Issuu on Google+

LifeSciences Insight - No 3 - 2012

12 1 - 20 - No igh t s Ins

r ted!

cience

BIOT TERN BUSINECH & MATIONAL Raw materials. ESS P EDTEC LAN Service. Expertise.www.b COMH estof PETIT biote The fine art of ION ch.at pharmaceutical composition.

LifeS

LifeSciences Insight - No 3 - 2011

tech

ss sta

The M

agazi ne ab out L ife a nd

Scie nce in

Med icon

No 3 - 2012

busin e

the magazine about Life and Science in medicon valley

- 2012

// THE IN

No 3 - 2011

o ur f bio

No 1

best

get yo

The Magazine about Life and Science in Medicon Valley

Valle y

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.

Looking for Exposure? www.merck4pharma.com

Animation of the European Spallation Source in Lund

best

of bio

tech.in

dd

20: ESS wILL booSt futurE IN mEDIcoN vaLLEy 26:r&D FOR

1

Medicon Valley Alliance and RASK Media cooperate to publish the magazine LifeSciences Insight. anzeige_parteck_210x297_4c.indd 1

– AN TY D 24: STIL YEARS42:W L GO ING SITH STE 14: TRON M CEL LS G 32 :

3: Give inventions back to the inventors crevo.n

et

Merck Millipore is a division of

19.01 04.07.11 09:40 .12

14:13

IPR – potential and pitfalls

Pr EU pr oposals esiden fo cy ca r what th n achi e eve

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.

with

New vaccine construct opens up exciting new vistas

She is a tast 43, law ye r e for adve nt

ur e

Phot

o: Bi

onee

r A /S

36:

unde

Rese ar r cons ch beac ons tr uc tion

A strong Team

FREDRIK HEDLuND

LoNE FRANK

LifeSciences 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.

Distribution In addition to interesting and updated articles about the conditions of the industry, LifeSciences Insight gives companies in the region a unique opportunity to brand themselves both nationally and internationally. With its thoroughly selected distribution network, LifeSciences Insight is the ultimate and optimum opportunity to present one’s company. LifeSciences Insight is distributed in Denmark, Sweeden and Norway to: • Named decision-makers in the life sciences industry • Relevant MPs in Scandinavia • Investors • Medicon Valley Alliance’s members and • Science parks collaboration partners • Hospitals • Relevant national and international trade fairs, • Universities conferences and exhibitions in Europe, North • Life science media America and Asia 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.

10: Viruses and bacterias made into art

26: The answer to everything?

We shed light on synthetic biology

Would you like to know more? Please contact:

RASK Media Aps Phone: +45 2887 0770 E-mail: ce@raskmedia.com

JJ Kommunikation ApS Phone: +45 2011 0199 E-mail: rts@jjkommunikation.dk

4: Research and business highlights

18:

New chairman in Danish Biotech - meet Martin Bonde

36: Guide: How to protect your trade secrets


Contents

LifeSciences Insight no. 3 - 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. Publisher: RASK Media ApS Frydendalsvej 3 DK-1809 Frederiksberg C Denmark +45 3326 9520 info@raskmedia.com www.raskmedia.com

The column – Big Science or Big Thoughts? 

Highlights from Medicon Valley

New Survey – Biotech industry cuts to the bone

12

The biotech industry in the region has cut back drastically and the “burn rate” is down by 20 per cent.

18

New chairman of Dansk Biotek and CEO of a company that is thriving in tough times. Get the recipe for his success.

Theme: Spotlight on synthetic biology

26

Synthetic biology is said to be the means of creating revolutionary new types of medicine, climate-friendly foods and sustainable energy. And the Nordic countries have a chance to take the lead.

EBD GROUP www.ebdgroup.com

Guide: How to protect your trade secrets Editor in chief: Malene Aadal Bo Editors: Lone Frank, Carsten Elgstrøm

36

The need to protect confidential information is more important than ever. London-based solicitor Thomas Bjørn gives you a how-to guide.

Advertising: Carsten Elgstrøm +45 2887 0770 ce@raskmedia.com

News from the science parks

38

The Copenhagen-based bio science park COBIS optimistically reports on the positive trends from their own community.

René Thornborg Sørensen +45 2011 0199 rts@j jkommunikation.dk Cover photo: Luke Jerram

Ambassador on the road

Layout and print: artegrafix and PE Offset A/S

When Medicon Valley’s Life Science Ambassadors touch base in Denmark it is possible to book a free “consultation”. We went on tour with Thomas Jonsson.

Scan this code for subscribing to LifeScienses Insight newsletter.

4

Annual meeting; Get DKK 100,000; breakthrough in the fight against biofilm and much more.

Portrait: Martin Bonde

Partners: Medicon Valley Alliance www.mva.org

Next issue: November 2012 ISSN: 1904-4755

3

Lone Frank writes about a future when genetic codes will be created by humans.

XXX-XXX Printed matter

New Members and upcoming Events by Medicon Valley

40

43


Big Science or Big Thoughts? WHAT is Life? That was the title of a now legendary lecture given by Austrian physicist Erwin Schrödinger at Trinity College in Dublin in 1943. In the grip of the greatest crisis of the twentieth century – World War II – this small man with the big round glasses addressed biology’s most fundamental question. Schrödinger was the first person to discuss the possibility of a real genetic “code”, and his predictions on genetic material as an “aperiodic crystal” fired up a whole generation of researchers. Finding “life’s secret” became a goal fiercely pursued by the most courageous. And when James Watson and Francis Crick published the structure of the DNA molecule a decade later, they sent Schrödinger a message of thanks for his inspiration. This summer, almost 70 years later, the European Science Open Forum held a large meeting in Dublin, and American J. Craig Venter was called in to update Schrödinger’s landmark lecture. This was both appropriate and symbolic. Venter, a controversial figure with his company Celera and new unconventional methods, had helped to map the first human genome. Today, as leader of the J. Craig Venter Institute and co-founder of Synthetic Genomics, he is the undisputed figurehead and pioneer of synthetic biology, which changes the question from what life is, to what life can be?

Just a question of time We are rushing headlong into an era when the genetic code will not only be developed by evolution but will also be invented by people. Virtual genomes are constructed on computers and then converted via robot technology and the right chemical ingredients into new and

previously unseen organisms. It is probably only a question of time before genuine artificial life can be created. Living, reproducing, evolving organisms consisting exclusively of non-living components. Living organisms that may contain no DNA whatsoever. And as the American physicist Freeman Dyson has said; “The ability to design and create new forms of life marks a turning point in the history of our species and our planet”.

We need thinkers This is precisely when it is important to remember figures like Erwin Schrödinger. And that it was a theorist working outside his usual field with his ground-breaking vision who provided the first push towards what would later become biotechnology and the whole global biotech industry. Why is this important? Because on the one hand we desperately need great innovative thinkers, and on the other hand we have forgotten to emphasise and cultivate precisely that – thinking. We live in an era characterised by Big Science. Biology and biomedicine often involve huge amounts of genetic data in particular, which is dispatched on a tour of various pattern recognition computer algorithms in the hope that they will produce interesting new discoveries at the other end. But whether they are likely to produce genuinely radical breakthroughs is doubtful. In the midst of our enthusiasm for cascading flows of data, we must remind ourselves that the most valuable raw material in the world of research is actually human creativity. Because instead of making room for innovation, we have created

Photo: Lars Kaae

By Lone Frank

Lone Frank is a journalist and author with a Ph.D. in neuro­biology and a background in research. As a staff writer at Denmark’s leading news paper and LifeSciences Insight, she is a well-known voice in debates about science, technology and society. She is widely invited as a public speaker.

an academic system that largely rewards quantity more than quality – the number of publications counts more than how much they move the world. And overshadowed by the demand for eternal production, generating new ideas becomes difficult. For years, especially youngsters, who are actually in the most creative phase of their lives, are limited to mainly following other people’s overriding and sometimes antiquated ideas. We are facing colossal challenges. Climate change, demographic disasters and unpredictable opportunities for artificial life. This means that someone will have to lift his nose from the usual grindstone and seriously begin to think big. 

Translation: CLS Communication A/S

3


Highlights from Medicon Valley Edited by Malene Aadal Bo

A dynamic environment for clinical research is one of the most important cornerstones in ensuring future growth for the Life Science community in Medicon Valley. Clinical development provide new research, knowledge and skills and give patients access to new and often life-saving, medical treatment. However, the clinical research activity has faced dramatic falls in both Sweden and Denmark over a number of years. Fierce competition from foreign markets and a pressured agenda for public health care institutions, have been mentioned as explanations for the negative trend. Medicon Valley has excellent platforms for performing qualitative clinical research, but how can we regain our leading position? At the Annual Meeting of Medicon Valley Alliance we have asked Novo Nordisk and AstraZeneca to set the scene and benchmark Medicon Valley towards the rest of the world in terms of clinical trials. Together with researchers, hospitals and policymakers the two companies will discuss what it takes to regain Medicon Valley’s position on the “world map of clinical research”.

Photo: MVA.org

The Annual Meeting of Medicon Valley Alliance will be held Thursday 29 November 2012 from 1300-1900 hours at Hotel Hilton Copenhagen Airport. Participation is free for MVA members. Non-members DKK 4.000 ex. VAT. Register at www.mva.org/annualmeeting

4

Research steps up – I

At the end of August, the first ground was broken in a project involving the construction of a very special building. Christened the Panum Tower, it is an ambitious extension of the facilities at the Faculty of Health Sciences, University of Copenhagen. The tower will have 15 floors, all equipped with the latest laboratories and training and research facilities.

Photo: University of Copenhagen

Annual Meeting of MVA will focus on Clinical Research

“The new Panum is a beacon for the government’s ambition for more and better education at an international level,” said Martin Lidegaard, the Danish Minister for Climate, Energy and Building. According to Ulla Wewer, Dean of the Faculty of Health Sciences, the new tower will ensure that Copenhagen remains a leading light in terms of research into areas such as lifestyle diseases, healthy aging, immunology and cardio and brain disorders. A total of almost 43,000 square metres of auditoriums, laboratories etc. will be built in the 75-metre-high tower, which will rise as a clear landmark above the skyline. It was designed by architects from C.F. Møller and jointly funded by the A.P. Møller and Chastine Mc-Kinney Møller Foundation and the Danish University and Property Agency. The impressive building is expected to be completed in 2015. Read more at www.sund.ku.dk/byggeri


Photo: PR

Stricter rules for medical equipment in sight

Both in Denmark and on a European scale, the authorities are preparing to introduce stricter requirements for medical equipment. This will stop the many cases involving patients becoming seriously ill, for example, due to defective artificial hips – because they have not been tested properly. In Denmark, the government has a new patient safety package in the pipeline that will tighten the approval and safety requirements by introducing financial consequences for the industry if things go wrong. “This is a wake-up call which says that marketing such products just won’t do. Pilot studies, trials and product evaluations must be better,” says Ulla Astman (Social Democrat), Chairwoman of the Danish Region’s Health Committee, to Videnskab.dk.

Pharmaceuticals research focuses on cancer

Over half of the drugs under clinical development in Danish biotech companies are in the field of cancer. This was revealed by consulting material provided by Copenhagen Capacity – based on figures from the auditing and consultancy firm Ernst & Young. The analysis (which does not cover Novo Nordisk, Lundbeck, Leo Pharma and Alk-Abello) shows that together the Danish biotech companies, which are in a research and product development phase, have a total of 125 drug candidates in their pipelines: 54 per cent are within cancer research while the second-largest area, comprising about 12 per cent, is within metabolism and endocrinology, i.e. involving the metabolism and hormone related disease, including diabetes. In third place, 11 per cent of research and development is within neurology, i.e. brain disease in particular. This was reported by Medwatch.

Breakthrough in the fight against biofilm

Chronic infections are a huge problem throughout the western world and research into ways of exterminating these tenacious bacteria is intense. When the bacteria combine into what is called biofilm, they become resistant to antibiotics. Until now, researchers have only been able to guess at what actually happens when the chronic bacteria overpower the immune defence system. However, now researchers from the University of Copenhagen have managed to observe the bacteria directly in chronic infections. Using small silicone tubes and one of Europe’s most advanced microscopy centres they can see precisely how bacteria and immune defences interact in living tissue. This opens up for developing new medicines for fighting resistant bacteria. “Instead of looking down on the surface of bacteria, we can study the interaction on a cross-section and follow how the bacteria react to white blood cells and antibiotics,” says Associate Professor Thomas from the University of Copenhagen. The results have just been published in the scientific journal Infection and Immunity.

