Copenhagen Life Science feb. - 2014

NO. 1

FEBUARY/MARCH 2014

Portrait: Henrik Ørum from Santaris Pharma surfing the Danish biotech wave of success.

What’s his secret?

Theme: Vaccines

Vaccines and immunotherapy: A shot in the arm for researchers and the business world. See why

Jan Trøst Jørgensen “Soon we will see diagnoses based on rogue molecules and genes”

No. 1 – 2014

Contents 4

The column PUBLISHER:

Lone Frank on vaccines: “Territory sure to be paved with gold”

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Update RASK Media ApS 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 and Charlotte Strøm

MEDIAPARTNERSHIPS WITH:

www.ibceuroforum.dk

Newsflash on business, science and technology

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The picture The most beautiful hospital in the US

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Theme: Vaccines and immunotherapy – the new blockbusters Prevention and therapeutic vaccines are in focus in the world of medicine like never before, and researchers and investors agree “the sky is the limit”

- The wonder drug of the future ����������������������������������������������������������������������������������������������������������� 16 - It all began with a cow ������������������������������������������������������������������������������������������������������������������������������� 20 - Alligator Bioscience ��������������������������������������������������������������������������������������������������������������������������������������� 22 - Bavarian Nordic ���������������������������������������������������������������������������������������������������������������������������������������������� 24 - A portrait of the immune system ����������������������������������������������������������������������������������������������������� 26

Portrait – Henrik Ørum from Santaris Pharma

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“My motto is: Anything worth having is hard to get. This is one of the recurring truths in my life.” www.scanlab.dk

Talkin’ About

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Jan Trøst Jørgensen – tracing the progress of diagnostic technology.

Guide: Supplementary Protection Certificates www.health-rehab.dk ADVERTISING:

Solicitor Thomas Bjørn explains how two new rulings change the game

Calendar Selected Life Science meetings and seminars

NEM Media Hadsundvej 11, DK-2610 Rødovre Phone: +45 4281 1110 nem@nemmedia.dk

Cover Photo: Jakob Carlsen Layout and print: artegrafix and PE Offset A/S ISSN: 1904-4755

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Specielt til dig som trofast læser af COPENHAGEN LIFE SCIENCE! Ty r k i e t

Nikos

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Afrodisias Pamukkale Kusadasi Fethiye

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To have – kulturelle højdepunkter mellem Middelhavet og Ægæerhavet

fra kun

2. dag: Demre (St. Nicholas) – Fethiye I dag kører vi op langs Lykiens dejlige kyst via Finike til Demre (tidligere Myra). Her besøger vi St. Nicholas kirken, hvor biskoppen af samme navn, der siges at være den rigtige julemand, havde sit virke i det 4. årh. Herfra fortsætter vi til Fethiye, der tidligere hed Telmessos. Overnatning i omegnen af Fethiye.

1

pr. pers.

r i stedet foDKK

7490,,––

Læs og rejs: 8 dage | inkl. fly retur | 4- og 5-stjernede hoteller 1. dag: Rejse til Antalya og transport til hotellet

5. dag: Afrodisias – Antikkens juvel I dag går turen via den øvre Mæanderdal til den antikke

by Afrodisias. På grund af byens beliggenhed tæt på forskellige stenbrud opstod der her en blomstrende marmorindustri samt en berømt billedhuggerskole, der vandt internationalt ry. Den såkaldte propylon, den monumentale indgang til Afrodite-templet, det næsten fuldstændigt bevarede stadion og det romerske teater er blandt turens højdepunkter.

3. dag: Karien – seljtur til Dalyan I dag tager vi på en sejltur gennem den fredede lagune ved Dalyan. I den antikke by Kaunos besøger vi de berømte lykiske klippegrave og fortsætter så til stranden i Iztuzu (skildpaddestranden).

6. dag: Pamukkale (UNESCO-verdensarv) – Tavas – Taurusbjergene Efter morgenmaden sætter vi kurs mod Pamukkale (UNESCO-verdensarv), hvor vi holder en fotopause.

Herefter kører vi over Taurusbjergene videre til Tavas.

Undervejs passerer vi forskellige nomadelejre. I et 4. dag: Efesos – Artemistemplet – Mariakirken Et af højdepunkterne på rejsen er den antikke by traditionelt tæppeværksted 1300 m.o.h. får vi et lille Efesos. På antikkens tid var Efesos en blomstrende indblik i tæppefremstillingens kunst. metropol, hvilket bl.a. det pragtfulde Celsus-bibliotek, 7. dag: Antalya & den gamle byden Hadriantemplet, Agoraen og det store teater bærer I dag ser vi nærmere på Antalya. Provinshovedstaden vidnesbyrd om. Apostlen Paulus gjorde ophold i byen på byder på dejlig sol hele året samt masser af sine missionsrejser. Vi besøger koncilkirken, også kaldet kulturhistorie og skønne naturomgivelser. Efter en Mariakirken, hvor det tredje økumeniske koncil fandt længere sightseeingtur tager vi ind i den gamle bydel. sted i år 431 e.Kr. (Koncilet i Efesos). Om eftermiddagen Vi slutter turen af på hhv. en smykke- og læderfabrik, besøger vi Artemistemplet, et af den gamle verdens syv hvor der vil være lejlighed til at shoppe. vidundere. Vi runder dagens program af med et besøg i den middelalderlige Isa Bey-moské. Overnatning i 8. dag: Hjemrejse omegnen af Kusadasi.

Transport til lufthavnen og hjemrejse.

Februari '14 (24.–26.02.14) SISTA-MINUTEN:

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Inkluderet i prisen: Fly tur/retur til Antalya med anerkendt flyselskab 2515,– DKK 2 Transport lufthavn – hotel – lufthavn 118,– DKK 2 7 overnatninger på udvalgte 4- og 5-stjernede hoteller (tyrkisk standard) inkl. velkomstdrink og 7x stor morgenbuffet 3850,– DKK 2 Rundrejse i moderne busser med klimaanlæg 1007,– DKK 2 Samlet pris pr. person 7490,– DKK 2 Rabat pr. person – 6500,– DKK2 Fordelspris pr. person fra kun

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Marts '14

Marts '14

April '14

Maj '14

Oktober '14

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Rejsetidspunkter

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November '14 November '14 December '14

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* Visumfri indrejse til Tyrkiet for danske statsborgere, hvis opholdet varer maks. 90 dage. Ved indrejsen kræves fremvisning af pas, der på tidspunktet for indrejsen skal være gyldigt i mindst 6 måneder.

Det anbefales, at borgere fra andre lande indhenter oplysninger om de gældende indrejsebestemmelser på den tyrkiske ambassade i København. Der kan kun ansøges om visum til Tyrkiet på nettet: https:// www.evisa.gov.tr/en/tour/. Fra den 10.04.2014 kan visum ikke længere fås ved ankomst til landet.

1 Prisen gælder fra den 24.02. – 26.02.2014 og 07.12. – 14.12.2014. I forbindelse med andre afrejsedatoer påregnes sæsontillæg som angivet i tabellen. # Ferietillæg p. p.: 590,– DKK. Pris ved indkvartering i dobbeltværelse. Ved modtagelse af den skriftlige booking bekræftelse forfalder 20 % af rejseprisen til betaling. Det resterende beløb betales senest 35 dage før afrejsen. Rejsen er udelukkende beregnet for individuelt rejsende og gælder kun for tilbuddets modtagere og ledsagende personer, der har nået myndighedsalderen. For rejsen gælder TSS‘s rejsevilkår, der kan rekvireres hos vores rejsehotline. Se også på www.tss-travel.dk. Billederne i brochuren er medtaget som eksempler.

2 TSS tilbyder særprisen i forhold til den normale pris på 7490,– DKK på www.tss-travel.dk. Prisen for kulturog nydelsespakken relaterer til vores tyrkiske samarbejdspartners normale pris (www.nbkturizm.com).

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4 TSS Travel Service Scandinavia AS og RSD Reise Service Deutschland er del af en europæisk rejsekoncern, der tilrettelægger rejser for kunder fra flere europæiske lande. Undersøgelsen blev gennemført med personer, der rejste med RSD til Tyrkiet i februar 2013.

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Fokas

The column

The tugboats of preventive health

The invention of vaccines is without doubt one of the greatest healthcare advances in the history of man and medicine. Vaccines have saved countless millions from death, disease and the implications of illness, and they have eradicated or decimated a number of infections.

As William Foege, the US epidemiologist behind the strategy for eradicating the smallpox virus said: “Vaccines are the tugboats of preventive health”.

The ability to prevent an illness, rather than waiting until it strikes and then trying to treat it, is in its own way the holy grail of all medicine. Yet, vaccine technology is now consciously perceived as rather old fashioned. It involves mainly long-forgotten childhood illnesses and an annual flu jab if you remember.

“This is the beginning of a development that no one can see an end to.”

However, vaccines – in their widest sense – are largely a technology of the future and that future stretches much further than the microbes and infectious diseases that we associate them with today. We are talking about immunotherapy and

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making intelligent use of our own built-in defence mechanisms against whatever is threatening our health.

Whether this comes from outside or inside.

Alzheimer’s dementia is a striking example. Medications that can stimulate biochemical processes in the degenerating brain have been in focus for a long time, but now people are aiming for the immune system to prevent the build-up of abnormal proteins that cause the degeneration.

The first clinical testing of a vaccine against the tau protein is now being initiated by Swiss AC Immune.

However, immunotherapy is perhaps most interesting in connection with cancer. Since the 1980s, discussions have focused on activating the immune system to kill proliferating cells.

Photo: Lars Kaae

Translation: CLS Communication A/S

Lone Frank is a journalist and author with a Ph.D. in neuro­ biology and a background in research.

As a staff writer at one of Denmarks leading news papers and Copenhagen Life Science, she is a well-known voice in debates about science, technology and society. She is widely invited as a public speaker.

Territory to be paved with gold Now we are hearing that something is working, for example, in reports from Herlev Hospital, which is a regional pioneer in this field.

Recently, Inge Marie Svane and her colleagues have managed to extract T-cells from patients with melanoma cancer, activate the cells in the laboratory and then get them to attack the melanoma while activating the patient’s immune system in general.

The treatment is more than three times as effective as traditional chemo and one in every five patients lost all signs of illness.

Several international groups have achieved positive results combating other forms of cancer, and in late 2013, the journal Science named cancer immunotherapy as the scientific breakthrough of the year.

As it said, this is the beginning of a development that no one can see an end to.

