lifesciences insight no 3 - 2011

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20: ESS wILL booSt futurE r&D IN mEDIcoN vaLLEy

3: Give inventions back to the inventors

24: IPR – potential and pitfalls

42: New vaccine construct opens up exciting new vistas

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the magazine about Life and Science in medicon valley

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Animation of the European Spallation Source in Lund

LifeSciences Insightno. 3 - 2011

LifeSciences Insight is distributed in Denmark and

Sweden to:

• Named decision-makers in the life science industry

• Investors

• Science parks

• Hospitals

• Universities

• Life science media

• Relevant MPs in Scandinavia

• Medicon Valley Alliance’s members and

• collaboration partners

In addition, the magazine is available at relevant

exhibitions and fairs in Europe, North America and

Asia.

Publisher:

RASK Media ApS

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DK-1809 Frederiksberg C

Denmark

+45 3326 9520

[email protected]

www.raskmedia.com

Partners:

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EBD GROUP

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Editor in chief: Carsten Elgstrøm

Editor: Susanne Bergstrøm

Editorial team: Mikkel Ais, Susanne Bergstrøm,

Steven Kjeld Christensen, Jorun Christoffersen,

Claus Clausen, Marianne Ekdahl, Lone Frank,

Hans Henrik Lichtenberg, Charlotte Strøm,

Eva Tiwe, Birgitte Aabo.

Advertising:

Sales Manager: Mads Elgstrøm

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Cover photo: ESS, Lund, Sweden

Photographer: Christian Hjorth Øhlenschlæger

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Layout and print: artegrafix and PE Offset, Varde

Next issue: November 2011

ISSN: 1904-4755

ContentsThe column - Give inventions back to the inventors 3Research highlights from Medicon Valley 4Building Strong Ties between Strong Universities 10Cooperation between The Faculty of Pharmaceutical Sciences, University of British Columbia, and the Faculty of Pharmaceutical Sciences, University of Copenhagen

Second-cycle degree project at Lund University 12Medical students will spend 20 weeks on an elective project during their penultimate term. The work must be independent and will lead to a Master’s degree.

Biotech marketing must be razor sharp 16Claus Lønborg, the new managing director of Copenhagen Capacity: Professional quality is high in Medicon Valley – but the biotech industry can do an even better job showing the world its talents.

The Baton - Medicon Valley, the natural place to be for ESS 20The European Spallation Source being built in Lund will be the world’s leading neutron source, and will allow a wide range of biological materials to be studied in real-life conditions.

IPR – potential and pitfalls 24Professional guidance is necessary to work out the do’s and the don’ts in IPR.

Allocate time and resources to patenting 28Patience and resources such as money and manpower are required when patenting life science inventions.

The biotech industry’s storytellers 30The concentration of biotech and medico companies in the Øresund region has provided fertile soil for a number of specialist service companies providing services targeted to suit the industry’s needs.

People - A man out of the box 33Researcher, chairman of the board, scientific directorof BioLogic Media and musician on world tour all in one go may sound like an odd combination, but happens to be exactly what Jesper Eugen-Olsen has realised.

Medtech subcontractors with a competitive head start 36In a highly competitive environment, the trend is for subcontractors to document quality management systems at the same level as medtech manufacturers.

New vaccine construct opens up exciting new vistas 42In future, perhaps we can avoid the world panicking about new virus infections like swine flu, as happened in the summer of 2009, or diseases like SARS, bird flu or other new viruses.

Upcoming events and new members of Medicon Valley Alliance 46

XXX-XXXPrinted matter

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has also been pointed out that the very few tech trans employees at each institution are poorly equipped for the task of commercialising a whole range of inventions that are only just emerging from test tubes.

In fact, the original idea seems to be that if you could manage to patent everything that could be patented, then the money would start rolling in of its own accord. One thing is certain, patent office costs are by far the largest items in the budgets. After all, a skilled – and expensive – patent agent can squeeze patent rights out of just about anything. But that does not mean you can turn anything into a commercially viable proposition.

Glasgow University, for example, knows this only too well. They have estimated that less than 10% of the patents resulting from research on the premises are in fact worth the administration costs of the university. In recognition of the fact that small companies often benefit significantly from the patents, the rights are therefore given away in the local community. A principle that is being introduced elsewhere in Great Britain, by the way.

In Denmark we ought to consider whether the inven-tion should be given back to the inventor. Wouldn’t it be nice to know whether the Act on Inventions itself is the spanner in the works?

It is based on a fundamental mistrust in researchers’ motivation to exploit their inventions. And so we dampen their motivation and ardour by handing the initiative to busy lawyers who lack the professional insight into the inventions. Meanwhile, it seems we also lack faith in the ability of researchers and the Danish business com-munity to create contacts and transfer new knowledge and technology. Both aspects are wrong.

If anyone is motivated to develop an invention, it is the inventor. And in fact, university researchers and industry representatives are very good at finding each other when their research interests coincide – without a university lawyer holding their hands. If politicians want to do something effective to pave the way from research to invoices, they should put paternalism aside and try facilitating the process instead. Make it easy for researchers to obtain funding for patents – this would ensure patented inventions that researchers are motivated to continue working on and can see are useful. And it would make it easier for the motivated researchers to start up new companies based on their own inventions. Throw away the whip and bring out the carrots.

By Lone Frank, Ph.D. author & science journalist Translation: CLS Communication A/S

In 2000, a dramatic event shook the Danish research community. The new Danish Act on Inventions came into force and overnight universi-

ty researchers no longer owned their own inventions. In-stead the research institutes were assigned ownership. And to compensate for their loss, the researchers were given a new duty. No longer able to decide for them-selves whether they want to attempt to commercialise a project, they were now duty-bound to report new inventions to their institution. The brand new technol-ogy transfer unit would take care of any patenting and licensing requirements. Critics called this change in leg-islation an unreasonable confiscation, but the politicians assured them that this was really being done for the good of society. Now money would start pumping out of the public-sector research that we are all funding and a broad trail would be blazed linking research to invoices.

Today we can see this trail is anything but crowded. A report by the Danish Agency for Science Technology and Innovation shows that as recently as last year, the universities were spending significantly more money on patenting and administering their licenses than they were earning from the inventions they patented.

Overall, in 2010 the institutions earned almost DKK 30 million on patents and licenses, while they spent DKK 36.5 million on the associated costs. And that is before you consider rent for the tech trans units and sala-ries for the 49 full-time equivalent employees who man them. The figures show that, in fact, Aalborg University alone made a – rather modest – profit. And the total of 231 new inventions Denmark’s universities filed comprise only two thirds of the target they helped to set in the development contracts signed with the Ministry.

The picture is so bleak that even the Ministry itself has begun asking what could be wrong and how things can be put right.

In the media, quibbling and heavy administration procedures at the universities have initially been blamed for the fiasco. Both have undoubtedly played their part. However, most companies can testify that it is far more difficult to negotiate rights and commercialisation with an entire institution than with one or two inventors. It

Give inventions back to the inventors

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Research highlightsfrom Medicon Valley

By Susanne BergstrømTranslation: CLS Communication A/S

Maternal smoking during pregnancyIn collaboration with Finnish researchers, the Depart-ment of Growth and Reproduction at Copenhagen Uni-versity Hospital – Rigshospitalet, has studied more than 3,000 young men with a view to shedding light on the pos-sible effects of maternal smoking during pregnancy.

