Greater Copenhagen Life Science Sep/Oct 2018

Page 1

SEPTEMBER 2018

THEME SCIENTIFIC & CLINICAL COLLABORATIONS

— LEGAL UPDATE UPDATE ON RELEVANT ISSUES REGARDING THE EU GENERAL DATA PROTECTION REGULATION

— RECRUITMENT AND EDUCATION RESPONSIBILITIES AND OPPORTUNITIES

LabDays 2018

Secti on Page 22


CONTENTS

SEPTEMBER 2018 Publisher:

THE COLUMN By Copenhagen Health Science Partners

4

Høffdingsvej 34 2500 Valby Denmark E-mail: nem@nemmedia.dk Web: www.nemmedia.dk

RECRUITMENT & EDUCATION

6

Graduates

6

7

Photo: News Øresund - Johan Wessman

THEME 10

Editors: Karin Jensen Charlotte Strøm Arne Nielsen Clara Holm-Hansen Karin Absalonsen and Mohammed Ali Wachah.

Further Education of Life Science Employees

Scientific & Clinical Collaborations

Clinical Academic Groups on Asthma, Cancer,

Osteoarthritis, and Childhood Infections

UPDATES ON EVENTS

Graphics & Layout: Kapteina Reklame

10

14

18

BIO-Europe and MEDICA 2018

LABDAYS COPENHAGEN 2018 22 Introduction 22

Advertisement: Mohammed Ali Wachah +45 23238082 mw@nemmedia.dk

Venue Overview

24

News From Exhibitors

28

Magnus Andersen +45 4281 1110 ma@nemmedia.dk

NEW LAB ROBOT To Ease Pain and Save Time

32

Print:

NEWS FROM THE INDUSTRY

34

LEGAL UPDATE Updates on the EU General Data Protection Regulation

40

Green Graphic & Signtec Reklame

In cooperation with:

CALENDAR 43 Highlighted Fairs & Events

Two service providers – one name Elite Miljø becomes a part of COOR COOR provides specialized services for cleanroom businesses. We service the biotech, healthcare and pharmaceutical industries as well as other cleanroom and controlled environment industries. – And comply with all GMP and ISO standards… Enter our website www.coor.dk and learn more or contact us directly at +45 2835 4001

COOR OFFERS YOU:

ISSN: 2446-1776

2

• • • • • • • •

A proven success in cleanroom cleaning Certified training, retraining, audits and consulting Trained cleaning personnel on cleaning techniques in critical environments Trained technicians on cleanroom protocol, safety, security, cleaning techniques, and client specific procedures A comprehensive quality management system that is customized to your SOPs and other requirements A proven cleanroom concept, integrated into a dedicated organization Extensive experience with external and internal audits Specialized systems that comply with GMP and ISO standards

PASSION FOR SERVICE. PASSION FOR PEOPLE.


IS YOUR LABORATORY REACHING ITS TRUE POTENTIAL? Performing labs deliver results that drive better patient outcomes and improve healthcare value

Recognizing the challenges facing healthcare and clinical diagnostics, we at Abbott have been on a journey to deliver solutions that are personalized to your goals. Alinity is Abbott’s next-generation holistic family of systems, designed to simplify diagnostics and deliver unprecedented integration across key laboratory disciplines, helping you achieve measurably better healthcare performance. For more information, please visit Alinity.com, ask your local Abbott Ambassador, or send an email: wired@abbott.com

Clinical Chemistry Alinity c

Immunoassay

Informatics

Alinity i

Alinity PRO

Hematology

Point of Care

Alinity hs Alinity hq

i-STAT Alinity

Molecular Alinity m

Transfusion Alinity s

CHOOSE TRANSFORMATION


THE COLUMN

COPENHAGEN HEALTH SCIENCE PARTNERS – New Research Collaborations Promoting Health and Growth By Per Jørgensen, director at Copenhagen Health Science Partners

T

hese years the Danish healthcare system is very focussed on solving the growing challenges within the health sector. We are faced with an ageing population, more patients suffering from chronic diseases, increasing medicine and treatment expenses, a need for more coherent continuity of care across sectors and increased expectations from citizens. Political measures and structural changes of various kinds are part of the solution. But without research and innovation combined with fast and efficient implementation of new knowledge we will not succeed. In Denmark we must utilise our strong position within the health and medical sciences, health technology and the entire life science industry. A lot of the health challenges that research must help to solve are highly complex. They can no longer be solved by the researcher alone and one or two PhD students. We need large research collaborations

across universities and hospitals, where basic, translational, clinical and health technological research together contribute to finding, developing and implementing solutions. Though Danish researchers are already doing this, we need to be even better. Copenhagen Health Science Partners (CHSP) is a framework aiming to make it easier to do research and collaborate across the University of Copenhagen and the hospitals in the Capital Region of Denmark. We do this by initiating and supporting a series of cross-sectoral research collaborations called Clinical Academic Groups (CAGs). Each CAG is headed by a chairmanship consisting of one researcher from the university and one researcher from the region. In addition to the chairmanship, each CAG can have up to 10 key members, who may come from other organisations, including private enterprises. Within the framework of the CAG

the researchers and clinicians must cooperate on developing new methods for prevention and treatment and ensure that new knowledge will benefit the patients as fast as possible. Through excellent research and effective implementation of new knowledge CHSP helps improve the outcome for Danish patients. Furthermore, CHSP seeks to contribute to the Danish life science ecosystem through productive collaborations with the life science industry. The next chapter will look at the upcoming expansion of the group of partners with the Technical University of Denmark and Region Zealand. We hope the expanded partnership and the even more complete Greater Copenhagen Health Science Partners will strengthen Denmark as an interesting collaborator to universities and international companies within the life sciences.

"A lot of the health challenges that research must help to solve are highly complex. They can no longer be solved by the researcher alone and one or two PhD students."

4

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 2018

Per Jørgensen, director at CHSP


WORLD FORUM FOR MEDICINE Leading International Trade Fair

DÜSSELDORF, GERMANY 12–15 NOVEMBER 2018 www.medica.de

Member of

Forbrugsartikler medica.de/MWCF2

• Den medicinske verden for det essentielle

medica.de/MA2

• Opdag de aktuelle udviklinger • Det komplette overblik: Kun på MEDICA 2018

BE PART OF THE NO.1!

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



RECRUITMENT AND EDUCATION

CALL ON DANISH LIFE SCIENCE COMPANIES TO TAKE ON MORE DANISH GRADUATES By Karin Jensen

Young academics struggle to get a job after graduation and companies often require many years of experience or pick graduates from abroad. Recruitment agency calls on the Life Science industry to take on more Danish graduates and give them a chance to prove themselves. TEMP-TEAM, the Danish

Unemployment among

large generation of ageing

recruitment and temporar y

Danish graduates has been

employees who are getting

employment agency, is

a consistent problem since

close to retirement.

swamped with job appli-

the financial crisis. Howev-

cations from graduates,

er, many large Danish Life

who wish to work in the

Science companies are at-

Life Science industr y but

tractive to work for and are

do not even get invited to

often in a position where

a job inter view. And that

they can pick and choose

is a shame, because the

from top graduates from

graduates possess many

both Danish and interna-

Another idea could be to

qualities despite their lack

tional universities.

think in a more untradi-

of experience, according to the agency.

“It’s a problem that Danish companies pick foreign

Training at Atrium At Atrium, focus is on training and further edu-

“So why not hire more

cation in the Life Science

graduates and train them.

industr y, offering courses

They don’t have ten years of

for people who works in

experience, no, but expe-

all aspects of life science,

rience must be acquired,”

including pharmaceutical

says Kjær.

companies, the public sec-

tional way, for example train a graduate with an academic background to work

tor and medical agencies. “Our prime goal is to ensure that employees in life science are well-qualified, both in relation to their

“They are clever, fast and

graduates before Danish

adaptable, have an ac-

graduates,” says Kjær, who

ademic approach, good

would like to see Danish

lang uage skills, know IT

Life Science companies take

“We have to be a bit more

careers. We offer ever y-

and social media. There

on more Danish graduates

open and perhaps change

thing from introductor y

are so many competencies,

and help them gain expe-

the culture somewhat.

courses to Masters’ pro-

rience. Training a foreign

The graduate may be a bit

grammes,” said Søren-Ulrik

job inter view,” says Margit

graduate costs money and

overqualified for lab work

Rolsted Fangholm, Director

Kjær, who is responsible for

time too, she says.

but it’s also about getting

and Head of Department at

a chance, create a network

Atrium.

but they don’t even get to a

recruiting academics in the Life Science industr y.

Furthermore, the Danish labour market has a

in a laborator y as is often seen in other countries.

and gain some experience,” says Kjær.

ever yday work in a ver y restrictive industr y but also in relation to their personal

Examples of people taking courses at Atrium could be a pharmacist who has to learn the discipline of pharma-

"... the Danish labour market has a large generation of ageing employees who are getting close to retirement."

covigilance, or a business graduate finding employment in sales and marketing in the Life Science industr y.

