Cls #2 2015

Theme: The Brain Brain research is a Danish and Swedish point

Interview What should you do to get headhuntet? See one way in “Life Science and Me”

Legal Update June 2015

Data about a person’s health requires a higher level of data protection. But when is it health data and when is it not?

THE BRAIN ISSUE 1

Publisher :

Frydendalsvej 3 DK-1809 Frederiksberg C Denmark +45 3326 9520 www.raskmedia.com rask@raskmedia.com

Contents

No. 2 – 2015

Editor in Chief: Malene Aadal Bo Editors; Lone Frank, Carsten Elgstrøm, Fredrik Hedlund and Nanna Bisbjerg

The column

Mediepartners with :

Update business

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Fredrik Hedlund: A Long Way From Understanding Better to Understanding Completely

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Business, science and technology news flashes

www.cphlabmed.dk

The Picture

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Denmark’s Last Research Monkey Is Dead

Theme: The Brain www.labdays.dk

www.health-rehab.dk Advertisment:

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Brain research is a Danish and Swedish point of pride.

It will however take time before the biotech business seriously starts to make a profit from it, says a brain researcher.

- The Brain in Danish and Swedish Life Science - A Strong Focus on Research Is the Way Forward for Lundbeck - The Brain Prize: The Winner is…

- Providing Hope Where There Was None Before

Guide

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The Importance of Advice About Laboratory Equipment NEM Media Krondalvej 7, DK-2610 Rødovre Phone: +45 23 23 80 82 nem@nemmedia.dk

Portraits 30

Cover illustration: Jacob Schrøder

Legal Update

Print: PE Offset A/S ISSN: 2246-428X

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Call in the Expertise, Helle Nygård QA’er to the Core, Karen-Marie Dahlmoes

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When is It Health Data and When is It Not?

Calendar 42

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By Fredrik Hedlund

I

n 1865, the Locomotive Act was introduced in the United Kingdom. Amongst other things it stipulated that self-propelled vehicles must be proceeded by a man walking 60 yards ahead, carrying a red flag to warn other road users of the vehicles approach.

Today, we can laugh at the man with the red flag. However, the fear of new technology remains and is at least as great now as it was then.

And right now the greatest fear is artificial intelligence, AI. A number of influential technologists and scientists have warned of the risks of AI. I am thinking of Elon Musk (PayPal, Tesla & SpaceX), physicist Stephen Hawking, Bill Gates (Microsoft) and the Apple-cofounder Steve Wozniak. All have warned that the development of AI can lead to the end of mankind.

The brain is our most fascinating organ, and naturally it would be even more fascinating whether it would be possible to create an artificial brain. It is a thrilling and at the same time terrifying thought that has put fear into mankind, at least since the days of Mary Shelley.

Her Dr. Frankenstein certainly did not create true AI but rather awoke a dead body and brain, however it was still an intelligent creature that turned out to be uncontrollable, which seems to be our greatest fear.

In popular culture, uncontrollable and evil AI frequently appears.

Just think of HAL 9000 in 2001: A Space Odyssey, the self-aware

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Translation: David Allington

network SkyNet in the film Terminator, and the terminator itself which admittedly becomes the good guy in the later films, but only because there is an even worse bad guy.

The collective human imagining of AI can therefore be summed up as evil and uncontrollable.

Photo: PR

The column

A Long Way From Understanding Better to Understanding Completely

The Brain is an unknown area Brain research is probably the most promising branch of research in the life sciences at the moment.

Researchers have begun to understand certain issues, but there is still much more to be discovered.

To a great extent, the brain is an unknown area just waiting to be explored. It is through the progress of brain research that the next great leaps of mankind will be made, when illnesses such as epilepsy, MS, Parkinson’s and Alzheimer’s can be understood, alleviated or even cured.

But there is a long way from understanding better to understanding completely. Also, it becomes an almost philosophical question: is it possible for a human brain to understand how a human brain works? Completely? I don’t think so.

And if you cannot really understand how the brain works completely, can you create an AI that is better than the real thing?

Hardly. Certainly, you can make good chess computers and robots that can handle a range of limited tasks, but to create an AI that should manage all aspects of life,

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

handle all situations, read others’ emotions, could empathise and even love? No, I believe that Musk, Hawkings, Gates and Wozniak in this case are today’s men with red flags, warning of something more terrifying in our imagination than in reality.

Because in reality I am much more afraid of the human brain than of what it can think of. It is much more unpredictable than those that are programmed, and also, there is no power switch.

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UPDATE - BUSINESS

Business Update

By medwatch.dk

EU Suggests Significant Changes of Medical Industry Rules Health ministers in the EU Council have reached an agreement on two new law proposals that will mean profound changes for the regulation of medicine and diagnostic equipment in Europe.

The changes come in the aftermath of a number of scandals in Europe about medical equipment and there is a desire to tighten the rules for the approval of new medical equipment, in the same way that one

wants to increase the control of the equipment that is already on the market.

Read more on politico.eu

Significant Growth Predicted for Mobile Tools A greatly increasing number of people across the world with lifestyle diseases will, by all accounts, bring large growth in the global mHealth market. Such is the main message in a new report from Allied Market Research. According to the report, the global market is predicted to rise by 33.5% per annum between 2015 and 2020.

The report suggests that heart disease is the biggest area in mHealth at the moment, and it is also here that the greatest growth is predicted through to 2020.

Translation: David Allington

IMS Gets a Footing on the Danish Market IMS Health, who since the spring of 2014 has attempted to get a part of the Danish health market for drug data, has reached a final agreement to take over two daughter companies of the Danish company Rehfeld Holding ApS. Rehfeld offers business intelligence (BI) advice to many hospitals, the state and pharmaceutical companies.

“The purchase will increase IMS Health’s possibilities for developing strong BI offers to their customers and reaching new segments in Nordic countries,” says Carlo Ciapparelli, General Manager, Nordeuropa IMS Health.

In 2013, Peter Gudmund Nielsen, Ann Fullerton and Bent Højgaard started the biotech company Oncoral Pharma.

Now they are ready to go to the clinic with a chemotherapy treatment in tablet form at Herlev Hospital. They have developed and produced the tablets at the laboratory in Ballerup.

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The chemotherapy treatment itself is a known substance, Irinotecan, which Oncoral ‘re-packs’ from an intraveneous treatment to a product in tablet form. With tablets, one avoids hospitalisation and avoids giving patients the high dose that they often become sick from.

Photo: PR

Former Veloxis employees on the Way to the Clinic with the Chemo Tablet

New Seed Capital Fund Focuses on Medical Industry The venture fund Seed Capital recently announced that they are establishing their third venture fund, which will invest in so-called ‘high technological winners’ within IT and life science. So far, there is a half a billion Danish kroner in the investment fund, and according to managing partner in Seed Capital, Ulla Brockenhuus-Schack, up to half of the amount is intended for life science.

This page was compiled in collaboration with MedWatch.

Read more news at www.medwatch.dk

Photo: Scandinavian Stockphoto

Life Science’s Finance Directors among the best Half of the 10 highest ranked financial bosses in the Extel study of Danish listed companies come from life science. Novo Nordisk’s CFO, Jesper Brandgaard, was beaten from first place by CFO Stefan Ingildsen of the hearing aid group William Demant. On the topboss level, the gold goes to Lars Rasmussen from Coloplast, silver to Mærsk boss Nils Smedegaard Andersen, while Novo Nordisk top boss Lars Rebien Sørensen must share the bronze medal with William Demant boss Niels Jacobsen.

Novo Ventures:

A New Model on the Way Even the big players in Life Science face challenges when it comes to financing their research projects and, according to Novo Ventures’ managing partner Søren Carlsen, that has opened up for a new model of cooperation.

It is called “defined exit deals” and works by investors and the company defining in advance an exit and the result of a given exit. For example, Venture will have four times it’s investment in return, when a product is approved.

In this way, the large companies keep the rights to their products while they are able to drive more projects through the pipeline.

