Page 1

JULY/AUGUST 2016

»The challenge now for the small and midsize pharma companies, is how to make the most of its potential, and to understand when in the process to get onboard« — Steffen Thirstrup, consultant at NDA Advisory Services Ltd and previous Head of Medicines Licensing at the Danish Medical Agency.

THEME

CHALLENGES IN THE LIFE SCIENCE INDUSTRY

— GROWTH IN THE GLOBAL MARKET FOR CLINICAL TRIALS

— THE BRAIN PRIZE WINNERS 2016


CONTENTS THE COLUMN July 2016

4

DISTRIBUTION 6

Publisher:

THE BRAIN PRIZE 2016

8

THEME: CHALLENGES IN THE LIFE SCIENCE INDUSTRY

Høffdingsvej 34 DK-2500 Valby Denmark nem@nemmedia.dk

Editors: Karin Jensen Charlotte Strøm Arne G. Nielsen and Mohammed Wachah.

Graphics & Layout: Nikolaj Kapteina

Pharma fuel of future growth

11

NEXT: Private-public partnership Is pursuing development opportunities

14

Medtech meets market demands

16

Scandinavian CRO’s feel the pressure, but market seen picking up

18

QUALIFIED HANDS AND HEADS

20

CPH LABMED

22

WHAT’S NEW IN LABORATORY EQUIPMENT?

24

SHAKEN, BUT NOT BROKEN

28

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30

PATENT TERM EXTENSION

32

CALENDAR 34 SUPPLIERS 35

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CHALLENGES IN THE LIFE SCIENCE INDUSTRY

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THE COLUMN

BRIDGE THE NATIONAL LIFE SCIENCE STRATEGIES By Søren Bregenholt, chair of Medicon Valley Alliance, CVP of Novo Nordisk R&D

I

n neighboring Sweden, the responsibility for the national

integrated labor market (and the transport infrastructure to

life science strategy has been placed in the hands of the

support it) and the regional framework conditions for R&D

highly experienced, Anders Lönnberg, who has been named

collaboration and innovation, funding and public-private part-

the Swedish government´s national coordinator for life science.

nerships must be addressed, coordinated and aligned, when

In Denmark, the govern-

national politicians design

ment has recently decided

both the Swedish and

to set up a life science

the Danish national life

growth team headed

science strategy.

by Lundbeck CEO, Kåre

We have plenty of regional

Schultz. The team, which

strongholds and building

consist top academia and

blocks for two coherent

C-level executives from

national life science

the top Danish pharma,

strategies. Diabetes, CNS,

biotech and Medtech-com-

dermatology, infertility

panies, has been given the

treatment, structural biol-

task to provide the politi-

ogy and e-health are just

cal decision-makers with

a few specific examples of

recommendations that can

current strongholds. In

help boost R&D, growth

addition, a medico compa-

and the export of phar-

ny such as Coloplast has

maceuticals and medico

a global presence within

products. The focus on life

ostomy care, urology and

science is no coincidence.

continence care, and Dan-

Current export earnings

ish and Swedish biotech

are about 90 billion DDK

are also on the rise with a

and the industry employs

still untapped potential.

around 36.000 people in

In Skåne, the recently

Denmark. Consequently,

opened MAX IV Laborato-

life science is second-to-

ry and the construction of

none when it comes to the

The European Spallation

overall importance for the

Source initiated in 2014

national economy. That

will provide the Medicon

is also why we need to get

Valley region with world

it right and need to make

leading research facil-

sure that the policy rec-

ities with an enormous

ommendations accurately

potential for the regional,

identify the right needs

national and global life

and point to the right

science industry.

solutions.

Done right, Medicon Valley and the above-mentioned building

Although this is a Danish national strategy the potential in

blocks can contribute significantly to bridging the Danish and

the rather unique Danish-Swedish bi-national life science

Swedish national life science strategies and ensure that both of

cluster, Medicon Valley should be top of mind in this process.

them will be greater than the sum of their parts.

Important aspects such as talent attraction and retention, an

4

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Temperatures and safety play vital role in distribution of pharma products Distributing pharma products around the world is a complex task. A number of requirements are to be met before picking a supplier of logistics- and distribution. By Karin Jensen

B

eing a pharma- or biotech-company requires a patient soul. Years, even decades, are spend developing new drugs, having them clinically tested

and approved by authorities, but it does not end there. Once a drug is ready for the market, the complex process of finding the right supplier of distribution-solutions starts. »It’s not enough to make the best chemical processes, the best analysis and so on, you need to ensure the best quality in the entire supply chain too. We’re talking about medicines and it’s important to always put the patient at the center,« says Lars Peter Brunse, head of production and logistics at Ferring. A number of factors must be taken into consideration before selecting a partner for logistics- and distribution-solutions, as well as there are a number of requirements that must be met to ensure the quality and integrity of the medicines, from manufacturer to the patient.

6

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 1 6


DISTRIBUTION

“Firstly, there are the GDP guidelines to

small-pox vaccines to the U.S. Strategic

vials, to see if the supplier can live up to

consider, or Good Distribution Practice.

National Stockpile for emergency use.

the requirements set out in the tender.

It’s very important for Ferring, and other

“Our vaccines must never be left

Afterwards, Bavarian Nordic’s quality de-

pharma companies, that you’re in compli-

unguarded and must be kept in a locked

partment carries out yearly audits to make

ance with these guidelines. It’s our license

facility. Not many distributors can live

sure the requirements are fulfilled.

to operate,” says Lars Peter Brunse.

up to our requirements so we’re primar-

“It’s a time-consuming process and

There are different ways to ensure

ily taking about the really big suppliers.

many things need to be approved before

that there is compliance, the best being

They will need large storage facilities in

delivery can commence. Our quality de-

an audit with the supplier to see if the

the airport as well as transportation from

partment ensures that the sites handling

guidelines are understood, according to

the airport to the site of delivery in the

our vaccines are fully trained and that the

Lars Peter Brunse. Among the require-

US must not be too long,” says Ole Larsen,

distributors we’ve chosen are capable of

ments that must be met are storage and

CFO at Bavarian Nordic.

handling the task,” says Ole Larsen.

temperature.

Furthermore, the vaccines must be

At Ferring, the increasing problem with

“In the Ferring portfolio we have prod-

stored at -20C, or colder, and the distribu-

counterfeit pharma products is something

ucts that has to be frozen during distribu-

tor must keep the vaccine at this tempera-

that is being taken very seriously and

tion and storage, others must be stored at

ture at all time or else the US government

extra attention on the safety of the supply

room temperature and some at 2-8C,” he

will refuse the batch.

chain is one way of avoiding this.

explains.

“We’ve had special containers developed

“There are different ways of avoiding

for the batches, each filled with dry ice and

this, fx as the EU prescribes, to do seriali-

Safety is key

with four temperature loggers to ensure

sation codes for each product or shipment,

Safety is another key issue when distribut-

a temperature of -20C or below,” tells Ole

a code which shows when and where it’s

ing pharmaceutical products.

Larsen.

produced. This way you can always track a

One company which is particularly

Before a supplier starts distribu-

attentive to security, is Danish biotech

tion of the vaccines, mock deliveries are

company Bavarian Nordic, which delivers

carried out, usually with empty capped

batch,” says Lars Peter Brunse.

