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YEARBOOK 2019

THE ME DICON VA LLE Y

YEARBOOK

2 019

RAISING CAPITAL

ARTIFICIAL INTELLIGENCE

PATENT LAW

A SUCCESFUL LISTING

INNOVATION AND

ORIGINAL MEDICINES VS.

IN STOCKHOLM

TECHNOLOGY

GENERIC SUBSTANCES

DIGITALIZATION

CAREER & RECRUITMENT

INITIATIVES & OPPORTUNITIES

REDUCING MISSED

WORKING IN THE LIFE

INTERNATIONALISATION

TRIAL DEADLINES

SCIENCE INDUSTRY

BOOST


CONTENTS YEARBOOK 2019 Publisher:

THE COLUMN By Søren Bregenholt, Medicon Valley Alliance

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2018 5 A Look Back

Høffdingsvej 34 2500 Valby Denmark E-mail: nem@nemmedia.dk Web: www.nemmedia.dk Editors: Karin Jensen Charlotte Strøm Arne G. Nielsen Andreas Christensen Jan Pedersen Karin Absalonsen Signe Walther Mørck

A SUCCESSFUL LISTING IN STOCKHOLM Scandion Oncology

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ARTIFICIAL INTELLIGENCE IN LIFE SCIENCE - Innovative Technological Solutions

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- Digital Co-Creation Closer to the Patient

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REDUCING MISSED TRIAL DEADLINES By Digitalizing Patient Recruitment

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ORIGINAL MEDICINES VERSUS GENERIC SUBSTANCES Patent Law Stands Above the Rules on Substitution

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and Mohammed Ali Wachah

GDPR 46

Graphics & Layout: Kapteina Reklame

An Update

Advertisement: Mohammed Ali Wachah +45 2323 8082 mw@nemmedia.dk Magnus Andersen ma@nemmedia.dk Contact the editors at

INDUSTRY NEWS A Mix of News

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COMPANY INDEX

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CALENDAR 74 Highlighted Fairs & Events

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THE COLUMN

JOIN FORCES! We are strongest together! By Søren Bregenholt, Medicon Valley Alliance chairman of the Board and Chief Business Officer, IO Biotech For the 2016 United States presidential campaign of Hillary Clinton the slogan “Stronger Together” was not enough. However, for the Medicon Valley region the “stronger together-approach” is a precondition for success. It does not in itself guarantee success, but then again, “approaches” and slogans never do! The proof is always in the pudding! Looking back, the Medicon Valley region has successfully established itself as the undisputed, top life science cluster of the Nordics and served as a knowledge and growth generator to the benefit of patients, businesses and society as a whole. For the past 20 years we have effectively demonstrated that we are indeed strongest together, and in the life science cluster organization, Medicon Valley Alliance, we have worked continuously to secure Danish-Swedish collaboration not only in the academic sphere, but also between individuals, companies and regional and national governments. But success in the past is no guarantee for success in the future. Fortunately, several hard facts give reason for continued optimism. Medicon Valley is currently positioned as one of Europe’s ten largest life science research clusters according to CWTS Leiden Ranking. In 2018 Sweden and Denmark were among the innovation leaders in the EU, with Medicon Valley ranked among the most innovative regions in the EU. If we look at an indicator such as life science patent applications to the European Patent Office (EPO), both Denmark and Sweden can register an increase of 15 % and 6 % respectively from 2016-2017. Since patents are one of the crucial preconditions for commercializing innovation in the life science industry, the development of patent applications bodes well for longer term growth of the industry

in the region and our ability to serve local as well as global markets with innovative life science products. Life science R&D and trade are both intermingled in the Nordics and although US and China are the key export markets for both Sweden and Denmark, Sweden and Norway are both on the top-10 of export markets for Danish life science and Norway and Finland are on the similar Swedish top-10 list. To keep the R&D and growth engine running in the long run, we now need to do at least two things. We need to substantially increase our investment in research and innovation and we need to join forces and align national life science strategies in the Nordics. This goes for Denmark and Sweden in particular, but optimally, a coherent strategy should be developed which embraces all the Nordic countries and the different strongholds in not only the Medicon Valley cluster, but also the clusters of Gothenburg, Stockholm-Uppsala, Oslo and Helsinki. As documented in the recently published State of Medicon Valley analysis and indicated by the very successfully executed Bio Europe conference in Copenhagen last year, the Medicon Valley region has

Søren Bregenholt, Medicon Valley Alliance chairman of the Board and Chief Business Officer, IO Biotech

all the pieces needed to position itself as the most vibrant and most attractive science cluster in Europe. What is now needed is a dedicated effort on all levels to put the pieces together, including continued industry support and support from the national political level in both Sweden and Denmark. If you look at the current national life science strategies, there are only some weak indications that the two governments have carefully explored the potential involved in aligning their strategies around the strongest life science cluster in the Nordics. Here is one of the few pieces still missing. Fortunately, it will be easy to find, if you go looking for it! And if we do so, and if we put the pieces together, together, we will be even stronger in the future than we are today..


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WHAT HAPPENED

WHAT HAPPENED SCIENTIFIC/CLINICAL COLLABORATIONS A joint initiative from The Capital Region and Copenhagen University, Copenhagen Health Science Partners (CHSP), aims at shortening the distances between the researchers at the laboratories and the clinicians by strengthening the translational collaborations between researchers.

THE BRAIN PRIZE - PRIZE WINNERS 2019 The world’s largest brain research prize is Danish and was established by the Lundbeck Foundation. Each year, 1 million euros is awarded to one or more brain researchers who have had a ground-breaking impact on brain research. The Brain Prize 2019 was awarded to MarieGermaine Bousser, Hugues Chabriat, Anne Joutel and Elisabeth Tournier-Lasserve. Aiming for treatment, they have spent more than 30 years describing, understanding and diagnosing the most common inherited form of stroke, CADASIL. The disease

Four scientific/clinical collaborations were announced as Clinical Academic Groups Per Jørgensen, (CAGs) by CHSP, highlighting a stronger Director at CHSP focus on bringing ideas and results from the laboratories into clinical practice for improved patient care. The set-up of the CAGs with a strong management focus is inspired by similar initiatives in the UK. The CAGs create forums where the reflections and ideas of the researchers and the clinicians enrich each other. Each CAG receives 0.5 million Danish kroner each year for two years, and in addition the costs of enrollment of 3 ph.d. students equivalent of 1.35 million Danish kroner. In total the research grant amounts in an estimated value of 2.35 million Danish kroner.

belongs to a family of disorders called the leukodystrophies. The most common clinical manifestations are migraine headaches and transient ischemic attacks or strokes.

A GOLDMINE OF DATA Denmark has a strong position in digitalisation and Soren Niegel, Director, Sales, Production & Marketing at ALK believes there is a huge potential from the billions of health data that exists in the country. But it needs a political seal of approval before it can be turned into a business model. “It’s a goldmine of data, which could benefit the research community. Of course, it’s a hot topic with data protection, but there is real scope for public-private cooperation here,” said Niegel. The data goes back decades and could help strengthen Danish life science further through new business opportunities. Key is finding a business model that doesn’t compromise personal data security. “We as an industry are used to handling sensitive data and we’re a highly regulated industry.” “I would like to see this area strengthened. I’m sure it’s a goldmine. We’re a small country, but we have an abundance of data,” said Niegel.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019

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WHAT HAPPENED

INTERNATIONALISATION EFFORTS

MAIN EXPORT MARKETS FOR DANISH LIFE SCIENCE

The Trade Council, which is part of the Danish Ministry

Exports in millions (DKK) 2017

Annual growth 2008-2017

USA

22964

14%

China

8640

26%

strengthened cooperation with health authorities.

Germany

6346

5%

Sweden

5009

3%

Key markets with large potential, such as North America

Japan

4705

7%

and China, are being targeted. Through dialogue with

UK

3915

7%

relevant authorities, the Trade Council and its partners

Italy

2838

8%

try to establish what is required in the specific market,

France

2786

1%

e.g. approval procedures. In China, the Danish Embassy

Norway

2698

11%

facilitates cooperation between the Danish Medicines

Spain

2264

8%

Agency and the Chinese Food and Drug Administration

Source: Statistics Denmark

of Foreign Affairs, has been part of the secretariat

Markets

supporting the creation of the Government’s Growth Plan for life science and will assist the industry with its internationalisation efforts in future. Efforts include a

(CFDA).

MAIN EXPORT MARKETS FOR SWEDISH LIFE SCIENCE

Attracting knowledge intensive life science investments to Denmark is another area on the list of internationalisation efforts, which means targeting potential investors, such

Markets

as foreign life science companies showing an interest

Exports in millions (DKK) 2017

Germany

8012

3%

China

7882

30%

in Denmark, and then engage in dialogue with them. This could for example be a foreign life science company planning clinical studies in Denmark.

USA

7289

1%

Japan

4300

23%

Employees at Invest in Denmark, a unit of Trade Council,

Norway

3220

1%

are scouting the most obvious markets in North America,

France

3086

-5%

Europe and Asia to find out which companies are looking

Australia

2980

4%

to expand their research activities or are looking to

UK

2113

-2%

establish in Europe. All in close dialogue with the set-up

Belgium

1995

-7%

in Denmark, but also in close dialogue with foreign life

Finland

1683

-3%

science companies already established here.

Source: SCB/Statistics Sweden and Riksbanken

KEY AREAS IN INTERNATIONAL PERSPECTIVE In 2018 we spoke to Britt Meelbye Jensen, then CEO of Zealand Pharma. Three areas were identified as having the upmost importance for the Danish life science industry in an international perspective: 1) Ease the access to highly qualified labour and ensure attractive conditions for international employees; 2) Create solid conditions to support the industry, including the creation of a strong innovative environment, cooperation with Danish universities, hospital researchers and industry; 3) Ensure access to venture capital for biotech and encourage Danish pension funds to invest more in the local biotech industry. Many smaller biotech companies are struggling to raise capital to allow them to grow and compete internationally. Denmark could look for inspiration in Sweden, the UK and the US, where life science companies have better conditions attracting long-term funding.

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Annual growth 2008-2017

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


WHAT HAPPENED

INTERNATIONAL COMPETIVINESS Competition is fierce in the international life science industry

INTERNATIONAL DELEGATES FOUND INSPIRATION IN DENMARK

and several countries are offering attractive tax benefits and

In 2018, delegations from many different countries

deductions to attract the best employees and companies. In

visited Denmark to look for inspiration.

the UK and the Netherlands, for example, there are much better conditions. Denmark has a very strong position, but that can easily disappear if we don’t have life science as an area of focus.

A group of hospital directors from all over Switzerland visited the cities of Copenhagen, Odense, and Horsens to learn more about Danish digitization and hospital IT. First they visited the Danish Health Data

The government’s growth plan is an important first-step

Authority for an introduction to data integration in

and it is positive that the government has listened to the

Danish hospitals. Next, the delegation headed to the

recommendations outlined by the industry. Strengthened

Danish Ministry of Health for an overall introduction

authority cooperation is one important element in the plan,

to the Danish healthcare system, new hospital

which will strengthen both the Danish industry and the

constructions, and e-health solutions. In Odense, the

Danish Medicines Agency.

delegates visited Odense University Hospital where

The cooperation between the Danish Medicines Agency and China’s CFDA deserves to be highlighted. For a Danish life science company, it can be difficult to navigate in the Chinese FDA, but the cooperation means that Danish life science companies now have a partner with insight and knowledge. China can potentially be a large market, with exports from the Danish life science sector to China are on the increase. Changing Danish governments have over the years hired life science experts in embassies in key markets such as China, the US, Japan and some European countries, to assist Danish life science companies.

they learned about how the hospital has optimized efficiency by implementing a task management system that provides overview for the staff and creates a better and more efficient work flow. Ending at Regional Hospital in Horsens where the delegates were introduced to the process of implementing a new Clinical Logistics system, Columna Clinical Logistics, with the purpose to increase efficiency, quality of treatment, and improve the working environment. A French delegation of hospital directors from the think tank GRAPH visited Copenhagen, Denmark, to learn more about Danish experiences and strategies

Attracting highly-qualified labour to Danish life science

within hospital transformation and digitization. The

companies remains a challenge and is necessary if Denmark

delegation wished to consult Danish hospitals to

is to maintain its position as a leading life science nation. The

hear about past and current challenges regarding the

research tax scheme, which provides specific tax benefits for

transformation.

scientists and other key staff when working in Denmark, has been extended by two years to seven years now. This is surely a positive step along the way.

The delegates also visited The French Embassy in Copenhagen to hear about the Danish healthcare system including the structure, challenges, and initiatives. They learned about overall decisionmaking and financial management at hospitals

LIFE SCIENCE TAX CONTRIBUTIONS

and how a cross-sectoral collaboration has been

Denmark Income tax Corporation tax Income and corporation tax

9 billion DKK 7.3 billion DKK 16.3 billion DKK

established within rehabilitation. Second, the delegates heard about the role of flexicurity in hospital management. The visits were organized and hosted by Healthcare

Sweden

DENMARK.

Income tax

6.9 billion SEK

Corporation tax

5.2 billion SEK

Income and corporation tax

12.1 billion SEK

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019

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WHAT HAPPENED

NEWS FROM THE SCIENCE PARKS DTU Science Park inaugurated its new incubator, Futurebox, in Lyngby, which consists of refurbished containers. The incubator can potentially accommodate 40 companies. Medicon Village, in Lund, is building a new office building with room for 600 people. Medeon is building a new structure that will accommodate 200 workplaces. An additional 3,000 m2 of leasable space will be added to the existing 20,000 m2. COBIS leased a floor to BioInnovation Institute, which was established in 2018.

BIOINNOVATION INSTITUTE OPENED The large new center will help innovative entrepreneurs and talented researchers develop research projects to the point at which they attract crucial capital investment. BioInnovation (BII) is a Danish initiative, situated in the centre of a huge research environment in COBIS, and has an international perspective. The BII is funded by the Novo Nordisk Foundation, with a budget of 392 million DKK, in a three-year initial phase in order to build up operations at the Institute. The Foundation’s Board of Directors will then decide whether

A NEW NAME TO REFLECT FUTURE VISION More than 400 different names were considered during the process, before it was decided that DTU Science Park, would be the new name of the science park located in Greater Copenhagen. The name clearly states the purpose and describes the community that the more than 260 companies are part of. All future visions are based on one overall ambition, which is to position DTU Science Park as Denmark’s leading innovation community for deep tech companies developing new technologies.

to establish BII as an independent foundation.

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


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PROFILE

Expert services for GMP facilities With an in-depth understanding of the life science industry, Eltronic Pharma Engineering offers a one-stop-shop for all services related to GMP, QA and compliance. Moreover, experienced automation engineers will ensure a smooth transition from manual to automated processes. Before a medicinal product is stored on the shelves at the pharmacist’s, a vast amount of details must be carefully and consistently documented during the production process. Thomas Bo Sølver, GMP and Compliance Consultant at Eltronic Pharma Engineering, has many years of experience from the pharmaceutical industry and is able to take the clients through all required steps of the documentation process. -Collecting the information for Module 3 of a regulatory file is a tedious, yet important task. From the point of having a drug master file, the processes and specifications are defined, and the process validation is performed. We support all these activities and ensure complete compliance – right from development and on to the commercial stage of the drug, Thomas Bo Sølver says and continues: -For small and midsize companies who typically don’t have adequate QA competencies in-house, we provide the expertise and experience required to carry out a complete documentation process. We are able to spot and analyse potential

Thomas Bo Sølver, GMP and Compliance Consultant

Lyskær 8 DK-2730 Herlev T: +45 76 74 01 01 E: info@eltronic.dk W: www.eltronic.dk

10

problems, prepare a project plan, and to ensure that no stones are left unturned. Thomas Bo Sølver also acts as a Qualified Person and conducts audits. Often, these roles give him additional insights: -One of our strengths at Eltronic Pharma Engineering is that we are able to identify and interpret the issues and challenges that affect every small step of the production process. Some pharma and biotech companies may not have complete overview of the potential QA risks that can arise, e.g. from suppliers. We spot the problems, and we use our experience to project and propose costefficient solutions, he explains.

Validation of process equipment For validation of the process equipment, the GMP and Compliance experts at Eltronic Pharma Engineering work closely with their customers on collecting all required documentation. Collecting documentation for a GMP facility is hard work – it may take several months to qualify a facility. Eltronic Pharma Engineering offers those extra sets of hands and heads that are required to get the documentation right, validate the equipment, and to get the facility approved for production in due time. Irrespective of whether the production facility is new or whether a manual process is to be automated, the project


PROFILE

specifications are based on the requirements and wishes of the customer. During the process, the GMP and Compliance experts ensure compliance, and they prepare test protocols to make sure that they are ready for use as soon as the facility is validated.

