hospitals in Europe once they have completed the beta tests, which are currently under way in countries neighbouring on Denmark. Source: Rigshospitalet.dk


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By Charlotte Strøm, MD, PhD, Journalist

What is it?In the search for new and alternative methods for the treatment of the early stages of bladder cancer, urologists are looking to combine new and old therapies. Electromotive drug administration (EMDA) combines anti-cancer drugs with electricity which the drug effect is hypothetically enhanced.

Juan Luis Vasquez, MD and PhD student at the Uro-oncology Research Unit, Copenhagen University Hospital – Frederiksberg, explains:

“The standard treatment for early -stage bladder cancer has been endoscopic surgical resection, sometimes followed by the administration of anti-cancer drugs directly into the bladder. In vitro studies suggest that the addition of low voltage electricity enhances the effect of drugs in the deeper layers of the bladder, and keeps the drugs present for a longer duration.”

What can it do?A clinical study has shown reduced risk of bladder cancer recurrence after EMDA therapy. The method is currently being experimentally tested in patients who are incapable

due to comorbidities or unwilling to have their bladder removed due to cancer, and the aim is to test if the surgeons can make it work. The effect is evaluated through analysis of tumour biopsies for pharmacodynamic (tissue reaction, cell death, proliferation) and pharmacokinetic parameters.

The urologists are collaborating with Consultant Oncologist Julie Gehl from the Department of Oncology, Copenhagen University Hospital – Herlev, pathologists from Copenhagen University Hospital – Bispebjerg and experts at the Technical University of Denmark.

“From tumour biopsies we are able to determine how deep the drugs have travelled into the deeper layers of the bladder, and the effect on the tissue is also evaluated,” Juan Luis Vasquez explains.

So far five patients have been treated. One patient has had recurrence of bladder cancer. “While we work on improving the method, our aim is to be able to offer improved treatment to the large group of patients who suffer from early-stage bladder cancer,” Juan Luis Vasquez says.

Why use the method?Early stage bladder cancers account for 25 per cent of the resources in a Danish urology department with 10,000 cystoscopic operations under general anaesthesia and 20,000 control examinations a year in Denmark.

“There is a considerable need for improved treatment of early-stage bladder cancer, as we currently only have limited treatment options. For a majority of the patients all we do is keep a close eye on them, and doing that is laborious, costly and has a huge impact on patients’ quality of life,” says Gregers G. Hermann, Head of the Uro-oncology Research Unit and Consultant Urologist at Copenhagen University Hospital – Frederiksberg.

He calls attention to recently published data from the Danish Bladder Cancer Registry: “The progression rate of some of these early stage bladder cancers, which we once considered relatively harmless, is up to 30 per cent. This lowers the five-year-survival rate in patients with bladder cancers that are not invading the bladder muscle to between 55-69 per cent.”

He has taken the initiative to introduce EMDA at the Department of Urology at Copenhagen University Hospital

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Get to know a completely new type of real-time PCR instrument at:www.lightcycler-nano.com

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spot on a new technologyelectromotive drug administration(EMDA) Danish urologists and oncologists are combining chemotherapy with electricity in order to find new and improved methods for the treatment of bladder cancer. The research team is now looking for development partners.

In vitro studies suggest that the addition of low voltage

electricity enhances the effect of drugs in the deeper layers

of the bladder, and keeps the drugs present for a longer

duration.

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– Frederiksberg as the first place to offer the treatment in Denmark.

What happens now?Bladder cancer is among the five most frequently occurring cancers in Denmark with 1,700 new cases each year. For years the treatment of bladder cancer has moved very little, leaving surgeons treating these patients in frustration. Irrigation of the bladder with BCG immunotherapy is the standard of care for high-grade, non-invasive bladder tumours and has been shown to have a positive effect on recurrence and perhaps also on progression.

Intravesical chemotherapy with various drugs has consistently demonstrated reduction in short-term tumour recurrence rates but no impact on disease progression. The efficacy of intravesical treatments using chemotherapy drugs is limited because the drugs do not penetrate the deeper layers of the bladder wall and because the effects wear off within two years.

“If we can improve the treatment for this group of patients we can truly make a difference. That’s why this method is very interesting,” Gregers Hermann says.

The surgeons and researchers who are working with EMDA at the Department of Urology at Copenhagen University Hospital – Frederiksberg have a number of items on their wish list, including an improved catheter for drug administration in the bladder, innovative electric

equipment for improving the application of electricity to the bladder and analytic models for estimating the penetration of drugs into tissue.

“We know about diagnosing and treating the patients and that is our expertise. Our shortcomings as physicians are all the other disciplines that this treatment concept involves. Therefore we would like to join forces with experts who know about working with electricity, pharmaceutical companies and medtech companies who are willing to co-develop this treatment concept with us,” concludes Gregers Hermann.

Get to know a completely new type of real-time PCR instrument at:www.lightcycler-nano.com

Roche Diagnostics A/SRoche Applied Science2650 Hvidovre, Denmark

© 2012 Roche Diagnostics. All rights reserved.LIGHTCYCLER is a trademark of Roche.

For life science research only.Not for use in diagnostic procedures.

Size: Reduced. Fun: Amplified.

About Electromotive Drug Administration• First introduced by an Italian urologist, Savino M.

Di Stasi, in the late 90s• EMDA is based on iontophoresis, which is the

accelerated transport of ions (into tissues) by means of an electrical current passed through a solution containing the ions

• The method appears to improve the efficacy of Mitomycin C

• Easy procedure to perform• Outpatient procedure with minor side effects• Could be a treatment option for patients needing

removal of the bladder but who are not fit for it

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The value of Nordic biotech has tripled in 12 yearsNordic biotech companies have more than tripled in value since 2000. And since 2005, the value of the Nordic companies has risen from DKK 13.5 billion to DKK 32 billion. This is what Henrik Ernø, Director, Corporate Finance at Danske Bank writes in a comment in the magazine Dansk Biotek.

His conclusion is that the industry is mature, and measured on how far the company has come with clinical trials, progress has been made. In 2005, 16 pharmaceuticals were under development in phases II and II, while there are currently 30 pharmaceuticals from listed companies in the same phases. But that is not the whole story, and there is no time to relax, according to Henrik Ernø:

“As a capital-intensive industry, biotech competes with other investment opportunities. That’s why biotech companies in the Nordic countries must increase their returns to attract capital. The first element of this involves an exit strategy.”

According to Henrik Ernø, there are two possible exit strategies – either a stock exchange listing or sale, and as the first option is often reserved for very mature companies, small biotech companies must often resort to selling, and this is where the Nordic countries lag behind the rest of western Europe. Source: Dansk Biotek

Super grants attract top researchersThe establishment of two extraordinarily large and extraordinarily long-term grants totalling DKK 40 million is sure to make some of the best foreign researchers notice Denmark. The DKK 40 million, which is to be distributed over seven years, will go to heads of research working with biomedicine and biotechnology. One of the conditions for receiving a grant is that you work outside Denmark. Other than that, there are no requirements concerning nationality, so a Dane employed abroad can also apply for the two grants, which are called Novo Nordisk Foundation Laureate Research Grants.

“The purpose of the grants is to strengthen internationalisation of biomedical and biotech research at Danish universities, so Denmark can seriously stand out as a research beacon on the international horizon,” says Birgitte Nauntofte, Director, Novo Nordisk Foundation. www.novonordiskfonden.dk

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New national research institute to be established in Sweden in 2013 The Knut and Alice Wallenberg Foundation and AstraZeneca announced today that they will be making sizeable financial contributions to the new Swedish national research institute that is to be established in 2013 – Sweden Science for Life Laboratory (SciLifeLab). The project is currently a partnership project between four universities (Uppsala University, Stockholm University, Karolinska Institutet and the Royal Institute of Technology). These four universities will be the main stakeholders in the new institute. The plan is for SciLifeLab to have sales of around SEK 1 billion per annum within a few years. From 2013, SciLifeLab will be developed into a national research institute for life science.

“The research concerns our major future issues and crosses borders in many ways. It’s about diseases and health, the development of both healthcare and new pharmaceuticals, resistance to antibiotics, the environment and energy,” says Eva Åkesson, Vice-chancellor of Uppsala University. See more at www.uu.se

Accelerace Bio is a successThe Accelerace model proved its worth long ago as a good and efficient tool for helping to get entrepreneurs up and running. But the development of viable life science companies poses special demands, so when the COBIS science park launched the “Accelerace Bio” project with a number of players in 2010, success was by no means guaranteed.