Temperature and Humidity Monitoring. Reliable, flexible, compliant. WWW

%rH

°C

Photo: Jan Henrik Ardenkær-Larsen

Danish invention optimises efficiency in the fight against cancer

A Danish researcher has invented a machine and method that make MR scanners up to 100,000 times more sensitive, which would be able to indicate immediately whether cancer drugs are working. The new invention is a machine that can magnetise trace elements. Together with a normal MR scanner, it gives an incredibly precise and unprecedented picture of what is occurring in the body and in the cancer cells. “We are currently testing magnetised trace elements in patients with prostate cancer but we have already been successful with animal experiments. If our project is completely successful, it could be a game changer in the fight against cancer,” says professor Jan Henrik Ardenkjær-Larsen, DTU, Electrical Engineering, who is behind the new invention, to Videnskab.dk.

Pa CO2 • Central Monitoring System for warehouse, cleanroom and laboratory applications • Calibration laboratory • Warehouse qualification and temperature mapping • More information on www.gmp-monitoring.com

b at Scanla Meet us -005B Booth C3 ELPRO NORDIC ApS | +45 45 17 41 60 | www.elpro.com

5


Research steps up – II

Nokia’s old headquarters in Copenhagen has been taken over by heaps of rucksacks and cycles since the winter – in other words students attending what is now the headquarters of Aalborg University in Copenhagen in Sydhavn, Copenhagen’s South Harbour district. There is room for all the university’s research and educational activities in the capital region – and Nokia has left some very special gifts in the offices; hi-tech equipment and laboratory facilities previously used by Nokia’s research and development department. The ambition is for the South Harbour address to be the setting for no less than the innovative university of the future. The buildings already house a number of knowledge companies and they want to attract more from Denmark and abroad. At the same time, the 42,500 square metre building is to house a number of start-up companies that will help identify uses for the knowledge and research produced at the university. “We are helping to create a new model for how universities and companies work together. Our research aims to help solve actual problems faced by private and public-sector institutions,” says AAU’s Rector Finn Kjærsdam.

Research steps up – III

Photo: RUC

The natural sciences cannot stand alone when solving future challenges. That is the view at Roskilde University, where they have taken the initiative to encourage better interdisciplinary conditions. As a visible sign of stepping up research, Henning Larsen has been asked to design a brand new building for the natural scientists. The new teaching and laboratory building is designed to support Roskilde University’s special project-based teaching form and focuses clearly on creating interdisciplinary teaching and research, while encouraging close cooperation between the researchers and students. This is achieved partly by gathering the individual researcher’s laboratories around and with direct access to the shared classrooms and partly by each unit housing researchers from different subjects. The former University and Property Agency under the Danish Ministry of Science granted funding for the building.

Productivity increases by 10 per cent a year for companies that enter into research partnerships with DTU. This is revealed by a survey conducted by DAMVAD consulting company. Companies cooperating with DTU on research have experienced an average rise of 10 per cent in productivity measured over a six-year period. This corresponds to an average gain of more than DKK 70,000 per employee or DKK 30 million per company. President of DTU Anders Bjarklev says: “Danish universities are essential for Danish growth, and the survey indicates currently unexploited potential. DTU has a goal of creating innovation for and with the Danish companies as we believe new knowledge and innovation is vital for achieving higher productivity to improve our welfare, which is precisely what this survey shows.”

Free knowledge available

If you have a small or medium-sized company, you may be able to receive up to DKK 100,000 in grants to purchase knowledge. The Danish Agency for Science, Technology and Innovation administers the scheme, which supports individual SMEs cooperating with a public-sector knowledge institution. This is accomplished via ‘knowledge vouchers’ worth up to DKK 100,000. The idea is for the company to benefit from the specialist knowledge built up in the public-sector knowledge institutions. At the same time, the vouchers increase the knowledge institutions’ attention to the companies’ needs and help strengthen the quality and relevance of public-sector research. The scheme has an ongoing application deadline and can be applied for regardless of whether you already have a cooperation partner or just an idea. See more at: www. fi.dk/tilskud/forsknings-og-innovationsprogrammer/ samspil-mellem-erhverv-og-vidensinstitution/videnkupon

We need these medicines…

The European Medicines Agency (EMA) is conducting a large-scale investigation of unmet needs within medicines for children. For example, the work is intended to enable companies to identify opportunities for business development, and in the first report, just published, they have mapped the needs within cardiovascular disease. See the list here: www.ema.europa.eu/docs/en_GB/ document_library/Other/2012/08/WC500131636.pdf The Agency will release similar lists in other therapeutic areas for public hearings during 2012 and 2013 according to Videnskab.dk.  Translation: CLS Communication A/S

6

Photo: DTU

Photo: PR

Technical University of Denmark (DTU) stimulates considerable growth in Danish companies


Medicon Valley and Massachusetts, USA,

sign pioneering agreement A new agreement will give researchers and businesses easier access to US research and funding. The partnership between the US State of Massachusetts and the Capital Region of Denmark, Zealand and Skåne focuses specifically on research and business development in the biotech, pharmaceutical and medical devices industries. By Claus Clausen A new partnership agreement between the US State of Massachusetts and the Capital Region of Denmark, Region Zealand and Region Skåne was signed in June at the major BIO 2012 convention in Boston. Potential benefits of the agreement include enhanced research partnerships, exchanges of researchers and students between Medicon Valley and Massachusetts, easier access to US research funding and increased business development in the Oresund Region. The new transatlantic agreement has been brought about by the Life Science Ambassador in Boston, Torsten Jepsen. “A cornerstone of this agreement will be the formation of strong consortia between Danish-Swedish researchers and companies and likewise from Massachusetts. These partnerships will be able to apply for research funding within the EU framework programmes and the American counterpart, the National Institute of Health (NIH),” says Torsten Jepsen.

Home to 500 biotech companies Massachusetts is home to more than 500 biotech companies and a large number of top-class health research environments, including Massachusetts Institute of Technology (MIT) and Harvard University. Last year biotech companies in Massachusetts received USD 1 billion in venture capital. This represents 23 per cent of the total US venture capital raised for biotech last year.

Facts: Nearly 900 drug candidates are under development in Massachusetts, and the state is home to the five hospitals in the US that receive the most state funding for research; last year totalling USD 2.5 billion from the National Institute of Health (NIH).

High expectations The three regions in Øresund have high expectations for the agreement. “Region Skåne’s objective is to be the most innovative region in Europe by 2020, so this is fully in line with our strategy. This is an important partnership that gives both our organisation and our employees an opportunity for development and training. But above all, good research and development mean better treatment for patients in Skåne,” says Region Skåne’s Executive Member Catharina Blixen Finecke. Marianne Stendell, Chair of the Capital Region of Denmark’s Committee for Future Education, Training and Research, sees the agreement as an important milestone: “We want the Capital Region of Denmark to be an international knowledge region that works with the best research environments and businesses in the world. The agreement with Massachusetts is an important milestone in this strategy.” Also Region Zealand is very much looking forward to the cooperation with Massachusetts. “We want Region Zealand to be an innovative region. A partnership across the Atlantic will put us

The partnership agreement between the Commonwealth of Massachusetts and the Capital Region of Denmark, Region Zealand and Region Skåne is designed to: • Promote exchanges of researchers and students • Promote activities that can enhance research partnerships in the field of life science • Identify special projects, partnerships or collaborations between the partners that can lead to new or enhanced research partnerships • Identify and use relevant state resources and programmes to support partnerships and the commercialisation of research and development projects and results • Establish a framework within which each of the partners can be involved in joint research and development projects financed by, e.g., the EU or the National Institute of Health, to develop new products and processes that can be used commercially on the global market. Find out more at www.mva. org or contact Medicon Valley Alliance for more information.

into contact with strong sparring partners and place us in a better position when we apply for research funding,” says Ole Drost, Chair of the Committee for Research, Innovation, Education and Training, Region Zealand. 

7


New name:

Annette Bang Oturai She is a pioneer within mapping the genes that give multiple sclerosis, but for a long time both she and her work were largely unknown. This changed overnight when she received the award for Danish Research Result of the Year in 2011, and the name Annette Bang Oturai has since earned its place in magazine columns and begun blazing a slightly wider trail in terms of research grants. By: Mikkel Ais Andersen In April, Annette Bang Oturai and her research colleagues Helle Bach Søndergaard and Finn Sellebjerg from the Danish Multiple Sclerosis Centre visited the University Hospitalet in New Orleans to participate in an international research consortium. Discussions centred on how to further develop the

Blue book Name: Annette Bang Oturai, 53 years old Position: Chief consultant, PhD and senior researcher at the Danish Multiple Sclerosis Centre, Neurological Department, Copenhagen University Hospital. She is also chief consultant in neurology and works as chief consultant at the sclerosis clinic at Copenhagen University Hospital.

8

research that, with the help of genetic variations, can illustrate how multiple sclerosis is caused – research that won Annette Bang Oturai and her research team the prestigious Danish Research Result of the Year Award in 2011. The award was the crowning glory for Annette’s work and a fitting reward for her long, hard and patient work. She began with research into mapping genes that can cause multiple sclerosis back in 1994, and this led her to pioneer uncharted territory. It was extensive work.

10,000 patients When Annette Bang Oturai began her research in the mid-1990s, only 400 genetic markers had been discovered. Today a chip enables us to read more than 500,000 genetic variations. Annette’s ambition was to identify which genes indicate a predisposition for multiple sclerosis but at that time technology was not sufficiently advanced. She had to think creatively to make the research happen. No one had previously approached the area from such a broad angle and that meant she needed to use far more patient material than was available.


So what do you do? You think big – outside the box and across national borders. Annette Bang Oturai managed to get an international collaboration up and running. A collaboration that was later to become the world’s largest genetic investigation. It included 10,000 patients and 17,000 controls and took her one step closer to solving the riddle of multiple sclerosis.

it is much easier for her when applying for new research funding to continue her research. However, she and her research team are not resting on their laurels. The groundbreaking results are providing even greater opportunities for continuing to develop the research and break the genetic code behind multiple sclerosis. And this only fires up her enthusiasm to keep working – because success may now be within her grasp and the many years of work can benefit patients. 

No resting on her laurels In connection with the International Multiple Sclerosis Genetic Consortium in 2011, Annette Bang Oturai discovered 29 new genetic variations specifically linked to patients with sclerosis. It was now time to analyse half a million genetic variations, and with the results, in one fell swoop, she more than doubled the number of known genetic variations found in patients with sclerosis. The results were published in the internationally acclaimed journal Nature and her research was suddenly in the spotlight, which resulted in her winning the Danish Research Result of the Year Award. No funding was linked to the award but it has meant that a lot of new people suddenly took notice Annette Bang Oturai. Now her name is appearing in various magazines and

Multiple sclerosis is a chronic disease that attacks the central nervous system and over time means that messages from the brain to various parts of the body have trouble or completely fail to get through. 10,000 Danes suffer from multiple sclerosis, which in the worst case can be debilitating and lead to life in a wheelchair.

Size: Reduced. Fun: Amplified.

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

For life science research only. Not for use in diagnostic procedures. LIGHTCYCLER is a trademark of Roche.

Roche Diagnostics A/S Roche Applied Science 2650 Hvidovre, Denmark © 2012 Roche Diagnostics. All rights reserved.

