Greater Copenhagen Life Science YEARBOOK 2017 by Nem Media

YEARBOOK 2017

THE ME DICON VA LLE Y

YEARBOOK

2 017

BIOTECH

MEDTECH

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PHARMACEUTICAL

BIOTECH

REGULATORY

CENTRALIZED

NUMBER OF

IN GROWTH

WINDS ARE

PROCEDURES

CLINICAL TRIALS

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IS GROWING

CONTENTS March 2017 Publisher:

THE COLUMN Søren Bregenholt

MEDICON VALLEY The science parks

WHAT WE LEARNED 2016 A look back

BRAIN PRIZE WINNERS 2017

2500 Valby

ONE BY ONE - OVERVIEW

Denmark

BIOTECH 18

E-mail: nem@nemmedia.dk

PHARMA 24

Web: www.nemmedia.dk

MEDTECH 29

CRO's 33

CDMO's 40

BUSINESS SERVICE PROVIDERS 44

Høffdingsvej 34

Editors: Karin Jensen Charlotte Strøm Arne G. Nielsen and Mohammed Ali Wachah

INDEX 54 CALENDAR 64

Graphics & Layout: Kapteina Reklame

Advertisement: Mohammed Ali Wachah +45 23238080 mw@nemmedia.dk Rasmus Andersen +45 42811110

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Print: Green Graphic & Signtec Reklame

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THE COLUMN

It never gets easier…. By Søren Bregenholt, Chairman of Medicon Valley Alliance, Corporate Vice President, and Head of External Innovation and Stakeholder Relations, Novo Nordisk ..you just go faster – this reflection from the three times Tour de France winner, US cyclist Greg Lemmond, is very appropriate for Medicon Valley. We enter 2017 going faster than ever. During the past 10-15 years our Danish-Swedish life science cluster, situated in “Greater Copenhagen” has established itself as by far the strongest Nordic Life science cluster on almost any measure. As documented in our recently published “State of Medicon Valley” 2016 analysis. Actually, we see positive developments across the life science ecosystem; despite setbacks, the pharma industry has thrived, especially on the Danish side. The biotech industry established around the turn of the century has come off age – resulting in significant exits, mature pipelines and even companies with marketed products. We are seeing a new wave of start-ups and with them the region’s

private funds, exemplified by (re-)funding of world class research centers, and infrastructure investment like the recently inaugurated 15 floor ultra-modern building, “Maersk Tower at the University of Copenhagen´s Faculty for Health and Medical Sciences. And last but not least, Lund is about to reemerge as a regional life science beacon with its unique combination of academic achievement, science park development and the development of the world standard materials research facilities MAX IV and the European Spallation Source. This year Medicon Valley Alliance celebrates its 20 year´s anniversary, and the “speed of affairs” is a welcome birthday present. To be the strongest life science cluster in the Nordic Countries is an important stepping stone for an organization aiming realize to realize the potential of position Medicon

science parks continue to grow. Moreover, this development is boosted by significant investment from government and

Valley as the most competitive and vital life science cluster in northern Europe – the leader of the peloton. But to be faster today than yesterday is by no means a guarantee that you will be faster tomorrow. Like

Søren Bregenholt,

Greg Lemmond’s lesson to us all, we need to keep up the effort to go even faster and consolidate our lead… Board. Corporate Vice otherwise we risk sliding through the pack ending up in President, and Head of the gruppetto, which as cycling aficionados will know, External Innovation and is not the ideal position if you actually intend to win a Stakeholder Relations, race. Likewise, we need to keep investing heavily in the Novo Nordisk A/S Greater Copenhagen life science ecosystem to ensure continuous success. It never gets easier…. More – not less - public investments in life science relevant education and R&D are needed. A focus on Danish-Swedish synergies and collaboration must be reflected in the national life science strategies being developed in both countries. chairman of the

We need to continue to integrate in the global life science sector. The current effort to attract events to the region should be strengthened further allowing us to compete on equal terms with the most attractive life science clusters in Europe. We should also work to ensure that specific conferences such as Nordic Life Science Days, which will be held in Malmoe later this year and Bio Europe, which will take place in Copenhagen next year, will be recurring regional activities. And last but not least, we need to promote the Greater Copenhagen region and the bi-national Medicon Valley cluster as a credible and relevant contender for the new home for the European Medicines Agency after the Brexit. If we join forces, we have a winning team, and the ambition to become the most competitive and vital life science cluster in northern Europe is certainly within reach. But it will require focused team-work, sincere and continuous dedication and a whole lot of pedaling.

Three outstanding figures Last year, we asked whether intelligence is contagious. When we look at the results of the companies living and working in Scion DTU, there are clear indications that this is indeed the case. The companies boast average growth rates of 72 per cent, they took out a total of 151 patents, and 93 per cent of the companies recommend Scion DTU. The good news is that we have vacant office space, if you also want to become infected here in 2017.

sciondtu.com

MEDICON VALLEY

SCIENCE PARKS IN

MEDICON VALLEY 2 11

10 8 4 1

1 CAT Science Park

6 5

2 NOVI Research Park

CAT Science Park provides office space with other start-up organisations, to build an entrepreneurial environment. Based in Roskilde, the offices are adjacent to CAPNOVA, an investment fund, giving advice and guidance on the growth of developing businesses. The park has around 2000m2 of office space, shared by organisations from various industries. This allows the inter-disciplinary exchange of ideas and experiences within the park.

NOVI is one of Denmark’s innovative science parks, in which more than 1,000 employees in 100 companies work alongside each other every day to create an office and research environment that brings together new ideas, networks and innovation. NOVI acclaims ideas, entrepreneurship and – not least – people that are able to turn ideas into reality. The research park creates opportunities, stability and provides the ideal setting for network-based knowledge and growth.

More at www.cat-ejendom.dk

More at www.novi.dk

3 INCUBA Aarhus has a number of international class research environments. INCUBA is at the centre of the three strong clusters along the knowledge axis from the Cleantech cluster on Navitas over the IT cluster at Katrinebjerg and the Health cluster in Skejby. INCUBA’s three locations together house almost 200 innovative companies at Navitas, Katrinebjerg and Skejby in a close network with one another, Aarhus University and a range of network and advisory bodies, as well as capital investors. More at www.incuba.dk

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MEDICON VALLEY

4 Symbion

7 Medeon Science Park in Malmö

Symbion is based in Copenhagen and creates a leading entrepreneurial environment. They currently have a large network of over 250 entrepreneurs and small companies working on areas such as IT, life sciences and cleantech. Symbion work in partnership with Scion DTU and COBIS to create the best environment for science focused organisations.

Medeon's philosophy is that each and every growth industry has its unique needs. The science parks focus is on knowledge-intensive companies in the life science field (pharmaceuticals, medical technology, biotechnology and healthcare). Medeon offers:

• •

More at www.symbion.dk

•

5 COBIS (Copenhagen Bio Science Park) The science park is centrally located in Copenhagen in an environment of excellence when it comes to knowledge and commercial use of biotechnology, medicine, and pharmacology. COBIS is an ambitious center of growth, creating the right conditions for the biotechnology successes of tomorrow. COBIS has something to offer you regardless of whether you represent an established life science company, a CRO within life science, or even if you simply have a good idea and need help to get started. Among the science parks neighbors are Copenhagen University Hospital, Faculty of Health Sciences and the Faculty of Pharmaceutical Sciences from Copenhagen University. More at www.cobis.dk

6 Scion DTU in Hørsholm Scion DTU creates, offers and supports a close network, where entrepreneurs eat, live and work alongside high technology businesses. It is close to the laboratories, the knowledge and researchers of one of the world’s best technical universities, DTU, where potential investors regularly stroll down the familiar hallways. It’s a place where entrepreneurs meet businesses, business meets research, and ideas meet money. Scion DTU and the businesses which are based there have proven to create higher growth than if you compare with businesses outside the science park. Inventors, entrepreneurs and the smaller businesses specifically highlight the access to relevant networks, the intense growth development which is facilitated and the opportunity to work directly with researchers at DTU as crucial.

•

Flexible premises with room for expansion Close co-operation with health care providers and universities. Powerful incubator and network functions. Reception, switchboard services, travel agency and restaurant and more.

Medeon is centrally located in Malmö and Medicon Valley, with only 20 minutes to Copenhagen's airport. More at www.medeon.se

8 Ideon Science Park Ideon Science Park has a diverse set of competencies within connectivity, ICT, Life science, cleantech, medtech, smart materials and food innovation. Ideon was build over 30 years ago right next to the University of Lund in order to connect science and research with innovators and entrepreneurs. Ideon was the first Science Park of its kind in Sweden and northern Europe. Ideon Science Park not only attracts competent individuals. Companies like Bosch, Sony, Ericsson, Volvo, Huawei, Texas Instrument and Schneider Electrics have R&D departments or offices here, to benefit from the mix of competences when developing the future. More at www.ideon.se

9 Medicon Village Science Park Medicon Village is about proximity and bringing together diverse areas of life science. People may have various specialties and different jobs but they all have life science as a common denominator.

service, which gives small companies the advantages of the big ones. More at www.mediconvillage.se

10 Krinova Incubator & Science Park At Krinova innovation and development is promoted from collaborations between companies, organisations, universities and society. The science park offers a creative growth environment with incubators and innovation arenas to support development and innovation initiatives, and furthermore arranges 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. Krinova Incubator & Science Park is owned by Kristianstad Municipality and Kristianstad University. More at www.krinova.se

11 Videum Science Park Videum’s business concept is to utilize the scientific environment for development and growth in and around the Linnaeus University in Växjö. This means that Videum is actively involved in developing new ideas. Videum’s key role is to support the establishment of new businesses in Växjö. Approximately 100 businesses and organisations representing over 600 employees are currently important parts in the development process at Videum Science Park. Linnaeus University is Videum’s largest tenant. The science park also offers conference facilities and meeting rooms, primarily for our tenants but also available to others. More at www.videum.se

Medicon Village encapsualtes the entire life science world – from prevention and diagnostics to treatment and care. The science park focuses on creating a value chain from concept to support and development of a finished product or

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WHAT WE LEARNED IN 2016

WHAT WE LEARNED IN 2016 – A LOOK BACK NEXT: PRIVATE-PUBLIC PARTNERSHIP IS PURSUING DEVELOPMENT OPPORTUNITIES Time and data quality is of essence during drug development,

haematology, infectious disease, respiratory medicine as well

which is some of the key purposes why the National

as bioinformatics.

Experimental Therapy partnership (NEXT) was established. NEXT responds to the needs from pharma for easy access to conducting clinical trial yielding high quality data. NEXT works to strengthen Denmark as a preferred country for early clinical research, particularly proof-of-concept trials, i.e. Phase 2a and 2b trials, by acting as a showroom for international pharmaceutical companies, displaying the regional academic competences, and the partnership has put effort into five different areas: dermatology, oncology /

While phase 2a and 2b trials are undertaken by pharma headquarters, affiliates typically welcome an increased number of local activities. Contract research organisations, laboratories, diagnostics, and medtech suppliers altogether represent an ecosystem of its own that is fertilised by increased clinical trial activity. The hospital employees are moreover well trained and experienced in clinical trial conduct, which is known to improve data quality.

ATTRACTING FOREIGN INVESTMENTS Invest in Denmark, part of the Ministry of Foreign Affairs, have a proactive approach and outreach in their efforts of attracting foreign companies to place investments and jobs in Denmark. The organisation has specialized staff across the globe with corporate background and industry insight, who work to identify companies for whom Denmark would be an optimal place for investments arguing competitiveness within a range of areas, and typically access to highly educated workforce and technology. They participate in conferences and a range of events where they present the clear opportunities for doing business in Denmark – drawing upon a large network of potential partners to

further facilitate an investment. Denmark has a lot to offer foreign companies, e.g. worldclass research, highly qualified staff, a long tradition for private-public partnerships. One of the areas that have drawn attention is within medical research and clinical trials, where Denmark has a lot to offer with a unique social security number system, long-standing tradition for patient and population registration, and access to comprehensive biobank. Denmark has a homogeneous population and individual patients are easily traced, reducing the low lostto-follow-up rate.

DISTRIBUTING PHARMA PRODUCTS - REQUIREMENTS A number of factors must be taken into consideration before

security is the Danish biotech company Bavarian Nordic,

selecting a partner for logistics- and distribution-solutions,

which delivers small-pox vaccines to the U.S. Strategic

as well as there are a number of requirements that must be

National Stockpile for emergency use. The distributer of the

met to ensure the quality and integrity of the medicines,

vaccines must never leave the batch unguarded and it must be

from manufacturer to the patient. One of the requirements

kept in a locked facility. Large storage facilities in the airport

we learned about in our article in the summer of ’16 is the

is a must as well as transportation from the airport to the site

GDP guidelines (Good Distribution Practice). Among the

of delivery in the US must not be too long. Furthermore, the

requirements that must be met are storage and temperature.

vaccines must be stored at -20C, or colder, and the distributor

Safety is another key issue when distributing pharmaceutical

must at all time keep the vaccine at this temperature.

products. One company which is particularly attentive to

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WHAT WE LEARNED IN 2016

PHARMACEUTICAL INDUSTRY IS THE ONLY INDUSTRY THAT CREATES JOBS - Development in employment in Danish industries 1990-2013 (Index, 1990 = 100 )

PHARMA â&#x20AC;&#x201C; THE GREATEST VALUE CREATOR In 2015 export of medicinal products was DKK 85.7 billion;

convincing. Data states that 26.500 are employed in the

representing 13.5% of the total Danish export. While other

pharmaceutical industry, resembling 2.5% of the employed

industries have declining and stagnating export numbers,

workforce in Denmark. The pharmaceutical industry

the pharmaceutical industry has had a doubling in export

generates yet more jobs, among life science service providers,

since 2009.

CROs, CMOs, etc. In total 90.000 jobs originate directly or

In the value chain, creation of jobs in pharma and supporting

indirectly from the pharmaceutical industry.

industries is continuously growing. The numbers are rather

Source Statistics Denmark.

