Gr cph life science yearbook 2018

YEARBOOK 2018

THE ME DICON VA LLE Y

YEARBOOK

2 018

BIOTECH

CMO’S

REGULATORY COMPLIANCE

FASTEST GROWING

DISRUPTION HITS

INCREASED NUMBER

INDUSTRY

THE CMO MARKET

OF REQUIREMENTS

LIFE SCIENCE TALENTS

MEDTECH

PHARMACEUTICAL

CAMPAIGN WILL SEEK

HIGH EXPECTATIONS OF

ACKNOWLEDGEMENT

TO ATTRACT THE VERY

THE GOVERNMENT’S LIFE

OF THE INDUSTRY IS A

BEST

SCIENCE GROWTH PLAN

BREAKTHROUGH

March 2018 Publisher:

Høffdingsvej 34 2500 Valby Denmark E-mail: nem@nemmedia.dk Web: www.nemmedia.dk Editors: Karin Jensen Charlotte Strøm Arne Nielsen Clara Holm-Hansen and Mohammed Ali Wachah.

Graphics & Layout: Kapteina Reklame Advertisement: Mohammed Ali Wachah +45 23238082 mw@nemmedia.dk Rasmus Andersen +45 42811110 ra@nemmedia.dk

CONTENTS THE COLUMN

By Søren Bregenholt, Medicon Valley Alliance

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WHAT HAPPENED IN 2017 A Look Back

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INTERNATIONAL LIFE SCIENCE TALENTS Campaign Will Seek to Attract the Very Best

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REGULATORY COMPLIANCE Finding the Balance

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ONE BY ONE - SECTION OVERVIEW

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BIOTECH 30

MEDTECH 35

PHARMA 38

CRO's 42

CMO's 48

BUSINESS SERVICE PROVIDERS 50

LABORATORY & MEDICAL EQUIPMENT 56

COMPANY INDEX

62

CALENDAR Highlighted Fairs & Events

74

Print: Green Graphic & Signtec Reklame In cooperation with:

Cross-cultural management, cooperation and communication We help staff at major life science organisations succeed in an international multicultural working environment. Our activities include: Management and cooperation in the multicultural team

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Knowledge-sharing

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Negotiation techniques

Feedback techniques

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Presentation techniques

Scientific and business English

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Translation and proofreading

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ISSN: 2446-1776

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www.global-denmark.dk +45 33 86 29 30

global@global-denmark.dk

Bringing life science professionals together

JOIN MEDICON VALLEY ALLIANCE

- your chance to tap into a handful of life science professional networks in the DanishSwedish Greater Copenhagen region

CREATE OPPORTUNITY NETWORK & EXPAND INNOVATION & RESEARCH Visit www.mva.org to learn more about the benefits and costs of MVA membership, how to join the networks and who you can expect to meet at which types of MVA events.

Feel free to contact MVA Head of Communication & Public Affairs, David Munis Zepernick (dz@mva.org), or Senior Project Manager, Helen Pettersson (hp@mva.org), for a non-committal meeting.

Executive

Club Club

medicon valley

THE COLUMN

Let´s pick up the gauntlet!

By Søren Bregenholt, Medicon Valley Alliance chairman of the Board and Corporate Vice President, Novo Nordisk ” La france a perdu une bataille mais la france n'a pas perdu la

University and the local Swedish life science community as such

guerre!” (France has lost a battle, but France hasn´t lost the war)

have very proactively reached out to Denmark and contributed to the realization of our joint regional vision. Hopefully, the

The famous and somewhat dramatic 1940 quote from French

national policy makers in Stockholm, although some 600 km

general, later president, Charles de Gaulle, has been used ever

away from the Medicon Valley life science hotspot, will also find

since to encourage someone to fight on despite even very serious

it useful to prioritize life science in Sweden’s southern region

setbacks.

as part of their upcoming national strategy. By mobilizing national, regional, public and private, academia and indus-

The situation in Greater Copenhagen, following the strong but

try, we can build and develop a first-class life science

unfortunately failed effort to attract the European Medicines

cluster to the benefit of Danish and Swedish R&D,

Agency, is fortunately less dramatic. But in terms of motivation,

Danish and Swedish industry, Danish and Swedish

dedication and unity, we now face a similar challenge.

employment and welfare and last but certainly not

We need to work together, plan ahead and mobilize support for

least Danish and Swedish healthcare. Only life sci-

our vision of a world-class Danish-Swedish life science cluster.

ence can deliver the same unique combination of

We must effectively put the Medicon Valley region on the global

societal benefits and in no other industry sector

life science map and firmly position the region as the leading

are Denmark and Sweden together so uniquely

life science cluster in Northern Europe.

positioned to harvest the fruits of strengthened

In the spring of last year, The Danish life science growth

ply the best business case we have got

collaboration. Investments in life science is simteam delivered 17 recommendations to a national life science strategy. They definitely point in the right direction; more

The potential is bigger than ever, and 2018

investment in public sector R&D, the need for talent attraction,

will show if we have what it takes to grasp this

coordination of clinical research, a home market that functions

opportunity. Reproductive health, oncology,

more convincingly as an international show-case, and better

dermatology, CNS and diabetes are already

tax incentives for research-intensive companies are among the

established scientific strongholds in Medicon

specific recommendations.

Valley. With Europe's largest life science conference, BIO Europe, coming to Copenhagen

Sweden´s has chosen a different process, but the objective to

in November, we have an excellent opportu-

have a national strategy for the future of Swedish life science is

nity to showcase our groundbreaking R&D,

the same. It is my hope, that these parallel processes will soon

our innovative companies and our attractive

merge into coordinated efforts between our two countries. Since

living and working conditions to the world of

Copenhagen and most of the Danish life science stakeholders

life science.

are located in the Medicon Valley region, the inclusion of the regional perspective would seem obvious. Region Skåne, Lund

4

But we have to agree to pick up the gauntlet!

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WHAT WE LEARNED

WHAT HAPPENED CLINICAL TRIAL ACTIVITY IMPROVES HEALTH CARE, EMPLOYMENT, AND LEARNING Edited by Arne Nielsen In 2017 The Danish Association of the Pharmaceutical

as well as an interest in strengthening the scientific

Industry (LIF), the NEXT Partnership, and Invest in Denmark

network. Moreover, clinical trials tend to implicate clinical

released a report provided by Copenhagen Economics

improvements at participating hospitals e.g. by changes made

quantifying the value of industry initiated clinical trials in

to daily clinical practice, treatment guidelines, changes made

Denmark.

to national guidelines etc.1 Furthermore, the respondents

The report puts into numbers the effects that may appear difficult to quantify properly, such as the learnings and knowledge sharing among health care professionals from working with a clinical trial. More than 53% of respondents agreed that they felt working with clinical trials had

pointed to a trend that clinical trial activity subsequently resulted in increased scientific activity taking place at the institution, i.e. attracting more clinical trials or other research activities, publication of scientific results directly or indirectly related to the clinical trial etc.

improved their clinical skills, and 61% responded that their

Clinical trials initiated by the life science industry tend to

knowledge had been shared with colleagues.1

attract millions in investments, improving capacity and

The motivation among health care professionals to join clinical trials as investigators covers a professional interest in being part of the most recent pharmaceutical development

1

qualifications with the staff. Moreover, the industry initiated clinical trials also create jobs and improve the gross national product.

Source Værdien af kliniske forsøg i Danmark. NEXT Partnership, Lægemiddelindustriforeningen og Invest in Denmark. Jan 2017.

http://lif.dk/SiteCollectionDocuments/Analyser%20mv/V%C3%A6rdien%20af%20kliniske%20fors%C3%B8g%20i%20Danmark%2030JAN17.pdf

RAISED APPLICATION FEES AND OVERHEAD COSTS PUT STRAIN ON CLINICAL TRIAL BUDGETS Edited by Arne Nielsen Through an executive order the Danish Medicines Agency

Critics of the raise of fees at DKMA claim that the increase

(DKMA) raised the fees to be paid to the agency for

in costs may jeopardize the activity on clinical trials. The

applications on clinical trials of medicinal products as of

Danish Medical Association worries on the raised fees

the 1st of July 2017. The fees apply to all, irrespective of the

particularly concerning the investigator initiated trials. The

origin of the trial sponsor.

Danish Association of the Pharmaceutical Industry (LIF) also

During the public hearing prior to the decision made by the

raised concern regarding the increase in fees.

Minister of Health, Ellen Trane Nørby, several stakeholders

LIF has compared the level of fees with the National

raised their concerns on the remarkable raise in the fees.

Competent Authorities in 17 European countries. The key

An application involving new medicinal products from 01

concern with the numbers is that the fees in Denmark are

July 2017 costs 6.087 EUR, applications involving already

now in the high end.

marketed products cost 3.066 EUR. Additionally, as a new item, an annual fee of 1.711 EUR applies to every trial for every ongoing year. Amendments to the protocol cost 635

The Minister of Health, Ellen Trane Nørby, suggested that the raised fees will be subject to evaluation after some time.

EUR. Overall, the fees have been raised considerably.

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WHAT WE LEARNED

MEDICON VALLEY ALLIANCE CELEBRATED ITS 20 YEARS ANNIVERSARY Edited by Arne Nielsen Members, life science collaborators, and academia joined the

only across the bridge but also across sectors, in the political

20 years anniversary reception of Medicon Valley Allicance

community, academia, and the industry as drivers of growth.

(MVA) in august 2017.

Sindra Peterssson Årsköld, Senior Adviser, enthusiastically

Since the beginning in 1997 the life science organization,

told the audience about the vision and ambitions for the

MVA, has watched the cluster thrive and grow into the

European Spallation Source (ESS), a true example of what

largest life science cluster in the Nordic. CEO at MVA, Petter

Region Skåne and Capital Region Denmark is capable of when

Hartman, welcomed the guests and on a running basis

joining forces, resources, man power, and talent. The ESS will

introduced the speakers who were invited to put into few

open in 2023 and will improve the scientific possibilities and

words what the scientific perspectives are for this Danish-

potential within a range of different disciplines.

Swedish connection.

Thomas Kongstad Petersen, Chairman of NEXT Partnership

Søren Bregenholt, Chairman of the MVA Board and Corporate

and Vice President at LEO Pharma highlighted that the NEXT

Vice President at Novo Nordisk highlighted that the MVA

partnership has proven to be a successful way to attract the

as organization has three equally important pillars: Strong

early phase clinical trials to the region. Albeit there is still

academic institutions, cutting edge health care sector and a

a lot of work to be done in order to improve the framework

vibrant life science environment.

conditions, he pointed out that he is convinced that the puplic-private partnerships are here to stay.

Joining forces Lars Gaardhøj (Socialdemokratiet), Chairman of the Business and Growth Committee in the Capital Region of Denmark puts effort on the high ambitions for collaborations, not

With the courtesy of Copenhagen University, the Vice Dean, Trine Winterø, co-hosted the anniversary reception at the top of the Maersk Tower at the Panum Institute in the midst of Copenhagen.

THE GOVERNMENT’S GROWTH TEAM FOR LIFE SCIENCE DELIVERED 17 RECOMMENDATIONS Edited by Arne Nielsen Earlier last year, the government’s growth team for Life

make sure that the educational system can deliver the right

Science delivered 17 recommendations on how to improve the

competencies in future. Politicians, universities and industry

framework conditions so that the industry can create growth,

must work closely together.

develop new innovative treatments, strengthen research and innovation and increase exports.

investments on the Swedish side of Oresund. I think Denmark

We asked Medicon Valley Alliance, the Danish-Swedish life

can benefit from investments in Sweden, for example the

science networking organisation about their view on the

ESS (European Spallation Source), MAX IX Laboratory at the

recommendations.

Lund University, where ground-breaking research is being

Petter Hartman, CEO Medicon Valley Alliance (MVA): ”Overall, it’s a really ambitious job that’s been done here with some strong recommendations. If these are implemented the right way, then it can have real significance but it’s now up to politicians to create the right conditions.

done.

“The third important part of the recommendations is the entire banding aspect, to visualise the position of strength we have and become even better at marketing the region and make it attractive for international talents and investors to look towards Denmark. For Greater Copenhagen to be

”For MVA, what we’re especially interested in is access to

perceived as a leading Life Science hub, marketing and

qualified labour. This is the key issue. We have to work really

internationalisation are enormously important.

hard in the region to attract international talents but also to

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“Investments in research is another important area, also

(More related to this topic on pages 30-40)

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2018

WHAT WE LEARNED

THE 17 RECOMMENDATIONS ARE: 1.

2.

Denmark should allocate more resources to and target the public research as well as increase the private research, which form the basis of innovation within Danish Life Science. At the same time, the education of highly qualified researchers to the private and the public sector should be reinforced.

The coordination of clinical research in Denmark should be gathered in one unifying place under the existing NEXT cooperation which should be expanded into a national organization covering all clinical areas. The new NEXT 2.0 is anchored between state, regions and companies, and the possibilities of clinical research at the hospitals are enhanced.

3.

Efforts to create the framework for transparency and trusting public-private cooperation between healthcare sector and companies should be enhanced.

4.

It should be possible to use IT and health data in a secure manner in order to develop and research in new and innovative forms of treatment and to contribute to a better, more secure and coherent healthcare sector.

5.

The Danish Medicines Agency should be reinforced to be one of the top medicines agencies in Europe.

6.

There should be more notified bodies (bodies that certify medical devices) in Denmark with the relevant top quality capacity to meet demands.

7.

Denmark should be a pioneering country within personal health technology.

8.

The Danish education system should be organized so it can, to a higher degree, deliver world-class employees with the right skills for the entire value chain within the Danish Life Science industry.

9.

Danish Life Science is global - and the conditions for attracting and keeping international talents and qualified labour should be at the European top.

10. Denmark should increase the focus on entrepreneurship and innovation within the Life Science research and education environments as well as improve the conditions for this.

11. Denmark should pave the way for more Life Science

companies through better access to early financing.

12. Opportunities for attracting investments for Danish Life Science companies should be enhanced.

13. The tax incentives for research-intensive companies and for investors should be improved.

14. In Denmark Life Science companies should have a fa-

vorable framework for manufacturing with research and development as a basis.

15. Continuous work has to be done to support a flexible,

stable, rational and innovation-boosting home market that can work as an international show window.

16. A national exporting strategy for Life Science should be prepared and this should be supported by new earmarked funds for export-promoting activities with the aim that the export of Danish Life Science solutions should be doubled towards 2025. Moreover, an action plan should be prepared to form the basis of increased targeted efforts to attract foreign investments to the Danish Life Science group.

17. A growth plan for Life Science should be prepared based on the Growth Team's recommendations and a permanent Life Science office referring to the Danish Minister for Industry, Business and Financial Affairs should be established.

EMA FOUND A NEW HOME Edited by Arne Nielsen One of the consequences of the United Kingdom’s vote to

a new location. The big question in 2017 was where. The

leave the European Union comes into act by 1 April 2019

answer was found in November 2017, and EMA will relocate

when the European Medicines Agency (EMA) will open in

to Amsterdam.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2018

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WHAT WE LEARNED

LIFE SCIENCE HIGHLIGHTS FROM FOLKEMØDET 2017 More than 100.000 visitors over four days at the annual political festival, Folkemødet, 15-18 June at Bornholm participated in around 3.200 different events. Among them were a lot of events related to life science.