FACTS • As a division of Eltronic, a con-

Advantages of automated processes

sulting and engineering company specialized in optimization of

The specifications collected and documented by the GMP and Compliance department allow automation engineer Thomas Holm Larsen to develop automation software. -A range of components may physically affect the production flow. I have a thorough understanding of the details that may e.g. close or open a valve or activate a shunt in a manual system. I transfer this knowledge when I design and programme an automated process for a customer, Thomas Holm Larsen explains. Thomas Holm Larsen stresses that there are many advantages to be harvested from automating processes. -By eliminating the human factor, it is possible to ensure a uniform production. Further, as the operators typically are logged in to the system, and the log reporting is generated

Thomas Holm Larsen, Automation Engineer

automatically, traceability and system tracking will be improved and a lot less time consuming. Streamlined project management Moving from manual to automated production is typically not only a large investment, it is also a significant change to the company. Eltronic Pharma Engineering’s collected delivery of services aim at streamlining and smoothening this transition. One way of doing that is to handle the project management efficiently. Hence, the experts at Eltronic Pharma Engineering pay close attention to potential risks during the transition to automation. Moreover, as a single supplier with all competencies inhouse, customers can save precious time. By working closely together across departments, Eltronic Pharma Engineering is able to provide efficient project management and streamline large automation projects and investments for pharma companies.

industrial processes, Eltronic Pharma Engineering is spearheading the business within life science. • Eltronic Pharma Engineering

provides expert services and advice within GMP-manufacturing of medicinal products, quality management, compliance and production and processes within GxP-regulated environments. • Additionally, Eltronic Pharma En-

gineering offers IT and automation solutions tailored to the Life Science industry. • Eltronic Pharma Engineering em-

ploys 10 quality management and automation experts. • Learn more at:

https://www.eltronic.dk/markets/ life-sciences/

at Eltronic Pharma Engineering, we use a

Quality Management All requirements are met - but redundant

holistic project approach.

requirements are eliminated. Focus on

No matter what type of project we take on

“need-to-have” instead of “nice-to-have”. The approach integrates aspects from 3 main areas - Quality Management, Change Management and Lean Management. All members of our team have extensive

Change Management Changes are implemented at all relevant levels of the organization.

experience working with all 3 areas. Using

Lean Management Projects are carried out as efficiently as

the approach, we are able to ensure that:

possible both with regard to time and cost.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019

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”What I am really looking forward to this year, is the Novo Nordisk Foundation’s BII (Bioinnovative Institute), which will help researchers turn their ideas into innovation and then to a real company. This will be exciting to follow this year, the first full year since being established.” “BII has an entire floor with laboratories and joint facilities, where researchers from many different fields can help and inspire each other.” “There have been very few new biotech companies in Denmark the past ten years. Considering the level of research usually being made here, then there should be a basis for more new companies, and I hope BII will help facilitate this.” Hans Schambye, CEO at Dansk Biotek, a promoter of innovation, research and development in the life science industry in Denmark

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A SUCCESFUL LISTING

Scandion Oncology after a successful listing in Stockholm:

“We would do it all again” Last November, Scandion Oncology listed on the Spotlight Stock Market in Sweden after having failed to raise capital among local investors in Denmark. It raised SEK 26 million from the listing but could have raised four times that amount. By Karin Jensen

T

he Danish biotech firm, Scandion Oncology, founded in 2017 as a spin-off of the University of Copenhagen and former NeuroSearch, Saniona, was looking to raise capital in 2018 for the further development of its new cancer treatments to help overcome chemotherapy resistance. However, as a young biotech company there are not many opportunities to raise capital due to the lack of risk capital and attempts to raise capital among private investors did not result in sufficient cash. “I had previously been involved in two IPO’s (Initial Public Offerings), a Swedish biotech company and the Danish Oncology Venture company, so I knew the process and knew it was a possibility,” says CEO Nils Brünner. Scandion Oncology chose Stockholm’s Spotlight Stock Market, a bourse for start-ups and growth companies, for its IPO and mandated the Swedish financial advisory firm, Sedermera Fondkommission, to help with the listing.

The Spotlight Stock Market in Stockholm has more than 170 growth companies listed from different industries and countries. “We were looking to raise SEK 26 million. First a pre-IPO placement and then a regular IPO,” says Brünner. The IPO was oversubscribed four times at approximately SEK 104.7 million. A total of almost 3,000 investors had subscribed for shares in Scandion Oncology, but only half of them were allocated shares. “We ended up with 1,500 new shareholders and had to make a draw because of the overwhelming demand,” the CEO says. The drug candidates being developed

by Scandion Oncology have been taken over from Saniona. They have already been tested by NeuroSearch in four Phase I clinical trials, but for non-cancer diseases, at a total cost of around DKK 100 million. “When we took over the drug candidates, development was already far advanced, which means we can start directly with Phase II clinical trials,” says the CEO. The drug candidates are currently being produced in Sweden and as soon as production is completed, the Phase II trials on cancer patients will commence. Saniona still has the rights for the drug candidates and owns a large stake in Scandion Oncology.

“We ended up with 1,500 new shareholders and had to make a draw because of the overwhelming demand,”

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019

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A SUCCESFUL LISTING

Stockholm outclasses Copenhagen There had been an opportunity to list the shares in Copenhagen, where a new Spotlight Stock Market for growth companies opened this autumn, but Scandion Oncology still decided to go with Stockholm and has no regrets. “We are not sorry we chose Stockholm. There has not been the same flow in the Danish spotlight market since opening as you see in the Swedish market, so we are very pleased to be listed in Stockholm,” says Brünner, insisting Scandion Oncology is still a fully Danish company.

Nils Brünner highlights the level of professionalism in the Swedish stock markets and the enormous support and help it got from both Sedermera and the Spotlight Stock Market. “Swedish investors are also very active. Their Share Savings Account, for example, has no ceiling whereas ours has a maximum of DKK 50,000. Lots of private investors in Sweden invest their own pension funds and it’s just a different culture there because they have had the Share Savings Account for so many years,” he says.

The Swedish Shareholders’ Association, which is the world’s largest member organisation for private investors, is also very active and holds meetings and presentations for its members across Sweden. “The Danish Shareholders’ Association could learn from its Swedish counterpart, reach out a bit broader to more ordinary Danes who wish to invest in companies. In Sweden, small companies get the chance to present themselves and to meet potential investors across the country. It means everything to meet people face-to-face,” says Brünner. As a listed company, Scandion Oncology is obviously subject to the rules laid down by the Financial Supervisory Authority, but this is not a problem. “Naturally, there are clear rules you must abide to but that’s only reasonable.” “Overall, I think the whole process has been really good and educational and we would do it again. Our advisors have guided us all the way through and there is nothing to be scared off,” says Brünner.

Nils Brünner, CEO at Scandion Oncology

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


A SUCCESFUL LISTING

Sweden is bigger and better Per Hansen, investment economist at Nordnet, says it makes very little sense to compare Denmark and Sweden when it comes to IPO’s. “Sweden is perhaps among the best in Europe” says Hansen. He explains that the Swedish stock market is much larger and more well-developed than the Danish stock market just as Sweden has a long tradition for investing in shares, which has helped create a different culture among private investors. “The Swedish stock market is twice the size of Denmark’s and it’s been a very active market for a very long time,” says Hansen. ”It takes many years to build up a culture for investing in the stock market. I don’t think Denmark is all that bad, considering our size, it’s not

ostentatious either. But we should at least stop comparing ourselves with a country that is among the best” says Per Hansen. Per Hansen says Danish politicians could help make the Danish stock market much more active, for example by removing the DKK 50,000 ceiling on the Share Savings Account and cut taxes on share gains. Danish investors pay a 42% tax on share gains above DKK 54,000, which puts Denmark in the top among OECD countries. “Perhaps this should be cut to 30%, or somewhere around the average international level,” says Per Hansen. The Danish Minister for Industry, Business and Financial Affairs, Rasmus Jarlov, did not return a request for a comment.

Scandion Oncology’s technology is dedicated to developing new cancer treatments that will overcome chemotherapy resistance for thousands of patients. Scandion Oncology has two major assets under development, SCO-101 and SCO-201, and more than 800 analogues for the future. The target indications for the analogues are solid tumors. In addition, Scandion Oncology has access to a screening platform of drug resistant cancer cells. This platform screens for the ability of analogues to restore drug sensitivity.

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“We experience an increasing interest for the Life Science cluster, Medicon Valley, in Greater Copenhagen. We are in contact with foreign companies, for example Japanese life science companies, looking to establish Nordic Hubs or R&D facilities or enter strategic research partnerships particularly within pharma.” ”We are also experiencing an increasing interest in the Danish health care data for research use. Denmark has attractive research strongholds within the Microbiome area, bacteriology, neurology, diabetes, metabolism and immune technology.” “This autumn, the Nordic Life Science Days, the biggest life science event in Scandinavia, will be held in Malmø, but we hope to attract the event to Copenhagen next year. We hosted the BIO-Europe event last November, the first time it was held outside Germany and we broke all records with the highest number of participants ever. It was a success and confirmed Medicon Valley as a significant Life Science cluster in Europe. We hope will be able to host the conference again.” Anette Steenberg, director, Investment Promotion at Copenhagen Capacity, a Danish investment promotion agency for Greater Copenhagen

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


LEARN MORE ABOUT LIFE SCIENCE IN THE MEDICON VALLEY REGION

A COMPARISON OF SCIENTIFIC PUBLICATIONS IN 10 EUROPEAN LIFE SCIENCE CLUSTERS

Download the free ‘STATE OF MEDICON VALLEY 2018 ANALYSIS’

STOCKHOLM-UPPSALA

SCOTLAND

and ‘SCIENCE PARKS IN MEDICON VALLEY 2018-ANALYSIS’ mva.org > press > publications

MEDICON VALLEY

NETHERLANDS LONDON-CAMBRIDGE-OXFORD

FLANDERS

ÎLE DE FRANCE

BIOVALLEY

MUNICH

ZURICH

STATE OF MEDICON VALLEY 2018 An Analysis of Life Science in Greater Copenhagen

www.mva.org


ARTIFICIAL INTELLIGENCE

Big benefits to harvest from machine learning and artificial intelligence Ideas and concepts aiming to take advantage of innovative technological solutions seem like a logical path to take for life science. Despite the obvious opportunities for truly data driven decision-making parts of pharma are still reluctant to hop on board. By Charlotte Strøm, MD PhD Journalist

L

ike in any other line of business artificial intelligence (AI) has become a real buzzword in life science. It does seem pretty straightforward to take aid from computers in situations, where the human brain and cognitive capacity either falls short or is slower than the performance of computers. The large data generation in pharmaceutical companies seem like the perfect place to make use of digital innovation. Here’s Morten Remmer’s, an experienced marketeer within digital transformation, take on this: -The use of AI in diagnostics and in drug discovery are currently the two areas with the most deal activity and the most investments from pharma companies. The first one benefits from the fact that computers can process and base decisions on way more data and real-life cases than any human being can. With the expected large growth of the older population in the not so distant future it will be crucial for a healthcare sector already under pressure to spend their time where

it benefits the most and get as much support as possible for the more trivial decisions. Diagnostic tools allowing for either screening or actual triage of patients may in fact take some pressure off the healthcare system. Initially primarily as tools for the HCP but increasingly put into the hands of the patients, he says, continuing: -In drug discovery the access to Real World Evidence will amass data at a much larger scale than any randomized clinical trial to a point where it wouldn’t be feasible to process them without the use of machine learning and AI. He points to a third area with massive business potential: the pharma supply chain. -Consider this, any pharmaceutical company would love the prospects of being able to manufacture exactly the amount of medicines that is needed, avoid large stocks or even worse running into backorder. There is an enormous potential to gain from

Morten Remmer, previously Head of LEO Innovation Lab Incubator and Head of Growth Hacking and Communication, today owner of ten-EXE

tapping intelligently into the data and gain knowledge to help predict demand and balance that with supply, Morten Remmer explains. Value transfer is essential As previous head of LEO Innovation Lab Incubator and Head of Growth Hacking and Communication Morten Remmer has gained hands on experience on how intelligent use of data and digital solutions can also optimize and evolve marketing in pharma.

Artificial intelligence and machine learning The terms machine learning and artificial intelligence (AI) are often used randomly and widely overlap. Although strict definitions may be hard to agree on, machine learning is often referred to as reading and understanding algorithms based on the requirements humans set up, whereas Al applies to the simulation of human intelligence processes by machines, especially computer systems. These processes include learning (the acquisition of information and rules for using the information), reasoning (using rules to reach approximate or definite conclusions), and self-correction.

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


ARTIFICIAL INTELLIGENCE

-Some of the biggest marketing costs today in pharma have very little attribution or evidence of their impact. The impact of sales reps is constantly debated, and the enormous sums spend on conference and congress marketing are often based on legacy; “we’ve always done this” or fear of missing out: “the others are doing it”. But machine learning can help identify correlation between activities and sales with a level of accuracy that can eliminate a lot of the uncertainty. This is quickly becoming common practice in many other industries. Paradigm shift to embark on data driven marketing However, machine learning and AI might not be the immediate go-to next step for pharma marketing. Maybe there is a cultural transformation needed for pharma marketers to comfortably embrace such methods.

New strong entry to American partners in life science and artificial intelligence Denmark's new innovation center in Boston will give Danish research institutions and companies access to world-leading universities and innovative companies. The Innovation Center was opened by the education and research minister Tommy Ahlers on 28 January. The Innovation Center builds a bridge between Danish research institutions and companies and world-leading universities and innovative companies in the Boston area. The center will highlight Danish strengths within eg. health research, robotics and clean energy, and strengthen collaboration across the Atlantic between Danish and American researchers, students, and companies. Among other things, the innovation center participates in the MIT European Career Fair at MIT to attract local talents to Danish businesses and research. In connection with the opening, Tommy Ahlers also visited a number of leading research and educational institutions and companies in the Boston area, where he spoke about Danish strengths, while also finding inspiration in the institutions' work with innovation, entrepreneurship in the education programs, models for universitybusiness cooperation and efforts within AI and life science.

Morten Remmer believes the concept of data driven decision making is a necessary first step in medical marketing: -Today many pharma companies tend to map out a calendar year and

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plan to produce a series of marketing campaigns months ahead. However, these campaigns fail to leverage the fundamental input from customers on what relevance a given campaign has to him or her. And there is very little if any personalization to cater to the individual recipient. The approach from data scientists, growth hackers, software developers and digital innovators in general is based on data and short iteration loops: Let’s test what is relevant to the user. If the content is not relevant to the user it is changed overnight and continuously instead of several months down the road when the next marketing campaign is outlined, he says. -There is so much unexplored potential in the data and when properly assessed it could in fact fertilize a true paradigm shift within medical marketing, Morten Remmer ends.

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ARTIFICIAL INTELLIGENCE ARTIFICIAL

Digital co-creation closer to the patient Optimized diagnostic and treatment processes, decision support, and targeted prophylaxis. Healthcare data collected on a daily basis throughout our lives render a massive amount of information. Used intelligently there is an enormous clinical potential to gain from the historic as well as the data collected real time. By Charlotte Strøm, MD PhD Journalist

T

he Nordic countries are quite famous

Digital solutions can be tested on data

for the longstanding tradition of

available from the large registers holding

collecting healthcare data in numerous

healthcare data and moreover real time

registries, allowing for research to be

data are collected continuously.

performed in massive data sets and collecting historic information in situations where prospective data may be hard to come? due to practical or ethical reasons. However, the data collection and the access to data also prove valuable when innovative companies set their minds to embark on digital problem solving in the healthcare sector. Henning

He stresses that making optimal use of healthcare data, requires safe data environment and transparency on what the data is being used for and how it is stored. The law is far from clear in all aspects about this, and that may leave start-ups with some hesitation to jump on board.

Henning Langberg, Director at the Copenhagen Healthtech Cluster

Langberg is Director at the Copenhagen

-By building bridges between the public

and tangible it’ll probably ease the

Healthtech Cluster with Copenhagen

and the private sector, we also assist

transition, Henning Langberg says, and

Capacity. He is working to facilitate

companies within digital healthcare

ends:

public-private collaborations specifically

innovation by mapping out potential

within technical solutions for healthcare.

obstacles e.g. with the legislation or

-Nurses and physicians can identify much more precise what the hurdles and the gaps in the healthcare system are. They

the interpretation of it, the timing that may be an issue, or the access to human resources.

-An early warning e.g. from a wrist buzzer prior to your ICD (implantable cardioverter defibrillator) delivers an electrical shock to restore normal heart rhythm, is a very tangible type of benefit

know what problems they would like to

How ready are patients for digital

to patients. Other examples are very

have solved. Hence, digital developers

transformation when it comes to healthcare?

early diagnosis to prevent lung cancer

can embark on creating solutions to solve these issues, rather than trying to apply a good idea that may or may not fit into e.g. the diagnostic process at the hospital. This approach of co-creation makes much more sense, Henning Langberg explains.

-Healthcare data is an arbitrary and quite abstract thing to many citizens. So, for sure it requires maturation to get everyone’s minds set to embrace digital solutions based on their healthcare data. However, if the benefits are very evident

“.. it requires maturation to get everyone’s minds set to embrace digital solutions based on their healthcare data,”

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and other cancers with poor prognoses, optimized home care of patients with chronic congestive heart failure, or prevention of urosepsis – all just some of many examples where the data enable disclosure of patterns that allows for identification of the specific problem, which in turn leads to a solution. But it starts and ends with accessing and assessing the data.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


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“One of the new initiatives we’re working within the framework of, is the government’s growth plan for the life science industry. This was launched in March 2018 and a lot has happened since then, not least us joining the Healthcare DENMARK partnership. We have high expectations for this.” “The life science growth plan has set many things in motion and there’s now more coordination between the different stakeholders across government and enterprise through structured dialogue between the Ministry of Foreign Affairs, the Ministry of Health, the Ministry of Industry, Healthcare DENMARK, the large life science companies and key industry associations. We have for example established a dialogue forum, where we meet three times a year to discuss coordinated internationalisation initiatives. We have a clear expectation that this will strengthen the Danish life science industry and its internationalisation even further.” “The role of sub-contractors to the life science industry and their contribution to the economy is often underestimated. However, we have so many competent companies in Denmark and they are creating a lot of value for the country. Not long ago, life science industry sub-contractors were told by their customers what products to manufacture and how. That relationship has seen a dynamic shift where they are now creating value propositions from product concept and development, to highly specialised manufacturing and even supply chain management.” “We acknowledge the importance of the sub-contractor segment both in terms of value-add to the Danish economy and as a crucial source of innovation for global life science customers, and we are therefore highly focused on also helping this part of the industry to increase its international footprint.” Thomas Andersen, Head of Danish Health Tech Group at the Danish Export Association

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PROFILE

Ola Gudmundsen

More than two decades of steady CRO growth With a strong foothold in the Nordics LINK Medical has over the years succeeded in continued organic growth and is looking to grow even further with the acquisition of biometrics expertise. LINK Medical, a Nordic and Northern European contract research organisation (CRO) looks to continued growth in the years to come. The company was founded in 1995 by CEO, Ola Gudmundsen, PhD, with a strong Scandinavian culture and based on solid values. Through the years the company has developed a unique way of working based on four distinct, yet integrated pillars: Competences, agility, technology, and integrity. Ola Gudmundsen explains: -We are committed to providing top competence in clinical development to deliver optimal solutions faster. Moreover, we constantly assess best practices to find smarter ways of working, using highly sophisticated technological solutions and data handling processes, for accurate delivery of high-quality data. Our agility as a partner in clinical development revolves around the value our deliveries have for our customers. The integrity comes from offering our customers the access to our expert guidance for optimal decisionmaking, through rigorous evidence-based documentation, he says. Taking complete vendor responsibility for regulatory guidance and clinical conduct and management interacting with customers on a strategic level requires us to be able to provide solid advice that will create value for customers and allows them to make the optimal decisions. He stresses that the recent acquisition of PCG Clinical Services AB in Uppsala, Sweden was a perfect match as it strengthened key service areas. For example, the strong competences in biometrics was a significant complement to our core business, and filled in the competence gap that we had in the area. Today, we are a stronger full-service CRO

in Northern Europe providing a wide range of services for pharmaceutical and medical device industries, Ola Gudmundsen says. He also comments that competences are far from just a matter of acquisition or hiring new people: -Keeping competences at the highest level involves all parts of our business. We constantly review our procedures, check up on our onboarding processes, and update our internal training and education at the top level as well as throughout the organisation.