MEDTECH MEETS MARKET DEMANDS

COMPANIES BENEFIT FROM TRAINEES

In order to meet the market demands the medtech

From our research in the summer 2016 we learned that

industry constantly develop novel and innovative

there are a number of benefits from having a trainee

products. Taking an idea from the sketchpad to the

onboard, however it may cost a bit of time on the short

market can however be quite challenging, which is

term.

why improved financial support and access to startup incubational environments may facilitate young and still immature start-up companies. It is quite the political task and responsibility to ensure that favourable conditions facilitate start-ups which is essential for a constant inflow of new products. One of the more alarming trends is the focus on price. Even if total cost considerations implies, that there is an additional cost attached to cheap products from a higher risk of infections, re-admissions to the hospital

It can lift the laboratory to have a trainee onboard, who is likely to have a different approach and may challenge the way the laboratory staff usually works and ask relevant questions. A trainee often brings new ideas to the laboratory. There is also the Corporate Social Responsibility (CSR) element to consider. If we want capable laboratory technicians in future, then perhaps this is where we can make an effort.

or surgical complications, price seems to be a very high

The hiring a laboratory technician trainee for is for term

priority leaving total cost considerations out.

of a 1-year internship, and It is estimated that it takes about six months for a trainee to be able to work as a fully trained laboratory technician.

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WHAT WE LEARNED IN 2016

ACROSS BORDER COLLABORATION Invest in Skåne and Copenhagen Capacity are regional business promotion organisations for the southernmost part of Sweden and Greater Copenhagen, respectively. Both parties work to attract business and investments to the region and join forces to promote the life science industry. Both organisations work closely with their national counterparts Business Sweden and Invest in Denmark, respectively. There has been a steady increase in the number of investments in Skåne during the past years, generated by co-operation, regionally, across our borders and helping companies find the right international business opportunities. At the Nordic Life Science Days in Stockholm 2016 the two organisations promoted the region in a joint booth. In September 2017 the conference will take place in Malmö– attracted by the regional actors. The strong Swedish-Danish cooperation has also been a contributing factor in landing Europe’s largest biotech conference BIO-Europe, which will be held in Copenhagen and Malmö in 2018.

A SHORTAGE OF QUALIFIED CANDIDATES Over the past five years, the industry is facing increasing demands within e.g. regulatory affairs, data management, and quality assurance, and thus requiring more people. There is a lack of qualified candidates to fill the open positions within life science. International recruitment is a potential solution but it is difficult to attract foreign candidates to positions in Denmark. Some of reasons we learned about in our article in the summer ’16 are that the pay check is not as high in Denmark and Scandinavia as elsewhere in the world, especially not at an executive level. Cost of living is also considerable, and moreover insufficient integration of the spouse and the family has proven time and time again to jeopardize successful international recruitment.

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THE BRAIN PRIZE 2017

Research into learning wins the 2017 Brain Prize The Lundbeck Foundation's research prize – The Brain Prize – has been awarded to three UKbased brain researchers for explaining how learning is associated with the reward system of the brain. The prizewinners found a key to understanding the mechanisms in the brain that lead to compulsive gambling, drug addiction and alcoholism. By Karin Jensen

t is said that the greatest joy lies in the anticipation. This saying implies that we become disappointed if we don’t receive the reward we expect – such as a good mark for an examination. If we get the mark we expect, we are satisfied. But if we achieve more than we expect, we are overjoyed and learn from the experience. This unexpected reward is associated with an increased release of the brain’s neurotransmitter dopamine in specific brain cells, stimulating learning and motivation. The three winners of the 2017 Brain Prize, English Peter Dayan, Irish Ray Dolan and German Wolfram Schultz, have identified how learning is linked with anticipation of reward, giving us fundamental knowledge about how we learn from our actions. Through animal testing, mathematical modelling and human trials, the three prizewinners have proven that the release of dopamine is not a response to the actual reward but to the difference between the reward we expect and the reward we actually receive. The greater the surprise, the more dopamine is released. The Brain Prize is for EUR 1m, or approximately DKK 7.5m, and is the world's largest brain research prize. The organisation behind the prize is the Lundbeck Foundation, one of Denmark's largest sponsors of biomedical sciences research. “The research of these three prizewinners offers far-reaching perspectives on our understanding of human behaviour and how we make decisions. Their research has also provided a valuable key to understanding what goes wrong when people succumb to compulsive gambling, drug addiction, obsessive compulsive disorder and schizophrenia,” said the chairman of the foundation’s Selection Committee, Professor Sir Colin Blakemore, when explaining the reason behind the award.

stances such as cocaine, nicotine or alcohol. The system becomes overstimulated by dopamine – or hi-jacked – leading to addiction in some. The same applies to compulsive gambling where anticipation of an even bigger win leads to increasingly risky behaviour. “Mapping the connection between learning and reward is essential if we’re to understand human behaviour and how to improve treatment of brain disorders. With elegant experiments and mathematical models, the prizewinners have described how dopamine plays a crucial role in the motivation that drives learning,” says Professor Morten Kringelbach, a researcher of the hedonic brain at the universities of Oxford and Aarhus.

Same mechanisms The three prizewinners are receiving this award for increasing our understanding of dopamine neurons, according to the Lundbeck Foundation. In animal trials, Wolfram Schultz has mapped the parts of the brain in which dopamine neurons are located and has illustrated how they react to reward and external stimuli, helping control the behaviour of the laboratory animals. Peter Dayan uses mathematical models to describe the way in which dopamine neurons react to the difference between what is expected and what actually happens and he has proved it probable that the dopamine neuron system helps control learning and actions. In collaboration with Peter Dayan, Ray Dolan has tested these hypotheses in human trials and, applying brain scanning techniques to humans, has shown that human behaviour is controlled by the same mechanisms present in laboratory animals.

“Small devils in the brain” The human brain has one million brain cells that carry the neurotransmitter dopamine. These dopamine neurons are located in the centre of the brain but have pathways to many other parts of the brain. Prizewinner Wolfram Schultz describes the dopamine neurons as “small devils in our brains”. These are the cells that make us exert ourselves and act to gain ever greater rewards. But they are also the cells that are under attack when we consume sub-

From left, Wolfram Schultz, Peter Dayan and Ray Dolan. The Brain Prize for 2017 is jointly awarded ‘for their multidisciplinary analysis of brain mechanisms that link learning to reward, which has far-reaching implications for the understanding of human behaviour, including disorders of decision-making in conditions such as gambling, drug addiction, compulsive behaviour and schizophrenia’

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THE BRAIN PRIZE 2017

An asset to Danish brain research The Brain Prize, which honours European brain research and international collaboration, is being awarded for the seventh successive year. The outreach programme attached to the prize invites the three prizewinners to Denmark to participate in meetings and workshops together with Danish brain researchers. The programme is organised in partnership with the three largest Danish universities and the Danish Society for Neuroscience. “The Brain Prize and its associated activities help strengthen, internationalise and raise the profile of Danish brain research, providing a perfect supplement to the DKK 250m granted by the Lundbeck Foundation to Danish brain researchers each year. As a result, Denmark is gradually becoming a ‘brain research nation’, and opportunities for attracting leading international researchers are steadily improving – for the great benefit of Danish research,” said Kim Krogsgaard, managing director of The Brain Prize. The Brain Prize, which will be presented on May 4th in Copenhagen, was established by the Lundbeck Foundation in 2010 as a European prize and was awarded for the first time in 2011. It is a personal prize, awarded annually to one or more scientists who have achieved distinction through outstanding contributions to European brain research.

About the prizewinners Peter Dayan is from the UK. He read mathematics at the University of Cambridge and obtained a PhD from the University of Edinburgh for his dissertation on artificial intelligence. He has held postdoc positions at the MRC Research Centre in Brain and Behaviour in Oxford, UK, at the Computational Neurobiology Laboratory, The Salk Institute, La Jolla, USA, and at the Department of Computer Science, University of Toronto, Canada. In 1998, he was attached to the Gatsby Computational Neuroscience Unit, University College London (UCL), and has been director of the unit since 2002. He is also a professor of computational neuroscience at UCL. Most recently, Peter Dayan

was appointed Deputy Director of the new UCL-Max Planck Centre for Computational Psychiatry and Ageing Research. Ray Dolan was born in Ireland, read medicine at University College, Galway, Ireland and later specialised in psychiatry. From 1981 to 1994, he worked at the Royal Free Hospital Medical School in London. In 1995, he moved to the Institute of Neurology, University College London (UCL), where he subsequently became director of the Wellcome Trust Centre for Neuroimaging. Ray Dolan was recently appointed Co-Director of the new UCL-Max Planck Centre for Computational Psychiatry and Ageing Research. He is a Fellow of the Royal College of Physicians, the Royal College of Psychiatrists, the Academy of Medical Sciences and the Royal Society. Dolan received the Minerva Foundation Golden Brain Award in 2006, the International Max Planck Research Award in 2007 and the Zülch Prize in 2013. Wolfram Schultz is German. He read medicine, mathematics and philosophy at the universities of Hamburg and Heidelberg, Germany, from 1966 to 1971. He completed postdoc studies at Göttingen, Germany, from 1973 to 1975, at the State University of New York, Buffalo, from 1975 to 1976 and at the Karolinska Institute, Stockholm, from 1976 to 1977. Wolfram Schultz worked at the Institute of Physiology at the University of Fribourg, Switzerland, from 1977 to 2001, after which he moved to the University of Cambridge, UK, where he was appointed Professor of Neuroscience and Wellcome Trust Principal Research Fellow. Schultz has been honoured with many prizes, among others the Minerva Golden Brain Award in 2002 and the Ipsen Prize in 2005. He is also a Fellow of the Royal Society.

PROFILE

Work in Denmark

– matching international candidates for life science companies The demand for qualified labour is comprehensive in the Danish life science industry and there is a shortage of candidates available. Work in Denmark helps to attract foreigners to come and work here. “We’re in dialogue with many Danish companies to help them find qualified employees from abroad. Either foreigners coming to Denmark to work or foreigners already living in Denmark,” says Kirsten Thomsen, director at Work in Denmark. The type of employees in demand covers the entire range of the Danish life science industry, including research & development, regulatory affairs, immunology, monocular biology and validation, and companies are looking for both experienced candidates as well as graduates and PhD-students. Work in Denmark has several tools to offer to companies, among them a jobbank with Danish jobs in Danish, a database with CV’s from highly qualified international candidates and participating in targeted job fairs around Europe. “At the job fairs, we present highly qualified Danish jobs in English. Part of the job fairs in which we participate are specialised in life science and a perfect place to meet potential candidates. “We visit the job fairs to ensure an inflow of qualified candidates. We present the candidates for the companies or ask the candidates to apply directly to the company,” Kirsten Thomsen tells. Work in Denmark works closely with the organisers to find the right candidates.

Qualified employees are in demand, not least in Northern Europe. “We’re not the only ones searching for qualified candidates. Other countries also have programmes such as ours. But it seems that candidates find Denmark a very interesting country to live and work in,” says Kirsten Thomsen. She highlights the good career opportunities that exist in Denmark, but also attractive working conditions, high standard of living, free schools and healthcare as well as good opportunities for spouses to find a job, as some of the key selling points. “Denmark also offers a good international environment. We try to attract international candidates by talking about the opportunities that exists in Denmark and at the same time create awareness of the job openings here,” Thomsen says. This year, Work in Denmark will look a little wider for international candidates and visit the MIT European Career Fair in Boston in the United States in search for qualified candidates for the Danish life science sector. “We’re visiting the MIT fair in February. It’s on a test basis. Boston is the place where you find some very interesting universities, not least the MIT, and has some of the best candidates in the world,” says Kirsten Thomsen. Work in Denmark cooperates with DI, the Confederation of Danish Industry, on the Boston fair and on attracting talents to come and work in Denmark. Work in Denmark consists of three centres,

one in Copenhagen, one in Aarhus and one in Odense. In 2016, the three centres presented some 2,000 candidates to Danish companies, visited 42 job fairs in Europe exposing around 13,000 highly qualified Danish jobs.

Facts about WorkinDenmark •

WorkinDenmark presented 835 international jobseekers to Danish companies in 2015

•

More than 250 of the 835 international jobseekers were looking for specialist positions within life science

•

Most international jobseekers come from Europe and the remaining come from the US, Canada, China, and India

•

WorkinDenmark has three centres which are located in Copenhagen, Aarhus, Odense and Aalborg

Contact Workindenmark: +45 72 22 33 00 workindenmark@workindenmark.dk www.workindenmark.dk

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

university of copenhagen

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Courses in 2017 Deal-making in the Pharmaceutical Industry Pharmacology Biopharmaceuticals Drug Development Quality by Design (QbD) in Pharmaceutical Development Market Access for Pharmaceutical Products – trends and challenges QA, QC, GXP for Pharmaceutical Production Clinical Pharmacology and Biostatistics Discovery and Development of Medicines

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MASTER OF MEDICINES REGULATORY AFFAIRS Become the expert that can help secure a safe, coherent and successful regulatory process The Master will give you Thorough insight into the regulatory process at all stages during the development of medicines An overview of the differences in regulatory demands globally The competencies to analyse, predict and advise on medicines regulations and directives The Master programme is offered in collaboration with Medicademy – part of Lif Education. Enroll in the full programme or take individual courses

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Courses in 2017 Global Medicines Legislation and Guidelines Clinical Development – Efficacy of Medicines Regulatory Science Perspectives on Clinical Development Safety of Medicines – From Non-clinical Development to Pharmacovigilance Ethical, Societal and Assessment Aspects of the Regulation of Medicines Regulatory Affairs in the USA Regulatory Affairs in the EU Biopharmaceuticals – Quality Development and Documentation Quality – Active Substance and Medicinal Product

OVERVIEW

BIOTECH pages 18-23

PHARMA pages 24-28

MEDTECH pages 29-32

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OVERVIEW

CRO’s pages 33-39

CDMO’s pages 40-43

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“It remains to be seen what can be accomplished, but I am optimistic that it can bring positive changes to the industry.” Martin Bonde, CEO at VacciBody and chair at DANSK BIOTEK.