Edited by Arne Nielsen Politicians and people, representing private companies, public organizations, NGO’s, and the media gathered to discuss and debate all kinds of topics during the major annual stakeholder event, Folkemødet. Events related to life science enclosed topics such as patient safety, medical innovation and growth, clinical trials, healthcare technology, personalized medicine, big data, education, impartiality in healthcare decisions, transparency, and much more.

By end March 2017 the Growth Team on Life Science under the Ministry of Industry, Business, and Financial Affairs presented 17 recommendations to support and further develop life science growth. Anders Thelborg from the Growth Team on Life Science pointed to the need for an office to govern, coordinate, and provide assistance for life science in the same manner as what is seen in agricultural and maritime business areas as top of the wish list. Christian Vintergaard from The Danish Foundation for Entrepreneurship stressed that the universities focus too little on entrepreneurship. Dean Ulla Wewer from Copenhagen University underlined that providing competent candidates and a highly educated work force remains the key delivery of the universities.

Representatives from the Danish Medicines Agency, Kræftens Bekæmpelse as a major NGO, Siemens Healthcare, and Neurescue discussed how patient involvement drives innovation in life science. Siemens Healthcare outlined how customized patient applications and changes in existing equipment are readily based on patient feedback. Nikolaj Brun from the Danish Medicines Agency pointed out that any interaction that the Agency has with the pharmaceutical industry is highly transparent to the public, which is a foundation of the work of the Agency. And from a patient perspective, the involvement in clinical trials drives improved health and prognosis as stated by Leif Vestergaard, CEO at Kræftens Bekæmpelse.

Several events discussed the opportunities and inborn potential ethical concerns related to the use of big data.

Real world evidence has become an important tool in patient safety surveillance and treatment benefits in large populations.

For more information: www.folkemoedet.dk

FOUR NEUROSCIENTISTS RECEIVE THE BRAIN PRIZE FOR CRUCIAL RESEARCH ON ALZHEIMER'S The tireless efforts of these four leading scientists to understand Alzheimer's have provided the foundation for treatment of one of the most devastating diseases of our era. For this, they are receiving the world's most valuable prize for brain research, The Lundbeck Foundation Brain Prize, worth 1 million euros.

By Dr Kim Krogsgaard, Director of The Brain Prize

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Denmark sees 7,500 new cases of dementia every year, changing the lives of Danish families for ever. 80,000 patients already live with some form of dementia – and, little by little, their brain cells are destroyed. Around 50,000 of these patients have Alzheimer's disease.

the world's most valuable prize for brain research, The 2018 Brain Prize, worth 1 million euros (approximately 7.5 million Danish kroner). This year’s prizewinners were announced on Tuesday, 6 March at the spring meeting of the Danish Society for Neuroscience.

There is still no cure for dementia such as Alzheimer's; we can only provide medication for temporary alleviation of symptoms, but thanks to four leading European scientists and their many years of intense research in the laboratory, the way is now paved for better treatment and, in time, prevention.

Together, these four internationally respected neuroscientists have revolutionised our understanding of the harmful changes in the brain that lead to Alzheimer's disease. Their research achievements form the basis for development of the drugs that are currently tested as therapies for the disease.

The four scientists are Bart De Strooper from Belgium, Michel Goedert from Luxembourg, Christian Haass from Germany and John Hardy from the UK. They are recognised for their highly specialised studies of Alzheimer's disease and other dementia disorders and are now being awarded

The organisation behind the prize is the Lundbeck Foundation, one of Denmark's largest sponsors of biomedical research. (www.thebrainprize.org/www.lundbeckfonden.com)

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WHAT WE LEARNED

CELL-BASED THERAPY FOR MORE T1D PATIENTS

By Clara Holm-Hansen The widespread prevalence of diabetes is growing, but only a few T1D patients are receiving cell-based therapy through transplantations of insulin-producing beta cells from deceased organ donors. The complex procedure requires technical purification and selection of millions1 of pancreatic islets, located on the lower stomach, for the therapy to work effectively. However, according to a new groundbreaking

study2, cell-based therapy might be a tangible reality for more patients with type 1 diabetes in the future. The study shows success in generating human pluripotent stem cells (hPSC) with the same properties as organ donated beta cells.

A constant source of insulin-producing cells simply means that patients will have easier access to cell-based therapy and further treatment in the future.

1

https://www.niddk.nih.gov/health-information/diabetes/overview/insulin-medicines-treatments/pancreatic-islet-transplantation

2

http://www.cell.com/cell-reports/fulltext/S2211-1247(17)30364-9

NEW DEVELOPMENT IN MS GENE THERAPY

By Clara Holm-Hansen A new study shows a possible treatment of multiple sclerosis by stimulating the immune system to inhibit harmful T-cells through gene therapy. After hundreds of attempts of treating mice with a condition similar to multiple sclerosis, researchers have recently seen a regrowth and repair of the myelin coating around the damaged nerves causing MS in mice. By using a unique molecule, obtained by implementing a gene from a myelin-based protein into a virus, the researchers were able to stimulate and ‘manipulate’ the immune system of the mice. The mice reacted to the

molecule by developing benign T-cells, which helped them become more tolerant to infections while inhibiting the ‘bad’ and more aggressive T-cells that caused the breakdown of myelin. The study takes advantage of basic scientific knowledge on how the body reacts to infections, which makes the gene-developed vector similar to a vaccine. Though the study holds great knowledge on neuro inflammation and MS gene therapy, it is not yet ready to be applied to humans at this stage.

GROUNDBREAKING CELL THERAPY TO TREAT LEUKEMIA

By Clara Holm-Hansen In late 2017, US Food and Drug administration (FDA) approved a new cell-based CAR-T leukemia treatment that helped a 5-year old girl with aggressive leukemia get completely cancer free. Dr. Tim Cripe, who is part of the FDA committee, called the cancer treatment “one of the most exciting he’s ever witnessed”1. By developing blood cells genetically, the treatment has shown to be effective in treating children and adults with certain types of large B-cell lymphomas. The blood cells are manipulated to attack leukemia in the bloodstream by collecting and genetically

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modifying the patient’s T-cells. This creates a new gene that kills the lymphoma cell. In other words, the treatment takes use of a patient’s own immune system to destroy the cancer1.

Although the side effects from treating leukemia with CAR-T treatment is characterized by ‘severe’ – just like chemo therapy – it has cured several patients with fast-growing, late-stage leukemia. CAR-T is on its way to countries all around the world and is currently being used on leukemia patients in the US.

1

https://www.sciencealert.com/a-cancer-treatment-that-one-expert-called-the-most-exciting-thing-i-ve-seen-in-my-lifetime-just-got-approved

2

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581216.html

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 2018

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SCIENCE PARKS

SCIENCE PARKS IN

MEDICON VALLEY

1

1 NOVI NOVI is one of Denmark’s biggest science parks holding more than 100 companies with a thousand employees. They seek to set up businesses within science and scientific entrepreneurships. As a network of innovative and creative companies, they continue to stand strong internationally while helping to generate growth and catalyze scientific protects. NOVI is in close cooperation with Aalborg University and its students to whom they offer

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scholarships and scientific research opportunities.

2 INCUBA Research Park Located in Aarhus, Denmark, INCUBA Science Park was created with a primary goal to strengthen small scientific companies and research institutions. This has been made possible through professional consultancy and by raising capital for projects that strive to make a difference. They have recently held a lecture presenting the development of a new, effective cholesterol medicine based on basic research from Aarhus University.

The project has received 2.5 million from the Novo Nordisk Foundation for development work.

3 CAPNOVA / CAT Science Park As an investment- and development company, Capnova seeks to catalyze entrepreneurship, ideas and innovations as a host and mentor within science. They have recently invested in an amazing surgical instrument, developed by two Danish engineers, that improves the treatment of lung patients. The instrument, called “KatGuide”, guides the pulmonary tract to the right place in the lung cavity creating more accurate operations

5 COBIS Copenhagen Bio Science Park (COBIS) holds an incomparable value for a lot of biotech companies - both internationally and in Denmark. COBIS is home to a wide range of organizations and companies in a 12.000 square foot building - a few minutes from Copenhagen - in ‘Medicon Valley’. They recently published news on Danish biotech company Acesion Pharma, who just got an approval of their drug addressing acute and persistent AF (Atrial Fibrillation) as an effective treatment for heart patients.

and fewer misplaced drainage cases.

6 Scion DTU

4 Symbion Symbion Science Park hosts conferences that aim to establish cooperation between researchers and innovators. It houses around 250 businesses that offer two growth programs. It was founded in 1986 by six scientists and approved by the Danish Ministry of Sciences shortly after as an ‘innovation environment’. Representing innovations within science, mediocre and artificial intelligence, the co-working space at

University based science park Scion DTU, who collaborates with companies within medico, biotech, cleantech and IT, has recently presented exciting news on methods to effectively diagnose heart patients. Danish life science startup MedTrace has developed a system that produces and injects a “radioactive water tracer” in a patient. They have created a unique solution that provides the most accurate and efficient diagnosis, so that heart patients can get the treatment they need.

Symbion offer exciting developments in all fields.

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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 2018

SCIENCE PARKS

- It takes more than four walls and a computer to create scientific results leading to innovative life science solutions. Science and technology parks in Greater Copenhagen, provide the ideal set-up for innovative life science companies, by promoting entrepreneurship through facilities and network etc.

10

8

6 4 3

9

7

5

7 Medeon Science Park

9 Ideon Science Park

Medeon Science Park is located in the heart of ‘Medicon Valley’ in the middle of the Öresund Region. It houses a cooperative and open meeting place for people active in life science.

Medeon gather some of the biggest voices in life science to hold exciting lectures in close cooperation with Danish scientists.

Medeon Science Park is a major player in the medical industry in Malmö and Medicon Valley – a research park offering a creative and inspiring environment for scientist enthusiasts and professionals.

8 Medicon Village

With an ideal location in Lund, Sweden, Ideon Science Park has taken huge steps towards more cooperation opportunities within life science companies. Ideon was the first science park to ever be established in Sweden and has become a front figure for future developments within ICT, life science, cleantech and medtech.

Through close cooperation with Danish science organizations, Ideon Science Park has recently gathered top leaders from the pharmaceutical industry to create a future meeting space for researchers and entrepreneurs.

10 Krinova Science Park

Medicon Village is a Swedish life science research park offering lectures and meeting spaces in close cooperation with Danish researchers and companies. The park has more than 1,200 employees within its 100 organizations. In 2018/19 a great, purpose-built complex will stand ready as part of Medicon Village, providing more space for innovative researches and ideas. The first ever Swedish conference on advanced therapy will take place at Medicon Valley on 15th of March.

As a place for science enthusiasts, new research and creativity, Krinova has become one of the most popular science parks in Sweden, gathering people from all over the world. The science park incorporates debate-based lectures in their exciting program. Krinova is a platform and catalyzer for innovation and ideas circulating around food, environment and health.

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 2018

15

PROFILE

Ballerup steps up – new Open Innovation Lab to elevate its world class life science cluster Ballerup is to launch sale of land for life science and IT companies and start-ups. The aim is to form an even stronger life science cluster for the future, mixing life science with IT and tech.

And a new Open Innovation Lab will play a key role.

T

he Municipality of Ballerup is home

The companies buying land here will not

to one of Denmark’s strongest life

be picked randomly but will be carefully

science clusters and is now gearing up for the future by inviting established life science and tech companies and start-ups to join them.

selected.

“In this new industrial area, we will focus primarily on inviting life science companies to join us. Established

“The future is digital. The life science

companies, but also start-ups, in life

cluster here in Ballerup is keen to take

science, health tech and IT, that’ll be

that next leap forward towards a more

our target,” said Jette Rau, Director

Jesper Würtzen, Mayor of

Jette Rau, Director of

digital future and we want to facilitate

of Business Development at Business

Ballerup Municipality

Business Development

this. That’s why we’re now selling land for

Ballerup.

life science, tech companies and start-

The established companies in Ballerup are

ups to come and join us here,” said Jesper

increasingly talking about digitalization

Obviously, Ballerup will not be going

Würtzen, Mayor of Ballerup.

just as there is an increasing interest in

into business, but we will facilitate the

creating the foundation for the future,

companies, help them cooperate in new

where life science will be coupled with IT.

ways and we will create the right frames

Initially, Ballerup will sell six acres of land at the Kildedal industrial area, which borders the town of Maalov. In the second

“This spring we will begin to discuss

phase, a further 26 acres will be sold.

in more detail how we can do this.

16

for them,” Rau 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 2018

PROFILE

The Municipality of Ballerup, a suburb to Copenhagen Population: 48,231 Jobs: 45,000 – 34,500 private sector jobs and 10,500 public sector jobs Ballerup is part of a regional workforce.

Every day, almost 35,000 commutes to Ballerup to work

Ballerup is the municipality in Denmark with:

Open Innovation Lab

“Forty years ago, there was nothing but

One of the ways the municipality of Ballerup will help facilitate the life science cluster will be through a new Open Innovation Lab, a place where corporates and start-ups can work closely together to find new solutions to the

fields here. Then came the oil crisis of the 1970’s, and the municipality of Ballerup

•

25,5% share; •

It’s the companies of the future we’re focusing on. That’s a clear strategy, both

The highest rate of IT employees in Denmark with 22% of the total

decided to focus on business. Not heavy industries, but knowledge companies.

Most foreign corporations with a

amount of jobs; •

The highest hourly rate at DKK 294;

(Source: The Municipality of Ballerup)

challenges we face in future such as

then and now,” Würtzen says.

lack of doctors. The Open Innovation

The Open Innovation Lab will include

The municipality of Ballerup has three

facilities such as a lab hotel co-working

main clusters: IT/Tech, Finance/Fintech

space, where lab producers can test new

and Life Science.

facilities too, facilities for Med Tech and

The Life Science cluster employs 4,900

Health Tech, auditorium and meeting

people in more than 30 corporations,

“Disruption is a buzzword these days

facilities, living facilities for short term

making it the second biggest life science

and not least in healthcare. With the

contracts and close relation to top

cluster in the country after Gladsaxe,

Open Innovation Lab, we can help our

universities and hospitals.

which is home to health care heavy

Lab will also be a place where start-ups can challenge corporates and extract tomorrow’s business and ways of dealing with growing healthcare issues.

companies work in the intersection of IT, tech, pharma and life science to come up with the solutions of tomorrow and perhaps take it global too,” says Jesper Würtzen.

Ballerup’s life science cluster is home to more than 60 established life science

“Ballerup is perfectly positioned with short travelling distance to numerous

weighs Novo Nordisk and Novozymes (Source: Medicon Valley Alliance).

universities and hospitals and with an excellent infrastructure, such as airport, trains and busses,” says the Business Development director.

corporates, including large players such

“Ballerup is open for business, so don’t

as Novo Nordisk, Origio, LEO Pharma, GN

hesitate to get in contact,” she says.

and Pfizer.

“But we want to make it attractive for start-ups too. We want to engage the large corporates, attract exciting start-ups, which can support what the corporates do, but also create new growth companies.

That’s our aim,” says Rau. Developing the new business area in Ballerup is a project for the long term and even though the full picture is not drawn up yet, the endpoint is very clear. We are looking for partners that are interested in going in to this with us, both in design but also financing and building the project, says the mayor.