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Ground-breaking research into memory wins The Brain Prize 2016 Three British neuroscientists, Tim Bliss, Graham Collingridge and Richard Morris, have won The Brain Prize 2016, the world’s most valuable prize for brain research, for their outstanding work on the mechanisms of memory. By Karin Jensen

T

he research by Professors Bliss,

ing effects of failing memory,« Sir Colin

tute in London, upon news of receiving

Collingridge and Morris has

Blakemore, chairman of the selection

the award.

focused on a brain mechanism

committee said.

known as ‘Long-Term Potentiation’ (LTP),

The award to three UK neuroscientists

Richard Morris, professor of neuroscience at the University of Edinburgh, said,

which underpins the life-long plastici-

testifies to the strong and sustained sup-

»while much of the work we have done

ty of the brain. Their discoveries have

port that the UK funding bodies, particu-

on LTP has been driven by our curiosity

revolutionised our understanding of how

larly the Medical Research Council, have

about how the brain stores memories,

memories are formed, retained and lost.

given to their research over the past three

The three neuroscientists have

decades. The three neuroscientists are

independently and collectively shown

naturally all honoured and delighted to

The Brain Prize is awarded by the

how the connections – the synapses -

receive the award.

independent, charitable Grete

between brain cells in the hippocampus

»Research into LTP has been a won-

Lundbeck European Brain Research

(a structure vital for the formation of new

derfully stimulating field to work in. Ex-

Foundation, which is founded by

memories) can be strengthened through

perimentally it can be studied at so many

the Lundbeckfonden. Professors

repeated stimulation.

levels, from the molecular machinery

Bliss, Collingridge and Morris will

»Memory is at the heart of human

that underpins it to the behaviours that

share the prize of one million Euros,

experience. This year’s winners, through

depend on it. And from the beginning it

which was presented to them at a

their ground-breaking research, have

has held up the promise of explaining the

ceremony on 1 July in Copenhagen.

transformed our understanding of

neural basis of memory,« said Tim Bliss,

memory and learning, and the devastat-

visiting worker at the Francis Crick Insti-

8

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 1 6


THE BRAIN PRIZE 2016

it is inevitable that knowledge of basic mechanisms will lead to approaches for alleviating the pathologies of memory that are becoming increasingly prominent in our ageing society.« Graham Collingridge, professor of neuroscience in anatomy at the University of Bristol, chair of the department of physiology at the University of Toronto and senior investigator at the Lunenfeld-Tanenbaum Research Institute of Mount Sinai Hospital, Toronto, Canada, said »working on the cellular mechanisms of learning and memory has been both richly challenging and intensely rewarding for me. I am really excited about now

Graham Collingridge, Richard Morris, Timothy Bliss, Crown Prince Frederik and Povl Krogsgaard-Larsen, Chairman.

translating discoveries about LTP into new treatments for dementia.«

apses in the brain might be a staggering

The human brain consists of approximately 100 billion neurons. They are

500 trillion.

Synaptic plasticity is now seen as an essential feature of how the brain works.

The key contribution of the three

It plays a part in normal development

interconnected via synapses, which allow

prizewinners was to describe LTP of syn-

early in life, as well as in memory and

the neurons to communicate with each

aptic connections in the hippocampus, to

many forms of learning. It also enables

other. On average, there are probably

work out its mechanisms and to establish

the brain to reorganize itself and, to some

about 5,000 synapses on each neuron.

its actual involvement in the formation of

extent, to restore functions that are lost,

That means that the total number of syn-

memories.

for example after a stroke.

Lundbeckfonden Call for Nominations for

THE BRAIN PR1ZE THE PRIZE OF € 1 MILLION WILL BE AWARDED IN COPENHAGEN MAY 2017 Nominations by 15 September 2016 Nominations will be reviewed by the Selection Committee: ANDERs BjöRkLuND, Sweden, Vice-chairman

TOM jEssELL, USa

COLIN BLAkEMORE, United Kingdom, chairman

sTORY LANDIs, USa

jOsEPH COYLE, USa

PHILIP sCHELTENs, the netherLandS

GEOFFREY DONNAN, aUStraLia

IRENE TRACEY, United Kingdom

For the nomination Form and detaiLS oF the nomination ProcedUre, PLeaSe ViSit: WWW.THEBRAINPRIZE.ORG

Prize Winners 2016 Timothy Bliss, The Francis Crick Institute, United Kingdom, Graham Collingridge, University of Bristol, United Kingdom Richard Morris, The University of Edinburgh, United Kingdom

The Brain Prize recognizes and rewards outstanding contributions to European neuroscience, from basic to clinical


THEME

CHALLENGES IN THE LIFE SCIENCE INDUSTRY The life science industry holds great potential for growth under the right circumstances, given the ability to overcome specific local, regional or global challenges. This series of articles

casts light on some of the potential hurdles that various stakeholders define as major challenges of the mid-term future, and simultaneously presents possible solutions to overcome them.

THEME CONTENT 11 | PHARMA FUEL OF FUTURE GROWTH 14 | NEXT: PRIVATE-PUBLIC PARTNERSHIP IS PURSUING DEVELOPMENT OPPORTUNITIES 16 | MEDTECH MEETS MARKET DEMANDS 18 | SCANDINAVIAN CRO’S FEEL THE PRESSURE, BUT MARKET SEEN PICKING UP 20 | QUALIFIED HANDS AND HEADS


THEME CHALLENGES

Pharma fuel of future

growth

Pipeline and new drugs in the product portfolio will drive future growth in the pharmaceutical industry. Still, the number of new marketing authorisations is stagnating in Europe as well as in the US. Does this imply that the engine is running out of fuel? By Charlotte Strøm, MD PhD Journalist

O

n average it takes 15 years from

with NDA and previous Head of Medicines

proof of principle in the laborato-

Licensing at the Danish Medical Agency,

this is obviously a good thing; the more

“From the patients’ perspective

ry until a new medicinal product

has years of experience with the interna-

specific and individualized the treatment

is granted marketing authorisation. The

tional regulatory process. He thinks the

is the better chances are for responding

drug development process is costly, labo-

concept of drug development is changing

to intervention. But before we get there,

rious, and has an inbuilt risk of failure.

due to fundamental changes in our under-

the benefit / risk has to be demonstrated

The upside is a large return-on-invest-

standing of diseases.

in properly powered controlled clini-

ment with regulatory approval and data

»While the low-hanging fruits have

cal trials. So from a drug development

protection for approximately 8 years be-

already been picked, e.g. statins against

perspective, small and midsize biotech

fore generic products tend to take over the

hypercholesterolemia, anti-diabetics and

and pharma companies may be seriously

market. Over the last 10 years the number

anti-hypertensive drugs etc., what we see

challenged in delivering the required

of marketing authorisations on new me-

now in biomedicine is how molecular biol-

documentation based on small and select-

dicinal products granted by the European

ogy is gradually dismantling our under-

ed populations with highly specific and

Medicines Agency (EMA) and the Food

standing of diseases – and rebuilding it

individualized disease targets.”

and Drug Administration (FDA) in the US

to become increasingly differentiated and

has been stagnant if not declining. If this

complex. Cancer is hardly ever just can-

Priority Medicines

is the fuel for future growth in the indus-

cer; instead highly selective and specific

He explains how the FDA for years now

try, then the question is how well pharma

molecular targets allow for individualized

have been addressing this challenge

is actually doing?

treatments,« Steffen Thirstrup explains,

through regulatory Fast Track and recent-

continuing,

ly added the Breakthrough process allow-

Steffen Thirstrup, who is a consultant

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 1 6

11


THEME CHALLENGES

ing expedited evaluation and in addition

did not face the same threat as small mol-

a process during which the companies are

ecules have had from generic competition,

offered scientific advice during clinical

this is no longer the case with biosimilars

development.

entering the market.

