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Contents The column
Scienceparks in medicon Valley
The Year in review
What lies ahead
One by one - BioTech - Medical Device Industry - The Pharmaceutical Industry - Business Service Providers - CMO - CRO - Academic Institutions
28 32 34 38 52 54 60
Index 70 Calender
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Welcome to the Yearbook on Life Science in Medicon Valley
By Malene Aadal Bo
The Nordic life sciences sector is, despite a relatively small combined population of approx. 25 million inhabitants, well-developed and holds some of the world’s most innovative and promising projects in its pipeline.” Such reads the conclusion of “The Nordic Life Science Sector Study 2014” published by the Swedish life science industry organisation, SwedenBIO. It supports my analysis of the sector today as we all start shaking off the financial crisis and the shock waves it sent through the Nordic life science industry. For several years in a row now the life Sciences industry funding totals have been increasing with pharmaceutical companies dominating in both Sweden and Denmark in terms of revenue.
We are at the forefront Looking around, I see a Nordic market which is very attractive for the Life Sciences sector for several reasons, including a welleducated labour force, renowned researchers, well-developed infrastructure, high innovation rates and established data registries. As a result, the Nordic
countries – with Denmark at the forefront – are among the leaders in European drug development.
“The sector faces two major challenging trends: digitalisation and the emergence of personalised medicine. These two trends seem to fundamentally disrupt the traditional way of doing things within the life sciences industry.” Moreover, several of the Nordic clusters are counted among the strongest in Europe, hosting excellent interplay between public and private partners and providing unique testing environments, which enable clinical research to turn into business on a fairly large scale. However, this does not mean
Translation: CLS Communication A/S that being a Danish or Swedish life science company is a walk in the park. The challenges are comprehensive and persistent. Access to high-risk investments is limited, regulations are increasing and there is a pressure on public health budgets which impacts the prices in the entire sector. In addition, the sector faces two major challenging trends: digitalisation and the emergence of personalised medicine. These two trends seem to fundamentally disrupt the traditional way of doing things within the life sciences industry, putting pressure on companies to develop a broader set of skills.
The answer is cooperation According to SwedenBIO, the answer to the challenges of today is cooperation. Close networks within the life sciences industry, crosscutting private-sector companies, research institutions, various support structures and dynamic partnerships with both customers and authorities across national borders are what it takes to face these challenges. Let this Yearbook be your place to start. These pages offer an overview of the life sciences sector in Medicon Valley. It holds a general introduction to the industry and a forecast of the years to come, and it provides a sector-by-sector listing of the companies located and working in your immediate vicinity.
Where great minds meet Working at a science park is quite unlike anything else. 62% of our companies experience growth. 53% launch new products. 54% collaborate with DTU, and 67% feel that Scion DTU contributes positively to their growth. Why donâ€™t you join us? We still have available space at our scenic science park in HĂ¸rsholm. We are a group of knowledge-intensive businesses, many with hardware focus, as the facilities are very well suited for this purpose. Please feel free to pay us a visit. For more information, call +45 4586 4100.
1. COBIS (Copenhagen Bio Science Park)
COBIS is a result of the political vision of the Ministry of Higher Education and Science and the Capital Region of Denmark to strengthen the biotechnological competences of the region. It was established in 2009 with the ambition of being a centre of growth by creating the right conditions for the biotechnology successes of tomorrow. The business Accelerace Bio development programme was launched in 2010. Find out more at www.cobis.dk
Science parks in
2. Scion DTU in Hørsholm
Scion DTU is DTU’s high-tech science park. It is the focal point for 200 international knowledge companies of all sizes within medico, cleantech, IT and biotech. The companies comprise Denmark’s largest biotech cluster measured by the number of employees, with high-tech companies ranging from 2 to 600 employees. The science park was established in Hørsholm in 1962 and merged with DTU in 2004. More at www.sciondtu.dk
3. Symbion in Copenhagen
SSymbion was established in 1986 by six researchers who wished to create synergy between research and the business community. Today, Symbion is one of Denmark’s leading business environments with laboratories, business development and capital for entrepreneurial activities within ICT, knowledge consulting, cleantech and life science, in particular. Around 30 companies within biotech and medtech, healthcare or service/contract are based at Symbion. More at www.symbion.dk
4. CAT Sciencepark
CAT Sciencepark is a privately-held company, helping entrepreneurs and innovators to find the capital and the right competences required to turn ideas into enterprises. Forskerparken CAT is a unique combination of governmentbacked, pre-seed capital, science park, and venture company. We are capable of functioning both as host as well as mentor for your good idea. All the way – from the first tentative steps to a viable enterprise. Our highly educated investment team has many years of experience in evaluating the market potential of the multitude of ideas presented to us each year. Our investment team opens up access for you to consulting and to the right competences when starting up your enterprise.
Incuba contributes with sparring and consulting services and utilises its extensive network of major innovation players and commercial partners to promote the innovation activities and growth of the resident businesses. In close proximity to local research and educational institutions, INCUBA's locations generate synergy effects that give its many diverse enterprises excellent opportunities for commercial innovation
6. NOVI Research Park
NOVI Research Park currently houses some 100 businesses, most of them high-tech. At Novi, these businesses have access to a dynamic, full-service environment. NOVI Science Park, has a building complex of 43.000 square metres in Aalborg East, an area in fast development. Our buildings lie across from our new super-hospital, and next to Aalborg University.
11. Medeon Science Park in Malmö
Established in 1985, Medeon Science Park houses about 40 companies. The focus is on knowledgeintensive companies within life science, mainly drug development, biotechnology and health. In 2007, the science park also gained its own incubation environment. Altogether, more than 100,000 square metres are reserved for the science park, which is expecting to grow significantly in the years ahead. More at www.medeon.se
10. Medicon Village in Lund
The former Ideon Science Park now houses more than 1,100 people in 100 organisations targeting especially cancer research, prevention, diabetes and nanomedicine. Medicon Village maintains close contact with the Biomedical Centre (BMC) in Lund and the Clinical Research Centre (CRC) in Malmö, as well as with the developing research facilities ESS and the MAX IV laboratory. More at www.mediconvillage.se
9. Ideon Science Park
Ideon Science Park is like a life-giving lung for the whole of the expansive, northeastern area of Lund. With the University, the Faculty of Engineering and the School of Management and Economics in its immediate vicinity, Ideon Science Park is the obvious meeting place. St Ericsson, Sony Ericsson, Axis Communications, Active Biotech and Gambro all have their development centres right beside the Park. 7
Krinova is one of the country's 60 or so incubators and science parks, where innovation and development is promoted from collaborations between companies, organisations, universities and society. We offer a creative growth environment with incubators and innovation arenas to support development and innovation initiatives. We also arrange tailor-made conferences, and offer flexible office premises. Krinova's interdisciplinary profile area of food - environment is a by-product of the local economy of Kristianstad and the areas of expertise of Kristianstad University.
7. Videum Science Park
Videum Science Park is the region's fastest growing knowledge environmemt. More than 100 companies and organisations are now located in a creative environment on the Växjö University Campus - one of Sweden's most expansive campus areas. At Videum Science Park you can rent anything from a desk in an office landscape or a small office right through to a complete floor or a whole building. In other words, there are premises to suit all companies, no matter what their size or stage of development. Videum offers access to experienced and professional business advice and finance
Nordens mest attraktive erhvervsområde
Scanport er Københavns nye internationale erhvervsområde i hjertet af Skandinavien med lufthavn, Øresundsbro, motorvej og metro lige ved døren. Området ligger direkte ud til Øresund, har sin egen lystbådehavn og byder på natur- og kulturoplevelser – tæt på Københavns centrum.
Området udvikles af Skanska med en vision om arkitektur i verdensklasse, byrum med sociale samlingspunkter og et aktivt havnemiljø. I udviklingen tilgodeses jeres ønsker og identitet for at skabe de bedste rammer for jeres forretning, medarbejdertrivsel og driftsøkonomi.
For en uforpligtigende præsentation kontakt Skanska på tel: 44 68 05 65
Be part of a world-class life science village Medicon Village is a roaring success and now its residents are sending a special invitation to Danish companies to come and join the party. At Scheelevägen 2 in beautiful Lund, you will find a very special community. In just three years, it has gained more than 1,000 residents, who all share one dream – or rather two. They want to contribute to the health and well-being of humankind. And they want to do so in a community where everyone works together to transform bright ideas into business. The goal is to shorten the process from concept to finished product with the help of the entire community. “Medicon Village isn’t just another science park. It’s a place and a group of people who work together to create a unique environment for players within Life Science,” says Kerstin Jakobsson, Executive Vice President of Medicon Village. Half a
FACTS ABOUT Medicon Village • Established in 2012 in the former premises of Astra Zeneca in Lund, Sweden. Created by the charitable foundation, Mats Paulsson’s Foundation for Research, Innovation and Societal Development, for the purpose of bringing scientists and companies together in the search for innovative solutions to improve people’s health and well-being. • Currently comprises 80,000 square metres of unique laboratory and office facilities. Members include Lund University, Region Skåne, Lund Life Science Incubator and companies specialising in cancer, diabetes, nanomedicine and eHealth. Find out more at www.mediconvillage.se
decade ago, when a charitable foundation took over the site from Astra Zeneca, it was with ambitious plans to create an environment where research, innovation and entrepreneurship could work hand in hand for the benefit of the health and well-being of ordinary people. There would be a special focus on cancer, diabetes nanomedicine and eHealth, and building strong relations to stakeholders of all types was of particular importance.
Three years later, the venture shows every sign of success. More than 100 companies and organisations have moved into the science park and the 1,000+ men and women who work in the village on a daily basis include researchers, entrepreneurs, service providers and employees in established companies. The companies located in the village represent the entire health chain, from prevention and diagnostics to care and treatment. And the portfolio of promising projects and valuable partnerships is impressive. “The environment we have created has already proved it works. Our members have experienced a radical improvement in their visibility and opportunities for collaboration,” explains Kerstin Jakobsson. Today, most of the residents are Swedish. However, Kerstin Jakobsson hopes that more Danish companies will discover the unique opportunities that await them if they venture to cross the Sound. “Fantastic location and facilities, excellent opportunities for local and international collaboration and increased visibility with all the advantages that come with it. This is what we can offer. Plus neighbours who share the same passion and professional interests and challenges as many other companies in Life Science,” concludes Kerstin Jakobsson.
Huge boost for life science in Central Denmark Region At the new super hospital in Aarhus on the Danish peninsula of Jutland, a large-scale efficiency optimisation and digitisation project is currently underway. At the same time, the region is involved in an initiative aiming to help the public health system and private-sector companies in the region benefit more from each other. In Aarhus, one of Denmark’s future super hospitals is gradually evolving. It currently spans a full kilometre from one corner to the other, and as it is being built up, Lars Ganzhorn Knudsen, IT project manager, is working hard to ensure that it is also a super-efficient, functional and patient-friendly unit, despite its enormous size. The keyword is digitization. “Extensive digitization,” clarifies Lars Ganzhorn Knudsen. “What we are doing here is entirely unique. No other place in the world is carrying out such extensive digitization at a hospital.” The ultimate aim in the region’s view is to create the best possible conditions for the 100,000 inpatients and 850,000 outpatients, who the hospital will be treating in future. That and the desire to seize this opportunity to create as efficient a system as possible. Lars Ganzhorn Knudsen’s work is therefore centred to a great extent on optimisation and on minimising the annoyances that waste the time and energy of both staff and patients. For instance, a survey has revealed that a nurse can easily spend half an hour each day simply looking for things. Other figures show that patients often have to wait for their transport because the orders only rarely reach the porter who is closest to them. The new fully digitised hospital will change all of this and more. “On a monitor, it will be possible to see where equipment and people are located. It will be possible to order patient transport in a centralised system that sends the order to the closest porter. And it will be possible directly from a bed to enter into the system that it is dirty and needs to be replaced by a clean one – the centralised system will then calculate the most efficient procedure for completing the task,” explains Lars Ganzhorn Knudsen. It’s a difficult and comprehensive venture – to use Lars Gan-
zhorn Knudsen’s own words – that has also involved a great many private-sector companies in the region, including both IT firms working with the digitization process itself and those involved in the development of the necessary readers, pads and units. “And along with the entire process come opportunities and requirements for the companies that supply medical equipment, medicine and services to the health sector. We will be expecting them to add value to the entire chain – what they supply must help us streamline processes and constantly increase quality,” explains Lars Ganzhorn Knudsen. A helping hand for private-sector companies At the same time, the region is participating in another initiative to help local companies with just that – partnering efficiently with the public health system and ensuring that the knowledge and knowhow created at the hospitals is also converted into new products. This initiative is anchored in the Med Tech Innovation Consortium (MTIC), which was started six years by the Central Denmark Region and a handful of Life science companies in the region. “They picked up on new needs from the health sector and they all experienced challenges in getting exchanges between the public health system and private companies to run smoothly,” explains Trine Winterø, CEO, MTIC. Today, MTIC is backed by the region, Aarhus University, VIA University College and 12 municipalities in central Denmark. The consortium has been very successful at helping companies to understand the conditions and challenges that the public health system is subject to – and to commercialise the knowledge and research created at the region’s hospitals and universities. “We don’t have a stake in anything, and we don’t need to take out patents. We’re here to help both parties help each other. We have managed to open the public health sector up to the private companies and vice versa,” says Trine Winterø. MTIC has people placed at the hospitals, giving them direct access to the researchers and clinics with whom the business community wants to collaborate. At the same time, they have daily contact with people who know how to run a business and can see the commercial potential in the ideas that emerge. “You could say that we contribute with exactly what a company or research unit needs. Small entrepreneurs with a bright idea who need a helping hand. Or large companies who are looking for inspiration for innovative thinking. All with the ultimate goal of creating better products for the health sector and contributing to more sustainable companies in the region,” concludes Trine Winterø.
The year in review 2014 We have gone through the archives of Copenhagen Life Science to find the most important news on business and research, some of the most telling pictures and the central quotes from our cover persons. Walk with us through 2014.
Science and Business in brief Latex led to surprising skin discovery Danish scientists have discovered that the skin communicates with the liver. The surprising discovery was made using genetically engineered lab mice that lacked a special fatbinding protein, known as the acyl-CoA-binding protein, whose function the researchers wanted to examine. The absence of this protein caused fat to accumulate in the liver. The researchers covered the mice in liquid latex and saw the mice’s livers return to a normal and healthy state. “This is very surprising and may have implications for people who suffer from a variety of skin diseases, because their disease may also affect their internal organs,” says Professor Susanne Mandrup, of the Department of Biochemistry and Molecular Biology at the University of Southern Denmark.
