Greater Copenhagen Life Science Magazine September 2019

SEPTEMBER 2019

THE NEW GOVERNMENT IN DENMARK EXPECTATIONS

— THE DECISION TO LOCATE IN COPENHAGEN DAIICHI SANKYO

— TOP 7 LEARNINGS ON GDPR AND CLINICAL TRIALS LEGAL UPDATE

2019

LabDays Section Page 14

2019

DiaLabXpo Section Page 22

SEPTEMBER 2019 Publisher:

CONTENTS THE COLUMN

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BY DIALAB Høffdingsvej 34 2500 Valby Denmark E-mail: nem@nemmedia.dk Web: www.nemmedia.dk Front-page photo: nicolaiperjesi.com

BIG UPCOMING EVENTS

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IN DENMARK, SWEDEN AND GERMANY

THE NEW GOVERNMENT

8

EXPECTATIONS

DAIICHI SANKYO

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THE DECISION TO LOCATE IN COPENHAGEN Editors: Karin Jensen Charlotte Strøm Arne Nielsen Martin Bintzer Lind and Mohammed Ali Wachah.

Graphics & Layout: Kapteina Reklame

LABDAYS 2019 14 EXHIBITORS 15

FLOOR PLAN

17

DIALABXPO 22 EXHIBITORS 23

FLOOR PLAN

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LEGAL UPDATE Advertisement: Mohammed Ali Wachah +45 23238082

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TOP 7 LEARNINGS ON GDPR AND CLINICAL TRIALS

CALENDAR 31

mw@nemmedia.dk Magnus Andersen +45 4281 1110 ma@nemmedia.dk Print: Green Graphic & Signtec Reklame

In cooperation with:

Cross-cultural management, collaboration and communication in the life science industry We help people succeed in an international multicultural working environment. Our activities include: •

Management and cooperation in the multicultural team

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Negotiation techniques

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www.global-denmark.dk/life-science ISSN: 2446-1776

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+45 33 86 29 30

global@global-denmark.dk

THE COLUMN

40 YEARS OF COLLABORATION – in DiaLab we stand strong together

By Henrik Christensen, chairman DiaLab and Henrik Lundgaard Sedenmark, head of secretariat, DiaLab 40 years ago, a group of companies selling IVD equipment and equipment to laboratories decided, that the growing complexity in legal regulations and the complexity in the laboratory business itself called for the businesses to stand together. The solution was, to establish a trade association, where the members could put in a common effort in promoting the business and work towards a good regulatory framework for the business.

Now, 40 years later, the trade association is still going strong.

With 60 members representing approximately 80% of the Danish laboratory and IVD equipment sales, we find that we are stronger than ever. In addition, the need for a community is probably larger than ever. If we thought the business was complex in 1979 - it is nothing compared to 2019.

Most of the legal regulations are common for the EU and are decided in the EU institutions in Brussels. DiaLab is therefore a member of the trade association called MedTechEurope, representing businesses all over the EU. The importance of standing strong together is also found here. For the moment, especially Brexit plays a big role for Danish companies selling or buying laboratory and diagnostic equipment in or through the UK. DiaLab is

collaborating with The Danish Camber of Commerce and the Danish Medicines Agency in finding good solutions for the companies regarding Brexit and communicating news regarding Brexit to the members of DiaLab. DiaLab is looking forward to seeing which direction the new Danish government will take regarding the LifeScience businesses. For Denmark, the LifeScience industry is a major industry and thus it deserves a dedicated focus from the government, securing workplaces and income to Denmark. A healthy competition between companies, sensible framework conditions and an educational strategy securing new and well-educated employees to the businesses are some of the key elements.

This year, DiaLab is co-hosting the brand-new exhibition DiaLabXpo. The exhibition has been on the

drawing board for several years, and this year it finally is becoming real with more than 60 businesses showing their best and newest IVD equipment and equipment for laboratories, combined with three days of inspiring talks and debates with CEOs, parliament members, researchers etc. This exhibition truly shows, what it means to stand strong together.

DiaLab – Danish Diagnostics & Laboratory Association is looking forward to the next 40 years as the leading association for companies that produces and sell IVD and laboratory equipment. The need for a strong community and collaboration between businesses has not been diminished since 1979 – on the contrary – the need for a cooperation is bigger than ever in the struggle for better regulatory framework and awareness amongst decision makers.

Henrik Christensen, chairman DiaLab and Henrik Lundgaard Sedenmark, head of secretariat, DiaLab

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

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Big Events in the Fall 2019 Nordic Life Science Days Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech, but also from finances, research, policy and regulatory authorities.

medical devices and e-health business. There will be plenty of opportunities to connect with others from the life science industry.

Participants from 40 Countries

The Nordic region is proud to host some of the world’s most innovative biotech, medtech and pharma companies. It also has the 12th strongest economy, making it the perfect place to invest. Set in the vibrant MalmÜ-Copenhagen region, in the heart of the Medicon Valley, the conference offers conference super sessions, seminars, company presentations, exhibition, face-toface meetings and unique receptions, providing many opportunities to network with peers, potential partners and investors. The 2019 conference design will feature a new exhibition layout creating more interactions with the exhibitors, an enriched program featuring 6 Super Sessions, 6 topical seminars, academic and startup contests, innovative 6mn and 12mn company presentations bringing more value to the presenters and the audience, new partnering areas allowing more comfort and privacy, extended informal networking opportunities. NLSDays 2019 will take place in MalmÜ on September 10-12.

2800+ Scheduled Meetings

For more information https://www.nlsdays.com

Based on cutting-edge and advanced partnering and networking tools, Nordic Life Science Days showcases the best the Nordic region has to offer. NLSDays offers networking and knowledge for anyone interested in the Nordic life science, biotechnologies, pharmaceuticals,

NLSDays 2019 is expecting:

1300+ international delegates.

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

UPCOMING EVENTS

MEDICA 2019 + COMPAMED 2019 More dynamic, more digital and more networked than ever: the medical industry is taking strides into the future. If you want to be in peak condition for taking on the challenges of tomorrow, you need to keep your finger on the pulse, inform yourself and deepen your exchanges with specialists. MEDICA has been offering the best opportunities to do this for almost 50 years.

Exhibitors, visitors and medical representatives from all over the world will come together again at the world’s biggest leading medical trade fair, held in November in Düsseldorf this year (run time: 18 – 21/11/2019 International bookings account for threequarters of the 5,000+ exhibitors taking part. We are expecting to see trade visitors from more than 170 countries. The individual themed focal points are clearly structured to fit the halls and include: Electromedicine/medical technology (approx. 2,500 exhibitors), laboratory technology/diagnostics, physiotherapy/orthopedic technology, commodities and consumables, information and communication technology, medical furniture and specialist furnishings for hospitals and practices.

This year, the 28th COMPAMED will be held in parallel to MEDICA. COMPAMED will number almost 800 visitors and will take place in halls 8a and 8b.

COMPAMED, a supplier trade fair, has become the ultimate hotspot for complex high-tech solutions and services throughout the entire value-added chain for the medical technology industry and is now the international leading event in its segment.

The increasing digitalisation of processes in the healthcare economy will remain a top theme this year.

This prevailing trend will not only be represented by exhibitor innovations at the MEDICA, but is

also reflected in the programs of the accompanying conferences and forums.

These conferences and forums include the MEDICA HEALTH IT FORUM (on IT topics such as big data, artificial intelligence and cyber security), the MEDICA CONNECTED HEALTHCARE FORUM (hardware and software solutions for connected healthcare) and the MEDICA MEDICINE & SPORTS CONFERENCE, held entirely in English, which takes a look at the use of applications which are used in close proximity to the body and wearables for monitoring vital signs.