9


Photo of the month If you know a bit about viruses and bacteria, you’ve probably already recognised the object in the picture as a common or garden E. coli. Artist Luke Jerram has been fascinated by viruses and bacteria since 2004 and has a flair for recreating them as beautiful glass sculptures. The sculptures are correct three-dimensional reproductions of the various viruses and bacteria, and today they can be found in art museums all over the world as well as in medical journals and text books. www.lukejerram.com

10


11


Biotech industry

cuts to the bone The biotech industry in the Øresund Region has cut back drastically on activities. According to a new analysis from Medicon Valley Alliance, the “burn rate” was down in 2011 by 20% in Denmark and 18% in Sweden. By Claus Clausen According to a new survey conducted among 48 unlisted private venture capital-based companies in Medicon Valley, biotech companies in the Øresund Region are still struggling to stay afloat. The ”burn rate”, a measure of total corporate capital consumption, was down in 2011 by 20% in Denmark and 18% in Sweden. Overall, employment is expected to decline by close to 10 per cent, to some 400 employees, in the 48 companies in 2012. Moreover, 40 per cent of the companies need fresh capital this year to maintain their existing level of activity. “Luckily, there has been no spate of failures among the Medicon Valley biotech companies, but activities have been drastically reduced. There are some bright spots such as the recent sale of Action Pharma to Abbott. But a number of companies have shifted into low gear, putting projects on hold, and several companies are shedding their physical offices to adopt a virtual model

with very few employees, meaning that they spend a large share of the funds raised outside Medicon Valley,” says Stig Jørgensen, CEO of Medicon Valley Alliance. Overall, the 48 companies participating in the survey raised fresh capital totalling DKK 694 million in 2011. In a similar survey conducted among 44 biotech companies in 2010, DKK 555 million was raised. However, the DKK 694 million includes DKK 250 million received by Symphogen in 2011 out of total capital raised of DKK 750 million.

Signs of stability The challenges faced by the biotech industry in terms of raising capital are not confined to Medicon Valley. Rather, these challenges have become a general issue in the wake of the financial crisis. However, Ernst & Young’s annual biotech report, Beyond Borders: global biotechnology report 2012, shows that the financial performance of the biotech sector may be stabilising.

Capital Raised, 2009-2011 M€ 80 Danish Companies

Swedish Companies

70

76,35 (with Symphogen)

60 50

53,27

40

42,85

39,67

20

20,17

16,81

10 7,31 0

2009

12

2010

2011

Source: Medicon Valley Alliance

30


“The global biotech industry showed a second straight year of increasingly stable financial performance in 2011, with established biotech markets registering more than 10 per cent revenue growth for the first time since the start of the global financial crisis. However, longer-term sustainability remains challenging, with the traditional funding-and-innovation model for precommercial biotech firms under unprecedented strain and the industry’s efforts to date to “do more with less” uncertain to deliver significant productivity gains,” the report says. On the Danish side of Medicon Valley, there are flickers of light when it comes to the venture capital market. In recent years, SEED Capital, Sunstone Capital, Lundbeckfond Ventures, Northzone Ventures, Novo Growth Equity, Venture Partners and Vækstfonden, among others, have provided fresh capital. But the fresh capital has not really been put to work in the companies yet. One explanation is that investment requirements have been tightened after the lessons learned from previous mistakes, another is that there is a lag from the time the capital is placed in the funds until it is converted into real investments in companies. While the Danish venture capital market is showing signs of thawing, the Swedish side of Medicon Valley remains in dire straits. In Scania, a number of venture

About the survey The survey focuses on unlisted biotech companies, and 57 relevant companies have been identified in Medicon Valley, nine of which did not wish to participate. In the spring of 2012, questionnaires were sent to all companies, surveying them, in part, on their actual financial circumstances in 2011 and, in part, on their expectations in terms of their financial position this year (2012). Medicon Valley Alliance has been conducting this financial survey for the last three years, each year with a different circle of biotech companies as participants. In the current survey, 34 of the 48 companies also participated in the 2010 survey. Accordingly, the findings of the previous financial surveys are not fully comparable, but they do point to trends and indications in the companies’ financial performance.

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

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

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

Biomarkers Identification, validation and documentation of disease relevantbiomarkers.

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

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

Bioneer A/S Kogle Allé 2 DK- 2970 Hørsholm

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

13

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


capital companies such as PULS AB, Malmöhus Invest, Teknoseed, Rosengård Invest and Innovum Invest have cut back drastically on the flow of venture capital for new investment. Hans Möller, Chairman of Swedish Incubators & Science Parks (SISP) and CEO of Ideon, calls the lack of venture capital for a “disaster”. Heads of the Swedish science parks have begun looking at the possibility of setting up their own venture capital funds in order to finance growth companies. The science parks are inspired by the Stockholm-based incubator, Sting, which earlier on this year began the work of raising 200 million for a new fund.

Lack of foreign directors on company boards Stig Jørgensen, CEO of Medicon Valley Alliance, points out that Medicon Valley faces an additional set of challenges when it comes to raising venture capital. “Much excellent research is conducted in Medicon Valley, and we have a relatively strong pipeline of potential new drug candidates. But we fail when it comes to attracting foreign venture funds. For one, the industry in general suffers from poor framework conditions, for another the biotech companies are not sufficiently international in their operations. For instance, there is a severe lack

Leading experts in language services to the Life Science Industry

CLS Communication A/S DK-1160 Copenhagen K | T +45 3332 3452 | info-dk@cls-communication.com | www.cls-communication.com |

11555 / JPbureau Group

CLS Communication offers a full spectrum of language services. However exacting and varied your requirements, we have the experience and linguistic expertise to fulfil your needs.

19 local CLS offices worldwide make sure your message matters: Basel | Beijing | Chiasso | Frankfurt | Hong Kong | Copenhagen | Lausanne | London | Madrid | Moncton | Montreal | New York | Ottawa | Paris | Quebec | Shanghai | Singapore | Toronto | Zurich

14

of foreign directors on company boards and advisory boards,” says Stig Jørgensen. The companies participating in the survey are planning to raise DKK 427 million in 2012. Almost one out of three companies (38 per cent) assess that they have more than a 50 per cent chance of raising the necessary capital. At the same time, the expectation is for the burn rate to grow by 28 per cent in Sweden and 24 per cent in Denmark. In 2011, half of the biotech companies spent more than 20 per cent of their R&D expenses outside Medicon Valley. “It is a sign of danger because providers of research and development activities in this region are struggling in the competition due to, among other things, our high level of expenses,” says Stig Jørgensen.

New funding models required Medicon Valley Alliance points out that the biotech industry needs to look into new funding models. Most founders of new companies have been driven by the vision of developing a new Novo Nordisk. But the road from idea to fame is a very long and bumpy one. Stig Jørgensen therefore calls attention to a new model under which a company no longer has to take a drug through the entire process from development to market. “We don’t need 25 companies to develop 25 products. Rather than having each company struggle to build the in-house competencies to drive the entire development of a drug towards exit to the market, it may be better to split up the process and have specialised companies handle specific phases of the development process.” Stig Jørgensen points out that some companies could specialise in maturing early-stage research, e.g. by universities to a stage where a few development candidates for each idea are evaluated and patented. By being proficient in the very early stages, the same team could mature 10 candidates and sell them to new companies specialised in completing the pre-clinical development until the first dose to humans. Once the idea reaches the clinical development phases, other specialised companies take over until an almost finished product can be sold to one of the major global companies with the clout to handle international marketing and sale. The advantage to organising the sector in this manner is that the overall risk, and thus gain, is divided equally between a large number of players, and the chance that some of the original ideas will make it all the way to market increases significantly. Stig Jørgensen suggests that such companies could be set up under the tech transfer environments at the universities, as they are designed to partnerships between research and industry. “The important thing is for the government to assume greater responsibility and risk in the very early stages – against the possibility of a later gain. Private investors find it difficult to cope with the risk in the very early stages. They only enter the scene when an idea has proved to be viable.” 


15


The Turning Point

One day

in Stockholm…

Bert Junno, CFO of Swedish-based Wnt Research, has given innumerable presentations on his company’s research in the effort to raise funds. But one day in Stockholm he finally spoke to an audience that would ultimately secure the development of the company. In the end, that day promised SEK 19.5 million to the company.

By Elisabet Ottosson, MSc, journalist Wnt Research in Malmö was established as a company five years ago in order to realise the development of professor Tommy Andersson’s and his scientific team’s discovery at Lund University. The company develops a

drug that targets the fatal phase of the cancer disease: metastasis formation. The researchers had shown that lack of a specific molecule, Wnt5a, in cancer cells was linked to cancer progression in a variety of tumour types. The preclinical tests showed very promising results. But as for most companies of this kind, every day is a fight to raise the necessary funding to keep the business running. Eventually, the day came that would tip the scales and serve as a turning point for the company.

Wnt Research

It doesn’t come easy

Wnt Research was founded in 2007 as a spin-out from Lund University.

One year ago, Bert Junno was invited to speak at a meeting in Stockholm, arranged by a shareholder association. Some of the participants contacted him after the presentation. They turned out to be Swedish representatives of the large investment group Global Emerging Markets, GEM. “They already knew about Tommy’s successful research. And they had confidence in the management’s ability to succeed. All this led them to offer us the funds we need,” says Bert Junno. Quite often investors contact him in connection with meetings, so he was not surprised by the attention.

The focus and aim of the company is to develop novel, anti-metastatic therapies for the treatment of cancer patients. The company has two projects: Foxy-5 and Box-5. The drug candidate Foxy-5 has proven in the initial studies to affect colorectal, breast and prostate cancer.

16


The Turning Point

Sometimes these investors promise the world, but then in the end it comes to nothing. “This kind of thing doesn’t come easy. You have to work hard to achieve results; have many meetings with possible investors. It’s like an athlete who has to exercise every day in order to win,” he explains. But a few weeks ago the deal was reality. The small drug development company was granted up to SEK 19.5 million from the GEM. This is the biggest funding promise ever received by Wnt Research. Together with the probable additional grants from the Eurostars funding and support programme, the path is paved for further

development of the drug candidate: Foxy-5, through clinical phase 1 and continuing into phase 2 clinical studies.

Important to be convincing When asked how he feels about the agreement, Bert Junno smiles and answers: “I’m very pleased that we have attracted international investors, which is promising for future financing.” One of the success factors for being able to raise substantial funding is to have experienced people in the company, in science and entrepreneurship. “Also, you should have a product which targets an important medical need, and you must be convincing when you say you can create value,” concludes Nils Brünner, CEO of Wnt Research. 

Photo: Lund University

You have to work hard to achieve results; have many meetings with possible investors. It’s like an athlete who has to exercise every day in order to win.

Professor Tommy Andersson, Lund University.

17


I caught

‘the biotech bug’ Martin Bonde is CEO of EpiTherapeutics, a successful biotech company, and the new chairman of Dansk Biotek. His advice to others wanting to run a business in this sector is forget choosing between being a nerd or a businessman and make sure you are both.

By Morten Steen Photo Bengt Juliusson

“Everything starts with the market. Your products must be in demand. Getting fired up and just chasing one technological whim or another is a systematic waste of time – and I’m not interested in that anymore.” The answer is prompt but that is hardly surprising really. The man giving this answer has spent most of his life working in the biotech industry, so he has had plenty of time to consider the link between research and business. The answer given by Martin Bonde, a civil engineer with a PhD in chemistry and more than two decades of experience as a biotech initiator and entrepreneur in both Denmark and the USA, rings true to some extent, and he summarises his attitude to the ideal interaction between basic research and making a profit thus:

We were fuelled by our own enthusiasm over being able to make biochips and all kinds of things with it, but we forgot to ask ourselves who needed them

18

“You must begin by identifying a need in the market. Probably our greatest mistake was when I once helped found Torsana Biosensor. We were fuelled by our own enthusiasm over being able to make biochips and all kinds of things with it, but we forgot to ask ourselves who needed them,” explains Martin Bonde. The start-up company was good business nevertheless because it was sold to a US company – but the buyer subsequently had trouble placing the technology in the market. The chairman of Dansk Biotek has remembered this lesson throughout his career. Today, he is CEO of EpiTherapeutics, a small Danish biotech company with four years under its belt that produces medicines to fight cancer. “One of the first things we did at EpiTherapeutics was to ask whether a new way of treating cancer patients was even needed. The answer is clearly yes! There is a government-guaranteed need for new cancer medicines in the market, and I am definitely convinced that the medicines Epitherapeutics can produce will be needed.”