Researchers find body’s HIV alarm Researchers have unlocked a mechanism behind how our body goes into alarm mode when the HIV virus invades our cells. A special ‘alarm protein’ detects strings of HIV DNA, triggering an immune response before the virus has time to take over the cell. “The protein we’ve discovered is like a speed bump on the road which slows down the virus. By making the bump bigger we could, in theory, slow the spread of the virus, gaining time to activate the innate system and make it harder for a virus like HIV to establish itself in the body,” says the lead author of the study, Martin Roelsgaard Jakobsen from the Department of Biomedicine at Aarhus University. The HIV ‘alarm’ is known as the IFI16 protein.
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 subsequently 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.
A ‘feeling’ prosthesis was only the first step In early 2014, a Danish amputee became the firstever 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 was granted an additional DKK 45 million in funding. “We will be testing three different models: electrical
Established understanding of the immune system shattered A new, groundbreaking discovery from Aarhus changes our understanding of how the immune system is activated when bacteria enter the body. All over the world, textbooks on immunology will have to be rewritten. “Our discovery provides entirely new basic knowledge of a core defence mechanism in the immune defence’s complement system. The discovery opens up the possibility of the longterm development of new medicines, but the breakthrough has cost blood, sweat and tears,” says Søren E. Degn, PhD, one of the driving forces behind the new study, published in the international magazine PNAS. Researchers from Aarhus University’s Department of Biomedicine have worked out how a central enzyme (called MASP-1) in the complement system is activated. For a long time, it was thought that this occurred via a molecular change in a protein (a patternrecognition protein). However, the new experiment has revealed something different: When a patternrecognition protein recognises the surface pattern of a bacterium, a large amount of MASP-1 gathers in a small area and begins making another enzyme called MASP-2. The enzymes thus activate each other, thereby triggering the immune system’s defence mechanisms.
stimulation on the skin surface, mechanical stimulation through pressure sensors in a hand prosthesis and electrical stimulation of the nerves,” says Associate Professor Winnie Jensen of Aalborg University.
A whole new class of antibiotics invented An increasing number of the existing antibiotics are losing their ability to combat bacteria. Now scientists from the Danish Center for Antibiotic Research and Development (DanCARD) are developing a brand new class of antibiotics that will hopefully put an end to the progression of multi-resistant bacteria once and for all. They consist of tiny protein fragments called peptides that rip apart the outer shell of the bacteria. “Peptides work incredibly well when it comes to killing bacteria. We have already proved that,” says Professor Niels Frimodt-Møller, MD and director of research at DanCARD. “We’re working to ensure that the peptides are also harmless to people. It looks promising, and it’s an exciting new area of antibiotics research.” The DanCARD project has identified several small peptides that either bind themselves to the surface of the bacteria, making a channel that other matter can pass through in order to kill the bacteria, or simply tear the outer shell of the bacteria apart, causing the bacteria to die.
Novartis executive: 2020 will be the year of copycat medicines “Biological copycat medicine will not play a major role in the health system for the next two to three years,” said Novartis’s top executive, Joe Jimenez, at a recent event. However, he expects the tide to turn in 2017-2019 as several large, expensive patents for antibody medicines are destined to expire. “And by 2020, just five years from now, we will see a big impact,” says Joe Jimenez. Biosimilar medicines have generated sales of about USD 500 million for Novartis, with sales growth of 20% a year.
Novo drops inflammation Moving into the area of inflammation was a high-risk venture that ultimately failed. The decision has therefore been made to close it down, according to Chief Science Officer Mads Krogsgaard Thomsen. “Gaining a foothold in the area of inflammation was more challenging than we had anticipated. At the same time, we have had a higher success rate than we ever dared hope for within diabetes, so this is where we intend to devote our R&D,” he says. Novo has now terminated all research and sold off the rights to the antibodies for treating chronic arthritis etc
Symbion to focus more on health technology Start-up companies working within health technology can look forward to greater interest from Symbion, which, via Accelerace, is investing in fledgling companies. According to Symbion’s CEO Peter Torstensen, several factors make health technology an interesting investment proposition. “On the one hand, new hospitals are being built and, on the other, many beds are being phased out. We think that a wide range of brand new technologies will need to be developed to achieve success,” he says, adding that Symbion will also work with specific goals to attract foreign start-up companies to Denmark.
The best top executives named In a survey, Danish daily Jyllands-Posten and Dansk Aktie Analyse (Danish Stock Analysis) asked which Danish top executives scored best on: credibility, growth, strategy, efficiency and human resources. In 2014, first place was seized by Lars Rasmussen, CEO of Coloplast, dethroning Novo Nordisk’s (now former) CEO 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
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Genmab raises a billion The Danish antibody company Genmab has raised DKK 998 million via a targeted emission to selected investors. The shares were sold at a price of DKK 217, which is slightly lower than the closing price of DKK 228.50 for the share on the date of sale. The new investors therefore received a modest discount. The money will be used to purchase companies, technologies and products, and the company will exploit the ‘extra padding’ to secure better cooperation agreements.
Major differences between FDA approvals Researchers from Yale University have investigated the clinical basis for a number of new drug approvals from the FDA. The conclusion seems to be that there is no link. The survey of 188 drugs approved between 2005 and 2012 showed that some were approved on the basis of comprehensive clinical studies, but about one-third of the drugs were approved based on a single clinical study – often a short one at that.
These pages has been compiled in collaboration with Videnskab.dk and ScienceNordic.com.
These pages was compiled in collaboration with Medwatch. Read more news at www.medwatch.dk 16 16
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.
The FDA approves Victoza rival Tanzeum. That is the name of the diabetes drug produced by British GlaxoSmithKline, which will very soon clash with Novo Nordisk in the US market. At the end of April, the US Food and Drug Administration approved the drug, which is also known as albiglutide, 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.
The ancient Greeks knew that architecture, music and art are decisive factors in getting ill people back on the road to recovery. They built the world’s oldest hospital – the beautiful Temple of Asclepius with a concert hall, decorated walls and a lovely garden. In the Middle Ages, it was also believed that aesthetics possessed a healing power, and medical students who could demonstrate their knowledge of music were more likely to be accepted. Now, once again, it is being acknowledged that skilled surgeons and the medicines we offer patients are not the only factors influencing recovery. For example, American Roger Ulrich has clearly demonstrated the powerful effect of architecture and decoration on illness, health and recovery, and at Copenhagen University Hospital, heart patients have clearly made better progress with bed rest in plenty of daylight accompanied by good music. This increased focus on aesthetics has encouraged the Americans to rate the country’s hospitals – not only according to professional standards, survival rates, treatment times and the like – but also on their physical beauty. These were voted among the 20 most beautiful hospitals in 2013. See the entire list at blog.soliant.com/most-beautiful-hospitals/2013/
Getting close Photo credit: Larry Ostby, National Cancer Institute
Azidothymidine, or AZT, was the world’s first drug against HIV and plays a supporting role in the Academy Award-winning movie Dallas Buyers Club. AZT was first developed as a cancer medicine back in 1964, but it was rejected for failing to have the desired effect. Twenty years later, researchers discovered it had an inhibitory effect on the HIV virus and it was put into production and used for years as part of the combination treatment of patients with HIV. Here photographed by Larry Ostby magnified by 50x.
ZMapp had only been tested on primates and was actually years away from use in practice when the dreaded virus that causes the Ebola haemorrhagic fever began to spread across West Africa in early summer 2014. Doctor Kent Brantly, an American Ebola specialist, was engaged in the battle against the virus as it spread much faster than had ever been seen before, and soon a public health emergency was declared in Liberia and Sierra Leone. When Brantly noticed that he had the symptoms of Ebola in early August, he located one of the few doses of ZMapp in the world and treated himself with it. Today, Brantly is recovered and WHO has decided that is it ethically justifiable and necessary to also offer treatment to the many ordinary people who have contracted Ebola – even though there is currently no fully tested and approved vaccine or treatment for Ebola. One company to step forward is Fujifilm from Japan, which wants to add a component to the already approved Favipiravir influenza vaccine so that it can be used against Ebola. Another is Danish Bavarian and, especially, GSK from the US, which has a vaccine consisting of a common cold virus that has been engineered to carry two genes of the Ebola virus. Animal testing has shown that when the adenovirus infects cells, the Ebola genes produce harmless proteins that stimulate the immune system to produce Ebola antibodies.
Experimental medicine mobilised in the battle against Ebola
Somehow the manager’s role always ended up in my lap; I’m not sure though if ambition had much to do with it from the start, moreover it came down to my dedication to the team and my commitment to the employees.
53-year-old Alejandra Mørk made a career move into the pharmaceutical industry 25 years ago, realising that she was too much of a team player to be seated alone in lab as a scientist. In 2000, she became Vice President Project Management in Nycomed and in 2008 she moved to KLIFO as CEO. Since 2013, she has chaired the Pharmaceutical Society of Denmark.
I do not consider myself 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. At 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. Up until 2008, she was CEO at Zealand Pharma, which she founded in 1998 after a number of years as head of R&D at H. Lundbeck and as professor of clinical pharmacology at Aarhus University.
“My motto is that anything
worthwhile is hard to get – if it’s easy, everyone has it and then it’s probably worthless. That’s another way of saying that hard work is the secret to success and it’s one of the recurring truths I’ve met most frequently in my life.”
Henrik Ørum, 58 years of age and PhD in molecular biology. Chief Scientific Officer and VP of Business Development at Santaris Pharma. His greatest career successes are founding Exiqon and Curion. The latter merged with Pantheco in 2000 to form Santaris Pharma, which has specialised in developing the LNA molecule for realising antisense technology.
Local empowering of industry and research
The North Denmark Region has a proven track record in establishing successful private-public collaborations focusing on innovative healthcare and technological solutions. By Charlotte Strøm, MD PhD Journalist With a series of initiatives the North Denmark Region has established itself as an active public partner in private-public collaborations, particularly within healthcare and technology. Among other projects is the Eir Research and Business Park, the only environment in Europe, which fully integrates biomedical technology, basic medical research, and applied research in successful private-public collaborations. Eir – an abbreviation of Empowering Industry and Research – is a research and business park in the North Denmark Region that aims to facilitate development and innovation within the field of health science and technology. “The Eir set-up is quite unique, in that the industrial stakeholders are closely connected to the researchers and, furthermore, located in the midst of the public healthcare system enabling and moreover encouraging collaborations on innovative technological healthcare ideas,” says Steen Andreassen, Professor at the Institute of Medicine and Healthcare Technology at Aalborg University, board member at Eir, and on top of that managing director at a small spin-off company, Treat Systems, developing health IT solutions. Eir Research and Business Park is physically located at the premises of Aalborg University and Aalborg University Hospital.
The private partners in Eir collaborate closely with scientists at Aalborg University and specialists at Aalborg University Hospital. Facilitated development Ideas for innovative healthcare solutions are generated locally. Ideas may arise from both ends of the private-public partnership. At Aalborg University Hospital the “Idea Clinic” receives input from employees, patients, and spouses on how to do things smarter with new products, methods, and solutions for diagnostic, treatment, and rehabilitation purposes. Some of these ideas may be taken up for further evaluation and development by partners in Eir. “There is a rather strong tradition in this region for establishing private-public collaborations within healthcare, reflecting that we have 70 medtech companies in the North Denmark Region. At Eir you’ll find a capacity that allows for facilitated development that builds on the synergies between the public and private partners,” Steen Andreassen says, pointing to the results: “In 2014 Eir counted three spin-off companies with several more in the pipeline, while the total number of spin-off’s in Denmark was 15, describing that this set up works well.” Read more about Eir at www.eirbusinesspark.com
TeleCare Nord exemplifies a three-step rocket in telemedicine
The prehospital patient record, amPHITM, is ready to leave home
The North Denmark Region, Falck, and Judex have developed the automated prehospital patient record system, amPHI™, in a joint venture. The amPHI™ is now being implemented in ambulances nationally. Reflecting on the development phase, Product Manager at Judex, Peter Moltzen-Juul, acknowledges the interaction between the partners in the project. “We have worked very closely together with the end-users at Falck and at the regional emergency departments with a very constructive and open dialogue,” he says, continuing, “The short distance from breaking an idea to putting it into action and testing, getting the feedback, and aligning the project ensured the establishment and validation of the amPHI™ in a rather short time.” At emergency calls the amPHI™ prehospital record is generated automatically in the ambulance. Data such as blood pressure, oxygen saturation, heart rate, ECG etc. are transferred wirelessly to the computer and stored along with use of medication etc. Simultaneously, the staff at the emergency department receives the prehospital data on the patient – ensuring proper preparation prior to and handling upon arrival at the emergency department. “amPHI™ saves time for registration; moreover, the registration is much more accurate and validated than what can be done manually even with the best intentions. This reduces the risk of errors and allow for improved patient care in emergency situations” says Peter Moltzen-Juul. The amPHI™ has for some years now been installed in ambulances and at emergency departments in the North Denmark Region. The next generation of amPHI™ will be implemented nationally – and in addition the system is being exported to Stockholm with a series of suppliers headed by CSC Scandihealth.
The telemedicine project, TeleCare Nord, was recently concluded and by now, data from the 1.200 participating patients with chronic obstructive pulmonary disease (COPD) are being analysed. Half the patients have received patient care through telecare based intervention; the other half has received patient care by regular standards. Professor at Aalborg University Ole Hejlesen is one of the driving forces of the project, and he sees it as an excellent model for developing health IT systems. “Ideally, it is a three-step rocket. At first you think and work your way through to a system that you believe will work full scale and perform small user tests. Secondly, you conduct a pilot study, e.g. 2 x 50 patients. Thirdly, you test the system regionally – and fully explore the benefits and potential downsides to the system.” The TeleCare Nord health IT project is a cluster-randomized, controlled clinical trial, where randomization has taken place at the level of the healthcare professional (HCP) rather than at patient level. The trial aims at investigating the effect of telecare in COPD patients measured by hospital admissions, exacerbations, use of medication, and perceived quality of life. Furthermore, the trial explores the costs shouldered by the municipality (e.g. home care etc.) as well as by the region (e.g. hospital admissions etc.). Ole Hejlesen stresses that the trial operationally has reflected the daily way of doing business. As an example, it varies from one part of the region to the other if the HCP staff is doing eLearning or taking a class room course in order to learn about new ways of working. “In the trial we have allowed for the HCP participants to adapt and learn the way they are used to, reflecting their daily professional mode of operation and this we believe ensures that the testing is closer to a real life setting,” he says. Positive results on the perceived quality of life, sense of security, and safety among a subgroup of patients has already been disclosed, but Ole Hejlesen is expectantly looking forward to the full set of results. He points to the set-up as a standard within telecare projects. “If it works the way we hypothesize, we have established a system that will work well within COPD. We still need to do the trial properly in other indications such as hypertension, diabetes etc. However, the side effect of the TeleCare Nord project is that we have proven to have the infrastructure in place for conducting large scale trials – and as such we feel ready for more,” he ends. Read more about TeleCare Nord at www.telecarenord.dk
Read more about amPHI™ at www.csc.com/sundhed
ahead What lies
What lies in store for Nordic life science in 2015? A simple yet complex question. One approach to finding an answer is to consider the dominant international trends and challenges, as they will also affect us. By Louise Bruce Illustration: Ann Malmgren
hen describing the outlook for Nordic life science in the near future, it is impossible to ignore the particular importance of the future of Swedish and Danish healthcare. As they comprise the industry’s most important customer, I believe the two are inextricably linked. It is therefore relevant to outline the challenges facing healthcare in the years ahead. Today, people are living longer. And while that is positive for the people involved, it also presents challenges; to healthcare, among other things. However, we are also sitting still for longer periods, consuming more sugar and gaining weight. These factors will trigger a boom in the number of patients with chronic lifestyle diseases. In addition, the range of potential treatments for patients has expanded, and patients are consequently demanding more in terms of the quality and scope of treatment. In other words, pressure on the healthcare sector is increasing. One solution has been to increase hospital efficiency. Now, however, a vital new item has appeared on the agenda for politicians, economists and doctors: ‘treatment quality’. Specifically, during negotiations, the Danish Regions, the public authorities that manage the healthcare system in Denmark, have requested new payment principles. These include, for instance, rewarding quality treatment on an equal footing with rapid treatment. Quite how quality will be measured has yet to be determined. Many different parameters could be applied, depending on the ultimate goal. If fewer
re-admissions and infections are the aim, then this is where action should be taken. Regardless of the focus selected, the changes will raise the bar for providing information to patients, who must be equipped to make qualified choices. To accommodate this, the industry needs to adopt an active role in obtaining and distributing the necessary information about their treatments in a form that ensures patients comprehend the scope and consequences of particular treatments.