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 2018

7


RECRUITMENT AND EDUCATION

“There is a ver y special

“We also have courses for

After graduating, Harting

“It’s a great opportunity to

ling uistic code you need to

those with fifteen years of

was unemployed for almost

show a company what you’re

learn before getting a job

experience and two Masters’

six months and, like many

made of. During the eight

in the industr y. And the

degrees,” says Fangholm.

other graduates, struggled

weeks, Boehringer Ingel-

to get a break. He then

heim saw my potential and

decided to take the course

offered me a job,” says Søren

“Pharma Understanding,”

Harting.

more experience you gain, the more specialised you’ll have to be, and the higher

From unemployed to international job at GN Hearing

the requirements will be,”

A one-day course at Atrium

where he met people from

Fangholm says.

kick-started Søren Harting’s

the Life Science industr y.

career in the Life Science

Introductor y courses

industr y. Søren Harting

provide newcomers in the Life Science industr y with knowledge on for exam-

graduated from the Copenhagen Business School in 2015 and during his studies,

ple anatomy, physiolog y

he worked at Novo Nordisk

and medical understand-

and wrote his Masters’ the-

ing but other wise Atrium

sis at Pfizer.

offers courses at all levels to match the entire value

“I have always been fasci-

chain in life science, from

nated by the pharmaceu-

research, clinical trials,

tical industr y” says Søren

reg ulator y work, authority

Harting.

approval and market

Harting worked for Boehringer Ingelheim for around

“I spoke with someone from

two years and a few weeks

Boehringer Ingelheim and

ago, he started a new job at

we agreed that I should send

GN Hearing.

my CV over. After a while, I was invited to an informal job inter view,” says Harting.

“It’s a dream job for me. I get to work with international responsibilities,

Initially there were no spe-

which was always my goal,”

cific job openings, but Søren

says Harting.

Harting and Boehringer Ingelheim agreed that he should do an eight-week internship.

access and launch. Margit Kjær, Senior Recruitment Specialist at Temp-Team and Søren-Ulrik Rolsted Fangholm, Director and Head of Department at Atrium


DO YOU HAVE THE RIGHT EXECUTIVE SEARCH PARTNER WITHIN TECHNOLOGY & LIFE SCIENCE? Best Talent is a Nordic Market Leading Search company and partner of the international Global Executive Search Organisation ENEX.

We have a solid knowledge of the market conditions and a very attractive executive network, in which we employ search strategies that attract highly qualified candidates.

Best Talent performs Executive Search across all functional areas within Engineering, Medical Device, Pharmaceutical, Biotechnology and Food Science. We have more than 15 years of experience in assessing talents skills and potential.

Please do not hesitate to contact Best Talent for further information on +45 4556 5300. Read more at www.besttalent.dk

NUMBER 1 PROVIDER OF HUMAN TALENT WITHIN TECHNOLOGY & SCIENCE

Best Talent · Rungstedvej 41 · DK-2970 Hørsholm · T: +45 4556 5300 · info@besttalent.dk · www.besttalent.dk Best Talent is member of Enex Global Executive Search Organisation and is represented worldwide in more than 40 countries.

SERVICES FOR THE PHARMACEUTICAL INDUSTRY » IT/MES/MIS » AUTOMATION » VALIDATION » OPTIMIZATION » PROJECT MANAGEMENT

+45 48 25 10 00 info@angroup.dk www.angroup.dk

CONTACT AN GROUP


THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

THEME

SCIENTIFIC & CLINICAL COLLABORATIONS COPENHAGEN HEALTH SCIENCE PARTNERS - A joint initiative from The Capital Region and Copenhagen University, which aims at shortening the distances between the researchers at the laboratories and the clinicians by strengthening the translational collaborations between researchers.

10

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 2018


THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

FROM PETRI DISH TO BEDSIDE IMPLEMENTATION By Charlotte Strøm, MD PhD Journalist

In late June 2018 four scientific/clinical collaborations were announced as Clinical Academic Groups (CAGs) by Copenhagen Health Science Partners (CHSP), highlighting a stronger focus on bringing ideas and results from the laboratories into clinical practice for improved patient care. Usually it takes years from

it brings together scientists

a basic research finding is

who normally would have

done till it is implemented

never met if it was not for

in clinical practice to the

this specific collaboration.

benefit of patients. A joint

I believe that both basic

initiative from The Capital

researchers and clinicians

Region and Copenhagen

gain new insights and

University, CHSP, aims at

inspiration from these col-

shortening the distances

laborations, says Director

between the researchers

at CHSP, Per Jørgensen.

at the laboratories and the clinicians by streng thening the translational collaborations between researchers. The initiative was inaug u-

The Clinical Academic Groups represent an initiative of bringing scientists together in new collaborations. It’s an opportunity for both basic

rated in 2017 and the first

researchers and clinicians to gain new insights

four CAGs were announced.

and inspiration, says Director at Copenhagen

In late June 2018 another four CAGs were announced. The set-up of the CAGs with a strong management focus is inspired by similar initiatives in the U K. -The structure and management of the hospitals and the universities represent different mindsets that tend to be carried over into thinking a bit in silos. The CAGs create forums where the ref lections and ideas of the researchers and the clinicians enrich each other. And certainly,

Health Science Partners, Per Jørgensen. Photo by Pernille Hollerup.


THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

International panel of peers select the CAGs He explains how the selection of this year’s CAGs within asthma, cancer immunotherapy, osteoarthritis, and childhood infections was done.

money. Each CAG receives

sions of the traditional

-We are currently nego-

0.5 million Danish kroner

research networks – also

tiating with The Danish

each year for two years,

for the established research

Technical University and

and in addition the costs

groups, Per Jørgensen says,

The Region of Zealand to

of enrollment of 3 ph.d.

continuing,

join the CHSP. We will have

students equivalent of 1.35 million Danish kroner. In total the research grant amounts in an estimat-

-We have established an

ed value of 2.35 million

independent, international

Danish kroner. Some would

panel of experts to evalu-

arg ue that these are small

ate the applicant projects,

amounts compared to the

in acknowledgement of

considerable size of the

the importance of having

research projects outlined

competent peers review the

in the CAGs.

project plans. The panel of experts have understanding of both basic, translational, and clinical research, and moreover research management.

-Some of the research groups, both at the hospitals and at the university, may be somewhat isolated. The CAGs aim to facilitate the f low of information and also possibly solve practical issues, such as the need for access to blood samples for the basic researcher.

to change the name accordingly to accommodate the larger geographical reach of the partnership. It is an important achievement to enclose more hospitals and thus more patients and clinical researchers along with technical expertise and scientists with different perspectives and

Long-term commitment

approaches on the problem

ers in the new CAGs are

Per Jørgensen highlights

solving from the DT U, Per

well established with

that both Copenhagen Uni-

Jørgensen says.

long standing tradition of

versity and the politicians

fundraising. The money is

at The Capital Region have

-Most of the research-

not what makes the biggest

committed themselves to

A total of 13 projects had

difference here. It helps,

use CHSP for a continued

applied to become a CAG

obviously, but I do think

focus on streng thening the

this year and four of these

that the most important

cross-sectional research

were selected as this year’s

aspect is that the CAGs

for improved patient care.

CAGs. With the announce-

manage to establish new

In fact, CHSP is about to be

ment comes also a bag of

collaborations and exten-

expanded.

About Copenhagen Health Science Partners •

Copenhagen Health Science Partners is a partnership between The University of Copenhagen and The Capital Region of Denmark. The partnership is established to strengthen the cooperation between researchers in basic laboratories and clinical researchers in the hospitals.

University researchers and clinical researchers can use CHSP to learn from each other and develop new ideas, resulting both in faster scientific results and better treatment of patients.

A strong collaboration between university and hospitals aim to create breakthroughs within near-patient health research and facilitate increased cooperation with the business community, creating more jobs in the healthcare industry. At the same time, the research result will raise the level of education among university graduates employed in the healthcare system.

The Capital Region of Denmark provides a number of health services to its 1,8 million citizens and attends to an average of 13.000 patients each day in hospitals and clinics. More than 4.000 scientists conduct innovative research at the University of Copenhagen and the hospitals.

12

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 2018


CLINICAL PROJECT MANAGEMENT New diploma programme at Atrium! A clinical trial relies on many factors to be executed successfully, and managing a clinical development project is a complex and intricate process. In collaboration with IMPLEMENT Learning Institute we have developed a project management course aimed at professionals working in clinical development.

MODULE 1: MANAGE YOUR CLINICAL DEVELOPMENT PROJECT Date: 26 - 28 November 2018 Price: 18.100 DKK ex VAT MODULE 2: LEAD YOUR PROJECT TEAM Date: 14 - 16 January 2019 Price: 17.350 ex VAT After the two modules you will have the tools and methods to maximize the efficiency and success of your project and know how to make the best use of your project team’s knowledge and experiences.

Read more at www.atriumcph.com or contact Programme Director Gitte Hornemann Møller at +45 39 15 09 20 or ghm@atriumcph.com

Implement Consulting Group has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI)


THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

CAGS 2018 ON ASTHMA, CANCER, OSTEOARTHRITIS, AND CHILDHOOD INFECTIONS By Charlotte Strøm, MD PhD Journalist

Four new research collaborations were presented at the announcement of CAGs 2018. The projects cover a wide range of common diseases with major impact on patient health in both children and adults. Read on and learn more about this year’s CAGs and what questions the researchers are trying to find the answers to. CAG Modulating the Infant Microbiome for Disease Prevention CAG Modulating the Infant Microbiome for Disease Prevention is looking into improved prevention of chronic inf lammator y diseases and treatment of paediatric asthma. Imbalance in the bacterial composition and maturation of the intestines and air ways can affect children’s risk of developing asthma later in life. The overall aim of the CAG is therefore to understand the connection between

data collected from a moth-

immunotherapy are rapidly

require greater knowledge

er-child group within the

being approved for treat-

exchange and collabora-

COPSAC2010 project. Over

ment of still more forms of

tion between clinicians

the last eight years the

cancer. The new treatment

and researchers. CAGci

project has followed chil-

options indicate that far

has established a strong

dren with an imbalance in

more patients, even where

research-clinical partner-

the bacterial compositions

the disease has spread, can

ship organization between

and thus increased risk of

become sur vivors of cancer.

universities and hospitals

developing diseases. The

Immunotherapy is based

in the Capital Region of

mother-child group data

on the immune system’s

Denmark. By streng thening

offers a unique opportu-

ability to approve and kill

the cross-institutional and

nity to outline the mecha-

cancer cells and will lead to

cross-disciplinar y knowl-

nisms that link the infant

changes in most, if not all,

edge exchange between

microbiome – before the

forms of cancer treatment

clinicians and researchers

emergence of disease – to

over the next few years.

within cancer immuno-

the development of common chronic inf lammator y diseases.

