Cls yearbook 2016 net by RASK Media ApS

2016

The Medicon Valley Trends to Watch 路 Biotech Companies 路 Medtech & Laboratory Equipment Contract Research Organisations 路 Pharmaceutical Companies Patents and Regulatory Complience Companies 路 Recruitment Companies

The column

In a Time of Hope and Despair By Fredrik Hedlund

But in spite of these rather disheartening memories of last year, 2015 was still a very good year for humanity. Check this out. The part of the world who suffer from malnutrition has dropped from 19% in 1990 to just under 11% last year. And the mortality rate for children under five during the same period declined from 12.7 million to fewer than 6 million – that’s more than half in 25 years, largely due to the vaccine against measles and cholera. Other positive news is that 2015 was the first year without a single case of polio in Africa, which means that the disease now only exists in Pakistan and Afghanistan and is,

therefore, well on track to being eradicated from the planet. Last year was also the year when the international community together succeeded in stopping the Ebola epidemic and, moreover, in a short time managed to develop an Ebola vaccine that is 100% effective. On the home front, the new hepatitis C treatments started being used clinically. Patients who previously would have been condemned to death are now brought back to life. Another milestone was the first biosimilars on biological medicines. The TNF-alpha inhibitor Remicade received competition from Inflectra and Remsima, and in a short time the price for the treatment fell significantly. And there is more to come. At the beginning of the year, Benepali – the first biosimilar TNF inhibitor Enbrel – will be launched. Currently, Enbrel is the medicine that costs the hospitals most money. Also, 2016 can be the year that nanomedicine gets its breakthrough. There are now over 130 nanomedicines in pipeline, and 25 of them are in phase III with the potential of soon being approved. As knowledge and technology develops, nanotechnology will be able to increase efficiency and reduce dosage, side effects, and the costs of a large number of today’s traditional medicines. There is a medical revolution that is just waiting to happen.

Photo: PR

hen I look back at 2015, I sometimes feel that it is easy to lose hope. A complicated war in Syria has created the biggest refugee disaster since World War II. A situation that Europe has until now failed to handle. The same Europe that is now falling to pieces when Britain threatens to leave. A united Europe that does not actually seem so united when it really counts. In a turbulent time such as this, the need for heroes increases and we are currently drowning in superheroes in cinemas. Meanwhile, the real heroes are being treated like rubbish. Edward Snowden, who revealed the United States and many other countries’ interference in everyone’s digital integrity is seen by most countries as a spy and a criminal.

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

Another area that will most likely affect the biotechnology world this year is the genetic scissor Crispr. The partly Swedish gene technique, which Science magazine named as last year’s most significant scientific breakthrough, consists of a simple, inexpensive, and highly accurate technique for cutting up DNA and placing genes exactly where the researchers want. It could completely revolutionize gene therapy. The future may not look so gloomy then. So let’s just hope that Europe stays together, takes care of the refugees from Syria, and gives Edward Snowden political asylum before he becomes a Russian citizen. Then 2016 can be a really good year.

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Contents 2

The column PUBLISHER:

Fredrik Hedlund on the future “that might not look so gloomy after all”

The year in review 8 RASK Bladproduktion ApS Frydendalsvej 3 DK-1809 Frederiksberg C Denmark +45 3326 9520 www.raskmedia.com rask@raskmedia.com Editorial board: Carsten Elgstrøm, Malene Aadal Bo and Nanna Bisgaard

Business and research highlights 4 initiatives to make Medicon Valley thrive

The year to come 18 Interview with Steen Christiansen, chairman of Greater Copenhagen Trends in Medtech

One by One Biotech Phama The Medical and Laboratory Device Industry Contract Research Organisations Patents and Regulatory Compliance Companies Recruitment Companies

Index

Calender

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Smitter intelligens? At arbejde i en forskerpark er ikke som at arbejde andre steder. 80 % af virksomhederne oplever vækst. 76 % lancerer nye produkter. 52 % samarbejder med DTU, og 65 % mener, at Scion DTU bidrager positivt til deres vækst. Alt det kan du blive en del af. Vi har stadig ledige m2 i forskerparken i Hørsholm, der ligger nemt tilgængeligt i skønne grønne områder. Vi er en samling af højteknologiske virksomheder med fokus på biotek og hardware. Du er velkommen til at kigge forbi og blive smittet. For mere information ring 4586 4100.

sciondtu.dk

Science Parks in 1. NOVI Research Park

NOVI Research Park currently houses some 100 businesses, most of them high-tech. At Novi, these businesses have access to a dynamic, full-service environment. NOVI Science Park, has a building complex of 43.000 square metres in Aalborg East, an area in fast development. Our buildings lie across from our new super-hospital, and next to Aalborg University.

2. INCUBA

Incuba contributes with sparring and consulting services and utilises its extensive network of major innovation players and commercial partners to promote the innovation activities and growth of the resident businesses. In close proximity to local research and educational institutions, INCUBA’s locations generate synergy effects that give its many diverse enterprises excellent opportunities for commercial innovation.

3. CAT Sciencepark

CAT Sciencepark is a privately-held company, helping entrepreneurs and innovators to find the capital and the right competences required to turn ideas into enterprises. Forskerparken CAT is a unique combination of governmentbacked, pre-seed capital, science park, and venture company. We are capable of functioning both as host as well as mentor for your good idea. All the way – from the first tentative steps to a viable enterprise. Our highly educated investment team has many years of experience in evaluating the market potential of the multitude of ideas presented to us each year. Our investment team opens up access for you to consulting and to the right competences when starting up your enterprise.

4. Symbion in Copenhagen

Symbion was established in 1986 by six researchers who wished to create synergy between research and the business community. Today, Symbion is one of Denmark’s leading business environments with laboratories, business development and capital for entrepreneurial activities within ICT, knowledge consulting, cleantech and life science, in particular. Around 30 companies within biotech and medtech, healthcare or service/ contract are based at Symbion. More at www.symbion.dk

5. COBIS (Copenhagen Bio Science Park)

COBIS is a result of the political vision of the Ministry of Higher Education and Science and the Capital Region of Denmark to strengthen the biotechnological competences of the region. It was established in 2009 with the ambition of being a centre of growth by creating the right conditions for the biotechnology successes of tomorrow. The business Accelerace Bio development programme was launched in 2010. Find out more at www.cobis.dk

6. Scion DTU in Hørsholm

Scion DTU is DTU’s high-tech science park. It is the focal point for 200 international knowledge companies of all sizes within medico, cleantech, IT and biotech. The companies comprise Denmark’s largest biotech cluster measured by the number of employees, with high-tech companies ranging from 2 to 600 employees. The science park was established in Hørsholm in 1962 and merged with DTU in 2004. More at www.sciondtu.dk

7. Medeon Science Park in Malmö

Established in 1985, Medeon Science Park houses about 40 companies. The focus is on knowledgeintensive companies within life science, mainly drug development, biotechnology and health. In 2007, the science park also gained its own incubation environment. Altogether, more than 100,000 square metres are reserved for the science park, which is expecting to grow significantly in the years ahead. More at www.medeon.se

8. Ideon Science Park

Ideon Science Park is like a life-giving lung for the whole of the expansive, northeastern area of Lund. With the University, the Faculty of Engineering and the School of Management and Economics in its immediate vicinity, Ideon Science Park is the obvious meeting place. St Ericsson, Sony Ericsson, Axis Communications, Active Biotech and Gambro all have their development centres right beside the Park.

Medicon Valley 11 10

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10. Krinova

Krinova is one of the country’s 60 or so incubators and science parks, where innovation and development is promoted from collaborations between companies, organisations, universities and society. We offer a creative growth environment with incubators and innovation arenas to support development and innovation initiatives. We also arrange tailor-made conferences, and offer flexible office premises. Krinova’s interdisciplinary profile area of food - environment - is a by-product of the local economy of Kristianstad and the areas of expertise of Kristianstad University.

11. Videum Science Park 9. Medicon Village in Lund

The former Ideon Science Park now houses more than 1,100 people in 100 organisations targeting especially cancer research, prevention, diabetes and nanomedicine. Medicon Village maintains close contact with the Biomedical Centre (BMC) in Lund and the Clinical Research Centre (CRC) in Malmö, as well as with the developing research facilities ESS and the MAX IV laboratory. More at www.mediconvillage.se

Videum Science Park is the region’s fastest growing knowledge environmemt. More than 100 companies and organisations are now located in a creative environment on the Växjö University Campus - one of Sweden’s most expansive campus areas. At Videum Science Park you can rent anything from a desk in an office landscape or a small office right through to a complete floor or a whole building. In other words, there are premises to suit all companies, no matter what their size or stage of development. Videum offers access to experienced and professional business advice and finance

Illustration: Ann Malmgren

Science and Business int Brief E THE PICTUR

asto find the L ’s k We have gone through the archives of Copenhagen Life Science r ad a m n De rch Monkey Is Demost important news on business and research. R Walk a us through 2015. esewith Aadal Bo By Malene ming Højer Photo: Flem

Danish Researcher Swallowed 600 Intestinal Worm Eggs A researcher from University of Copenhagen infected himself with hundreds of whipworms for the sake of science. For the past two years he has lived with the 4 to 5-centimeter-long intestinal worms in his bowels. The idea to infect himself with the worms occurred because Peter Nejsum needed a ‘freshly caught’ worm for genetic analyses of whipworms. Together with international colleagues, he found the whipworms genetics interesting because the animals are in one way or another able to cheat the human immune system and in this way are allowed to live undisturbed in our intestines. “My immune system cannot get rid of the worms. The worms must be cheating the immune system so that they aren’t recognised as foreign parasites but are allowed to remain,” explains Peter Nejsum. Test subjects were not queuing up to help and so instead Peter Nejsum ended up ordering a stool sample from a whipworm-infected child from Uganda. For three months he stored the eggs while they matured. Then one day he swallowed 600 worm eggs. In the fall of 2015 there were still whipworms in his colon, and the first results of his self-infection had just been published in the Journal of Helminthology.

A greatly increasing number of people across the world with lifestyle diseases will, by all accounts, bring large growth in the global health market. Such was the main message in a report from Allied Market Research published in the spring 2015. According to the report, the global market is predicted to increase by 33.5 % per annum between 2015 and 2020. The report suggests that heart disease is the biggest area in mHealth at the moment, and it is also here that the greatest growth is predicted through to 2020.

T Denmark’s Last

Research Monkey Died The second half of his life, Sebastian lived a completely normal monkey life in Ree Park on Djursland, Denmark. But Sebastian was anything but a normal capuchin as son of Thom monkey.me and a new life and everyday d after the earch an is name ey’s life r of the res ey Sebasti A new ho e in rch monk e the leade The monk tion and tiv ea en am tia res att bec ini e c th 00 bli the s pu o in 20 basement For many years home wasWein the That wa d at . He took rge, wh . Grow ing his so lutions an ns Hospital until 2004 rk. d t at St. Ha find other existence widesprea ve to Ree Pa departmen re mo earchers to to mo res eys me led monk s beca criticism of pig under St.timHans Psychiatric Hospital allowing the in Roskilde, e the use the same reased tal use. me with inc experimen calife ld e ou tiv sh ec s and forhis everyday consisted of being the ious housing. It reqfeauirr edand EU dir tal monkey Finally, an to. their prev experimen their n’t live up vior due to ts for how to reduce k back Hans could her beha took time requiremen St. Ot it d s. at ey an th en we loo t ts subject of emaenrange ofustests with ing monk andt experiments a big effor full and wh ess. live – requir ed to stop was success a big succ ized, bu cid s it an t de wa th s Bu . eu ing wa re it stress try we many a re-socialis un g t e Therefore, co go th vin e ns at ha th d th say St. Ha npsychoses d ende m nkeys in for ag new medicines the treatment of and ca an fro mo we s ely ue rch let resea colle d comp aard. d 11 of his ey recovere nd. per Stageg bastian an being was Th on Djursla ,” says Jes o ended up gegaard, it Ree Park good years otherSenepsychiatric diseases. Jesper Sta an died, wh still used w home in rk’s CEO, o the park 15 Sebasti pa 20 int imates are d ay the ve M to ey. In monk Pr rch developing eys who mo According l ea in nk cia res rk mo t so ers’ wo atised ark’s las strongly Denmark’s rch um nm re ea tra tu res De of na d tories Sebastian ended up being last op in an a tro 04. The act labora companies they all ning of 20 ens at contr in Danish ether, and ay it happ in the begin earch t to be tog ine, but tod times as res never learn dic ir d me ha the m als fro passed away in May 2015. research He anim monkey. of stress abroad. heav y signs showed ic animals. m stereotyp suffered fro “They all

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”One of MVA’s major tasks is to support the attraction of talent to the region. Without the right workforce it is difficult to form a strong foundation for the region’s life science.” Photo: Jeppe Carlsen

Significant Growth Predicted for Mobile Tools

lived a , Sebastian Park lf of his life life in Ree he last ha fe monkey sa al, was rm no t Sebastian Bu completely . ark nd, Denm . For many on Djursla in monkey al capuch St. Hans but a norm ent under anything in the basem s ever yday wa his me ho e, and ild sk years his Ro in l tests and c Hospita a range of Psychiatri subject of atment of ed of being s for the tre ine dic life consist me w . ts with ne c diseases experimen psychiatri with er als oth im d an nt an psychoses are intellige kes them monkeys . That ma Capuchin to humans were r ila ey th sim e ry s, befor a psyche ve w medicine testing ne suited for tents. on pa c ge tri led ychia know given to ps ed to gain letely eys were us ether comp The monk discover wh to ing the ed giv us st and by fir tic ho yc sideeffects ps antietamines, s could be lp of amph new drug with the he s with psychoses e monkey th at monkeys tre to ards try ing and afterw s. ug dr dical different me

Søren Bregenholt from Novo Nordisk and newly appointed chairman of Medicon Valley Alliance.

New Discovery Changes Our Understanding of Pain Photo: Harvard

Researchers discovered a gene that is crucial in our ability to feel pain and temperature. It is the gene PRDM12 that has shown itself to be crucial in the development of well-functioning nerve connections and the feeling of pain. “With the discovery, we have a new point of attack which can be used in the treatment of the many pain sufferers. Pain disorders are an important area for the health system and pharmaceutical industry, and our new understanding has great potential for the development of new drugs,” said Jens Michael Hertz, one of the researchers behind the research. He is a professor at University of Southern Denmark and chief physician specialising in clinical genetics. “One suspects that people

EMA Opens for Sharing of Side Effects in the EU

with chronic pain disorders have overactive pain receptors,” says Troels Staehelin Jensen from the Danish Pain Research Center at Aarhus University. “Therefore, if one can, with the new drugs, regulate the activity or formation of new pain receptors in the body by regulating the protein PRDM12, one can also help people to feel less pain and with fewer side effects,” he adds.

From June 2016, it became easier to form an overview of the side effects of drugs that are approved in the EU. The board of the European Medicines Agency (EMA) decided that the information in the so-called periodic safety update reports (PSURs) should be collected in an electronic database. All regulatory authorities and pharmaceutical companies in the EU have access to the database of side effects.