Regulatory is key The regulatory department readily counts 45 employees, reflecting that regulatory guidance is essential for the customers throughout clinical development. LINK Medical conducts mostly phase I, II and IV clinical trials. Interestingly, smaller, and intelligent study design set-ups in phase III oncology studies are increasingly finding their way to the Nordic countries. -Oncology generate a lot of projects – and the Nordics is a great place to conduct these types of trials, Ola Gudmundsen says.

He believes, that the strong Scandinavian anchoring is also part of the explanation of the company’s strong position as a strategic partner. Looking to the future, Ola Gudmundsen acknowledges that continuous focus on improved processes is a top priority. -We constantly work on ways to reduce costs and make the most of technological solutions. We do this to ensure that we consistently deliver high quality services at a good price level in order to maintain our competitive edge, while still adding value to the business itself as well as to our customers, he ends.

About LINK Medical • LINK Medical is a full service CRO

for biotech, pharma, and MedTech in Scandinavia • Has 168 employees, servicing

customers from offices in Oslo, Stockholm, Malmö, Copenhagen,

-The centres are able to recruit the patients, they have access to the facilities and to advanced labs, and very often the departments are part of larger research institutions with improved access to some of the best academic capacities.

• Provides services within all

LINK Medical is thus primarily operating in the Nordics.

• For more information

-We have a strong foothold here; our corporate spirit is reflected in the way things are done in Scandinavia. While being perfectly able to conduct smaller trials in a wider set-up on mainland Europe, it is by far the Scandinavian countries that remain our home turf. This is where we are industry experts, Ola Gudmundsen points out.

Berlin, and London aspects of life cycle management from preclinical to market access http://linkmedical.no Contact information: Ola Gudmundsen, CEO, LINK Medical Mobile: +47 92 46 22 00 ola@linkmedical.no

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REDUCING MISSED TRIAL DEADLINES

Reducing missed trial deadlines by digitalizing patient recruitment Patient recruitment is one of the most difficult and time-consuming aspects of clinical trials. More than half of missed trial deadlines are caused by recruitment-failures. By Arne Nielsen It is a serious matter, as patient recruitment is the number one reason for clinical trials failing to meet deadlines. One of the reasons clinical trials fail to recruit patients is lack of knowledge from potential study candidates. People simply don’t know that they have the opportunity to participate in clinical trials. It is difficult for potential study candidates to find clinical trials through media and health platforms. Sites like clinicaltrials.gov can be difficult to use for people outside of the industry. And it’s even more concerning when you learn that 3 out of 4 say that they would be interested in participating if they only knew about it.

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Generating awareness We need to start at the root of the problem. People need to know that clinical trial participation is an option, and that it is up to the individual to choose whether to try an established method or take part in developing new methods through clinical trials. To reach that goal, information needs to be much more visible, like appearing on trustworthy platforms. Patiro · Patient Recruitment is a European patient recruitment company that owns a wide range of brands, which create hubs providing information about how to join clinical trials, what participation entails, as well as articles about new disease insights

Jonas Spott, Chief Marketing Officer at Patiro

and health news. The brands – ‘Health Panel’, ‘Sundhedspanel’ and ‘Gesundheitshandbuch’ etc. - are locally represented in 15 countries. These brands share information through their own websites, social media, search engines and other relevant channels.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


REDUCING MISSED TRIAL DEADLINES

-The idea behind Health Panel is to make sure candidates are well informed and feel comfortable sharing health information in order to be considered for a study, says Jonas Spott, Chief Marketing Officer at Patiro, and he continues: -We want to answer all the questions a potential study candidate might have about clinical trials and present precise and honest information. For those who wish to sign up to become eligible we also provide a simple and safe way to share personal information, he says. Modern marketing The marketing toolbox in 2019 is filled with digital opportunities. Unfortunately, patient recruitment strategies often only use traditional media like newspapers, print and radio commercials, which these days should not stand alone as you won’t get as many campaign testing opportunities as you can with the digital media. Traditional media does not offer the same extent of analysis, tracking and targeting to segmented audiences. Digital marketing platforms offer a wider range of tools that traditional marketing media do not have access to, which allows them to run much more efficiently, and to be optimized in real time. This is done through segmentation, tracking, targeting, comparison and analysis. Traditional media also conflict with the signup process since the majority of study candidates sign up through digital forms. It is far more convenient to click on a link on a digital advertisement than remembering a link from a newspaper advertisement. High conversion rates with social media By using the digital tools available, the marketers can remove a lot of the guesswork, and instead test a wide range of advertisements. The

campaigns that don’t work can be shut down - and the ones that perform well can be expanded upon and rolled out on other platforms. Furthermore, marketers will be able to target a specific audience. When enough data is collected, it can also be used to forecast the trial progress. -We see some extremely high conversion rates by combining high quality information with answering the questions of potential study candidates. It enhances our belief that awareness, information and easy signup helps find participants for clinical trials, says Jonas Spott. For a Phase III Diabetes Type 2 study, Patiro saw sign up conversion rates above 25 percent from the campaigns. Desktop devices converted the best, with almost 31 percent in conversion rate. Mobile devices were performing with a conversion slightly lower than that. Also, Patiro has recently had success of recruiting 100 percent of the randomized patients for a cancer study in three European countries. Alongside Patiro two other patient recruiters participated. Some of the success could point to the fact that Patiro primarily is data-driven and AI-driven. When campaigning Patiro uses digital tools like social media, search engines, affiliate networks, online patient groups including the Health Panels etc.

Mobile devices Obviously mobile devices have become a great way of reaching people. In all studies of 2018, which had Patiro as recruiting partner, mobile devices were more than twice as effective in creating awareness as to desktop devices and tablet devices. -Our focus on mobile device platforms and campaigning for mobile devices will only increase over time. It’s such a strong channel for creating a connection with potential study candidates, says Jonas Spott, continuing: -Although mobile devices are a great channel for generating awareness, it isn’t as effective when it comes to registering for clinical trials. The reason for this probably is the difficulty in signing up, when you’re working with a smaller screen. On average, Patiro finds that desktop devices have a conversation rate 25 to 40 percent higher than mobile and tablet devices, he says, before ending with: -We are expecting to see even more mobile activity in 2019. And we are already experiencing campaigns for a Phase III study where mobile devices is generating more than 75 percent of new potential study candidates, while computers are at only 16 and tablets even lower.

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TRIAL NATION

A new organisation to attract more clinical trials to Denmark In December 2018 the establishment of a new organisation became a reality, as a result of a broad political cooperation between the Ministry of Business Affairs, the Ministry of Health, Danish life science companies and Danish Regions. The new organisation contains the two initiatives One Entrance and NEXT, and its purpose is to make it easier and more attractive for global companies to conduct clinical trials in Denmark. By Arne Nielsen With the new organisation the

our healthcare system, and not

life science as for the promotion of

various entrances to clinical research

least Danish patients, who will have

clinical trials.

are now in one place, and therefore

quick access to new and innovative

it will be easier and thus much more

medicine. The establishment of

attractive for companies to conduct

the new organisation, named Trial

trials in Denmark, which will benefit

Nation, is one of the key initiatives

the Danish research communities,

in the government's growth plan for

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-At the same time, it creates better opportunities for companies to carry out clinical trials and obtain evidence that their products are safe and have

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


TRIAL NATION

“It is crucial for new products to hit the market and be put into use in the Danish health service"

even more clinical trials to Denmark.

Rasmus Jarlov, Minister of Industry, Business and Financial Affairs.

benefit from new, effective medicine

the wanted effect. It is crucial for

the patients. Together with the other

new products to hit the market and

initiatives in the growth plan for life

be put into use in the Danish health

science, we create strong research

service, says Rasmus Jarlov, Minister

environments, new jobs and growth.

of Industry, Business and Financial

It is hard not to rejoice.

Affairs.

It also means that patients in this country can be among the first to - moreover, in a setup where high standards for patient safety are top priority. Several clinical trials can be one of the ways to lift the treatment in our healthcare system. And exactly why the regions invest resources and

The two organisations NEXT and One

money in the new organization,”

From the Ministry of Health, Health

Entrance have largely overlapping

says Stephanie Lose, chairman of the

Minister Ellen Trane Nørby says;

tasks, processes and objectives, so it

Danish Regions.

-By improving the possibilities for clinical trials in Denmark, we now ensure that the Danish healthcare system continues to develop. The merger of the current two entrances

makes sense to combine them under a common management, backed by state, regions and companies, while maintaining both organisations’ knowledge and strengths.

The name of the new organisation is chosen to reflect what the new initiative is about, which is to attract clinical trials and international potentially ground-breaking

for life science companies in Denmark

“It is gratifying that we now have

to one creates a strong national

one united and strong organization.

organization - all for the benefit of

In this way, we can hopefully attract

experiments to Denmark.

Sweden – Denmark – Norway – Finland

EARN TRUST - MAKE DIFFERENCE A+ Science is a Contract Research Organisation run by its employees. We provide services in clinical trials for pharmaceuticals (phase I-IV) and medical devices. We also offer broad expertise in pharmacovigilance services during clinical trials and post marketing. Small enough to care, large enough to deliver. A+ Science AB, www.a-plusscience.com Luntmakargatan 22, SE-111 37 Stockholm info@a-plusscience.com

A growing successful clinical CRO Contact details

+46 18 100 550 – www.scro.se – info@scro.se Scandinavian CRO AB – Skolgatan 8, P.O 150 27 – SE-750 15 Uppsala


The Nordic CRO market is characterised by a number of small CROs and a few big Nordic and international CROs In the 1990’s the CRO industry experienced an explosive

growth caused by a dramatic rise in costs for pharma companies and the introduction of good clinical practice (GCP). The earliest CROs started back in the 1940s and 1950s and the industry as we know it today has existed since the 1980s when the pharma companies developed their first blockbuster drugs. In the 1990s, their numbers increased significantly and today CROs are an integral part of life science.

Increasing competition from the Asian CROs

Until 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, we see 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.

More CROs tend to look to the medtech industry,

which is growing, as more and more MedTech companies in urgent need of assistance to keep up with the new EU legislation that comes into force in 2020.

2/3 CROs are responsible for two thirds or all clinical trials. 1/4

In Denmark, one in four clinical trials are today conducted by a CRO and in Sweden. Denmark is one of the countries in the world with the highest number of clinical trials per capita.

10 %

The overall likelihood of approval of a drug from Phase I for all developmental drug candidates is only around 10%. Rare disease programmes and clinical trial programmes utilizing biomarkers tend to have higher success rates at each phase of clinical development.

70% of experimental drugs pass Phase I 33% of experimental drugs successfully complete both phase I and II studies

70% to 90%

of drugs that enter phase III studies successfully complete this phase. Application for marketing authorization is applied for, after the completion of phase III Phase IV studies are conducted after a drug or device has been approved by the national or international regulatory authorities. Phase IV studies can result in a drug being taken off the market or restrictions of use could be placed on the product depending on the findings in the study

Typical services

Senior consultancy services, regulatory advisory services, pharmacovigilance, medical writing and the implementation of clinical operations, including site coordination, health and research staff etc. Large and midsize international CROs also provide a full range of e-clinical solutions, including diaries, e-CRF systems, eCTD systems, pharmacovigilance and safety

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PROFILE

INCORPORATING CLINICAL TRIALS IN GLOBAL REGULATORY FILES A key concept of building a regulatory file is to start it right from the very beginning. IWA Consulting has generated years of expertise and experience within regulatory services specifically aiming at meeting the global demands for regulatory filing of medicinal products. Over the past decade the landscape of clinical trials being conducted in the Nordics have changed. -In the Nordics we tend to see fewer large-scale phase 3 trials and more specialized trials in rare diseases, cancer indications, or phase 1 or phase 2 trials with highly specialized designs, entailing scientific reflections and considerations that drug developers haven’t really been used to before, says Lillan Rejkjær, Managing Partner at IWA Consulting. -The regulatory implications of onboarding this operational change especially in SMEs, is that drug developers meet different challenges during the development process than before. The point is to stay at the forefront of these challenges by understanding the science and starting the documentation right from the beginning by incorporating the documentation into the eCTD format in an appropriate way, she says.

As of 1st of January 2019 submission of marketing authorization applications in the EU is only accepted in the eCTD format. The FDA also only accepts marketing authorization applications in the eCTD format; further this is also a requirement for the Investigational New Drug Applications (IND) as of May 2018. -There is no more paper documentation, so if you want to avoid delays in the regulatory and get-to-the-market process the best way is to start the collection of documentation, using a global platform that applies to both the European regulatory processes as well as the American, Lillan Rejkjær explains. Local operations with global outlook Connie Lyngbek Thestrup, Managing Partner at IWA Consulting, seconds her colleague and stresses the thinking around developing and bringing a medicinal product to the market with renewed mindsets. -Unfortunately, we often see that

Lillan Rejkjær,

Connie Lyngbek Thestrup,

Managing Partner

Managing Partner

the scientists, the clinical developers, and the regulatory departments have individual understandings and processes, that tend to collaborate too little across departments. However, it is our experience that the way to success is shorter when you understand building the regulatory documentation for a marketing authorization and start the eCTD in a global format with contributions from all sides, Connie Lyngbek Thestrup says. IWA Consulting provides the platform and the regulatory knowledge for building the eCTD in a global format. -Time is of essence in drug development. And starting the documentation right – in the right format from the beginning in all departments of the company is by far the shortest and quickest way to success, Connie Lyngbek Thestrup ends.

About IWA Consulting • Is a Consultancy Company with core competences, expertise,

and decades of experience within regulatory affairs • The company employs 20 regulatory experts • The IWA Consulting Team provides regulatory affairs spe-

cialists expert services to international private and public clients

Phone: +45 56 66 04 90 E-mail: info@iwaconsulting.dk Web: www.iwaconsulting.dk

• The IWA Consulting Team assists biotech, pharma, and

medical device companies in achieving major regulatory milestones timely • Learn more about IWA Consulting at www.iwaconsulting.dk

in managing Global Regulatory Affairs

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019

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“I expect life science to continue to be the single most promising growth engine and high value job generator in Greater Copenhagen, and I expect regional and national decision-makers to invest accordingly.” ”Since life science is at the very top of the political agenda in both Denmark and Sweden, I hope national life science strategies are also aligned to the extent possible to increase the competitiveness of Nordic life science as a whole.” Petter Hartman, CEO at MVA, Medicon Valley Association, a Danish-Swedish network organisation for the entire life science industry in Greater Copenhagen.

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CAREER

Greater Copenhagen is a great place for global life science talents - Copenhagen is the world’s second best city for talents By Arne Nielsen

C

openhagen has once again established

- No. 13 in quality of life (Retain)

its position as one of the world’s most

- No. 16 in removing barriers (Attract)

attractive cities for international talents. The city comes second in the 2019 Global Talent Competitiveness Index, ranking talent powerhouses able to attract, grow and empower entrepreneurial talent.

industry in Skaane, Sweden, are certainly

developing stronger roles as attractive

cross beneficial, and the good ranking of a

talent hubs, especially for entrepreneurial

city in Greater Copenhagen focus positive

talent – and they are the ones who

attention to the whole region.

today’s digitized and globalized society.

just followed by Oslo, Norway.

The close ties with the life science

-Cities rather than countries are

will drive innovation and growth in

Outranked by Washington DC, US, and

- CTCI 2019

About the Index

Copenhagen offers an inclusive business

The 2019 GTCI report, published by

Out of 114 cities worldwide, Denmark’s

culture and a high quality of life, which

INSEAD, the Business School for the

capital city Copenhagen is ranked

most internationals moving here really

World, in partnership with the Adecco

second best when it comes to enabling,

appreciate. This makes Copenhagen a

Group and Tata Communications, is a

attracting, growing and retaining

great choice for global talents as well

comprehensive annual benchmarking

talent according to the Global Talent

as for companies looking to expand to

measuring how countries and cities

Competitiveness Index 2019.

Northern Europe, says Nikolaj Lubanski,

grow, attract and retain talent,

Talent Director at Copenhagen Capacity.

providing a unique resource for decision

-This year’s report has a special focus on

makers to understand the global

entrepreneurial talent; how it is being

Denmark is the fifth best country for talent

encouraged, nurtured and developed.

The GTCI report also ranks countries, and

develop strategies for boosting their

Denmark takes the fifth place, surpassed

competitiveness. The 2019 index covers

only by Switzerland, Singapore, USA and

125 national economies and 114 cities.

Entrepreneurial talent is critical to the development of vibrant innovation ecosystems, bringing focus to small and

Norway.

medium-size enterprises, including startups and unicorns. - CTCI 2019.

-Denmark is a top performer. Strong

Talent drives innovation and growth

are complemented by an exemplary

regulatory and market landscapes

The CTGI report includes four pillars

labour and business Landscape that

on the input side — enable, attract,

combines flexible labour markets

grow and retain — focusing on actions

with comprehensive social protection.

for policymakers and business leaders,

As for retaining talent, the country

and two output pillars, benchmarking

boasts strong performances in both the

national performances in technical/

sustainability and lifestyle sub-pillars.

vocational and global knowledge skills. Copenhagen’s performance: - No. 4 in business environment (Enable) - No. 9 in employment, innovation and leadership (Build Global Knowledge) - No. 11 in education and training (Grow)

Nikolaj Lubanski, Talent Director

at Copenhagen Capacity

talent competitiveness picture and


CAREER

In a recent report, conducted by Albright Life Sciences based on a survey where more than 100 Danish life science executives shared their thoughts, insights and evaluations on industry trends, growth prospects and barriers, we gained insights on what executives from the life science sector have found to be the most likely drivers of growth, which growth strategies they expect to employ, as well as what they see as the biggest threats to future growth.

The Albright life science report I

n a recent report, conducted by Albright Life Sciences

71% of executives are concerned that insufficient access to talent will limit growth

based on a survey where more than 100 Danish life

70 % are concerned that increasing pricing pressure will limit growth in the future

science executives shared their thoughts, insights and evaluations on industry trends,

83 % of the respondents expressed confidence in their organisation’s prospects for revenue growth

growth prospects and barriers, we gained insights on what executives from the life science

75 % are confident that strategic alliances and partnerships will contribute to future growth

sector have found to be the most likely drivers of growth, which growth strategies they

The two most important growth drivers are strategic alliances and partnerships and advanced data analytics

expect to employ, as well as what they see as the biggest threats to future growth.