»Europe has clearly been lagging be-

»It is going to be interesting to see how

hind in this context. However, this spring

this may impact public health in the

EMA has initiated a new process, PRIME

coming years. to see how this may impact

(Priority Medicines) hoping that this

public health. For sure there is a potential

will speed up the process around find-

for more health at a lower cost.«

ing, developing, and getting new drugs

Biosimilars face strict regulatory de-

approved,« Steffen Thirstrup says.

mands on marketing authorisation – and

PRIME has come into action under the

far more than what the manufacturers of

»Molecular biology has fundamentally changed our

current international act on medicinal

original biologic products make it look

perception of diseases. Cancer is hardly ever just

drugs – by the initiative of EMA itself,

like. »Biosimilars are approved based on

cancer; instead highly selective and specific molecular

proactively trying to encourage early

a large package of quality documentation

and agile interaction with the regu-

and a clinical phase 3 trial, so the require-

latory authorities, from as early on as

ments for biosimilars do go beyond the

proof-of-principle.

definition of generic drugs in a regulatory

and powerful antibiotics to handle an

context.«

increasing global public health threat

»The challenge now for the small and midsize pharma companies for whom the

targets allow for individualized treatments,« Steffen Thirstrup says.

from e.g. multi-resistant bacteria. »Over

PRIME process with EMA could potential-

Future prospects

the past few years the national health au-

ly be beneficial, is how to make the most

From a public perspective there is a need

thorities, the EU commission and the EMA

of its potential, and to understand when

for ongoing research and drug develop-

have become increasingly open towards

in the process to get onboard,« he says.

ment in a wide range of therapeutic areas.

taking part and responsibility in collab-

Steffen Thirstrup points to private-public

oration with pharmaceutical companies;

Generics and biosimilars

partnerships as potential solutions to

a positive trend that will hopefully be

While manufacturers of biologics for years

solving truly unmet needs such as new

fruitful for all,« Steffen Thirstrup ends.

12

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Fra god idé til livsvigtige produkter

Ferrosan Medical Devices A/S udvikler produkter, der er med til at redde liv. HØIBERG er rådgiver i patentprocessen. Når man udvikler biomaterialer og elektromekaniske løsninger til kirurgi og diagnostik, befinder man sig på et konkurrencepræget - og bogstavelig talt - livsvigtigt marked. At redde liv er hvad der i over 60 år har drevet Ferrosan Medical Devices til at forske og udvikle nye produkter. Det er omfattende viden, Ferrosan Medical Devices trækker på, når de udvikler fremtidens produkter. Det kræver en ligeværdig og målrettet partner, der kan rådgive kompetent om patenter og IPR strategi. Og det har Ferrosan Medical Devices i HØIBERG. For HØIBERG er det et privilegium at bidrage til unikke løsninger og dermed bedre forhold for læger, sygeplejersker og især patienter. For Ferrosan Medical Devices betyder rådgivningen en solid patentbeskyttelse af idéerne i relevante markeder samt muligheden for at kunne navigere strategisk i forhold til konkurrenters IP rettigheder.


THEME CHALLENGES

NEXT:

Private-public partnership Is pursuing development opportunities Time-to-market is a cornerstone in successful and rapid drug development ensuring return on investment for pharmaceutical companies. NEXT offers solutions for pharma while representing a proactive approach towards turning Denmark into an attractive site for running clinical trials. By Charlotte Strøm, MD PhD Journalist

F

or pharma, time is of essence

this is where Denmark can benefit from a

during drug development. So is

strong research environment and experts

data quality. In 2014 a private-pub-

who know specifically to address these

lic partnership, National Experimental

issues.«

Therapy partnership (NEXT), was estab-

»NEXT aims at strengthening Denmark as a preferred country for early clinical research, particularly proofof-concept trials,« says Thomas Kongstad Petersen, Chairman of the NEXT Steering Committee.

lished with the key purpose of responding

Killing several birds with one stone

to the needs from pharma for easy access

The NEXT concept aims at meeting

care and productivity is improved at sites

to conducting clinical trial yielding high

challenges from several ends in the drug

that undertake clinical research.«

quality data.

development process. Thomas Kongstad

NEXT acts as a showroom for internation-

Petersen explains:

al pharmaceutical companies, displaying

»We work to strengthen Denmark as a preferred country for early clinical

»Pharma companies need access to pa-

research, particularly proof-of-concept

tients, and collaborations with academia

has put effort into five different areas:

trials, i.e. Phase 2a and 2b trials,« says

with the purpose of obtaining high qual-

dermatology, oncology / haematology,

Thomas Kongstad Petersen, Chairman

ity data documenting a new medicinal

infectious disease, respiratory medicine

of the NEXT Steering Committee,

product. Academia, and on the other hand

as well as bioinformatics.

continuing,

strengthen their position internationally

»The early clinical trials look to answer specific biomedical hypotheses, and

14

the regional academic competences, and

»We put it on display so to speak

when doing clinical research. And we

and inform about what experts we have

know for a fact that the quality of medical

available, and demonstrate accessibility

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 1 6


THEME CHALLENGES

to relevant study populations,«

Ecosystem of its own

of its own that is fertilised by increased

Thomas Kongstad Petersen explains.

While phase 2a and 2b trials are under-

clinical trial activity,« he says, and ends,

NEXT is working to optimise all processes

taken by pharma headquarters, affiliates

relating to the start-up and implementa-

typically welcome an increased number

well trained and experienced in clinical

tion of clinical trials, where optimising

of local activities. Thomas Kongstad Pe-

trial conduct, which is known to improve

legal and statutory processes has a high

tersen points to further secondary effects

data quality. Furthermore, the demand

priority.

that an increased number of clinical trials

for medical experts that can operate in an

potentially have on a range of clinical

intersection of science, clinical expertise

trial suppliers:

and bioinformatics will stimulate the edu-

»A high degree of predictability in the clinical trials is a key element. The trials are being started as planned, and

»Contract research organisations, lab-

the agreed number of patients are being

oratories, diagnostics, and medtech sup-

recruited,« he says.

pliers altogether represent an ecosystem

»The hospital employees are moreover

cation of next generation of experts.«

FACTS ABOUT NEXT •

National Experimental Therapy

partnership (NEXT) is a public-private partnership within clinical research

The partners have invested DKK 74

million

The Innovation Fund Denmark (Innovationsfonden) has invested DKK 50 million in the partnership in

Partners count 12 pharma and

2014 and DKK 42,4 million in 2016

biotech companies, one authorised

The partnership was established

provider of technological services

The project runs until 2019; by that

the 1st of November 2014 as an

- a GTS entity, and five regions

time NEXT should prove itself as

Inno+partnership

including university hospitals

self-sustainable

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THEME CHALLENGES

ÂťPrice goes above all, leaving potential risk of risk and total cost considerations out,ÂŤ Peter Huntley says in concern about market access for medical device.