Illustration: Pixabay

Danes and Swedes Welcome Robots with Open Arms The robots are coming! And they are more than welcome. At least, a study from autumn 2015 showed that a total of 84 % of Danes generally have a positive view of robots. Denmark is, together with Sweden, the country in Europe most open to the technologies. The results make Denmark and Sweden attractive places to test and introduce new welfare technology.

“There is no doubt that, in the future, foreign companies will use Denmark as a living laboratory for the testing of new technologies,” says Henning Langberg, who researches the development of welfare technologies at the University of Copenhagen.

Gene Mutation Protects Diabetics Against Dangerous Eye Disease These pages was compiled in collaboration with Medwatch. Read more news at www.medwatch.dk

These pages has been compiled in collaboration with Videnskab.dk and ScienceNordic.com.

A very particular mutation in a single gene of diabetics prevents the feared eye disease retinopathy from developing into blindness. Researchers followed 130 people with type 1 diabetes for 16 years and at the same time closely studied 23 genes that, from earlier research, are known to have an effect on the development of diabetes. They discovered that none of the patients with a particular gene variation in the CTSH gene, at any time displayed symptoms of the eye disease retinopathy. The CTSH gene, where the protective mutation is located, contains the recipe for a protein that manages cell death and creation of blood vessels. The alleles in the CTSH gene can occur in three variants: CC, CT, and TT. Patients with the TT combination were apparently protected against blindness. “The gene manages actual cell death in the beta cells, which are those that produce insulin in the pancreas. It also has some other functions in relation to making new blood vessels,” explains research assistant and medical student Kristian Sandahl, who is the main author of the new study. The study was published in the scientific journal Graefe’s Archive for Clinical and Experimental Ophthalmology.

Regionsudbud.dk is the name of the Danish Regional Authorities’ new website that will gather all the information about the regions’ tenders. The website will create openness for partners, suppliers, and others who are interested in finding all the necessary information about future, current, and already completed tenders. The website gathers information about the regions’ joint purchases in order to strengthen cooperation regarding joint tenders across the regions.

Photo: pbs.org

Danish Regional Authorities Gather Tenders on New Website

Medicine Distribution a Hundred Years Ago In 1925, a diphtheria epidemic began spreading amongst children in the town of Nome in Alaska. The serum that could stop the epidemic was in Anchorage, around 1,600 kilometres away. The only plane nearby had a frozen motor and couldn’t start. This was the start of what has since become known as “the serum race to Nome.” A journey with dog sleds that happened at a time when all other forms of transport had stopped due to a violent snowstorm. Balto and the rest of his group of huskies overcame severe challenges and were the ones to reach Nome with medicine for the sick children.

Faeces from Planes Can Reveal the Spread of Infectious Diseases release from DTU. For example, amongst other things, the study shows that there were several genes with resistance to antibiotics, such as tetracycline, macrolide, and beta-lactam from South Asia and North Asia in relation to the tests from North America. The study was published in the scientific journal Scientific Reports. Photo: CC

Bacteria and infectious diseases find their way around the world in many ways, and international doctors have difficulty in finding out how and which diseases will spread. Now it will possibly become a little easier. Danish researchers from Technical University of Denmark (DTU) have, with the help of toilet waste from 18 planes that arrived at Copenhagen Airport and gene technology, been able to discover which diseases were potentially onboard. That creates new possibilities for making it easier to monitor diseases, as reported by dtu.dk. “Our work has shown that there is a great potential to make airports places where data can quickly be collected on resistant genes and certain microorganisms,” explains Frank Møller Aarestrup, Professor at DTU National Food Institute, in a press

Bioneer Takes Your Company to the Forefront of Innovation

PROFILE

FACTS ABOUT The use of new technology and know ledge is a decisive competitive factor in the life science industry. As an Approved Technology Provider (GTS institute), Bioneer’s goal is to make available the latest knowledge and technology to support the innovation and competitiveness of Danish companies. Bioneer offers stateof-the-art services within biomedicine and biotechnology. “As a GTS institute, we have a high professional level and close relationships with leading research institutions. SMEs rarely have the opportunity to build up either the modelling expertise or technology park that we have. They will typically outsource many activities, and we support with product development

services and consultancy,” says Business Development Manager, Hans Christian Wegge. Among other services, Bioneer assists in drug development from discovery through the pre-clinical stage and has at disposal an advanced Dynamic Gastric Model (DGM); an in-vitro model providing predictive simulation of the complex functions of the human stomach. “The DGM offers unique possibilities for studying e.g. dissolution, disintegration and food effects of different types of oral delivery systems and APIs,” Hans Christian says. Both SMEs and large actors in the industry closely follow Bioneer’s work in turning the latest knowledge into useful services. “In particular our work with induced pluripotent stem cells has close attention,” Hans Christian tells. “It is a very advanced area and we are one among very few companies worldwide who are able to handle these types of cells. In time, this technology can revolutionise the possibilities for testing e.g. CNS drugs. If one can test a drug on a predictive stem cell derived model

BIONEER

Service and consultancy organization within biomedicine, biomedical technology and biotechnology. • Patient-specific disease models • Human immune system models • Molecular detection and histology • Recombinant protein production • Drug development and formulation For more information: www.bioneer.dk

of, say Alzheimer’s, then the impact on screening and drug development will be significant!,” says Hans Christian and sums up: “The stem cell area is a good example of what we are established to do – to develop and offer the latest technologies to companies for the benefit of everyone, including, ultimately patients.”

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Initiatives That Create Good Frameworks for Life Science in the Valley

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In order to help this development move forward, a range of initiatives have been taken by public and private stakeholders whose goal is to create the best possible framework for life science in Medicon Valley. We take a closer look at four of the initiatives.

Illustration: Ann Malmgren

48 parallelle mini fermentorer

Everything suggests that the Ă&#x2DC;resund region has the potential to become a strong centre for life science and, in time, compete with similar centres of excellence in other parts of Europe.

By Malene Aadal Bo

Medicon Valley Alliance

Since 1997, Medicon Valley Alliance (MVA) has been a meeting point for the Øresund region’s life science community and has worked to create synergies between the valley’s research institutions, private companies, and public stakeholders. MVA represents the entire region’s life science community and works to create synergies through strategic initiatives and day-to-day activities. MVA recently got a new man at the helm – Novo Nordisk Vice President Søren Bregenholt, who’s ambition is to lead the organization back to the starting point of being the platform that gathers stakeholders and “helps give birth to the ideas that come from these collaborations,” as he says. The most important focus areas for MVA in 2016 is to help attracting the right labour to the region and to support the smaller and newer companies in particular with raising financing.

“Partly by making investors aware of the local success stories and the investment potential. But also through advice and inspiration to and between the members, so that they discover the opportunities that they otherwise wouldn’t have seen,” says Søren Bregenholt.

“It should help give birth to the ideas that comes from gathering the stakeholders” MVA was founded in 1997 as an EU Interreg II project under the name Medicon Valley Academy. Informal discussions about creating the organization, however, had already started in 1992 when work on the Øresund bridge

between Denmark and Sweden began. As the bridge became a reality, expectations about closer interaction between research and business communities in the two countries grew. The main initiators behind Medicon Valley Academy were the universities in Lund and Copenhagen, strongly supported by the major pharmaceutical companies in the region: Novo Nordisk, Lundbeck, and AstraZeneca. Today, MVA has grown to a 250-member non-profit organization covering the Danish-Swedish life science cluster Medicon Valley. The 250 members employ approximately 140,000 people and include universities, hospitals, human life science businesses, regional governments, and service providers. See news, events, and details about membership at www.mva.org

Greater Copenhagen

Denmark has taken the initiative to spark an ambitious business development of the Øresund region. A region that has the potential to compete with metropolises such as Stockholm, Berlin, and Hamburg – that is, if one is able to join forces and create a focused cooperation in East Denmark and the Southern part of Sweden. The initiative has been named Greater Copenhagen and covers a strong common brand for the region, and a platform for creating the best possible framework for the region’s companies and workplaces. The overall vision for Greater Copenhagen is to break down the borders between the Øresund region’s councils, regions, and countries. There is a desire to form a collaboration where everyone is pulling in the same direction and resources are used specifically to promote business, so that growth and jobs are created. The areas in which the stakeholders have agreed to

join forces are life science and clean tech – sectors that are already strong in the region and which show a great potential to become even bigger. “In the collaboration, we want to create one cohesive job market and one coherent business policy. We want to increase the international focus in the region and not least we will make an effort to show internationally, how attractive Greater Copenhagen is for both companies and employees,” chairman Steen Christiansen sums up. The first three challenges, which according to the chairman must be solved in order to transform the Øresund region into the desired nerve centre for investment and knowledge, are branding, infrastructure, and attracting knowledge and talent.

See the current projects and read more about Greater Copenhagen at www.greatercph.dk

National Experimental Therapy Partnership (NEXT)

The capital region of Denmark has set two ambitious goals for Nordic life science. One is to ensure that the public health sector can provide treatment and health services of the highest possible quality. The other is to further develop life science as a regional cluster to drive job creation, innovation, and economic growth. And the National Experimental Therapy Partnership (NEXT) is crucial to fulfilling these ambitions. NEXT is a formalized national partnership between the Danish university hospitals and a number of the major pharmaceutical companies. Two national centres have been established – for oncology & haematology and for dermatology anchored at Rigshospitalet and Bispebjerg Hospital respectively, and with participation by clinical departments from the other Danish hospitals. “NEXT is a unique public-private collaboration – also seen in an international context. It seeks to attract more phase 1 and phase 2 trials to Denmark in order to give Danish patients access to the latest in experimental treatments, promote new and better research, and increase

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our attractiveness to new investments, ultimately creating both growth and new jobs,” explained Kristian Johnsen, deputy chief executive in last year’s Life Science Yearbook. In practice, NEXT offers the pharmaceutical industry and hospital researchers easy access to Denmark’s clinical research environments during the early phases of clinical research, national recruitment of patients, and optimized administrative and regulatory processes.

“NEXT will give patients access to the latest in experimental treatments and promote new and better research” As an independent entity, Bioneer hosts the partnership and amongst other things provides facilities for the project’s employees. “Bioneer feels a certain duty to advance research and in particular to support this research being used for the treatment of Danish patients. Therefore, it is natural for us to support initiatives like NEXT,” says the company’s director Poul Andersson. According to him, the NEXT partnership should lead to four things. Firstly, Danish patients should have faster access to new treatment options. Secondly, Danish clinical research environments can be strengthened by gaining access to the new knowledge that comes from carrying out early clinical tests. Thirdly, the associated hospitals should preferably experience an increased income, which can contribute to financing their clinical research activities in general. “And then there is a strong ambition that NEXT will support the development of personalised medicine, also called precision medicine, where genomic analyses of the individual patient or patient groups are used to develop and select the best treatment for precisely that patient,” says Poul Andersson. Already today, the project also includes a network of leading bioinformatics experts in Denmark who will focus on precision medicine within oncology and haematology by supporting the generation, validation, and implementation of common standards for patient classification based on genomic analyses. In 2016, NEXT will expand into new disease areas to attract further commercial interest in clinical trial collaborations. For further information of NEXT please visit the webpage www.nextpartnership.dk

Medicon Village

represent the entire health chain, from prevention and diagnostics to care and treatment. The village has in particular gained international recognition for its role in the area of research into nanotechnology, cleantech, food, and medicine. Medicon Village is closely linked with the Biomedical Centre in Lund (BMC), the Clinical Research Centre in Malmö (CRC), and Medical Malmö, as well as the new research facilities ESS and the MAX IV laboratory and is – together with the Danish science parks – providing a huge lift to the entire region. To really become an international player, the village has recently formed the first of a series of international partnerships – so-called twin clusters – with life science clusters around the world. The partnerships include a range of opportunities, from scientific collaborations over international networks for clinical trials to fundraising and business investments. Three collaboration agreements have been signed so far; with Life Tech Limburg & Bioville in Belgium, with Welsh Government life science sector in Wales, and Sherbrooke Innopole, Canada.

Established in 2012 in the former premises of Astra Zeneca in Lund, Sweden, Medicon Village has grown to become a world class research and development business infrastructure. It was created by the charitable foundation Mats Paussons’s Foundation for Research, Innovation and Societal Development with the purpose of bringing scientists and companies together in the search for innovative solutions to improve people’s health and well-being.

”The vision was to “not just be another science park” The vision was to “not just be another science park but being a place and a group of people who work together to create a unique environment for players within Life Science,” as Executive Vice President Kerstin Jakobsson has put it. In three years, the 80,000 square meters has become home to more than 100 companies employing more than 1,200 people. The companies located in the village

SINGLE CELL ANALYSIS

Explore Medicon Village at www.mediconvillage.se

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ELISA PROTEIN ANALYSIS IMAGING

FLOW CYTOMETRY

IHC/FISH BIO APPLIANCE

QPCR

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â&#x20AC;&#x153;With Greater Copenhagen, we will create the prerequisites for exploiting the positive tendensies. I have no doubt that the potential is thereâ&#x20AC;?

By Malene Aadal Bo

Steen Christiansen:

Life Science Must Be the Engine of the Entire Region Life science will play an absolutely central role in the effort of getting the Øresund region on a par with the most successful metropolises in Europe. This is according to Albertund’s mayor Steen Christiansen, who is also chairman of the organisation that is going to make it happen.

t has been three years since KKR Hovedstaden in collaboration with the Capital Region of Denmark took the initiative to transform what can best be characterised as “haphazard” to a strong and

comprehensive plan for the business development of the Øresund region. A region that, according to Albertslund’s mayor and chairman of Greater Copenhagen, Steen Christiansen, has the potential to compete with metropolises such as

Stockholm, Berlin, and Hamburg – that is, if one is able to join efforts and create a focused cooperation in East Denmark and the Southern part of Sweden. The initiative, which is only just formally getting underway, has

been named Greater Copenhagen. It covers a strong common brand for the region, and it is not least a network and platform that both in practice and politically will be part of creating the best possible framework for the region’s companies and workplaces. “Already now we have created history by joining three regions and seventy-nine councils in a joint initiative. Everyone understands that it’s necessary to work together and there is agreement that we need to focus our energy and attention,” says Steen Christiansen.

The areas that the stakeholders have agreed to join forces on are life science and clean tech – industries that are already strong in the region, and which show a great potential to become even bigger. “The fundamental idea is to focus on the areas of strength that the region already has. And one of them is without doubt life science. Today, life science employs over 40,000 people in Denmark alone and the growth potential in the form of companies and research is big,” says Steen Christiansen. Denmark is currently number two in the world when it comes to developing biotechnology solutions, and on the Swedish side of the Øresund the establishment of the new Medicon Village offers enormous possibilities. “With Greater Copenhagen, we will create the prerequisites for exploiting the positive tendencies and to use these two strong industries as growth engines for the entire region. I have no doubt that the potential is there – our task is, therefore, to create the best possible

Break down the borders in the Øresund region The overall vision for Greater Copenhagen is to break down the borders between the Øresund region’s councils, regions, and countries. There is a desire to form a collaboration where everyone is pulling in the same direction and resources are used specifically to promote business so that growth and more jobs are created. “In the collaboration, we want to create one cohesive job market and one coherent business policy. We want to increase the international focus in the region and not least we will make a big effort to show internationally, how attractive Greater Copenhagen is for both companies and employees,” Steen Christiansen sums up.