The municipalities with the biggest life science sector W

hen we take a look at which

On the Danish side:

in Sweden, where 92% of the positions

municipalities the life science

Gladsaxe, Copenhagen, Ballerup,

that disappeared from the life science

Kalundborg, and Hillerød.

sector from 2008–2016 are those

sector is concentrated, in Medicon Valley, measuring employment rates are a great parameter. The life science sector is mainly concentrated in a few municipalities in and around the biggest cities. Eight of the total 79 municipalities in the Greater Copenhagen region provide employment for three-fourths of those employed in the life science industry in Medicon Valley.

On the Swedish side: Malmö, Lund, and Helsingborg.

The shift to a more highly educated workforce In Denmark as in Sweden, highly educated employees or those with research training make up a larger share of those employed in the sector

The largest municipalities for life science

in 2016 than they did in 2008. This

companies are:

development is particularly apparent

generally sought by employees with a lower level of education, while only 8% of the positions are competed for by highly educated applicants. In Denmark, 82% of the positions created in the life science sector from 2008–2016 were competed for by people with a high level of education, and a mere 18% more jobs were created for people with a lower level of education.

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LIFE SCIENCE CITIES IN MEDICON VALLEY

The municipalities with the biggest life science sector - Approximate numbers of employment in the biggest municipalities in the life science sector

Kalundborg: 4100 employees Novo Nordisk production site and Novozymes production site.

Helsingborg: 1000 employees

Hillerød: 3200 employees

McNeil and Helsingborg Hospital.

Novo Nordisk, Biogen production site, PolyPeptide and Zymenex.

Lund: 1000 employees Baxter (Gambro Lundia), Lund

Gladsaxe: 8800 employees

University and Ideon Science Park.

Headquarters and large facilities for Novo Nordisk and its subsidiary Novozymes.

Ballerup: 5700 employees

MalmĂś: 1900 employees

Novo Nordisk, LEO Pharma

Rechon Life Science, PolyPeptide

headquarters and production site, GN Hearing, Symphogen and Pfizer.

Copenhagen: 6100 employees

Group, Nordic Drugs, Qpharma and Eurodiagnostica.

H. Lundbeck headquarters and factory, Ferring Pharmaceuticals research facility, Xelia Pharmaceuticals, Genmab, Novartis, Boehringer Ingelheim, Stryker and AstraZeneca.

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


PROFILE

COMPETENCY ALWAYS NEARBY IN LUND! The city of Lund has a long-standing tradition of doing business within the Life Science sector. Global trends have a huge effect in development and innovation in smaller companies with unique competencies, and this is not least also the case in Lund. In the former premises of Swedish medical giant Astra Zeneca, there are now more than 140 companies located. Worldclass researchers are also making their way to Lund University, Medicon Village and the SmiLe incubator, where their ideas are transformed into successful ventures Lund and the pharmaceutical industry combined are proven to be a successful recipe. Previously, researchers at Lund University could put their knowledge forward to major companies like Astra Zeneca or Baxter – nowadays, Medicon Village offers great opportunities to transform ideas into products and services for companies. "Great progress has been made at Medicon Village with a bundle of exciting companies," says Per Persson, director of the business department at the City of Lund.

What is the secret behind Lund’s success within Life Science? "It’s the connection between the private sector, municipality, the health sector and the university that are the essential elements in Lund," says Kerstin Jakobsson, CEO of Medicon Village Innovation. Lund has everything in proximity - the city is like a large campus.

Kerstin Jakobsson also predicts eHealth and pre-emptive healthcare as important areas. Competencies from the Astra Zenecaage are also starting their own service-companies. Medicon Village offers an environment where ideas from science can be transformed into an ecosystem of products and services. The smaller company receives the big corporate advantage but also gets unique laboratories and competencies. This cross collaborative methodology has garnered excellent returns, especially in EU-financing. Five companies at Medicon Village were granted 15 mEUR in total, without need for counter financing – this could be regarded as a quality mark for ground-breaking projects. Medicon Village also houses around 20 startups at SmiLe incubator. Incubates are given opportunities to work together on their own or in shared spaces with advanced equipment.

Medicon Village accommodates companies that are focusing on people’s health and creating better lives. Successful ventures are found within diagnostics and treatment of cancer such as immunotherapy, but also areas involving cellular, gene therapy and efforts against antibiotic resistance.

For more visit www.lund.se

Kerstin Jakobsson

Ebba Fåhraeus, Foto: Jenny Leyman

"We have unique laboratory structures," says Ebba Fåhraeus, CEO at SmiLe incubator. "Our environments are also Open Labs for companies and researchers from the outside who need a distinct form of analysis." SmiLe also offers 250 years of experience in Life Science among their staff and healthy relations to investors. 2018 was particularly successful, seeing 70 alumni companies of the incubator receiving investments around 728 million SEK in venture capital. "These companies also received accolades in both Sweden and internationally," Ebba Fåhraeus tells us. "Besides that, we’ve had an industry and investor network put in place during 2018. We have significant buildings blocks that’s now formed into a brand that is known around Europe."

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SHARP MINDS

Sharp Minds in Life Science Good access to skilled employees with the right professional skills has been one of the most important drivers for the Danish life science industry, which has grown very large in the past 15-20 years. It is a unique strength that must be maintained. Edited by Arne Nielsen More than every fifth application of

-A key component of today’s success

match between the industry's future

life science job postings is aimed at

within Danish life science is easy access

needs and the employees with the

researchers with a PhD degree, and more

to highly qualified employees. The life

sharpest competencies.

than every third job search is aimed at

science companies employ a very high

graduates with a master's degree, and

number of highly skilled experts with

while vocational education programs are

specialized academic training – far

less demanded now than before, targeted

beyond what is seen in other parts of

basic education is steadily increasing in

Danish industry. This makes a solid basis

demand. Chief Consultant at the Danish

for development, implementation and

Association of the Pharmaceutical

use of the latest scientific knowledge and

Industry (Lif), Jakob Bjerg Larsen says:

modern technology. The foundation stone of today's successful life science industry was laid many years ago with important Danish scientists like Hans Christian Ă˜rsted and Niels Bohr, as well as with the pathbreaking research at the Carlsberg laboratories and elsewhere. Many researchers became skilled, particular in chemistry, physics and fermentation, and it provided the foundation for an entire industry that we all reap the benefits of today. If we also are to be successful in the next 10, 20 and 50 years, it is imperative that we continue to focus on how to create the best

It requires interaction and collaboration between companies and universities. And the better we know how to exchange both knowledge, and employees, between the public and the private sectors - and between the companies internally - the better we are prepared for the future. As a research-based and innovative industry, we are looking into a digital transition that will require completely new skills. Already, there is a struggle for the digital experts who can drive the conversion and decode the potential of the new technological opportunities, but digitalization will also place greater demands on the employees' ability to collaborate, work across disciplines, work in teams and in knowledge partnerships. It is a huge challenge that must be met by many parties. One of the areas where the digital challenge is particularly relevant is in the production of pharmaceuticals. Robots, virtual reality, augmented reality, artificial intelligence and machine

Jakob Bjerg Larsen, Chief Consultant at the Danish Association of the Pharmaceutical Industry (Lif)

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


SHARP MINDS

learning are today part of the inventory

to the many exciting educational and

leading practice-oriented campus and

of the pharmaceutical companies -

career opportunities within science,

innovation center for biomanufacturing

Industry 4.0 has moved in. This requires

technology, engineering and mathematics

and process technology. Initiatives like

experienced employees to be updated

(STEM), including biotechnology in the

this that will help us attract and retain

to use and exploit the technology. But it

manufacturing sector in Denmark.

the best life science talents and secure

also requires that future employees have

-We hope that events like the Danish

the skills, courage and desire to embark

Championships in Biotechnology ("DM

on modern drug production and biotech production - something that may not be at the top of the light board of the country's high school students.

vital future technological innovations in product supply, Christian Beenfeldt says.

i Biotek") will help raise awareness

The aim of the Danish Championships

among young people, of the many

in Biotechnology and the biotechnology

opportunities that they have in the life

engineering education near the

science field, including in the areas of

companies in Kalundborg is to help

- Being an industry sector depended

biomanufacturing and product supply,

contribute to the solution to the national

on a highly skilled workforce it is of

Christian Beenfeldt, the Project Director

lack of STEM competencies. A challenge

outmost importance that the Danish

of Knowledge Hub Zealand, says.

that will only be further enhanced for

society continues to priorities education and research. In order to support the continued growth of the Danish life science industry we must continue to educate new talented technicians, engineers, pharmacists, chemists, data scientist etc. We must create a strong ecosystem where companies, universities and other educational institutions interact and collaborate. Furthermore, we should not forget to focus on the importance of having a strong continuing and further educational system that makes is easy for both companies and employees to develop and update key competences for the future, Jakob Bjerg Larsen says.

It is no coincidence that Danish Championships in Biotechnology are held in Biotech City Kalundborg. Here the

The sharpest minds for researching, developing, and producing future drugs

insulin manufacturing plant, the

will not come by themselves. This requires

world's largest enzyme production, and

a focused effort - and new initiatives.

Denmark's largest refinery. In Biotech

Danish life science is dependent on us

City, University College Absalon also

being visionary, just like Ørsted, Bohr and

educates biotech engineers in a small,

Carlsberg. That we as a society focus on

close and strong academic environment,

education and research, and that we at the

where the students work closely with

same time become skilled at conveying

the country's largest biotechnology

the exciting panoply of high-tech

companies and develop competencies

education and career opportunities that

in development and production. This is

exist within both research, development

done in a close link between theory and

and modern drug production.

Knowledge Hub Zealand and the

students learn how the theory works in

Kalundborg Recruitment Alliance,

practice, e.g. when a drug production

together with many life science

is to be scaled up to a world market. In

companies, production companies and

addition to tasks within biotechnological

process companies in Western Zealand,

production, biotech engineers also

is working to change. On January 23,

work with areas such as nutrition,

2019, they hosted Denmark's first Danish

environment and energy.

students. 450 students participated, and the winners were the class 3.T from Stenhus Gymnasium in the city of Holbæk, who developed and described a project that will address plastic pollution in the oceans. The purpose of the event is to direct the students' eyes

educational cities in Denmark.

is located, including the world's largest

practice, where the young engineering

Biotek) for 2nd and 3rd year high school

far away from Copenhagen and the large

largest biotech production in Scandinavia

However, this is something that

Championships in Biotechnology (DM i

companies that have business activities

-The need for future life science talents in Danish biotech and pharmaceutical product supply is very real. In Biotech City Kalundborg, we address this need by working to create the “Knowledge Hub Zealand Campus”—Scandinavia's

Christian Beenfeldt, Project Director of Knowledge Hub Zealand

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019

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CAREER, TRAINING & EDUCATION

BRINGING THE BEST TALENTS AND IDEAS INTO PLAY A silo mentality, internal competition and personal barriers can stand in the way of knowledge sharing, without managers and employees even being aware of it. However, through culture-neutral work tools, organisations and people can transcend substantial barriers and bring the best ideas and talents into play, according to a communications expert. By Signe Walther Mørck, Journalist

M

ulti-cultural working groups can

or because they fear that their feedback

“At GlobalDenmark, we work with a

greatly contribute to innovation

will lead to frustration and a thirst

special feedback model that maps out

in an organisation. Nevertheless, many

for revenge”, said Claus Adam Jarløv,

opportunities, allowing a valuable

businesses and managers are unaware

explaining that feedback is therefore

exchange of ideas to take place by virtue

that, irrespective of the organisational

often reduced to an unstructured and

of cultural differences, and not despite

set-up, employees sometimes tend to

superficial response that does not create

cultural differences”.

withhold information and ideas, and this

real value.

can obviously harm the organisation’s internal learning and ability to bring good ideas and talents into play. An American research study conducted by the Academy of Management and published in 2017 reported on the reactions on feedback from almost 2,000 employees. The results showed that, unlike employees who only cared about improving their own performance, employees who were curious and motivated to receive feedback attracted more and higher-quality feedback from their surroundings. If you want motivated employees who are willing to share information internally in their department or with the entire organisation, it is crucial that the company culture is based on trust and cross-cultural communication. This should be the organisation’s DNA, according to Claus Adam Jarløv, CEO of the consultancy firm GlobalDenmark.

Culture-neutral work tools enhance constructive generation of ideas

Feedback across professional groups and nationalities GlobalDenmark’s feedback model, DIDS

If conducted in the right way, feedback

(Describe, Identify, Discuss, Summarise)

can serve as an important catalyst for

is a catalyst for learning and ideas. The

stimulating the best ideas and talents in

model is culture-neutral and steers clear

an organisation. Consequently, feedback

of irrelevant psychological speculation.

is a crucial element in the organisation’s

GlobalDenmark has been using the

toolbox. GlobalDenmark offers courses

model for the last ten years and has

on how to promote the use of culture-

tested it on PhD students from all over

neutral tools that are quick and easy

the world, as well as on researchers and

to implement, while at the same time

senior researchers from private life-

reflecting a number of psychological and

science companies and public-sector

cognitive processes that break down the

research organisations. According

silo mentality and cultural barriers in an

to Claus Adam Jarløv, the feedback

organisation.

model makes it possible to focus on

“By using tools that are culture-neutral, cultural differences are no longer disturbing elements, but rather a factor

a performance or an idea without letting assumptions and psychological guesswork interfere in the process.

that contributes to creativity and

“The DIDS model may seem simple, but

cooperation”, said Claus Adam Jarløv,

it’s actually more complex than that.

adding that:

When used correctly, the model steers clear of a large number of psychological and cultural mechanisms, while at

“From a psychological point of view,

the same time enhancing knowledge

feedback is a sensitive process, because

sharing and generation of ideas,” said

we not only comment on a person’s

Claus Adam Jarløv, adding that the

performance; we also, implicitly, assess

model paves the way for dialogue across

the person’s right to be part of the

cultures, professional backgrounds and

group. Professionals are often ambitious

hierarchies.

and competitive individuals, and many people live in fear of their incompetence being displayed. Moreover, employees also avoid engaging in colleague-tocolleague feedback, either because they are afraid to hurt other people’s feelings,

38

Claus Adam Jarløv, CEO at GlobalDenmark


CAREER, TRAINING & EDUCATION

GRADUATES BRING INNOVATION Young academics struggle to get a job after graduation and companies often require many years of experience or pick graduates from abroad. By Karin Jensen TEMP-TEAM, a recruitment and

“So why not hire more graduates and

industry but also in relation to their

temporary employment agency, is

train them. They don’t have ten years of

personal careers. We offer everything

swamped with job applications from

experience, no, but experience must be

from introductory courses to Masters’

graduates, who wish to work in the Life

acquired,” says Kjær.

programmes,” said Søren-Ulrik Rolsted

Science industry, but do not even get invited to a job interview. And that is a shame, because the graduates possess many qualities despite their lack of experience, according to the agency. “They are clever, fast and adaptable, have an academic approach, good language skills, know IT and social media. There are so many competencies, but they don’t

Another idea could be to think in a more untraditional way, for example train a

Fangholm, Director and Head of Department at Atrium.

graduate with an academic background

Examples of people taking courses at

to work in a laboratory as is often seen in

Atrium could be a pharmacist who has to

other countries.

learn the discipline of pharmacovigilance, or a business graduate finding

“We have to be a bit more open and perhaps change the culture somewhat. The graduate may be a bit overqualified

employment in sales and marketing in the Life Science industry.

for lab work but it’s also about getting a

“There is a very special linguistic code

Kjær, who is responsible for recruiting

chance, create a network and gain some

you need to learn before getting a job in

academics in the Life Science industry.

experience,” says Kjær.

the industry. And the more experience

Unemployment among Danish and

Training graduates

Swedish graduates has been a consistent

At Atrium, focus is on training and

even get to a job interview,” says Margit

problem since the financial crisis.

you gain, the more specialised you’ll have to be, and the higher the requirements will be,” Fangholm says.

further education in the Life Science

However, many large Life Science companies Denmark and Skåne (Skaane) are attractive to work for and are often in a position where they can pick and choose from top graduates from both domestic and international universities. “It’s a problem that Danish companies pick foreign graduates before domestic graduates,” says Kjær, who would like to

industry, offering courses for people, who works in all aspects of life science, including pharmaceutical companies, the public sector and medical agencies.

Introductory courses provide newcomers in the Life Science industry with knowledge on for example anatomy, physiology and medical understanding but otherwise Atrium offers courses at all

“Our prime goal is to ensure that

levels to match the entire value chain in

employees in life science are well-

life science, from research, clinical trials,

qualified, both in relation to their

regulatory work, authority approval and

everyday work in a very restrictive

market access and launch.

see Danish Life Science companies take

“We also have courses for those with

on more graduates and help them gain

fifteen years of experience and two

experience. Training a foreign graduate

Masters’ degrees,” Fangholm ends.

costs money and time too, she says. Furthermore, the Danish labour market has a large generation of ageing employees who are getting close to retirement.