“These types of companies and projects make very special demands on the team, the technology and the road to commercialisation, so we were very excited to see if the model could also be applied to biotech,” says Morten Mølgaard Jensen, CEO at COBIS.

Now, almost two years later, he can announce that the project has outperformed all expectations. Accelerace Bio has spread from the capital city and is now a national phenomenon, successfully helping to establish no fewer than eight new biotech companies. “Accelerace Bio offers a unique dash of specific operational experience combined with training in the entrepreneurial way where hands-on work is core, and where COBIS supports business development in a broad sense. And it seems to work,” says Morten Mølgaard Jensen. Read more at www.cobis.dk or www.acceleracebio.dk

Biotech director: Biotech companies need to focus more clearlyThe Nordic biotech industry needs to relinquish thoughts of taking a drug the whole way from concept to market, and instead focus on individual development phases. This announcement comes from Stig Jørgensen, CEO of the Medicon Valley Alliance life science cluster. He wants people to think about funding and development in a new way.

He believes the industry should be divided up into many smaller companies that can focus on different phases of development and work on several projects at a time, but over a shorter period.

“The project might start in a company specialising in taking research from a very early stage to the point where it is clear that it has the potential to become a drug. When that has been achieved, it could be sold to another company with expertise in aspects related to the preclinical phase, and so on,” says Stig Jørgensen.

This would make it easier for investors to see an exit date for their investments, which would attract more investors and thereby open up the opportunity for individual companies to work on several projects at the same time. Source: Medwatch

Patent case could spell disaster for tailor-made medicineThe US Supreme Court has decided to overrule a patent granted to Prometheus Laboratories in 1998. As a consequence, Susanne Høiberg, CEO and partner at the Høiberg patent office, now fears it could be very difficult to obtain a patent for diagnostic methods in the vast American market. Many patent experts expected Prometheus to win the case or that the verdict would be formulated in such narrow terms that it could not be used for setting a precedence in other cases. But this was not the case.

The US Biotechnology Industry Organization (BIO) is concerned about the verdict, and Susanne Høiberg believes, at worst, the decision could make it very difficult to obtain patents for diagnostic tools. The Prometheus patent claim for the diagnostic tool contains three premises: The first is that it is a drug, the second that it measures the level of metabolites, which are products that degrade in the body, and third that you mentally process the measured level and can then change your actions.

“We have previously been informed that the claim would be considered as a whole. When you consider the Prometheus patent claim, it is right that one aspect can be said to be a natural phenomenon, but as it is incorporated in a context, it should be eligible for a patent. The Supreme Court believes the other part of the patent was known beforehand, and therefore the only new element is the natural phenomenon, and therefore Prometheus cannot patent it,” explains Susanne Høiberg.

The problem for the biotech industry is that developing an understanding of these aspects is expensive and if it turns out that this type of processing is as a rule ultimately classified as a natural phenomenon, then diagnostic companies cannot patent their tools.

“This will hit everyone because it will affect US patenting. It will also make the US a less interesting market,” she says. Source: Ingeniøren.dk


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By Jannie Schjødt Kold Photo: Jeppe Carlsen The white property that looks like a regular house nestled in the embassy district north of Copenhagen is home to Lundbeckfond Ventures, the investment branch of the Lundbeck Foundation. I am met in the hall by the tall, smartly dressed 47-year-old CEO. She apologises for the mess, which turns out to be a simple suede jacket, which she resolutely removes from the coat hook to make room for my coat.

Here in Mette Kirstine Agger’s office with its view of the garden and a toy motorbike on the window sill from when her sons were little, she and her team of two – soon to be three – employees distribute and manage the DKK 1.4 billion that Lundbeckfond Ventures will be investing in biotech over the next three years.

For Mette Kirstine Agger, who has worked in the biotech sector both in a patent office and as an entrepreneur, investing money rather than raising the capital herself is like sitting on the other side of the desk. “I like seeing things from another angle and learning something new. The investments we are making in high-risk biotech are in an entirely new field and we’ll be following them for some years,” she says, offering me a Nespresso at her small round coffee table. An obvious medical needThe investments she is talking about involve DKK 1.4 billion, which the venture fund has announced it will invest before the end of 2014.

“The Lundbeck Foundation decided to invest specifically in life science because we can see this area is really taking off at the moment. And because there are relatively few major investors,” says Mette Kirstine Agger.

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“I believe anything’s possible” She’s been called a leading light within biotech and is said to write so fast on her keyboard that it sounds like a machine gun. For Mette Kirstine Agger, CEO of Lundbeckfond Ventures, which is currently investing DKK 1.4 billion in high-risk biotech, it all began with a love of animals.

Before making an investment, the venture fund requires that the projects meet an ‘obvious medical need’.

Mette is a fast talker and her favourite subject is the investment fund and all the professional issues that have always interested her. Once in a while, an English word slips in among the Danish, and when we touch on the matter of products in the pipeline, she is enthusiastic. For example, the venture fund has already invested in the biotech company Celladon, which is using gene therapy to try to help patients with serious heart defects.

“We aim for quality regarding the product concept, the

The project must be well documented, and the product must make a difference and have clear commercial potential

“

12 Sweden: +46 8 791 66 40 · Denmark: +45 45 79 01 02 · Norway: +47 90 14 02 93 · Finland: +358 9 8520 2700 · [email protected] · www.irwcro.com

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12

ABouT METTE KIrsTInE AggEr

Mette Kirstine Agger (b. 1964), graduated as a biologist from the University of Copenhagen.

She was employed in the Plougmann and Vingtoft patent office, took an MBA and joined NeuroSearch

in 1995. In 2000, she helped found the biotech company 7TM Pharma – an achievement that earned her

the title of biotech entrepreneur of the year in 2006.

In 2009, she was offered the position of leading partner in Lundbeckfond Ventures, which works with

biotech investments. Mette Kirstine Agger participates in several Boards of Directors and is a member

of VL Groups – The Danish Top Executive Network.

She is married to Carsten Agger, and they have two children aged 19 and 14.

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

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Are you looking for the right expertise to manage your clinical study in the Nordic region? Stop looking – we are here!

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sation with offices in all Nordic countries. Our

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project management, monitoring, medical writing,

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We look forward to assist you in managing your

clinical study, please contact us to schedule an

individual meeting.

project must be well documented, and the product must make a difference and have clear commercial potential,” she explains.

In other words, Mette Kirstine Agger is also saying that the projects which will be considered are relatively far along in the development phase. The selection work carried out by the CEO and her team in the house in Hellerup involves sitting through a lot of project presentations. And she is not shy of issuing a challenge:

“We see a lot of presentations that are carried by very high levels of scientific enthusiasm. But they are also too technical and too academic, and don’t really present a clear plan for execution or funding,” she says, then smiles. She recognises the scientific enthusiasm as a trait she shares. From geese to tropical diseases Mette Kirstine Agger grew up as the eldest of three sisters in her family home in Klampenborg. Her mother was a teacher and her father a hospital doctor.

“It was a home with a piano,” she says, “and we were encouraged to do our best.”

Even as a young girl, Mette was fascinated by animals. Not only as pets to fuss over but also as research subjects.

“I was interested in animal behaviour and evolution from an early age and thought I would become a behavioural biologist.”

So halfway through completing her biology courses at the University of Copenhagen, she went to Scotland and England as a volunteer, observing the behaviour of ducks and geese.

“There I sat, aged twenty, staring at ducks that were older than I was,” she laughs about the ambitious project that followed the birds over many years.

She realised that animal behaviour would not keep her captivated. So instead she specialised in immunology and parasitology and supplemented her studies with a trip to Tanzania with a Danida-funded training project on immunology and tropical diseases.

When she came home, she wrote her one and only real job application to date. To the Plougmann and Vingtoft patent office, which snapped her up. The transformation from biologist to business woman had begun.

It was easier with my second child than it was with my first when I went back to work ten days after giving birth

“

14

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“I guess I have a flair for pursuing what I want. While studying, for example, I applied for a job at Denmarks Aquarium, which I didn’t get, but I kept bothering them until I got a student job working with visiting schoolchildren,” she says.

