Copenhagen life science # 2

NO. 2 FEBUARY/MARCH 2014

at u o y See abMed th L 9 CPH er 7th b Octo

Portrait:

The queen of Danish biotech – towards new horizons Theme: Medical Devices Becoming a key industry solving future health challenges

Talkin’ about

Kristian Helin on manmade chromosomes

No. 2 – 2014

Contents 4

The column Publisher :

Frydendalsvej 3 DK-1809 Frederiksberg C Denmark +45 3326 9520 www.raskmedia.com rask@raskmedia.com Editor in Chief: Malene Aadal Bo Editors; Lone Frank, Carsten Elgstrøm, Charlotte Strøm and Fredrik Hedlund Ad sales : NEM Media Hadsundvej 11, DK-2610 Rødovre Phone: +45 4281 1110 nem@nemmedia.dk Cover Photo: Jeppe Carlsen Print: PE Offset A/S ISSN: 1904-4755

Fredrik Hedlund: Time for medical technology to join the party

Business, science and technology news flashes

The picture

Theme: Medical Devices

- AMBU: The key to long-lasting success in the medtech business ������������� 18 - They key to solving future health challenges ��������������������������������������������������������������������� 22 - Cases: Diginata, DELTA, Rhinix Aps and Oticon ��������������������������������������������� 24

Portrait – Eva Steiness

Welcome to CPH LabMed 7.-9. Oct

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Talkin’ About

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Kristian Helin – on manmade chromosomes and the future

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Solicitor Thomas Bjørn on the impact of the new Block Exemption Regulation and Guidelines for Technology Transfer.

Selected Life Science meetings and seminars

www.dadif.dk

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“From time to time the critics were loud and outspoken.

I knew then and I know now that they were wrong, and that in general people just do things as best they can to manage their lives.”

Calendar

www.health-rehab.dk

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They play a central role in the Danish and Swedish governments’ growing focus on health and welfare solutions and are recognised as one of the keys to solving future health challenges.

Legal update: New Regulation on Technology Transfer www.ibceuroforum.dk

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AZT. The world’s first drug against HIV

In cooperation with :

www.cphlabmed.dk

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Update

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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 relevant biomarkers.

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.

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info@bioneer.dk www.bioneer.dk

By Fredrik Hedlund

I

’ve been a medical journalist for almost 20 years and written about most aspects of medicine, but almost never about medical technology. Medical technology has just never been considered sexy.

Monty Python is probably to blame. Who can forget “the machine that goes ping” from The Meaning of Life back in 1983? That scene poked fun at all kinds of medical technology for an entire generation.

Or perhaps it is because the small and medium-size companies pioneering medical technology are always doomed to lose the tug of war against the major pharmaceutical companies that have thundered on with their gigantic marketing muscles flexing.

However, now I predict a new era for medical technology. It will be ‘the new black’ for medicine for two main reasons:As the pharmaceutical industry is having increasing difficulty conjuring up one great new drug after another, competition for interesting news in the area of medicine is waning.

But more importantly, plenty of very exciting developments in medical technology are being made right now.

Take nanotechnology, for instance, which has the potential to transform many accepted truths about how materials act and their applications.

Cultured organs and microsurgery are two other areas with similarly bright prospects that will definitively change the parameters for what is possible within medicine.

However, I believe the budding area of bioelectronics is even more exciting. This discipline is about

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Translation: CLS Communication A/S

“Who can forget the machine that goes ping” from The Meaning of Life back in 1983?” learning to recognise the signals in nerve fibres and thereby use medical technology, in the form of pulse generators, to help control nerve impulses. We now know that many diseases involve controlling nerve signals. And this applies not only diseases that we currently target with treatment against synaptic cleft, such as depression or Parkinson’s disease, but many other diseases as well, including diabetes, obesity and high blood pressure.

Joining the party Is this article beginning to sound like science fiction or a scene from the new Robocop film? Well, this is fact, not faction.

Researchers have recently treated patients with rheumatoid arthritis by stimulating the vagus nerve in the neck. The relatively new knowledge that the immune defence system is controlled by the brain has prompted the discovery of a way to reduce inflammation accompanying rheumatoid arthritis in a physiological way, entirely without drugs.

Hold on, though. The UK pharmaceutical company

Photo: PR

The column

Time for medical technology to join the party

Fredrik Hedlund is a medical journalist with qualifications as pharmacist from Uppsala University and as a journalist from Stockholm University. After having been editor-in-chief of the journal Läkemedelsvärlden and medical reporter for Sweden’s leading daily, Dagens Nyheter, he is now a freelance based in Malmö.

He contributes regularly to journals such as Läkertidningen, tandläkertidningen, Medicinsk Veteskap, Läkemedelsvärlden and Copenhagen Life Science.

GlaxoSmithKline has already set up a department for bioelectronics, employed some heavyweight researchers in the area, established a research fund to finance 40 independent researchers, and is offering a one million dollar award for the team of researchers that solves some specific hurdles.

Medical technology is joining the party, but will the medical technology companies follow suit or will the international pharmaceutical companies win the tug of war after all?•

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For Pipeline Biotech A/S, an Aarhus based contract research organisation (CRO) with expertise in early discovery, maintaining an open continuous dialogue and close collaboration with clients in pharma and biotech is an essential part of their way of doing business.

“The early discovery projects that we work with reflect the potential future of our client’s business. We understand that the scientists are keen on looking over our shoulders during the critical phases of a study, and that is exactly why we keep the lines open and have a high level of reachability for our clients,” says Johnny Krogh Hansen, CEO at Pipeline Biotech A/S, carrying on, “We believe in bringing our business closer to the client by continuously communicating the status of the study, the wellbeing of the animals, and allowing for a transparency that keep our clients well informed all the way in the discovery process rather than just handing in a signed report in the end.”

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molecular biologist and he points to the core competence of the company in acting as a trustworthy business partner for pharma and biotech: the fundamental scientific knowledge.

“As trustworthy scientists we are for sure competent in scientific decision making and drawing of conclusions. However, the close collaboration and continuous sparring with our clients during outline, study set up, execution, and reporting is a far more fruitful and long lasting way of doing business.”

The service areas cover in vitro and primarily in vivo pharmacokinetics, pharmacology, potency, and efficacy in a number of different disease models for cancer, inflammation, obesity, diabetes, or custom tailored models when required.

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With the expansion into higher species (dogs and minipigs) the services at the Swedish facility will synergistically complement those of the facility in Aarhus, Denmark, where primarily rodent studies take place. Additionally, the Swedish facility of Pipeline Biotech A/S will provide services to the nearby Medicon Village, an incubator for innovative start-ups and small biotech companies.

UPDATE - BUSINESS

Update

Business By medwatch.dk

More medicines on the market New figures charting the development of medicines in Europe indicate that corporate pipelines

Photo: Scanstock

are once again producing results.

During 2013, EMA has registered 81 drugs for approval by the EU Commission – compared with 57 in 2012. Two are based on gene or cell therapy, four are biosimilar medicines and nine are preliminary approvals for products that either meet unsatisfied needs or treat diseases so rare that it is impossible to collect the data normally required.

The FDA approves Victoza rival

A PPRO

VED

Tanzeum. That is the name of the diabetes drug produced by British GlaxoSmithKline, which will very soon clash with Novo Nordisk on the US market. At the end of April, the US regulatory authority the Food and Drug Administration approved the drug, which is also known as albiglutid, for treatment of type 2 diabetes. Tanzeum is already approved in Europe and belongs to the GLP-1 analogues, the same class of drugs as the Danish diabetes giant’s golden egg, Victoza, which generates DKK 11.63 billion in 2013.

Major increase in dangerous medical equipment recalls The number of serious recalls of medical equipment with potentially severe injuries or fatal consequences has risen by more than 900 per cent over the past decade, according to an FDA report. The Medical Device Recall Report states that 1,190 recalls were registered in 2012 compared with 604 in 2003. The most serious cases totalled 1 per cent in 2003, while in 2012 they comprised 5 per cent. “This increase is particularly due to growing awareness and greater efforts to improve safety,” according to the report.

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Translation: CLS Communication A/S

DKK 8.66 billion for new life science fund One of the USA’s largest institutional investors in the biotech and medical arena, Deerfield Management, is planning to establish a new investment fund in the life science sector, according to FierceBiotech. The new fund, Deerfield Private Design III, will invest in companies in the areas of biotechnology, medicinal, medico, the health care service and animal health care. Deerfield Management has already raised USD 1.6 billion – equivalent to DKK 8.66 billion – for the purpose.

Verbal reprimand for the pharmaceutical industry Unethical marketing practices and widespread lack of transparency have placed multinational pharmaceutical companies lowest in terms of reputation among patient organisations. This is the conclusion of the third annual report on the industry’s reputation published by the English research organisation PatientView.