Chemical engineer with a head for business “Serial entrepreneurs” is what they call Martin Bonde’s kind in the US. Over the years, he has helped establish and run a good handful of biotech companies. With a PhD in chemistry from the Technical University of Denmark (DTU) and a BCom in foreign trade, Martin Bonde has a foot in


Martin Bonde CEO Epitherapeutics Aps and Chairman of the industry association DANSK BIOTEK


both camps in terms of research and business. A chemical engineer with a passion for business adventures, you could say, but is he more of a biotech nerd or a business developer? “I probably focus most on the business side, but in biotech you need a basic understanding of what is happening in terms of technology. If you don’t understand the product, you can’t sell it.” The specific combination of chemical engineer and business flair that gelled to form Martin Bonde’s destiny was due more to chance than career planning. “My mother, who is a laboratory technician, once told me with a wry smile that chemical engineers had an easy life and didn’t do very much. It sounded appealing and no doubt affected my choice,” smiles Martin Bonde, before once again becoming serious. “I found chemistry easy and you have to choose something or other after high school. I grew up in Aarhus, but wanted to move to Copenhagen, so DTU was a fairly obvious choice.” The courses sparked the young student’s interest and triggered his ongoing career, but at that time Martin Bonde had no clear idea that his future would lie in the field of biotech. “Often life is a matter of chance. I can remember enjoying some courses on antibodies and genetic

About Martin Bonde Martin Bonde is a 49-year-old civil engineer with a PhD in chemistry from DTU. He also holds a BCom in foreign trade. After completing his PhD, Martin Bonde began his career in 1990 as a researcher at Dako. Two years later he changed to Osteometer Biotech, where in addition to working in the laboratory he acquired a taste for business development. This led to a position as Vice President for Business Development and then Managing Director of the company.

HB Medical packs, repacks and fills up for pharmaceutical and biotech companies. HB Medical packs and distributes for clinical trials HB Medical offers pharmaceutical consulting services HB Medical has been approved under section 39 by the Danish Health and Medicines Agency and is authorized by the Danish Veterinary and Food Administration • Production/packing/repacking • Storage and distribution of study medicine • Storage room with refrigerating facilities • GDP / GMP • Consulting business HB-MEDICAL APS KANALHOLMEN 25-29 · BUILDING 6 DK-2650 HVIDOVRE T: +45 36 49 55 00 F: +45 36 49 55 07 E: HB@HB-MEDICAL.DK WWW.HB-MEDICAL.DK

20

In 1998, Martin Bonde was offered the chance to get in on the ground floor with a new company when he helped found Torsana Biosensor. Just two years later the company was bought by US investors so Martin Bonde moved to San Francisco with his family to continue the company under the name CelTor Inc. After two years in the US, he returned home to Denmark and became CEO first at Combio A/S and then at NatImmune A/S. In 2009, he became CEO at EpiTherapeutics ApS while also founding a company called Aros Pharma ApS. He has since left Aros Pharma ApS. Martin Bonde was recently elected chairman of Dansk Biotek, an industry association. In his youth, Martin Bonde played elite team handball in Denmark’s top division for six years. His team won a bronze medal in the Danish Championships in 1985 with Ulrik Wilbek, a young and at that time unknown coach who is now head coach for the Danish men’s national handball team. Martin Bonde is married and has three children.


engineering. I got to know some interesting people working with the subject and at the same time the funding appeared for a new research centre and I was asked if I wanted to do a PhD. And that’s how it all began.”

Facts on EpiTherapeutics Epitherapeutics was founded in 2008 and works with cancer research within epigenetics (the operating system for decoding human genes.)

Research and business Martin Bonde earned a PhD in chemistry but life as a researcher turned out to be less appealing than the opportunity to work with business. His first job outside academia was in a development department of a company called Dako, which worked with antibodies. Although Martin Bonde was employed in a development department, he quickly became interested in the cooperation between business and research in the company – or rather the lack of it. Therefore in late 1992 he seized the opportunity to join one of the first Danish biotech companies to be launched and took the helm in terms of business development. The company was Osteometer A/S, and its focus area was osteoporosis. “I was both working in the laboratory and a one-man army in the sales department. I had an idea that I could develop the interaction between the two.” Martin Bonde then became Vice President in charge of Business Development, and in 1995 was promoted to Managing Director. That was when the biotech industry took off. At Osteometer, Martin Bonde could pursue his passion for the

Looking for specialists?

EpiTherapeutics works to find specific inhibitors for a group of enzymes that are overactive in cases of prostate and oesophagus cancer. The inhibitors must therefore be developed into new medicines. Today the company has 17 employees in Denmark and nine in Canada and has so far received DKK 70 million from investors. EpiTherapeutics is based on pioneering research by professor Kristian Helin and his team at the Biotech Research & Innovation Centre (BRIC) at the University of Copenhagen. Kristian Helin works as a consultant for the company. The investors include Novo Seeds, SEED Capital Denmark and Lundbeckfond Ventures, Astellas Venture and Merck Serono Ventures. Read more at www.epitherapeutics.dk

Looking for new challenges?

Workindenmark is a special unit under the Danish Agency for Labour Retention and International Recruitment that provides professional free of charge service for Danish companies and foreign specialists. We offer a high level of assistance in the field of recruitment, settlement and retention in Denmark. For companies

For specialists

• • • • •

• • • • • •

Database with highly skilled candidates Branding your company on job fairs abroad International branding of your vacancies Facilitating your contact to Danish authorities Settlement and retention of your international employees

Largest job bank in Denmark for foreign specialists Matching your profile with Danish companies Facilitating your contact to Danish authorities Information about living and working in Denmark A good start for you and your family Job search and support for spouses

www.workindenmark.dk

21


commercial aspect of the work while enjoying the freedom to try his hand at selling the products in earnest. “That’s when I caught ‘the biotech bug’. Not all biotech companies succeed in their work, but we did. That’s why it was so incredibly exciting to be part of it. And once I’d seen the world of opportunities opening up, naturally my next project was also in biotech,” says Martin Bonde. After a good five years at Osteometer Biotech, in 1998 he founded Torsana Biosensor, and has since helped found and develop companies such as CelTor Inc., Combio A/S, NatImmune A/S, Aros Pharma ApS, Visiopharm A/S and most recently EpiTherapeutics ApS.

The way forward A cornerstone of all companies is the link between innovative ideas and the ability to create a successful business. And as chairman of Dansk Biotek, this is the very

idea Martin Bonde wants to strengthen within the biotech industry in general. Initially, he will focus particularly on the innovative values and on safeguarding the fuel on which the companies will run. The innovative discoveries will play a vital role in the industry’s continued success, Martin Bonde believes. He has proven this with EpiTherapeutics, which since 2008 has raised DKK 70 million through its work in cancer treatment based on research from the Biotech Research & Innovation Centre (BRIC) at the University of Copenhagen. “The theme linking my career has been the desire to develop exciting new biotech products, and the most interesting aspect is when we manage to create something customers value enough to buy. I’ve always been interested in that – whether or not I worked in a laboratory or had business responsibility.” 

The chairman’s visions for danish biotech In May, Martin Bonde was appointed as the new chairman of Dansk Biotek, an industry association. Here he describes his vision for the future of the Danish biotech industry. What is the situation for the Danish biotech industry today? There is great potential. Companies such as Novo Nordisk, Lundbeck and Leo Pharma are taking off and in the area of industrial enzymes we have the world’s two leading companies, Novozymes and Danisco to be precise. On the management side, a number of ‘serial entrepreneurs’ have emerged who have been involved with a variety of biotech companies and know what it takes. With Novo Ventures/Seeds, Seed Capital, Sunstone Capital and Lundbeckfond Ventures, we also have a range of venture funds that have money. Consequently, there are decent opportunities for starting and funding companies in Denmark, though getting money out of the venture people is no easy task.

22

Nowadays, the idea that a new Novo Nordisk or Genentech will evolve from a newly founded biotech company is unrealistic. The venture companies want a faster return on their investments and as the major companies need new projects in their pipeline they are poised to buy as soon as the small companies produce robust results. That’s all very well but it requires a special business model that makes research and tech trans more structured and builds up a “package” that can be sold to the major companies. Fortunately, universities and tech trans offices are becoming increasingly interested in commercialising research. In 2004, the small Danish biotech companies achieved turnover of DKK 800 million. In 2010, this had risen to DKK 5 billion. There is plenty of growth potential but how do we realise it? Within drug development it takes far too long for one biotech company to take a product to market, making it much too

expensive. We therefore need to focus on finding exciting drug candidates and selling them on to pharma companies that can market them. We generally need to be very pragmatic and within each field of the biotech industry find the business model that best suits the market. It is good practice to do what you are best at. As professionals, we therefore need to pursue areas where we are the strongest in the world. That’s the best way to generate the most possible value out of every single penny invested in the company.


Quality Research Deserves Quality Logistics – Please Let Us Help You Succeed 2010 World Courier is the first specialty courier to offer fully GxP-compliant transport to the pharma R&D community.

Let’s get acquainted! We would like to invite you to visit our facilities, to learn more about our services, GxP approach, and meet the staff. Call us today to arrange a tour.

Meet us at: BioPharma Nordic Convention December 4–5th 2012, Crown Plaza Towers, Copenhagen

For contact information visit www.worldcourier.com COPENHAGEN: +45 32 46 06 80 | HELSINKI: +358 9 8700 3300 | OSLO: +47 63 94 62 00 | STOCKHOLM: +46 8 594 414 80


What happened to...

The cure for schizophrenia? In 2008, several major newspapers featured the headline that a Danish research team had cracked the code for treating schizophrenia. The research opened up a host of new opportunities and expectations were high. Now, four years later, the once promising results have still yet to be converted into concrete treatment options, but the man behind the research is convinced that groundbreaking results will be seen within the next few years. By Mikkel Ais Andersen Schizophrenia and other serious mental conditions have traditionally been shrouded in mystery. Proposed remedies have included exorcism and lobotomies, and Hitler believed you could eradicate mental conditions by exterminating the people suffering from them. Naturally, none of these methods proved particularly successful. Today, schizophrenia is an incurable illness that is difficult to treat because it is a complex combination of nature and nurture, and you cannot just dissect a human brain to remove the illness. All that is about to change, however, with indications that entirely new insight into schizophrenia may be revealed within a few years. This will form the basis for developing new types of medicine to help patients who are seriously affected.

Great expectations To identify the technology that has a bright future, we need to go five years back in time. In 2008, the head of research at the Institute of Biological Psychiatry, Thomas Werge, hit the headlines in the national media. The articles explained how he had solved the riddle of the illness, and his results were expected to be able to produce a whole new treatment method. The riddle, or the paradox as it was referred to in the

Schizophrenia About 20,000 Danes have schizophrenia The risk of developing the illness is approx. 1 per cent. Schizophrenia affects both sexes equally frequently and usually begins at15-30 years of age. The illness was previously called ‘youth lethargy’ in Danish.

24

headlines, was that people with schizophrenia have fewer children than the rest of the population, which should mean, as the illness is genetic, that it should slowly die out. Over time, fewer people should be affected by the illness – but that was not the case. Thomas Werge and his research team discovered that schizophrenia can result from a newly created mutation caused by fundamentally unstable genetic material – like the genetic roots of hare lip and Down’s syndrome. And even if such mutations are constantly removed from the population, it will continually reappear, so the illness never disappears. The Danish Association for Mental Health, SIND, hoped at the time that over the long term, the research team’s breakthrough would lead to gene manipulation and better treatment for the illness. It was heralded as a massive breakthrough – a revolution. The question is what has happened since then? “Since 2001, I’ve been researching the causes of schizophrenia to find new treatments and there is no doubt that the discoveries in 2008 were a major breakthrough. We discovered dimensions of the illness that were previously unknown,” he says. The paradox and its solution paved the way for entirely new knowledge after 2008 and new opportunities for researching into the genes that cause schizophrenia. Thomas Werge blazed a completely new trail and has since made additional new discoveries. “We have exposed a brand new type of genetic variation and were surprised to find that as many as 70-90 per cent of the population has the gene variations that can produce schizophrenia.” Thomas Werge explains with enthusiasm. “As the majority of the population carries genetic variations that are disposed to schizophrenia, these variations are probably of positive evolutionary importance to mankind and perhaps schizophrenia is the price humanity must pay to achieve the positive effect: a positive effect with a background that remains unknown to us.” Meanwhile, Thomas Werge has continued researching and found more genetic variations that could explain the


cause of schizophrenia, and he is determined to continue his work. “The more genetic variations we reveal, the more we will understand the illness, and that will increase our opportunities for developing new treatments,” he explains.