MEDICA 2019 and the 42nd German Hospital Conference, which takes place in parallel, will be opened by Jens Spahn, the German Federal Minister of Health.

For more information https://www.medica-tradefair. com/ and https://www.compamed-tradefair.com/

MEDICA (2018) at a glance:

5,286 Exhibitors 120,116 Visitors 96 % Visitor satisfaction COMPAMED (2018) at a glance:

120,116 trade visitors from 155 nations 784 exhibitors from 37 nations 5,286 MEDICA exhibitors 98% visitor satisfaction

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

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UPCOMING EVENTS

BIO-Europe 2019 - in Hamburg, Germany BIO-Europe is the preeminent partnering conference for the life sciences, bringing together international decision makers from the biotechnology, pharmaceutical and financial sectors, offering networking opportunities, workshop and panel participation, a high-profile exhibition, and private, prescheduled one-to-one meetings.

Delegates from all parts of the biotechnology value chain come to BIO-Europe to quickly identify, engage and enter into strategic relationships that drive their businesses successfully forward. Investment and collaboration opportunities developed in prior BIO-Europe conferences have produced many highly successful business partnerships.

The BIO-Europe 2019 partnering event is expected to draw over 4,000 industry attendees for three days of

BIO-Europe (2018) at a glance:

4,354 attendees 2,325 companies 60 countries represented 131 exhibitors 139 company presentations 5,203 licensing opportunities posted 26,092 one-to-one meetings

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high-level networking, representing more than 2,000 companies from over 60 countries.

Partnering as an overall business strategy has transformed drug development in bringing together innovators and visionaries with seasoned experts from every corner of the globe. Partnering at BIO-Europe is powered by EBD Group’s partneringONE, the industry’s most advanced networking system, which enables participants to efficiently mine a large pool of potential partners and pre-arrange private one-to-one meetings with dozens of company targets. The system—industryspecific, web-based and interactive—is uniquely suited for the needs of life science companies.

In addition to the program, two key elements at our partnering events are the presenting companies and the exhibition. At BIO-Europe, presenting companies are grouped into several tracks, including Biotech, Midsize Pharma, Next Generation, and Academic Innovators. The high-exposure exhibition is the heart of the conference, and presents a prime opportunity to showcase products and services in a high-traffic location.

BIO-Europe is produced by EBD Group, a leading partnering firm for the global biotechnology industry, with the support of the Biotechnology Innovation Organization (BIO).

BIO-Europe will take place in Hamburg on November 11-13.

For more information https://ebdgroup.knect365.com/ bioeurope/

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

More than 25 years of experience DB Lab possesses 3,200 m2 of which 2,000 m2 are laboratory facilities on our site in Odense, Denmark.

Here we perform chemical and microbiological GMP analyses on raw materials, intermediates and finished products and process samples for the pharmaceutical and biotech industry.

Chemical and microbiological GMP analyses Method development and validation Pharmacopoeia and customised methods Stability studies Probiotic testing

Contact: +45 6593 2920 ¡ dblab@dblab.dk ¡ dblab.dk

EXPECTATIONS FROM THE NEW GOVERNMENT

MVA bets on new Danish government to stay the course with ambitious life science strategy

By Karin Jensen

An invitation has been sent to Simon Kollerup, Minister of Industry, Business and Financial Affairs, to attend Medicon Valley Alliance’s Annual Meeting in November. The organisation hopes, and expects, the new Danish government will continue the work of the previous government with an ambitious strategy for the life science industry.

M

edicon Valley Alliance (MVA), the Danish-Swedish networking organisation for the life science community in Greater Copenhagen, is convinced the new Danish social democratic government will pursue the ambitious strateg y for the life science industr y set out by the previous centre-right government.

“It is my clear hope and expectation that the new government will continue on the same track as laid out by the previous government and really prioritise the needs of the life science industr y,” said Petter Hartman, CEO at MVA. In March 2018, the former government launched a growth strateg y for the life science industr y, containing 36 concrete initiatives that targeted barriers and possibilities in the industr y.

“The life science industr y is important for the Danish economy, both in terms of jobs, productivity and tax revenues,” said Hartman.

“If we want to retain the standard of today’s welfare system, then we have to focus on industries where

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we have core competencies and where we can generate growth, create jobs, tax revenues and so on. I am absolutely convinced the new government fully understands this,” Hartman added.

The new Danish government took office at the end of June and Hartman has therefore not had the chance to discuss the life science industr y with the industr y and business minister. However, Kollerup has been invited to participate in MVA’s Annual Meeting on 4th November. His Swedish counterpart, Minister for Business, Industr y and Innovation, Ibrahim Baylan, has already accepted an invitation and MVA hopes this could be the start of a dialogue between the two ministers.

“My hope is that this can be a way for both ministers to discuss in which way Greater Copenhagen is an important factor for the economies of both Denmark and Sweden and why we need a strong cooperation to benefit the most from the efforts being done, not least in life science,” Hartman said.

Hartman believes the Greater Copenhagen region has been somewhat neglected nationally in recent years with a lack of investments in new initiatives and he hopes this will change with the new government.

“We need to create the best conditions for growth in the industr y. For example, a lot of Danish life science companies list on the Swedish bourse, but we also see a lot of Swedish companies raising capital in Denmark. It is important that we acknowledge this and not build barriers between the countries,” he said.

Denmark and Sweden are both small countries and are up against some ver y large life science corporates from big nations such as the US, UK, France and Germany. Cooperation, not competition, is the way for ward, Hartman believes.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

Petter Hartman, CEO at MVA

Leading International Trade Fair “We have to think in a Nordic perspective and in that context, Greater Copenhagen and the life science industr y we have in Medicon Valley, are a ver y important part in conveying this message,” Hartman said.

The MVA CEO also believes that there is a window of opportunity in the sense that both the Danish and the Swedish governments are now social democratic.

“The Swedish government is currently finishing its life science strateg y and if we were a bit proactive, then we could establish a discussion between the two ministers on how to align their respective life science strategies, synchronise the level of ambition,” Hartman said.

DÜSSELDORF, GERMANY 18–21 NOVEMBER 2019 www.medica.de

Member of

WORLD FORUM FOR MEDICINE

Focus on the future!

Laboratory equipment and diagnostics in halls 1 and 3 www.medica.de/labtech2

For yderligere information: Intermess ApS Rådhusvej 2 _ DK-2920 Charlottenlund Tlf.: 45 50 56 55 _ Fax: 45 50 50 27 messe@intermess.dk _ www.intermess.dk

Public-private collaboration key to Daiichi Sankyo’s decision to locate in Copenhagen

By Karin Jensen

When choosing the location for its new Nordic oncology research unit, Japan’s Daiichi Sankyo was especially impressed by the public-private collaboration in the region. A strong position in oncology in Greater Copenhagen’s thriving life science ecosystem was also a decisive factor.

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n November 2018, Daiichi Sankyo Oncolog y Nordics opened its new office in Copenhagen but prior to that had been a long process to find the right location in the Nordic region. And there were several reasons why the Japanese pharma group choose Copenhagen, according to Patrik Grandits, General Manager & CEO, Nordic Region Daiichi Sankyo.

“We were especially impressed by

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the collaboration between public and private organisations in this region,” said Grandits.

Grandits said the Nordic region is a key market for oncolog y and therefore considers a presence here a milestone in the development of Daiichi Sankyo’s oncolog y business.