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BIOTECH

AGAINST ALL ODDS – BIOTECH IN GROWTH

Several biotech companies stand out in 2016 as remarkable successes. Despite the inborn challenges of being biotech, the business is overall growing and gradually becoming a significant player in life science, in total accounting for DKK 85 billion export in 2015. By Charlotte Strøm, MD PhD Journalist “In 2016 three items stand

oncology while the value of

development deal with Baxalta

been around for many years

out as beacons in biotech,”

the company has outgrown

(later acquired by Shire) at

now, and now the company

says Martin Bonde, CEO

several of our local pharma

the handsome amount of

is taking off for a whole new

at VacciBody and chair at

companies.”

EUR 160 million in addition

ballgame.”

DANSK BIOTEK, the Danish trade organization of biotech companies.

Martin Bonde stresses that this progress leaves a learning that biotech can in fact work

“We have some flagships

out as a durable business in

that do really well. Genmab

Denmark:

is an example, a wellestablished biotech company that by now is one of the leading innovators within

to milestone payments etc.,” Martin Bonde says and carries on, “The amount testifies that Symphogen truly has a unique

Having said that, Martin Bonde finds the third highlight of 2016 being that finally the framework conditions for life science seem to be put on the political

“The nature of the game

and proprietary technology

is that out of 20 biotech

and expertise that have

agenda.

companies, 17 are closed after

high value. Hopefully, it marks a turning point in

One point of entry

a few years, two companies suffocate slowly, while one

Symphogen. People in the

forces with the industry,

industry have been waiting

stakeholders from pharma and

for Symphogen to make a

biotech and started a so-called

big deal. Investments into

Life Science Growth Team.

Symphogen are much above

This is a major advance that

the average biotech companies

we – as an industry – have

in Denmark. The new Baxalta

one point of entry where the

deal should enable a quantum

framework conditions can be

leap in development that

discussed,” he says.

does a fantastic job. However, it is also a key learning that biotech can actually be done in this country.”

Big money is back Another highlight is that apparently big money does make its way to Danish biotech.

will take them to the next level, growing, and creating more jobs. It also tells me

“Symphogen has

that persistence pays off,

recently signed a co-

because Symphogen has

“The government has joined

“It remains to be seen what can be accomplished, but I am optimistic that it can bring positive changes to the industry.” He points to life science being

Martin Bonde, CEO at VacciBody and chair at DANSK BIOTEK

a profound and well developed

is happy that in 2016 the Danish biotech industry performed

industry in Denmark going

really well, demonstrated overall growth and raised big invest-

back more than 100 years.

ments, enabling further growth and development.

“This is more than innovation, and facilitating innovation, it is also a matter of being able to attract the right people with the right competences. People that can actually transform

BIOTECH

laboratory research in e.g.

Orphan disease was term

immunology or oncology and

coined in the 1980s to describe

use it as a basis to develop

diseases of small patient

targeted drugs to treat cancer

populations and with a very

and chronic diseases.”

high unmet need. Developing

Moving into clinical development The year 2016 Orphazyme Aps illustrates this point. The biotech company develops new therapies for the treatment of rare and genetic diseases and is now moving into phase III clinical development with the lead compound. “It is a major change to move into clinical development, and first thing is to get the right people on board in order to drive these processes efficiently,” Anders Hinsby, CEO at Orphazyme explains, referring to hiring Thomas Blaedtler as a chief medical

to accommodate for the low sometimes the regulatory process to getting the therapy

“We develop therapies for ultra-rare diseases which

This family of genetic disorders consists of more than 45 diseases and includes Niemann-Pick disease type C. Lysosomal storage diseases often affect children, most of whom are currently untreatable.

•

www.orphazyme.com

10.000 patients. The market size is typically smaller than for big indication medicinal products, and therefore a lower market size than for big ‘blockbuster’ indications. On trials are also typically

“It is a major change to move into clinical development," Says Anders Hinsby, CEO at Orphazyme Aps about the biopharmaceutical company now preparing to embark on a phase III clinical trial in a rare lysosomal storage disease, Niemann-Pick.

indications, and therefore less costly. Clearly, it requires a distinct value proposition

Anders Hinsby points to

says, ending,

different things being

“We do get some advantages

developers.

•

mean diseases with less than

to investors,” Anders Hinsby

innovators into being

The lead program is in development as a treatment for lysosomal storage diseases.

larger diseases.

Make it or break it

transformation from being

•

approved is different from

smaller than for the bigger

a challenge in this

well characterized mechanism of disease.

number of patients, and that

The newly appointed CMO

development experience.

genetic diseases and neurodegenerative diseases with

the clinical trials have to be designed in a special way,

Orphazyme ApS is a Danish biopharmaceutical company that develops medicines for the treatment of

disease implies that often

the other hand, the clinical

with many years of clinical

•

a product for an orphan

officer (CMO).

joins the company from Roche

Facts about Orphazyme

in the shape of flexibility from the regulatory authorities. On the other hand, rare diseases are often not very well

“Well, it definitely takes

described clinically and with

a different mindset and

no previous drug products

expertise to do clinical

to benchmark against. By

development as compared

not knowing the disease well

to research. The stakes are

enough you run the risk of not

much higher, and so are the

selecting the relevant clinical

expectations that we hit

endpoints for your trial.”

bullseye. Having said this, it is obviously also much more expensive to do clinical development. You need support from deep pocketed investors,” he says. He explains how Ophazyme develops treatment for rare diseases, a distinct part of the orphan diseases segment.

PROFILE

Helping medtech developers make the right decisions Article by Charlotte Strøm

At DHI experts in toxicology advise the medtech industry on developing tomorrow’s medical device that meets impending EU regulation. The new EU regulations (the Medical Device Directive (MDR) and the In vitro device directive (IVDR)) increase requirements for documentation in medical devices. The directives are expected to come into force in 2020 and 2022 respectively, but for medtech developers the implications of the regulation already affect operations and

of materials and chemical constituents such as additives, residual monomers and metabolites. Moreover, we investigate impurities and degradation substances in order to optimise the safety aspects of medical devices, he says. Brian Svend Nielsen gives an example: -It could be selection of rubber or plastic

Improved patient safety

development projects. -When you are in the early phase of development, the most vital decision to make is the right choice of material. Consequently, careful consideration must be given to selection of materials and chemical constituents with regard to toxicity, Business Development Manager at

material for a tube or a pumping system that will carry medicine. Several issues must be addressed, such as potentially migrating substances and their toxicity. Moreover, a careful assessment needs to take place in order to avoid or minimize use of substances classified either as mutagenic, carcinogenic or reprotoxic

The new MDR and IVDR also require each device to be registered with a unique identification tag. -There will especially be an increased control with use of substances having carcinogenic, mutagenic, reprotoxic, or endocrine disrupting properties. For some types of medical device even very small

DHI, Brian Svend Nielsen says. He is a senior toxicologist and helps medtech developers and manufacturers optimize their choice of material, enabling a cost-efficient development as well as ensuring minimized negative effects on human health.

(CMR), for instance classified phthalates in polyvinylchloride (PVC). He continues, -If the medical device has just the right texture to fulfill its purpose, using substances that are identified as being endocrine disrupting chemicals (EDC), then you will inevitably run into problems as a manufacturer with the new regulation. But – there are alternatives, and at DHI we have the expertise to help medtech companies working their way through this jungle.

amounts of these substances have to be labelled, Brian Svend Nielsen ends

-With our extensive knowledge of toxicity of chemicals and experience with REACH (Registration, Evaluation, Authorisation and Restriction of Chemical substances) and global chemical regulations, we provide safety assessments

Brian Svend Nielsen points to the increased control as a clear patient benefit, primarily on safety. -This will clearly raise the demands among the medical device developers and manufacturers, he says.

Facts about DHI and services in medical devices •

Biocompatibility evaluation and documentation

•

Regulatory support for global market access

•

Intelligent test strategies and data mining

•

Read-across strategies, QSAR and in silico models to predict toxicological end points.

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

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PHARMA “… patient involvement and the speed of recruitment in addition to data quality are major issues that also tend to drive more clinical trial activity in our direction” Ida Sofie Jensen, CEO at The Danish Association of the Pharmaceutical Industry.

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PHARMA

POLITICAL ACKNOWLEDGEMENT OF THE SIGNIFICANCE OF THE INDUSTRY A Life Science Growth Team was established in June 2016. The industry welcomes the initiative as a major step forward in getting acknowledged for its value in export and in creating jobs By Charlotte Strøm, MD PhD Journalist “A life science strategy

set-up. The point is that the

Cutting down on funds for

and politics creating and

politicians finally seem to

research, education etc.

optimizing the frame

acknowledge the significance

is a step in the opposite

work conditions for the

of the industry,” she says.

direction. The numbers speak

pharmaceutical industry and other life science companies. That is what we hope for and expect to come from the work of the Life Science Growth Team,” says Ida Sofie Jensen, CEO at The Danish Association of the Pharmaceutical Industry (Lif). “Perhaps we can even expect to get a Minister of life science, modeled after the UK

And the numbers do create respect. The export of the life science industry has grown exponentially over the past 10 years and is expected to pass DKK 90 billion in 2016. “An increased focus on the industry as a value creator, will hopefully also increase the focus on scientific research as the key driver in this export fairytale.

“Perhaps we can even expect to get a Minister of life science, modeled after the UK set-up."

for themselves, research in life science is a heavy contributor to the export and

Ida Sofie Jensen, CEO at The Danish Association of the Pharmaceutical Industry (Lif )

furthermore it is an industry with a continuously growing employment rate,” Ida Sofie Jensen says.

the highest number, 40.7, of

Number of clinical trials is growing

clinical trials per capita. And

Ida Sofie Jensen points to

in clinical trials per capita,

the fact that the number

Danish pharma companies

of clinical trials that are

rank as number 2. Overall

performed in Denmark,

on a European index of the

and investments in clinical

pharmaceutical industry,

trials made by Danish

covering export, investments,

pharmaceutical companies

employment, and production

seem to be growing.

per capita, Denmark takes a

“In Europe, Denmark has now

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

when it comes to investments

second place,” she says.

PHARMA

EUROPEAN PHARMA INDEX: Pharmaceutical export per capita, private pharmaceutical R&D investments per capita, employment in the pharmaceutical sector per capita, pharmaceutical production per capita and number of industry initiated clinical trials per capita. The index shows the total average

“Obviously, there is an

Investing in clinical trials

intense focus on cost when

Furthermore, Pharmacosmos

it comes to clinical trials,

has increased its focus

which typically accounts for

on clinical trials and is

major investments. However,

currently embarking on

it appears as if patient

major investments to further

involvement and the speed

document the benefit of

of recruitment in addition to

its products to drive future

data quality are major issues

growth.

that also tend to drive more clinical trial activity in our direction,” says Ida Sofie Jensen.

Tobias S. Christensen, Vice President at Pharmacosmos Corporate Strategy and Business Development

Tobias S. Christensen, Vice President

explains why now seems to be

at Pharmacosmos Corporate Strategy

Source: World Bank, OECD

90% of the turnover is export

STAN database, EFPIA key

With a turnover of DKK 514

heavily in clinical trials:

figures, Clinicaltrials.gov.

million, a growth rate around

rank of the countries on all five parameters.

Switzerland Denmark Belgium Ireland Sweden Germany Holland UK France Italy

1 2 3 4 5 6 6 8 9 10

20%, and >90% of revenue generated abroad, the Danish pharmaceutical company, Pharmacosmos, exemplifies how life science is a major exporter and growth driver. The company manufactures and markets intravenous iron for the treatment of iron deficiency, present in a number of different chronic

She points to initiatives like NEXT, the National Experimental Therapy

diseases. Pharmacosmos expects continued high growth, is starting a new

the right timing for investing

and Business Development feels encouraged by the confidence from academia in the significance of iron

“We experience an increasing understanding and clinical

deficiency anaemia, as Pharmacosmos is about to embark on two large scale clinical trials.

acknowledgement of the impact of iron deficiency in different chronic conditions.

is supporting the trial and

The British Heart Foundation

giving the initiative its stamp

is financially supporting

of approval.

a hard endpoint clinical

“Encouraged by the

trial (IRONMAN) with

confidence from academia and

approximately £ 2 million,

the BHF support of IRONMAN,

investigating the effect of intravenous iron on death and re-hospitalization in patients suffering from chronic heart failure. Pharmacosmos also

we have decided to conduct two large clinical trials (FerWon IDA (Iron deficiency anaemia) and FerWon Nephro) each including 1,500 patients,

Partnership, a public-private

affiliate in Germany, and has

partnership within clinical

just made a deal with a leading

research for attracting more

Japanese company to market

clinical trials. Furthermore,

the lead product (Monofer®)

The IRONMAN study is

disease and one study in

the willingness among the

in Japan, the second largest

an investigator-initiated

iron deficiency with chronic

pharmaceutical companies to

market worldwide for

trial. At Pharmacosmos it

kidney disease,” Tobias S.

invest in clinical trials locally,

medicinal products.

is perceived positively that

Christensen ends.

seem to have returned.

supports the study with a

one study in iron deficiency

significant grant.”

anaemia without kidney

the British Heart Foundation

Facts about Pharmacosmos •

•

on improving the lives of patients

Pharmacosmos is a family-owned,

with iron deficiency with or without

in the Nordics, the UK and the US

international healthcare company

anaemia. More than 1 billion people

and its products are sold in more

with more than 50 years of inno-

live with iron deficiency anaemia

than 80 countries across the world.

vation and leadership in iron- and

and it is the leading cause of death

Its manufacturing facilities are

carbohydrate-based treatments and

for an estimated 180.000 people

approved, among others, by the

solutions for human and animal use.

every year. This makes it one of the

Danish Medicines Agency and the

largest global health challenges of

US FDA.

A research-based company, its ongoing R&D programme focuses

•

Headquartered in Denmark,

our time.