The only stakeholders given a worse ranking by the patient organisations are providers of private health insurance, and they have better relationships with the producers of generic drugs than with the producers of the original drugs.

New Danish country manager for Pfizer As of 1 April, Henriette Dræbye Rosenquist is the new country manager of the pharmaceutical company Pfizer in Denmark. She replaces Tolga Tanguler, who has moved to a position with global responsibility at Pfizer’s headquarters in New York. Henriette Dræbye Rosenquist, aged 44, is also director of the business unit Global Innovative Business with responsibility for Denmark and Iceland. She has worked in the biopharmaceutical industry for 18 years, 10 of them with Pfizer.

This page was compiled in collaboration with Medwatch.

Read more news at www.medwatch.dk

Top executives: Growth ahead in the next year New initiative to help companies with the proof-of-concept stage

The best top executives named In a new survey, Danish daily Jyllands-Posten and Dansk Aktie Analyse (Danish Stock Analysis) have studied which Danish top executives score best on: credibility, growth, strategy, efficiency and human resources. This year, first place was seized by Lars Rasmussen, CEO of Coloplast, dethroning Novo Nordisk’s Lars Rebien Sørensen.

Life science leaders’ ranking: 1. Lars Rasmussen – Coloplast 2. Lars Rebien – Novo Nordisk 7. Peder Holk Nielsen – Novozymes 23. Jan van de Winkel - Genmab 24. Lars Marcher – Ambu 27. Terje List – Matas 33. Jens Bager – Alk-Abello 33. Ulf Wiinberg - Lundbeck 44. René Schneider – Neurosearch 44. Niels Jacobsen – William Demant

to Genetic Engineering & Biotechnology News (GEN).

The idea is through advice, licensing agreements and financing to assist companies with medicine development at a time when many start-up companies are struggling to attract venture funding.

Stem cell breakthrough falsified It certainly caused a stir when a clinical stem cell trial was published in the renowned journal of science Nature at the beginning of this year. And the trial, which was carried out by a team of Japanese researchers, was heralded as the dawn of a new era in medical biology as it revealed a simple way of reprogramming adult cells in animals back to their foetus-like state, enabling the generation of many different types of tissue.

However, the trial is apparently seriously flawed, possibly even falsified.

Photo: Bioneer

The US, non-profit research organisation The Scripps Research Institute (TSRI) has joined forces with the Johnson & Johnson Innovation Center, among others, concerning a new research initiative to bring clinical research along to the medicine stage, according

The US and China will drive growth in the world’s life science companies over the next 12 months. This is evident from PwC’s Global CEO Survey 2014, which included the participation of 119 life science CEOs. The next country on the list is Germany (20%), followed by Brazil (19%), Russia (14%) and Japan (10%). Top executives’ greatest concerns are overregulation, increasing taxes and inability to protect intellectual property rights.

Serendex turns to the Norwegian stock exchange A Danish biotech company may be considering a stock exchange listing. However, most likely not on the Danish stock exchange, which has seen no Danish biotech companies since Zealand Pharma rang the bell in 2010. The company involved, Serendex, is turning to the

Oslo Stock Exchange instead. “The Oslo Stock Exchange is the largest in the Nordic region – double the size of all the others combined.

Investors in the Nordic market are also more positive and optimistic,” according to CEO Kim Arvid Nielsen.

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UPDATE - BUSINESS

Should we outsource the boss too?

Ten years ago, the first outsourcing wave rolled across Denmark, Norway and Sweden. There were plenty of teething problems that left their mark, but the life science sector continues undaunted, delegating some of its corporate operations to external suppliers. Thomas Andersen, a partner at Deloitte, takes stock here and provides some useful tips.

By Malene Aadal Bo

Translation: CLS Communication A/S

W

English is already spoken in many places, but otherwise it would be a good idea to start getting up to speed. We also need to get used to the idea of many work processes being divided up, and employees who are skilled at creating coherence and steering processes that are largely outsourced could easily be most sought-after in the future.

“Attractive employees, in future, will still be those who possess the knowledge that the company earns its livelihood from selling. However, demand is increasing for those who are good at managing the company and skilled at managing outsourcing,” says Thomas Andersen.

Many surveys show that management is a crucial parameter for corporate success. That said, management is not a function that you can benefit from outsourcing, if you ask Thomas Andersen. Not even if you would gain greater management expertise by doing so.

“It’s an interesting idea but no, you can’t outsource the boss. Generally speaking, you shouldn’t outsource parts of the company dealing with strategy and management.

You should never compromise on control,” he says.•

hen sitting at the breakfast table of a Nordic life science company, there is a pretty good chance that the people sitting next to do the same job as you do.

Since the turn of the millennium, companies have been steadily outsourcing more functions that are not core for the product the company produces. And there is no indication that the tide will turn. On the contrary, says Thomas Andersen who, as a partner at Deloitte, is following the trend closely.

“First the companies outsourced their cleaning and canteens. Since 2004, we have seen a large wave of outsourcing IT operation and maintenance, in particular, and more recently also a great deal of business process outsourcing – in other words HR, finance, sourcing and procurement and the like. And today we also see companies are outsourcing tasks within clinical data management, pharmacovigilance, research etc,” he says.

Cheaper and scalable In his view, the overall trend is clearly towards more outsourcing, and he does not believe that the Nordic companies have yet reached

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a reasonable outsourcing limit.

“There is constant pressure to be competitive, and outsourcing achieves two objectives. It gets workintensive tasks done cheaper and it is a more scalable model. Furthermore it also becomes easier to get access to specialists since experiences can be drawn from other similar companies,” says Thomas Andersen.

According to him, development projects, new regulations or specific processes can rapidly require extensive expertise in very narrow fields – expertise that can soon become surplus to requirements.

It therefore makes limited sense to employ and train people for the task.

Never compromise on control “There are functions that very quickly become outdated, but require many very highly skilled specialists. And even the most sceptical readers can appreciate the advantages of joining forces with global companies that specialise in carrying out precisely this function,” says Thomas Andersen.

He believes that more outsourcing also changes the conditions for employees in life science companies.

New campaign to attract talents to Denmark Talent Attraction Denmark is currently charming its way across Germany in an attempt to attract foreign specialists to the life science sector in Denmark. Innovation, productivity and exports are following in their wake.

A

n expat who gets a job in a Danish life science company generates an average of two extra Danish jobs, and according to data from Talent Attraction Denmark, more foreign specialists produce more innovation, productivity and exports for the companies or universities that employ them.

This is according to Morten King-Grubert of Copenhagen Capacity, project lead for Talent Attraction Denmark, who is eagerly looking forward to the results of the promotion he and his colleagues are running in Germany now and over the next few months. The aim is to introduce the Germans to the professional environment, Danish working culture, Danish companies and specific jobs within life science in Denmark – especially the “passive” job applicants who are not personally motivated to consider applying in Denmark but who, according to Morten King-Grubert may take the bait.

“In relation to jobs and career prospects, Denmark has a strong position with an internationally recognised industry and exciting innovative companies that are leaders in their fields. And in Denmark, we also have a work-life balance that optimises the chances of having both a career and

a rich family life. That attracts a competent and relevant audience,” says Morten King-Grubert.

Even though we have many skilled people in the Nordic region, foreign specialists are very interesting for both universities and the business community, in Morten King-Grubert’s view.

“In the years ahead, we will be seriously demographically challenged and will lack well-educated workers. At the same time, international employees bring an infusion of experience, skills, networks and new points of view, which have proved to significantly strengthen individual companies,” says Morten King-Grubert. •

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UPDATE - SCIENCE AND TECHNOLOGY

Update

Science and technology

By Videnskab.dk

Computer model to detect prevalent diseases Although we know that genes play a major role in the development of many widespread diseases, doctors are currently only able to carry out reliable genetic risk assessments of a few of them. However, a Danish research project now aims to remedy this shortage of adequate testing by using a statistical computer model.

“We will compare a person’s sequenced genome to large

amounts of data from people who have one of these hereditary disorders.

This will enable the statistical model to calculate a person’s genetic risk of developing the disorder,” says Bjarni Johann Vilhjalmsson of Aarhus University who aims to develop a tool that can promote the genetic revolution in medicine.

Photo: Patrizia Tocci

New method makes cancer tests more accurate

A ‘feeling’ prosthesis is only the first step Earlier this year, a Danish amputee became the first-ever person to feel through his prosthetic limb.