“Denmark’s strong position within oncolog y research and treatment as well as the close collaboration

between universities, hospitals, authorities and the industr y played a key role in our decision to establish the Daiichi Sankyo Oncolog y Nordics affiliate in Copenhagen – directly into the heart of research and science,” said Patrik Grandits, who also highlighted the Danish life science growth plan, which “targets barriers and opportunities for the industr y across the entire value chain.”

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

DAIICHI SANKYO

Trial Nation The public-private partnership that so impressed Daiichi Sankyo, is Trial Nation, which offers a single, national entr y point for global companies, patient organisations and clinical researchers who wish to conduct clinical trials in Denmark. Trial Nation is funded by the Danish state and the five national regions as well as several life science-companies.

“At Trial Nation we have a dedicated network in oncolog y, and this makes it both easier and faster to enter into a scientific dialogue on the different clinical protocols, just as you get the opportunity to really qualify your clinical protocols as you get in touch with all the right people,” said Marianne Pilgaard, Managing Director at Trial Nation. “It is a real streng th in Denmark that we have experience with public-private cooperation, it is quite unique at this level,” she said.

Copenhagen Capacity, the Danish investment promotion agency,

Marianne Pilgaard, Managing Director at Trial Nation.

Niels Thun Andersen, Senior Investment Manager, Life Science at Copenhagen Capacity’s Investment Promotion unit.

which supports foreign companies looking to set up business in Greater Copenhagen, agrees that Trial Nation played a significant role in attracting Daiichi Sankyo to the region.

“Based on the knowledge we had about Daiichi Sankyo before we invited them to Copenhagen, we introduced them to Trial Nation as we knew that would be a strong argument for this specific company with their impressive pipeline within oncolog y,“ said Niels Thun

Andersen, Senior Investment Manager, Life Science at Copenhagen Capacity’s Investment Promotion unit.

Even if the Japanese pharma group with its 15,000 employees worldwide, is a large multinational company, the Nordic oncolog y unit is a research company involved in clinical trials. During its visit to Copenhagen, the Japanese group was therefore introduced to COBIS Bioscience Park by Copenhagen Capacity.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

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DAIICHI SANKYO

“We knew it was a location that would suit Daiichi Sankyo as it was near clinical environment, academia and the start-up community,” said Thun Andersen.

Patrik Grandits said the decision to choose COBIS was that “it allows for a multicultural corporate environment and puts us in direct contact with our customers with its central location between Denmark’s leading Rigshospitalet and other major university hospitals such as Karolinska Institute in Sweden.”

Daiichi Sankyo Oncolog y Nordics currently employs 12 people in Copenhagen but is heavily expanding.

“To further streng then and leverage our world class science, and bring meaningful value to the patients, we are already engaged in a couple of projects and plan to be an active participant in the eco-system around Medicon Valley,” said Grandits.

Trial Nation has an excellent cooperation with Daiichi Sankyo Oncolog y Nordics and is pleased to see how the Japanese pharma group has engaged in local cooperation by joining cluster organisations such as Medicon Valley Alliance.

“It has great significance, the cooperation and learning from each other,” she said.

Patrik Grandits, General Manager & CEO, Nordic Region Daiichi Sankyo.

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“From the ver y beginning it was fantastic to experience how enthusiastically we were welcomed and how eager ever yone was to talk and to engage with us,” said Patrik Grandits and added this demonstrates that profound scientific research really makes a difference and that there are many like-minded organisations to partner with.

Daiichi Sankyo Oncolog y Nordics is now a member in the Danish Chamber of Commerce and networks like the Medicon Valley Alliance and partner with organisations like Lif, the Danish Association of the Pharmaceutical Industr y, the Capital Region, and Copenhagen Capacity.

Daiichi Sankyo has a strong oncolog y pipeline and the goal is to deliver seven distinct new molecular entities over eight years during 2018 to 2025.

“We are looking for ward to actively contributing to the thriving ecosystem of universities, hospitals, authorities and industries in the quest to find even better patient solutions together,” Grandits said.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

join the largest Nordic life science conference 1 500 participants 800 companies/organizations 40+ countries represented 3 000+ face-to-face meetings expected in 2019, based on previous attendance

www.nlsdays.com N o r d i c

n a t i o n a l

c o - h o s t s :

N o r d i c

r e g i o n a l

c o - h o s t s :

a

event, powered by

m e d i a :

AARHUS

11. - 12. september

LabDays 2019 Fagmesse for laboratorieteknik

n Massespektrometri temadag n BioPeople konference n LSB temadag & årsmøde n Over 75 udstillere n Laboratorieudstyr n Diagnostik n Forskning n Kvalitetskontrol

T

he 11th and 12th of September, the fourth version of the LabDays fair takes place in Aarhus, Denmark.

Almost 80 exhibitors are looking forward to meet the life science industry.

An important part of the concept is to maintain industry meetings in parallel with the fair. The goal is to gather industry activities so that the exhibitors as well as the visitors will benefit further from attending the LabDays fair. This year, BioPeople will organize a conference on how to avoid injuries and a panel discussion on the laboratories of the future. Also, The Laboratory Medical Society for Bioanalysts (LSB) will conduct their

labdays.dk

theme day about innovation in the healthcare sector in parallel with the exhibition.

All visitors have to register, when visiting the fair, which can either be done by pre-registering on the website (Labdays.dk) or at the entrance of the fair.

HIGHLIGHTED ACTIVITIES: Exhibitors FREE Lab Theater The exhibitors will execute smaller seminars from the open stages.

Wednesday, September 11th Thursday, September 12th Registration is not required.

LSB’s theme day The Laboratory Medical Society for Bioanalysts (LSB) will conduct their theme day about innovation in the healthcare sector for members (no costs) – non-members can attend for the price of 300 Dkk. Thursday, September 12th Registration is required.

BioPeople conference on how to avoid injuries Wednesday, September 11th BioPeople - A panel discussion about the laboratories of the future Wednesday, September 11th

FACTS:

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Venue: Scandinavian Congress Centre Margrethepladsen 5, 8000 Aarhus C

Registration Pre-register on Labdays.dk or register at the entrance of the fair.

Opening hours Wednesday, the 11th of September: 9:00 pm to 4:00 am Thursday, the 12st of September: 9:00 pm to 4:00 am

Parking Scandinavian Congress Centre has 1.100 near-parking lots which can be used against payment.

Wardrobe You can store clothes, bags and other stuff in the staffed wardrobe. It is free of charge.