Innovative treatments and personalised medicine While adequate information is one prerequisite that the sector must be ready to provide in the future, another part of the solution involves new innovative products with fewer side effects. Various products with improved
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efficacy and side-effect profiles targeting typical lifestyle diseases and cancer have been launched in recent years, but continuous development is still required. Despite this, several areas have been characterised by limited development in treatment. Consequently, medical experts have high expectations regarding 2015, especially concerning high cholesterol. By the end of 2015, Sanofi and Amgen are highly likely to have PCSK9 inhibitors in the American market. PCSK9 inhibitors, a new treatment regime for combating high cholesterol, are recognised as groundbreaking in this field. The term ‘groundbreaking’ also applied when the human genome was first sequenced in 2001. Since then, we have witnessed rapid development in ‘personalised medicine’, and the rationale behind it is gaining favour both in the industry and with payers. Personalised medicine allows the identification of very specific sub-patient groups who will benefit from a particular treatment, and not least those who will not benefit. Often, biomarkers are used to indicate whether individual patients will benefit from a certain treatment. For example, the BRCA mutation, a mutation of the BRCA1 or BRCA2 gene, has been used as a biomarker when treating breast cancer. Recently, the BRCA mutation was also discovered to play a role in ovarian cancer, and companies, such as AstraZeneca, are working on treatments associated with this mutation. I believe we will see many such advances in 2015.
which the first national solutions are outlined. Perhaps the regional telemedicine strategy defined in 2011 will be fully implemented. This would involve homebased telemedicine monitoring solutions, telemedicine videoconferencing and image transfer among departments and hospitals.
No development without qualified labour We want quality care, we want innovative new medicines, and we want continued growth in the Nordic life science industry. However, unless action is taken now, we will face a shortage of qualified labour. This is the message from various industry sources. Novo Nordisk has announced that 6,000 employees will be hired in Denmark up to 2022. But only if the candidates are adequately qualified, mind you. Doctors with clinical experience, for example, are in short supply. This fact will have to be addressed by both the educational institutions and the healthcare sector. The Triple Helix collaboration is therefore expected to be strengthened in 2015 and beyond. Triple Helix is an alliance comprising the universities, industry and public-sector healthcare system, which aims to promote the education of qualified labour – also in life science. Another reality that will impact on Denmark in 2015 is the upcoming Parliamentary election. The debate that precedes it is highly likely to touch on healthcare costs in Denmark – the size and priority as well as methods of funding allocation. Both the Danish Association of the Pharmaceutical Industry (Lif) and the Danish Regions are calling for amendments to the economic agreements for the health service. The current allocation strategy encourages pressure on budgets at the beginning of the year with resulting cutbacks, and then during the Finance Act negotiations in the autumn, additional funding is often allocated to the area. The stop-and-go effect this produces in hospitals is described by the regions and Lif as an obstacle to planning cost-intensive, long-term projects. All in all, this will be an interesting year for everyone associated with Nordic life science.
Since the human genome was first sequenced in 2001, we have witnessed rapid development in ‘personalised medicine’, and the rationale behind it is gaining favour both in the industry and with payers.
Outpatient care thanks to telemedicine Another trend involves growth in outpatient care as an alternative to hospital admission. Efficiency gains and technological developments have already resulted in more widespread outpatient care. This development will continue in the future as telemedicine solutions and other technological measures are now available to support patient care away from hospitals. Currently, Denmark has a number of regional telemedicine initiatives, and 2015 may be the year in
Life Science as the answer to everything The Capital Region of Denmark has plans for Life Science. Two plans, actually. It is a clear goal for the region to ensure that the public health sector can provide treatment and health services of the highest possible quality. At the same time, it is a strong ambition to maintain and further develop the Life Science cluster in the region as a driving force for job creation and economic growth. In the autumn of 2014 the two regions and the 46 municipalities on Zealand have jointly decided upon a strategic collaboration under the common brand, Greater Copenhagen. The key aim of the collaboration is to boost growth by collaborating and concentrating on the strengths that the area is already known for. And Life Science is one of Greater Copenhagen’s best cards with a global position of strength in public research, pharmaceuticals, biotechnology and medical technology. “Greater Copenhagen is a story about a region where the public sector and the private sector work close together in strategic alliances and where the conditions for growth job creation, research and innovation are in order. The common brand will thus be followed up by a series of growth-promoting initiatives.” These are the words of Kristian Johnsen, deputy chief executive, Centre for Regional Development. In front of him, he has a draft version of the upcoming Regional Growth and Development Strategy, which identifies Healthy Growth as one of four strategic themes driving growth and
FACTS • More than DKK 2 billion in research is conducted annually at the region’s hospitals • 4,000 people working at the hospitals conduct research; of these 1,000 are affiliated with the University of Copenhagen Approx. 3,600 scientific articles are published annually • Approx. 800 research collaboration agreements are concluded annually between the region’s hospitals and the industry. The Capital Region of Denmark’s vision is to develop Greater Copenhagen as an international hub and hotspot in the area of Healthy Growth in 2025 Find out more about the ‘one stop shop’: http://www.regionh.dk/menu/Forskning/
development. This is good news for Danish and Swedish Life Science companies, emphasizes Kristian Johnsen. “I very much hope that the companies – both the large pharmaceutical and smaller biotech companies in the region will feel a positive effect from our efforts to really boost Life Science in the region. Along with the other players in the Greater Copenhagen region, we are working hard to create conditions that make it easier to attract investors and talent, to establish start-ups and to grow as companies here in the region”. He mentions two specific initiatives that have already made a difference. The Capital Region of Denmark has established a “one stop shop for industry”. It serves as a gateway for all companies wishing to collaborate with the hospitals in the region on research, innovation and clinical trials. For biotech and pharma companies, the facility has worked successfully since 2010, making clinical trials better and simpler, both for local and international companies. And since autumn 2014, the service has been expanded to also include medtech companies: “Many companies are dependent on being able to develop, trial and test their products in collaboration with hospitals and with the involvement of patients and staff. In the past, they would have to find relevant contacts at the hospitals and establish various agreements on their own. Now everyone can contact us via “one stop shop” and get professional support.” In October 2014, the initiative was joined by the NEXT project – a formalised national partnership between all the Danish university hospitals and a number of the major pharmaceutical companies with the goal of attracting more early phase clinical trials to Denmark. Two national pilot project centres have initially been established – for oncology and dermatology - both anchored at hospitals in the Capital Region, but with participation by clinical departments from the other university hospitals in the rest of Denmark. The ambitions of the parties involved in NEXT are high and in 2015, another pilot centre is expected to be established based in western part of Denmark. “NEXT is a unique public-private collaboration – also seen in an international context. NEXT seeks to attract more phase 1 and phase 2 trials to Denmark in order to give Danish patients access to the latest in experimental treatments, promote new and better research and increase our attractiveness to new investments, ultimately creating both growth and new jobs,” concludes Kristian Johnsen.
one byone Foto: Ann Malmgren
Medical Device Industry
The Pharmaceutical Industry
Business Service Providers
CRO 54 Academic Institutions
The Danish biotech industry is thriving. And 2014 has been a particular good year. In Sweden and Norway it is quite the opposite. Chairman of the Danish biotech association, DANSK BIOTEK, casts light on possible explanations and unveils his predictions for the future of the Danish biotech industry.
By Louise Bruce
he Danish biotech industry has undergone a dramatic development since the first companies were established in the late 1980s. It is an industry characterised by great opportunities and a high risk of failure. In 2007, the industry was at an all-time high with 2,000 employees. Today, the number of employees has been reduced by half. Yet, according to the Danish Growth Fund, biotech products account for an amazing 70 per cent of the total turnover, when looking at the bestselling pharmaceuticals. In 2001, that figure was only 7 per cent.
Scandinavian biotech At the beginning of 2015, the Danish biotech industry is characterised by optimism and the future looks promising. In Sweden, however, the biotech industry is smaller and less optimistic. And in Norway the industry is characterised by start-ups. According to chairman of the Danish biotech industry association, DANSK BIOTEK, Martin Bonde, the explanation is to be found in how the pharma industry developed in the three countries: “The difference between the three countries is a combination of several factors. One thing is the development of the pharma industry; the lack of big pharma companies in Norway and the drastic decline in pharma activities in Sweden. Another thing is the ability to fund the industry. In Denmark, we have a
well-founded pharma industry and specialised venture funds that know the market and have the necessary insight,” says Martin Bonde. In Sweden, only one major classic venture fund invests in biotech, while there are none in Norway. The expertise of the venture funds is essential to the biotech industry as the funds not only contribute with funding, but also with a relevant network and know-how.
IPO’s and seed investments In 2014, the Danish biotech industry has benefitted from several acquisitions and approx. 10 start-ups have seen the light of day. In addition, venture funds have experienced reasonable returns on their investments, especially in the US, with 112 new IPOs (compared to 60 IPOs in 2013). The positive ROIs for the venture funds increase their ability to invest in new companies. But although there is a significant propensity to invest, Martin Bonde calls for more seed investments (investment in early stage research). “Seed stage companies still lack funding. In Denmark, Novo Seeds is the only venture fund putting serious money into this kind of investment. With the Copenhagen Spin-Outs initiative, we have already come a long way, but the seed segment is still a challenge. At the moment, we lack an innovation strategy that can foster the commercialisation of basic research,” says Martin Bonde.
The Danish biotech industry at a glance • The Danish biotech industry counts approx. 100 companies. • Danish venture-funded biotech companies have more than 1,000 employees. • The turnover for Danish venture-funded biotech companies is more than DKK 4 billion, of which DKK 3 billion is export. • Venture capital investments in Danish biotech have produced a money multiplier of 1.45, which accounts for a multiplier of 2.03 for investments in pharmaceuticals and 0.41 in development of platform technology and diagnostics. • In the period 2000-2013, Danish venture funds have invested DKK 5 billion in Danish biotech companies, of this DKK 3.3 billion has been invested in pharmaceuticals. • In the past 20 years, venture funds have invested in approx. 1,000 Danish biotech companies. Approx. 35 of these companies are still active today. • Historically, most funding has been directed towards development within big disease areas, such as cancer, diabetes and heart diseases. • Today, focus has shifted to include to a greater extent rare diseases and the underlying technology. Source: Dansk Biotek gennem 25 år – Ventureinvesteringer, afkast og exitter (25 years of Danish biotech – Venture investments, returns and exits), The Danish Growth Fund, 2014.
Turning basic research into business According to Martin Bonde, one of the biggest challenges in the years to come is how to commercialise the most promising basic research. In recent years, a great deal of public funding has been allocated to basic research. Yet, by the time the findings are ready to be turned into business, they are subject to the same market conditions as if a venture fund had been funding the research, which makes it very difficult. According to Martin Bonde, publicly funded basic research should have financial advantages when entering the biotech market. “Publicly funding the commercialisation of basic research could be the solution. One way of going about it could be to use just a small fraction of the funding allocated to basic research,” Martin Bonde explains. “This is why Dansk Biotek is developing an idea catalogue for the politicians. The catalogue is meant
as an aid to creating increased growth and better conditions for the Danish biotech industry and ultimately for Denmark as well. We are planning to launch the catalogue in May,” he concludes.
WHAT IS BIOTECH? • Biotech (short for biotechnology) is the development of useful products based on living systems and organisms. • Biotech is usually divided in to three sub groups:
- Pharmaceutical biotech - Agricultural biotech - Environmental biotech • A biotech company is characterised by being a nonestablished, start-up company that does not have all functions in-house.
Basic and translational research – for a sustainable and better world Established in 2011 the Novo Nordisk Foundation Center for Biosustainability (CFB), DTU has a clear vision for its contribution to a more sustainable world. The DTU Center has set out to become a leader in the transformation of chemical production from a petrochemical industry to a more sustainable bio-based
FACTS ABOUT The Novo Nordisk Foundation Center for Biosustainability (CFB) • was funded in 2010 via a Novo Nordisk Foundation grant to DTU • received two further grants from the Novo Nordisk Foundation in 2012 - one covering genomescale science for CHO cells aiming at generating optimized CHO cell factories to produce the next generation of biopharmaceuticals – and one facilitating further internationalization of CFB • is a multi-site operation with over 200 people associated • is currently housed in Scion-DTU, and has satellites hosted by the UCSD, Chalmers, Copenhagen University, KTH, UC Berkeley and KAIST For more information http://www.biosustain.dtu.dk/english
industry, in addition to becoming an international hub and Center of Excellence for interdisciplinary research leading to the design of new and improved microbial and mammalian cell factories. “We identify and construct cell factories to produce chemicals that can be made biologically – thereby reducing global dependence on oil,” says Jens Kindtler, Chief Business Officer, carrying on, “Furthermore, we strive to identify and efficiently produce therapeutic proteins with tailored properties for medical therapy and small molecule anti-bacterial compounds.” The science taking place at CFB reaches out internationally to chemical industries, biotechnological, and pharmaceutical companies. In the mind of Jens Kindtler a dedicated research and development effort is required in order to identify commercially interesting compounds and to speed-up the strain design process in order to further strengthen Denmark’s position within bioprocessing. “This is what CFB is all about. A wide range of significant products, from small molecules to large proteins, that can be made using cells as production hosts or cell factories. These cell factories will impact chemical and biopharmaceutical production notably over the coming decades,” he ends.