Small positive steps are being made all the time and patience is required when waiting for research results at this level. The National President of SIND, Knud Kristensen, had hoped that the results, which were revolutionary at the time, would have generated more specific knowledge and treatment methods. But he acknowledges that this takes time. “I realise that serious mental illnesses are extremely difficult to treat – and not least cure. And naturally, it will take time to unravel the entire illness and then create the perfect treatment options. I am an optimist, however, and I believe that in the short term the new research results could help to improve the medicines, so we can minimise the side effects currently associate with them.” Thomas Werge has a much rosier view of the future. Together with his colleagues from Copenhagen and Aarhus, he has just received DKK 121 million from Lundbeck’s research foundation and is working with a research team from H. Lundbeck A/S and deCODE Genetics in Iceland to introduce genes with the schizophrenia disease in mice.

Photo: Scandinavian Stock Photo

Minimising side effects

Within the next few years he hopes to have new animal models that can be used to develop the next generation of medicines for schizophrenia. “The vast majority of large pharmaceutical producers worldwide have stopped developing medicines for treating serious mental illnesses because what can be developed has already been developed on the experimental platforms available. I think we can help change that, so we can create the foundation for new medicine and treatment methods,” he says optimistically. 

Buy ELGA LabWater products online Order high quality watertreatment systems and consumables online – whenever it suits you.

PURELAB Flex

MEDICA

PURELAB Ultra

Visit www.eshop.elgalabwater.dk Or contact: Mette Linding Nielsen, ELGA specialist T: +45 26 28 31 41, E: mln@kruger.dk

ELGA distributor Fabriksparken 50 2600 Glostrup, Denmark

25


Spotlight on synthetic biology

If you are wondering what line of work to pursue in the future, you could do worse than add “synthetic biology” to your list. That is what the chairwoman of the Danish Council for Strategic Research believes, and both researchers and investors agree, calling its potential “mindblowing”. By Malene Aadal Bo In 1974, a cancer specialist at the University of Wisconsin predicted a world in which science had learned to master biology so thoroughly that it could create life from scratch. Forty years later it appears that Waclaw Szybalski, which was the man’s name, would seem to be right. Szybalski called the method synthetic biology, and today many people perceive the work of synthetic biologists as being among the most promising in modern science. “I think our imagination alone limits what we can achieve. The human genome has been mapped, artificial life has been created successfully, and we have come a long way using living organisms to produce substances and materials that they do not usually produce, and in a magnitude and form managed and designed by humans. And that is just the humble beginning,” according to Professor Gunna Christiansen. She is former head of the Institute for Medical Microbiology and Immunology at Aarhus University and chairs the Danish Council of Ethics and Technology working group that compiled a report last year on the opportunities presented by synthetic biology. She and many others believe that synthetic biology is the route to creating some of the things the world needs most; revolutionary new types of medicine, healthy and climate-friendly food and not least sustainable energy.

But what exactly is synthetic biology? Synthetic biology as a concept was coined decades ago and should be seen more as a method and scientific approach than independent technology. The cornerstone is

26

cross-disciplinary work between the various Life Science technologies such as genetic engineering, biochemistry, molecular biology etc., and the vital addition is the systematic and logical production line mindset common to the art of engineering. As Gunna Christensen says, “biotechnologists are very good at moving genes around, but if they are to upgrade to anything more complex starting with the drawing board, having some engineers involved is a major advantage.” This has now begun in earnest at some of the world’s leading research institutes, and the number of researchers and practitioners, who are called or call themselves synthetic biologists, is rising day by day. Some work on becoming even more advanced at skills we already have to some extent, such as influencing and managing natural organisms’ own processes via, e.g., gene therapy or cloning. Others have thrown themselves into more advanced branches of synthetic biology, where you use the knowledge you have about nature to create entirely new life with a particular purpose in mind. The latter has, so far, proved most successful for the US geneticist and synthetic biologist J. Craig Venter, who was the first to map the human genome, and who produced an artificial genome in 2010, inserted it in an otherwise empty host organism and got the new organism to reproduce. The perspective for synthetic biologists is that you can choose and compose a genome exclusively with the functions you need and insert that gene into a suitable organism – just as you would build a computer programme from different pieces of code and insert it in a computer. This makes it possible to build small machines for making effective and pure productions of the exact substance you want.


The Nordic region has good prospects Gunna Christensen is in no doubt that this new professional and methodical watershed represented by synthetic biology will produce many important and useful products that can make a difference to humanity. Peter Olesen, Chairman of the Danish Council for Strategic Research, agrees. “Right now we are moving very fast at a time when the world is threatened by shortages of especially energy and food. This creates a need for being able to produce more and in a sustainable way. I think synthetic biology can help solve that challenge – the entire technological arsenal is being used and combined for the purpose of making effective and sustainable production systems,” he says. And the chairman believes that Denmark and the other Nordic countries have good scope for becoming genuine pioneers in this area; because we have a tradition for research policy that involves working together across research areas and technologies; because we have some very large Danish biotech production companies; because we have already come a long way with the entire concept of sustainability and because we have some very strong biotech research environments, according to Peter Olesen. The research environments include the synthetic biological research centre at the University of Copenhagen, and the Center for Fundamental Living Technology at the University of Southern Denmark (SDU), which the Danish Ministry of Science, Technology and Innovation has so far supported with a total of DKK 150m.

Peter Olesen is convinced that the knowledge created in these and similar places will prove to be relevant – also for companies and investors because – as he says – it’s just a question of time before formal requirements and market specifications begin increasing demand and the need for sustainable solutions.

Biofuel will be first Trygve Brautaset has a PhD and is research manager at SINTEF, the largest independent research institute in the Nordic region. He helped to start two small companies based on synthetic biology and is currently coordinating a major EU project in the area. He agrees with the Danes that the potential in the field is enormous, and is an area the industry is keeping a very keen eye on. “There is no doubt that a watchful eye is being kept. Not least when it comes to developing sustainable energy, which is an aspect synthetic biologists are working on. I think almost all the major oil companies in the world are currently pumping both money and attention in that direction,” says Trygve Brautaset. He has just returned from a conference with some of the world’s leading synthetic biologists and can see that in addition to sustainable energy, researchers are focusing especially on developing new treatment forms and medicines – and the industry is following their progress with interest. According to Trygve Brautaset, much of what is

Bioanalytical Solutions · York · Sandwich · Copenhagen

Lamprocapnos spectabilis (lyre-flower, Venus’s car) Lycorine: a potent antitumor compound under investigation for cancer treatment

We make a difference to the development of new medicines Unilabs, Denmark, Tel: +45 3374 3091

27


What is synthetic biology? Professor Trygve Brautaset from SINTEF (the largest independent research institution in Scandinavia) calls synthetic biology a “powerful cocktail of biotechnology and engineering” and defined it as “redesign of biological systems and their parts for useful and practical purposes”. He highlights that it really isn’t a new science but a conceptually new mindset and way of drawing on many subjects and disciplines. He considers system biology – understanding how all the parts of a cell cooperate to create and maintain life – as the core of synthetic biology, and he defines four phases that must be navigated to create new biologically inspired products: 1) Understanding nature’s unique connections and properties (genes) 2) Discovery of new properties possessed by existing organisms 3) The isolation, modification and combination of these modules in other host organisms 4) Construction of new “unnatural” biological systems for specific purposes Key technologies within synthetic biology are therefore: 1) Gene synthesis and DNA sequencing 2) Viral and non-viral transfer methods 3) Model-based assessment of genetic systems According to a report from the Danish Technological Institute, synthetic biologists basically work in two ways: bottom up – or top down. With a top-down approach to synthetic biology, researchers focus on simplifying cells. Often you start with living cells and remove the genes from the genome until the genome is so simple that the cell is just able to reproduce itself. The genes can then be taken apart and used as “biobricks” for producing new organisms. New artificially produced genomes can also be transplanted into living cells. This approach is a natural extension of traditional gene technology and is also called “radical genetic engineering”. With a bottom-up approach, researchers focus on producing a minimally living system – a protocell – from non-living, inorganic materials. One variant uses materials that are essentially different from modern biological molecules. Another uses the components from existing biological cells. Bottom-up is a natural extension of the studies of the origin of life and research into artificial life, through which you also experiment with life in media such as robots and computer networks.

28


taking place is still at basic research level and for a while yet major breakthroughs will depend on public-sector support for the universities and the independent research environments. “Here at the institute, we are currently working on developing new microorganisms that can live on better and cheaper non-food raw materials – specifically, we are trying to get them to live on methanol, which is inexpensive and widely available, unlike sugar, which they often live on today,” says Trygve Brautaset. This knowledge can be very important to companies that will be using microorganisms in future to produce everything from biofuel to medicine. However, so far, no company or investor has injected money into the basic research. And that is fair enough, says the head of research, who does, however, warn that the patience the outside world has for synthetic biology is unlikely to last very long. “The potential is huge and so is the interest but it is very important that the synthetic biology very quickly begins to demonstrate its commercial potential and starts delivering results and marketable products,” he says.

Is there anyone willing to pay? The same testimony comes from Sten Verland, a partner in the venture company Sunstone Capital – the largest investor in Nordic biotech.

“Synthetic biology is a super interesting research area with major potential and one where we have a strong position in the Nordic countries,” he says. But Sunstone Capital does not invest in research – it invests in early product development phases. “The most important aspect for us is whether there is a specific product time. Whether there are any patients it can help. And whether anyone will pay for the product when it is finished,” says Sten Verland. Synthetic biology is not a new investment area for Sunstone Capital, which was among the first to invest in Evolva, for example, which uses baker’s yeast as a synthetic facility for producing various substances. However, in this field products suitable for investment are few and far between. “I expect that within 3-5 years we’ll be seeing more product-oriented projects and that within 10 years we’ll be seeing projects that are so mature that they are very interesting for venture investors such as Sunstone Capital. And when the projects come, we will definitely be interested,” promises Sten Verland, giving three good pieces of advice to potential entrepreneurs: “Firstly, what is vital to us as investors is not whether the technology behind the product is exciting or revolutionary – the vital aspect is whether the product has a place in the market. Then focus on the product. Secondly, it is important to choose the method that

enterprise Software for in-house IPR management. By Patrafee. Patrawin® gives you instant control of your IPR families divided into product categories or business areas. This easily installed application simplifies everything from control of deadlines to mass-updating and document management. A web interface is included for access and distribution within your organisation. For more information about Patrawin® and the patent annuity services provided by Patrafee, visit patrafee.com »

IPR Renewal ManageMent & SoftwaRe SolutIonS

w w w. p a t r a f e e . c o m

29


Photo: J. Craig Venter Institute

minimises uncertainty as far as possible – if you have a product that can be made in several ways, I would definitely consider using the method with the least risk – even if you could perhaps achieve a slightly better product using another method. Thirdly, we only invest in knowledge that is protected, so make sure it is a product or a technology that is patented or protected in another way,” says Sten Verland. According to Sten Verland it will take 10 years before we see a major commercial breakthrough for the synthetic biology in the Nordic region, and according to Gunna Christiansen it could take anything from two to 100 years. However, both agree with Peter Olesen and Trygve Brautaset that now is the time for Nordic researchers and companies to jump on the bandwagon. “I would definitely advise large life science companies to allocate time and resources to looking into the area in more detail and I’d advise smaller ones with fewer resources to keep as close to the core synthetic biological research environments as possible. Much of what is created is actually knowledge that everyone can access if they keep close,” concludes Gunna Christensen. 

The role model CRAIG VENTER Researchers, companies and politicians tend to look to the US geneticist and synthetic biologist J. Craig Venter when talking about the future within medicine, food and sustainable energy. In 2000, he led the team of researchers who announced the first mapping of the human genome in 2003; in 2008 he took important steps towards creating actual “artificial life”; and in 2010, after 15 years of hard work, he successfully inserted a whole genome in an entirely different organism and got the new organism to reproduce itself. This was the first time anyone had managed to create “new life” with new properties. The artificial bacterium was produced using synthetic biology, which was possible because a number of different sciences were combined – including molecular biology and nanotechnology.