The ’feeling’ prosthesis was a sensation in itself, but this was only a small part of a much larger international project, TIME, coordinated by the Department of Health Science and Technology at Aalborg University, Denmark. One of the objectives was to look at whether sensory feedback from implantable electrodes in the prosthesis can help the 70 per cent of amputees who experience phantom pains. The project has just been granted an additional 45 million kroner.

“We will be testing three different models: electrical stimulation on the skin surface, mechanical stimulation through pressure sensors in a hand prosthesis, plus electrical stimulation of the nerves,” says Associate Professor Winnie Jensen of Aalborg University.

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Thousands of women are misdiagnosed with ovarian cancer every year. It is a difficult diagnosis to make, but a Danish chemist has come up with a method that may significantly improve existing ovarian cancer tests. Today, if a doctor suspects that a woman has ovarian cancer, the woman is usually offered a so-called CA125 test.

“But the test is not very accurate. If a woman is menstruating or has a harmless infection, this could lead to an increased level of CA125,” says Professor Klas Ola Blixt of the University of Copenhagen.

He suggests adding a step to the process. Many cancer cells are covered with a sugar layer, which is chemically distinct from the sugar groups found on the surface of healthy cells. The idea is that the existing tests will identify the body’s CA125 proteins, and then also check if the CA125 proteins are covered with sugar groups that are specific to cancer patients.study, humans age the quickest, in relative terms.

Pharmaceutical companies are already looking for ways to develop a drug based on the identification of genetic mutations that lower the risk of type 2 diabetes by 65 per cent.

An international team of scientists has identified a gene, SLC30A8, with 12 mutations, all of which reduce the risk of developing type 2 diabetes. They have compared DNA from patients with type 2 diabetes and healthy people with the aim of finding new ways of treating diabetes. In a very small number of healthy people, the researchers came on the track of rare mutations in the SLC30A8 gene, which produces the protein Znt8. This is a protein whose functions include transporting zinc into the insulin-producing cells in the pancreas. The mutant gene inhibits this transport, and it appears to protect from developing type 2 diabetes. Pfizer and Amgen have already arrived on the scene to try to develop a treatment based on the new findings. The idea is that the medicine should prevent the onset of type 2 diabetes by acting on the zinc transporters in the same way that the mutant gene does.

Workplace noise does not make you sick The largest-ever study of occupational noise surprises by failing to establish a correlation between noise and cardiovascular disease. This contradicts previous findings, which show that noise increases the risk of high blood pressure, stroke and other cardiovascular diseases.

“Even at high noise levels, we could not find the results that others have found at much lower noise levels. This came as a big surprise to us,” says Zara Ann Stokholm, PhD, the Institute of Clinical Medicine at Aarhus University, Denmark.

Stokholm and her colleagues measured the noise levels at 76 workplaces. They then delved into the various Danish national registers and identified the employees at these 76 noisy workplaces and they checked for a correlation between the level of noise exposure and the employees’ risk of developing cardiovascular disease.

“We did not establish any correlation – not in terms of high blood pressure, increased risk of cerebral haemorrhage nor cerebral infarctions,” says Stokholm.

Photo: Ron Hudson/Scanstock

Mutant gene protects against type 2 diabetes This page has been compiled in collaboration with Videnskab.dk and ScienceNordic.com.

Researchers first to map mammal brain A team of researchers has mapped the connections between groups of brain cells in a mouse’s brain. This is the most complex brain ever mapped in this way.

Admittedly, the brain of the roundworm Caenorhabditis elegans was mapped back in 1986, but it only has 302 brain cells. By comparison, a mouse brain has 75 million brain cells.

The researchers have so far mapped how groups of brain cells are connected and will continue to flesh out the atlas with more details that may also be useful for improving our understanding of the human brain.

The results published in the scientific journal Nature are a preliminary milestone for an open project called The Allen Mouse Brain Connectivity Atlas. This atlas can be freely studied in 3D at connectivity. brain-map.org/af.

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THE PICTURE

Getting close

By Malene Aadal Bo

Azidothymidine, or AZT, was the world’s first drug against HIV and plays a supporting role in Acadamy Awarded movie “Dallas Buyers Club” .

AZT was first developed as a cancer medicine back in 1964 but rejected for failing to have the desired effect. 20 years

later, researchers discovered it had an inhibitory effect on the HIV virus and it was put into production and for years used as part of the combination treatment of patients with HIV. Here photographed by Larry Ostby at magnifications of 50x.

Photo: AZT Photomicrographs

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THEME: MEDICAL DEVICES

Medical devices play a central role in the Danish and Swedish governments’ growing focus on health and welfare solutions and are recognised as one of the keys to solving future health challenges.

By Louise Bruce

T

he Danish and Swedish medical device business is growing rapidly. New products are being regularly introduced and innovation and entrepreneurship are thriving in the industry.

The business is characterised by many startups, in part due to the fact that timelines for the development of medical device products are shorter than for biotech and pharmaceuticals.

The short development timelines also make the medical device industry attractive for investment funds, often working with an investment horizon of five years.

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“The medical device business is growing concurrently with an increasing need for treatment. At the same time, there is a socioeconomic potential in the development of telemedicine solutions designed to ensure that patients have fewer hospital days and thus can be treated in their own homes. Further, there is the fact that new hospitals are deliberately being built with fewer beds than are needed today in the confident belief that the development of new medical devices will mean less occupancy of hospitals,� says Peter Huntley, CEO,

of Nordic life science

Tools at the center

Medicoindustrien (the Danish medical device industry association).

In Sweden, the trend seems to be the same. According to Anna Lefevre Skjöldebrand, CEO of the Swedish medical device industry association, Swedish Medtech, the trend points towards care and treatment being moved from hospitals and into the homes and workplaces.

“Care and treatment will not be as concentrated at the general practitioners and the hospitals as it is today. It will be integrated into everyday activities in an entirely different way than what we see today. It is already happening, but we will see even more in future,” explains Anna Lefevre Skjöldebrand.

Close collaboration with the clinical environment

Close collaboration with the clinical environment Denmark and Sweden have a long and fruitful history of cross-industry and inter-clinic collaboration. Many medical device companies started out as collaborations

between doctors and engineers and are now huge companies with worldwide sales. A highly educated and skilled workforce in Denmark and Sweden, as well as a broad willingness to help each other across companies and sectors, also contribute to a beneficial foundation for the industry.

In Denmark, Peter Huntley describes the Danish stronghold for the medical devices industry as comprising a good clinical environment, a good research base and some very innovative companies.

“However, we will not succeed without strong public-private collaboration. We need to improve that collaboration continuously to ensure that clinical testing and product development environments become even more geared towards medico. Although, the Danish market might only account for a minor market share, the importance to the Danish companies is not to be underestimated,” says Peter Huntley.

For the large Danish-based international companies, Photos: Scanstock

Intelligent Chemistry Biolab A/S Automation Specialist AndrewTM

THE SWEDISH MEDICAL DEVICE INDUSTRY

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• In Sweden, there are about 590 medical device companies with five or more employees and with revenues of at least SEK 1 million. Approx. 180 of these companies are engaged in research and development in Sweden.

• The Swedish medical device industry employs approx. 22,600 people.

• Medical device companies in Sweden have annual sales of more than SEK 85.6 billion and exports account for SEK 23.9 billion.

Source: Swedish Medtech

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

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THEME: MEDICAL DEVICES

“It is the first time medical device products have been assessed based on the value they bring to society. We have been lobbying for this for many years, so it is very pleasing to see that policymakers are now considering the overall benefits and do not only focusing on price” Anna Lefevre Skjöldebrand

it is crucial that they implement development projects and launch their products in Denmark. It is difficult to enter another market with a product that is not supported in your country of origin.

It is a quality stamp when a product has been developed and tested and is now marketed in the country of origin.

One of the biggest challenges for the medical device industry in Denmark and Sweden is the assessment of price vs. value. In both countries, there is a lack of formalised assessment procedures and tools to evaluate the socio-economic benefits of medical devices. Over the past year, however, an assessment model for evaluating medical devices in Sweden has been tested by the Dental and Pharmaceutical Benefits Agency, TLV. “It is the first time medical device products have been assessed based on the value they bring to society. We have been lobbying for this for many years, so it is very pleasing to see that policymakers are now considering the overall benefits and do not only focusing on price,” says Anna Lefevre Skjöldebrand.

The new model bears witness to a rising awareness among Swedish policymakers that medical devices may play a central role in future

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Anna Lefevre Skjöldebrand PR-Photo

Price vs. value

THE DANISH MEDICAL DEVICE INDUSTRY • In Denmark, approx. 1,000 companies work in some way with medical devices, and for about 220 companies, medical devices are their core business.

• The Danish medical device industry is characterised by having a few large companies and a large number of smaller companies.