For further information visit: www.labdays.dk

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

AARHUS

11. - 12. september

LabDays 2019 Fagmesse for laboratorieteknik

n Massespektrometri temadag

LABDAYS2019 AARHUS EXHIBITORS

n BioPeopleP konference

A

G

Agilent Technologies 25

Greater CPH Life Science A

B

H

Pall International 81

n LSB temadag & årsmøde Peak Scientific Instruments 74

B.I.P.E.A. 30

Pekema 78 n Over 75 udstillere Perkin Elmer 6 Help Care Company 29

Biolab 8

Histolab 65

BioPeople 58

HK - Dansk Laborant Forening 34

Biotecon Diagnostics 42

Hounisen Laboratorieudstyr 31

Perten Instruments n Laboratorieudstyr

Pfeiffer Vacuum Scandinavia 51

Phenomenex n Diagnostik

17

Promega Biotech 19

Brooks Life Sciences Systems 71

n ForskningProvidion

Buhl & Bønsøe 63

I

Busch Vakuumteknik 67

ICM 52

BÜCHI Labortechnik 13 C

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66

n Kvalitetskontrol S

J

Salli Systems 24

Jørgen P. 15

SAMSI Instruments 12

labdays.dk

Colly Flow tech 32

Saveen & Werner 87

L

Sciex 17

D

L AB Denmark 14

Scotsman Køleteknik 47

D-S Sikkerhedsudstyr 1

Labsupport 73

Sero 55

Denios 64

LabVikar 22

Sikre Prøver 16

DFM 28

LabWare Nordic 20

Sof tware Point 53

Dorte Egelund 33

LGC Standards 45

Strandmøllen 37

Drif ton 72

LH Laboratorie Ser vice 62

Strenometer 2

Logos Logit 50 E

Lovmand Diagnostics 43

T TATA A Biocenter 7

Eppendorf Nordic 46 Ergotec 86

M

TAWI DANMARK 69

Etisof t Nordic - Eticalls.com 70

MD Scientific 48

TechMedia - Dansk Kemi 35

Eupry 33

Mettler-Toledo 36

Thermo Fisher Scientific 49

Miele 54 F

Mikrolab Aarhus 4

V

Fameco Analy tical 88

Miltenyi Biotec Norden 57

VACPRO 66

Flow Robotics 44

Molecular Devices 18 Y

Fluidic Analy tics 82 Food Diagnostics 68

N

Fooddes 56

NLSinsight B

FOSS Nordic 23

Nordic Biolabs 38

3

Frisenette 83

Nordic Biosite 3

3M - Food Safety Department 56

You Do Bio 21

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

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AARHUS

11. - 12. september

LabDays 2019 Fagmesse for laboratorieteknik

n Massespektrometri temadag n BioPeople konference n LSB temadag & ürsmøde n Over 75 udstillere n Laboratorieudstyr n Diagnostik n Forskning n Kvalitetskontrol labdays.dk

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

SEE YOU AT LABDAYS2019 AARHUS Ready to assist you in the lab Flowbot ONE has been deveoped in close collaboration with users from industry and academia. It requires no programming, and visitors at our booth get the chance to set up a program and see it do the pipetting in action.

Danmarks eneste landsdækkende vikar- og rekrutteringsbureau specifikt for laboratoriebranchen. Med over 20 forskellige laboratorierelaterede faggrupper indenfor alt lige fra fødevareområdet og pharma over biotek og medicinal til dentalområdet med flere. LabVikar ApS modtog Børsens Gazelle i 2018 - og har 13 års erfaring indenfor vikar- og rekrutteringsløsninger til laboratorier.

Meet us at booth 22 - www.labvikar.dk

Meet us at booth 44 - www.flow-robotics.com

LabWare is the clear industry leader in laboratory automation software Busch Vakuumteknik is one of the largest manufacturers of vacuum

with LabWare LIMS ™ (Laboratory Information Management System)

pumps in the world.

and LabWare ELN ™- a fully integrated Electronic Laboratory Notebook

Our product range comprises the largest selection of solutions for vacu-

application.

um technology in all industry sectors worldwide.

LabWare’s Enterprise Laboratory Platform is a unique and proven suite of product capabilities that encompass LIMS, ELN and LES method execution

Accurate analysis results, repeatable experiments and productivity are

in an integrated and enterprise ready solution.

indispensable in any laboratory or research facility. Quiet operation and

LabWare has delivered powerful lab automation solutions to many

low heat emission represent further key factors for a decent working

different industries, and our single core product strategy benefits every

environment. With the help of Busch Vakuumteknik all these requirements

LabWare customer because it enables all of our development, support and

can be met.

implementation resources to focus on a common solution.

We can draw on more than 50 years of experience in vacuum pump and system manufacturing.

Meet us at booth 20 - www.labware.com

Meet us at booth 67 - https://www.buschvacuum.com/dk/da

Discover new ways to enhance your life science research.

Promega products are used by life scientists who are asking fundamental questions about biological processes as well as by scientists who are ap-

Steelco Denmark er et dansk A/S og datterselskab til Steelco SpA, der udvikler og producerer vore produkter til anvendelse indenfor Infection Control. Indenfor LifeScience, LAB og Pharma er der et omfattende program af autoklaver, vaskemaskiner og automation, herunder animal research.

Steelco DK har ansvar for at sælge og servicere Steelcos totale program i DK. Vor hovedafd. har adresse på Lottenborgvej 24, 2800 Lyngby. Henvendelse på e-mail steelco-denmark@steelcospa.com eller tlf. 69136040.

plying scientific knowledge to diagnose and treat diseases, discover new therapeutics, and use genetics and DNA testing for human identification.

No matter what your field of study, we are committed to help you enhance

Meet us at booth 70 - www.eticalls.EU

your research! Visit the Promega booth! Make chance to win fun prizes.

Meet us at booth 19 - www.promega.com

Biolab A/S har eksisteret mere en 46 år og er en danskejet handels- og service-virksomhed i laboratorieudstyrsbranchen. Fra vort domicil i Risskov betjener vore ansatte alle Danmarks vigtigste forsknings- og uddannelses-institutioner såvel som fødevare, farmaceutisk og den bioteknologiske industri.

Representatives of the magazine Greater Copenhagen Life Science will be present at the exhibition, where we will walk amongst the visitors and exhibitors handing out free magazines.

Greater Copenhagen Life Science is the primary mouthpiece for the Medicon Valley region’s many companies and organizations within biotech, medtech and pharma as well as companies who have this segment as their customers or suppliers.

Biolab har i 25 år været ISO-9001 Certificeret og vor pipettekalibreringservice er DANAK akkrediteret. Via uddannelse, træning og lang anciennitet besidder vi en unik viden og kapacitet indenfor instrument integration og analyse-automatisering. Under mottoet "Prøv os - vi kan mere end de fleste...." repræsenterer Biolab over 20 internationale udstyrs- og reagens-producenter på det Danske marked.

For more visit www.nemmedia.dk

Meet us at booth 8 - www.biolab.dk

LABDAYS

Danish robotics company expands its activities The Danish robotics company Flow Robotics, who designs and builds pipetting cobots for lab automation, engages in a collaboration with VWR International A/S, a global supplier of solutions for the life sciences.

“It is great that we can now be even closer to our customers in a market with a growing interest for lab automation,” says Annika Isaksson, director in Flow Robotics. She continues: “There is a need for reducing burdensome pipetting tasks, and it is important to us to be reachable to customers who have identified this issue.

We see a growing interest for our

18

product both in Denmark and abroad, and so it is really good that V W R International A /S now assists us in reaching the customers.”

User-friendly is core The pipetting cobot f lowbot ONE is built to be f lexible and user-friendly. It does not require any programming and so ever yone

in the lab can use it. Flow Robotics categorises it as a cobot – a collaborative robot, which refers to the assistive role that f lowbot ONE will take on in the lab. By automating some of the burdensome and repetitive tasks, one is ensured more consistent test results and a higher productivity as well as avoiding work-related injuries. To Flow Robotics, it is important that users do not feel that automation suddenly is a burden itself - thus f lowbot ONE is designed to be easy and fast. With f lowbot ONE all types of labs can start automating.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

LABDAYS

New feature for etiCALLS

By Joanna Heler-Kończakowska

The development of the laboratory industry has made etiCALLS get a new face, adapting to the needs of the demanding market. It’s not just a new logo, a website dedicated to etiCALLS, but also a much wider product range. etiCA LLS is the result of our many years of experience, supported by cooperation with leading laboratories. The solution consists of specialized labels, a matching thermal transfer ribbon, software, printing devices, and code readers. The solution allows you easily and quickly create labels using text, barcodes, 2D codes and graphics (warning signs, chemical symbols etc.). It also allows you to insert numbers and the current date and time.

The etiCA LLS label solution is products of different materials and adhesive that fix attachment on surfaces to be frozen to - 196 or -80 degrees +150 degrees.

The special labels and thermal transfer ribbons guarantee legibility and durability even under extreme conditions of storage, as well as excellent adhesion to a variety of surfaces.