•

Pharmacosmos has subsidiaries

www.pharmacosmos.com

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PROFILE

RNA in situ hybridization

- a game changing technology in the field of RNA detection. Article by Boye Schnack Nielsen, R&D Manager of Molecular Histology, Bioneer and Vibeke Dalhoff, Business Development Manager, Bioneer

Antibodies are routinely used for diagnostic assessment, particular in the oncology area. Reliable tools for in situ detection of proteins as diagnostic immunohisto-chemical markers are key in histopathological diagnosis and important in the growing focus of personalised medicine, but development of efficient antibodies are time consuming and technically demanding. Fortunately, novel mRNA in situ hybridization (ISH) detection tools have emerged that may partly replace and/or accelerate protein diagnostics development. RNAscope® is a highly reliable ISH

technology tool for visualising the expression of any gene within FFPE tissues, and is fully validated to detect RNA at single molecule sensitivity. The ability to analyse gene expression in situ in routine clinical specimens with high sensitivity and specificity, makes RNAscope® a promising platform for translating many RNA biomarkers into clinical use. The technology delivers valuable information within a short timeline to any biomarker discovery or target validation studies in oncology, diabetes or other disease research areas. Moreover, the presence of an mRNA ISH signal in a cellular entity suggests that a translated protein likely is present as well and therefore mRNA ISH is also a valuable documentation tool in antibody development. The unique probe design eliminates any cross hybridization, and provides absolute specificity for the chosen target. Available probes cover human, rat, mouse, monkey, dog and many other species allowing to appoint location of expression of any target in both preclinical and clinical discovery work.

Boye Schnack Nielsen,

Vibeke Dalhoff, Business

R&D Manager of Molec-

Development Manager,

ular Histology, Bioneer

Bioneer

of immunohistochemistry and in situ hybridization technologies. Furthermore, Bioneer has expertise in the areas of human disease models, drug development and recombinant protein manufacturing – areas that support industry and academia in their development of new effective and safe compounds for the benefit of society and patients.

Bioneer is a certified provider of RNAscope® assays, and offers routine assay services on this technology as part of our proven track record of providing comprehensive services in the field

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

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MEDTECH

“… as a trade organization we still think that it is a good thing that we finally know what we are facing”

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MEDTECH

NEW REGULATORY WINDS ARE BLOWING IN MEDTECH For the medtech industry a highlight of 2016 was that the EU Commission Regulation concerning medical device and in vitro diagnostics finally came into action. By Charlotte Strøm, MD PhD Journalist “We welcome regulations that

medtech companies, as a trade

(TCO) allowing to look at

basically a repetition from

will raise the quality assurance

organization we still think that

innovation and optimization

2015,” Christian Boel says,

and overall standards for the

it is good thing that we finally

in addition to the price of a

CEO at Boel Nordic.

medtech business, and we

know what we are facing. But

product. We call this the most

have been waiting for this for

we hope that it will not limit

economic advantageous tender

quite some time now,” Peter

the innovation in the industry.

(MEAT),” Peter Huntley says.

Huntley says, director at

Furthermore, it remains now

Medicoindustrien, the trade

to be seen if the authorities

organization of 190 Danish

have in fact invested adequate

medtech companies.

resources into the national

A year of significant growth

in the dental area, which is

notified bodies that are going

“Medtech is growing

also a major growth driver.”

to process the regulatory

continuously, and the

applications without delaying

reason being that it is highly

approval processes and

innovative,” Peter Huntley

subsequent product launches,”

says, pleased with the fact

Peter Huntley says, airing his

that the medtech business as

concern.

a whole has performed well in

“There is no doubt that even though it will be a challenge in the years to come especially for some of the smaller

More TCO and MEAT in 2017

“We hope to see much more TCO and MEAT in 2017.”

Boel Nordic is an example of

to finding the key to market

just that. The Danish medtech

access as a cornerstone for

company delivers automated

success in medtech.

packaging, feeding, inspection and marking for the medical device, pharma and biotech

advocating a value

industries.

based approach in public

markets such as Sweden and Switzerland as key drivers in the company’s growth. “We have seen higher demands

New product launches in pharma, biotech and medtech are positively reflected in the order book of Boel Nordic in 2017. “As a rule of thumb, pharma

2016.

Additionally, he is pointing

“We are continuously

He points specifically to

procurement, incorporating

“We have had a double-digit

the total cost of ownership

growth in 2016, and this is

counts for about 10.000 products and medtech counts for about 500.000 existing products in the market, so clearly we are busy delivering both the packaging solutions and equipment for various parts of the end line solution,” Christian Boel ends.

FACTS about Boel Nordic •

Develops and delivers process equipment adapted to the medicinal product or device

•

Covers filling, sorting, assembling, packaging, and printing

•

Ensures barrier integrity of sterile products

•

For more information visit http://boelnordic.com

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PROFILE

Customised technological solutions for life science The Life Science division at Danish Technological Institute (DTI) provides novel solutions to a wide range of obstacles in pharma, bio- and medtech. "At DTI the overall mission of Life Science is to challenge the status quo by inventing outstanding technological solutions in cooperation with clients, technology providers, hospitals, end-users, and and universities," says Vice President Sune Dowler Nygaard, Danish Technological Institute. He continues, "Our Life Science division is rather unique as it gives our clients access to a range of platforms and technologies for testing, analysing, and characterization. We

have specialists in physics, biology, chemistry, molecular biology, engineering, etc. Who can find or develop the right solutions that are customised to meet the individual client´s needs and requirements." Director Trine Rolighed Thomsen, Biotechnology at DTI exemplifies the variety of solutions in the portfolio: "We’ve tested coatings and materials used in in vitro analyses, optimised cleaning procedures for reusable medical devices, tested autoclaving systems for medical equipment, and validated products for improved wound treatment. We are experienced in using genomics, transcriptomics, and proteomics data for applied R&D, e.g., when investigating infection and drug mechanisms and performing drug target deconvolution. We have also contributed significantly to the development of market-ready diagnostic assays for patient stratification." Sune Dowler Nygaard stresses that the network of clients can benefit from the knowledge and science base available at DTI:

Få svar på diagnostiske spørgsmål ved hjælp af scanning og blodprøvesvar

Vi sætter en ære i at levere innovative skræddersyede løsninger, der opfylder de nuværende og fremtidige behov inden for billeddiagnostiske- og biokemiske løsninger til diagnostiske enheder; radiologiske afdelinger og laboratorier.

Engineering success. Pioneering healthcare. Together. www.healthcare.siemens.dk

Facts about Danish Technological Institute •

Offers applied R&D, consultancy, and services within a wide range of business areas

•

Has extensive testing facilities, specialists, equipment, and processes that meet the highest professional standards

•

www.dti.dk/31469

"The diversity of our competences reflects the great variation in the type of tasks and challenges that we can manage for life science", he concludes.

CRO’s

Contract Research Organisations

“It is a question of preparing for innovation, and considering how you work to possibly achieve your goals” Lillan Rejkjær, Managing Partner and Head R&M Development at IWA Consulting.

CRO’s

CENTRALIZED PROCEDURES AHEAD On both sides of Øresund new centralized procedures pertinent to clinical trial activity are keeping contract research organizations (CROs) busy, and will continue to do so in the coming years. By Charlotte Strøm, MD PhD Journalist

n 2018 the EU will establish

it reflects back on initiatives

“We perform all kinds of

a central procedure for trial

taken by the Swedish

clinical trial activities from

application within the union.

Government.

planning to report. We provide

“The preparations and work

“It has been a long-term

around this within the

strategy for the Swedish

authorities have been going on

government to attract more

for quite some time now – and

clinical trial activity by

will continue to be in focus in

improving the operational

2017,” Anna Fröling says, CEO/

framework around life

CFO at A+ Science, a Swedish

science in order to attract

based CRO with outreach in

more investments. It has paid

the Nordic.

off, we do see an increase in

pharmacovigilance services, outsource consultants, and we have our own site management organization (SMO). The SMO is quite unique in its setting and handles phase 2-4 clinical trials,” Anna Fröling explains, and continues,

trials,” Anna Fröling says.

eCTD is here to stay and will embed all RA activities including policy 0070 and marketing material In the EU the electronic common technical document (eCTD) is already mandatory for all submissions in Centralized Procedures and for

national trial activities,” she

“Our clients range from small

new MAAs in Decentralized

says.

to mid-size pharmaceutical,

and Mutual Recognition

biotech and medical device

Procedures (human) (DCP &

companies that are currently

MRP) and will be mandatory

increasing their clinical

for all DCP and MRP life cycle

trial activities encouraged

activities by January 2018. The

A+ Science is based in

by governmental initiatives.

Food and Drug Administration

Stockholm and founded in

The EU strategy for

(FDA) in the US requires

1997, one of the first CROs

centralized trial approval

electronic Investigational

in Sweden, the company

clearly aims at stimulating

New Drug applications

As a CRO, A+ Science has

celebrates 20 years in the CRO

trial activity within EU –

(eIND) from May 2018, and

already witnessed an increase

business in 2017. The full-

and I am optimistic that

applications for marketing

in local clinical trial activities

service CRO is based on four

it will encourage further

approval (eNDA & eBLA) from

locally. Anna Fröling thinks

pillars:

investments into clinical

May 2017. In addition to this,

“Centralizing the approval process for clinical trial activity may facilitate and stimulate clinical trial activity. The aim is obviously to shorten the approval process and make the process smoother through one point of entry,” Anna Fröling says.

Increased clinical trial activity

Anna Fröling, CEO & CFO at A+ Science.

Lillan Rejkjær, managing partner and Head R&M Development at IWA Consulting

CRO’s

new submissions and policies

around filing for a marketing

like the policy 0070 with

authorization with both

active publication of pivotal

the EMA and the FDA,

clinical trials used as basis

simultaneously,” Lillan

for the marketing approval

Rejkjær says.

and submission of marketing material will be linked to the eCTD submissions.

“Integration of eCTDs is not easy at all, but I assure that it is a whole lot easier – and

“We embark on a new era

quicker - if the eCTD mindset

regulatory wise. We move

is introduced upfront instead

from ‘can do’ to ‘must do’

of when the regulatory people

when it comes to electronic

is compiling the marketing

applications,” Lillan Rejkjær

authorization application.

Facts about A+ Science •

CRO with four core business areas

•

20 years of experience in Life Science

•

Dedicated personnel

•

Flat organization, easier decision making process

•

www.a-plusscience.com

says. She is managing partner and Head R&M Development at IWA Consulting, a CRO with focus on regulatory affairs during development projects and throughout the life-cycle of the product.

Be prepared “The regulations around eCTD will most definitely have an impact on pharma, biotech, and life science – and moreover on academia,” Lillan Rejkjær says, carrying on “Scientific groups in academia is hardly prepared for what is actually ahead of them, when aiming for commercialization

What type of bridge are you looking for? Building bridges or clinical documentation makes no difference. It is a question of competence, experience & trust. We can support your clinical development at any stage. From design of Phase I to final report of Phase IV studies. Larix is a full-service clinical CRO providing high quality services to the biotech, pharmaceutical and medtech industries.

of pharma projects and planning for regulatory filings globally.” Does this carry a risk of drying out innovation? Lillan Rejkjær is not afraid that the new regulations will disable scientists from getting new groundbreaking ideas. “It is a question of preparing for innovation, and considering how you work to possibly achieve your goals”

We offer insourcing of professionals and full service solutions with offices in Denmark, Sweden, Norway and Finland. Contact us today for a meeting to discuss your needs

she says. “It may in fact be an optimization of the way we tend to do things today in Europe. Furthermore, it may optimize the processes

Larix A/S Lyskær 8b • DK-2730 Herlev • Denmark P: +45 7027 2221 • E: info@larixcro.com www.larixcro.com

CRO’s

It requires a clear knowledge

“We hope that representatives

about the format of the file,

from academia will also make

and I guess overall it is going

time to explore further on the

to be a very different working

possibilities and challenges

process in the future,” she

ahead, and moreover to learn

says.

how to overcome them.”

Still, Lillan Rejkjær

The two-day event will be held

acknowledges that in

at COBIS, the Copenhagen Bio

particular within academia

Science Park. The conference

the new eCTD requirements

will feature presentations

affairs services to support the development and reg-

may be challenging.

and discussions with life

istration of human medicines, including originators,

science industry profiles

generics, biotech products and medical devices

“To give further insights,

and representatives from

IWA Consulting is arranging

authorities. Some of the

an international eCTD conference in the beginning of 2017. The event follows up on the November 2014 conference on the same theme, offering

topics that will be highlighted involve submission of your

•

Founded in 1997; the owners and management partners are Lillan Rejkjær and Connie Thestrup

•

Offer medical and regulatory services in the EU and US

•

Offer a complete portfolio of regulatory and medical

•

Specialized in global eCTD submissions

•

Quality Management System certified according to DS/

first eCTD, outsourcing of

EN ISO 9001 since September 2009

eCTD and discussing the eSubmission roadmap for both

a practical perspective on the

Facts about IWA Consulting

•

www.iwaconsulting.dk

the EU and the US.

eCTD,” Lillan Rejkjær says, and ends,

The Lundbeck Foundation

the brain pr1Ze 2017 1 million € is jointly awarded to

Peter dayan

ray dolan

wolfram schultz

Gatsby Computational neurosCienCe unit, uCl, united KinGdom

max planCK uCl Centre for Computational psyChiatry and aGeinG researCh and WellCome trust Centre for neuroimaGinG, uCl, united KinGdom

department of physioloGy, development and neurosCienCe, university of CambridGe, united KinGdom

‘for their multidisciplinary analysis of brain mechanisms that link learning to reward, which has far-reaching implications for the understanding of human behaviour, including disorders of decision-making in conditions such as gambling, drug addiction, compulsive behaviour and schizophrenia.’

the award ceremony will take Place on 4 may in coPenhagen all nominations were reviewed by the distinguished selection committee: anders björKlund, sWeden, viCe-Chairman Colin blaKemore, united KinGdom, Chairman joseph Coyle, usa

Geoffrey donnan, australia tom jessell, usa story landis, usa

philip sCheltens, the netherlands irene traCey, united KinGdom

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

Moving day for heavy metals analyses

PROFILE

- This is what we are really good at, namely tailoring our services specifically to the

From January 1st 2017, the heavy metal analysis described in the European Pharmacopeia chapter 2.4.8 has been deleted from all human monographs. Instead, heavy metal testing will be performed with atomic absorption spectrometry (AAS) and inductively coupled plasma (ICP) spectrometry. DB Lab, a GMP contract laboratory, has extensive experience in providing these analyses to the pharmaceutical industry. - Currently, we are dealing with a change of methods that have been applied for over 100 years. I consider this an improvement for our clients, as the ICP is a more specific and sensitive analysis, says Michael Wamberg, Sales Manager at DB Lab. An ICP analysis still requires many individual assessments where the real asset is our extensive experience. He points to the fact that the changes that currently apply to the European Pharmacopoeia will also apply to the US pharmacopoeia as of January 1st 2018. The conversion of methods has implications which clients need to take into account during drug manufacturing. - ICH Q3D ‘guideline for elemental impurities’ applies to tests for heavy metals on the final product. When it comes to API and excipients, manufacturers can either perform the test to eliminate any potential risk or perform a risk assessment. This puts a new demand on the subcontractor of the raw materials who now has to supply their customers with documentation regarding the heavy metals, Michael Wamberg explains.

needs of our client at all times.