The Medical Device Industry Innovation is the key to success in the highly competitive market for medical devices, with demand for medtech solutions increasing. While the industry faces several challenges in the coming years, it is a strong, growing industry characterised by optimism.
By Louise Bruce Illustration: Ann Malmgren
ost people may think of hearing aids and single-use products such as ostomy bags when they think of the Danish medical device industry. However, although the companies behind these products dominate the Danish market, the Danish medical device industry comprises a range of small and midsize companies. Denmark is one of the leading countries in Europe when it comes to developing and manufacturing medical devices. Considering the size of the Danish population, Denmark is the second largest market for medical devices in Europe. “Innovation is the key to success in the medtech industry. We develop innovative solutions that make a difference here and now,” says Mette-Marie Harild, Vice President, Medtronic.
Regulatory constraints In 2012, the medical device industry was subject to a range of product scandals, which has led to a series of regulatory constraints. The latest additions are a new procurement directive, new procurement legislation and a new directive for medical devices. Most likely, it will affect the national procurement structure as well as the general regulation of the market, for instance in relation to reporting adverse events.
private-public partnerships and develop constructive solutions that not only to guarantee the quality of treatment but also give all patients equal access to the new and best solutions,” Mette-Marie Harild explains. According to Peter Huntley, partnerships and socioeconomic analyses are a means to improve the Danish healthcare system. A growing number of patients and increasing requirements for outpatient treatment will put the system under pressure and create a need for identification of the most optimal treatments.
Telemedicine solutions A solution to the coming challenges to the healthcare system might be found in telemedicine, which has undergone rapid development in recent years. Telemedicine helps eliminate distance barriers and the need for long-term hospitalisation. In Denmark, telemedicine is still waiting for a real breakthrough, which can boost the business. But Peter Huntley anticipates that the breakthrough is just around the corner. “At the moment, we are reaping the initial experience with telemedicine from small-scale projects. Hopefully, we’ll see national use of telemedicine solutions in 2015. If we do, it will set the scene for the future use of telemedicine,” Huntley says.
Rethinking procurement structure “In all the Nordic countries, the medical device industry is growing, although they are subject to strict governmental procurement strategies. The coverage is under pressure and the competition is tough,” says Director General, Peter Huntley, Medicoindustrien (The industry association for medical device companies in Denmark). 2014 has been dominated by big EU tenders, which have pushed prices down. To companies whose turnover is mainly based on EU tenders, this is quite challenging. Thus the industry calls for more focus on the added socioeconomic value of the devices. The first tentative steps towards a change in procurement strategy have been taken as the industry in 2014 has entered into a more open dialogue with relevant healthcare officials. “There is a need to develop new ways to treat the growing number of patients. I think we can all agree that in the long term, the current healthcare system model is not sustainable. We simply cannot afford to go on like this. We therefore need to create
THE MEDICAL DEVICE INDUSTRY • The medical device industry comprises companies that develop, manufacture and sell medical devices. • Medical devices are basically all the equipment that we see when we go to the doctor or are admitted to a hospital. It also includes the aids used in nursing homes and in-home care. • Medical device companies in Denmark and Danish medical device companies abroad have annual turnover of more than DKK 50 billion and employ more 30,000 people. • Approx. 250 Danish companies have medical devices as their primary business area. • The Danish medical device industry mainly consists of small and midsize companies.
The pharmaceutical industry in Denmark is thriving. However, if that growth is to continue, conditions must be right. It will require collaboration between the industry and the authorities. And we must continue being innovative in both the development and use of medicines, according to the Danish Association of the Pharmaceutical Industry (Lif).
By Louise Bruce
here is no doubt that the Danish pharmaceutical industry is doing well. It is one of the only sectors that has managed to grow despite the financial crisis. Exports have doubled over the past seven years and are expected to double again up to 2020. “Denmark has become a real pharma nation with some very large players enjoying success, each one in its own area. That success is due mainly to the Danish companies developing products based on their own research and launched in the global market,” explains Director General of Lif, Ida Sofie Jensen. At the same time, the Danish pharma industry is largely foundation-owned or comprises a stable ownership. Consequently, the Danish companies are doing very well, for example compared to Swedish companies, according to Ida Sofie Jensen. In Sweden, broadly speaking, the major pharma companies have been acquired by international companies. However, at this rate, development will be required in a number of areas.
More research needed One of the pharma industry’s core conditions for developing new products is its dependence on the public sector. Regardless of how skilled the companies are at researching and developing new products, they cannot go solo without the public health sector, as all products must be tested on humans. That is part of the regulatory regime. At Lif, we are therefore pleased with the productive dialogue that has been built up between the public sector and the pharma industry, which among other things has resulted in joint
public-private commitment to create a unique setting for early stage clinical trials. The project is called NEXT and is a community partnership involving Region Hovedstaden, University of Copenhagen, Odense University Hospital, Aarhus University Hospital and Aalborg University Hospital, Bioneer as well as LEO Pharma, Novo Nordisk, Roche, MSD and Novartis. Over the next five years, Innovation Fund Denmark and the partners will invest a total of 120 million DKK. Initially, the project, which after only a few months is already well underway, will focus on early clinical trials within cancer and skin diseases – later more areas will be added. Nevertheless, it will takes more than the right setting for conducting early stage clinical trials to attract international research to a small country like Denmark. Denmark also needs to show willingness to use the new products developed.
Approval of new products as a competitive parameter Pharma is among the most highly regulated industries in the world. Naturally enough, as drugs are potentially harmful. However, obtaining subsidies for new products has become more difficult, despite the fact that it is crucial if the products are to be used. According to Managing Director at Lundbeck Pharma Thomas Klee, this will be no easier in 2015 – perhaps the contrary. And that will have consequences for research, among other things: “Unless Denmark becomes better at acknowledging and providing subsidies for the innovative new products, we risk the industry relocating its clinical research elsewhere,” says Thomas Klee. He adds: “In order to be an attractive research country, Denmark must also show its willingness to use the
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products that are ultimately produced. Denmark is a small country in an international context and faces fierce competition from some major new players, such as Brazil and China.” Ida Sofie Jensen supports his view, pointing out that it is vital for continued growth that Denmark is a first mover when it comes to using the new products. “We must do this because it makes sense, it creates the scope for improving efficiency, it gives better quality in the health service, and it benefits patients,” she explains.
THE PHARMACEUTICAL INDUSTRY • The Danish pharma industry is the second-largest in the world in terms of population – surpassed only by Switzerland. • In Denmark, 20,000 people are employed by pharma companies • The pharma industry is the source of 70,000 jobs in Denmark. • The pharma industry represents 11 per cent of Danish exports (2013), corresponding to medicine exports worth DKK 71.3 billion.
SOURCE: DANISH ASSOCIATION OF THE PHARMACEUTICAL INDUSTRY (LIF)
Experience and flexibility With forty some years of experience from the pharmaceutical industry, Kjeld Clemmensen-Rotne at Trial- Support presents his insights and viewpoints as a consultant with considerable leverage. His company, Trial- Support offers contract research services, and while he collaborates with larger CRO’s in bigger projects requiring several consultants or special deliveries, he generally operates on his own – and with great flexibility on smaller projects, e.g. investigator initiated studies, or other projects that are publically funded that may need support in project management, document handling, trial registration, regulatory issues, monitoring etc. “I have
FACTS ABOUT Trial-Support • Manages local as well as international clinical trials • Handling of Regulatory Affairs • is certified in EudraVigilance (ICSR and XEVMPR) • iPreparation of protocols, description of procedures, and design of clinical trial documents and files
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For more information, please contact Kjeld Clemmensen-Rotne Managing Director/Clinical Research Manager, email@example.com, www.Trial-Support.eu, Phone: +45 20 48 60 84
the experience and capacities to contribute at many different levels in a clinical research project, and in principle take part from idea to publication,” Kjeld Clemmensen-Rotne says and carries on, “In particular the practical lead on projects may suffer in publicly funded clinical research, as the focus of hospitals remains the clinical production. This is where I act as project manager providing the link between the investigators and their staff and the health care professionals who are conducting the trial” Additionally, Trial-Support operates in international set ups: “Being the coordinating national centre in a large scale international research project is prestigious for the hospitals, however also binding. It requires professional handling and strong project management, which is what Trial-Support offers,” Kjeld Clemmensen-Rotne explains. In addition to his close collaboration with a couple of specialized CRO’s, Trial-Support also works closely with the Danish GCP Units.
Business service providers â€“ recruitment and law firms
Recruitment and law firms working with life science are largely subject to the same terms. Both industries are highly specialised and both depend on general trends in the life science industry. However, these trends affect them in different ways.
By Louise Bruce Illustration: Ann Malmgren
ithin both the recruitment and law sectors, only a few Nordic companies have become life science specialists. This is because customers expect their advisors to have specialist insight into their reality. “Our advice is closely linked to a customer’s product and follows a product throughout its lifetime. Similarly, our customers operate in a strictly regulated market. They therefore expect us to have specialist knowledge of their reality and to have our finger on the pulse,” says Partner and Sector Head of Horten Law Partnership’s Life Sciences and Healthcare Practice Group, Martin Dræbye Gantzhorn.
Specialisation is also a demand in the recruitment industry:
Advisors for business service providers in the life science industry face more than just demand for extensive insight. They also depend on trends in the life science market and the success of individual companies. In the legal sector, this is most clearly visible in the notable fall in the number of transactions in recent years, i.e. company acquisitions and divestments, and consequently in demand for the services that follow in their wake. On the other hand, a certain amount of optimism is being experienced among the law firms with regulatory competences. It has become harder to get products on the market, and similarly more difficult to obtain product subsidies. Meanwhile, the legal sector has experienced an increased trend for licensing rounds, which has put prices under pressure. The view in the recruitment sector is that many patents are expiring and this has played a role in recent years, along with the financial crisis, which largely halted recruitment. Turnover did not begin to increase until 2012. For some recruitment firms, the crisis years clearly left their mark while others coped better.
When recruiting within life science, you must come from the industry yourself or be qualified to understand the mechanisms in the sector. We deal with a very knowledge-intensive industry with very complicated research.
“When recruiting within life science, you must come from the industry yourself or be qualified to understand the mechanisms in the sector. We deal with a very knowledge-intensive industry with very complicated research,” says Kjeld Birch, Managing Partner, SAM Executive Search A/S.
Life science market trends set the agenda
BUSINESS SERVICE PROVIDERS LAW FIRMS
• There are 22 law firms specialising in life science in the Nordic region*
• There are about 50 recruitment firms focusing on life science in the Nordic region
• The sector deals mainly with consulting in three areas:
• Recruiting for life science involves mainly the following professions:
Regulatory affairs Research specialists Intellectual property rights (especially patents and trademarks)
pecialists and managers for production S companies, e.g. engineers and pharmacists
Transactions Source: Who’s Who Legal (www.whoswholegal.com)
alespeople, marketing talents and people S working in the interface with research (medical marketing) for sales companies
Customized risk evaluation in pre-clinical drug development The Contract Research Organization (CRO), BioAdvice A/S, has years of experience and expertise in pre-clinical GLP/ non-GLP pharmacological, and toxicological testing of drug candidates for pharma and biotech. Along with a significantly expanded facility, BioAdvice is now additionally providing cutting-edge technologies for risk evaluation, particularly useful in early drug candidates. “These core competences are the back bone of the company – and in particular the models we provide for inflammation, wound healing, and diabetes reflect a deep level of insight, expertise, and experience,” Lars Siim Madsen, Chief Operational Officer at BioAdvice, explains. He describes the business as a ‘pharmacological workshop,’ implying that both standard set-up’s as well as customized are feasible at the CRO. “For pre-clinical testing we have a large capacity to flexibly adapt to specific needs and requests from a customer – and moreover we have expertise to provide professional sparring as well,” Lars Siim Madsen says. “We manage continuously to establish new Proof of Concept models in various therapeutic areas. This implies that we look for customized solutions in collaboration with our costumers whenever a standard model somehow is inadequate for the drug candidate in question.” This level of flexibility has been fruitful for BioAdvice, and the company has recently expanded the facility with 750 square meters, and thereby doubled the size of animal facilities for studies in pigs, minipigs, dogs, rats, mice, rabbits, and guinea pigs.
FACTS ABOUT BIOADVICE A/S • BioAdvice is a leading Contract Research Organisation (CRO) in Denmark, providing qualified pharmacological and toxicological research and development with laboratories and animal facilities for mice, rats, rabbits, guinea pigs, pigs, minipigs, and dogs – and zebra fish • BioAdvice has a GLP-authorisation to perform preclinical pharmacological and toxicological studies • BioAdvice has a GMP-authorisation to perform biological quality control tests on human and veterinary medical products • BioAdvice’s facilities are located at Lyshøjvej 21, DK-3650 Ølstykke about ½ hour’s drive from Copenhagen International Airport
Early risk evaluation From a time and cost perspective it makes sense to design your pre-clinical program as efficient as possible understanding the risk profile of your drug candidate as early as possible. At BioAdvice this is acknowledged, hence a new technology has been taken on board. “As BioAdvice is following recommendations of The Animal Experiments Inspectorate (Dyreforsøgstilsynet) we have adapted to the 3 R´s (Replacement, Reduction and Refinement) by implementing an early screening technology in zebra fish to increase the likelihood of success in pre-clinical testing. As a drug developer you want to gather as much information as possible – as early as possible. This is why we offer the zebra fish technology for early risk evaluation,” Lars Siim Madsen explains. The zebra fish technology is performed in collaboration with Professor Søren Peter Olesen at the Department of Biomedical Sciences section of Heart and Circulatory Research at the University of Copenhagen. “The use of the zebra fish technology has exploded these past few years internationally, as the method has been scientifically acknowledged in being useful in early screening and selection of drug candidates. In turn the early exposure of zebra fish larvae is a valuable supplement for pharma and biotech before moving their projects into higher species, providing them with an understanding of potential toxicity or cardiovascular issues related to the molecule,” Lars Siim Madsen explains, describing why this new technology is provided by BioAdvice. “As a drug developer in general you want to understand the toxicological profile of your drug candidate as early as possible before moving into the more cost and time demanding models, and certainly before clinical testing. So we provide this new service for our customers to facilitate early screening of toxicological side effects in their early drug development,” Lars Siim Madsen ends. http://bioadvice.dk
“The special thing about recruiting within life science is that some companies blossom and others do less well – regardless of the financial crisis. As a recruitment firm, if you are lucky, the specific companies in your portfolio do well. However, you can also easily have companies that lose ground because of patents expiring or various other issues. Progress was achieved in 2014, and indications for 2015 are good,” explains Kjeld Birch.