The human immune system is extremely complex and immensely dynamic and is still far from being fully explored and understood. You could say that we are dealing with one of biology’s final frontiers – territory sure to be paved with gold.

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UPDATE - BUSINESS

Update

Business Janssen establishes new department

Photo: DFIDPhoto

Janssen Pharmaceuticals has established a new department, Janssen GPH, to develop and

market medicine for the povertystricken in the world. The new company will be driving clinical and product development as well as developing and implementing medicines, diagnostic products and services within areas of illness affecting poor countries in particular. Janssen GPH will also implement new pricing and financing models that increase access to medicine for patients in developing countries.

Lundbeck presents data for ‘the hidden diamond’ in March Lundbeck and its Japanese partner, Otsuka, will present new results regarding the medicine Brexpiprazol against severe depression at a convention in early March. Initial figures show a significant improvement in the average MARDS score for patients who have received combination treatment with Brexpiprazol and an improvement in relation to the placebo on all secondary indicators. Lundbeck and Otsuka will consider submitting a registration application to the FDA at a later date.

Fund worth billions sees potential in medico Erhvervsinvest, a Danish investment fund, has invested in Scanbur and subsequently discovered the potential investments in the medico and laboratory industry.

So says Managing Partner Thomas Marstrand, who describes the fund as a generalist fund that does not actually work within delineated sectors. “However, Scanbur has opened our eyes to the fact that there are interesting companies in a direction we had not previously explored.”

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New partner at SEED From the turn of the year, Swedish Ulf Rosén became a new partner at SEED Capital, a Danish early-stage venture fund. He will be replacing Carsten Schou, who wishes to ease up after being an active part of the life science environment. Ulf Rosén has been President and CEO of NeoPharma, consultant and temporary head of a number of medico or pharmaceutical companies. The seed fund is increasing its focus on medico rather than biotech, and this will also be reflected in the new partner’s role.

DTU seeks patent for DNA search engine Enormous amounts of DNA information and an increasing number of genomes are now publicly accessible. However, all this data will not be truly useful until a rapid search can be conducted to trace the DNA in a sample back to an organism. Researchers from the Technical University of Denmark’s (DTU) Department of Systems Biology have therefore made a highspeed search engine that has been tested at Hvidovre Hospital and has reduced the response time for a urine sample from one week to 18 hours, for example.

Photo: SEED Capital

By medwatch.dk · Translation: CLS Communication A/S

Major differences between FDA approvals Researchers from Yale University have investigated the clinical basis for a number of new drug approvals from the FDA. The conclusion seems to be that there is no link.

The survey of 188 drugs approved between 2005 and 2012 showed that some were approved on the basis of comprehensive clinical studies but about one-third of the drugs were approved based on a single clinical study – often a short one at that.

E V O R P P A

This page was compiled in collaboration with Medwatch.

Read more news at www.medwatch.dk

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Genmab raises a billion the date of sale. The new investors therefore received a modest discount. The money will be used to purchase companies, technologies and products, and the company will exploit the ‘extra padding’ to ensure better cooperation agreements.

Photo: Genmab

The Danish antibody company Genmab has raised DKK 998 million via a targeted emission to selected investors. The shares were sold at a price of 217, which is somewhat below the closing price of DKK 228.50 for the share on

Danish recruiting company embarks on foreign adventure

Intelligent contact lenses coming from Google

Photo: Wikipedia

An antenna thinner than a human hair, a microchip and sensor that resembles glitter. Inserted between two ultra-thin layers in a contact lens. These are the ingredients for the intelligent contact lens that Google is developing. The aim is to help people with diabetes to measure their blood sugar.

Google recently made an acquisition and entered Danfoss’ neck of the woods and is now looking for partners who are experts in bringing similar products to market.

German pharmaceutical company Grünenthal Group.

“Their Contract Manager called to hear if we could help them in the rest of Europe. And we developed a taste for it,” says Torben Lind, Medicollect.

EU millions fund fresh look at old drugs Professor Marja Jäättelä from the Danish Cancer Society has been granted DKK 18 million from the European Research Council. She has shown that well-known drugs against e.g. depression, heart disease and malaria appear to be effective against cancer.

Combine them with chemotherapy, for instance, and you can kill cancer cells faster. This research is so interesting that the European Research Council (ERC) has granted her an Advanced Grant of DKK 18 million for further research.

New initiative to create serial entrepreneurs Good news for Danish entrepreneurs dreaming of inventing a future blockbuster. With help from e.g. Novo Seeds and the University of Copenhagen, the CELLS project, Copenhagen Entrepreneur Lab for Life Science, is being launched to

help future talents on their way. The project will be based in COBIS, where offices, laboratories and coaching for young entrepreneurs will be available. CELLS is the first project of its kind in Denmark, and is attracting praise along the way.

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Photo: The Danish Cancer Society

Since 2012, a recruiting company called Medicollect has helped researchers to recruit patients for clinical research projects and now the company is sufficiently mature to move into the international market at the request of one of its customers – the

UPDATE - SCIENCE AND TECHNOLOGY

Update

Science and technology

By Videnskab.dk

Emotions mapped out in the body

Photo: Aalto University

To help us better understand mood swings, depression and anxiety, researchers have studied how emotions feel in the body. This led to a colourful outline of the physical reactions to emotions. 701 study participants were asked to describe how they experienced such emotions as happiness, shame, love and depression, and were then asked to colour the bodily regions whose activity they felt increasing or decreasing. The researchers, from Aalto University in Finland, used participants from Finland, Sweden and Taiwan to demonstrate that emotions are represented in the somatosensory system as culturally universal categorical somatotopic maps.

Ageing theory needs to be revised

Latex led to surprising skin discovery Danish scientists have discovered that the skin communicates with the liver. The surprising discovery was made using genetically engineered lab mice that lacked a special fat-binding protein, known as axylCoA-binding protein, whose function the researchers wanted to examine. The absence of this protein caused fat to accumulate in the liver. The researchers covered the mice in liquid latex and saw the mice’s livers return to a normal and healthy state.

“This is very surprising and may have implications for people who suffer from a variety of skin diseases because their disease may also affect their internal organs,” says Professor Susanne Mandrup, of the Department of Biochemistry and Molecular Biology at the University of Southern Denmark.

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Everything ages – and the older we get, the greater the risk of dying. This is the popular conception of ageing, but new research suggests that not all species age in the same way – far from it.

Scientists, led by Owen Jones from University of Southern Denmark, have studied the ageing processes of a broad group of animals, humans and plants. And the study demonstrates that for several species, the risk of dying decreases as they age and other species do not age at all.

When it comes to the ability to produce offspring, the researchers found species that actually grow more fertile as they age and some that have a steady ability to produce offspring throughout their lives. One of the most surprising findings was that out of all the species featured in the study, humans age the quickest, in relative terms.

Photo: Uschi Hering ScanStockPhoto

Photo: Syddansk Universitet

The maps show the most active reactions to emotions highlighted with yellow and red, while the slow or absent reactions are illustrated with shades of blue.

The scientific breakthrough of the year 2013 Science magazine named immunotherapy as the scientific breakthrough of year in 2013. Some other candidates for the title are shown below.

1. Microsurgery on your genes: CRISPR is a method for ‘slicing up’ the genome – i.e. a surgical toolset that can activate, deactivate or change individual genes. The method was originally invented for bacteria but the CRISPR method “became red hot, as more than a dozen teams wielded it to manipulate specific genes” in a number of plants, animal and human cells, writes Science’s publisher AAAS. 2. A transparent brain: A new technique, called CLARITY, can render brain tissue transparent, so that neurons and other brain cells become visible. According to AAAS, CLARITY has changed researchers’ perception of our intricate and complex brain.

3. Researchers growing miniorgans: In 2013, researchers made “remarkable progress” by growing human “organoids”. For example, they have produced liver buds, mini-kidneys, and even rudimentary human brains from human stem cells. According to AAAS, these mini-organs could be much better research models for investigating diseases than research models.

4. Structural biology creates new vaccine: This year, researchers managed to exploit knowledge of the structure of an antibody by designing an immunogen – the main ingredient of a vaccine – against a childhood virus that hospitalises millions of infants each year, according to AAAS. “This is the first time structural biology has clearly led to such a powerful immunogen,” writes AAAS. 5. Human embryo cloned: Researchers are now able to derive stem cells from cloned human embryos. According to Science, the method could prove to be a strong tool for research and medicine. For years, other researchers have been trying to do the same but it was only accomplished this year after researchers realised that “a dash of caffeine, which appears to stabilise key molecules in delicate human egg cells, solves the problem,” writes AAAS. 6. Health based on bacteria in our body: Research on the billions of bacteria living in the human body “came closer to pinning down several key roles for these cells and genes”. According to AAAS, researchers who develop the very highly publicised forms of personalised medicine will need to take our microbial guests into account in order to be effective.

Researchers find body’s HIV alarm Researchers have unlocked a mechanism behind how our body goes into alarm mode when HIV virus invades our cells. A special ‘alarm protein’ detects strings of HIV DNA, triggering an immune response before the virus has time to take over the cell.

“The protein we’ve discovered is like a speed bump on the road which slows down the virus. By making the bump bigger we could, in theory, slow the spread of the virus, gaining time to activate the innate system and make it harder for a virus like HIV to establish itself in the body,” says the lead author of the study, Martin Roelsgaard Jakobsen from Department of Biomedicine at Aarhus University.

The HIV ‘alarm’ is known as the IFI16 protein.

Smokers produce fewer antibodies against oral bacteria. This increases the risk of infections, and researchers suspect a link to cancer, new study shows. ”Smoking causes major changes to the mucous membranes in the mouth. Growth conditions for the good bacteria deteriorate, resulting in the lack of bacteria weakening our immune system,” says Anne Tjønneland from the Danish Cancer Society Research Center.

People who had quit smoking also had a much lower number of antibodies than non-smokers. In fact, they only had slightly more than the study participants who still smoked.

Luke Jerram - HIV 2011

Photo: Javier Psilocybin

Smoking destroys our oral immune system

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

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UPDATE

A piece of equipment:

“Atlin the Robot” A relative’s lengthy stay in hospital after a traffic accident gave director Knud Andreasen the idea for a new training robot. He had it developed and witnessed how his relative made a much better recovery than expected. His company, Atlinas, has now improved and fine-tuned the invention known as “Atlin the Robot”.

By Malene Aadal Bo

Translation: CLS Communication A/S

What:

The geriatric department at Odense University Hospital has estimated that patients lose an average of 20% of their muscle mass while staying in hospital.