The findings are interesting: Men whose mothers smoked tend to be both shorter and fatter. It has been demonstrated that smoking damages the cells that pro-duce the male hormone testosterone. Maternal smoking reduces the active and available share of testosterone, resulting in boys starting puberty earlier and subse-quently reducing the number of years in which they have to grow and increasing their predisposition for obesity.

The reduced amount of available testosterone also means that men have more problems with recall and con-centration. Furthermore, they tend to lose muscle and bone mass resulting in increased risk of broken bones. Finally, this study also supports the findings of previous studies which have demonstrated that maternal smoking during pregnancy has a negative impact on sperm quality.

The researchers are now working on a secondary hypothesis that these men also have an increased risk of type 2 diabetes and heart disease as a result of the increased tendency towards obesity established by the researchers in the present study. This hypothesis will be tested by re-examining the same group of men later in life.

Lactobacillus plantarum HEAL 19 – can this very special probiotic prevent obesity?According to research conducted at Lund University, daily consumption of Lactobacillus plantarum HEAL 19 appears to prevent obesity. Test rats who were admini-stered this special type of probiotic for their entire lifespan, beginning while still in utero, put on considerably less weight even though they consumed the same amount of food as the rats in the control group.

Lactobacillus plantarum HEAL 19 is a beneficial bac-terium in the probiotic category that can be found in, among other things, cultured dairy products. This new study confirms previous studies in which the results indicate that healthy bacterial flora can have a positive effect on obesity. However, it is the first time that this particular bacterium has been found to be significant.

Research in obesity is being targeted by both re-searchers and the pharmaceutical industry with enor-mous resources and funding. An effective cure for obe-sity would be the blockbuster of all times.

The trials in Lund have so far only been carried out on rats.

Menkes syndrome – a result of copper deficiencyMenkes syndrome is a hereditary neurological disease primarily affecting male children. They are born with kinky hair, develop brain damage very quickly and rarely survive past their third birthday.

Researchers from the Kennedy Centre in Glostrup, in collaboration with researchers from Aarhus University, have identified the pathogenic gene of the desease. The disease’s of this gene codes for a copper pump in the human body that, among other things, makes sure that the correct amount of copper is retained in blood for the body to keep vital functions and organs going such as the liver and brain.

Today there are no effective treatments available for children with Menkes syndrome. Administering copper to patients with a mild form of the disease only delays its progress somewhat.

Smoker’s geneA total of 56 per cent of Danes have a special genetic variation that codes for significantly higher risk of deve-loping lung cancer and other tobacco-related diseases if they smoke. People with this gene should be extra mo-tivated to quit smoking, according to one of the resear-

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chers behind the new discovery, Børge Nordestgaard, professor at the University of Copenhagen and chief consultant at the Department of Clinical Biochemistry at Copenhagen University Hospital – Herlev.

A total of 10,000 Danes have been examined, DNA screened, interviewed about smoking habits and fol-lowed by doctors for 18 years. Among the heavy smokers, the prevalence of tobacco-related diseases has been determined: Their risk of developing lung cancer is 3,200 per cent higher, for COPD (Cronic Obstructive Pulmonary Disease) it is 800 per cent higher, for bladder cancer it is 100 per cent higher and for coronary thrombosis it is 50 per cent higher! The study shows that heavy smo kers with the gene variant should multiple these same risk percentages by 1.5. Statistically, this means that heavy smokers with the gene variant actually have a 5,000 per cent higher risk of developing lung cancer than someone who has never smoked.

The gene variant can be determined using a simple blood test.

Strong argument for nursing babiesResearchers at the Department of Health Sciences, Lund University, who discovered HAMLET (Human Alfalac-talbumin Made LEthal to Tumour cells) in 1994, a compo-nent of breast milk, have now determined exactly which mechanism enables the component to kill cancer cells.

In laboratory experiments, HAMLET has been shown to have a positive effect on more than 40 different types of cancer cells from all over the body. It does so by influen-cing the oncogenes, i.e. the genes that contribute to the mutation of normal cells into cancer cells. Cancer cells have an altered metabolism which makes them depen-dent on high amounts of glucose. The effect of HAMLET is quite simple – it inhibits the cancer cell’s ability to metabolise glucose causing it to die within an hour. This happens by affecting the c-Myc gene.

This discovery has attracted a great deal of atten-tion all over the world, and the researchers in Lund have entered into a collaboration with the Cold Spring Harbo laboratory in the USA on further work on the discovery.

From skin cell to brain cellFor the first time, researchers at the Department of Health Sciences, Lund University have successfully reprogrammed connective tissue cells into nerve cells, creating new potentials for cell transplants.

The researchers extracted mature cells directly from human skin and transformed them into specific types of nerve cells, including brain cells, without passing the stem cell stage. The technique consists of activating three of the type of genes in the skin cells which are also known for being active in the formation of foetal brain cells.

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receptive to instructions. The discovery is a significant step towards the goal of creating nerve cells for trans-plants that come directly from the patient. The vision is to be able to do a biopsy, generate new cells and trans-plant them back into the patient, for instance in the treatment of Parkinson’s disease. This would eliminate the current risk of the cells mutating into tumours after transplantation, and the body’s own immune system is more likely to accept its own cells.

The new gene technology also makes it possible to avoid the ethical dilemmas associated with stem cell research.

Fast diagnosis for SLEThe chronic disease systemic lupus erythematosus (SLE) can now be quickly diagnosed using a simple blood test. In the past, patients with this disease could live for years without a correct diagnosis because the symptoms of SLE are vague and often mistaken for other diseases.

Researchers at the Faculty of Engineering, Lund Uni-versity, in collaboration with doctors of rheumatology at Skåne University Hospital, have developed the new test which is expected to be in use in hospitals within two-three years. The technique consists of dripping a blood sample on a plate comprising specific antibodies. Via the proteins or biomarkers found in the patient’s body, the antibodies can create a unique fingerprint of the indivi-

dual patient. This makes it possible to determine whether the patient has the disease, which variety is active and how advanced the disease is. The researchers hope this will make it possible to predict whether a relapse is on the way and to prevent it by administering the right medication in the right dosage.

The researchers have formed the company Immunovia, which owns the patents for the key biomarker signatures.

New and effective antibiotics on the wayWith the creation of synthetic biomolecules, a chemist from the Department of Chemistry, University of Co-penhagen, has given biologists a tool to prevent and cure deadly bacterial infections such as anthrax, septicaemia and meningitis.

When we contract an infection, we develop a fever, inflammation and possibly organ failure. This is the body’s reaction, i.e. its immune response, to a sugary substance produced by the so-called Gram Positive bacteria. How-ever, this substance is so fragile that it has been impos-sible to test how the substance attaches to the body’s cells.

In conjunction with German researchers, the chemist has now managed to produce this sugary substance synthetically, which will enable the researchers to test it in pure form. In this way, it will be possible to identify ex-actly what in the bacteria activates the immune defence

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system, which will make it possible for researchers to develop drugs for the treatment of the many multi-drug resistant bacteria strains that unfortunately thrive in a number of hospitals all over the world.

New methods for tracking a drug’s path through the organismNature’s plants have potent toxins that not only pro-tect the plant against animals, bacteria and fungi but also have the potential to aid in the treatment of human diseases.

