Copenhagen life science #3 2014 by RASK Media ApS

Update News flashes on business, science and technology of danish and nordic Life Science

Theme: CRO’s Insight into a business of contract research organizations that continue to grow in spite of declining revenues.

NO. 3

OCTOBER 2014

Talkin’ about Oluf Borbye Pedersen on how intestinal bacteria has the potential to revolutionize medicine.

See CPH you at Octob LabMed er 7th - 9th

Alejandra Mørk:

“Somehow the manager’s role always ended up in my lap" 1

Publisher :

Frydendalsvej 3 DK-1809 Frederiksberg C Denmark +45 3326 9520 www.raskmedia.com rask@raskmedia.com Editor in Chief: Malene Aadal Bo Editors; Lone Frank, Carsten Elgstrøm, Charlotte Strøm and Fredrik Hedlund Grapics & Layout: Jacob Schrøder Rask Media Graphics

Mediepartners with :

www.cphlabmed.dk

Contents

No. 3 – 2014

The column

Fredrik Hedlund: Big Pharma’s new (record) deal is sweet music

Update

Business, science and technology news flashes

The Picture

The day it became ethically justifiable to use untested medicine.

Theme: Contract Research Organisations

www.ibceuroforum.dk

- Room for growth in the Nordic CRO market - One of the first danish CRO’s - Pipeline - Amon the biggest - IRW

Portrait Alejandra Mørk

16 18 22

“I take the lead, i guess. I take action. I look for the light at the end of the tunnel and head towards it.”

Talkin’ About: Intestinal bacterial www.health-rehab.dk Advertisment:

Oluf Borbye Pedersen on “How intestinal bacterial could revolutionize medicine”

Career

Henrik Brabrand takes stock of the career prospects within Life Science NEM Media Hadsundvej 11, DK-2610 Rødovre Phone: +45 4281 1110 nem@nemmedia.dk

Cover Photo: Jeppe Carlsen Print: PE Offset A/S ISSN: 1904-4755

Welcome to CPH LabMed 7.-9. Oct

Legal update

Thomas Bjørn on “When human embryos are human embryos”

Konta

Steven Wilsen sales m +45 28 anager 35 40 01

Har du brug for en professionel service-leverandør, der ved, hvad du taler om, når du siger CNC, GMP, GDP, klasse B... Så er Elite Miljø et godt bud på din kommende serviceleverandør.

Med Elite Miljø får du en erfaren samarbejdspartner, der: • • • • •

har mange tilfredse kunder i medicinal- og medicoindustrien har styr på GMP-træning, sidemandsoplæring, retræning og dokumentation har et omfattende kvalitetstyringssystem, der bliver tilpasset dine SOP’er og øvrige krav har et gennemprøvet ”renrums” koncept, integreret i en dedikeret renrumsorganisation har stor erfaring med eksterne audits og ledelses krav om interne audits

Læs mere på www.elitemiljoe.dk/renrum

By Fredrik Hedlund

recall a time when Big Pharma was seen as the temple of major innovation. As a Swedish undergraduate chemist, I had heard my share of stories about how researchers from Astra created and developed metoprolol (Seloken), terbutaline (Bricanyl) and the fantastic tale of how Astra researcher Ivan Östholm defied corporate instructions and created omeprazole (Losec), which later became the top-selling drug worldwide. Defied instructions...what a rebel! Naturally, Astra researchers were not the only ones being innovative. Lundbeck produced amitriptyline (Saroten) and later citalopram (Cipramil); the American company Merck, or MSD, produced e.g. indinavir (Crixivan) and simvastatin (Zocord); Pfizer created fluoxetine (Prozac) and sildenafil (Viagra); Novo Nordisk had its insulins of course; and Pharmacia contributed hyaluronic acid (Healon). All these substances have track records within their respective companies that depict how employees have fought, worked hard and solved problems along the way. It goes without saying that afterwards the companies developed and manufactured all their medicines themselves. However, this is no longer the case. Big Pharma is phasing out its research and production facilities at a dizzying speed. Instead, the major companies are focusing on

buying up innovations from other sources and then marketing them on a global scale. Big Pharma’s retreat from its previous core activities of researching and manufacturing medicine has created the scope for a number of new players such as biotech companies, contract research organisations (CROs) and also contract manufacturing organisations (CMOs), which are all demanding more from big business. But what is the core issue here? Why is Big Pharma abandoning its core activities of research and manufacturing? What are they actually hoping to achieve?

I have figured it out. Big Pharma has changed its business model entirely and is currently transforming itself into the record label of the pharmaceuticals world. Instead of conducting research, it is now looking for talents, promising new substances that it can refine and sell worldwide. But if Big Pharma has assumed the role of record label, what roles do the other players have? Well, biotech companies are the substances’ managers who are trying to sell their talents to the record labels for as much as possible. CROs are the talent scouts who are asked by the record labels to find talents among the many promising candidates. CMOs can be seen as the record producers of the pharmaceutical world, and

Translation: CLS Communication A/S

Photo: PR

The column

Big Pharma’s new (record) deal is sweet music to CROs

Fredrik Hedlund is a medical journalist with qualifications as pharmacist from Uppsala University and as a journalist from Stockholm University. After having been editor-in-chief of the journal Läkemedelsvärlden and medical reporter for Sweden’s leading daily, Dagens Nyheter, he is now a freelance based in Malmö. He contributes regularly to journals such as Läkertidningen, tandläkertidningen, Medicinsk Veteskap, Läkemedelsvärlden and Copenhagen Life Science.

chemists are the end of the chain like record shops. Now it is simply a case of hoping that the players can produce some real hits together. Then perhaps we will see the new P!nk pill, Coldplay capsules, Madonna medicine or Dylan drug?

Rock on!

Fertin Pharma har gjort brug af DFD’s store ekspertise ifm. med opgraderingen af vores samlede beklædningsløsning. DFD har i hele processen været professionel og en rigtig god sparringspartner. De har været med i hele implementeringsfasen, og har støttet med gode og konstruktive løsnings- og forbedringsforslag. Peter Olesen Manager, Warehouse & Facility hos Fertin Pharma

HØR HVORDAN VI GØR HYGIEJNISK OG EFFEKTIV LABORATORIE RENGØRING BÆREDYGTIG. BESØG CPH LABMED EXHIBITOR’S FREE LAB THEATER TIRSDAG KL. 13, ELLER KOM FORBI STAND 127.

DFD Cleanroom er en værdiskabende samarbejdspartner og leverandør af fremtidssikrede og fuldt dokumenterede beklædnings- og rengøringsløsninger til cleanroom. Lige fra kontrollerede produktionsområder til ISO klasse 5 in operation/klasse 2 at rest (GMP klasse A/B). Læs mere på dfd.dk og følg os på Linkedin.

UPDATE - BUSINESS

Business Update

By medwatch.dk

Photo: Symbion

Symbion to focus more on health technology

Start-up companies working within health technology can look forward to greater interest from Symbion, which, via Accelerace, is investing in fledgling companies. According to Symbion’s CEO Peter Torstensen, several factors make health

technology an interesting investment proposition. “On one hand, new hospitals are being built and, on the other, many beds are being phased out. We think that a wide range of brand new technologies must be developed to achieve success,” he says, adding that Symbion will also work with specific goals to attract foreign start-up companies to Denmark.

The capital is better at commercializing The number of inventions conceived at hospitals in the Capital Region of Denmark and subsequently sold to companies has risen dramatically. From just one in 2012 to eight so far in 2014. “This grueling legwork is now bearing fruit. At a personal level, we probably have a number of profiles who can talk roughly peer-to-peer with the industry, and we have a range of inventions that have reached a mature level of development,” says specialist consultant Martin Lind from the Capital Region of Denmark’s Unit for Research and Innovation.

Translation: CLS Communication A/S

Lundbeck hopes launch will make billions Lundbeck is hoping that its recently launched drug Northera will prove to be worth billions. Used to treat neurogen orthostatic hypotension, Northera was added to Lundbeck’s portfolio as part of the DKK 3.5 billion acquisition of Chelsea Therapeutics. Thus far, the product only has approval for the US market, but Lundbeck is counting on it generating revenue in the billions. “A return of 29% is a very normal level for this kind of corporate acquisition, and I would even say that is at the low end of the scale,” says CFO Anders Götzsche.

Photo: Lundbeck

Moving into the area of inflammation was a high-risk venture that ultimately failed. The decision has therefore been made to close it down, according to Chief Science Officer Mads Krogsgaard Thomsen. “Gaining a foothold in the area of inflammation was more challenging than we had

anticipated. At the same time, we have had a higher success rate than we ever dared hope for within diabetes, so this is where we intend to devote our R&D,” he says. Novo has now terminated all research and sold off the rights to the antibodies for treating chronic arthritis etc.

Photo: Novo Nordisk

Novo drops inflammation

Photo: Scandinavian Stockphoto

Danish uni-company on course for European award Danish company Biosyntia, which was started by students from the Technical University of Denmark, the University of Copenhagen and Aarhus University, has been nominated as one of the five most innovative small biotech companies in Europe. They are now competing for EuropaBio’s prestigious Most Innovative EU Biotech SME Award. Biosyntia conducts fermentation, and its core technology, Riboselect, accelerates the discovery of novel enzymes and pathways required for cell factory development and optimization based on E. coli and yeast. The award will be presented on 8 October.

This page was compiled in collaboration with Medwatch. Read more news at www.medwatch.dk

Biological copycat medicine will not play a major role in the health system for the next two to three years,” said Novartis’s top executive, Joe Jimenez, at a recent event. However, he expects the tide to turn in 2017-2019 as several large, expensive patents for antibody medicines are destined to expire. “And in 2020, which is only five years from now, we will see a big impact,” says Joe Jimenez. Biosimilar medicine has generated sales of about USD 500 million for Novartis, with sales growth of 20% a year.

A new survey from the Seed Capital venture fund shows that Danish venture funds invested far more money in Danish life science companies during the first six months of this year than in the same period last year. If the trend continues throughout the rest of the year, the total investment will amount to DKK 222.8 million, an increase of 75.8%. “You have to go right back to 2007-08 to find an investment level that matches the current level,” says Jannick Nytoft from the Danish Venture Capital and Private Equity Association (DVCA).

Mixed ratings fortunes for Swedish and Danish clusters Photo: Scandinavian Stockphoto

Danish venture funds investing more in life science

Photo: Novartis

Swedish life science clusters are experiencing difficulty remaining among the international elite, according to a new report from Forum for Health Policy. The competitiveness of the Swedish life science clusters is relatively strong, particularly in southern Sweden and Stockholm, but no Swedish clusters have top ratings. On the list of Europe’s 30 strongest life science clusters, southern Sweden is number 15, Stockholm is 18 and Uppsala is 38. Copenhagen comes in fifth, while Oresund represents the sixth-best life science cluster in Europe. See the entire report at healthpolicy.se.

Demand creates a new science park in Odense Work has begun on a 7,500-squaremetre science park scheduled for completion in the summer of 2015. The current science park cannot house all the start-ups hoping to join this special scientific environment in Odense. Syddanske Forskerparker has therefore chosen to build a brandnew science park for new start-up

companies that can potentially benefit from assistance with incubator activities.

