Cls #3 2015

# 3 SEPTEMBER/OCTOBER 2015

Meet Copenhagen Life Science at LabDays September 23th - 24th

INTERVIEW:

Søren Bregenholt Leading the way forward Theme: Supply Chain What does a modern day supply chain look like?

Legal Update How to comply with the new regulations

# 3 – 2015

Contents The column

Publisher :

Frydendalsvej 3 DK-1809 Frederiksberg C Denmark +45 3326 9520 www.raskmedia.com rask@raskmedia.com Editor in Chief: Malene Aadal Bo Editors; Carsten Elgstrøm, Karina Kvisgaard and Fredrik Hedlund Translation and proof reading: David Allington Ad sales: NEM Media Krondalvej 7, DK-2610 Rødovre Phone: +45 23 23 80 82 nem@nemmedia.dk Cover Photo: Jeppe Carlsen Print: PE Offset A/S ISSN: 1904-4755 In cooperation with :

Update

The picture

Interview: Søren Bregenholt

www.cphlabmed.dk

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After a turbulent time, the organisation for life science in the Øresund region, Medicon Valley Alliance, put a new man at the helm.

Theme: Supply Chain

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- Advicing ���������������������������������������������������������������������������������������������������������������������������������������������������������������������� 20 - Finishing and filling ������������������������������������������������������������������������������������������������������������������������������������� 22 - Packing ���������������������������������������������������������������������������������������������������������������������������������������������������������������������� 26 - Distribution ���������������������������������������������������������������������������������������������������������������������������������������������������������� 30

Careers

34

The win-win of interns in the laboratory industry.

Legal Update

38

How to comply with the new regulation on the use of genetic resources

42

Selected Life Science meetings and seminars

A list of suppliers

www.dadif.dk

10

A dog in carge of medicine distribution

Suppliers

www.health-rehab.dk

6

Business, science and technology news flashes

Calendar www.cphlabmed.dk

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Fredrik Hedlund: Sex, Women, and Drugs

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ADVERT

From the Crossroads of Research and Business Unconventional consultancy and product development services built on research-based advice strengthen the competitiveness in Danish life science companies by creating innovative and forward-looking solutions.

The consultancy IPU positions itself between research and industry, and advises the life science industry drawing on their close collaboration with one of the world’s best tech­ nical universities DTU. “We do not provide standard solutions to standard problems,” CEO Hans Enggrob says and elaborates, ”We stand out by drawing on such a large pool of resources and experts. We are way ahead of the typi­ cal consultancy company regarding the use and implementation of the newest products, technologies and research results. We know where to find the right specialist, and we can set up and manage efficient teams with an expertise second to none.”

At IPU innovation is systematized and new knowledge made applicable and put to use to solve the industry’s most compli­ cated problems or to develop new ground-breaking products.

“The companies recognize us as the troubleshooters they can call to solve tough challenges,” Hans says, and Head of Section Mogens Arentoft adds, “For the companies we are the means to reach a higher level of innovation and to secure that their products represent the state-of-the-art technology and will stand out on the market.”

Polymer, hygiene and floor solutions are requested consulting areas “An area where we experience a massive demand for new solutions is polymer technologies and the use of induction heating in connection with injection molding.” Mogens tells and continues:

FACTS ABOUT

IPU

Founded 1956. Offers research-based consultancy within the life science, food and energy industries.

Key competences: • Hygienic design • Flooring solutions • Polymer technologies • Damage inspection • Product development For more info: www.ipu.dk

“By using induction heat­ ing the polymer flows better into the mold, securing more ac­ curate copies, which is especially important when microstructure surfaces are wanted.

Injection heating enables increased quality and at the same time lower energy and less residual stresses and the oppor­ tunity to speed up the production time due to faster heating and cooling time compared to other heating methods.”

This is a great advance for e.g. the medico industry, which produces very small and detailed devices using both microstructure surfaces, micro technology and mechatronic features. IPU advises on all stages from product design to process technology.

Hygiene is another area where consultancy is in high demand.

“Within hygienic design, we advise on production equip­ ment ensuring that the hygienic qualities are first class. In collaboration with DTU we also offer testing and validation in accordance with EHEDG guidelines.”

Life science companies often require clean room production, and here flooring solutions are a frequently overlooked factor.

“Failures such as cracks, delamination and decomposition can be sources of contamination and lead to production close-down”, Hans tells. “At IPU we have leading experts at hand and offer independent consultancy on flooring solu­ tion, damage control and root cause analysis.”

Eco-innovation and sustainable design are the future When asked where the future’s demands for consultancy lie, Hans and Mogens both answer “Eco-design.”

“We approach projects from a business-oriented angle, but because we are cutting-edge regarding implementation of new knowledge and technologies we also have the possibility to generate new visions with our clients. This especially ap­ plies to sustainable design” Hans says and concludes: “There is an element of creating a better world in play here that is very stimulating, and combined with our access to knowledge and technology we can create high-class in­ novative and competitive products that are also eco-friendly.

Some of the products we are involved in developing are really second to none on these parameters.”

The column

Sex, Women and Drugs

By Fredrik Hedlund

Try, try and try again When flibanserin was approved in August this year, it was the third time that the substance was up before the FDA for the same condition. The first time, in 2009, it was Boehringer-Ingelheim who was behind it. But they could not show any significant effect, on the primary endpoint sexual desire. The FDA said no.

The substance was sold to a small, start-up company called Sprout Pharmaceuticals. They tried again in 2013, with a new study in which they managed to show a significant effect. But it wasn’t big. Over a six month period, the women who received daily treatment were successful in experiencing on average a total of three satisfying sexual experiences more than those who received the placebo.

But the study also showed side effects such as dizziness, nausea, hypotension, fainting and fatigue, as well as an increased risk of these side

4

effects when the agent was combined with alcohol or certain medicines, such as birth control pills. Therefore, the FDA said no again.

FDA accused of being sexist At this point, the company Sprout started the campaign ‘Even the Score’ where, together with a number of women’s organizations, they accused the FDA of being sexist. The campaign encouraged Americans to write to their members of Congress to tackle the problem of inequality and thus put pressure on the FDA. With absolutely no new data on its efficacy and a safety study on alcohol made with 23 men (!) and only 2 women, the FDA finally approved the drug.

But at the same time, the new data shows that the whole diagnosis of HSDD was established by a number of pharmaceutical companies who developed drugs for it in the early 2000s.

There is no scientifically established norm for sexual activity, feelings or desire, making it difficult to define what is abnormal.

A reasonable definition would be women that feel that they suffer from a decreased sexual desire, but the companies stressed that women themselves often don’t know that they are suffering from the condition, that even women interested in sex, but not with their current partner, and women who are satisfied with their sex lives, but where their husbands are not, can also be included in the diagnosis.

In the end, the American Psychiatric Association have reacted and in the most recent diagnostic manual, DSM-5, the diagnosis HSDD no longer exists and has been made

Photo: PR

H

ow often should a woman feel the desire to have sex? It might sound like a strange question, but it is actually a legitimate one to ask.

In mid-August, the US FDA approved the drug Addyi with the active ingredient flibanserin for treating Hypoactive Sexual Desire Disorder, HSDD, in premenopausal women. In the press, it has been described as a female Viagra and approval has obviously meant a lot of attention, both in the US and here.

But when the details behind the FDA’s approval appeared, I wondered if the American authorities had been the victim of a coup?

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.

into a diagnosis of sexual interest/ arousal disorder that defines much more strictly those who really have long-term problems with low libido.

But all this applies to the US, so why worry? Two days after the approval, Sprout was purchased by the Canadian company Valeant for a billion dollars in cash, and it is only a matter of time before there is an application with the EMA in London.

I’m all for female sexuality and think that women should have sex, lots of sex if they want. I also understand that there are women who are experiencing problems with low libido who feel that they need help.

But I still hope that the EMA is able to withstand a possible sexist debate here in Europe if better data isn’t presented for this treatment.

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UPDATE - BUSINESS

Update

Business By medwatch.dk

FDA Warning to Leo Pharma

Photo: Scanstock

Shingles, allergic reactions, swelling around the eyes. These are the side effects reported about the use of Leo Pharma’s psoriasis gel Picato, which has led the FDA to issue a warning. The FDA writes that it “is warning about reports of severe

allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). […] As a result, FDA is requiring changes to the label to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product.”

At Leo Pharma the case is being taken seriously, but at the same time notes that there is talk of patients who have not used the product as prescribed.

Danish Medicines Authority to be Re-Established As part of wider organisational changes in the Ministry of Health, the Danish Medicines Authority is being re-established and, according to Health Minister Sophie Løhde, this is due to listening to the pharmaceutical industry.