Her first job was a milestone combination of research and business – with a focus on the biotech world. And at Plougmann and Vingtoft she also learned something else that is essential about entrepreneurship. “What I brought with me from my time with Ole Plougmann was the belief that anything is possible. Something I probably also picked up at home, where everyone always had faith in me,” she says. The meeting with the legal and commercial mindset of the patent world prompted the result-oriented Agger to take an MBA. Along the way, she changed position and became head of Business Development at Asger Aamund’s company NeuroSearch, which at the time was the leading biotech company in Denmark.

Doesn’t watch the clockAfter five years, Mette Kirstine Agger found herself in a career dilemma, as professor Thue W. Schwartz invited her to join him and start up a biotech company called 7TM Pharma.

“I had my doubts. The children were still young and I still hadn’t finished my MBA, and there are only so many hours in a day,” Mette thought at the time, though looking back

DKK 1.4 billion for biotechLundbeckfond Ventures is investing a total of DKK 1.4 billion in biotech that targets an obvious medical need until the end of 2014. As something new, the fund will also invest in Growth Equity, which involves companies that have completed an important part of their technological investment but require a vitamin injection for commercial purposes. At the moment, the fund has invested in biotech companies such as Celladon, Allocure and Enterome.

How to apply for funding:If you’d like a share of the sought-after funding, send in a presentation that clearly and precisely describes the idea and goal of your project, and include documentation for the product’s efficacy, position in the market and plan for raising capital.

Read more at: www.lundbeckfondventures.dk

15

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she doesn’t recall any specific individual periods as being difficult.

“I just don’t seem to think like that, at least not for very long. However it is clear that it was easier with my second child than it was with my first when I went back to work ten days after giving birth,” she says. She doesn’t want to gloss over the fact that it has taken many working hours to get to where she is today. “I don’t watch the clock when I’m working, but let’s just say it’s not a 37-hour working week,” she says dryly.

Despite the fact that Mette Kirstine Agger can get tired, she never gets tired of natural sciences. She thrives on operational, result-oriented work that involves specifics. She is therefore looking forward to following the venture fund’s investments.

“We are following the companies closely. We work with their strategies and objectives and follow up continuously. It’s such an exciting field,” she says explaining that even in her spare time, natural science interests her.

“Did you see that programme on honey ants in the US the other day?” she exclaims, for example. “It was extremely interesting.”

Her family also enjoys watching animal programmes on TV. But only time will tell if Mette’s children will follow in their mother’s footsteps in the same scientific direction.

“That’s entirely up to them, but they certainly haven’t been spared in that sense,” she laughs.


16

Business Profile

CLS Communication is one of the world’s largest translation companies, with branch offices all over the world, and specialises in translation within the field of life science.

Due to Denmark’s modest size, Danes have come to understand that learning another main language is necessary to make headway outside their national borders, and they generally feel comfortable with English. We sing along to English songs, easily follow dialogue in American films and have no trouble making ourselves understood on holidays abroad.

Many of us even make the claim that translating from Danish into English and vice versa is a piece of cake. But translating is a science in its own right, and in a business sense, making sure your translation appeals to its target group is quite an art.

Professional charismaThe life science business, in particular, has integrated English as its main language in all communication, as working across national borders is vital, according to Steen Magnussen, CEO Nordic and Baltic at CLS Communication, which provides translation services especially to the thriving life science sector.

“As a life science company you may have a fantastic product but if you can’t put that into words efficiently and clearly, you won’t be able to establish the necessary international collaboration. Naturally, most people can write and speak in English, but you mustn’t underestimate the importance of communicating the finer points of your message in native English. Perfect language reflects a high degree of professionalism,” he explains.

CLS Communication is an international company that was founded in Switzerland – partly because of the country’s many banks and its need to communicate across languages, but also because the area around Basel houses an enormous life science environment, with which the company works closely.

CLS Communication has 14 branches throughout the world – from Hong Kong to Quebec, Paris, Madrid, New York and Zurich – and when the company was considering opening a new branch in Scandinavia, the initial choice was Stockholm, but was then changed to Copenhagen thanks to its central location in relation to Medicon Valley.

Multiple translations of the same textIn 2005, Steen Magnussen opened the Scandinavian branch in Copenhagen with the aim of optimising communication for life science companies in the Øresund Region. Experience from Switzerland revealed that many life science companies had their own communication department but did not necessarily possess cross-linguistic competence, and this is where CLS Communication steps in to help get the message across, as Steen Magnussen puts it. That’s because a translation is not just a translation.

“For example, one original text can be translated in many different ways depending on the target group and context in which it will appear. For that reason we specialise in life science and can assist clients with customising the ideal translation, whether it is a press release, annual report, exhibition brochure, insert or something else entirely. We work closely with our clients, investing the time it takes to deliver the right text rather

than simply translating from one language into another,” he explains.

All time zonesCLS Communication in Denmark has grown steadily since 2005 and now has almost 20 employees. They work with various life science companies, and having branches in every time zone worldwide represents a tremendous strength and increased capacity. Lotte Fuhr, Sales Manager, uses an example to explain:

“The BRIC countries are forging ahead at the moment and this

It takes perfect language skills to charm the international marketMore and more companies are adopting English as their prevailing business language and in order to compete in the international market, high-quality correct English is nothing short of essential if you wish to appear professional.

Lene Bengtsen,

Language Operations Manager

Lotte Fuhr,

Sales Manager

17

means that Russian, Chinese and Brazilian Portuguese, in particular, have become very important languages for any company moving their production to these areas or doing business with them – both importers and exporters. And as we have branches in so many countries, we can operate with translations in just about all languages,” she says. Lene Bengtsen, Language Operations Manager at CLS Communication and member of the management team, explains how CLS Communication has a clear and cohesive approach to its translations because all the CLS companies across the different countries work on the same platform with the same processes and identical very high security standards. This produces a homogenous product that clients know they can count on and where security and confidentiality are top priority.

“We communicate internally among the company’s branches in many different countries. We have defined processes so clients always know they can rely on us to deliver their translations quickly and efficiently. The translated texts are reviewed by other language experts to ensure the high quality the company strives to deliver.”

Not just translationLene Bengtsen, who holds an MA in International Business Communication from Copenhagen Business School, describes how CLS Communication not only translates texts. She is referring to the concept of transcreation.

“This means we can also offer a service that resembles copywriting. Life science companies are specialists in their own field and it’s a shame if a good product fails in the market because of a translation that calls general quality standards into question. We are therefore often part of the preliminary phase of the solution, sparring with the customer and helping to shape and angle the message to suit the target group,” she says. She adds that the company’s wide-ranging experience within life science has given CLS translators such in-depth insight into the subject that they can appreciate the background for the translation and that it inspires a general sense of faith in the specific life science company.

“Unlike many other translation agencies, we employ full-time translators as well as using freelancers. And we can guarantee the quality of all our employees’ work – 100 per cent. It also means our clients deal with one CLS contact, who gets to know them and their requirements and can deliver texts that are uniform and consistent in terms of quality and style. We know the market and can therefore produce the perfect tailored text,” she explains.

Competition requires perfectionOn a global scale, CLS Communication is one of the largest translation companies specialising in life science and is a leading company in Scandinavia in this field.

On the strength of this, the company has landed an important EU contract put out to tender to provide the official and authorised Danish translations of all terms for medical equipment that all Danish producers of medical equipment are under obligation to follow, known as the Global Medical Device Nomenclature.

CEO Steen Magnussen explains why promoting your

Steen Magnussen, CEO, Nordic & Baltic

CLS Communication Services• Writers specialising in financial, medical, marketing

and technical texts – in all languages • Support across the whole project – from briefing

to proofreading the final version • Powerful global reach – we deliver on time, even

when deadlines are tight and volumes are high • A highly secure IT environment and rigorous

processes

www.cls-communication.com

image in faultless English is alpha and omega for a company.

“The European science clusters are collaborating more and more, which is vital for competing against the BRIC countries and the USA. Companies need to understand that translations are taken seriously – that is the foundation stone of collaboration,” he says, concluding that it’s not just a matter of language.

“The knowledge sharing constantly taking place between our branches all over the world enables us to keep our finger on the pulse and identify trends appearing in the global life science market. We are therefore more efficiently geared to help our clients remain at the cutting edge with clear external and internal communication.”