• Two-thirds of all biomedical companies in Denmark have fewer than 50 employees and the 20 largest companies account for 75 per cent of the total revenue.

• Venture investments in the Danish medical device industry have increased from approx. 17 per cent in 2010 to nearly 30 per cent in 2013.

• Danish medical device companies have annual sales of more than DKK 50 billion and employ more than 30,000 people.

• The Danish market represents 0.5 per cent of the global market for medical devices.

• Medical device exports have increased by 68 per cent in the past 10 years, now totalling DKK 16 billion.

• Together with Germany, Denmark is the largest market in Europe in terms of market size per capita.

• Denmark is the European country that employs the second largest number of people in the medical device when population size is taken into account.

Source: Medicoindustrien

GE Healthcare Life Sciences

treatment. In Denmark, however, Peter Huntley is still waiting for a similar model to be implemented.

“We need a better dialogue on optimal treatment economy and the value of patient safety and not just basing commissioning on product price. We lack a platform for how to assess new products – a health technology assessment (HTA). However, this requires skilled personnel in the public sector system, who understand the medical device industry and can relate to the information,” Peter Huntley explains. •

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17

THEME: MEDICAL DEVICES

The key to long-lasting success in the medtech business A strict focus on single-use medtech products plays a significant role in the success of one of Denmark’s oldest medtech companies. According to Ambu CEO Lars Marcher, a high level of innovation, passionate employees and the ability to implement plans and strategies have been of vital importance to achieving their success.

By Louise Bruce

T

he overall Ambu strategy is to focus all business activities on medtech products for single use. The demand for products in this category is growing rapidly as hospitals continuously have to reduce the costs of surgical procedure and the risk of infection. According to Lars Marcher almost 5 per cent of all surgical procedures result in an infection within the patient due to poor cleaning of the tools used. Single use products eliminate that risk which, among other things, is why there is a trend towards single use product within many product categories. At Ambu, airway related products are the primary business area.

“Our main focus is on airway ventilation, which we have chosen to divide into to two subcategories: inside hospital and outside hospital products. Our inside hospital products include video scopes and laryngeal masks. Outside hospital products include products used in ambulances. Treating the patient as quickly as possible is a critical factor for the paramedics. We like to think

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that we play a crucial role in this process, for instance as developers of the Ambu bag used for ventilation in ambulances,” says Lars Marcher.

Reverse innovation In order to continuously develop new and innovative products, Ambu collaborates with 15 of the world’s leading anaesthesiologists. The doctors provide Ambu with information on the need for new types of products or new product categories.

“We use the information for what we call reverse innovation. When we introduce a new product, we know there is a demand, and we know that it works in the clinic. Previously, we concentrated on advancing our product portfolio. Now we consider ourselves developers of breakthrough technology,” Lars Marcher explains.

New medtech products often involve a change of methods, routines and procedures. Thus, as Lars Marcher points out, it is a challenge to get doctors and

Grete Lundbeck European Brain Research Foundation Call for Nominations for

THE BRAIN PR1ZE THE PRIZE OF € 1 MILLION WILL BE AWARDED IN COPENHAGEN MAY 2015 Nominations by 15 September 2014 Nominations will be reviewed Photo: PR

by the Selection Committee:

AScope is the first-ever fibre optic video scope for single use that makes it possible to examine the patient’s lungs from the inside.

HuDA AkIL, uSA ANDERS BjöRkLuND, Sweden, Vice-chairman COLIN BLAkEMORE, United Kingdom, chairman jOSEPH COYLE, USa FRED H. GAGE, USa FLORIAN HOLSBOER, germany RANGA R. kRISHNAN, Singapore PHILIP SCHELTENS, the netherlandS For the nomination Form and detailS

paramedics to use a new and never-before-seen product.

However, innovation is what drives Ambu forward towards even greater market shares.

“If you are not innovative, you stand still and then you lose. It is that simple,” says Lars Marcher.

“As a manager you have to continuously motivate and drive your employees to think innovative. A global organisation like ours needs highly motivated and dedicated employees, who go to work in the morning because, they want to contribute to our mission; to save human lives,” he continues.

oF the nomination procedUre, pleaSe ViSit: WWW.THEBRAINPRIZE.ORG

Prize Winners 2014 Stanislas Dehaene, Paris, France, Giacomo Rizzolatti, Parma, Italy and Trevor W. Robbins, Cambridge, UK

Transition towards global markets Over the past many years, Ambu has undergone a transition towards a more global market. In order to reflect the new market situation, closing and reorganisation of production facilities and research centres has been necessary. Production facilities have been moved from Denmark to Malaysia and

The Brain Prize recognizes and rewards outstanding contributions to European neuroscience, from basic to clinical

19

THEME: MEDICAL DEVICES

PR-photo

“I believe Danish companies have to enter the global market. If not, we will not achieve the strength needed for investing in innovation and developing our companies” Lars Marcher, CEO

China. Recently Ambu added another 550 people in manufacturing in USA. On all location Ambu has established research centers to be able to innovate 24/7. ”Regardless of the business area, I believe Danish companies have to enter the global market. If not, we will not achieve the strength needed for investing in innovation and developing our companies,” says Lars Marcher.

Contrary to the current trend, where many companies consider Asia as their emerging market, Ambu has chosen to look west towards the USA. At the moment the USA accounts for 50 per cent of Ambu’s turnover and the share is expected to grow due to the growth potential on the US market. The Danish market, however, only accounts for 1 per cent of Ambu’s turnover. But, as Lars Marcher points out, you have to be successful in your home market in order to succeed abroad, as it makes an important showcase •

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FACTS ABOUT AMBU • Founded in 1937 • Number of employees: 1,500 • Headquarters: Denmark • Research centres: Denmark, USA, Malaysia, China • Production facilities: USA, Malaysia, China • Primary business areas: Medtech products for airway complications

SINGLE USE MEDTECH PRODUCTS • The use of medtech products for single use is increasing.

• People live longer and suffer from more lifestyle and cosmetic diseases that require surgery.

• Hospitals and outpatient services are subject to a constant requirement to cut costs and develop even more efficient work processes.

• Infection risks in connection with surgical procedures have to be eliminated.

• Products for single use meet those needs and help reduce surgery costs in different ways, including: -- Being less expensive -- Eliminating the risk of infection because tools do not need cleaning -- Eliminating the use of chemicals for cleaning tools -- Reducing readmissions due to surgery-related infections

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Creating specialized solutions for life science Building a highly specialized laboratory or manufacturing facility for life science takes more than engineering skills. Fully comprehending the life science processes is a major competitive driver at the Kemp & Lauritzen Group.

“Value engineering is what we mean by combining engineering skills with branch specific insight ensuring that when it comes to e.g. laboratories, GMP, API etc. we know what the updated specific requirements are,” says Thomas Schalek, Business Manager Pharma360® at Glenco.

Pharma360® Glenco specializes in ventilation and cooling and as part of the Kemp Thomas Schalek, Business manager, Pharma360® & Lauritzen Group and responsible key account for life science, Glenco offers Pharma360® that encloses the full list of services from Glenco, Kemp & Lauritzen (electricity), and L&H-Rørbyg (piping / plumbing). Offering a one-stop-shop allows the engineers and project managers at Glenco to be far more efficient and maintain a high level of expertise pertinent to the needs of life science industry partners, while building on 35 years of experience.

“Participation from the early phase of the project, contributing in designing and planning, ordering components, building of the room, and finally handing over the key to the client on the date we agreed to while simultaneously implementing the life science specific requirements into the project is what Pharma360® is about,” Schalek says.

Adding value by continuous training Expertise tends to build confidence with clients. When The Kemp & Lauritzen Group recently worked with Novo Nordisk on the construction of a 500 square meter production facility this became evident.

“Our understanding of what needs to be taken into consideration when building a manufacturing facility facilitates the working process and makes it far more agile, which is key

when time is of great essence,” Schalek explains.

The specialists at the Kemp & Lauritzen Group are trained in ISO14644, GLP, and GMP. “We add value to our clients’ projects by knowing these requirements in great detail, and apart from the ongoing training we also participate in network like R3 Nordic and the Lab group, continuously discussing how to e.g. optimize cleanroom and laboratory facilities,” says Schalek.

Thinking out of the box The requirements by authorities seldom leave room for interpretation. Still, it does happen that clients face special challenges where innovative thinking is called for.

“It could be the need for floor ventilation, specially conditioned air etc. The point is – we can do it,” Schalek says.

Morten Mølgaard Jensen, CEO, Copenhagen Bio Science Park, was convinced of the two-edged competences at the Kemp & Lauritzen Group at completion of phase II of the Copenhagen Bio Science Park: “COBIS is ambitiously creating conditions for the biotechnology of tomorrow. The Kemp & Lauritzen Group demonstrated that they know what it takes to design and build a cutting edge research facility.”