285,000 Danes live with a cancer diagnosis. In Denmark the one-year sur vival

therapy CAGci will be able to explore the potential of immunotherapy of benefit to patients, relatives and

the infant microbiome and

The CAG Modulating the

rate for cancer is 75% for

the development of chronic

Infant Microbiome for

men and 77% for women.

inf lammator y diseases.

Disease Prevention involves

The implementation of new

CAGci enclose 12 research

a total of 29 research part-

forms of immunotherapy

partners across universities

ners across universities and

has been so rapid that many

and hospitals.

hospitals.

clinicians face pressing

In the Western world the prevalence of asthma and other chronic inf lammator y diseases has more than doubled over the last 50 years. Between 250,000 and 300,000 adult Danes have been diagnosed with asthma, and a total of 7-10 per cent of all schoolchildren in Denmark suffer from asthma.

CAG in Cancer immunotherapy (CAGci)

questions and challenges with regard to the treatment. The overall aim of

society.

CAG Host Infections Laboratory research Drugs (CAG CHILD)

CAGci aims to improve

CAGci is to develop evi-

CAG CHILD aims to improve

treatment with immuno-

dence-based clinical solu-

prevention and treatment

therapy for cancer patients

tions to these challenges

of the large number of

to ensure that more cancer

and to offer evidence-based

children affected by infec-

patients sur vive. Immuno-

training of health staff in

tions each year. There is a

therapy represents a major

cancer immunotherapy.

need for fast and reliable

and significant break-

Further development

The studies will be based

through in cancer treat-

on a large amount of unique

ment, and new forms of

14

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 2018

within immunotherapy will

diagnostics and effective prevention of infections. This lack causes 50% of all


THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

children to be treated un-

ers and clinicians, including

knowledge in practice, thus

to rarer, life-threatening

necessarily with antibiotics

all four paediatric wards in

reducing the consequences

infections such as menin-

during the first two years of

the Capital Region of Den-

of these diseases.

gitis.

their life and 30% to be hos-

mark. This makes it pos-

pitalized with an infection

sible to collect biological

Infection is the most

The CAG will contribute to

during childhood. This has

material from children suf-

frequent cause of disease

the implementation of the

significant socio-economic

fering from infections and

among Danish children

latest new knowledge on

and human costs and con-

infection-like inf lammation

and responsible for 10% of

prevention and diagnosing

tributes to the antibiotic

and to apply it in basic

all deaths among children

in the healthcare system’s

resistance crisis.

research. The research col-

below the age of one. In-

handling of infections in

fections include ever y thing

children and employs a to-

from common air way infec-

tal of 60 research partners

tions not requiring treat-

across universities and

ment seen in all children

hospitals.

CAG CHILD consists of an ambitious group of highly committed basic research-

Photograph www.ty-stange.dk

laboration will contribute with new evidence-based strategies and streng then the implementation of new


THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

CAG Research OsteoArthritis Denmark – Prevention and treatment through the lifespan of patients (CAG ROAD) It hurts and it is wide spread. Osteoarthritis (OA) is increasing in prevalence and CAG ROA D aims to im-

without OA. Similarly, persons with OA who are active in the work force have 3.3 million more sick days a year than other workers. In total, OA-related expenses cost society 11.5 billion Danish kroner in 2010.

prove the quality of life of

CAG ROA D focuses on pre-

persons with OA, which is

vention and development

the second most widespread

of better treatment for pa-

condition in Denmark

tients. Based on the latest

next to allergies. Around

new research-based knowl-

900,000 Danes suffer from

edge CAG ROA D will shed

At the launch of the 2018 CAGs representatives from each CAG made a short

OA, and the costs of the

light on the risk factors

presentation of the aim of the CAG, while Per Jørgensen (Director CHSP), Ulla Wever

condition both with regard

and disease mechanisms

to treatment and loss of

affecting the development

production are substantial.

of OA. In light of the demo-

In Denmark persons with

graphic development with

OA pay their general prac-

increased life expectancy

titioners 2.7 million more

and an expected increase

visits a year than people

in the number of persons with obesity, the number of persons with OA is likely

(Dean Copenhagen University) Diana Arsovic Nielsen, (Director at The Capital Region), and regional politician, Lars Gaardhøj explained on the motivations behind establishing the partnership and the CAGs. Photo by Simon Skipper Christiansen.

significant socio-economic

and other professionals

consequences in the form of

within the field of OA.

treatment costs, handicap,

Together they will translate

reduced quality of life and

basic and clinical research

lost earnings.

into improved quality of life for persons with OA.

to grow possibly leading

CAG ROA D is a streng th-

to great human and social

ened cross-disciplinar y

CAG ROA D holds 29 re-

costs. In addition, OA has

partnership between

search partners across uni-

researchers and clinicians

versities and hospitals.

Photograph www.ty-stange.dk

16

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 2018


university of copenhagen

f a c u lt y o f h e a lt h a n d m e d i c a l s c i e n c e s

MASTER OF INDUSTRIAL DRUG DEVELOPMENT Get insight into the entire drug development process from molecule to market access Developed in close collaboration between University of Copenhagen and the pharmaceutical industry Courses combine outstanding academic-based research with an extensive contribution from leading experts from the pharmaceutical industry

det sundhedsvi

kø b e n h av n s u n i v e r

Courses in the study year 2018/2019 Discovery and Development of Medicines Drug Formulation and Delivery Chemical Process Development and Production of Active Pharmaceutical Ingredients (API) Drug Regulatory Affairs in Drug Development Pharmacology

Enroll in the full programme or take individual courses

Read more at mind.ku.dk or e-mail master@sund.ku.dk

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

Read more at mra.ku.dk or e-mail master@sund.ku.dk

Courses in the study year 2018/2019 Discovery and Development of Medicines Drug Regulatory Science The EU Regulatory Environment – Procedures and Applications The US Regulatory Environment Quality – Drug Substance and Drug Product Safety of medicines - from non-clinical development to pharmacovigilance Biopharmaceuticals – Quality Development and Documentation Clinical Development and Documentation


UPCOMING EVENTS

MEGA EVENTS

BIO-EUROPE 2018 IN MEDICON VALLEY & MEDICA 2018 IN DÜSSELDORF Edited by Arne Nielsen 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 2018 partnering event is expected to draw over 4,000 industry attendees for three days of 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— industry-specific, web-based and interactive—is uniquely suited for the needs of life science companies.

MEDICA 2018 + COMPAMED 2018 with almost 6,000 exhibitors - digital transformation remains a hot topic

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.

When top decision-makers in the healthcare business meet in Düsseldorf in the middle of November at the world's leading medical trade fair, MEDICA 2018, (date: 12 – 15/11/2018; Monday to Thursday), over 5,000 exhibitors from at least 70 countries will meet them once more, as consistent partners who are enthusiastic about innovation and offer tailored solutions for outpatient and clinical care. Digital transformation remains at the top of everyone’s list this year. It is shaping the health economy worldwide and changes both processes and business models alike.

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

This prevailing trend will not only be represented by exhibitor innovations at the MEDICA, but is also reflected in the programmes of the accompanying conferences and forums.

For more information and online registration please visit our conference website at https:// ebdgroup.knect365.com/bioeurope/?utm_source=MSPO&utm_medium=web&utm_term=NemMedia&utm_campaign=BEU18.

"The BIO-Europe 2018 partnering event is expected to draw over 4,000 industry attendees for three days of high level networking," 18

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 2018


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. This year, the COMPAMED will be taking place for the 27th time, in parallel with MEDICA, with just under 800 exhibitors (in Halls 8a + 8b). A while ago, the items presented here would generally include simple parts, components and equipment for technical devices and medical products, but today, COMPAMED is a hotspot for complex hightech solutions such as innovative materials, microtechnology and nanotechnology.

Over the previous years, MEDICA and COMPAMED have regularly received between 120,000 and 130,000 visitors between them annually, with around 60% of these visitors coming from outside Germany. This year, Federal Health Minister Jens Spahn will also be among the visitors. On November 12, he will open MEDICA 2018 and the parallel 41st German Hospital Conference. This globally unique combination means that both MEDICA and COMPAMED will reflect the entire process chain and present a comprehensive range of medical products, devices and instruments. Together, they occupy the entire space at Düsseldorf's exhibition centre.

Svanholm.com DreamTeam! MS til offgas. OUR, CER og RQ

Online måling af levende celle densitet med kapacitans

For more information: www.medica-tradefair.com or www.compamed-tradefair.com

"Over the previous years, MEDICA and COMPAMED have regularly received between 120,000 and 130,000 visitors, between them annually,"

Lineær OD sensor, stor range, der ikke forstyrres af bobler

Optisk Densitet (OD) med høj følsomhed

Physoxia Workstations. Optimalt arbejde med celler

Lucullus PIMS software styrer alle fabrikater af fermentere. Numera automatisk prøveudtagningssystem sampler 24/7


BIOTIN INTERFERENCE IN IMMUNOASSAYS

Recent studies and case reports are driving awareness that Biotin can interfere with laboratory testing. Patients, laboratories and physicians may not know about the presence of Biotin, so education and awareness can help reduce the potential for diagnostic errors.