This has major negative consequences for the patient, but something can be done about it if rehabilitation gets started earlier – i.e. while the patient is still bedridden.

“Atlin” the training robot is ideal for weak and bedridden patients. It functions via a set of pedals that move in a straight line, unlike conventional “bed cycles”.

With the classic bed cycle, patients had trouble getting their legs around the top of the circular motion, which also has two “dead positions”, where weak patients need help to keep the motion going.

Photo: Atlinas

Why:

10

Photo: Atlinas “Atlin” also automatically adjusts the resistance and speed to suit the pressure the patient is applying on the pedals. In practice, this means patients can train using Atlin without waiting for assistance. And even weak patients with fractured hips and partial paralysis can train on their own, and get started while they are still bed-ridden.

Atlin’s built-in sensors also deliver detailed data to the doctor and physiotherapists concerning the patient’s efforts and activity. The data input can be adjusted as required and, for instance, be used to plan a rehabilitation programme during and after admission to hospital.

How: The robot has been developed and designed in close cooperation with the Danish hospital departments and doctors and physiotherapists with specialist knowledge on rehabilitation. And specialists within electronics, mechanical engineering, construction and plastics have also been involved.

Altogether, Atlin has it cost DKK 5 million to develop.

The plan now is for Atlinas, together with selected hospitals in Denmark, to try out the robot and test its effect on reducing loss of muscle mass in patients admitted to hospital – as well as the long-term effect of early rehabilitation.

•

More info: www.atlinas.dk

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GE Healthcare Bio-Sciences AB, Björkgatan 30, 751 84 Uppsala, Sweden. © 2013–2014 General Electric Company - All rights reserved. First published Nov. 2013

11

UPDATE

Europe gets its own stem cell bank and Bioneer is to deliver stem cells When one of the largest and most strategically focused biotechnological investments ever by the EU, pharma, and academia, The European Bank for induced pluripotent Stem Cells (EBiSC) is kicked off in February 2014, Bioneer will provide the stem cell lines that will serve as a future ‘federal reserve’ of biological material.

By Charlotte Strøm, MD, PhD, Journalist

Photo: Bioneer

The European Bank for induced pluripotent Stem Cells (EBiSC) aims at supporting EU-based as well as global research. Christian Clausen, MD, MSc and Head of Department at Bioneer, has taken part in the project planning and will also take a seat as board member of EBiSC. He is excited about the improved research opportunities that the European stem cell bank will offer to scientists, hospitals, and life science.

“The iPS technology is a quantum leap forward in

12

drug discovery. It will enable improved patient-specific disease models, allowing a deeper understanding of disease mechanisms and in turn uncover novel treatment targets,” Christian Clausen says.

The stem call bank will hold a large number of quality-assured patient-specific stem cells that can be programmed to different cell types in order to reproduce specific disease mechanisms in stem cellbased models of diseases.

“A European stem cell bank has been on top

• Bioneer is an independent, research-based service company within biomedicine, biomedical technology and biotechnology • Bioneer carries out industry-sponsored research and develops new product and process opportunities by cross-linking ideas from the world of science with those of the market • Bioneer is a fully owned subsidiary of the Danish Technical University (DT) and is located in ScionDTU research park in Hørsholm www.bioneer.dk

of the wish list for many years among scientists and organizations working with biomedicine and biotechnology,“ says Christian Clausen, who is also the Chair of The Danish Stem Cell Society.

total budget of € 50 million the project has several sponsors from the pharmaceutical industry and is based on the international Innovative Medicines Initiative (IMI). The European Union has granted € 37 million. A fundamental difference to many other cross country scientific projects, is the way the funding is put together.

The financial support from IMI and EU will get the stem cell bank up and running, and after four years the EBiSC must be “financially self- sustaining.”

Poul Andersson, CEO at Bioneer, believes that this important large-scale EU set-up will provide critical support to the European bioscience community, and he is excited about Bioneer taking part.

“This is an excellent opportunity to showcase our expertise and, in addition, to expand our network of international collaborations with scientific experts across the EU,” he says.

Stem cell technology has been a key business area for Bioneer for a number of years.

“Stem cell technology is developing rapidly and we strive to remain close to the frontier,” Christian Clausen ends.

•

Bioneer is spearheading Danish cutting edge stem cell expertise Among the group of SME (small-medium enterprises) and academic partners, Bioneer is the only Danish member of the EBiSC consortium.

Christian Clausen is hoping that clinicians and scientists working with stem cell technology will welcome the EbiSC initiative.

“The European stem cell bank unfolds unlimited possibilities for Danish pharma and biotech companies and certainly also for scientists and university hospitals working with stem cell biology or disease modelling,” he says.

Showcase of Bioneer’s expertise EBiSC is co-funded by the EU and pharma. With a

• The purpose is to establish a European repository for research and grade human induced pluripotent stem cells (iPS) at an unprecedented scale • A repository to be run on a self-sustaining, notfor-profit basis and on terms of open access for all qualified users • A repository to catalyse and support international collaborations to the forefront of applied human disease-related iPS research

CLS Communication offers a full spectrum of language services. However exacting and varied your requirements, we have the experience and linguistic expertise to fulfil your needs.

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13

THE PICTURE

By Malene Aadal Bo

The ancient Greeks knew that architecture, music and art are vital for healing the sick.

They built the oldest hospital in the world – the beautiful Temple of Asclepius with a concert hall, decorated walls

14

and a lovely garden. And in the Middle Ages people believed in the healing power of aesthetics, preferring to accept medical students who demonstrated knowledge.

Now we have once again re-

alised that health is not found solely in the skills of the surgeon or the content of the tablets we offer patients.

American Roger Ulrich, in par­ticular, clearly proved the significant impact of architecture and

interior decoration on illness, health and healing, and Copenhagen University Hospital has seen heart patients recovering much better in rooms with plenty of daylight and nice music.

The increased focus on

aesthetics has encouraged Americans to rate the country’s hospitals – not according to professional level, survival rates, treatment times etc. – but according to how beautiful they consider each hospital. And this

one - Elmhurst Memorial Hospital in Elmhurst, Illinois - was within the top five.

See the entire list at blog. soliant.com/most-beautifulhospitals/2013

15

THEME: VACCINES

Vaccines wonder drug of the future

Three blockbusters and a number of research breakthroughs in just a few years have put vaccines centre stage, attracting the attention of researchers, companies and investors alike.

Prevention and not least therapeutic vaccines are in focus in the world of medicine like never before and the human immune defence system is considered by many to be the key to curing, well... almost everything.

By Malene Aadal Bo

Translation: CLS Communication A/S

Second only to clean drinking water, vaccines have saved the most lives over time. Yet years have passed since vaccines were in vogue among researchers and the business community in the pharmaceutical industry.

But that was only until Wyeth (now Pfizer) developed the vaccine for pneumococci, which was the first

vaccine ever to reach sales of more than USD 2 billion a year. And only until Sanofi Pasteur and Glaxo Smith Kline launched separate vaccines for HPV that will save thousands of lifes by preventeing HPV associated cervical cancer.

Both are expected to notch up sales of USD 1 billion by 2015.

Third but not least today we see

16

hospitals all over the world using Yervoy, British-based Bristol Myers Squibb’s immunotherapeutic product to treat metastatic melanoma.

Such events have put both preventive and, especially, therapeutic vaccines on everyone’s lips, causing the magazine Science to name immunotherapy the scientific breakthrough of 2013.

Photo: US Library Of Congress A doctor inoculate a litte girl against typhoidfever in Texas 1944.

“And this is just the beginning,” says Else Marie Agger, head of the Department of Infectious Disease Immunology at Statens Serum Institut (SSI) in Copenhagen.

A fledgling discipline Since the beginning of the last century, SSI has developed vaccines – many of them long

before scientists seriously began researching the human immune system.

“Immunology is a fledgling discipline, and vaccine development has previously been based largely on empirical data. However, now we are beginning to understand more clearly how vaccines influence the immune defence system and why they work. I

predict a steep learning curve and I think we will experience some major medical miracles in this area.”

Else Marie Agger is leading SSI’s research into tuberculosis vaccines and her colleagues are now working intensely on developing a vaccine for Chlamydia as well as one for prostate cancer.

“We are appreciating more and

17

THEME: VACCINES

4 facts on vaccines 1. A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins. The agent stimulates the body’s immune system to recognise the agent as foreign, destroy it, and “remember” it, so that the immune system can more easily recognise and destroy any other microorganisms of this type it later encounters.

2. Revenue from vaccines currently comprises only 2% of the world market, however in terms of revenue growth, vaccines have outperformed all other sectors.

3. Prevnar is a pneumonia vaccine for infants and young children. It is the first and only vaccine to exceed USD 2 billion in annual sales 4. Global sales for the HPV vaccine Gardasil (Sanofi Pasteur) reached USD 988 million in 2013, and are expected to climb to USD 1.25 billion by 2015. Sales for a similar vaccine, Cervarix (by Glaxo Smith Kline), reached USD 375 million in 2013 and are forecast to reach $848 million in 2015.

Source: WHO and SSI

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more clearly how useful the human immune defence system can be.

Ultimately, I can easily imagine the human immune defence system will be used to cure all infectious diseases – and perhaps also a number of other conditions,” says Else Marie Agger.

Strong commercial prospects Jørgen Clausen is chief economist at the Danish Association of the Pharmaceutical Industry. He also believes that we have seen only the very beginning of the heights to which biological medicines can reach.

“Considerable advances have been made in immunotherapy, in particular. Now we are seeing the products reaching the market and doing well. And that has a habit of rubbing off. Today, 15% of the pharmaceutical market in Denmark comprises biological medicines that influence the immune system, but I can easily imagine some even more impressive advances in future – not least due to all the progress and improvements that will emerge with the ongoing use of the various products,” he says.

And he strongly believes that the Nordic countries will play a key role.

“Denmark has a lengthy and strong tradition within pharmaceuticals research and we are the country in the world with the most clinical studies per inhabitant. We generally have a good life science environment and also some strong research institutions within vaccines and immunotherapy, which are establishing and supporting many start-up businesses in their wake. So I’m convinced several of the large and many small companies in the Oresund region will have something to offer here.”

At Sunstone Capital, analyst Jacob Lange Moresco confirms that Nordic start-up companies are interested in vaccines.

Immunotherapy targeting various

forms of cancer is especially popular among the 300 or so business plans and project descriptions that Sunstone receives every year from companies wishing to attract investments. And investing in vaccines can be an excellent idea, according to Jacob Lange Moresco.