“We want an agency that can play a more active role in Europe and attract and keep skilled employees, and that can both check the pharmaceutical companies and give them competent professional advice. Because that is what is needed so that Denmark, can be at the very forefront,” says Health Minister Sophie Løhde.

Danish Parallel Importers Merge to Create Billion Kroner Business Danish EuropharmaDK has bought two parallel import companies.

Together they will create a billion kroner turnover by 2017 at the latest.

The headquarters for the new, potentially billion kroner enterprise will be located in Esbjerg.

“We have to move up to a higher gear if we are going to be an attractive partner, both for suppliers and customers. So it made a lot of sense to join things together, and we’ll get a lot of synergies because the match is as perfect as it is,” explains Administrative Director for EuropharmaDK, Torben H. Pedersen. The goal of the purchase is a turnover of 1 billion DKK in 2017.

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Coloplast Maintains Top Spot For the fourth year in a row, Coloplast takes first place in a global reputation study of 28 medical companies. Research organisation PatientView surveyed 463 patient organisations in 58 countries on their views of the chosen medical companies.

Coloplast won, ahead of competitors Roche Lifesciences, Medtronic, and St. Jude Medical. The recognition gives great satisfaction to Coloplast, who can see confirmation that their focus on customers is paying off. Coloplast won four of the six categories, which led to the overall first place.

Danish Regional Authorities Gather Tenders on New Website Regionsudbud.dk is the name of the Danish Regional Authorities’ brand new website that will gather all the information about the regions’ tenders.

The website will create openness for partners, suppliers, and others who are interested in finding all the necessary information about future, current, and already completed tenders. The website gathers information about the regions’ joint purchases, in order to strengthen cooperation regarding joint tenders across the regions.

Users Are Nervous about Mobile Technology Even though the latest, smart, mobile health tools are gaining ground, users are still in doubt about the security of their personal data.

In the USA, 35% of American users fear that their personal information will not remain confidential if they are typed in online, a new study from Parks Associates shows. This scepticism of the technology can put a stop to both innovation and use if it is not addressed, believes Harry Wang of Parks Associates.

Lundbeck to Lay Off 1,000 in Massive Restructuring Round Lundbeck’s new CEO, Kåre Schultz, has already left his mark on the Danish drug group by announcing a massive restructuring round that should reduce costs by 3 billion DKK in a few years, but will also lead to 1,000 lay-offs – 300 of them in Denmark.

Lundbeck will restructure its headquarter functions and

Novo Director After Phase 3 Study: We Are Disappointed On the basis of data from a phase 3 study, Novo Nordisk will not be sending a registration application for Victoza for the treatment of type 1 diabetes.

“The studies show that liraglutid, given as a supplementary treatment to insulin, fulfilled the primary goal of improving blood sugar regulation for people with type 1 diabetes, but unfortunately without the advantage in relation to hypoglycaemia,” explains Mads Krogsgaard Thomsen, Executive Vice President for Research and Development.

Liraglutid is a human analogy of the naturally occurring hormone glucagon-like peptide-1 (GLP-1). The drug is approved for the treatment of type 2 diabetes under the name Victoza.

commercial operations in Europe and other markets. In connection with the restructuring program, provisions and write-downs at the level of 1.7 billion DKK will be made in the third quarter 2015.

The restructuring efforts also mean the company has scrutinized its expenses for research and development.

This page was compiled in collaboration with Medwatch.

Read more news at www.medwatch.dk

The Danes Welcome Robots with Open Arms The robots are coming! And they are more than welcome. At least, a new study shows that a total of 84% of Danes generally have a positive view of robots.

Denmark is, together with Sweden, the country in Europe most open to the technologies. The results make Denmark an attractive place to test and introduce new welfare technology.

“There is no doubt that, in the future, foreign companies will use Denmark as a living laboratory for the testing of new technologies,” says Henning Langberg, who researches the development of welfare technologies at the University of Copenhagen.

Acarix Gets Approval in Europe It is with great satisfaction that Stig Visti Andersen, Administrative Director for the Danish medical company Acarix, can announce that the company has received European approval of its CADScor system.

CADScor is a minicomputer unit that is combined with a special heart plaster. Via sound measurements and algorithms, the CADScor system makes it possible for earlier diagnoses and saves patients from having to undergo expensive and invasive examinations. Stig Visti Andersen expects that Acarix will be ready to launch the CADScor system in the end of the first quarter of 2016.

Million DKK to Blood Test Technology The Nordic medical company OBI Medical has received 2.1 million DKK from the Market Development Fund.

This is happening in connection with a financing round in which the fund is giving a total of 63.7 million DKK to 15 projects. OBI Medical is the only company in the life sciences who has been granted funds in this round.

“The goal is to test v-TAC – a new software solution that makes it possible to replace arterial blood tests with less complex venous blood tests combined with a blood gas analysis,” reports OBI Medical.

OBI Medical’s project with testing of v-TAC will cost up to 4.6 million DKK.

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UPDATE - SCIENCE AND TECHNOLOGY

Update

Science and technology

By Videnskab.dk

Gene Mutation Protects Diabetics Against Dangerous Eye Disease AA very particular mutation in a single gene of diabetics prevents the feared eye disease retinopathy from developing into blindness. Researchers have followed 130 people with type 1 diabetes for 16 years and have at the same time closely studied 23 genes that, from earlier research, are known to have an effect on the development of diabetes.

They discovered that none of the patients with a particular gene variation in the CTSH gene, at any time displayed symptoms of the eye disease retinopathy.

The CTSH gene, where the protective mutation is located, contains the recipe for a protein that manages cell

death and creation of blood vessels. The alleles in the CTSH gene can occur in three variants: CC, CT, and TT. Patients with the TT combination were apparently protected against blindness.

“The gene manages actual cell death in the beta cells, which are those that produce insulin in the pancreas. It also has some other functions in relation to making new blood vessels,” explains research assistant and medical student Kristian Sandahl, who is the main author of the new study.

The study is published in the scientific journal Graefe’s Archive for Clinical and Experimental Ophthalmology.

Connection between Bacteria and Arthritis

Fish Oil Stops the Development of Psychoses

Researchers from the University of Copenhagen have, together with Chinese researchers, made a discovery that could make it much easier to diagnose arthritis.

People with arthritis actually have a different composition of bacteria in the intestines and mouth than people without arthritis. Specifically, arthritis patients have a surplus of certain bacteria, while other bacteria are lacking. Therefore, the disease can be diagnosed with a simple analysis of bacteria from the mouth instead of taking blood tests and using bio-markers, as is the current practice.

The discovery is yet another proof of the great importance that the composition of bacteria in the body has for our immune system and for the development of different diseases.

Researchers cannot yet say whether the different composition of bacteria is the cause of arthritis, or whether arthritis is the cause of the different bacteria composition. The new discovery is published in the scientific journal Nature Medicine.

A twelve-week treatment with fish oil greatly reduces the risk of young people developing psychoses. This is shown in a new Australian-Austrian study that, according to the researchers behind it, can change the preventative treatment of illnesses such as schizophrenia and obsessive thoughts.

In the study, researchers followed a group of young people with a high risk of developing psychoses. Half of the group received fish oil, while the other half received a placebo.

After seven years, 40% of those in the placebo group had developed a form of psychosis, while only 10% in the fish-oil group had developed a psychotic condition.

“The preventative treatment is a ‘game changer’ which will probably benefit many young people who are disposed to developing a psychosis,” says the study’s main author, Paul Amminger, Professor at the University of Melbourne.

Omega-3 fatty acids are essential for the development and functioning of the neural network, and previous studies have shown that a shortage of omega-3 can lead to different mental disorders.

In addition, the fat has an anti-inflammatory effect on the brain and influences the level of dopamine in the regions of the brain that are relevant for schizophrenia.

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Designs to improve the world

Faeces from Planes Can Reveal the Spread of Infectious Diseases

Photo: Air France

Bacteria and infectious diseases find their way around the world in many ways, and international doctors have a difficulty finding out how and which diseases will spread. Now it will possibly become a little easier.

Danish researchers from Technical University of Denmark have, with the help of toilet waste from 18 planes that arrived at Copenhagen Airport and gene technology, been able to discover which diseases were potentially onboard. That creates new possibilities for making it easier to monitor diseases, as reported by dtu.dk.

“Our work has shown that there is a great potential to make airports places where data can quickly be collected on resistant genes and certain microorganisms,” explains Frank Møller Aarestrup, Professor at DTU National Food Institute, in a press release from DTU. For example, amongst other things, the study shows that there were several genes with resistance to antibiotics, such as tetracycline, macrolide, and beta-lactam from South Asia and North Asia in relation to the tests from North America.