Nordic network plays a central role According to Kjeld Birch, two mechanisms in the recruitment sector are decisive when composing a company’s customer portfolio: 1 You cannot have directly competing companies in your portfolio, i.e. they must not compete on major indicators. This could result in having to find the same candidates (sales personnel, physicians and researchers) to different clients at the same time.
“There are small companies with a national outlook and 2-3 employees. They typically recruit from the Danish market. Then there are those that have joined a more lose network. There are also a few international players with their own subsidiaries that can help them to find candidates,” says Kjeld Birch. Unlike the recruitment sector, international chains within the legal sector have failed to penetrate the Nordic countries. With only a few agencies that have the necessary specialisation, the trend is to have a much freer network. “No legal firms cover the entire Nordic region. However, the best firms have a good network that is used on the basis of an evaluation of competences and personality. It’s all about having the freedom to let the customer and the assignment define who you contact,” says Martin Dræbye Gantzhorn.
2 W hen making a living from finding candidates, you rely on being able to explore a large market to find the most suitable person. And you can’t find candidates among your own customers. For that reason, a recruitment company can never represent more than a low percentage of the market because you have to have the majority of the market as a source of candidates. For Kjeld Birch, having an extensive Nordic and international network of subsidiaries on which to draw when finding the best candidate is an obvious advantage.
Medical Device Consult (MDC) is a Danish based consulting company founded in 1995 by Vivi Thulstrup. Today, MDC is managed by Henrik Kvistgaard. • Specialised in assisting Medical Device and In-Vitro Diagnostic companies in meeting the US & European regulatory and Quality System requirements • Assist your company through interpretation of the regulatory requirements relevant for the product in question and a range of services to facilitate the CE marking process in Europe or the 510(k) & PMA process with US FDA • Developing, implementing and maintaining a Quality Management System, specifically encompassing the processes relevant for your company • Quality Management System is developed in an interactive process with your company to accommodate your needs and, to the extent it is relevant, incorporate regulatory requirements. Medical Device Consult ApS Brordrupvej 64 • DK-4000 Roskilde, Denmark www.medecon.dk
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CCBR CCBR (Center for Clinical and Basic Research) was founded with the aim of providing a new concept in combining scientific knowledge with efficiency and effectiveness in the management of patient involvement and care in clinical research. What began in 1992 with just a single research center in Ballerup, Denmark, expanded with clinics in Aalborg and Vejle and in 2001, the first research center outside Denmark was established in Tallinn, Estonia. Since then, CCBR has expanded to become an organization with a network of more than 20 clinics across Europe, Latin America and Asia. CCBR is now one of the world’s largest organizations dedicated to the conduct of clinical research with the capability of looking after more than 25,000 patients participating in global clinical trials. “The aim is the same as when we first started” says Anette Vierning, Director of Operations at CCBR. “We have now achieved a unique capability in the performance of clinical research. The network of clinical trial centres has greater access to patients, better training and expertise, more resources and equipment and higher quality processes than other centres taking part in clinical trials.” There are a number of elements to the service that CCBR provides to clinical research. Firstly, the professional input to the development of clinical protocols and how best to conduct the research at the investigator sites. “Our background in science and opinion leading insight means that we are able to work closely with the clinical teams to come up with optimum processes for the conduct of clinical trials activities at investigator sites”
says Anette Vierning. “This has enabled us to become trusted partners with pharmaceutical companies and contract research organisations responsible for the clinical trials” The second factor is the capacity that CCBR has built into its network of clinical sites. CCBR sites are located, resourced and equipped for the enrolment and treatment of large numbers of patients taking part in clinical research. Patient Recruitment is one of the biggest challenges that sponsors face in the achieving successful outcomes in research. CCBR consistently contributes the highest performing sites in clinical trials. “We develop study specific strategies for patient recruitment, including direct contact with potential participants through our established database, which ensures that we meet or exceed our enrolment targets for every trial” says Anette. From screening to randomization, visit management and follow up, CCBR conducts all the clinical procedures required by the protocol. “Our standards of patient care ensure that patient retention rates are consistently higher than non-CCBR sites”. “Finally, compliance with protocols and GCP procedures is of paramount importance to the successful delivery of clinical studies at investigator sites” says Anette. “CCBR’s approach to Quality Assurance through standardisation of training, systems and processes ultimately ensures reliable and clean data to be provided in a timely fashion to the sponsor at the end of the trial.” “In the end this can make the difference in making new treatments available to patients suffering from a wide range of chronic illnesses.”
Flexible consultants with specialized life science expertise and experience With professional insight and years of experience from life science, PharmAdvice is a specialized consultancy with expertise in regulatory affairs, pharmacovigilance and marketing support to a range of global, local or Nordic clients within life science. PharmAdvice acts as an extra pair of hands as well as the expert consultant. “Some clients focus their local or Nordic organizations primarily on sales, and may not have the internal resources for general regulatory maintenance and pharmacovigilance systems and safety surveillance,” Janne Fehrn-Christensen, CEO at PharmAdvice Aps explains, and continues, “We solve specific assignments within regulatory affairs in the early stages of the development process of pharmaceuticals e.g. for biotech and at later stages we provide regulatory development and strategies, prepare and handle scientific advice, review or prepare documentation, and finally we compile and submit the eCTD.”
FACTS ABOUT PharmAdvice • was founded in 2002 by MSc. Pharm Janne FehrnChristensen and today the company employs seven people • has a proven track record within EU regulatory affairs
Expert level PharmAdvice’s experts in regulatory affairs and pharmacovigilance have decades of experience from working in pharma, hence they all have a thorough knowledge of their line of work. In pharmacovigilance PharmAdvice can act as partner on safety during clinical development as well as provide services post marketing, e.g. pharmacovigilance master file, safety surveillance, periodic safety updates, act as Qualified Person for PharmacoVigilance, prepare risk management plans etc. “We have the capacity and expertise to work highly self-driven and independently from our own office – however, when needed, we can also operate from the client’s premises,” Janne Fehrn-Christensen says. Marketing Support Services for marketing support comprise translation of summaries of product characteristics, package leaflets, and labelling; and legal review of promotional material. Janne Fehrn-Christensen acknowledges that this is a growing business area. PharmAdvice takes the necessary steps to meet demands: “Continuous training and updated education ensure that our employees comply with current marketing regulations for medicinal products and devices. In other words we are well prepared to meet the demands our clients face,” Janne Fehrn-Christensen ends.
• is certified in EudraVigilance (ICSR and XEVMPR) • is located in Søborg, close to Copenhagen For more information http://www.pharmadvice.dk
Looking for a strong partner in your network? As a chemicals company within life science, it can be extremely difficult to manage the constant flow of new legislation, requirements and regulations. Kemi & Life Science, a trade association for the chemicals and life science industry, set out to address this challenge and today the organisation has become an invaluable partner for companies in the industry and for their associated stakeholder companies. Regular newsletters containing all relevant updates in legislation and regulations. Good advice on how the sector as a
Kemi & Life Science • K emi & Life Science is an independent trade association under the Danish Chamber of Commerce.
• The association offers a unique, network-based community in the industry, representing companies throughout the value chain from contributors to innovation through production and transport to application, consulting etc. • The aim is to look after members’ interests by providing them with important information about legislation and other conditions affecting the industry. • The association also seeks influence and promotes the interests of its members in relation to decision-makers. and authorities through its membership of the European Association of Chemical Distributors (FECC) and the Danish Chamber of Commerce, as well as through the network of Nordic sister organisations. More information, www.kemi-og-life-science.dk or contact Director Jakob Zeuthen on +45 3374 6114
whole and the individual companies should act. A strong network where members can find inspiration, build competencies and form partnerships. And an influential voice in relation to policymakers and authorities. This is how Rene Fleischer sums up the core product of the professional association formerly called Kemikaliebranchen (The Chemicals Sector), which may once have been a bit of a musty endeavour, but which today has re-emerged as a strong and relevant trade association under the name Kemi & Life Science. Rene Fleischer is chairman of the organisation and COO of Brenntag Nordic A/S: “Kemi & Life Science’s primary objective is to look after the interests of our members. We do this by providing them with the information and knowledge they need to be a responsible and reliable company and partner in the Danish foods and life science sector,” says Rene Fleischer. Another important objective, according to the chairman, is to help members to be innovative and to adapt to the changes and challenges they face in the near future. In this regard, newsletters and advice from the association’s experts are a vital service. However, participation in the various networks and committees, as well as the lectures and courses that the members have access to, are also of great value for the members. Today, the members include a wide range of companies that import and distribute chemicals or otherwise work professionally with chemicals for Danish foods and life science companies.
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Emotional intelligence predicts performance and success! At Best Talent recruiting candidates for life science is taken beyond the usual level of outlining skills and competences. Emotional intelligence is the key to success – also in life science. In a high performing environment intensely focused on intelligence (as measured by IQ), skills, and competences it may come as a surprise that the emotional intelligence (EQ) rather than the IQ is an indicator of how successful you will become. “Research now points to EQ as being the critical factor for star performances and business success directly linked to level in the hierarchy and salary, and more so than the IQ,” Helle Jørnung, Managing Director at Best Talent explains, carrying on, “And this is data driven – I might add.” She refers to studies demonstrating that among 90% of top-performers the EQ is more pronounced than the IQ and that among 20% of bottom performers the EQ is fairly low. Acknowledging emotional intelligence as a key instrument to finding the right candidate who will also live up to the employer’s expectations on performance is quite essential by the book of Best Talent.
Assessing both IQ and EQ “Life science is a hard core data driven business area, and it only comes natural to be highly focused on university degrees, professional skills and expertise during the process of recruiting. The point is however, that the highly skilled candidate, who may appear perfect on paper, may still end up being a poor per-
FACTS ABOUT Best Talent • Best Talent Performs Executive Serach in Scan globally with an Executive Life Science network of headhunters located in more than 30 countries. • Best Talent accquires top talent for key organizational positions
The Talent Model
The Model maps out talent in a broad respect and is an important tool to help uncover expectations from all stakeholders. Furthermore exploration of both the EQ and IQ ensures the match between the employer and the candidate, allowing him or her to become a high level performer with long-term success.
former. The key to solving this discrepancy is to assess and evaluate the EQ as well as the IQ of candidates,” Helle Jørnung says.
EQ can be acquired The consultants at Best Talent have accepted the fact that it takes more than masters of science or business, PhD’s and publication lists to demonstrate what added value as an employee a candidate will bring. Hence, every candidate is assessed by the EQ as well as IQ – and the results are integrated to match the expectations, demands, culture, values etc. of the employer. “IQ is a constant factor – that does not change much over time. EQ however, is a set of competences that can be acquired and developed in time. EQ grows on us – so to speak – as we grow as human beings physically and mentally. Our model takes this into account, and with this tool we have a unique method to predict who will match a specific job – and the working place,” she says, and ends, “Testing the EQ alongside the IQ is a unique way to identify and match the right candidates with focus of delivering high performing and successful employees to our life science clients.”
• For more information, visit:www.besttalent.dk
In-depth knowledge and understanding of life science enable specialized recruiting A speciality unit within TEMP-TEAM handles life science specific recruiting. With a background as a bachelor in biomedical laboratory technology, senior consultant at TEMP-TEAM, Margit Kjær knows at first hand where her clients are coming from. “We have worked with a number of the largest companies within pharma and medtech for many years and have significant experience in recruiting staff at all levels,” she says. But isn’t TEMP-TEAM an employment agency for
FACTS ABOUT TEMP-TEAM • Handles temporary services of staff, recruiting, outplacement, executive search, and international recruiting • Has a specialized team to handle recruiting for clients in life science • Is a member of the Juhler Group, an international corporation, represented in Norway, Sweden, Finland, UK, and Singapore
temporary staff? Margit Kjær catches that bird flying: “TEMP-TEAM is much more than the agency delivering temporary staff, albeit we do that all the time especially for administration services. However, with this life science specific industry service we successfully recruit for permanent positions in QC, QA, R&D, Medical Affairs, Pharmacovigilance, and Regulatory Affairs,” Margit Kjær explains. She points to the list of candidates in the network of TEMPTEAM which includes bachelors in biomedical laboratory technology, pharmacists and people with masters of science in human biology, biotechnology or else. “Our main priority with our recruitment service is to ensure that our clients’ new employees fit in with the organization from day one,” Margit Kjær ends.
For more information www.temp-team.dk
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Strategy and execution embedded as leadership concept Strategic thinking at all levels A recent project comprised leadership development for all managers in a company. The aim was to improve the strategic thinking and execution at all levels, from executive management to team leader, through strategy-labs. A different project focused on bringing down the employee turnover by focusing on better people management (based on an analysis of exit-interviews). “Both projects represent areas where we have core competences to offer. It is great to have a strategy that has been wisely conceived by the management. But it is of little use if nobody in the organization knows how to execute it” Tune Hein explains. At Hein & Partnere they are excited to receive client acknowledgement: “We have excellent experiences with Hein & Partners in organizational development projects and executive coaching” says Lars Dalgaard Andersen, former director at Novozymes. John Lindskog, CEO at Unomedical / ConvaTec, says: “It had a significant impact on the executive team – with a relatively modest investment.” Tune Hein has a long track record as a management consultant, working globally with change management, organization and leadership development. Still, the concept of Hein & Partners represents a different approach to strategic management. “By combining strategic management with business psychology we create a platform from where organizations can grow and leaders can develop,” Tune Hein explains, carrying on, “There are more sides to complex organizations, and some sides may be uncovered with a traditional approach. This is why we embed various tools to cover all sides, strategic thinking, culture, and execution – as the three fundamental elements of leadership.” He exemplifies: “It may be a wise strategy for two companies to merge. And to ensure a success competent change management from all managers are required. However, there is more to a merger than change management… Two companies represent two different cultures which need to be integrated, in order for the synergies to arise and be harvested.” Whether it is the executive team, a management level, or all managers in the company Tune Hein and the consultants at Hein & Partners see the leaders as key to any change or development in a company.
Company culture that makes sense Tune Hein points to projects concerning company culture as a third example of where Hein & Partners can make a difference. “Company culture is of great importance to the organizational performance. You need to lead the culture. And it has to make sense to the employees in order to add value. Working with the culture, leading it and living it can make a tremendous difference,” Tune Hein ends. For more information: http://heinogpartnere.dk/
Manufacturing Organisations Not many CMOs exist in Scandinavia. However, the few that do can look forward to a future with more drug candidates and therefore more work.