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 2018

17

INTERNATIONAL TALENTS

COPENHAGEN CAPACITY KICKS OFF CAMPAIGN TO ATTRACT LIFE SCIENCE TALENTS TO GREATER COPENHAGEN A newly launched international campaign will seek to attract the very best life science talents to the Greater Copenhagen region. Arranged by Copenhagen Capacity, the campaign involves six companies.

By Karin Jensen Copenhagen Capacity started

Copenhagen Capacity is

mobilising potential passive

talents. In total, six companies

some 25 years ago with the

not a competitor to private

international jobseekers,

have signed up for the

aim to create growth in the

recruitment firms, nor is it

who have not yet considered

campaign, each with up to

region by attracting foreign

involved with industries,

working in Denmark,” said

three job postings.

investments. Today, it also

where there is sufficient

Nikolaj Lubanski.

helps companies recruiting

labour.

“We ended up with four

On February 28th,

categories: Regulatory Affairs,

“We’re an add-on, a

Copenhagen Capacity and

Quality Control/Quality

“Our focus areas are IT/Tech,

supplement to a company’s

Invest in Skåne launched an

Assurance, Engineers, and

Cleantech and Life Science,”

own recruitment efforts.

international campaign to

Laboratory Technicians,” said

said Nikolaj Lubanski, Talent

Companies typically recruit

help life science companies

Nikolaj Lubanski.

Director at Copenhagen

in the vicinity but where we

in the Greater Copenhagen

Capacity.

can make a difference is by

region attract international

international talents.

18

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | M A RC H 2018

INTERNATIONAL TALENTS

After the eight weeks,

for smaller and medium-

Michael Hallgren expects the

Once the campaign is over,

the companies will be

sized companies, cultural

cooperation with Copenhagen

Novo Nordisk Kalundborg

sent between two and ten

differences can be a barrier,”

Capacity will increase Novo

will evaluate the candidates

candidates, who have been

said Nikolaj Lubanski.

Nordisk Kalundborg’s profile

Copenhagen Capacity finds for

internationally.

them and compare them with

screened by Copenhagen Capacity.

Customised Messages

Novo Nordisk Kalundborg Although known throughout the world, Novo Nordisk’s

A media channel strategy was

Kalundborg production facility

also put together, specifically

still has problems attracting

targeting the talents on social

and retaining talents

media such as Facebook,

commuting from Copenhagen,

Twitter and Youtube.

who often prefer jobs in the

Messages are customised and

bigger cities.

serves to trigger the curiosity of the talents and make them want to know more about working and living in Greater Copenhagen.

“We also expect to get a broader field of candidates to choose from than usually, and

the almost 100 international candidates already employed at Novo Nordisk Kalundborg.

perhaps even a higher level of

“We have a clear expectation

quality among the potential

that the candidates that move

candidates,” said Michael

to Kalundborg, stay here,” said

Hallgren.

Michael Hallgren.

“We’re looking at alternative ways to recruit, including attracting international talents, and that’s why we decided to join up with

Messages focuses on

Copenhagen Capacity for

place branding, the life

this campaign,” said Michael

science cluster in Greater

Hallgren, Senior Vice

Copenhagen, and then the

President at Novo Nordisk

actual job.

Kalundborg.

So far, Copenhagen Capacity has run five campaigns, which has led to 23 employments in total. However, the exposure has been enormous with films and banners on social media being showed around 70 million times over the course of the campaigns.

“It’s an enormous exposure

“We’re an add-on, a supplement to a company’s own recruitment efforts. ,” says Nikolaj Lubanski, Talent Director at Copenhagen Capacity.

and we really see this as a long-term investment. We’re planting a seed and create awareness about Greater Copenhagen,” said Nikolaj Lubanski.

The talents being sought are coming from both within and outside of EU. “We look at countries where we can offer something in terms of wages and social conditions. Secondly, there must be a cultural match as well otherwise it’s too much hassle for the company. Not for the big companies, but

19

INTERNATIONAL TALENTS

From Greece with love Stavros Kalafatakis, Research Scientist, Fermentation Discovery team at FMC, is one international talent who found happiness in Denmark.

Kalafatakis decided to leave his home country Greece in 2011 to do his Master’s and later Ph.D in a new country.

“I wanted to go to a country which was quite developed and had low unemployment.

education programs are taught

pleased with his choice and

in English, not to mention

highlights a good social life

that unemployment was very

with friends and good working

low at that time,” said Stavros

conditions. Last summer he

Kalafatakis.

landed his first job after his

A strong welfare system, health care, paid holidays and a rich cultural life in Copenhagen also attracted Kalafatakis.

“Also, the pictures looked nice and always sunny,” said Kalafatakis with a smile.

Denmark offered free tuition,

Now, seven years after his

and most of the higher

arrival, Stavros Kalafatakis is

Ph.D, as a research scientist with FMC, and is about to start a family with his soonto-be Danish wife.

“I like it here, both personally and work-wise. It’s an excellent place to build a career and have a good lifework balance,” said Stavros Kalafatakis.

“I wanted to go to a country which was quite developed and had low unemployment."

Stavros Kalafatakis, Research Scientist, Fermentation Discovery team at FMC

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28/02/2018 20.34

PROFILE

Work in Denmark helps attract international candidates to Denmark As the official International recruitment unit under The Ministry of Employment, Work in Denmark facilitates contact between Danish companies and International candidates and communicate knowledge and experience to all interested parties.

Work in Denmark provides international jobseekers and Danish employers with the information, guidance and tools necessary to find each other. It is a public employment service for highly qualified international candidates looking for a job in Denmark, and Danish companies searching for talented foreign candidates. Work in Denmark is part of the Danish Ministry of Employment and a member of the European Employment Service, EURES. The three Work in Denmark offices located in Copenhagen, Odense and Aarhus, offer a series of recruitment services to employers as well as information and guidance to international jobseekers.

“Our services include job match, where we match the right candidates with the companies. Once the candidate has decided to move to Denmark, we help with the necessary registration, both before and after arrival here. We also participate in job fairs and help brand Denmark as an attractive place to work,” said Mette Wassmann, International Recruitment Consultant at Work in Denmark.

Work in Denmark’s mission is to assist the thousands of well-educated foreigners who come to Denmark every year to live and work. Many are attracted by the opportunity to combine professional challenges, comfortable living conditions and family-friendly working hours.

To meet the future need for well-qualified labour, Denmark needs to attract more

talented people from abroad. Many Danish private and public organisations are keen to recruit highly skilled international workers and make great effort to ensure that their international employees settle well into their new life in Denmark.

“There’s a shortage of highly specialised candidates, primarily within engineering, IT and life science and this will only be more prevalent in future. This is a trend we see in the rest of the world too,” said Mette Wassman.

“This job fair is particularly important because MIT is one of the world’s leading technical universities, whose candidates count among the very best. Because it’s a European fair, the candidates we meet there have already decided to seek a career in Europe and our job is to make sure they look towards Denmark,” said Mette Wassmann.

All services from Workindenmark are free of charge.

For further information – please contact Mette Wassmann at Work in Denmark at mwa@workindenmark.dk

Work in Denmark participates in many different job fairs around Europe targeted at highly qualified candidates in areas where Denmark has a shortage. Work in Denmark has extensive experience in organising tailor-made recruitments abroad. In close co-operation with other EURES countries, Work in Denmark ensures a solution that meets the needs of both candidate and businesses. Work in Denmark can help promote vacancies, collect applications and provide preselected candidates. Some job fairs are general job fairs attracting candidates from many different areas while others are more targeted in relation to the demand in Denmark.

This year, Work in Denmark is once again participating in the MIT European Career Fair in Boston, USA in a collaboration with the Confederation of Danish Industry, Copenhagen Capacity, the Technical University of Denmark and the University of Copenhagen. This provides Danish companies with the opportunity to work directly with one of the world’s leading technical universities to recruit some of the best-qualified candidates from the IT, life science and engineering sectors. The MIT European Career Fair takes place at Massachusetts Institute of Technology (MIT) in Boston and is especially tailored for candidates interested in working in Europe.

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 2018

21

REGULATORY COMPLIANCE

Finding the balance in regulatory compliance Life science companies have over the past two decades faced an increasing number of regulatory compliance requirements. Simultaneously, this rather conservative industry has generally been reluctant to fully implement new technologies for more efficient work flows.

By Charlotte Strøm, MD PhD Journalist

T

ime to market has key priority in the life science industry. But on top of that price pressure and regulatory pressure apply, leaving the industry sitting on top a melting iceberg: Become more efficient or lose your business!

Chief Consultant Mikkel Møller Rasmussen at The Danish Association of the Pharmaceutical Industry (Lif) thinks the matter is complex: -This is one of the fundamental areas of our industry, hence also one of the areas we and our members are very concerned with. Many

22

considerations can and must be weighed in relation to each other. Basically, patient safety is and will always be the most important, Mikkel Møller Rasmussen says, carrying on: -It’s true that the documentation requirements related to the regulatory compliance are growing. But I don’t find that strange at all because the trust in the system and the products are crucial, both for the patients and for the pharmaceutical companies. You will probably be able to find examples of regulatory compliance rules

that are overly implemented.

Nevertheless, it is important to have rules that make it possible to rely on the products produced in our industry. After all, it is a different matter to produce medicines than it is to produce rye bread.

legacy of being risk aversive and too conservative to apply and specifically make optimal use of new IT systems and processes. In that way the regulatory compliance becomes a costly affair that does not truly add value to the business, says Klavs Esbjerg.

Klavs Esbjerg, CEO at Epista Life Science argues that some areas of the pharmaceutical industry would benefit from a leaner approach.

He points to the key findings of a recent market survey that was done within stakeholders of the Danish life science industry.

-The problem is that regulatory compliance is overly implemented, while the industry as a whole has a

-The industry faces a tough balance that overspending time and resources on regulatory compliance may

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 2018

REGULATORY COMPLIANCE

put the companies out of business, while underspending may put them at risk of losing control of compliance. 51% of the respondents from life science companies responded that regulatory compliance and business requirements are seen as opposing forces in the company.

Lack of transparency and predictability The market survey uncovers a lack of transparency and predictability with the regulatory compliance area.

This is seen locally within the company and centrally with the regulatory authorities.

-Generally, the life science industry is extremely good at providing documentation, i.e. demonstrating to themselves and the outside world that they are in control. But along the way they failed to ask themselves how and what specific parts of the regulatory compliance that add value to the business, Klavs Esbjerg comments on the survey and carries on, -What we typically see is over-doing, over-engineering, and over-implementing best practice in a way that’s turning into malpractice, claiming that this is a regulatory requirement while in fact it is a misinterpretation of the intentions.

But regulatory compliance is a matter of patient safety, how can that be a misinterpretation? ¬-True and this is certainly not an argument to let go of the standards when it comes to patient safety. But the issue

is that the crucial steps to ensure patient safety has been moved into every corner of the business and overly applied in a manner that no longer has any relevance to patient safety.

To Chief Consultant at Lif, Mikkel Møller Rasmussen, this is also a matter of credibility.

-This is an industry with many internal rules that were born centrally within EFPIA (The European Federation of Pharmaceutical Industries and Associations) for the majority and sanctioned locally by ENLI (Etisk Nævn for lægemiddelindustrien).

The rules put in focus the advertising rules, the industry image - and thus the confidence that we act responsibly. There may be internal business rules that may appear "too much".

But I think it is worthwhile to keep in mind that there may be more to it than that, arguments that you as an outsider may not know.

regulatory authorities. An example of that would be the e-application for marketing authorizations of medicinal products. It’s more than a decade ago that it was implemented, still ask yourself whether the use of paper documentation has actually decreased during that same period of time, Klavs Esbjerg argues.

He stresses that the costs of bringing a medicinal product to the market is undergoing a disturbing development.

-In the 80’ies the cost of bringing a new drug to the market was around 0.5 billion, today the estimated cost is 1.5 billon US dollars. It is not all due to better drugs.

It reflects an overspending of compliance resources.

Faced with the external pressure from pricing and reimbursement, the life

science industry need to start asking the question on how this can be balanced, he says and ends, -Currently the life science industry is aiming to run a marathon in record breaking times with massive overweight on its shoulders.

The companies that have the courage to apply e.g. new IT technologies in order to become more efficient, who take advantage of cloud sourcing and furthermore have the trust and courage to challenge the regulators on moving into the 21st century, are the ones that will make it in the end.

Read more about the survey: http://www.epista.com/ compliance-maturity-2017

Updated IT systems and processes Regulatory authorities set out framework on the regulatory requirements. Is this a problem that lies with the hen or the egg?

-In general, there is a fundamental fear in the life science industry of changing specific processes, e.g. applying a tool that would improve the work flow around patient reporting in clinical trial settings.

They don’t know how it is going to come down with the

“There is a fundamental fear in the life science industry of changing specific processes, e.g. applying a tool that would improve the work flow,” says Klavs Esbjerg, CEO at Epista Life Science.

23

PERSONALIZED MEDICINE

Medical University of Vienna (MUW) to collaborate with bio.logis GIM in pharmacogenetics MUW will implement bio.logis Genetic Information Management Suite (GIMS) / platform for the automatic creation and online display of diagnostic reports and treatment recommendations / safety code card for patients.

Source bio.logis Genetic Information Management GmbH

W

ithin the framework of U-PGx, an EU project for promoting the use of pharmacogenetic insights in healthcare, the Medical University of Vienna (MUW) will implement the Genetic Information Management Suite (GIMS) developed by bio.logis Genetic Information Management GmbH. The platform is the first of its kind to largely automatically translate genetic analysis results from laboratories into easily understood diagnostic reports, including the right treatment recommendations from the internationally renowned KNMP (the Royal Dutch Pharmacists Association). Here, the MUW uses the Diagnostic Report Module (GIMS.DRM) in combination with a QR-based safety code card, developed

by MUW, for patients. This card is used to make patients’ personal analysis results accessible.

There is still far more scope in medical practice to use pharmacogenetic insights. The

EU-funded project Ubiquitous Pharmacogenomics (U-PGx) would like to support this because pharmacogenetics enables important progress in personalized medicine. As a key partner of the U-PGx project, bio.logis GIM has implemented its Genetic Information Management Suite (GIMS) at selected university hospitals and institutions in various European countries, including the Medical University of Vienna. bio.logis and MUW have now agreed to offer the safety code card—an emergency card for patients, the size of a credit card—beyond the scope of the U-PGx project.

A QR code printed on the card gives patients an easy and quick access to a web portal which provides dosing recommendations based on the patient´s genetic analysis.

These recommendations will support the attending physician in prescribing the right medication in the right dosage.

“Within the framework of U-PGx, the bio.logis Genetic Information Management Suite enables us to automate and speed up the creation and delivery of easily understood genetic-diagnostic reports,” says Assoc.-Prof. Matthias Samwald, MUW, who is also one of the U-PGx project leaders. “We will offer the products jointly developed during our cooperation also outside of this project.” bio.logis GIMS works with pre-configured standardized expert knowledge. With the system’s Diagnostic Report Module (GIMS.DRM), creating a genetic-diagnostic report is done in a matter of seconds.

An enormous time and cost saver, compared to traditional methods. The Delivery Module (GIMS.DM) can then be used by authorized physicians or the patients themselves to fetch these reports. The safety code card supplements the information for the patients.