The study is published in the scientific journal Scientific Reports.

Photo: INDEX

Every second year the Danish prize INDEX: Award is given to a design that makes the world better.

For this year’s competition, 1,123 design ideas from 72 countries were found. Everyone can take part in the competition, from large multinational companies to small charitable organisations to individual people – it’s just about having an idea that can make a difference.

Among this year’s finalists was Peek (Portable Eye Examination Kit) that, with a small adapter for a mobile phone camera, transforms a regular smartphone into a device that can be used for eye examinations. In the same genre, Foldscope can be found – a small, incredibly cheap microscope that you can put together yourself. It consists of paper that has to be folded in the right way and then fitted with lenses. It takes less than 10 minutes to put together and costs in the region of 5 DKK. A third design is a protective suit that is specially developed for health workers who are working with Ebola victims. It is easy to put on, made of lightweight materials, and doesn’t get too warm when wearing it.

See many more of the exciting designs and this year’s winner at: www.designtoimprovelife.dk

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

Danes Lack Gene that Prevents Alzheimer’s The occurrence of plaque around the brain cells is especially common in Alzheimer’s and dementia patients. A new study shows that a special gene variant which protects against plaque is much rarer in the native population of Denmark Denmark than in people from Sweden, Norway, Iceland, and Finland.

“We initially didn’t believe our results, but it turned out to be correct. It seems that we Danes are very different from our neighbours on this particular area, even though we are so alike in most other aspects,” says study co-author Jonas Mengel-From, Associate Professor of Molecular Epidemiology at the University of Southern Denmark.

The scientists were particularly interested in the gene variant A673, which is known to affect the amount of plaque in the brain. Only one out of 3,487 Danes had the gene variant while around 1 in 125 of the other Nordic groups had it.

Another analysis found that 1 in 500 had the gene variant.

Mengel-From says they cannot explain why the Danes are so different from their neighbours in this particular area.

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THE PICTURE

Medicine distribution a hundred years ago

By Malene Aadal Bo Photo: pbs.org

I

n 1925, a diphtheria epidemic began spreading amongst children in the town of Nome in Alaska.

The serum that could stop the epidemic was in Anchorage, around 1,600 kilometres away. The only plane nearby had a frozen motor and couldn’t start.

This was the start of what has since become known as “the serum race to Nome.” A journey with dog sleds that happened at a time when all other forms of transport had stopped due to a violent snowstorm.

A great deal of the world followed the rescue attempt and, in particular, the Norwegian Gunnar Kaasen and his sled dog Balto, who afterwards became famous for their efforts.

Kaasen didn’t consider Balto to be an especially good

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sled dog, but Balto proved his worth as he continued to follow the trail at times when Kaasen couldn’t see his own hands in front of him. In particular, when he saved his team from running straight into the ice-cold Topkok river.

The race was run in teams, but Kaasen and his group of huskies arrived too late at the meeting point with the next team and therefore they had to do the rest of the journey themselves.

On 2 February 1925, Kaasen, Balto, and the rest of his group of huskies arrived in Nome with medicine for the sick children.

Source: Wikipedia

ADVERT

First-Class Scandinavian Distributor of Diagnostic and Life Science Products A broad product range, flexibility and fast delivery combined with highly competent personnel and high QC standards have earned the company Biotech-IgG 13 years of ISO 9001 certification for outstanding customer service.

The distribution company Biotech-IgG has a strong history of providing Scandinavian life science with products for both rou­ tine and research areas. In addition to life science areas such as microbiology, nuclear compounds and proteins and pep­ tides their product range covers diagnostics and counts more than 10.000 different types of immunoassays and specialized assays for both clinical routine and research laboratories.

The broad portfolio has always been crucial, the compa­ ny’s Managing Director Dr. Kirstin Kriz says, “We work close together with the manufacturers to meet all of our custom­ ers’ needs for first class quality products and we have exclusive distribution rights on most of our products.”

Customer service is of highest priority to Biotech-IgG. The company is among the very few ISO 9001 certified distribu­ tors, meaning that they have proven to excel in customer service and satisfaction.

The high customer satisfaction Kirstin believes is owed not only to the broad product range but also to the company’s day-to-day delivery services and highly competent personnel.

“There is a high level of education among our work force, most of our sales personnel hold PhDs and have worked in research and laboratories themselves. They know the prob­ lems and they have used the instruments and kits them­ selves and can advise our customers accordingly.”

Another much-appreciated service is the company’s flexibility regarding customized packaging of radioisotopes.

Normally you have to order a specific quantity of a particular isotope, but Biotech-IgG being a long-time distributor in this

FACTS ABOUT

Biotech-IgG Group Scandinavian distributor of a broad portfolio of diagnostics and life science products.

30 years of experience and ISO 9001 and 14001 certified.

• Immunodiagnostics Kits (ELISA and RIA) and Reagents, Single-Use Rapid Tests • Molecular Diagnostics Assays and Reagents, PCR/HRM Instrumentation, Point-Of-Care Testing

Kirstin Kriz, Managing Director field can deliver customized quantities on a day-to-day ba­ sis. This secures minimum waste of valuable material, a fact that the company highly appreciates. “We strive to minimize waste on all levels, from delivering customized quantities to recycling all packaging”, Kirstin tells.

Last year the company became ISO 14001 certified prov­ ing their commitment to good environmental performance.

“It was a natural next step for us and something that we really wanted to do,” Kirstin says.

Expanding into Molecular Diagnostics Within recent years Biotech-IgG has branched out into molecu­ lar diagnostics and point-of-care testing, meeting a demand on the rise and at the same time increasing company turnover.

“We are always staying informed on new research and products and our level of expertise means that we know where to look and gives us an advantage when choosing the best for the future among new products,” Kirstin says.

And in the future, we will definitely see more molecular diagnostics, Kirstin explains. Molecular diagnostics are now being used for point-of-care testing, and the faster turnaround time from patient sampling to result has a great significance, for example patients can be isolated faster and prevent diseases from spreading.

“Fast results can be life saving,” Kirstin says, “an example is sepsis; with this condition the mortality rate is high because the sepsis quickly becomes widespread. Normally you both have to incubate the blood culture bottle and then culture the sample, but with the molecular tests you can obtain a result in a little over an hour after incubation. I am sure that in the very near future you will be able to run molecular tests directly on blood for sepsis right at the patient bedside. That will have a great impact and can mean a significant drop in the mortality rate. In the end, this is what it all comes down to, saving and improving lives,” The Managing Director sums up.

• Life Science Clinical Microbiology, Nuclear Instrumentation, Ra­ diochemicals, Antibodies & Proteins For more info: www.biotech-igg.com

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“MVA’s core task is to be a forum that gathers all the stakeholders. And MVA should be the unifying actor, who helps to give birth to the ideas that come from these collaborations.”

12

INTERVIEW

Søren Will Lead the Way Forward After a turbulent time, the organisation for life science in the Øresund region, Medicon Valley Alliance, put a new man at the helm.

Søren Bregenholt from Novo Nordisk will use the first year to lead MVA back to the starting point: being the one who gathers stakeholders and forms a strong foundation for the region’s life science.

By Malene Aadal Bo.

S

øren Bregenholt is Corporate Vice President at Novo Nordisk, and in his everyday life he heads the department for external innovation.

If you talk to Søren Bregenholt for a couple of days in a row though, you will discover that he is rarely in the same place for very long. USA and Germany one week, and touring between Novo’s Danish addresses in Bagsværd, Søborg, and Måløv the next. And then just a quick visit to Arne Jakobsen’s Allé on Amager where Medicon Valley Alliance and Søren Bregenholt’s newest chairman position is located.

With a desire to bring together the strands of life science’s expert hands, and sharpen the strategic focus, in

Photo Jeppe Carlsen

spring 2015 the board agreed to offer Søren Bregenholt the important post. The task was to put himself at the fore of a process that has to bring the alliance together after a turbulent year, and not least to ensure that efforts are turned inwards so that as many of the synergies as possible that can bring the region together are realised.

Making the environment vibrant again “At the moment, MVA is now the only organisation that actively works to gather together Danish and Swedish life science and create a network and foundation that can make the environment vibrant again. It is important work that Novo Nordisk and I personally find both relevant and

13

INTERVIEW

One of MVA’s major tasks is to support the attraction of talent to the region. Without the right workforce it is difficult to form a strong foundation for the region’s life science.

interesting,” says Søren Bregenholt. The new chairman has been with Novo Nordisk A/S since 2010 and was previously director in the biotech firm Symphogen. For more than 10 years he has worked professionally with innovation, external relationships, strategic partnerships, and building alliances between universities, biotech and the pharmaceutical industry.