EMA Opens for Sharing of Side Effects in the EU From June 2016, it will become easier to form an overview of the side effects of drugs that are approved in the EU. The board of the European Medicines Agency (EMA) has recently decided that the information in the socalled PSUR reports (periodic safety update reports) will be collected in an electronic database. All regulatory

authorities and pharmaceutical companies in the EU will have access to the database of side effects.

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UPDATE - SCIENCE AND TECHNOLOGY

Update

Science and technology 22 Scientists Make Their Way into Krak’s Blue Book Krak’s Blue Book has just been published for the 106th time. Access has been given to 244 new people and, from a scientific perspective, 22 names are particularly interesting.

They are namely people from the world of science who have made their way into the new edition.

Among them you can find: Professor Barbara Ann Halkier from University of Copenhagen, who in 2012 won Videnskab.dk’s ‘Annual Danish Research Result’ for her work in changing poisonous plant waste into nutritious animal feed.

Infections Can Damage Your IQ

Photo: Wikipedia

Infections in the body are not necessarily over when the fever has passed and the pain is gone. A new Danish study shows that if the infection is serious, it can lead to a long-term effect on a person’s IQ and cognitive abilities.

“We have studied whether intelligence is affected, if one has an infection so serious, that one has been admitted to hospital. We can see that it does. It is not just infections in the brain, but also other places in the body that diminish cognitive abilities,” says Dr. Michael Eriksen Benrós from Copenhagen Psychiatric Center.

Michael Eriksen Benrós is one of the researchers behind a new study which shows that young people in military service, who have at some point in their lives been admitted to hospital with an infectious disease, have on average a lower IQ than their peers. The study is published in Plos.

Peter Leutscher, who is head of research at Randers Regional Hospital believes the result provides a reason to link neuropsychologists to the hospital departments where serious infections are treated..

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Professor Rubina Raja from Aarhus University, who earlier in the year was one of the winners of the ‘Elite Research Prize’, amongst other things on the basis of her archaeological work in Jordan.

Professor and Institute Director Klavs Flemming Jensen from the respected Massachusetts Institute of Technology, USA. See the complete list of the scientists included in Krak’s Blue Book 2015-16. www.blaabog.dk

New Discovery Changes Our Understanding of Pain Researchers have discovered a gene that is crucial in our ability to feel pain and temperature. It is the gene PRDM12, that has shown itself to be crucial in the development of well-functioning nerve connections and the feeling of pain.

“With the discovery, we have a new point of attack which can be used in the treatment of the many pain sufferers. Pain disorders are an important area for the health system and pharmaceutical industry, and our new understanding has great potential for the development of new drugs,” says Jens Michael Hertz, one of the researchers behind the new research. He is a professor at University of Southern Denmark and chief physician specialising in clinical genetics.

“One suspects that people with chronic pain disorders have overactive pain receptors. Therefore, if one can, with the new drugs, go in and regulate the activity or formation of new pain receptors in the body by regulating the protein PRDM12, one can also help people to feel less pain with and with fewer side effects,” says Troels Staehelin Jensen from the Danish Pain Research Center at Aarhus University.Blackburn, head of the research team at the University of Edinburgh.

Photo: Gads Forlag

By Videnskab.dk

Photo: Wikipedia

Danish Researcher Swallows 600 Intestinal Worm Eggs A researcher from University of Copenhagen has infected himself with hundreds of whipworms for the sake of science. For the past two years he has lived with the 4 to 5-centimeter-long intestinal worms in his bowels.

The idea to infect himself with the worms occurred, because Peter Nejsum needed a ‘freshly caught’ worm for genetic analyses of whipworms. Together with international colleagues, he found the whipworms genetics interesting, because the animals are in one way or another able to cheat the human immune system and in this way are allowed to live undisturbed in our intestines.

“My immune system can not get rid of the worms. The worms must be cheating the immune system, so that they aren’t recognised as foreign parasites, but are allowed to remain,” tells Peter Nejsum.

Test subjects were not queuing up to help and instead Peter Nejsum ended up ordering a stool sample from a whipworm-infected child from Uganda.

For three months he stored the eggs while they matured. Then one day he swallowed 600 worm eggs. Today, there are still whipworms in his colon, and the first results of his self-infection have just been published in the Journal of Helminthology.

Photo: Flick’r

Breakthrough in Cancer Treatment: Here are PD-1 Inhibitors A new class of drugs, that enables the body to fight cancer cells, shows again and again promising results in research on humans. The drugs are already approved in the USA and EU for treatment of melanoma and lung cancer. They are called PD-1 inhibitors and work by boosting the body’s natural defence against cancer.

One of the drugs that has shown convincing results in the treatment of melanoma cancer is Pembrolizumab. It breaks the bond between a protein (PD-1) on the surface of the body’s T cells and another protein that binds to PD-1 (PD-L1). T cells are the body’s natural defence against cancer, but when PD-L1 is bound to PD-1, it is like putting the breaks on the immune system’s defence. However, when the bond is broken by Pembrolizumab, it is like taking the foot off the break, and the T cells become much more effective against the cancer cells. There are also other forms of immunotherapeutic drugs on the way that either take the immune system’s foot off the break or, so to speak, put its foot on the accelerator.“This is happening after many years wandering in the desert, where there has been very high expectations of immunotherapies.

Now something is happening,” says Per Thor Straten, head of the cancer research center, CCIT, at Herlev Hospital.

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

Myth Debunked: Chromosomes Do Not Decide Your Mortality Danish researchers have rather surprisingly found that short telomeres, the ends of our chromosomes, do not lead to increased mortality. At conception we are given different length telomeres, and these telomeres are worn down as we grow older.

However, now researchers behind the new study conclude that the genetic telomere length, i.e. the telomere length we are born with, does not in general play a role in our mortality.

Instead, it has shown that in relation to cancer mortality, it is actually an advantage to be born with short telomeres.

“We found the opposite of what we expected,” says Stig Bojesen, who explains the lower cancer mortality through genetically short telomeres being because people have long telomeres, because their cells are good at maintaining and repairing them. The disadvantage is that people’s cancer cells are also good at maintaining their telomeres.

If one can go in and target the repair process then, in principal, one can better stop cancer,” explains Stig Bojesen.

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THE PICTURE

Denmark’s Last Research Monkey Is Dead

By Malene Aadal Bo Photo: Flemming Højer

T

he last half of his life, Sebastian lived a completely normal, safe monkey life in Ree Park on Djursland, Denmark. But Sebastian was anything but a normal capuchin monkey. For many years his home was in the basement under St. Hans Psychiatric Hospital in Roskilde, and his everyday life consisted of being subject of a range of tests and experiments with new medicines for the treatment of psychoses and other psychiatric diseases.

Capuchin monkeys are intelligent animals with a psyche very similar to humans. That makes them suited for testing new medicines, before they were given to psychiatric patents.

The monkeys were used to gain knowledge on sideeffects and used to discover whether completely new drugs could be anti-psychotic by first giving the monkeys psychoses with the help of amphetamines, and afterwards trying to treat the monkeys with different medical drugs.

A new home and a new life That was the research monkey’s life and everyday existence until 2004. Growing public attention and criticism led researchers to find other solutions and at the same time the use of pigs became more widespread for experimental use.

Finally, an EU directive came with increased requirements for how experimental monkeys should live – requirements that St. Hans couldn’t live up to.

Therefore, it was decided to stop using monkeys. Other research monkeys in the country were euthanized, but Sebastian and 11 of his colleagues from St. Hans got a new home in Ree Park on Djursland.

According to the park’s CEO, Jesper Stagegaard, it was a troop of traumatised monkeys who moved into the park in the beginning of 2004. The in nature strongly social animals had never learnt to be together, and they all showed heavy signs of stress from their times as research animals.