Researchers at the Faculty of Pharmaceutical Sci-ences, University of Copenhagen, now have a new tech-nique to enable the scanning of a plant point by point in order to determine exactly where in the plant the toxin is active. The process consists of making an impression of the leaf on a porous Teflon surface and then analysing it to reveal how the active substances are transported throughout the plant.

The research team is currently tracking the metabo-lism of a drug through an organism, in this case labora-tory mice and rats. This will enable the researchers to see whether the drug reaches its intended destination where it will take effect and whether it changes during the process. In the long term, this will give researchers a better understanding of the metabolism of drugs in the brain, which is vital in the process of developing new pharmaceuticals.

Platinum drugsToday, many types of cancer are treated with drugs containing platinum. In order for platinum drugs to be effective, the platinum must be absorbed by the cancer cell and bind to its DNA. This prevents cancer cells from dividing and ultimately they die.

Drugs for treating cancer with platinum can be ef-fective on one type of cancer while only having a limited or no effect on other types of cancer. Patients can also become resistant to the therapy – and then there are all the known side effects, such as a weakened immune system, hair loss and nausea.

Chemotherapy is often administered directly in the blood stream where the platinum drug binds to pro-teins. Today, it is unclear whether this process effec-tively transports the drug directly to the cancer cells or whether the drug’s protein binding process inhibits the absorption of the drug by the cancer cells. There is also a suspicion that some of the side effects of chemotherapy are caused by the protein binding process itself.

Researchers at the Department of Pharmaceutical Sciences, University of Copenhagen, have now deve-loped a new and highly sensitive analysis method that can determine the amount of the platinum drug in the blood, even in very low concentrations – something which has not previously been possible. The technique can be used in the process of developing better and less harsh chemotherapies.

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manipulating how the scout molecules cooperate in or-der to boost or suppress the immune system.

Breast cancer geneHereditary breast cancer is often caused by mutations in the BRCA2 gene. BRCA2 acts as a brake that stops growth in a defective gene in order to repair the da-mage before the cells continue dividing. This brakingmechanism is vital as cells containing damaged DNA can develop into cancer if they are permitted to divide unchecked.

Researchers at the Biotech Research and Innova-tion Centre (BRIC), University of Copenhagen, have now unco vered the mechanism behind the process. Using new technology to screen known cancer genes, re-searchers have discovered that cells without BRCA2 divide unchecked despite containing damaged DNA. Hereditary mutations in the BRCA2 gene are thus the cause of the increased risk of breast cancer from mother to daughter.

The study has also shown that cells with BRCA2 mu-tations are more sensitive to radiation treatment than cells without mutations. This means that breast cancer patients with BRCA2 mutations can actually benefit more from radiation treatment, which can be used as an indicator upon which to base decisions regarding type of therapy.

Danish pioneering research in blood clotsA coronary thrombosis produces scar tissue which can subsequently cause heart failure and increased morta lity. The Heart Centres at Copenhagen University Hospital – Rigshospitalet and Aarhus University Hospi-tal – Skej by have tested on both rats and humans the diabetes medicine Byetta by injecting it into the heart muscle after a blood clot. The tests show that when combined with standard balloon angioplasty and blood thinning medication, the risk of the development of scar tissue and loss of dead heart muscle are significantly reduced. After three months, scans showed that pa-tients who received injections of Byetta had 19 per cent more heart muscle left.

In the future, international patient trials will be car-ried out, funded by the pharmaceutical industry. How-ever, it will take between three to five years to deter-mine whether the method will become a standard part of the treatment of blood clots in Denmark.

Source: www.videnskab.dk Experimentarium NewsPolitiken [Danish daily newspaper]Lund UniversityUniversity of CopenhagenTechnical University of Denmark

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The scout molecules of the immune systemOur immune defence system is in a constant state of alertness to protect us from invading dangers in the form of viruses, bacteria and fungi. The vanguard comprises certain scout molecules that swim around in the blood and attach themselves to foreign bodies. If a foreign body manages to infect our system, the body reacts with inflammation, which is the body’s way of destroying the infected body tissue, containing the infection and expelling the pathogen from the body.

When a pathogenic foreign body is identified by the scout molecules, the rest of the immune system is alerted that something needs to be expelled from the body. Researchers at the Faculty of Health Sciences, University of Copenhagen, and the Department of Clini-cal Immunology, Copenhagen University Hospital – Rigs-hospitalet, have discovered that under certain condi-tions, the scout molecules actually work together, and as a result the immune system reacts more efficiently and much more strongly than the sum of the reactions from the scout molecules when working individually.

Researchers are now exploring the possibilities of

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By Steven Kjeld ChristensenTranslation: CLS Communication A/S

Both the UBC and KU are universities with strong facul-ties within the pharmaceutical sciences; however a joint venture can significantly strengthen their profiles. At least

that is the motive behind a new Statement of Coopera-tion signed by both faculties. The Statement of Coopera-tion marks the beginning of a collaboration in which both faculties expect not only to exchange knowledge, but also develop collaborative research projects and exchange stu-dents, scholars, faculty and post-doctoral fellows.

Even though the initial agreement is for five years, Pro-fessor Sven Frøkjær, Dean of the Faculty of Pharmaceuti-cal Sciences, ensures that the cooperation can continue as long as it yields mutually beneficial results.

“The aim of the five-year timeline is not only to avoid a premature evaluation. It is also a way for us to signal that we are in it for the long haul. During these five years, we expect to gain not only knowledge, but also academic ties to a university that in the future can be of great value to the research conducted here at KU. I predict that this collaboration will not only result in a strong network of skilled scientists and academicians, but also raise the bar for the research conducted at both faculties. There are so many areas that could be mutually beneficial, so I have high expectations,” says Sven Frøkjær.

The First StepsA symposium has been held at KU-PHARMA to give the two faculties the opportunity to present their research and for both faculties to gain insight into which research areas can create the most synergies between the universities.

The programme featured several high profile profes-sors from UBC who presented their research in areas that could be of potential interest for the collaboration. As of now, a similar symposium is scheduled for the end of the year at UBC; however the current task for both faculties lies in the assessment of which research areas hold the most interest for the joint venture.

The Ambassador Program – the Network FacilitatorThe Life Science Ambassador Program has been the

Building Strong Ties between Strong UniversitiesWith the intent of strengthening and developing research as well as building strong networks, the Faculty of Pharmaceutical Sciences, University of British Columbia (UBC-PS), and the Faculty of Pharmaceutical Sciences, University of Copenhagen (KU-PHARMA), have now taken the first steps towards a long-term strategic cooperation. Søren Harbel, Life Science Ambassador to British Columbia, has been a key driver in making this partnership a reality.

Tectra has three main functions:1. Business-related utilisation of inven-

tions, including patenting and com--mercialisation as well as establishing companies.

2. Consulting in the areas of research and development agreements.

3. Strategic and support initiatives aimed at improving conditions for commercialisation and collaboration with business and industry.

Tectra covers the followingmain focus areas:· Evaluation of new inventions, inclu-

ding preparation of market analyses.

· Involvement in the establishment of new start-up companies.

· Assisting Hospital Executives with bases for decisions concerning inventions and, research and development agreements.

·

Negotiating agreements with poten-tial corporate licensees.

· Drafting of license agreements, shareholders’ agreements etc. as well as research and development agree-ments.