And it is precisely this collaboration that will be central in the new strategy for MVA.

Talent attraction is key “MVA’s core task is to be a forum that gathers all the field’s stakeholders. Danes and Swedes have to work together, research parks and investors have to work together, hospitals, universities, and the private companies have to work together. And MVA should be the unifying actor, who helps to give birth to the ideas that come from these collaborations,” Søren Bregenholt sums up.

According to the chairman, there are especially two areas that Danish life science in particular should bet on

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in the near future and where MVA can play a role.

The first is in attracting the right workforce. According to Søren Bregenholt, it is going really well for Danish life science, that both has the industry, with Novo Nordisk, Lundbeck, Leo, Novozymes, and Chr. Hansen, and also a good biotech layer, that is in the process of getting going again. And moreover, in several areas there is a very strong university sector, with University of Copenhagen and Technical University of Denmark at the forefront.

“But across the board, Denmark has a problem with access to Danish and international talent. Already today we are lacking both good researchers and engineers in the different companies. We hear that it is difficult to get hold of doctors and other specialists, and that means that research and development projects progress more slowly than they should,” says Søren Bregenholt.

According to him, we can’t get around the fact that many of the right people in particular have to be brought to the region from abroad, because the industry’s demand for workers has exceeded supply in recent years.

One way could be to become better at holding on to the

SØREN BREGENHOLT Chairman of the Board of Medicon Valley Alliance • Søren Bregenholt is Corporate Vice President and Head of External Innovation and Stakeholder Relations at Novo Nordisk and as such is responsible for the company’s strategy and activities for securing access to external innovation through commercial licensing, university collaboration, and public private partnerships. In addition, he is responsible for Novo Nordisk’s global R&D-based PhD and Post Doc programmes, as well as research-, innovation-, and educational policy. In 2010 Søren took the seet as Vice President and Head of Corporate Alliance Management in Novo Nordisk.

• Søren Bregenholt is a Dane, born in 1971. In 1995, Søren graduated from the University of Copenhagen and received his PhD in biomedical research in 2000, also from the University of Copenhagen.

After his post-doctoral research at the Pasteur Institute in Paris, Søren joined Novo Nordisk in 2001 as a scientist and project manager.

From 2002 to 2010, Søren held a number of management positions in the Danish biotech company Symphogen, including the role as Chief Operating Officer with responsibility for the company’s research and development project portfolio.

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• He is the author and co-author of more than 50 scientific papers. He represents Novo Nordisk in various organizations, including EFPIA and PhRMA

many international students who are educated in Danish universities, but all too rarely stay here afterwards.

Another way could be to attract the unemployed workforce from Sweden, where big life science companies have shut down in the past few years, and where entrepreneurship in some areas have more difficult growth conditions.

“There are skilled people in Sweden who I believe could be enticed to come to Denmark. It will be a win for life science on both sides of the Øresund – at the moment it would provide important workers for the Danish companies, and it would also give the Swedes a workforce with industry experience, who are ready when the market improves again in Swedish life science.”

However, Søren Bregenholt doesn’t believe that it is possible to attract talent to Denmark from, for example,

For yderligere information: Intermess ApS Rådhusvej 2 _ DK-2920 Charlottenlund Tlf.: 45 50 56 55 _ Fax: 45 50 50 27 messe@intermess.dk _ www.intermess.dk

15

INTERVIEW

Boston or Japan. That was one of the ambitions of MVA’s ambassador programme, which existed for a couple of years before it was recently closed down.

“I believe we have to be a little bit more humble in the beginning and think regional. And so we shouldn’t believe that it is a task, that MVA can or should carry out alone.

There are actors out there, for example, Copenhagen Capacity, who are better equipped for working globally, and who I believe we should build the collaboration with,” he says.

The other big topic that Søren Bregenholt sees as a challenge for life science in the area, where MVA can play a role, is the relationship with financing.

MVA can work together with actors such as Greater Copenhagen and the different equity funds and growth initiatives, and be part of creating greater awareness of the good ideas and contribute to making it easier for innovators and potential investors to find each other.

Adapting MVA to the present “We can also assist in more actors being aware of the possibility, for example, that the Swedish Aktietorget provides for raising capital. More life science companies in the region with Danish-Swedish innovators have successfully made use of the possibility, and it’s probably not everyone on the Danish side who are really aware of the possibility,” he explains.

And what about MVA – how can it be measured in a year’s time whether the new strategy is a success?

“The vision that is leading my chairmanship work is about adapting MVA to the present. To avoid using resources on everything that others are doing just as well or better, but find the core and then develop it from there. And to put it briefly, the core is of course to facilitate knowledge-sharing and create a common foundation that the whole region’s life science can build on. Whether MVA becomes twice as big or three times as

big, I don’t know. I don’t even know whether that should be the intention,” says Søren Bregenholt and adds, “Now we have to prove that we can create a significant and visible value across the Øresund.”

MEDICON VALLEY ALLIANCE • Medicon Valley Alliance was founded in 1997 under the name Medicon Valley Academy. Informal discussions about creating the organization, however, had already started in 1992 when work on the bridge between Denmark and Sweden began. As the bridge became a reality, expectations about closer interaction between research and business communities grew.

• The main initiators behind Medicon Valley Academy were the universities in Lund and Copenhagen, strongly supported by the major pharmaceutical companies in the region: Novo Nordisk, Lundbeck, and Astra-Zeneca.

The idea was to create a platform where Danish and Swedish life science actors could meet.

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• Today, MVA is a non-profit membership organization in the Danish-Swedish life science cluster Medicon Valley. The 250 members, who together employ approximately 140,000 people, include universities, hospitals, human life science businesses, regional governments, and service providers.

• MVA represents the entire region’s life science community and works to create synergies through strategic initiatives and day-to-day activities. In 2015, MVA was awarded with the cluster organisation ‘Gold Label’ by The European Secretariat for Cluster Analysis (ESCA). The Acting Director of MVA is Petter Hartman.

Read more at www.mva.org

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Finding and Developing the Leaders and Specialists of Tomorrow The demand for talented managers and specialists within the life sciences is growing.

Professional assistance in staff recruitment and development is a means to future-proofing your company.

In just 10 years, the consultancy group People & Perfor­ mance has become one of Denmark’s largest recruitment companies, three times elected Gazelle Company and growing still. The consultancy group works with recruitment, leadership training, and business development.

“What characterizes us is that we know a lot about leadership in general,” says CCO and one of the Founding Partners Niels Prehn, and continues: “Talented managers and staff are behind good perfor­ mance, and therefore we believe that the recruitment and development of talented personnel is the path to success.”

Head of Recruitment Anders Jørgensen adds: “With us as a recruitment partner you get more than just recruitment. Because of our extensive knowledge about leadership, we help companies to focus on what it is they need in a leader and what type of leader is needed to execute their strategy. It’s also a discussion about how they achieve their business aims - we help companies turn their strategic goals into human resources and competences.”

People & Performance offer individually customized programmes and work with local businesses as well as internationally with large multinational companies.

“By using a professional partner, you get a larger field of applicants. Our consultants have up-to-date knowledge about the market and know where to look – many of them come from management positions in the business world.

We always put together the best team for the customer’s

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needs, make sure that the market is properly covered, and that what is right on paper is also right in practice.”

It also makes sense to spend time on getting the best applicants, because employing the wrong person can have huge consequences.

“Employing the wrong person can be an expensive mis­ take, but that’s not the worst thing,” says Niels Prehn, and explains, “It’s much more expensive to employ someone who is ‘good enough’ but not one of the best – that can mean a difference of millions in terms of growth.”

Staff Retention and Development Is as Important as Recruitment People & Performance also offer staff development and training programmes.

“It’s important to attract the right workers, but it doesn’t matter about attracting those at the top, if you’re not able to attract and retain young talent, and show that you’re an ap­ pealing place to be for many years,” says Niels, and contin­ ues, “A mistake that many companies make when in talent development is that they focus on the managers. In that way, they cannot hold onto the specialists who are actually those people in the life science branch that companies depend on. In order to hold onto talented staff, they have to feel that they can continuously develop themselves in the company.

We run talent programmes for some of the largest Danish companies, where specialists are an important part of the programme. With joint management training and personal development you create a common goal and language in the company, and therefore we educate and train lasting compe­ tences that can turn the strategy into practice.”

And the high demand for skilled managers and talented staff in the life science branch suggests that in the future it will be more and more important to spot and develop that talent.

“If you can spot the talent and their future potential, then you’ll be in a strong position, and this is where it can be a big advantage to get professional help. We don’t just find the best person for the job, we find the best person who can still develop and be even better.”