1818

Business Profile

Biomedical and biotechnological service provider, Bioneer, offers a range of services that are useful in diagnostic, prognostic and therapeutic contexts. The solutions for monitoring biomolecules, including nucleic acid and proteins, may be done in a range of biological specimens from tissue biopsies, blood, cells, bacteria, and viruses.

“Over the past few years, biomarker has become a buzzword within the world of biotechnology and drug development. I believe, it reflects the growing aspiration among drug development companies to develop highly targeted therapies and furthermore to document the

Biomarkers in drug development and patient care

With a range of different services and a molecular toolbox related to the identification, validation, and documentation of disease-related biomarkers and drug targets, Bioneer facilitates pre-clinical development and clinical drug development.

make use of immunohistochemistry, in situ hybridisation and staining techniques for visualisation of biomarkers (e.g. proteins and microRNAs) directly in the tissue without extracting the sample. When the morphology remains intact a lot of information can be obtained from the sample.

“We are able to document the presence of a potential drug target, e.g. involved in a signalling mechanism in the diseased part of the tissue

effect in parallel to clinical trials and simultaneously gain a deeper understanding of the mechanisms of action,” says Kim Holmstrøm, Head of Department – Biomarkers and PhD at Bioneer.

His group of scientists assists biotech and pharmaceutical companies as well as clinical laboratories with identifying, validating and documenting biomarkers for use in improved patient care and drug development. Bioneer offers a wide range of biomolecular-based analyses for this purpose.

Molecular histologyThe scientists at Bioneer have special expertise in molecular histology and

About BioneerBioneer A/S is a subsidiary of the Technical University of Denmark (DTU) and is approved by the Danish Ministry of Science and Technology as an authorised provider of technological services – a GTS entity.

The company was started 25 years ago.

Bioneer has state-of-the-art facilities in the Scion-DTU Science Park in Copenhagen.

Figure 1: Combined ISH/IHC assay:

miR-21 and alpha-actin expression

in breast cancer tissue. miR-21

expression in cancer-associated

fibroblasts has been observed in

colon, breast and lung cancer. Most

cancer-associated fibroblasts express

a-smooth muscle actin and are

named myofibroblasts. In this image,

co-expression of miR-21 (green) and

a-smooth muscle actin (red) is seen

in breast cancer myofibroblasts.

Tumor cells do not express miR-21 and

a-smooth muscle actin. Counterstain:

DAPI (blue).

Photo: Bioneer A/S

1919

biopsy and potentially also see the effect of the drug on the tissue by demonstrating that this particular mechanism is shut down,” says Kim Holmstrøm, and continues:

“The precise localisation of a given biomarker (drug target) to a specific type of cell in a suspension or in a tissue section is of primary importance for the interpretation of the value of a given marker. Therefore these technologies provide much more information than traditional staining techniques.”

Histology at the next levelBioneer has developed the HistoFlex ™ device in collaboration with DTU-Nanotech. This device provides highly flexible and advanced histological analyses, enabling the detection of multiple biomarkers on the same tissue section with automated sequential histological assays and high assay reproducibility. HistoFlex furthermore offers improved sensitivity of detection and significantly shorter assay times compared to conventional protocols.

Kim Holmstrøm explains:“We are capable of running

multiplex assays, for instance on tissue sections (Figure 1), where we combine immunohistochemical detection of protein or peptide biomarkers and in situ hybridisation of nucleic acid biomarkers on the same tissue section. This allows us to address the complexity and heterogeneity of solid tumours in a new way, which we believe will provide the pathologist with an improved decision tool in the future.”

Identifying new biomarkers for rare cells with Shadow Stick technologyThrough collaboration with Aarhus University, Bioneer now offers Shadow Stick technology (Figure 2), which may be used to identify specific cell surface-exposed biomarkers, e.g. for cancer stem cells. The technology relies on the use of phage display to select antibodies against rare cells.

“We are currently working with scientists at Aarhus University to utilise this technology to isolate recombinant antibodies, recognising rare breast cancer stem cells in tissue sections or cell populations.

FACTSBiomarker and drug target validation at Bioneer are provided through: • In situ visualisation: FISH, CISH, IHC and combinations thereof • Quantitative PCR targeting mRNA, ncRNA and miRNA • Traditional northern and western blotting methodology

For more information about Bioneer’s services in the field of biomarkers, please contact Kim Holmstrøm by phone: +45 4516 0444 or email: [email protected]

The Shadow Stick “protects” the phage particles, expressing a library of recombinant antibodies, and the technique results in an enrichment of new specific antibodies for the protected cells, although they are rare, few and in a complex context,” says Kim Holmstrøm, and goes on:

“The shadow stick technology provides a convenient and quite unique new way of identifying specific antibodies for surface-exposed antigens of rare cells, which otherwise can only be identified by morphological characteristics or intracellular biomarkers. Novel surface-exposed biomarkers are of interest in diagnostics and especially for use in cell sorting devices to enrich for live cells.”

Assay development and consultancyBioneer participates on an ongoing basis in large-scale scientific projects and research consortiums and can

act as co-developer of the required biomarker assay.

“The analyses performed by Bioneer on our tissue samples gave us new information that we hadn’t found with the methods we have available. Especially the in situ hybridisation of the biomarkers we work with yielded information on spatial distribution and possible cellular origin,” says Steen Knudsen, PhD, CSO at Medical Prognosis Institute.

Medical Prognosis Institute (MPI) is a biotech company that develops companion diagnostics for cancer drugs from biotech and pharma and prognostic assays for cancer.

“We have the expertise and state-of-the-art facilities to assist in the development phase, and we can cover most aspects of the pre-clinical biomarker and drug target development process,” Kim Holmstrøm concludes.

Figure 2: The principle of Shadow Stick technology. A microscope slide

with a heterogeneous population of cells is shown. One “red” cell is being

protected by the Shadow Stick, after a suspension of a phage display library

has been incubated with the entire sample. The UV-light inactivates non-

protected phages and only antibody-expressing phages in the shielded area

can subsequently be screened for specific binding to the rare cell of interest.

cells

Seen from above

Seen from the sideslide

UV-C light

Shadow Stick

Graphics: Bioneer A/S

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DnA – uncovering the secret of lifeSince the discovery of the DNA double helix, scientists have continuously searched for a better understanding of the human heritage, the genome. The sequencing of the entire human DNA yields increasing insight and opportunities for targeted drug development. Still, many questions remain to be answered.


Scientists are working constantly to identify protein-coding genes and their functions. The objective is to find disease-causing genes and possibly use the information to develop more specific treatments. It may also be possible to locate patterns in gene expression, which could help give physicians insight into the body’s properties. Does this imply that we are close to curing cancer?

“I believe we have some 20-30 years ahead of us before we have sufficient information to cure a common multifactorial disease based on genomics,” says Karsten Kristiansen, professor at the Department of Biology, University of Copenhagen.

Karsten Kristiansen is heading the Danish pan-genome project, aiming to map out the genetic variation in the Danish population. He explains about the enormous complexity of the human genome:

“DNA sequencing is one step on the way towards better understanding of the human heritage. We are on track, and in terms of diseases many specific genes have been identified, coding for, among other things, type II diabetes, cancers, neurologic diseases etc.,” he says, continuing:

“The genes, however, explain only minute parts – a few per cent – of the variation within the disease, and we still need to learn and understand how lifestyle, environment, food and so forth interact with the genes.”

Technology developing rapidly In 1953, James D. Watson and Francis Crick discovered the double-helix model of the DNA structure. Uncovering of the fascinating structure of DNA (deoxyribonucleic acid) became a landmark for the modern molecular biology and together with Maurice Wilkins they were awarded the Nobel Prize in physiology or medicine in 1962 for the discovery. The technology has since developed rapidly.

“What seemed to be an enormous, laborious and very expensive task just 15 years ago, sequencing the entire human genome can now be done within a few weeks with high-throughput sequencing technologies,” Karsten Kristiansen says.

In 2003 the entire human genome was published in the scientific journal Nature.