· Boosting the general knowledge level regarding utilisation of research in the region’s hospitals and building networks with and between the hospitals.

· Building networks with the regional biotech and medtech industry and otherrelevant parties, such as innovation incubators, the venture capital sector, the business community etc.

with competencies within the natu-ral sciences, business development, patents, legal counselling and start-up of biotech companies, as well as a comprehensive international network in the venture capital sector and the pharmaceutical and biotech industries.

Tectra is the interdisciplinary unit for technology transfer established by the Capital Region of Denmark. It serves all the hospitals and psychiatry units in the region and is located in Copenhagen Bio Science Park (COBIS). Tectra represents the connecting link between the inventors, on the one hand, and the collaborative partners, the companies, on the other.

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facilitator of the new collaboration between UBC and KU. “I can honestly say that if it weren’t for Søren Harbel

and the Ambassador Program, this joint venture would not be a reality at this point. He not only made the introduc-tions, but he also facilitated the following negotiations,” says Sven Frøkjær.

The negotiations started a year and a half ago when Bob Sindelar, Dean of UBC-PS was introduced, while on a tour of Europe, to Sven Frøkjær by Søren Harbel. With both faculties eager to broaden their networks and fur-ther their research, it was a perfect match.

As they both describe it:“The next step is pre-eminence, a strategic partnership

between UBC and KU Pharmaceutical Sciences.”

Details of the Statement of CooperationThe Faculty of Pharmaceutical Sciences, University of British Columbia, and the Faculty of Pharmaceutical Sci-ences, University of Copenhagen, will explore areas of po-tential collaboration with respect to the following activities:

• The exchange of visiting students, scholars, faculty and post-doctoral fellows

• Collaborative graduate education and research training• Shared endowed Faculty position(s)• The exchange of scholarly information, including re-

search papers, indexes to theses, and books on relevant subjects

• The exchange of invitations to attend scholarly and technical meetings, forums and conferences

• Joint conferences, seminars, workshops and exhibitions• Review of other possible areas of cooperation in a

varie ty of research and academic projects• Neither UBC-PS nor KU-PHARMA are obligated to com-

mit funds or resources, nor will either institution grant any rights with respect to intellectual property unless a legally binding agreement has been entered into. The Statement of Cooperation is intended for a five-year period unless renewed; however either institution may terminate the Statement of Cooperation with 60 days notice.

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From the left: Professor Sven Frøkjær, Dean of the Faculty of Pharmaceutical Sciences; University of Copenhagen, Ralf Hemmingsen, Chancellor, University of Copenhagen, Bob Sindelar, Dean of the Faculty of Pharmaceutical Sciences, University of British Colombia, Stephen J. Toope, President and Vice-Chancellor of the University of British Colombia.Photo: John Edelsgaard Andersen, University of Copenhagen

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By Eva TiweTranslation: CLS Communication A/S

“We have a substantial and significant task ahead of us, and I would urge as many people as possible to take

Second-cycle degree project at Lund UniversityThe medical programme in Lund is expanding, with the addition of the course “Second-cycle degree project” in term 10 from spring 2012. This means that medical students will spend 20 weeks on an elective project during their penultimate term. The work must be independent and will lead to a Master’s degree.

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the opportunity to be a supervisor for these degree projects,” says Bo Ahrén, Dean of the Faculty of Medi-cine, in a newsletter.

“By involving ourselves in supervising clinical or ex-perimental projects, we can all help to build a creative and inspiring educational environment and workplace.

“Thanks to their scope, ambition and timing towards the end of the programme, these new degree projects provide a new chance for postdoctoral lecturers, researchers and doctors working at the Faculty of Medicine or for Region Skåne to work with highly moti-vated students as supervisors of this work.”

“We also hope to be able to involve supervisors from outside the university and the health service,” adds Martin Garwicz, professor of neurophysiology at Lund University and coordinator of the development of the new course.

Many students are very keen to look for projects in the pharmaceutical industry and biotechnology. These students will have an opportunity to enhance their professional development, boost their scientific skills and develop a more schooled critical approach. Their interest in research is also expected to be stimulated.

Rewarding professionally and personally“And it’s not only students for whom this is an oppor-tunity,” stresses Garwicz.

The supervisors also stand to benefit. Doctors and researchers with extensive experience supervising undergraduate and postgraduate students find this work enjoyable and rewarding, both professionally and personally. The students also put a great deal of time into their projects, and many of them could never be implemented without their input.

Supervisors must hold a doctorate – in other words, have a qualification one level above the stu-dents they are to supervise. It will be up to the students themselves, based on their own particular interests, to get in touch with suitable supervisor

13

candidates and agree on what exactly the projects are to entail.

“Supervisors will get a chance to show off what they’re doing and maybe even interest their charges in future research or clinical work in their fields,” says Garwicz.

Those who have previously supervised medical students in terms 5 and 11 are very pleased with the results. A ten-week first-cycle degree project is already included in the latter part of term 5 of the medical programme. This was introduced in autumn 2009 and consists of a theoretical part and a super-vised project. Like the ten-week project during term 11, this has proved a success. Several students have gone on to a research internship or continued on to the doctoral programme.

New project databaseThe introduction of a 20-week second-cycle degree project is an important part of adjustment to the Bologna Process. The idea is that this extended period will produce high-quality results which are ideally of a sufficiently high standard to be published in a scien-tific journal, although this is neither a requirement nor a goal in itself.

There are a variety of medical research databases that are a goldmine of information, but it is not always easy for students to find the most relevant material. Knowledge and experience are needed to know where to begin to look, and this is one area where supervi-

Martin Garwicz,

professor of neurophysiology

at Lund University and

coordinator of the develop-

ment of the new course

Bo Ahrén,

Dean of the Faculty of

Medicine

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sors can assist students with their projects.Experienced supervisors emphasise the impor-

tance of finding the projects they are supervising interesting, so that the work does not feel tedi-ous.

“A project database will be set up to facilitate contact between students and prospective su-pervisors,” says Garwicz.

Supervisors will be able to add project descrip-tions, and students will then be able to search these projects.

“We hope to have the project database in place during the autumn”,but those who already know that they wish to supervise students in their field can let students know about this through the officers responsible in Lund and Malmö,” says Gar-wicz. He is looking forward with great interest to the results of these Master’s projects.

Considerable importance will be attached to these projects when the Swedish National Agency for Higher Education assesses the medical pro-gramme in future.

Responsible officers in Lund and Malmö respectively: [email protected], [email protected]

Payment for supervision will be based on 70 hours per student or 105 hours if a project involves two students. There will also be a standard sum of SEK 5,000 for literature studies and SEK 10,000 for experimental or clinical studies for the increased cost of materials.

Further information about this new second-cycle course can be found under the following link: www.med.lu.se

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By Charlotte Strøm, MD Phd Journalist

In July 2010 Merck KGaA acquired Mil-lipore and in doing so Merck Millipore, the new division arising out of Mil-lipore and elements of Merck KGaA’s life science products and services businesses, became a global sup-plier of innovative products used in research, formulation, and production by the life science industry.

“The two product ranges combined within Merck Millipore are very com-plimentary. This has given us a larger customer outreach because we now encompass a much larger range of products and services,” says Tim Brimble, Head of Regional Sales.

Business as usual with a twist He acknowledges that customers may not notice combination at first.