• Recruitment – Search & Selection • Leadership Training and Development • Strategy and Business Development • Sales Training, Sales Excellence and Key Account Management • Offices in Holte, Horsens, and Sønderborg For more information: www.pphr.com

17

18

Supply Chain

THEME: SUPPLY CHAIN

A hundred years ago medicine was manufactured by hand and in some places distributed by dogsledge. But what does a modern day supply chain look like?

We have taken a closer look.

19

THEME: SUPPLY CHAIN

Advise:

From Linear Supply Chain Model to PatientCentric Value Network Supply chain management is more critical than ever. However, the traditional supply chain model cannot keep up with the challenges and opportunities that the life science industry faces today. Accenture advises that it should be replaced by a demand-sensitive and patient-centric value network.

By Karina Kvisgaard

E

ffective supply chain management is crucial in order to increase forecast accuracy and customer service, reduce shortages and transportation costs, increase inventory turnover and sales revenue, and enhance working capital efficiency. Accenture is one of the management consulting companies that have made a business from helping life science companies build streamlined supply chains to increase profitability and respond to market challenges quickly.

Traditional Model Outdated Patient therapies have grown increasingly complex, involving a convergence between products and services, and between different players within the healthcare value chain. Consequently, the traditional supply chain model is outdated and should be replaced by a dynamic, patientcentric value network, Markus Hayek, Managing Director in Accenture Strategy, advises: “Today, we are seeing patient therapies requiring more than just basic medicine. Therapies that are more complex are being used to treat patients. For instance, cancer or diabetes therapies require medicine, regular hospital treatment services, medical device monitoring, etc., to improve patient wellness. Therefore, we are seeing a much wider ‘network’ of product and service providers across the industry supporting the patient ‘value chain’, i.e. the network of stakeholders involved in delivering products and services to treat a particular patient.”

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ABOUT ACCENTURE • Accenture is a global management consulting, technology services, and outsourcing company, with more than 323,000 staff, serving clients in more than 120 countries.

• Accenture’s Life Science group helps producers of pharmaceutical, biotech, and medical device products reshape their supply chains into dynamic end-to-end value chains that respond to market challenges quickly and effectively.

• Globally, Accenture has more than 10,000 life science professionals in 50 countries, more than 3,500 supply chain experts and more than 200 analytic experts.

• Accenture established a Life Science Strategy hub in the Nordic region in 2012-13, advising mid-size and large bio-pharma and med-tech companies on supply chain, R&D, and commercial functions. In recent years, • Accenture Strategy has increasingly strengthened its value added by leveraging global and local industry and functional expertise across project settings.

(Source: Accenture)

changing customer/patient demand patterns. This also includes real-time tracking of products in transit, so that companies know exactly how much of a product is located throughout the world,” he explains.

Segmentation and Flexibility

Jennifer E. Seeley, Senior Strategy Manager and Markus Hayed, Managing Director in Accenture Strategy

Intelligent Supply Chains Needed “Life science supply chains have, historically, been very ‘linear’ and have put the patient at the end of the chain, which makes it difficult for patient feedback to be considered in improving the quality of care at an earlier stage. Traditional supply chains are ‘push-based’ and they are not ‘intelligent’, meaning they do not collect data or take into consideration the differing or changing needs of the patients, such as how patients are responding to treatments, lifestyle differences, adherence to treatment schedules, etc.,” says Jennifer E. Seeley, Senior Strategy Manager in Accenture Strategy.

“This traditional, linear model of a supply chain must transform to enable a ‘value network’ - a set of chains that are patient-centric, dynamic, and responsive to market demands,” she says.

Sense Future Demands Being able to predict and respond to market demands quickly is crucial in order to compete in today’s market: “The ‘Internet of Things’ concept means that everything is connected, and data points can be collected from patients, devices, medicines, manufacturing, and supply chain processes, etc. With this information, companies are using digital capabilities to proactively model and ’predict’ what will happen next, based on historical trends. One valuable application of this is called ’demand sensing’, meaning that companies can ’sense’ what the demand for products will be in the future and, therefore, plan for this future demand with a high level of certainty,” says Markus Hayek.

“It’s important that a company can predict needs to switch production – and even have the manufacturing equipment ’sense’ when production is running lower than expected – and have the agility for changing over to meet an unexpected change in demand and avoid running out of stock. For transportation, this is used regularly to allow for more dynamic routing of products based on

“More life science companies are segmenting their supply chains to ensure they are treating customers appropriately based on differing needs, market demand volatility, etc.

And, most importantly, we are seeing a strong growth of digital capabilities - digital supply networks - and flexible, cloud-based solutions to enable rapid, scalable, and ‘intelligent’ growth to meet changing demands.

Life science companies must embed flexibility into their supply chains because of the continuous - and disruptive - changes that are happening more frequently in the life science industry. And new digital solutions enable companies to implement capabilities quickly without high fixed costs,” he adds.

HOW TO BUILD PATIENT-CENTRIC VALUE NETWORKS 1: Collect and analyse the insights and data required to understand the demand characteristics of each product and segment. It is essential to invest in the collection of critical data as well as integration with partners, suppliers, and customers in order to share plans and information that allow everyone across the end-to-end system to collaborate and plan more effectively.

2: Once you understand the demand characteristics of your product, the next step is to develop supply strategies to ensure predictable, compliant, and secure supply when and where the patients need it. Supply strategies must be evaluated in the context of demand and market trends to ensure that the right capabilities are built into the product supply network to ensure a reliable and compliant supply of materials from the manufacturing and operations process.

3: Put in place a cloud-based control tower to enable end-to-end visibility and analytics across the value network and ensure that products and services are efficiently delivered to the patient. To compete, life science companies must start moving away from their traditional IT systems and data silo integration and architecture approach to a crossenterprise, process-oriented digitized value network.

(Source: Accenture)

21

THEME: SUPPLY CHAIN

Finishing:

Helping Large and Small Players Reach the Finish Line Granulating and making tablets, filling bottles with reagent fluids and capped vials with medicines, and medical devices, etc. Filling and finishing is a crucial step in the manufacturing process, making sure the manufactured medicine or medical device is finetuned and ready for packaging.

22

23

THEME: SUPPLY CHAIN

Hans Harborg is Vice President of Production at HB Medical ApS. He and his collegues make a business from helping large and small companies with the finishing and filling of their pharmaceutical and medical device products.

By Karina Kvisgaard

H

B Medical ApS, situated in beautiful green surroundings at the science park in Hørsholm, north of Copenhagen, has made a business from helping both large and small companies with the finishing and filling of their pharmaceutical and medical device products.

“There are several reasons why pharmaceutical companies chose to outsource finishing and filling of their products to companies like us. Some of our customers are very small companies that don’t have any manufacturing facilities themselves and, therefore, outsource the different process steps to different suppliers,” says Hans Harborg, Vice President of Productions at HB Medical ApS. Manufacturing facilities for medicines must be approved according to GMP (Good Manufacturing Practices) and the relevant health authorities. For

24

Photo: Jeppe Carlsen

instance, there is a big difference between facilities for mixing powders and making tablets and facilities for filling capped vials with sterile medicines. Many small companies don’t have these facilities.

“Our manufacturing facilities are approved by the European Health Authorities through the Danish Medicines Agency. This means we are allowed to manufacture human and veterinary medicinal products both for the market and for clinical trials, and to import medicinal products from countries outside the EU. We also have a license from the Danish Veterinary and Food Administration,” he adds “Larger pharmaceutical companies, on the other hand, usually have their own manufacturing facilities, but sometimes during busy periods they have to outsource as well, in order to be able to deliver to the market,” he adds.

Specialized Flexibility To HB Medical ApS, specialization and flexibility is key.

They don’t offer any standard solutions. Every solution is developed from the ground up, and they see this as one of their strengths.

“We don’t have a big factory full of machines. Our manufacturing facility is relatively small, and that is our strength. Our machines are small and can be combined and customized according to the different tasks, which gives us and our customers a great flexibility,” he says.

“In our filling and finishing business, we are specialized in the production and filling of liquids and gels, etc. For example, we are responsible for production and filling of a solution for a product to spray in your mouth to prevent catching a cold. We also produce and fill solutions used in technical devices for different analyses. For instance, we fill bottles with reagents used in technical devices which are used for analyses, such as blood sample analyses at hospitals. This is a very complex process with strict requirements,” he says.