THEME CHALLENGES

Medtech meets market demands The medtech industry needs to constantly adapt and act with agility to meet market and regulatory demands. Having said that the industry holds great potential for future growth with innovative products in the pipeline of which 95% is up for export. By Charlotte Strøm, MD PhD Journalist

A

t Medicoindustrien, the trade

for the industry on a national level and

the higher regulatory demands, have put a

organization of 190 Danish med-

continues:

strain on the national notified bodies, and

tech companies, the definition of

»Price goes above all! Even if total

delayed the case processing time. This

future challenges for the industry com-

cost considerations implies, that there

may jeopardize or shorten the potential

prises the constant need for innovation,

is an additional cost attached to cheap

of the product life cycle, that ranges from

market access, and handling regulatory

products from a higher risk of infections,

2 – 4 or maximum 5 years.«

demands. Director at Medicoindustrien,

re-admissions to the hospital or surgical

Peter Huntley, cuts things short in outlin-

complications, price seems to be a very

ing the future challenges of the industry.

high priority leaving total cost consider-

»The medtech industry constantly come up with novel and innovative

ations out.« He encourages to value based procure-

products – in order to meet the mar-

ment to curb this highly conservative ap-

ket demands. Taking an idea from the

proach which also tend to preclude launch

sketchpad to the market can however be

of products with higher quality and in

quite challenging. So the way we see it,

fact may end up being more expensive for

improved financial support and access to

society in the long run.

start-up incubational environments may facilitate young and still immature start-

Increasing regulatory demands

up companies,« he says.

With the EU Commission Regulation

He points to this as a political task and

concerning medical device in 2016, the in-

responsibility to ensure that favourable

dustry faces a high level of requirements

conditions facilitate start-ups:

for documentation.

»This is essential for a constant inflow of new products.«

»Clearly, this is challenge for the industry. The upside to the increasing regulatory demands is obviously that it

Market access is a challenge

will hopefully act as a quality assurance

»We see an alarming trend in the way public procurement is handled,« Peter Huntley says, defining a second challenge

on the approved and marketed products,« Peter Huntley explains, and ends »Moreover, a current concern is that

FACTS ABOUT THE DANISH MEDTECH INDUSTRY •

Traded for more than DKK 52 billion in 2014, growing 3% from the previous year

95% of the production is up for export

About 250 Danish medtech companies employs 33.500 people locally and internationally (2014)

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17


THEME CHALLENGES

Scandinavian CRO’s feel the pressure, but market seen picking up Scandinavian Clinical Research Organisations (CRO’s) have been under pressure in recent years, but there are signs that the market for clinical trials is picking up. And although small in size, Scandinavian CRO’s have a lot of potential. By Karin Jensen

S

candinavian CRO’s have been

have been under is in stark contrast to the

Asia, believes the Scandinavian CRO mar-

under pressure for some years. The

number of large international, and very

ket is characterized by heavy competition.

financial crisis was in part to blame

successful, pharmaceutical companies

»The global market for clinical trials is

for this as the number of clinical trials

that exist in the Medicon Valley region.

growing again, so the market is increas-

dropped, but also intense competition

»When you look at the number of

ing in size. There’s a lot of competition

from the very large US CRO’s, which dom-

successful international pharmaceutical

in Scandinavia, though, with some 25-30

inate the market.

companies we have in the Copenha-

active players in the market,« says Erik Carp.

»Even if you merged all the Scandi-

gen-Malmoe region, then it’s interesting

navian CRO’s into one, it would still be

to see that local CRO’s have had difficul-

a small player compared to the large US

ties making it beyond just being a small

US CRO’s dominate the market

players,« says Klaus Juel Olsen, CEO at

local player,« says Klaus Juel Olsen.

Even though the global market for clinical

Larix, a full service Danish CRO, offering assistance in all aspects of clinical trials. The pressure Scandinavian CRO’s

18

Erik Carp, head of the Nordic region at

studies is on the increase, there seems to

Ecron Acunova, a German CRO with local

be a tendency that the very large Amer-

offices in Europe, India and South East

ican CRO’s take the brunt of these deals.

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THEME CHALLENGES

Large international pharmaceutical com-

medicine in the US, which again means

is characterized by a high level of quality

panies are increasingly entering global

that everybody focuses on getting a drug

and predictability,« says Eric Carp.

agreements with the very large American

approval in the US. It’s a massive market

CRO’s, which provides a full-range service

and you can earn a lot of money there.

says especially those companies which

palette.

The US CRO’s benefit from this large

understands that the market is dynamic

home market,« says the Larix-CEO.

and it is important to develop.

sive American home market.

Market is picking up

operating in life science, which means

»The US is the place in the world where

After a downturn in the market for clini-

that we now have a number of IT-tools

you pay the most for medicine and that’s a

cal studies in recent years, there are now

available, making it easier and faster to

decisive factor,« says Klaus Juel Olsen.

signs that the market is picking up again,

work with clinical studies,«

also in the Scandinavian market, which

says Erik Carp.

To understand why US CRO’s are so dominant, one needs to look at the mas-

He points out that there are two

Eric Carp is hopeful for the future and

»We were acquired by an IT-company

things that have been decisive in forming

has a lot of potential, according to Erik

the huge US CRO market: FDA, the US

Carp.

At Larix, Klaus Juel Olsen is also hopeful for the future although he be-

Food and Drug Administration, which

»I see a potential in getting more

lieves the challenges of the past few years

is the most influential agency for drug

clinical studies to Scandinavia. We have

is unlikely to change in the coming time.

approvals, and prices.

many capable doctors here and a very

»The past year or two has seen signs of a

good infrastructure between authorities,

pick-up in the market. My assessment is

Agency) also has significant influence, but

»The EMA (The European Medicines

science, ethical committees, access to

that we right now see a nice and steady

the main difference between Europe and

patients and so on. The entire set-up here

progress,« says Klaus Juel Olsen.

US is that you pay considerably more for

in Scandinavia for making clinical trials

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19


THEME CHALLENGES

»Take human talent and make the most of it in your organization,« Helle Jørnung, President of Enex and Managing Director at Best Talent, advises.

QUALIFIED HANDS AND HEADS Over the recent years it has been discussed numerous times that sufficient and qualified manpower is a prerequisite for future growth. While discussing, reality has been catching up. By now life science is challenged by a shortage of qualified candidates to fill in the vacancies. By Charlotte Strøm, MD PhD Journalist

H

uman talent does not grow on

in life science,” she says.

or no potential of professional develop-

trees. If it did life science as a

She points to international recruitment as

ment or does not hold new challenges?

whole would be one challenge

a potential solution, even if it has its own

The companies have a vacant position –

challenges:

and try to make the human talent fit into

down. Helle Jørnung, President of Enex and Managing Director at Best Talent, a

»It is notoriously difficult to attract

recruitment agency specialized in exec-

foreign candidates to positions in Den-

looking for talent – and asking them-

utive search within engineering, pharma

mark – even if it is as attractive as life

selves how and where in the organization

and life science, points to the shortage of

science tend to be. The pay check is not

they could make the most of him or her,«

qualified candidates as a considerable and

as high in Denmark and Scandinavia as

she says.

very tangible challenge for life science:

elsewhere in the world, especially not at

»Over the past five years, the industry

the job description, while they should be

She is convinced that the change of

an executive level. Cost of living is con-

mindset will come – it just takes time.

is facing increasing demands within e.g.

siderable, and moreover insufficient inte-

»Employee branding is not a buzz word

regulatory affairs, data management,

gration of the spouse and the family has

everywhere yet. But I believe that the

and quality assurance, and thus requir-

proven time and time again to jeopardize

circumstances in the market will gradu-

ing more people. The need for qualified

successful international recruitment.«

ally force the companies to change and

hands and heads is therefore not at all a

also work more proactively on policies for

challenge of the future – it is a challenge

Change of mindset

keeping employees of 60+ years on for a

of today,« Helle Jørnung explains.