About testing for heavy metals

•

As of January 1st 2017, the heavy metals tests described in the European Pharmacopoeia chapter 2.4.8 were

Michael Wamberg, Sales

Ulrika Rosdahl, Sales &

deleted from all human monographs,

Manager at DB Lab

Business Development

affecting 753 monographs and the

at DB Lab

same will apply to the US Pharmaco-

ICP screening by classification His colleague Ulrika Rosdahl, Sales & Business Development at DB Lab carries on, - Whereas AAS is a technique that handles one metal at a time, ICP can perform a total screening of all the metals that the product contains. ICH Q3D has classified the metals according to their toxicity: Class 1, 2A, 2B, 3 and ‘other elements’. We can do a quantitative or a qualitative screening based on the classification as well as on individual metals. Having both ICP-OES and ICP-MS, we can accommodate sample material of both high and low concentrations.

Method validation required Ulrika Rosdahl acknowledges that some drug manufacturers have already enclosed the new requirements regarding heavy metal testing by purchasing ICP equipment of their own. In these cases, DB Lab remains a qualified partner in the process. - At DB Lab, we have a range of specialist chemists who offer their expertise regarding ICP when it comes to method optimisation and validation, she says and ends:

poeia from January 1st 2018.

•

AAS and ICP-OES/ICP-MS are the techniques that are now in use for heavy metals testing.

About DB Lab • DB Lab is a qualified contract laboratory providing chemical and microbiological analyses after Good Manufacturing Practice (GMP) standards with a longstanding experience regarding ICP analyses. • DB Lab is working with pharmaceutical clients all over Europe, primarily the Nordic countries. • The company has more than 20 years of experience with GMP analyses, a staff of 42 employees, and is located in Odense. • www.dblab.dk

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

CRO’s

CRO’s – what we learned Global market for clinical studies is on the increase By Arne G. Nielsen

candinavian CRO’s have been under pressure for

some years. The financial crisis was in part to blame for this as the number of clinical trials dropped, but also intense competition from the very large US CRO’s, which dominate the market. The pressure Scandinavian CRO’s have been under is in stark contrast to the number of large international, and very

range service palette. To understand why US CRO’s are so dominant, one needs to look at the massive American home market. The US is the place in the world where you

Medicon Valley region. Even though the global market for clinical studies is on the increase, there seems to be a tendency that the very large American CRO’s take the brunt of these deals. Large international pharmaceutical companies are increasingly entering global agreements with the very large American CRO’s, which provides a full-

way and provide new ideas and

Pharmacologist at Zealand

solutions

Pharma. Combining some key points from the separate interviews gave us the following insights:

-More-than-one-service packages -Experience with markets / Local presence

pay the most for medicine

-The CRO must meet the

which is a decisive factor. It’s

agreed scope, and deliver

-The size of the CRO, but

a massive market and you can

high-quality data, on time and

it is not always that being

earn a lot of money there. The

on budget, continuously

biggest is best. If the trials

US CRO’s benefit from this large home market.

-The CRO must live up to the hiring company’s guidelines/ code of conduct

successful, pharmaceutical companies based in the

Bysted, Principal Clinical

What pharma and biotechgroups want from a CRO In our search for insight in what Scandinavian pharmaceutical- and biotechnology groups primarily consider when

it requires less resources to

from the management of

cooperate with just one CRO,

the CRO, showing that there

which furthermore heightens

is backing and support

consistency in terms of

throughout the organisation,

processes applied within a

is a high priority.

given study. The experience

employees at the CRO

H. Lundbeck and Britta Væver

CRO with a global presence is often preferred, because

study, we spoke to Lone

Danish pharmaceutical group

different parts of the world a

governance and oversight

-Professionalism among all

Clinical Study Management at

proportion of patients in

-The degree of internal

hiring a CRO for a clinical Brandborg, senior director

are global with a large

-Being pro-active is weighed highly. A partner, which can contribute in a constructive

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

with smaller CRO’s is that they are often easy to build a close relation with and provides personal sparring.

To Earn Trust-Make Difference A+ Science is a unique Contract Research Organisation with focus on customer satisfaction. We have experience of services within clinical trials since 1997. Contact us to learn more about our services. A+ Science AB, www.a-plusscience.com Luntmakargatan 22, SE-111 37 Stockholm info@a-plusscience.com

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CDMO’s Contract Development and Manufacturing Organisations

“There is certainly an opportunity for consolidation to help customers to reduce their supplier base and bring more stability to the industry.” Mark Quick, Executive Vice President, Corporate Development at Recipharm.

CDMO’s

Increased drive to outsource manufacturing in life science Pharmaceutical companies tend to find partners for handling manufacturing by contract development and manufacturing organisations (CDMO). This implies a shift from a tactical to a more strategic activity. By Charlotte Strøm, MD PhD Journalist

life science industry

the newer and smaller

of manufacturing may also

building large production

pharma companies. They

play a role for big pharma.

facilities seems to be obsolete,

take the outsourcing route to

as more pharmaceutical

manufacture early on from

companies tend to outsource

the beginning of the product

manufacturing of their

life cycle,” Mark Quick says,

medicinal products, and

Executive Vice President,

furthermore to take a decision

Corporate Development at

upfront to do so.

Recipharm.

“We see this trend among

He explains how outsourcing

“Mature medicinal products often face a challenge in that volumes tend to decline. It is important for pharma

Mark Quick. Photos: Recipharm

companies to manage the costs as they also typically face generic competition. One route to achieving this

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

CDMO’s

"Emerging markets such as India are fast growing markets and all our customers are growing in these markets" is to outsource. When doing so, some companies take a strategic decision and not only outsource production but actually transfer the manufacturing facility to a CDMO. This is a win:win, as the CDMO can focus on selling spare capacity to other companies and the transferring pharma company benefits from this as the

Fragmented CDMO market Recipharm is a contract development and manufacturing organisation (CDMO) with more than 20 years of experience in the business. The company is listed on NASDAQ Stockholm, and the CDMO also has its headquarter in the Swedish capital. Recipharm employs about 5.000 people.

customers to reduce their

behind our recent acquisitions

greater number of units. In

Over the years Recipharm

supplier base and bring more

in India.

other cases, the possibility of

has acquired a number of

outsourcing come into action

competitors.

he says.

“The CDMO market is really

Recipharm is today a leading

Food and Drug Administration

CDMO and has more than 20

(FDA), effective from 2017

manufacturing facilities –

and the European Medicines

with operations in Sweden,

Agency, effective from 2019,

the UK, Germany, France,

require manufacturing

Portugal, Spain, Italy, Israel,

authorization holders to

and India.

demonstrate traceability of a

fixed costs are spread over a

when the company, may be small, mid-size or big pharma for that matter, does not have the relevant technology or does not want to invest in it,” Mark Quick explains.

quite fragmented with a lot of small players. There is certainly an opportunity for consolidation to help

stability to the industry.”

Traceability New regulations from the

“Emerging markets such as India are fast growing markets and all our customers are

single pack medicinal product to the pharmacy level for patient safety reasons.

growing in these markets.

“Clearly, we are working on

It therefore makes a lot of

providing solutions that will

sense for us to be present in

enable this single traceability,

these places to support them

as it is in demand from our

and also participate in this

clients,” Mark Quick ends.

growth. That is what was

Facts about Recipharm •

Is a leading contract development and manufacturing organisation

•

Was established in Sweden in 1995 and is headquartered in Stockholm

•

Is listed on the NASDAQ Stockholm

•

Employs about 5.000 people and has more than 20 production facilities globally

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

Medical Device & Pharma Packaging • Packaging Machine Lines • Blister Production • 4 Side Pouch Sealing • Contract Packaging • Thermoforming Film

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BUSINESS SERVICE PROVIDERS

45 | Thereâ&#x20AC;&#x2122;s much more to it than personal delivery 48 | EU General Data Protection Rules 51 | Patent term extension

DISTRIBUTION

There’s much more to it than personal delivery World Courier provides global specialty logistics services for clinical trials, which are governed by GxP. Additionally, delivery of trial medication direct to the patient is a new and growing trend in life science requiring specialty operating procedures with the logistics provider. By Charlotte Strøm, MD PhD Journalist “The setup of clinical trials

of the shipping data. In that

World Courier has recently

requires frequent, efficient,

respect, our attitude has

refined the DtP service even

and professional shipping

earned trust from our clients

further by embarking on a

of clinical trial material and

by having the same strict

strategic partnership with

medication. The complexity

standard operating procedures

Medical Research Network

of a clinical trial often

(SOPs) as they have. No less.”

(MRN), a UK-based nursing

requires tailor-made logistics

Kenneth Skovgaard explains.

service. This service is

solutions that reach far beyond standard routing and handling. In many cases these shipments have special

Improved patient retention with direct-to-patient (DtP) service

requirements that stem from

Delivering trial medication

their temperature sensitivity,

directly to the patient at his

limited shelf-life and special

home, is new and growing

handling and regulations that

trend in clinical trials.

apply to biological samples, and temperature controlled therapeutic agents, which call for a specialty logistics provider,” – says Kenneth Skovgaard, Managing Director at World Courier Denmark.

medication.

setup may allow for enrolment of clinical trials with patients who may have declined the trial participation due to logistical issues and easing the burden of travelling also

picks up the investigational

improves patient retention.

medicinal product at e.g.

“In situations where travelling

We practically pave the way

the hospital pharmacy and

to the clinical trial site is very

for them with our specialty

delivers it directly to the

difficult due to severe disease

logistics services and

patient,” Kenneth Skovgaard

or disability, compromised

understanding of clinical

says and concludes:

trials.”

by geography, or the study subject is a child, DtP may be a solution worth considering,”

facility is one of more than

“This specialty service

140 offices around the

requires special training for

globe located in over 50

the staff, in order to maintain

countries. The vast majority

patient confidentiality.”

sciences.

with administration of the

“At the end of the day, this

appointment; World Courier

Kenneth Skovgaard says.

Denmark originates from life

when the patient needs help

at World Courier Denmark.

“The nurse books the

The Danish World Courier

of the company’s business in

particularly relevant in cases

Kenneth Skovgaard, Managing Director

Within the field of clinical

Facts about World Courier •

Operates globally in over 50 countries from more than 140 offices

•

Services include individual pickup and delivery, 24/7

operations there is an

customer service, wide range of temperature-con-

increasing focus on patient

trolled packing materials and an expertise in regula-

“Traceability is absolutely

retention. Even if the DtP

tions and documentation

essential in clinical trials,

solution might sound

and as a specialty logistics

complicated and expensive,

provider we see ourselves

Kenneth Skovgaard argues

staff of 20 and has a satellite at Incuba Science Park

as partners, implying that

that it may in fact prove to be

in Aarhus

we share the responsibility

a solid return on investment

for these shipments and we

by improving patient

understand the importance

retention. As a consequence

•

World Courier Denmark is located in Hvidovre with a

www.worldcourier.com

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

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NEW EU DATA PROTECTION REGULATION

NEW EU DATA PROTECTION REGULATION – IMPLICATIONS FOR THE LIFE SCIENCES SECTOR By: Karin Absalonsen, Partner, attorney-at-law, Nyborg & Rørdam 1. Scope of the new Regulation (GDPR)

times performed in accordance with the

Data Protection Officer (DPO) -

The EU General Data Protection Rules

GDPR. Controllers must ensure a level

Controllers will be required to appoint

(the “GDPR”) entered into force in May

of security appropriate to the risk of the

a DPO where the core activities of the

2016 and will take direct effect in all

data subjects. This will impact controllers

controller consist of processing on a large

member states from 25 May 2018.

in the life sciences sector as processing

scale of sensitive data.

The GDPR will substitute the rules of Directive 95/46/EC from 1995 and the Danish Act on Processing of Personal Data

of sensitive data is a key part of their daily operations. The measures must be reviewed and updated where necessary.

Personal data breach - Controllers must without undue delay notify a security breach to the supervisory authority

from 2011 and will significantly affect

Records of processing - The GDPR no

within 72 hours. If the security breach

data controllers and data processors in the

longer requires registration with national

is likely to result in a high risk, the

life sciences sector.

data protection authorities. Instead

controller must also communicate the

data controllers must maintain detailed

breach to the relevant data subjects.

Collection, analysis and transfer of sensitive personal data are vital for the life sciences industry to be able to develop and supply safe and effective medical products and devices. The GPDR is likely to significantly increase the burden of compliance and will be a challenge

records of all of their data processing activities. Upon request the records are to be made available to the supervisory authority. The impact of this requirement should not be underestimated and may turn out to be very cost-intensive.

Consent - To be lawful all processing of personal data must be made on a legitimate legal basis. As a main rule, clinical trials involving processing of sensitive data require the explicit, fully informed consent for specified purposes.

to pharmaceutical companies, clinical

Data protection impact assessments

Data subjects have the right to withdraw

research organisations, laboratories,

(“DPIAs”) - Controllers must carry out

consent at any time, and they must be

sponsors and statisticians etc.