“They all suffered from stereotypic

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The monkey Sebastian is named after the son of Thomas Werge, who in 2000 became the leader of the research department at St. Hans Hospital. He took the initiative in allowing the monkeys to move to Ree Park.

behavior due to their previous housing. It required a big effort and it took time to reduce their fear and stress. But it was successfull and when we look back we can say that the re-socialising was a big success.

They recovered completely and ended having many good years,” says Jesper Stagegaard.

In May 2015 Sebastian died, who ended up being Denmark’s last research monkey. Primates are still used in Danish companies and researchers’ work in developing medicine, but today it happens at contract laboratories abroad.

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Our Nordic focus is an asset Over the years, the competition has increased, making it even more important to stand out to remain the preferred Nordic CRO partner. The CRO market has undergone a transition towards a more global focus among the big pharma clients as well as among CROs. More and more CROs are being consolidated, running offices all over the world and offering global clinical trials. By contrast, IRW has chosen to keep its focus on the Nordic region and consider it an asset.

“Many of the big pharma companies are represented in Stockholm or Copenhagen, from where they cover the entire Nordic region. In my experience, our clients value the fact that we have a local focus and offices and personnel in all four Nordic capitals. We have the

IRW CONSULTING • Business areas: Clinical Operations, Project Management, Regulatory, Clinical Data Management, Biostatistics, Pharmacovigilance and Medical Writing • Assignment range: clinical trial phases I-IV, medical device investigations, non-interventional trials and registry trials • Clients: Biotech, Medtech, big pharma companies and other CROs

required expertise to quickly set up clinical trials and determine the most beneficial and cost-effective set-up.

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

Even CROs have to be innovative Besides the knowledge of the Nordic clinical research environment, it is key to IRW Consulting that they are responsive and innovative.

“In a competitive market, one of the best ways to achieve success is by meeting the clients’ needs by being flexible and able to innovate and adjust accordingly.

That means hiring people according to our clients’ needs and keeping abreast of the latest technology. We have to be able to offer our clients technological solutions that meet the need for variation in complexity and price,” explains Jeppsson.

“A concrete example of how a client’s need has evolved into a new technological solution is electronic patient diaries. After FDA and EMA opened up the possibility of keeping electronic patient diaries, clients requested the service. We have developed an ePRO system (electronic Patient Reported Outcomes) and are now able to offer the service to other companies,” says Jeppsson.

Preparing for the future In spite of the strong competition, Jeppsson believes that IRW has a strong position in the market. Nevertheless, he recognizes that they have to keep being innovative and flexible as the market situation could quickly change.

“We want to be the preferred partner when it comes to conducting clinical trials in the Nordic countries.

That’s why we will keep hiring the best employees and be the best at outsourcing personnel. And we will keep developing our skills, making us even better at conducting clinical trials and addressing the clients’ challenges. We will keep growing in the Nordics. But in order to succeed, we have to be extremely responsive and adaptive to the clients’ needs,” says Jeppsson.

• Founded in 1999 • Number of employees: 50 • Number of current ongoing clinical trials: 40 • Number of outsourced employees: 25

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THEME: THE BRAIN

The Brain in Danish and Swedish Life Science Brain research is a Danish and Swedish point of pride. It will however take time before the biotech business seriously starts to make a profit from it, says a brain researcher.

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Photo: Scandinavian stockphoto

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THEME: THE BRAIN

By Kristian Sjøgren Translation: David Allington

B

oth Denmark and Sweden have proud traditions and great expertise in brain research. In the 1960s, the Dane Niels A. Lassen and the Swede David Ingvar were behind the development of the first brain scanners for mapping brain activity and function. Their research took the two countries to the driving seat of international brain research – where they still are today.

Denmark is also at the forefront regarding the molecular biological understanding of the brain. Early pioneering work in the field led

to the development of new drugs such as antidepressants and antipsychotic medicine. These drugs set the foundations for Lundbeck, who built on the work from the large Danish universities.

Today, new techniques for examining the brain are surging forward. Optogenetics and twophoton microscopy are the new superstars in brain research. These techniques are also a Danish focus area that can, with time, become a national area of strength.

According to Albert Gjedde, professor and brain researcher

with the BRAIN laboratory at the Department of Neuroscience and Pharmacology, University of Copenhagen, we can certainly be proud of our brain research.

“The understanding of the brain’s metabolism and circulatory physiology and the molecular biology in the brain are completely central areas of brain research. These are areas that Danish and Swedish researchers have been a part of pioneering, and we are still in the front row in international research in the areas,” says Albert Gjedde.

Not a Large Part of the Biotech Landscape Despite the proud traditions, brain research is not a large part of Danish and Swedish life science. A few years ago, NeuroSearch went under and left Lundbeck as the only large player in the Danish market. Lundbeck has, in return, had good success with antidepressants and antipsychotic medicine, and the pharmaceutical company is trying to build on its success with drugs for Alzheimer’s and epilepsy.

In Sweden there are few companies, and in both countries there is a lack of smaller firms to bring fresh blood into the area.

“We are clearly lacking an undergrowth of biotech companies with a focus on the central nervous system. For a company such as Lundbeck, it is incredibly important that smaller companies exist who can pioneer new paths to brain medicine,” says the head of

According to Albert Gjedde, professor and brain researcher, we can certainly be proud of our brain reasearch in Denmark and Sweden.

Photo: PR

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secretariat for the trade organisation Danish Biotech, Christian Quaade.

One can rightly ask, why is there this large gap between world-class brain research and the few biotech firms who focus on the brain in Denmark and Sweden?

Not least because of the financial incentives should be there. The European Brain Council has calculated the EU’s collective costs caused by illnesses related to the brain. In Europe, the costs are up to 800 billion euros per year.

Over half of that amount goes to illnesses that we still do not know the cause of, for example, ADHD, schizophrenia and autism.

Also, large pharmaceutical companies such as Pfizer, Janssen, Sanofi and Merck have so much faith in the potential that, only a few years ago, they threw large sums at the development of medicine for the central nervous system.

However, most have failed. In 2012, two phase-III studies with Alzheimer’s drugs from Pfizer/ Johnson and Johnson and Eli Lilly failed. The development of the two drugs cost the companies in the region of 600 million dollars each, and many of the other large players have drastically reduced their activities in the area.

the reasons behind the different psychological diseases and illnesses in the brain.

“If we look at antidepressants and antipsychotic medicine, they were almost discovered by accident. Antipsychotic medicine was originally designed against tuberculosis, and even today we don’t understand why antidepressants work. We cannot design medicines against a range of different brain diseases until we find out what the problem is in general with the brain, when the disease occurs. Therefore, the biotech business are left waiting

until there is more knowledge.” explains Albert Gjedde.

International focus on the brain Currently, there is a great deal of international focus on the acquisition of this new knowledge.

USA has launched NIH’s ‘Brain Initiative’, while the EU has thrown a billion euros at ‘The Human Brain Project’. In recent years, these big donations have been dealt out to researchers who will deepen our understanding of the brain and what is going wrong when it isn’t working as it should.

According to Albert Gjedde, these

Grete Lundbeck European Brain Research Foundation Call for Nominations for

THE BRAIN PR1ZE THE PRIZE OF € 1 MILLION WILL BE AWARDED IN COPENHAGEN JULY 2016 Nominations by 15 September 2015

Nominations will be reviewed by the Selection Committee: HUDA AkIL, USA ANDERs BJöRkLUND, Sweden, Vice-chAirmAn COLIN BLAkEMORE, United Kingdom, chAirmAn JOsEPH COYLE, USA TOM JEssELL, USA RANGA R. kRIsHNAN, SingApore

Discovered by accident Even though billions and billions of dollars in revenue is apparently awaiting the company who can crack the Alzheimer’s code, cure ADHD, schizophrenia and Parkinson’s, or discover a pill against autism, clearly nothing is happening at the moment.

Presumably because we still lack sufficient knowledge in order to actually make effective treatments.