Helle Jørnung stresses that the life science

longer time,« Helle Jørnung says and ends,

She believes the recent financial crisis has

industry may want to seriously consider a

left its footprints all over the market.

change of mindset. She explains that the

needed in life science, i.e. at all ages and

companies demonstrate less risk taking

with a wide range of different academic

took the risk of changing jobs. By now

when it comes to filling vacant positions.

backgrounds. Each company needs to

the financial climate has begun to thaw,

Instead they tend to expect results from

find its own position and actions towards

and the willingness to change jobs has

day one.

handling the challenges, but increased

»During the financial crisis, nobody

returned, however the lack of manpower

»The only candidates who may meet

is noticeable. We simply lack qualified

these demands come from similar posi-

candidates to fill the open positions with-

tions. But who changes jobs if it has little

20

»For sure the manpower is already

flexibility and part-time jobs may be a good place to start.«

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Best talent bryder grænser i jagten på talent

to denmark??? • Biotechnology • Public Health & IT • Health Management • Veterinary

Hvis vi skal bryste os lidt, er vi nogle af de bedste til at finde nye talenter inden for technology og science. Vi udfører executive search til senior executives og top level specialister worldwide til følgende brancher:

Best talents succes beror på stort kendskab til vores kunders krav og udfordringer – og vi ved, hvad der kræves i forhold til at tiltrække de rette talenter.

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Manglen på kvalificeret arbejdskraft kan bremse udviklingen, og dermed risikerer Danmark, at

det rammer vores vækst, hvis dette fortsætter. For at kunne tiltrække top talent fra udlandet har vi etableret os i et internationalt search samarbejde, der er repræsenteret i mere end 40 forskellige lande – heriblandt Usa, Kina, indien og australien. Det er fint med globaliseringspuljer og for skerordninger, men samtidig må man også som virksomhed være klar til at yde en ekstra indsats, når det gælder integration af det nye talent.

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 partner in ENEX Global Executive Search Organisation and is represented worldwide in more than 40 countries.

At Studieskolen we help employees break down the language barrier in order to get them comfortably settled into Danish culture and work life. We offer both customised courses and regular group courses. Location: In the centre of Copenhagen or at your company. Read more at studieskolen.dk/life-science.

DANISH FOR FOREIGNERS


CPH LabMed

Everything is going according to plan, as around 120 exhibitors have signed up for CPH LabMed 2016 and are preparing for what is expected to be huge a gathering of the life science industry. It is expected to reach the same level, or more, as last time (2014), when 134 companies mainly from Scandinavia exhibited. By Arne Nielsen

I

n 2014 the exhibition attracted a total

and exhibitors, as well as successful new

LabMed) have signed an official coopera-

of 5483 visitors as the event was con-

initiatives with various meetings under

tion agreement regarding the event.

ducted the first time and the premiere

‘one roof’,” says Morten Dyrner.

»We are very pleased that the parties have

was considered a great success. Morten Dyrner, Managing Director at Holm &

agreed to enter into a cooperation agreeThis year the CPH LabMed exhibition

ment for the industry’s major trade fairs.

Halby A/S and member of the board of

is to be held September the 27th – 29th,

fairs. Many of our members will exhibit at

directors at DiaLab was satisfied with the

once again at the Locomotive Venue

industry trade shows; so we believe that

overall setup of the events.

in Copenhagen, which is known for its

it is natural that we now have formalized

“As an exhibitor as well as a member of

charming and rustic look.

the close cooperation with each other, so

the board of directors at DiaLab, I would have to say that our high expectations were met with a large number of visitors

that we can develop the fairs for the ben Dialab (the Danish Trade Association) and J.B. Exhibitions (organizer of CPH

efit of the entire industry together,« says Morten Dyrner.

ACTIVITIES DEKS USERMEETING 2016 Danish Institute for External Quality Assurance of Laboratories in the health sector will hold their Usermeeting in parallel with CPH LabMed 2016. The meeting contains plenum- and parallel sessions, as well as workshops and poster exhibition. Wednesday September 28 Thursday September 29 Registration is required.

LSB'S 10TH CONGRESS Laboratory Medical Society for Bioanalysts executes their 10th congress in parallel with CPH LabMed 2016.

22

Wednesday September 28 Thursday September 29 Registration is required.

16TH NORDIC MASS SPECTROMETRY Conference The Danish Society for Mass Spectrometry is this year host for the Nordic conference for Mass Spectrometry, and the conference will be hold in parallel with the CPH LabMed fair. Tuesday September 27 Wednesday September 28 Thursday September 29 Registration is required.

DIALABS’ PURCHASERS DAY Danish Diagnostics & Laboratory Association (Dialab) will hold a meeting for purchasers from both the public and private sectors. Tuesday September 27

EXHIBITORS FREE LAB THEATER The exhibitors will execute smaller seminars from the open stages registration is not required Tuesday September 27 Wednesday September 28 Thursday September 29 The full program is advertised a few weeks before the start of the fair.

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CPH LabMed Skandinavisk fagmesse for laboratorieteknik

n Nordic Mass Spectrometry Conference n DEKS Brugermøde

n LSB’s 10. årskongres n Laboratorieudstyr n Diagnostik n Bioteknologi n Forskning n Kvalitetskontrol n Over 130 udstillere

Lokomotivværkstedet 27. - 29. september 2016 cphlabmed.dk

Do you need help with.. WE OFFER TEMPORARY AND PERMANENT STAFF WITH SPECIFIC KNOWLEDGE WITHIN:

Quality Control Quality Assurance Research & Development

PCR/qPCR NGS library prep Restriction enzymes Cloning Electrophoresis Antibodies Cell culture media Custom services

Medical affairs Pharmacovigilence Regulatory affairs

Meet us at Cph LabMed Fair – booth no. 101 Tel. +45 33 36 09 44 l www.temp-team.dk

www.bionordika.dk info@bionordika.dk +45 3956 2000


Copenhagen 27th - 29th September 2016

CPH LabMed

Scandinavian trade fair for laboratory technology

Berendsen Cleanroom Offer a wide range service solutions for cleanrooms with clothing and accessories for all types of production. GMP compliance and ISO certifications ensure documentation of behavior and quality to our customers.

Founded in 1997 Almeco/DACOS A/S has required an extensive experience and expertise regarding manufacturing and distribution of unique laboratorial products in plastic for the medical and food industry.

For more information please visit: www.berendsen.dk

www.almeco.dk

We develop and deliver intuitive IT Tools, ready to use in the laboratories. The tools improve the workflow and overview in the laboratory, combined with an enhancement in the quality. The ’Electronic Instrument Logbook’ replaces the handwritten logbooks – and supports read receipts on different levels.

Strenometer ApS has specialized in test equipment – mainly for test and characterization of all kinds of surfaces. For more than 50 years, we have provided instruments and chambers to a wide range of applications, including:

The ‘Labelchecker’ checks and documents that labels are identical when splitting samples.

Our product range includes our own Danish produced MAXXLINE, the distribution of TPP (Tissue culture products), Labcon, Copan and more.