For more information http://www.kemp-lauritzen.dk/

FACTS ABOUT The Kemp & Lauritzen Group • Holds three specialised companies, Kemp & Lauritzen, L&H-Rørbyg, and Glenco with solid specialist skills and experience • Provides technical solutions for electricity, piping /plumbing, and ventilation/cooling • Has about 1900 employees • Glenco specializing in ventilation and cooling and is the key account for life science partners

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THEME: MEDICAL DEVICES

The key to solving future health challenges The medical device area is proclaimed to be a key industry that will contribute to solving future challenges in healthcare. Medicoindustrien and Swedish Medtech present their views on the future of medical devices.

By Louise Bruce he medical device industry started as an aid to the performing physician. Today, the technological advances have facilitated the development of devices for therapeutic and diagnostic use. An area predicted to hold the key to future health challenges.

“The constant hunt for cures is also relevant when it comes to medical devices. I expect that we will see more and more devices for treating and potentially curing patients,” says Peter Huntley, CEO, Medicoindustrien (the Danish medical device industry association).

According to Peter Huntley, the treatment potential of medical devices will trigger dramatic growth in the medical device industry.

Improving diagnostics The trend towards increased use of information technology could give

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Peter Huntley, CEO PR-Photo

T

healthcare professionals a better opportunity to use patient health data to support diagnosis.

“Today we have an incredible amount of information available that can be used to improve treatment, if we only had the right tools to really analyse the data. Information technology represents an opportunity to significantly improve the quality of diagnosis,” says Anna Lefevre Skjöldebrand, CEO, Swedish

Medtech (the Swedish medical device industry association).

Since diagnosis quality is defined by the specific treatment regimens it indicates, the more data you are able to process and analyse the better are your chances of prescribing the right treatment.

According to Anna Lefevre Skjöldebrand, the potential of integrated information technology does not stop at diagnostics. She

also sees opportunities in integrated care systems, where a medical device takes over part of the treatment, e.g. to create an artificial pancreas to produce insulin for patients with diabetes type 1.

Innovation factors Companies with worldwide markets as well as small start-ups contribute to the innovation environment that characterises the medical device industry in Denmark and Sweden.

And even though you would expect the larger companies to be the most innovative simply because they have access to more money, Anna Lefevre Skjöldebrand points out that often the smaller businesses come up with the most unexpected ideas.

Close collaboration with research institutions is, in many ways, a prerequisite for developing new devices. For example, the virtual

“This tragedy shows a clear example on how medical device manufacturers focus on needs driven innovation to the benefit of the user or patient” autopsy table evolved from a close collaboration between Swedish medical device company Interactive Institute, the Norrköping Visualization Center and the Center for Medical Image Science and Visualization (CMIV) in Linköping, Sweden. The device uses a synthetic MRI technology, which makes it possible to scan deceased person.

Innovative ideas may occur anywhere or arise from needs created by external events, such as the tragic incident with Thalidomide (Neurosedyn in Swedish) usage

amongst pregnant women in the beginning of the 1960s, which led to a large number of children born with severe disabilities. After the accident, a good deal of effort was put into supporting the children, leading to highly skilled expertise within the field in Sweden and Norway.

“This tragedy shows a clear example on how medical device manufacturers focus on needs driven innovation to the benefit of the user or patient,” says Anna Lefevre Skjöldebrandt.•

Tryghed når du vælger laboratorieudstyr Med kunden i fokus Hos Ninolab har vi fokus på høj kvalitet og sætter altid dine behov i centrum. Vores kvalitetsmål er at kunne levere et korrekt tilpasset produkt, med de rigtige funktioner, til aftalt tid og ikke mindst til den rigtige pris.

Produkter fra verdens bedste leverandører Vi udvælger og skaber kontakter med de producenter, der er kendte for deres seriøsitet og ansvarlighed i fremstillingen af laboratorieprodukter i højeste kvalitet. Ninolab forhandler på nuværende tidspunkt produkter fra omkring 30 udvalgte producenter fra hele verden.

Tryghed når du vælger Ninolab For dig som kunde er det en tryghed at vide, at når du vælger Ninolab som leverandør, vil du altid blive tilbudt de bedste produkter.

Kvalificerede og engagerede medarbejdere er vigtigt. Ninolabs produktspecialister er til rådighed ved spørgsmål om applikationer og med support generelt. Vores serviceafdeling tilbyder alle former for service på dine produkter.

Kontakt os hvis du vil vide mere om hvordan gode produkter bliver endnu bedre med den rette leverandør!

- Din leverandør af basis laboratorieudstyr

e

adress e y n Vores

Cordozasvinget 6, 2680 Solrød Strand tlf.: 44 91 10 07 · info@ninolab.dk 23 · www.ninolab.dk

THEME: MEDICAL DEVICES

Intelligent patch can help diagnose chronic diseases What:

An intelligent patch that can monitor and transmit physiological data, such as heart rate and activity

How:

A sensor mounted on chest monitors stores and wirelessly transmits physiological data

Who:

Developed and produced by DELTA ePatch is an intelligent patch that can monitor and transmit physiological data such as heart rate, ECG and movement of the body.

“The occurrence of chronic diseases is increasing and thus the need for monitoring the heart.

Our product represents an easy,

convenient solution with many applications,” says Jens Branebjerg, Director Key Accounts ePatch, Delta.

The Danish company Delta has developed the technology and the design for the ePatch. In collaboration with their German partner Apoplex Medical Technology, they have developed a solution consisting of the ePatch and an analysis tool that can automatically detect atrium fibrillation.

“The ePatch is currently used for monitoring heart arrhythmias. The potential is even bigger, which is why we are currently partnering up with an Austrian company that wants to use the ePatch for monitoring the stress levels of business people and elite athletes,” Jens Branebjerg explains.

Because DELTA’s core competence

is technology development, they are always look for external partners with ideas for new applications and the corresponding software needed to analyse the monitor results.

Convenient microtechnology ePatch emerged from the idea that microtechnology would be able to replace the large, inconvenient heart monitors, loaded with annoying wires. The ePatch is a small, wireless device, which makes it convenient for patients, and it can be worn up to three days, providing the doctor with consistent results over longer periods of time. Although the clinical data is of the same quality as the old heart monitors, it is a challenge for quick acceptance and widespread use that the curves look different.

Small filter reduces allergic rhinitis What:

Nasal filter for reducing allergic rhinitis

How:

A small filter placed in the nostrils prevents pollen getting into the nose, thus reducing the symptoms of allergic rhinitis

Who:

Developed and produced by Rhinix aps.

Is it possible to make an almost invisible filter with a mesh fine enough to prevent pollen from getting into the nose, but leaves room to breathe easily? Four years ago, Rhinix founder Peter Sinkjær Kenney asked himself just that question, as a good friend of his was suffering from serious allergic rhinitis. The result was the Rhinix

24

filter, which has shown promising results in reducing allergic rhinitis. Rhinix is a small filter for single use that you place in your nose, where it will take shape of your nostrils. It is developed to reduce allergic rhinitis and has shown a positive effect compared to placebo, especially on sneezing, itching and runny nose symptoms. It has also shown good effect on irritated throat, which was reduced by 75 % compared to placebo. Peter Sinkjær Kenney sees a great potential in the filter and has high hopes for his product: “There are 500 million people with allergies worldwide.

I believe most of them will want to try Rhinix. How people use it in their daily life will differ depending on personal preferences,” Peter Sinkjær Kenney says.

The filter will be launched in May 2014, and will only be available via the Rhinix website. Over the summer, further testing will take place, leading to increased production and sales in 2015.

Chemo hair loss is not inevitable What :

A medical cooling device that prevents or greatly reduces the risk of hair loss in chemotherapy patients

How:

Liquid coolant is pumped through a cap to lower the scalp temperature.

Who:

Developed by Dignitana AB It all started more than 10 years ago with a Swedish nurse who wanted to give her cancer patients undergoing chemotherapy treatment a better quality of life. She had seen how loss of hair in connection with chemotherapy often affected her patients’ quality of life negatively and,

therefore, together with a Danish engineer, she developed what is now known as The DigniCap® System.

The system is a cooling system that pumps liquid coolant through a cap, which lowers the scalp temperature and reduces blood flow. The reduced blood flow results in a smaller amount of the chemotherapy drug being available for uptake in the cells, and the decreased temperature results in less absorption. Together, these two factors reduce the risk of hair loss. ”I believe that DigniCap® has great potential. It is a product that has a high impact on the patients’ quality of life, and we already have a worldwide sales organisation in place. With government approvals in Europe, Australia, Canada, China, several Latin American countries, and working

towards FDA approval, we expect market shares to increase significantly over the next years,” says Ivar van der Linden, Area Sales Manager, Dignitana.