“I’m in no doubt that immunotherapy targeting cancer, in particular, is of great commercial interest. It’s early days yet, but we have already seen some dramatic results and major opportunities. The current hype may well fade slightly, but I feel certain there will be opportunities in this area for a long time to come,” he says.

Sunstone is the biggest independent investor in Nordic biotech and has been cultivating a personal fondness for the vaccines for a long time. At the moment, the venture investor is funding four companies of this type – Vaximm, Alligator Bioscience, Minervax and Anergis.

These are all relatively small companies and according to Jacob Lange Moresco, small companies can also do well in this context.

“Everyone is still finding their feet in terms of therapeutic immunotherapy. Only a few of the major companies have a pipeline worth mentioning in the area, and this gives the small companies the chance to position themselves,” he says.

It can be simple or very complex It doesn’t have to be too complex, according to several sources. Or to be more precise – there are distinct differences between the complexity of individual technologies and products within the range we collectively call vaccines and immunotherapy.

Vaccines started out as a bit of goo from a cowpox dabbed on an open wound. This was quickly followed by killed (cholera, rabies and polio) or weakened (measles,

A change in dogma Director Per Thor Straten is based elsewhere in Denmark. Together with his colleagues at the Center for Cancer Immunotherapy at Herlev Hospital, he is focusing on some far more complex aspects of immunotherapy and is, among other things, trying to fight cancer with

Photo: scanstockphoto

yellow fever) microorganisms, which then progressed to subunit vaccines (a part of a microorganism) and conjugate vaccines (polysaccharides connected to a protein). And modern therapeutic vaccines also cover a wide range.

ALK’s bestselling grass pollen allergy vaccine is basically just a freeze-dried extract of the grass pollen that the company has been using for 50 years. According to Senior Scientific Communication Manager Jørgen Nedergaard Larsen, the vital difference is that now they can freeze dry it and make it into tablets rather than administering it as an injection.

“It is considerably less risky in terms of side-effects and is much more accessible for the patients,” he says.

T cell therapy. They take a sample from a tumour in a patient, isolate the T cells, grow them and then give them back to the patient.

“We have observed that T cells can fight cancer, so by increasing their number and strength, we are attempting to help them work more efficiently inside the patient.

In some patients all their tumours disappear, in others some of the tumours disappear and in a third group, nothing happens. We’re trying to establish why as it would possibly allow us to make intelligent improvements of this treatment,” says Per thor Straten.

In his view, what they are doing right now isn’t particularly interesting from a commercial perspective,

primarily because the process cannot be protected by patents. However, Provenge, a vaccination based T cell therapy against prostate cancer, is already in use, and Novartis has a large study underway based on treating leukaemia patients by adding a novel tumor recognition element to the T cells.

“Immunotherapy is becoming an equal partner for chemotherapy, hormone therapy and surgery. We’re experiencing a change in dogma. If you had called Danish oncologists just five years ago, few would have believed it, but today vaccines and in more general tems the potential impact of immunotherapy has been fully recognized,” says Per thor Straten.

•

A selection of immunotherapeutic products on market or in pipeline PRODUCT

STAGE AND EXPECTED LEAD INDICATION

COMPANY

CATEGORY

Provenge

Marketed, prostate cancer

Dendreon

Dendritic cell therapy

Yervoy

Marketed, melanoma

Bristol-Myers Squibb

Nivolumab

Phase III, non-small cell lung cancer

Bristol-Myers Squibb

Lambrolizumab

Phase III, melanoma

MSD (known as Merck in US)

RG7446

Phase II, non-small cell lung cancer

Roche

MEDI4736

Phase I, solid tumors

Astra Zeneca

CTL019

Phase II, chronic lymphocytic leukemia

Novartis

Chimeric antigen receptor T-cell therapy

T-VEC

Phase III, melanoma

Amgen

Oncolytic virus and immunostimulant

PROSTVAC

Phase III, prostate cancer

Bavarian Nordic

Viral cancer vaccine and immunostimulant

ALECSAT

Phase II, glioblastoma

Cytovac

T-cell and NK-cell therapy

CTLA-4, PD-1 or PDL-1 Immune Checkpoint Inhibitor

19

THEME: VACCINES

The history of vaccines

It all began with a cow

By Malene Aadal Bo

Photo: Georgios Kollidas Scanstockphoto

In most works describing the origin of vaccines, the story is said to begin in England in the 1700s. The smallpox epidemic was decimating the population but tended to leave milkmaids unscathed. Dr John Fewster was the first to consider that this may be because they were already infected with the smallpox variant contracted by the cows and he wrote an article on the subject in 1765. Later, farmer Benjamin Jesty had some success vaccinating his wife and two children during a smallpox epidemic in 1774.

On 14 May 1796 another doctor, Edward Jenner, also noticed the milkmaids’ immunity and, like his predecessors, linked it to the cowpox they were in contact with regularly. He scraped puss from the boils on a milkmaid’s hand and used it to inoculate Phipps – Jenner’s gardener’s eight-year-old son, who later featured in Jenner’s first research article on vaccination.

Phipps had a fever and felt unwell but did not develop more serious symptoms. And when Jenner later injected him with the real smallpox virus, nothing happened. The boy was immune.

Jenner has since been recognised, not for devising the method, but for testing it thoroughly and proving that

Translation: CLS Communication A/S

it worked, thereby ensuring that it could be put into widespread use.

Hence his title as the father of vaccines has remained somewhat intact, although it has later transpired that whole communities centuries before had known about and used vaccines.

Common knowledge in the East long ago Indian drawings from the 8th century – reproduced in The Madhava Nidana – show people being vaccinated, and historians Joseph Needham and Robert Temple claim that pox inoculation began in China at around the turn of the first millennium.

A Song Dynasty chancellor of China lost his eldest son to smallpox. In order to save the rest of his family, he gathered wise men from the whole country who devised the method, according to the two historians.

The method spread from the East to England in the early 1700s, where ambassador’s wife Lady Mary Wortley Montagu returned with her son, who had been vaccinated overseas by the embassy surgeon Charles Maitland. After a demonstration at court, Maitland was permitted to vaccinate six British prisoners and in 1722 the Prince of Wales’ daughter was also inoculated.

Two hundred years later, and not least due to Jenner’s influence, the smallpox vaccine had spread far beyond the bounds of England and scientists, including especially the French chemist Louis Pasteur and his team, had further developed the concept with the creation of vaccines for diseases such as rabies, tetanus and diphtheria.

Diphtheria was the indirect reason why Statens Serum Institut was founded in 1902 in Copenhagen. Since then, research and development into vaccines and vaccination programmes for the population of Denmark have been conducted at the institute, which has pioneered the fight against major epidemics and pandemics such as polio and whooping cough.

Much more to vaccinate against Edward Jenner, said to be father of vaccines.

20

Over the years, the number of diseases that can be vaccinated against has steadily risen. The well-known,

Photo: Knud Nielsen Scanstockphoto

run-of-the-mill vaccines guard against more than 20 diseases, while new preventive vaccines are being developed or tested for at least as many diseases – including a number of conditions that have only recently begun to be viewed as diseases, such as obesity, smoking and substance dependence.

Recent years have also seen the advent of therapeutic vaccines for diseases that are already present in the body.

The aim here is to change how the immune defence system responds to the diseases. This category includes “allergy vaccines”, which are intended to stimulate the immune defence system to stop producing allergic symptoms when the allergens are present. And there are vaccines that in various ways stimulate the immune system to attack and destroy the body’s own cells – for example attacking cancer cells in various places in the body.

The work of Jenner, said to be the founding father of vaccines, has saved the most lives on a global scale. And vaccines are still central to human health and survival.

Nothing suggests that the area of vaccines has finished developing. The more we learn about the immune defence system, the more potential there seems to be in treating diseases using primarily the immune defences found in our own bodies.

P.S. Smallpox was officially declared extinct on 9 December 1979. The most recent natural case was diagnosed in Somalia two years earlier – in 1977.

•

Source: Wikipedia and SSI.

Development of vaccines over time * HPV * Rota virus * Acellular pertussis * Hebatitis A * H. Influenzae b * Hepatitis B * Pneumococcus * Meningococcus * Rubella * Mumps * Measles * Polio (Sabin) * Polio (Salk) * Yellow fever * Influenza

1900 1920 1940 1960

1980

2000

21

Graphics: Artegrafix

* Cholera * Typhoid

* Pertussis * Tetanus * Tuberculosis * Diphtheria

THEME: VACCINES

Alligator Bioscience:

Local immunotherapy has the potential to cure cancer Alligator Bioscience, one of Sweden’s leading developers of immunotherapy, hopes to crack the code to curing cancer. The best chance of finding a cure lies within immunotherapy for local intratumoral administration, according to CEO Sibylle Lenz.

By Louise Bruce

Though it doesn’t exactly roll off the tongue, ADC-1013 is a name worth remembering as the most promising drug in Alligator Bioscience’s pipeline. Based on the experimental works of Professor Thomas Tötterman, Uppsala University, Alligator Bioscience started developing the antibody in close collaboration with the professor. So far, testing has shown that ACD-1013 is able to eliminate tumours, which gives it the potential to cure. Just over a year ago, Alligator Bioscience started producing ACD-1013, which is now in the preclinical phase. Later this year it will enter phase I clinical trials with the first results expected in a couple of years.

“We are still investigating the types of cancer that are most relevant, and at this time I cannot reveal which ones we are considering. But one of the great things about immunotherapy is that it has the potential to be used to treat several types of cancer,” says Sibylle Lenz, CEO of Alligator Bioscience.

From technology to bioscience Alligator Bioscience’s original field of expertise was quite different. Focusing on antibody optimisation, they developed a new technology called Fragment INduced Diversity (FIND®), based on single stranded DNA. But as often happens in the technology business, other companies started developing similar technologies.

“Some of our biggest clients, the big pharmaceutical

22

ALLIGATOR BIOSCIENCE • Alligator Bioscience discovers and develops innovative antibody-based immunotherapies for the treatment of cancer.

• Alligator Bioscience was founded in 2001 and is a privately held company located in Lund, Sweden.

• Alligator has a pipeline of innovative antibodybased compounds within cancer immunotherapy treatment.

• Lead product candidates are: ADC-1013, an immune activating antibody developed for local intratumoral administration. The compound is in the preclinical phase and will enter phase I trials in 2014.

ADC-1015, a bispecific immune activator, developed to induce superior immune activation after local intratumoral injection.