- Color measurements - Stability test: o Temperature and/or humidity o According to ICH Guidelines Q1B + Q5C - Plant growth chambers o Chambers o Walk-in - Mixing

For more information, please visit: www.sonacc.net

www.strenometer.dk

Apodan is the leading supplier of pharmaceutical packaging items in the Nordic. Our main activities are development, production and sale of a wide range of pharmaceutical packaging items.

- ELISA

- Molekylærbiologi

- Flowcytometri

- Next Generation Sequencing

- IHC

- Laboratorieservice

- Western Blot

- Food & Feed kits

Our products are sold worldwide, and the Nordic countries is the primary market area.

Visit us at our booth or at www.apodanpharma.dk for more information.

Besøg os på stand nr. 35 - www.nordicbiosite.com

Arbejdspladsbrugsanvisninger (APB), labels and other chemical compliance documents.

Moment Professionals er eksperter i at rekruttere og onboarde leder- og specialist talenter inden for Life Science og Technology.

Intelligent and automated software for APB, label and SDS authoring with advanced chemical management. Improve quality and save time with chemical management software AlphaOmega.

Kom forbi stand 3 på CPH LAB MED og hør hvordan vi effektivt kan hjælpe dig med at finde specialister og ledere indenfor RA, QA/QP, QC, analysekemikere og laboranter, Mechanical/Design Engineers, pharmacovigilance, produktspecialister/produktchefer mm.

Learn more from our many costumer cases. For more information visit: www.chymeia.com

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www.moment.dk/pro

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Copenhagen 27th - 29th September 2016

CPH LabMed

Scandinavian trade fair for laboratory technology

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!

www.svanholm.com

http://www.labware.com/

Biotech-IgG is a Scandinavian distributor of medical diagnostic and life science products with more than 30 years of in-field experience. We offer a large range of immunodiagnostic kits (RIA, ELISA & rapid tests), real-time PCR kits, microbiology products, radiochemicals, immunochemicals (antibodies & proteins) and automatic liquid handling systems.

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

Regus Fairway, Arne Jacobsens Allé 7, 5. Floor -2300 KØBENHAVN S - DENMARK Phone: +45 3538 0500 or +46 46 12 37 40

www.biotech-igg.com

www.haemomedtec.dk

Buch & Holm is a family-owned, ISO-certified company established in 1935. We offer advice, support and service of equipment to laboratories, quality control and the industry. Our products and services are offered to the Danish and Swedish market. We represent leading manufacturers worldwide. At CPH LabMed we will be demonstrating chosen products. Visit our sales pitch and see what it takes…

Siemens broad spectrum of asays and analytical systems within the fields of immunoassay, chemistry, hematology, hemostasis, infectious diseases, molecular, urinalysis, and blood gas, in conjunction with automation solutions, informatics and services, can serve the needs of laboratories of any size – today and tomorrow. Visit us at CPH LabMed 2016 and hear more about how we can help you optimize your laboratory production to fit the demanding needs in the future.

www.buch-holm.dk

www.healthcare.siemens.dk

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

Sæt nye detaljer på din karriere, og mød andre laboranter, miljøteknologer og professions bachelorer. Dansk Laborant-Forening organiserer laboranter, laboratorieteknikere, miljøassistenter, miljøteknikere og studerende/-praktikanter, der er ansat på private og offentlige kontrol- og produktionslaboratorier, på forskningsinstitutioner og på højere læreanstalter, professionsbachelorer i laboratorieteknologi og laboranter med relevante diplom uddannelser.

www.retsch.dk

www.hk.dk

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25


LABORATORY EQUIPMENT NEWS

What’s new in laboratory equipment? FROILABO LAUNCHES NEW FREEZER SERIES

NEW MICROMAN-E PIPETTE FROM GILSON

Froilabo has launched a new series of ultra-low temperature

Gilson’s new Microman-E pipette is an upgraded version of the

freezers for storage of samples at ultra-low temperatures.

classic Microman pipette, it contains several ergonomic and

Among the new features are innovative and intelligent ergo-

safety improvements. Microman-E is a “Psitive Displacement”

nomic handles, LED-indicator which makes maintenance and

pipette, which means it can handle difficult fluids such as

service much easier, user-friendly touchscreen for the most

blood, oil and solvents with a precision that far exceeds that of

important information, fast reestablishment of temperature,

an ordinary “Air Displacement” pipette. (Source: Biolab)

and ecomode for reducing electricity consumption. There are three models: Essential - for long-term storage of samples; Evolution – for daily use and frequent opening of the

THERMO SCIENTIFIC HCS PLATFORM

door; Expert – for complex control of samples and optimization

Thermo Scientific CellInsight CX7 High-Content Screening

of storage. (Source Axeb Lab Solutions)

(HCS) Platform, an integrated system for all-around performance in screening and analysis. The new platform offers a choice of imaging modes to extract the information needed

SYSMEX LAUNCHES NEXT GENERATION URINALYSIS PORTFOLIO

from the samples. The entire fluorescence spectrum can be

Sysmex Europe has launched a new series in its urinalysis

used to optimize the assay, while either wide-field or confocal

portfolio: the UN-Series, including analysers, digital imaging,

optics can be selected for any channel. (Source: Thermo Fischer Scientific)

samplers, and software. With fluorescence flow cytometry at the heart of the analysis, the company is advancing further in terms of delivering quality of results and diagnostic signifi-

BIOTEK AUGMENTED MICROSCOPY

cance and enhancing lab efficiency. Adding fully-automated

The Lionheart FX Automated Live Cell Imager with Augmented

imaging for the final step in the urinalysis workflow, thereby

Microscopy enables superior microscopy with high resolution

reducing turnaround time and potential human error.

images up to 100x. Live cells ssays benefit from Lionheart’s

The advances in the new UN-series is the result of new ad-

available environmental controls, including temperature and

vanced technology, e.g. a new blue laser, which greatly enhanc-

gas control, plus humidity chamber for cell protection during

es bacterial screening capabilities, while a new depolarised side

long-term assays. (Source: Biotek)

scatter light signal solves the issue of discriminating between red blood cells and crystals. (Source: Sysmex)

26

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PROFILE

ALMECO LAUNCHES NEW SLIMMED-DOWN CRYOTUBE WITH EXTERNAL THREAD It has been a number of years underway, but now it is here – Almeco’s new slimmed down cryotube, which has already received a lot of positive feedback in the industry. »The positive feedback

the task was to try and develop a cryotube, which took up less

we received when intro-

space in the boxes, hence increasing the number of cryotubes per

ducing the new cryotube to

box.

customers, has been over-

The result is a cryotube, which has the same diameter on the inside,

whelming.« Max Terpager,

but has been slimmed on the outside.

CEO at Almeco, tells.

»With the new cryotube we have designed, we can actually

A substantial number of

fit 100 tubes in the same type of box which would previously fit

cryotubes are used every day

just 81 tubes. That’s an extra 23% space in each box,« says Max

around the world to store and freeze bioanalytical tests. For some reason, the market for cryotubes has not changed over the years, and the boxes containing the cryotubes, holds 81 tubes at a time. It is the same standard used around the world – and no one seems to know why. »I have spent three years visiting mainly embryologists around the country, I have spoken with hundreds of people to find out how to make the cryotubes more up-to-date and it soon became evident that the main problem is space. Cryotubes may not be very large, but they take up an enormous amount of space,« Max Terpager explains.