Photo: Greater Copenhagen

Key Words are Life Science and Clean Tech

framework for the companies,” says Steen Christiansen.

“We want to increase the international focus in the region and show internationally hos attractive Greater Copenhagen is to both companies and employees”

The Three Biggest Challenges The first three challenges, which according to the mayor must be solved in order to transform the Øresund region to the desired nerve centre for investment and knowledge, are branding, infrastructure, and attracting knowledge and talent. To take the last thing first: According to Steen Christiansen access to competent labour is decisive both now and in the future when companies must choose a place to locate. The Danish employees are competent and well-educated, but there are too few. According to the engineer union IDA, there is currently a shortage of 13,500 engineers in Denmark, and,

for example, Novo Nordisk has recently announced that they have a serious challenge with regard to recruitment. Therefore, one of Greater Copenhagen’s tasks will, according to Steen Christian, be to attract foreign researchers and employees to the region. “Politically, we have to work to make is easy to relocate in the region. We have to ensure that there is easy access to accommodation, that educational offers for children are available, and that all in all it is easy to come her.” The second challenge on Steen Christiansen’s mind has to do

with infrastructure. To ensure that Copenhagen Airport is equipped to service a region in growth. And to ensure that the local infrastructure is first class, so that, for example, it isn’t a problem to travel between the Danish and Swedish side of the Øresund. “The current refugee discussions and the accompanying closing of the border is a challenge and a potentiel problem that we are aware of, just as we are very much aware of realising an effective connection over the Fehmarn belt,” he explains. The last big task, which perhaps is really the first, is to create a strong brand and make “Greater

Copenhagen” known throughout the world. “The engine for this will be the participation of councils and regions, but to a great extent also the network of international partners who are working to build the brand as we speak. And then it is my ambition and my hope that the Danish and Swedish companies in life science will see a potential in this and be active players in the work to make Greater Copenhagen a recognised brand,” concludes Steen Christiansen.

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By Carsten Elgstrøm and Nanna Bisbjerg

Trends in MedTech and Medical Devices Impressions from the MEDICA 2015 Fair The patient will play an increasing role in diagnosing and treating illnesses. That was one of the general trends at the world’s largest trade fair for medical technology and medical devices: the annual MEDICA fair in Düsseldorf. Here, we take a closer look at three trending areas from MEDICA 2015 that we will definitely see more of in 2016.

Medicon Valley Alliance

The Danish-Swedish life science network organization MVA is a non-profit membership organization in the Danish-Swedish life science cluster Medicon Valley. Our 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. Our vision is to be a well-known and respected member driven contributor to the realization and positioning of Medicon Valley as the most competitive and vital life science cluster in northern Europe. We are always searching for innovative ways to bring the right people together and make Medicon Valley an even more integrated bi-national life science cluster. Read more about how to benefit from membership, how to become a member and how you can use MVA to connect with potential business partners, research partners, customers, suppliers and other agenda-setting life science stakeholders at www.mva.org

Søren Bregenholt Chairman MVA EVP, Novo Nordisk A/S

Petter Hartman CEO Medicon Valley Alliance

Photo: Medica

“What started as mini-programs for smartphones and fitness armbands has develped into a megatrend. It will shape treatment in the future considerably” Joachim Schäfer, director of the MEDICA fair

Miniaturisation Portable Devices for Monitoring, Testing and Diagnostics

ore compact, more efficient and easier to operate. This is how Managing Director of the MEDICA fair, Joachim Schäfer, described the overall state of medical devices, and these do seem to be the keywords for development in this field. Within equipment for testing, diagnostics, and monitoring of a long list of diseases and conditions, we saw compact formats at the fair not seen before.

Cleanrooms will never be the same!

Intuitive design with the emphasis on user-friendliness and soft shapes were a recurring theme many places and underlined that medical devices are no longer aimed only at healthcare professionals. Beurer, the German manufacturer of health and medical devices, presented a device that looked somewhat similar to a small UFO or a Frisbee. Placed under the mattress and linked to a smartphone app, it monitors and evaluates sleep activity with the

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same precision that until now has only been seen in professional sleep laboratories. One of the giants in healthcare technology and in particular within medical imaging, Siemens, presented a portable ultrasound system featuring performance data and equipment comparable to premium systems but in a compact 15-inch notebook format, weighing less than 8 kilograms. The fair also featured the presentation of CardioSecur, a 22-channel ECG system consisting of a small ECG cable with four electrodes weighing only 150 grams, which connects directly to a PC or smartphone and allows the entire heart to be monitored, providing a 360 degree view. The solution comes with two associated apps for interpreting the data, one for professionals and one for patients. Behind CardioSecur is the German company Personal MedSystems. Likewise, there were several presentations of on-the-

spot blood test solutions, which, without the need for a laboratory, made it possible to test for everything from acute myocardial infarction, different forms of drugs and narcotics, to influenza, hepatitis, and even HIV. Joachim Schäfer reflects on this development: “With reference to mobile diagnostic systems (‘pointof-care testing’), usefulness in the field of health care can be easily brought to light. Experts expect that the lack of doctors will particularly increase in rural areas at a great rate. Therefore, there are enormous advantages in modern diagnostic processes that make results already available after a few minutes. The same applies to the situation in developing countries, where the distance to the next doctor or laboratory is frequently very far away.”

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Wearables Much More than Pedometers

he category of medical electronic devices called ‘wearables’ takes the miniaturisation trend even further. The name wearables covers devices that are carried on or even in the body, where they monitor a range of vital signs and/or provide treatment. Wearables can be connected to, for example, a smartphone app, which calculates the data the device collects and interprets it for the user. Some wearables can also send the information directly to professionals, allowing the remote monitoring of patients. From mostly having been something that one used as an accessory for fitness and exercise, wearables are generally on the rise within medical equipment and, amongst other things, the MEDICA fair featured

wearable devices that could carry out constant heart monitoring or sleep tracking, measure blood sugar level or ovulation, or could perform local pain relief for migraine headaches via electrical impulses. Generally today, wearables can measure many more vital signs with greater accuracy than earlier– amongst other things, thanks to the developments within optical sensors. At the fair, these could be seen designed to fit into earpieces and are said to be just as comfortable as in-ear headphones. A new trend that was seen at MEDICA 2015 was ‘intelligent patches’ or ‘smart patches’ – a non-invasive solution that continually retrieves physical data, but can also administer medications. The patch-like wearables can monitor a range of indicators, from blood sugar levels, sleep and heart activity, to humidity, UV level, and temperature, or could be used in the treatment of various skin conditions. Another new and highly current topic in the field of wearable technologies was the measurement of moods. Wearable devices that measured blood pressure, heart

11. Danish Conference on Biotechnology and Molecular Biology May 26 – 27, 2016. Hotel Munkebjerg, Vejle

Glycobiology and Carbohydrate Biotechnology Carbohydrates are essential for life of all living cells. With functional roles in biological processes and interactions they are of significant importance to human health and nutrition, and to symbiotic activity in the digestion system. Glycans play major roles for the pharmacokinetic properties of therapeutic glycoproteins. Recent pharmaceutical efforts are aimed at producing recombinant glycoproteins with simple and more homogeneous glycan structures in order to avoid immunogenicity and improve uptake and circulatory half-life. The present conference will focus on the latest developments in glycobiology and glycomics in relation to pharma, nutrition and analytical methods. The conference is organised in collaboration with Danish Society of Biochemistry and Molecular Biology and includes a poster session as well as a commercial exhibition of equipment, consumables and services to Danish biotechnology. Registration on-line will start December 1, 2015 at www.biokemi.org. Deadline for poster abstracts and registration: April 10, 2016. Secretariat contact Anne Dalgaard, IDA Netværkscenter, Kalvebod Brygge 31 33, DK-1780 Kbh V Tel.: 3318 4634, Fax: 33 18 48 99, e-mail: ada@ida.dk. Speakers confirmed -

Birte Svensson, Enzyme and Protein Chemistry, DTU Systems Biology, DK Carl H. June, University of Pennsylvania, USA Richard D. Cummings, Harvard Center for Glycoscience, Boston, USA Jørn Dalgaard Mikkelsen, DTU Biochemical Engineering, DK Norbert Sprenger, Nestlé Research Center, Nestec Ltd, CH Susanne Brix Pedersen, DTU Systems Biology, DK

Lars Bode, USCD, USA Martin Røssel Larsen, SDU, DK Jin-Ho Seo Seoul, National University Nico Callewaert, University of Gent, Belgium Niels Banke, Glycom, DK Hans Wandall, Glycomics Centre KU, DK

Photo: Medica

rate, and heart rate variability can, for example, together with activity and sleep data generate a better overall picture of the wearer and, with the help of an associated app, can help the wearer manage stress levels and differentiate between healthy and unhealthy stress.

“Experts expect the lack of doctors to increase. Therefore there are anormous advantages in modern diagnostic processes”

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Health and Medical Apps Apps Offer Patients Independence and Empowerment

ince last year, the MEDICA Trade Fair has held the MEDICA App Competition. Ten finalists were chosen from the submitted proposals from developers all over the world and were presented in connection with the fair. The winner of the 2015 competition was the app TALKITT by the Israeli development team VOICEITT. The app is aimed at people with speech or voice disabilities, enabling better communication. The app itself is trained by means of speech sounds. The meaning of the speech sound is entered into the app. In this way, the vocabulary of the app is continually expanded. In doing so, the right word or complete sentence deriving from the spoken speech sounds is shown on the display. Second place went to an app for monitoring smoking addiction, and third place went to an app for professionals aimed at conducting smarter visual cervical cancer screenings.

“What started as mini-programs for smartphones and fitness armbands has developed into a mega-trend and will shape treatment in the future considerably, such as after inpatient care at home for example,” stated Joachim Schäfer and referred to the rising number of medical apps that today number around 55,000. And, according to American PwC Health Research Institute, the number of apps doubled from 2013 to 2015, with over 500 million smartphone users already having health-related apps today. Health and health-related apps are aimed at both healthcare professionals and patients. In addition to the already mentioned apps connected to wearables or use at-home devices, a smartphone with the help of an app can often itself be used as a ‘wearable’, just like a vast number of apps can be found that are based on the data one types in, speaks, or records via the telephone’s camera.

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FACTS ABOUT

The MEDICA Trade fair and The COMPAMED specialist supplier trade fair • The World’s largest trade fair for medtech and medical devices • Held yearly in Düsseldorf, Germany since 1969 • MEDICA 2015 had nearly 5.000 exhibitors from 70 countries and more than 130.000 visitors from 120 countries • COMPAMED 2015 had 779 exhibitors from 37 countries and 18.800 visitors • Together the two fairs cover an exhibition area of more than 1.160 m2 distributed on 19 exhibition halls • MEDICA and COMPAMED 2016 will take place 14 – 17 November 2016 See more at www.medica-tradefair.com

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Biotech................................................... 34 Pharma.................................................. 38 The Medical and Laboratory Device Industry................ 42 Contract Research Organisations...... 46 Patents and Regulatory Compliance.. 57 Recruitment.......................................... 62

Illustration: Ann Malmgren

By Malene Aadal Bo

Biotech is an industry characterized by great opportunities and a high risk of failure. After challenging years, the industry is once again thriving and has recently seen a number of great technological, commercial, and financial successes. Martin Bonde, chairman of DANSK BIOTEK, and Tine Bryan Stensbøl, vice president at Lundbeck, take a closer look at the year just passed and the one lying before us.

What Were the Highlights of 2015? “2015 really offers a lot of good stories from Danish and Nordic biotech,” begins Martin Bonde, chairman of the trade association DANSK BIOTEK. “First and foremost, 2015 was the year where we in Denmark proved that we have left high school and entered adulthood. We are not making the same beginner’s mistakes that we did only a few years ago, and we have gotten control of both the management side (today there are experienced people who have become good at starting and running biotech companies) and the venture side. And we are now reaping the rewards of this,” he says. According to Martin Bonde, there has been success at both listed companies, who are strongly positioned, and the smaller companies, of which many have had an exceptionally good year with regard to raising new capital. Another very important event in 2015 was, according to

Biotech at a Glance • Biotech (short for biotechnology) is the development of useful products based on living systems and organisms. • Biotech is usually divided into three subgroups: pharmaceutical biotech, agricultural biotech, and environmental biotech. • The Nordic biotech companies are characterized by being non-established, start-up companies. • The focus for Danish biotech is to a large extent big diseases such as cancer, diabetes, and heart diseases, but also and increasingly rare diseases and the underlying technology. • The Danish biotech industry counts around 100 companies with an annual turnover of just above 4 billion DKK. • Danish venture-funded biotech companies have more than 1,000 employees and are growing rapidly.

Martin Bonde, that a new venture capital fund has entered the stage: Lundbeckfund Emerge, who wants to invest 300 million DKK in early start-ups over the next four years. “Until now, the new biotech companies have only been able to go to Novo Seeds. Now, there is an alternative and a possibility for co-financing. Overall, it provides a much more solid financing opportunity for early biotech,” says Martin Bonde.

New ways has opened At Lundbeck, Vice President Tine Bryan Stensbøl is just as excited about the year that has just passed. She leads the team at Lundbeck that is working with the company’s new antidepressiva Brintellix. In 2015 the product received the European authorities’ word that it has an effect on aspects of cognitive dysfunction and the company is currently seeking the same in US. Cognitive dysfunction is a distinct effect on a patient’s ability to carry out common tasks like shopping, calling the doctor, or planning a child’s birthday. “We are the first pharmaceutical company to get a claim on a drug showing effect on aspects of cognitive dysfunction in depression. It will without doubt show significant for the entire industry that the authorities now acknowledge that cognitive dysfunction is an independent element to treat within depression.” “It opens new ways for us and for others who work with the biology relating to these things.” adds Tine Bryan Stensbøl, who is especially proud that a relatively small player such as Lundbeck has been able to move an entire field.

But what about research? According to her, it is proof that it is crucial to have a focus on research. The specific result is the result of many years of work amongst Lundbeck’s researchers who, early in the work with Brintellix, saw something interesting which they got time and support to pursue. It therefore worries Tine Bryan Stensbøl that public research in Denmark has been deprioritised in 2015.

“Danish and Nordic biotech is deeply dependent on a strong and active public sector research environment, which can carry out the free research and basic research that companies don’t perform. And who can educate the graduates and develop the technologies and methods that all the other innovation builds on,” she says and adds: “We certainly don’t welcome the spending cut, and if it is a trend that continues in the future, then both Lundbeck and the whole branch will feel the consequences of it.”