Biotin beware – why? GORDON AVERY MSC, SCIENTIFIC LIAISON MANAGER IN ABBOTT, GIVES A BRIEF OVERVIEW OF BIOTIN INTERFERENCE IN SOME IMMUNOASSAYS In 2015 a 55-year-old man with multiple sclerosis was referred to a hospital thyroid unit because the screening thyroid function tests showed markedly elevated FT4 and FT3 results and low (apparently suppressed) levels of TSH 1, this pattern of results typically suggests a severe form of Graves’ disease. However a thyroid scan with 123-Iodine showed a normal thyroid gland with normal radioiodine uptake. The patient showed no symptoms of hyperthyroidism. As the biochemical results were discordant with the patient’s clinical assessment, investigations for assay interference from drugs or other compounds were conducted. It emerged that the patient had taken very high doses of biotin (300 mg daily, roughly 1,000 times the recommended daily intake) as a study had suggested that biotin might be beneficial for multiple sclerosis patients. The discontinuation of biotin supplements resulted in the FT4, FT3 and TSH results returning to within reference range values in just a few days. BIOTIN INTAKE AND ASSAY INTERFERENCE Biotin interference in immunoassays from several manufacturers has been described by other authors, with clear examples of potential clinically misleading test results 2. The mechanisms for biotin interference in immunoassays have also been described 3. Biotin (vitamin B7) is a hydrophilic compound that acts as a coenzyme in carboxylase reactions, and is therefore an essential nutrient. Biotin is readily available in many foods and the recommended daily intake (about 30 μg per day) is easy to achieve. Although initially only very high levels of biotin have been considered as a cause of “incorrect” laboratory results, further studies demonstrated that even at moderately elevated biotin concentrations, some assays may be affected, causing either a falsely elevated or a falsely decreased test result 4, 5.

The mechanism of biotin interference differs depending on the format of the assay 5. When biotin-streptavidin binding is used as part of a sandwich assay format, for example for some TSH assays, excess biotin in the sample can displace biotinylated antibodies resulting in falsely low results. In contrast in competitive immunoassays, for example some FT4 assays, excess biotin in the specimen can compete with the biotinylated analog for the binding sites on streptavidin resulting in falsely high results.

Patients may not realize they are taking supplements that contain biotin, labs will not know if specimens contain biotin and physicians could make decisions based on inaccurate lab results.


Immunoassays involving streptavidin-biotin interaction are used by many reagent manufacturers and have the potential to show interference from biotin by one of the mechanisms described above. Patients not taking biotin supplements would not be expected to show any assay interference. However, people taking biotin supplements may have much higher biotin intakes, with daily oral doses of up to 40 mg per day. Supplements, often described as “good for nails and hair”, containing very high doses of biotin are readily available, even on supermarket shelves, and are becoming increasing popular. Some studies, in patients with multiple sclerosis and demyelinating pathologies, show patients receiving very high doses of biotin (300 mg per day). In the presence of high biotin concentrations there is potential for competitive and sandwich assays using the streptavidinbiotin format to generate misleading test results 5. It is therefore important that the laboratory considers its choice of assay, and recognises the possibility of biotin interference if test results do not fit with each other or with the clinical picture. Where biotin interference is possible or expected, the biochemical results should be obtained or checked with assays that are not affected by biotin interference.

Abbott has recently conducted an evaluation and no on-market ARCHITECT assay formulations use the free capture streptavidin/biotin assay format referenced in recent articles that have been associated with interference from ingested high dose biotin.6

5 STEPS

TO HELP REDUCE LABORATORY ERRORS CAUSED BY BIOTIN

ADD-00061021_EN_WIRED_Issue 4_Biotin May 2018

1. Raise Awareness 2. Know your assays and the impact biotin can have on them 3. Educate your health care providers and patients 4. Have a contingency plan for acute care settings 5. Recognize there are laboratory methods that are not impacted by biotin that can provide an alternative option for your patients

ABOUT: BIOTIN Biotin, also referred to as Vitamin B7 or H, is a water-soluble B-complex vitamin that helps the body metabolize proteins, fats, carbohydrates and process glucose. Biotin is a safe and essential vitamin for supporting overall health and plays a role in medicine and the beauty sector.

SUMMARY • Biotin (vitamin B7) is an essential nutrient for which an intake of 30 μg per day is recommended. Supplementation is normally not necessary since biotin is ubiquitous in common foods. • As well as being available as a “beauty” supplement, biotin may be administered to patients with multiple sclerosis, myopathies and with some inherited metabolic diseases. • Though biotin is considered non-toxic even at high dosage, the potential clinical issue is that these doses have the potential to generate misleading results in some immunoassays. • Biotin has been demonstrated to impact assays that use biotin–streptavidin binding as part of the assay format, including thyroid function tests, other endocrine assays, assays for cardiac biomarkers and other analytes. • Some immunoassay formats are not affected by biotin and may be used to check unexpected results from assays that are affected, and/or may be preferred if the patient is known to be receiving biotin supplementation.

References: 1. Barbesino G. Misdiagnosis of Graves’ disease with apparent severe hyperthyroidism in a patient taking Biotin megadoses. Thyroid 2016, 26: 860 – 863. 2. Elston MS, Sehgal S, DuToit S, Yarndley T, Conaglen JV. Factitious Graves’ disease due to biotin immunoassay interference – a case and review of the literature. J Clin Endocrinol Metab 2016, 101: 3251 – 3255. 3. Wijeratne NG, Doery JC, Lu ZX. Positive and negative interference in immunoassays following biotin ingestion: a pharmacokinetic study. Pathology 2012, 44: 674 – 675. 4. Kwok J S-S, Chan I H-S, Ho-Ming M. Biotin interference on TSH and free thyroid hormone measurement. Pathology 2012, 44: 278 – 280. 5. Piketty ML, Polak M, Flechtner I, Gonzales-Briceño L, Souberbielle JC. False biochemical diagnosis of hyperthyroidism in streptavidinbiotin-based immunoassays: the problem of biotin intake and related interferences. Clin Chem Lab Med 2016. DOI: 10.1515/cclm-2016-0606. 6. Product Information Letter PI1011-2017.


LABDAYS COPENHAGEN 2018

WELCOME TO

LABDAYS

COPENHAGEN 2018 The CPH LabMed fair, which was last conducted in Copenhagen almost two years ago, has changed its name in connection with this year's fair, and with the new name LabDays Copenhagen, a new venue and a change in a large number of items at the lab fair, expectations are high. By Arne Nielsen

T

he exhibition will open its doors at 9 am, Wednesday the 12th and Thursday the 13th of September in the venue Oeksnehallen (Ă˜ksnehallen) centrally located in Copenhagen. About 100 companies can be found in the venue exhibiting already known as well as new exciting products and services, and the variety in different companies exhibiting is noticeable, and is expected to attract a lot of different visitors from the entire industry. Almost two years ago the fair was conducted in

22

Lokomotiv vĂŚrkstedet, and one of the major changes is that it has moved to the Oeksnehallen, which is centrally located in Copenhagen. It is expected that the smaller venue in combination with the change in duration of the event from 3 to 2 days, will create more energ y and dynamics. An important part of the concept is to maintain industry meetings in parallel with the fair, and the advantage of Oeksnehallen is that custom made meeting rooms can be established side by side with exhibition. The goal is to gather industry activities so that the

exhibitors as well as the visitors will benefit further from attending the LabDays fair. 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. All visitors have to register, when visiting the fair, which can either be done by pre-registering on w w w.Labdays.dk or at the entrance

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 2018


of the fair.

FACTS: Venue: Øksnehallen, Halmtorvet 11 1700 København V Opening hours Wednesday, 12th September: 9:00 am to 4:00 pm Thursday, 13th September: 9:00 am to 4:00 pm Registration Pre-register on Labdays.dk or register at the entrance of the fair.

Parking The Oeksnehallen is af part of DGI-Byen, and DGI-Byen has their own parking house.

Wardrobe You can store clothes, bags and other stuff in staffed cloakroom, and the price is DKK 25.

There are 192 parkings lots. Prices per hour - from 06.00 - 22.00 o'clock is DDK 32. And from 22.00 - 06.00 o'clock the prices is DDK 10. An alternative is to park in Kødbyen or along some of the streets in the area around DGIByen (Ingerslevsgade, tietgentsgade or Kvægtorvesgade).

Price It is free of charges to visit the fair.

COPENHAGEN

For further information visit: www.labdays.dk

12. - 13. september

LabDays 2018 Fagmesse for laboratorieteknik

n LSB Temadag & Årsmøde n Laboratorieudstyr n Diagnostik n Bioteknologi n Forskning n Kvalitetskontrol n DSMS Temadag Øksnehallen

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 2018

23


WELCOME TO LABDAYS COPENHAGEN 2018 Øksnehallen - Copenhagen the 12th & 13th of September

Toilet

Toilet

Toilet

Registration Wardrobe

Main Entrance

24

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 2018

Toilet


WELCOME TO LABDAYS COPENHAGEN 2018 Øksnehallen - Copenhagen the 12th & 13th of September

3M A Abbott Laboratories Agilent Technologies Denmark Anton Paar Apodan Nordic Axlab B Bio-ITech Biolab Bipea Bio-Rad Laboratories Bruker Nordic Optics division Buhl & Bønsøe Busch Vakuumteknik Büchi Labortechnik C Cereal Tester Charles River Colly Flowtech D DANOMED DFM-Danmarks Nationale Metrologinstitut Dorte Egelund Drifton D-S Sikkerhed Dynamostol E Elpro Nordic Eppendorf Ergotec Eticalls.eu Eupry F Flow Robotics Food Diagnostics Fooddes FOSS Nordic

G Getinge Danmark Glas Nordic GM Merc Gr. Cph Life Science

N NanoTemper Technologies Neotron Nordic Nordic Biolabs Nordic Biosite

H Hamilton Robotics Histolab Products HK - Dansk Laborant-Forening Hologic Denmark Hounisen Laboratiorieudstyr

P Pekema Perkin Elmer Life & Analytical Sciences Pfeiffer Vacuum Scandinavia Phenomenex Procurator Promega Biotech

I ICM ICU Scandinavia In Vitro iVention B.V. IVUS J Jørgen P. K KEN Hygiene Systems KNF Neuberger L L.A.B Analytical Nordic LABEX OF SCANDINAVIA Lablog+ Lab Science Labsupport LabWare Nordic LAT LGC Standards Li-Cor Biosciences Link Logistics M MD Scientific Mettler - Toledo Micromeritics BV Miele - Professional Molecular Devices MSC

R S Sakura Finetek SAMSI Instruments SANI Membranes Sartorius Nordic Saveen & Werner Scotsman Sika Footwear Sikre Prøver Software Point SSI Diagnostica Spectro Inlets Strandmøllen Strenometer Svanholm.com Svanholm Holding T Tecan Nordic TechMedia Temp Team Thermo Fisher Scientific T&O Labsystems U UGAB Industries V VACPRO

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 2018

25


SEE YOU AT LABDAYS COPENHAGEN 2018 Øksnehallen - Copenhagen the 12th & 13th of September

We create breakthrough products – in diagnostics, medical devices, nutrition and branded generic pharmaceuticals – that help you, your family and your community lead healthier lives, full of unlimited possibilities. Today, 99,000 of us are working to make a lasting impact on health in the more than 150 countries we serve.