ADC-1016 a systemic localising immunotherapy, a bispecific immune activator that is administered systemically while the effects are restricted to the tumour area.

Photo: Alligator Bioscience

companies, developed their own technologies, which meant a decrease in the demand for our product. And although we were and still are the only ones with a technology that uses single stranded DNA, the board of directors changed Alligator’s line of business,” says Sibylle Lenz.

In 2008, Alligator Bioscience shifted focus to become a biotech company with its own drug discovery pipeline.

As a consequence, many new employees skilled in drug discovery and development were recruited from biotech and pharma companies, including the CEO. “Building a pipeline from scratch is quite challenging, so we started collaborating with Professor Thomas Tötterman, who is a pioneer within local administration of immunotherapy and has done extensive research in antibodies. Based on the knowledge and techniques from our antibody optimisation technology, we then started developing our first immunotherapeutic compounds,” she continues.

Antibodies for local administration According to Sibylle Lenz, intratumoral administration of immunotherapy has many benefits compared to systemic administration of immunotherapy, which is why Alligator is focusing on this niche market.

“Instead of administering the antibody systemically in the vein, you inject it directly into the tumour. This method makes it possible to selectively activate the part of the immune system that is directed towards the tumour, thus killing the cancer cells,” Sibylle Lenz explains.

“Immunotherapy might represent a new era for cancer treatment.

We haven’t seen anything like it for many years.”

CEO, Sybille Lenz

“Local immunotherapy is effective at lower doses, but can also be administered in higher concentrations compared to systemic administration therapies. The therapeutic window is thus much larger. Furthermore,

Sybille Lenz, CEO, Alligator Bioscience

when you administer locally you minimise the risk of systemic immune activation, which can cause a lot of adverse events and autoimmune side effects”.

Today most immunotherapies are developed for systemic use and Sibylle Lenz acknowledges that locally administered immunotherapies cannot stand alone, but will be part of a treatment regime.

“There are cases where the tumour is located in places that are very hard to reach with a needle. If, for instance, you have a brain tumour, you might need to treat it systemically,” Sibylle Lenz points out.

A new era for cancer treatment Immunotherapy is said to be the preferred cancer treatment of the future.

“Immunotherapy represents a new era for cancer treatment. We haven’t seen anything like it for many years. Patients are still dying. With systemic administration of antibodies you might be able to prolong overall survival by 30-40%. But that is still not enough. We are looking for a cure, which removes the cancer completely. And hopefully, we have found it,” concludes Sibylle Lenz.

•

23

THEME: VACCINES

Bavarian Nordic:

The future lies in immunotherapy Immunotherapy will be one of the biggest pharmaceutical advances in future cancer treatment. With an immunotherapy candidate now in phase III clinical trials, Bavarian Nordic is a frontrunner with the right prerequisites for success, according to CEO Anders Hedegaard.

By Louise Bruce

The impending terror threat that emerged after 9/11 in 2001 turned out to be a window of opportunity for the Danish biotech company, Bavarian Nordic.

At the time, they were in the development stage of a nonreplicating smallpox vaccine (IMVAMUNE), a vaccine that the US Government needed as part of their terror readiness programme.

With financial aid from the US Government, Bavarian Nordic was able to develop the vaccine for use in humans and has so far sold more than 20 billion vaccines to the US Government.

The vaccine helped transform Bavarian Nordic into a leading biotech company in one of the most interesting new cancer treatment regimes, immunotherapy.

“The future lies in immuno­ therapy, and I believe we will be part of the exclusive group of successful companies with a product in this category. We have the knowledge and the manufacturing facilities needed for a success,” says Anders Hedegaard.

First immunotherapy candidate in phase III Bavarian Nordic has developed

BAVARIAN NORDIC • Bavarian Nordic is an international biotechnology company that develops and manufactures novel cancer immunotherapies and vaccines for infectious diseases.

• Bavarian Nordic was founded in 1994 and is headquartered in Kvistgaard, Denmark.

• Bavarian Nordic’s lead product candidates are: -- PROSTAVAC, an immunotherapy for advanced prostate cancer that is the subject of ongoing pivotal phase III clinical trials.

Photo: Carsten Andersen

-- IMVAMUNE, a nonreplicating smallpox vaccine supplied to the US Strategic National Stockpile and approved in Canada and Europe.

In Europe, the vaccine is marketed as IMVANEX®.

CEO Anders Hedegaard

24

an immunotherapy candidate for the treatment of prostate cancer (PROSTAVAC), which is now in phase III trials, and the first clinical results are expected in a couple of years.

“We hope PROSTAVAC will show good results in the phase III trials and ultimately be used as a basic cancer therapy in combination with other treatments according to the patient’s needs,” Anders Hedegaard explains.

The future lies in immunotherapy, and I believe we will be part of the exclusive group of successful companies with a product in this category.

CEO, Anders Hedegaard

In future, Bavarian Nordic expects to extend the indication to include other cancers as well.

Doctors are the real challenge Even though immunotherapy is considered a tremendous advance in cancer treatment showing promising preliminary results, Anders Hedegaard points out that convincing doctors to adopt the new treatment paradigm will be a significant challenge for Bavarian Nordic.

“It is an entirely new kind of treatment, which calls for new routines and new ways of thinking among doctors. Thus, the more companies that break through with their products and show that this is the way forward, the easier it will be for us to succeed with our product. As such, we consider it a positive thing that all the big pharmaceutical companies are looking into cancer immunotherapy, although we don’t have any direct competitors with a similar product at the moment,” he concludes.

•

Do you have critical chemicals in your process?

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For years, life science has not had to speculate too much about chemicals. But new European legislation spares no one and according to consultants at DHI, life science companies face the prospect of more requirements – and may have to change their processes.

Twice a year, the European Chemicals Agency (ECHA) publishes a list of chemical substances as candidates for being phased out or subject to prior approval before use. And equally often, European life science companies will have to review their production to see whether they depend on even small amounts of critical substances.

“Life science companies cannot use whatever substances they like by claiming to produce medicines and by referring to FDA approvals.

REACH, the European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals, is now gaining full traction, leaving life

science companies with a major new task,” says Helle Westphal, Head of Department at DHI. As a toxicology consultancy, DHI sees Scandinavian companies that risk running aground because they are unaware about the stricter new rules.

Companies contact DHI for help, first to clarify whether they even have a problem, and later, if challenges are revealed, DHI can help solve them.

“We manage all the details concerning documentation requirements, applying for special permits etc. And our customers particularly appreciate our employees’ very strong toxicology and ecotoxicology expertise ,” says

Helle Westphal. DHI also train companies’ own employees to comply with the new requirements.

Read more at www.tox.dhigroup.com

25

THEME: VACCINES

The immune system holds the key The immune system has been attracting a good deal of attention in recent years. But what do the immunologists actually think about that, and how do they view the human immune system? We asked Claus Henrik Nielsen, immunologist and researcher at Copenhagen University Hospital and coauthor of a textbook on immunology.

By Malene Aadal Bo

“I think the immune system deserves all the attention it is getting. It is, after all, incredibly interesting and very important. It

Translation: CLS Communication A/S

is what enables individuals and the human race to survive. It is our defence against everything we are constantly attacked by from outside

but also against the inherent mistakes the body is constantly making, which can lead to diseases such as cancer.

An extremely complex system.

Some people have trouble understanding this. We all accept that our brains are complex, but we have trouble accepting that the immune defence system may be just as complex.”

Photo: Lisbeth Westergaard Rigshospitalet

Billions of years of arms race

Claus Henrik Nielsen, immunologist and consultant at Copenhagen University Hospital, thinks the sky is the limit when it comes to using the human immune system to both prevent and fight disease.

26

“The immune system actually began as a very simple process. But what we are seeing today is the result of an evolutionary arms race spanning billions of years building up an increasingly strong and more complex defence system, allowing humans to survive increasingly advanced attacks by viruses, bacteria and other microorganisms.

And this very complexity is where the challenge lies. Every time you think you have grasped the big picture, you discover it isn’t that simple after all. For example, years ago, some T-cells were discovered and scientists believed they had identified their function. But then

it emerged that there were several different types of T-cells. And that these types can be classified into different subtypes with different

“I was asked the other day if the immune system wasn’t a bit of a woosie, as it needed so much help to protect us properly.”

functions. And it’s like that at every turn.”

“The first building blocks of knowledge were in place over a hundred years ago and every day little bits of knowledge are added to our understanding. It is hard to say that one block is more important than another. However, I think discovering vaccines represents a quantum leap. Perhaps the biggest leap medical science has ever made.

Now we have vaccines for a long list of diseases, and many other both therapeutic and preventive vaccines and immunotherapies are on their way. With this said, we must bear in mind that immunotherapy is largely in its infancy. In reality, very few patients have been cured of their cancer in this way. One exception

CLAUS HENRIK NIELSEN MSc, MB, PhD Specialist in Clinical Immunology Consultant at and head of the Institute for Inflammation Research, Clinic for Infectious Diseases and Rheumatology, Copenhagen University Hospital.

Author of 90 articles on immunology and co-author of the text book Immunologi (Immunology), which is used at several Danish universities.

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THEME: VACCINES

Existing vaccines Cholera Diphtheria H. influenza B Hepatitis A Hepatitis B Human Papilloma Virus Influenza Japanese Encephalitis Measles Meningitis C Mumps Pertussis Pneumococcus Polio Rubella Smallpox Tetanus Tick Borne Encephalitis Tuberculosis Typhus Varicella Examples of new infection targets Borrelia Chlamydia Cytomegalovirus Enterococcus ETEC Group A strep.

Group B strep.

Hepatitis C Herpes HIV Legionella Malaria Meningitis B Mycoplasma Neisseria Pseudomonas Rickettsia RSVSARS Shigella Staphylococcus Toxoplasma Treponema And not least Cancer therapy Alzheimer’s Allergies Source: SSI

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Is it a woosie?

“I was asked the other day if the immune system wasn’t a bit of a woosie, as it needed so much help to protect us properly. But what we don’t notice or see are all the times we don’t get ill.

We are bombarded with billions of viruses and bacteria without ever realising we have been under attack. Similarly, we don’t notice all the cases of cancer that never get the chance to develop because our immune system destroys them before they become a problem.

“The immune system is extremely potent and the risk is always present of unleashing a force that you can’t control.”

I can see no downsides to all that’s happening now. The only danger is that we sometimes lack the necessary insight to accomplish our aspirations.