Photo: Peter Larsen

Photo: Scandinavian Stockphoto

Novartis executive: 2020 will be the year of copycat medicine

UPDATE - SCIENCE AND TECHNOLOGY

Update

Science and technology By Videnskab.dk Translation: CLS Communication A/S

A new, ground-breaking discovery from Aarhus changes our understanding of how the immune system is activated when a bacterium enters the body. All over the world, textbooks on immunology will have to be rewritten.“Our discovery provides entirely new basic knowledge of a core defense mechanism in the immune defense’s complement system. The discovery opens up the possibility of the long-term development of new medicines, but the breakthrough has cost blood, sweat and tears,” says Søren E. Degn PhD, one of the driving forces behind the new study, published in the international

magazine PNAS. Researchers from Aarhus University’s Department of Biomedicine have worked out how a central enzyme (called MASP-1) in the complement system is activated. For a long time, it was thought that this occurred via a molecular change in a protein (a pattern-recognition protein), but the new experiment has revealed something different: When a patternrecognition protein recognizes the surface pattern of a bacterium, a large amount of MASP-1 gathers in a small area and begins making another enzyme called MASP-2. The enzymes thus activate each other, thereby triggering the immune system’s defense mechanisms.

HIV research attracts interest abroad

Photo: AUH

Activation of the HIV virus has long been considered a critical first step towards creating a proper treatment for HIV. And that is precisely what a team of researchers from Aarhus, Denmark, have managed to accomplish – a feat that has attracted international attention. A major challenge when combating HIV is that the virus can hide, dormant, in the genetic material in what are called CD4 cells. The CD4 cells cannot fight the virus themselves and the T cells that could kill the infected cells cannot tell from the cells’ appearance that they contain the dormant HIV virus. However, if you activate the virus, it will leave traces on the outside of the infected CD4 cells and in principle they can then be traced and destroyed. In the new study, the researchers from Aarhus gave the cancer medicine to six HIV patients and were suddenly able to measure the virus in their blood, explains Ole Schmeltz Søgaard from Aarhus University Hospital.

The world’s first stem cell organ transplant Researchers from Scotland have become the first in the world to transplant a functional organ, created from scratch from stem cells, into a mouse. First, the researchers created a thymus, an important organ in the immune defense system, exclusively from stem cells. They subsequently transplanted the thymus into a live mouse, where it functioned like a conventional thymus. This is the first time that researchers have successfully created a whole organ from stem cells in the laboratory and subsequently transplanted it into a living organism. “This is a very exciting advance and it’s also very tantalizing in terms of the wider field of regenerative medicine. Patients who need a bone marrow transplant and children who are born without a functioning thymus could all benefit,” says Professor Clare Blackburn, head of the research team at the University of Edinburgh.

Photo: Scandinavianstock photo

Established understanding of the immune system shattered

Find out which diseases lie in wait Jernmangelan¾mi

In a new study involving data from more than six million patients in Denmark, researchers have mapped how diseases develop. They can see, for example, which diseases usually accompany each other, and in future they will be able to predict which diseases you may get.For 15 years, researchers from the University of Copenhagen and the Technical University of Denmark have monitored 6.2 million Danes’ diseases through the National Patient Registry. This incorporates data on all types of visits made to doctors and hospitals by Danes from 1996 to 2010. The large volumes of data have created networks that reveal the most frequented disease pathways for Danes. One goal is to be able to predict which diseases an individual will most likely encounter. That will be achieved by combining this study with sequencing of the part of the DNA that describes the genetic diseases, according to professor Søren Brunak of the Technical University of Denmark and the Novo Nordisk Foundation Center for Protein Research, University of Copenhagen. D50

Andre sygdomme i perifere kar

Andre former for leddegigt M06

Andre generaliserede bindev¾vssygdomme M35

Akut myokardieinfarkt I21

Kronisk isk¾misk hjertesygdom

I48

D64

Myelodysplastiske syndromer D46

Udvidelse af bronkier

F¿lger efter karsygdom i hjernen

J47

H¾mofilusJ14 lungegbet¾ndelse

I69

J18

I25

Brystkrampe I20

Andre an¾mier

I73

Lungebet¾ndelse

N30

Bl¾rebet¾ndelse

Atrieflagren og -flimren

This page has been compiled in collaboration with Videnskab.dk and ScienceNordic.com.

Urinsur gigt

M10

I46

Hjertestop

K29

Mavekatar

J15

I50

Hjertesvigt

Komplikationer og dŒrligt definerede hjertesygdom

K52

I51

Akut an¾mi D62 efter bl¿dning

Andre ikke infekt. bet¾ndelsestilstande i maves¾k og tarm

Bakteriel lungebet¾ndelse

I11

Blodtryksforh¿jelse med hjertesygdom

E87

E86

Andre forstyrrelser i vand elektrolyt og syre-basebalance

Udt¿rring og nedsat ekstracellul¾rvolumen

Antal patienter

1,000

Photo: Scandinavian stockphoto

A whole new class of antibiotics invented An increasing number of the existing antibiotics are losing their ability to combat bacteria. Now scientists from the Danish Center for Antibiotic Research and Development (DanCARD) are developing a brand new class of antibiotics that hopefully will put an end to the progression of multi-resistant bacteria once and for all. They consist of tiny protein fragments called peptides that rip apart the outer shell of the bacteria. “Peptides work incredibly well when it comes to killing bacteria. We have already proved that,” says Professor Niels Frimodt-Møller, MD and director of research at DanCARD. “We’re working to ensure that the peptides are also harmless to people. It looks promising, and it’s an exciting new area of antibiotics research.” The DanCARD project has identified several small peptides that either bind themselves to the surface of the bacteria, making a channel that other matter can pass through in order to kill the bacteria, or simply tear the outer shell of the bacteria apart, causing the bacteria to die.

10,000

100,000

...

How cells gain identity The human body comprises 220 different cell types, each with a different function. The combination of genes that are turned on or off determines whether an individual cell develops into a skin cell, a liver cell or a blood cell, for example. Now Danish researchers have worked out how the cells control which genes are turned off and which genes are turned on. A protein complex called PRC2 binds to genes that should remain turned off. The protein complex thereby helps the cells to retain their identity once it has been established. The discovery of PRC2’s function may help to clarify our understanding of how various types of cancer occur. “We have known for years that PRC2 played an important role in some forms of cancer, as a flaw in the protein complex can lead to uncontrolled cell growth. It is therefore interesting that we can now reveal the precise function of PRC2 in regulating which genes are turned on and off,” says Professor Kristian Helin, director at the BRIC research center, University of Copenhagen. Photo: Scandinavian stockphoto

UPDATE - EQUIPMENT

Analyzere, sensorer og cell imaging til biogas, stamceller, fermentering og cellekultur

Massespektrometre til offgas

Gas-sensorer til fermentering +biogas; O2 CO2 CH4 H2 EtOH

Optisk DO og tryksat pH. Optisk Densitet og Viable Cell Density til online måling.

OD og VCD

Cell imaging med fluorescens

48 parallelle mini fermentorer

Perfusion styring og Single use perfusion

1010

A piece of equipment

Photo: Dreamstime

ECM – the Global Positioning System for enterprises Research shows that companies with good ECM skills have improved their efficiency by 33% and achieved a fourfold increase in productivity. But what is ECM exactly? We asked Michael Fray, chief consultant at Konica Minolta Business Solutions. By Malene Aadal Bo

Translation: CLS Communication A/S

- any midsize or large company or organisation. The word ‘content’ is slightly harder to grasp. In this context, it means ‘digital data’ of importance to the enterprise. Lastly, the word ‘management’ is more difficult to fathom. In the world of ECM, managing digital data in a

CM stands for Enterprise Content Management, i.e. managing content in an enterprise. Although it sounds pretty simple, in reality few people actually understand the full concept of ECM, according to Michael Fray. “The word ‘enterprise’ is easy enough

company means taking control of how the company deals and works with content,” he explains. Essentially, ECM is a piece of software that, when combined with the right strategies, functions as a satellite navigation system for enterprises – a system that shows you the fastest route from A to B or the fastest way to get something done. It is a system for handling and managing millions of important documents related to financial transactions, contracts, customer files, employee files, partners and assets. And this is all achieved through highly automated processes. Although many companies already have systems and procedures for some of their business needs, most lack a back-end system that routes jobs through the company in the most efficient way. “The last time I spoke to a CFO

about ECM, he admitted he neither knew nor cared a lot about the system. But he changed his mind when we started talking about putting in a system where he could store all kinds of important business documents (financial documents, contracts etc.), and then start building up digital workflows to speed up processing and handling of these documents. By the time we reached eventually automating large parts of these processes, he was very interested and was suggesting where we could start. The concept of taking control of content, maintaining control and letting the content flow and work for him was a subject he could easily relate to,” says Michael Fray.

How to work with ECM Although implemented by technology, ECM is based on strategy and a

mindset in the enterprise, according to Michael Fray. Top management must identify what they wish to gain and start mapping the relevant roads and procedures. As the business map of roads from A to B becomes progressively more advanced, possibilities for taking alternative routes appear. At the same time, logic can be built into workflow steps and tasks via sensors that inform both users and process operators about ‘accidents’ and other events that may impact on daily operations. “In this way, you can improve your efficiency and productivity, remain more compliant with standards and best practices (e.g. ISO and ITIL), meet legal responsibilities, and locate information and documents when you need them. It’s like having your own business Global Positioning System,” says Michael Fray.

Mød os på CPH LabMed 2014 Kom og prøv en dynamostol, og tal med os om ergonomi og aktive siddestillinger. Dynamostole benytter kroppens naturlige balance til at træne og styrke rygmuskulaturen. Sid dig stærk på en Dynamostol.

G på FiRnIdNos 6 stand 3

1111

dynamostol.dk

THE PICTURE

121212

Experimental medicine against Ebola

A victim of deadly Ebola virus is carried from his home in West Point in Liberias capital Monrovia. Photo: Daniel Berehulak/Scanpix

By Malene Aadal Bo Translation: CLS Communication A/S

Mapp had only been tested on primates and was actually years away from use in practice when the dreaded virus that causes Ebola hemorrhagic fever began to spread across West Africa early in the summer. Doctor Kent Brantly, a US Ebola specialist, was engaged in the battle against the virus. When he showed the first symptoms of Ebola in early August, he located one of the few doses of ZMapp in the world and treated himself with it. Today, Brantly is healthy and WHO has decided that is it ethically justifiable and necessary to also offer treatment to the many ordinary people who are contracting Ebola â&#x20AC;&#x201C; even though no fully tested, approved medication exists. One company to step forward is Fujifilm, which wants to add a component to the already approved influenza vaccine Favipiravir. Another is danish Bavarian and GSK from the US, which has a vaccine consisting of a common cold virus that has been engineered to carry two genes of the Ebola virus. â&#x20AC;˘

13 13

Agile CRO partner with strong local anchorage To Contract Research Organization (CRO), TFS, the close, yet agile, interaction with the client and fundamental trust in the collaboration are major priorities in doing business. This has successfully led the company to 15% growth last year as the ideal partner to SME in pharma and biotech. To TFS the local anchorage is paramount. Jan Hellqvist, Nordic Regional Manager at TFS explains why “When we state that we are global in mind – local at heart, we want to signal that even if we handle global projects, as our client you still find your project manager locally, speaking your language and maintaining the close day to day contact that drives the project forward and detects issues to be solved before they grow into problems. All it takes is trust and close collaboration, and this is what we build our business on.”