Trends to Watch in 2016 In 2016, there is one thing in particular that Tine Bryan Stensbøl predicts that nordic biotech will need to respond to – namely, the European authorities’ decreasing will and ability to pay for new medicines.

“It is an increasing challenge for the biotech and pharmaceutical industries that the price of medicines has to such an extent become something that the authorities want to push down. For example, Germany has just refused to pay the price for Brintellix that we believe it should cost, and if this becomes a trend, then it will of course reduce our opportunity to develop new innovative medicines,” says Tine Bryan Stensbøl. She finds it crucial to open the discussion on how to know much earlier in the development of a product, whether or not the new product will have sufficient socioeconomic value for the authorities wanting to purchase the product. ”Today we develop medicines that are approved by the

We will see exciting things in 2016 Also Martin Bonde has noted the authorities changed price policy, but still experiences, however, a willingness to pay for medicine that can do something new and different. The technological fields that he particularly keeps an eye on are the development in immuno-oncology and personalised medicine. “Today, we have the perfect combination of technologies: gene sequencing and bioinformatics, which have both become so cheap and effective that it makes sense to work with treatments and medicines that are customised to the individual patient,” says Martin Bonde. “This will create drugs that are safer and more effective, and I am in no doubt that it is, amongst other things, in this field that we will see exciting things in 2016 and the following years.”

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Illustration: Ann Malmgren

“Today we have the perfect combination of technologies: gene sequencing and bioinformatics, which have both become so cheap and effective that it makes sense to work with treatments and medicines that are customised to the individuel patient”

medicines agencies. Their focus is the risk benefit for the patient, but not necessarily the economic value to society. When we develop medicines in the future it is important that we incorporate appropriate measures of value to society in the development program, because reality is that the authorities that decide the prize of medicines wish to understand the value to society and not just the value to the patient,” says Tine Bryan Stensbøl.

PROFILE

Tailored IT and Automation Solutions for the Life Science Industry For almost four decades, AN GROUP have assisted manufacturing companies in the life science industry, supporting and optimizing their production, QA, and validation processes by providing IT and automation solutions and consultancy services customized to meet the needs of the industry. Production within the life science industry, particularly the pharmaceutical industry, is characterized by extensive regulatory requirements and a rapid pace of change within both the industry and surrounding regulations. With many years of experience and some of the largest pharma and medico companies among their regular clients, AN GROUP knows all about the specific needs and requirements in the industry. ”We are specialized in production IT and automation systems customized for the pharma, medico, and food industry. We manage all the steps of the process, from needs analyses and development, to establishment, implementation, optimization and staff education, and we offer both consultancy services, turnkey solutions, and specially designed systems to meet the needs of every individual client. In these industries, every little procedure needs to be followed up and documented. Implementing the right IT solution to effectively support production means that all the data is collected and can be used for traceability and validation

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purposes,” says Managing Director Ole Okkels, and continues: “And traceability is not solely a question of ensuring that the manufacturer meets all current regulations. It also offers the possibility of optimizing the whole production process, giving a better overview and planning basis and minimizing the risks for failures and stoppages. For us at AN Group, it is important to always discuss with our clients these possibilities in connection with the implementation of traceability systems and other IT solutions.” Collaboration Partner Rather than Just Supplier High professional standards and thorough knowledge of the life science industries gathered through many years of experience have given AN GROUP a unique understanding of their clients’ businesses and their demands. “We are not the kind of supplier who just comes by and drops off a box on the floor. We work together with our clients and their staff and follow every project through. To successfully integrate a system in a company depends on teamwork and a mutual understanding and involvement throughout the whole project,” Ole Okkels explains. Making sure that every project is thoroughly implemented and that the client gets the full potential of their solutions is part of Validation Consultant Mette Rasmussen’s job. “Above all, IT solutions for these industries have to be agile – this is essential to meet the complex and shifting demands in this industry. It is of critical importance for the companies to be able to quickly implement new regulations and get the whole production process trimmed to meet new demands. No matter whether we are talking about living up to regulations, optimizing production, or opening up new production lines, it is important to know the full effect of every little change. The high demands for documentation

in this line aof business mean that these processes can risk taking up a huge amount of time. Customized and agile IT and automation solutions and professional consultancy assistance from the supplier, including failure mode effect analysis, ensure that this does not happen. Working in accordance with GAMP, GxP, and CFR11, we can assist our clients and act as a dedicated partner in all stages of production,” says Validation Consultant, Mette Rasmussen, and Managing Director, Ole Okkels, sums up: “We are proud that our clients perceive us as a partner rather than just a supplier. This reputation comes from years of experience and dedication to creating result-oriented solutions.”

Illustration: Ann Malmgren

By Malene Aadal Bo

Denmark has really become a pharma nation with a total export of nearly 85 billion Danish kroner in 2015 and a forecast of continued growth, especially within diabetes, diseases of the central nervous system, and skin diseases. Allan Skårup Kristensen, chief consultant of The Danish Association of the Pharmaceutical Industry (Lif), and Michael Lange, head of public affairs in Novartis guide us through the highlights of 2015 and point towards the trends worth watching in 2016.

What Were the Highlights of 2015? “This year it has been difficult to be a pessimist when one finds oneself in pharma,” begins Allan Skårup Kristensen. He is chief consultant in The Danish Association of the Pharmaceutical Industry and can look back at a year where Danish pharma and life science has thrived. Actually, pharma has had growth for many years and has even grown during the financial crisis and in all the years since. “Export has doubled in the past seven years, and everything suggests that it will double again over the next seven. At the same time, new figures show that the value

added per employee in the pharmaceutical industry is twice as large as in the industry in general, and pharma on its own had exports of nearly 85 billion Danish kroner in 2015. It is a big industry and a stable industry which is doing fantastically well,” says Allan Skårup Kristensen. The mood is just as positive when speaking with Michael Lange who is head of public affairs at one of the country’s big pharma companies, Novartis. In particular, he considers it a highlight of 2015 that the Danish politicians recognised the social economic importance of the life science industry.

Experience and flexibility With forty some years of experience from the pharmaceutical industry, Kjeld ClemmensenRotne at Trial- Support presents his insights and viewpoints as a consultant with considerable leverage. His company, TrialSupport offers contract research services, and while he collaborates with larger CRO’s in bigger projects requiring several consultants or special deliveries, he generally operates on his own – and with great flexibility on smaller projects, e.g. investigator initiated studies, or other projects

FACTS ABOUT

TRIAL-SUPPORT • Manages local as well as international clinical trials • Handling of Regulatory Affairs • Preparation of protocols, description of procedures, and design of clinical trial documents and files • Facilitation of co-operation between clinical research and the health care industry For more information, please contact Kjeld Clemmensen-Rotne Managing Director/Clinical Research Manager, kcr@trial-support.eu, www.Trial-Support.eu, Phone: +45 20 48 60 84

PROFILE

that are publically funded that may need support in project management, document handling, trial registration, regulatory issues, monitoring etc. “I have the experience and capacities to contribute at many different levels in a clinical research project, and in principle take part from idea to publication,” Kjeld Clemmensen-Rotne says and carries on, “In particular the practical lead on projects may suffer in publicly funded clinical research, as the focus of hospitals remains the clinical production. This is where I act as project manager providing the link between the investigators and their staff and the health care professionals who are conducting the trial” Additionally, Trial-Support operates in international set ups: “Being the coordinating national centre in a large scale international research project is prestigious for the hospitals, however also binding. It requires professional handling and strong project management, which is what Trial-Support offers,” Kjeld Clemmensen-Rotne explains. In addition to his close collaboration with a couple of specialized CRO’s, Trial-Support also works closely with the Danish GCP Units.

“It has created an increased focus on ensuring that the industry has good conditions. For example through NEXT (National Experimental Therapy Partnership), with the goal of attracting clinical studies to Denmark. In 2015 alone, it has resulted in more than 40 additional new studies in Denmark and with those come opportunities, jobs, and technology transfer,” says Michael Lange. In 2015, it was decided to establish an equivalent initiative for medtech, which in the same way will boost research and development, and create jobs and growth in Denmark. Allan Skårup Kristensen and Michael Lange agrees however that the government’s decision to significantly cut basic research in Denmark is a big mistake. “The industry needs the Danish public sector to contribute with talented graduates and good basic research. When one cuts these things, it hits us right in the chest. In the short term, we risk that companies move their research away from Denmark. In the long term, it can slow down the entire pharmaceutical industry,” says Allan Skårup Kristensen.

Trends to Watch in 2016 When the politicians decide to cut research so drastically it must, according to Allan Skårup Kristensen, amongst other things be because the industry has not been able to show how crucial research is. Therefore, a close collaboration with the politicians is certainly one of the association’s focus areas for 2016 – in particular, the desire to gather the stakeholders and make a proper strategy for pharma and life science in Denmark. “They have had great success with it in England, and both Sweden and Norway are on their way with similar strategies. Also, Denmark needs a collective plan for what we want, and how we can create the best framework for the industry,” says Allan Skårup Kristensen, who has initially experienced a great deal of support for the idea. Michael Lange from Novartis welcomes the idea and has two suggestions as to what ought to be discussed in connection with such a strategy. The first is how to create real opportunities for treating patients as individuals. “The Danish Regions is planning to sequence the first 100,000 citizens’ genomes. This is yet another step on the way to making personalized medicine a reality. The exciting thing is then whether one is able to create the frameworks for that – for example, will the new hospitals be designed so that a patient with heart failure, COPD, and diabetes will no longer have to be treated for their illnesses individually in separate clinics, but instead experiences a customised treatment?” asks Michael Lange. He continues: “And can we imagine that the same interdisciplinary mind-set will spread to the tendering

system so that, in the future, regions can purchase medicine as a collective portfolio to a group of patients with certain illness combinations?”

New discussion around medicine prices Novartis has already decided to do pilots on this in the year to come. The idea is that the pharmaceutical companies do not only sell one product at a time but are involved in the considerations about the best combination of products to patients with multiple illnesses and get the opportunity to sell medicine in specially designed portfolios. “It could mean a larger volume in our sales and therefore, also lower the prices. And it could raise the quality, because it is experts in the individual products who together select and combine the portfolios,” says Michael Lange. According to him it is absolutely possible that they in this way – to a greater extent than the individual doctor who must combine on the basis of what is on the shelves – are able to find the combinations that together give the best results and fewest side effects. Another thing that Michael Lange is looking forward to in 2016 is the chance to shift the current debate about medicine prices from being exclusively focused on the purchase price to being about quality and the overall economy. “If a product is better, then it can easily be cheaper in the long run. It is difficult to make the calculations in the way that it is currently organised, where the initial expense is paid by the region, while home help, rehabilitation, sick pay, and pensions are paid by councils and the state. But I believe that the numbers will look different if one includes all of these things,” says Michael Lange.

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Pharma at a glance • Danish pharma is the second largest in the world in terms of population – surpassed only by Switzerland. • It employs 27,000 people and the value added for one employee in pharma is twice a great as in the industry in general. • Pharma represents 12 percent of Danish exports, counting almost 85 billion Danish kroner in 2015. And it is expected to double within the next 7 years. • Danish pharma is specialized within diabetes, diseases with the central nervous system (depression, Parkinson’s, and schizophrenia), and allergy and skin diseases. Source: The Danish Association of the Pharmaceutical Industry

PROFILE

IRW

– one of the biggest Nordic CROs From the very beginning in 1999, it has been the ambition of Ingela Wiking, CEO of IRW Consulting, to create the preferred Nordic CRO partner. With offices in all four Nordic countries, IRW has become one of the biggest Nordic CROs, conductingclinical trials, non-interventional studies and medical device studies through all four phases. Depending on the client’s requirements, the staff is either outsourced or works on in-house projects. Our Nordic focus is an asset Over the years, the competition has increased, making it even more important to stand out to remain the preferred Nordic CRO partner. The CRO market has undergone a transition towards a more global focus among the big pharma clients as well as among CROs. More and more CROs are being consolidated, running offices all over the world and offering global clinical trials. By contrast, IRW has chosen to keep its focus on the Nordic region and consider it an asset. “Many of the big pharma companies are represented in Stockholm or Copenhagen, from where they cover the entire Nordic region. In my experience, our clients value the fact that we have a local focus and offices and personnel in all four Nordic capitals. We have the required

IRW CONSULTING • Business areas: Clinical Operations, Project Management, Regulatory, Clinical Data Management, Biostatistics, Pharmacovigilance and Medical Writing • Assignment range: clinical trial phases I-IV, medical device investigations, non-interventional trials and registry trials • Clients: Biotech, Medtech, big pharma companies and other CROs

expertise to quickly set up clinical trials and determine the most beneficial and cost-effective set-up. We know the clinical research environment,” says Ola Jeppsson, vice president, IRW Consulting. Even CROs have to be innovative Besides the knowledge of the Nordic clinical research environment, it is key to IRW Consulting that they are responsive and innovative. “In a competitive market, one of the best ways to achieve success is by meeting the clients’ needs by being flexible and able to innovate and adjust accordingly. That means hiring people according to our clients’ needs and keeping abreast of the latest technology. We have to be able to offer our clients technological solutions that meet the need for variation in complexity and price,” explains Jeppsson. “A concrete example of how a client’s need has evolved into a new technological solution is electronic patient diaries. After FDA and EMA opened up the possibility of keeping electronic patient diaries, clients requested the service. We have developed an ePRO system (electronic Patient Reported Outcomes) and are now able to offer the service to other companies,” says Jeppsson. Preparing for the future In spite of the strong competition, Jeppsson believes that IRW has a strong position in the market. Nevertheless, he recognizes that they have to keep being innovative and flexible as the market situation could quickly change. “We want to be the preferred partner when it comes to conducting clinical trials in the Nordic countries. That’s why we will keep hiring the best employees and be the best at outsourcing personnel. And we will keep developing our skills, making us even better at conducting clinical trials and addressing the clients’ challenges. We will keep growing in the Nordics. But in order to succeed, we have to be extremely responsive and adaptive to the clients’ needs,” says Jeppsson.