Terpager. The cryotubes come in sizes of 1, 2, 4 and 5 millimeters, but almeco has also developed a new size of just 0.5 Millimeter for very

Terpager wrote down all the answers, logged the data and

small samples.

made statistics. He investigated the market for cryotubes and hired

The extensive survey among embryologists also revealed that

a graduate to do a market survey to find out what sort of samples

better ergonomics was needed and Almeco has therefore produced

are being made and how long the samples need to be frozen for.

the new cryotube with a half-quick turn lid, making it much easier

That may vary from 14 days to 30 years.

to open. Although the cryotube is slimmed-down, the tube still has

»Producing a new cryotube is a very long process. Once the

an external thread, which prevents fluid from sticking and the tip

tube had been designed, we hired a firm to do the product in 3D,

of the pipette from hitting the thread. Furthermore, the tube can be

we examined the cryotube in-depth, had temporary boxes made

fixed in the box, allowing the embryologists to open it with just one

and went out to customers and showed them the prototype,« Max

hand. And finally, the bag containing the sterile tube is a practical

Terpager tells.

stand-alone bag with a zipper.

»New tools were manufactured, and now Almeco is producing

»Technically, what we have done is very, very complicated.

the new cryotubes on full steam, seven days a week,« says Max

We’ve asked a lot of people what they needed and we’ve gone

Terpager.

through the trouble of meeting those needs. For us, it was all about developing a high-quality product at the highest level and in this

23% extra in each box The boxes containing the cryotubes typically measure 133 x 133 millimeter and fit any system anywhere in the world. For Almeco,

context, dialogue with the customer is vital,« says Max Terpager. For more information please visit www.almeco.dk

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27


LABVIKAR

SHAKEN, BUT NOT BROKEN RIKKE MERTON CONTINUES FIGHTING Rikke Merton, who owns and runs LabVikar, a small employment agency, which specialises in recruiting temporary staff for laboratories, found herself up against almighty HK, Denmark’s largest union for salaried employees. It almost meant the end of her business, but determination made her fight.

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LABVIKAR

By Karin Jensen

W

hen Rikke Merton came face to face with HK union, she was brought to her knees financially. Not only was her business close to succumbing, she had to borrow money from family to pay her bills, and in the midst of everything, her bank turned on her too and decided to close her business account. “You cannot run an employment agency without an overdraft facility in your bank. Luckily I had temps working for me who helped by waiting a few days to get their money,” says Rikke Merton. The final straw was her bank closing all her accounts but where most people would have decided to give up, Merton found extra energy and strength to fight back. “Most people would have given up, but I’m not like that. HK probably thought a small employment agency such as mine wouldn’t put up such a fight, or that the money box would soon be emptied,” says Rikke Merton. The money box was in fact soon emptied and Rikke Merton had to use from the company’s equity to help finance the court case just as she could not pay out a salary for herself for most of last year. “Personally, it has been a really ugly experience. It has made me frustrated and people have told me over and over again that I should give up,” says Rikke Merton and adds that it all just made her more determined to continue to stand up for what she believes is wright. The fight seems to have paid off and today LabVikar is a striving business.

The case relates to a temp Rikke Merton send out to work at the laboratory of Arla Foods in Hobro. She paid the temp 150 DKr per hour, believing the rate contained contribution to pension, holiday and other since Arla Foods had not informed her otherwise. HK filed a lawsuit on behalf of the temp, one of its members. The case is the first of its kind in Denmark related to the new law for temporary workers, which took effect in 2013, and relates to the principle of equal treatment. The case has been tried in the District Court and the Maritime and Commercial Court, and is now scheduled for the Supreme Court. “I don’t think HK is after LabVikar, but more the employment agencies in general,” says Rikke Merton. At HK Privat, lawyer Klara Hoffritz says the union brought on the case because it believed its member was not treated with the same rights as the permanent workers at Arla Foods. “If a person, our member, do not get the rights which we believe she is entitled too, then we have an obligation to bring such a case to trial,” says Klara Hoffritz. She rules out that HK has speculated in going after a small employment agency and says the next case to be tested at court according to the new law for temps, will be against one of the biggest employment agencies in the country. ”We’re here to help our members if they are in trouble. We have certain obligations as a union and we live up to that,” says Klara Hoffritz.

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• presentation techniques

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Er du optaget af at opretholde renheden i jeres renrum? sikre kontamineringskontrol i dit renrum. Ved på Flexi Mat,Flexi tagerMat du et mod en måde at Deteterskridt vi! Cleanroom erskridt den bedste renere fremtid. sikre kontamineringskontrol i dit renrum.

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global@global-denmark.dk


WATER QUALITY

Reliably measuring the water quality for pharmaceutical use By Ole Stender Nielsen

W

ater is essential in the

a reliable and accurate sensor calibration

absorbs CO2, and the conductivity may

production, processing and

is required to provide measurement confi-

rise from the level of ultrapure water (5.5

formulation of pharmaceu-

dence and ensure compliance.

ÂľS/m) to a saturation value close to the

tical products. For pharmaceutical use,

Conductivity sensors are used over a

limit of 130 ÂľS/m set by USP. Stable and

water is usually sourced from a system

wide range of conductivity (see Figure 1),

reliable CRMs are not available at this lev-

that purifies potable water in order to

and the sensor calibration must be traced

el. For that reason, many sensor calibra-

comply with the pharmacopoeias, such as

to a single standard. A primary cell with

tions are made at higher conductivities,

the United States Pharmocopoeia (USP) or

a geometrically measured cell constant

e.g. at 0.1 S/m, under the assumption that

the European Pharmacopoeia.

ensures traceability to the SI system and

the measurements are still valid at low

enables production of certified reference

conductivities. Although one may assume

ter is electrolytic conductivity, which is

An important water quality parame-

materials (CRMs) for sensor calibration

that the cell constant does not vary over

related to ionic impurities. It is usually

with stable and accurate conductivity

several decades of conductivity, an ex-

measured by conductivity sensors, which

values from about 0.01 S/m and higher.

trapolation of the calibration to cover the

are sensitive, simple and robust. However,

Purified water for pharmaceutical use

whole range of the sensor system is risky,

Figure 1 - Electrolytic conductivity scale covering ultrapure water (UPW), requirements by the United States Pharmacopeia (USP), potable water and sea water.

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G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 1 6


WATER QUALITY

Figure 2 - DFM’s primary cell for calibrations at low electrolytic conductivity, essential to “closed-loop” calibrations of conductivity sensors.

because the calibration highly depends on the choice of frequency range, time scale and data fitting algorithms. In a response to this, Danish Fundamental Metrology (DFM) has developed an accredited “closed-loop” calibration measurement system with direct traceability to the SI unit system for conductivity sensor probes. The system spans the range from the UPW conductivity level up to a range covering values of CRMs. The sensor probe to be calibrated is mounted in the same flow loop as DFM’s primary cell (see Figure 2). After calibration, the sensor may reliably and accurately measure over the whole range of conductivity, and is ready for monitoring the water quality in pharmaceutical applications.

FACTS A conductivity sensor measures the resistance between two electrodes. The conductivity is derived as the ratio between the sensor’s cell constant and the resistance. The resistance is not measured at constant voltage, as the electrodes would charge up. Instead, either swept frequency or pulse response techniques are applied in combination with data fitting algorithms.