According to Albert Gjedde, the problem is that we still do not know

PHILIP sCHELTENs, the netherlAndS IRENE TRACEY, United Kingdom

For the nominAtion Form And detAilS oF the nominAtion procedUre, pleASe ViSit: WWW.THEBRAINPRIZE.ORG

Prize Winners 2015 Winfried Denk, Max Planck Institute of Neurobiology, Germany, Arthur Konnerth, Technical University Munich, Germany, Karel Svoboda, Janelia Research Campus, HHMI, USA, David W. Tank, Princeton University, USA

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

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THEME: THE BRAIN

projects must be completed before anyone can expect the biotech branch to develop medicines for the treatment of everything from ADHD and autism to Alzheimer’s and dementia.

Christian Quaade agrees, but also believes that we in the Nordic countries must exploit the waiting time to strengthen the position we have in biotech, so that we are ready when the possibility arises.

“We have some very special competences in the area and generally a good environment for biotech. If we can create good conditions for small companies with a focus on brain research, the potential is huge,” says the head of secretariat.

FACT • In Denmark, Lundbeck is the largest company with a focus on the central nervous system. In addition, smaller companies can also be found, such as Biomediq, Avilex Pharma and Nsgene.

• In Sweden, the companies Neurovive and Active Biotech focus respectively on protection of the brain’s cells and Huntington’s disease.

• Find more about the American “Brain Initiative” at www.braininitiative.nih.gov • And the EU’s “The Human Brain Project” at www.humanbrainproject.eu

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16

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17

THEME: THE BRAIN

A Strong Focus on Research Is the Way Forward for Lundbeck A range of big pharmaceutical companies have withdrawn from developing new treatments for brain diseases. But Lundbeck is still committed to improving the quality of life of people living with these diseases. Partnerships and a research-intensive strategy seem to be the key to success.

By Louise Bruce Photo: Lundbeck

R

esearch and development of drugs for the central nervous system (CNS) is typically a very difficult and lengthy

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process due to the complexity of the brain. Development of new drugs often takes several years longer than for other disease areas.

Typically, 10 to 12 years out of a 20 year patent. However, Lundbeck defies the tendency among the big pharmaceutical companies to

withdraw from the CNS market.

But why do they persist? According to Country Manager, Thomas Klee, the reason should be found in Lundbeck’s extensive experience within the disease area.

“With many of the big pharmaceutical companies out of the picture in terms of developing treatments for brain diseases, the pressure on us is constantly rising. But Lundbeck has many years of experience in this disease area and is 100% focused on CNS. Thus, we believe that we are in a good position to deliver innovative drugs for the treatment of patients suffering from diseases in CNS. Among other things, we allocate 20% of the revenue to research and development of new treatments,” says Thomas Klee.

In the coming years, Lundbeck is expected to launch a range of new treatments. Meanwhile, the patents

on many of their current treatments are expiring.

Treatment for the ‘Untreatable’ Lundbeck has a very strong focus on research, which among other things has led to the development of

a potential therapy for Alzheimer’s disease. Treatment options for Alzheimer’s disease have been very limited and researchers have yet to definitely discover what causes the disease. Though no causal relationships have been finally

ABOUT LUNDBECK Lundbeck is a Danish global pharmaceutical company highly committed to improving the quality of life of people living with brain disease.

Lundbeck’s primary focus is research, development, production, marketing and the sale of pharmaceuticals for the treatment of brain diseases such as depression and anxiety, psychotic disorders, epilepsy, and Huntington’s, Alzheimer’s and Parkinson’s diseases.

Lundbeck was founded in 1915 in Denmark, has a revenue of 13.5 billion DKK (2014) and approx. 6,100 employees in 57 countries (2,000 in Denmark).

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THEME: THE BRAIN

Bjørn Grønning is Senior Director at Lundbeck. He predicts that the company will a phase III trial on their Alzheimer treatment ready sometimes during 2017.

companies strive to develop new treatments that can alleviate the symptoms. ”Currently, we are running three phase III trials on one of our Alzheimer treatments. It is developed to improve cognition and daily function.

Servicing pharma and biotech since 2000 The first trial is CONTRACT MANUFACTURING expected to be finalized next year, CLINICAL TRIALS SUPPLY and in principle, we BIOTECH SERVICES will be able to file CONSULTING for approval once the last trial is finished, -perhaps sometime during 2017 if HB Medical is approved under section 39 everything goes by the Danish Medicines Health Agency and according to plan,” is authorized by the Danish Veterinary Senior Director, and Food Administration Bjørn Grønning explains.

“However, these kinds of trials HB MEDICAL are very big and DR. NEERGAARDS VEJ 17 imply a great DK-2970 HØRSHOLM amount of risk.

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verified, most research is focused on protein deposits in the brain, which seem only to occur in Alzheimer patients. Meanwhile, pharmaceutical

2020

especially the improvement of daily function is very difficult to prove.

But though we look upon it as a risk, the patients see it as an opportunity, which gives them hope. And that is what counts in the long run,” Bjørn Grønning continues.

As part of their development program in Alzheimer’s, Lundbeck is also working on a vaccine that stimulates the body’s own immune system to fight the protein deposits involved in the development of the disease.

“At the moment, we are starting up the first trial in humans, and we are very excited to see the outcome,” says Bjørn Grønning.

Partnerships Are Part of the Strategy A strong pipeline and several products already on the market require among other things well established marketing organizations all over the world. With offices in 57 countries and products launched in more than 100, partnerships play a significant role in the Lundbeck strategy.

“It is part of our strategy to look upon each country and evaluate how we approach the market most appropriately. In general we look for partnerships within development and marketing. How we set up the individual partnerships depends on which country or region we are talking about, and on the task at hand,” says Thomas Klee.

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Compliance with REACH also applies to drug manufacturers Chemical substances used in drug manufacturing processes may be subject to comply with EU law The list of Substances of Very High Concern (SVHC) currently counts 161 substances of which 31 now require authorisation before use (authorization list). The list is intended to grow and currently another 22 substances are prioritised for uptake.

This may become highly critical to a number of life science companies.

“Medicinal products are exempted from the REACH regulation as pharmaceutical legislation applies to this area. However, drug manufacturing processes using chemical substances that are on the REACH authorization list must comply with these requirements,” Jens Tørsløv says.

Jens Tørsløv is Ph.D and Head of Projects at DHI, Environment and Toxicology where they have specialized in chemical management and act as consultants. He stresses the sense of urgency in this matter.

“Many drug manufacturers may not be fully aware of the impact the authorization requirements under REACH may have, or may have the misconception that REACH is inapplicable to their production,” he says.

“REACH is putting pressure on the industry to identify new methods and replace SVHC’s with other substances, however, acknowledging that this is not done easily or rapidly, the users must apply for permission to use substances on the authorization list to continue the use,” Jens Tørsløv explains.

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es-soon-to-become SVHC during drug manufacturing. This calls for action! The companies need to identify SVHC in use and develop a strategy on how to act. Intermediates are exempted but for other substances on the authorization list applying for permission is an option.

The experts at DHI know how to trouble shoot in this matter, firstly by knowing what to look for and secondly by knowing what to do with their knowledge.

“It should be explored if authorities can be convinced not to place a critical substance on the authorization list, by documenting the impact it has on business and by exploring other ways of regulation,” says Jens Tørsløv, continuing, “In situations where no alternatives are available and the only use is in well controlled industrial settings, it may be worthwhile to try to argue to keep the substance off the list.

REACH actually opens possibilities to influence the decision process.”

For more information about SVHC and REACH www.echa.europa.eu/support/restriction www.dhigroup.com/areas-of-expertise/product-safe ty-and-enviromental-risk/chemicals-and-regulato ry-compliance

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perates globally and has offices in more than 30 O countries For more information http://worldwide.dhigroup.com/

2121 21

THEME: THE BRAIN

The Brain Prize: The world’s biggest brain researcher prize ‘The Brain Prize’ was this year awarded to the developers of the ‘two-photon microscopy’.

It is a unique research tool that is constantly providing new breakthrough research results.