Søren-Ulrik Rolsted Fangholm, Director and Head of Department at Atrium

Margit Kjær, Senior Recruitment Specialist at Temp-Team

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39


”Two things spring to mind for 2019 and 2020. One is the upcoming Health Care Act and how it will help promote the innovative interaction between the public health sector and industry. The Health Care Act will be decisive for how productive and how strong a cooperation can be developed between the two parties. It relates to everything, from procurement to experimental development projects and we have very high expectations. It’s greenfield right now but there are possibilities to set up some very exciting constructions. The upcoming general election may indeed spoil things and there’s a real danger that it may fall through.” ”The other thing is implementation of the EU Commission’s new regulatory set-up on medical equipment, and whether it will be ready and functional in time. We are rather nervous whether the Commission will get there in time because there have been large delays, both in nominating the notified bodies, approving equipment and technical guidelines, have institutions in place but also the common European database for equipment and suppliers. If it’s not in place in time, then there could be serious problems.” "Brexit is obviously something we’re keeping an eye on in relation to approval of equipment, trade with equipment. Roughly 50% of all equipment is approved by notified bodies in the UK but they don’t have jurisdiction in the EU if the UK leaves.” Peter Huntley, CEO at Medicoindustrien, the industry association for companies in Denmark, which develop, manufacture and sell medical devices

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


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ORIGINAL MEDICINES VS GENERIC SUBSTANCES

Patent law stands above the rules on substitution A ruling by the Danish Maritime and Commercial High Court prohibits substitution with generic medicines for indications that remain patent protected. Subsequently, the Danish Medicines Agency has changed the rules on substitution. By Charlotte Strøm, MD PhD Journalist

P

resumably, innovative drug developers look to the outcome of the Danish Lyrica® court case with some relief and even encouragement. According to the ruling made by the Danish Maritime and Commercial High Court, prescription-only medicinal products protected by second medical use patents no longer risk patent infringement caused by substitution of the original medicinal product with a generic medicinal product. The case1 is described in a publication in the journal European Pharmaceutical Law Review by attorneys-at-law Mikkel Vittrup and Mette-Marie Henrichsen, both legal experts of intellectual proprietary rights with the Danish law firm, Plesner. The publication outlines the controversies evolving around off-label use of generic medicines, substitution of original medicinal products on one side and the patent protection of innovative medicines on the other. According to the previous rules on substitution of medicines, generic products could be placed in the same substitution group despite not being approved for marketing authorization for the same indications. The implication of these rules was that pharmacies had the obligation to always dispense the cheapest generic product even if the product was prescribed for a patent protected indication. With the ruling, the Danish Medicines Agency has changed the rules on substitution ensuring that in the future patent protection of specific indications, is considered when the pharmacies dispense medicinal products. However, this change came around only recently due to the Lyrica® case.

1The Maritime and Commercial High Court's case A-6-15.

42

Pregabaline for neuropathic pain Warner-Lambert Company LLC (part of the Pfizer group) owns the Danish patent DK/EP 0 934 061 T6 that provides protection for use of pregabalin manufacturing of medicinal products for the treatment of pain i.e. second-medical use patent. In Denmark, the Danish subsidiary Pfizer ApS, markets the prescriptiononly product Lyrica®, which contains pregabalin as an active ingredient. Lyrica® is approved for the treatment of three different indications: A) epilepsy, b) generalized anxiety disorder and C) neuropathic pain. Lyrica® was previously protected by a product patent for the active ingredient pregabalin. However, Pfizer continued research into the clinical use of pregabalin and later filed an application for the so-called second-medical use patent for pregabalin as Pfizer had made the discovery that pregabalin can also be used effectively for the treatment of neuropathic pain. While the two first indications had come off patent, the indication for neuropathic pain remained patent protected until 16 July 2017. Due to the second- medical use patent Pfizer was the only one allowed to offer medicinal products containing pregabalin for treating pain. However, generics were free to offer pregabalin products for the nonpatented indications. Accordingly, the generic product Pregabalin ‘Krka’, was approved only for the non-patented indications. The original product and the generic product were placed in the same substitution group, entailing that all pharmacies had to dispense Pregabalin ‘Krka’ in situations where merely the active ingredient was prescribed for pain and even in situations

where patients had been specifically prescribed Lyrica® for the indication of pain by the physician. Thus, Pfizer commenced legal proceedings against Krka and all pharmacies in Denmark requesting a preliminary injunction. According to the legal publication, Pfizer approached the Danish Medicines Agency requesting the authority to change the rules prior to filing the request for preliminary injunction against the pharmacies and Krka. Still, the Danish Medicines Agency did not find basis for changing the rules and subsequently intervened in the case on its own initiative to support the pharmacies. A preliminary injunction was granted by the Danish Maritime and Commercial High Court on 25 June 2015 against all pharmacies' dispensing of generic versions of the product Lyrica® for the treatment of pain. Notably, the preliminary injunction was granted against the pharmacies, as the pharmacies had been obliged to substitute Lyrica® with the cheaper generic product Pregabalin ‘Krka’, and even in situations where Lyrica® prescribed by the doctor for treating the patent protected indication pain. From the article it is further stated: “The court did not grant a preliminary injunction against Krka as it found that Pfizer's primary claim on Krka being enjoined from selling Pregabalin ‘Krka’ without ensuring that the product was not dispensed for the treatment of pain was too unclear to later be enforced by the Enforcement Court.” In addition, the court found that Krka already had complied with requests from Pfizer by providing specific written instructions that the product could not be distributed and/or dispensed for the treatment of pain.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


Risk of undermining the approval system According to the Danish Association of the Pharmaceutical Industry (Lif) this ruling is a support of pharmaceutical companies making efforts and investments to provide innovative medicines to Danish and European patients: -For medicinal products we have an approval system in place that builds on extensive clinical studies and monitoring performed by medical doctors and the data thoroughly assessed by the regulatory authorities. And for good reason, because this system provides the highest level of security that a medicinal product, once approved, has documented efficacy while simultaneously ensuring patient safety, says Ida Sofie Jensen, CEO at Lif. She continues, -It is highly disturbing if patient safety is compromised by selection of a medicinal product for the treatment of a condition that it was not approved for. She points to the specificity of the approval process of authorities where medicinal products only obtain approval for marketing authorization within the indications where efficacy and safety are adequately documented, and the benefits of the treatment outweighs potential risks to the patient. -There may be situations where no approved medicines are available, where the treating physician may want to look to medicines that are approved for different indications. The important thing is however, if this call is made by the treating physician or if it is happening due to recommendations from the national health authorities. In case of the latter, it is likely that over time the trust to the efficacy and safety of approved medicinal products will be undermined by the authorities that in fact are representatives of this very approval system, Ida Sofie Jensen ends.

Reference: Mikkel Vittrup and Mette-Marie Henrichsen. Is Off-Label Use and Recommendations for Off-Label Use of Medicinal Products Legal? Regulatory and Patent Implications from a Danish Perspective. EPLR (3) 2018. DOI: 10.21552/eplr/2018/3/4

Ida Sofie Jensen, CEO at Lif


PATENTING

PATENTING NATURE-BASED PRODUCTS IN THE US By Andreas Lauge Christensen, Patent Attorney at Plougmann Vingtoft and Jan Mondrup Pedersen, European Patent Attorney & Partner at Plougmann Vingtoft

Life science and pharmaceutical companies seeking patent protection of nature-based products are increasingly challenged by strict and complex US patent laws. Here, we highlight a key element that should be considered before filing a patent to the US authority. Until recently, the bar for patentable subject-matter in the US was defined by “anything under the sun that is made by man”. Two recent decisions from the US Supreme Court has done away with this mantra, in a way that affects products that are nature-based. With Mayo Collaborative Servs. vs. Prometheus Labs. Inc. (2012) and Ass. Mol. Pathology vs. Myriad Genetics Inc. (2013) has come a new paradigm with the aspiration of the US Supreme Court

to prohibit monopolizing patents that tie up future use and innovation. This concept is known as pre-emption and has been the primary motivation for the USPTO to draw up new guidelines (Interim Guidance on Patent Subject Matter Eligibility) for their Examiners to follow when deciding whether a patent claim related to a nature-based product is patent eligible or amounts to a judicial exception under 35 USC § 101. Under this new paradigm, life science

and pharmaceutical companies seeking to protect products, processes or uses that in some aspects may be related to naturally occurring equivalents, are more frequently challenged by objections under the new strict and complex interpretation of 35 USC § 101. THE MAYO-TEST A principal set of questions, schematically illustrated in fig. 1, determines if a patent claim to a nature-based product is deemed patent eligible or not. Steps 2A-B are known as the Mayo-test and are used to evaluate e.g. compounds from natural extracts, food products, organisms such as bacteria and plants, and proteins and peptides. According to the guidelines, the Examiners are obliged to present prima facie evidence (such as a court decision) to justify a 35 USC § 101 objection. However, the reality is that the burden of proof to pass the Mayo-test for patentability often lies with the applicant. Consequently, it is important to act proactively in prosecution opposite the USPTO. STEP 2A – “MARKEDLY DIFFERENT” FROM THE NATURALLY OCCURRING EQUIVALENT? The first step of the Mayo-test boils down to whether the nature-based product can be categorized as markedly different from the closest naturally occurring equivalent. Only those limitations of the patent claim relating to the naturally occurring equivalent are evaluated in step 2A. Practice of the USPTO is largely formed by the jurisprudence of the courts, where markedly differences may for instance be found in:

Fig. 1: This infographic shows how the United States Patent and Trademark Office (USPTO) assess patentability under 35 USC § 101.

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PATENTING

Biological or pharmacological functions or activities

Chemical and physical properties

Phenotype, including functional and structural characteristics

Structure and form, whether chemical, genetic or physical

Only if the natural equivalent is not considered markedly different will the nature-based product be further evaluated in step 2B. STEP 2B – “SIGNIFICANT MORE” THAN THE NATURALLY OCCURRING EQUIVALENT? In the second step, the Examiner evaluates if further elements are sufficient for the patent claim to constitute significant more than a judicial exception according to step 2A. In contrast to the markedly different-analysis of step 2A, the patent claim is evaluated as a whole in the significant more-analysis of step 2B. This part of the Mayo-test is relative vague, but amongst others the USPTO

provides the following examples from the Supreme Court that qualify as significant more: •

Improvements to another technology or technical field

Effecting a transformation or reduction of a particular article to a different state or thing

Adding a specific limitation other than what is well-understood, routine and conventional in the field

The additional features of a patent claim must be evaluated both individually and in combination with each other. Individual elements, which do not amount to significant more, may in combination represent significant more than a judicial exception. LEGAL VALIDITY OF INTERIM GUIDANCE According to the USPTO, patent claims related to nature-based products that clearly do not tie up future use and innovation will not be evaluated by the Mayo-test, but will be prosecuted under streamlined analysis. As the

USPTO has emphasized that the new guidelines are by no means binding to the US courts, questions concerning the validity of such patents pertains. Thus, future opponents will likely challenge the validity of patents granted under the streamlined analysis at the USPTO Patent Trial and Appeal Board or in district court with the argument that the patent claims are not valid under a complete Mayo-test. PATENT CLAIMS IN THE US PROSPECTIVELY At present, handling of objections under 35 USC § 101 is unpredictable and subject to the interpretation of the individual Examiners. At Plougmann Vingtoft we have experience with objections raised under the new paradigm and recommend to focus on solid fallback options containing structural limitations. This recommendation is corroborated by the fact that the US courts appear also to prefer structural limitations.

Nyborg & Rørdam har lang erfaring med rådgivning til virksomheder indenfor life science og biotech. Vores rådgivning fokuserer på resultatorienterede og praktisk anvendelige løsninger, der bygger på et indgående kendskab til branchens strategiske og kommercielle forhold samt forretningsmodellen hos det enkelte selskab. Vi lægger vægt på at opbygge tætte og tillidsfulde relationer til vores klienter. Vores rådgivning omfatter blandt andet:

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AN UPDATE ON GDPR

GDPR UPDATE In a previous article in Greater Copenhagen Life Science June 2018 I gave an overview of the most important GDPR features relevant to the Life Science sector. This article aims to give you an update of relevant GDPR issues that may have an impact on the daily operations of businesses in the Life Science sector. By Karin Absalonsen, Attorney and Partner at Nyborg & Rørdam Lawfirm The EU General Data Protection Regulation (”GDPR”) has significant impact on businesses in the Life Science sector. Life science organisations must consider how to handle the GDPR requirements and to demonstrate compliance. Extra territorial effect One of the major impacts of the GDPR is that it applies not only to Life Science organisa-tions established within the EU but also extends its applications to organisations estab-lished outside the EU if they offer goods or services to individuals in the EU and/or moni-tor the behavior of data subjects within the EU. In other words, companies established outside the EU such as in the US, Canada, China etc. targeting European consumers or monitors personal data on European citizens must comply with the GDPR. As an example a US healthcare/ life science company must comply with the GDPR if it receives personal information collected in the course of clinical trials from a CRO estab-lished in the EU. Data transfer outside the EU Transfer of personal data collected in the EU to a country outside the EU is forbidden by the GDPR unless the relevant third country ensures an adequate level of personal data protection that is recognized by the European Commission. The current list¹ has 12 ap-proved countries including, among others, Argentina, Canada, Israel, New Zealand and Switzerland. For transfer of personal data from EU to the US the data importer must be certified to the EU-US Privacy Shield,

see below. For Japan an adequacy decision was made in 2018 and finally adopted by the Commission on 23 January 2019. South Korea will most likely follow soon. In the absence of an adequacy decision by the Commission the data exporter must take certain precautions such as signing the Commission’s Standard Contractual Clauses or adopting Binding Corporate Rules (BCR). EU-US Privacy Shield The EU-US Privacy Shield was adopted on 12 July 2016 to replace the Safe Harbour scheme that was invalidated in 2015 by the European Court of Justice (CJEU) in the Schrems case (C362/14). Certification under the EU-US Privacy Shield is achieved by vol-untary commitment to a set of data processing principles. Members are subject to su-pervision by the US Federal Trade Commission. The Privacy Shield provides for an annual review process designed to assess the functioning, implementation, supervision, and enforcement of the Privacy Shield. After the first formal review in September 2017 a number of issues and concerns were raised by the WP29 (now replaced by the European Data Protection Board (EDPB)), the Commission and the European Parliament. The second annual review was made in December 2018 and the Commission’s Report concludes that the Privacy Shield “continues to ensure an adequate level of protection” for personal data transferred from the EU to the US. The Commission also found that the implementation of a number of the recommenda-

tions following the first annual re-view in 2017 improved several aspects of the Privacy Shield. However, the Commission also highlights a few aspects of the Privacy Shield which need to be closely monitored as they affect elements that are essential for the continuity of the adequacy finding. These include continued review of the effectiveness of mechanisms and tools for the US De-partment of Commerce to monitor compliance with the Privacy Shield, and the appoint-ment of a permanent Privacy Shield Ombudsperson which is expected to be in place by 28 February 2019. Digital Ireland has initiated a case for invalidation of the Privacy Shield which is currently pending before the CJEU. Brexit Following Brexit, life science companies that transfer data to the UK must be aware that UK will become a so-called “third country” outside the EU. This means that transfer of personal data from the EU to the UK requires a basis for transfer under the GDPR. In Denmark, “Datatilsynet” (the Danish Data Protection Agency) has provided an overview of the consequences of the various Brexit scenarios, which can be found on Datatil-synet’s website². In the event of an agreement between the EU and the UK before 29 March 2019, there will be a transition period until 31 December 2020 where transfer of personal data from the EU to the UK can be made on the same conditions as to other EU countries, and no action is required.

¹https://ec.europa.eu/info/law/law-topic/data-protection/data-transfers-outside-eu/adequacy-protection-personal-data-non-eu-countries_en ²https://www.datatilsynet.dk/internationalt/brexit/

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AN UPDATE ON GDPR

security purposes, ensuring that any such use of per-sonal data would be limited to what is necessary and proportionate and subject to independent oversight and effective redress mechanisms.

If the UK decides to stop the Brexit process, it will continue as member of the EU, and all transfers of personal data from the EU to the UK can be made on the same terms and conditions as apply now. In the absence of an agreement between the EU and the UK prior to 29 March 2019 (no-deal Brexit), and if the UK has not stopped the Brexit process before this date, the UK will, as of 30 March 2019, no longer be a member of the EU and will consequently be-come a so-called “third country”. In such case, it will only be possible to transfer personal data from the EU to the UK if a basis of transfer in the form of one of the following in-struments is established:

Standard or ad hoc Data Protection Clauses

• •

Binding Corporate Rules

Derogations

Codes of Conduct and Certification Mechanisms

The European Data Protection Board (EDPB) has adopted a Guidance³ on the procedure for transfer of personal data to the UK in such situation that provides information on how to apply these transfer instruments. Free flows of personal data between EU and Japan and South Korea On 23 January 2019 the Commission adopted its adequacy decision on Japan, allowing personal data to flow freely between the two economies as of this date on the basis of strong protection guarantees. Japan put in place additional safeguards to guarantee that data transferred from the EU enjoy protection guarantees in line with European stand-ards. The key element of the EU-Japan adequacy decision covers:

Supplementary Rules regarding the protection of sensitive data, the exercise of individual rights and the conditions under which EU data can be further trans-ferred from Japan to another third country. These Supplementary Rules will be binding on Japanese companies importing data from the EU and enforceable by the Japanese independent data protection authority (PPC) and courts.

A complaint handling mechanism to investigate and resolve complaints from Eu-ropeans regarding access to their data by Japanese public authorities, which will be administered and supervised by the Japanese independent data protection authority.

The EU adequacy decision for South Korea is pending legislative amendments to Korean data protection law. South Korea has quite strong data protection rules, and the process of getting an EU adequacy decision was initiated in 2015. However, there are problems with the independence of its enforcement bodies and the legislative amendments will hopefully clear the way for the adoption of an adequacy decision by the Commission. The adequacy decisions regarding Japan and South Korea will greatly facilitate flows of personal data between Life Science organisations in the EU these countries and will cre-ate the world's largest area of safe transfers of personal data. Recent developments in Denmark

half of 2018 but as of today it has not announced any conclusions or decisions in this respect. The legal system in Denmark does not provide for administrative fines which must be imposed by a competent national court. Datatilsynet may initiate fines by referring the matter to the Danish police, which will then be in charge of and conduct the investigation before the matter is brought before the court. On its website, Datatilsynet has published the planned focus areas for investigations to be conducted during the first six months in 2019. The focus areas relevant for life science organisations include:

• • •

Personal data breaches Encryption of e-mails The data subjects’ right of access.

Data processors – demonstration of GDPR compliance As part of its obligations under the GDPR a data controller must be able to demonstrate that its data processors are in compliance. As a tool to conduct and demonstrate such control “FSR” (Danish Auditors, which is the Danish trade organization of auditing, ac-counting , tax and corporate financing) has in cooperation with Datatilsynet published a declaration for data processors₄.