Next step:

Preventing brain damage The Dignitana subsidiary BrainCool, which just recently became an independent company, is currently testing the BrainCool system.

BrainCool is a further development of the DigniCap® technology intended for stroke and cardiac arrest patients which may have the potential to prevent brain damage by cooling down the brain by just one degree when used in ambulances as part of the pre-hospital care.

LH Laboratorie Service A/S Din foretrukne leverandør af basis laboratorieudstyr til den rigtige pris

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PORTRAIT

Challenges and changes for

The prevention of professional stagnation In April 2013 Eva Steiness, MD and DSc, rang the bell at Oslo Børs, marking the listing of Serodus, a small Oslobased biotech company. Taking on the challenge as the CEO of a small innovative biotech business follows a natural path for Eva Steiness, looking for inspiration and challenges in dynamic environments.

By Charlotte Strøm, MD, PhD, Journalist

A

t the age of 72, some might have called it a day and retired. Eva Steiness, however, is still up for more and finds the dynamic biotech environment invigorating. Since 2010, she has been in charge of Serodus and four development projects, of which one is currently in phase II clinical development and one is on its way into phase II. The company just raised an additional NOK 40.5 million to drive the existing projects further and to start looking for new projects and patents, hidden away on shelves in university laboratories around the world. The therapeutic focus is primarily cardiovascular indications. Serodus counts Photo: Jeppe Carlsen

26

Translation: CLS Communication A/S only four people, still Eva Steiness finds the small biotech quite stimulating.

“Few people keep many plates spinning, so you tend to take on a range of responsibilities – also in handling outsourcing – in a small company like Serodus. The good thing is that you are less likely to get stuck professionally in a dynamic and agile organisation like this. So this model suits me quite well,” she says.

The combination of a solid clinical background and expertise in clinical pharmacology paved the way for a long career in clinical development. After more than 25 years in the business, Eva Steiness’ merits

27

Photo: Jeppe Carlsen

PORTRAIT

and successes include several landmarks in Danish pharma and biotech. On this, specifically, she comments concisely, “I have been fortunate to be in the right place at the right time, and on top of that I have always worked hard.”

Commitment as the main driver Even if her track record demonstrates a strong performance as an individualist, she believes in the value of teamwork. Working hard may or may not be met to the same degree by team members, but to her the commitment is what really matters.

“I respect that people may want to allocate less time than I might do on a project. I think I have a fairly realistic approach when it comes to that. But I believe in management by objectives, and once you have committed to a common objective in the project, then you deliver accordingly,” says Eva Steiness, and continues: “How much time people spend and at what hours of the day is basically up to them. The focus is the objective.

Personally, I have lots of working energy and like to use up all of my capacity. The downside to that, I guess, is that I plan everything in great detail, because I simply prefer to manage my time.”

She does not believe in being judgemental, and critics around her commenting on her way of doing things affected her like water off a duck’s back. Eva Steiness reflects back on the time when, as a young widow, she

28

supported three children and simultaneously attended in the duties of her newly appointed position as the first female Dean of the Faculty of Health and Medical Sciences at the University of Copenhagen (KU).

“From time to time the critics were loud and outspoken about my capabilities, or lack thereof, as a mother. I knew then and I know now that they were wrong, and that in general people just do things as best they can to manage their lives.”

Do you consider yourself tough?

“I can get emotional, but I try to navigate by being polite, open-minded, and by arguing my case, a strategy that has taken me far. Others may not always agree with my point of view, which is fair enough, but I have always felt a great sense of humility and respect towards the data.”

What’s in a plasma curve?

It was not carved in stone that Eva Steiness was going to have a career in pharma and biotech when she graduated as a doctor from Aarhus University in 1968. While working in internal medicine, she showed interest in resolving pharmacological issues that she encountered, leading her deep into the disciplines of pharmacokinetics and pharmacodynamics, even though these areas had hardly been properly defined at that time.

“For some drugs, like digoxin, the belief at that time was that the route of administration, whether

“I allowed myself to have no blind spots whatsoever.

That may have left me some enemies”

Jeg har været i branchen i mange år, og det ender altid med en DFD løsning på grund af de krav, som bliver stillet i den branche, som jeg er i.

Jørn Sondrup Andersen Manager CMS, Xellia Pharmaceuticals ApS

MØD OS PÅ CPH LABMED DEN 7. – 9. OKTOBER

DFD Cleanroom er en værdiskabende samarbejdspartner og leverandør af fremtidssikrede og fuldt dokumenterede beklædnings- og rengøringsløsninger til cleanroom. Lige fra kontrollerede produktionsområder til ISO klasse 5 in operation/klasse 2 at rest (GMP klasse A/B).

Læs mere på dfd.dk og følg os på Linkedin.

29

Copyright © DFD0614007

Det er vigtigt, at den leverandør, vi har, kan levere en langt højere standard end det, vi egentlig selv vil kræve.

Vi har valgt De Forenede Dampvaskerier, fordi de leverer et produkt i en god kvalitet, og vi har tillid til dem.

PORTRAIT

intramuscular or intravenous, didn’t matter that much.

It puzzled me, however, that the plasma curves looked strange after intramuscular administration, and by coincidence I realised that intramuscular injections inflicted muscular necrosis.”

Her findings led to a dissertation in clinical pharmacology in 1978 and set off her academic career.

As Dean, Eva Steiness worked intensively on developing and implementing a new strategy for the Faculty that sought specifically to improve the theoretical education.

This included defining the specialty of environmental medicine, the topic of toxicology, and forming the basis of an MSc in human biology. Some of the new elements were implemented at the expense of other functions or specialties, leaving her rather unpopular among academia, politicians and others. But this did not give her cause to pause: “During this process, I allowed myself to have no blind spots whatsoever. That may have left me some enemies.

However, most of the plans in the strategy ended up being implemented, and I take immense pride in that.”

Eva Steiness left KU for Aarhus in 1985 when she was appointed Professor in clinical pharmacology.

I have to admit - i enjoyed it very much Eva Steiness was the first woman to take the position as Head of R&D at Lundbeck in 1989, and in 1993 she became a member of the top management. The radical shift from academia into pharma came down to a simple personal request.

“Inspiration,” she says, “I started reflecting on where to source my inspiration from on a regular basis.

Fortunately at Lundbeck I had the pleasure of working with a team of very gifted scientists, and I have to admit I enjoyed it very much.”

During her time at Lundbeck, the company grew markedly as did the group of employees under Eva Steiness alongside the company’s pipeline with a series of drug candidates that basically forms the foundation of the company’s activities today.

For better and for worse One of the drugs being developed for the indication of schizophrenia had demonstrated a cardiac side effect visualised by prolonging the QT-interval, and thus a potential risk of causing arrhythmia.

“Very little was known about pro-arrhythmia at that time. We looked carefully into the matter, and ensured that the QT prolongation was carefully assessed while developing the drug for the indication of treating schizophrenia. We worked to address a practical and clinical problem that could have ended up a serious safety concern, if not handled pragmatically. We described everything in great detail and submitted it

30

along with the registration file. Today, this method of assessing QT prolongation is adapted by the European Medicines Agency as Points to Consider.”

The former Lundbeck CEO was, however, not convinced about the rationale of meticulously mapping out potential safety concerns in a product the company was preparing to launch – and Eva Steiness was let go.

“Being fired pulled the carpet out from under me. I was 57 years old, I was concerned about my financial situation, and I was devastated by the fact that I had been sacked despite the many successes I had contributed with during my time at Lundbeck. It was a difficult time for me,” she says and continues, “I learnt a lot from that experience – the hard way, I might add. But from a distance I have come to realise that a great deal of good things came out of it, too. Life doesn’t come to an end, and in fact the change led me back to the essence of drug development, closer to the lab, so to speak, preventing me from stagnating as an administrator in a large office.”

After a short, while she became an entrepreneur, aiming at funding a new biotech company, Zealand Pharma, by venture capital. Eva Steiness began cherry-picking employees from Lundbeck and brought them with her to Zealand Pharma. Commenting on this method, Eva Steiness says: “It didn’t say in my contract that I couldn’t do that. So I did – in order to create the optimal team to work with

BLUEBOOK Eva Steiness, Professor, CEO 2010: CEO at Serodus 1998 - 2008: Founder and CEO at Zealand Pharma 1989 - 1998: Head of R&D at H. Lundbeck 1985: Professor, Clinical Pharmacology, Aarhus University 1982 – 1985: Dean, Faculty of Health and Medical Sciences 1978: DSc, Digoxin-Clinical Pharmacology 1974: Associated Professor, University of Copenhagen 1968 MD, Aarhus University Born in 1941

Photo: Jeppe Carlsen Photo: Jeppe Carlsen

PORTRAIT

at Zealand. Sure, since then that clause has been entered into the contract of every employee, I’ve hired. We all get wiser as we go along,” shrugging her shoulders.