By Kristian Sjøgren

I

f brain researchers will ever crack the codes for curing Alzheimer’s, Parkinson’s, ADHD, autism, schizophrenia etc., the key is for researchers to be able to study the individual brain cells one at a time.

Only in this way can they find out, what is going wrong in the brain when the illness develops.

Studies of the individual brain cells used to be completely impossible, but today researchers can do exactly that with the help of the revolutionary two-photon microscope.

The invention of the two-photon microscope has been so crucial for brain research that the inventors behind the microscope were awarded the prestigious brain research prize ‘The Brain Prize’ in May, which is given by the Grete Lundbeck European Brain Research Foundation to researchers who have excelled themselves with an outstanding contribution to European brain research.

The recipients of the prize are the German Winfried Denk, Romanian Arthur Konnerth, Czech Karel Svodoba, and American David W. Tank.

Winfried Denk developed the two-photon microscope at Cornell University, USA, and in 1990

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Translation: David Allington published an article in Science about the invention. Since then, the technique has been further developed by, amongst others, the other prize winners, and the microscope is today a unique research tool that is constantly providing new breakthrough research results. Along with the prize, which was presented by the Danish Crown Prince Frederik, one million euros was given.

How It Works The prize-winning two-photon microscope works by sending infrared laser light into the living tissue, for example in the brain, and when the laser light hits fluorescent-dyed molecules in the cells, a microscope camera is able to capture the reflected light in the form of light quanta.

The signal from the florescent-dyed molecules gives researchers a picture of even the smallest details in the brain’s individual cells.

Amongst other things, the microscope enables researchers to study and compare the differences between healthy and sick cells in, for example, Alzheimer’s or epilepsy, or study the interaction and communication between different types of brain cells.

The Winner is…

The two-photon microscope is superior to other forms of studying the brain in several ways.

Firstly, it makes it possible for researchers to study what the individual organelles inside the brain cells are doing.

It can, amongst other things, focus on the exact function of organelles in the nerve cell’s supporting cells, which researchers knew little about before the invention of the two-photon microscope. For example, if we compare it to MRI brain scanning, researchers using MRI can only see in a resolution of approximately 50,000 cells in a network of cells at a time.

In relation to another much used tool for studying tissue, confocal microscopy, two-photon microscopy is able to penetrate much deeper

into the tissue and maintain a high resolution, and the tissue damage is also much less. This is because the two-photon microscope emits two photons with long wavelengths of approximately 800nm.

With the long wavelength, it is possible to penetrate deeper into the tissue, and the use of two photons to excite the florescent-dyed molecules, instead of one photon, focuses the excitation very close to the level where the laser is most concentrated.

This means minimal tissue damage in the levels above and below the laser’s focus area.

The two-photon microscope is still being developed, and without doubt it will come to play a big role in future studies of the brains function – both when the brain is healthy and when something is wrong.

FACT: • In the past five years, the Brain Prize has been awarded to researchers who have excelled themselves with an outstanding contribution to European brain research. The honour is accompanied by a cheque for one million euros.

• The prize is awarded by the independent, charitable Grete Lundbeck European Brain Research Foundation.

• The prize has existed for five years, and the previous four years’ winners are: Péter Somogyi, Tamás and György Buszáki for research on the hippocampus (2011) Christine Petit and Karen Steel for research on the ear’s genetics (2012) Ernst Bamberg, Ed Boyden, Karl Deisseroth, Peter Hegemann, Gero Miesenböck and Georg Nagel for the invention and development of optogenetics (2013) Giacomo Rizzolatti, Stanisls Dehaene and Trevor W. Robbins for research into consciousness (2014) Photo: PR

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THEME: THE BRAIN

Providing Hope Where A dedicated focus towards developing novel treatments for patients with rare and unmet needs has turned Genzyme into one of the world’s leading biotech companies. For over a decade Genzyme has worked to develop new treatments for the autoimmune disease multiple sclerosis.

By Louise Bruce

F

ounded in 1981, Genzyme is one of the world’s leading biotech companies focused on developing transformative therapies for rare diseases and multiple sclerosis (MS).

It started with rare diseases back in 1981 in Boston. Since then, we have expanded our focus to also include MS. MS is a chronic disease that affects the central nervous system, i.e. the optic nerve, brain and spinal cord, and

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is a disease where the treatment options have been very limited for a very long time.

But over the past few years, new treatments have been developed resulting in a greater focus on the

disease, which in turn will bring more funds and research to the area in benefit of the patients, says Country Manager, Lis Callesen, Genzyme Denmark.

While many existing MS

There Was None Before It has always been of utmost importance to Genzyme to have a high level of research to benefit the patients Here Genzyme site in Framingham, Massachusetts

treatments which are currently available to patients worldwide.

MS is a devastating disease and patients remain in need of new treatment options that may offer greater efficacy. With the further development of alemtuzumab we might be able to change the perception that MS is a chronic disease that worsens over time.

Alemtuzumab is a monoclonal antibody that rebalances the immune system in a way that potentially reduces and even reverses the MS disease activity, with a minimal impact on other immune cells, says Lis Callesen. treatments modulate the disease’s symptoms, Genzyme’s focus is on research and development of future treatments that reset the damaged immune system.

Currently, they are researching a

small molecule that could actually repair the myelin sheath, which is damaged by MS. The pillars of the neurological research within MS have been laid by the two developed and marketed

Treatments for the Unmet Need Lis Callesen explains that one of the reasons why MS became a focus area is that Genzyme constantly strives to develop treatments within areas, where

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THEME: THE BRAIN

there is an unmet need. It

important for us to be able to help patients with rare and unmet needs. We want to provide hope, where there was none before.

It has always been of utmost importance to us to have a high level of research to benefit the patients. There are still many diseases where the treatment

ABOUT GENZYME • Genzyme is an international biotech company developing transformative therapies for patients with rare diseases and unmet medical needs.

• Genzyme’s primary focus is research, development, production, marketing and the sale of pharmaceuticals for the treatment of rare diseases and multiple sclerosis.

• Genzyme was founded in 1981 in Boston. In 2002, the Nordic headquarter in Copenhagen was inaugurated. In 2011, Genzyme became a part of the Sanofi Group.

• Genzyme has a revenue of approx. 20 billion DKK, 10,000 employees worldwide and 90 employees in the Nordic countries.

options are non-existing or not enough to help the patients sufficiently. These patients are the ones we care about, Lis Callesen explains.

In 2011, Genzyme became a part of Sanofi and thus all research is conducted in cooperation. Their research facilities are located in Boston, however Denmark is a highly prioritized country in terms of running clinical trials, all the way from phase 1-4.

“Denmark has a very high standard, when it comes to running clinical trials and over the years different initiatives have made it more attractive to place the trials here. Our healthcare professionals are highly skilled and reliable, and the bureaucratic process has been made smoother over the years,” says Lis Callesen.

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GUIDE

The Importance of Advice About Laboratory Equipment Laboratory equipment is a big expense, but without the proper advice and support, the costs can easily be even bigger. The knowledge that accompanies the equipment is at least as valuable as the equipment itself.

By Nanna Bisbjerg Translation: David Allington

L

aboratory equipment must not only deliver precise and reliable results, it must also meet a long list of requirements with regard to documentation, quality and security, as much in relation to the company’s own quality requirements as requirements from customers and international authorities.

Good advice and support is part of ensuring that all the requirements are met, that all the results can be documented, and that you get the most out of your equipment. Laboratory equipment is by no means a purely material investment. Specialised knowledge, training, and support, together with the right documentation is just as much what you invest in.

“One often pays as much for documentation that the apparatus lives up to all the standards and specifications as for the apparatus itself,” says Morten Dyrner, member of the board of the branch association DiaLab and director at Holm & Halby.

“But if one does not have the documentation in place, then one risks that fx an FDA inspection will close the production down, and if the production stands still for just a few days, then it can easily cost 10 to 100 times as much as the equipment itself.