“Our expert team, consisting of experienced specialists in human genetics diagnostics,

biologists and IT professionals, has developed bio.logis GIMS—a software platform using special algorithms, workflows and modular components for creating genetic-diagnostics reports and making them available at the point of care in very short time,” emphasizes Prof.

Daniela Steinberger, Medical Managing Director, bio.logis GIM. One of the most important considerations for bio.logis in every development is the security and protection of personal data. The system itself processes exclusively pseudonymized analysis data.

Every communication channel is generally encrypted. This ensures that the allocation of analysis results to individuals can only be done by the responsible medical staff within the clinic. bio.logis complies with existing data security regulations including the EU-wide General Data Protection Regulation (GDPR), coming into force on May 25, 2018.

About bio.logis Genetic Information Management GmbH

24

bio.logis Genetic Information

(GIMS)” IT solution which, in the

in laboratories for automatically

tion systems as well as electronic

Management GmbH translates

process chain required for genetic

generating such expert content,

health records. For more infor-

genetic data into medically

diagnostics, focuses on the "last

and in hospitals with specific clini-

mation about our company and

leverageable information and

mile” from physician to patient

cal suggestions. The physician

our products, please visit https://

makes it available to physicians

by merging raw genetic data with

reports and recommended action

www.biologis.com/.

and patients. To that end, it has

clinically leverageable knowl-

generated by GIMS is delivered

developed a special “Genetic

edge for prompt application.

straight to the point of care via

Information Management Suite

GIMS supports physicians both

laboratory and physician informa-

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 2018

DOOR SOLUTIONS

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OVERVIEW

BIOTECH pages 30-33

MEDTECH pages 35-37

PHARMA pages 38-40

CONTRACT RESEARCH ORGANISATIONS pages 42-45

CONTRACT MANUFACTURING ORGANISATIONS pages 48-49

BUSINESS SERVICE PROVIDERS pages 50-54

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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 2018

OVERVIEW

LABORATORY, MEDICAL & PHARMACEUTICAL EQUIPMENT pages 56-60

COMPANY INDEX pages 62-71

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PROFILE

Efficient detectives hunting impurities in the pharma industry.

When pharmaceutical production lines or QA (quality assurance) detect an irregularity in a medical product, a rapid, reliable identification and characterization is required.

-Speed is often an issue. It is costly to halt e.g. a production line or withhold a batch due to irregularities, so we do our utmost to deliver analysis results and identification within these sometimes rather strict deadlines, Specialist Jacob Markussen from FORCE Technology explains.

He is heading the team of specialists working with material and surface characterization at FORCE Technology, an authorized provider of technological services – a GTS entity.

At FORCE Technology a characterization typically starts in the scanning electron microscope (SEM), which allows magnifications up to 1 million times.

Further analyses may be undertaken in other microscopes such as the FTIR (Fourier Transform InfraRed spectroscopy) microscope along with a large number of other chemical analysis methods. But there is more to it than having the right technological equipment, Jacob Markussen stresses: -We have a team of specialists, who are highly competent and experienced within their own area, e.g. metals, plastics, organic material, minerals, composites etc. Identification is often more a matter of pattern recognition than the technical analysis itself. Recognizing from experience and expertise what the different irregularities typically resemble allows us to test and verify our findings rapidly to the benefit of our clients.

28

Once the irregularity has been identified and characterized the information goes back to the client.

-The important information is obviously to find out what we are dealing with, and whether or not it impairs the safety and the quality of the product. Once that information has been established reliably, we typically assist in locating the source and cause of the contamination. It could be a metal, which can be traced back to a certain area of the production line, or a rubber material that are used only in certain sealings.

Independent experts The skills as true detectives are also used when acting as independent experts in arguments about faulty deliveries.

-Medtech or pharma companies often have deliveries from a range of sub-suppliers.

In case of an irregularity, it can become quite crucial to find the source of the contamination to stop it and in order to get reimbursement, Jacob Markussen says and ends, -In general, the life science business work by very high standards, by having agile and thorough quality assurance systems in place that manage to capture even minute signs of contaminations. Our finest job at FORCE Technology is to help our clients make qualified decisions based on reliable knowledge and facts.

Facts about FORCE Technology •

FORCE Technology is a leading technological consultancy company.

We offer consultancy and services within energy, oil and gas, the maritime sector, manufacturing, the service sector and infrastructure.

•

Provides in-depth knowledge about the surface of materials and products for the life science sector along with a series of other industries.

•

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 2018

For more information please visit: http://FORCEtechnology.com

Conference on Big Data in Biotechnology and Biomedicine May 31 – June 1, 2018, Hotel Munkebjerg, Vejle, Denmark High throughput methods are constantly refined to enable large-scale investigation of complex biological systems. The basic scientific paradigm is to understand and predict the relation between architecture, structural information and function. The continuous and massive increase in DNA and protein sequence information and advances in quantitative experimental technologies in biology, represents an enormous potential for research of academic, industrial as well as biomedical value. The challenge remains how to get meaningful information out of this vast “ocean” of data information derived from a multitude of species including individual human beings.

The conference will focus on the latest developments in creating, utilizing, handling and methods for analyzing Big Data in biotechnology and biomedicine including sessions on - Precision medicine - Statistical genetics - Single cell analysis - Systems biology in medicine and process biotechnology - Biological and genomic networks - Microbiomics - Best practice on handling and storage, safety and ethics Speakers accepted • • • • • • • • • •

Speakers invited

Armand Valsesia, Nestlé , CH Henrik Rindel Gudbergsen, IBM Nordic, DK Henrik Bjørn Nielsen, Clinical Microbiomics, DK Jens Nielsen, Chalmers, S José-Maria Gonzalez-Izarzugaza, DTU, DK Mads Albertsen, AAU, DK Markus Herrgard, NNF Biosustain, DK Mathias Uhlén, KTH, S Sandrine Muller, Massachusetts General Hospital and Broad Institute of MIT and Harvard, USA Thomas Senderovitz, Danish Medicine Agency, DK

• • • •

Chris Spencer, Welcome Trust, UK Lude Franke, University of Groningen, NL Matt Might, University of Alabama, USA Martin Hemberg, Sanger Institute, UK

The conference is organised in collaboration with Danish Society of Biochemistry and Molecular Biology and includes a poster session as well as a commercial exhibition of equipment, consumables and services to Danish biotechnology.

Scientific Committee Ole Nørregaard Jensen, University of Southern Denmark Leif Schauser, Qiagen Jochen Förster, Carlsberg A/S Eric Paul Bennett, University of Copenhagen Leonor Rib, University of Copenhagen Lars Haastrup Pedersen, Aalborg University Deadline for poster abstracts and registration: April 10, 2018. For questions regarding participants registration, please contact Anne Dalgaard, The Danish Society of Engineers, IDA, at ada@ida.dk.

Registration will open December 1, 2017 , see announcements at www.biokemi.org or www.ida.dk Participation fee: 3500 DKK ; reduced fee for students (Ph.D. and M.Sc.): 1800 DKK. M.Sc. student scholarships find info at www.synapse-connect.org

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“It takes a constant inflow of innovation to maintain a vibrant industry.”

Martin Bonde, Chairman of the trade organization of the Danish biotech companies, DANSK BIOTEK, and

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BIOTECH

FASTEST GROWING INDUSTRY The Danish biotech industry is constantly on the move, growing and getting stronger.

Still, funding from the stock market appears to be challenging in Denmark whereas Sweden has a different IPO culture for small and midsize life science companies.

By Charlotte Strøm, MD PhD Journalist

T

his biotech industry has

history for listing of small

I believe that a single-entry

companies that have been

so many good things

biotech on the Copenhagen

point to the political system

around for a decade or more

going on. It is the fastest

stock exchange. History drives

will be a major advantage for

and are still going strong,

growing industry in the coun-

the culture and the legacy

us.

mentioning Genmab, Bavarian

try, and the companies have a

that fertilizes the investing

series of very exciting research

environment, he says.

projects going on, says Martin Bonde, who is the Chairman of the trade organization of the Danish biotech companies, DANSK BIOTEK, and CEO at the biotech company Vaccibody. He continues,

ing the necessary investments

that the increased political

at the Copenhagen stock

commitment to the life science

exchange, some take their

industry as a major industrial

exits to the stock exchange in

and economic national growth

Sweden.

factor will gradually help the willingness to invest into Danish biotech companies into

are sold to foreign investors

the right direction. He points

and some perhaps a little too

to the intention of establish-

soon. Most often it unfortu-

ing a life science office at the

nately implies that the tech-

Ministry of Industry, Business,

nologies they represent and

and Financial Affairs as the

the jobs exit the country.

first step to start organizing

continuously risk aversive and perhaps conservative stock

and establishing and improving the industry’s conditions to operate.

market culture in Denmark as

-Until now we’ve had two-

a major obstacle.

three-four different ministries

-Clearly, we struggle as an industry without strong

stantly face challenges in rais-

Martin Bonde is anticipating

-Regrettably, some companies

Martin Bonde points to a

As the biotech companies con-

to address organizational matters of the industry with.

-Over the past few years

Nordic, Zealand Pharma, and recently in 2017 Orphazyme was publicly listed on the Danish stock exchange, hence going against the trend of taking the IPO to Stockholm.

Strategic investments in biotech and start-ups

almost all IPO’s among small

Martin Bonde stresses the

biotech companies have taken

importance of maintaining

place in Sweden, where there

a solid foundation of growth

is a different tradition and

and points to the venture

back-up also among private

capital as instrumental in that

investors. We seem to lack a

setting. Beyond that he high-

public market in Denmark that

lights a recently announced

allows for the best Danish bio-

investment made by the Novo

tech companies to raise money

Nordisk Foundation as major

here, Martin Bonde says.

highlight of the past year.

He does point out, however,

-In December 2017, the Novo

that by now, a number of

Foundation decided to invest

continuously growing biotech

in the establishment of a Bio-

companies have demonstrated

innovation Institute with the

the power of innovation, i.e.

primary purpose of promoting start-ups in the life sciences in Denmark.

"We seem to lack a public market in Denmark that allows for the best Danish biotech companies to raise money here"

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 2018

The Bioinnovation Institute is a long-term initiative of 10 years and the Foundation has

31

BIOTECH

awarded a grant of DKK 392

-We hope that we can high-

-It takes a constant inflow

million to cover the 3-year

light Denmark as a strong

of innovation to maintain a

establishment phase. The

powerhouse in northern

vibrant industry. This initia-

institute is a Danish initia-

Europe for maturing research

tive aims at creating synergy

tive that has an international

and start-ups in the life

with the existing academic

perspective. It will be located

sciences so that Danish and

and general research envi-

at Copenhagen Bio Science

international investors will

ronments and the life science

Park (COBIS) in Copenhagen,

perceive the life sciences in

environment located in the

close to the universities.

Denmark as an attractive

area, Martin Bonde says, and

field for investment. This will

ends,

The Chairman of the Novo Nordisk Foundation, Scheibye puts it this way in the press release from the Novo Nordisk Foundation.

enable the solutions developed to benefit everyone and to create new companies and jobs in the long term.

-With that I set my hopes for a new year that can take off where the previous one ended.

"We struggle as an industry without strong history for listing of small biotech on the Copenhagen stock exchange. History drives the culture and the legacy that fertilizes the investing environment" Says Martin Bonde, Chairman of the trade organization of the Danish biotech companies, DANSK BIOTEK, and CEO at the biotech company Vaccibody.

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“This recommendation demonstrates the acknowledgement of a strong regulatory authority with the right competences and enough hands to meet the need of the applicants.�

Peter Huntley, CEO at Medicoindustrien

MEDTECH

HIGH EXPECTATIONS OF THE GOVERNMENT’S LIFE SCIENCE GROWTH PLAN

By Charlotte Strøm, MD PhD Journalist

I

n 2017, Medicoindustrien,

innovation, and growth.

Life Science Growth Team’s

the Danish medtech trade

CEO at Medicoindustrien,

recommendations that were

organization published a

Peter Huntley stresses that

presented in 2017.

booklet of industry specific

Danish medtech industry is

statistics. The numbers

vibrant and productive. Still,

demonstrate a strong position

he is enthusiastic about the

in terms of export, jobs,

political responsiveness to the

Stronger regulatory focus On the list of recommendations from the

-The initiatives that have

Life Science Growth Team

been announced based on the

was a strengthening of the

recommendations from the

position of the Danish Medical

Life Science Growth Team are

Agency.

promising. And by far this stands out as a highlight of 2017, Peter Huntley says.

-This recommendation demonstrates the acknowledgement of a strong

He points specifically to the

regulatory authority with the

increased political attention

right competences and enough

on the life science industry

hands to meet the need of the

with a life science growth

applicants, Peter Huntley says

plan, along with more

and continues,

general considerations and actions that hopefully result in optimized conditions for continued growth, not only within medtech – but overall in biotech and pharma as well.

-It is no secret that the medtech industry is challenged seriously by the increased regulatory requirements. We do support the necessity for clinical documentation and we

CEO at Medicoindustrien, Peter Huntley, has high expectations to the increased political focus on life science growth.

believe that it will give us better products of higher quality. However, it is a major challenge for our members that the capacity on notified bodies appointed to assess the clinical documentation does not meet the demands.

There is a transition period that runs through 2020 for medtech equipment and through 2022 for diagnostic tests for the companies to have their products recertified.

MEDTECH

"It is no secret that the medtech industry is challenged seriously by the increased regulatory requirements. We do support the necessity for clinical documentation and we believe that it will give us better products of higher quality."

-I fear that the lacking

-Many of the medtech

Coming back to the increasing

within the industry in order

capacity will in fact make

companies spark from

regulatory demands, he also

to learn more about how to

some companies refrain from

engineering entrepreneurship.

sees some downsides to the

document the impact of the

re-certifying some products

Characteristically, they are far

‘upbringing’ and traditions of

products in patients, Peter

and if that turns out to be the

from patient-related activities

the industry.

Huntley says and concludes,

case, the Danish healthcare

and the turnover of products

system no longer has access to

is much higher than in pharma

-Clearly, as an engineer,

-Register-based research is an

these products.

or biotech for that matter. The

you don’t reflect a lot about

area of key interest to us. We

clinical documentation.

have no tradition of making

You have your mind set on

use of these type of data,

different matters related to

but we are keen on looking

the technology. So, we need to

into what opportunities and

improve our skills overall

learnings we can draw from it.

Innovation-driven industry

good thing about this type of environment is that it is

The industry has a legacy of

highly attractive to venture

innovative start-ups, which

capital and investors, Peter

tends to affect the culture and

Huntley says.

the mindset of the companies.

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PHARMA

“It is worthwhile noting that clinical trial activity eases the access of innovative medicines for patients, educates the health care professionals, and altogether adds value to the Danish health care system.�

Henrik Vestergaard, Deputy Director at Lif

PHARMA

STRONG POLITICAL LIFE SCIENCE FOCUS IS A MAJOR BREAKTHROUGH The Danish Association of the Pharmaceutical Industry (Lif) looks back at 2017, pleased with politicians who finally acknowledged the significance of the industry. Another breakthrough, although on the negative side from Lif’s perspective, was the establishment of a prioritization institute on medicines.