“The majority of our customers remain in contact with the people with whom they are used to doing business. However, Merck Millipore benefits tremendously from the joint forces legacy Merck and legacy Mil-lipore brings together. We have with one stroke increased the level of competences in different yet highly related areas of biopharmaceutical formulation and production,” says Tim Brimble.

The Merck legacy has its strengths in the chemically derived pharma-ceutical products, in formulation,

upstream or downstream processing of raw materials through to API or drug product.

The Millipore legacy is the hard-ware part of the business. The products are often customer specific solutions that are created to meet the challenges of a particular produc-tion.

Drug delivery system – new kid on the blockMerck Millipore is also supplying drug delivery systems, and Tim Brimble in particular has expectations to a new pegylated liposome based drug delivery system. He explains how the product development at Merck Mil-lipore is highly influenced by the needs of their customers.

“We reflect upon the issues or challenges that our customers meet in various projects – and we think about possible ways of solving them. In some cases we manage to come up with solutions and the liposome based drug delivery system is an example of this.

Complete integration aheadOn a short and midterm horizon the major goal of Merck Millipore is to fully integrate the two companies after the transaction.

“I do believe that we can bring out the best from both companies – and we can even further strengthen our

position in delivering high quality solu-tions for biopharmaceutical academia and businesses,” Tim Brimble says.

He ends with a content reflection of what working life is like in the new and larger company:

“For what it is worth – as an em-ployee I think it is very exciting times because I actually see the syner-gies happening every day. That is not always the case in acquisitions but that is why I truly think that this is certainly not bad at all.”

Business Profile

Joint forces and competences yield synergy with a larger outreach

• Merck Millipore is the result of the Merck KGaA acquiring Mil-lipore in 2010

• Offers 400.000 diffe-rent products within bioscience, laboratory and process solutions

• Operates in 64 countries worldwide through 10.000 employees

• In the MVA region Merck Millipore has an office in Hellerup, Strandvejen 102 B, Hellerup and furthermore in Solna near Stockholm.

Find more information at: www.merckmillipore.com

When German based Merck KGaA acquired US based Millipore, it was the perfect match. The customer outreach expanded and the product range broadened considerably. Moreover, Merck Millipore benefits from the way the different competences in the two companies complement each other.

Claus Lønborg, 42: The newly appointed managing director for Copenhagen Capacity will be joining the company on 1 November.Currently he is managing director of Innovation Centre Denmark in Shanghai.He holds an MSc, former marketing manager for IBM Denmark and before that employed at Rockwool Inter-national and MD Foods.Born and raised on the island of Funen, he will be moving back to Roskilde in the Autumn with his wife and their four children.

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Biotech marketing must be razor sharp

Professional quality is high in Medicon Valley – but the biotech industry can do an even better job showing the world its talents, according to Claus Lønborg, the new managing director of Copenhagen Capacity.

made where the best and cheap-est conditions are avaible. That may sound obvious, but the market wasn’t always this transparent – it hasn’t always been easy as it is now to obtain an overview of the best areas to invest. This can be a threat, but it also opens up oppor-tunities. It is therefore imperative that commercial management and marketing are razor sharp. You have to accurately explain what you are good at. In some cases, biotech can do this better,” according to 42-year-old Claus Lønborg.

He is looking forward to being involved in the marketing aspects of his new position:

“I’m really going to enjoy the mar-keting aspects of showing where we excel,” he says. He also wants to look more closely at the scope for strengthening cluster environments generally and promoting marketing via cluster organisations, such as the Medicon Valley Alliance.

Too good to refuseIn actual fact, Claus Lønborg’s con-tract covered a longer stay in China:

“But when a headhunter called me and I heard more about this

By Birgitte AaboTranslation: CLS Communication A/S

“The level is impressive.”Claus Lønborg is in no doubt that

the professional biotech qualities are high in Medicon Valley. He has gained this insight in his current position as managing director of the Danish Ministry of Foreign Af-fairs’ innovation centre in Shanghai, which works to attract Chinese in-vestments, and he will soon be even closer to the industry as a whole.

After four years in Shanghai, it won’t be long before Claus Lønborg and his family will be relocating back home to Roskilde. On Tuesday 1 No-vember, he takes on his new role as managing director of Copenhagen Capacity, the capital region’s official investment and business promo-tion organisation, and his duties will include attracting investments to Medicon Valley.

One item he is set to put on the agenda is better marketing for the biotech industry:

“Competition is very tough in the international market, and attrac-ting investments and companies is very challenging. Investments is

17

managed to create more than 1,000 jobs, according to their own calcula-tions.

Claus Lønborg has defined some special focus areas. In addition to marketing, he points to, for exam-ple, the global sales channels which need to be strengthened via more Danish agents. And he is very aware of the importance of continuing to make it attractive for foreign students and researchers to move to Copenhagen.

Along the same linesAt Copenhagen Capacity, they will not notice any major changes, how-ever, when he steps in to replace Steen Donner, who has chosen to seek new challenges as managing director of Scion DTU A/S.

“I’m not mounting a revolution – there’s no need. In 2010, Copen-hagen Capacity had its best year ever measured by the number of new workplaces, and this year it had the best half year to date. I’ll be continuing the good work.”

Last year Copenhagen Capacity

job, it sounded so interesting that I couldn’t say no. So now we’re up-rooting the whole family again.”

When Claus Lønborg and his wife, Tine, moved to Shanghai with their young twin daughters and two school-age sons in 2007, their primary goal was to get out and ex-perience something. Initially, it was a major upheaval, especially for the couple’s two boys, who at that point understood nothing but Danish – they cried every night for three months at the prospect of another day at the international school.

But eventually the family settled in:

“My wife was lucky enough to get a job with Vestas and the children are also happy here. So we are very aware that coming home will be another upheaval. It might seem as if we’ll just be moving back home to familiar pastures, but everything has changed at home too, including friends and family, so we’ll be star-ting from scratch,” says Claus Løn-borg on his mobile from Shanghai.

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Business Profile

By Charlotte Strøm, MD PhD Journalist

The European Medicines Agency (EMA) and the US based Food and Drug Administration (FDA) has for some time receiving electronic ap-plications for drug product regi-stration applications (ie eCTD or eNDA). It is the preferred way of making a drug product application. But there is more to it than putting electricity to paper.

“It is essential that applicants get the documentation started in the right manner for an e-applica-tion. It will save work load and time to get on track from the beginning,” says Connie Lyngbek Thestrup, Head of Procedure Management at IWA Consulting.

She continues:“As early as during the develop-

ment phase it is important to think of eCTD and consequently how to manage documents, templates etc. Even the clinical trial application can be handled electronically as an eCTA/eIND.”

The regulatory specialists at the Medicon Valley based IWA Con-sulting offer a long track record and broad experience in medical and regulatory affairs and specifically when it comes to electronic appli-cations they are experts in the field.

“We often assist small and mid-size companies who are short of manpower to get a specific amount of work done in a short time. But we also act as consulting partners with big pharma in development projects,” Connie Lyngbek Thestrup says and points out that IWA Con-sulting operates globally with their main focus in Europe.

Think eCTD and get regulatorydocumentation right from the startPharmaceutical businesses face different requirements with electronic drug product registration applications at international regulatory authorities. It is worthwhile to do things right from the beginning.