The immune system is extremely potent and the risk is always present of unleashing a force that you can’t control. The same forces are those that the hygiene theory would say explain the increase in allergies and autoimmune diseases.

Today we are surrounded by so much cleanliness that much of our immune system is not used for combating, say, parasites.

According to the theory, this prompts the system to make mistakes or overreact to harmless influences, such as pollen.

However, nothing suggests that immunotherapy damages the immune system. And certainly not vaccines. Vaccines can be seen as training for the system.

The response required from the immune defence system is the same regardless of whether it is exposed to a vaccine or the real disease.”

Is the price too high?

“I am currently working on a new drug – a therapeutic antibody for use on autoimmune diseases. It’s going well, although we are just starting out. However, treating people with this antibody – and similar biological drugs, as well – will be terribly expensive.

Drugs that manipulate the immune system are so expensive they could blow the health service out of the water.

But apart from that, I think the potential is almost infinite. If we can prevent one infection, or type of cancer, nothing suggests we can’t also prevent the next. The sky is the limit.”

•

Photo: Scanstockphoto

Vaccines now and in the future

however, is the tens of thousands of bone marrow transplants being conducted all over the world that have saved countless lives.”

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A strong Team

MALENE AADAL BO

LONE FRANK

FREDRIK HEDLUND

Copenhagen Life Science is a high-quality magazine that weights validity and thoroughness highly. Therefore we have joined forces with a strong team. As previously life science journalists Lone Frank (DK) and Fredrik Hedlund (SE) will take turns writing a column for the magazine, and editor in Chief is Malene Aadal Bo. The exclusive and close cooperation with our partners ensures that Copenhagen Life Science constantly has an in-depth knowledge of the life sciences industry, the latest trends and conditions in the market.

Distribution In addition to interesting and updated articles about the conditions of the industry, Copenhagen Life Science gives companies in the region a unique opportunity to brand themselves both nationally and internationally. With its thoroughly selected distribution network, Copenhagen Life Science is the ultimate and optimum opportunity to present your company to customers and business partners.

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29

Photo: Jakob Carlsen

PORTRAIT

Henrik Ørum:

The road to success in Danish biotech Henrik Ørum from Santaris Pharma is riding high on a wave of success in Danish biotech. Here is his secret.

By Kristian Sjøgren. Photo: Jakob Carlsen

It’s Saturday evening at Stamford Bridge in London.

José Mourinho is standing on the sidelines, clawing at his scalp and shouting at the players like mad. The score is still equal and time is running out for the starstudded, Chelsea team.

Among the sea of blue Chelsea fans, Henrik Ørum, VP and CSO of Santaris Pharma, is suffering shoulderto-shoulder with the home crowd. He and his son Alexander have travelled to London together to cheer on their favourite club Chelsea. It’s their quality time together.

But why begin the story of a successful 20-year career in the biotech sector with a snapshot from an English football match?

The answer is hard work – Henrik Ørum’s mantra.

His path to success is the determination to work more for his ambitions and goals than anyone else. This has applied since he was a little boy running up and down the pitch with dreams of being the next Diego Maradona.

But it also applies to the molecular biologist with a dream of developing drugs to heal the world. Countless hours of hard work pay off, and Henrik Ørum has certainly lived by this motto all his life.

“My motto is that anything worthwhile is hard to get – if it’s easy, everyone has it and then it’s probably worthless. That’s another way of saying that hard work is the secret to success and it’s one of the recurring

Translation: CLS Communication A/S

truths I’ve met most frequently in my life,” says Henrik Ørum describing the theme that has coloured his whole career and lifestyle.

Perhaps that’s precisely why he takes particular pleasure in following top athletes around Europe.

There’s a link with the players on the pitch.

Behind every strong man there’s…

When, like Henrik Ørum, you are head of product development and product sales in a successful biotech company that is charging ahead like an express train, you inevitably have long working days and many days’ travelling on top of that. Henrik Ørum spends over 100 days a year touring the world holding speeches about Santaris Pharma’s technologies and products “to anyone who can be bothered to listen”, as he says.

When he’s home, the trips abroad are replaced by endless meetings and business dinners.

“Anything worthwhile is hard to get - if it’s easy everyone has it.”

31

PORTRAIT

Photo: Jakob Carlsen

Henrik Ørum generates the energy for his demanding job through his deep passion for pharmaceutical development and in a well-functioning home base that since their youth his wife, Rie, has managed with a firm and loving hand. In that way, his successful career and family success are inextricably linked.

And he’s not afraid to admit it: “Let’s be honest. When you work as much as I do, you don’t have the energy to organise big social gatherings on your days off. But luckily, Rie has always made plans so we see friends and family when I’m home,” he explains.

Henrik Ørum also admits that being married to a husband working in the ever-changing biotech landscape, where new opportunities mean an exceptionally heavy workload, has sometimes required unusually high levels of patience.

“Things have gotten better though. Today, I can leave

Henrik Ørum, 58 years of age and PhD in molecular biology. Chief Scientific Officer and VP of Business Development at Santaris Pharma.

Married to Rie, with whom he has Stephanie (26) and Alexander (16).

His greatest career successes were founding Exiqon and Curion. The latter merged with Pantheco in 2000 and formed Santaris Pharma, which has specialised in developing the LNA molecule for realising antisense technology.

Henrik Ørum has extensive experience in founding, developing and managing biotech companies.

32

work behind when I get home. I don’t think I was very good at that before,” he says.

Broke with family tradition It wasn’t in the cards at all that Henrik Ørum would be a biotech entrepreneur when he was choosing his education back in the 1970s.

Three generations of lawyers were pointing clearly in one direction and true to family tradition, the young lawyer’s son chose to study law. But just 18 months later, Henrik Ørum realised that he was on the wrong career shelf and decided to study biology instead.

“I got the idea that I wanted to be a marine biologist – Denmark’s answer to Jacque Cousteau,” he says.

“But I quickly realised that all marine biologists ended up working on fisheries enforcement, so I quickly went off the idea again,” he laughs loudly.

Later on, molecular biology became a study option and fuelled a passion in the renegade lawyer’s son.

Instead of trying to sue the world, he wanted to research it and save it instead. The new-found interest in research gradually led to specialising with DTU’s genetic engineering team, a PhD at Panum and a postdoc at the Royal School of Pharmacy.

In 1993, Henrik Ørum faced one of the most momentous decisions of his entire career. After finishing his postdoc, he was offered a job as head of research at PNA diagnostics, a small, recently started Danish biotech company that developed diagnostic tools based on LNA technology.

It was a golden opportunity to take a step in the right career direction.

“I was always destined to join the private business community. University lectureships and masterships involved too many teaching obligations, leaving too little time for research, which was my great passion. I was also driven by results-directed research so when I was offered the job with PNA diagnostics, I seized it. I have never regretted that decision,” says Henrik Ørum.

From diagnostics to medicines The position as head of research at PNA diagnostics set off an avalanche of career moves. First the biotech company was purchased by Boehringer Mannhein and later by Hoffman la Roche before once again ending up in Danish hands with Dako.

With every new sale, Henrik Ørum climbed higher up the ladder of success. He also gained great insight into leading and developing a biotech company. This meant that after six years with PNA diagnostics, he had the tools to embark on a whole new adventure.

“I think by then I’d had enough of molecular diagnostics. My main goal was to get into medicine development and that’s why I left PNA diagnostics with

my colleague Troels Koch. My brother Mikael Ørum, Leif Helt Jensen and I started Curion, which was based on therapeutic exploitation of the LNA molecule for antisense technology,” explains Henrik Ørum.

Just a year later in 2000, Curion merged with Pantheco, and Santaris Pharma saw the light of day.

Motto for life His first years with Santaris Pharma clearly reflected his motto, because hard work was definitely in focus.

In the spirit of his life philosophy, he rolled up his sleeves and devoted many hours to visiting potential customers to tell them about Santaris Pharma’s work on LNA antisense technology with no strings attached.

That was what it took as it was a sceptical world he was meeting.

“Many pharmaceutical companies have previously been involved in the development of antisense technology but had put their projects on ice. At this point, it was my job as CSO and VP of Business Development to try to convince them that the LNA molecule was what could take the technology to the finishing line. We realised that it would be a particularly difficult task, so we approached the industry very early

on and had noncommittal chats with our research colleagues – like a kind of scientific Friday seminar,” explains Henrik Ørum.

The early move proved to be a stroke of business genius. Gradually, as the LNA molecule emerged as the long-awaited breakthrough in antisense technology, the Friday seminars suddenly began attracting visitors from corporate business departments.

“You should seal the deal when you can” After six years of hard work, success had finally arrived. In 2006, Santaris Pharma signed its first cooperation agreement with Enzon, and many have since followed.

On the product development front, the company is equally successful. The company and its partners have brought a total of six products to clinical trials within

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PORTRAIT

cancer and metabolic and infectious diseases. The product that is furthest along is a product for treating hepatitis C virus (HCV infection), which is in its third phase-II trial.

Henrik Ørum sees promising opportunities for the medicine reaching its target. He will certainly do his best to see that it happens.

“I think in a few years we’ll look back on the ‘noughties’ and say that something important happened for pharmaceutical development in that little company in Hørsholm. These are the kinds of thoughts that make me get up and go to work every day,” says Henrik Ørum.

When reflecting on his success as a biotech entrepreneur, Henrik Ørum can see two specific success parameters that have formed his career. One is hard work. It takes time to achieve success.

But hard work alone is not enough. As a biotech entrepreneur, you also have to display due diligence to reach the top in this industry.

“There are some common denominators for the biotech companies that have achieved success. To generalise a bit, I’d say you should seal the deal when you can and take the money when it’s there. Biotech is a venture financing industry where speculation often focuses on whether you can get capital for a better price or make a bigger deal for your products if you wait until they have progressed further along the development process. But in my experience, the companies that do best are those that take the money when it’s there, and that involve partners relatively early on in product development, which is very cost-intensive and risky,” is Henrik Ørum’s advice for future biotech entrepreneurs.

•

Hard work and due diligence are key words for great athletes.

The same virtues has brought Henrik Ørum to where he is today.

Family time Henrik Ørum and his wife, Rie, have two children – Alexander, 16, and Stephanie, 26.

Family time is an important part of Henrik Ørum’s life. He shares a love of sport with Alexander and together they often take minibreaks abroad to attend sporting events.

“I try to find time to do sport regularly but my business trips

34

don’t always make that easy.

Luckily, I have my son to keep me in line and he’s really good at that,” says Henrik Ørum.