WE OFFER TEMPORARY AND PERMANENT STAFF WITH SPECIFIC KNOWLEDGE WITHIN: - Quality Control - Quality Assurance - Research & Development - Medical affairs - Pharmacovigilance - Regulatory affairs

For more visit www.abbott.com / Meet us at booth no. 47

For more visit www.temp-team.dk / Meet us at booth no. 100

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.

For Axlab gælder det om at være et skridt foran, læse den teknologiske

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.

udvikling, forstå morgendagens udfordringer, og ikke mindst fornemme de nye politiske og forskningsmæssige vinde. Vi arbejder for løsninger, der sikrer kunderne effektivitet langt ind i fremtiden. I den forbindelse råder vi ikke bare over det mest avancerede teknologiske udstyr, men er også udstyret til fremtiden gennem vores innovative tænkning og rådgivning. Resultatet er tidsbesparelser, bedre arbejdsmiljø og ikke mindst bedre service for både nutidens og fremtidens brugere og patienter. Hvis ikke vi forandrer verden, forandrer den os. I vores verden handler det at tænke fremad samt at formidle ny energi i alle vores kunderelationer.

For more visit www.biolab.dk - Meet us at booth no. 42

For more visit www.axlab.dk – Meet us at booth no. 104

Flow Robotics creates flexible, user-friendly liquid handling robots for lab automation. It aims to replace repetitive, time-consuming and burdensome manual pipetting tasks, yielding consistent results and freeing up time to work on interesting scientific problems.

LABEX offers system solutions for logistics, quality assurance, diagnostic By challenging today's routines By challenging and standards, today's byroutines being curious and standards, and creative, by being we help curious our and creative, we help our analysis andbetter production totobetter blood banks, laboratories, biotech and customers succeed with customers what matters succeed them.with what matters clinical to them. Together with our customers, Together we save with lives our customers, we save lives. . pharmaceutical industry.

LABEX offers system solutions LABEXfor offers logistics, system quality solutions assurance, for logistics, diagnostic quality analysis assurance, and diagnostic analysis and production to blood banks,production clinical laboratories, to blood banks, biotech clinical and pharmaceutical laboratories, biotech industry. and pharmaceutical industry.

Website: www.labex.dk /Website: Meet us at www.labex.dk booth no 108/ Meet us at booth no 108

As the robots are controlled using an Internet browser, no installation is required. And better yet, no programming is required.

By challenging today's routines and standards, by being curious and creative, we help our customers succeed better with what matters to them. Together with our customers, we save lives.

For more visit www.flow-robotics.com / Meet us at booth no. 44

For more visit www.labex.dk / Meet us at booth no 108

26

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 2018


SEE YOU AT LABDAYS COPENHAGEN 2018 Øksnehallen - Copenhagen the 12th & 13th of September

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.

LabWare has achieved success by meeting commitments and exceeding expectations in LIMS and ELN projects large & small, local & global, routine & complex. LabWare is the clear industry leader in laboratory automation software with LabWare LIMS ™ (Laboratory Information Management System) and LabWare ELN ™ - a fully integrated Electronic Laboratory Notebook application. Results Count!

For more visit www.svanholm.com / Meet us at booth no. 39

For more visit www.labware.com / Meet us at booth no. 96

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

MSCi: All kinds of complete solutions for GC – GCMS – HPLC. We deliver instruments and support for analytical chromatography and work with all aspects: Sale of complete, fully automated and unique solutions - Service and support - Training/workshops and applications

For more visit www.apodanpharma.dk - Meet us at booth no. 155

For more visit www.msconsult.dk - Meet us at booth no. 83

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. For more visit www.nemmedia.dk

MSC: We have access to a modern and comprehensive selection of instruments, and offer: Consulting and contract analysis work Training courses, chromatography and biotechnology

A COMPLETE PROGRAM FOR SINGLE-USE SYSTEMS! Let us handle the hassle to compose your single-use application

- All components are handled in our own clean-room - Double bagged and gamma irradiated - Complete control with documentation and certs. - We handle drawings and logistics - Open architecture, use your validated critical component - Full flexibility, minimum order quantity = one unit

Meet us at booth no. 74

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 2018

27


NEWS FROM THE LABDAYS COPENHAGEN 2018 EXHIBITORS Single-Use provides flexibility and new opportunities in the Pharma Industry Colly Flowtech is part of the large and expanding industri-

ma industry as more than just a full-fledged alternative,

al group Indutrade, and has for many years been a supplier

and is increasingly becoming the first choice because of

of hoses from Saint Gobain and quick connectors from

obvious advantages:

CPC Colder.

• The time consumed by the customer is reduced

As part of our activity we have produced ready-made

• Cleaning flow of equipment is minimised

Single-Use kits and solutions for part of the pharmaceuti-

• Lower cross-contamination risk

cal industry, but we have now decided to fully support the

• Increased flexibility, faster start-up of production

implementation of Single-Use to the Bio-Pharma market,

• Increased utilization of the equipment

by expanding our staffing with Rikke Wedfeldt, who has a

• Individual Customization, (One size does not fit all)

master degree in Biology and has worked with biopharma-

• Risk mitigation, hereby better security for consistent

ceuticals. In parallel, together with our Indutrade owned

produc

tion by specialized personnel.

sister departments in Europe and UK/Ireland, the brand

• Lower investment costs

Ultrapure International has been established, by which we

• Facilitates multi-product manufacturing

have access to an ISO 14644-1 certified cleanroom, from

• Provides fast batch changeover

which the assembly and production of Single-Use products

• Lower overall environmental load (Smaller footprint)

can be carried out by highly specialized staff, delivered

• Improved segregation strategy

completely customer-specific and eventually gamma

• Closed system integrity

irradiated. The very large product-portfolio enables us to deliver

Colly Flowtech, together with selected suppliers are

according to the open architecture principle, since we can

pleased to provide a more detailed presentation of possi-

deliver products built precisely with the desired products

bilities on Labdays Copenhagen 2018.

or brands any customer would wish - or need have to according to their specifications.

Source: Colly Flowtech - For more visit www.collyflowtech.se

The single-use concept is now recognized in the Bio-Phar-

Detection of volatiles at PPT level Selected Ion Flow Tube – Mass Spectrometry (SIFT-MS) is a mass spectrometric analysis technique for organic components in air (VOC’s), where the typical detection limit

Typical work-areas: Molecular size: C1 – C20 Components: VOCs, Aroma components, Residual solvents

is low-mid ppt. The system is typically on-line, which

Detection limits: ppt level

uses up till eight different CI-reagents. A large number of

Strength:

VOC’s can therefore be analysed “simultaneously”, either

Fast analysis

on-line or using a high capacity headspace sampler, in

PPT detection limits

which case the typical analysis time will be around 30

Multiple CI-reagents

seconds.

Weakness:

Source: MSC, MSCi - For more visit www.msconsult.dk

Seriously complicated matrices

Analysis of isomers (the lack of chromatographic separation) Analysis of unknowns

28

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 2018


NEWS FROM THE LABDAYS COPENHAGEN 2018 EXHIBITORS New Ergonomic LidTwister Reduces Hand Injuries Take care of your hands with the new LidTwister from In Vitro. The LidTwister is designed to twist the lid on and off, on standard plastic centrifuge tubes in the sizes of 15 and 50 ml. The LidTwister is a great help to laboratory staff who daily repeat the unhealthy movement by turning the centrifuge lids on and off. The many twists throughout the day can result in permanent hand and arm injuries over the years. Some of these damages can now be eliminated by the LidTwister. The LidTwister is very easy to operate. You simply place the tube in the holder, close the door, and the device turns off the lid of the centrifuge tube and leaves it loosely on top. Likewise, the devise turns the lid back on. The LidTwister are reliable and ensures a uniform and tight screwing of the centrifuge lids every time. A device as the LidTwister is the right investment for a laboratory that wishes to take care of its employees and be leading with an ergonomically correct laboratory solution. Source: In-Vitro A/S - For more visit www.in-vitro.dk

Intelligent Chemistry

s 2018 LabDayos på

JASCO UV/VIS & NIR RESEARCH SPECTROPHOTOMETERS V-700 Series

Mød r. 155 stand n

ApodanNordic PharmaPackaging A/S Kigkurren 8M • 2300 Copenhagen S • Denmark +45 3297 1555 • Fax: +45 3331 2994 packaging@apodanpharma.dk • www.apodanpharma.dk Established in 1962

Biolab A/S Sindalsvej 29 DK-8240 Risskov Telefon 8621 2866 Telefax 8621 2301 E-mail: sales@biolab.dk


NEWS FROM THE LABDAYS COPENHAGEN 2018 EXHIBITORS Facing difficulties in qPCR? Especially if your DNA sample comes from natural sources (plant or soil material), the preparation can often contain inhibitors. Usually, they are hard to remove and troubleshooting can be time-consuming. PROCOMCURE’s VitaTaq® ProPlant Mix might be just right for your application. Its specialized formulation makes it up to 35-times more tolerant against the most prominent PCR inhibitors derived from plant samples compared to regular qPCR mastermixes while keeping the reaction setup and handling steps identical. PROCOMCURE’s VitaTaq® ProPlant Mix is a convenient 2X qPCR Mastermix for SYBR® Green-based detection. If your device requires normalization, a universal concentration of ROX™ compatible with all common thermocycling devices (including Bio-Rad devices) is included. An additional HotStart feature grants maximum control over the reaction start and the included dUTP blend allows for pre-PCR UNG digestion if cross-contamination is an issue. The combination of all these features makes VitaTaq® ProPlant Mix an easy-to-use, all-round talent for difficult qPCR applications as well as for regular applications.  Suitable for all qPCR cyclers

The VitaTaq® ProPlant Mix is available at Dorte Egelund

 dUTP blend for optional UNG digestion

ApS with full customer support.