DPIAs if processing operations presenting

informed hereof prior to giving their

high risks to the rights of data subjects

consent.

Implementation of the GDPR requires planning and reflection. 25 May 2018 is not far away, and for that reason life sciences companies should get started now.

due to the nature, scope and purpose of processing and in particular where new technologies are used. Life sciences companies processing personal health data and conducting medical research

This article aims to provide life sciences

on a large scale are likely to be subject to

companies with a practical overview of

this obligation. If the DPIA indicates that

the most significant changes relevant to

processing will result in a high risk, the

your business resulting from the GDPR.

controller must consult the supervisory

2. Relevant GDPR rules to life sciences sector

authority prior to processing. Where appropriate controllers should also seek the views of the data subjects on

New obligations on data controllers Broad territorial application – The GDPR not only applies to data controllers established in the EU/EEA but also to organisations with no operation in the EU but which operate a study or clinical trial in the EU. Implementation of appropriate technical and organisational measures - The GDPR requires data controllers to ensure and – as a new requirement - to be able to demonstrate that processing is at all

the intended processing. This could for example require CRO’s to consult with patients before processing their personal data in clinical trials. ”Privacy by design and by default” Controllers must use technical solutions designed to implement data protection principles such as data pseudonymisation and data minimisation, and in the given circumstances such solutions must be incorporated as standard default settings.

Increased rights of data subjects Information and increased rights - Data subjects must receive significantly increased information about processing of personal data and are entitled to rectification, erasure, restriction and to object to processing of personal data. The new data portability right entitles data subjects to receive all personal data provided to the controller in a structured and machine-readable format. These rights may significantly impact the daily operations of clinical trials and may also impact the findings of performed research. Transfer of personal data to third countries Transfer of personal data outside EU is highly relevant for research projects and clinical trials and in the event of outsourcing of the processing of personal data to service providers using cloud computing.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

NEW EU DATA PROTECTION REGULATION

The GDPR prohibits transfer of personal

awareness and respect for personal data

- incident detection and response

data to countries outside EU unless

through entire life cycle

–conduct regular data application

transfer is made to so-called “secure third countries” approved by the European Commission, or by application of:

- policy framework - create and implement - IT systems and information technology

- Standard contract clauses (SCC),

– ensure robust security such as updated

- Binding Corporate Rules (BCR), or

antivirus, antispam and firewalls and regular security code peer reviewa

- Agreements entered into by the

inventories and restore availability and access in a timely manner. The GDPR is perhaps the most important EU legislation in many decades for the industry. However, if handled right implementation of the GDPR could be an opportunity to streamline and improve

European Commission with other

- physical environment – create effective

business processes and a strategic tool

countries, e.g. the United States

entry control systems, video surveillance

and competitive element.

(Privacy Shield).

and clean desk policies

Sanctions The GDPR introduces sizeable fines for failure to comply with the rules of up to 20 million EUR or 4 % of the global annual turnover. Data controllers and data processors may also become liable to pay damages to data subjects for a breach of the GDPR.

3. How to ensure compliance with GDPR? The best way to get started is to conduct a high level risk analysis to identify the categories of personal data processed by the company itself or via subcontractors and the areas where a DPIA is needed. A DPIA must cover all relevant business processes and should also include a gap analysis to identify non-compliance with the GPDR rules. Analyse your business processes and IT infrastructure in order to: - create a general view of and describe personal data flows through the entire life cycle - clarify whether you are data controller and/or data processor - integrate the requirements of the GDPR into relevant business processes and IT infrastructure and when purchasing new IT systems (”privacy by design and by default”) - establish necessary structures, allocate roles and prioritise the tasks. Focus on the following key issues: - management and employees buy-in and training – create a culture of risk PHOTO: Nyborg & Rørdam

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

PROFILE

NJORD Law Firm

– the legal partner for the European life science and health care industry Life science and health care are complex areas, not least when it comes to regulation and jurisdiction. NJORD Law Firm has specialised in advising the industry, covering the entire process from development to sales. Life science and health care are complex areas, not least when it comes to regulation and jurisdiction. NJORD Law Firm has specialised in advising the industry, covering the entire process from development to sales. Product counterfeiting is an increasing problem in the life science and health care industry. Parallel importers are constantly trying to stretch the limits of what is legal. Public budgets are tight, and medicines agencies around Europe are asked to “relax” standards to accommodate cheap alternatives to authorized products. “There are numerous areas, both

“We operate in the entire Nordic region. However, as legislation is based on EU legislation, more and more of the advisory work we do is on a European level,” says Thomas Ryhl. One of NJORD Law Firm’s greatest legal victories in 2016 took place in the EU last November when the Court of Justice of the European Union ruled that it is definitely prohibited to repack parallel imported drugs if the only reason for repacking is the wish to improve earnings. “After twenty years on the defensive for the pharmaceutical industry, a new and important judgement has been rendered by

Ferring logo, name and brand and instead issued the new boxes with the Orifarm name added on it. “Parallel imports are often a good idea, it bodes for free competition. But there must be a limit, especially when repackaging the original product. Otherwise, you undermine the significance of the brand and jeopardise the consumer’s guarantee that it is an original product,” says Ryhl. The EU Single Market means that the EU is one territory without internal borders or regulatory obstacles to the free movement of goods and services, including drugs. But the EU Court of Justice has now ruled that

within drugs and medical devices, where legislation is open for interpretation because there are so many grey areas. To find your way around this jungle, to know your rights and avoid the pitfalls, you need a good lawyer,” says Thomas Ryhl, lawyer and partner at the Danish law firm NJORD. NJORD Law Firm has multiple years of experience working with and advising the life science and health care industry, both pharma and medical devices, covering the entire process from counselling on clinical trials, regulation, authority approval, protection of intellectual property rights, patents, manufacturing, distribution, marketing and sales.

the EU Court of Justice. At long last we saw a victory for the pharmaceutical industry,” says Thomas Ryhl, who conducted the trial on behalf of his client, Ferring. The case was brought against parallel importer Orifarm, which had bought tenpiece packs of the Ferring drug, KLYX, in Norway, repacked them and sold them in Denmark as one-piece packs to obtain a higher profit. Furthermore, Orifarm had discarded the original Ferring box with the

if economic benefits are the only reason to repack, then it is prohibited. “This ruling is very important, and it will set a precedence for the entire health care industry in Europe. It will also apply to medical devices, hearing aids, implants and the likes,” says Ryhl. Thomas Ryhl has worked with the life science and health care industry since the mid-1990s. NJORD Law Firm’s life science and health care team counts more than ten lawyers, all with many years of experience within the industry, the legislation and the fight for a fair treatment of original manufacturers and patent holders.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

PATENTS

PATENT TERM

EXT ENSION By Louise Aagaard, European Patent Attorney

SPC Requirements:

patent usually expires after 20 years. In the pharmaceutical

industry the development of new products is often very lengthy, and the consequence is therefore that the patent can only be exploited in a fraction of the 20 years.

one SPC for each active ingredient. If a

The pharmaceutical product must be protected by a patent in force.

The applicant must have a valid patent protecting the medicine. If the patentee wishes to apply for an SPC in Denmark, there must be a valid Danish patent pro-

Supplementary Protection Certificate (SPC), is a patent term extension of

tecting the product. Furthermore it is important that the product is an active ingredient. SPC’s are not

a maximum of 5 years, which can be

granted for adjuvants without therapeutic

granted to a marketed medicine as a

effect.

compensation for the often lengthy

The patent does not have to be a prod-

approval procedure. The patent term extension can be extended by a further 6 months, if the marketed medicine has gone through an approved pediatric

uct-patent protecting the medicine itself: the patent can also cover a use of the medicine, i.e. it may be a so-called “sec-

investigation plan.

ond medical indication” patent.

The SPC is granted to the patentee of a conditions in all of the EU member states.

The protection conferred by an SPC is

The marketing authorization on which

very different to the protection provided

the patentee bases the SPC application

by a patent. Even though an SPC is

must concern a human or a veterinary

granted to compensate for lost patent

medicine. The marketing authorization

time, an SPC only provides protection for

can be issued to another company than

the approved medicine.

the company which owns the patent, but

national or European patent on equal

A valid authorization to place the medicine on the market must be

available.

the SPC application can only be filed by

patent covers a specific use of an active ingredient, then it is under certain circumstances possible to obtain an SPC covering that specific use, even if an earlier SPC has been granted on the ingredient.

The valid marketing authorization must be the first authorization to

place the product on the market as a medicine The first authorization for marketing of a product in Denmark is the first authorization to market a medicine in which the product is an active ingredient. It is important to consider at a very early stage – in other words, already while drafting the patent application - which active agents are to be part of the final medicine to be marketed sometime in the future. Please discuss this with your patent attorney. The deadline for filing a SPC application expires either 6 months from the grant of the patent or 6 months from the notifi-

the patentee.

cation of the marketing authorization

Thus, coordination between the persons

of the medicine whichever expires later.

The product has not already been the subject of an SPC

Thus, in general there can only be issued

involved with obtained the marketing authorization and the persons involved with SPC is of great importance.

20 years patent duration

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

5 years patent extension ( SPC )

SIKA BUBBLE

SID DIG STÆRK Din stol er et vigtigt redskab, når du arbejder. Ved at sidde aktivt får du det bedste ud af en lang arbejdsdag.

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4675 0970

dynamostol.dk info@dynamostol.dk

Read more and find dealers at www.sikafootwear.eu/sikabubble

IPR | Patents | Trademarks | Designs

ILI

TE PA

IPR TOTAL™ TRAD

AIN DOM

EMAR

RIG PY CO

We have a wide span of IPR areas of expertise, so that both core knowledge, ideas and IPR strategy are in safe hands with us. With IPR TOTAL™, we also ensure that different kinds of business areas are linked so that you have access to a full range of professional and competent attorneys. Please contact us and tell us about your requirements.

At Chas. Hude, we have professional competences and specialist knowledge bringing a legal and IPR-related dimension to research and innovation. When we advise on Intellectual Property Rights, we create value so that your patents, trademarks, designs and domains are protected, managed and developed as business assets.

LEG

We have created a formula for your IPR

DESIGN

Value = Innovation x Commitment2

Chas. Hude A/S is one of the leading companies in Denmark within the field of IPR. Chas. Hude currently employs 45 employees. Read more about our value-creating employees at chashude.com

INDUSTRY NEWS

NEWS FROM THE INDUSTRY By Arne G. Nielsen

DOOR SYSTEM EI₂60-C FIRE DOORS MEET NEW EUROPEAN REQUIREMENTS Door System A/S develops, manufactures and installs door solutions for the pharmaceutical industry. Over the last years, the company has invested a great amount of resources in developing and testing EI₂60-C fire doors in accordance Door System has invested a great amount of resources in developing and testing fire door solutions.

with new European standard EN16034 which tightens the requirements for fire doors. One major requirement is that the EI₂60-C doors need to be tested

from both sides. The fire doors also need to be approved for the different wall types in which you mount your fire door. Door System is on top of all these requirements and can advise customers choosing the right fire door solution. Furthermore, doors from Door System are developed specifically for maximum reliability, which is paramount in pharmaceutical companies, and for a top clinical production environment.

NEW INNOVATIVE GLOVE SYSTEM REDUCES THE RISK OF SKIN DISEASES GloVac has developed a new innovative glove system which reduces the risk of getting skin diseases. The system is also an environmental friendly solution. Everyone who uses onetime latex or nitrile gloves during a workday knows just how difficult it is to take the gloves on and off. It is time consuming and the gloves often break. As a consequence staff often either wears the gloves all the time or not at all. Both options increase the risk of getting eczema or allergies on their hands. The glove system can be mounted directly on machines with magnets, on the wall, on cleaning trolleys or be placed in its own stand. The gloves are stored in a vacuumizer when not in use, and by pushing a valve with a finger, it equalise a pressure and release the glove. This way the gloves are always dry, when they are needed. “With this technique one can take the gloves on and off in just two seconds.

(source: DoorSystem A/S)

(Source: GloVac)

NEW IN EUROPE

ALMECO LAUNCHES NEW SLIMMEDDOWN CRYOTUBE WITH EXTERNAL THREAD

HaemoMedtec in Denmark is developing an automated patient-system for outpatients. When arriving, the patient scans his ID (social security card) and behind the wall the BC-ROBO 8000 system prepares tubes for the patient using the data from the LIS/HIS system.

queue number.

the world. For Almeco, the task was to try and develop a cryotube, which took up less space in the boxes, hence

The result is a cryotube, which has the same diameter on the inside, but has been slimmed on the outside.

The patient receives the bag automatically, and moves on to the waiting area where he waits for his queue number to be shown on the screen. The patient gives the bag with his tubes to the phlebotomist who makes the blood collection as usual.

The new cryotube actually fits 100 tubes in the same type of box which would previously fit just 81 tubes. That’s an extra 23% space in each box. The cryotubes come in sizes of 1, 2, 4 and 5 millimeters,

The first system is already sold to Aalborg University

(Source: HaemoMedtec)

133 x 133 millimeter and fit any system anywhere in

increasing the number of cryotubes per box.

Out comes a bag complete with ID, labelled tubes and

Hospital in Denmark.