ENDNOTE

Less time in the detail. More time for the big picture

Specifically, the researchers took a synthetically produced genome that was transplanted into an existing bacterium cell and this cell then became a new self-replicating cell controlled by the synthetically produced genome. Although the genome comprises less than 1% of the biological machinery, it marks a milestone and is proof that a genome can be computer designed, produced chemically in a laboratory and transplanted into a receptor cell. From this perspective, you can design your own bacteria to produce the desired products. Venter is convinced that this is the source of infinite opportunities that can benefit the public, and they are continuing their research into creating bacteria that can be equipped to produce such things as fuel, special medicines etc. This is being achieved in his capacity as president of the J. Craig Venter Institute, as researcher within synthetic biology and via his company Synthetic Genomics, which focuses on using modified microorganisms to produce the biochemicals and fuel of the future – the latter in cooperation with, e.g., ExxonMobil, which invested USD 600m in the company in 2009.

Call +45 36 94 66 31 Email info@alfasoft.dk

our knowledge - your advantage

30

www.alfasoft.dk

While Venter applies to patent “the first life form created by humanity” – which will probably be called the Mycoplasma laboratory – he has been named one of the world’s most influential figures by Time Magazine and New Statesman, among others. See more at: www.jcvi.org, www.celera.com, www.syntheticgenomics.com


CASE

Center for Synthetic Biology University of Copenhagen

In 2009, the University of Copenhagen received DKK 120m from the Ministry of Science, Technology and Innovation under ‘UNIK’, which stands for university research investment capital.

By Malene Aadal Bo The money was to create a centre for synthetic biology, and the goal was to collect some of the country’s leading lights within, e.g., nano, bio and information technology and let them work together on solving some of today’s most important social issues – initially the lack of sustainable energy and the need for better and cheaper drugs. “The dream then was for us to learn to ‘harvest sunshine’, as it was formulated by Thomas Bjørnholm, head of the centre at the time, who imagined that perhaps one day in the future we could let organisms use solar energy to produce various substances – as plants do during photosynthesis,” explains Nanna Heinz. She is research coordinator at the centre that has grown since 2009 into an environment with 60 permanently affiliated researchers and a strong network in the Danish business community and close contacts with synthetic biologists all over the world. According to her, the Copenhagen centre is now a leading research environment in the field, and researchers have achieved remarkable results within two areas in particular: The biosensor area, in which researchers have been successful at getting living cells to grow on a mesh of nanowires that can potentially be used to decode a cell’s state and thereby to diagnose disease or adapt and test medicines for individual patients. And energy, where the vision of harvesting sunshine has been realised in a pioneering way (see box). “The many good results are due without doubt to an interdisciplinary approach that reveals its strength here. Achieving these pioneering results has placed considerable demands on the researchers involved, as a whole new language had to be developed spanning many subjects and disciplines – but when it succeeds, everyone realises they can suddenly achieve much more than they could working alone. Then you start moving forwards in leaps and bounds,” says Nanna Heinz. The researchers at the centre work on basic research but the goal is always to solve specific social issues. Cooperation is therefore close with the business community and with the Novo Nordisk Foundation Center

for Biosustainability based at the Technical University of Denmark, where Birger Lindberg Møller leads the Plant Pathway Discovery section. The idea here is to make basic research more accessible, particularly for small and medium-sized companies which would never have the

Simple & Easy Cold Chain Temperature Logging • Thin, compact size for easy placement • No proprietary readers or software required • Pre-calibrated and programmed for time and temperature • Free Draft SOP included • Direct USB to PDF document generation

Actual Size

Order your FREE fully functional demo today: www.vaisala.com/coldchain

www.vaisala.com/lifescience Tel. +46 8 7509420

Life_Sciences-Insight-Vaisala_CEN_LSH_Quality_Toolkit_85x141.indd 1

31

29.6.2012 10.57


capacity themselves to optimise a special organism in order to Plant power: Development of sustainable cellular factories for produce a certain substance, for production of high-value compounds (pharmaceuticals, food example, though they appreciate ingredients, colorants, industrial proteins) how such a system could form the basis for new industrial production and thereby create Danish jobs. The centre also focuses on the new trends within open science and open access, which give entirely new opportunities for knowledge sharing with the associated new requirements for patenting and legislation. “There is a fantastic entrepreneurial spirit in the open access environment, and being part of it is very inspiring and educational. Not least UNIK Synthetic Biology because new models are devised for shared patent schemes results are currently being created and we see good combined with knowledge sharing that can make it more times ahead for synthetic biology as a field and as a way attractive for researchers and companies to share their of working,” she says.  discoveries – and make us all wiser faster to our mutual benefit,” says Nanna Heinz. See much more at synbio.ku.dk “And we are heading in the right direction. Fantastic

Consultancy service your partner in outsourcing Regulatory Affairs or Pharmacovigilance activities? ■

A-consult offers all the services you need.

A well-established internal quality management system gives you high quality solutions every time.

Our specialists and senior consultants can solve your difficult tasks.

LEt us bring you to A sAFE LAnDing A-consult group is a European consultancy organisation founded in 1983, with a team of highly educated and experienced employees in Denmark and France. A-consult group has serviced more than 200 companies and handled regulatory tasks in more than 80 countries. A-consult is offering professional regulatory affairs service to companies working with pharmaceuticals, 32 nutraceuticals, foods, food supplements, medical devices and cosmetics.

A-consult Group, Denmark & France, www.a-consult.com, Tel: +45 3833 0080


4 results to notice

1

A Japanese research team in Osaka, led by Tesuya Yomo, has developed a design for a minimal synthetic cell that they are now implementing. Their artificial cells consist of an artificial cell membrane that is full of artificially produced biochemical components that can copy artificial DNA. The various cells have different DNA. The cells are “fed” so that they can grow and copy their DNA. The individual cell is then artificially divided into two new daughter cells, which repeat the process.

2

Jay Keasling and his team at the University of California have developed a yeast cell that secretes the malaria agent artemisinin. Artemisinin is already found and produced from extracts of Chinese wormwood, but the process is slow and expensive. Keasling’s method is based on introducing about a dozen synthetic genes in yeast cells that are then cultivated by allowing them to ferment with sugar. The added gene cassettes control the biochemical reactions that lead to the creation of a precursor chemical, artemisinic acid, which is then converted via a chemical route into the final agent. By producing artemisinin in living yeast cells it will also be possible to change the biological structure and thereby be prepared for any future variants of artemisinin-resistant malaria.

3

At the Center for Synthetic Biology, researchers have managed to construct a system that uses light as the energy source for synthesising complex bioactive substances. In a plant cell, light energy is converted into chemical energy via photosynthesis. The solar energy is captured in the plant’s chlorophyll granule, where it is converted into carbohydrates. When these are broken down, energy is released to create e.g. proteins and fatty substances and the defence compounds the plant needs to defend itself against disease and insect attacks. These bioactive substances are created in the membrane system, which is called the endoplasmatic reticulum. Researchers at the Center for Synthetic Biology have succeeded in moving the necessary enzymes from the endoplasmatic reticulum into the chlorophyll granule’s membranes. This means the energy from the light can be used to produce the desired substances in the host cells. The cells are cultivated in large plastic bags that can be penetrated by the light, which thus functions as the sole energy source. In the long term, the aim is to create an environment and energy-friendly system that can replace the part of the oil-based industry that supplies us with many of the substances we surround ourselves with today – from plastics to flavourings and medicines.

4

US universities such as MIT and spinoff companies such as Ginko Bioworks and the BioBricks Foundation are well under way with building an open-source infrastructure that is very likely to boost product development. It’s a matter of sharing knowledge and ideas but also specifically building up a bank of, e.g., DNA units that can be mass produced. The genetic and biological building blocks can then be sold on the Internet as individual parts that can be fitted into or combined with living cells to construct entirely new biological systems. See more at www.biobricks.org

33


“The most difficult part is getting people to understand what we do” So says CEO of Evolva, a Danish-Swiss biotech company that is among the first in the world to use synthetic biology in the health and nutrition sector. A journey that is leading to new discoveries such as a simple baker’s yeast producing some of the world’s most expensive spices: vanilla and saffron.

By Jannie Schjødt Kold Photo: Evolva

“That sounds exciting but I don’t quite follow you.” This is the response that CEO Neil Goldsmith and his team at the biotech company Evolva often get and describes the challenge the company faces. Because how do you explain something that basically does not exist yet? The company was formed in Denmark in 2001, but in 2004 moved to Basel in Switzerland to focus on pharmaceutical products. From 2006, the company

gradually began changing its focus more towards developing technologies and products to use in the health and nutrition sector. Today, 22 of the 84 employees are located in Denmark. The Danish-Swiss company is pulling out all the stops to be the first in the world to be able to distribute vanilla, produced by fermentation, on the market by the turn of 2013. A process that propels the company’s 84 employees into uncharted and untested territory. Or as Neil Goldsmith says: “There are no models or templates for what we are doing, and although we know we want to get from A to B, we don’t know the way there.”

From the pharma industry to fine spices

Neil Goldsmith, CEO, Evolva

34

British-born CEO Neil Goldsmith, 49, explains enthusiastically over the telephone from Basel in Switzerland, where the 11-year-old company is listed, about the work that will potentially create things that have never previously existed. Today, the main focus is on


developing the world’s most expensive spices – vanilla and saffron – as well as the sweetener called Stevia. It has not always been that way for the company, which first saw the light of day in Denmark in 2001. Three years later, Evolva relocated to Switzerland to pursue its goal of developing methods and medicines for the pharmaceutical industry via the company’s biosynthetic platform. From 2006, the focus shifted gradually to the health and nutrition sector, where Neil Goldsmith is expecting significant growth over the next five years. A change in strategy that has also prompted the company to move part of its organisation back to Denmark, where know-how is thick on the ground and where 22 of the 84 employees are currently located. “We are agnostics in relation to who buys our products. The most important aspect for us is our core technology: creating products no one has made before,” says Neil Goldsmith describing the company’s special working methods.

Saffron and Vanilla are two of the products, that Evolva produce using synthetic biology.

Hops put fermenting one jump ahead “Our core technology is to create biosynthetic paths in yeast that make it do things nothing else can get yeast to do,” explains the CEO. The whole story begins when Evolva’s employees graft artificially produced chromosomes into baker’s yeast. When the chromosomes are developed and grafted into the yeast, there is a new and unique genetic combination on top of each yeast cell’s gene pool that makes the yeast produce an entirely new substance. One of these products is a calorie-free sweetener called Stevia, which can thus be produced inexpensively and with precisely the desired flavour. In addition to Stevia, Evolva is working intensely on preparing vanilla, which according to plan will be on the market at the end of next year. The ambition is then for Evolva to launch one new product a year for the next 4-5 years.

such as baker’s yeast. As long as we operate according to the long established rules on the sort of work we do, I cannot really see any disadvantages. What we are doing is bringing something new into the world that will do good – allowing people access to better health wellness and nutrition, produced in a sustainable manner,” he says. 