By Charlotte Strøm, MD PhD Journalist

L

ike other key stakeholders

He is positive that the

attempt to refrain patients

the negative aspects of the

in the life science

initiative of a life science

from gaining access to

Danish Medicines Council’s

industry, the Deputy Director

office will maintain the

medicines, Henrik Vestergaard

work.

at Lif, Henrik Vestergaard,

political focus to a much

says.

seconds the enthusiasm

larger extent than what has

about the governmental

been the case so far.

-The council is hardly up

He points to the council’s

and running, due to the new

alleged power to omit certain

and increased standards of

Prioritization institute

medicines from the standard

impartiality to the experts

recommendations of the

Henrik Vestergaard is

of care national programmes

that are going to be running

Life Science Growth Team in

considerably more subdued

based on the costs alone,

the assessments. By all

March 2017.

on the establishment of the

refraining from making use

means, impartiality is highly

plan to issue a growth plan for life science based on the

-Clearly this is a breakthrough, because this is the first time ever that the politicians acknowledge the potential of this industry that goes beyond merely having a strategy for medicines, Henrik Vestergaard says.

prioritization institute, The Danish Medicines Council.

of standardized measures like quality adjusted life year

important, but so is clinical experience, and we fear that the experts who live up to the

The purpose of the council

(QALY) in their assessments of

is to assess new hospital

new medicines.

medicines and several

Henrik Vestergaard admits,

experienced clinical experts in

however, that Lif does not – in

the therapeutic field. But we

January 2018 – have a series of

still have to wait and see how

negative cases to demonstrate

this goes.

medicines within the same therapeutic area.

-We see this as a coordinated

high demands of impartiality may not be the most

"The council is hardly up and running, due to the new and increased standards of impartiality to the experts that are going to be running the assessments."

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 2018

39

PHARMA

Access to health care data

By May 2018 the EU law on General Data Protection Regulation will come into action. Henrik Vestergaard stresses that this will have Lif’s continued focus in the coming year.

-It has been and is continuously being discussed intensely who should have access to the citizens’ health care data. The pharmaceutical industry is obviously highly interested in health care data for research purposes. But it is immensely important

to underline that while the research is looking for patterns within large populations, individual events and personal pieces of information are of no interest whatsoever, Henrik Vestergaard notes, carrying on: -At Lif we have a hard time seeing how the society as a whole can continuously make progress without maintaining access to and allowing researchers to gain knowledge and improved understanding from health care data. This is not an issue for our members only, it is

Deputy Director at Lif, Henrik Vestergaard, sees the political receipt of the Life Science Growth Team’s recommendations as a breakthrough in 2017.

also potentially obstructing epidemiological research in academia. Hence, we will do what we can to help kill the myths and misunderstandings of this topic.

Working on NEXT 2.0 Henrik Vestergaard points to the successful NEXT private-public partnership on attracting early clinical research to Denmark. But the dream scenario is that big pharma’s clinical development programmes will find their way back to Denmark, including the largescale phase 3 trials.

-Currently big pharma is having a hard time seeing that Denmark should stay on the map of attractive clinical trial sites. We hope to be able to change that over time in collaboration with the Danish Regions, he says and ends, -It is worthwhile noting that clinical trial activity eases the access of innovative medicines for patients, educates the health care professionals, and altogether adds value to the Danish health care system.

40

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CONTACT AN GROUP

CRO’s

Contract Research Organisations

Last year we asked the Scandinavian pharmaceutical- and biotechnology groups what they primarily considered when hiring a CRO for a clinical study. One of the most repeated answers was local presence, which a lot of the CRO’s are aware of, and expansion cross Scandinavian borders is a common trend.

CRO’S

ESTABLISHING LOCAL PRESENCE IN NORDIC COUNTRIES Scandinavian CRO, the Uppsala-based Swedish CRO, plans to double in size in five years and its goal is to become a leading Nordic CRO. Part of the strategy is to establish local presence in the other Nordic countries. Denmark, it believes, is one of the most interesting areas in life science right now.

By Karin Jensen The Swedish CRO,

The goal is to become a

other Nordic countries with

streng thening the life

Scandinavian CRO (SCRO),

leading Nordic CRO and

local presence in Denmark,

science in Denmark. The

has just embarked on a new

to expand further in the

Nor way and Finland and

ambition of making clinical

grow th strateg y, which will

region and the first step

will be recruiting additional

trials available for more

see the group double in size

will be to double in size

staff to join the team.

patients, and aims for

in the coming years.

over the next five years.

“During the past ten years

“Today, we’re

Greater Copenhagen Life

we have built a healthy,

approximately 25 employees

Science cluster, is an area

sustainable and successful

in Sweden and Nor way

where SCRO has high

company. We have reached

covering the Nordic market

expectations.

the goals we set up and

and with revenue of 27

now it’s time to take the

million SEK,” said Ulrika

next step in our journey,”

Hammarström Lüllmaa.

said Ulrika Hammarström Lüllmaa, CEO at SCRO.

Denmark, and the

“Denmark, and

attracting clinical trials to the area, is of course a key factor for us to invest,” said Ulrika Hammarström Lüllmaa.

Need for a “smaller” CRO

Copenhagen, is one of the

SCRO’s new strateg y is

most interesting areas

based on a thorough market

SCRO is also currently in

right now with the many

analysis, which identified

the process of expanding to

concrete initiatives for

the need from the life

“Today, we’re approximately 25 employees in Sweden and Norway covering the Nordic market and with revenue of 27 million SEK,” Ulrika Hammarström Lüllmaa, CEO at SCRO

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 2018

43

CRO’S

"Our USP is HOW you do it! We have developed a unique business climate in our company where skills such as communication and team work it highly prioritised. Business is done between people with people."

Ulrika Hammarström Lüllmaa, CEO at SCRO

science industr y for a “smaller” CRO with more f lexible and tailor-made solutions and partnerships.

“One of our streng ths is that we understand our clients’ day to day work and the challenges of resources and time frames they need to tackle. Time is money and you need to move fast with quality,” said Ulrika Hammarström Lüllmaa.

Lüllmaa said another trend it is targeting is the Medtech industr y, which is growing and with more and more MedTech companies in urgent need of assistance to keep up with the new EU legislation that comes into force in 2020.

“We have adopted all our standards and routines and have broad competence within the MedTech area,” the CEO said.

Quality and competence are obvious key factors for a CRO,

44

CRO’S

according to Lüllmaa,

SCRO has developed a

of working,” said Ulrika

who believes that with a

Project Model, or Project

Hammarström Lüllmaa.

more digitalised world,

Culture, which includes a

spinning faster and faster,

framework of processes for

the personal meeting and

target settings, timing,

the understanding for each

risk management, quality

other's day to day work gets

assurance, documentation,

more and more important.

resources, budget,

“Our USP is HOW you do it! We have developed a

leadership and team

She said that in her experience, the larger CRO’s make the clinical trials more complex and less efficient with large systems and heav y administration.

“One responsibility we have

building.

unique business climate in

“It gives us and our clients

our company where skills

an efficient and modern

such as communication

way of setting the purpose

and team work it highly

and goal for each project.

prioritised. Business is

It is important to stress

done between people with

that the model is NOT a

people. You must not forget

system that comes with

that,” stressed Ulrika

more administration but

Hammarström Lüllmaa.

builds an efficient way

as a CRO, is to facilitate for clinical sites and investigators to participate in clinical trials, not to overload them with administrative work,” the CEO emphasised.

Building a robust bridge?

Clinical research is like building robust bridges. It is a question of expertise, experience & trust We can support your clinical development at any stage. From design of Phase I to final report of Phase IV studies Larix is a full-service clinical CRO providing high quality services to the biotech, pharmaceutical and medtech industries

To Earn Trust-Make Difference A+ Science is a complete clinical service CRO with focus on customer satisfaction.

We have experience of services within clinical trials since 1997.

Contact us to learn more about our services.

A+ Science AB, www.a-plusscience.com

We offer insourcing of professionals and full service solutions with offices in Denmark, Sweden, Norway and Finland.

Contact us today for a meeting to discuss your needs

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

Communication - Proactivity - Quality on Time

Luntmakargatan 22, SE-111 37 Stockholm

PROFILE

LINK Medical Research strengthens its focus on Real World Evidence (RWE) LINK Medical Research has recently established the LINK Medical RWE department, which will see a further strengthening of the CRO’s focus on Real World Evidence (RWE). LINK Medical now offers a full palette of services for the pharmaceutical and medical device industry, but it stays true to its core values, which has been at the heart of the company since the beginning.

LINK Medical Research is a Scandinavian

pharmaceutical groups have increasingly

which may require large subsidies from

full-service Contract Research

tested their drugs outside clinical trials

the state. However, the benefits of that

Organisation (CRO), offering project

and secured large amounts of patient

drug may be even bigger and could save

management and product development

data, which can help provide a bigger and

costs for society in the longer term.

services for the pharmaceutical and

fuller picture of how a drug works in real

medical device industry. At the beginning

life.

of 2018, its new LINK Medical RWE department opened.

“A drug for Parkinson’s disease, for example, is very expensive and will

LINK Medical RWE collects these data

require large subsidies. But the drug may

from various registers and provides

also help the patient to be more self-

“RWE is growing fast and is becoming

analysis for the pharmaceutical

reliant so that he or she can stay at home

more and more popular, especially among

companies.

for a longer time instead of going to a

“With a RWE analysis we can see how a

nursing home. The RWE analysis can help

drug works in the real world, for example

determine those benefits,” said Marianne

in populations not studied in the clinical

Holst, General Manager LINK Medical

The new RWE department, headed by Dr.

trial or by comparing it to a competing

Denmark.

Yngve Mikkelsen, will create value for

drug. An RWE analysis can also help

customers through secondary analysis

determine what the economic benefits are

Medical Device

of observational data from health care.

to society,” said Jan Hellqvist.

big pharmaceutical groups,” said Jan Hellqvist, General Manager LINK Medical Sweden.

Before a drug is being approved by health authorities, it has been through years of clinical trials. However, in recent years

An analysis on health benefits to society can for example be a very expensive drug,

Further to offering a full palette of traditional CRO services, LINK Medical also has a separate Medical Device department, with skilled and experienced

LINK Medical’s customers are mostly small and medium sized pharmaceutical and medical device companies and customer satisfaction is another key value for the group.

46

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 2018

PROFILE

staff to take care of areas such as

CRO in Europe, not the largest.

regulatory requirements, documentation and risk management.

“Our values are our hobby horse. The focus is not on creating profit but on

“The regulatory process for medical

reputation, credibility, quality and

devices is becoming more and more

putting people first. Then everything else

similar to the rigorous regulatory process

will follow.”

for pharma and the requirements needed to get an authority approval are getting higher and higher too,” said Jan Hellqvist.

“Personal values too, such as keeping our word and delivering on time. It might sound a bit old-fashioned, but I believe

Jan Hellqvist, General

Marianne Holst, General

Manager LINK Medical

Manager LINK Medical

Sweden

Denmark

Regulatory requirements range from the

it’s our strength and probably why we

different phases in product development,

have such a low turnover of employees of

such as evaluation of CE classification,

less than 5%. I guess we’re very good in

documentation and clinical evaluation

recruiting the right people and holding on

report and interaction with Notified Body.

to them,” said Marianne Holst.

“We also offer Medical Writing, both

LINK Medical’s customers are mostly

business and has seen the company grow

within pharmaceuticals and medical

small and medium sized pharmaceutical

steadily over the years.

devices, and we have skilled people in

and medical device companies and

Denmark, Norway and Sweden dedicated

customer satisfaction is another key value

to this. In addition, we have hired some

for the group.

very skilled people in recent years to help our clients with for example quality systems and quality assurance,” said Marianne Holst.

LINK Medical’s values coupled with its extensive palette of services being offered to customers, provides for a healthy

“A lot of CRO’s have crumbled over the years but LINK Medical has managed to grow, even during the financial

“Our customer retention rate is above

crisis. It means a lot for both employees

70%, which is very unique in this industry.

and customers that we have a stable

We work with lots of small and medium-

economy,” said Marianne Holst.

sized companies and because of our

People and Values

level of experience, we’re in a position to

Founded 22 years ago in Norway by Dr. Ola Gudmundsen, LINK Medical is now present in Norway, Sweden, Denmark and Germany and employs 120 people. Ola

provide strategic advice to our customers.

A CRO with predominantly junior staff cannot give the same level of advice” said Jan Hellqvist.

Gudmundsen’s goal was to create the best

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 2018

47

CMO’s

Contract Manufacturing Organisations

"The development is going faster and faster and you have to be part of that otherwise you’ll be left behind,” Flemming Jensen, managing director at HB Medical

CMO’S

DISRUPTION HITS THE CMO MARKET – HB MEDICAL HAS THE ANSWER TO FUTURE GROWTH Danish Contract Manufacturing Organisations (CMO’s) are under pressure. Prices are low and competition tough, not least from Eastern European and Asian players. But HB Medical has found the answer – investments in full-automatic production.

By Karin Jensen

D

isruption is a buzz word

to pay slightly more for a

The investments in the

Before making the

in many industries

Danish CMO, which are known

automated production is

investments in

and the CMO industry is no

for their quality, according to

a one-off investment and

automatisation, HB Medical

exception. Automatisation and

Flemming Jensen.

the management of HB

examined the entire

Medical sees a fast return on

production line to find

investments.

out where it could replace

robotics will see the industry change in coming years and the Danish CMO, HB Medical, has prepared for the future with investments in a new fully automated production.

“This is our response to the high Danish wages. As a CMO, we’re not allowed to charge high prices, so we’re up against rather

“To be able to have “Made in Denmark” printed on their products is regarded as positive, and this speaks for slightly higher prices,” he said.

Danish CMO landscape will change The Danish CMO industry

Many international CMO’s in the US, Europe and

is dominated by a few, large

significantly higher than

players but the competitive

those in Eastern Europe and

landscape is likely to change

Asia, which makes it difficult

in years to come because many

to compete on equal terms.

CMO’s have not seen the way

“Automatisation is an

the world is moving, and the

international trend and it’s

way technology is changing

happening everywhere. The

the game.

development is going faster

“The investments we’ve made

competition. Our answer

in automated production is

is automatisation,” said

our chance. We’re nearly there

Flemming Jensen, managing

with certifications of these

“Disruption is just at the

director at HB Medical.

new standards,” said Lars

beginning. It’s a process that

Ibsen, head of production at

will continue in coming years.

HB Medical.

The industry will change

competition especially comes

example filling bottles.

However, Danish wages are

tough international price

International price

human hands with robots, for

from Eastern European and

“We expect to land new

Asian players, which can offer

customers and then,

significantly lower prices than

hopefully, the result will

their Danish peers. However,

be strong growth in the

some customers are prepared

business,” he added.

Asia are also investing in automatisation and robotics these days.

and faster and you have to be part of that otherwise you’ll be left behind,” said Lars Ibsen.

because automatisation is

“I expect several Danish

a general feature, which all

CMO’s will be left behind

industries will experience. Old

because they haven’t made

fashioned manual production

the right investments,” said

is just not sustainable,” said

Flemming Jensen.

Flemming Jensen.

“Disruption is just at the beginning. It’s a process that will continue in coming years.

The industry will change because automatisation is a general feature, which all industries will experience.”