He is convinced that the way TFS has chosen to do their business make a significant difference to the clients. And an increase in revenue of 15% last year tends to prove him right. “The closeness both physically and mentally – between the client and the CRO is what matters. You may as small or midsize pharma or biotech have to outsource your clinical development project in part or completely, still you want to be updated continuously and know in depth how things are moving along. Our business model takes into account the need

for operational closeness; hence we have offices all over the Nordic region in order to ensure that our clients can have their local TFS partner nearby.” Explore, Develop, and People With three distinct business areas, TFS ExploreTM, TFS DevelopTM, and TFS PeopleTM, Contract Research Organization (CRO) TFS provide services for clinical development projects in pharma, biotech,Functional Food and medtech. “A smaller biotech company may be in need of comprehensive assistance

PROFILE from the early phases, putting together the pre-clinical file, setting up phase 0 studies, pharmaco-dynamic and pharmaco-kinetic studies before they are ready to move into first-in-man,” says Jan Hellqvist and carries on, “This is where our experts at TFS Explore can help. And when moving into phase 1 and furthter, TFS Develop provides all sorts of services needed during planning, initiation, execution, and reporting.” Hence TFS draws on a long standing collaboration with a number of phase 1 clinics throughout the Nordic region in order to assist their clients through the first phase of clinical development. “Last but not least TFS People – is like the name suggest a source. A source of people, extra hands, and moreover experience and in-sight. Along with project managers, clinical trial associates we also have skilled and experienced Statisticians, Data Managers, Regulatory Managers, Medical Writers, Compliance Officers and Medical Advisers to assist on specific projects or more over a

period of time if needed as in-sourced employees,” Jan Hellqvist explains. A copy machine to start with The current Chief Executive Officer, Daniel Spasic, who used to work as a CRA and Medical Writer originally founded TFS in 1996. His idea was to streamline and professionalize the production of clinical trial report forms, and so he set out in the basement of his house in Lund, Sweden, with a copy machine to support the pharmaceutical companies with trial forms, hence the name Trial Form Support. “Today our services are comprehensive and stretch far beyond trial forms. So we use only the abbreviation of the name now, albeit remembering and respecting it’s origin,” Jan Hellqvist says. And from one copy machine and a couple of student workers to operate it, TFS has grown considerably over the past 18 years in terms of people, affiliations, clients, and assignments. Jan Hellqvist points to a competitive edge, he knows makes a tremendous difference with the clients, i.e. the loyalty of the employees. “Where the annual change of employees is 40% in the CRO business as a whole, we count an annual rate of change in employees of only 5%. This makes a big difference to our clients because they often in the forefront of a clinical project not only with the client himself, but also with collaborators at hospitals and other clinical institutions where the trial takes place.” In contrast to many other CRO’s the employees have offices locally instead of being home-based, and Jan Hellqvist is convinced this increases the company loyalty among employees in a business area where this is rarely the case.

Today TFS counts 650 employees and has 21 legal entities throughout Europe and in the US. Moreover clinical operations are conducted through local partners in countries outside these in up to 40 countries. Functional foods and medtech What’s in the future? Jan Hellqvist takes a look into the future aspirations of TFS. “We are getting an increasing number of requests from clients on the areas of functional foods and medtech, hence we have just staffed up and consolidated our competences and services to offer in these fields, where we believe many new exciting projects will start in the years to come. And now we are prepared for it, too,” Jan Hellqvist ends.

FACTS ABOUT

• now the largest CRO in Denmark and the Nordic region • i s the largest global, privately held clinical Contract Research Organization (CRO) • counts 650 employees and has legal entities in 21 countries in Europe and North America • operates in a total of 40 countries • offers comprehensive, clinical development services through TFS Explore, TFS Develop, and TFS People Learn more at: http://www.tfscro.com/home/

THEME: CRO’S

Room for growth in the Nordic CRO market In spite of thinning pipelines and rising costs in the pharma industry, entrepreneurs have managed to create a business out of providing solutions to pharma companies. We highlight the Nordic contract research organization (CRO) industry and provide an insight into a business that continues to grow in spite of declining revenues. By Louise Bruce

hough the earliest CROs started back in the 1940s and 1950s, the CRO industry as we know it today only began to emerge in the late 1970s and early 1980s. In the 1980s, the pharma companies developed the first blockbuster drugs. At the same time, costs rose dramatically, providing a niche for the expansion of the CRO market. Together with the introduction of good clinical practice (GCP) in the 1990s, the CRO industry experienced an explosive growth in demand for its services.

Need for expertise and flexibility Today, the CRO market is versatile and includes CROs with different specialties such as preclinical develop-

ment, clinical trials and registration. In Sweden, clinical CROs are involved in two thirds of all clinical trials. In Denmark, one in four clinical trials is carried out by a CRO. The market is driven by a need for expertise and flexibility. The CROs offer highly skilled personnel within therapeutic areas, clinical operations and GCP. They can also provide the flexibility needed. “All pharma and biotech companies experience variations in the number of clinical trials they are conducting or are about to conduct. The trials require a lot of resources, and if you want to avoid postponing trials due to lack of resources, you have to employ a lot of people to ensure you have the right resources when you are con-

CONTRACT RESEARCH ORGANIZATIONS IN BRIEF • Contract research organizations (CROs) conduct research and development on behalf of other companies within the pharma, medtech or biotech business. • Clinical CROs conduct clinical trials from design to execution, monitoring and reporting, and they outsource clinical research associates (CRAs) to conduct clinical trials in-house at pharma and biotech companies. • The Nordic CRO market is characterized by several smaller CROs and a few big Nordic and international CROs. • In Sweden, contract research organizations (CROs) were involved in two thirds of all clinical trials in 2013. • In 2013, one in four clinical trials were carried out by a CRO in Denmark. • In Denmark, DKK 21.9 million has been spent on clinical trials carried out by CROs in 2013. • In 2007, the international CRO sector was worth USD 15 billion. • The top 10 companies control 56% of the market and employ tens of thousands of workers around the world.

1616

Top 5 Nordic CROs

n 2010 the international Contract Research Organization (CRO) industry was worth $ 20 billion. In Denmark one in four clinical trials are carried out by a CRO, whereas in Sweden CROs are involved in two thirds of all clinical trials. In Denmark 21.9 billion DKK was spend on clinical trials carried out by CROs. In terms of number of employees the top five full-service CROs established in the Nordic countries includes:

ducting most trials,” explains Alejandra Mørk, CEO of KLIFO and board member of Danish Biotech. “Or you can outsource a clinical trial or insource clinical research associates (CRAs) from a CRO when needed. This gives companies the possibility of hiring a person with a high level of skills within the area of a specific trial and it is cheaper in the long run,” says Mørk.

Nordic challenges CROs have developed the expertise and technology to rival pharma companies. Their basis in the profitability problems of big pharma means they are not going to be facing any shortage of clients in the coming years. However, a decrease in the number of clinical trials conducted in the Nordic countries has led to a 25–30% decline in the market since 2008¹, albeit the market seems to have stabilized over the past two years. “You might find some of the explanation for the decrease in clinical trials conducted in the Nordic countries in the tendency to place clinical trials in Asia and Eastern Europe due to pricing. When they do conduct clinical trials in Western Europe, the big pharma companies tend to choose investigator sites in larger markets, which puts Scandinavia well down the list. The sales potential in Scandinavia just isn’t big enough,” says Mørk.

Maintaining an attractive market From a CRO perspective, however, the Nordic market represents a unique opportunity, as Rob Davie, PhD, vice president and general manager Europe at Covance, explains: “I believe the international drawing power of the Nordic countries comes down to the entrepreneurial spirit and vibrant research community, highly qualified human resources, an abundance of leading universities and research hospitals, and good infrastructure. Also, the Nordic population is well documented as being keen on participating in clinical trials for research,” says Davie. In Denmark, CROs are working together with, for instance, the Danish regions and hospitals to ensure a good clinical environment that can attract even more clinical trials. •

THE TOP FIVE FULL-SERVICE NORDIC CROS ARE: TFS TRIAL FORM SUPPORT • E stablished in 1996 No. of employees: 189 (in the Nordics, 660 globally excl. subcontractors) Revenue: 67 million CEO: Daniel Spasic

SMERUD MEDICAL RESEARCH INTERNATIONAL • E stablished in 1993 No. of employees: 90 Revenue: N/A CEO: Knut Smerud

NORMA • E stablished in Denmark in 1990 No. of employees: 90 Revenue: N/A CEO: Niklas Lindberg

IRW CONSULTING • E stablished in Sweden in 1999 No. of employees: 50 Revenue: SEK 60 million CEO: Ingela Wiking

KLIFO • E stablished in Denmark in 1994 No. of employees: 40 Revenue: $13 million CEO: Alejandra Mørk

Pipettecenteret Pipettecenteret

Pipettecenteret

Kalibrering og service af alle af alle Kalibrering og service fabrikater pipetter.

fabrikater pipetter. Kalibrering og service af alle

Vi kalibrerer både ved indsendelse fabrikater pipetter. både ved indsendelse ellerVipåkalibrerer kundens adresse.

eller på kundens adresse. eller adresse. Salgpå af kundens pipetter og laboratorie varer. Pipettecenteret Salg af pipetter og laboratorie varer.

Viafkalibrerer både ved indsendelse Salg pipetter og laboratorie varer.

Skovkanten 41 · 4700 Næstved Pipettecenteret Tlf. +45 55 73 62 05 Skovkanten 41 · 4700 Næstved MobilPipettecenteret +45 30 33 32 49 Tlf. +45 55 41 73 ·62 05 Næstved Skovkanten 4700 Email. nielslindgaard@stofanet.dk Mobil +45 Tlf. +45 55 30 73 33 62 32 05 49 www.pipettecenteret.dk

Email. nielslindgaard@stofanet.dk Mobil +45 30 33 32 49 www.pipettecenteret.dk Email. nielslindgaard@stofanet.dk www.pipettecenteret.dk

1) FoU 2014 - Research and development of drugs in Sweden, LIF – de forskande läkemedelföretagen, 2014Results of Lif and Dansk Biotek’s survey of clinical research activities in Denmark 2013, Lægemiddelindustriforeningen and Dansk Biotek, 2014

1717

THEME: CRO’S

Business portrait: Pipeline - from backyard company to prefered big pharma partner

A backyard company with only two employees saw the light of day in 1999. The dream was to start a contract research organization (CRO) focusing on preclinical research. Today, Pipeline Biotech has 20 employees and facilities in Denmark and Sweden.