• Founded in 1999 • Number of employees: 50 • Number of current ongoing clinical trials: 40 • Number of outsourced employees: 25

Illustration: Ann Malmgren

By Karina Kvisgaard

This year is expected to be the year when the long awaited change in procurement strategy finally catches on and the focus shifts from price to added socio-economic value, as the medical and laboratory device industry has been calling for for years. Peter Huntley, director general in Medicoindustrien, and Henrik Christensen, Chairman of the Board in DiaLab (the Danish Diagnostics and Laboratory Association) look back at 2015 and share their expectations for 2016. What Were the Highlights of 2015 Denmark is one of the leading countries in Europe when it comes to developing and producing medical devices. Taking the size of the Danish population into consideration, Denmark is the second largest market for medical devices in Europe. According to Peter Huntley, director general in Medicoindustrien, the rising number of patients is currently putting the Danish healthcare system under pressure. This has resulted in a strict price focus in connection with procurements, making the market for medical and laboratory devices extremely competitive. On the bright side, it is also a growth factor for the medical and laboratory device industries who offer both treatment options and diagnostic tools for identifying the optimal treatments: “The rising number of people requiring treatments creates a potential growth in the market, and the Danish market is a growth market for the medical device industry. However, it is a very competitive market which has been dominated by a strict focus on price, and the market has consolidated. In 2015 though, the focus started to change somewhat towards added socioeconomic value,” he explains. In his opinion, the Danish – as well as the Scandinavian – procurement culture is at a crossroad: “The question is whether we are going to continue the current strategy

which focuses solely on which products are cheapest, or if we would like to create an innovative market? From our point of view, the latter is definitely to be preferred, as the consequence of the current strategy

may be that patients do not have access to the best diagnostic tools and treatment devices,” Peter Huntley explains. At DiaLab, Chairman of the Board Henrik Christensen agrees

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that, overall, 2015 was a good year for the diagnostics and laboratory device industry as well. However, there are also challenges to overcome, he says. “For instance, we still see that investments in diagnostics and laboratory devices are delayed, because the decision processes that changed in connection with the counties being replaced by the regions are still not completely in place. Things are done quite differently from place to place, but we expect this to stabilise in the future,” he says.

Trends to Watch in 2016 Looking at 2016, the two see challenges for the industry to overcome, but also a positive change towards a more socioeconomic approach to procurements, which will benefit the industry. New regulations for medical devices are on their way, which will, most likely, result in more fixed boundaries and better control with medical and laboratory devices. Laboratory devices are facing a whole new classification. This means stricter rules for clinical documentation, recycling of devices, use of phthalates, etc. In particular, Henrik Christensen predicts the changes to the directive for in-vitro diagnostics will be an important challenge for the companies operating in the diagnostics area of the industry in 2016: “The directive for in-vitro diagnostics is being changed, and this can have negative consequences for the diagnostic device industry. There has been a tendency to apply the same strict rules that apply to pharmaceutical products, which poses significant challenges and does not make sense as it is a completely different world,” he says. “The strict regulations are meant to protect the patients, but we don’t need the same strict regulations for diagnostics as for pharmaceutical products. Actually, new stricter regulations for diagnostic devices may end

Medtech and Laboratory Industry • The medical device industry consists of companies that develop, manufacture, and sells medical devices. • Medical equipment is basically all the equipment that we see, when we go to the doctor or are admitted to a hospital. It also includes the aids used in nursing homes and in home care • Medical device companies in Denmark,Danish medical device companies abroad and DiaLab members have a turnover of more than 52 billion DKK per year and employ more 31.000 people • App. 300 Danish companies has medical devices as their primary business area • The Danish medical device industry mainly consist of small and mid size companies

up being a serious disadvantage for the patients, as diagnostics will become more expensive, which will lead to a more restrictive use and, consequently, fewer people will get the correct diagnosis and optimal treatment on time. Earlier diagnosis means considerable savings, so it is a disadvantage for both the patient and society,” he explains.

Great Expectations to New Procurement Law According to Peter Huntley, partnerships and socioeconomic analyses are important ways of improving the Danish healthcare system. And, therefore, he has great expectations for the new procurement law that came into effect in Denmark 1 January 2016. “The way procurements take place today is a big challenge for our industry. There are a lot of rules and tenders of poor quality. Companies spend a lot of time and energy on the tenders, taking into consideration the limited value of the tender and what society gains from it. Hopefully, the new procurement law will solve some of this by paving the way for a better dialogue and cooperation in connection with procurement of medical devices,” says Peter Huntley.

Maybe a More Socio-economic approach? According to him, we are also starting to see a change in the way medical, laboratory, and diagnostic devices are assessed towards a more socio-economic approach where the value for the patient plays a much greater role and the price is viewed in that context. The focus is more on creating value for the patient than looking solely at the price. This change started in 2015 and is expected to continue in 2016. “In 2016, the focus will be on creating more value in the procurement, and hopefully that will lead to a new agenda which will create a win-win situation for all parties – the authorities, healthcare professionals, patients, and producers,” he says. Henrik Christensen agrees: “Overall, there is a tendency towards a more pragmatic approach, and that is one of our hopes for 2016: that 2016 will be the year where the long-awaited change in procurement strategy finally catches on, and the focus shifts from price of product to the socio-economic value that the product gives,” Henrik Christensen says. And despite the challenges that the diagnostic and laboratory device industry faces, he is optimistic about the future: “The diagnostic and laboratory device industry is continuously granted appropriations from the pharmaceutical industry as well as public funding, which enables us to keep developing new devices and techniques. However, it is not a very profitable industry and hard work is required. But we expect 2016 to be quite okay, and we have a positive view on the future,” Henrik Christensen says.

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By Louise Bruce

After some difficult years and consolidation of the market, the Nordic CROs are back on track. They are still under pressure from the large international CROs and from Eastern Europe, but representatives from three of the leading Nordic CROs are optimistic about the future. Walk with them through the highlights of 2015 and the expectations to 2016. What Were the Highlights of 2015? Pharmaceutical, biotech, and medical device companies need assistance to facilitate their ongoing clinical trials and therefore seek expertise from contract research organisations (CROs). CROs have a wealth of experience in dealing with project management, regulatory processes, quality systems, and many other services, which allows them to quickly integrate into the operations of the sponsor organisation. “The number of CROs in the Nordic region has increased over recent years. However, we have seen some mergers and competition is tough. You have to be good at what you do, be cost efficient, and most of all gain trust,” says Tania Persson, director of business development at A+ Science. According to the report published by SwedenBIo with support from Vinnova in December 2015, there was an accumulation of projects in phase I & II, which is expected to increase even further. Yet, the number of phase III trials has decreased. “Nordic CROs are mostly carrying out clinical trials within biotech. But the Nordic CROs also participate in large international clinical trials within big pharma as subcontractors to European and international CROs that are not present in the Nordic countries,” says Ola Jeppsson, vice president in the Nordic CRO IRW Consulting. “Overall, the Swedish drug development pipeline has moved forward. However, we have to admit that the

Contract Research Organisations • CROs conduct research and development on behalf of other companies within pharma, medtech and biotech. • Clinical CROs conduct clinical trials from design to execution, monitoring and reporting, and they outsource clinical research professionals to conduct clinical trials in-house at pharma and biotech companies. • The Nordic CRO market is characterised by a number of small CROs and a few big Nordic and international CROs.

projects today are shorter – multinational trials which lasted for several years are far less today,” Tania Persson explains. “Like 2014, 2015 was better than the previous years. It seems the number of clinical trials has stabilised. It was the same in 2015 as in 2014 – not nearly as high as in the 00s, but much better than when the financial crisis was at its peak,” says Klaus Juel Olsen, CEO in the Nordic CRO Larix. Ola Jeppsson agrees: “Looking back at the past five years, the number of clinical trials conducted in the Nordic region has decreased, but in the second half of 2015, we actually experienced quite a rise in the number of new projects in our company,” he says.

Trends to Watch in 2016 According to Klaus Juel Olsen, the future is promising for the Nordic CRO industry, but a return to the golden days in the 00s is not likely. There has been a consolidation in the market during recent years, and the large international CROs are still winning market share: “The CRO industry is dominated by the large international, typically American, CRO companies with only a handful of Nordic CROs. It is a tough market, and we are pressured by the large international companies that have better access to the pharma industry, and I think it is possible that the Nordic CRO sector will consolidate in the future,” Klaus Juel Olsen says. Tania Persson adds: “We notice that more and more companies tend to turn to CROs for assistance. Outsourcing of our qualified consultants by pharma/biotech companies has become very attractive,” she says. “We see an increased number of inquiries to hire our consultants, which indicates that the companies need to strengthen their clinical teams due to workload, which is of course positive. The way our organisation works today has obviously attracted the market, so the size of the company does not matter, it is the way you work and deliver your cost efficient services, with a good relationship from start,” she continues. Tania Persson has noticed that the phenomenon

‘preferred partnership’ is changing gradually. Big pharma has started contacting and contracting smaller CROs. We feel they have taken different strategies, which is extremely important for the survival of small CROs.

Facing increasing competition Competition from Eastern Europe is increasing, and for the Nordic CROs to compete it is important to focus on high quality, our ability to recruit patients and timely delivery, while competing on price is a challenge. “When it comes to attracting large international clinical trials to the Nordics, it is also important to have researchers of high international standard and a smooth and professional processing of applications. And we have that,” Klaus Juel Olsen says. “Furthermore, to compete with the large international CROs, it is essential to have a Nordic organization and be present in the Nordics, not just in one or two countries”, Ola Jeppsson says. According to Tania Persson, the focus for the clinical

trials has shifted to some extent: “Last year we saw an increase within oncology and I believe that this will continue over the next years as oncology is high priority among the big pharma companies,” she explains. All in all, both Ola Jeppsson and Klaus Juel Olsen are optimistic about the future for the Nordic CROs. “Another important part of the Nordic CROs business is outsourcing of personnel to pharma companies present on the Nordic markets. Here, the Nordic CROs, with our local presence, have an advantage,” Ola Jeppsson says. Tania Persson agrees: “The Nordic CRO market, including early- and latestage development services, is growing. As seen in recent years, pharma companies are continuing to focus on cutting costs and shortening development timelines without compromising quality. These factors are driving increased business for CROs due to the potential flexibility offered by these arrangements. We believe that 2016 will continue to be just as positive as 2015,” she says.

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PROFILE

Trust means everything in clinical research The research park Scion DTU north of Copenhagen is the basis of the Nordic division of Ecron Acunova – a clinical CRO that calls itself medium-sized in a global context and which is proud of having played a decisive role in more than 200 marketing authorizations over the years. Leading the Nordic division is Erik Carp. He has extensive experience with outsourcing tasks to CROs before he in 2015 was recruited to Ecron Acunova. Therefore, he has an excellent understanding of the needs and requirements that both larger and smaller companies have when outsourcing clinical trials. “In my previous positions within clinical research, trust was absolutely crucial. Trust that the CRO understood my company’s needs, trust that it could deliver the right quality at the right time. And not least trust that, regardless of the thorough preparation, the CRO could solve the problems that often arise in clinical trials” says Erik Carp. Today, it is Erik’s conviction that it is precisely Ecron Acunova’s ability to deliver this trust and a strong track record which provides peace of mind for new business partners. For 30 years, Ecron Acunova has played a key role in approx. 1.300 trials from phase I to IV at 13.500 sites worldwide. Ecron Acunova is known for excellent quality service and this has made sponsors to return with new projects on a regular basis. “We are a strong partner in clinical trials. We have the network, global reach, a lean organisation with competent and accountable people who act quickly and effectively, and at the same time we have a solid foundation in European traditions and quality standards” says Erik Carp. Until today, Ecron Acunova employs

ABOUT

ECRON ACUNOVA A/S For more information: Ecron Acunova A/S: www.ecronacunova.com Take Solutions: www.takesolutions.com

approx. 400 experts worldwide and has offices and research facilities throughout Europe, Asia, and the Americas. The Danish office and the strong global network are some of Ecron Acunova’s major strengths in the Nordic region. “When a sponsor decides to outsource their clinical trials, it mainly happens for three reasons: they need additional external manpower resources or they lack the highly specialised knowledge required for planning, carrying out, and documenting the results. Thirdly, they lack access to the right doctors and patients in adequate numbers to create good and valid results” says Erik Carp. This is offered by Ecron Acunova which, in addition to contacts in the USA and Europe, also has a strong network in India and a number of other Asian countries. According to Erik, the needs of Ecron Acunova’s customers are very different, as they range from big pharma companies to small biotech and medtech companies. Some lack expertise in writing protocols, others need assistance for establishing and monitoring the trials. Some are in doubt about handling and analysing trial data correctly, and others need our experts to compile the results to meet the regulatory authorities’ requirements. “But regardless of what the need is, I know that I have colleagues who are experts in exactly that. And regardless of the task’s size, we do everything we can to deliver exactly what is needed to help the customer develop pharmaceuticals or medical devices with the potential to help lots of people. This is what drives us” concludes Erik Carp. “We manage projects for clients and here it is important that we have local project management and monitoring in many countries. We also have centralized functions such as data management, statistics, medical writing and pharmacovigilance to increase efficiency and lower costs” says Erik Carp. Ecron Acunova is now in the process of merging with TAKE Solutions and

Erik Carp on an exciting journey with Ecron Acunova and expansion of clinical development and IT services.

this will bring new synergies in services for the life science industry worldwide. TAKE is a global IT solutions and service provider with end-to-end solutions across R&D, commercial, and operations for Life Sciences. “We are expecting a very positive development within the new TAKE family which will have around 1.300 employees worldwide” states Erik Carp.

PROFILE

Intangible Resources are The Driving Force When Choosing a CRO Partner Facility constraints, physical capacity of equipment and cost effectiveness are reasons for pharmaceutical and biotech companies to choose CRO outsourcing. Today intangible resources can be added to the list of reasons. DB Lab confirms the trend. As a CRO laboratory, DB Lab has a solid experience in carrying out analytical services for the life science industry. According to Michael Wamberg, Sales Manager at DB Lab, outsourcing has proven effective at reducing operational and infrastructure costs to fit market demands. It is often such a simple, yet real problem as physical capacity that turns out to be the driving force. It would simply cost too much moving to bigger facilities to accommodate the extra equipment and staff needed. “With a well-equipped laboratory and 2000 m2, we often become the choice instead of investing in internal expansion. But it takes more than a well-equipped laboratory to fit the need. The value for our customers lies in the overall way we handle their problems, and the actual analyses are just a small fraction of that,” Michael explains. Do What You Do Best Outsourcing to a CRO means gaining a niche partner with specialized experience in their field. That gives both partners a chance to focus on doing what they do best, which gives both companies leverage and a competitive advantage. Ulrika Rosdahl, Business Developer at DB Lab, knows how to combine the advantages

FACTS ABOUT

DB LAB

GMP-authorized CRO laboratory founded in 1985. 40 highly skilled employees and a 2000 m2 wellequipped laboratory. Offers customized services within: • Chemical and microbiological analyses • Method development and validation • Pharmacopoeia analyses • Stability studies For more information: www.dblab.dk

of being a niche business and a relatively small company to fit the needs of their business partners: ”There is a real advantage in being a small CRO. The concept smallness in business means responsiveness and expert help in our market field. Working with life science products all the way from discovery to released product, we gain specialized know-how about this type of product life cycle. With this expertise we can assist our customers in the task of moving a new drug or medical device from conception to the market, without the customers having to maintain a staff for these services. This means cost efficient trouble shooting, professional sparring and customized solutions that add value for our customers. We profit from creating value for our customers,” Ulrika concludes. Advantages in Having a Nordic Partner Coming from cost efficient outsourcing solutions from countries like China, amongst others, where wages are low and competitive, businesses are now returning back to Europe and especially the Nordic countries, and there is a reason for that: “Of course you want to cut down the costs and often choose the cheaper price-per-analysis-alternative. Some of our customers have tried that, but long-term it ends up being an expensive solution, because in terms of knowledge and professional advice these contract labs are not competitive,” Michael Wamberg explains, and Ulrika Rosdahl continues: “The Nordic culture plays a big part when businesses choose their partner. Critical thinking, asking questions and providing solutions is part of our Nordic DNA. Furthermore, our honest work ethic is a strong resource. We have a customer who asked for a specific analysis for their product. We were of course able to perform the analysis, but we could tell them that this analysis was only required for products approved for a completely different purpose. That saved them un-

Ulrika Rosdahl, Business Developer at DB Lab

Michael Wamberg, Sales Manager at DB Lab

necessary costs. Being a GMP laboratory, we’re always up-to-date with developments and regulations on the market and since we do not have our own production, we focus entirely on creating value for our customers. In the end, the advantage of having a Nordic CRO partner often means a quick and safe route to the market for our customers’ products.”