Henrik Ørum’s daughter, Stephanie, is following in her father’s footsteps and doing a PhD in molecular biology at Oxford University. Even though she has chosen the same career path as her father, according

to Henrik Ørum it’s because of an inspirational high school chemistry teacher rather than any influence from home.

“My wife and I were actually surprised that she chose to study chemistry,” explains Henrik Ørum.

This natural interest in science shared by the father and daughter is a source of great pleasure for them both.

Photo: Jakob Carlsen

On the road to success

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35

TALKIN’ ABOUT

How location-based diagnoses are to be replaced by test-based identification of molecular and genetic variations The development of diagnostic technology is seeing tremendous advances, as molecular biology clears the way for new understanding, new classification and new treatments.

Jan Trøst Jørgensen, MSc and PhD, has followed developments for more than a decade. He gives us an update and some predictions for what the future will bring.

By Louise Bruce

What is the big talking point in your world these days?

“Over the past 10-20 years, the molecular biological understanding of the causes and development of diseases has revolutionised the entire approach to disease treatment, especially within cancer treatment.

Here, we talk about an actual paradigm shift: diagnoses that are based on the cancer’s original location will gradually be replaced by test-based identification of molecular and genetic variations which can inform decisions on the most efficacious treatment for each patient.”

“– It is a success story that has already resulted in a range of new treatment possibilities that are guided by molecular testing – known as companion diagnostics

(CDxs) – which has also made a difference for a great many cancer patients all over the world.”

What do you think about that?

“The first milestones were about locating a so-called biomarker that is able to tell us, via a CDx, whether a patient is likely to benefit from a targeted treatment.

Since then, several different targeted treatments have been developed. They have all shown good efficacy, but their weakness is that the effect has been time limited in almost all cases.

Both non-clinical and clinical data have shown that, through mutations in other genes and pathways, the targeted anti-cancer treatments can develop resistance, resulting in new disease progression.”

Why is this such a hot topic?

“There is a need for new thinking and innovative treatment strategies.”

36

“Six months ago, I spoke at and reported from the 2nd European Symposium of Biopathology in Paris, France.

The symposium addressed several important aspects in relation to the future direction of CDxs and the key message was that there is a need for new thinking and innovative treatment strategies.”

Furthermore, being able to use blood instead of tissue samples to detect the development of drug resistance in patients with advanced diseases will certainly improve the handling of testing technology.

Photo: Ole Ziegler

“Today’s challenge is to make testing logistically and practically doable. We have the technology, more or less.”

JAN TRØST JØRGENSEN holds an MSc in pharmaceutical science and a PhD in clinical pharmacy from the University of Copenhagen.

He has 30 years of R&D experience from pharmaceutical, biotech and diagnostic companies, including Novartis, Novo Nordisk, Dako and several smaller diagnostic and biotech companies.

Within the last 10-12 years, his focus has been on drug-diagnostic co-development projects in oncology.

As editor and co-author, he published a book on personalised cancer medicine and molecular diagnostics.

Furthermore, he is currently guest editor of the Frontiers in Oncology issue on drug-diagnostic codevelopment in oncology.

“Today’s challenge is to make testing logistically and practically doable. We have the technology, more or less. The big challenge is to make it cheaper, faster and broadly available for clinical use. I am sure this will be achieved within the next five to ten years.”

•

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“We will see combination therapies with more targeted treatments emerge, which will require knowledge about multiple pathways and biomarkers in order to make an optimal treatment decision.

We have already seen the first examples of how we can improve the efficacy of targeted treatments by combining different treatments and, thus, blocking more pathways.“

What’s next?

“The new multi-targeted strategies will be a challenge for molecular diagnostic testing. Customer-defined multiplex assays and DNA-sequencing technology, using next generation sequencing, are likely to play a decisive role in the future development of treatment strategies. Initially, we have seen their introduction for clinical use in both the USA and Europe.

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37

GUIDE

Legal update on Supplementary Protection Certificates Photo: PR

Following a number of ambiguous and sometimes conflicting legal decisions, it has for a number of years been unclear whether it is possible for a patent holder to obtain more than one Supplementary Protection Certificate if the basic patent covers more than one product. Two rulings from the CJEU now provide some clarity.

By Thomas Bjørn

The significant value of an extension of the protection period under a basic patent is obvious.

But the rules under EC Regulation concerning the supplementary protection certificate for medicinal products (generally referred to as the Regulation) have in practice given rise to a number of difficulties, and courts throughout Europe have struggled to determine the scope of protection available under the Regulation.

One particular question has been whether Article 3 of the Regulation permits a patent holder, whose basic patent protects more than one product, to obtain an SPC for each product.

A relevant example could be where the basic patent protects a number of active ingredients which are used in different products, either alone and/or in combination with each other.

In a decision from November 2010 relating to the pharmaceutical company Medeva, the Court of Justice

38

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 first ruling was in the case of Actavis Group v. Sanofi (C-443/12), which concerned a product containing an active ingredient protected by the basic patent combined with another active ingredient which was not protected by the patent.

Under these circumstances, the CJEU held that, where the patent holder has already obtained an SPC for a product based on the protected active ingredient, the patent holder is precluded from obtaining a second SPC on the basis of the same patent for a combination product which includes another active ingredient not protected by the patent. The rationale is that it would not be acceptable if the holder of a basic patent could obtain a new SPC, potentially for a longer period of protection, each time he sends a medicinal product

Photo: scanstockphoto

of the European Union (CJEU) made a statement suggesting that a patent holder would be limited to one SPC per basic patent.

Initially this statement was interpreted differently in different countries across the EU, but in two recent decisions from 12 December 2013, the CJEU has now delivered important rulings on SPCs which clarify the situation somewhat.

to market containing the principle active ingredient, protected as such by the holder’s basic patent and constituting the core inventive advance of that patent, together with another active ingredient which is not protected as such by that patent.

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39

GUIDE

The second ruling was Georgetown University v. the Dutch Patent Office (C-484/12). This case also concerned the issue of obtaining more than one SPC for products protected under the same basic patent.

Georgetown University held a patent for an HPV vaccine, claiming a combination of four active ingredients as well as one active ingredient individually, and in connection with the expiry of the patent went on to apply for several SPCs covering combinations of the active ingredients as well as the ingredients individually.

The applications were refused by the Dutch Patent Office on a number of grounds, including that the Regulation does not permit more than one SPC per patent regardless of the number of products covered by the patent.

The matter was referred by the Dutch courts to the CJEU which made a ruling allowing multiple SPCs under the same patent on the basis of all the active ingredients being protected by the patent. In its ruling, the CJEU stated that “where, on the basis of a basic patent and a marketing authorisation for a medicinal product consisting of a combination of several active ingredients, the patent holder has already obtained an SPC for that combination of active ingredients ......

Article 3(c) of [the Regulation] must be interpreted as not precluding the proprietor from also obtaining an SPC for one of those active ingredients which, individually, is also protected as such by that patent.”

Although the decisions in the two cases may at first seem contradictory, this is due to the fact that the circumstances in the two cases differ.

The first case – where Actavis were not allowed multiple SPCs – concerned an additional product combining an active ingredient protected by the basic patent with an active ingredient which was not protected by the patent.

The second case – where Georgetown University were in fact permitted to hold multiple SPCs – concerned additional products combining active ingredients which were all protected by the same basic patents.

Although there are still many unanswered questions, these two decisions have brought about some much needed clarification. And the latter of the two cases must be regarded as very good news to SPC holders, who can now assume that the local patent authorities will issue additional, separate SPCs on the basis of applications for different products provided they are protected by the same basic patent.

•

Supplemtary Protection Certificates Supplementary Protection Certificates (SPCs) are issued under Regulation 469/2009/EC (Regulation).

The purpose is to extend the patent protection of a

And this means that...

medicinal product. The underlying objective is to

The decision means that where a basic patent protects a number of different products, the Regulation must be interpreted as permitting the patent holder to obtain an SPC for each of those different products, provided that each of those products are protected as such by that basic patent.

make up for the part of the patent protection period which is spent securing a marketing authorisation (MA) for the product.

An SPC is issued for a period of up to five years and the exact duration is calculated as the period between the date of the filing of the patent application and the date of the MA for the product minus five years. An additional protection period of six months is available for certain paediatric products.

Jusmedico is a specialist law firm providing legal services to the biotech, pharmaceutical, medical device and dentistry industries, life science investors and to suppliers and service providers thereto.

Jan Bjerrum Bach

Jusmedico Advokatanpartsselskab Kongevejen 371, DK-2840 Holte Tel: +45 4548 4448 Mbl: +45 4029 4124 E-mail: jbb@jusmedico.com www.jusmedico.com

40

The Intellectual Property Office of the United Kingdom has issued an extensive guide on SPCs which is available at www.ipo.gov.uk/spctext.pdf.

A shorter guide (in Danish) is available from the Danish Patent and Trademark Office at http://paguidelines.dkpto.dk/aa/supplerendebeskyttelsescertifikater.aspx.

ADVERT

Honest counselling on proprietary rights Founding director at Tropa, Niels Uth’s mission is to provide life science companies with comprehensive and honest counselling on international proprietary rights based on thorough analysis.

As an inventor, it is difficult to know exactly what implications patenting has.

It is therefore of crucial importance to derive benefit from honest counselling based on a thorough analysis of the scope of your invention.

Thereby, your company can be guided safely around the patent landscape such that your ideas are protected and infringement of competitors patent rights is avoided.

“Patents are like spices, they should be used with care, at the right time and in the right amount” Niels Uth, Founder and Managing Director at Tropa.

Filing patent applications may not always be in the best interest of the firm, it depends on the circumstances.

“In fact sometimes the best advice

on IPR is not to patent a certain invention. In some cases, enforcement of potential patent infringements is very difficult or even impossible. In other cases, the manufacturing process of an invention is so complex and hard to copy that it makes more sense not to publish the method in a patent,” he explains.

Facts about Tropa • Provides counselling on international proprietary rights matters in life science • Was founded in 2012 by MSc, PhD Niels Uth and today has three PhD counsellors For more information tropa.dk

Analysis is the foundation All the regular IPR disciplines are available at Tropa, i.e. assessments of novelty, freedom to operate, infringement counselling, database searches, and writing patent applications. However, the key competence is the capability to analyse.

“Analysing the invention and its environment to truly understand the

essence of the invention, puts us in a far better situation on counselling our clients,” Niels Uth says.

He is MSc and PhD in biomechanics and human physiology and founded Tropa in 2012.