By Louise Bruce

he story of Pipeline Biotech began in the back room of a rodent breeding company in Ry, Jutland. Klaus Kristensen, founder and CBO of Pipeline Biotech, and a colleague had decided to start up their own CRO focusing on preclinical testing. A good portion of enthusiasm and ingenuity kept Kristensen and his colleague going as they tried to find their first clients. Fifteen years later, Kristensen looks back at the start-up period with astonishment.

1818

Skeptical clients Starting up a preclinical CRO focusing on pharmacology was not easy. The founders had no track record

“We didn’t know the market or the procedures very well. We thought it would be easier than it turned out to be. If I knew then what I know now, Pipeline Biotech would probably not exist. It’s like the bumblebee that doesn’t know it can’t fly.” and were met with skepticism when they pitched their service to potential clients. “I clearly remember my first meetings with potential clients. I visited everyone I knew. They were all skeptical – and I don’t blame them. We were new to the business and didn’t have a track record. But somehow we managed to get our first clients, and subsequently

more clients were added,” says Kristensen. The skepticism they encountered did not only relate to their capabilities. At that time, outsourcing was a relatively new phenomenon in the biotech business. “The biotech companies wanted to do everything themselves. Very few managers had heard about outsourcing and considered it a relevant initiative. We had to argue in favor of outsourcing as a cheaper alternative. If we did succeed in convincing them to outsource, we faced another challenge: Why choose Pipeline Biotech?” explains Kristensen.

Specialize to be attractive Six years ago, Pipeline Biotech started focusing on cancer research. Being specialized attracts bigger clients such as big pharma companies. “In the beginning, we took on any project we could get – with varying results. After a while, we realized that we had to specialize to be attractive. Over the years, we’ve developed long-term key accounts with big pharma companies and some of the big biotech companies. That keeps us going

Communication  Proactivity  Quality on time Larix A/S is a full-service CRO with more than 12 years’ experience from companies within:  Pharmaceutical  Biotech  Medical device With our extensive experience we can assist you plan and manage your studies from :  Study design and feasibility  Statistical analysis  Clinical monitoring  Reporting  CRF and database design  Pharmacovigilance Our mission is to deliver high quality within agreed budget and timeline Larix A/S, Tempovej 44, 2750 Ballerup, Denmark – phone: +45 7027 2221 – email: info@larix.dk – www.larix.dk 19

THEME: CRO’S

PIPELINE BIOTECH • Pipeline Biotech conducts pharmacological preclinical contract research in rodents. • In 2013, Pipeline Biotech opened a facility in Sweden offering pharmacological preclinical testing in pigs. • Pipeline Biotech works for both pharma and biotech companies located in Denmark (50%), elsewhere in Scandinavia (40%) and the rest of Europe (10%). Its clients include Novo Nordisk, Ferring, Leo Pharma and Genmab. • Founded in 1999 • Number of employees: 20

during a recession as they are not as sensitive to economic changes as the smaller biotech companies,” explains Kristensen.

Danish advantages According to Kristensen, the secret to keeping a Danish CRO going for 15 years is flexibility and proximity. “We offer proximity. That’s what keeps us in business. Our clients could easily find CROs in India or China who could do our job for a fifth of the price. But they also need a CRO that is close by, that speaks their language and has the same cultural background. Not to mention a CRO who does what Danes are really good at – communicating and being flexible. Though we promote our skills within cancer research, we do offer other services as well. We are flexible and can adjust according to the client’s needs,” says Kristensen. •

ADVERT

Regulatory affairs expertise and experience – seasoned with courage For pharma and medtech it is a dream scenario to get a head start with your regulatory documentation. IWA Consulting Aps stresses that the start should also be the right one, because it is the most time and cost-efficient way to get your product registered and marketed. Lillan Rejkjær, Vice President, Regulatory & Medical Development at the CRO, IWA Consulting, gives an example: “Filing simultaneously in the US and EU may appear to be impossible, due to the differences that the separate registration files have. Our approach is different as we focus on content resemblances, and on getting things into the right format from the beginning. Our track record proves the sceptics wrong.” Part of this success, she believes, is that IWA Consulting continuously operates with the Common Technical Document dossier in a fully integrated eCTD solution, and she furthermore points to the CRO’s long term experience in both regulatory and medical affairs along with in-depth knowledge as the cornerstones of

2020

the services at IWA Consulting. “Knowing where you are going shortens the journey, and we are committed to our clients’ goals. However, we trust in doing things right from the beginning, and we have the courage to give honest advice. This leaves our clients confident that we will help them finding the fastest and most cost-efficient path from development through registration to life-cycle for pharmaceuticals and medical devices,” Lillan Rejkjær ends.

FACTS ABOUT IWA Consulting Aps • offers a complete portfolio of regulatory affairs and medical affairs services • is DS/EN ISO 9001 certified

For more information please visit, http://iwaconsulting.dk

Fresh ideas about clinical development When the ship crew Doctor James Lind in the 1700s tried various forms of treatment among crew members on board the ship Salisbury, he never thought that this would go down in history as the first clinical trial in the world. He drew the conclusion that citrus fruits helps against scurvy. A result that still stands today.

Leading CRO with expertise in Sweden, Norway, Finland and Denmark Today clinical trials are done to evaluate new pharmaceuticals’ and medical devices’ safety and efficacy. IRW has been performing clinical trials since 1999. All employees have academic degrees in Life Science and many years of combined experience from pharmaceutical industry

as well as academia. We can assist with Study Design, Project Management, Clinical Monitoring, Data Management, electronic patient diaries (ePRO), Pharmacovigilance, Medical Writing and more.

Please call us at +46 8 791 66 40 when you need assistance with your clinical studies! IRW Consulting AB • Box 703 • Svärdvägen 3A, 7 tr, 182 17 Danderyd 08 791 66 40 • info@irwcro.com • www.irwcro.com

THEME: CRO’S

Business portrait: IRW

– one of the biggest Nordic CROs The market for contract research organizations (CROs) is highly competitive and dominated by international organizations. The vice president of one of the biggest Nordic CROs, IRW Consulting, explains how they have been able to grow, achieve success and still maintain their Nordic focus.

“We have to be able to offer our clients technological solutions that meet the need for variation in complexity and price.” By Louise Bruce

rom the very beginning in 1999, it has been the ambition of Ingela Wiking, CEO of IRW Consulting, to create the preferred Nordic CRO partner. With offices in all four Nordic countries, IRW has become one of the biggest Nordic CROs, conducting clinical trials, noninterventional studies and medical device studies through all four phases. Depending on the client’s requirements, the staff is either outsourced or works on in-house projects.

Our Nordic focus is an asset Over the years, the competition has increased, making it even more important to stand out to remain the preferred Nordic CRO partner. The CRO

2222

market has undergone a transition towards a more global focus among the big pharma clients as well as among CROs. More and more CROs are being consolidated, running offices all over the world and offering global clinical trials. By contrast, IRW has chosen to keep its focus on the Nordic region and consider it an asset. “Many of the big pharma companies are represented in Stockholm or Copenhagen, from where they cover the entire Nordic region. In my experience, our clients value the fact that we have a local focus and offices and personnel in all four Nordic capitals. We have the required expertise to quickly set up clinical trials and determine the most beneficial and cost-effective set-

IRW CONSULTING • Business areas: Clinical Operations, Project Management, Regulatory, Clinical Data Management, Biostatistics, Pharmacovigilance and Medical Writing • Assignment range: clinical trial phases I-IV, medical device investigations, non-interventional trials and registry trials • Clients: Biotech, Medtech, big pharma companies and other CROs • Founded in 1999 • Number of employees: 50 • Number of current ongoing clinical trials: 40 • Number of outsourced employees: 25

patient diaries, clients requested the service. We have developed an ePRO system (electronic Patient Reported Outcomes) and are now able to offer the service to other companies,” says Jeppsson.

Preparing for the future In spite of the strong competition, Jeppsson believes that IRW has a strong position in the market. Nevertheless, he recognizes that they have to keep being innovative and flexible as the market situation could quickly change. “We want to be the preferred partner when it comes to conducting clinical trials in the Nordic countries. That’s why we will keep hiring the best employees and be the best at outsourcing personnel. And we will keep developing our skills, making us even better at conducting clinical trials and addressing the clients’ challenges. We will keep growing in the Nordics. But in order to succeed, we have to be extremely responsive and adaptive to the clients’ needs,” says Jeppsson. •

up. We know the clinical research environment,” says Ola Jeppsson, vice president, IRW Consulting.

Even CROs have to be innovative Besides the knowledge of the Nordic clinical research environment, it is key to IRW Consulting that they are responsive and innovative. “In a competitive market, one of the best ways to achieve success is by meeting the clients’ needs by being flexible and able to innovate and adjust accordingly. That means hiring people according to our clients’ needs and keeping abreast of the latest technology. We have to be able to offer our clients technological solutions that meet the need for variation in complexity and price,” explains Jeppsson. “A concrete example of how a client’s need has evolved into a new technological solution is electronic patient diaries. After FDA and EMA opened up the possibility of keeping electronic Ola Jeppsson, vice president, IRW Consulting. Photo: PR

ILS – Din leverandør af pålidelige og effektive måleinstrumenter, tilbehør, support og teknisk service til sygehuse og industrilaboratorier. ILS’ know how sikrer kunderne maximalt udbytte og stor tilfredshed i arbejdet med vores instrumenter. ILS er ISO 9001 certificeret, og har eget lager i Allerød – din sikkerhed for hurtig levering! ILS leverer udstyr og tilbehør til koagulation, klinisk kemi, blodgas, elektroforese, rheologi, autoimmune sygdomme, vandanalyser og fødevareanalyser. Mød os på CPH LabMed Lokomotivværkstedet, 7.-9. oktober 2014 på Stand nr. 071. Vi glæder os til at se dig! www.ilsdk.dk

2323

THEME: CRO’S

When starting your own CRO In spite of the competitive market, there may still be room for new contract research organizations (CROs). We asked two CRO managers for their best advice for those considering starting their own preclinical or clinical CRO. By Louise Bruce

ased on talks with Klaus Kristensen, Pipeline Biotech CBO, and Alejandra Mørk, board member at Dansk Biotek, we can provide the following advice:

nity to find a niche and offer a service within your remit. Specialization often requires partnerships with other CROs to meet the client’s needs. There is a risk of being too dependent on other companies for success.

Experience and contacts You need experience within the field and a track record. International experience will give you a stronger position. An established network will make the start-up easier as your first clients can be found among existing contacts.

Specialization Specialization can be a good idea as long as you consider the pros and cons.Specialization gives you the opportu-

Finding clients Starting a one-person business can be difficult as clients tend to value CROs of a certain size. Use opportunities to collaborate with CROs in other countries to maximize your services. Starting your own CRO has to be fun, which is why engaging a financial advisor to minimize your economic challenges and worries is a good idea. •

Environmentally safe? Meet the regulation When introducing new medicine there are a numerous requirements to be met. One that many pharmaceutical companies tend to forget or postpone is the required documentation of the products environmental impact. “Only few pharmaceutical companies have focus on this topic. They often only look into it just before introducing a product on the marked. But that might delay the introduction of the product,” says Margrethe Winther-Nielsen, Head of Innovation at DHI and expert in environment and toxicology. She recommends initiating the process of testing and documenting the products environmental impact 1-2 years before launch. The regulations on medicines environmental impact is part of a struggle to avoid medicine and medicine waste to travel into our drinking water, surface water and soil and affects all producing medicine for human use. It requires thorough long-term ecotoxicological tests and well documented guidelines on the use and disposal of the medicine.