PROFILE

Pipeline Biotech - The Fast Track through Early Drug Discovery Phases With less than 1 in 5.000 candidates ever making it to the market, professional, cost-efficient and rapid tests and research results are essential in the selection of drug candidates for further assessment and development. The Danish CRO Pipeline Biotech has specialized in offering services within biological research in the early drug discovery phases. The company carries out in vitro and in vivo studies on toxicology, efficacy, and pharmacokinetics covering cancer, inflammation, and customized disease models. CEO Klaus Kristensen founded the company in 1999: ”There was a gap in this field, since too few CROs assisted in early preclinical research. With so few compounds ever becoming marketable drugs, the need to effectively get through the earliest stages of drug research is evident, and there was this bottleneck drawing out the process and increasing costs. This meant that both larger and smaller companies with good ideas spent way too long in the preclinical stages or at times gave up on their projects,” Klaus Kristensen explains. Therefore, Pipeline Biotech has from the beginning focused on meeting the industry’s need for progress and rapid study turnovers and works with a 14/14 policy on lead times keeping the timeline on standard studies to no more than 14 days for study start up and a maximum of 14 days on study reports as well.

FACTS ABOUT

PIPELINE BIOTECH CRO specialized in preclinical biomedical pharmacology. 15 years of experience and departments in Aarhus and Skåne. Offers GLP/GMP compliant contract research within: • Cancer, inflammation, and customized disease models • Pharmacokinetics, toxicity, and efficacy • Screening and GMP quality control programs For more information: www.pipeline-biotech.dk

“Time and flexibility are of immense importance to our clients. Pipeline Biotech, is geared precisely to work with these processes, allowing us to offer rapid lead times and at the same time always be able to take on rush jobs,” Klaus Kristensen says, and continues: “Our success is based on two factors: one being fast and flexible services and the other being trust. We emphasize openness and close collaboration. Our clients are always welcome in our facilities and they can be involved in designing studies and specialized disease models if they wish. In general, we act as an extension of their own research department. This openness, together with our professional and dedicated staff, generates a trusting and giving collaboration. And I actually see this as the best part of my job – I get involved in all these exciting and promising projects, much more so than if I worked in any one company. I do not forget these projects, and our clients do not forget us and our help in the early, fumbling steps of the projects either. From time to time, we receive greetings and thank you notes from clients when their projects make it to the clinic. That is always amazing, because after all that is the purpose of all our work. Expanding into Lead Optimization and Companion Diagnostics Recently, Klaus Kristensen and Pipeline

Biotech have been granted a considerable loan from The Danish Growth Fund, a state investment fund, and now plan to expand their services and also assist in the hit to lead process and in the development of companion diagnostics. “At the moment, more and more companies are starting to see the advantages in outsourcing and, with the growth in the field of personalized medicine and the regulatory requirements for companion diagnostics within this area, the demand is not getting any smaller,” the dedicated CEO says, and continues: “We wish to meet this demand and, at the same time, it is logical for us to go into companion diagnostics, since it is most effective to think in and develop these tests at an early stage. At the same time, this loan gives us the opportunity not only to cover the hit to lead stage of drug discovery, as we already do, but to offer lead optimization as well. And this is something I very much look forward to, to be able to take our clients one step closer to the clinic.”

By Malene Aadal Bo

Of Course You Should Outsource Clinical Trials – The Question Is How Far? It has become completely normal for Nordic life science companies to outsource their clinical trials to a contract research organisation (CRO). For the Nordic CROs, the challenge now is to show the customers what they can do to relation to the at first cheaper Asian competitors.

ntil 20 years ago, the vast majority of the clinical studies submitted to the Danish Medicines Agency were carried out in Western Europe or USA. Today, Chief Medical Officer Jens Heisterberg sees applications based on studies from almost all over the world and performed by investigators, who can just as likely be Eastern European, Indian, or South Asian as they can be Western European and American. The globalization of clinical trials is, in other words, nearly total and has meant that it is more important than ever that the Nordic CROs cultivate and highlight the qualities that will make companies choose them instead of, for example, Asian competitors. “Previously, companies perhaps had an idea that the quality of clinical trials conducted outside the Western world was dubious and that the trials, therefore, must be located in Western Europe and North America. But this is no longer the case. Today, we see high quality trials carried out in, for example, Southeast Asia and South America and trials from Europe that are problematic. And I don’t have reason to suggest that the data from pharmaceutical trials that we see are of a better or worse quality in one region of the world rather than another,” says Jens Heisterberg. This doesn’t mean though that the Danish Medicines Agency is indifferent as to where the clinical studies are performed and by who.

Because people are different Applications based on studies performed outside of Europe often raise more questions than those carried out in, for example, Denmark. Primarily because people, cultures, and medical practices are different. “Depending on race, we metabolise certain pharmaceuticals differently, which can have an impact on

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.

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

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

the dosage, effect, and side effects. According to culture, we experience and describe side effects differently, which can make results more difficult to interpret. And depending on practices, there can be differences in how a disease is diagnosed and treated, which can mean that the patients being treated cannot, in reality, be readily compared,” Jens Heisterberg explains.

“Overall, i believe that Denmark is the perfect trial country... for reasons that we simply have to prommote and become even better at telling” All in all, things which potentially can mean that one cannot necessarily give the tested treatment to a European population and expect the same result as in the trials. “And it is of course crucial that one can do that. So, when the studies are performed outside of the EU, it means that we have to think about it very carefully and consider all of these things,” he says. According to Jens Heisterberg, this means in practice that the European authorities, in certain circumstances, will prefer that the tests are supplemented with trials on a European patient group. And, for example, that extra analyses of the trials are required in order to clarify whether the results from a given region of the world can be applied to the European market.

3 things to be aware of Even with these conditions, there are, however, great and increasing competition from the Asian CROs. In particular, because the costs are initially much lower, and because the large populations often mean quicker and easier access to the right number trial participants and the right kind. Some CROs solve the challenge by forming close networks or even merging with Asian companies. For those that do not actually have an integrated Asian division in their company, help can be found with organisations such as Pacific Bridge Medical. Their task is to help companies that are considering to outsource clinical trials to the Asian market and CROs that want to form a network with Asian colleagues. In particular, they highlight three areas to be aware of.

The first point is that clinical trials in Asia often end up being more expensive than first anticipated. Namely, there are often a range of unexpected expenses including various approvals, experiments for transport of medicine and other equipment for the trial venues, translation of the often comprehensive amount of instructions and other documentation, expenses for the transport of patients and so on. The other is that the total bureaucracy can be significantly more demanding and slower than in one’s home market, and overall that can delay the entire process. And last but not least they warn that, in connection with clinical trials in the Asian market, it is important to be particularly careful with things such as confidentiality agreements.

Maybe One Should Just Stay at Home Kristian Teglkamp is a head consultant at the Capital Region of Denmark and clinical coordinator in the Danish regions’ special initiative to attract clinical trials to Denmark. According to him, there are a number of things that the Nordic CROs can highlight when they have to argue why companies should place their trials in Denmark or the neighbouring Nordic countries instead of Eastern Europe og Asia. “Overall, I believe that Denmark is the perfect trial country,” he begins. “The doctors are in an international league, which makes them good partners. The patients are positive and take responsibility for producing valid data. The hospitals have the right equipment which is already certified and the staff are skilled and competent users. The infrastructure is good, with minimal bureaucracy. And Denmark also has some completely unique databases,” details Kristian Teglkamp. In particular, the CPR register coupled with bio-banks and the additional health data make Denmark ideal as what Kristian Teglkamp calls “a laboratory for testing hypotheses.” “By combining the registers, one can supplement one’s clinical trials with hypothesis testing, and one can get a comprehensive knowledge about the population’s health profile and a specific disease’s prevalence and development. All together something that is completely unique for Denmark,” says Kristian Teglkamp. According to him, Denmark is one of the countries in the world with the highest number of clinical trials per capita. “And there are of course good reasons for that. Reasons that we simply have to promote and become even better at telling,” concludes Kristian Teglkamp.

•

PROFILE

May We Give You Some Advice? – When You Start, Start Right Even minor errors can cause delays in development when companies are in the process of testing a new medical product or getting it approved for the European market. This is a reality known by IWA Consulting, who specialise in advising companies in meeting the authorities’ requirements. The list of rules, requirements, and regulations that govern the global legislation around pharmaceuticals is very long and it quickly becomes a full-time job just to keep track of the constant changes. One of the big mistakes that you can make as a pharmaceutical company is to miss the opportunity to get all the regulatory aspects “right from the start.” “Even small mistakes with regard to being compliant with the authorities’ requirements can cost companies delays, extra studies, and further documentation. My experience shows that it can really pay for itself to get the regulatory aspects in place from the very beginning so that the documents generated during the development phase can also be used in the marketing authorisation application and are eCompatible.” This is according to Connie Lyngbek Thestrup who is managing partner in one of Denmark’s largest regulatory affairs consultancy companies, IWA Consulting. She sees companies outsource large parts of the documentation handling and the work in collecting applications in eCTD format to companies in, for example, Asia.

FACTS ABOUT

IWA Consulting • offers medical and regulatory affairs services in the EU and US. • offers a complete portfolio of regulatory and medical affairs services to support the successful development and timely registration of human medicines, including originators, generics, biotech products, and medical devices. • was founded in 1997 and the owners and management partners are Lillan Rejkjær and Connie Lyngbek Thestrup. • employs 20 regulatory experts. For more information: www.iwaconsulting.dk

These companies can initially solve the task both quickly and cheaply. “You will get what you pay for. If you initially choose the cheapest solution, then what is done is exactly what is asked for. But it is not carried out by an expert who can advise you and who spots mistakes and improves the end result along the way,” says Connie Lyngbek Thestrup.

As yet more companies recognise the value of strong and competent regulatory advice, IWA Consulting has grown from a one-man company to a consultancy company with more than 20 employees. IWA Consulting offers regulatory advice, from regulatory strategies, regulatory tasks and assistance from the early development phase to the submission of the final marketing authorisation application and subsequent maintenance of the products, where everything is completed with a view to being used in an electronic marketing authorisation application. IWA Consulting itself compiles electronic applications in eCTD format in their own publishing software. “At IWA Consulting, everything is done by experts who constantly keep in mind what the different studies have to be used for and in which context the documentation has to be used. That gives an exceptional quality and a much better process for our customers,” says Connie Lyngbek Thestrup. A number of customers are small start-up companies, who often hire IWA Consulting as consultants for the entire development process so that they are sure of having the necessary regulatory competencies and the documentation completed at the right time. Others are medium-large companies who likewise buy “the whole package” in order to make sure that they meet the often changing requirements. In addition, there are a

number of IWA Consulting’s employees who are continuously outsourced to some of the country’s largest life science companies, who in particular contact them when they are lacking staff or enters new product areas and concepts outside of their own core competences. “Regardless of size, our customers benefit from having a partner who is completely up-to-date with the regulatory guidelines and knows how to align with the authorities’ requirements. We have a pharmaceutical and biotechnological professionalism that make us able to advice in relation to development and clinical testing of the products. And not least we offer solutions, that are lasting when the documentation in due course has to be used in a marketing authorisation application,” says Connie Lyngbek Thestrup. Here she is, amongst other things, referring to the focus that IWA Consulting has on producing reports and documents in formats that can easily be used in electronic marketing authorisation applications. This is already now obligatory for marketing authorisation applications in the EU and US, and within a few years also expected to become obligatory for clinical trial applications for permission to carry out clinical studies with non-approved pharmaceuticals when it becomes a standard in a few years. “We have ready to use templates which comply with the requirements for eCompatibility and which enables usage of the documentation directly in the eCTD format - it’s about “when you start, start right,” she concludes.

PROFILE

Finding a CRO Partner Fit to the Task Makes All the Difference Having found their ideal size, securing fast study start-ups, tailor-made solutions, and dynamic collaborations, the Danish pre-clinical CRO, BioAdvice, are focused on strengthening their expertise within their core areas, aiming to offer their clients an even more rewarding collaboration. “Our mindset has developed from being a service provider to being a pre-clinical collaborator. Today we see ourselves as a member of our customers’ project team. This mindset is essential for our long lasting customer relationships. We invest time in understanding the needs of our customers and finding the best solutions. This requires a close dialogue from which both parties benefit.” These are the words of Lotte Martoft, CEO of the successful CRO BioAdvice, which since 2000 has assisted biotech and pharma with in-life research particularly within diabetes, dermatology, toxicology and medical devices testing. BioAdvice provides GLP and non-GLP rodent and non-rodent models and is highly specialized in conducting studies in non-rodents such as mini pigs, pigs, and dogs. “We see ourselves as an ‘animal power house’,” says the company’s new CSO Henrik Duelund Pedersen. “We have highly specialised personnel dedicated to ensure high ethical standards in the studies and we believe that unstressed animals is a key to generation of reliable in vivo data.”

FACTS ABOUT

BIOADVICE

A GLP and GMP certified Preclinical CRO specialized in rodent and nonrodent in vivo studies, with a special focus on flexible and fast start-up of tailor made solutions. Areas of expertise: • Pharmacokinetic and Pharmacodynamic Diabetes and Dermatology models • Surgical models for test of medical devices • Local toxicology/tolerability • Batch release tests For more information: www.bioadvice.dk

Lotte Martoft continues: “The size of the company makes it possible to provide contract research differently than our competitors. We deliver fast start-up and reporting and at the same time, we are extremely flexible. We do not have large administrative hurdles, our customers can quickly add orders and we are able to give every single customer professional attention. Close communication is essential in order to create customer trust resulting in a rewarding partnership. It is also very motivating for the BioAdvice team that we get the opportunity to be so involved in the projects and really experience that we can support our customers in their objectives and provide data to their decision making. The customer feedback we get is highlighting our unique enthusiasm and dedication combined with a professional technology platform, as an important factor for their selection of BioAdvice.” Specialized Knowledge and Close Collaboration Is the Recipe for Success The management team at BioAdvice are launching a new vision and strategy for the company. BioAdvice will expand the technology platform within certain areas securing a continued experts position in those. The areas of focus are diabetes, dermatology and device testing. “Our clients can rely on us as a partner offering sparring, trouble shooting and solutions. We want to be a preferred partner within our areas of expertise. We are developing new models internally and in collaboration with both universities and other research institutions,” tells Lotte Martoft. One area where BioAdvice has extensive focus is the creation of a new surgical unit, setting up specialized models, testing new medical devices, and advanced PK models. “We see an unmet need and are looking forward to grow in this area providing cutting edge technologies and

support to our customers,” says Henrik Duelund Pedersen and continues: “As take home message to our future customers I can say; “the more we are involved, the more you get out of our partnership.” So again, we are back to the close personal contact. Trust is a decisive factor when a company – be it a small start-up or a large international pharma – outsource their activities. Therefore, BioAdvice welcome customers to take active part in the execution of their projects as “hands on” or as auditors. “Providing customers with the option to oversee and take active part in their project, to experience our commitment and professionalism is a very central part of a good beginning and a rewarding partnership” ends Lotte Martoft.