“We receive the reagent from our customer, fill it into the bottles and return it to the customer. The customer outsources this part of the process to us, because this filling process is very complex and requires special equipment. For instance, in some cases, it is imperative

that the reagent does not contain any metal ions at all, since that would ruin the reagent and make it unsuitable for its purpose, and therefore all the tubes, filling needles, etc. must be made of plastic and not metal. We have the right facilities and are able to adjust our equipment for this task,” he explains.

ABOUT HB MEDICAL APS • HB Medical works with all aspects related to contract manufacturing, from customized production of substances and products to the ordering and shipment process. The company offers services relating to product development and its involvement extends from advice relating to initial development, tests, and primary and secondary packaging material to shipment.

• The company is specialized in filling and packaging small and medium series and offers GMP-based contract manufacturing of medicinal products, medical devices, dietary supplements, etc.

(Source: HB Medical ApS)

THEME: SUPPLY CHAIN

Packing:

When the Medicine Is Packed For 15 years, GMPack in Hadsund has been contract packing medicines and herbal medicines for others. Now they, and all the other Scandinavian contract packers, are battling with the competition from Eastern Europe.

By Kristian Sjøgren

A

truck stops in front of loading bay number 9 in Hadsund. Large bags with millions of small orange gelatine capsules are unloaded and moved into the storage facility in the small contract packing company GMPack. The pills have to be packed in small bottles with 28 pieces in each, so that they can be sent out into the world.

Before the pills have landed at GMPack’s warehouse,

26

there are months of negotiations on quality requirements, matching of expectations, and delivery agreements between the customer and the contract packer.

A large report with every single step of the process must be approved by the Danish Health and Medicines Authority, and only after this is a commercial agreement signed between the pharmaceutical company and the packing center.

The commercial agreement includes that the contract packing center purchases the containers, labels, leaflets, bottle tops, etc., in line with the customer’s wishes and the Danish Health and Medicines Authority’s requirements.

Before the big green start button is pushed, the whole packing process is reviewed and a packing manual is worked out, which will guide the process. From the customer’s first enquiry to the first pills start to fill up the bottles in Hadsund, it can easily take up to six months of negotiations.

the branch, and it’s what we spend most of our time on,” explains Owner and Director of GMPack, Margith Adler Christensen.

At GMPack and similar companies there is a packing line for different products. It can be about a packing line for bottles, blister packs, or liquids. Each packing line is fully automated and has to be calibrated for the individual product.

Over time the packing process has increasingly been taken over by machines, electronics, and sensors, and the few hands in the packing center today ensure that the machine functions as it is meant to.

There is no room for human error in the pharmaceutical industry.

To ensure that the machine doesn’t pack 29 instead of 28 pills in 40,000 bottles, the packing process always begins with running through the different control checks in the packing process. That means that the packing center’s staff check that the control units in the machines

“There is no room for human error in the phamaceutical industry.”

Control, control, control “If you have to describe the branch of contract packing of pharmaceutical products with only a few words, it would have to be: control, control, control, and then reporting. Every single detail of the process must be reported to both the customer and the Danish Health and Medicines Authority, who check everything that we do. These are the conditions of

A

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27 27

THEME: SUPPLY CHAIN

many Scandinavian companies have closed their doors.

“We can sense that many businesses like ours are closing. This means, that we are taking over some of the closed businesses’ customers, but we also lose customers ourselves. Especially in natural medicines there has been a significant reduction in production in recent years, and we’ve been able to feel that,” says Margith Adler Christensen and explains that, today, she doesn’t have any Danish customers at all.

FACTS ABOUT GMPACK • GMPack is a small packing company located in Hadsund, between Aalborg and Randers. The packing company has been in existence since 2000 and today employs 40 staff, where 20 of them work with the company’s own cosmetic line while the other half work in the packing center.

are working correctly. The control units check that the bottles are standing the right way, that the correct number of pills are poured into the bottles, that the lids are screwed on correctly, and the labels are sitting properly.

Only once all of the control units are checked for each production is the start button pressed, and in the course of one day, a company such as GMPack produces 40,000 bottles with 28 gelatine capsules in each bottle. The customer can collect the finished, packed products at the packing company’s warehouse.

The Branch Is Threatened from the East It is clear that the branch’s conditions mean that many pharmaceutical companies have their own packing department and do not use contract packing centers to get their key products into packages and bottles.

Therefore, the typical customers for GMPack and similar companies are large or small customers with a little product that they would like to pay to not pack themselves, so that they don’t have to invest in specialised packing equipment.

In these situations they contact a contract packing center. However, competition is hard in the globalised world, and especially Poland and the Czech Republic offer contract packing of pharmaceuticals for prices where the Scandinavian companies can no longer follow.

Large Danish pharmaceutical companies have trucks running daily to and from the Czech Republic with packed and unpacked products. The large shift in contract packing to other countries has meant that

28

• GMPack has specialised in the packaging of soft gelatine capsules and also carries out repackaging, where products have to be placed into new containers. scientific papers. He represents Novo Nordisk in various organizations, including EFPIA and PhRMA.

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29

THEME: SUPPLY CHAIN

Distribution:

The Route from Pharmaceutical Producer to the Pharmacy When a drug is finally packed, it is ready to be transported out into the world. Until now, this market has been dominated of large wholesale companies, but now a new start-up company wants to pull the rug from under the feet of the established giants.

Photo: PR

30

By Kristian Sjøgren

B

efore a medicine is passed over the counter of one of the country’s pharmacies, it has been on a long journey since it left the conveyor belt of the pharmaceutical company.

In Denmark, medicines have typically been through a wholesale supplier in the beginning, and all the transportation has been in temperature-controlled trucks.

Storage and handling of the products follows strict regulations, which in many cases require specially trained staff.

The distribution of medicines in Denmark, similar to many other countries in Europe, is run by wholesale companies. Today in Denmark there are two large international wholesalers: TMJ and Nomeco.

But in a time when companies are increasingly trying to cut the middle man out, more and more

pharmaceutical companies in Denmark are looking towards countries such as Sweden, Finland, and England, where the distribution of medicines is carried out from the pharmaceutical producer directly to the pharmacy. The concept is known as Direct To Pharmacy (DTP), and in Denmark the company Pharmadirect is in the process of bringing the concept to life.

“It is very much the current trend to cut back on unnecessary links in the supply chain. In the distribution of medicines, the wholesalers are the unnecessary link.

Many pharmaceutical companies want a DTP solution, because that way they get closer to the customer by cutting the wholesaler out,” tells Sales Director at Pharmadirect, Lars Vangsgaard Pretsch, who previously worked for 12 years at the pharmaceutical wholesaler Nomeco.

31

THEME: SUPPLY CHAIN

“In the distribution of medicines, the wholesalers are the unnecesary link,” says Lars Vangsgaard Pretsch, Sales Director at Pharmadirect.

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32

• Pharmadirect is a Danish company and daughter firm of Fonden DBK. Pharmadirect was founded in 2011, with the goal of bringing Direct To Pharmacy to Denmark.

In its start-up phase, the company has spent time customizing the processes in its automated storage facility in Køge, collecting the relevant certification for handling medicines as well as developing IT-integration with the pharmacies’ product ordering system.

• Pharmadirect is in discussions with several large and small pharmaceutical companies, who would like to move from the wholesale model to a Direct To Pharmacy model. The first physical deliveries from Pharmadirect started in June this year.

• Today, the majority of pharmaceutical distribution is handled by TMJ and Nomeco.

order, the order is sent electronically to the storage facility, from where the product is dispatched. The storage facility selects and packs the order and ensures that the products are delivered, so that the customer has them the next morning. According to Lars Vangsgaard Pretsch, the big difference lies in that the wholesaler is gone, and therefore costs from a whole link are saved.

As it stands today, the pharmacies’ purchase price is fixed by the pharmaceutical companies, and a wholesale price is also fixed. The ownership of the product passes to the wholesaler, who alone can decide how the customers, for example, the pharmacies, achieve the different discounts.

With Direct To Pharmacy, pharmaceutical companies can themselves decide the conditions for customers and reward rational purchases.

To enter a so well-established market such as the distributions market for medicines is clearly a hard fight, and that can only happen by taking market share from the established companies.

Lars Vangsgaard Pretsch recognises that for Direct To Pharmacy companies it is a David versus Goliath fight, but he is also convinced that a leaner supply chain is the way forward. The branch wants it. It can

be said that simply. “The whole pharmaceutical branch is changing at the moment. The big pharmaceutical companies continue to grow – they are buying up and consolidating themselves.

Add to that, that many new medicines are coming onto the market and patents are expiring. Prices, products, and services have to be competitive across the board, and many are looking at whether the distribution is optimised,” says Lars Vangsgaard Pretsch.