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 2018

49

BUSINESS SERVICE PROVIDERS

EU GENERAL DATA PROTECTION RULES WILL TAKE DIRECT EFFECT THE 25TH OF MAY 2018 Edited by Arne Jensen

T

he EU General Data Protection Rules (GDPR) entered into force in May 2016 and will take direct effect in all member states from 25 May 2018. The GDPR will substitute the rules of Directive 95/46/ EC from 1995 and the Danish Act on Processing of Personal Data from 2011 and will significantly affect data controllers and data processors in the life sciences sector.

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

50

organisations, laboratories, sponsors and statisticians etc.

describe personal data flows through the entire life cycle

Implementation of the GDPR requires planning and reflection and 25 May 2018, is just around the corner.

- clarify whether you are data controller and/or data processor

How to ensure compliance with GDPR The best way to get started is to conduct a high level risk analysis to identify the categories of personal data processed by the company itself or via subcontractors and the areas where a DPIA is needed. A DPIA must cover all relevant business processes and should also include a gap analysis to identify noncompliance with the GPDR rules.

Analyse your business processes and IT infrastructure in order to: - create a general view of and

- integrate the requirements of the GDPR into relevant business processes and IT infrastructure and when purchasing new IT systems (”privacy by design and by default”) - establish necessary structures, allocate roles and prioritise the tasks.

Focus on the following key issues: - management and employees buy-in and training – create a culture of risk awareness and respect for personal data through entire life cycle - policy framework - create and implement

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 2018

- IT systems and information technology – ensure robust security such as updated antivirus, antispam and firewalls and regular security code peer review - physical environment – create effective entry control systems, video surveillance and clean desk policies - incident detection and response – conduct regular data application inventories and restore availability and access in a timely manner.

The GDPR is perhaps the most important EU legislation in many decades for the industry.

However, if handled right implementation of the GDPR could be an opportunity to streamline and improve business processes and a strategic tool and competitive element.

BREXIT

CONSEQUENCES OF BREXIT! Naturally there will be consequences for the United Kingdom, but certainly also for the remaining Member States who will lose a significant member of the Community.

Edited by Arne Jensen

F

ollowing BREXIT, life

to the EU/EEA will be met

science companies are

with a number of important

now experiencing the first

regulatory requirements. This

consequences. The impact

applies among other things to

has varying degrees, both for

applications for, or the transfer

pharmaceutical manufacturers

of a marketing authorisation for

and manufacturers of medical

an EU/EEA country, as well as to

equipment established in the

documentation that the products

United Kingdom, as well as those

live up to EU standards and quality

companies in the industry that

requirements.

conduct research and development as well as maintain production in the United Kingdom.

In this way, BREXIT has led to a flurry of questions to the European Medicines Agency (EMA), and in

A relatively simple example

its response, the EMA published an

consists of the many contracts (e.g.

opinion concerning the immediate

concerning case files, licensing or

consequences of BREXIT for

distribution), which parties have

holders of centrally authorised

concluded, where it is stated that

medicinal products.

obligations of the contract/rights apply to the territory designated as the "EU" or its equivalent.

Marketing authorisation after BREXIT

Companies should as soon as

Marketing authorisations

possible in each case deal with

for human and veterinary

business-critical contracts so that

medicinal products issued by

there is clarity. Perhaps it would

the EU Commission on the basis

also not be a bad idea to consider

of an EMA approval are valid

whether it would be advantageous

throughout the EU. The marketing

to move production/research and

authorisation is as a starting point

development activities from, or

valid for five years but may be

even to the United Kingdom.

extended.

The immediate consequence

The holder of the marketing

of BREXIT is that the United

authorisation (MAH) for a

Kingdom from late March, 2019,

medicinal product for both human

will no longer be subject to EU

and veterinary use, must be

legislation, and the country will

established in an EU/EEA country.

thereby acquire third country

BREXIT therefore means that

status, such as e.g. Switzerland

holders of centrally authorised

or the USA. The effect will be,

medicinal products, where the

that pharmaceutical substances

MAH has been established in the

and finished medicinal products

United Kingdom, must transfer

produced in Great Britain will

current marketing authorisations

be treated like other medicinal

to a stakeholder established in

products that are imported

an EU/EEA country or appoint a

into the EU/EEA from a 'third

representative in the Community.

country'. After BREXIT,

This also applies to medicinal

pharmaceutical manufacturers

products authorised for the

in the United Kingdom who

treatment of rare diseases (orphan

want to sell medicinal products

drugs).

Documentation of the quality of medicinal products As a starting point, production of medicinal products in the EU/EEA follows the GMP standard, "good manufacturing practice". Medicinal products and active substances produced in the United Kingdom and intended for sale in an EU/ EEA country must therefore in the future be accompanied by a valid GMP certificate that documents that the product lives up to EU quality requirements.

For finished medicinal products, an importer must be appointed in the EU/EEA country in which the manufacturer wishes to sell and distribute its medicinal products. The importer must comply with existing rules for the import of medicinal products and semi-finished products into the Community, in order for the importer to be able to release the products for sale. This imposes requirements to the importer’s quality assurance and control, as well as his organisation, staff, facility and equipment, etc.

Qualified Person for Pharmacovigilance The pharmaceutical company’s "Qualified Person for Pharmacovigilance" (QPPV) must be a resident in the EU/EEA. As a consequence of BREXIT, the QPPVs who are connected to MAHs situated in the United Kingdom, will be forced to move to an EU/ EEA country to be able to continue their work tasks. Alternatively, a MAH may appoint a new QPPV who is already a resident within the EU/EEA. The Danish Medicines Agency expects that a QPPV is routinely present in the company, is familiar with all of its premises, and is present for a minimum of 10 hours per week.

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 2018

51

GENERIC DRUGS AND BIOSIMILARS

GENERIC DRUGS AND BIOSIMILARS When medicinal products come off patent, generic products stand ready to take major market shares. While original medicines provide innovation, generic drugs and biosimilars first and foremost provide increased access and lower costs.

Edited by Arne Jensen -The patent protection of

Hence, as a rule of thumb

there are minor differences

to detect a change in the

innovative original medicines

generic medicines enter

from one batch to another,

quality attributes, Peter

provide exclusivity to the

the market some 10 years

and manufacturers must be

Jørgensen explains.

market. This is obviously

after the original medicinal

able to document that these

of great importance to the

product was granted market

differences do no impact the

society, and is duly reflected

authorization. Generic and

safety and efficacy of the

in revenues. However, on

biosimilar medicinal products

product.

the other side of the ‘patent

provided to the Danish

fence’, generic medicines

market have all been granted

and biosimilars have equally

marketing authorization based

demonstrated value to society

on the regulations outlined

by providing increased

centrally by the European

access as well as lower costs,

Medicines Agency or locally

says Peter Jørgensen, CEO

by the Danish Medical Agency.

at The Danish Generic and

Peter Jørgensen points to

Biosimilar Medicines Industry

the requirements being

Association (IGL).

put in place and described

-As society, innovation is of the utmost importance, and clearly, that’s what the patent protection is there for. But I dare say, once the patent is no longer in effect, sustainable costs of medicines are of equal importance. It is the name of the game.

52

thoroughly by the authorities.

The generic small molecules

This may entail evaluating the product at multiple stages, and implies that additional testing and quality control

-For biosimilars a comparability exercise is required, implying that the manufacturer of biosimilars can ascertain that the original and biosimilar drug product is comparable in terms of quality, safety, and efficacy.

To reach this goal, the product should be evaluated at the

may be required.

-Still, the biosimilars have managed to overcome the initial skepticism upon their entry, and are now duly acknowledged by physicians, national advisory boards, payers, and politicians, Peter Jørgensen ends.

process step most appropriate

must provide data to support that there is no clinically meaningful difference to the original product. But with the introduction of biosimilars the definition of similarity

Facts •

Patent protection is 20 years, and in general for medicinal products this implies exclusivity around 10 years post marketing authorization.

•

The turnover of medicines in Denmark is app. DKK 20 billion / year

•

The proportion of the yearly turnover of medicines in DK pertinent to generic medicinal products amounts to more than 50% at the hospitals and close to 70% at the pharmacies – in volume. This reflects app. 20% in value of the total turnover.

had to be revisited. Even for original biological medicines

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 2018

PATENT TERM EXTENSION

PATENT TERM EXTENSION OF A MAXIMUM OF 5 YEARS Edited by Arne Jensen

A

patent usually expires

for the often lengthy approval

the protection provided by a

lost patent time, an SPC only

after 20 years. In the

procedure. The patent term

patent. Even though an SPC

provides protection for the

pharmaceutical industry the

extension can be extended

is granted to compensate for

approved medicine.

development of new products

by a further 6 months, if the

is often very lengthy, and

marketed medicine has gone

the consequence is therefore

through an approved pediatric

that the patent can only be

investigation plan.

exploited in a fraction of the 20 years.

The SPC is granted to the

Supplementary Protection

European patent on equal

Certificate (SPC), is a patent term extension of a maximum of 5 years, which

patentee of a national or conditions in all of the EU member states.

can be granted to a marketed

The protection conferred by

medicine as a compensation

an SPC is very different to

is the go to international law firm for over 50% of the world’s largest life sciences companies.

“There are certain firms that, worldwide, are established as leaders in life sciences, and of course Bird & Bird is one.”

- Chambers & Partners

twobirds.com Aarhus & Abu Dhabi & Beijing & Bratislava & Brussels & Budapest & Copenhagen & Dubai & Düsseldorf & Frankfurt & The Hague & Hamburg & Helsinki & Hong Kong & London & Luxembourg & Lyon & Madrid & Milan & Munich & Paris & Prague & Rome & Shanghai & Singapore & Stockholm & Sydney & Warsaw

SPC Requirements: •

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

•

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

•

The product has not already been the subject of an SPC.

•

The valid marketing authorization must be the first authorization to place the product on the market as a medicine.

DISTRIBUTION

WRONG TRANSPORT CHOICES CAN COST LOSS IN PRECIOUS RESEARCH FUNDING Link PHARMA offers all research institutions and medical companies a safe shipping of research results, samples, etc. There are different shipment methods to choose from and quality guidance and service ensures the optimal solution.

Edited by Arne Nielsen

B

irgitte Bosse Knudsen

can talk to them during the

has more than 20 years

process, explains Birgitte

of experience from shipments

Bosse Knudsen who today is

for Global Research in Novo

the Pharmaceutical Transport

Nordisk, and with what

Manager at Link Logistics.

requirements and challenges there are for these types of shipments. Birgitte and Link Logistics had worked together when she was employed by Novo Nordisk and she saw a need for help with the transport of sensitive research material. Birgitte contacted Link PHARMA, which is a department in Link Logistics A/S. - It is important for us that the customer has a good feeling and that they know that their package is being shipped safely. The customer must be confident that the package will be supplied with

When Researchers or Laboratory Technicians have or gets a request of shipping, of important trials that needs to be in fx the United States as soon as possible, it is of highest importance to seek

Jonas Bay Kaas, Pharma Manager

Transport Manager

competent advice, because the wrong transport choices can

Birgitte Bosse Knudsen, Pharmaceutical

become expensive.

Birgitte helps with all the

- We anticipate using our

necessary documents, and

category divisions in C, B,

- The first step in a new

Pharma Manager Jonas Bay

A and A+, where C is the

agreement is to make a

Kaas is a specialist in the

cheapest and A+ the most

thorough agreement of

transportation itself.

expensive. We know that

expectations between the customer and us. What is the correct shipping type?

Does the customer want courier, airfreight, car, handheld transport? Can the

- We have answered the expectations from our customers by developing a

startup companies face many challenges regarding their research materials reaching

simple business strategy to

the final customer in good

meet their requirements – we

condition and in due time.

give our clients a small palette

Therefore, Link PHARMA has

fx dry ice or kept at the right

customer withstand losing

temperature if, for example,

of easy and understandable

a special offer for all startup

the shipment? etc. Next, all

held in customs - which

transport solutions based on

companies, he ends.

papers, including customs

the client’s needs, which we

sometimes happens. We know

papers, are prepared, says

call the ABC model, says Jonas

the agents over there and

Birgitte.

and carries on,

A+

Premium

The Safe Choice

B

Standard

C

Economy

Hand-carried shipment

GdP compliance

Express airfreight service

Express courier service

Maximum surveillance and security

GPS tracking and live monitoring temperature measurering

Temperature regulated shipment to consignee’s location

Shipment without temperature regulation

Temperature datalogger

Individual customs

Temperature regulated shipment to consignee’s location

brokerage service

Documented, unbroken cold chain GPS tracking and live monitoring temperature measurering

54

A

Worldwide proactive follow up and track & trace

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 2018

Economically favorable Worldwide proactive follow up and track & trace

PROFILE

DHI assists medtechs to unravel regulatory ambiguities of REACH and MDR With its toxicological expertise and regulatory know-how, DHI is the perfect partner for the medtech industry when embarking on the lengthy process of developing effective and safe medical devices. Not only is choosing the right material crucial, chemical substances used in the device must be evaluated too.

Developing effective and safe medical devices is a lengthy process and manufacturers often find it difficult to find their way in the complex legislation.

New EU regulation such as the Medical Device Directive (MDR) and the In Vitro Device Directive (IVDR) increases the requirements for documentation of medical devices, while the EU chemicals regulation may impact the substances to be used in the devices as classification and REACHlegislation have consequences on medical devices.

“Based on our regulatory know-how, we can help manufacturers of medical devices to evaluate their products. We can also help with chemical registrations and application for authorities as set out in the EU chemicals regulation, REACH, which provides the tools to limit the use of substances with very high concerns, the so-called SVHC’s,” said Brian Svend Nielsen, Senior Toxiclologist, ERT at DHI. However, the interfaces between the different types of legislation and often difficult to detect and sometimes the legislation in one sector may have impact on the legislation in another sector.

“A medical device may be manufactured

in EU and contain a problematic substance that is subject to authorisation in REACH, but only if the substance is on the authorisation list due to human health concern, whereas substances subject to authorisation for environmental reasons would require a specific use permission under REACH,” said Nielsen.

“A lot of people are not aware of this and that’s a problem.”

“We help our customers unravel legal and regulatory issues, for example whether a substance used in the medical device is covered by the REACH obligations or not.

There are many overlaps and ambiguities,” said Brian Svend Nielsen.

DHI helps manufacturers of medical devices to assess the toxicity of materials and chemical substances, it carries out biocompatibility evaluations and documentation, performs analyses of possible migration of chemical substances when using the medical device, evaluates the need for further tests, and carries out validation of risk assessments.

“There’s a lot of focus on the new regulations and standards and you need to be on top of this to get a CE marking of your device,” said Brian Svend Nielsen.

REACH (Registration, Evaluation, Authorisation and Restriction of Chemical Substances) aims to protect human health and the environment through better and earlier identification of the intrinsic properties of chemical substances.

Manufacturers and importers of chemicals are required to gather information on the properties of their chemical substances and to register data at the European Chemicals Agency in Helsinki.

The Regulation also calls for the progressive substitution of the most dangerous chemicals (SVHC) with suitable alternatives.

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 2018

55

LABORATORY & MEDICAL EQUIPMENT

LABORATORY & MEDICAL EQUIPMENT

News From the Industry Edited by Arne Nielsen

Setting a new standard for reversed-phase separations of monoclonal antibodies and antibody drug conjugates In addition to getting performance-driven columns, users of BioResolve brand columns will receive application-focused standards, templated methods, and an enhanced level of applications support to help ensure that they can consistently and reliably perform state-of-the-art bioseparations.

