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
RELIABLY MEASURING THE WATER QUALITY
30
PATENT TERM EXTENSION
32
CALENDAR 34 SUPPLIERS 35
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CHALLENGES IN THE LIFE SCIENCE INDUSTRY
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10 | THEME
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Her er tre tal vi rigtig gerne vil vise frem. Vi spurgte sidste år, om intelligens smitter. Når vi kigger på resultaterne for de virksomheder, der bor og arbejder i Scion DTU, er der noget, der tyder på det. For den gennemsnitlige vækst var 148%, der blev udtaget 110 patenter, og 99% af virksomhederne kan anbefale Scion DTU. Den gode nyhed er, at vi har ledige m2, hvis du også vil smittes her i 2016.
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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
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
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.
• Pharmaceuticals • Biopharmaceuticals • Medical Devices & Diagnostics • Engineering & Technology • Consulting
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.
28
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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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FLEXI MAT – ET SKRIDT MOD EN RENERE FREMTID
• presentation techniques
• communicating in multicultural teams
• scientific and business writing
• negotiation
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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
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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).
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SUPPLIERS
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.
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
www.sonacc.net
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:
www.strenometer.dk
- 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
www.dfd.dk - +45 44 22 55 60 - crmar@dfd.dk
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
13 hrs
7.5 hrs
PrOPOr TFF single-use
cassettes reusable
THIS IS IncreaSIng PrODUcTIVITY TFF hollow fibre
Ready to use cross flow filtration High flux, low fouling modified PES membrane No pre-rinse or cleaning required
PROPOR TFF hollow fibre filters provide maximum process performance and are available in single-use, reusable and autoclaveable formats to meet the needs of your microfiltration or ultrafiltration applications. What’s more, the single-use products are supplied glycerin-free and ready to use with no pre-flushing offering significant time and cost saving benefits over cassettes. Parker Hannifin Danmark • Tel. +45 4356 0400 • parker.dk@parker.com • www.parker.com/propor-tff