FACTS:

• DNA sequencing determines the order of the nucleotide bases in a genome

• Full genome sequencing provides information on all 6 billion bases in the human genome

• The human genome was sequenced for the first time in 2000

• The Human Genome Project is an international scientific research project with the primary goal of determining the sequence of the chemical base pairs which make up the DNA

• The Human Genome Project will identify and map out the approximately 20,000-25,000 genes of the human genome from both a physical and functional standpoint

• Danish and Swedish genome projects are currently ongoing and will map out the genetic variation of the two populations, respectively

Basics about related research areas:

Metagenomics is the study of metagenomes, i.e. genetic material recovered directly from environmental samples, such as gut microbiota.

Pharmacogenomics is the branch of pharmacology which deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug’s efficacy or toxicity.

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22

Making the most of medical interventionPharmacogenomics is the whole genome application of pharmacogenetics, which examines the single gene interactions with drugs and holds promise of the development of optimised drug therapy.

By Charlotte Strøm; MD, PhD, Journalist

Pharmacogenomics aims to develop rational means to optimise drug therapy with respect to the patients’ genotype to ensure maximum efficacy with minimal adverse effects. Personalised medicine is the result of in vitro testing in which drugs and drug combinations are optimised for each individual’s unique genetic makeup.

MVA-based Medical Prognosis Institute has specialised in companion diagnostics using a combination of in vitro measurement of drug effect, transcriptomics (messengerRNA and microRNA) and systems biology.

The MPI Drug Response Predictor is applied on a pre-treatment patient sample, e.g. tumour tissue or blood

sample, to make a prediction of drug sensitivity that is specific to that patient.

“With this technology we can predict which patients will respond to a drug and we can also predict which disease or indication has the highest share of responders. This will limit the clinical trial population to those patients who are predicted to respond to a new drug, dramatically increasing the probability of successful phase III drug development,” says Steen Knudsen, founder and Chief Scientific Officer at MPI.

The Drug Response Predictor is universal and works for 90 per cent of the small-molecule drugs, biologics and monoclonal antibodies that have been tested so far – and is clinically very well validated.

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As drug developers have increased focused on optimisation of medical intervention and regulatory authorities also require the biomarker status to be known, MPI is currently collaborating with pharmaceutical and biotech companies in both Europe and the US.

Visualisation of biomarkers, drug targets and the effect of drugsBiomedical and biotechnological service provider, Bioneer, also provides services within biomarkers and has special expertise within molecular histology. The technologies allow for the visualisation of biomarkers (e.g. proteins and microRNAs) directly in the tissue without extracting the sample.

“With the morphology intact, a lot of information can be obtained from the sample, and with this technology we are able to document the presence of, say, a given drug target in the diseased part of the tissue biopsy and potentially also see the effect of the drug on the tissue,” says Kim Holmstrøm, Head of Department and PhD at Bioneer.

In addition to this, quantification of, e.g., specific biomarkers in the tissue can be achieved using state-of-the-art image analysis software from Visiopharm, a biotechnological service provider also based in MVA. This kind of analysis provides a whole new level of information to be taken into account when characterising individual disease cases.

Read more about • MPI: www.medical-prognosis.com• Bioneer: www.bioneer.dk• Visiopharm: www.visiopharm.com

FACTS about in vitro diagnostics and drug registration

• In the US the Food and Drug Administration is the authority for approval of in vitro diagnostics and marketing authorisation of drugs, however interaction may not necessarily apply

• The European Medicines Agency’s Committee for Human Medicinal Products (EMA/CHMP) expects biomarker status to be known and documented before patients are exposed to a drug

• EMA/CHMP does not grant approval of in vitro diagnostic tests

• The in vitro diagnostic tests require CE labelling according to European Directive 98/79/EC on in vitro diagnostic medical devices, or the IVD Directive (IVDD)

24


To understand our heritage it would make sense to look at where we come from. The theory that we all – in principle as one big global family – derive from the first humans who dispersed out of Africa was seriously challenged only last year by a group of Danish researchers. Based on genomic sequencing a spectacular publication in Science in October 2011 documented that aboriginal Australians are descendants of an early human dispersal into eastern Asia, possibly 62,000 to 75,000 years ago.

This dispersal is separate from the one that gave rise to modern Asians 25,000 to 38,000 years ago. The aboriginal Australian genomic sequence was obtained from a 100-year-old lock of hair donated by an Aboriginal man from south-western Australia in the early 20th century and was published by Professor Eske Willerslev and his colleagues at the Centre for GeoGenetics, Natural History Museum of Denmark, University of Copenhagen.

“Our findings support the hypothesis that present-day aboriginal Australians descend from the earliest humans to occupy Australia, likely representing one of the oldest continuous populations outside Africa. We detected no evidence of European admixture,” says Eske Willerslev.

Exploring the genetic foundation of type II diabetes “In terms of understanding how diseases evolve, this

will give us new information.”

Genomics in the study of human origin:

Where are we from?Based on genomic sequencing, Danish scientists in 2011 documented that aboriginal Australians are descendants from an early human dispersal into eastern Asia possibly 62,000 to 75,000 years ago. This dispersal differs genetically from both Asians and Europeans and opens the way to a closer look at the genetic foundation of the development of type II diabetes.

He is currently negotiating with the aboriginal Australians to investigate the population with respect to type II diabetes, which is exceptionally frequent in this population.

“The high prevalence of type II diabetes may be related to a part of the genome that modern humans share, but it could also suggest that a mutation has occurred. In either case it is extremely interesting, and if we do share an ancient part of our genome with the aboriginal Australians then we will have hints of what to look for in a European cohort,” explains Eske Willerslev. Read more: Referencen fra Science

THE SECOND HUMAN GENOME The genome of the human gut microbiota is sometimes referred to as the second human genome.

LuCamp (the Lundbeck Foundation Centre for Applied Medical Genomics in Personalised Disease Prediction, Prevention and Care) consists of scientists from Hagedorn Research Institute in Gentofte, the University of Copenhagen, Steno Diabetes Center, other Danish Universities and the Beijing Genomics Institute in Shenzhen.

LuCamp is part of a European research consortium called MetaHIT which is sponsored by the EU.

The MetaHIT project aims to identify, by sequencing, the full human gut microbiome, i.e. the collective genomes of all gut bacteria, and in this context LuCamp is responsible for physiological studies of the volunteers who participate in the project and, especially, studying the role of gut bacteria in the development of obesity and type 2 diabetes.

Read more: Links til LuCamp / MetaHIT

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to establish a unique Danish reference pan-genome, gain an understanding of the genetic structure of the Danish population and build a platform for the development of new pharmaceuticals.

Initially 150 people will be DNA-sequenced. They all come from a well-described cohort with well-known family patterns.

“We need to establish the platform first and provide proof of principle. The next step will be to raise funding for the full sequencing of approximately 1 per cent of the Danish population,” says professor Karsten Kristiansen, Department of Biology, University of Copenhagen. He is heading the project in which Aarhus University, Aalborg University, DTU and BGI Europe A/S are also taking part.

Read more• About LifeGene: www.lifegene.se• About the Danish pan-genome project:

http://hoejteknologifonden.dk/projektgalleri/rojektgalleri/kraeftvaccine_og_kortlaegning_af_danskernes_arvemasse

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scandinavian genome projectsIn coming years, knowledge of the variation of the genetic structure of the Danish and the Swedish populations will be elucidated in large-scale research projects.


Within a decade from now, researchers will know more about the specific genetic variation of the Danish and the Swedish populations. LifeGene is the name of a remarkable Swedish DNA sequencing project aiming to map out the local genetic makeup. Several hundred thousand people in Sweden from 18 to 50 years of age are to be recruited as volunteers from 2010 and the following eight years to have their genome sequenced.

The Swedish universities have undertaken the project and the Karolinska Institute in Stockholm is hosting the project. The aim is that LifeGene will provide new knowledge about the most common diseases and health problems, such as asthma, allergies, infections, obesity, repetitive strain injuries, chronic fatigue and pain, in addition to major diseases in later life – cardiovascular diseases and cancer.

What is known as the Danish pan-genome project was launched in 2011 by a grant from the Danish National Advanced Technology Foundation. The research project aims

26

The urge to know one’s genetic potentialWhile full sequencing of the human genome remains costly, some may find less but more specific information satisfactory. Specific genetic testing is offered to consumers as personal risk stratification.