Encryption of confidential and sensitive personal data when transmitted by email Datatilsynet enforced a mandatory requirement to encrypt confidential and sensitive personal data when transmitted by email via the internet as of 1 January 2019. Organisa-tions in the life Science sector must ensure implementation of appropriate measures to be able to comply with these rules. Investigations on the application of the GDPR The supervisory authorities must conduct investigations on the application of the GDPR. Datatilsynet has conducted a number of investigations during the second

Karin Absalonsen, Attorney and Partner at Nyborg & Rørdam Lawfirm

Safeguards concerning the access of Japanese public authorities for criminal law enforcement and national

³ https://edpb.europa.eu/sites/edpb/files/files/file1/edpb-2019-02-12-infonote-nodeal-brexit_en_0.pdf ₄ https://fsr.dk/Faglige_informationer/Om_revisor/Persondataforordningen/FSR%20lancerer%20paa%20 baggrund%20af%20samarbejde%20med%20Datatilsynet%20ny%20erklaering%20om%20persondata

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019

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ENDRESS+HAUSER INVESTS IN RAMAN TECHNOLOGY

Turning differences into synergies – "Lab and Process" - Endress+Hauser invests in Raman technology The Endress+Hauser Group presented their extended portfolio of analysis products for the entire company for the first time in 2017. Several investments have been made since to meet customer requirements from the laboratory to process development through to the process engineering stage in 2019. Laboratory analysis A large number of process automation customers operate development or quality labs. The challenge they face are often laboratory measurements which are still carried out manually to a large extent. By acquiring companies such as Kaiser Optical Systems and Analytik Jena, the process automation specialist has gained access to the world of laboratory measurement instrumentation and process development. The group's new range of products including Analytik Jena's CyBio product line helps users to automate precisely these processes, for example, in chemistry and biology labs. Another objective of expanding into new business segments is to ensure

that new product developments or process optimization solutions released into production on the customer side are of a consistently high quality. In the life sciences industry particularly, this is achieved through ongoing involvement in the "scaling up" stage, from research to product and process development through to production. In short, the expansion signals a wider range of analysis products for customers as well as added value through the pooling of expertise and joint efforts for future product developments. Matthias Altendorf, CEO of the Endress+Hauser Group explains "With the acquisition of Analytik Jena and Kaiser Optical Systems we have been able to broaden

our analytical process expertise and expand into the laboratory sector". He goes on to say "We often find ourselves dealing with the same customers in the laboratory industry as in process technology. In future, we would like to be able to support them all the way from the research phase, through product and process development, to production and quality control." Since the acquisition of Kaiser Optical, Endress+Hauser has invested 4.9 million euros in a new building in Lyon for better technical support of all European customers. But also investments in the manufacturing facility for Raman analyzers have been made.

New construction: Endress+Hauser has invested 8.6 million US dollars to expand the manufacturing facility for Raman analyzers in Ann Arbor, Michigan in the US.

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ENDRESS+HAUSER INVESTS IN RAMAN TECHNOLOGY

“The new state-of-the-art manufacturing facility will allow us to produce higher volumes, while maintaining the highquality standards our customers demand,” emphasizes Tim Harrison, Managing Director of Kaiser Optical Systems.

With the acquisition of Analytik Jena and Kaiser Optical Systems Endress+Hauser will be able to broaden their analytical process expertise and expand into the laboratory sector.

Kaiser Optical Systems Inc. employs some 100 people around the world and has been part of the Endress+Hauser Group since 2013. The company is a leader in the field of Raman spectrographic instrumentation and applied holographic technology. The acquisition of Kaiser Optical Systems underscores Endress+Hauser’s strategic goal of employing advanced analytical technologies in process control applications and supporting the customer from laboratory to process.

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THE BRAIN PRIZE 2019

The Brain Prize 2019:

French neuroscientists honoured for outstanding research into small vessel strokes in the brain Aiming for treatment they have spent more than 30 years describing, understanding and diagnosing the most common hereditary form of stroke, CADASIL. For this, the four French neuroscientists are now receiving the world's most valuable prize for brain research – the Lundbeck Foundation Brain Prize, worth 1 million euros. Source: The Lundbeck Foundation

E

ach year 17 million people worldwide suffer a stroke. Around 30 percent of these are mini strokes caused by changes in the small vessels of the brain. To begin with, these strokes cause temporary symptoms such as weakness, numbness and impaired coordination. However, they tend to relapse, and since each new mini stroke affects the brain’s function, depression, concentration difficulties and dementia often follow in their wake. In 1976, Professor Marie-Germaine Bousser was consulted by a middleaged man who had suffered a minor stroke and showed clear signs of rapidly progressing dementia. His disease presentation was highly unusual, and less than 10 years later, the patient's offspring developed similar symptoms. Professor Bousser realised that this had to be a hereditary disorder, as yet undescribed. In order to solve this conumdrum she took the initiative to collaborate with colleagues at Lariboisière Hospital from Greater Paris University Hospitals /AP-HP, Inserm and Paris Diderot University : Professor Hugues Chabriat, Dr Anne Joutel and Professor Elisabeth

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Tournier-Lasserve. This working relationship would continue for more than 30 years. The four scientists are now being awarded The Brain Prize, worth 1 million euros, for their comprehensive, in-depth and relentless research efforts. Together, they have solved the puzzle and shown that this is a hereditary disease, caused by a mutation in the NOTCH3 gene on chromosome 19. Mutations in this gene result in accumulation of protein in the walls of the small blood vessels. The changes occur throughout the body but only cause symptoms from the brain. The disease is hereditary, and children of mutation carriers have a 50% risk of inheriting the disease, which is known as CADASIL (Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy). The team has developed a diagnostic test and is involved in testing a potential treatment in animal models. THE BRAIN PRIZE EXPLAINS THE REASONING BEHIND THIS YEAR’S AWARD The organisation behind The Brain Prize is the Lundbeck Foundation:

Denmark's biggest funder of brain research. ‘There’s a huge need to develop and strengthen brain research, both in Denmark and internationally. The world’s population is getting older, and increasing life expectancy brings with it a wide range of brain disorders – at great cost to society. But they’re also a devastating burden for patients and their relatives. CADASIL is a good example of how traumatic it can be to have a brain disorder. The brain doesn't merely control a number of our bodily functions, speech, thoughts and communication – it's where our personal identity lies, and CADASIL sufferers feel this,’ says Kim Krogsgaard, Director of The Brain Prize. Professor Anders Björklund, Chair of the Foundation’s Selection Committee, explains the reasoning behind the award: ‘The research of the four prizewinners is a textbook example of so-called translational research. This constant interaction between clinical observations and lab work has produced results with far-reaching consequences for our understanding of strokes and dementia disorders – two of the most burdensome diseases for our society,’ he says.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


FLOWBOT ONE

New lab robot to ease pain and save time for laboratories A new robot from Flow Robotics, the flowbot ONE, can take over tedious and time-consuming liquid handling tasks in the laboratory. This will help the many laboratory technicians and medical laboratory technologists who experience pain on a daily basis, but can also help save time.

A recent report from the National Research Centre for Work Environment shows that 37% of laboratory technicians experience pain several times a week. And this is just laboratory technicians. Add to that the medical laboratory technologists. Flow Robotics launched its new lab robot, the flowbot ONE, which can perform liquid handling tasks in the laboratory and take over many of the repetitive and burdensome

manual pipetting tasks. Unlike other lab robots, the flowbot ONE does not require programming skills and can be used by anyone. Flowbot ONE can also take over time-consuming parts of the workflow, thereby freeing up time for other tasks. Not just in pharmaceutical and biotech companies, but also in research institutions. A pilot robot has been tested at a biotech company and at the Technical University of Denmark (DTU) for a year and an upgraded and final version of flowbot ONE is now ready for the market.

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INDUSTRY NEWS

NEWS FROM THE INDUSTRY Edited by Arne Nielsen

LACTOBIO IS DEVELOPING A NEW SCREENING PLATFORM

The new screening platform consists of new probiotic isolates collected from multiple different sources and donors. The new strain collection is the foundation for screening and identification of new lactic acid bacteria with specific characteristics suitable for

modulation of the microbiome to prevent or manage different diseases. Screening technologies include various antimicrobial assays with focus on the fight against antibiotic multi-resistant bacteria. Lactobio has isolated and identified new probiotic strains being able to inhibit growth of Methicillin Resistant Staphylococcus aureus (MRSA). MRSA is a major concern and currently one of the most common nosocomial pathogens, thus a leading cause of a variety of hospital-acquired infections. Lactobio will commercialize the first product in 2019 based on live probiotic strains with antimicrobial activity against MRSA. For more visit w w w.lactobio.com

STATE-OF-THE-ART FLOW CYTOMETRY CRO IMMUMAP EXPANDS TO OFFER ELISPOT The immune oncolog y field is rising and has been since pivotal phase III data were published nearly 10 years ago. With the increased focus comes the need for understanding the mode-of-action of lead compounds. Crucial players are the antigen-specific CD8 T cells and enumeration of these using the enzyme-linked spot forming assay, better known as ELISPOT, is widely applied in animal and human studies. Both the intra-assay and inter-laboratory variances are challenging for this assay, and therefore letting experts take care of such studies is advisable. We have the necessary expertise and deliver accurate data with a rapid turnaround, freeing up your time and energ y.

measuring antigen-specific T cells, complementary to our f low cytometry-based services. Thus, we believe this initiative will be attractive for both existing and new customers”, says ImmuMap CEO Thomas M. Frøsig. For more information visit w w w.immumap.com

Applications of ELISPOT: • • •

Enumeration of functional antigen-specific cells Immune monitoring of pre-clinical or clinical cell samples Confirmation and further characterization of cytokine secretion as a follow up on previous f low cytometry data.

“We are happy to expand our assay portfolio to including ELISPOT. This is the golden standard for

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Schematic depicting the specific interaction between a cancer cell and a specific CD8 T cell with following activation of the CD8 cell and killing of the cancer cell.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


INDUSTRY NEWS

AQ90 High Fidelity DNA Polymerase – Unique, chimeric and engineered for high-performance PCR. Edited by Maiken Eriksen The development and construction of a new high fidelity DNA polymerase with ultra-high fidelity has been a key point for Ampliqon. High fidelity DNA polymerases are essential for PCR experiments whose outcome is strictly dependent on amplifications with very low error rates, such as cloning/sub-cloning, NGS applications, SNP analysis and mutagenesis. AQ90 High Fidelity DNA Polymerase from Ampliqon displays the following features; high fidelity measured 50x higher than Taq DNA polymerase, ability to amplify problematic DNA targets, such as those with low to high GC content and ability to perform amplification on DNA targets longer than 12 kb. These features of AQ90 High Fidelity DNA Polymerase have been attained by combining functional domains from two wildtype Archaeal high fidelity DNA polymerases, thereby creating a unique and chimeric DNA polymerase displaying the most desired features from both wildtype DNA polymerases. The improved high fidelity feature of AQ90 High Fidelity DNA Polymerase dramatically lowers the risk of carrying out mistakes during DNA amplification. If by mistake an incorrect dNTP is incooperated into the DNA, the proofreading capacity of the AQ90 High Fidelity DNA Polymerase senses the mispaired dNTP, which is then immediately removed by the 3’ -5’ exonuclease activity and hereafter replaced by the correct dNTP. Inspiration for the name of the AQ90 High Fidelity DNA Polymerase was taken from several places: Its key features (Accuracy), its manufacturer (Ampliqon) and lastly from the molecular weight of the enzyme (90 kDa).

AQ90 High Fidelity DNA Polymerase is supported with an optimized PCR buffer system allowing robust amplification on AT-rich, GC-rich and long DNA targets. For more convenient handling AQ90 High Fidelity DNA Polymerase is also available as a 2x Master Mix. Ampliqon is a Danish manufacturer of PCR enzymes and laboratory reagents. The Ampliqon PCR enzyme collection covers all standard DNA amplification set-ups in use in modern laboratories. Specialised knowledge of both enzyme purification, innovation and DNA amplification provides DNA laboratories with reliable and high quality products. PCR products from Ampliqon is widely used in hospitals, universities, research institutions and life-science industries worldwide. More information about the PCR enzymes from Ampliqon visit ampliqon.com

NanoCuvette™ One Now you can measure samples that do not absorb light in a standard spectrophotometer. For enzymes, proteins, fermentation, chemistry, DNA, and foods. Learn more at cphnano.com

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INDUSTRY NEWS

INTEGRA HAS DEVELOPED THE ASSIST PLUS PIPETTING ROBOT INTEGRA has developed the ASSIST PLUS pipetting robot to streamline routine pipetting tasks and provide excellent results at an affordable price. Using INTEGRA electronic multichannel pipettes, the system automates pipetting tasks, eliminates physical strain and ensures superior reproducibility and error free pipetting. Multichannel pipettes increase throughput in today’s laboratories. However, prolonged manual pipetting takes up precious time and can lead to repetitive strain injuries. In addition, ever-decreasing sample sizes have made it increasingly difficult to pipette without errors.

Protocol setup and selection, can be done directly on the pipette, using the pipettes intuitive user interface. The Touch Wheel allows extremely fast menu navigation and volume adjustments. Simply choose a predefined program and adapt the default settings to your requirements.

The VIALAB software offers a simple and intuitive graphical user interface, allowing you to create protocols with a few clicks, without extensive programming knowledge. VIALINK Pipette Management Software offers advanced users the ultimate freedom of defining pipetting programs step by step

ASSIST PLUS ensures: •

optimal tip immersion depths

consistent pipetting angle

controlled pipetting speeds

precise tip positioning in wells

no pipetting mistakes are made

strict adherence to pipetting programs

Possibilities for programming pipetting tasks:

DANDIAG EXPANDING THEIR FREE SERVICE CONCEPT

Dandiag has throughout the years build its foundation on providing high quality products together with service and calibrations. Dandiag’s free service concept for Sartorius pipettes is now expanded to also include Integra Viaf lo pipettes. The service concept gives the customers the possibility to have their pipettes serviced free of charge once a year at Dandiag’s workshop, throughout the lifetime of the pipet. Preventive maintenance of pipettes is important, since it improves performance and prolongs the lifetime. The company’s service department is currently counting 14 skilled and experienced technicians. All the technicians, has been thoroughly trained internally and externally by the suppliers. Today they

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are able to service and calibrate almost all brands and types of pipettes, and are one of the biggest pipetting calibrating laboratories in the Nordics with approximately 22.000 pipette calibrations per year. Service and standard calibrations on pipettes are also available at the customer site. Quality and documentation are strong parameters in Dandiag and the demand is growing from the customers. In 2008, the company achieved a DANAK accreditation on pipettes. In 2017, they achieved a DANAK accreditation on balances, and in 2018, Dandiag achieved Denmark’s first DANAK accreditation on burettes and bottle top dispensers. All efforts have the purpose of meeting the customers’ demands, which remains the top priority.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


INDUSTRY NEWS

NEW CELLULAR IMAGING ACQUISITION AND ANALYSIS SYSTEM AT AN AFFORDABLE PRICE POINT Molecular Devices latest automated cell imaging system, the ImageXpress Pico, is a compact, affordable cell imaging system for individual biolog y labs that combines high-resolution imaging with powerful analysis. Significant savings in time over manual microscopy are possible through automating both acquisition steps and post processing of images to deliver data. The ImageXpress Pico features a fully integrated environmental control option which utilizes both humidity and real-time gas monitoring to promote healthy cell growth during long exposure experiments, so scientists can monitor and run livecell and timelapse assays. Scientists can also capture sharper images for deeper insights into 3D models by leveraging “plug and play” image visualization with the Z-stack acquisition module. Bringing all of this together is the powerful icondriven, user-friendly CellReporterXpress® software.

ImageXpress Pico Automated Cellular Imaging System Whether running f luorescence imaging or brightfield assays, the comprehensive portfolio of preconfigured protocols for cell-based assays shortens the learning curve, so users can start running experiments quickly. It’s no wonder this system is growing in popularity as scientists seek to expand their research to include more relevant cell model systems and more complex analysis - at an affordable price point.

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- HIGH PERFORMANCE - BEST QUALITY - ULTRA FLEXIBLE Biolab A/S - Sindalsvej 29 - DK-8240 Risskov - +45 8621 286 - sales@biolab.dk


INDUSTRY NEWS

VIROGATES SUPARNOSTIC® TURBILATEX PRODUCT – A DISCHARGE DECISION AID FOR HOSPITALS EMERGENCY DEPARMENTS The prognostic biomarker suPAR (soluble urokinase Plasminogen Activator Receptor) is a strong measure of chronic inf lammation and underlying risk of negative outcomes including short-term mortality, and is highly suited for risk evaluation in hospitals Emergency Departments. suPAR can now easily be measured in the hospital laboratories, as the first suPARnostic® TurbiLatex product has just been launched – validated for Roche Cobas analyzer. Thereby suPAR can be automatically determined simultaneously with other blood parameters at the central laboratories, and the result automatically reported into the laboratory information system.

The new suPARnostic® TurbiLatex product from ViroGates

suPAR is an unspecific biomarker elevated by most diseases and correlated to disease severity, and is superior to other biomarkers in risk prediction. A low suPAR level is a safe indicator for a good prognosis and can therefore be used for discharge decisions. This way, the healthcare systems can allocate resources more effectively. In the figure is shown the guideline for suPAR in acute medical patients. A low suPAR (<3 ng/ ml, 56% of patients) supports the decision to discharge the patient – and a high suPAR (>6 ng/ml, around 12% of the patients) calls for immediate clinical attention and further investigation.

Guideline for suPAR in acute medical patients

For more information visit www.virogates.com

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


Din partner inden for salg, service og kalibrering af laboratorie- og pipetteringsudstyr

NYT AUTOMATISERINGSINSTRUMENT FRA INTEGRA VIAFLO FEATURES • Fyldning af plader • Fortyndingsrækker • Plader fra 12 til 384 brønde • Automatisk spidspåsætning • Automatisk spidsafskydning • Racks til forskellige størrelser rør • Programmering via PC

Kontakt os på salg@dandiag.dk for mere information

www.dandiag.dk

Fast, reliable, smart and safe solutions for the pharma industry Since Metrohm acquired B&W Tek in 2018, Metrohm now offers a complete range of Raman instruments

• • • •

Instant Raw Material Identification Outgoing Quality Control Innovative See Through Technology Full compliance with 21 CFR Part 11

For more information - Phone: +45 70 200 561 E-Mail: mail@metrohm.dk


INDUSTRY NEWS

The NanoCuvette™ One – Now you can measure samples that do not absorb light in a standard spectrophotometer The NanoCuvette™ One is a new Danish product based on state-of-the-art nanotechnology that transform a spectrophotometer into a onesize-fit-all solution for enzymes, proteins, fermentation, DNA, chemistry, and foods. Just put your sample in the NanoCuvette™ One and you are ready to go! The NanoCuvette ™ One is based on a new optical filter made from photonic crystals that interacts with the sample on the nano-scale. This allows the user to reliably measure both surface refractive index and absorbance in a standard spectrophotometer to extract both static parameters and kinetics. The free online software makes it easy and efficient to convert .txt, .csv or .spc data from any instrument into results and graphs ready for presentation. Together with the online software, the NanoCuvette™ One provides a turnkey solution in a standard laboratory format without any up-front investment. •

Save time: Combined UV-Vis absorbance and surface refractive index (nD).