 HotStart feature  Increased resistance against PCR inhibitors

Source: Dorte Egelund - For more visit www.dorteegelund.dk

 Optimized for plant-derived DNA samples

30

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 2018


NEWS FROM THE LABDAYS COPENHAGEN 2018 EXHIBITORS Ny teknologi til paraffinsnit, frys og urincytologi Til LabDays i 2018 har Axlab valgt at fokusere på ny teknologi til paraffinsnit, frys og urincytologi. Fælles for de nye teknologier er, at de ikke alene øger den diagnostiske værdi af præparatet, men også giver et mere standardiseret præanalytisk flow og derigennem bedre mulighed for optimering af efterfølgende teknologier. Ny teknologi til skæring af paraffinblokke AS-410 Automatic Sectioning Instrument AS-410 er den nyeste og mest avancerede teknologi til automatisk skæring af paraffinsnit. På vores stand har du mulighed for at høre mere om denne nye teknologi, som ikke alene rummer fordele med henblik på automatisering, men også digitalpatologi på grund af en mere standardiseret kvalitet. Frys med samme kvalitet som et paraffinsnit PrestoCHILL er en ny type indfrysning af præparater, der sikrer en langt bedre morfologi end de tidligere kend-

The Only Complete Contamination Monitoring Solutions Provider Direct Service and Sales in Denmark

te teknologier - især på fedtvæv. Derudover eliminerer PrestoCHILL brugen af farlige reagenser i forbindelse med indfrysning. hTERT Immuncytokemisk farvning til urincytologi Med det nye anti-hTERT antistof er det i forbindelse med detektion af blærecancer nu muligt at løfte urincytologien kvalitativt. Denne cytologi har altid været behæftet med stor usikkerhed, og brugen af cystoskopi er derfor ofte brugt i forbindelse med diagnosticering. Dette kan anti-hTERT imidlertid ændre. Anti-hTERT bruger telemorase til at detektere cancer og kan derfor blive et værdifuldt redskab til at vurdere cytologien, før patienten eventuelt sendes videre til en både dyr og ubehagelig cystoskopi. Source: Axlab – For more visit www.axlab.dk

D

A

T A

M A N A G E M E

N

T

Contamination Monitors

STERILITY ASSURANCE

Services

Environmental Monitoring Systems

Training and Education

D

A

T

A

M M A N A G E

For more informtion contact us at:

pmeasuring.com T: +45 7070 2855 E: pmsnordic@pmeasuring.com

E

N

T


NEW LAB ROBOT

NEW LAB ROBOT TO EASE PAIN AND SAVE TIME FOR LABORATORIES By Karin Jensen

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

ly shoulders, arms and hands,”

“You press the screen, just like

National Research Centre for

says Charlotte Rossmeisl, CCO

a smart phone.”

Work Environment shows that

at Flow Robotics.

37% of laboratory techni-

“Previously, lab robots have

Charlotte Rossmeisl, Chief Commercial Officer at Flow Robotics

Flow Robotics is currently

been difficult to set up but

launching its new lab robot,

we’re changing that. Our

the flowbot ONE, which can

robot is easy to use and is

perform liquid handling tasks

quickly to set up just as it can

Another advantage of the

in the laboratory and take over

perform many different tasks.

flowbot ONE is that it can take

many of the repetitive and

That can be an advantage for

over time-consuming parts of

“Manual pipetting is a large

burdensome manual pipetting

those laboratories, which have

the workflow, thereby freeing

part of liquid handling in a

tasks. Unlike other lab robots,

not previously been able to

up time for other tasks. Not

laboratory. That means repet-

the flowbot ONE does not re-

automate its tasks because

just in pharmaceutical and

itive work for hours and hours,

quire programming skills and

things change all the time,”

biotech companies, but also in

often in a fixed position, and

can be used by anyone.

says Rossmeisl.

research institutions.

cians experience pain several times a week. And this is just laboratory technicians. Add to that the medical laboratory technologists.

the result is strain to especial-

32

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 2018

Time saving


NEW LAB ROBOT

“A PhD student, for example, spends his or her precious time on manual pipetting. With the flowbot ONE, time can be spent more sensibly by letting the robot do the manual work,” says Charlotte Rossmeisl.

History Kasper Støy, professor and co-founder of Universal Robots together with assistant professor Andres Faiña realized the need for highly flexible, low cost

A pilot robot has been tested at a biotech

liquid handling robots while coordinating a large-scale EU project involving

company and at the Technical University

partners in chemistry and biotechnology. They started to develop their ideas

of Denmark (DTU) for a year and an up-

of a flexible and user-friendly platform suitable for automating simpler liquid

graded and final version of flowbot ONE is

handling tasks that change often. This became the starting point for Flow

now ready for the market.

Robotics A/S, which was founded in 2015.

“The biotech company and DTU used the

By bringing together experts from biotech, IT and robot automation Flow

robot as much as possible during that year

Robotics has been able to create a small, flexible lab robot for handling liquid,

and provided useful feedback, which we

taking into account the needs of users and bringing new technology such as

have used to further develop the robot

Augmented Reality into play.

during that time. The feedback we got was priceless because the robot was actually used in real laboratories for real tasks,” says Rossmeisl.

The demo version of flowbot ONE was ready in August 2017 and hereafter pilot customers from the public and private sectors started using it in their laboratories. In close collaboration with pilot customers and researchers at the IT University, the robot was further developed to become increasingly efficient

Flow Robotics expects the flowbot ONE will be a success and has already seen lots of interest for the new lab robot.

and user-friendly. By august 2018 the flowbot ONE was launched.

Din leverandør af basisudstyr til laboratorier

Ser du Netflix? Har du set the Rain, så er alt filmet laboratorieudstyr leveret af A/S Ninolab! Vores kerneværdier

Fleksibilitet:

Kunde fokus:

Åbenhed:

Engagement:

Innovation:

Pålidelighed:

Stabilitet:

Vores engagement for at levere topkvalitet

Betjener vores kunder og opfylder deres behov

Vi giver aldrig op i vores ambition om at overgå vores kunders for-ventning

Vi skal levere hvad vi lover og altid tage ansvar for vores handlinger

Vi tilpasser os kundernes behov og ønsker

Vi kommunikerer åbent og ærligt

Ved at fokusere på en innovativ tankegang skal vi give den bedste løsning til vores kunder

Vi har en sund finansiel platform til et langsigtet samarbejde

A/S Ninolab • Cordozasvinget 6 • 2680 Solrød Strand • 44911007 • info@ninolab.dk • www.ninolab.dk


INDUSTRY NEWS

NEWS FROM THE INDUSTRY Edited by Arne Nielsen

Biotech Execution The path from research idea to regulatory approval and introduction of a biotech product to market is complex and fraught with pitfalls. To successfully negotiate this path, or even just parts of it, requires specialist knowledge in a vast array of niche areas. Biotech Execution gives small companies the opportunity to call upon a network of independent specialists with experience of each stage in the development pathway. Whether the ultimate goal is to go all the way to market, to secure partnership, or to sell the asset, small companies can benefit from a bespoke service that saves time and frustration, allowing them to utilise the knowledge of industry experts in regulatory affairs, project management, biostatistics, data management, medical writing,

pricing, PRO outcomes, health economics, and KOL networks. “Biotech Execution helps small companies plan and execute essential tasks on a par with mature companies, be it in communication with the various regulatory authorities, documentation or strateg y”, says Tove Holm-Larsen, CEO of Pharma Evidence and founder of the Biotech Execution initiative. Biotech Execution offer a first meeting free of charge, and our network of specialists look forward to helping your company reach its full potential. Source Pharma Evidence - For more visit www. pharmaevidence.com

DUKADA® Trio – Unique add-on for insulin pens ¬DUK ADA Trio® is a unique Smart Cap especially designed for the insulin pens Novo FlexPen® from Novo Nordisk and Sanofi Solostar® from Sanofi. The coverage of other insulin pens is considered. The base is thinking on how to make insulin pens meet daily life needs of users of insulin pens. It is one of the most innovative insulin pen add-ons in Europe which was designed and is produced in Denmark. The high quality Danish design is elegantly blended with functionality. It includes distinctive features that facilitate diabetes life with insulin pens. •

Timer

Needle Light

Flex-Grip

Sun-Light protection

The unique sun-light protection (useful all year round but especially in summer time) protects the insulin container of the insulin pen when the insulin pen is used.