Take your pipes or bottles with you on LabDays and get test results applied for later test at home to your own freezer.

etiCA LLS system brings many value-added benefits such as ease of identification, elimination of errors, and the introduction of good practices to improve the quality and productivity of laboratories. With the use of etiCA LLS, the cost of operating the laboratories decreases as only the requested quantities of appropriately selected materials are printed.

In this movie at the minute 4:00 there are some little vial shown: https://w w w.youtube.com/ watch?v=JMxjmK9ebV0&t=38s

Etisoft now combines the Italian developed Print and Apply solution Pk-50-M with their specialized label solution etiCA LLS.

Source: Etisoft

Or search: Pk 50 M Applicatore etichette semi-automatico

The etiCA LLS system will therefore work in those institutions where cost optimization goes hand in hand with quality, precision and reliability.

The labels within etiCA LLS can be used for samples, straws, tubes, histopathological slides and cassettes, multi-grain plates and petri dishes, blood bags, cr yogenic shelves, laborator y equipment, documentation and more.

Print and paste in a workf low is now possible on small round tubes LabDays 2019 is the place where Etisoft presents the solution that allows fast, safe and consistent printing and applying labels on tubes and round bottles all the way from Ø 120mm down to a diameter of only Ø 10mm.

It is the result of own developed labels for both cr yo and freeze storage environments and a small Italian developed Print and Apply solution.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

19

LABDAYS

Efficient and low cost LabN6 peristaltic pump with timer function Great flexibility is often needed when testing products in laboratories. It can be difficult to find the right equipment for simple dosing tasks as you have to take many variables into consideration. With the efficient LabN6 peristaltic pump you have many functionalities without having to handle much programming.

LabN6 is a standard peristaltic pump with an A BS motor cabinet and the pump is particularly suitable for universities and R&D laboratories. With a rpm range from 0.1 to 600 rpm you have the possibility to adjust the speed and the f low rate can be set between 0.007 and 2,280 ml/min. You can choose between two types of pump heads and you can mount up to two pump heads at the same

time. All these f lexible options make the pump the ideal choice in a laborator y where the daily work situation often changes.

With the LCD-display you have an easy over view of the current settings of the test and as an extra feature you have a simple timer function that you can use if you would like to use time as a setting. The LabN6 has low vibrations and is ver y quiet.

Learn more at w w w.drifton.eu.

LIFE SCIENCE SPECIALIST RECRUITMENT BY TEMP-TEAM -

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We specialise in Executive Search, Selection and Temporary Staff.

Tel. + 45 33 36 09 44 // www.temp-team.dk

JJASCO SPECTROPHOTOMETERS

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

NYHED DIAGNOSTIK- OG LABORATORIEBRANCHENS MØDESTED

dialabxpo.dk

24.-26. september 2019 BESØG DIALABXPO – HVOR NETVÆRK SKABES DiaLabXpo er den nye fagmesse og mødested for hele diagnostik- og laboratoriebranchen. Her kan du møde branchens førende virksomheder, som vil byde dig indenfor til et væld af nye produkter og løsninger til fremtiden.

TRE TEMADAGE MED VIDEN OG INNOVATION Oplev blandt andet: • En debat om hvordan vi sikrer Danmark som life science-nation?

• DEKS, DSKM, DSTH og DSKB: Laboratoriespecialernes fremtid i den danske sundhedssektor • En paneldebat om sygehusvæsenet i Danmark • Future Lab konference med emner som Digitale Verdenslaboratorier, Kunstig Intelligens, Future Lab og nye innovative tilgange til branchen

SE HELE PROGRAMMET OG HENT DIN GRATIS BILLET PÅ DIALABXPO.DK

DiaLabXpo har branchens opbakning:

mikrobiologi & biotech

Lokomotivværkstedet | Otto Busses Vej 5A | 2450 København SV | mch.dk

DIALABXPO

WELCOME TO DIALABXPO THE DIAGNOSTIC AND LABORATORY INDUSTRY´S NEW EXHIBITION IN 2019 HIGHLIGHTED EVENTS BUSINESS/TRADE – TUESDAY 24 SEPTEMBER 2019 •

Buyers Day: Sustainability - from vision to reality

•

DTU ScienceShow: Science in a colourful and explosive way

•

Debate: How to ensure Denmark as a life science-nation?

SCIENCE – WEDNESDAY 25 SEPTEMBER 2019

D

iaLabXpo is conducted for the first time the 24th to 26th of September 2019 at Lokomotiv værkstedet in Copenhagen. It is a new exhibition for the diagnostic and laboratory industry, which highlights product innovation, along with the newest trends and developments within the industry. There will be several opportunities for being inspired through exciting and professional presentations, debates, workshops and lectures, in order to generate knowledge and insight into new trends and developments.

DiaLabXpo has been developed in close collaboration with the trade association DiaLab and MCH Messecenter Herning and gathers the diagnostic and laboratory industry. DiaLabXpo will be conducted every other year at Lokomotiv værkstedet in Copenhagen. In the years where the exhibition is not scheduled in Copenhagen, it will be held at MCH Messecenter Herning together with the food technology expo FoodTech.

•

DEKS, DSKM, DSTH and DSKB: The future of the Danish health sector

•

DTU ScienceShow: Science in a colourful and explosive way

•

Panel discussion: The hospital ser vice in Denmark – in which direction are we going?

•

Speakers Corner: Experience professional and general presentation from the exhibitors

FUTURE – THURSDAY 26 SEPTEMBER 2019 •

Future Lab is a innovative conference and exhibition of prototypes and gadgets. The main topics are Digital World Laboratories, Future Lab, Artificial Intelligence (AI) and new innovative approaches to the industry

•

Speakers Corner: Experience professional and general presentation from the exhibitors

OPENING HOURS Tuesday 24 September, 09.00 am – 16.00 pm

DiaLabXpo offers a great opportunity to see some products in person, touch them and get in contact with many people with a great deal of product knowledge.

Wednesday 25 September, 09.00 am – 16.00 pm

The visitors who attend the exhibition can in addition to greeting all their everyday suppliers, be enriched by all the conferences, political panel debates and other elements at the exhibition.

DiaLabXpo will be held at Lokomotiv værkstedet

Entrance is free for industry professionals. The exhibition is held at Lokomotiv værkstedet in Copenhagen.

Thursday 26 September, 09.00 am – 16.00 pm

Lokomotiv værkstedet Otto Busses Vej 5A DK-2450 København SV, Denmark For more, visit w w w.dialabxpo.dk

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

DIALABXPO

A

F

N

A /S Ninolab - 3034

Flow Robotics A /S - 3098

Nordic Biolabs AB - 3078

AH Diagnostics A /S - 1022

Frisenette ApS- 1034

Abbott - 3062

G

ApodanNordic PharmaPackaging A /S - 4010

GreenMatic A /S - 1064

Arctiko Ohaus - 3022

O OHAUS Europe GmbH - 3022

H

Orion Diagnostica A /S - 3043

HaemoMedtec A /S - 3082 B Becton Dickinson A /S - 1030 Biolab A /S - 3076 Bionordika Denmark A /S - 3070