For more information: tropa.dk

Tropa was founded in 2012 by MSc, PhD Niels Uth and today has three PhD counsellors. Provides counselling on international proprietary rights matters in life science.

41

CALENDAR

Translation: CLS Communication A/S

MARCH Medtech & Biomaterials 2014 - Future Technologies for Clinical Solutions 4 March 2014 8:30 am - 6:00 pm Sahlgrenska Science Park, Wallenbergssalen, Medicinaregatan 20 A, Gothenburg.

Registration at www.medtechandbiomaterials.com The Forum will be a meeting for those involved in medical devices and biomaterials, including stakeholders from industry, academia, healthcare, and investors.

The main focus of this event will be on the recent research and developments in the medtech field (e.g. from new organs, biocompatible materials, wound healing, “hard core medtech”, imaging/ simulation, nanomedicine, etc.).

Important cases will be presented showing how innovative ideas and research can be translated and put into practice with an emphasis on patient benefit.

Both Swedish and international participants are welcome, and all lectures will therefore be held in English. We expect about 300 participants and 30 exhibitors.

The organisers are Kemivärlden Biotech Kemisk Tidskrift and Medtech Magazine.

BIO-Europe Spring 2014 10-12 March, Turin, Italy.

Register and more info at edbgroup.com BIO-Europe Spring ® is the springtime counterpart to EBD Group’s flagship conference, BIO-Europe®, and continues the tradition of providing life sci-

ence companies with high-calibre partnering opportunities.

Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and start-up partnerships with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative start-ups.

BIO-Europe Spring annually attracts top international executives from: • Established and emerging biotech companies • Pharmaceutical companies • Academic innovators • Private investors including venture capital and private equity • Companies developing companion diagnostics • Other industry related service companies

Life Science Management Day 25 March 2014. Operaterrassen, Stockholm, Sweden Register at www.managementday.se To succeed in this business, you need more than a fantastic product. You must also be able to sell it. On 25 March, Life Science Sweden will be holding a one-day seminar on how managers can bring an idea to market.

We will also be presenting Life Science Sweden’s new Life Science leader of the year award to a person who has taken a company or product to new heights. Nominate your candidate. Mail to ingrid.helander@ mentoronline.se

The seminar will include the following subjects and more: • What type of leadership is required for commercialisation?

• Where do you find commercial leadership?

• How to change the company’s focus on existing employees.

• What company structure is necessary for the company’s various phases?

• How to strengthen your trade mark in relation to the capital market.

• Where can customers be found • Expand in the domestic market or adopt an international approach?

26th Annual EuroMeeting Vienna 2014 25-27 March, ACV, Vienna, Austria Register and info at diahome.org The DIA’s Annual EuroMeeting is global in scope and attracts well over 3,000 professionals from more than 50 countries. It brings together professionals from the biopharmaceutical industry, contract research and service organisations, academic research centres, regulatory agencies and health ministries as well as delegates from patient organisations.

This topic of the meeting is “Different perspectives – one vision: Better healthcare for patients”. We are proud to have attracted a number of very high-level speakers from institutions including the European Commission, heads of National Regulatory Agencies and the European Medicines Agency.

Furthermore, we are delighted to have attracted additional views from outside Europe, including international speakers from the agencies in the US and Japan.

APRIL ICBMB 2014 International Conference on Biochemistry and Molecular Biology 17-19 April 2014, Vienna, Austria Registration at biochem.conference-site.com ICBMB 2014 brings together innovative academics and industrial experts in the field of Biochemistry and Molecular Biology in a common forum.

The aim of the conference is to promote research in the field of Biochemis-

42

try. Another goal is to facilitate the exchange of new ideas in these fields and to create a dialogue between scientists and practitioners.

Please submit your abstract and it will be reviewed by the editors of the International Scientific Journal and independent reviewers. All the selected papers will be published in the Journal of Medical & Biological Sciences. You can submit an abstract by sending it to adeo. office@gmail.com as an attachment. In

the subject field, please, write Biochemistry abstract.

You can also participate as a listener without submitting the paper.

The conference will take place in Vienna Grand Hotel, the majestic five-star hotel in the heart of Vienna. Included in the programme is a sightseeing tour which will not only be educational, but will also help participants to establish necessary contacts.

MAY EuroMedtech 2014 7-8 May 2014, Linz, Austria Registration and info at edbgroup.com EuroMedtech™ is Europe’s leading medical technology partnering conference, providing collaboration opportunities to medtech decision-makers and investors.

EuroMedtech caters to companies involved in all areas of the advanced medical technology industry, from those serving mainline therapeutic categories, such as orthopaedics and cardiovascular, through diagnostics, imaging and eHealth to those involved in platform technologies, such as biomaterials and regenerative medicine.

Also attending are companies serving the industry, such as manufacturers, law firms, CROs and distributors.

Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and do business with attending companies, from large international medtech companies and just-launched start-ups, to venture capitalists and private equity firms.

BIO Equity Europe 21-22 May. Amsterdam, Netherlands Registration and info at edbgroup.com The 15th collaborative gathering of the corporate and investment communities for the European Life Science. Bio€quity Europe pioneered the turf-neutral concept, creating an open door for all members of the financial community and business development and licensing professionals to do business with independently selected presenting companies.

Now celebrating its 15th meeting, Bio€quity Europe is the seminal industry event for financial dealmakers looking for investor-validated life science companies positioning themselves to attract capital, and for pharmaceutical licensing professionals to assess top prospects.

Bio€quity Europe has showcased more than 600 leading European companies to thousands of investment and pharma business development professionals. Delegates from over 20 nations attended Bio-quity Europe last year.

SEPTEMBER Scanlab 9-11 September 2014, Bella Center, Copenhagen Info and registration at www.scanlab.dk In 2014, Scanlab is offering the largest and most ambitious conference programme ever. The conference is being held in co-operation with the Danish Technological Institute, Life Science division.

The special focus will be on: • Biotechnology • Analysis • Packaging • Food technology

Scanlab enters into close collaboration with the Danish Technological Institute With a desire to strengthen professionalism at Scanlab 2014, Bella Center is joining forces with the Danish Technological Institute to stage an ambitious international conference.

Scanlab 2014 and the Danish Technological Institute are joining forces to offer a free conference on Life Science analysis. The conference, which will be divided into three sessions, will cover the hottest topics within life science, food technology and laboratory technologies, analysis and quality control.

High professionalism with subject-specific speeches from the industry, producers and researchers will be in focus.

The Danish Technological Institute expects the conference to be a good supplement for the wellknown fair.

“We want to give visitors a professional boost so that they go home with new knowledge of life science and laboratory equipment that they can benefit from during their workdays,” says Sara Kobbelgaard, from the Danish Technological Institute.

Scanlab is the largest trade fair for laboratory equipment of its kind in Denmark. The combination of an exciting conference programme and state-ofthe-art equipment is intended to give visitors a highcalibre professional trade fair where they can obtain new input while studying and testing the equipment in practise.

“Scanlab 2014 is designed as a benchmark for the laboratory sector and will therefore help stimulate the industry’s development and growth,” says Head of Events Malina Lebrecht Hye, adding: “We want to gather specialists, growth layer representatives and first movers on one platform. Collaborating with the Danish Technological Institute and developing the fair is therefore a very logical initiative.”

Pipettecenteret Pipettecenteret

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

fabrikater pipetter.

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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.

Salg af Pipettecenteret 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

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50%

KONFERENCE KEY-NOTE SPEAKERS OPTIMALT NETVÆRKSMILJØ AMBITIØST KONFERENCEPROGRAM

50%

9. - 11. september 2014

FAGMESSE NYT MESSEKONCEPT OMFATTENDE AKTIVITETSPROGRAM INTERNATIONAL MARKEDSFØRING

BOOK DIN STAND PÅ SCANLAB 2014 SCANLAB HAR NYT PÅ MESSEFRONTEN Scanlab har gennem mange år været det centrale mødested for hele den samlede laboratoriesektor. Den 9. - 11. september 2014 slår Bella Center dørene op til Scanlab 2014, og vi glæder os til at løfte sløret for de mange nyheder, som sker på messefronten.

Scanlab byder ikke alene på en helt ny termin, som har givet plads til yderligere udvikling af messen, men også på det største og mest ambitiøse konferenceprogram nogensinde.

SCANLAB INDGÅR TÆT SAMARBEJDE MED TEKNOLOGISK INSTITUT Med et ønske om at styrke fagligheden på Scanlab 2014 har Bella Center indgået et tæt samarbejde med Teknologisk Institut om at skabe en ambitiøs international konference.

MØD INDKØBERE FRA STORE DELE AF VERDEN Som udstiller på Scanlab kan du bruge messen til at vedligeholde og udvikle dine kundeforhold face to face. Det giver indkøbere og brugere en unik mulighed for at få et billede af menneskene bag produkterne og trygheden ved et højt fag- og serviceniveau. Du får også mulighed for at eksponere din virksomhed ved at holde seminarsessioner tæt ved egen stand.

Kort sagt er Scanlab en unik platform til at markedsføre dine produkter og services samt demonstrere det nyeste udstyr, teknologi

og knowhow for et publikum af repræsentanter og beslutningstagere fra den danske og internationale laboratoriesektor. Messen markedsføres i Skandinavien og internationalt, og som udstiller får du derfor mulighed for at møde relevante indkøbere fra store dele af verden.

SCANLAB STYRKER SIN POSITION SOM BRANCHENS BEDSTE MØDESTED Når Scanlab åbner dørene, er det med en nyhed, som skal styrke messens position som bedste mødested for branchen. Det sker med et matchmaking-event i samarbejde med firmaet Netmatch.

Nye partnerskaber giver spændende og inspirerende oplevelser i nye messeområder som Speakers Corner, NEWS area til produktpremierer, match making samt sociale arrangementer. Scanlab løfter hermed barren med stærke netværk og stærk dialog.

SCANLAB AWARD Som noget helt nyt lancerer vi SCANLAB AWARD. Prisen har til formål at sætte ekstra fokus på aktuelle produktnyheder. Prisen uddeles til en udstiller, som kan præsentere den mest innovative nyhed, der er kommet på det danske marked i 2013.

Velkommen i Bella Center til 3 dages professionel fagmesse, hvor hele den samlede laboratoriesektor vil være repræsenteret.

FÅ 25% RABAT PÅ STANDLEJEN Læs mere på scanlab.dk

Bella Center • Center Boulevard 5 • 2300 København S • scanlab.dk