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PATENT TERM EXTENSION

PATENT TERM

EXT ENSION As inventor you can be rewarded by obtaining exclusive rights to your invention through a patent. This is an advantage for both the inventor and for society, since the access to inventions promotes innovation. Af Louise Aagaard Partner, European Patent Attorney

A

patent usually expires after 20 years. In some areas the develop-

ment of new products is very lengthy, and the consequence is therefore that the patent can only be exploited in a fraction of the 20 years. This applies to especially the pharmaceutical industry, where high standards must be met in order to obtain access to the market. Pharmaceutical research plays an essential role in improving the general health and EU has therefore chosen to compensate patentees for some of the time spend on acquiring a marketing authorization.

20 years patent duration

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PATENT TERM EXTENSION

SPC patent extension Requirements:

1

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

The applicant must have a valid patent

4

The valid marketing authorization

WHAT IS AN SPC?

must be the first authorization to

place the product on the market as a

protecting the medicine. If the patentee

medicine

SPC, an abbreviation for Supplemen-

wishes to apply for an SPC in Denmark,

The first authorization for marketing of a

tary Protection Certificate is a patent

there must be a valid Danish patent

product in Denmark is the first authori-

term extension of a maximum of 5

protecting the product.

zation to market a medicine in which the

years, which can be granted to a mar-

Furthermore it is important that the

product is an active ingredient.

keted medicine as a compensation for

product is an active ingredient. SPC’s are not granted for adjuvants without

the often lengthy approval procedure. It is important to consider at a very

The patent term extension can be

therapeutic effect.

early stage – in other words, already

extended by a further 6 months, if the

The patent does not have to be a prod-

while drafting the patent application -

marketed medicine has gone through

uct-patent protecting the medicine

which active agents are to be part of the

an approved pediatric investigation

itself: the patent can also cover a use of

final medicine to be marketed sometime

plan.

the medicine, i.e. it may be a so-called

in the future. Please discuss this with

“second medical indication” patent.

your patent attorney.

2

The SPC is granted to the patentee of a national or European patent

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

The deadline for filing a SPC appli-

on equal conditions in all of the EU

cation expires either 6 months from the

member states.

available.

grant of the patent or 6 months from the

The marketing authorization on which

notification of the marketing authoriza-

The protection conferred by an SPC

the patentee bases the SPC application

tion of the medicine whichever expires

is very different to the protection

must concern a human or a veterinary

later. Thus, coordination between the

provided by a patent. Even though

medicine. The marketing authorization

persons involved with obtained the mar-

an SPC is granted to compensate for

can be issued to another company than

keting authorization and the persons in-

lost patent time, an SPC only provides

the company which owns the patent, but

volved with SPC is of great importance.

protection for the approved medicine.

the SPC application can only be filed by

Other countries

the patentee.

3

The patentee is not limited to apply for The product has not already been

patent term extension in EU. The rules

the subject of an SPC

vary from country to country. In some

Thus, in general there can only be issued

countries the extension is given as a

one SPC for each active ingredient. If a

compensation for delays caused by the

patent covers a specific use of an active

authorities. In USA it is possible to get

ingredient, then it is under certain

an extension compensating for delays

circumstances possible to obtain an

with Food and Drug Administration

SPC covering that specific use, even if

(FDA).

an earlier SPC has been granted on the ingredient.

There are also some countries in which you cannot apply for patent term extension, e.g. in China.

5 years patent extension ( SPC )

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CALENDAR 2016

HIGHLIGHTED EVENTS – SECOND HALF OF 2016 NORDIC LIFE SCIENCE DAYS 2016 September 14-15- Stockholm www.nlsdays.com The Nordic region is proud to host some of the world’s most innovative biotech, medtech and pharma companies. It also has the 12th strongest economy, making it the perfect place to invest. Set in the idyllic city of Stockholm, the conference offers conference sessions, panel discussions,

company presentations, exhibition, face-to-face meetings and unique receptions, providing so many opportunities to network with peers, potential partners and investors.

NNOVATION IN BIOTECH – WHAT IS THE BUZZ REALLY ABOUT TODAY? September 26 - London www.ducc.co.uk/events Biotechnology is a field that has in the past been synonymous with innovation and great pioneering ideas making a positive difference to millions of lives through among other medicines, enzymes and microbes – but what

are all the innovation buzz words really about today and can we continue to outperform ourselves?

CPH LABMED – SCANDINAVIAN TRADE FAIR FOR LABORATORY TECHNOLOGY September 27-29 - Copenhagen www.cphlabmed.dk Companies from all over Scandinavia exhibit and show their newest products while visitors get inspiration for future purchases and new knowledge. Parallel with the fair is a number of professional societies executes confer-

ences, user meetings and theme days (amongst them Nordic conference for Mass Spectrometry).

FOODTECH November 1-3 - Herning www.foodtech.dk FoodTech is Northern Europe›s leading trade fair for food technology, and in 2014, it was visited by 8,288 highly qualified decision makers. As an exhibitor at FoodTech, you have an ideal opportunity to meet current as well as potential customers face-to-face in an attractive, inspiring and

professional setting. In three days, you can arrange several »customer visits« in only one place. More than 100 of your colleagues have already reserved a stand at the fair. Do the same and be part of the first round of stand allocation.

MEDICA AND COMPAMED November 14-17 - Düsseldorf 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. In addition to the professional trade fair our »MEDICA Conferences and Forums« have become an integral part of the trade fair: the MEDICA EDUCATION CONFERENCE (the largest interdisciplinary forum of Germany), the German

34

Hospital Conference (the leading communication platform for decision-makers in German hospitals), the EUROPEAN HOSPITAL CONFERENCE (EHC) taking place every second year, theMEDICA MEDICINE + SPORTS CONFERENCE, the MEDICA PHYSIO CONFERENCE and the International Conference on Disaster and Military Medicine (DiMiMED).

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 1 6


SUPPLIERS

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We develop and deliver intuitive IT Tools, ready to use in the laboratories. The tools improve the workflow and overview in the laboratory, combined with an enhancement in the quality. The ’Electronic Instrument Logbook’ replaces the handwritten logbooks – and supports read receipts on different levels. The ‘Labelchecker’ checks and documents that labels are identical when splitting samples.

www.berendsen.dk

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Strenometer ApS has specialized in test equipment – mainly for test and characterization of all kinds of surfaces. For more than 50 years, we have provided instruments and chambers to a wide range of applications, including:

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- Color measurements - Stability test: o Temperature and/or humidity o According to ICH Guidelines Q1B + Q5C - Plant growth chambers o Chambers o Walk-in - Mixing

DFD Cleanroom is a value-added partner and supplier of innovative and fully documented clothing and cleaning solutions to clean room. Our state-of-the-art clean room laundry meets or exceeds all known requirements.

• Newest clean room technology • ISO class 5-8 in operation (GMP class A/B) • ISO class 2 at rest • Possibility of washing with EDI water • ESD

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CPH LabMed Skandinavisk fagmesse for laboratorieteknik

n Nordic Mass Spectrometry Conference n DEKS Brugermøde

n LSB’s 10. årskongres n Laboratorieudstyr n Diagnostik n Bioteknologi n Forskning n Kvalitetskontrol n Over 130 udstillere

Lokomotivværkstedet 27. - 29. september 2016 cphlabmed.dk


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Greater copenhagen life science juli august 2016  

Scandinavian life science magazine

Greater copenhagen life science juli august 2016  

Scandinavian life science magazine