Until recently the most commonly known use of genetic fingerprinting by consumers was for paternity testing to determine whether two individuals have a biological parent-child relationship. As the technology on DNA profiling has rapidly developed and become more advanced, the profiling has opened up for consumers to uncover their genetic potential beyond knowledge about paternal or maternal origin.

“We offer specific predictive genetic tests at Gonidio with the aim of enlightening our clients about what risks they may have of developing a certain disease, such as type II diabetes, cancer etc. The knowledge you gain from the test enables you to make the most of your life from this point onwards,” says Otto D. Lück, MD and founder and CEO of Gonidio International A/S.

He continues:“People may have an idea – a suspicion if you like – that

they may carry a certain genetic disposition. Or they’d like to have a general health screening. The testing will enable them to plan for improved and more targeted disease prevention. This could involve yourself – but it could also be your children. If they are predisposed to type II diabetes, it makes sense to ensure they are lean and active while they are still young.”

Risk assessmentCritics of consumer accessibility to DNA testing argue that it involves an unnecessary medicalisation of otherwise perfectly normal and healthy people. In a series of articles in the Danish consumer magazine

Tænk about home-testing, the Danish Consumer Council strongly discourages a range of tests that can be performed by consumers, arguing they are likely to make people feel more ill than what is actually the case. Additionally, it raises concern that the testing is generally done without medical attention and counselling.

Otto D. Lück present his reasoning: “There is a discrepancy between diagnostic tests and

assessing whether you have a genetic risk of developing a disease. People generally only get their DNA tested because they have a suspicion that they carry a risk, and they feel they need to know.”

Furthermore he argues that the result of the DNA testing performed at Gonidio is followed-up by a report and counselling in writing on targeted prevention if the test comes out positive.

Data processing is the hurdleKarsten Kristiansen, professor at the Department of Biology, University of Copenhagen, is well aware that specific genetic testing is a growing industry, although he finds the relevance minimal.

“Apart from the well-known inherited monogenetic diseases, for which we already test, the impact of a given genetic code on a disease is enormously complex and difficult to understand. We are still only looking at the tip of the iceberg in terms of how much information is out there. This understanding is probably still 20-30 years away,” Karsten Kristiansen says.

He stresses that while the sequencing of the genome

FACTS

• Gonidio is Greek for ‘the gene in me’

• Typical DNA testing performed by consumers comprise testing for the risk of developing cancer, type II diabetes, asthma, allergies and obesity

• Anti-aging and sports-performance tests have also become popular

• The test is performed based on an oral swab of the mucosa from inside the mouth

• DNA tests are carried out using the PCR (Polymerase Chain Reaction), which enables the production of millions of copies of a specific DNA sequence in approximately two hours

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itself is technologically feasible and cost about USD 5,000, the data processing and interpretation of the DNA sequences is the primary hurdle to full genome sequencing becoming a consumer ‘must-have.’

“The sequencing can be done fairly easily, but the point is what you can do with this information. The genome sequence by itself doesn’t give you much information.”

Sensitive informationOtto Lück acknowledges that the information from a DNA test is as sensitive as one’s social security number. Hence, the information that the DNA testing yields remains private, anonymous and confidential.

The Danish-based company was established in October 2011 in what appears to be a growing albeit fairly immature market. Scandinavian consumers previously had to turn to international, most often US-based, websites to have specific DNA testing done.

“Consumer DNA testing is merely a logical development of the technology that is readily available and in principle not further away than the internet,” Otto D. Lück says and believes that the Scandinavian consumers will embrace the opportunity to explore their genetic potential.

Read more about Scandinavian companies offering specific DNA testing: •Gonidio International A/S: www.gonidio.dk•DNA-guide: www.DNA-guide.com•GenoSkan: www.genoskan.dk

A campaign from Gonidio urging parents to have their infants

tested.

28

By Kristian Holte

More and more life science companies choose to outsource their clinical trials to save time or money. This involves addressing a number of legal issues. Clinical trials come with a number of legal obligations and the parties involved often have conflicting interests. This makes it necessary to define and allocate responsibility between sponsors, CROs and other parties. Even though the sponsor decides to outsource some tasks, the sponsor remains responsible in relation to the authorities. Ultimately, the sponsor risks being fined or ending up with useless research data.

In this article I identify five important legal issues from the sponsor’s perspective and offer a way of dealing with each issue.

#1 - Ensure compliance with patient data regulationsAn extremely important issue is the consent given by the individual patient. This consent needs to be “informed”. The exact requirements may vary from country to country.

If you are a sponsor based outside the EU you need to obtain the consent of each individual to transfer the data outside the EU. Otherwise you run the risk of not being able to use the data as intended.

The EU has strict rules on the transfer of personal data, including particularly sensitive data like patient data. Generally a transfer is only possible with the consent of the individual involved. There are other possibilities, such as the Safe Harbour scheme in the US, but these measures cannot be relied on in every situation.

The easiest solution is to obtain their consent from the outset.

You also need to pay attention to any translation of the written consent into the patient’s own language. In case of doubt, the patient’s language will likely prevail, which might cause you unwanted headache.

#2- Agree on ownership of research data & IPIf you want to use the research data produced by the clinical trial, you must secure ownership of the data. An alternative to ownership is to secure a right to use the data which has sufficient room for the intended use. This includes a transfer of ownership of the rights to the database and the copyrights to the documentation created by the trial.

Problems may arise at this level.The database rights naturally belong to the

people actually creating the database, which means the investigators. Depending on the country, the copyright may belong to the employees producing the documentation. In some countries, the copyright is automatically transferred to the employer and in other countries a written transfer document is required. Whatever might be the case, you need to take local legislation into account and make sure that a valid transfer of ownership takes place.

#3 - Be aware of foreign laws on corruption and anti-briberyA successful clinical trial increases the risk of fraud and anti-kickback allegations from competitors. This is especially the case if you have used a respected professional who is affiliated with a potential customer in one way or the other. Countries such as the UK and US have particularly extensive legislation in place, which might affect sponsors outside these territories. For instance, US law generally applies to any company which has “substance” in the US. Although not applicable to all companies, a lot of companies fail to recognise the risk of foreign laws.

Depending on the area of life science, guidelines exist to guide you when dealing with healthcare professionals. Important features include: agreements with consultants must be in writing, consultants must be paid fair market

HoW To Deal with legal issues when outsourcing clinical trials

Three important legal issues when outsourcing clinical trials:• Ensure compliance with patient data regulation

• Agree on ownership of research data & IP

• Tie milestones to consequences

29

value and any disclosure requirements laid down by the local law must be complied with.

#4 - Tie milestones to consequencesMilestones are used as an instrument to map out a clear path and keep an eye on results. Milestones must be drafted very clearly to avoid doubt. Ways to do this include using metrics such as the inclusion of first patients, number of clinical research facilities, last patient out and specific dates.

Make sure that only one party, preferably yourself, has the final say as to whether the milestone was met or not. Otherwise the process can be delayed due to disagreements. An effective instrument is to link milestones to consequences. It is possible to agree on the payment of a fine, a reduction in the amount payable by you or the termination of the clinical trial if a certain milestone is not met. In this context, you should not make assignment of IP conditional upon any payment.

#5 - Build a way outOften a sponsor would like a way out if the clinical trial – for one reason or another – does not work out as planned. Such a way out can be secured by including a termination clause in the clinical trial agreement. On the other hand, the CRO is often interested in preventing switching if results appear to turn out disappointing or to require payment for termination.

In either case, you need to contemplate the mechanics of a termination clause. When are you allowed to terminate? Must there be a remedy period so that the CRO can fix the problems? Should the CRO be obligated to assist in the termination? These are just a few relevant questions to consider.

On the flip side, you might find it relevant to allow the CRO to terminate if the CRO, at an early stage, realises that certain milestones cannot be met. In this case, you need to secure the right to continue the trial with the participating patients.

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30

The Baton

Life science in the Øresund Region – Fact of Fiction?By Jannik Hilsted, Hospital Medical Director, Copenhagen University Hospital – Rigshospitalet

The Øresund Region seems to have the potential to be one of the strongest and most innovative regions in Europe in all aspects of life science. Is that fact or fiction? Browsing the web quickly brings up the data and key facts about the Region: We are 3.5 million inhabitants and 40.000 employees in the private life science sector. There are 12 universities, 5 of which supply life science-related educations, with some 165,000 students, 10,000 researchers and 6,000 PhD students,

32 hospitals, 11 of which are university hospitals. And we have a high concentration of science and business.