57 Illustration: Ann Malmgren

By Malene Aadal Bo

A general growth in Nordic life science and especially the new European unitary patent means a busy time for lawyers and regulatory experts specialising in life science. Jakob Krag Nielsen, attorney-at-law at Rønne & Lundgren and coordinator for the Association of Danish Law Firms’ IP/life science special committee, Jesper Lykkesfeldt, attorney-at-law at Rønne & Lundgren and Kim Wagner, partner at IP law firm Plougmann Vingtoft lead us through the year just passed and the one ahead. What Were the Highlights of 2015? “The really huge revelation for IP law firms/ consultancies is the European unitary patent and the Unified Patent Court, which Denmark voted in favour of in 2014 and which we have spent 2015 preparing ourselves for. When it comes into effect, it will become much cheaper to obtain a patent and be more simple and cheap to enforce patents so that it will, to a much greater extent, become a realistic possibility also for small and medium companies.”

Such is the opening remark from Kim Wagner, who is European patent attorney and partner at Plougmann Vingtoft. According to him, the IP law firms have been kept on their toes in 2015 in order to follow the development of the unitary patent and to be able to advise and guide their clients in relation to the new conditions and possibilities. “With the unitary patent and the Unified Patent Court we get an entirely new legal remedy. A new possibility to obtain and defend patents throughout

Europe, which in particular smaller companies have in practice not had in the past. That will probably result in growth in the number of European patents, also with applicants from outside Europe,” predicts Kim Wagner. His speciality is cases where patents are in conflict, where there are attempts to make patents invalid, or where they must be defended or challenged. And he also expects many more of these kinds of cases, which he is looking forward to. “Such cases are often very complex and with a lot of money at stake, and where you really get to dive into the details. Those cases are ‘the Rolls Royces’ within this particular part of the IP law firm business,” he says. Jakob Krag Nielsen from Rønne & Lundgren and co-ordinator of the Association of Danish Law Firms’ IP/life science special committee also has the unitary patent as one of the previous year’s big events. “More companies can expect to have to defend their patents, and because there are very short deadlines in the new system, then one must be able to react quickly. Already now, companies need to be prepare how to

The Industry at a Glance • There are approximately 25 law firms specialising in life science in the Nordic region. • The sector mainly deals with consulting in three areas: Regulatory affairs, Intellectual property rights (especially patents and trademarks), Transactions

counter the lawsuits that will come, and many of them have already begun working on it in 2015,” he says. Another thing in 2015 that has increased the demand for advice was some new executive orders from the Danish Health Authority issued in late 2014. Among other things, the executive orders require

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greater transparency in relation to the co-operation between pharma and medtech companies and healthcare personnel. The new regulatory framework has made it even more complex for companies to navigate the rules, adds Jakob Krag Nielsen’s colleague Jesper Lykkesfeldt, also from Rønne & Lundgren. Otherwise, it has in particular been those who advise in relation to financing and sales who have been busy in 2015. “We have absolutely been able to feel that 2015 was a year where there was a breakthrough financially. Large licencing agreements have been signed, there have been stock market listings, and a number of other large deals have been done. It has made 2015 a good year for lawyers too,” Jakob Krag Nielsen sums up.

Trends to Watch in 2016 Jakob Krag Nielsen and Kim Wagner both agree that absolutely the most important reference point in the

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coming year will be the unitary patent. But in addition to this, they name three areas which are particularly interesting. The first is greater requirements for patent applications: “There has been a tendency within biotech in particular that patent applications have been made based on an idea of something that perhaps one day can become something. But in 2016, one cannot get away with receiving a patent based on broad wordings and rough ideas. To an increasing extent, one must have ‘something in one’s hand’ and a proof of concept before the authorities approve the patent,” says Kim Wagner. He therefore advises his clients to wait with applying until they are further along in the development of an idea and a product, in contrast to just a few years ago. “It is actually both sensible and healthy that the authorities now refuse the very theoretical applications and require that one must at least have some experimental indications that an idea works. It is just something we all must get used to,” he says. Something else that the branch must get used to is that the tempo is increasing. The technologies are developing and with that also the knowledge that advisors must be in possession of. And with the technological development follows requirements that agreements and collaborations are signed much faster, because otherwise the momentum is passed.

“More companies can expect to have to defend their patents, and because there are very short deadlines in the new system, then one must be able to react quickly”

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“Not only must we learn to regulate the many new forms of collaboration which arise in life science, we must also be able to draw up the contracts very quickly. Years ago it could easily take half a year to work out Renrumsannonce 2.indd 1

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a such an agreement – today, we have to be able to do it within 24 hours,” says Jakob Krag Nielsen and continues: “One of our challenges with this is that it requires a great deal of experience and expertise from everyone to be able to react so quickly, plus that no longer do we only have to be exceptionally good at our profession, we must also be very good negotiators. They are exciting challenges, but they also make it much harder to be new in the branch and therefore in the end it is also difficult for companies to recruit people.”

Data poses another great challenge The last tendency, which according to the experts requires particular focus in 2016, is the necessity to prepare for the new EU General Data Protection Regulation (GDPR) expanding requirements and conditions for the processing of personal data. The GDPR is expected to come into force in a few months and businesses and public authorities must be in compliance with the new requirements before

spring 2018. The GDPR tightens the requirements for processing, places substantial accountability obligations on data controllers to demonstrate compliance, introduces new obligation to safeguard personal data and to protect individual’s rights and increases the sanctions for violations considerably. According to Jakob Krag Nielsen, the new levels of fines alone means that companies will need to be interested in how they can be absolutely sure that they are complying with the rules. “And it is complex cases which amongst other things hits companies and products which were previously not so tightly regulated – for example, in medtech. So we expect that a number of our colleagues will use 2016 and the coming years to advise companies on how one collects, stores, and exchanges data in just the right way,” ends Jakob Krag Nielsen.

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Illustration: Ann Malmgren

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The growth in life science is having a positive effect on those who make a living from recruiting people to the branch. At the moment, the challenge is bottlenecks, because the demand for certain employees grows incredibly quickly. Morten Islin, partner in Compass Human Resources Group, and Søren Bregenholt, vice president of Novo Nordisk and chairman of Medicon Valley Alliance, share their take on 2015 and what to expect from 2016.

What Were the Highlights of 2015? “For us who make a living from recruiting in life science, 2015 has been a good year. There is growth and new optimism, and as the companies over several years have secured their finances by saving and cutting costs, there is now a general need to grow again. It has meant an increased demand for talented people.” Such are the opening lines from Morten Islin who is partner and head of life sciences and healthcare practice at the Nordic executive search company Compass Human

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Resources Group. The revenue from searches in the life sciences & healthcare practice in Compass alone has grown by 35% in 2015, and that is partly because over just a few years a bottleneck has developed in several areas within life science, and therefore the companies are to an increasing extent asking recruitment companies for help to fill the many vacant positions. “It is far from only being the upper management and top executives that the companies are asking us to help with recruiting. Actually, at the moment it is just as

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often specialists and mid-level managers, who are being headhunted and who there is great competition for,” says Morten Islin. In 2015, the bottlenecks became so serious that many named attracting qualified labour as a decisive factor for continuing the positive development. Amongst others by the interest organisation Medicon Valley Alliance, where Novo Nordisk Corporate Vice President Søren Bregenholt is chairman. One of his two main priorities is to attract the right workforce. “The industry is thriving, but across the board it is a challenge to attract sufficient Danish and international talent. We are already lacking both good researchers and engineers, and it is also becoming difficult to get hold of specialized medical doctors and other specialists,” says Søren Bregenholt, who is concerned that the lack of specialist labour will slow down the life science industry’s progress.

Trends to Watch in 2016 In 2016, Medicon Valley Alliance will therefore prioritize collaborations and initiatives that can attract and retain

talent in the region. In particular, by tempting available labour from Sweden to Denmark and by making a particular effort to hold onto the many international students who graduate from the Danish universities but all too rarely stay here afterwards. “And we will also reiterate, how unfortunate it is that the government decided to significantly cut the resources for both education and research. Already now, we see job cuts at the universities, and there is no doubt that this in the long term will have a direct effect on our nation’s ability to educate the work force that life science and a long list of other industries need,” says Søren Bregenholt. Morten Islin already experiences that many companies are settling for younger and more inexperienced candidates than they would otherwise have done. “Currently, there is a huge demand for candidates within quality assurance and regulatory affairs. All of this area is to a great extent in focus, amongst other things because both the FDA and EMA have raised the requirements,” says Morten Islin, who experiences how the increased demand on the plus side allows easier access to, for example, new graduates.

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Recruitment at a Glance • There are still rather few firms specializing in life science within the Nordic region. • Recruiting for life science involves mainly the following professions: Research specialists, Specialists and managers for production companies, Quality Assurance, Regulatory Affairs and Sales people, marketing talents, market access etc.

A possibility could of course be to bring in talent from other countries, but Morten adds that Compass has found this extremely difficult because of the high tax levels in Denmark. The candidates find Denmark and the positions in itself attractive, but the salary package is usually simply not attractive enough to move the family to Denmark for a specialist job. Instead, he sees new and other profiles finding their way to life science – in particular, the sales & marketing departments are being populated by a new type of profiles. “This is connected with the changes that have occurred

over the last years in the health sector’s decision- and purchasing processes. The way the companies previously had to market their products has changed as the decisions are being centralised and the political pressure on the healthcare budgets increases,” says Morten Islin. According to him, the main stakeholders are changing and it is not only the doctors who subscribe the medicine or use the medical devices who are important. It is increasingly economists, experts in procurement and other who sit together in the Regions or in eg. RADS and KRIS. “It means that the companies have to change their focus. They must be much more innovative and creative in the offers and value propositions that they present to these new decision makers, and they must change their organisational models and acquire new competences and talent to understand and address the new and complex decision-making processes in this system,” says Morten Islin and adds: “This is something that to a greater extent requires health economists, analysts, consultants and experts in market access and in developing innovative solutions rather than sticking with the classic sales and marketing profiles.”

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Jetpak A/S Petersdalvej 1A 2770 Kastrup tlf. 36 32 11 00 www.jetpak.com

We provide fast, precise, reliable and easy to use door-to-door delivery services in Denmark, the Nordics and Europe. All inclusive, exact prices presented at the time of the booking. Effective customs handling provided. 99% of our deliveries are made on time. Door-to-door, sameday deliveries between UK and Europe. Jusmedico is a specialist law firm providing legal services to the biotech, pharmaceutical, medical device, food supplement and dentistry industries, life science investors and to suppliers and service providers thereto.

Jusmedico Advokatanpartsselskab Kongevejen 371 2840 Holte Phone: +45 45 48 44 48 jbb@jusmedico.com www.jusmedico.com

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 2014, 2015 and 2016 Jusmedico has been awarded the Corporate INTL Global Award Price as Biotech Law Firm of the Year in Denmark. At Veolia Water Technologies, we understand how important it is for scientists to obtain a choice of water qualities that range from primary grade, for simple routine washing and rinsing, through to ultrapure for the most critical science and analytical applications.

Krüger A/S The modular Gladsaxevej 3631 water treatment unit from ELGA 2860 Søborg Phone: +45 39 69to 02choose 221 enables you the kruger@kruger.dk water system that matches

exactly the requirements of your laboratory - we offer a customised solution.

LBKPATENTStand ApS 29 Ole Maaløes Vej 3 2200 Copenhagen N for more information: lbk@lbkpatent.dk www.kruger.dk Phone: +45 30 50 38 78

Petersen-Bach A/S Engholm Parkvej 6 3450 Allerød Phone: + 45 70 15 46 00 pb@pb.dk www.pb.dk

Plougmann Vingtoft Rued Langgaards Vej 8 2300 København S Danmark Phone: +45 33 63 93 00 pv@pv.eu

Within the pharmaceutical industry, water is most commonly used in liquid form, not only as an ingredient in many formulations but also as a cleaning agent. Production of purified water, highly purified water, pyrogen-free water and WFI to international pharmaceutical standards is widely recognized as a critical process.

As its primary business area LBKPATENT is focusing on providing IP, in particular, Patent consulting to Pharmaceutical companies, Biotechnology companies having focus within the therapeutic area. The main areas of expertise are organic chemistry, peptides, polypeptides and proteins. LBKPATENT is also able to provide patent consulting within the broader life science area and the chemistry area, as well as mechanical area.

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.

All biotech firms depend on their intellectual property rights. Their IP rights, often patents, will either be a result of the firm’s own R&D or they may have been bought or licensed in from another party. Patenting of biotech inventions offers special challenges, which require an updated knowledge on special patent case law in Europe. Plougmann Vingtoft has this knowledge and will help you through the process. You are more than welcome to contact one of our IPR experts for more information on patenting of biotechnological inventions.

Hendriksholms Boulevard 59 2610 Rødovre Denmark Email: info(@)youdobio.com Phone: +45 25 57 38 76 www.youdobio.com

You Do Bio is a sales agency for genomics products and services in Denmark and Sweden. You Do Bio represents a number of innovative companies, providing great research tools. Being a small company, we will work extra hard to give you the knowledge you need to make informed decisions regarding the right technology. We virtually guarantee that you will save money, which is great for the vast majority of researchers who are on a tight budget. You are also certain to learn something of use, though of course we also hope you will buy from the companies we represent! We represents the following Life Science suppliers in Denmark and Sweden: IDT, EMP Biotech, Isohelix, Molecular Devices, Optigene and Ahram Biosystems.

Contract Research Organisations AN GROUP Mejeribakken 8 DK-3540 Lynge Tlf +45 48 25 10 00 Mail info@angroup.dk

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.

Lyshoejvej 21 DK-3650 Oelstykke Phone: +45 38 25 20 15 bioadvice@bioadvice.dk

Bioadvice assists in making qualified pharmacological and toxicological research and development possible for companies which do not have the necessary in-house resources and/or know-how. • Intensive attention and personalized service in the in-life phase. • High quality. • High flexibility and rapid reporting.

Bioneer A/S Kogle Allé 2 DK-2970 Hørsholm Phone: +4545160444 bioneer@bioneer.dk www.bioneer.dk

With 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.