If one wants to really scare a responsible worker at a pharmaceutical company, then one just shouts ‘FDA inspection’. It really is something that can keep people in the branch awake at night,

2828

because the consequences are so great,” he says, only half joking.

Therefore, quick access to support is to a great extent demanded in the branch.

“Employees in documentation and QA have a huge responsibility, both economic as well as securityand quality-wise. For them, it is important to have that security that can be found in easily and quickly being able to get support” says Jesper Hardt, vice chairman of DiaLab and director at Ramcon.

Environmental and Security Requirements Must Be Met Not only the lack of documentation can close down production.

Environmental requirements are tightened all the time and must be met.

It is important to take nature into account in production.

Likewise CSR and codes of conduct in this area are important for the companies..

Security and environmental law must also be upheld, and so

training in the use of the equipment is essential. If there is only one or two people with a thorough knowledge of the equipment, the company is vulnerable in the event of illness or staff departing – yet another important reason to make sure that new equipment and all the knowledge about it is implemented thoroughly.

“Today, equipment is highly advanced and can do many things, but of course it cannot do it on its own. It requires that users gain the knowledge, for instance, about

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the software that comes with the equipment,” says Jesper Hardt.

The Development is fast One area in particular that demands both thorough knowledge as well as proper installation, support and maintenance is measuring and analysis instruments.

“The biggest and most reprehensible consequences of not getting proper support on one’s equipment is that you do not get the precise results that you think you are getting, and in this way all of the research or QC is based on the wrong measurements,” says Morten Dyrner.

Calibration of measuring instruments occurs most often, to put it simply, with the supplier coming out and taking measurements of the advanced measuring instrument with

their even more advanced measuring instrument.

“The very large companies, fx such as Novo, have their own meteorological department. When we deliver equipment to them, they check how we calibrate our equipment and double check our measuring equipment with their measuring equipment in order to be completely sure that we are delivering up to their standards,” tells Morten Dyrner.

Yes, precision and security is highly important in this branch.

Jesper Hardt tells that measuring instruments in particular are a type of equipment whose use is expanding into other industries.

“We are able to measure more and more things. Fx breweries measure carbonation in their products to ensure that they live up to their own quality requirements. At

the same time, the documentation requirements are becoming greater and greater. One must be able to clearly document the amount of fx phthalates and other substances in products.”

In general, the development in laboratory equipment goes fast, so it is a good idea to keep updated.

Automatisation and measuring equipment are two areas where development really is going quickly.

“The measurements are becoming even more precise and instruments needs smaller amounts in order to measure – and they become quieter and take up less space.

“In the olden days, they were huge machines,” says Morten Dyrner, “and the most expensive thing in a laboratory is often desk space – there is never enough of that,” he concludes.

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LIFE SCIENCE AND ME

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Call in the Expertise The field of quality and Helle Nygård’s career have developed together, and she has worked with all aspects of QA from the field’s beginning.

Today, Helle is employed in the consultant firm AlfaNordic and is assigned tasks where her particular knowledge is needed.

Helle Nygård, 52 Consultant for Medical Devices AlfaNordic Employed since December 2014 Qualified pharmacist and chemical process engineer

By Nanna Bisbjerg How did you get your current job?

I was headhunted for the position through my LinkedIn profile. I was invited for an interview and was on-board straight away, since I saw the possibility to use my strengths.

I have been in many different companies, and so I have a great deal of experience. Also, I believe it was important that I am able to fit in and work well with lots of people.

What does your work entail?

I am a consultant for medical devices and in particular work with quality and documentation.

As a consultant, I am sent to pharmaceutical companies or to firms who produce everything from urine bags to pacemakers.

Typically, I am called in when a new product’s quality has to be documented, or in order to maintain quality or carry out validation and documentation.

As a consultant, I can be sent out for anything from a single day to

two years. I am currently with Novo Nordisk, where I will work for about two years. They are in the process of starting a new packaging line.

I am responsible for making sure the documentation that will accompany the packaging line is appropriate and meets the applicable quality requirements.

How has your career been?

I have twenty year’s experience from the pharmaceutical and medical device industries and have been employed in ten different companies. I have worked with all aspects of QA and QA-related issues. It is slightly by chance that my career ended up being the field of quality, however I have been present for the whole development process that has happened in the field. Nearly the entire field of quality has been established during my career – in this way, I have always been there with the development.

Translation: David Allington What has been the greatest challenge in your career?

Occasionally, one of course works under great time pressure, when it is important that one finishes on time. That can be a challenge.

Otherwise, it is when one becomes stuck and cannot immediately work out what the problem is. Several years ago, I was at a company where the machines began discarding one carton after the other. We couldn’t find any mistakes on the cartons, but they continued to be discarded.

So it was necessary for us to manually sort and approve them, while we searched for the error. We went through everything.

There was no weight difference, and we also looked at the cartons under the microscope. Finally, we contacted the subcontractor and asked whether anything at all had been changed in the production of the cartons. It turned out that a new type of lacquer was being used, amongst other things, on the area

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LIFE SCIENCE AND ME

where the batch number and expiry date should be printed.

That was enough. And it took us almost two weeks to solve it. It was necessary for us to go back to the old lacquer and then it worked again.

What is the best thing about your job?

things through as a consultant, since you are employed on the basis of your specific knowledge and are seen as a qualified resource. You do not need to first build up acceptance

“I have also had the possibility to travel. Amongst other places, I was in California to audit four suppliers”

The versatility and that I deal with the areas that I am best at.

As a consultant, I am sent out and work with the areas where I am strongest and am able to use my experiences and strengths.

It is also a little easier to get

and knowledge every time you come to a new place, as you otherwise often would do when starting a new job.

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I have also had the possibility to travel. Amongst other places, I was in California to audit four suppliers. It was exciting to experience the differences in work culture between Denmark and California, but also just from the north of the state to the south.

In particular, there was a difference in how I was received when I came to audit. In some places the attitude was very much ‘We know best and you cannot ask about anything.’ In other places they were much more welcoming.

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Anvendes i følgende brancher: Hospitals- og laboratorieudstyr, tandlæge- og optikerudstyr, museer, universiteter og laboratorier, apoteksinventar, elektronik, emballage og meget andet.

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FACTS ABOUT KELLY SERVICES

FACTS • Farhan Haqui is a consultant in engineering and IT at Kelly Services and has been a part of finding and employing Helle Nygård at AlfaNordic.

“In particular, Helle’s experience with GMP combined with her QA competencies meant that it was a good match in relation to AlfaNordic. In addition, Helle has just the right personal qualities, since her job requires a lot of independence, thoroughness and overview,” says Farhan.

According to Farhan, the sciences typically demand QA/QC, project leaders, process engineers and medical advisors.

At the moment, Kelly Services is experiencing particular demand for QA’s, process chemists, project leaders, and validation specialists.

Cloud based chemical inventory and compound management.

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• Arranging personnel for permanent and temporary positions at all levels from laboratory assistant in R & D to validation specialists and leaders.

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LIFE SCIENCE AND ME

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QA’er to the Core Karen-Marie Dahlmoes has never said ‘no’ to a challenge.

She has worked in both Hungary and Holland, and has been part of starting up a daughter company from the bare concrete walls.

She has now come ‘home’ to the field of quality in a position as Corporate Quality Manager.

By Nanna Bisbjerg Translation: David Allington Karen-Marie Dahlmoes, 52 Corporate Quality Manager SP Medical Employed since March 2015 Trained laboratory technician

What does your work entail?

We produce medical devices, both to order and for our own production. Our own production is guidewires, e.g. for heart and keyhole surgery. My main function is personal leadership for QA, QC and RA areas in our Danish and Polish departments as well as advising customers on quality assurance.

How has your career developed?

I am a trained laboratory technician and have worked in the colour and lacquer industry. Since the challenges became to easy, I sent my information to Temp Team, and a week later I was called for an interview.