Intelligent Purification Gilson Trilution LC-MS Purification Gilson PLC2020 Personal LC Genevac Rocket Evaporator

Bringing something new into the world And Neil Goldsmith explains that developing new products will lead to new and interesting discoveries – as has been the case up to now. One of the staggering insights gained to date is that vanilla is not far from chilli. Well, in purely biological terms, at least. “We have discovered that some of the biological reaction paths used in the production of vanilla are linked to the reaction paths for chilli – and also for pain killers. In other words, we know that by developing a yeast that closely resembles what we already have, we can create some products that on the surface are very different but are surprisingly similar when you study the biological ‘pathways’ closely,” says Neil Goldsmith, calling the process “mind blowing”. As an enthusiast, he also has trouble seeing the potential disadvantages of synthetic biology. Although some people have questioned the ethical implications involved in creating novel or so called engineered organisms, he believes there are very few compared with the advantages. “We work with well-understood, very safe organisms

Biolab A/S · Sindalsvej 29 DK-8240 Risskov Telefon 8621 2866 Telefax 8621 2301 E-mail: sales@biolab.dk

35


Guide

How to

protect your trade secrets Trade secrets, confidential information and know-how play an increasing role in the life sciences industry and the need to protect such information from disclosure is becoming more important than ever. This article presents practical ways of protecting your valuable information. As most information is stored and shared today in digital form and can be accessed and reproduced instantly, the risk of unauthorised use is increasing. Arguably the modern work culture emphasises speed of response to the detriment of time to reflect and compose, we do not always take the appropriate time to consider what is confidential and what should not be disclosed. • Disclosure of trade secrets and other confidential information typically occurs in connection with • Exploration of the potential for commercial collaborations • Due diligence investigations in connection with mergers and acquisitions • Actual commercial collaborations, e.g. research collaborations and out-licensing of technology • Employment relationships

#1 Draw up effective non-disclosure agreements These situations will normally be covered by nondisclosure agreements (NDAs) and it is obviously important to ensure that such agreements are sufficiently effective. An NDA (or the non-disclosure provisions in other agreements) should, as a minimum, cover the following key areas: • A clear definition of confidential information It is important that the definition of confidential information is as wide as possible and that the confidentiality and non-use provisions include not only the information itself but also all results based on any use the recipient may make of the confidential information. Know-how should be defined specifically. • A duty to use the information only for the permitted purpose The agreement must define the purpose for which the information may be used, typically for the evaluation of a proposed collaboration or transfer of rights.

What are trade secrets? There is no authoritative legal definition of trade secrets, however typical examples within the life sciences industry include technical information such as formulae and recipes, genetic material, know-how and research data and commercial information, such as customer and supplier lists, business strategies and methods and price information. According to a recent report from the European Commission, there is no harmonised system for the protection of trade secrets in the EU and the manner and effectiveness of legal protection varies significantly from state to state.

• The duration of the agreement Most NDAs have a single, overall duration of 5 or 10 years covering all information. There is, however, an important difference between the lifespans of different types of information. The commercial value of general business information, organisational structures etc. will typically be relatively short lived whereas actual trade secrets such as know-how, unpatented methods and formulae may retain their commercial value indefinitely. A party disclosing such information must therefore consider whether it is acceptable for the recipient to have such information at its free disposal at the expiry of a five-year term or whether the confidentiality period for trade secrets should be indefinite. • Permitted disclosures NDAs must set out the circumstances in which,

36


Guide

negotiations and disclosures – in practise this can often boil down to little more than creating a separate folder of all relevant correspondence (from both Inbox and Sent Items!) in Outlook; • Hold back the most confidential details until the final stages of the negotiations (staggered disclosure); and • Limit the use of electronic documents and instead use hard copies, which can be numbered and taken back at the end of the negotiations. 

Photo: Miller Rosenfalck

and the persons to whom, the receiving party may disclose the information. Disclosure to employees and advisers is usually permitted and it is generally seen as too onerous to request that all employees and advisers who receive the information sign separate agreements with the discloser. Legally it is, however, often impossible to control trade secrets which become part of the general skill set of an employee of a recipient, and it is reasonable to request that confidential information is disclosed strictly on a need-to-know basis and that the receiving party takes full responsibility for breaches of confidentiality by its employees or advisers. • Return of confidential information The NDA should provide for the return or destruction of the confidential information in the event that the project or transaction does not proceed, or, in some cases, on demand, although a receiving party may be legally required to retain certain records containing confidential information (such as board minutes).

#2 Follow the 10 good housekeeping rules In addition to making sure that appropriate NDAs are in place, the following good housekeeping rules will help to minimise the risk of breach of confidentiality. • 0n a day-to-day basis: • Ensure that employee contracts contain clear and appropriate confidentiality provisions; • Implement company-wide policies for the protection of know-how (and personal data) and have a robust security policy addressing both physical and electronic document security, including secure email systems, encryption of documents, use of USB keys etc.; • Provide regular training to employees on confidentiality and make sure that training covers the particular risks of digital storage and IT issues such as the meta-data which are embedded in and may be extracted from electronic documents; • Maintain records of which projects each employee has worked on and remind departing employees and consultants of their duty of confidentiality and ask them to confirm in writing that they have returned all company property; and • Audit security procedures frequently. • When commercial negotiations make it necessary to disclose truly confidential information or high-level trade secrets: • Make sure that confidential information or trade secrets are disseminated on a need-to-know basis only and that documents are marked confidential; • Restrict access to areas where confidential processes are conducted, or developments are being made; • Keep a contemporaneous written record of the

About the author Thomas Bjørn is a solicitor with Miller Rosenfalck LLP in London. Thomas Bjørn has a law degree from the University of Copenhagen and has worked in private legal practice and the pharmaceutical and biotech industries in England, Switzerland and Denmark. His areas of expertise include the protection and commercialisation of intellectual property, regulatory affairs and sale of goods and services to the NHS. Miller Rosenfalck LLP is an international law firm with offices in London and Copenhagen, specialising in commercial law and with a strong focus on the life science industries.

37


News from the science parks

Biotech optimism at Copenhagen Bio Science Park At COBIS there is a condensed and highly specialised environment focusing on early biotech. Clustering early biotechnology projects has proven to be a very successful strategy. The building is full, and recently it was decided to expand the capacity with a further 7,000 m2.

By Charlotte Strøm, MD, PhD, Journalist

While the aftermath of the financial crises remains tangible in the global biotech industry, the Copenhagenbased bio science park COBIS optimistically reports on the positive trends from their own courtyard. In less than two years after the centre opened COBIS Managing Director Morten Mølgaard Jensen has successfully attracted more than 25 companies and is today running a fully booked building. Consequently, it has been decided to build COBIS phase 2 comprising an additional 7,000 m2 of office and laboratory facilities for early biotechnology development projects and companies.

Increased exposure Morten Mølgaard Jensen explains the success of the bio science park:

“At COBIS a number of very early biotech projects are pooled together, enabling easier exposure to potential scientific collaborators, international networks and, especially, investors. And we are now seeing the first signs of the true value of this type of environment; being located in a growth environment like ours simply increases the chances of attracting investors and/or strategic partners.” Morten Mølgaard Jensen is convinced there is added value in clustering similar projects together. It makes it easier to communicate messages and to market the science park and its tenants among stakeholders. “We concentrate on positioning COBIS in the mindset of investors as the place to come and look for early biomedical projects, and having this focus is certainly much easier from a communication perspective than having to embrace all types of businesses or all sizes.”

COBIS fosters start-up biotech and early projects The owners of COBIS are the two Science Parks, Symbion and Scion-DTU. “COBIS was built by people who have a lot of experience in this line of business and who have a clear understanding of the need for a highly specialised environment, allowing the organisations there to grow scientifically, before they are turned into actual companies,” says Morten Mølgaard Jensen, who goes on to explain that some businesses will, in fact, outgrow the scope of COBIS. “From the very beginning it has been our aim to make room primarily for early projects and start-up biotech, and this remains our scope with the new building as well,” he says. The Symbion and Scion DTU Science Parks both have the capacity and the square metres to house rapidly growing businesses with changing and increasing requirements regarding laboratory facilities etc.

Strategically located

Morten Mølgaard Jensen, Managing Director, COBIS

38

COBIS’ location in the heart of the biomedical university centre in Copenhagen, close to Copenhagen University Hospital – Rigshospitalet and the Faculty of Health and Medical Sciences at the University of Copenhagen is no coincidence.


News from the science parks

“The vast majority of our tenants have close relations with academia. Some are research projects that have been spinned off from public research laboratories, some collaborate with researchers at the university, and still others take in academic board members, advisors, consultants or students to assist their projects. I believe the positive yield from being neighbours to the academic institutions is quite fundamental to our success as a science park,” says Morten Mølgaard Jensen.

Best new science-based incubator in the world Morten Mølgaard Jensen believes the branding value of Medicon Valley has been instrumental to COBIS, particularly in the beginning. He says: “About a year after our opening in 2010 we signed up for a global competition as the world’s best new incubator. And we won.” Even though the award gave rise to joy and pride at COBIS, Morten Mølgaard Jensen has kept his feet on the ground: “Sure, we praise ourselves as an innovative place with new ideas and unique offerings for early biomedical research projects. But in all fairness, I believe the branding value of Medicon Valley played a significant role in COBIS winning this award. It placed us on the world map.”

Changing environment Trends in the biotech industry are based on the financial circumstances and opportunities available. With intensified competition for the available resources, projects in need of investors are looking to new models and methods that will enable their survival. “At the peak of the financial crisis, we have seen a clear trend where businesses are moving closer together, on an organisational as well as on a mental level. And they are also moving closer together physically. The lack of investments has forced many organisations to develop and work from new and revised business models, and this includes finding sparring and synergies in organisations that are facing similar challenges,” says Morten Mølgaard Jensen. He continues: “At COBIS we see businesses and start-up projects helping each other out with a kind of community mindset. They realise that helping each other – and benefitting from the advantages of synergies – improves their own chances of survival.”

Construction work ongoing Work on COBIS phase 2 began earlier this year, and by New Year’s 2013-2014, Morten Mølgaard Jensen will be ready to open the doors to yet another 7,000 m2 in COBIS, hopefully marking a new and ascending curve of optimism and growth for biotech and biomed entrepreneurs in Medicon Valley. 

FACTS about COBIS Copenhagen Bio Science Park is the first dedicated biotechnology science park in the region COBIS is centrally located close to the country’s leading hospital and major universities COBIS phase 1 comprises a 5,000 m2 building of modern architecture with lab facilities and offices 25-30 dedicated early start-up projects and biotechnology businesses are currently located at COBIS COBIS phase 2 will add a further 7,000 m2 to the facilities and will open at the end of 2013 – beginning of 2014 For more information please visit www.cobis.dk

39


Photo: Steven Christensen

Ambassador on the road for Medicon Valley The life science industry, academia and the public sector in Medicon Valley have the opportunity to sign up for personal meetings with the Life Science Ambassadors when they occasionally touch base in Denmark. But what kind of assistance do the ambassadors offer? We went on tour with Thomas Jonsson, Medicon Valley’s Life Science Ambassador based in Kobe-Kansai, Japan. By Claus Clausen Japan is called the “Empire of the Sun”, but on this beautiful morning, Sweden and Denmark could easily compete for the title as a big, lacy, blood-orange sun appears on the horizon. Thomas Jonsson, Medicon Valley’s Life Science Ambassador based in Kobe-Kansai, Japan, has already been awake for several hours, seemingly unaffected by jetlag and a time difference of +7 hours to Japan. He is used to a lot of travel as his job is to build relations and networks and help Medicon Valley companies and organisations gain access to the relevant people in Japanese and South Korean companies, investors, universities and hospitals. “The goal is to increase business-to-business interactions and to encourage and facilitate universityindustry collaborations between the regions,” Thomas Jonsson explains.

Fluent in Japanese Thomas Jonsson, age 47, was born in Sweden and holds a bachelor in marketing and Japanese from the University of Gothenburg. He met his Japanese wife at the university and moved to Japan shortly after finishing his studies. In his professional life he has worked both in the Medicon

40

Valley area and, for more than 15 years, in the Japanese life science sector. Since 2008 he has been Medicon Valley Life Science Ambassador. To top it all off, he is fluent in Japanese and very familiar with the Japanese business culture. “The Japanese business culture is very different from the Danish and Swedish way of doing things. For example; in Japan, relations are extremely important. You don’t just set up a meeting with potential business partners, you have to take time to build a relationship and earn their trust before entering into business negotiations,” says Thomas Jonsson.