Facts About IWA Consulting:

• offers Medical and Regula-tory Affairs services in the EU and the US

• offers a complete portfolio of regulatory and medical affairs services to support the successful development and timely registration of human and veterinary medi-cines including originators, generics, biotech products and medical devices

• was founded in 1997 and the management consists of Inge Walløe Andersen, Jørn Andersen, Lillan Rejkjær, and Connie Lyngbek Thestrup

• counts 12 regulatory ex-perts as employees

• is located in Ølby nearby Køge, just off the highway connecting to Copenhagen from the South

www.iwaconsulting.dk

Quality, safety, and efficacy The three cornerstones in a drug product application are the drug quality documentation, non-clinical, and clinical documentation of safe-ty, and efficacy. At IWA Consulting they have made it their company pay-off.

“We focus on quality in every-thing we do, and our clients can rest

The staff at IWA consulting. From left to right: Inge W. Andersen, Søren Toubro, Tina Christensen, Lillan Rejkjær, Hanne-Mette Schlichting, Jørn Andersen, Helle Ørbæk, Engeline Kosiara, Stine Engelbrecht, Helle Schou, Rikke Ibsen Jensen, and Connie Lyngbek Thestrup.

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Business Profile

assured that the delivery is done in a cost effective manner,” says Connie Lyngbek Thestrup.

There is more to it than just words. IWA Consulting continuously conducts procedure reviews and has obtained an ISO 9001 certifica-tion, stressing their focus on the reliability of their services. Connie Lyngbek Thestrup explains:

“The ISO certification underlines that we work in LEAN, quality driven and quality assured manner. This is a customer benefit of true sub-stance.”

IWA Consulting was founded by Inge Walløe Andersen 14 years ago. Today a total of 12 regulatory specialists have a broad foundation of all disciplines within Medical and Regulatory Affairs and de m on -strate strong e-competences. Apart from putting together an application file for a drug product registration, the services of IWA

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Consulting cover all regulatory activities during development and life cycle management of a medici-nal product such as applications for clinical trials, translation of patient insert leaflets, summary of product characteristics etc. The specialists at IWA Consulting work from their own office in Ølby, just a 30 minute drive on the highway south of Co-penhagen or they may work tempo-rarily as in-sourced consultants at the client’s office.

Is paper out?As an applicant for a drug pro duct registration you may consider alternatives to the e-application.

“The regulatory authorities are not allowed to decline paper appli-cations, but they encourage the applicants to submit drug product applications in eCTD format,” Connie Lyngbek Thestrup says.

She explains how a so called NeeS

(simplified e-application) (in Europe) resembles an intermediary stage between a paper application and an electronic version.

“The NeeS was a compromise when realizing that applicants were not fully up to speed with the e-application. The expectation is however, that it will be phased out and overtaken fully by e-CTD,” says Connie Lyngbek Thestrup.

Medical devices in focus A new focus area at IWA Consulting is medical devices.

“Many pharma companies face increasing competition from gene-rics and the trend is now to estab-lish a use of the original product in combination with a medical device. So we are very focused in this area and the changing requirements within the clinical documentation field,” Connie Lyngbek Thestrup ends.

work, and the risk that the baton, passed from hand to hand in a particular way, might be dropped.

With this expirence in mind, the fact that I was handed a baton of a different kind by Jan Björklund, the Swedish Deputy Prime Minister (but more impor-tantly, perhaps for us at ESS, the Swedish Research Minister!) was also a source of some quiet satisfaction.

The ESS project is in good health. It is gather-ing momentum. It is out of the blocks, to continue the athletic simile, and heading for the first bend. Of course it is not a sprint, it is more of a marathon. But what are we racing against? Well, we are racing against time, that’s for sure, but when we arrive in 2019 at that finish line we want to have maintained

The world athletic championships have just ended. As usual there has been drama. I have always been heavily involved in athletics. Some may think it might have been the armchair kind of involvement but in my teenage age years it went beyond that. Through force of circumstances, I took up the discus in school and reached a certain level of success. Not enough to take me to the world championships nor even the All-England championships, but for many years I held the distance record at this event for the county of West-morland in the North-West of England. My active in-volvement in athletics has long passed. Nevertheless, I was always excited by the relay races and particularly the 4 x 100 metres with its need for drilling and team-

Medicon Valley, the natural place to be for ESSWith ESS, the Öresund Region will get a unique chance to build a large European research facility and attract thousands of leading scientists every year. The European Spallation Source being built in Lund will be the world’s leading neutron source, and will allow a wide range of biological materials to be studied in real-life conditions. “I believe that this will be a great advantage for Medicon Valley and a boost for the R&D competitiveness of the region”, writes Colin Carlile, ESS Director-General.

The Baton

Photo

: Anim

ati

on

ES

S

Animation of the European Spallation Source in Lund.

Scheduled plant opening 2019.

21

our budget and we want to have delivered on speci-fication. And of course the finishing line is but the beginning for ESS. The long period of delivering scien-tific output from ESS will begin. I look forward to that time when perhaps I will be observing this success from the grandstand. I will have passed on the baton. But I don’t intend to be observing from my armchair. It will be too early for that.

A tool for advanced scienceESS will be built in the middle of the dynamic and internationally competitive Medicon Valley. This is the natural place to be for a research facility that will be world-leading in its kind, and also particularly suited for advanced analysis of organic samples.

But what will the ESS mean to Medicon Valley? Be-fore answering that question, I would like to place the ESS in its scientific setting.

In recent years, advances in scientific analysis have led to considerable progress in improving human health, particularly in understanding the causes of disease at the molecular level. Of key importance has been the development of analytical techniques that enable scientists to ‘see’ deep inside biological mate-rials, down to the scale of atoms. One of these tech-niques is neutron scattering, that is done at neutron sources such as the ESS.

Intense beams of particles, such as neutrons, can reveal the arrangement of atoms in complex biologi-cal molecules including proteins. When neutrons are scattered off an array of biomolecules, they pinpoint the spatial positions of the atoms to give a three-dimensional structure of the molecular assembly. Measuring the accompanying changes in the energy of the neutrons can even detect atomic and molecu-lar movements. In this way, researchers can probe biological mechanisms that are the basis of life.

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Today, a range of sophisticated experiments using neutrons is uncovering how life works at the deepest level. However, this requires increasingly advanced instruments and – most importantly – selectively tailored beams. The generation of neutron beams is possible only at costly and technologically demanding large-scale facilities that are increasingly developed as international collaborations, like the ESS.

Neutrons and life scienceNeutrons provide valuable tools for life science, since they offer crucial advantages for studying complex biological structures and processes under non-damaging conditions that are as close as pos-sible to those inside a living organism. They can easily distinguish all the elements relevant to life - carbon, nitrogen and oxygen, and are also uniquely sensitive to hydrogen isotopes, so that substituting hydrogen with deuterium in components of a biomolecular as-sembly highlights those structures for study. Equally, neutrons can elucidate the crucial role of water mole cules and hydrogen atoms in biological processes.

Why do we need the ESS?Currently, Europe has two major international neu-tron facilities – the Institut Laue-Langevin in Greno-ble, France and ISIS near Oxford in the UK. Although

The Baton

CEO Colin Carlile at The ESS Industry Day in Copenhagen 2010

Baton with Points of View“The Baton” is a point of View feature about life science in Medicon Valley. It is written by business people, researchers, politicans ans opinion-shap-ers with a personal and extensive commitment to Medicon Valley. The holder of the Baton passes it on to a new person along with one or more ques-tions related to life science in Medicon Valley.