On the business side, there are approx. 80 (red) biotech companies, 20 pharma companies and 100 medtech companies. There are 7 science parks with a significant focus on life science. We have 6 incubators, of which 3 have a significant focus on life science, and approx. 80 contract research organisations and contract manufacturing organisations.

We also have affiliates from more than 200 pharma companies and 170 medtech companies.

More cold hard factsThere are more positive facts to highlight. Next to Norway, the largest investments in medical research have been made by Sweden and Denmark (OECD 2005). After Switzerland, Sweden and Denmark have the highest productivity in medical research measured as the number of publications per million inhabitants. Sweden and Denmark publish the highest number of publications on clinical trials per million inhabitants per country. And in the biomedical area, Denmark ranks as the fourth most frequently cited country (2004-2006) with Sweden in eighth place.

The Øresund Region is among the leading regions in Europe in terms of R&D expenses as a share of GRP (Gross Regional Product). In 2005. 32 per cent of the total R&D investments made in Denmark and Sweden by the business community were based in the Øresund Region, and it has increased its share over the years. Finally, accessibility is an important competitive parameter for a Region and its business community. Here too, the Øresund Region has a strong position with Copenhagen Airport (Kastrup) and a well-developed infrastructure.

So in a nutshell, Life Science in the Øresund Region is a fact and the framework conditions are promising – but this alone is not enough. More investment is needed.

A shot in the arm In the most recent edition of Life Science, Carsten Rose briefly mentioned the European Spallation Source (ESS) before passing the word to me. I would like to exploit ESS’ potential because it is unique: In the years ahead, one of

the world’s largest and most advanced research facilities will be built in the Øresund Region in the form of a neutron scattering facility that will act like an extremely large and very advanced microscope.

ESS can be used to investigate hard, soft and biological materials by firing a large number of neutrons at a material and registering how the neutrons scatter. This enables precise pictures to be taken of the materials’ structures – from simple crystals to the various macromolecules of cells. Because the neutrons can penetrate far into the materials without damaging them, the technique is especially suitable for researching biological and medical systems. Examples of research that use neutrons include the development of new super conductors and research into the structure and functions of proteins.

This opens up new opportunities for scientific discoveries, not least within biotechnology. As neutron scattering technology can be used within a wide range of research areas, ESS will assume importance not only for narrow basic scientific research but also for companies and more application-centric research and development. The associated data centre to be based in Copenhagen close to the University of Copenhagen and Copenhagen University Hospital – Rigshospitalet will house researchers and technicians who will collect data and help visiting researchers with analyses and interpretation. When completed in 2019, it will also give companies more scope for using ESS.

Pluses and minusesAll in all, the future looks bright from a number of

Jannik Hilsted, Hospital Medical Director, Rigshospitalet

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angles. But collaboration across the Region is a little patchier. For example, interaction between the Region’s university hospitals is not all that strongly established. The relationships are angled more towards “the world at large” – than across the bridge. We don’t make enough use of our own neighbourhood assets. Skåne and Zealand each have large environments that do not draw on each other’s expertise.

I think there are several explanations. One is that we think “internationally”, so our thoughts focus father away – and not in the immediate vicinity. Another is that national borders and national legislation comprise the same barriers regardless of the wish to cooperate with neighbouring countries or the US. Thirdly, none of us are good enough at facilitating and seeking employment with each other for a couple of years. Fourthly, we think in terms of “cross-national collaboration” such as projects – and not as something we do naturally on a daily basis. Everyday cooperation works very well – we know that from the treatment of severely ill people with help passing both ways across the Øresund Bridge.

In terms of cancer research, as Karsten Rose mentions in the latest ”Baton”, Copenhagen University Hospital was determined to avoid repeating past mistakes concerning collaboration. We need to establish a basis for research and development in the field of cancer in close collaboration with Skåne University Hospital and Lund University rather than with geographically more distant partners. Patients will benefit more if we work closely across a distance of less than 50 kilometres rather than with more distant business partners.

The view from Copenhagen University HospitalFrom the top of Copenhagen University Hospital, we have a privileged view over the Øresund with all its promising potential. The hospital is a sound source of benefit for the whole Øresund Region. We have made some good and timely choices: We have focused on Copenhagen University Hospital patients. We have initiated transnational research. We have invested in the required infrastructure and built up and invested in collaboration. Our business partners are the University of Copenhagen with Panum and the other departments. We work with hospitals in the Capital Region of Denmark and in other regions. And we collaborate with the Technical University of Denmark (DTU), with Malmö and Lund in Sweden, and with European and North American research institutes. Our research priorities concern maintaining a strong, broad position as well as focusing on research areas where we excel: radiotherapy, clinical physiology, HIV epidemiology, neurology with dementia and sclerosis, gynaecological cancer, fertility and transplantations. And we realise that in the future we need to continue to invest in infrastructure, building new facilities – including those for particle therapy, and expanding internationally while maintaining our focus on our nearby business partners in Denmark and around Øresund. We also need to focus on the research areas that we as Nordic countries can pioneer, among other things because Danish citizens and patients are better registered and clinically classified than people in, say, the UK and the US.

If the Øresund Region also continues to invest in

infrastructure, collaboration and broad scope while exploiting the advantages provided by the Region’s culture and society, we will be well on our way – not towards fiction but towards a very exciting future.

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

Jannik Hilstedgives the relay baton to Olle Stendahl, professor, Hälsouniversitetet, Linköpings Universitet. The question that Jannik Hilsted will pose to Olle Stendahl is: “What is the status of the cooperation between the hospitals in the region? – With special focus on the essential interaction between natural science, health science, med-tech, pharma and treatment – from the viewpoint of clinical research.

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By Linda Viberg

There is a pioneering spirit in the air in Medicon Village in Lund. You can almost hear the sound of people putting down roots. The premises on Scheelevägen and Tunavägen in Lund are gradually being filled. Already, 350 people have jobs here and this figure will increase to at least 500 before the end of 2012. The members will include groups of researchers from the university, small start-ups, more established companies and operations associated with Region Skåne. A large part of the activities concern cancer research and cancer treatment.

“The ambition is for at least 900 people to work here within two years, that is, just as many as AstraZeneca employed at the start of 2010,” says Mats Leifland, CEO of Medicon Village.

Life science in the futurePlanning is currently in full swing for the house-warming party on 24 May. During the afternoon, there will be an open event to which the general public and others with an interest are welcome. Before this the fifth European Healthcare Deciders’ Forum will be held here, on 3-4 May, with speakers including David Brennan, CEO of AstraZeneca.

However, the first major event at Medicon Village was held on 28 March 2012. The theme was “The future for Swedish and Danish life science” when Kemivärlden Biotech organised a very well-attended network day which attracted just over 420 participants and more than 60 exhibitors.

“Out of the ashes of the closure of AstraZeneca, Medicon Village has arisen as a collection of successful small plants. It is important to spread this optimism, particularly now when AstraZeneca is also closing its operations in Södertälje,” says Maria Eriksson, Media Manager and Project Manager at Kemivärlden Biotech.

The organisations that have already moved in to Medicon Village include ESS, which has its head office here, Lund Life Science Incubator (LSI), which helps entrepreneurs and start-ups in the field of life science to commercialise their ideas, and several small companies. The Region Skåne operations already in place are Labmedicin Skåne, Biobank and Primärvården Skåne’s management and administration. Regionalt Cancercentrum Syd (RCC Syd) also plans to move here, as well as some of the cancer research at Lund University. Medicon Village also has several ‘business-to-business companies’ that focus on life science and more are on the way.

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Hidden gold in the science parks

Medicon Village is boomingThree months have passed since Medicon Village took over AstraZeneca’s old premises in Lund, Sweden. Network days are already been organised here to discuss the future of life science in the region.