The boxes containing the cryotubes typically measure

but Almeco has also developed a new size of just 0.5 millimeter for very small samples. (Source: Almeco)

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

INDEX

Hjælp et talent godt på vej, ta’en studerende i praktik

Dansk Laborant-Forening/HK Weidekampsgade 8 Postboks 470 0900 København C Tlf. 33 30 44 70 E-mail: dlf@hk.dk www.dl-f.dk

COMPANY INDEX

Academic Institutions and Support Structure Organisations With more than 25 years experience in meeting the diverse needs of the biotech and pharma industry, Bioneer is ready and able to deliver competitive and on-time solutions to companies, large as well as small. Explore our expertise in your area of interest on our website for an example within drug development, biomarkers, protein manufacturing, immune targeting, active ingredients and microorganisms, licensing opportunities etc. Bioneer A/S Kogle Allé 2 DK-2970 Hørsholm Tel. +45 4516 0444 E-mail: bioneer@bioneer.dk Web: www.bioneer.dk

Dansk Laborant-Forening er en tværgående landsforening under HK, som er et af Danmarks største fagforbund med omkring 300.000 medlemmer. Det betyder, at alle, der er medlem af Dansk Laborant-Forening, samtidig er fuldgyldigt medlem af HK og dermed nyder godt af alle medlemsrettighederne her. Som organiserede i HK kan vi derfor bruge HK's konsulenter i f.eks. arbejdsmiljø-, uddannelses- og juridiske spørgsmål. DL-F / HK Weidekampsgade 8 Postboks 470 0900 Copenhagen C Tel. +45 3330 4470 E-mail: dlf@hk.dk Web: www.hk.dk

DTI (The Danish Technological Institute) Gregersensvej 1 2630 Taastrup Tel. +45 7220 2000 E-mail: info@teknologisk.dk Web: www.dti.dk

We collaborate with universities, hospitals and private companies within medical, pharmaceutical and biotech industries. In particular, we have experience in R&D projects within the areas of infection diagnostics and biomarker development. We perform accredited standard analyses and customized development tailored to meet the needs of our clients and projects. We have extensive experience in both national and international R&D projects, e.g., Innobooster, Eurostars and EU projects. We offer an array of analyses and technologies for biomarker discovery, DNA- and RNA-based molecular biology, proteomics, protein characterization, biofilm characterization, antimicrobial solutions and in vitro systems.

The Faculty of Health and Medical Sciences is an important part of a dynamic interaction with the surrounding community. The purpose of this interaction is to use our knowledge to create value for citizens and improve general health. For this reason, our core task is to educate talented students who can go on after their graduation to devote their strong skills to their working lives. The faculty constantly discovers valuable new insights that can contribute to growth and employment in the community.

Faculty of Health and Medical Sciences University of Copenhagen Blegdamsvej 3b 2200 Copenhagen N Tel. +45 3532 7900 E-mail: email@sund.ku.dk Web: www.healthsciences.ku.dk INNO-X Healthcare offers courses and continuing education programs based on need-driven innovation. A common feature of the courses is that we want to sharpen participants' ability to integrate innovation as a natural part of their work. Thus, we give the participants qualified to create and develop innovative solutions to existing needs in the health sector.

INNO-X Healthcare Aarhus University, Department of Clinical Medicine Hedeager 3, DNU 03 8200, Aarhus N Tel. +45 4041 2536 E-mail: Info@innox.dk Web: www.innox.au.dk

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

COMPANY INDEX

Lundbeckfonden awards anually the 1 mio. € Brain Prize. Lundbeckfonden is an active industrial foundation established in 1954. Its main objective is to maintain and expand the activities of the Lundbeck Group, and to provide funding for scientific research of the highest quality. The Foundation annually grants DKK 400 - 500 million to support medical research of the highest quality and supports educational and communication activities related to science. Lundbeckfonden, The Brain Prize Scherfigsvej 7 DK-2100 Copenhagen Ø Tel. +45 3912 8000 E-mail: info@thebrainprize.org Web: www.thebrainprize.org Medicon Valley Alliance (MVA) is a non-profit membership organization in the Danish-Swedish life science cluster Medicon Valley. Our approx. 230 members, who together employ approximately 140.000 people, represents the region’s triple helix and include universities, hospitals, human life science business, regional governments and service providers. We create value for our members by co-hosting, launching and driving meetings, working groups, seminars, conferences and projects, that strengthen the collaboration, networking and knowledge-sharing in the regions life science community, create critical mass and help realizing the full potential of Medicon Valley.

Medicon Valley Alliance Arne Jacobsens Allé 15, 2. Ørestad City DK-2300 Copenhagen S Phone: +45 70 20 15 03 Email: mva@mva.org www.mva.org

Scion DTU is an international science park rooted in the university environment. We are the optimal place for innovative people and knowledge-intensive companies to realize high-tech ideas and make them marketable. We are an innovative environment that offers flexible facilities, access to relevant networks and services that makes it easier for the businesses to grow. Scion DTU collaborates with more than 230 companies within medico, cleantech, biotech and IT.

Scion DTU a/s Diplomvej 381 DK-2800 Kgs. Lyngby Web: www.sciondtu.com

Workindenmark East Gyldenløvesgade 11 1600 København Tel: +45 7222 3300 E-mail: workindenmark@workindenmark.dk Web: www.workindenmark.dk

Workindenmark provides international jobseekers and Danish employers with the information, guidance and tools to find each other. Workindenmark is a public employment service for highly qualified international candidates looking for a job in Denmark, and Danish companies searching for talented foreign candidates. Workindenmark is part of the Danish Ministry of Employment and member of European Employment Service (EURES). There are three Workindenmark centres, located in Copenhagen, Odense and Aarhus.

Contract Research Organisations A+ Science is a Contract Research Organisation (CRO) with long experience of clinical services within pharmaceutical (Phase I-IV) and medical device studies in the Nordic countries. Our services include clinical trial management, pharmacovigilance, outsourcing of consultants, City Site (SMO), continuing medical education and others. We conduct custom tailored services according to customers’ needs. A+ Science works in broad spectra of therapeutic areas in the Nordic Countries. We have close collaboration with other CROs in Europe to facilitate study logistics and work in a cost efficient manner.

A+ Science Luntmakargatan 22 111 37 Stockholm SWEDEN info@a-plusscience.com www.a-plusscience.com

CroxxMed ApS Agern Allé 24 DK-2970 Hørsholm Mobile: +45 2015 1221 E-mail: bte@croxxmed.com Web: www.croxxmed.com

At CroxxMed we are a team of experienced personnel striving to make your experience as smooth as possible. Nordic by nature, we provide complex knowledge built on a solid foundation of years in clinical research within many different therapeutic areas. CroxxMed offers services in all phases (I-IV); clinical operation, regulatory affairs, data management, statistics, medical writing, pharmacovigilance, and consulting services for all types of medical device studies. We are at all times updated on the market. At any time, fully in tune with the regulatory requirements and trends in the industry. We are less boring than average and you are our top priority.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

COMPANY INDEX

DB Lab is a GMP contract laboratory with more than 20 years of experience. We offer chemical, physical and microbiological analyses on raw materials, intermediates, finished products, and process samples to the pharmaceutical and biotechnological industries. We value ongoing dialogue with our partners in order to provide the best service possible. Quality and credibility are core values to both our partners as well DB Lab.

DB Lab A/S Lille Tornbjerg Vej 24 5220 Odense SØ Phone: +45 65 93 29 20 dblab@dblab.dk www.dblab.dk

IRW Consulting AB Svärdvägen 3A, Box 703 SE-182 17 Danderyd Tel. +46 879 166 40 E-mail: info@irwcro.com Web: www.irwcro.com

IRW is a Nordic Contract Research Organization (CRO) with more than 15 years of experience in conducting clinical trials, Non-Interventional Studies (NIS) and medical device studies. IRW has built an extensive network throughout all Nordic countries, as well as the rest of Europe and the US. Depending on the customer’s requirements, our staff is either outsourced or works with in-house projects. We cover all the stages of clinical development, from phase I to phase IV, including pediatric and non-interventional studies and all classes of medical device investigations. With regional offices in Denmark, Finland, Norway and Sweden, IRW has experienced locally-based staff providing an optimum combination of local knowledge and expertise to assist you conduct your clinical trial as per country specific guidelines.

Larix is a full service Clinical Research Organization, offering assistance in all aspects of clinical trials (phase I-IV): Clinical operations, statistics, data management, medical writing, system validation, GCP, vendor audits and pharmacovigilance. We work with all types of pharma/biotech/medtech/diagnostic companies. We are here for the patients, our employees and our customers. We take pride in being passionate and dedicated, delivering high quality on time. Key focus is oncology. We have offices in all Nordic countries. Larix A/S Lyskær 8b DK-2730 Herlev Tel. +45 7027 2221 E-mail: info@larixcro.com Web: www.larix.dk Lindland Roest ApS is a pharmaceutical development consulting business offering services to biotech and pharmaceutical companies. With a strong scientific background from Regulatory Affairs, Lindland Roest provides hands-on expertise & strategic advice, focusing on CMC activities and project management. The company´s core competences are writing CMC documentation for Clinical Trial Applications, handling all aspects of regulatory development activities and project coordination/management. Lindland Roest ApS Nicklas Lindland Roest, MSc. (Pharm) CEO & Senior Regulatory Specialist Ejbyvej 60C, Dk-4623 Lille Skensved, Tel. +45 2630 1985 E-mail: nr@lindlandroest.com Web: www.lindlandroest.com

Business Service Providers

Best Talent A/S Rungstedvej 41 DK-2970 Hørsholm Tel. +45 4556 5300 E-mail: info@besttalent.dk Web: www.besttalent.dk

Best Talent is specialized in Executive Search and Selection within Engineering, Pharma and Life Science. Best Talent has quickly grown to become the favorite collaborative partner as a result of our experience, background and network. We solve projects on both a tactical and strategic level. We “speak the language”, know the market and attract highly qualified candidates. We possess the largest and most desired talent database in the field with over 10,000 life science candidates.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

COMPANY INDEX

Chas. Hude A/S is one of the leading companies in Denmark within the field of IPR. When we advise on Intellectual Property Rights, we create value so that your patents, trademarks, designs and domains are protected, managed and developed as business assets. Chas. Hude A/S H. C. Andersens Boulevard 33 DK-1780 Copenhagen V Tel. +45 33 19 34 00 E-mail: chashude@chashude.com Web: www.chashude.com

We have a wide span of IPR areas of expertise, so that both core knowledge, ideas and IPR strategy are in safe hands with us. With IPR TOTALTM, we also ensure that different kinds of business areas are linked so that you have access to a full range of professional and competent attorneys. Chas. Hude was founded in 1896 and employs 45 employees. Read more about our value-creating employees at chashude.com.

THE MOST ADVANCED CLEANROOM LAUNDRY IN SCANDINAVIA • Traceability, validated processes and documentation based on innovative cleanroom technology. • Specializes in on-site training of operators in correct use of cleanroom clothes and cleaning articles. De Forenede Dampvaskerier - DFD Cleanroom V. Henriksens Vej 6 DK-4930 Maribo Tel.+45 4422 5560 / +46 406 566 500 E-mail: crmar@dfd.dk Web: www.dfd.dk

• Preferred partner of unique cleanroom solutions in accordance to ISO and GMP compliance. For more information: www.dfd.dk

At DHI, we possess an extensive knowledge base related to chemicals regulations worldwide, with respect to product safety. Moreover, we have an established network of contacts with national authorities on worldwide markets. We’re therefore well placed to support you efficiently in bringing your products to the market. We can effectively help you to fulfil regulation and instruction requirements as well as standards and local labelling. For pharmaceutical products, we can help you develop strategies as well as monitor and interpret experimental studies. DHI Hørsholm - Head Office Agern Allé 5 2970 Hørsholm Tel. +45 4516 9200 E-mail: dhi@dhigroup.com Web: http://www.dhigroup.com/ Elite Miljø performs classified cleanroom cleaning in the pharmaceutical industry and hospital sector. We work with both high and low classified cleanrooms. We offer a complete cleaning solution where we have management and control over the entire process.

Elite Miljø Ormhøjgårdvej 12 DK-8700 Horsens Tel. +45 7015 4800 E-mail: info@elitemiljoe.dk Web: www.elitemiljoe.dk

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

Jusmedico is a specialist law firm providing legal services to the biotech, pharmaceutical, medical device, food supplement & dentistry industries, life science investors and to suppliers and service providers thereto. Internationally Jusmedico is member and co-founder of BioLawEurope F.m.b.A. 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 challenges. Moreover Jusmedico operates a representative office in New York, USA. In 2015, 2016 and 2017 Jusmedico has been awarded the Corporate INTL Global Award Price as Biotech Law Firm of the Year in Denmark.

NJORD assists Life Sciences and Healthcare companies with specialised corporate services, including counselling on clinical trials, protection of intellectual property rights, manufacturing, distribution, marketing and sales. We are also significantly experienced in litigation in transactions, conclusion of contracts, intellectual property issues, product development, legal actions, patent litigation, competition matters, consultation responses, angel and private equity fund investments. NJORD Denmark Pilestræde 58 DK-1112 København K Tel. +45 3312 4522 E-mail: Copenhagen@njordlaw.com Web: www.njordlaw.com

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

COMPANY INDEX

Petersen-Bach A/S has 30 years’ experience as Denmark’s leading supplier of security systems and video surveillance. We supply 'best of breed' products and solutions for our turnkey projects. We have achieved ISO 9001 quality certification for video surveillance, access control and automatic intrusion alarm systems by the Danish Trade Organisation for Safety & Security.

Petersen-Bach A/S Engholm Parkvej 6 DK-3450 Allerød Tel. + 45 70 15 46 00 E-mail: pb@pb.dk Web: www.pb.dk

At World Courier, each trusted partnership we form with a customer is deeply rooted in our shared vision of improving global health, and it starts with gaining a holistic understanding of your strategic business objectives. With this knowledge in hand, we design and execute world-class logistics processes that mitigate risk, maximize the return on R&D investments and advance medicine. No other specialty logistics company has the experienced personnel, global offices and in-market expertise required to ensure the optimal handling, transport and delivery of vital healthcare products.