Hamilton Robotics - 4002

P

Holm & Halby A /S - 3014

Perten Instruments AB - 1054

Hounisens Laboratorieudstyr A /S - 3072

Bio-Rad Laboratories - 3080

Q Qiagen Danmark - 3046

BioSense Solutions ApS - 4000

I

Buch & Holm A /S - 3022

I&L Biosystems Nordic A /S 3044

Busch Vakuumteknik A /S - 1026 BÜCHI Labortechnik GmbH - 3017

ICU Scandinavia AB - 3032 ILS Danmark - 3016 In Vitro A /S - 3058

D

Insatech A /S - 2004

Dandiag A /S - 3006 / 2018

R Ramcon A /S - 3074

S Sanita Footwear A /S - 1036 Saveen Werner ApS - 1056

Dansk Laborant Forening - 3028 K

DFM A /S 1032

Kem-En-Tec Nordic A /S - 1024

DiaLab - 5080

Ken Hygiene Systems A /S - 3084

DiaSorin AB - 3024

Siemens Healtingeers - 1038 Sikre Prøver - 1054 Simoco Diagnostics ApS - 2006 SSI Diagnostica - 3042

Djurhuus IT P/S - 3018 L

Dorte Egelund ApS - 1058

Lab Denmark - 1062 Labware - 3094

E

Luminex Corp. - 2000

Elpro Nordic ApS - 2002

T Tecan Nordic AB - 3086 TechMedia A /S - 1020 Triolab A /S - 1046

Eppendorf Nordic A /S - 1044 Ergotec Arbejdsmiljø ApS - 3088 Eupry - 3096

M MERCK KGaA Darmstadt - 1040 Metrohm Nordic ApS - 1028, 0001

V V WR International A /S 3056

Miele A /S - 3040 MikroLab Aarhus A /S - 3066

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

23

DIALABXPO

Komprimator

Mens Room 5 toilets & 1 urinal

Ladies Room 6 toilets

Port 4

Dør 8

Dør 10

Dør 11

Dør 6

Dør 9

Dør 4

Port 1

Dør 7

Dør 5 Movia

Storage

Dør 3

Dør 2

Port 2 Rum 14 (Køkken) Dør 1 2 x Registrering

PC VELKOMMEN

Production Office

1 : 400 01.08.19 MM Vardevej 1

24

DK-7400 Herning

mch.dk

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

T. +45 99 26 99 26

F. Teknisk service +45 99 26 99 01

SEE YOU AT DIALABXPO Ready to assist you in the lab Flowbot ONE has been deveoped in close collaboration with users from industry and academia. It requires no programming, and visitors at our booth get the chance to set up a program and see it do the pipetting in action.

DiaLab is the Danish Trade Association for companies engaged in the trade and/or production of products used by laboratories.

The laboratory sector includes hospital laboratories and research laboratories - both public and private - practitioners and laboratories in a number of other sectors including pharma, food, environmental sector and Biotech.

The association is a member of Dansk Erhverv (The Danish Chamber of Commerce) and works to strengthen the member companies’ competences within ethics, environment and CSR and raise industry standards in general.

Meet us at booth 3098 - www.flow-robotics.com Meet us at booth 5080 - https://www.dialab.dk/

Busch Vakuumteknik is one of the largest manufacturers of vacuum pumps in the world.

LabWare is the clear industry leader in laboratory automation software

Our product range comprises the largest selection of solutions for vacu-

with LabWare LIMS ™ (Laboratory Information Management System)

um technology in all industry sectors worldwide.

and LabWare ELN ™- a fully integrated Electronic Laboratory Notebook application.

Accurate analysis results, repeatable experiments and productivity are

LabWare’s Enterprise Laboratory Platform is a unique and proven suite of

indispensable in any laboratory or research facility. Quiet operation and

product capabilities that encompass LIMS, ELN and LES method execution

low heat emission represent further key factors for a decent working

in an integrated and enterprise ready solution.

environment. With the help of Busch Vakuumteknik all these requirements

LabWare has delivered powerful lab automation solutions to many

can be met.

different industries, and our single core product strategy benefits every

We can draw on more than 50 years of experience in vacuum pump and

LabWare customer because it enables all of our development, support and

system manufacturing.

implementation resources to focus on a common solution.

Meet us at booth 3094 - www.labware.com

Meet us at booth 1026 - https://www.buschvacuum.com/dk/da

Sanita Footwear has 110 years of experience in improving the classic Biolab A/S har eksisteret mere en 46 år og er en danskejet handels- og service-virksomhed i laboratorieudstyrsbranchen. Fra vort domicil i Risskov betjener vore ansatte alle Danmarks vigtigste forsknings- og uddannelses-institutioner såvel som fødevare, farmaceutisk og den bioteknologiske industri.

Biolab har i 25 år været ISO-9001 Certificeret og vor pipettekalibreringservice er DANAK akkrediteret. Via uddannelse, træning og lang anciennitet besidder vi en unik viden og kapacitet indenfor instrument integration og analyse-automatisering. Under mottoet "Prøv os - vi kan mere end de fleste...." repræsenterer Biolab over 20 internationale udstyrs- og reagens-producenter på det Danske marked.

clog.

This enables us to present footwear in Danish design that meets the increasing demands from the professional industry.

At DiaLabXpo you will see the well-known San Flex clog, which today is available in many different colors and prints. We will also present our popular Edge and Wave series, newly developed shoes and clogs with increased comfort and with features you need for long days at work.

Meet us at booth 1036 - www.sanitaworkwear.com

Meet us at booth 3076 - www.biolab.dk

HaemoMedtec ApS har udviklet SBCSystem - Safety Blood Cart System – en prøvetagningsvogn inklusiv en præanalytisk robot.

Og vi synes, vi har opnået et godt resultat!

SBCSystem er bygget omkring den præanalytiske robot HENm som sætter Apodan is the leading supplier of pharmaceutical packaging items in the

label med korrekt barkode på det korrekte prøverør. Og dette kan gøres

Nordic. Our main activities are development, production and sale of a

lokalt ved patienten, f.eks. på afdelingen, hvor barkoden på patientens

wide range of pharmaceutical packaging items.

armbånd skannes. Herefter hentes informationer omkring prøvebestill-

Our products are sold worldwide, and the Nordic countries are the primary

ingen i LIS/HIS og efter få sekunder leveres prøverørene med påsat label

market area. We are specialists in standard packaging solutions as well as

i et tray.

in customized packaging solutions, which is developed in close coopera-

SBCSystem indeholder flere features som optimerer workflowet – både

tion with the customer.

ved patienten, under transport og på laboratoriet.

Visit us at booth no. 4010 - www.apodanpharma.dk

Meet us at booth L3082 - https://www.haemomedtec.dk/

DIALABXPO

A Cart Including a Preanalytical Robot HaemoMedtec ApS has, in cooperation with Danish bioanalysts and other Danish companies, developed the SBCSystem – a cart including a preanaly tical robot.

And we think we made a good result!

SBCSystem - Safety Blood Cart System - is built on our SBQIntercom-software which is used in the SBQSystem (Safety Blood Queue System) which deliver bags with prelabelled tubes directly to the patient together with a queue number.

The cart is built around the pre-analy tical robot HENm, which prepares the correct sample tubes with the correct barcode labels. SBCSystem makes it possible to do this locally, where the barcode on the patient's bracelet is scanned, and then LIS/ HIS automatically delivers the information about the order. And in seconds the sample tubes are printed and delivered in a tray, where after the phlebotomy is performed as usual.

During the design and development of the SBCSystem, we have focused on

ever y thing should be easily accessible.

The cart is not wider than other wagons used until now and there is still easily room to bring it for example between two beds. We have made a workplace in front where ever y thing is right by the hand, and you can easily place the filled test tubes, the used needle etc.

With the help of several extra features, we have focused on making the workf low as optimal as possible, both besides the patient, during transport and at the laborator y.

HaemoMedtec provides diagnostic and pre-analytical equipment for many types of organizations.

The latest focus is pre-analytical systems, such as our own SBQSystem and a brand-new cart which, as something completely new in Northern Europe, includes a pre-analytical robot.