The timer provided on DUK ADA Trio records the time since the latest insulin injection, and it can be easily retrieved. The needle light allows diabetics to take insulin in the dark, while the Flex-Grip is dedicated to diabetics that have shaking hands – or inject insulin on the go - and it has been proved a highly helpful

34

means that stabilizes the hands during the insulin injection.

DUK ADA ApS has developed a network of distributors and retailers in Europe. Recently, DUK ADA ApS started the distribution of their products in Amazon all over Europe. Source DUKADA ApS - For more visit www.dukada.com

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 2018


INDUSTRY NEWS

Lactobio is developing a new screening platform The new screening platform consists of new probiotic isolates collected from multiple different sources and donors. The new strain collection is the foundation for screening and identification of new lactic acid bacteria with specific characteristics suitable for modulation of the microbiome to prevent or manage different diseases. Screening technologies include various antimicrobial assays and a new project focus on the fight against antibiotic multi-resistant bacteria has obtained very promising results. Lactobio has isolated and identified new probiotic strains being able to inhibit growth of Methicillin Resistant Staphylococcus aureus (MRSA). MRSA is a major concern and currently one of the most common nosocomial pathogens, thus a leading cause of a variety of hospital-acquired infections. The isolated lactic acid bacteria have antimicrobial activity and inhibit the growth of MRSAs.

Source Lactobio ApS For more visit www.lactobio.com

ViroGates announces the first suPARnostic® TurbiLatex product. The prognostic biomarker suPAR (soluble urokinase Plasminogen Activator Receptor) is a strong measure of chronic inf lammation and underlying risk of negative outcomes including short-term mortality, and is highly suited for risk evaluation in Emergency Departments. Now it will be even easier to measure suPAR in the hospital laboratories, as the first suPARnostic® TurbiLatex product has just been launched – validated for Roche Cobas analyzer. Thereby suPAR can be automatically determined simultaneously with other blood parameters at the central laboratories, and the result automatically reported into the laboratory information system. suPAR is an unspecific biomarker elevated by most diseases and correlated to disease severity, and is superior to other biomarkers in risk prediction. A low suPAR level is a safe indicator for a good prognosis and can therefore be used for discharge decisions. This way, the healthcare systems can allocate resources more effectively.

In the figure is shown the guideline for suPAR in acute medical patients. A low suPAR (<3 ng/ml, 56% of patients) supports the decision to discharge the patient – and a high suPAR (>6 ng/ml, around 12% of the patients) calls for immediate clinical attention and further investigation. Source ViroGates - For more visit www.virogates.com

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 2018

35


INDUSTRY NEWS

New generation of single-use bags reduces the risk of process loss and contamination The utilization of single-use systems continues to grow, and so does the concern about the purity levels of the single-use components and their potential impact on high-value final products. From the high cost of losing product due to assembly failures at fill/ finish, to ever-increasing scrutiny from regulatory bodies, every angle requires protective measures. With a product design that incorporates the purity, integrity and performance standards of the microelectronics industry with the regulatory and quality requirements for life sciences, the new Aramus single-use 2D bags from Entegris allow you to protect and store your high-value process solutions with reduced risk of process loss, contamination or compromised quality and efficacy. The Aramus single-use 2D bags are made of a

high-grade, gamma-stable f luoropolymer (Tef lon), providing higher purity, greater compatibility and increased safety for critical process f luids and final products. With a new single-layer technolog y that contains no curing agents, antioxidants, plasticizers or adhesives, the number of potential contaminants is greatly reduced. These single-use bags offer the widest operating temperature range, making them more durable in frozen applications (down to -85° or lower without going brittle or porous). This groundbreaking quality offers a safer process, reducing the risk of product loss. Source: Alf low – For more www.alf low.dk

Xvivo System - X3 Hypoxia Hood and Culture Combo Xvivo X3 is the world's first incubation and handling system designed exclusively for meeting the needs of cells. Unlike traditional CO2 incubators and BSCs, the CytoCentric® Xvivo X3 platform features several design attributes to accommodate a Cell’s need for: •

Full Time Protection: closed incubators, closed hoods, medical grade gases, and continuous internal HEPA filtration ensure that cultures are never exposed to room borne contaminants

Full Time Optimization: every cell incubation, cell handling, and cell analysis step occurs within a controlled, cell optimized workf low that prevents exposure to randomly varying and non-optimal room air

Physiologic Simulation: all incubator and hood modules are programmable for matching in vivolike levels of O2, CO2, pH, and Temp

Protocol: since different cell cultures require different conditions, independently control multiple cell experiments at the same time under different cell protocols of O2 and CO2

36

Dynamics: since the cellular microenvironment isn’t static, program any incubator chamber or hood module with controlled changes of O2 and CO2 to match metabolic state, cell expansion requirements, or pathological modeling

Fit: the f lexible design of Xvivo X3 provides configurations for any application, any budget, and any space with plenty of future upgrade options to avoid equipment dead-ends

Source Ninolab - For more visit www.ninolab.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 2018


WHEN CHOOSING YOUR REGULATORY PARTNER IS A MATTER OF TRUST DONE RIGHT – FIRST TIME EVERY PROJECT AND EVERY CLIENT IS DIFFERENT A-consult group offers the whole palette of Regulatory Affairs, Quality and Vigilance. Our objective is to ensure that you get the best professionals every time. A-consult group offers solutions adapted to your timelines and your budget in compliance with local regulations. Learn more about our services online: www.a-consult.com

HURTIGERE!

g! n i remertrohm.dk t i T www. NU OGSÅ KARL FiSHER!

OMNIS

VI HÆVER STANDARDEN TIL ET NYT NIVEAU MEGET HURTIGERE

MERE SIKKERT

MEGET NEMMERE

Udfører op til fire automatiske titreringer med det samme system på samme tid.

Ingen udsættelse for kemikalier længere som følge af kontaktfri udskiftning af reagens.

En grafisk brugerflade & letforståelig brugervejledning gør OMNIS simpelt og sjovt at styre.


INDUSTRY NEWS

Brighter and higher resolution 3D images of live cells with Olympus Advances in microscopy have

Designed for live cell imaging with

glycerol immersion objectives

revealed numerous key research

120-nanometer resolution, the

have been primarily used. A key

findings. In particular, as confocal

Olympus FluoView and IXplore

benefit of silicon objective lenses

microscopes have come into more

SpinSR10 super resolution imaging

is the ability to avoid mismatching

general use, this has enabled

systems balance speed, resolution,

refractive indexes. When used as

researchers to obtain sharp

and efficiency in a single, f lexible

an immersion medium, silicone

three-dimensional f luorescence

platform. Olympus developed

oil greatly reduces spherical

images of proteins, DNA, and other

silicone immersion objectives that

aberration, which is the inability of

molecules of individual cells.

enable high-contrast, long-term

light rays to come to a single focal

3D live-cell imaging.

point in Z. As a result, brighter

With research making rapid progress, confocal microscopy is

Refractive index mismatch, and

being used for prolonged 3D live-

resulting spherical aberration, has

cell imaging to capture dynamic

historically plagued researchers

change over time as well as for

interested in long term, live-cell

three-dimensional f luorescence

imaging at high resolution, and

imaging.

in the past, water immersion or

and higher resolution 3D images of live cells and living tissue can be acquired, especially at deeper sample depths. Source Olympus

Universal ergonomical tool for the lab Mikrolab ErgoSkru reduces wrist twist and effectively reduces EBA when screw caps are to be closed and opened on bottles and vials. Automation of routine tasks ErgoSkru from Mikrolab is designed so that both the vial and the screwdriver are fixed in the direction of rotation. This prevents twist in wrists and hands when tightening and loosening of the screw caps. ErgoSkru ensures consistent screwing and unscrewing, and eliminates sources of error caused by manual closing. The torque of the screwdriver can be adjusted to suit different types of glass, tubes and bottles. Intuitive operation and setup Special training is not required to operate Mikrolab ErgoSkru. Quick installation and setup: Connect

Pneumatic equipment creates safe working conditions

compressed air and mount suitable rack and screw

ErgoSkru can be used in and out of fume cupboards

head and the device is ready for use. Pressing the

or LAF benches and is 100% powered by compressed

button on the screw motor quickly selects between

air, which allows it to be used in explosion hazardous

screwing and unscrewing. It can be customized to

areas (ATEX).

any size or type of lid. The base plate is not fixed and

Mikrolab offers a free three weeks trial.

can easily be moved around in the laboratory. Can be purchased with a screw head that holds the lid if it

Source: Mikrolab – For more visit www.mikrolab.dk

needs to be re-screwed shortly after.

38

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 2018


Welcome to the future 13-15 November 2018

The entire food industry meets at FoodTech, and you are invited. Come and join thousands of colleagues when more than 300 Danish and international exhibitors give you insight into the future food industry. You can experience many exciting activities at FoodTech 2018: FoodLab area where suppliers of laboratory equipment present the latest products and solutions for the food industry and several other events. Read more and get your free ticket at uk.foodtech.dk

PROCESSING & PACKAGING | 13 - 15 NOVEMBER 2018


LEGAL UPDATE

GDPR UPDATE By Karin Absalonsen

In a previous article in Greater Copenhagen Life Science June 2017 I gave an overview of the most important GDPR features relevant to the Life Science sector. This article aims to give you an update of relevant GDPR issues that may have an impact on the daily operations of businesses in the Life Science sector.

T

he EU General Data Protection Regulation (”GDPR”) came into effect on 25 May 2018 and has significant impact on businesses in the Life Science sector. To comply with the GDPR Life science organisations must have policies and procedures in place to handle the GDPR requirements and to demonstrate compliance.