“A segment of the scientist community regards mAb and ADC separations as overly complex. The causes of their

Blood culture-free detection of sepsis

frustrations are many and they include poor data quality, degradation of the target mAbs, poor recovery, excessive

T2Candida® is the first sepsis pathogen diagnostic panel

carryover and erratic results due to column-to-column

requiring no blood culture, delivering faster, easier and

irreproducibility. To address these issues, we tasked our

accurate results in an average of 4.3 hours. Run on the T2Dx®

research scientists to engineer a column that would raise

Instrument utilizing T2 Magnetic Resonance (T2MR®)

the bar for separation performance and take the hassle out

technology, the T2Candida Panel rapidly identifies the five

of the measurement process,” said Dr. Erin Chambers, Vice

clinically relevant species of Candida direct from whole

President, Chemistry, Waters Corporation.

blood so appropriate therapy can be initiated. The T2Candida Panel detects the five clinically relevant species of Candida: Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata.

”Our ultimate goal is to enable biopharmaceutical scientists to generate consistent results that meet international regulatory requirements to confirm product efficacy and safety.”

In bulletpoints:

• • • •

Species-specific results direct from whole blood with no blood culture in an average of 4.3 hours

With the introduction of BioResolve RP mAb Polyphenyl

Limits of detection as low as 1 CFU/mL

Columns, Waters continues its commitment to the

Accurate results even in the presence of antimicrobials

biopharmaceutical industry by meeting the needs of

Fully automated with limited hands-on time

analytical scientists and lab managers across the discovery, development and manufacturing pipeline.

www.t2biosystems.com For more information: www.waters.com

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info@drifton.dk Telefon 3679 0000

Tilbuddet er gældende frem til 31.05.2018

Se udvalget på webshoppen www.drifton.dk

LABORATORY & MEDICAL EQUIPMENT

Hospitals can detect fevers earlier thanks to a new wearable device Blue Spark Technologies invented, patented and manufactured TempTraq®, the only wearable, Bluetooth®

Laboratory group Laboratoires Réunis capitalizes genetic information management software suite for complex laboratory reports

continuous temperature monitor, and has received promising

With more than 50 blood sampling locations, a centralized

clinical study results for its medical device. A University

laboratory in Junglinster, Luxembourg, as well as laboratory

Hospitals Seidman Cancer Center (UH) study shows the

sites in Trier, Germany, and Fléron, Belgium, Laboratoires

wearable can detect a rise in body temperature up to 180

Réunis is one of the largest private laboratories in

minutes earlier, in a majority of patient cases, than the

Luxembourg and considered to be a national pioneer for

current standard-of-care (SOC) method, allowing medical

molecular diagnostics and personalized medicine. Apart

professionals the chance to intervene more quickly.

from a broad spectrum of analyses in areas such as clinical

Unlike other devices and methods that provide physicians with only one point of data and offer no continuous monitoring or alerts, this patented device is the ideal, non-invasive, solution for doctors and nurses who need a continuous, smarter way to track, log and respond to fevers quickly.

chemistry or immunology, the Laboratoires Réunis group also offers a number of genetic analyses, a field in which it wants to expand further in future. In order to meet the challenges of efficiently producing high-quality clinical reports during these complex analyses, the lab’s scientists now use bio. logis GIM’s IT solution, specifically designed for this area of application.

To study this continuous, real-time method of body temperature measurement, UH tested the feasibility of monitoring body temperature for patients specifically undergoing stem cell transplant or intensive chemotherapy for leukemia. The patches were applied every 24 hours on 10 neutropenic patients throughout their hospital stays.

Body temperature was recorded remotely with TempTraq in 10-minute intervals totaling 14,342 temperature measurements, versus the current SOC of one measurement every four hours.

The starting point is the introduction of the software suite’s “Diagnostic Report Module (DRM)” to largely automate the creation of diagnostic reports on the basis of genetic analysis results. Using a centralized content management system for medical content ensures that the reports are also standardized and always up to date. DRM makes the reporting process highly efficient and improves its scalability.

In addition, there are plans to successively introduce more Genetic Information Management Suite modules to further optimize existing processes. Both parties are also working

The TempTraq system is scalable and can support a single

on establishing individual functionalities of the Diagnostic

hospital or a multi-hospital/physician group healthcare

Report Module so that other diagnostic fields also benefit

system.

from enhanced efficiency.

For more information: www.temptraq.com

For more information: www.biologis.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 2018

10

Press release - February 2018

INNOVATION PRIZE An event by Universal Biotech

8

CALL FOR PROJECTS

INNOVATION PRIZE 2018

Universal Biotech, our consulting company specialized in innovation management for the healthcare sector, has launched the 10th edition of its Universal Biotech Innovation Prize.

Each year, the innovation prize awards the most innovative projects in the healthcare field from either young startups (<8 years) or academic research groups.

Since 2009, this competition has benefited or benefits from the support and collaboration of many pharmaceutical companies such as GSK, L’Oréal, Pierre Fabre and Servier as well as internationally renowned academic institutions such as ANR, European Commission, Pasteur Institute and the Karolinska Institute.

In 2017, for its 9th edition, more than 260 candidates from 31 different countries participated in the competition. Three teams were rewarded: NLS Pharma (Swiss) – Biotech Prize BaseCamp Vascular (France) – Medtech Prize Sinnovial (France) – Digitech Prize WHY SHOULD I PARTICIPATE IN THE 2018 INNOVATION PRIZE? By submitting your project to Innovation Prize 2018, you will increase its exposure within the Life Science market and help introduce it to potential partners and investors. Your project will also be assessed by leading experts who will provide you with expert advice and feedback to help you optimize your business plan.

Each laureate will also win up to €30 000 in the form of a cash prize and consulting services from Universal Biotech.

HOW CAN I PARTICIPATE? Three prizes will be awarded for this 10th edition: the Biotech Prize, the Medtech Prize and the Digitech Prize (health NICTs including e/m-health, platforms and connected objects).

The project leader can apply online by filling out an application on our call for projects platform, Open Innovation Access. The platform will remain open until April 30th, 2018.

Our jury panel, made up of international experts from pharmaceutical companies and academic institutions, will assess your project based on the following criteria: Scientific quality of the innovation Team expertise and diversity Intellectual Property strategy Project feasibility Chances of success on the market The Innovation Prize 2018 awards ceremony will take place next October in Paris.

Innovation Prize Team prix-innovation@universal-biotech.com

CONTACT: Olivia MIOSSEC - +33(0)1 41 12 27 87- olivia.miossec@universalmedica.com FOR MORE INFORMATION, VISIT THE WEBSITE: www.universal-biotech-prize.com

LABORATORY & MEDICAL EQUIPMENT

Innovative biomedical technologies from the Graphene Flagship Graphene and related materials are paving the way for novel

The Graphene Flagship showcased four demonstrators of

biomedical diagnoses and treatments thanks to their unique

innovative biomedical technologies at the MEDICA 2017

properties such as high surface area, electron mobility and

exhibition in Germany. Funded by the European Union

surface functionalization. For instance, the surface area of

Graphene Flagship partner Catalan Institute of Nanoscience

graphene makes an excellent platform for drug delivery and

and Nanotechnology displayed two of these demonstrators:

the conductivity allows for effective biosensors. The ability

a graphene sensor able to detect the electrical activity of the

of graphene to be made into scaffolds whilst maintaining the

brain providing early detection for neurological events such

inherent conductivity can be used in tissue engineering. New

as epileptic seizures; and a retinal implant which can serve as

research has shown that graphene can also be incorporated

optical prostheses for people who have lost their sight. A fully

with a polymer to make electromechanical sensors and

functional robotic hand controlled by graphene sensors was

deep brain implants. Professor Andrea C. Ferrari, Science

demoed by Flagship Partner Istituto Italiano di Tecnologia

and Technology Officer of the Graphene Flagship and

(IIT); IIT is developing this research project with INAIL, the

Chair of its Management Panel said â&#x20AC;&#x153;Health, Environment

Italian National Institute for Insurance against Accidents at

and Bio-Medical applications are part of the roadmap for

Work. The Graphene Flagship Partner Guger Technologies

graphene and related materials. We are excited to present

(g.tec), headquartered in Austria, presented a brain computer

innovative devices to medical professionals and companies.

interface containing graphene electrodes capable of

This is yet another step towards the full development of

measuring brain activity.

novel biomedical solutions enabled by graphene and related materials.â&#x20AC;?

For more information: www.graphene-flagship.eu

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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 2018

LABORATORY & MEDICAL EQUIPMENT

FocalSpec’s UULA answers the demand for automated quality control in fast-growing medical device markets FocalSpec, the Finnish expert in highprecision quality control devices, launched their first 3D imaging and metrology system UULA. UULA can be used both in at-line quality control and in laboratories.

It works especially well in measuring 3D topography and dimensions in medical device manufacturing as well as studying seal integrity of medical packages.

UULA can be used to inspect a variety of medical devices and components where the parts must be designed on a micron scale to ensure the devices’ operational reliability.

Chips used in microfluidic analysis can also be inspected, as well as biosensors.

The former can be used in detecting

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

the outbreak of cancer and the latter in measuring blood sugar or drug concentration in the human body.

The research made in the field of medical devices, as well as product development and quality control processes, can be made more efficient and safe through automatization. As an example, the seal quality of sterile packages in operating rooms has traditionally been inspected manually. This has also had the effect of destroying the inspected package. With UULA, the inspection is quick and accurate, and the product doesn’t suffer in the process, a result that saves resources as well as reduces waste.

For more information: www.focalspec.com

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

8

COMPANY INDEX

64 | Academic Institutions and Support Structure Organisations 66 | Business Service Providers 68 | Contract Research Organisations 69 | Laboratory, Medical & Pharmaceutical Equipment 71 | Contract Manufacturing Organisations 71 | Other

COMPANY INDEX

Academic Institutions and Support Structure Organisations The Department provides the research framework for the engineering study programmes in Medical Biotechnology, Biotechnology, Chemical Engineering and Environmental Engineering as well as the Chemical and Biological Sciences Programs.

In both teaching and research the department combines theory and practice and emphasize collaboration with companies and public sector organizations both nationally and internationally. The department offers both Bachelor (Bsc) and Master (Msc) programs as well as regular PhD courses.

Department of Chemistry and Bioscience Aalborg University Fredrik Bajers Vej 7H DK-9220 Aalborg T: +45 9940 3605 E: info@bio.aau.dk W: www.en.bio.aau.dk

Lif Uddannelse, Medicademy and DLI Udstilling, are now Atrium – 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

With more than 25 years experience in meeting the diverse needs of the biotech and pharma industry, Bioneer is ready and able to deliver competitive and on-time solutions to companies, large as well as small. Explore our expertise in your area of interest on our website for an example within drug development, biomarkers, protein manufacturing, immune targeting, active ingredients and microorganisms, licensing opportunities etc.

Bioneer A/S Kogle Allé 2 DK-2970 Hørsholm Tel. +45 4516 0444 E-mail: bioneer@bioneer.dk Web: www.bioneer.dk

Business Ballerup Municipality of Ballerup Hold-an Vej 7 DK-2750 Ballerup T: +45 4477 2000 E: businessballerup@balk.dk W: www.ballerup.dk

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

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The Municipality of Ballerup, a suburb to Copenhagen has a population of 48,231.

Ballerup is part of a regional workforce. Every day, almost 35,000 commutes to Ballerup to work.

Jobs: 45,000 – 34,500 private sector jobs and 10,500 public sector jobs.

Ballerup is the municipality in Denmark with the most foreign corporations with a 25,5% share.

The municipality has the highest rate of IT employees in Denmark with 22% of the total amount of jobs.

Also it has the highest hourly rate at DKK 294 (Source: The Municipality of Ballerup).

The Life Science cluster in Ballerup employs 4,900 people in more than 30 corporations, making it the second biggest life science cluster in the country after Gladsaxe (Source: Medicon Valley Alliance).

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’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.

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 2018

COMPANY INDEX

Dansk Laborant-Forening er en tværgående landsforening under HK, som er et af Danmarks største fagforbund med omkring 300.000 medlemmer.

Det betyder, at alle, der er medlem af Dansk Laborant-Forening, samtidig er fuldgyldigt medlem af HK og dermed nyder godt af alle medlemsrettighederne her.

Som organiserede i HK kan vi derfor bruge HK's konsulenter i f.eks. arbejdsmiljø-, uddannelses- og juridiske spørgsmål.

DL-F / HK Weidekampsgade 8 Postboks 470 0900 Copenhagen C Tel. +45 3330 4470 E-mail: dlf@hk.dk Web: www.hk.dk

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

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

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

Faculty of Health and Medical Sciences University of Copenhagen Blegdamsvej 3b 2200 Copenhagen N Tel. +45 3532 7900 E-mail: email@sund.ku.dk Web: www.healthsciences.ku.dk 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.

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 2018

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COMPANY INDEX

Business Service Providers When choosing your regulatory partner is a matter of trust.

A-consult group offers the whole palette of Regulatory Affairs, Quality and Vigilance. We know that very project and every client is different. Our objective is to ensure that you get the best professionals every time.

A-consult a/s Gladsaxevej 382 DK-2860 Søborg T: +45 38330080 E: a-consult@a-consult.dk W: www.a-consult.com

A-consult group offers solutions adapted to your timelines and your budget in compliance with local regulations.

We provide highly qualified engineering consultancy within all disciplines relating to project management, GMP compliance, technical advice, production efficiency and process verification in the pharmaceutical-, biotechnological-, medical device- and food industry.

Andreasen & Elmgaard A/S possesses expert skills acquired through many years of extensive industry experience and can contribute with valuable consultancy throughout an entire project - from the initial design phase to the final launch of the product, and continuous process optimization.

Key-areas include, but are not limited to the following, project management, technical know-how, process verification, quality assurance (GMP), equipment qualification and process validation.

Andreasen & Elmgaard A/S Generatorvej 8C, 2. Th. DK-2860 Søborg T: +45 3117 8232 E: sales@aoge.as W: www.aoge.as

Best Talent is specialized in Executive Search and Selection within Engineering, Pharma and Life Science.

Best Talent has quickly grown to become the favorite collaborative partner as a result of our experience, background and network.

We solve projects on both a tactical and strategic level. We “speak the language”, know the market and attract highly qualified candidates. We possess the largest and most desired talent database in the field with over 10,000 life science candidates.

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

Bird & Bird is an international law firm, with a rare and invaluable grasp of strategic commercial issues.

With over 240 experts globally and a wealth of hands-on experience from working in life sciences and healthcare companies and regulatory bodies, clients choose us as their strategic partner to guide them through some of their most complex legal challenges.

Bird & Bird Sundkrogsgade 21 DK-2100 København Ø Tel: 72 24 12 12 E-mail: Denmark@twobirds.com Web: www.twobirds.com

Bird & Bird is the go to international law firm for over 50% of the world’s largest life sciences companies.

THE MOST ADVANCED CLEANROOM LAUNDRY IN SCANDINAVIA • Traceability, validated processes and documentation based on innovative cleanroom technology.

• Specializes in on-site training of operators in correct use of cleanroom clothes and cleaning articles.

De Forenede Dampvaskerier - DFD Cleanroom V. Henriksens Vej 6 DK-4930 Maribo Tel.+45 4422 5560 / +46 406 566 500 E-mail: crmar@dfd.dk Web: www.dfd.dk

• Preferred partner of unique cleanroom solutions in accordance to ISO and GMP compliance.