Colin Carlile gives the relay baton to Mats Leifland, the recently appointed CEO of Medicon Village. The question to Colin Carlile will pose to Mats Leifland: “How can Medicon Village strengthen Medicon Val-ley’s global competitiveness?”

Ideon Medicon Village will open its doors at the former Astra Zeneca site in Lund in mid-January. It will include an environment where research, in-novation and enterprise interact to create value for human health and wellbeing. This investment in medicine and health means that the Ideon area will double in size to become one of Europe’s largest science parks.

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regularly upgraded, both are several de cades old. Re-quests for experimental time at neutron facilities are growing rapidly – as well as demands for ever-more intense neutron beams so that molecular structure and function can be seen more clearly. Thus, a new and more advanced neutron source is required to meet the scientific challenges of the 21st century.

In 2003, European scientists proposed the con-struction of a new facility, ESS, and in 2009, EU Research Ministers agreed that the preferred site would be in Southern Sweden. Rapid progress is currently being made towards realising ESS. ESS is co-hosted jointly by Sweden and Denmark, and 17 European countries have already agreed to join ESS. Construction will start in 2013 and we foresee the first neutrons for 2019. ESS will form the lar-gest component of a major new research centre in Lund, which will also include the new high-intensity X-ray beam facility, MAX IV, also suitable for studying biological systems. The many life-science companies of Medicon Valley, as well as elsewhere in Europe, will benefit from the co-location of both facilities, which will enable full use of the complementarity neutron and X-ray beams.

Neutrons and biomedical researchWith the ESS, the Öresund Region will get a unique chance to host and benefit from a large European research facility. ESS will be the world’s leading neu-tron source, and will allow a wide range of biological materials to be studied in real-life conditions.

We cannot foresee what scientific discoveries the future will hold, but we can get a glimpse through looking at some of the major scientific topics studied with neutrons today:

• Disease and cell functionLiving cells host highly intricate molecular pathways that mediate the processes of life. Discovering these pathways, and understanding how small changes in the behaviour of biomolecules can lead to disease, is the basis of much life-science research. Neutrons contribute by analysing the molecular structures and interactions involved at the atomic scale.

• InfectionMany of the processes resulting in infectious di-seases such as HIV can be investigated by neutron scattering – for example, the molecular interactions of viruses with the proteins that control their pas-sage into cells, and the behaviour of the viral genetic material inside the cell.

• Pharmacology and drug design Neutron experiments provide information helpful in the rational design of new drugs, based on how they interact with cellular receptors and how they can be delivered to their target most efficiently.

The Baton

• Surgical treatmentsNeutron-scattering methods are essential for study-ing biomimetic materials (for dental implants, healing of broken bones and wound dressings); the ability of neutrons to probe the multi-component structures, and their deep penetration into materials, are key advantages.

• Environmental healthNeutron studies help in optimising the properties of many materials to improve health and safety – for ex-ample by reducing the toxicity of paints, cleaning-up contaminated soil, and improving the quality of food.

In conclusion, ESS will provide unique research op-portunities within a broad range of life science areas, and also attract thousands of leading scientists to the region every year. This will enhance the scientific dynamism in the region and lead to new discoveriesand innovations. I am convinced that this will be a great advantage to Medicon Valley and a boost for the R&D competitiveness of the region.

The enthusiasm for the ESS project in the science community is impressive. There is already a number of dynamic and forward-looking Danish and Swedish sci-entists involved in the planning of the future ESS sci-ence. Later on, regional industry will be able to benefit from the advanced science tools at ESS. I truly hope they will make use of this opportunity!

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the need for flexibility in handling life sciences data, and of being a “statistical detective” to find useful patterns and signals in data through exploration.

The JMP Pharmaceutical Technical Manager Valerie Ned-bal showed a lot of the functionality in JMP Clinical during two sessions. JMP is in fact already one of the most used statistical exploratory tools that FDA uses when assess-ing clinical data. JMP and JMP Clinical can be implemented in compliancy with FDA’s 21 CFR Part 11, and at this point a majority of FDA approvals are being obtained using JMP. Valerie showed for example Bubble Plots for monitoring Hy’s Law profiles in Lab tests, predictive modelling, Kapplan Meier Curves to detect significant variations of Mortality Rates, Tree Maps to visualize frequency of adverse events, Volcano plots to detect signals, Venn diagram to find patients with common adverse events, Time window that showed the change in significance and relative risk for all adverse events and concomitant medications for each day of the trial, data filtering, visualizing, mouse-over effects, animated reports and lots of other cool stuff making the audience eager to raise questions and discuss variations in needs and functions.

The Quality & manufacturing track featured lead con-sultant Kasper Munck from NNE Pharmaplan speaking about how JMP supports cycles of learning within Quality by Design initiatives. The efficient exploration of oppor-tunity spaces with JMP’s custom designer is a key aspect driving the process understanding needed for Quality by Design. In the following session Ian Cox introduced JMP Pro, a new version of JMP containing the more powerful approaches to analysis required to build models whose predictions have the best chance of generalising well. The presentation was about how to create reliable predictive models for data mining using logistic regression, decision trees and neural networks. Ian underlined that all we have already learnt about working with data is still appropriate - Even when using smart software you have to think care-fully about issues of data quality, consistency and validity, he concluded.

Find more information about the seminar og the JMP family at www.sas.com/dk/JMP further

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“Speeding up the process or enhancing the value crea-tion in the clinical trial process is key to companies in Life Science, says sales director Thomas Rasmussen from SAS Institute. This privately owned software company has a long track record in the pharmaceutical business with both the JMP family and the SAS software offering. Recently sixty-one participants from a wide range of Life Sciences companies converged to the message from SAS Institute hosting a practical day of making statistical discovery with the JMP family of software products. The event held in Copenhagen had two parallel tracks, one for R&D/clinical and one for Quality & manufacturing, and demonstrated how the JMP product family offers huge potential for re-searchers, scientists and analysts in the Life Sciences to get more from their data.

“The glue is statistical discovery. This is what JMP is all about, and what has been the core for these products for twenty years. JMP is a Swiss army knife for discovering patterns in data and for building useful predictive models”, said Ian Cox, Marketing Manager within the JMP Division of SAS.

The proper exploitation of data has long been a corner-stone of value creation in Life Sciences, and its importance is increasing as the pace of innovation accelerates and data volumes explode. JMP sets the standard for FDA ap-proval in many pharmaceutical companies, but despite this, many attendees were not aware of more recent versions and developments in the JMP family. Ian introduced the au-dience to JMP Pro, JMP Genomics and JMP Clinical, as well as JMP itself, which has been in development for more than twenty years. For example, JMP Clinical now blends the visualisation capabilities of JMP with the analytic horse-power of SAS to allow easier and more reliable detection and reporting of adverse events in clinical trials to help streamline FDA approval.

“All data are contextual - If you don’t appreciate the proper context of your data, it can be damaging to your appreciation and understanding of your results. This is not about automating everything, because humans are much more capable of grasping context, relevance and value than computers. Our mission is to make JMP your tool for making these evaluations”, said Cox. He also emphasized

Statistical discovery speeds up clinical trialsGetting, handling, modelling, visualizing and reporting on huge amounts of data is key to clinical trials in Life Science. Powerful statistical tools enables individuals in the industry to speed up the process. One of the “tool boxes” is the JMP family.