ADVERT

“They are actually not difficult requirements to meet,” says Margrethe Winther-Nielsen. But as pharmaceuticals are difficult substances they are also difficult to handle in test systems and require specific attention. That is the reason why pharmaceutical companies For turn to DHI. DHI all the has years, life has science not had mixtures. “Our laboratories are accredited necessary expertise to carry out the testing to speculate too much about chemicals. new according to aBut number of European schemes andlegislation prinand documentation required and DHI particspares no one and according to consultants at DHI, life science compaciples and our European lab is also authorized ipated in the development of the guidance to carry out studies in compliance with the nies face the prospect of more requirements – and may have to change documents for OECD on how to test difficult OECD Principles of Good Laboratory Practice substances.their processes. (GLP),” says Margrethe Winther-Nielsen. “We offer support on how to meet the ecotoxicological information requirements. We advise on efficient use of existing data and literature search and carry out further laboratory studies when needed,” Margrethe Winther-Nielsen sums up. From own facilities DHI offers a wide range of standardized ecotoxicological tests and tailor-made studies to generate the necessary data. Tests concerning among others, biodegradability, toxicity and bioaccumulation of chemical substances, products and complex

Read more at: www.lab.dhigroup.com

ADVERT

Pharmacological workshop:

Customized risk evaluation in pre-clinical drug development The Contract Research Organization (CRO), BioAdvice A/S, has years of experience and expertise in pre-clinical GLP/ non-GLP pharmacological, and toxicological testing of drug candidates for pharma and biotech. Along with a significantly expanded facility, BioAdvice is now additionally providing cutting-edge technologies for risk evaluation, particularly useful in early drug candidates. “These core competences are the back bone of the company – and in particular the models we provide for inflammation, wound healing, and diabetes reflect a deep level of insight, expertise, and experience,” Lars Siim Madsen, Chief Operational Officer at BioAdvice, explains. He describes the business as a ‘pharmacological workshop,’ implying that both standard set-up’s as well as customized are feasible at the CRO. “For pre-clinical testing we have a large capacity to flexibly adapt to specific needs and requests from a customer – and moreover we have expertise to provide professional sparring as well,” Lars Siim Madsen says. “We manage continuously to establish new Proof of Concept models in various therapeutic areas. This implies that we look for customized solutions in collaboration with our costumers whenever a standard model somehow is inadequate for the drug candidate in question.” This level of flexibility has been fruitful for BioAdvice, and the company has recently expanded the facility with 750 square meters, and thereby doubled the size of animal facilities for studies in pigs, minipigs, dogs, rats, mice, rabbits, and guinea pigs.

FACTS ABOUT BIOADVICE A/S • BioAdvice is a leading Contract Research Organisation (CRO) in Denmark, providing qualified pharmacological and toxicological research and development with laboratories and animal facilities for mice, rats, rabbits, guinea pigs, pigs, minipigs, and dogs – and zebra fish • BioAdvice has a GLP-authorisation to perform preclinical pharmacological and toxicological studies • BioAdvice has a GMP-authorisation to perform biological quality control tests on human and veterinary medical products • BioAdvice’s facilities are located at Lyshøjvej 21, DK-3650 Ølstykke about ½ hour’s drive from Copenhagen International Airport

Early risk evaluation From a time and cost perspective it makes sense to design your pre-clinical program as efficient as possible understanding the risk profile of your drug candidate as early as possible. At BioAdvice this is acknowledged, hence a new technology has been taken on board. “As BioAdvice is following recommendations of The Animal Experiments Inspectorate (Dyreforsøgstilsynet) we have adapted to the 3 R´s (Replacement, Reduction and Refinement) by implementing an early screening technology in zebra fish to increase the likelihood of success in pre-clinical testing. As a drug developer you want to gather as much information as possible – as early as possible. This is why we offer the zebra fish technology for early risk evaluation,” Lars Siim Madsen explains. The zebra fish technology is performed in collaboration with Professor Søren Peter Olesen at the Department of Biomedical Sciences section of Heart and Circulatory Research at the University of Copenhagen. “The use of the zebra fish technology has exploded these past few years internationally, as the method has been scientifically acknowledged in being useful in early screening and selection of drug candidates. In turn the early exposure of zebra fish larvae is a valuable supplement for pharma and biotech before moving their projects into higher species, providing them with an understanding of potential toxicity or cardiovascular issues related to the molecule,” Lars Siim Madsen explains, describing why this new technology is provided by BioAdvice. “As a drug developer in general you want to understand the toxicological profile of your drug candidate as early as possible before moving into the more cost and time demanding models, and certainly before clinical testing. So we provide this new service for our customers to facilitate early screening of toxicological side effects in their early drug development,” Lars Siim Madsen ends. http://bioadvice.dk

THEME: CRO’S

From the client’s perspective Most of the big pharmaceutical companies use contract research organizations (CROs). Mats Thoring, Head of Clinical Operations at Bayer, gives an insight into the considerations when collaborating with a CRO. By Louise Bruce

hy use a CRO in the first place? “When we choose to work with a CRO, it is often because we need highly skilled personnel within a specific therapeutic area. We might not have employees with the required skills, or they might not be available at the time. We don’t want to postpone a clinical trial just because the relevant employees are not available,” explains Mats Thoring. “Another reason is that the number of clinical trials varies, as does the

THE USE OF CROS AT BAYER • At Bayer, CROs are widely used to assist with their clinical trial program in both outsourcing of entire clinical trials and insourcing of clinical research associates (CRAs). • Whereas Bayer Scandinavia uses CRAs to conduct clinical trials in house, Bayer Global manages the outsourcing of entire clinical trials. • Mats Thoring, Head of Clinical Operations at Bayer Scandinavia, collaborates with CROs in Scandinavia and leads a team consisting of both Bayer employees and insourced CRAs.

2626

need for employees associated with them. We want to avoid hiring people and then having to let them go shortly afterwards,” says Thoring.

a very close collaboration with the same group of CROs over a long period of time,” explains Thoring.

Price and location Finding the right CRA According to Thoring, skills and personality both play a significant role when insourcing a CRA. Finding the right CRA can be challenging and requires close collaboration with the CRO managers. “When you choose to insource a CRA, there are a number of things you have to take into consideration. It’s best compared to hiring a new employee,” says Thoring. “Of course, the CRA has to have the basic skills in place, but it is also important that the CRA fits into your team on a personal level.” Unlike when hiring a new employee, insourced CRAs are not interviewed beforehand. They are chosen by the CRO manager, who must have a thorough understanding of the client’s needs and preferences. “Good CRO managers communicate with their clients on a regular basis to stay up to date on what kind of people the clients need. It is very important that you know the CRO managers and that they know you. You need to work closely together. They choose the CRA who is going to work for you and you share the management. The CRO manager has staff responsibility for the CRA and you are the day-today manager. For me, that requires

When working with a CRO, Thoring emphasizes two other points to consider. First of all, the CRO has to have thorough knowledge of your local market. For Thoring, that means the CROs must at least have offices in all the Nordic countries. A second important point is pricing. “Using CROs is usually not cheap. It would be cheaper in most cases to employ permanent staff, but then you lose flexibility. You have to find a balance. If you hire too many CRAs, it gets costly and there is a risk of losing the corporate culture. In my opinion, only about one third should be insourced CRAs,” says Thoring.

MATS THORING, HEAD OF CLINICAL OPERATIONS AT BAYER, GIVES THE FOLLOWING ADVICE ON INSOURCING CRAS: • Make sure you have a close collaboration with the CRO manager. • Make sure the CRA has sufficient experience of the relevant disease area and data management system. • Find the right person – he or she will be working for you as part of your team.

27 27

PORTRAIT

2828

Photo: Jeppe Carlsen

Plant and harvest as a pharmaceutical developer Action-oriented team player, Alejandra Mørk, is reaping the fruits of 25 years of commitment to the pharmaceutical industry By Charlotte Strøm, MD, PhD, Journalist

n the midst of her blooming kitchen patch during harvest time, 53-year old Alejandra Mørk, MSci Pharm, PhD and Chief Executive Officer at KLIFO a/s, feels at ease and mentally fulfilled. She finds her close relationship with Mother Nature symbolic of the approach she has always taken to her working life. Whether she is focusing on project management, regulatory affairs, clinical development, Group Management, CRO services, or consultancy, she remains dedicated to her fundamental values and beliefs. “I am a rather action-oriented person, and I like the closeness between entering an effort and reaping the fruits of your work. It gives me pleasure in a quite similar way to the joy I feel about having my home grown salad and vegetables for dinner,” Alejandra Mørk says. This fundamental need to strive for

results supported her decision to leave the world of academia after finishing her PhD and join the pharmaceutical industry back in 1989. “Being a scientist was too lonely for me. I am a team player – and I realized that quite early on in my career. I enjoy being with people and creating action and results together with dedicated colleagues.”

Project management – a multidisciplinary function A major part of her career has been focused on project management, and her first job in the pharmaceutical industry was as a project manager with DAK. Thinking back Alejandra Mørk acknowledges that she was too inexperienced in handling project management at that time. “Project management is a multidisciplinary function. You cannot – and you need not know the details

of every contributing specialty, i.e. regulatory affairs, proprietary rights, marketing, clinical development etc. However, in order to be a successful project manager it is essential that you have a thorough understanding of each contributing discipline in order to drive the project forward effectively.” After Hafslund Nycomed had acquired DAK, Alejandra Mørk, took the opportunity to develop her expertise within the specific classical clinical development disciplines and in 1992 she became Head of Clinical Development and in later Head of Regulatory Affairs. She felt driven by a deep professional interest of how to develop medicines. However, she never moved far away from project management – and returned as Head of Project Management at Nycomed in 2000. “Once I had had time to learn much more about both clinical

PORTRAIT

BLUEBOOK Alejandra Mørk, MSci Pharm, PhD, CEO 2013 Chair at The Pharmaceutical Society of Denmark 2008 CEO at KLIFO 2007 Senior Vice President, Portfolio, Project and Alliance Management, R&D, Nycomed 2003 Senior Vice President, International Product Development, member of Group Management, Nycomed 2000 Vice President Project Management, Nycomed 1994 Head of Regulatory Affairs, Nycomed 1994 Acting as censor at Copenhagen University 1992 Head of Clinical Development, Nycomed 1989 Project Manager, Nycomed 1985 Master of Science Pharmacy, Copenhagen University Born in 1961

learning,” she says. She seconds the wisdom of her former manager at Nycomed, colleague, mentor, and friend, the late Thor-Björn Conradsson: “When you work with people, who are smarter and more skilled than you are, it will improve your own level of expertise. And I was a lot smarter and more skilled to take on the task as a project manager again after having learnt so much.” Alejandra Mørk continues, Leading experts in language “Also the timing was services to the Life Science right; the strategy for Industry Nycomed at that time CLS Communication offers a full spectrum of during Nordic Caplanguage services. However exacting and varied ital’s ownership was your requirements, we have the experience and linguistic expertise to fulﬁl your needs. to base the pipeline on drug-candidates CLS Communication A/S being in-licensed at Østergade 55 | DK-1100 Copenhagen K | T. +45 3332 3452 info-dk@cls-communication.com | www.cls-communication.com phase II or III, register 19 local CLS ofﬁces worldwide make sure your message matters: and market them. To Basel | Beijing | Chiasso | Copenhagen | Frankfurt | Hong Kong | Lausanne | London | Madrid Moncton | Montreal | New York | Ottawa | Paris | Quebec | Shanghai | Singapore | Toronto | Zurich do that we needed a 11555 / JPbureau Group

development and regulatory affairs, I felt much more confident in the role as a project manager. It made perfect sense to take these years of

3030

strong and agile project management – and I enjoyed the job of taking charge of that process.”