Analyzere, sensorer og cell imaging til biogas, stamceller, fermentering og cellekultur

Massespektrometre til offgas

Gas-sensorer til fermentering +biogas; O2 CO2 CH4 H2 EtOH

Optisk DO og tryksat pH. Optisk Densitet og Viable Cell Density til online måling.

DO

pH

While the Norwegian biotech industry appears both younger and narrower therapeutically, Eva Steiness finds it remarkable how successful Oslo Axess serves as a stock exchange for small cap businesses in Norway, to an extent that Firstnorth has never managed in Denmark.

“The focus on venture capital in biotech is rather narrowminded. I encourage small biotech companies to look deeper into the possibilities of business angels or getting listed at the stock exchange,” Eva Steiness says, adding:

“The focus on venture capital in biotech is rather narrow-minded.

I encourage small biotech companies to look deeper into the possibilities of business angels or getting listed at the stock exchange”

OD og VCD

Cell imaging med fluorescens

48 parallelle mini fermentorer

Perfusion styring og Single use perfusion

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Finding the funding

“I don’t doubt the great advantages of venture funding that some may applaud. Venture capital is generally willing to take on larger risks, but operationally it is a difficult environment to navigate, with extensive demands on reporting at various time points and in different formats. It’s really rather time consuming,” Eva Steiness says referring to her time at Zealand Pharma.

Eva Steiness’ work at Zealand Pharma came to an end in 2008 when the chair of the board thought she was ready for retirement.

“I believe it was an act of age discrimination. Yet again, something good came out of this change too – it moved my focus towards the next level of challenges and opened up my mind to new projects.”

The question of how long she will carry on is irrelevant: “Prior to taking my current position, I was asked how long I was willing to commit myself. That’s refreshing. The answer is for as long as I still enjoy it and my skills and experience contribute to the goals,” she concludes.•

See you at

CPH LABMED

Welcome to Copenhagen LabMed Denmark’s new trade fair and conference for users and suppliers of laboratory equipment and pharmaceuticals

7–9 October 2014 CPH LabMed is a three-day event with a focus on Denmark’s leading laboratories in the health-care sector and industry as well as on education and research institutions.

CPH LabMed is a new, multi-disciplinary meeting place with lectures, workshops, walk-in sessions, seminars, supplementary training, conferences and other sector events gathered under one roof and combined with a trade show.

Consequently, CPH LabMed simplifies contact between suppliers and purchasers by forming a central meeting point for stakeholders in the laboratory industry.

CPH LabMed selects the Train Workshop The Train Workshop is unique and one of Denmark’s most

special exhibition venues. At almost 10,000 square meters it is also one of the largest exhibition venues in Copenhagen.

As its name suggests, for almost a century the hall was a site where trains were repaired. The historic atmosphere and impressive architecture, with floor-to-ceiling windows and a roof structure made of wood and glass, form a versatile venue with a special rough look and atmosphere.

The hall itself has been maintained with its original rough look for maximum possible authenticity.

Cph. LabMed has therefore selected the Train Workshop as the distinctive setting for its future trade fairs featuring laboratory equipment and pharmaceuticals. Our aim is to create an entirely new forum for the industry, one that stands out significantly from previous trade fair experiences.

Check: www.cphlabmed.dk

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TALKIN’ ABOUT

The importance of US researchers recently creating a synthetic, fully functional chromosome.

The yeast, called Saccharomyces cerevisiae, is now thriving with the manmade chromosome III as part of its genetic material. The successful creation of an artificial chromosome has attracted great attention in scientific circles, including at the BRIC research centre at the University of Copenhagen where Kristian Helin is director and professor.

By Kristian Sjøgren

Why have artificial chromosomes attracted so much attention?

Within synthetic biology the achievement is impressive.

Researchers in this field think it is very impressive.

First and foremost, it is ‘proof of concept’ as the US researchers have shown that complete artificial chromosomes can be made and inserted into a eukaryote cell that works as if it were equipped with a completely normal chromosome.

This has previously been accomplished with half of

“We are sure to see a

host of new research results from this approach in the near future.”

Translation CLS Communication A/S

a chromosome from yeast, a virus and bacteria but everything becomes a good deal more complex when using a eukaryote. The long-term aim is to make synthetic organisms from scratch, and this achievement is an important step towards that goal.

Is the technique revolutionary?

Actually, no. The researchers have used old techniques to synthesise the chromosome bit by bit. It is made by students using simple PCR reactions to connect the nucleotides in a predetermined sequence. The products of the PCR reactions are then glued together to form the final chromosome, which is inserted in the yeast. Even so, it has taken seven years to achieve this finished result.

This proves it is not easy. So it is revolutionary. Today, the same result can be achieved quicker because techniques have become more advanced in the meantime. Now, in collaboration with a number of others, researchers want to make the rest of the yeast’s 16 chromosomes and thereby create a 100% synthetic organism.

What use are synthetic chromosomes?

Yeasts with synthetic chromosomes can be used to answer many questions, such as how long do telomeres have to be to ensure the DNA is not damaged. Various

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FACT • Kristian Helin has worked with molecular Kristian Helin, Professor Pr-photo

cancer research for 25 years at Massachusetts General Hospital, Harvard Medical School and the European Institute of Oncology, among other institutions. In recent years, he has also worked with epigenetics and stem cells.

• He is professor at the University of Copenhagen and director of the Biotech Research & Innovation Center (BRIC). Kristian Helin also leads the Center for Epigenetics and is a founding group leader at the Danish Stem Cell Center (DanStem). In addition, he has founded the biotech company EpiTherapeutics, which makes cancer medicine based on epigenetics.

parts of the chromosome can also be erased, have something replaced or something added.

Many research questions will be much easier to answer with synthetic chromosomes. If I were a yeast technician, I would try to obtain S. cerevisiae 2.0 to attempt to answer some of these questions. I am also sure that the US researchers would like to share the

• Kristian Helin has close to 175 scientific articles under his belt and has received a number of awards for his research..

FACT

yeast strain so that other researchers can test various hypotheses or just play with it and see what happens.

We are sure to see a host of new research results from this approach in the near future.

• A US research team led by Professor Jef Boeke from New York University was the first in the world to design a eukaryote chromosome from scratch and insert it in a yeast cell.

Research is one thing.

What about the biotech industry?

• It has taken researchers seven years to create the completely artificial version of the yeast Saccharomyces cerevisiae’s chromosome III – nucleotide by nucleotide. Initially, they used a computer model to design the chromosome itself to give it the appearance they wanted.

Then it took more than 60 students to create the chromosome bit by bit with the help of PCR reactions. The researchers glued the products of the PCR reactions together to form the final chromosome, which they inserted in the yeast cell. The yeast cell worked as if an entirely naturally created chromosome III was inside its genome.

This is a little more difficult to fathom. In most cases by far, it would be like using a sledgehammer to crack a nut. Of course, you get a tool that enables very precise control of the yeast’s protein production, for example, but there will be technicians who are better at designing chromosomes to suit requirements. However, there will probably be some researchers out there who can appreciate the opportunities in using artificial chromosomes to solve problems in the industry that are currently difficult to solve.

What will happen now?

S. cerevisiae has 12 million base pairs and I believe researchers will be able to use more recent techniques to create the entire yeast by about 2016. The ultimate goal is to make, say, transgenic mice with artificial chromosomes, but it’s a long way from yeast up to mice or humans. I don’t know if it can be done.

•

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LEGAL UPDATE

Legal update on Technology The European Commission has adopted a new Technology Transfer Block Exemption Regulation (TTBER) and revised guidelines on the application of Article 101 of the Treaty on the Functioning of the European Union (TFEU) to technology transfer agreements.

By Thomas Bjørn, Solicitor, Royds in London

I

n its press release, the Commission refers to the new rules as “incremental improvements to the current regime” and it is correct that there are no fundamental changes to the existing system. The new rules are, however, less permissive, particularly in relation to the restrictions on passive sales, exclusive grant back arrangements and termination upon challenge provisions and they are likely to increase the overall burden of self assessment on contracting undertakings.

The main substantive changes are as follows: • The TTBER contains a number of new or modified definitions for technology rights, technology transfer agreements, competing undertakings, selective distribution systems and exclusive licences.

• Article 2 of the TTBER additionally provides that the safe harbour also apply to provisions in technology transfer agreements relating to the purchase of products or to the licensing of other IP, provided that such provisions are linked directly to the production or sale under the licensed technology.