FACTs MEDICon VILLAgEShortly after AstraZeneca’s decision in March 2010 to close its operations in Lund, the Skåne Research and Innovation Council (FIRS), consisting of members including Lund University, Region Skåne and the Cities of Malmö and Lund, began negotiations with AstraZeneca to take over the facility. The entrepreneur Mats Paulsson established a foundation that acquired AstraZeneca’s facility for SEK 450 million. He made the first donation of SEK 100 million. In January 2012, Medicon Village took over the 80,000 m2 facility, of which 30,000 m2 are laboratories. The vision for Medicon Village is to be a unique meeting place where value is created to improve human health and living standards. The entire profit from property management will be ploughed back into research and innovation.Read more on www.mediconvillage.se

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Former employees of AstraZeneca back with their own businessesThe company Truly Translational, which is based in Medicon Village as part of Lund Life Science Incubator, is a living example of the trend for an increasing proportion of the development of new pharmaceutical substances to take place in small companies. Its three founders previously worked for AstraZeneca in Lund. When the company closed down, they joined forces and struck out on their own. The company provides assistance on preparing strategies in connection with the development of pharmaceuticals, from project idea to early clinical trials.

“It takes courage, open eyes and a lot of planning. But most of all it’s fun,” says Charlott Brunmark on her journey from employee of a large company to businesswoman.

Truly Translational is one of a total of 29 companies started up by former employees of AstraZeneca. Together they have created the Supernova company network.

Life Science Foresight Institute – recently started upThe recently established Life Science Foresight Institute also has premises in Medicon Village. The institute analyses trends for 10-20 years into the future for the life science industry and carries out more specific horizon scanning for decisions in individual companies.

“The best way of influencing the future is to be involved and shape it,” says Paula Zeilon, the head of the institute.

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Three important parts of the Medicon Village concept

Listed by Mats Leifland, CEO

• Research can be coordinated here, both clinical and preventive, as well as health-promoting research.

• As a member of Medicon Village, a small company gets the advantages of a big company. These include unique access to the laboratory equipment left behind by AstraZeneca. This is essential to many small companies.

• There is an unbroken chain of research, business development, start-ups, established companies, business-to-business companies and public sector operations here.

Medicon Village offers all of this, along with meeting places, conference premises and a restaurant open to everyone. Spontaneous, unexpected encounters that promote growth are created in this unique, dynamic environment.

By this she means, among other things, the ability to use analyses of the future to see which needs will arise so that you can create your own trends.

And there is unlikely to be any visitor to Medicon Village who doubts that new trends can be created in this dynamic meeting place at the crossroads of academia, the business community and the public sector.

34

Imaging Resource AB www.imagingresource.seImaging Resource AB is a professional service supplier in the Øresund region offering surface and particle characterisation capacity for a variety of different materials: pharmaceuticals, coatings, packaging material, cell tissue, medical devices, nanomaterial etc. We have access to a wide range of characterisation equipment with a special focus on Scanning Electron Microscopy (SEM). An additional service is scientific illustrations based on SEM images. The technical images are refined into eye-catching marketing material for web pages, exhibitions or posters.

ClinTrials Skåne AB www.clintrialsskane.se ClinTrials Skåne AB is a public limited company that develops and supplies services for clinical trials in Region Skåne. ClinTrials Skåne acts as a link between the life science industry and healthcare and can help the industry/CRO to find the right researchers for their studies.

iNovacia ABwww.inovacia.se iNovacia is focused on providing external research, bridging target discovery to preclinical development. iNovacia has proven efficiency and expertise, competes successfully on a global scale and has professionally delivered a large number of high-throughput screens and quality lead compounds to pharmaceutical and biotech companies in Europe and the US. iNovacia’s primary goal is to deliver novel IP with a strong SAR. iNovacia has a long track record as a Centre of Excellence in Lead Discovery from Kabi, then Pharmacia/Upjohn/Searle and finally from Biovitrum, from which iNovacia was spun out in May 2006 as an independent company.

Nuvisan Pharma GmbHwww.nuvisan.com Nuvisan Pharma Services is a global provider of product development and support services to the pharmaceutical, biotechnology and medical device industries. The company group delivers services ranging from a single lab test to fully integrated drug development programmes, including “First in Man” and Phase II-IV trials. Through combined experience and expertise, the Nuvisan Group offers the industry’s most favoured partners in the fields of (early) clinical development, bioanalytics, pharmaceutical analytics and clinical trial supplies.

NordicBiocube ABwww.nordicbiocube.com NordicBiocube is a one-stop-shop when it comes to all processes and supporting services for biological material. The company provides extensive knowledge in working with biological material and its processes both internationally and locally. An easy and efficient process for biological material reduces time and worries today and tomorrow. It is also an important component to make sure your science will meet QA and regulatory demands in early and late development in order to reduce timelines in clinical trials and when your company is looking for investments. NordicBiocube offers companies the following services: consulting, create processes for biological materials, labelling, labkit, logistics and storage (in place Q2 2012).

Zenit Design Group ABwww.zenitdesing.se Zenit Design has long and extensive experience in the development of medical products, e.g. dry powder inhalers, metered-dose inhalers, nebulisers, nasal devices, blood analysis equipment, injectors etc. Zenit Design has in-depth experience in pharmaceutical product development and all regulatory and quality implications. Zenit Design provides services at all stages of the development process, from early conceptual ideas to design for high-volume manufacture. Zenit Design combines innovative industrial design with state-of-the-art product development and strong pharmaceutical expertise.

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35

MAy 2012

25 MayMedicon Valley Golf Championship 2012 Medicon Valley Alliance presents the Medicon Valley Golf Championship 2012 for CEO’s and Executives in Medicon Valley. Besides offering an outstanding golf and nature experience, you will have the opportunity to meet and network with peers from the region’s life science sector in a relaxed setting.Venue: Bokskogen Golf Club, Skåne, SwedenTime: 7:30-17:30More information: www.mva.org/golf

JUNE 2012

15 JuneDevelopment of Drug Formulations & QANordic Journal of Chemistry & Biotechnology/Kemivärlden Biotech med Kemisk Tidskrift, Medicon Valley Alliance, and MerckMillipore are joining forces to organise an important networking event. The speakers will discuss current issues in drug formulation and QA. The seminar will be held in English and will feature about 15 exhibitors and 130 participants.Venue: Medicon Village, Scheelevägen 2, LundTime: 9:00-16:00More information: www.mva.org/development-drug-formulations-qa

OCTOBER 2012 4 OctoberIntroductory Meeting to Medicon Valley AllianceJoin other members and non-members at the introductory meeting to MVA and learn more about the many benefits of being a member of Medicon Valley Alliance. Hear about MVA and our networks and initiatives.Get an insight into what value your organisation gains from your membership in MVA. Learn more about how MVA works to maintain and develop the attractiveness of Medicon Valley.Venue: Arne Jacobsens Allé 15-17, 2300 Copenhagen S, Denmark Time: 15:00-18:00More information: www.mva.org/introductorymeeting

InSphero AGwww.insphero.com InSphero is a leading supplier of organotypic 3D microtissues for highly predictive in vitro drug testing. The company, headquartered in Zurich, Switzerland, currently counts six of the top ten global pharmaceutical, biotech and cosmetics companies as customers. InSphero’s 3D microtissues are scaffold free, highly reproducible and delivered in an automation-compatible 96-well format to replace conventional monolayer cell assays for better biological relevance and predictivity. 3D cancer microtissues reflect tumour physiology and are used routinely for screening. 3D liver microtissues remain viable for more than five weeks for chronic studies and predict even rare cases of idiosyncratic toxicology.

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26: FORTY YEARS WITH STEM CELLS

– AND STILL GOING STRONG 14: Proposals for what the

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with a taste for adventure36: Research beacons

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The Magazine about Life and Science in Medicon Valley

Photo: Bioneer A/SMedicon Valley Alliance and RASK Media 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 TeamLifeSciences Insight is a high-quality magazine that weights 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, the latest trends and conditions in the market.

DistributionIn 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, Sweeden and Norway to:

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.

Looking for Exposure?

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• Named decision-makers in the life sciences industry• Investors• Science parks• Hospitals• Universities• Life science media

• 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

Would you like to know more?

Please contact: RASK Media Sales Department Phone: +45 28 87 07 76 E-mail: [email protected] www.raskmedia.com

10: She iS inveSting 1,4 billion in biotech ‒ Meet Mette KirStine Agger

7: Research and business highlights from Medicon Valley

20: Targeted medicine - how far have we come?

28: How to out-source clinical trials

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12 the Magazine about life and Science in Medicon valley

LifeSciences Insight no 2 - 2012

Documents

Transcript of LifeSciences Insight no 2 - 2012