Pre-analytical robots are an area of increasing focus, as many have discovered how much gain is obtained, not only for the individual patient and the laboratory, but also socio-economically, by focusing on this part of the analysis work.

Via these preanalytical robots we in HaemoMedtec focus on the correct labeling of test tubes, that it is the correct test tubes, and not least to automate some processes and thereby release staff for other tasks.

Source: HaemoMedtec

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

DIALABXPO

Pharmaceutical Cleanroom Monitoring in Extreme Environmental Conditions.

Particle Measuring Systems releases the new Airnet II® Stainless Steel with IP65 rating for Cleanroom Monitoring in High Dust and Moisture Environments.

Aug ust 16th, 2019, Boulder, CO – Particle Measuring Systems® introduces the new Airnet® II Stainless Steel with IP65 cleanroom aerosol monitoring instrument for use in high dust and moisture environments. Built on the tried and true Airnet II 501/510X R platform, this particle sensor offers a small footprint, reliable performance, and data transmission capabilities while meeting the specification of ISO 21501-4 and ISO 146 4 4-1:2015. In addition, the Airnet II with IP65 boasts a 316L stainless steel exterior and was third party laborator y tested to CEI/ IEC60529 standards to withstand both

the harshest dust environments tested and liquid environments equivalent to direct contact from a waterjet. Thus, essentially eliminating the risk of damage from cleanroom environmental and cleaning processes.

Add the Airnet II IP65 to your existing PMS monitoring system to save money by eliminating the need for additional instrument enclosures and installation costs; or upgrade to a system with FacilityPro® software today and ensure that your cleanrooms stay continuously monitored while your rigorous cleaning procedures stay intact.

About Particle Measuring Systems Particle Measuring Systems Inc. (PMS), a subsidiary of Spectris plc, is a global technology leader in contamination monitoring, the inventor of laser particle counting, and is now the leading provider of solutions for monitoring and controlling many forms of contamination that impact companies that manufacture in ultra-clean environments.

For more information visit pmeasuring.com.

Source: Particle Measuring Systems

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

Etablering og opstart af nye virksomheder Tilførsel af ny kapital og finansiering af drift Fusion, opkøb og salg / exit Aktieincitamentsprogrammer Rekonstruktion Persondatabeskyttelse og opfyldelse af EU’s persondataforordning Skat - selskabs- og personbeskatning Læs mere på www.nrlaw.dk

Top Seven Learnings on GDPR and Clinical Trials

By Martin Binzer Lind, attorney at Jusmedico Law Firm W hen the summer of 2019 was still ver y young, Jusmedico Law Firm met with Life Science law yers from all over Europe in the BioLawEurope network.

ings from the Opinion: - The sponsor is always Data Controller under GDPR.

hence activate GDPR (when the sponsor is located in EU ).

- Study data may be used for other (research) purposes (secondar y use).

We all had the feeling that GDPR

- Do not rely on Informed Consent un-

would be a huge task for our clients.

der GDPR as a legal basis for process-

On a daily basis we meet uncertainty

ing health data.

Correct Legal Basis for Processing – Who is responsible?

- The correct legal basis for process-

We often discuss with the sponsor who

ing health data is GDPR 9(2)(i) and/or

is responsible for determining the cor-

(j) as processing is carried out in the

rect legal basis for processing health

public interest.

data in a clinical trial. If such a legal

from clients when they are planning a clinical trial. The major concern regards the interplay between GDPR and the upcoming Clinical Trials Reg ulation 536/2014 (CTR) – planned to apply from October 2019. From company to company, from countr y to

- Study data should not be deleted if a study subject revokes his/ her consent

basis is not correct, i.e. the data processing takes place in a manner and with a scope that is neither consent-

countr y, GDPR is applied differently in

to participate, not even after GDPR.

clinical trials, but to give us all a hand

- Prepare a Data Processing Impact

the European Data Protection Board

authorised in the quoted legal basis,

Assessment (DPIA).

huge fines may apply under GDPR and

has published an Opinion .

- Study data collected outside the EU

To summarise the Top Seven Learn-

1

will always pass through the EU and

ed to in a GDPR-appropriate way nor

the trial data could be jeopardised under CTR.

Opinion 3/2019, EDPB, https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_opinionctrq_a_final_en.pdf

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

LEGAL UPDATE

The compliance responsibility is vest-

on the other hand, does not offer any

ing health data in a clinical trial or

ed in Sponsor and/or the Institution

help for a sponsor who plans on using

the sponsor has a legitimate interest

under which the clinic is organised

the health data retrieved from a study

in carr ying out such processing. The

and the investigator is affiliated.

subject in a situation where the study

correct legal basis being GDPR art.

subject revokes his/ her consent to

9(2)(i) or art. 9(2)(j), as further de-

participate. If the sponsor relies on

tailed below

Fingers will point to the sponsor as the sole responsible party if the legal basis for processing health data is not in place. Moreover, the clinic and/or the institution could be held responsible in trials where, for example, they have inf luence on the security measures taken to protect the health data.

informed consent as the legal basis for processing health data, the sponsor must, as a starting point, accept the risk that such data may have to be deleted if the study subject requires such a measure to be taken. This is detrimental to any clinical trial as

However, the general principle of

the general public can no longer rely

sponsor as data controller is some-

on the data.

times modified. If the sponsor and CRO decide the purpose and means of processing, which, for example, has been seen with German CROs, a responsibility split between the CRO

Luckily, other legal bases offer more help to the sponsor. Either the sponsor carries out a task in the public interest when process-

and sponsor makes sense and must be established in a joint controller agreement, cf. GDPR art. 26.

Distinguish between Processing regarding Safety and Processing related to Research Many of our clients are concerned about what will happen to the study

Martin Binzer Lind, attorney at Jusmedico Law Firm

data if a study subject revokes his/ her consent to participate in the clinical trial.

Under ICH GCP it is an obligation to retrieve informed consent from the study subject before including him or her in a clinical trial. The rationale behind this is that the informed consent helps preser ve human dignity and integrity. The informed consent under GDPR, however, comprises the legal basis for a sponsor being entitled to process personal data, and is not primarily founded on ethical considerations, but on the right to decide the faith of the data concerning a person.

If a study subject revokes his/ her consent, CTR helps the sponsor by making it ver y clear (art. 28(3)) that activities carried out before a withdrawal are not affected. Thus, under CTR the sponsor is not required to delete all data related to a study subject, even if requested by the study subject. GDPR,

2

Recitals 25-28, Opinion 3/2019 EDPB

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

29

LEGAL UPDATE

.

Processing Health Data in the Public Interest

answer. The withdrawal only impacts

clinical trial, cf. GDPR art 35. A DPIA

data generated after the withdrawal

will reveal the routes of data travel

has been communicated, whereas data

and the means the data use to travel

generated prior to the withdrawal

them. Furthermore, the DPIA re-

On a daily basis, we discuss the pur-

must not be deleted, thus implying

veals whether the correct IT security

pose of the processing of health data

that already generated data may still

measures have been implemented. The

with sponsors-to-be. As a starting

be processed and are not affected by

Danish Data Protection Agency made

point we map the f low of the data

the withdrawal.

it compulsor y for sponsors to encr ypt

in the specific clinical trial. If the purpose of a certain operation is to demonstrate the reliability of the data or if it is for safety reasons (archiving CTR art. 41 and 43, and safety reporting art. 58) we may reach the conclusion that the sponsor has a legal obligation to process data. Hence, GDPR 6(1)(c) is the correct legal basis for processing some categories of data. W hen it comes to health data it can be arg ued that the processing is necessar y for reasons of public health, GDPR art. 9(2)(i).