No response – what to do? Thomas Jonsson arrives at the meeting in Denmark. At least four times a year he touches base in Medicon Valley, and on these occasions it is also possible to book a free “consultation” with the Ambassador. This time he has seven meetings scheduled. One is with a small biotech company with a dilemma that is a good example of a typical obstacle when doing business in Japan. The company wants to outlicense a project, and at a conference back in January they met a potential partner, a large Japanese pharmaceutical company. A couple of months later, in March, the biotech


Thomas Jonsson has 15 years of experience in Japan: At least four times a year, Thomas Jonsson, Medicon Valley’s Life Science Ambassador covering Japan and Seoul, touches base in Medicon Valley. On these occasions it is possible to book a free “consultation” with the Ambassador.

company was invited to Japan, where they presented their technology at a very positive meeting. “They were well-prepared and had assembled the right team. They were also very interested in our technology and the message was that they would like to proceed with it in their organisation,” says the CEO. Since then the company has not heard from Japan. It’s been three months and the CEO is asking the ambassador’s advice on how to interpret the “radio silence” and how to proceed with the Japanese firm. “The lack of response is not necessarily negative,” says Thomas Jonsson. “Large Japanese companies look at a lot of projects, and an assessment can easily take 3-6 months. That might seem like a long time to us, but not to them,” says Thomas Jonsson who gives the biotech company some tips and offers to make a personal contact if there is no response within another month.

Partner search In Ørestad, Copenhagen, another company has requested time with the ambassador to discuss the clinical

Since 2008:

Life Science Ambassador, Medicon Valley

2005-2008:

Marketing Trainer, Merck & Co., Inc. based in Japan

2001-2005:

Managing Director, Ambu Japan KK

2000-2001:

Marketing Director Arthritis and Pain, Pharmacia KK

1998-2000:

Product Manager Viagra, Pfizer Japan KK

1997-1998: 

Assistant Marketing Manager, Excerpta Medica KK

1993-1997:

Product Manager Respiratory, Astra Japan KK

development of their product in Japan – and the day before that a Swedish biotech company asked Thomas Jonsson for help finding data on the prevalence of a rare disease and to possibly involve him in a partner search in Japan. Another company is interested in finding a medtech project within a specific therapy area which they can buy and develop; and the Municipality of Næstved, south of

B U I L D I N G VA L U E T H RO U G H PA RT N E R S H I P S

BIO-EUROPE

®

18TH ANNUAL INTERNATIONAL PARTNERING CONFERENCE

2012

NOVEMBER 12–14, 2012 HAMBURG, GERMANY CCH CONGRESS CENTER HAMBURG BIO-Europe® is Europe’s largest partnering conference, serving the global biotechnology industry. The conference annually attracts international leaders from biotech, pharma and finance along with the most promising start-ups and emerging companies. It is the “must attend” event for getting business done in the biotech industry. Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain. In addition to productive partnering, BIO-Europe offers high level workshops, panels, company presentations and a lively exhibition.

© 2012 EBD Group AG

For further information, please view our conference website at www.ebdgroup.com/bioeurope

Join the p re-confer ence par tnerin g process 41


Copenhagen, is considering ways to expand a programme on a showcase for best practice within elderly care, which has attracted a great deal of interest from a wide range of Japanese organisations. His last stop on the tour of Medicon Valley this time around is with Medicon Village in Lund, Sweden, the newlyestablished life science village. Mats Leifland and Ursula Hultkvist Bengtsson, CEO and Deputy CEO of Medicon Village, respectively, are interested to find out how they might be able to make use of the Ambassador Programme when dealing with the USA, Japan and South Korea. During the past four years, Thomas Jonsson has visited more than 300 Japanese organisations showcasing Medicon Valley, and he has identified more than 200 inlicensing leads for the Danish-Swedish organisations. After this last meeting, Thomas Jonsson heads back to Copenhagen Airport where an 11-hour flight to Tokyo awaits. On the way, Thomas Jonsson’s mobile rings. The pharmaceutical company Lundbeck would like a brief, impromptu meeting with Thomas Jonsson to discuss some assignments in South Korea. After checking-in his suitcase at the airport, Thomas Jonsson heads for Lundbeck: “As Life Science Ambassadors, we are always just a call away; whether we are in Medicon Valley, Japan, South Korea or the US,” says Thomas Jonsson. 

In addition to Thomas Jonsson, it is also possible to book meetings with Torsten Jepsen, Medicon Valley Life Science Ambassador in Boston, USA. The dates for the Life Science Ambassadors’ visits to Medicon Valley will be announced on mva.org. Contact information: Thomas Jonsson Life Science Ambassador, Japan and South Korea thomas.jonsson@mva.org Mobile:+81 90 6506 7580 Torsten Jepsen Life Science Ambassador, Boston, USA torsten.jepsen@mva.org Mobile: +1 617 583 2044

Contact Kjeld Birch, MD Managing partner +45 4054 2440 42


New members & Upcoming Events Events by Medicon Latest members of Medicon Valley Alliance Valley Alliance Expand your network:

SensoDetect www.sensodetect.com SensoDetect Ltd has developed a rapid, psychoacoustic method of support for diagnostic evaluation of schizophrenia and ADHD. The need for such support is required in many areas of clinical psychiatry. Reported symptoms may be indistinct for long periods and clinical investigation is often introduced at a late stage. SensoDetect’s method can improve the validity of the diagnosis, which can be crucial in psychiatry and forensic psychiatry.   Quintiles AB www.quintiles.com Quintiles is the only fully integrated biopharmaceutical services provider offering clinical, commercial, consulting and capital solutions worldwide. More than 24,000 talented, committed employees in nearly 60 countries deliver on promises to customers every day, working with an unwavering commitment to patients, safety and ethics. They help customers manage change, navigate risk and seize opportunities in the new health landscape. Quintiles has helped develop or commercialise all of the top 50 bestselling drugs.   SIRION BIOTECH GmbH www.sirion-biotech.com SIRION Biotech specialises in viral vector platforms and provides sophisticated cell modelling. This enables much improved target identification and compound screening in the drug, food and cosmetics industries. It also allows for much better chances to succeed with primary cell immortalisations. SIRION Biotech is able to construct adenovirus serotype vectors serving as the basis for novel future vaccines with much improved immunity. Specifically, SIRION Biotech offers Cells by Design (e.g. customised in vitro cell models, cell lines with built-in reporter genes) and licensing arrangements.   Scottish Development International www.sdi.co.uk Scottish Development International (SDI) is the trade and investment arm of the Scottish Government. SDI is 100 per cent publicly funded and our aim is to assist in the growth of the Scottish economy by encouraging inward investment and helping Scottish-based companies develop international trade.  

WntResearch AB www.wntresearch.com WntResearch (WNT.ST), a public company listed on the Swedish AktieTorget, is a research-based biotech company spun out of Lund University, Sweden, founded in 2007. The focus and aim of WntResearch is to develop novel anti-metastatic therapies for the treatment of cancer patients, meeting a largely unmet medical need. The company has two projects, Foxy-5 and Box-5. The lead project is Foxy-5, which is currently being tested in vivo and is set to enter and finalise phase 1 clinical trials in metastatic cancer in 2012. Foxy-5 was well tolerated by both in rats and dogs in two toxicology studies completed in summer 2011.  

Colloidal Resource AB www.colloidalresource.se Colloidal Resource, a team of innovative experts with backgrounds in chemistry and physics, delivers the combination of high scientific standards and product focus that is appreciated by the industry. The company can offer research facilities and close collaboration with clients, resulting in efficient Product Development and new IP. Scientific Sanity Checks provide advice in the due diligence phase or as a part of a Risk Assessment in the start-up phase. The Scientific Rescue Team provides analyses of unwanted situations and experimental work in order to overcome problems and move forward.  

ADAPT Localization Services www.adapt-localization.com ADAPT Localization Services is a leading provider of translation and localisation services for the Life Sciences and IT/ Telecom industries. The company offers services necessary for manufacturers to be successful in international markets, from translation into all languages through software localisation, pre-press and readability testing. ADAPT works for both global Fortune 500 corporations and smaller companies, combining linguistic and subject matter expertise with stateof-the-art language technology, an ISO 13485 compliant quality management and a supreme commitment to customer care.  

4 October 2012 MVA Introductory Meeting Want to hear how MVA can create value for your organisation? Want to learn more about our various networks and initiatives? Do you know how MVA can assist you through our international network? Would you like to find out how you can gain coverage through MVA sponsorships and news coverage? Both members and non-members interested in learning more about how to benefit from membership of MVA are welcome to attend this meeting. Venue: Arne Jacobsens Allé 15-17, 2300 Copenhagen S, Denmark  Time: 15:00-18:00 www.mva.org/introductorymeeting   11 October 2012 Cancer Crosslinks Sweden 2012 – Personalised Medicine Cancer Crosslinks brings researchers from healthcare providers, academia, industry and representatives from regulatory units together in a oneday meeting. The purpose is to initiate interdisciplinary discussions that could lead to new partnerships and develop the area of Personalised Medicine. Venue: Auditorium, Medicon Village, Lund Time: 8:00-18:00 www.mva.org/cancer-crosslinkssweden-2012-personalized-medicine   26 - 27 November 2012 The Secret Sauce of Deal Making MVA in cooperation with BioMentorz presents this course targeted at individuals tasked with developing collaborations directly or as a key collateral assignment in addition to their other daily activities. The Secret Sauce is about getting people who impact deal making charged up and giving them new ideas and methods to go about their mission. It is not about calculating NPVs, creating yet one more brochure or building endless upbeat spreadsheets of activities. It is about people. Because people armed with interesting opportunities make the real difference. Venue: Arne Jacobsens Allé 15-17, 2300 Copenhagen S, Denmark  Time: 8:00-17:00 www.mva.org/secret-sauce-deal-making   29 november Annual Meeting of MVA on Clinical Research At Hotel Hilton Copenhagen Airport. Participation is free for MVA members. Non-members DKK 4.000 ex. VAT. Register at www.mva.org/annualmeeting

43


LifeSciences Insight - No 3 - 2012

12 1 - 20 - No igh t s Ins

r ted!

cience

BIOT TERN BUSINECH & MATIONAL Raw materials. ESS P EDTEC LAN Service. Expertise.www.b COMH estof PETIT biote The fine art of ION ch.at pharmaceutical composition.

LifeS

LifeSciences Insight - No 3 - 2011

tech

ss sta

The M

agazi ne ab out L ife a nd

Scie nce in

Med icon

No 3 - 2012

busin e

the magazine about Life and Science in medicon valley

- 2012

// THE IN

No 3 - 2011

o ur f bio

No 1

best

get yo

The Magazine about Life and Science in Medicon Valley

Valle y

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.

Looking for Exposure? www.merck4pharma.com

Animation of the European Spallation Source in Lund

best

of bio

tech.in

dd

20: ESS wILL booSt futurE IN mEDIcoN vaLLEy 26:r&D FOR

1

Medicon Valley Alliance and RASK Media cooperate to publish the magazine LifeSciences Insight. anzeige_parteck_210x297_4c.indd 1

– AN TY D 24: STIL YEARS42:W L GO ING SITH STE 14: TRON M CEL LS G 32 :

3: Give inventions back to the inventors crevo.n

et

Merck Millipore is a division of

19.01 04.07.11 09:40 .12

14:13

IPR – potential and pitfalls

Pr EU pr oposals esiden fo cy ca r what th n achi e eve

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.

with

New vaccine construct opens up exciting new vistas

She is a tast 43, law ye r e for adve nt

ur e

Phot

o: Bi

onee

r A /S

36:

unde

Rese ar r cons ch beac ons tr uc tion

A strong Team

FREDRIK HEDLuND

LoNE FRANK

LifeSciences 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.

Distribution In addition to interesting and updated articles about the conditions of the industry, LifeSciences Insight gives companies in the region a unique opportunity to brand themselves both nationally and internationally. With its thoroughly selected distribution network, LifeSciences Insight is the ultimate and optimum opportunity to present one’s company. LifeSciences Insight is distributed in Denmark, Sweeden and Norway to: • Named decision-makers in the life sciences industry • Relevant MPs in Scandinavia • Investors • Medicon Valley Alliance’s members and • Science parks collaboration partners • Hospitals • Relevant national and international trade fairs, • Universities conferences and exhibitions in Europe, North • Life science media America and Asia 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.

10: Viruses and bacterias made into art

26: The answer to everything?

We shed light on synthetic biology

Would you like to know more? Please contact:

RASK Media Aps Phone: +45 2887 0770 E-mail: ce@raskmedia.com

JJ Kommunikation ApS Phone: +45 2011 0199 E-mail: rts@jjkommunikation.dk

4: Research and business highlights

18:

New chairman in Danish Biotech - meet Martin Bonde

36: Guide: How to protect your trade secrets


LifeSciences Insight no 3 - 2012