While the branch is in a process of change, some things nevertheless remain the same: an order from a pharmacy pops up on the screen at a storage facility somewhere in Denmark. As long as the order is placed before 6 p.m., the products will be delivered the following morning, before the pharmacy opens. The delivery time won’t change regardless of whether the wholesaler or the pharmaceutical industry owns the storage facility.

At Pharmadirect, the medicines are picked by staff at the automated storage facility, where the packing boxes are automatically placed, so that the staff walk the least possible steps. The products are packed and, in the early hours a temperature-regulated delivery van drives through the night.

When your clinical tests require reliable delivery without breaking the chilled or frozen supply chain

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CAREERS

“The time you invest in introducing the intern to the job is repaid to you tenfold in the form of a dedicated, qualified helper in the laboratory,” says Bente Rudkjær Jensen, who is Sofie’s intern counsellor at Xellia. Photo: Xellia

Interns in the Industry A qualified and dedicated help in the laboratory, personal development, and a chance to make a difference. If you ask Bente Rudkjær Jensen from the pharmaceutical company Xellia, these are just some of the things you gain from having a laboratory technician student as an intern.

By Karina Kvisgaard

F

or the past six months, 22-year-old Sofie Merot has spent 37 hours a week working as an intern at the pharmaceutical company Xellia as part of her studies to become an academy profession graduate in chemical and biotechnical science – or a laboratory technician as it used to be called – at Metropolitan University College in Copenhagen.

Bente Rudkjær Jensen is a laboratory technician at Xellia, and she is Sofie’s intern counsellor there. She strongly recommends her colleagues in the pharmaceutical industry to employ an intern.

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The Time Invested is Repaid Tenfold “The time you invest in introducing the intern to the job is repaid to you tenfold in the form of a dedicated, qualified helper in the laboratory who works independently and helps you free time up for other tasks such as introducing new machines into the laboratory, etc.,” she says.

“For me, personally, it has also been a chance for personal development. I have worked as a laboratory technician for many years, and having an intern has been very interesting in terms of learning how to pass on my knowledge and being responsible for her achieving her learning goals. That has been very rewarding,” says Bente.

INTERN FACTS

LOOKING FOR AN INTERN?

• Laboratory technician students and biomedical laboratory science students can choose an internship at a pharmaceutical company as part of their education. Companies can send information about internship vacancies to the school for the students to apply for.

• If you would like to learn more about the opportunity to have an intern, you are welcome to contact: • Charlotte Yttesen, Intern Coordinator for laboratory technicians at Metropolitan University College in Copenhagen (telephone: +45 7248 7773 e-mail: chyt@phmetropol.dk)

• The company has to appoint a counsellor who, together with the intern, makes a plan to ensure the intern achieves his/her learning goals during the internship. The plan is approved by the school.

• Susanne Wahl, Intern Coordinator for biomedical laboratory science students at Metropolitan University College in Copenhagen (telephone: +45 7248 7634 e-mail: suwa@phmetropol.dk)

(Source: Metropolitan University College in Copenhagen)

The Dream Job Before her internship, Sofie was certain her future job would be in the biological field, and she actually thought the chemical field was a bit boring and dusty. But when she got the chance to be an intern at Xellia, she decided to give it a chance and, during her internship there, she learned how much the chemical field has to offer: “I analyse samples and test for pH, UV, etc. But I do so much more than that. I help develop medicines for serious infectious diseases. This internship has opened my eyes to how dynamic and interesting the pharmaceutical industry is, and this is really my dream job now,” she says.

Hjælp et talent godt på vej, ta’en studerende i praktik

A Match for Future Employment Sofie and Bente agree that an internship is also a great way for the student and the company to see if they are a good match for future employment.

Sofie’s internship at Xellia runs for six months more. After that she will take her final exam where Bente will be in the audience to show her support and celebrate with Sofie. And, afterwards, Sofie will be employed as a laboratory technician for maternity leave cover at Xellia.

The internship has been rewarding for both Sofie and Xellia, and the company plans to take on a laboratory technician intern again from next summer.

Dansk Laborant-Forening/HK Weidekampsgade 8 Postboks 470 0900 København C Tlf. 33 30 44 70 E-mail: dlf@hk.dk www.dl-f.dk

8

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CAREERS

What’s in It for the Company?

What Does the Company Gain?

“Having an intern is a great help, and I strongly recommend it. You get a qualified, dedicated person who, if you do your job as a counsellor right, is quickly able to work on her own with her own tasks, which frees resources for other tasks in the laboratory,” says Bente Rudkjær Jensen.

intern counsellor in your company who is responsible for the intern. In Denmark, the labour union HK offers a two-day counsellor course where you have opportunity to be inspired and learn from experienced counsellors. This is my first time as a counsellor, and I found the course very helpful,” she adds.

How Do You Prepare for an Intern?

What Should You Consider Beforehand?

“There are a lot of laboratory technician students out there looking for internships. I think we all have a responsibility to do our best to help them.

But you have to be sure you have the time to introduce the intern to the job. Otherwise you shouldn’t do it. You have a responsibility to this young person and his/her education, and you have to live up to this responsibility.

But if you have the time and energy to invest in it, your efforts will be rewarded tenfold,” she says.

“When you take on an intern, you have to appoint an

“Make sure you are prepared to welcome the intern on her first day. You should have a plan and goals for what she should do and learn week by week.

The intern and you will adjust the plan together, but you have to give it some thought beforehand. And the little things that make her feel welcome on her first day: that her work clothes and computer are ready, that you welcome her with flowers and breakfast, etc.,” she says.

Form fremtidens laboranter University College Syddanmark uddanner engagerede laboranter til fremtidens laboratorium.

Sidste led i laborantuddannelsen er et års praktik i en virksomhed. Skal det være din? Du får nye øjne på gamle vaner, og du er samtidig med til at forme og specialisere en eventuel fremtidig medarbejder.

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What’s in It for the Intern?

Why Be an Intern at a Pharmaceutical Company?

“Besides being a great chance to translate the things you have learned at school into practice, it gives you a great insight into the pharmaceutical industry. It’s fascinating to learn how much it takes to produce a medicine and to be part of this. You also learn how to cooperate closely with engineers, chemists, etc., and you get a lot of experience and responsibility,” Sofie says.

What’s Your Advice to Others?

“Be open to opportunities. And be proactive. Don’t just wait for the perfect internship to come along. Go out there and look for it. Ask in your network if anyone knows a pharmaceutical company who could use an intern and initiate contact with the different companies. And keep an open mind. Sometimes your dream job can be something you never imagined, and an internship is a great way to learn more about a field and a company,” she says.

Vi er Danmarks største udbyder af laborantuddannelsen.

Hvert år optager vi 155 studerende.

“It’s fascinating to learn how much it takes to produce a medicine and to be part of this,” says Sofie Merot.

Værd at vide! om Metropols laborantuddannelse

Vi uddanner til medicinal-, fødevare-, kemiske- og bioteknologiske virksomheder samt forskningslaboratorier.

Undervisningen veksler mellem teoretisk og praktisk tilgang til fagområderne.

Vores laborantuddannelse baserer sig på sidste nye viden udefra og viden skabt i vores De studerende er ofte eget forskningsmiljø. med til at skabe denne viden under deres studietid på Metropol.

Ca. 50% af undervisningen foregår i moderne og veludstyrede laboratorier.

Vil du vide endnu mere, så kontakt Uddannelsesleder Lise Rølmer Nielsen på Tlf.: 7248 7751 eller lsni@phmetropol.dk 37

LEGAL UPDATE

The Nagoya Protocol – A Practical Overview

The Nagoya Protocol aims to regulate the access to genetic resources and to ensure the fair and equitable sharing of benefits arising from their utilisation.

Compliance with the protocol is important, especially since some countries, including Denmark and the United Kingdom, have the power to impose fines and – in the case of wilful non-compliance – a custodial sentence.

By Thomas Bjørn and David Hobson “The Nagoya Protocol was adopted under the Convention on Biological Diversity (CBD) and the EU Nagoya Regulation (Regulation Nr. 511/2014) came into force on 12 October 2014. The enforcement regime will be fully implemented through national legislation in member states with effect from 12 October 2015”.

The protocol and the regulation makes it an offence to use traditional knowledge or conduct commercial or non-commercial research and development on non-human genetic resources or derivatives thereof if they have not been accessed in accordance with the protocol.

In other words, it will be the responsibility of any

natural or legal person (including any researcher) who uses genetic resources and the associated traditional knowledge (i.e. a user) to ensure that consent for access and terms for the sharing of arising benefits have been agreed before any research and development is carried out on such resources (e.g. microorganisms) and derivatives thereof (e.g. proteins expressed by a particular genetic resource).