W hen processing data is not related to safety, but to the research part of the

GDPR application leads to the same conclusion as suggested earlier in this article, i.e. that already generated data may be processed and archived,

see it as a huge task to provide the

handling is based on consent only.

DPIA. Some have not yet completed

Do not use consent as a legal basis. If

the DPIA, others, especially CROs, see

consent is applied as a basis, the pro-

it as a competitive edge to be able to,

cessing must stop when the withdraw-

early in the process, provide a DPIA.

al is received, and, if no other legal

Sometimes it is included in the bid

basis justifying the retention can be

offer. Both sponsors and CROs, sites

provided, data must be deleted.

and vendors, risk fines if a DPIA is

Does GDPR apply when Sponsor Transfers Data outside the EU? whereas CRO and sites could reside

ing better cures to illnesses and GDPR

in the US or unsafe third countries,

art. 6(1)(e) in conjunction with art. 9

i.e. countries outside the EU (soon

(2) (i) would be the place to look.

presumably to include the U K!). In these cases, our analysis shows that in 100% of the cases health data travel back and forth over the frontiers of

Short answer: No. There are two

EU territor y. It is fundamental that

completely different logics behind

the receiver organisation is able to

CTR consent and informed consent to

demonstrate that data will be pro-

process a study subject´s data under

cessed according to EU data protec-

GDPR. Under GDPR consent must be

tion measures, hereunder robust IT

freely given, which is inappropriate

security protocols, which include the

because there is an imbalance between

encr yption of correspondence and ISO

the sponsor and the subject (sponsor

27xxx certification .

who is eager to receive free medicine).

Under CTR the logic behind consent is to ser ve both an ethical standard and a procedural obligation. It is a safeg uard and only consenting participants can be included in the trial.

What happens to Study Data if a Subject withdraws the Consent?

Art. 28(3) of the CTR gives a clear

3

met in all processes in a clinical trial.

I have not met a sponsor who does not

ing is in the public interest of achiev-

and study subject to be an individual

whether such a requirement has been

for the subject in question if the data

Often our clients are based in the EU,

is assumed to be a greedy capitalist

health data. The DPIA often shows

whereas new data cannot be registered

clinical trial, we find that the process-

Does a CTR Consent Serve as a GDPR Consent?

all messages containing personal

not concluded prior to a clinical trial being commenced.

The sponsor may conclude a specific DPIA covering each clinical trial or a DPIA covering all the sponsor´s clinical trials. It is my experience that most biotech and pharma companies in Denmark prefer to make a detailed DPIA covering all clinical trials.

What about Secondary Use of Health Data?

Sometimes we are asked by a sponsor or investigator whether personal data may be used for other purposes outside the protocol. CTR art. 28(2) indicates that such secondar y use is applicable only under the study subject´s informed consent. However, the

W hen IT security measures are imple-

EDPB points at GDPR art. 89, cf. art

mented a legal basis for the transfer

5(1)( b) allowing secondar y use only

is always appropriate. In some cases,

for further research without having

GDPR art. 49 (d), transfers in the pub-

to retrieve a supplementar y consent.

lic interest, may apply. However, often

However, such secondar y use may oc-

an EU Standard Contractual Clause is

cur only in ver y limited cases and with

entered into.

special attention the GDPR fairness

Should the Sponsor prepare a DPIA? Under GDPR it is an obligation for a

and lawfulness principles. The EDPB promises to elaborate further on the possibilities in the future.

sponsor to conclude a DPIA covering a

Working Party 29, 2/2015 on Cloud Computing p. 10

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

CALENDAR

HIGHLIGHTED FAIRS AND EVENTS IN 2019 NORDIC LIFE SCIENCE DAYS

Date: 10.09.2019 – 12.09.2019, Malmö, Sweden

For more visit: www.nlsdays.com

Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry.

Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends.

Nordic Life Science Days attracts leading decision makers from

the Life Science sector, not only from biotech, pharma and healthtech but also from finances, research, policy and regulatory authorities.

Based on cutting-edge and advanced partnering and networking tools, Nordic Life Science Days showcases the best the Nordic region has to offer.

LABDAYS AARHUS WITH THE BIGGEST CONFERENCE PROGRAM EVER Date: 11.09.2019 – 12.09.2019, Aarhus, Denmark

For more visit: www.labdays.dk

4 huge conferences and 16 exhibitor seminars is the status of the conference program at LabDays Aarhus 2019.

The Laboratory Medical Society for Bioanalysts has announced that they will conduct their annual meeting and a theme day with the titel “Innovation in the health care system” in parallel with the LabDays Fair in Aarhus.

BioPeople, Denmark’s Life Science Cluster has decided to collaborate with LabDays Aarhus.

During LabDays Copenhagen last year, the Danish Society for Mass Spectrometry conducted an "Open House" conference, with great success, which has resulted in a similar conference in LabDays Aarhus 2019.

DIALABXPO IS THE DIAGNOSTIC AND LABORATORY INDUSTRY’S NEW EXHIBITION Date: 24.09.2019 – 26.09.2019, Copenhagen, Denmark

For more visit: www.dialabxpo.com

DiaLabXpo is the diagnostic and laboratory industry’s new exhibition that brings product innovation into sharp focus, along with the newest trends and developments within the industry.

There will be several opportunities for being inspired through exciting and professional presentations, debates, workshops and lectures, in order to generate knowledge and insight into new trends and developments.

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

BIO-EUROPE 2019

Date: 11.11.2019 – 13.11.2019, Hamburg, Germany

For further information: www.ebdgroup.com

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

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

MEDICA & COMPAMED 2019

Date: 18.11.2019 – 21.11.2019, Düsseldorf, Germany

For further information: https://www.medica-tradefair.com/ and https://www.compamed-tradefair.com/ The combination of major international medical trade fair and leading medical-technology supply industry event is absolutely unique. Come and discover the entire process chain from A to Z at a glance: COMPAMED is a chance for companies to discover the current innovations that could shape their future innovations. A platform for in-depth exchange where needs meet solutions and ideas investors. Take advantage of direct access to your target group at the medical sector’s largest global meeting point – to maintain your network, do business and drive forward innovation.

The best for both worlds, at the same time in the same place. Join us to harness the synergy that is set to make COMPAMED 2019 another huge success.

MEDICA is where the world of medicine meets. Join the largest international communication and networking platform in the industry. And it offers a lot: take advantage of this combination of the world’s largest trade fair for medicine, the leading supply market event for the associated production sector and a dynamic atmosphere to drive forward your success. The entire process chain at a glance: at COMPAMED, discover the current innovations that could shape your future innovations. The MEDICA START-UP PARK matches ideas and investors. A wide range of forums, conferences and events celebrate the topics and trends of tomorrow. All this at the same time in the same place – for the synergy that will make MEDICA 2019 as successful as previous editions.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2019

31

Celebrating 25 years of facilitating partnerships that drive life science dealmaking 25TH ANNUAL INTERNATIONAL PARTNERING CONFERENCE

NOVEMBER 11–13, 2019 // HAMBURG, GERMANY

This "must-attend" event is Europe's largest life science partnering conference. BIO-Europe's world-class workshops, panels and active exhibition along with thousands of prescheduled one-to-one meetings make this event an unrivaled forum for companies across the biotech value chain to meet and do business.

WHAT YOU CAN EXPECT:

26,000+ 5,200+ 4,300+ One-to-one meetings

Licensing Opportunities

Attendees

2,300+

140+

130+

Companies

Company presentations

Exhibitors

Find out more: ebdgroup.com/bioeurope Produced by

In collaboration with