By Kristian Sjøgren Translation: CLS Communication A/S
hen life science companies lack the production apparatus to produce drug candidates, who do they call? A CMO (Contract Manufacturing Organisation). This enables them to outsource costly production to a company with both the experience and facilities to make qualityapproved drugs for clinical research. In 2001, Senior Technology Partner at NNE Pharmaplan Morten Munk helped to start CMC Biologics, which is now Denmark’s largest CMO. He explains that life science in Scandinavia needs good CMOs in order for pharma and biotech to develop. “In 2000, we had many small companies that were largely compelled to look abroad to transform their good ideas into products for clinical tests. This was inconvenient. A logical consequence of Scandinavia having a Medicon Valley, therefore, is that there should also be high-calibre international CMOs,” explains Morten Munk.
The advantages of CMOs in Denmark Having CMOs in the back yard has given Danish and Swedish biotech and pharma companies useful business partners that have helped them to realise their research targets. For CMOs, being based specifically in Scandinavia is another major advantage. The Nordic reputation for attention to detail, reliability and high quality is renowned worldwide, which helps explain why many of the CMOs’ contracts are international. These Nordic qualities were also put to the test in the wake of the financial crisis when the global focus on costs increased the risk of customers moving their orders to India and China, for example. A number of companies also tried cheaper business partners in Asia, which some of them bitterly regretted. The bad experiences with CMOs in Asia prompted the customers to return to CMOs in the west. Consequently, the CMOs in Scandinavia have experienced a very positive growth in sales in recent years. “We are busier than ever before, and we still export the majority of our projects. I expect that to be the case for some time yet,” explains Jørgen Godt Olsen, Executive Vice President at Niels Clauson-Kaas.
More products in the future Prospects for the Scandinavian CMOs are looking bright, according to both Morten Munk and Jørgen Godt Olsen. There will be fewer huge blockbuster products and a higher number of specialised products that will all have
to pass through the long product development process. By far the majority will involve production tasks for CMOs, and more products mean more work for the CMOs. In addition, the companies that are the CMOs’ customers have changed their structures. “More and more companies are becoming small virtual companies without their own laboratory infrastructure. This means that they possess knowledge exclusively and have to outsource their production. That’s good for us,” says Jørgen Godt Olsen. There are challenges in store, however, according to Morten Munk. “A base of small innovative biotech companies is vital in order to feed the industry from below. However, at the moment, companies are experiencing difficulty obtaining project financing, which means that only large international companies are customers at CMOs. There is the fear that industry development will move abroad if the opportunities for financing here fail to improve,” says Morten Munk. Jørgen Godt Olsen also feels that there is currently a shortage of the innovative minds who started up all the biotech companies in the 2000s. “Ten to fifteen years ago, plenty of people were taking the plunge and starting up biotech companies. That is no longer the case, and for the first time, the number of biotech companies has stagnated. That does not impact us much as we are a global company, but we would like to have more Scandinavian customers,” says Jørgen Godt Olsen.
CMOS IN SCANDINAVIA • Within large molecules, CMC Biologics is Denmark’s largest CMO with 185 employees in Denmark and gross profit of DKK 37 million (figures from 2013). • In addition to CMC Biologics, the Technical University of Denmark (DTU) has its own CMO (Bioneer) within large biotech molecules. Bioneer has 45 employees. • In Denmark, Niels Clauson-Kaas (28 employees in Denmark) and Poly Peptide (450 employees globally) work in the field of small molecules. • Recipharm is Sweden’s leading CMO with 2,100 employees globally and turnover of SEK 3.2 billion. Indian-based Kemwell Biopharma, which has more than 1,000 employees on a global scale, also has an office in Sweden.
One in four clinical trials are today carried out by a CRO and in Sweden the CROs stand for two thirds and experts predicts that we will see a growth in multi-year, highly-integrated engagements between pharma/ biopharma companies and CROs.
By Malene Aadal Bo
My first encounter with CROs was in the mid90s, but at that time, they have a pretty bad reputation. Since then, the Nordic and global Contract Research Organisations have changed and developed significantly. Today, the Life Science Industry relies on CROs to handle crucial parts of their clinical development programmes and make sure that they are conducted in accordance with GCP guidelines and in a cost-effective and efficient manner.” The opening remarks come from Jan Hellqvist, Regional Managing Director of the largest Nordic CRO, TFS. TFS was founded in 1996 when the CRO industry experienced an explosive growth caused by a dramatic rise in costs for pharma companies and the introduction of good clinical practice (GCP). The earliest CROs started back in the 1940s and 1950s and the industry as we know it today has existed since the 1980s when the pharma companies developed their first blockbuster drugs. In the 1990s, their numbers increased significantly and today CROs are an integral part of life science – in Denmark, one in four clinical trials are today conducted by a CRO and in Sweden CROs are responsible for two thirds or all clinical trials.
CROs, while global CROs have grown even bigger. According to Klaus Juel Olsen and Jan Hellqvist, the prospects for 2015 vary a great deal depending on your starting point. “The strong ones with unique competences and a good operational model will increase their revenue and profit during 2015. But I also think we will see some of the small poorly positioned CROs go down,” says Jan Hellqvist. After experiencing growth in the 1990s and at beginning of the millennium, CROs were heavily hit by the financial crisis and the drop in the pharma companies’ ability and willingness to invest in drug development. But the expectation for 2015 is that the number of clinical trials performed in the Nordic countries will increase, albeit only a little. Jan Hellqvist shares this optimism based mainly on three factors: 1) T he biotech and medical device industry is rather strong in the Nordic Countries.
Those with the advantage Typical services provided by a clinical CRO include: senior consultancy services, regulatory advisory services, pharmacovigilance, medical writing and the implementation of clinical operations, including site coordination, health and research staff etc. Large and midsize international CROs also provide a full range of e-clinical solutions, including diaries, e-CRF systems, eCTD systems, pharmacovigilance and safety systems. Especially knowledge of specialist areas, such as regulatory, safety, data management and statistics, will see an increase in demand from 2015 and onwards, predicts Klaus Juel Olsen, CEO of one of the top five Danish CROs, Larix. “CROs specialising in these areas will have an advantage as will those with capabilities within information and communication technology (ICT). ICT is increasingly being integrated in clinical research and we are likely to see a growing number of studies with real time data submitted by the patients themselves,” he says. Recent years have seen a degree of consolidation and globalisation that has led to fewer small and midsize
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2) It has become less attractive to move clinical trials to other markets as prices have gone up in Eastern Europe and new regulations in India have made it cumbersome to perform trials there. 3) The Nordic region remains an excellent area for performing clinical trials because of a high level of clinical competence, good infrastructures, and predictable and competent authorities. “I have sensed a vitalisation of the business in the last couple of years. And even though the bulk of large phase III trials will be performed in the biggest and fastest evolving markets, I still see room for growth here,” he says. Klaus Juel Olsen, while less sure, is also hopeful: “I do think we will continue to see more multi-year, highly-integrated engagements between pharma/ biopharma companies and CROs. The areas where we will see growth are adaptive trials, programmes for personalised medicine and orphan drugs. And also in the areas of medical devices, outcomes research and non-interventional studies,” he concludes.
CONTRACT RESEARCH ORGANISATIONS IN BRIEF • C ontract research organisations (CROs) conduct research and development on behalf of other companies within the pharma, medtech and biotech sectors. • Clinical CROs conduct clinical trials from design to execution, monitoring and reporting, and they outsource clinical research professionals to conduct clinical trials in-house at pharma and biotech companies. • IThe Nordic CRO market is characterised by a number of small CROs and a few big Nordic and international CROs.
• In 2007, the international CRO sector was worth USD 15 billion.
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The strong ones with unique competences and a good operational model will increase their revenue and profit during 2015. But I also think we will see some of the small poorly positioned CROs go down. Jan Hellquist, Regional Managing Director, TFS
– one of the biggest Nordic CROs From the very beginning in 1999, it has been the ambition of Ingela Wiking, CEO of IRW Consulting, to create the preferred Nordic CRO partner. With offices in all four Nordic countries, IRW has become one of the biggest Nordic CROs, conducting clinical trials, non-interventional studies and medical device studies through all four phases. Depending on the client’s requirements, the staff is either outsourced or works on in-house projects. Our Nordic focus is an asset Over the years, the competition has increased, making it even more important to stand out to remain the preferred Nordic CRO partner. The CRO market has undergone a transition towards a more global focus among the big pharma clients as well as among CROs. More and more CROs are being consolidated, running offices all over the world and offering global clinical trials. By contrast, IRW has chosen to keep its focus on the Nordic region and consider it an asset. “Many of the big pharma companies are represented in Stockholm or Copenhagen, from where they cover the entire Nordic region. In my experience, our clients value the fact that we have a local focus and offices and personnel in all four Nordic capitals. We have the required
IRW CONSULTING • Business areas: Clinical Operations, Project Management, Regulatory, Clinical Data Management, Biostatistics, Pharmacovigilance and Medical Writing • Assignment range: clinical trial phases I-IV, medical device investigations, non-interventional trials and registry trials • Clients: Biotech, Medtech, big pharma companies and other CROs • Founded in 1999 • Number of employees: 50 • Number of current ongoing clinical trials: 40 • Number of outsourced employees: 25
expertise to quickly set up clinical trials and determine the most beneficial and cost-effective set-up. We know the clinical research environment,” says Ola Jeppsson, vice president, IRW Consulting. Even CROs have to be innovative Besides the knowledge of the Nordic clinical research environment, it is key to IRW Consulting that they are responsive and innovative. “In a competitive market, one of the best ways to achieve success is by meeting the clients’ needs by being flexible and able to innovate and adjust accordingly. That means hiring people according to our clients’ needs and keeping abreast of the latest technology. We have to be able to offer our clients technological solutions that meet the need for variation in complexity and price,” explains Jeppsson. “A concrete example of how a client’s need has evolved into a new technological solution is electronic patient diaries. After FDA and EMA opened up the possibility of keeping electronic patient diaries, clients requested the service. We have developed an ePRO system (electronic Patient Reported Outcomes) and are now able to offer the service to other companies,” says Jeppsson. Preparing for the future In spite of the strong competition, Jeppsson believes that IRW has a strong position in the market. Nevertheless, he recognizes that they have to keep being innovative and flexible as the market situation could quickly change. “We want to be the preferred partner when it comes to conducting clinical trials in the Nordic countries. That’s why we will keep hiring the best employees and be the best at outsourcing personnel. And we will keep developing our skills, making us even better at conducting clinical trials and addressing the clients’ challenges. We will keep growing in the Nordics. But in order to succeed, we have to be extremely responsive and adaptive to the clients’ needs,” says Jeppsson.
Compliance with REACH also applies to drug manufacturers Chemical substances used in drug manufacturing processes may be subject to comply with EU law The list of Substances of Very High Concern (SVHC) currently counts 161 substances of which 31 now require authorisation before use (authorization list). The list is intended to grow and currently another 22 substances are prioritised for uptake. This may become highly critical to a number of life science companies. “Medicinal products are exempted from the REACH regulation as pharmaceutical legislation applies to this area. However, drug manufacturing processes using chemical substances that are on the REACH authorization list must comply with these requirements,” Jens Tørsløv says. Jens Tørsløv is Ph.D and Head of Projects at DHI, Environment and Toxicology where they have specialized in chemical management and act as consultants. He stresses the sense of urgency in this matter. “Many drug manufacturers may not be fully aware of the impact the authorization requirements under REACH may have, or may have the misconception that REACH is inapplicable to their production,” he says. “REACH is putting pressure on the industry to identify new methods and replace SVHC’s with other substances, however, acknowledging that this is not done easily or rapidly, the users must apply for permission to use substances on the authorization list to continue the use,” Jens Tørsløv explains.
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es-soon-to-become SVHC during drug manufacturing. This calls for action! The companies need to identify SVHC in use and develop a strategy on how to act. Intermediates are exempted but for other substances on the authorization list applying for permission is an option. The experts at DHI know how to trouble shoot in this matter, firstly by knowing what to look for and secondly by knowing what to do with their knowledge. “It should be explored if authorities can be convinced not to place a critical substance on the authorization list, by documenting the impact it has on business and by exploring other ways of regulation,” says Jens Tørsløv, continuing, “In situations where no alternatives are available and the only use is in well controlled industrial settings, it may be worthwhile to try to argue to keep the substance off the list. REACH actually opens possibilities to influence the decision process.”
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Collaboration between the industry and universities has been strengthened in recent years. Both parties benefit significantly but challenges still remain.
By Kristian Sjøgren Translation: CLS Communication A/S
he universities generate many good research ideas. These are subsequently filtered out in the industry, as in the case of life science, where they are transformed into medicine, enzymes, laboratory equipment etc. In that sense, the universities and the life science industry go hand in hand. However, according to the universities the two parties have for many years had a love-hate relationship. Many researchers believed that close collaboration with the industry was tantamount to ‘being in their pockets’. Today, all this is slowly changing as the top management of the Swedish and Danish universities appreciate that cooperating can be valuable for both parties, and research that benefits the industry has high priority. Ole Skøtt, Dean at the Faculty of Health Sciences, explains: “In the past, researchers tended to isolate themselves in an ivory tower. But that has changed and now they are generally interested in collaborating with the industry. Similarly, all the work in the field of innovation has been professionalised. Researchers now know what to do when they have a good idea that could potentially benefit both the industry and society,” says Ole Skøtt.
Research must be useful Dean at the Faculty of Health Sciences, Aarhus University, Allan Flyvbjerg, agrees with his colleague and believes that it is the universities’ duty to ensure that their research is useful to society either directly or through collaboration with the industry. “A large portion of our funding comes from the public sector, and it is therefore also our social and scientific duty to see that our research does not simply gather dust in the researchers’ offices. It must be disseminated to the outside world where it can benefit the population and society, and the industry can help with that,” says Allan Flyvbjerg. Allan Flyvbjerg feels that collaboration between the universities and the life science sector, for example, will significantly improve in the next few years. However, a university is like a large aircraft carrier that cannot turn on a sixpence. Changing course takes time. On some points, however, he sees clear signals that the collaboration has been reinforced and will become even stronger in the future. “There are clear advantages for us in collaborating with the industrial community. Among other things, many of our researchers receive part of their funding from foundations such as the Novo Nordisk Foundation and the Lundbeck Foundation, which generate their
funds from the companies under the respective foundations. It is therefore also in our best interests that our research benefits the industry, because when the industry flourishes, so do we. It’s a matter of maintaining the lifecycle by helping each other with the competences we each possess,” says Allan Flyvbjerg.