Fits your instrument: Compatible with 12.5 x 12.5 mm holders and all 8.5-15.0 mm beam heights.

Minimum cleaning: Sample in contact with disposable plastic container, not the instrument.

Minimum calibration: No expensive calibration liquids or buffers with limited life-time.

Drag and drop results: Analysis and data management made simple by cloud software.

The NanoCuvette™ One can be ordered from stock at w w w.hounisen.com with one-day delivery service in Denmark. For more information: w w w.cphnano.com

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


INDUSTRY NEWS

THE RIGHT GROWTH SURFACE MAKES FOR HAPPY CELLS You can optimise the growth of your cells by choosing the right surface, which is why SARSTEDT now offer three different growth surfaces for your cell culture f lasks, dishes and plates. Selecting a suitable cultivation surface is essential to ensure happy and satisfied cells that demonstrate optimal growth in cell culture. Whether youâ&#x20AC;&#x2122;re working with suspension cells, adherent cells, or particularly sensitive cells, they all have different requirements with regard to the substrate on which they can or prefer to grow. As a result, SARSTEDT offer three different growth surfaces for the cultivation of cells. For adherent cells, you can choose between the red colour-coded standard and the yellow colour-coded Cell* surfaces. The treatments applied to these two surfaces enable the adhesion of the cells. The green colour-coded surface is hydrophobic to minimise cell losses caused by unwanted cell microadhesion during sub-cultivation, and is therefore ideal for the cultivation of suspension cells. Why is this important? Adherent cells often have different requirements when it comes to the growth surface to which they adhere. For example, primary cells, sensitive cell culture lines and cells that are cultivated under serum-reduced/serum-free conditions do not usually adhere to the hydrophilic standard surface for adherent cells. In these cases, the growth surface must be coated with proteins (e.g. polylysine), resulting in additional time and costs. For more information: w w w.hounisen.com/guides

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019

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INDEX

64 | Academic Institutions and Support Structure Organisations 66 | Business Service Providers 68 | Contract Research Organisations 69 | Laboratory, Medical & Pharmaceutical Equipment 73 | Contract Manufacturing Organisations


COMPANY INDEX

Academic Institutions and Support Structure Organisations Atrium is a living, dynamic space where Life Science professionals come to learn, connect and network. Atrium is a place rich in tradition, insights and inspiration – an environment where opinions and knowledge are shared. We’re passionate about offering valuable learning experiences that help you advance professionally. Atrium Lersø Parkallé 101 DK-2100 Copenhagen T: +45 39 27 60 60 W: www.atriumcph.com

Lund and the pharmaceutical industry combined are proven to a successful recipe. Previously, researchers at Lund university could put their knowledge forward to major companies like Astra Zeneca or Baxter – nowadays, Medicon Village offers great opportunities to transform ideas into products and services for companies. It’s the connection between the private sector, the municipality, the health sector and the university that are the essential elements in Lund. In the former premises of Swedish medical giant Astra Zeneca, there are now more than 140 companies located. World-class researchers are also making their way to Lund University, Medicon Village and the SmiLe incubator, where their ideas are transformed into successful ventures. .

City of Lund T: +46 (0)46-359 50 00 W: www.lund.se

Copenhagen Capacity is the official organisation for investment promotion and economic development in Greater Copenhagen. The organisation supports foreign companies, investors and talent in identifying and capitalising on business opportunities in Greater Copenhagen - from initial considerations to final establishment. Copenhagen Capacity is the leading expert on developing and implementing business opportunities in Greater Copenhagen.

Copenhagen Capacity Nørregade 7B DK-1165 Copenhagen T: +45 3322 0222 E: info@copcap.com W: www.copcap.com

Copenhagen Capacity’s services are free of charge for all foreign-owned companies, who want to establish or invest in Greater Copenhagen, and provided in full confidentiality.

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

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

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

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


COMPANY INDEX

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

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

INNO-X Healthcare Aarhus University, Department of Clinical Medicine Hedeager 3, DNU 03 8200, Aarhus N Tel. +45 4041 2536 E-mail: Info@innox.dk Web: www.innox.au.dk Lundbeckfonden awards anually the 1 mio. € Brain Prize. Lundbeckfonden is an active industrial foundation established in 1954. Its main objective is to maintain and expand the activities of the Lundbeck Group, and to provide funding for scientific research of the highest quality. The Foundation annually grants DKK 400 - 500 million to support medical research of the highest quality and supports educational and communication activities related to science. Lundbeckfonden, The Brain Prize Scherfigsvej 7 DK-2100 Copenhagen Ø Tel. +45 3912 8000 E-mail: info@thebrainprize.org Web: www.thebrainprize.org Medicon Valley Alliance (MVA) is a non-profit membership organization in the Danish-Swedish life science cluster Medicon Valley. Our approx. 230 members, who together employ approximately 140.000 people, represents the region’s triple helix and include universities, hospitals, human life science business, regional governments and service providers. We create value for our members by co-hosting, launching and driving meetings, working groups, seminars, conferences and projects, that strengthen the collaboration, networking and knowledge-sharing in the regions life science community, create critical mass and help realizing the full potential of Medicon Valley.

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

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

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

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COMPANY INDEX

Business Service Providers AIMS International’s Life Sciences Practice is strategically positioned to serve the local and global life sciences industry. AIMS Life Sciences consists of fourteen specialized lead partners, with all owner/senior partners managing leading boutiques in their respective regions and countries. The fourteen partners leading the practice are supported by an infrastructure of research and recruiting consultants located in 82 offices in 50 countries. AIMS Life Sciences’ lead in Denmark is Helle Halken, senior partner and headhunter.

AIMS International Denmark Gl. Kongevej 102, 1. tv., DK-1850 Frederiksberg

AIMS Life Sciences has been placing exceptional leaders/specialists in life sciences for more than 20 years. We serve as the industry’s global partner, delivering the best life sciences leaders/specialists locally.

Head of Life Science Denmark Helle Halken - +4520626148 hh@aimsinternational.com www.aimsinternational.com

COOR provides specialized services for cleanroom businesses. We service the biotech, healthcare and pharmaceutical industries as well as other cleanroom and controlled environment industries. – And comply with all GMP and ISO standards… COOR OFFERS YOU: • A proven success in cleanroom cleaning • Certified training, retraining, audits and consulting • Trained cleaning personnel on cleaning techniques in critical environments • Trained technicians on cleanroom protocol, safety, security, cleaning techniques, and client specific procedures • A comprehensive quality management system that is customized to your SOPs and other requirements • A proven cleanroom concept, integrated into a dedicated organization • Extensive experience with external and internal audits • Specialized systems that comply with GMP and ISO standards

Coor Hørkær 12A 2730 Herlev, Denmark P: +45 44 77 88 88 E: info.dk@coor.com W: www.coor.dk

THE MOST ADVANCED CLEANROOM LAUNDRY IN SCANDINAVIA • Traceability, validated processes and documentation based on innovative cleanroom technology. De Forenede Dampvaskerier - DFD Cleanroom V. Henriksens Vej 6 DK-4930 Maribo T: +45 4422 5560 / +46 406 566 500 E: cleanroom@dfd.dk W: www.dfd.dk

Eltronic Pharma Engineering Lyskær 8 DK-2730 Herlev T: +45 76 74 01 01 E: info@eltronic.dk W: www.eltronic.dk

• Specializes in on-site training of operators in correct use of cleanroom clothes and cleaning articles. • Preferred partner of unique cleanroom solutions in accordance to ISO and GMP compliance.

As a division of Eltronic, a consulting and engineering company specialized in optimization of industrial processes, Eltronic Pharma Engineering is spearheading the business within life science. Eltronic Pharma Engineering provides expert services and advice within GMP-manufacturing of medicinal products, quality management, compliance and production and processes within GxP-regulated environments. Additionally, Eltronic Pharma Engineering offers IT and automation solutions tailored to the Life Science industry. Eltronic Pharma Engineering employs 10 quality management and automation experts. Learn more at: https://www.eltronic.dk/markets/ life-sciences/ The pulse of life sciences Trust a reliable partner who helps you achieve operational excellence

Endress+Hauser A/S Poppelgårdvej 10-12 DK-2860 Søborg T: +45 70 131 132 E: info@dk.endress.com W: www.dk.endress.com

Hays Specialist Recruitment A/S Kongens Nytorv 8 DK-1050 København K T: +45 33 38 32 60 E: info@hays.dk W: www.hays.dk

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You can count on our world-class instruments, designed to ASME-BPE standards and rely on our experienced engineering and support services. We partner with you to help you reach your goals of process optimization, increased plant availability and continuous improvement.

Hays plc (the "Group") is a leading global professional recruiting group. The Group is the expert at recruiting qualified, professional and skilled people worldwide, being the market leader in the UK and Asia Pacific and one of the market leaders in Continental Europe and Latin America. The Group operates across the private and public sectors, dealing in permanent positions and temporary assignments. The Group employs 11,700 staff operating from 262 offices in 33 markets across 20 specialisms. Hays Denmark has been present in the market for more than 10 years, operating from their office in Copenhagen, and primarily recruit within IT, Sales & Marketing, Engineering and Life Sciences.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


COMPANY INDEX

We are experts in pharmacovigilance and understand the value chain of pharma/biotech companies, as well as the regulatory environment in which industry operates. We also understand technology and the strong current that flows through industries as well as society - to digitally redefine and transform businesses. Trust us to help you harness the power of technology and optimize process and organization in order to deliver what is required - Today and tomorrow.

Insife Automatikvej 1, 3. Floor DK-2860 Søborg, Copenhagen T: +45 2810 5202 E: info@insife.com W: www.insife.com

Jusmedico Advokatanpartsselskab Klampenborgvej 248, 1. m.f. DK-2800 Kgs. Lyngby T: +45 4548 4448 E: jbb@jusmedico.com / mbl@jusmedico.com W: www.jusmedico.com

Jusmedico is a specialist law firm providing legal services to the biotech, pharmaceutical, medical device, food supplement & dentistry industries, life science investors and to suppliers and service providers thereto. Internationally Jusmedico is co-founder and member of BioLawEurope F.m.b.A. a network of independent law firms from EEA countries, UK 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 2017, 2018 and 2019 Jusmedico has been awarded the Corporate INTL Global Award Price as Biotech Law Firm of the Year in Denmark.

Munters provides air treatment solutions for clean rooms, laboratories and demanding production processes. Our system solutions secure a fully reliable and exact controlled climate around the year. Regardless the fluctuating outdoor conditions, we eliminate the impact of the ambient high humidity and temperature. Munters A/S Ryttermarken 2A 3520 Farum Tlf. 44953355 info@munters.dk

Nyborg & Rørdam Store Kongensgade 77 DK-1264 København K T: +45 33 12 45 40 E: info@nrlaw.dk W: www.nrlaw.dk

We develop, manufacture and deliver configurable systems with multiple options for dehumidification, humidification, pre-/post cooling and filtration. All in one single unit. More than 60 years of global experience and 300,000+ installations.

Nyborg & Rørdam har lang erfaring med rådgivning til virksomheder indenfor life science og biotech. Vores rådgivning fokuserer på resultatorienterede og praktisk anvendelige løsninger, der bygger på et indgående kendskab til branchens strategiske og kommercielle forhold samt forretningsmodellen hos det enkelte selskab. Vi lægger vægt på at opbygge tætte og tillidsfulde relationer til vores klienter. Vores rådgivning omfatter blandt andet: - Etablering og opstart af nye virksomheder - Tilførsel af ny kapital og finansiering af drift - Fusion, opkøb og salg / exit - Aktieincitamentsprogrammer - Rekonstruktion - Skat - selskabs- og personbeskatning - Persondatabeskyttelse og opfyldelse af EU’s persondataforordning

SAM International has more than 20 years of experience within headhunting and network in the Life Science business; national as well as international. Being an international company SAM International has departments in more than 15 countries. 600 assignments are solved on a yearly basis. It is our philosophy that the right person has to match the right job at the right time in order to succeed and improve your business – and that’s why we always set-up the best team for any assignment. SAM International T: +45 70 22 02 05 E: info@sam-int.com W: https://sam-int.com/

Want to know more about SAM, please contact us at info@sam-int.com

WE OFFER TEMPORARY AND PERMANENT STAFF WITH SPECIFIC KNOWLEDGE WITHIN:

TEMP-TEAM HOVEDKONTOR Vester Farimagsgade 6, 2. sal DK-1606 København V T: 33 36 09 44 E: info@temp-team.dk

- Quality Control - Quality Assurance - Research and Development - Medical Affairs - Pharmacovigilence - Regulatory Affairs

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COMPANY INDEX

Contract Research Organisations A+ Science is a Contract Research Organisation (CRO) run by its employees. We provide services in clinical trials for pharmaceuticals (phase I-IV) and medical devices. We also offer broad expertise in pharmacovigilance services during clinical trials and post marketing. Our core expertise is in the Nordic Countries, however through our close collaboration and partnership with other CROs, we cover several other countries. We offer customised, flexible and cost-efficient solutions to our clients. Earn Trust- Make Difference.

A+ Science AB Luntmakargatan 22 SE-111 37 Stockholm T: +46 (0)73 67 441 22 E: info@a-plusscience.com W: www.a-plusscience.com

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

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

DB Lab is a GMP contract laboratory with more than 25 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.

DB Lab A/S Lille Tornbjerg Vej 24 DK-5220 Odense SØ T: +45 6593 2920 E: dblab@dblab.dk W: www.dblab.dk

CEO Thomas M. Frøsig T: +45 61781882 E: tmf@immumap.com W: www.immumap.com

Mode-of-action cellular analyses using multiparameter flow cytometry • We are a contract-research organization generating data for customers needed in the decision-making process • We provide customer-tailored solutions in the field of immune-oncology and autoimmune diseases • We help biotech companies of all sizes, primarily the middle- and large-sized ones, and companies in the pharma industry • We offer state-of-the-art cellular immune analyses using multiparameter flow cytometry, cell culturing and ELISPOT • Our agility and flexibility are highly appreciated by our clients

IRW is a Nordic Contract Research Organization (CRO) with more than 20 years of experience in conducting clinical trials and with offices in Sweden, Denmark, Norway and Finland. We are offering our solid experience with all aspects of Clinical Research, Pharmacovigilance, Data Management and Biostatistics as well as Outsourcing based on experienced, well qualified, and flexible resources within clinical operations. IRW Consulting AB Svärdvägen 5, NB Box 703 SE-182 17 Danderyd T: +46 879 166 40 E: info@irwcro.com W: www.irwcro.com

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IRW Consulting is contributing to excellence in clinical research and thus enhancing people’s health and quality of life with a Global Reach and Local Expertise, and we all act with Respect, Responsibility, Loyalty, Integrity and Passion for excellence.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


COMPANY INDEX

IWA Consulting is a consultancy company with core competences, expertise, and decades of experience within regulatory affairs. The company employs 20 regulatory experts. The IWA consulting team provides regulatory affairs specialists expert services to international private and public clients. The IWA consulting team assists biotech, pharma, and medical device companies in achieving major regulatory milestones timely.

T: +45 5666 0490 E: info@iwaconsulting.dk W: www.iwaconsulting.dk

LINK Medical Research Vester Voldgade 96, 2.tv. DK-1552 København V T: +45 22 15 85 56 E: link@linkmedical.dk W: www.linkmedical.no

LINK Medical Research is a Scandinavian full-service Contract Research Organisation (CRO), offering project management and product development services for the pharmaceutical and medical device industry. At the beginning of 2018, its new LINK Medical RWE department opened, which will see a further strengthening of the CRO’s focus on Real World Evidence. LINK Medical now offers a full palette of services for the pharmaceutical and medical device industry, while still staying true to its core values, which has been at the heart of the company since the beginning. LINK Medical Research has offices in Oslo, Malmø, Copenhagen, Stockholm, Berlin, and London.

NCK A/S was founded in 1956 to conduct research and development in synthetic organic chemistry on a contract basis.

NCK A/S Rugmarken 28 DK-3520 Farum Tel. +45 4495 1881 Email: nck@nck.dk Web: www.nck.dk

NCK has worked for more than 190 customers world-wide. Most of the products which NCK develop are APIs for pre-clinical or clinical studies and are produced in accordance with cGMP. NCK routinely develops and validates analytical methods for release testing of APIs. Important core values are timely delivery, quality and communication.

Scandinavian CRO is a privately held clinical CRO headquartered in Uppsala, Sweden. Covering the Nordic area, the company performs complete studies or parts of projects within the field of clinical studies Both pharma and med tech. We facilitate clinical trial conduct in a wide variety of therapeutic areas and conduct trials in Sweden, Finland, Norway, and Denmark. Scandinavian CRO AB Skolgatan 8, P.O 150 27 SE-750 15 Uppsala T: +46 18 100 550 E: info@scro.se W: www.scro.se

The company is a full-service CRO that helps manage trial aspects such as feasibility studies, study design, medical writing, submissions, monitoring and pharmacovigilance, as well as study documentation, data management, and statistics. All to ensure clinical studies comply with national and international regulations. The company has an outstanding track record. We are confident that it is because we are agile, dedicated, and experienced, driven by our belief in building long-term relationships with our clients

Laboratory, Medical & Pharmaceutical Equipment

Ampliqon A/S Stenhuggervej 22 DK-5230 Odense M E: info@ampliqon.com W: www.ampliqon.com

Ampliqon is a Danish manufacturer of PCR enzymes and laboratory reagents. The Ampliqon PCR enzyme collection covers all standard DNA amplification set-ups in use in modern laboratories. Specialised knowledge of both enzyme purification, innovation and DNA amplification provides DNA laboratories with reliable and high quality products. PCR products from Ampliqon is widely used in hospitals, universities, research institutions and life-science industries worldwide.