Taking lead Alejandra Mørk has been a manager the vast majority of her career. “Somehow the manager’s role always ended up in my lap; I’m not sure though if ambition had much to do with it from the start, moreover it came down to my dedication to the team and my commitment to the employees.” At Nycomed she was Head of Clinical Development and later Regulatory Affairs, Head of Project Management, and then in 2003 she was offered the position as Head of International Product Development and member of the Group Management. “Heading IPD was a major milestone for me personally, because it let me work with Group Management for the first time on top of managing people, in which I took great pleasure and by the way still do,” she says. As a manager she describes

herself as the person with the red umbrella: “I take lead and I guess – I take action. I look for the light at the end of the tunnel and head towards it.” When asked what achievements as a manager she is particularly proud of, she responds: “When I was heading Clinical Development at Nycomed, I believe a cultural change took place. This may sound somewhat verbose but let me try to explain what I mean by this. Anyone who has worked with clinical development hands on knows that on a daily basis there are an endless number of things that can delay or even derail your project. The point is we go to work to do the job, to take action and get things moving into the right direction. We don’t go to work for fun – and we don’t

go to work only to let ourselves be stopped by the numerous hurdles and obstacles we run into. I certainly did not make this cultural change alone, but I am proud of the fact that I have facilitated and been part of implementing this behavioural change that everyone was focused on the common goal and getting there.”

New endeavours Alejandra Mørk thought at the time of her first job at Nycomed that she would hang around for about two years before it was time for her to move on. It did not quite turn out that way. By the end of 2007 after 18 years at Nycomed, she decided to leave and she took over KLIFO along with a few investors. KLIFO was originally founded in 1994 as

a Clinical Research Organisation providing clinical trial services and supply of drugs for clinical trials. Today the business has grown, employs 56 people, and in addition to the CRO services on clinical trials and clinical trial supply, KLIFO delivers consultancy on drug development. The company is located in Symbion Science Park in Copenhagen. “It was not carved in stone at all that I was going to be the owner of my own business with some fifty employees, having said that, working alone as a consultant was never really an option for Photo: Jeppe Carlsen

SOLUTIONS FOR BIOTECH/PHARMA Protein Production Bacterial and mammalian production - from process development to purified product.

From Active Compound To Administration Drug characterization, analysis and formulation development.

Immune Models In vitro models for prediction of immunoregulatory effects of compounds.

Biomarkers Identification, validation and documentation of disease relevant biomarkers.

Molecular Histology Service In situ detection of microRNA. Image analysis - quantitative ISH. Combined IHC and ISH service.

Stem Cell Technology Adult – and pluripotent stem cell characterization. Stem cell models for regenerative medicine. Cell (stem) motility models.

Bioneer A/S Kogle Allé 2 DK- 2970 Hørsholm

t +45 45 16 04 44 f +45 45 16 04 55

e info@bioneer.dk w www.bioneer.dk

PORTRAIT

me. I thrive among people and I thrive by managing and achieving results together with others,” Alejandra Mørk says. Leaving Nycomed was not as difficult as it may appear after 18 years. She felt she had come to a cross road. “In 2007 Nycomed had acquired German based Altana. The process around bringing the two companies together was extremely complicated. For me it implied much more travelling than I had been doing for many years before that. On a personal level this was difficult for me – and professionally I felt that I spent more time focusing on whether I had the right papers in my bag – on my way to the next meeting in the next country, rather than managing people and sponsoring projects as the Head of International Product Development. I was no longer thriving – so something had to be done.” Shortly after she had decided to leave Nycomed, the offer of acquiring KLIFO became real, and since January 2008 she has been the CEO at KLIFO.

Professional interest As a pharmacist she knows her line of work deep enough to be able to act as a competent sparring partner to employees as well as clients at KLIFO “Of course I am a generalist much more than a specialist and I totally respect the insights and expertise of every specialist I manage. However, understanding where they are coming from in terms of e.g. issues they run into makes it easier for me to act as a manager. If you have no idea what the cake is supposed to taste like, it is really difficult to pinpoint things about the recipe that is just not going to work,” she says, carrying on:

at Nycomed, qualifies me as a manager – and it also gives the employees certainty that at the end of the day, I do have the capacity to dig into the detail if need be.” On a personal level as a manager Alejandra Mørk remains authentic and easy going as in what-you-seeis-what-you-get. “In general anyone who tries can read me like an open book, and I have to admit that sometimes I wish I was able to be just a little less open. On the other hand, being honest, outspoken, and very clear in my communication has also been of great help, particularly in difficult situations.”

“I have to admit that sometimes I wish I was able to be just a little less open.” “I know my limitations, and I’m unlikely to succeed as the manager of e.g. an IT-department. I would not know what the basics of the deliveries are. But knowing the substance of our services here at KLIFO – and previously

She describes how she had to let four people go at KLIFO in 2010. “A large client had closed the account, simply discontinued the project completely. I realised quite soon that I had to do something drastically, and let people go or else the company would not make it. That was truly a severe challenge having to let people go when they were not to blame for the loss of the client, and no finger could be pointed at their work and effort whatsoever. The point is that you can make people understand the situation so that they can leave without bitterness; I learnt that later, when I was able to re-hire one of the employees, and she still felt that KLIFO remained the place she wanted to work, despite the fact that I had fired her previously.”

Taking breaks to recharge For how long will you carry on? “Right now I see myself doing what Photo: Jeppe Carlsen

3232

I do now for another six or seven years. But I would really love to work a little less in the future,” she says humbly wishing for the future. She would not go as far a calling herself a workaholic, but admits to being born as a diligent person. “Nowadays, where my children have moved out of the house, work tends to take up a lot of time. However, I consciously try to free up time to do things that are not work related, go to a concert or a play, reading books, or exercising in the running club. While working in the kitchen patch may feel strenuous to some, Alejandra Mørk on the contrary finds it relaxing and joyful. Hence it is among salads, beans, cucumbers, zucchinis, tomatoes, potatoes, and berries that she takes a break and recharges herself. “I believe in taking breaks, otherwise you just dry out,“ she ends. •

Taking a break from work in order to recharge herself is mandatory to Alejandra Mørk, CEO at KLIFO, and the perfect place to do so is in the midst of her kitchen patch.

Photo: Jeppe Carlsen

CPH LabMed Danmarks nye fagmesse for laboratorieteknik

• Diagnostik • Forskning • Bioteknologi • Kvalitetskontrol • Laboratorieudstyr • Fagkonferencer

DEKS-Brugermøde og LSB’s Årskongres 8. – 9. oktober

Lokomotivværkstedet

cphlabmed.dk

7. - 9. oktober 2014

TALKIN’ ABOUT

How intestinal bacteria could revolutionize medicine Whether intestinal bacteria will revolutionize medicine is the hot topic at the Novo Nordisk Foundation Center for Basic Metabolic Research. Professor and Scientific Director Oluf Borbye Pedersen is blazing an international trail for this pioneering research. Here, he outlines the area and identifies future medical opportunities. By Kristian Sjøgren

hat is the most exciting aspect of your research area at this point? “By far the most captivating aspect is research into the importance of intestinal bacteria for our health and risk of developing a number of diseases. Until four years ago, the majority of the 100 trillion bacteria we have in our intestines remained unknown because the bacteria in their natural environment live without access to oxygen and are therefore difficult to cultivate and characterize in the laboratory. However, by using advanced DNA technology and bioinformatics, large-scale international alliances have succeeded in mapping practically all the bacterial species frequenting human intestines based on their genetic profile. Altogether, we have helped map about 10 million bacterial genes in ‘our second genome’, as featured in various Nature publications. The genes from the microbes are then put together in a host of jigsaw puzzles with a view to defining the many previously unknown bacterial

3434

Translation: CLS Communication A/S

species and their functions in the intestines.” Why is that a milestone discovery? “It is a milestone discovery because knowledge of the various previously unknown bacterial species means we can begin mapping which bacterial compositions in the intestines characterize a healthy person, and which bacterial species characterize people with various diseases. We are currently conducting research projects to find out what characterizes the respective bacterial compositions among people living with obesity, diabetes, anorexia, sclerosis and schizophrenia, as well as people living on vegan or gluten-free diets.” How will that be useful? “The bacteria in the intestines work like a chemical plant if the neurotransmitters are in direct interaction with all our organs from the brain to the heart via absorption into our bloodstream through the walls of the intestines. Today, we know very little about the

molecular mechanisms that cause the intestinal microbiota to have a major impact on us, but we are well on our way to working that out, for example by combining the studies on human biology with mechanistic studies in mice.” Can we alter the composition of intestinal bacteria? “Yes, we certainly can, and this is where the incredibly exciting aspects of this research really lie. Studies on mice have already shown that if

you feed mice with bacteria from an obese person, the mouse becomes obese, while it does not become obese if it receives the intestinal bacteria of a slim person. It has also been demonstrated that a big reduction in the amount of some substances associated with autism in mice can be achieved simply by adding one type of bacteria to their diet. The composition of intestinal bacteria is thus not fixed, but can be modified to improve health or cure disease.” Can this be used in medicine? “That is the plan. Bacterial therapy is already being discussed as a potential medical revolution. Perhaps, for example, we will find bacterial compositions associated with anorexia that reduce appetite.