• In relation to agreements between non-competitors, restrictions on passive sales into territories or to customers remain strict - again subject to certain exceptions. It should be noted that the provision of the 2004 TTBER allowing such restrictions in respect of sales into territories assigned by the licensor to another licensee has been removed.

• The “Excluded restrictions” now include any direct or indirect obligation on the licensee to grant an exclusive licence or to assign rights, in whole or in part, to the licensor or to a third party designated by the licensor in respect of its own improvements to, or its own new applications of, the licensed technology.

• The “Excluded restrictions” now extend to termination upon challenge provisions in non-exclusive license agreements.

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They do, on the other hand, contain a number of clarifications and simplifications, both in relation to 2004 TTBER and in relation to the consultation draft which must be regarded as generally welcome.

Background It has always been acknowledged that technology licensing agreements can have an adverse impact on competition. A dominant licensor may seek to include

This means that provisions under which the licensor may terminate the agreement if the licensee challenges the validity of the licensed intellectual property will only benefit from block exemption in exclusive agreements.

• The Guidelines set out the Commission’s view on the competitive effects of technology pools and settlement agreements. In respect of the latter, it is particularly worth noting that settlement agreements are described as legitimate instruments for settling a technology disputes

but that agreements which lead to a delayed or limited ability for a party to launch a product into the market, may be prohibited under Article 101.

Jusmedico is a specialist law firm providing legal services to the biotech, pharmaceutical, medical device and dentistry industries, life science investors and to suppliers and service providers thereto.

Jan Bjerrum Bach

Jusmedico Advokatanpartsselskab Kongevejen 371, DK-2840 Holte Tel: +45 4548 4448 Mbl: +45 4029 4124 E-mail: jbb@jusmedico.com www.jusmedico.com

Transfer Agreements anticompetitive terms in an agreement or to exclude competing technologies from the market, or technology licensing agreements may be used by competing undertakings to divide a market between them.

Article 101 of the TFEU prohibits anticompetitive practices and contracting undertakings therefore have a duty to assess whether their agreements can be regarded as anticompetitive under these rules.

There are, however, certain agreements which are seen as unproblematic, either because they do not have a negative impact on competition or because the negative effects are outweighed by the positive ones. If an agreement meets the requirements of the TTBER, it will not be caught by the prohibition in Article 101 and there will therefore be no need for the parties to carry out a self-assessment of its potential anticompetitive effect. In other words, the TTBER

provides a block exemption or a “safe harbour” from Article 101 to the extent that parties can assume that such agreements will not be caught by the prohibition.

The New TTBER and Guidelines The TTBER sets out the terms under which a technology transfer agreement can benefit from the block exemption and the supporting Technology Transfer Guidelines provide guidance on the application of the TTBER and on the application of EU competition law to agreements which fall outside the TTBER. The benefit of the block exemption is – as was the case under the 2004 TTBER – restricted to agreements between undertakings with market shares below 20% (combined) for agreements between competing organisations and 30% between non-competitors. •

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CALENDAR

Translation: CLS Communication A/S

SEPTEMBER SEPTEMBER Scanlab Scanlab 2014 is cancelled more at scanlab.dk

Biopharm America 22-24 September 2014 Boston Marriot Copley Place, Boston Info and registration at www.ebdgroup.com BioPharm America™ is where biotech industry partnerships get started. Meet face-to-face with biotech and pharma executives from around the world to identify and enter strategic relationships. Equipped with partneringONE®, the world’s leading web-based partnering system for the life science industry, BioPharm America is the only event in North America based on the same reputable formula as EBD Group’s acclaimed European events BIO-Europe® and BIO-Europe Spring®.

Features of the conference are one-to-one partnering meetings, workshops to discuss the latest industry trends and panels featuring key biotech and pharma leaders. Company presentations and an international exhibition of major bio-industry leaders who showcase products, services and technologies.

Clinical Trials Workshop – Translating the New Clinical Trials Regulation into Practice 23-24 September (part I) & 24-25 September (part II) Millennium Gloucester Hotel, London Info and registration at diahome.org/meetings and training The new EU Clinical Trials Regulation is expected to become applicable in 2016. The new legislation will have implications on clinical trial sponsors preparing and submitting clinical trial applications. Member States will have to adapt their

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procedures for the assessment of clinical trial applications by competent authorities and review by ethics committees. Additionally, the new Regulation will impact how the conduct of a clinical trial is managed after approval has been granted. New provisions for public access to an EU clinical trials database will enforce disclosure of clinical trials data and information.

The first two-day workshops will provide a forum for information exchange and discussion on conceptual and practical questions through lectures, panel discussions and interactive break-out sessions. The adjacent two-day workshop, on clinical data transparency, will focus on practical considerations for the disclosure of clinical trials data. Attendees can participate in either one workshop or the entire three-day programme.

The two workshops will overlap with a day addressing the transparency aspects of the Clinical Trials Regulation.

OKTOBER OKTOBER Regulation of Medical Devices Date: 1 & 2 October 2014, Copenhagen Link: http://www.ibceuroforum.dk/produkter/14medico Extensive new requirements are emerging from European and Danish side - and do you have products in the U.S., FDA also represent immense regulation. IBC Euroforum invites the Danish medical industry to a conference on current and future regulation of medical devices and in particular on the practical challenges of compliance the legislation gives Danish companies. The industry’s main experienced players from home and abroad are on the list of speakers - from authorities to consultants and in particular the industry itself. They will share their experiences with regulatory approaches from the different parts of the industry they represent.

Copenhagen Lab Med 7-9 October 2014 The Train Workshop, Copenhagen Info and registration at cphlabmed.dk CPH LabMed is a three-day event focusing on Denmark’s leading laboratories in the health sector and industry as well as educational and research institutions. This new interdisciplinary meeting place will house lectures, workshops, walk-in sessions, seminars, training, conferences and other industry events all under one roof combined with a trade fair.

CPH LabMed simplifies contact between suppliers and buyers by acting as the central meeting point for lab industry stakeholders. CPH LabMed collaborates closely with the Danish Association of the Pharmaceutical Industry (Lif) and the Swedish labmed professional association. Because no equivalent trade fair exists in Sweden, the aim is to make the Danish fair more Scandinavian to appeal to the Swedish exhibitors and visitors.

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“Life science is generally characterized by unique exposures with unique claims. Risk analyses are complex and must be performed by specialized underwriters with insight in order to put together a programme customized to the exposures, ensuring compliance and meeting the legislation,” says Magnus Flyrin, Life Science Regional Manager at Chubb Insurance Company of Europe SE. From Stockholm and Copenhagen, the life science department at Chubb Northern Europe, provides service to the Nordic clients. Local presence, however, is contrasted by global operations.

“Clinical trials as an example are often international. We have the expertise and the capability to provide coverage and compliant documentation to fulfil the insurance requirements in most countries needed. Backed up by our automated web based system we can support some 25 countries in real time,” Flyrin says, explaining the tool giving Chubb a competitive edge, WorldCert. (https://www.youtube.com/watch?v=kCNFQbHKAfQ) “Detailed information concerning the trial is fed into WorldCert and returns immediate quotes and compliant documentation in local languages if needed.”

Ensuring compliance Compliance is of major importance in life science as testing, manufacturing, and marketing of medicinal products are strictly controlled by health and regulatory authorities. The EU directive on clinical trials with medicinal products, has impacted the insurance industry and clinical trials conducted in the EU. “Insurance or other indemnification is required by the sponsor to compensate the research subject for injury when participating in a clinical trial. However some countries (e.g. D, F, and NL) took this further and require by law national insurance policies covering damage locally. Medtech also face these requirements, e.g. by the Medical Device Law in Germany. Clearly this has

left sponsors challenged as to figure out exactly what is required regarding documentation, what limits of insurance to buy, and how to budget for the insurance cost,” Flyrin says.

“And as there is a discrepancy between what should be provided by recommendations, requirements e.g. by ethics committee, and Magnus Flyrin, by law, standard solutions Life Science Regional Manager are inapplicable and the expertise of Chubb’s life science underwriters and WorldCert come in handy.”

Insight, experience, and network Decades of experience at Chubb and a large global network form the basis of how highly specialized and customized insurance solutions are compiled in a cost-efficient manner. Within life science, insurance of clinical trials is a major business area, however the services of Chubb cover all phases through R&D, manufacturing, to the time when products are brought to market.

“We speak ‘life science’ and contribute to new products behind the scenes by taking thought-through decisions to protect our clients’ bottom line from the financial consequences of a loss or lawsuit,” Magnus Flyrin ends.

For more information http://www.chubb.dk/index.html

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