I was actually about to go on holiday, but I cancelled it.

maintain their receptur, but my work fell under the area of quality, and at the morning meetings we discussed the law and problems of production and release.

Here, I chirped up and it turned out that I had a good understanding of how we could interpret and solve problems. Therefore, I was employed as a QA assistant.

At one point, I decided to pursue a completely different life’s dream, and opened up a riding centre. It was 10 good but hard years before I returned as a QA coordinator at Abacus Medicine.

After three months, I became the head of QA and QC, and from there it went fast.

When the company was starting a daughter company in Hungary, I was project leader and was responsible

“The most fantastic thing has been to be part of establishing the Hungarian site, and it has also been the most challenging.”

The best part is working with the law. I think it is really exciting to interpret what the requirements are that we have to live up to, and to investigate whether we are living up to them and what is needed so that we do.

I got a job at Dako, and it was here that I began working in the field of quality. In reality, I was employed to

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LIFE SCIENCE AND ME

for everything regarding the start up and transfer. When we opened a department in Holland I was again the project leader.

Afterwards, I was Global Manager for all three sites. It was full steam ahead and it was fantastic. But one also gets carried away, and in order to force myself to wind down, in 2014 I said ‘yes’ to a position as production manager in Denmark.

From here I came to SP Medical where I am now. I am really a QA’er to the core, so it has been like returning home, to go back to the QA area.

What is the most exciting thing you have experienced in your career?

The most fantastic thing has been to be part of establishing the

Hungarian site, and it has also been the most challenging.

We had to start from the very bottom, finding an empty factory, getting it renovated, and being responsible for the whole large building project. We signed contracts with the locations in December and had the inspection in the middle of February. There was nothing, just two huge spaces with bare concrete floors.

Nobody believed that it could be done, but we set everyone in motion and worked from early morning until late in the day. I did everything – I was down in the basement and marking with tape where the machines should stand, and got the food and put tables

together. It was a fantastic feeling of teamwork. And we were finished by the day of the inspection!

Which abilities and competencies do you use in your job today?

It is unusual to have a laboratory technician in this particular function, so much of it has come from drive and personality. I had leadership abilities that I didn’t suspect I had. And I also had a fantastic boss at Abacus, who could see the possibilities in me.

He made all the difference. I have said ‘yes’ to all the challenges, I was offered. And now I’m sitting here.

For a little laboratory technician from dark Northern Jutland, it’s not so bad.

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High Quality Passion within the Life Science Industry For Danish-based life science consulting company, AlfaNordic, staying updated and one step ahead of developments in the life science sector is their passion.

The company, while going through rapid development and growing an impressive 70% in 2014, has established itself as a high quality consultancy through working with production support, QA, QC, project management, management consulting, validation, audits and IT/ automation.

Business Development Director Preben Lind Hansen explains the success: “Keeping up to date with current

FACTS ABOUT ALFANORDIC A/S Founded in 2008, the consulting company today has 46 dedicated and highly experienced consultants, with core services focused on: • Production support • QA/QC • Medical devices • Validation • Project management • Management consulting • Strategic compliance & risk management • IT / automation • Auditing For more info: www.alfanordic.com

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GMP in the Life Science sector has always been essential.

GMP, regulations and other areas are constantly changing and the ability to react quickly to changes is of prime importance for success in the industry. At AlfaNordic, we follow developments closely, our consultants have both extensive hands-on experience, a great overview, and know where the sector is heading.

AlfaNordic moves mountains for its clients, in the sense that we help and act as the extra pair of experienced hands the client needs. We consult regarding product recalls as well as quality risk management. We perform validations from analytical methods to validation of process equipment. Our experience ranges from audits of project management to QA and QP services. We help our clients establish batch documentation, write nonconformities and change requests – to approving and releasing APIs or finished pharmaceutical products”.

Throughout all lines of work, dedication is a core value at AlfaNordic. “All of us have a true passion for life science,” says Preben. “In the end, life science is about people and their well-being, and therefore dedication to ensuring quality is crucial. Quality is of key importance for us, it is in everything we do from auditing to validation, from management consulting to project management”.

AlfaNordic Excellence in GMP

FACTS • Margit Kjær, senior consultant at the recruitment agency TEMP-TEAM, has been a part of finding and employing Karen-Marie Dahlmoes at SP Medical.

“I’m currently experiencing a great demand for people to QC, both laboratory technicians and academics,” says Margit and continues: “Greater and greater quality requirements are being set all the time in this branch, and therefore it is in particular people who already have experience from QC and QA who are in demand. As well as the right professional qualifications, we are looking for people with good drive. They have to be proactive and adaptable – if they are not, then they will have difficulty in working in this branch, where development and changes are occurring constantly.

And therefore a personality that makes a good match with the company is crucial. For Karen-Marie’s position we actually had several good candidates with the right professional qualifications, but KarenMarie just fitted really well into the company’s culture – it was this that decided it.”

FACTS ABOUT TEMP-TEAM • Handles recruiting, outplacement, executive search and international recruiting.

• Has a specialised team to handle recruitment for clients in life science, and recruits at all levels for both temporary and permanent positions.

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LEGAL UPDATE

When is It Health Data and When is It Not?

Data about a person’s health is a special category of data which requires a higher level of data protection than many developers of health-related apps and devices are aware of. Moreover, it is not always obvious when data becomes health data. We share the highlights from a new guidance from the Working Party on the subject.

By Thomas Bjørn and David Hobson

O

ver the past years, we have seen a rapid growth in the market for health and fitness-related apps and devices, covering a large variety of fields of use, with recent examples ranging from general warning systems tracing the development of infectious diseases and platforms for app developers like Apple HealthKit over downloadable mobile apps to medical devices for professional use.

The common feature shared by most of these developments is the collection of data which regularly includes personal data.

Data protection has become an issue of increasing importance in the digital era. If the personal data collected by apps and devices are classified as health data, then they have to be appropriately protected and can only be processed if the data subject “unambiguously” gives his consent which must be clear, knowingly given and limited to a specific purpose.

But when is it health data ?

For developers and users of the rapidly increasing number of health-related apps, this is a very important question and an issue on which legal certainty is required. At the request of the Europe-

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an Commission, the Working Party has therefore recently published guidance regarding the use of health data which provides some warnings but also useful advice to developers and operators of apps and devices.

3 Types of Health Data Article 8 of the Data Protection Directive (95/46/EC) classifies health data as a special category of data which requires a higher level of data protection. The processing of such data is generally prohibited, unless an exception applies such as the express

consent of the data subject.

The Directive, however, does not offer a definition of “health data” – it merely lists the term together with other “special categories”, so up to now it has been unclear what the term actually means.

As a result, the numerous providers of health and wellbeing apps and devices may have been at risk of processing data in breach of the Directive and its implementation into national law. It is therefore helpful that the Working Party has now offered some guidance as to the kind

ABOUT THE AUTHORS THOMAS BJØRN works as a solicitor with Royds LLP in London. 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.

DAVID HOBSON is a part-qualified patent attorney at Mathys & Squire, which is one of Europe’s most established and renowned specialist IP firms, with specialist attorneys in a wide range of technical fields including biotechnology, phamacology, eletronics, engineering and more. David Hobson has experence of drafting and prosecuting UK, European and foreign patent applications for

at wide range of technologies pertaining to the field of biotechnology.

of data covered by the term.

The guidance makes it clear that health data can be classified into three categories: • Data that are inherently/clearly medical data; • Data that are raw sensor data that can be used alone or in combination with other data to draw a conclusion about the actual health status or health risk for a person; and • Conclusions – whether accurate or not – about a person’s health status or health risk.

The term includes the obvious health data, i.e. data about the physical or mental health status of an individual, their medical history, diagnosis and treatment, together with any data gen-

erated by apps or devices which are used in this context. However, at its broadest interpretation the guidance concludes that health data can be seen to be any data about an individual that can be associated with a condition or allow some kind of diagnosis or inference about health status.