We could then try to recreate this bacterial composition in people who are morbidly obese by transplanting intestinal bacteria from a person with anorexia to the obese person. Or perhaps, as with autism in mice, we will find bacteria that secrete bioactive substances in the intestines that have a curative effect on particular diseases or a healthpreserving effect in general. There are two major medical potentials. The first is that we can find a cocktail of bacteria that have the effect of promoting or preserving health. It would be possible to cultivate this cocktail of bacteria anaerobically and encapsulate them anaerobically. For example, this could involve a combination of 50–100 different species of bacteria that have a

OLUF BORBYE PEDERSEN • Oluf Borbye Pedersen is a professor and scientific director at the Novo Nordisk Center for Basic Metabolic Research, University of Copenhagen, where he and his research team are using genetic methods to conduct primary research into the causes of diabetes, obesity and cardiovascular diseases. They aim to find innovative methods for treating these rapidly spreading pandemics. • Oluf Borbye Pedersen has authored more than 600 scientific articles, many of which have been published in Nature magazine, and he has received 14 international and national awards for his scientific achievements. • He has played a major role in establishing international alliances between Denmark and foreign research institutions, including Beijing Genetics Institute, Shenzhen, Oxford University, Berkeley University, the Pasteur Institute of Lille and Imperial College London. • Oluf Borbye Pedersen was also chairman of the Danish Diabetes Association from 1995 until 2000.

beneficial effect on specific diseases. Conceivably, other combinations of bacterial species could be given to healthy people once or twice a day to support and maintain healthy gut flora that prevent disease. This is the next generation of probiotics. The second major medical opportunity involves a better understanding of the bioactive substances secreted by the bacteria in the intestines. Many of them probably help to promote health, and insight into these substances will provide us with access to a lot of new potential medicines without the fear of side effects. After all, the medicine has already been tested over several million years of peaceful coexistence between the bacteria and the human host.” •

plier!

New sup

Innovative and high quality solutions for your research. Cloning. PCR/qPCR. Next generation sequencing. Antibodies. Custom services. Expert technical support, delivery & service. BioNordika Denmark A/S Marielundvej 48, 1. 2730 Herlev tel 3956 2000 info@bionordika.dk www.bionordika.dk

3535 35

UPDATE - EMPLOYEES

Business bulletin

About the laboratory sector By Malene Aadal Bo

Translation: CLS Communication A/S

Originally, the planned extraction speed for fume cupboards in the University of Copenhagen’s new buildings was only 0.35 m/s. The speed reduction was to conserve energy. However, a new report from the Danish Technological Institute in cooperation with the University of Copenhagen has shown that speeds lower than 0.5 m/s could jeopardise employee health. Even a small reduction in the speed at which the fumes are extracted significantly When a fume cupboard is in use, the extraction speed must be 0.5 m/s, according to the reduces safety levels. Danish Institute of Technology The Danish Association of Laboratory Technicians should dispel any discussion of lower extraction speeds applauds the University of Copenhagen’s decision to set at laboratories in Denmark,” says President Susanne the extraction speed at the recommended 0.5 m/s, not Bahne Hansen, recommending intelligent fume least because the perspectives in the report reach far cupboards solutions that can save energy and provide beyond the university campus. ‘ a financial incentive for improving existing fume “The report from the Danish Technological Institute cupboards.

University to spend DKK 70 million on laboratory equipment Aarhus University has earmarked DKK 70 million for new equipment for the new research centre that is under construction. The new building, comprising 8,300 sq m of laboratories above ground and about 4,800 sq m of underground facilities, will require plenty of new furniture and equipment. “We are recycling to some extent but also seizing the opportunity to upgrade our facilities, and therefore much of the equipment will be new,” says Thomas G. Jensen, head of the Department

3636

of Biomedicine at Aarhus University. He mentions primarily equipment for housing mice, rats, fish and fruit flies. A significant amount will also be invested in autoclaves for sterilisation, and general laboratory equipment such as tables, cupboards and washbasins. The budget for equipment totals DKK 70 million. In addition to the tender scheduled for November, Thomas G. Jensen expects new equipment such as microscopes will be needed on an ongoing basis.

Photo: Claus Bjørn Larsen

Extraction must be at least 0.5 m/s

Do you havE ThE RiGhT ExEcuTivE SEaRch & SELEcTioN PaRTNER WiThiN LiFE SciENcE? Best Talent is specialized within Life Science and is a member of the international Global Executive Search Network Enex. Best Talent has more than 15 years of experience in assessing leaders skills, candidates skills,talents talentsand andpotentials. potentials. We have a solid knowledge of the market conditions and a very attractive executive network, in which we employ search strategies that attract highly qualified candidates. Best Talent performs Executive Search & Selection assignments across all functional areas within Medical Device, Pharmaceutical, Biotechnology and Food Science Pharmaceutical. Please do not hesitate to contact Best Talent for further information on +45 4556 5300. Read more at www.besttalent.dk

Nærumvang · Skodsborgvej 234 · 2850 Nærum · T: +45 4556 5300 · info@besttalent.dk · www.besttalent.dk Best Talent is a member of Enex Global Executive Search Network and is represented worldwide in more than 30 countries. BT_november_ann.indd 1

20/11/12 19.42

Banebrydende nyhed til laboratorier Det modulopbyggede vandbehandlingsanlæg giver dig frihed til at vælge det vandsystem, der dækker netop dit laboratoriums behov. Vil du være den første i Danmark til at prøve nyheden? Kontakt ELGA specialisten Mette Linding Nygaard på tlf. 2628 3141 eller e-mail: MLN@kruger.dk www.eshop.elgalabwater.dk

ELGA. Vores innovation. Dit valg.

PURELAB® Chorus

Mød os på LabMed 37

CAREER

If you want a career… Henrik Brabrand makes his living finding the best-qualified 10% in a given field. We have asked the recruitment specialist and partner at Albright Partners, to take stock of the career prospects in Danish Life Science. By Malene Aadal Bo

Translation: CLS communication A/S

he most popular men and women in Life Science right now are Quality Assurance experts and those who know how to work with Market Access. In both areas, the authorities have introduced stricter requirements for companies, resulting in e.g. a greater need to upgrade the skills of employees. “Those are the positions we are having most trouble filling with the right people. Demand simply outweighs supply, and far from everyone can adapt their skills to the new reality,” says Henrik Brabrand. His job is to find the best-qualified 10% within a given field, and his search covers both Denmark and abroad. He is looking for people who score high on the six parameters, or high performance indicators, that the company uses to navigate in its quest for talents: 1) previous and current performance 2) previous experience 3) professional competences 4) learning agility 5) cognitive skills 6) personality “People who create special value in Danish Life Science nowadays are those who are both highly professionally competent and also have the ability to cooperate smoothly in alliance with many different stakeholders. Job settings can change quickly and significantly, and agility is generally a vital success factor.” This is partly because technological development means that knowledge and competences quickly become out-

38 38

Photo: PR

dated, and new legislation and regulatory requirements in particular are increasing the need for companies to develop skills at top speed. If you are one of the few who can meet these demands, you are a valuable asset for Life Science. The question is, whether the Life Science sector is also top of the candidates’ wish lists? According to Henrik Brabrand, the answer is “yes”. Despite the financial crisis that continues to undermine

ALBRIGHT LIFE SCIENCE Albright Life Science is part of Albright Partners A/S – a highlyspecialised executive search & assessment company. It is one of the leading companies in Denmark and the Nordic countries within recruitment of both specialists and managers for the Life Science industry. Read more at www.albright.dk/lifescience

working conditions and job security in the industry, this is a field many people find appealing. At the same time, the financial climate means that more companies have invested in new scalable business models and become far more innovative. And that attracts employees. Yet most importantly, according to Henrik Brabrand, the sector is driven by some values and an objective that many people identify with: “Helping millions of people to fight disease or improve their life quality. I talk to many people for whom working in Life Science in particular gives them the chance to join in and

make a difference. And that means a great deal,” he says. And what about the future? “The future will bring increased globalisation – including corporate acquisitions, procurement of clinical portfolios and company mergers. The companies will focus clearly on ensuring operational efficiency, R&D/innovation, and growing the customer base while developing targeted service solutions. This is the future scenario in which to position yourself,” concludes Henrik Brabrand.

Denmark seeks foreign talent to fill recruitment gap in biotech industry In 2013 Denmark ranked # 1 in Europe on the Worldview Report and Bio-Innovation Scorecard. Now the Nordic nation needs foreign talent for its growing biotech sector. Can the world meet Denmark’s demand?

“

Biogen Idec´s forecast for next year is to recruit from 150 up to 200 positions at all levels from manufacturing to engineering to management,” states Jim West, Recruitment Manager at Biogen Idec at Hillerød, Denmark. “Further there are a number of large biotech companies in Denmark and I know that we are all ramping up. Amongst our companies we have hired more than 400 people this year to date and we have a feeling that there is not enough talent in Denmark to fill all future openings.” The talent deficit has led West and his counterparts to create a working group, Future Workforce Network, to discuss strategies to ensure a talent pipeline for their industry. Biogen Idec has also sought the assistance of Talent Attraction Denmark, a project that works to create targeted campaigns to attract foreign talent. “They can reach various markets for us and they are representing Denmark as a whole, not just one company,” describes West. “They can speak to the benefits of relocating to

Denmark and they can act as a third party to potential candidates in a way that an employer can’t.” “Biogen Idec in Hillerød is especially appealing for people who want a career in science and manufacturing that also allows them to apply their skill set to benefit the patients we serve. We provide an interface between scientific

Photo: PR research and innovative technology as part of our manufacturing strategy. People with a scientific background can really benefit from this opportunity.” describes Justin McCue, Director, Manufacturing Science at Biogen Idec who is in the midst of an 18 month placement at the Hillerød site.

Is your company also looking to attract Life Science professionals? Join our international recruitment campaign. Talent Attraction Denmark is currently running a targeted recruitment campaign to attract international high-skilled Life Science professionals. As a supplement to your recruitment strategy it also targets the ‘passive’ candidates, and it is free for your company to join. Contact project manager Merete Sandager at msa@copcap.com to join the campaign or learn more by visiting the campaign at: http://lifescience.talent attractiondenmark.com

3939

See you at Welcome to the premiere of CPH LabMed Copenhagen LabMed welcomes the whole lab industry to three hectic days in the new venue “Lokomotivværkstedet”. At the same time it is also a welcome to the biggest exhibition the industry has seen in many years. This premiere version of CPH LabMed has more than 133 exhibitors, who show all the latest and best laboratory equipment the industry has to offer. One of our goals with this new trade fair was to enhance the professionalism significantly. It is therefore with great satisfaction that we also welcome DEKS-User Meeting (Danish Institute for External Quality Assurance for Laboratories in Health) and LSB’s 9th Con-

Procurator er en førende producent og leverandør af personligt sikkerhedsudstyr, beklædning, rengøringsartikler samt uddannelser til enhver arbejdssituation inden for en lang række brancher i industrien. Vi har et bredt sortiment, der gør arbejdslivet effektivt og sikkert i alle arbejdsmiljøer

the fairs (the 8th – 9th). A new invention is the Exhibitors FREE Lab Theater – here we can offer a total of 28 professional features implemented on the latest in the industry. In other words, the visitors will have a great opportunity to see all the latest equipment, and simultaneously update their professional skills with lectures and seminars of high class.

gress (Laboratory Medicine Society of Bioanalysts) which will run parallel with

Apodan er Nordens førende leverandør af farmaceutiske emballager og tilbehør. Besøg vores stand eller www.apodanpharma.dk for mere information.