Such “prior informed consent” (PIC) for access and “mutually agreed terms” (MAT) for benefits sharing must be negotiated with the relevant governmental body of a provider country, i.e. the country from which the genetic resource or derivative thereof originates.

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.

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DAVID HOBSON is a partqualified 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.

The benefits shared may be either commercial or noncommercial and can include the sharing of data or intellectual property rights.

Where it is unclear whether a genetic resource has been accessed in accordance with the protocol, research and development on the resource must cease.

How Will the Nagoya Protocol Affect Users?

How Can Researchers Comply with the Protocol?

This means that users have a duty to carry out due diligence on any genetic resources that come into their possession, to ensure that they have been accessed in accordance with the Nagoya Protocol, and genetic resources should in the future be accompanied by documentation certifying this.

For 20 years after finishing research and development on a genetic resource, the user must, in addition, keep the internationally recognised certificate of compliance (IRCC) or information/documents concerning:

Article 14 of the protocol establishes the so-called ‘Access and Benefit-Sharing Clearing House’ which serves as a platform for exchanging information related to access and benefit sharing. It serves as a key tool for compliance with the protocol by giving access to information provided by relevant parties and by issuing the internationally recognised certificate of compliance.

The clearing-house mechanism is summarised below:

• the date and place of access.

• a description of the genetic resource.

• t he direct source of the genetic resource and subsequent users.

• access and benefit sharing (ABS) agreements, access permits, mutually agreed terms including benefitsharing, and any rights or obligations related to ABS.

1. A user wishing to use a genetic resource from providercountry A contacts the clearing house for information on obtaining PIC and MAT, 2. T he user contacts the relevant government department in country A and obtains permission for either noncommercial or commercial use, 3. Country A issues a national permit to the user and a copy is sent to the clearing house, 4. T he clearing house issues an internationally recognised

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LEGAL UPDATE

The protocol and the regulation makes it an offence to use traditional knowledge or conduct commercial or noncommercial research and development on non-human genetic resources or derivatives thereof if they have not been accessed in accordance with the protocol. certificate of compliance (IRCC) which is proof that the resource has been accessed in accordance with the Nagoya Protocol. The IRCC is an important document that will need to be presented when a compliance monitoring checkpoint is triggered, to indicate that access to the genetic resource complies with the Nagoya Protocol, 5.

T he user communicates details back to the clearing house which in turn contacts provider-country A to report on the research and development progress on the genetic resources. If necessary, country A can use this as an opportunity to negotiate new terms (e.g. pertaining to a commercialisation agreement).

A Requirement for EU-Led Guidance Compliance with the Nagoya Protocol, whilst burdensome, will be possible for simple scenarios where a genetic resource exists in situ in one provider country.

More problematic are situations where the origin of a genetic resource is uncertain. For example, if a user wants to perform research and development on wheat, how does the user identify the provider country?

If a user creates a variant protein or microorganism, what is the country of origin? The country from which it was first isolated or the country in which the variant was produced? If the same user wants to perform further research and development on the protein or microorganism

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does PIC and MAT need to be negotiated? The Nagoya Protocol and its implementation will have far-reaching consequences for research and development in the life sciences industry, and the EU has promised that guidance documents will be forthcoming in the third quarter of 2015.

However, the extent and format of such guidance has yet to be disclosed, and it remains to be seen whether it will address the numerous difficult questions arising as a result of this legislation.

HOW TO BE PREPARED Detailed below are some practical and proactive tips to aid with compliance for businesses, academic institutes, and users: Ii.

ensure that all genetic resources or derivatives thereof that were accessed before 12 October 2014 are clearly recorded as such, since the protocol is not retroactive and its provisions do not apply to genetic resources accessed prior to this date,

ii.

II

ensure all new genetic resources are properly categorised and be cautious of the origin of such material,

iii.

III

employers should ensure employees are aware of the protocol and that legal possession of a genetic resource does not automatically mean that research and development can be performed on the resource, and

iv.

VI

employers may wish to be involved in setting up “best practices� in their country of operation.

Once best practices have been established there will be an assumption that, by following these procedures, the due diligence requirements of the protocol have been complied with.

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Fighting for IP Rights in the Life Science Industry In the pharma and medico industries, intellectual property rights are continuously challenged. Complicated and at times unclear EU legislation in the industry calls for highly experienced legal advice to secure company rights.

Trademark and brand violation or theft is very costly and damaging for any business.

In the past, the problem to a greater extent concerned clothes, handbags, and perfumes, but bootleg copies and other infringements of intellectual property rights is a growing problem in the food and life science industries. “We have seen everything, from Parma ham which has never been anywhere near Parma, to life-threatening, diluted cancer medicine,” says lawyer and partner at Njord Law Firm, Thomas Ryhl.

Njord is a business-oriented law firm that advises various industries in the Nordic region, including the Baltic countries.

Njord has Denmark’s largest department working with the protection of IP rights in the life science industry, who over­ see the market with regard to violations of clients’ IP rights, reacting and prosecuting when necessary.

“Our experience from the other side of the table is invalu­ able. We know our clients’ needs and issues inside out and are able to advise them on their terms,” says Thomas Ryhl.

Parallel Imports and EU Legislation “In recent years, the area of parallel imports in particular has been the battleground,” explains Thomas Ryhl.

It is the interpretation and implementation of EU law in the area of parallel imports that is challenging. “The law on this area has to take many important factors into account, such as patient safety, consumer advice, equal competition con­ ditions for all manufacturers, and much more, and therefore it is incredibly complicated and, in some areas, unclear.

The original manufacturers of pharmaceuticals and medical

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equipment have huge expenses for research and develop­ ment, and even though research has always been a high priority in the EU, demands on funding authorities to save money, amongst other things, have meant an increased economic pressure on the pharmaceutical and medical industry, and the boundaries for how other companies are allowed to use one’s trademarks is being challenged all the time,” says Thomas, and continues: “The law says that imported original products may be repacked on certain conditions. It is an exception in pharma and medico, which isn’t seen in other branches. For exam­ ple, it’s hard to imagine that permission would be given to re-bottle imported soft drinks.”

The dispute revolves around how the text of the law should be interpreted exactly and when repackaging is legal.

The original manufacturers fear that their reputation and brand will be damaged and more importantly, that it will compromise patients’ safety if parallel importers do not have the necessary expertise or do not take time to check, for ex­ ample, that the package leaflets or dosage instructions are correctly translated when pharmaceuticals are repackaged.

“Currently, our client Ferring Pharmaceuticals has there­ fore chosen, for the sake of principle, to take the question of whether repackaging of products by a parallel importer is allowed when justified by financial profits only all the way to the Court of Justice of the European Union,” tells Thomas.

And there is a good reason to put one’s foot down.

Thomas Ryhl predicts that IP rights will continue to be an area where the boundaries are challenged, and he believes that the best thing a company can do to protect itself is to join forces with a competent and experienced legal partner.

For more information: www.njordlaw.com

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CALENDAR

SEPTEMBER OKTOBER Nordic Pharmacovigilance Day 2015 06 October, 2015 Copenhagen, Denmark Pharmacovigilance is evolving rapidly and is becoming everimportant in the pharmaceutical industry. Health Authorities are continuously focusing on the area and new legislation and policies from EU as well as globally are driving changes to processes and Technologies

Scandinavian Medical Device Packaging Conference 2015 07 October, 2015, Copenhagen, Denmark Scandinavian Medical Device Packaging Conference 2015 is the only one of its kind in Europe to offer participants overview of the production chain. Leading international experts on fields ranging from packaging and control to strategic design and labeling will speak about key issues relevant now and in the near future . In two days you will learn about the safest and most effective ways of working with medical device packaging.

Cancer Crosslinks 2015 14 October, 2015, Lund, Sweden By bringing together researchers from healthcare providers, academia, and industry with representatives from regulatory units in a one-day meeting, we want to start an interdisciplinary discussion that could lead to new partnerships to develop the area of ​​Personalized Medicine

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.

Join a Scandinavian Life Science delegation to Bio Japan 2015 14 October, 2015, Pacifico Yokohama, Japan BioJapan has played an important role in facilitating interaction between Japanese and global companies/organizations and

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stimulating new business opportunities. The Japanese and global biotechnology industry’s top business development and licensing professionals, alliance management professionals, R&D personnel and biotech company executives will gather in Yokohama for the 17th BioJapan!

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EMBO | EMBL Symposium: Non-coding Genome Date: 18–21 October 2015 Heidelberg, Germany In the 50 years since RNA was identified as a central component in the flow of genetic information, it has become increasingly clear that RNA performs many additional diverse and interesting functions. Regulatory RNAs are known to play.

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TOGETHER

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