For example, data encompassed by this definition could include (amongst others) information about a person’s drinking or smoking habits, membership of patient support groups or use of corrective glasses .

Clearly, this has important ramifications for health and wellbeing application developers who must strive to ensure that such data is protected in accordance with the relevant EU directives and national law.

At the other end of the spectrum, the Working Party recognises that there are categories of data generated by apps and devices which must be classified as raw, low privacy impact personal data.

As an example, the guidance mentions an app counting the number of steps during a single walk or making a single registration of a person’s weight, blood pressure or pulse. As no interpretation of the health status of the data subject can be made from such data, they cannot be classified as health data. It is, however, important to note that such low-impact information can very easily change into health data. If distance walked, weight and pulse are measured over time and/or used in combination with other information including diet, age, sex or even location data, it will be

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The firm has a highly specialised department with many years of experience, including in-house experience in life sciences.

For the team, a deep knowledge of the industry and its needs and challenges is the key to a successful partnership with life science players.

“We have to be able to understand the context of the client’s problems,” says associate partner Sune Nyland. Equity partner Niels Walther-Rasmussen adds: “It’s not enough to know the law. It is also essential to have insight into the industry in order to understand which challenges they face and to be able to advise them in a precise and relevant way. They live in a universe that is incredibly complicated legally. They have to meet complicated regulatory requirements, and at the same time provide capital for

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Mazanti-Andersen Korsø Jensen Law Partners Advises on all relevant matters of life science and medico.

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large research costs and make sure to protect intellectual property rights. They are highly specialised people in these companies, but they are not lawyers. Therefore, the industry needs specialist advice and a trusted advisor. We combine thorough legal knowledge with hands-on experience of the industry and a business-oriented approach. To have an experienced legal partner with a thorough knowledge of the industry, our clients are much better positioned in relation to ensuring their place in the market,” concludes Niels Walther-Rasmussen.

Mazanti-Andersen Korsø Jensen helps many large companies, but also start-up companies.

“We are there right from the conception of a bright idea, until the invention is protected and the company can go public,” says Niels.

Most recently, Mazanti helped the company Ascendis Pharma to go public on the NASDAQ in New York.

“It is incredibly satisfying when it is a company you have followed from the very beginning,” concludes Sune Nyland.

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LEGAL UPDATE

possible to draw conclusions about the health status of the data subject. If such conclusions can be drawn, the data will – regardless of whether the conclusions are correct or not – be regarded as health data and will be subject to the general prohibition in Article 8 of the Directive. The guidance recognises that for the functioning of some health apps it will not always be necessary to transfer the data off the device.

If the data processing takes place on the device itself and no personal data are transmitted outside the device, the processing will be covered by Article 3 (2) of the Directive and will therefore be exempt from the legislation.

If It is Health Data You Need Explicit Consent

If the operator of the app or device (the data processor) collects data which amount to health data as defined above, he can only do so by relying on one of the exemptions in Article 8. In relation to the processing of health data from apps and devices, the relevant exemption is

consent. Article 7 (a) requires that the data subject “unambiguously” gives his consent which must be clear, knowingly given and limited to a specific purpose. This is highly burdensome, both for the data processor and for the data subject.

The guidance provided by the Working Party is much needed given the growth in popularity of health and wellbeing apps, devices and wearable technology, with an expectation

of further growth in the coming years. The guidance also reveals new challenges for health and wellbeing application developers who must ensure the appropriate protection, responsible processing and storage of health data belonging to data subjects. The question is whether or not such requirements are realistic in the digital era – but that is another discussion. The Article 29 Working Party is composed of representatives from the data protection authorities of the EU member states and acts as an independent European advisory body on data protection and privacy.

Although not legally binding, the opinions of the Working Party are regularly referred to in legal decisions in the member states.

It’s not the formula of the tablet alone that does the job.

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Facts • Simplification of Publishing Fees and Easier Validation of European Patents from 1 April 2015 • On 24 March 2015, the Danish Parliament passed legislation that, amongst other things, means administrative simplifications for users of the patent • system. The changes concern the rules in patent law regarding the validation of European patents in Denmark and the fees for the publishing of patent specifications.

VALIDATION OF EUROPEAN PATENTS IN DENMARK • The requirements for validation of European patents in Denmark will be eased in cases where

the European patents are announced in English.

Today, patent holders must submit both descriptions with any drawings etc. from the European patent specification and a translation of the patent requirements in Danish by the validation deadline of 3 months.

From now on, patent holders are only required to submit a translation of the patent specifications in Danish by the validation deadline. The change in the law occurred following a wish from users of the patent system. In the future, we will therefore make sure that the English description with any drawings etc. is obtained from the European Patent Office.

• For more information see: http://www.dkpto.dk/ om-os/presse-og-nyheder/nyhedsbreve-fra-patent-og-varemaerkestyrelsen/nyhedsbrev/nyhedsbrev--marts-2015.aspx

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CALENDAR

and processes, and to supply participants with tools to stimulate new ideas of development and improvement of powder products and processes. Valley Alliance. The event

SEPTEMBER Nordic Life Science Days 2015 09 September, 2015 / 9 September 2015 (All day) to 10 September 2015 (All day) / Stockholm, Sweden Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry, bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends.

Powder Technology in Pharma, Food, Chemistry and Metallurgy 09 September, 2015 / 08:15 - 17:00 / Lund, Sweden Lund University offers a course in Powder Technology in Pharma, Food, Chemistry and Metallurgy with the purpose of providing a better understanding of powder products

provides a unique and effective opportunity to grow your Japanese network and develop new partnerships in the world’s second-largest life science market.

LabDays The event takes place at the Scandinavian Congress Center in Aarhus from 23 - 24 September 2015 In consultation with danish lab. association we launched this new trade fair for Laboratory Technology in Aarhus, Denmarks 2. biggest city located in Jutland. Our focus is to bring together a range of exhibition events/meetings (Annual and thematic meetings organized to different professional Associations), and partly to make a trade show for professionals in Western Denmark.

The Lab Days event will be held in the uneven years; and our other fair, CPH LabMed, will be held in the even years in Copenhagen.

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

The modular water treatment unit from ELGA enables you to choose the water system that matches exactly the requirements of your laboratory - we offer a customised solution.

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We offer fiber optics spectrometers, which combine unique features: excellent absolute accuracy of a multi-wavelength meter, ultra-high resolution of a laser spectrum analyzer and access to unprecedented high measurement rate.

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World Courier Biomedical Seminar 2015 17 – 18 September, 2015, The Palladium, Cologne, Germany The World Courier Biomedical Seminar is the global conference where pharmaceutical, research and regulatory leaders receive insight on the dynamic industry — and the impact on global specialty transport. You’ll collaborate with industry thought leaders to surface new and innovative ways to solve business challenges.

You’ll capture industry knowledge from the most trusted sources for insights and best practices throughout the product journey — knowledge you can use to make better business decisions. You’ll connect with peers and explore new ways to move medicine forward.

Nordic REACH Conference.

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The aim of the conference is to provide support to the Eu-

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Authorisations are gaining speed and the list of substances for authorisation is growing. Consequently, a broader range of industries will need strategies and tools for decision making.

OCTOBER IHW Conference 15 October, 2015 / 08:00 - 16:00 / Algrave, Portugal IHW is the first and only International Conference 2015 in Europe about Healthcare and wellbeing connected to most active complmentary sectors: Tourism, ICT, Corporate Finance and Real Estate.

Suppliers Berendsen Cleanroom offers a wide range of service solutions for cleanroom with clothing and accessories for all types of production.

GMP compliance and ISO certifications ensure documentation of behavior and quality to our customers. for more information: www.berendsen.dk/

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LBKPATENT is focusing on providing IP, in particular, Patent consulting to Pharmaceutical companies, Biotechnology companies having focus within the therapeutic area as well as start-up companies having focus within thetherapeutic area. LBKPATENT is also able to provide patent consulting withinthe broader life science area and the chemistry area, as well as mechanical area.

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