Formaling, Sigtning, Partikel Dimensionering og Varme Teknologi. Mød os på Stand 215 www.retsch.dk

Vi udstiller på Stand nr. 1

www.siemens.dk/diagnostics

Komplet printerløsning til laboratorier, Find os på stand 135 Etisoft: +45-86867733,

Se mere på:

www.eticalls.eu

40 40

Lovmand Diagnostics er forhandler for Randox, Neuation, Kartell, Conda, Biosepar og Accumax Vi udstiller på Standnr. CEV 7 se www.lovmand.com

www.procurator.dk

Siemens Healthcare Diagnostics tilbyder et bredt udvalg af diagnostiske løsninger til effektiv analysering indenfor in-vitro diagnostik.

Enjoy Bo Rasmussen Exhibition Manager - J. B. Exhibitions

Vi er på stand: CEV 12

Velkommen til Danmarks eneste landsdækkende vikar- og rekrutteringsbureau specifikt for laboratoriebranchen. Med over 20 forskellige laboratorierelaterede faggrupper indenfor alt lige fra fødevareområdet over læger, pharma, medicinal og biotek til dentalområdet. Nu med 8 års speciale på lab-området med vikariater og rekruttering!

www.tempus600.com

www.Labvikar.dk

TEMPUS600® is a transport pipeline designed for small clinical samples. Moving 600 meters in less than a minute, the samples arrive for analysis within a few seconds – directly from where the sample was taken

DFD Cleanroom er en værdiskabende samarbejdspartner og leverandør af fremtidssikrede og fuldt dokumenterede beklædnings- og rengøringsløsninger til cleanroom www.dfd.dk

DL-F i HK: Sæt nye detaljer på din karriere, og mød andre laboranter, miljøteknologer og professions bachelorer

ENTERPRISE CONTENT MANAGEMENT

BECOME MORE EFFICIENT WITH DIGITAL WORKFLOWS

Imagine that you know a partner, who can tell you how you are able to work more efficient with electronic documents and information. At Konica Minolta we do not only imagine this – we actually make it happen. Konica Minolta can make sure that your company can:

• Increase efficiency significantly • Increase productivity by 30 percent • Shorten response times to customers and colleagues with factor x 4 • Benefit from the sharing of knowledge between colleagues, partners and customers • Retain vital information and make it available in the future

Book a meeting and get an idea of how your business can become even more efficient.

For more information contact: Michael Fray, Senior Consultant ECM, Mobile: 4214 3077 E-mail: michael.fray@konicaminolta.dk, Web: www.konicaminolta.dk/ECM

OPTIMIZATION OF WORKFLOWS

Konica Minolta Business Solutions Denmark a/s Stensmosevej 15 • 2620 Albertslund • 72 21 21 21 • www.konicaminolta.dk

LEGAL UPDATE

When are human embryos, human embryos? Stem cell research is of significant importance to the biotech industry - the Court of Justice set to decide on whether inventions based on parthenotes are excluded from patent protection. By Thomas Bjørn, solicitor, Royds in London

nternational Stem Cell Corporation (ISC) had filed applications for two national UK patents claiming methods relating to pluripotent human stem cell lines produced from unfertilised human ova activated by parthenogenesis. The UK Intellectual Property Office (IPO), however, refused the ap-

plications and held that the inventions concerned the use of human embryos for industrial or commercial purposes which is excluded from patentability under the Biotechnology Directive. The IPO relied on the decision of the Court of Justice of the European Union (CJEU) in the Brüstle case where the CJEU held that an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis (a parthenote) constitutes a human embryo and therefore falls within the scope of exclusion from patentability. On the basis of 20 years of experience, DB Lab In its appeal to the offers to solve your analytical problems: High Court, ISC argued that the exclusion Chemical, physical and microbiological tests of in the Brüstle case primary and finished products should not extend to Development, validation and transfer of parthenotes because analytical methods according to ICH guidelines of the inability of such Light treatment and stability tests, storage in organisms to develop qualified climate facilities into human beings. The High Court therefore DB Lab is ISO17025 accredited by asked the CJEU to DANAK and §39 authorised by the Danish Medicines Agency comment on whether “unfertilised human ova whose division and further development have been stimulated by parthenogenesis, DB Lab A/S · dblab@dblab.dk · www.dblab.dk · Tel +45 6593 2920 and which, in contrast

GMP Contract Laboratory

4242

to fertilised ova contain only pluripotent cells and are incapable of developing into human beings, [are] included in the term “human embryos” in Article 6(2)(c)” of the Biotechnology Directive?

Are pathenotes human or not? The Court itself was clearly of the view that parthenotes, for the reasons suggested by ISC, should not be regarded as human embryos and that the patent applications therefore should have been allowed. The Attorney General agreed, stating that “the decisive criterion that should be taken into account for determining whether an unfertilised ovum is a human embryo hence is whether that unfertilised ovum has the inherent capacity of developing into a human being”. He therefore concluded that such unfertilised human ova are not included in the term “human embryos” in Article 6(2)(c) as long as they are not capable of developing into a human being and have not been genetically manipulated to do so. The Attorney General’s opinion appears to be in line with the overall principle laid down by the CJEU in Brüstle. The opinion does, however, add the important clarification that a parthenote, which does not in itself have the inherent capacity of developing into a human being, does not constitute a human embryo in the meaning of the Biotechnology Direc-

tive and that its use for industrial or commercial purposes should therefore not be excluded from patentability. There is obviously no guarantee that the CJEU will reach the same conclusion but the biopharmaceutical industry will undoubtedly see the opinion of the Attorney General as a welcome clarification of the decision in the Brüstle case.

The important stem cells Stem cells are likely to play an increasingly important role in the treatment of disease and the exclusion from patentability of inventions relating to cells which lack any capacity to develop into human beings would place the industry at a serious commercial disadvantage and may have a significant negative impact on stem cell research and the development of future treatments. •

ABOUT THE AUTHOR Thomas Bjørn works as a solicitor with Royds LLP in London. Thomas Bjørn holds a law degree from the University of Copenhagen and has worked in private legal practice and in the pharmaceutical and biotech industries in the UK, Switzerland and Denmark. His areas of expertise include the protection and commercialisation of intellectual property, regulatory affairs and the sale of goods and services to the NHS. Royds LLP is a London City based law firm providing legal services to the international business community. The firm specialises in commercial law and has a strong focus on intellectual property and the life science industries.

The opinion is available at: http://curia.europa.eu/juris/document/documentjsf?text=&docid=155123&pageIndex=0&doclang=en&mode=req&dir=&occ=first&part=1&cid=517966

Is your company looking to attract Life Science professionals?

Join our international Life Science recruitment campaign

Use our free marketing materials developed for international recruitment

Talent Attraction Denmark runs a targeted recruitment campaign to attract international Life Science professionals, and it is free for your company to join. Contact project manager Merete Sandager at msa@copcap.com or visit the campaign site at lifescience.talentattractiondenmark.com

In our Toolbox you will find free marketing materials such as videos, infographics, articles and more that can support your international recruitment and tell the story of life as an international employee in Denmark. Visit www.talentattractiondenmark.dk to find the materials relevant to support your recruitment strategy.

4343 43

ONCE UPON A RIGHT-ON-TIME...

EVERYONE LOVES A GOOD STORY World Courier’s customers have amazing tales of how we’ve moved their time- and temperature-sensitive products around the globe — sometimes at a moment’s notice.

The problem-solving mindset and global presence of World Courier staff resulted in delivery within 48 hours, with no temperature excursions.

For example, one client advised us late one evening that it needed to transport a large volume of temperature-sensitive, clinical trial product from Finland to Israel for reformulation. During logistics planning, it became clear that any mistake in handling or moving the product would disrupt the clinical trial.

Stories like these show why more pharmaceutical companies rely on us than any other specialty logistics provider in the world.

worldcourier.com marketing@worldcourier.com

linkedin.com/company/world-courier twitter.com/worldcourier

Creating specialized solutions for life science

ADVERT

Building a highly specialized laboratory or manufacturing facility for life science takes more than engineering skills. Fully comprehending the life science processes is a major competitive driver at the Kemp & Lauritzen Group. “Value engineering is what we mean by combining engineering skills with branch specific insight ensuring that when it comes to e.g. laboratories, GMP, API etc. we know what the updated specific requirements are,” says Thomas Schalek, Business Manager Pharma360® at Glenco. Pharma360® Glenco specializes in ventilation and cooling and as part of the Kemp Thomas Schalek, Business manager, Pharma360® & Lauritzen Group and responsible key account for life science, Glenco offers Pharma360® that encloses the full list of services from Glenco, Kemp & Lauritzen (electricity), and L&H-Rørbyg (piping / plumbing). Offering a one-stop-shop allows the engineers and project managers at Glenco to be far more efficient and maintain a high level of expertise pertinent to the needs of life science industry partners, while building on 35 years of experience. “Participation from the early phase of the project, contributing in designing and planning, ordering components, building of the room, and finally handing over the key to the client on the date we agreed to while simultaneously implementing the life science specific requirements into the project is what Pharma360® is about,” Schalek says. Adding value by continuous training Expertise tends to build confidence with clients. When The Kemp & Lauritzen Group recently worked with Novo Nordisk on the construction of a 500 square meter production facility this became evident. “Our understanding of what needs to be taken into consideration when building a manufacturing facility facilitates the working process and makes it far more agile, which is key

when time is of great essence,” Schalek explains. The specialists at the Kemp & Lauritzen Group are trained in ISO14644, GLP, and GMP. “We add value to our clients’ projects by knowing these requirements in great detail, and apart from the ongoing training we also participate in network like R3 Nordic and the Lab group, continuously discussing how to e.g. optimize cleanroom and laboratory facilities,” says Schalek. Thinking out of the box The requirements by authorities seldom leave room for interpretation. Still, it does happen that clients face special challenges where innovative thinking is called for. “It could be the need for floor ventilation, specially conditioned air etc. The point is – we can do it,” Schalek says. Morten Mølgaard Jensen, CEO, Copenhagen Bio Science Park, was convinced of the two-edged competences at the Kemp & Lauritzen Group at completion of phase II of the Copenhagen Bio Science Park: “COBIS is ambitiously creating conditions for the biotechnology of tomorrow. The Kemp & Lauritzen Group demonstrated that they know what it takes to design and build a cutting edge research facility.” For more information http://www.kemp-lauritzen.dk/

FACTS ABOUT The Kemp & Lauritzen Group • Holds three specialised companies, Kemp & Lauritzen, L&H-Rørbyg, and Glenco with solid specialist skills and experience • Provides technical solutions for electricity, piping /plumbing, and ventilation/cooling • Has about 1900 employees • Glenco specializing in ventilation and cooling and is the key account for life science partners

Reach your target â&#x20AC;&#x201C; and beyond!

More than 45 companies have already joined the fastest growing biopark in Scandinavia And we are honored to have them here in Copenhagen Bio Science Park, offering them our 12.000 m2 of exceptional office and lab space, network & services etc. So why not join the most vibrant life science community in Denmark and start your adventure. Give us a call today and learn more or check out www.cobis.dk for more information.

COBIS A/S Ole MaalĂ¸es Vej 3 DK - 2200 Copenhagen N +45 70 70 29 80 info@cobis.dk | www.cobis.dk