Extra territorial effect One of the major impacts of the GDPR is that it applies not only to Life Science organisations established within the EU but also extends its applications to organisations established outside the EU that offer goods or services to individuals in the EU and/ or monitor the behavior of data subjects within the EU. In other words, a company established in a so-called “third country” outside EU, such as the US, Canada, China etc., will have to comply with the GDPR if it targets European consumers or monitors any personal data on European citizens. As an example a US healthcare/life science company must comply with the GDPR if it receives personal information collected in the course of clinical trials from a CRO established in the EU.

Data transfer outside the EU As a main rule, transfer of per-

40

sonal data collected in the EU to a country outside the EU is forbidden by the GDPR unless the relevant third country ensures an adequate level of personal data protection that is recognized by the European Commission. The current list has 12 approved countries including, among others, Argentina, Canada, Israel, New Zealand and Switzerland. For transfer of personal data to the US the data importer must be certified to the EU-US Privacy Shield. Japan and South Korea will soon follow. In the absence of an adequacy decision by the Commission the data exporter must take certain precautions such as: 1.

2.

Signing the Commission’s Standard Contractual Clauses Adopting Binding Corporate Rules (BCR)

Since the date of implementation of the GDPR on 25 May 2018, there have been two important updates with respect to transfer of data outside the EU.

EU-US Privacy Shield Suspension demanded if US does not comply by 1 September 2018 One of the most heavily debated existing adequacy findings is the EU-US Privacy Shield which was adopted on 12 July 2016 to replace the Safe Harbour scheme that was in-

validated in 2015 by the European Court of Justice (CJEU) in the Schrems case (C-362/14). Certification under the EU-US Privacy Shield is achieved by voluntary commitment to a set of data processing principles. Members are subject to supervision by the US Federal Trade Commission. It has, however, already been subject to a legal challenge by the privacy advocacy group “Digital Ireland” and after the first formal review in September 2017 a number of issues and concerns have been raised by the WP29, the Commission and the European Parliament. On 5 July 2018 the European Parliament has issued a Resolution stating that the members of the Parliament (MEPs) request the Commission to suspend the EU-US Privacy Shield as it does not effectively procure adequate personal data protection for EU citizens. According to the MEPs this suspension should be ordered by the Commission unless the US abides by the EU standards for personal data protection no later than by 1 September 2018 and until the US complies entirely with such standards. The Resolution is a reaction to the Facebook/Cambridge Analytica scandal. The MEPs call for a stronger supervision of the Privacy Shield scheme and demand the US authorities

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 2018

Karin Absalonsen, Attorney and Partner at Nyborg & Rørdam

to react accordingly, including by removing the companies that failed to comply from the Privacy Shield Certification List. However, the Resolution is not binding on the European Commission who has the sole power to suspend or revise the Privacy Shield framework. But the Resolution is definitely a strong political signal, and with the case for invalidation of the Privacy Shield initiated by Digital Ireland currently pending before the CJEU, the future of the Privacy Shield does not look very bright.

EU and Japan have agreed on free flows of personal data On 17 July 2018 EU and Japan successfully concluded negotiations on the reciprocal findings of an adequate level of protection for personal data. The adequate decision ensures a high level of protection to EU citizens whose personal data is transferred to Japanese companies while at the same time facilitating the (intra-group) transfer of personal data to recipients in Japan. The key element of the EU-Japan adequacy decision covers personal data exchanged for commercial purposes and


LEGAL UPDATE

includes a mutual recognition of an “equivalent level” of data protection by both the European Union and Japan. However, to meet the European standards Japan has committed to still implement additional safeguards to protect EU citizens’ personal data, which includes: 1.

Strengthen the protection of sensitive data by expanding the definition hereof.

2.

Facilitate data subjects’ rights to access and rectify their personal data.

3.

Stricter conditions under which EU data can be further transferred from Japan to a third country.

4.

Implementation of a

compliant handlingmechanism to investigate and resolve complaints from European citizens regarding access to their data by Japanese authorities, supervised by the Japanese Independent Data Protection Authority. It is also highly likely that the EU-Japan adequacy decision will lead to an EU adequacy decision for South Korea in the very near future. The European Commission is expected to launch the adoption process based on Article 45 of the GDPR in order to have the EU-Japan adequacy decision formally adopted in the autumn of 2018. The South Korean adequacy decision is expected to follow shortly

thereafter. These adequacy decisions will greatly facilitate flows of personal data between Life Science organisations in the EU and Japan/ South Korea and will create the world's largest area of safe transfers of personal data.

Recent developments in Denmark The Danish Data Protection Authority (Datatilsynet) has on 23 July 2018 announced that it will make its practice regarding transmission of personal data by email via the internet more stringent. Since 2008 it has been the practice of the Datatilsynet that it is only a recommendation and not a legal requirement that the private sector should apply encrypted transmission of confidential

and sensitive personal data by email via the internet. For public authorities this has been a requirement since 2000. However, due to the risk-based approach of the GDPR for the safety of the processing of personal data and the technological development Datatilsynet has decided to change this practice for the private sector. The new rules will come into force as of 1 January 2019. Organisations in the life Science sector must ensure implementation of appropriate measures to be able to comply with the mandatory requirement to encrypt confidential and sensitive personal data when transmitted by email via the internet.

WE OFFER TEMPORARY AND PERMANENT STAFF WITH SPECIFIC KNOWLEDGE WITHIN: Quality Control Quality Assurance Research & Development Medical affairs Pharmacovigilence Regulatory affairs

Meet us at LabDays Copenhagen 2018 Booth no. 100

LIFE SCIENCE PLUS Advokater provides specialized and business oriented legal services to ambitious Life Science companies

www.lifescienceplusadvokater.dk Ole Maaløes Vej 3 | DK-2200 København N | cbh@lspadvokater.dk

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


HIGHLIGHTED COMPANIES

HIGHLIGHTED COMPANIES SEPTEMBER Lactobio has built a proprietary discovery and screening platform of new isolated probiotic strains. We are dedicated to the development of innovative microbial products and concepts to fight bacterial infections or microbiome dysfunctions associated with specific diseases. In Lactobio we focus on creation of new microbial solutions, we work with the gut, oral, skin and vaginal microbiota to create new products targeted to specific needs.

For more information visit www.lactobio.com

Mikrolab Aarhus A/S has been serving customers in Denmark and abroad for almost 50 years. The product range extends widely and includes everything in equipment and consumables for analysis in pharma, food, environment and industry. Latest news is a large range of sampling equipment for product control. Mikrolab also produces both standard and customer-specified equipment for optimization and prevention of work related injuries in the laboratory.

For more information visit www.mikrolab.dk

Alflow Scandinavia A/S offers a wide range of single-use products and solutions for the pharmaceutical and biotech industries. With 20 years’ experience and our one-stop-shop concept, we provide state-of-the-art, high-quality single-use products and solutions to help our customers secure and optimize their valuable single-use processes.

For more information visit www.alflow.dk

DUKADA ApS was first established in 2012 and started the development of the add-on for insulin pens, DUKADA Trio which was presented to the market in 2015. DUKADA Trio combines innovative solutions and Danish design for people living with diabetes. The company is focused on innovation in the field on injection delivery systems based on user experiences. Today DUKADA ApS has an important number of distributors, as well as presence in Amazon all over Europe.

For more information visit www.dukada.com

42

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 2018


CALENDAR

HIGHLIGHTED FAIRS AND EVENTS IN 2018 THE UNIVERSAL BIOTECH INNOVATION PRIZE 2018 Date: The award ceremony will take place in Paris in October 2018

For further information: 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.

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

For further information: www.ebdgroup.com The 24th 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 2018 Date: 12.11.2018 – 15.11.2018, Düsseldorf, Germany

For further information: www.medica-tradefair.com MEDICA is the world’s largest event for the medical sector. For more than 40 years it has been firmly established on every expert’s calendar. The event is the largest medical trade fair in the world – it has earlier attracted more than 5,000 exhibitors from more than 70 countries. Furthermore, each year, leading individuals from the fields of business, research, and politics grace this top-class event with their presence — naturally alongside tens of thousands of national and international experts and deci-

sion-makers from the sector. Six forums and several special shows on varied medical-technological topics are concisely presented in the halls as an attractive complement to the trade fair. E.g. MEDICA ECON FORUM, MEDICA HEALTH IT FORUM, MEDICA CONNECTED HEALTHCARE FORUM with MEDICA App COMPETITION, MEDICA TECH FORUM, MEDICA LABMED FORUM und MEDICA WOUND CARE FORUM.

FOODTECH 2018 Date: 13.11.2018 – 15.11.2018, Herning, Denmark

For further information: www.uk.foodtech.dk At FoodTech'18 there will be many opportunities for inspiration, finding new knowledge and be updated about new solutions and opportunities in the industry. The International Food Contest can again be experienced at FoodTech 2018, where the award for Denmark's best food product is presented. It is possible to try and judge the many products.

FoodLab is a part of FoodTech, which is organised in collaboration with the DiaLab industry organisation. FoodLab, which takes place in Hall L, brings together laboratory equipment suppliers who are demonstrating and presenting their products and solutions to the food industry.

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

For further information: www.atriumcph.com This is for you who works with clinical development and wishes to develop your competencies and skills within project management.

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 2018

43


24TH ANNUAL INTERNATIONAL PARTNERING CONFERENCE

NOVEMBER 5–7, 2018 ‍ ‍ ‍ / /‍ ‍ ‍ ‍ COPENHAGEN, DENMARK

Photo by Martin Heiberg, Copenhagen Media Center.

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:

4,000+ Attendees

150+

Company presentations

5,000+ Licensing Opportunities

24,000+ 2,000+ 100+ One-to-one meetings

Companies

Exhibitors

Save EUR 200 with code “Nem200” Find out more: ebdgroup.com/bioeurope Produced by

In collaboration with


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.