Industrial millions help the universities Individual researchers are not the only ones who can benefit from the headway being made in life science in Denmark and Sweden. The universities as a whole are also being granted large amounts by the well-padded foundations that shoot up in a successful industry. For example, Aarhus University was granted a quarter of a billion Danish kroner by the Lundbeck Foundation to build a centre for neuropsychiatric research, while the A.P. Møller Foundation donated over a half a billion towards the establishment of the Maersk building at the Panum Institute and a good quarter of a billion for a new Danish National Centre for Particle Radiotherapy and research. The new buildings will house various research laboratories. “The grants will improve our capacity for research and for training the talents that the industry will require in the future. We can also assist the business community by helping companies to upgrade their employees’ qualifications, refining their skill sets to include some of the competences we have. Working closely together is therefore mutually beneficial. We not only can but we must do this,” according to Allan Flyvbjerg.
FACT • In 2013 there were 1,429 public-sector subsidised healthcare research projects at the Danish universities. In comparison, Danish private sources financed 2,405, the EU financed 166 and other foreign sources funded 268. • In 2013, 2,814 PhD students were enrolled in health science departments at Danish universities. This is almost twice the 2009 figure, • In Sweden, private foundations contributed SEK 5,543 million to research in 2013, while Swedish companies contributed an additional SEK 1,636 million. Altogether, private foundations and companies represented 12% of university costs for courses and research in 2013.
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Danish laboratory equipment suppliers are looking forward to an exciting 2015 with demand increasing in both the private and public sectors.
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By Kristian Sjøgren Translation: CLS Communication A/S
he laboratory equipment industry in Denmark includes both producers and suppliers. However, as only very few producers exist in 2015, the suppliers comprise almost the entire industry. Until a few years ago, the Danish and Swedish suppliers of laboratory equipment were riding high. Back in the early 2000s, the Danish biotech industry was booming, and the companies in this investment-intensive segment of life science had an insatiable appetite for everything from pipett es and Petri dishes to precision scales and particle counters. Selling laboratory equipment back then was fun, whether or not yours was a generalist company with a broad portfolio or a company with specialist products. However, the financial crisis hit the biotech industry hard, and with their money disappearing, the biotech companies were forced to look far afield for more investors with venture capital. Demand for laboratory equipment therefore also waned significantly. Henrik Christensen is chairman of the industry association for laboratory equipment suppliers, DiaLab, and CEO of the laboratory equipment supplier Kem-En-Tec Nordic A/S. He explains that for a number of years, selling laboratory equipment has not always been fun: “We have been through a turbulent period with results in the industry at a critically low level. The loss of momentum in biotech hit the industry exceptionally hard. But I think we’re on our way up now and are once again finding our feet,” says Henrik Christensen. Henrik Christensen bases his optimism on his view of the industry as generally healthy, sound and built on healthy values that
FACT • The industry association DiaLab represents 60 Danish laboratory equipment suppliers that together account for 80+ per cent of all the laboratory equipment sales in Denmark. Overall, 1,100 people are employed by the Danish suppliers of laboratory equipment. • The largest company has 118 employees while the smallest is a one-person business. In Denmark, laboratory equipment generates more than DKK 750 million annually. • In both Sweden and Denmark in 2014, turnover in the industry increased slightly after many years in the doldrums. At the same time, the number of companies is declining, as many equipment suppliers are consolidating their efforts.
can benefit customers. For instance, Danish equipment suppliers are known for their extensive knowledge of the products they sell. Consequently, they can make additional sales via their products by supplying highcalibre support, service and training in the use of laboratory equipment. This benefits their customers and justifies purchasing from a Danish supplier.
Promising investments Morten Dyrner is CEO of Holm & Halby, one of Denmark’s largest suppliers of laboratory equipment. Like Henrik Christensen, Morten Dyrner is optimistic on the industry’s behalf and explains that the industry can probably look forward to a healthy 2015. “The past couple of years have been quite good for those of us selling laboratory equipment, and looking ahead, we can see some exciting projects under way that will further benefit the industry. The University of Copenhagen, for example, is building the large Maersk building on the Panum site. That will result in 50-100 extra laboratories. In addition, plenty of modernisation
projects involving hospitals with new instruments and other equipment are destined to positively impact the industry. Meanwhile, the large pharmaceutical companies seem to be stepping up their activities further and demand for the services we supply will therefore increase,” says Morten Dyrner optimistically. Yet, dealing with the public sector is not without its obstacles for laboratory equipment suppliers, and this is the source of the challenges facing the industry in the years ahead. When the public sector puts laboratory equipment out to tender, very little attention is paid in the tender to the extras involved in a purchase, such as training those using the equipment and subsequent service, which are the hallmarks of the Danish suppliers’ sales packages. The competition for tenders often boils down to a price war, leaving the Danish laboratory equipment suppliers at a disadvantage. They are already dealing with profit margins as low as about 2-7%, so not much more ground can be won on that front.
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Henrik Christensen and Morten Dyrner therefore agree that the industry’s goal in 2015 is to engage in more dialogue with those issuing the public-sector tenders. It must be made clearer that the various suppliers differ on more than price. With this in mind, the industry association organises meetings every year at which buyers and sellers can meet and discuss how the transactions take place and any strengths, weaknesses and aspirations involved in the individual transactions. This would provide laboratory equipment suppliers with an even better understanding of their customers’ needs and allow the buyers to further improve their understanding of the extra services provided by Danish suppliers. “Far too often, tenders must be repeated because of procedural mistakes caused by misunderstandings between the buyers and sellers. That is unfortunate for both parties and wastes both time and money. However, if we talk to each other, we can gain valuable insight into the process that will benefit not just us and them but also life science in Denmark as a whole,” says Henrik Christensen describing his goals and hopes for 2015.
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Improve laboratory performance by integrating software systems The Enterprise Laboratory Platform (ELP) is a product suite of software products by LabWare. Laboratory Information Management System (LIMS) and the Electronic Laboratory Notebook solutions (ELN) are fully integrated in the platform and Jørn Christensen, Nordic Sales Manager at LabWare describes the benefits of the platform: “With ELP our clients can move projects further and faster without risking loss of information in times of transition. LabWare LIMS and LabWare ELN are fully integrated within LabWare’s ELP platform, allowing laboratories to integrate, control, and communicate from information based on the same shared database. LabWare ELP is quite unique in that respect, as the integration within the platform improves the output of the individual software systems. You could say that one plus one is greater than two!” LabWare ELP can be tailored to meet specific industry requirements by using a combination of purpose built software modules along with LabWare’s pre-configured template solutions for rapid implementation, validation, and deployment of life science solutions.
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Grete Lundbeck European Brain Research Foundation is a charitable, nonprofit foundation established in 2010 by the Lundbeck Foundation. The purpose of Grete Lundbeck Brain Research Foundation is to enhance interest in brain research and its results and to encourage and reward outstanding brain research and to stimulate Danish research through increased interaction with other European brain research and thereby strengthen the scientific foundation for progressing within prevention, diagnostics and illnesses of the nervous system. The Foundation annually awards ‘the Brain Prize’ - 1 mio. to one or more scientists who have distinguished themselves through outstanding contributions to European brain research.
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Strandvejen 104 B, 2900 Hellerup Telefon:39 25 65 00 www.chubb.com
For more than 130 years, the Chubb Group of Insurance Companies has been delivering exceptional property and casualty insurance products and services to businesses and individuals around the world. Today, we are the 12th largest property and casualty insurer in the United States and have a worldwide network of some 120 offices in 26 countries staffed by 10,200 employees. The Chubb Corporation reported $50.4 billion in assets and $13.9 billion in revenues in 2013. According to Fortune magazine, Chubb is the 202nd largest U.S.-based corporation. We have emerged as a leader in the insurance industry not only on the basis of our size or our longevity. We consistently strive to build lasting relationships with our customers and 8,500 independent agents and brokers, and we aim to be the best at what we do by delivering unparalleled service and innovative, scalable and specialized products backed by financial strength and third-party endorsements.
DAWA Consulting ApS Designit A/S Emendo A/S Emmace Consulting AB Ernest & Young Exova METCH A/S Finnegan Europe Ltd Fisher Scientific A/S Genau & More GordiaKey GSB Clinical Services ApS Hansson Thyresson Patenrbyrå AB Henrik Lawaetz Consulting Aps Hertz & Ødum Forsikringsmæglere A/S Hilton Copenhagen Airport Høiberg A/S ImaGene-IT AB
www-dawa-consulting.com www.designit.com www.emendo.com www.emmace.se www.ey.com www.exovametech.com www.finnegan.com www.fishersci.com www.genauandmore.com www.gordiakey.com www.gsbclinical.com www.hanssonthyresson.se www.hertzco.com www.hilton.com www.hoiberg.com www.imagene-it.se
Kongevejen 153 DK-2830 Virum firstname.lastname@example.org
• H&P is a niche company focusing on strategic management – ie. development through the management and organization • A n experienced consultancy team, with strong linkage between strategic and professional psychological profiles • A dedicated partner who takes pride in business focus and good project management •We do not teach ABOUT leadership – we facilitate TO lead • We and our customers link good leadership = execution = good business
Innovator Skåne Inspicos A/S Invest in Skåne IVF-Kliniken
www.innovatorskane.com www.inspicos.com www.investinskane.com www.ivfkliniken.se
Jacobsen Pharma & Medtech Advice A/S JoComOn AB Kemivärlden Biotech
www.jacobsenadvice.com www.jocomon.com www.kemivarldenbiotech.se
Jan Bjerrum Bach Jusmedico Advokatanpartsselskab Kongevejen 371 DK-2840 Holte www.jusmedico.com
Jusmedico is a specialist law firm providing legal services to the biotech, pharmaceutical, medical device, food supplement and dentistry industries, life science investors and to suppliers and service providers thereto. Internationally Jusmedico operates a representative office in New York, USA, and is a co-founder of BioLawEurope FmbA, a network of independent law firms from EEA countries and Switzerland specialized in the rendering of legal services to clients facing life science related legal issues. In 2014 and 2015 Jusmedico has been awarded the Corporate INTL Global Award Price as Biotech Law Firm of the Year in Denmark.
KIPA - Krahbichler Interlectual Property Advisors AB Matrisen Redovisering & Rådgiving
Gyldenholm Alle 26 2820 Gentofte Denmark e-mail: email@example.com phone: +45 3050 3878 Medidata Solutions Monocl AB Navet Nordic Patent Analyzer AB Nne Pharmaplan Oracle
Store Kongensgade 77 1264 København K Tlf: +45 33 12 45 40 Fax: +45 33 93 45 40 www.nrlaw.dk/
As its primary business area LBKPATENT is focusing on providing IP, in particular, Patent consulting to Pharmaceutical companies, Biotechnology companies having focus within the therapeutic area. The main areas of expertise are organic chemistry, peptides, polypeptides and proteins. LBKPATENT is also able to provide patent consulting within the broader life science area and the chemistry area, as well as mechanical area.
www.mdsol.com www.monocl.com www.navet.se www.patentanalyzer.se www.nnepharmaplan.com www.oracle.com Nyborg & Rørdam was established in 1983 and provides high quality result oriented and dedicated counseling to both well established and newly established companies. All our solicitors possess a wide range of knowledge ensuring the comprehensive view necessary to provide good and sound legal assistance regarding both general and more specialized legal issues. We have a long experience in working with establishment and daily operation of biotech companies. Furthermore each solicitor has expert competences within one or more special legal areas, including, among others, Financing and Corporate Law, Mergers and Acquisitions, Labor Law, IPP and Tax. We also have a wide experience regarding Litigation.
PeakSearch Perkin Elmer AB Plougmann & Vingtoft A/S Dfind Science & Engineering
PharmAdvice ApS Generatorvej 8C, 1.tv. DK-2860 SĂ¸borg Denmark Tel.: +45 3940 4860
www.peaksearch.se www.perkinelmer.com www.pv.dk www.prooffice.dk PharmAdvice is an independent Danish Consultancy Company established in August 2002 by MSc. Pharm Janne Fehrn-Christensen. Today, the company employs 1 CEO, 2 Regulatory Affairs Managers, 1 Drug Safety Manager and 2 Regulatory Affairs Assistants.PharmAdvice offers services within Regulatory Affairs, PharmacoVigilance and Marketing Support to companies within the Pharmaceutical industry. Our clients range from large multinational pharmaceutical companies to smaller Nordic or Danish companies. PharmAdvice has long experience in EU Regulatory Affairs and is certified in EudraVigilance (ICSR and XEVMPR).
Precious People www.preciouspeople.se ProjektSupport S-O www.projektsupport.com Projekttypverkstaden www.projekttypverkstaden.com QP Support Relevans Royds LLP RSA Group SAM Executive Search A/S Science & Innovation AB Serderma Setterwalls AB Skillius Massageterapi SkĂĽnecare AB Sigma-Aldrich Denmark Skanska SPP Swedish Biomimetics 3000 AB Tebu bio ApS Truly Translational Valea AB Ventac Partners
www.qpsupport.se www.relevans.net www.royds.com www.therasgroup.com www.sam-int.com www.scienceandinnovation.se www.serderma.se www.setterwalls.se www.skillius.com www.skanecare.com www.sigmaaldrich.com www.skanska.dk www.spp.se www.swedishbiomimetics.com www.tebu-bio.com www.trulytranslational.com www.valea.se www.ventac-partners.com
Contract Research Organization A+ Science Luntmakargatan 22 111 37 Stockholm Tel +46(0)8 564 882 30 firstname.lastname@example.org www.a-plusscience.com
A+ Science was established in 1997 and is a Contract Research Organization (CRO) with experience of services in clinical trials for pharmaceuticals (Phase I-IV) as well as medical devices. Our services include clinical trial management, pharmacovigilance (pre-and post-marketing), outsourcing of consultants, City Site (SMO), continuing medical education and many others. We can conduct custom tailored services according to customers’ needs. Since December 2013, A+ Science is a CRO run by its employees. Our vision is to become the CRO best known for its unique and dedicated personnel with focus on customer satisfaction. To Earn Trust-Make Difference
Adroit Science AB BioAdvice A/S Bioneer A/S BioStata ApS CIToxLAB Scantox A/S Clintrials Skåne AB Colloidal Resource AB CROMSOURCE Ltd Dantrials ApS
Agern Allé 5 2970 Hørsholm Danmark Tel: (+45) 4516 9200 D’liver ApS EcronAcunova A/S Eurofins Pharma A/S Galenica AB Genovis AB Huntingdon Life Sciences Intomics A/S
Fredericiagade 15B DK-1310 Köbenhavn K Ph: +45 20 169 497
www.bioadvice.dk www.bioneer.dk www.biostata.com www.citoxlab.com www.clintrialsskane.se www.coloidalresource.se www.cromsource.com www.dantrials.com DHI is a global and independent consulting and research organisation within the fields of water, environment, health and toxicology. To ensure product safety and mitigate environmental risk, we assess the impact of products and processes on humans and the environment. Our extensive knowledge in this field provides support to authorities and industries around the world. Our expertise in risk assessment, chemicals regulation, toxicology and ecotoxicology helps the industry make critical decisions about chemical substances and assists them in complying with regulations on health, safety and prepare applicable documentation. DHI has more than 50 offices worldwide with a total number of 1100 staff.
www.dliver.com www.ecronacunova.com www.eurofins.dk www.galenica.se www.genovis.com www.huntingdon.com www.intomics.com IRW is a Nordic full-service Clinical Research Organisation (CRO ) with local offices and staff in Sweden, Denmark, Norway and Finland and with more than 15 years of experience of Clinical Research Outsourcing in Scandinavia. We offer cost efficient services in Clinical Operations, Project Management, Regulatory, Clinical Data Management, Biostatistics, Pharmacovigilance and Medical Writing for the whole range of customers from virtual Biotech and Medtech companies to Big Pharma and other CROs. We can manage your project from start to finish or function as a fully integrated part of your own project team.