Apodan is the leading supplier of pharmaceutical packaging items in the Nordic. Our main activities are development, production and sale of a wide range of pharmaceutical packaging items. Our products are sold worldwide, and the Nordic countries is the primary market area. We are specialists in standard packaging solutions as well as in customized packaging solutions, which is developed in close cooperation with the customer. ApodanNordic PharmaPackaging A/S Kigkurren 8M DK-2300 København S T: +45 32 97 15 55 E: packaging@apodanpharma.dk W: www.apodanpharma.dk

Visit us at www.apodanpharma.dk

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COMPANY INDEX

Biolab A/S har eksisteret mere en 46 år og er en danskejet handels- og service-virksomhed i laboratorieudstyrsbranchen. Fra domicilet i Risskov betjenes alle Danmarks vigtigste forsknings- og uddannelses-institutioner såvel som fødevare, farmaceutisk og den bioteknologiske industri. Biolab har i 25 år været ISO-9001 Certificeret og deres pipettekalibreringservice er DANAK akkrediteret. Via uddannelse, træning og lang anciennitet besidder teamet en unik viden og kapacitet indenfor instrument integration og analyse-automatisering. Under mottoet "Prøv os - vi kan mere end de fleste...." repræsenterer Biolab over 20 internationale udstyrs- og reagens-producenter på det danske marked. Biolab A/S Sindalsvej 29, 8240 Risskov T: +45 8621 2866 E: sales@biolab.dk W: www.biolab.dk

Buch & Holm A/S Marielundvej 39 DK-2730 Herlev T: +45 4454 0000 E: b-h@buch-holm.dk W: www.buch-holm.dk

Over the years Buch & Holm has developed into a company that adapts quickly to dynamic market conditions. This is achieved through know-how, consulting and competent personnel. In recent years, Buch & Holm has experienced strong growth, and today the company is one of the market leaders as a total supplier of equipment, inventory and consumables to laboratories, quality control and the industry. It’s all about adding value to the things we do. WE KNOW WHAT IT TAKES.

At Copenhagen Nanosystems, we believe that laboratory analysis should be simple and accessible for everyone. Founded in 2015, Copenhagen Nanosystems is a Danish high-tech company that develops next-generation digital plastic products. We expand the functionality of existing simple laboratory equipment by developing plastic labware with nanotechnology and analyzing data in the cloud –leading to faster and more accurate results while lowering upfront investments. Copenhagen Nanosystems ApS Diplomvej 381 DK-2800 Kgs. Lyngby T: +45 36 99 27 46 E: info@cphnano.com W: www.cphnano.com

Dandiag A/S Baldershøj 19 DK- 2635 Ishøj T: +45 4343 3057 E: dandiag@dandiag.dk W: www.dandiag.dk

Dandiag is your guarantee for a consistent solution in your liquid handling laboratory procedures. We have more than 30 years of experience as a supplier and partner in both the public and private sector. On a daily basis, we are in contact with laboratory technicians, bio analysts, researchers, students and people that work within our field of experience. We know the ergonomic and practical challenges that our customers face every day and that is a key reason, why our focus is on finding the best solutions for each individual customer. Our quality centric approach has led us to become a preferred supplier and service partner for some of the industry’s top manufacturers of pipetting equipment, pipettes, laboratory scales and water systems. Choose Dandiag as your preferred service partner within liquid handling equipment. Regardless of your needs, we will do our best to find the most viable solution for you. Diatom is an engineering & trading company, which since 1964 has represented international contacts in Denmark with market leading products where we have a commitment to achieving customer satisfaction by providing innovative, total system solutions that add value to our customer by improving manufacturing efficiency, reliability and quality.

Diatom A/S Avedøreholmen 84 DK-2650 Hvidovre Tel. +45 3677 3600 E-mail: info@diatom.dk Web: www.diatom.eu Drifton A/S offers a wide range of laboratory pumps and dispensing devices for use in laboratories. Our range of laboratory pumps includes peristaltic pumps, micro gear pumps and syringe pumps. We offer a wide range of ancillary products for the peristaltic pumps e.g. peristaltic pump tubing, dispensing nozzles, weights for tubing, luer lock adapters and tube connectors. Drifton A/S Avedøreholmen 84 DK-2650 Hvidovre T: +45 3679 0000 E: info@drifton.dk W: www.drifton.eu

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Our laboratory products include laboratory glassware, pipettes, bottle-top dispensers, hotplates and magnetic stirrers.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


COMPANY INDEX

Flow Robotics creates flexible, user-friendly liquid handling robots for lab automation. The lab robot flowbot ONE with two pipette modules will replace repetitive, time-consuming and burdensome manual pipetting tasks yielding more consistent results. The intuitive user interface of flowbot ONE enables setup within minutes and no previous experience with robots or programming is required. The flexibility of the robot makes it possible to use a wide range of tubes, vials and plates in an unlimited range of procedures. Ease of use is the life blood of Flow Robotics.

Flow Robotics A/S Glentevej 70A, st. tv. 2400 København NV T: +45 40185935 E: info@flow-robotics.com W: www.flow-robotics.com

Hounisen Laboratorieudstyr is your full-service supplier of consumables and chemicals to laboratories. We are experts in delivering customized solutions that suit the needs of our customers. At Hounisen, the customer is our focus – we emphasize the importance of matching the appropriate products to match the customer’s needs. Our product portfolio includes market-leading brands such as SARSTEDT, DWK Life Sciences, Honeywell, Thermo Scientific and many other products. We are offering professional support from our customer service team and you can order our products directly at www.hounisen.com with one-day delivery service in Denmark.

Hounisen Laboratorieudstyr A/S Niels Bohrs Vej 49, Stilling DK-8660 Skanderborg T: +45 86 21 08 00 E: salg@hounisen.com W: www.hounisen.com

WE PROVIDE INSTRUMENTATION, SERVICE AND CALIBRATION TO THE INDUSTRY

Insatech A/S Instrumentation and Automation Technology Næstvedvej 73 C DK-4720 Præstø T: +45 5537 2095 E: mail@insatech.com W: www.insatech.com

Since 1989 Insatech has provided instrumentation, service and calibration to the pharma and biotech industries. We perform accredited calibrations in our own laboratory as well as service on-site. Some of the products we provide are: Instruments: Flow, temperature, level, pressure and UV for water treatment Analytical Inst.: pH, total organic carbon (TOC), on-line photometers, dissolved oxygen (DO), conductivity including master meters and various single-use products Acc. Calibrations: Temperature, gas mass flow, conductivity and TOC LabWare is the clear industry leader in laboratory automation software with LabWare LIMS ™ (Laboratory Information Management System) and LabWare ELN ™- a fully integrated Electronic Laboratory Notebook application.

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

LabWare’s Enterprise Laboratory Platform is a unique and proven suite of product capabilities that encompass LIMS, ELN and LES method execution in an integrated and enterprise ready solution. LabWare has delivered powerful lab automation solutions to many different industries, and our single core product strategy benefits every LabWare customer because it enables all of our development, support and implementation resources to focus on a common solution. The LabWare technical architecture facilitates easy upgrades and functionality enhancements, so our customers are always current and remain well supported. Lactobio has built a proprietary discovery and screening platform of new isolated probiotic strains. We are dedicated to the development of innovative microbial products and concepts to fight bacterial infections or microbiome dysfunctions associated with specific diseases.

Lactobio ApS Ole Maaløesvej 3 DK-2200 Copenhagen N Contact-information at: www.lactobio.com

In Lactobio we focus on creation of new microbial solutions, we work with the gut, oral, skin and vaginal microbiota to create new products targeted to specific needs.

Fast, reliable, smart, and safe solutions for the pharma industry. Since Metrohm acquired B&W Tek in 2018, Metrohm now offers a complete range of Raman instruments.

Metrohm Nordic ApS Smedeland 7 DK - 2600 Glostrup T: +45 7020 0561 E: mail@metrohm.dk W: www.metrohm.com

- Instant Raw Material Identification - Outgoing Quality Control - Innovative See Through Technology - Full compliance with 21 CFR Part 11

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COMPANY INDEX

Advancing protein and cell biology We are one of the world’s leading providers of innovative instrumentation & software for protein & cell biology in life science research & drug discovery & development. Our portfolio includes:

www.moleculardevices.com de.moleculardevices.com fr.moleculardevices.com

• Microplate readers & washers • Automated microscopy/cellular imaging systems • High-content imaging systems • High-throughput screening systems • Conventional electrophysiology systems • Protein & cell biology reagents & assay kits With over 140,000 placements in laboratories worldwide, our instruments have contributed to remarkable scientific research as described in over 150,000 peer reviewed publications.

Promega products are used by life scientists who are asking fundamental questions about biological processes as well as by scientists who are applying scientific knowledge to diagnose and treat diseases, discover new therapeutics, and use genetics and DNA testing for human identification.

Promega Biotech AB Finnboda Varvsväg 16 pl 4 SE-131 72 NACKA T: +46 (0)8 452 2450 E: sweorder@promega.com W: www.promega.com

Our local teams in Denmark and Sweden support scientist through providing the highest quality products, the best possible customer service, unsurpassed technical support.

Siemens Healthineers offers a wide selection of diagnostic solutions for effective testing in in-vivo and in-vitro diagnostic.

Siemens Healthineers Borupvang 9 DK-2750 Ballerup T: +45 4477 4477 W: www.healthcare.siemens.dk

An estimated five million patients globally everyday benefit from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. We are a leading medical technology company with over 170 years of experience. With about 50.000 dedicated colleagues in over 70 countries, we will continue to innovate and shape the future of healthcare. Skanlab ApS provides solutions and products to laboratories.

SkanLab ApS Kvinderupvej 30 DK-3550 Slangerup T: +45 4738 1014 W: www.retsch.dk

• • • •

Crushers, Mills, Sieves and Sieves Shakers as well as Sample Dividers from Retsch GmbH (DE). Equipment for optical size and shape analysis of solids from Retsch Technology GmbH (DE). Ovens & furnaces from Carbolite-GERO (GB) with a tempature range from 30 to 3000 Cº. Counseling, service and sales of the world-renowned quality product from the the above mentioned companies in Greenland, Iceland, The Faroe Islands and Denmark.

Laboratory automation is our passion! - Development, production, service and sales from a single source

T&O LabSystems Leibnizstrasse 7 GE-24568 Kaltenkirchen T: +49 (0) 4191 99 13 88 3 M: info@to-labsystems.com W: www.to-labsystems.com

We are a family-operated developer and manufacturer of laboratory automation solutions located in Hamburg, Germany. T&O was founded in 2009 by our general manager Tom Lorenzen, who runs the company together with his sons Dave, who supports his father in the general management and Dennis, who is responsible for the software development. Engineers, technicians and economists complete the young interdisciplinary team of T&O, working in a familiar atmosphere, driven by innovation, to improve pre-analytical processes in clinical laboratories.

ViroGates is an international Medtech company headquartered in Denmark. ViroGates develops and sells prognostic products to the healthcare sector. The products are used in hospital emergency services to make a clinical decision on hospitalization or discharge of patients in hospitals Emergency Departments, which can lead to better clinical decisions, faster discharge and optimization of healthcare resources. ViroGates Blokken 45 DK-3460 Birkerød T: +45 2113 1336 E: info@virogates.com W: www.virogates.com

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ViroGates test suPARnostic® measures the protein suPAR (Soluble urokinase Plasminogen Activator Receptor) in the bloodstream. With the suPARnostic® Quick Triage and TurbiLatex test, hospital staff will get the result within just 20 minutes – a help to reduce Emergency Room crowding. The prognostic value of suPARnostic® is validated by more than 500 clinical trials and studies which included more than 300,000 blood samples

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


COMPANY INDEX

You Do Bio is a life science tools provider based in Greater Copenhagen, operating since 2008. At You Do Bio, we bring our customers together with the technology they need to move their work forward. Our customers know that breaking the status quo often leads to solutions within the life sciences. Areas of operation: • • • •

You Do Bio Hendriksholms Boulevard 59 DK-2610 Rødovre T: (DK) +45 2557 3876 / (SE) +46 21495 1818 E: info@youdobio.com W: www.youdobio.com

CELL & MOLECULAR BIOLOGY NUCLEIC ACID COLLECTION PURIFICATION SOTHERMAL PCR

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

Cambrex Björkborns Industriområde 691 33 Karlskoga Sverige Tel. +46 586 78 30 00 Web: www.cambrex.com

PolyPeptide Group Limhamnsvägen 108 PO Box 30089, 200 61 Limhamn, Sweden T: +46 40 366 200 E: scandinavia@polypeptide.com W: www.polypeptide.com

Recipharm AB (publ) (HQ) Box 603, SE-101 32 Stockholm T: + 46 8 602 52 00 W: www.recipharm.com

The PolyPeptide Group is a World Leading Contract Development and Manufacturing Organization supplying peptides for the cosmetic, pharmaceutical and biotechnological markets employing more than 800 people at six manufacturing sites located in Belgium, France, India, Sweden and the USA. Whether your need is gram quantities or 100’s of kilograms of peptide or peptide-like API’s, PolyPeptide’s experience, focus and established regulatory track record offers Global Support for a Quality Solution

Recipharm is a leading contract development and manufacturing organisation (CDMO) headquartered in Stockholm, Sweden. We operate 20+ development and manufacturing facilities in Europe, the US, India and Israel and are focused on supporting pharmaceutical companies with our full service offering, taking products from early development through to commercial production. For over 20 years we have been there for our clients throughout the entire product lifecycle, providing pharmaceutical expertise and managing complexity, with each customer’s needs firmly at the heart of all that we do.

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CALENDAR

HIGHLIGHTED FAIRS AND EVENTS IN 2019 The Future of Swedish & Danish Life Science 2019 Date: 04.04.2019, Lund, Sweden

For more visit: www.swedishdanishlifescience.se Theme: How can Swedish and Danish collaboration in R&D and innovation make the patient a winner? The international partnering-event includes a combination of partnering (pre-bookable one-on-one meetings), presentations, exhibition and informal networking.These four core elements of the day run in parallel and ensure that the event is a lively, energetic day designed to impart new knowledge and build new networks.

The event attracts 400-500 leading decision makers every year from all over the world from pharma, biotech and medtech as well as research, the healtchcare sector, policy, regulatory authorities and finance. The exhibition with about 30 exhibitors provides a platform for partners and vendors to engage and discuss collaborations and do business.

Health Horizons Future Healthcare Date: 26.06.2019 - 27.06.2019, Cambridge, UK

For more visit: www.horizons.health The conference, organised by the Innovation Forum, aims to facilitate interactions for the co-creation of improved future healthcare. There will be many speakers from e.g. Pfizer, SENS Research Foundation, Basque Ministry for Health, Amadeus Capital Partners, Cancer Research UK, DNB, Mayo Clinic, Apollo Ventures, Merck Ventures, IBM, University of Cambridge, and many more. Themes include novel therapeutic approaches (viruses, RNA, gene & cell therapy, tissue replacement), digital health, AI and data in healthcare, Cardiometabolic disease, delivering

affordable innovative medicines to patients, co-creation between disciplines and stakeholders, breakthroughs against the incurables, how to revolutionise clinical trials, and the future of oncology. Health Horizons is aiming to attract 1,500 attendees, 100+ speakers and numerous partners for you to access, plus the opportunity to discuss the most pertinent challenges to the health ecosystems with experts in their respective fields. Join us at Health Horizons - the meeting place for leading stakeholders driving the next generation of innovative healthcare technology.

Nordic Life Science Days Date: 10.09.2019 – 12.09.2019, Malmö, Sweden

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

ful encounters, with one-on-one meetings being one of the main features of NLSDays. Additionally, the high quality of topics and presenters provide insight into the most recent trends in science and business. NLSDays attracts leading decision makers from biotech, pharma and medtech as well as finance, research, policy and regulatory authorities. 1500 participants, 800 companies/organizations, 40+ countries represented, and 3000+ face-to-face meetings, are what is expected.

LabDays Aarhus with the biggest conference program ever Date: 11.09.2019 – 12.09.2019, Aarhus, Denmark

For more visit: www.labdays.dk 4 huge conferences and 16 exhibitor seminars is the status of the conference program at LabDays Aarhus 2019. The Laboratory Medical Society for Bioanalysts has announced that they will conduct their annual meeting and a theme day with the titel “Innovation in the health care system” in parallel with the LabDays Fair in Aarhus.

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BioPeople, Denmark’s Life Science Cluster has decided to collaborate with LabDays Aarhus. During LabDays Copenhagen last year, the Danish Society for Mass Spectrometry conducted an "Open House" conference, with great success, which has resulted in a similar conference in LabDays Aarhus 2019.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2019


CALENDAR

DiaLabXpo is the diagnostic and laboratory industry’s new exhibition Date: 24.09.2019 – 26.09.2019, Copenhagen, Denmark

For more visit: www.dialabxpo.com DiaLabXpo is the diagnostic and laboratory industry’s new exhibition that brings product innovation into sharp focus, along with the newest trends and developments within the industry. There will be several opportunities for being inspired through exciting and professional presentations, debates, workshops and lectures, in order to generate knowledge and insight into new trends and developments.

DiaLabXpo has been developed in close collaboration with the trade association DiaLab and MCH Messecenter Herning, and gathers the diagnostic and laboratory industry. DiaLabXpo will be held every other year at Lokomotivværkstedet and in the years that DiaLabXpo is not held at Lokomotivværkstedet, it will be held at MCH Messecenter Herning together with the food technology expo FoodTech.

BIO-Europe 2019 Date: 11.11.2019 – 13.11.2019, Hamburg, Germany

For further information: www.ebdgroup.com The 25th annual BIO-Europe® event is the largest biotechnology partnering conference held in Europe. Over 4,000 global decision makers from biotechnology, pharma and finance annually attend BIO-Europe to identify new business opportunities and develop strategic relationships. Business development executives and dealmakers consider BIO-Europe a must-attend event and an effective business strategy enabling them to meet and present to numerous potential partners. BIO-Europe features the industry’s most advanced

web-based partnering system enabling delegates from all parts of the biotechnology value chain to quickly identify, engage and enter into strategic relationships that drive their business successfully forward. BIO-Europe's world-class workshops, panels and active exhibition along with thousands of prescheduled one-to-one meetings make this event an unrivaled forum for companies across the biotech value chain to meet and do business.

CPH CONFERENCE CENTER – in the atmospheric Meatpacking district of Copenhagen Customized solutions for meetings, conferences and events from 2 to 4.500 people

Call and book your next meeting or conference T / +45 3329 8060 E/ salg@dgi-byen.dk dgi-byen.dk/konferencer


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Buch & Holm - Greater Copenhagen Life Science Yearbook, marts 2019

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Greater Copenhagen Life Science Yearbook 2019  

Greater Copenhagen Life Science is the primary mouthpiece for the Medicon Valley region’s many companies and organizations within biotech, m...

Greater Copenhagen Life Science Yearbook 2019  

Greater Copenhagen Life Science is the primary mouthpiece for the Medicon Valley region’s many companies and organizations within biotech, m...