For more information: www.dfd.dk

Advanced manufacturing facilities and processes are necessary to satisfy the exacting requirements of both consumers and the authorities. When you need inspections, testing and certification, we can help you to meet the requirements of national and international standards relating to quality, the environment, workplace environment management systems and audits. We can also offer you consultancy and services that enable you to improve your production processes and facilities.

FORCE Technology Park Allé 345 DK-2605 Brøndbyvester T: +45 43 25 00 00 E: info@forcetechnology.dk W: www.forcetechnology.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 2018

COMPANY INDEX

At DHI, we possess an extensive knowledge base related to chemicals regulations worldwide, with respect to product safety. Moreover, we have an established network of contacts with national authorities on worldwide markets. We’re therefore well placed to support you efficiently in bringing your products to the market. We can effectively help you to fulfil regulation and instruction requirements as well as standards and local labelling. For pharmaceutical products, we can help you develop strategies as well as monitor and interpret experimental studies.

DHI Hørsholm - Head Office Agern Allé 5 2970 Hørsholm Tel. +45 4516 9200 E-mail: dhi@dhigroup.com Web: http://www.dhigroup.com/ Elite Miljø performs classified cleanroom cleaning in the pharmaceutical industry and hospital sector.

We work with both high and low classified cleanrooms. We offer a complete cleaning solution where we have management and control over the entire process.

Elite Miljø Ormhøjgårdvej 12 DK-8700 Horsens Tel. +45 7015 4800 E-mail: info@elitemiljoe.dk Web: www.elitemiljoe.dk Cross cultural management, cooperation and communication. We help staff at major life science organisations succeed in an international multicultural working environment. Our activities include:

GlobalDenmark a/s Hauchsvej 14 DK-1825 Frederiksberg C T: +45 3386 2930 E: global@global-denmark.dk W: www.global-denmark.dk

• • • • • • •

Management and cooperation in the multicultural team Negotiation techniques Presentation techniques Cross-cultural knowledge-sharing Cross-cultural feedback techniques Scientific and business English Translation and proofreading

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 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 2016, 2017 and 2018 Jusmedico has been awarded the Corporate INTL Global Award Price as Biotech Law Firm of the Year in Denmark.

At Link Logistics, we’re passionate about our customers and our values – and both are cornerstones in everything we do. Your transportation is organized across the world’s leading logistics companies. We are your global and independent logistics link that makes sure your shipments reach their destination quickly and securely on time – always aided by innovative technology. Our entire staff is passionate about helping you through professional, close and personal service offered by specialists within all areas of logistics. At Link Logistics, we believe that it’s the small things that make the big difference.

Link Logistics A/S Vallensbækvej 51-53 DK-2605 Brøndby T: +45 3248 8873 E: linkpharma@linklog.dk W: www.linklog.dk

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

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

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COMPANY INDEX

Contract Research Organisations A+ Science is a complete clinical service Contract Research Organisation (CRO) with two decades of experience in clinical services within pharmaceutical (Phase I-IV) and medical device studies and across a broad range of therapeutic indications. Our core expertise is in the Nordic Countries, however through our close collaboration with other CROs, we cover several other countries.

We offer flexible solutions and customised services to our customers. Since December 2013, A+ Science is a CRO run by its employees.

A+ Science Luntmakargatan 22 111 37 Stockholm SWEDEN 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

Our vision is to become the CRO best known for its unique and dedicated personnel with focus on customer satisfaction. To Earn Trust- Make Difference.

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

DB Lab A/S Lille Tornbjerg Vej 24 DK-5220 Odense SØ Tel. +45 6593 2920 dblab@dblab.dk www.dblab.dk Larix is a full service Clinical Research Organization, offering assistance in all aspects of clinical trials (phase I-IV): Clinical operations, statistics, data management, medical writing, system validation, GCP, vendor audits and pharmacovigilance. We work with all types of pharma/biotech/medtech/diagnostic companies. We are here for the patients, our employees and our customers. We take pride in being passionate and dedicated, delivering high quality on time. Key focus is oncology. We have offices in all Nordic countries.

Larix A/S Lyskær 8b DK-2730 Herlev Tel. +45 7027 2221 E-mail: info@larixcro.com Web: www.larix.dk 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.

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

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LINK Medical Research has recently established the LINK Medical RWE department, 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, but it stays 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 and Berlin.

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 2018

COMPANY INDEX

Laboratory, Medical & Pharmaceutical Equipment • • • • •

IT/MES/MIS – Recipe-, Batch, Serialization, Traceability, OEE, Audit trail AUTOMATION – PLC, SCADA, DCS, VISION for Process-, Machine- and Quality control VALIDATION – Process-, Computer-, Machine-validation, GMP Compliance OPTIMZATION – Lean, Production improvements PROJECT MANEGEMENT

CONSULTANCY – SERVICES - PROJECT DELIVERIES – AN Group A/S Mejeribakken 8 DK-3540 Lynge T: +45 48 25 10 00 E: info@angroup.dk W: www.angroup.dk

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

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

Visit us at www.apodanpharma.dk

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.

Daintel is specialised in Patient Data Management Software for Intensive Care and Operation Wards.

The company enjoys a leader's position in Denmark and in Iceland. The solution has been developed by clinicians for clinicians and is the only solution in the world to save all patient data as time-stamped in high-resolution for research purposes.

SHARING EXPERTISE

Daintel Diplomvej 376, DTU DK-2800 Lyngby Tel. +45 7027 4470 E-mail: info@daintel.com Web: www.daintel.com 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

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COMPANY INDEX

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

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

Gammadata Instrument AB- Your partner in bioimaging Gammadata, founded in 1987, is a leading supplier in the Nordic and Baltic countries for all your bioimaging needs.

Gammadata Instrument AB P.O. Box 2034 SE-750 02 UPPSALA T: +46 (0)18-56 68 00 E: info@gammadata.se W: www.gammadata.se

We represent Horiba fluorescence and Raman microscopes, Femtonics 2-photon microscopes coupled to Coherent femtosecond lasers, in addition to lasers for confocal microscopy, Phenom World desktop SEM and CLEM systems, as well as AFM systems from Keysight. With the latest imaging techniques demanding the highest resolution we also provide anti-vibration tables from TMC Ametek to ensure the best quality images for your scientific publications.

Ultra rent vand er grundlæggende i alle effektive laboratorier, der arbejder med følsomt apparatur og kemiske og molekylærbiologiske analyser. Krüger Aquacare forhandler en række af ELGAs vandanlæg.

Vi tilbyder et bredt spekter af helhedsorienterede løsninger til laboratorier, der stiller høje krav til deres leverandører.

Krüger Aquacare Fabriksparken 50 DK-2600 Glostrup T: +45 4345 1676 E: aquacare@kruger.dk W: www.kruger.dk

Læs mere om vores professionelle løsninger her: http://www.kruger.dk/industri/loesninger/laboratorievand/

LabWare has delivered powerful lab automation solutions to many different industries. LabWare's 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.

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

Particle Measuring Systems Korskildelund 4-6 DK-2670 Greve T: +45 7070 2855 E: pmsnordic@pmeasuring.com W: www.pmeasuring.com

LabWare has created pre-configured Template Solutions to suit the requirements of specific industries.

LabWare's Template Solutions leverage our experience with implementing LabWare LIMS and LabWare ELN into many different industries. Template Solutions are now available for the following domains: Pharmaceuticals, Environmental Testing, Contract Labs, Forensics, Chemical/Petrochemical Process, Public Health, Clinical Research, Bioanalysis DMPK, Food, and Biobank.

Since 1972, Particle Measuring Systems has been the global expert in contamination monitoring, providing the pharmaceutical and other life science industries with the expertise to detect, analyze and manage cleanroom contamination so you can meet all regulatory requirements including ISO 14644-1:2015 and EU GMP Annex 1. As one of the world’s leading clean room contamination control experts<https://www.pmeasuring.com/en/about-us> and complete solutions provider, we offer fully integrated and robust monitoring solutions including: • Particle Counters and Microbial Samplers, remote and portable • Environmental and Facility Monitoring Systems • Data collection and Data Management (DM) • Advisory services including risk management and crisis handling • GMP Services

Siemens Healthineers offers a wide selection of diagnostic solutions for effective testing in in-vivo and in-vitro diagnostic. We continuously expand our value-added services – based on our broad portfolio of highly innovative medical technology. By introducing new enterprise and digital services, along with new business models, we strive to maximize opportunities and minimize risks for healthcare providers – transforming healthcare systems all together Siemens Healthcare A/S Borupvang 9 DK-2750 Ballerup Tel. +45 4477 4477 Web: www.healthcare.siemens.dk

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See www.healthcare.siemens.dk for more information.

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COMPANY INDEX

SSI Diagnostica A/S Herredsvejen 2 3400 Hillerød T: +45 4829 9100 E: info@ssidiagnostica.com W: www.ssidiagnostica.com

SSI Diagnostica A/S develops, produces and sells the best in vitro products available in the market. A flexible and customer-oriented approach provides you with thoroughly tested and innovative quality products at the right time. With more than 100 years of experience we ensure you the right answers on your tests. A proud tradition for research in Denmark is the foundation for our products making a difference in more than 50 countries.

Experience Matters.

Svanholm.com is a supplier of High-End Analyzers, Sensors and Equipment for biotech, biofuel, crystallization, stem cells, tissue engineering and tablet manufacturing areas. We distribute products of 25 suppliers in the Nordic countries, and we cover from raw material identification with Raman over solvent drying control with mass spectrometers to fermentation pH, DO, OD and Viable Cell Density sensors.

Svanholm.com Nordic Pharma and Analyzer Center Marienbergvej 132, 1.

DK- 4760 Vordingborg Tel. +45 7026 5811 E-mail: mail@svanholm.com Web: www.svanholm.com

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

Other Door System deliver durable door solutions that live up to the strict requirements to materials, hygiene and reliability in the pharmaceutical industry. Easy access to 100 % cleaning. Automatic controls encapsulated in stainless and waterproof boxes. No visible screws or fitting plugs. Interlock system between doors. Safety sensors on all automatic doors.

For further details, please contact Søren Rahbek, phone +45 42 14 52 02, sr@doorsystem.dk Door System A/S Hovvejen 148 DK-8361 Hasselager Tel. +45 86 92 11 71 www.doorsystem.dk

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THE MEDICON

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CALENDAR

HIGHLIGHTED FAIRS AND EVENTS IN 2018 RISK MANAGEMENT AND RISK BASED MONITORING IN A CLINICAL RESEARCH SETTING Date: 23.05.2018, Copenhagen, Denmark

www.atriumcph.com/course/Risk-Management-and-Risk-Based-Monitoring-in-a-Clinical-Research-Setting/21702 This course will allow you to appraise your current processes, people and technology with a view to improve monitoring and site efficiency and enhancing patient protection while maintaining high quality data.

Take the opportunity to practice the necessary skills to apply a risk based approach to monitoring activities.

We will review the principles of risk management and how to apply them within a clinical research or monitoring setting. The impact of introducing a risk based approach on site processes is also considered.

CONFERENCE ON BIG DATA IN BIOTECHNOLOGY AND BIOMEDICINE Date: 31.05.2018 â&#x20AC;&#x201C; 01.06.2018, Hotel Munkebjerg, Vejle, Denmark

www.biokemi.org or www.ida.dk The conference will focus on the latest developments in creating, utilizing, handling and methods for analyzing Big Data in biotechnology and biomedicine including sessions on, precision medicine, statistical genetics, single cell analysis, systems biology in medicine and process biotechnology, biological and genomic networks, microbiomics and best practice on

handling and storage, safety and ethics.

The conference is organised in collaboration with Danish Society of Biochemistry and Molecular Biology and includes a poster session as well as a commercial exhibition of equipment, consumables and services to Danish biotechnology.

NORDIC LIFE SCIENCE DAYS 2018 Date: 10.09.2018 â&#x20AC;&#x201C; 12.09.2018, Stockholm, Sweden

www.nlsdays.com Nordic Life Science Days is the largest Nordic partnering conference dedicated to the life science industry.

Since its inception in 2013, the event has nurtured a community of people from the world of life science, and created a unique place to do business.

Most attendees express their delight in the informal atmosphere, combined with an organized approach to meeting highly relevant people. The conference has

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created a space for meaningful encounters, with oneon-one meetings being one of the main features of NLS Days. Additionally, the high quality of topics and presenters provide insight into the most recent trends in science and business.

NLS Days attracts leading decision makers from biotech, pharma and medtech as well as finance, research, policy and regulatory authorities.

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LABDAYS COPENHAGEN 2018 Date: 12.09.2018 – 13.09.2018, Copenhagen, Denmark

www.labdays.dk This year the CPH LabMed exhibition has changed to a new LabDays Copenhagen concept. The changes result in the fair moving to a new venue central in Copenhagen. The fair will be conducted over 2 days instead of the usual 3 days. A new turnkey stand concept is introduced and the fair gets a new stand layout,

meanwhile the possibility of custom made stands is maintained. The Danish Society for Mass Spectrometry will organize a theme day in parallel with LabDays Copenhagen, and also, the Laboratory Medical Society for Bioanalysts (LSB) will conduct their theme day and their annual meeting in parallel with the exhibition.

THE UNIVERSAL BIOTECH INNOVATION PRIZE 2018 Date: The award ceremony will take place in Paris in October 2018 – not yet determined date.

www.universal-biotech.com The consulting company Universal Biotech has launched the 10th edition of its Innovation Prize.

The Universal Biotech Innovation Prize rewards the most innovative projects in the healthcare sector.

Universal Biotech is looking for both young startups (less than 8 years old) and academic researchers currently developing an innovative project, from discovery to pre-market stage.

This year, the Innovation Prize 2018 will reward projects in the fields of biotech, medtech and digitech.

Each laureate will win up to 30,000.00 euros in the form of cash and consulting services. The deadline for applications is April 30th 2018. Applications can be submitted through the prize’s online Open Innovation Access platform: https://www.universal-biotech-prize.com/

BIO-EUROPE 2018 Date: 05.11.2018 – 07.11.2018, Copenhagen, Denmark

www.ebdgroup.com For the first time ever, Bio-Europe will be conducted in Medicon Valley. The event offers powerful opportunities for you to network with the right partners, and brings together hundreds of the world’s most innovative leaders across biotech, finance and pharma for high-level networking, pre-scheduled partnering

meetings, strategic panel discussions and more. Last year the event attracted more than 4,000 attendees, 2,199 companies from more than 60 countries. 24,199 one-to-one meetings were held, 5,142 licensing opportunities were posted, 152 company presentations held and 106 exhibitors were present.

DIPLOMA IN CLINICAL PROJECT MANAGEMENT Date: 26.11.2018 – 28.11.2018, Copenhagen, Denmark

www.atriumcph.com This is for you who works with clinical development and wishes to develop your competencies and skills

within project management.

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Clester Oxendine Senior Research Associate QC

Active ingredients | Dynamic people Our people are at the heart of everything we do and every Cambrex success.

That’s why customers say we’re the experts they enjoy working with.

Discover why we’re one of the biggest names in small molecule APIs at

www.cambrex.com

Custom development & manufacturing

Generic APIs

Controlled substances