IWA Consulting Aps
Junvik Clinical Development Conulting AB
KLIFO A/S www.klifo.dk Larix www.larix.dk Lindeq A/S www.lindeq.com MVIC AB
NordicBiocube AB Norma A/S NUVISAN GMBH
www.nordicbiocube.se www.norma-cro.com www.nuvisan.com
Parexel International Pharma Consulting Group Pharmacosmos CRO A/S Phase One unit Pipeline Biotech A/S PRA Health Sciences
www.parexel.com www.pharmaconsultinggroup.com www.pharmacosmos.com www.pipeline-biotech.dk www.prahs.com
Qualiance Quintiles Denmark
Red Glead Discovery AB
SARomics Biostructure AB Sirion Biotech GMBH
www.saromics.com www.sirion-biotech.com Smerud is your expert full-service CRO for clinical development consulting and managing phase I-III clinical trials, and is also financing clinical trials in early phases as a cost-efficient development partner. Smerud has since 1993, with global HQ in Oslo, been conducting clinical trials to advance new medical compounds and helping pharmaceutical and biotechnology companies introduce their products faster to worldwide markets. Smerud also assist investigators with paperwork for planning, conducting and reporting academic clinical trials.
Smerud Medical Research International AS www.smerud.com +45 43 29 05 12
LARGE ENOUGH TO MANAGE â€“ SMALL ENOUGH TO CARE
Soltech ApS Statistikkonsulterna JoStat & Mr Sample AB Syntagon AB Taconic Europe TFS
www.soltech.dk www.statistikkonsulterna.se www.syntagon.com www.taconic.com www.tfscro.com
Laboratory equipment suppliers BioNordika Denmark offers a unique and innovative range of products in the areas of Cell & Molecular Biology, Immunology & Diagnostics, Instruments & Disposables and Custom Products & Projects. Our statement SCIENCE WHERE YOU ARE represents a unique combination of life science Premium Brands of products being stored, supported and marketed locally. In other words, we can help you with whatever product you need in your research.
BioNordika Denmark A/S Marielundvej 48, 1., 2730 Herlev Phone +45 3956 2000 email@example.com www.bionordika.dk
- Cloning - PCR/qPCR - NGS - Antibodies
Baldershøj 19, DK-2635 Ishøj, Tlf: 4343 3057. Email: firstname.lastname@example.org
At Dandiag we are specialized in solutions within liquid handling. We distribute different types of pipettes, pipetting instruments, tips, balances, water systems and other small equipment for your laboratory. Our focus is on quality, ergonomics and optimal use of our products. We are a strong partner in both field and in-house service and calibration. We handle all types and brands of pipettes. As an addition to our pipette service, we now provide service and calibration of balances and water systems. We are accredited by DANAK and ISO17025. We offer courses in pipette techniques and general liquid handling to your needs. Dandiag A/S |Your partner in sales, service and calibration of laboratory and liquid handling equipment
Avedoereholmen 84 2650 Hvidovre Denmark E-mail: email@example.com Tel: +45 3679 0000
Drifton A/S offers a wide range of professional equipment at competitive prices. We have specific focus on pumps and dispensing devices for use in laboratory, R&D and manufacturing units in Danish and European industry. Our range of laboratory pumps and accessories includes peristaltic tube pumps, gear pumps, syringe pumps, pump heads and tubing. For larger dispensing applications, we offer two-component dispensing systems and extrusion ram pumps. Furthermore, we offer a broad range of pneumatic dispensers, which can be used to apply chemicals e.g. adhesives. We also stock LED UV spot curing systems which cure UV adhesives in seconds.
Ormhøjgårdvej 12 DK-8700 Horsens
Insatech A/S Algade 133 DK-4760 Vordingborg Telefon: +45 55 37 20 95 E-mail: firstname.lastname@example.org www.insatech.com/
- Custom services - Expert technical support, delivery & service
Elite Miljø performs classified cleanroom cleaning in the pharmaceutical industry and hospital sector. And we can work with both high and low classified cleanrooms.We offer a complete cleaning solution where we have management and control over the entire process.
Insatech Pharma has more than 25 years of experience with automation and instrumentation in the pharmaceutical industry; we are your reliable and competent partner. We work according to the General Accepted Manufacturing Practice (GAMP) providing field tested solutions by industry standards, which means you will save money. Our calibration solutions, used in situ, for flow, quantity and pressure are designed as mobile rigs, easy to plug and play. Our solutions minimize insecurities introduced by manual calibration, increase production up-time and ensure a reliable calibration. You get full traceability and accreditation as per customer agreement
LaboRen is the leading supplier to Cleanroom, Laboratory and ESDenvironment, with many years of professional experience for complete solutions. Our customers are found in both the private and the public sector and within many different trades and areas:
Gardes Allé 24 2900 Hellerup Denmark +45 4045 1609 email@example.com
› Medical › Pharmaceutical › Electronics › Nanotechnology › Food
› Bio- og gene-technology › Fertility › Universities › Private and public hospitals
For more information about our products and services please call us at +45 40451609 or visit www.laboren.dk.
Through a personal and professional selection LabVikar delivers the best and most flexible employee solutions for companies that are in need of acute help with relieving the workload. Both inside and outside Denmark. Buchwaldsgade 50, 5000 Odense Telefon:50 70 19 72
Landskronavägen 25A Helsingborg 252 32 Sweden Tel: +46 42 375860
Tulstrupvej 5, Tulstrup DK-8340 Malling, Danmark. Tel: +45 22789540 Email: firstname.lastname@example.org www.lovmand.com
Klokkerfaldet 23, 8210 Aarhus V Tel. +45 70 27 85 65 email@example.com www.md-scientific.dk
Erhvervsvej 2 2600 Glostrup Telefon 43 27 14 00
Choosing a laboratory informatics solution has long-term implications and is an important decision for any organization. LabWare’s products have been proven in a wide range of industries over a period of more than 20 years. Our sole focus is laboratory informatics and we develop, market, and support a single well planned suite of products. At the forefront of our Enterprise Laboratory Platform (ELP) are our flagship products, LabWare LIMS (Laboratory Information Management System) and LabWare ELN (Electronic Laboratory Notebook).
Lovmand Diagnostics provides reagents and laboratory equipment for research and diagnostics. Lovmand Diagnostics represents RANDOX Laboratories, Neuation, Kartell Labware, Conda, Biosepar, Accumax and Aerte air purification. RANDOX produces reagents, controls and devices for clinical diagnostics and research. Neuation, Kartell and Accumax produce laboratory equipment. Conda produces agarose and culture media. Biosepar produces kit for sample processing. Pea is a system for cleaning the air of bacteria, viruses, fungi, smoke and odor.
MD Scientific is a Danish company specializing in the sale and service of instruments, related consumables and software from highly recognized international companies to Danish and Scandinavian hospitals, universities and companies.Products: HPLC/GC and GPC/SEC instruments, columns and accessories; Nitric Oxide Analyzer (in liquids and gasses); Complete macromolecular characterization using size exclusion chromatography; Liquid chromatography (HPLC/LC); Flash chromatography; Tablet Dissolution Test Systems; Osmometry; Gas generators; Automated nucleic acid isolation using chemagens’s technology for magnetic particle separation (chemagic MSM I & chemagic Prepito). Miele Professional Laboratory and medical technology. Safe, sterile and analytically clean. Systematic safety - For reliable and absolute cleanliness in all areas. Cleaning of instruments and laboratory glassware to the highest technological standard.
79 7979 79
Borupvang 9 2750 Ballerup Telefon (+45) 44 77 44 77 www.siemens.dk/diagnostics
Kvinderupvej 30 3550 Slangerup Tlf: 4738 1014
Siemens Healthcare Diagnostics offers a wide selection of diagnostic solutions for effective testing in in-vitro diagnostic.
Provides solutions and products to the laboratories. Equipment for optical, laser and physical grain size analysis of solids. Ovens & Furnaces from English Carbolite and German GERO with a temperature range from 30 to 3000 ° C. SkanLab offers counseling, sales and service in Greenland, Iceland, the Faroe Islands and Denmark, the world-renowned quality products from the German company Retsch GmbH and their subsidiary Retsch Technology GmbH.
TEMP-TEAMs specialafdeling formidler personale inden for bl.a.: ƒ QC - QA - R/D -ƒMedical affairs - Pharmacovigilence - Regulatory affairs
Hauser Plads 20, 5. sal 1127 København K Tlf. 33 36 09 44
Medtech companies Alteco Medical AB Aproxi ApS
Bang & Olufsen Medicom A/S
CellaVision AB Clinical Laserthermia Systems
Exini Diagnostics AB
Gambro Medicologic A/S PharmaControl Union Medico ApS Vibe IT Vigmed AB
www.gambro.com www.medicologic.com www.prologrehab.se www.unionmedico.com www.vibeit.se/ www.vigmed.com
Pharmaceutical companies AB Cernelle Astellas Astrazeneca Biogen Idec Manufacturing Diaprost AB Genzyme Biosurgery ApS H. Lundbeck A/S
Strandvejen 102 E 2900 Hellerup Denmark Tel: 0045 70 10 56 45 www.merckmillipore.com Leo Pharma A/S MSD Niconovum AB Nordic Drugs AB Novartis Healthcare Novonordisk A/S
Trial Support Pfizer Denmark
AvedĂ¸reholmen 96, 2650 Hvidovre Telefon:32 46 06 80
www.cernelle.com www.astellas.com www.astrazeneca.dk www.biogenidec.dk www.diaprost.com www.genzyme.nu www.lundbeck.com Merck Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers' success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, Merck Millipore serves as a strategic partner to customers and helps advance the promise of life science.
www.leo-pharma.dk www.msd.dk www.niconovum.se www.nordicdrugs.dk www.novartis.dk www.novonordisk.dk
www. www.trial-support-gmbh.de wwwpfizer.com
Since 1969, World Courier has been recognized as the 'gold standard' for worldwide time- and temperature-sensitive transportation services to the pharmaceutical industry. Relying on its own international network of over 150 company-owned offices in more than 50 countries - the largest such network in the world - World Courier works closely with customers to ensure regulatory compliance and supply chain integrity, and to identify and deliver the best logistical solutions for each individual study or shipment.
THE CALENDER May
April Horizons in Molecular Life Science: A inter-Nordic symposium on Stem Cells in Tissue Re-generation and Cancer April 16, 2015, Copenhagen, Denmark www.dascs.dk/event/ “This symposium will focus on the recent advances in stem cell biology, their role in cancer and in the use of stem cells for re-generation and transplantation. Kristian Helin and Jiri Bartek are organizers. The symposium is free of charge and open to the public but registration is required for all participants.” Medicon Valley Alliance’s Ordinary General Meeting 2015 22 April, 2015 Orestad, Denmark http://mva.org/event/medicon-valley-alliances -ordinary-general-meeting-2015/ “For members of Medicon Valley Alliance Members of Medicon Valley Alliance are invited to attend the Ordinary General Meeting 2015 The Ordinary General Meeting is followed by a dinner at the MVA premises.D17”
Danish Society for Neuroscience (DSfN) 2015 Annual Symposium: ”STEM CELL RESEARCH IN A NEUROTRANSLATIONAL PERSPECTIVE” May 11-12, 2015, Nyborg, Denmark www.dascs.dk/event/ The focus will be on subjects such as Stem Cells and Disease Modeling, Stem Cell Differentiation and Neural Development, Stem Cells and Brain Cancer, Stem Cell Research in Pharma Industry and Stem Cells and Therapy.
June Danish Conference on Biotechnology and Molecular Biology June 4-5, 2015 Hotel Munkebjerg, Vejle www.dascs.dk/event/ Stem cells and tissue engineering - The Conference will contain a lot of interesting topic session such as Cloning and reprogramming, Production and banking of stem cells for disease modelling, Tissue Engineering and organ design, Regulation and ethics in stem cell research, Bioengineering,
ALLE KAN FINDE ET KONFERENCESTED men kan du finde det rigtige?
DKBS.DK Danske Konferencecentre
Stem cells and diabetes, Poster and sponsor presentations and Regenerative Therapies. BIO International Convention 2015 15-18 June 2015, Philadelphia, USA http://convention.bio.org/2015/ In 2015 the BIO International Convention is headed to the heart of the U.S. biopharma industry. In close proximity to New York’s financial markets and Washington, D.C.’s regulatory center, the Philadelphia Metropolitan Area is home to more than 1,200 companies, ranging from the biopharma industry’s largest multinational companies to its fastest growing firms. The region’s vast array of leading universities and research institutions fosters a collaborative environment.
September Nordic Life Science Days 2015 September 9-10, 2015, Stockholm, Sweden http://apps.key4events.com/key4register/?e=347 “Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities,
providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech but also from finances, research, policy and regulatory authorities.Based on cutting-edge and advanced partnering and networking tools, Nordic Life Science Days showcases the best the Nordic region has to offer.”
October BIOTECHNICA 2015 6-8 October 2015 Hannover, Germany www.biotechnica.de/home “European event for Biotechnology, Life Sciences and Lab TechnologyFeaturing new topics and innovative marketplaces, BIOTECHNICA 2015 in Hannover will for three days once again serve as the central hub for Europe’s entire biotech sector and its clientele. From basic research to biotechnological production processes and the creation of market-ready products – the r ange of exhibits at BIOTECHNICA covers all stages in the biotech process chain. With the dedicated marketplaces Bioeconomy and Personalized Medicine Technologies. BIOTECHNICA will focus on the most topical industry trends.
Reach your target â€“ and beyond!
More than 45 companies have already joined the fastest growing biopark in Scandinavia And we are honored to have them here in Copenhagen Bio Science Park, offering them our 12.000 m2 of exceptional office and lab space, network & services etc. So why not join the most vibrant life science community in Denmark and start your adventure. Give us a call today and learn more or check out www.cobis.dk for more information.
COBIS A/S Ole MaalĂ¸es Vej 3 DK - 2200 Copenhagen N +45 70 70 29 80 firstname.lastname@example.org | www.cobis.dk