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

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 and to DB Lab.

Agern Alle 13 2970 Hørsholm TEL +45 45 16 88 00 www.ecronacunova.com

IWA Consulting ApS Ølbycenter 7,1 DK-4600 Køge Phone: +45 56 66 04 90 info@iwaconsulting.dk www.iwaconsulting.dk

Clinical Trials Phase II-IV Early development PhI, BA/BE, PK/PD Non-interventional Studies Central Lab Clinical Data Management and Biostatistics

Medical Writing Pharmacovigilance Regulatory Affairs Strategic Consulting

The IWA Consulting Team is a dedicated group of regulatory affairs specialists providing expert services to a range of international private and public clients. We do that based on our long term regulatory experience, in-depth knowledge, and expertise. We assist biotech, pharma, and medtech companies in achieving their major regulatory milestones, knowing and thoroughly understanding the sense of urgency that applies to this business area. Regulatory affairs – in every aspect of the discipline – is our core competence.

Larix A/S Lyskær 8b 2730 Herlev Phone: +45 70 27 22 21 info@larixcro.com

Larix A/S 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 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. Offices in all Nordic countries.

Niels Clausson-Kaas Rugmarken 28 3520 Farum Phone: +45 33 11 32 00 nck@nck.dk www.clauson-kaas.com

NCK A/S was founded in 1956 to conduct research and development in synthetic organic chemistry on a contract basis. Most of the products NCK develop are APIs for pre-clinical or clinical studies and are produced in accordance with cGMP. NCK develops and validates analytical methods for release testing of APIs. Timely delivery, quality and communication.

Pipeline Bio tech A/S Roevedvej 1 8380 Trige info@pipeline-biotech.dk www.pipeline-biotech.dk/

Trial-Support Christinelundsvej 7 4720 Præstø Phone: +45 20 48 60 84 kcr@trial-support.eu

The focus of our work is in vivo research, covering the following areas: Research pharmacology -Cancer -Inflammation -Obesity and Diabetes -Custom Tailored Models

In vivo drug characterization -Pharmacokinetics -Toxicity testing Long term contracts -Screening programmes -Facility management -GMP Quality Control programmes State of the art laboratories

Trial-Support offers flexible solutions for clinical research and for the health care industry for part or entire projects. Our main experiences is in Gastroenterology and Oncology, but other areas of pharmacology and therapeutics are also covered. We offer qualified support for clinical research, and we also offer team-coaching to ensure a superior performance, and fundraising; a task that has become increasingly necessary especially in investigator initiated clinical trials.

Laboratory & Pharmaceutical Equipment AH diagnostics Denmark: w ww.ahdiagnostics.dk Sweden: www.ahdiagnostics.se Norway: www.ahdiagnostics.no Finland: www.ahdiagnostics.fi

We offer the most cutting edge technologies for life science and diagnostics laboratories. Representing more than 20 suppliers, our application specialists are ready to help you prepare your next project, from assay set-up, training, implementation to analysis. Based on 30 years of experience we serve the Nordic region, with offices in Copenhagen, Aarhus, Oslo, Stockholm and Helsinki.

ELPRO Ledreborg Allé 130D 4000 Roskilde Denmark T +45 7070 7205 www.elpro.com

ELPRO is a leading Swiss manufacturer of innovative monitoring solutions and data loggers for documenting environmental conditions in production facilities, warehouses and the cold chain. We partner with our clients to develop solutions that integrate our high-quality measurement components into their business processes. Key words: Cold Chain; Central Monitoring of CleanRoom & Warehouses; Site Monitoring; Container Monitoring; Temperature Mapping.

Granlyvej 4 6920 Videbæk Phone: +45 53 50 15 16

HaemoMedtec is selling pre-analytical equipment, In-Vitro-Diagnostic equipment and laboratory equipment. We provide a high service and focus on each client’s needs, we ensure the most optimal and cost-conscious solutions. We choose our suppliers and products carefully, so that we only sell products of the highest quality. We guarantee quick and competent guidance, providing quality services at all stages and puts cooperation with our customers in mind. Leverandør af kvalitetsprodukter og service til hospital, forskning og industri.

Frydenborgvej 27 E 3400 Hillerød Phone: +45 36 77 55 55

Hettich centrifuger

Memmert ovne og inkubatorer

Arctiko køle- og fryseskabe

Greiner Bione One Vacuette blodprøvetagningsprodukter

Kontakt os på: 3677 5555 eller info@hettich.dk

LH laboratorie Service A/S Lyngsiesvej 14 8210 Aarhus V Phone: +45 86 92 37 71 info@lhlab.dk

Sales and service of laboratory equipment. Freezers, freezedryers, Incubators, Centrifuges and much more! We also performs 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 particular: - Keel and freezer - Centrifuges - Autoclaves - Incubators - CO² incubators

Tulstrupvej 5, Tulstrup DK-8340 Malling, Danmark. Tel: +45 22789540 Email: steen@lovmand.com www.lovmand.com

Lovmand Diagnostics provides reagents, controls and laboratory equipment for research and diagnostics. Lovmand Diagnostics represents Randox Laboratories, Neuation, Kartell Labware, Accumax and Aerte air purification. Randox produces reagents, controls and instruments for clinical diagnostics and research. Neuation, Kartell and Accumax produce laboratory equipment such as centrifuges, magnetic stirrers, shakers, pipettes, electronic pipettor and plasticware for the laboratory. Aerte is a system for cleaning the air of bacteria, viruses, fungi, smoke and odor.

MSC/MSCI Phone: +45 44 53 93 66 info@msconsult.dk www.msconsult.dk

MSCi sell and support high-end chromatographic solutions based on GERSTEL sample preparation and automation systems. We deliver training courses covering chromatography, mass spectrometry and biotech. We operate in the Nordic countries as distributor of: GERSTEL sample preparation and automation, Agilent Technologies VAR, DART MS products, MIDI microbial identification systems, OI Analytical specialized GC detectors, MARKES TOF MS and TD instrumentation

Erhvervsvej 2 2600 Glostrup Phone: +45 43 27 14 00

Miele Professional Laboratory and medical technology. Safe, sterile and analytically clean. Systematic safety - For reliable and absolute cleanliness in all areas. Cleaning of instruments and laboratory glassware to the highest technological standard.

PERSOLIT - Technical Insulation Glerupvej 22A 2610 Rødovre Phone: +45 43 69 11 11 persolit@persolit.dk

Persolit is a framework supplier for many pharmaceutical companies in Denmark. Safety, quality, and hygiene are the most important criteria in the industry, and after working for various pharmaceutical companies for many years, we know all the regulations for hot and cold insulation as well as those for ventilation. Persolit has the right solution for you, whether you need insulation with cellular rubber, polyurethane foam and stainless finish, or something else entirely

Skarby Rustfri Montage ApS Tunisvej 11 A 2770 Kastrup Phone: +45 26 27 04 16 www.skarbyrustfri.dk

We utilize our knowledge when developing technical solutions in connection with the tasks that we solve, since the requirements for function, hygiene, and production equipment are constantly becoming greater. The flexibility and versatility that we have developed has led to many exciting and demanding tasks in stainless steel as well as iron. We have specialised in building smaller systems/units at our workshop or with the customer. We solve tasks in collaboration with the customer, because in that way we are able to include the customer’s extensive knowledge in the specific area. In the design of equipment and systems, we work with certified welders in regard to EN 287-1 with PED approval and WPS/WPAR. We have a complete understanding that documentation of our work is a high priority. Contact us at (+45) 26 27 04 16 or send us an e-mail at skarbyrustfri@skarbyrustfri.dk

Kvinderupvej 30 3550 Slangerup Phone: +45 47 38 10 14

Skanlab ApS provides solutions and products to laboratories. -C rushers, Mills, Sieves and Sieves Shakers as well as Sample Dividers from Retsch GmbH (DE). -E quipment for optical size and shape analysis of solids from Retsch Technology GmbH (DE). -O vens & furnaces from Carbolite-GERO (GB) with a tempature range from 30 to 3000 Cº. -C ounseling, service and sales of the world-renowned quality product from the the above mentioned companies in Greenland, Iceland, The Faroe Islands and Denmark.

Soltech ApS Måløv Værkstedsby 69 2760 Måløv Phone: +45 44 97 25 32 www.soltech.dk

Soltech, your provider of Contract Product Development, Prototyping and small scale Production of Medical Devices. We are your hands on experienced partner and we have a well equipped inhouse tool shop and raw materials in stock, allowing us to build prototypes rapidly and early in the product development process. We enter product development projects at any stage from idea to finished product. We produce in small scale in our ISO class 8 Clean Room.

Svanholm.com Nordic Pharma and Analyzer Center Marienbergvej 132, 1. 4760 Vordingborg Phone: +45 70 26 58 11 mail@svanholm.com

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 the 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.

Strenometer ApS Nordic Pharma and Analyzer Center Kongevejen 213 2830 Virum Phone: +45 45 95 07 00 salg@strenometer.dk

Strenometer ApS has specialized in test equipment – mainly for test and characterization of all kinds of surfaces. For more than 50 years, we have provided instruments and chambers to a wide range of applications,including: - Color measurements - Stability test: Temperature and/or humidity According to ICH Guidelines Q1B + Q5C - Plant growth chambers Chambers Walk-in - Mixing From powder to chewing gum

Hardware & Software Arbejdspladsbrugsanvisninger (APB), labels and other chemical compliance documents. CHYMEIA ApS Universitetsparken 2, 4000 Roskilde Phone: +45 72 40 16 22 www.chymeia.com

Intelligent and automatized software for APB, label and SDS authoring with advanced chemical management. Improve quality and save time with chemical management software AlphaOmega. Learn more from our many costumer cases. Develco is an independent partner for development of products based on electronics and software

Delvelco A/S Olof Palmes Alle 40 8200 Aarhus N Phone: +45 87 40 03 00 info@develco.dk www.develco.dk

MPROF Consulting ApS Østervangsvej 39 6715 Esbjerg N Phone: +45 65 74 85 11 hgk@mprof-consulting.com www.mprof-consulting.com

Develco takes responsibility for development of your product. From idea conception to mass production Develco has many years of experience from different lines of business, including wireless communication, Internet of Things, automotive and healthcare Develco are ISO 14001 and ISO 9001 certified.

MPROF-Consulting is an electronic, service and consultancy company B2B. We are skilled technicians with each +20 years of industry experience at the highest level. We do a wide range of service, test and repair of electronic modules. RF, ECU, PCM, PLC, VMC, ABS, ESP, LETS C., ROBOT C., TCM, etc.

Highlighted fairs and events 2016 March

April

May

New Updates in Drug Formulation & Bioavailability March 30 MVA, Copenhagen www.mva.org/event

The Digital Transformation In Pharma April 13-14 Copenhagen www.mva.org/event

Formulation and bioavailability are critical steps in the development process of new effective drugs. One reason for failure in clinical trials might be explained by poor formulation and bioavailability properties of the drug. Meet R&D people, the pharma industry, increase your awareness and gain more knowledge about these topics.

Pharma is faced with new ways to market products and new channels to interact with doctors, patients and other stakeholders. Those who understand how to use technology, not only to produce better molecules, but also to improve the business model, the marketing process and to get closer to the patient, they are going to transform the industry. The Conference has the aim of sharing digital initiatives for patients and HCP’s and to discuss how organizations can become better in utilizing the online opportunities.

Analytica – international trade fair for laboratory technology, analysis and biotechnology May 10-13 Messe München www.analytica.de

The Future of Swedish & Danish Life Science 2016 March 31 MVA, Copenhagen www.mva.org/event How do we initialize cross-border partnerships between pharma, biobanking and healthcare? What roles will clinics and health organizations, academy and industry have in making this a reality? An inventory is needed to create a shared vision of how a triplehelix approach can be developed, leading to innovative processes and personalized solutions.

Focus on: Cancer Collaboration April 27 Medicon Village, Lund www.mediconvillage.se/sv/ events For the third year in a row we invite you to interaction around research and innovation in the oncology area. How can new ideas be created by working crossborder? How can companies, researchers and clinicians work together?

The international trade fair analytica has been your guarantee for the successful presentation of innovative laboratory technology and futureoriented biotechnology for more than 40 years. It is the most important industry gathering and brings together the entire range of topics that pertain to laboratories in research and industry.

11th Danish Conference On Biotechnology And Molecular Biology May 26-27 HOTEL MUNKEBJERG, Vejle www.biokemi.org/meetings/109 The present conference will focus on the latest developments in glycobiology and glycomics in relation to pharma, nutrition and analytical methods. The conference includes a poster session as well as a commercial exhibition of equipment, consumables and services to Danish biotechnology.

June The Bridge – Pushing Humanity Forward By Linking Science And Business June 22 Lund, Sweden www.thebridge.se The Bridge is about building and facilitating a platform where science and business can meet and prosperous relationships grow.

September Nordic Life Science Days 2016 September 14-15 Stockholm www.nlsdays.com The largest Life Science Invest and Partnering meeting in the Nordic region. The conference offers conference sessions, panel discussions, company presentations, exhibition, face-to-face meetings and unique receptions.

Innovation In Biotech – What Is The Buzz Really About Today? September 26 London www.ducc.co.uk/events Biotechnology is a field that has in the past been synonymous with innovation and great pioneering ideas making a positive difference

November MEDICA and COMPAMED November 14-17 Düsseldorf www.medica-tradefair.com

to millions of lives through among other medicines, enzymes and microbes – but what are all the innovation buzz words really about today and can we continue to outperform ourselves?

The MEDICA Trade fair and The COMPAMED specialist supplier trade fair is the World’s largest trade fair for medtech and medical devices. Held yearly in Düsseldorf, Germany since 1969 and in 2015 it had nearly 5.000 exhibitors and more than 130.000 visitors.

CPH Lab Med – Scandinavian’s trade fair for Laboratory technology September 27-29 Copenhagen www.cophlabmed.dk Companies from all over Scandinavia exhibit and show their newest product while visitors get inspiration for future purchases and new knowledge. Parallel with the fair is a number of professional societies executes conferences, user meetings and theme days.

Hvorfor tilpasse jer rammerne, når rammerne kan tilpasses jer? · Møde- og konferencecenter midt i København · Fra 2 til 7.000 personer · Eget p-hus muligheder og fleksibilitet · -Uanede fra CPH Conference til Øksnehallen

dgi-byen.dk/konferencer

MØDER · KONFERENCER · EVENTS

Reach your target â&#x20AC;&#x201C; and beyond!

More than 60 companies have already joined the fastest growing biopark in Scandinavia And we are honored to have them here in Copenhagen Bio Science Park, offering them our 12.000 m2 of exceptional office and lab space, network & services etc. So why not join the most vibrant life science community in Denmark and start your adventure. Give us a call today and learn more or check out www.cobis.dk for more information.

COBIS A/S Ole MaalĂ¸es Vej 3 DK - 2200 Copenhagen N +45 70 70 29 80 info@cobis.dk | www.cobis.dk