World Courier Denmark A/S Avedoereholmen 96-98 DK - 2650 Hvidovre (Copenhagen) Tel. +45 32 46 06 80 E-mail: ops@worldcourier.dk Web: www.worldcourier.com

Laboratory, Medical & Pharmaceutical Equipment Apodan is the leading supplier of pharmaceutical packaging items in the Nordic. Our main activities are development, production and sale of a wide range of pharmaceutical packaging items. Our products are sold worldwide, and the Nordic countries are the primary market area. We are specialists in standard packaging solutions as well as in customized packaging solutions, which is developed in close cooperation with the customer. Visit us at www.apodanpharma.dk

ApodanNordic PharmaPackaging A/S Kigkurren 8M 2300 København S Denmark Phone +45 32 97 15 55 E-mail: packaging@apodanpharma.dk

Biotech-IgG is a Scandinavian distributor of medical diagnostic and life science products with more than 30 years of in-field experience. We offer a large range of immunodiagnostic kits (RIA, ELISA & rapid tests), real-time PCR kits, microbiology products, radiochemicals, immunochemicals (antibodies & proteins) and automatic liquid handling systems. Biotech-IgG Regus Fairway, Arne Jacobsens Allé 7, 5. Floor DK-2300 Copenhagen S Tel. +45 3538 0500 or +46 4612 3740 Web: www.biotech-igg.com Diatom is an engineering & trading company, which since 1964 has represented international contacts in Denmark with market leading products where we have a commitment to achieving customer satisfaction by providing innovative, total system solutions that add value to our customer by improving manufacturing efficiency, reliability and quality. Diatom A/S Avedøreholmen 84 DK-2650 Hvidovre Tel. +45 3677 3600 E-mail: info@diatom.dk Web: www.diatom.eu

Drifton A/S Avedøreholmen 84 DK-2650 Hvidovre Tel. +45 3679 0000 E-mail: info@drifton.dk Web: www.drifton.eu

Drifton A/S offers a wide range of professional equipment with 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. We offer a range of ancillary products for the peristaltic pumps eg. a comprehensive range of dispensing tips, luer lock adapters and connectors. Our laboratory products are sold to the research scientists in universities, pharmaceutical and industrial laboratories.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

COMPANY INDEX

Dynamostol ApS Industrivej 38 E 4000 Roskilde Tel. +45 4675 0970 E-mail: info@dynamostol.dk Web: www.dynamostol.com

Dynamostol has developed a series of chairs specifically for the healthcare and laboratory environments. Our products ensure you an active and healthy posture throughout the working day. The chair adapts to your working position so that you avoid damage when working in difficult and stressful postures, both when working with patients and when you have concentration work at the bench, the bench, fume hood or at the desk.

ExamVision offers the perfect solution for all professionals for whom precision is paramount. For many years ExamVision has been a widely recognised name amongst those using bespoke magnifying loupes. Beautifully designed, optimal magnification, maximum sharpness and unsurpassed freedom of movement – a pleasure to work with! Our products are designed and manufactured using the finest materials, with the greatest precision, by people who care.

ExamVision ApS Industrivej 11 DK-8305 Samsø Tel. +45 8792 1210 E-mail: office@exam-vision.com Web: www.exam-vision.com

LH Laboratorie Service A/S Lyngsiesvej 14B DK-8210 Aarhus V Tel. +45 8692 3771 E-mail: info@LHLAB.dk Web: www.LHLAB.dk

Parker Hannifin Danmark Industriparken 35-37 DK-2750 Ballerup Tel. +45 4356 0400 Web: www.parker.com

LH Laboratorie Service provides sales and service of laboratory equipment. ULT Freezers, Incubators, Centrifuges, Climatic chambers and much more! We also perform repair and service of almost all kinds of laboratory equipment. We have running technicians in Jutland, Funen and Zealand. We also offer to perform service and maintenance - both operational and regulatory - of particularly - ULT Freezers - Centrifuges - Autoclaves - Incubators - CO2 incubators: Parker develops solutions specific to life sciences, focusing on the pharmaceutical, medical and diagnostics industries, where there are especially tough demands for quality and precision. Quality control, reliable delivery and know-how are key when Parker supplies made-to-measure solutions to the leading companies in the life sciences industry. Parker’s expertise covers a wide area, and the product portfolio basically takes in everything from filters that purify insulin to miniature components that go into hearing aids, dentists’ tools or other medical equipment.

Siemens Healthineers offers a wide selection of diagnostic solutions for effective testing in in-vivo and in-vitro diagnostic. See www.healthcare.siemens.dk for more information and how we strive to fulfill the needs of healthcare providers. Engineering success. Pioneering healthcare. Together.

Siemens Healthcare A/S Borupvang 9 DK-2750 Ballerup Tel. +45 4477 4477 Web: www.healthcare.siemens.dk

Sika Footwear A/S HI-Park 301 DK-7400 Herning Phone: +45 9721 1911 Mail: info@sikafootwear.dk Web: www.sikafootwear.eu

At Sika Footwear A/S we develop, manufacture and supply footwear for working people. The SIKA assortment is the result of several generations of experience in the development and manufacture of work and safety footwear of the highest quality. Today, all footwear is developed in close collaboration with a number of professional users, so that natural focus areas for product development are usage, function and fit. The SIKA assortment is especially concentrated around clogs for all industry sectors and work footwear targeted at the food and medical industries, the HORECA/food service sector, service and cleaning, as well as the hospital and care sector. Find more information at www.sikafootwear.eu

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

COMPANY INDEX

Svanholm.com is a supplier of High-End Analyzers, Sensors and Equipment for biotech, biofuel, crystallization, stem cells, tissue engineering and tablet manufacturing areas. We distribute products of 25 suppliers in the Nordic countries, and we cover from raw material identification with Raman over solvent drying control with mass spectrometers to fermentation pH, DO, OD and Viable Cell Density sensors. Svanholm.com Nordic Pharma and Analyzer Center Marienbergvej 132, 1. DK- 4760 Vordingborg Tel. +45 7026 5811 E-mail: mail@svanholm.com Web: www.svanholm.com

Triolab AS Tel. +45 4396 0012 E-mail: triolab@triolab.dk Web: www.triolab.dk

Triolab AS is a professional sales organization, founded in 1991. We offer products and services to hospital laboratories, general practitioners, pharmaceutical industry labs, research labs, and special university labs. We are specialized in the fields of POC, coagulation, haematology, microbiology, molecular biology, clinical chemistry, immunology, genetics, pathology, clinical microscopy, and preanalytical equipment. More info at www.triolab.dk

Software AN Group has developed standard IT solutions, sold and distributed as 'out of the box' products with options for customer specific add-on modules. All the products can be installed and put into production using the standard interfaces to equipment and administrative IT systems, but remain flexible for customer specific adaptions. AN Group also offers maintenance and support on installations with remote surveillance, second level user support, training and more.

AN Group A/S Mejeribakken 8 DK-3540 Lynge Tlf +45 48 25 10 00 E-mail info@angroup.dk Web: www.angroup.dk Daintel is specialised in Patient Data Management Software for Intensive Care and Operation Wards. The company enjoys a leader's position in Denmark and in Iceland. The solution has been developed by clinicians for clinicians and is the only solution in the world to save all patient data as time-stamped in high-resolution for research purposes. SHARING EXPERTISE

Daintel Diplomvej 376, DTU DK-2800 Lyngby Tel. +45 7027 4470 E-mail: info@daintel.com Web: www.daintel.com LabWare has achieved success by meeting commitments and exceeding expectations in LIMS and ELN projects large & small, local & global, routine & complex. LabWare is the clear industry leader in laboratory automation software with LabWare LIMS ™ (Laboratory Information Management System) and LabWare ELN ™ - a fully integrated Electronic Laboratory Notebook application. Results Count!

LabWare Nordic Landskronavägen 25A SE - Helsingborg 252 32 Tel. +46 4237 5860 E-mail: infoNordic@labware.com Web: www.labware.com

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

COMPANY INDEX

Contract Manufacturing Organisations Cambrex is an innovative life science company with a refreshingly human approach. Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years of active pharmaceutical ingredient (API) development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets. Cambrex has facilities in the US (Corporate), Sweden, Germany, Italy, Estonia. Cambrex is also active in the Danish market. Cambrex Björkborns Industriområde 691 33 Karlskoga Sverige Tel. +46 586 78 30 00 Web: www.cambrex.com

Special combustion and destruction Destruction by incineration in specialized plants Special Waste System A/S (SWS) is an environmental company based in Falster with strong skills in special incineration and disposal of hazardous chemical waste, including medical and confidential waste and clinical waste. A collaboration with SWS means safe disposal and documentation. SWS also offers customized UN-approved packaging for the shipment of hazardous waste. Contact: www.sws.dk. Special Waste System A/S Herthadalvej 4A 4840 Nørre Alslev Tel: +45 54 40 02 12 Mail: post@sws.dk

Other Boel Nordic offers state of the art process equipment to customers that require unique solutions, which matches their specialized product. Our customers primarily come from the pharmaceutical, medical devices and technical industries. We supply equipment covering filling, sorting, assembling, packaging and printing. In addition we manufacture highly specialized machines and delivery solutions beyond our standard areas of expertise.

Boel Nordic ApS Rude Vang 88 2840 Holte, Denmark Tel. +45 70 20 40 73 E-mail: info@boelnordic.com www.boelnordic.com Door System deliver durable door solutions that live up to the strict requirements to materials, hygiene and reliability in the pharmaceutical industry. Easy access to 100 % cleaning. Automatic controls encapsulated in stainless and waterproof boxes. No visible screws or fitting plugs. Interlock system between doors. Safety sensors on all automatic doors. For further details, please contact Søren Rahbek, phone +45 42 14 52 02, sr@doorsystem.dk Door System A/S Hovvejen 148 DK-8361 Hasselager Tel. +45 86 92 11 71 www.doorsystem.dk

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CALENDAR

HIGHLIGHTED FAIRS AND EVENTS IN 2017 THE FUTURE OF SWEDISH AND DANISH LIFE SCIENCE Date: 30.03.2017 - Lund, Sweden

www.swedishdanishlifescience.se Some 35 exhibitors and 400 visitors are expected at this annual international networking forum organized by Kemivärlden Biotech/Journal of Chemistry & Biotechnology, Medicon Village and Medicon Valley Allliance. The target audience is decision makers in the pharma, biotech, medtech and healthcare sectors, R&D-¬persons from the industry and academia. Other targeted

groups are investors, authorities and politicians. New for this fifth edition of the event is that partnering meetings will be facilitated by our one-to-one meeting partnering software available for all delegates at The Future of Swedish & Danish Life Science. We charge no entry fee and will provide lunch and refreshments.

UPGRADED LIFE FESTIVAL Date: 25.04.17 to 26.04.2017 - Helsinki, Finland

www.upgradedlifefestival.com Nordics biggest health startup and innovations event is back. Join the front line of influential people in health & wellness including startups, executives, investors, doctors, researchers and media sharing their insights and showcasing new solutions. Here the rising

stars of healthtech meet more established innovators across the industry. In 2016 the event gathered more than 1100 participants, 70 exhibitors and 80 speakers.

LABVOLUTION WITH LIFE SCIENCES EVENT BIOTECHNICA 2017 Date: 16.05.2017 to 18.05.2017 - Hannover, Germany

www.labvolution.de The next LABVOLUTION and BIOTECHNICA double-header event takes place from 16 to 18 May 2017 in Hannover, Germany. LABVOLUTION is Europe's flagship fair for innovative lab equipment and laboratory workflow optimization. It showcases all aspects of laboratory work, from the life sciences to analytical

chemistry. The exhibition program covers the full spectrum of equipment and infrastructure for research, analysis, production and training laboratories. LABVOLUTION is held right alongside BIOTECHNICA – the No. 1 showcase for research institutes and commercial enterprises in the biotech industry.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

CALENDAR

NORDIC LIFE SCIENCE DAYS 2017 Date: 12.09.2017 to 14.09.2017 - Malmoe, Sweden

www.nlsdays.com Nordic Life Science Days is the largest Nordic partnering conference dedicated to the life science industry. Since its inception in 2013, the event has nurtured a community of people from the world of life science, and created a unique place to do business. Most attendees express their delight in the informal atmosphere, combined with an organized approach to meeting highly relevant people. The conference has

created a space for meaningful encounters, with oneon-one meetings being one of the main features of NLS Days. Additionally, the high quality of topics and presenters provide insight into the most recent trends in science and business. NLS Days attracts leading decision makers from biotech, pharma and medtech as well as finance, research, policy and regulatory authorities.

LABDAYS 2017 Date: 20.09.2017 to 21.09.2017 - Aarhus, Denmark

www.labdays.dk In September 2015 the first LabDays event was conducted, and with 79 exhibitors and close to 1,500 visitors the premiere was considered a success. This marked that pleased to present all the details concerning how LabDays 2017 is expected to be implemented. A large majority of the exhibitors and visitors (from 2015) felt that Aarhus was the right location. And at

the same time was everyone satisfied with the venue, Scandinavian Congress Center. So LabDays 2017 will again be held in Scandinavian Congress Center in Aarhus. Similarly, a lot of exhibitors was satisfied with the exhibition concept with fixed turnkey stands. And thats why we also stuck to the concept with fixed turnkey stands for all exhibitors.

THE SCANDINAVIAN MEDICAL DEVICE PACKAGING CONFERENCE 04.10.2017 to 05.10.2017 - Copenhagen, Denmark

www.smdpc.com The conference will give an insight into how some of the best performing companies in this field have managed to incorporate complex requirements into their production planning and process handling. The speakers will provide you with the latest knowledge on design, packaging technology & packaging process, integrity, test and validation, sterilization, regulatory issues, quality assurance and UDI compli-

ance. You will be able to network with your peers and the conference offers you the opportunity to book a oneto-one session with leading specialists and organizations in their field. The main audience will be designers & developers, engineers within packaging and processing, regulatory affairs, purchasers, management and quality assurance staff.

BIO-EUROPE 2017 Date: 07.11.2017 to 09.11.2017 - Cologne, Germany

www.ebdgroup.com The event offers powerful opportunities for you to network with the right partners, and brings together hundreds of the worldâ&#x20AC;&#x2122;s most innovative leaders across biotech, finance and pharma for high-level networking, pre-scheduled partnering meetings, strategic pan-

el discussions and more. Last year the event attracted 3,692 attendees, 1,982 companies from 63 countries. 20,833 one-to-one meetings were held, 4,734 licensing opportunities were posted, 153 company presentations held and 105 Exhibitors were present.

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2017

| Active ingredients Dynamic people What do you need from your API partner? Custom development and manufacturing or generic expertise? Safety, quality and reliability? Excellent. Youâ&#x20AC;&#x2122;ll enjoy working with Cambrex.

www.cambrex.com

Erena Sawyer-Wagner Analytical Chemist Analytical Development