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invention is also increasingly being challenged with the Internet.

“Access to information is easier today than it was just a few years ago. Today you may have online ac-cess to recent research findings for presentation as abstracts at a medical congress weeks or even months before the actual meeting takes place. From an IPR perspec-tive this could turn into a night-mare, because it can mean that the invention does not fulfil the novelty criteria, and as an inventor it is dif-ficult to control. The best advice is to avoid disclosing anything pre-maturely, and only to do so after getting the appropriate confiden-tiality agreements signed,” Anne Schouboe says.

Getting the invention over the hurdle Sometimes the best advice to give to an inventor or researcher is not to file for a patent. The patent could be too difficult to enforce, the inventive step could be too difficult to prove, or development and com-mercialisation could be too difficult or costly. It takes money and this is usually a major hurdle.

“Inventors have to find inves-tors, sell or license the invention in due time. This is a real challenge for most academic researchers I’ve met,” says Lars Petersen, MD and Chief Executive Officer at CapDelta Group, a medical and scientific consultancy business that spe-cifically assists inventors to shape inventions as business proposals and present them to investors and potential partners.

In the life sciences, as in any other business, it is value creating to spot potential and get inventions patentprotected in a timely fashion. How-ever, the discipline of Intellectual Property Rights (IPR) is also a mat-ter of investigating the pitfalls and knowing how to avoid them.

“IPR can seem like a maze to people who are unfamiliar with the area. But no matter how you may feel about IPR, it should never be taken lightly,” says Anne Schouboe, MD, European Patent Attorney and Partner with Plougmann & Vingtoft, an IPR consultancy.

Avoid buying a pig in a pokeShe has worked with IPR within the life sciences for 22 years and she has seen how cases can go very wrong due to inadequate attention being paid to the IPR situation.

“You need to take care not to buy a pig in a poke. I have seen compa-nies go down because they didn’t perform careful due diligence in the patent situation. In one case, the patent legally belonged to a dif-ferent company than the one that sold it. In another case, the patents had not been maintained, i.e. the fees had not been paid duly and the patent protection was lost. In both cases, the buyers found themselves in a position of having purchased something that was completely worthless,” explains Anne Schouboe.

Increasing demandsAn invention must be novel. Se-

condly it must have inventive step, meaning it should not be something that is obvious to a person of ordi-nary skill in that particular field.

“The threshold for inventive step has clearly increased in recent years and in practice this makes it more difficult to obtain a patent these days,” Anne Schouboe says.

The question of the novelty of an

IPR – potential and pitfallsPatent protection in the life sciences is a complex and costly matter, which may have you wondering if it is really worthwhile. In the long run it is – at least in the vast majority of cases. However, professional guidance is necessary to work out the do’s and the don’ts in IPR.

By Charlotte Strøm, MD, PhD, JournalistTranslation: CLS Communication A/S

Lars Petersen, CEO, CapDelta Group

Anne Schouboe, MD, European Patent Attorney, Plougmann & Vingtoft

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“The urge to commercialise an invention is probably stronger than the urge to share knowledge.”

Anne Schouboe agrees and adds,“Inventors do pay back - so

to speak - to the community by disclosing the details of the inven-tion at an early stage when applying for a patent. Anyone can conduct research based on this information. The deal is that until the patent expires, the commercial exploitation is your property as a patent holder.”

Sometimes, knowledge sharingeven precedes inventions. The complete genome sequence of Mycobacterium tuberculosis was published in Nature by Cole and co-

CapDelta Group typically en-ters the innovative projects at the stage where the inventor realises that they cannot take the project further.

“Inventors are often resear-chers or clinicians with a good idea that solves a clinical problem they face regularly. For most inventors, however, their core competences don’t include creating progress with an invention. This covers getting the legal matters in place, ensuring IPR, investigating the market potential and competitor situation, drawing up the business case and, last but not least, finding investors or part-ners,” says Lars Petersen.

Later you need to manage the project or business into which the invention may develop. If the inventor does not have the capaci-ty or time to manage the business, CapDelta Group can act as interim management. However, the inventor cannot just drop out of the process.

“The researcher has to play an active role in the process while wri-ting and prosecuting the application and be in continuous dialogue with me. He or she is the expert on the invention, while I know how to get it protected,” Anne Schouboe says.

Patent protection versus knowledge sharingOne could argue that the whole idea of IPR goes against the bold but strong research spirit which em-braces sharing knowledge, leaving ideas available in open source, letting them flow freely benefit more people.

Lars Petersen, CEO at CapDelta Group comments:

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Inventors are often researchers or clinicians with a good idea that solves a clinical problem they face regularly.

26

IPR vocabulary

workers in 1998. And even though the word on the genome sequence was out and made publically avail-able, researchers from SSI (Stat-ens Serum Institut), an enterprise and research institution under the Danish Ministry of Interior and Health, later managed to patent specific tuberculosis vaccines.

“Even if the complete genome sequence was public, the novelty and inventive step was the know-ledge about where the coding that was relevant for the disease was located in the genome,” Anne Schouboe explains.

When the party endsPharma companies struggle to dif-ferentiate their original medicinal products from generic competition at patent expiry. Often this is a losing battle, which is fought on price only. Patent applications for second medical use, or new for-

mulations of an existing medicinal product, may make it harder for generic competitors.

“Second medical use of a known medicinal product is usually very hard to enforce and that’s probably why they give rise to so many court cases. But the fact of the matter is that they are numerous, imply-ing that it remains a good business case to do it,” Anne Schouboe says, continuing ,

“In such cases the larger compa-nies have an advantage. Generally, it takes a lot of effort to control and enforce second medical use patents.”

Pricy patentsFiling a patent application and obtaining patents in e.g. 10-15 countries is very costly, totalling around EUR 270,000-400,000. In addition there is the cost of main-taining the patents. This depends

on how many and in which coun-tries patent protection is sought but can amount to EUR 20,000 on a yearly basis and can be con-strued as a kind of tax. Generally, one should expect to invest about 10% of the costs of developing pharmaceutical inventions in pa-tenting, so the business potential of an invention must be significant to make it worthwhile.

“The fees are paid over time and the process of raising money for the patenting process is an ongo-ing issue,” says Anne Schouboe who acknowledges that most inventors at some stage are in need of busi-ness consultants that can take the invention one step further.

The saying ‘it takes money to make money’ applies well to this environment. In the past couple of decades the pharmaceutical industry has such drugs as fluoxetin (SSRI – antidepressant), simvasta-

IPR: Intellectual Property Rights Freedom to operate: Determines whether a particular action, such as testing or commercialising

a product, can be carried out without infringing valid intellectual property rights of others

Inventive step: A patent for an invention can be granted only if it contains an inventive step.

An inventive step means that the invention should not be obvious to a person of ordinary skills in that area of technology

IPR due diligence: A review of a company’s intellectual assets: Priority year: The period of priority, i.e., the period during which the priority right exists is

12 months in duration and is referred to as the “priority year” Preliminary examination: May be performed in continuation of the novelty search after 18 months. It

comprises one or two Written Opinions on the patentability and is finally con-cluded 2.5 years after the priority date of the invention with an International Preliminary Report on Patentability

PCT application: International patent application covering more than a hundred countries. Will

not in itself lead to a granted patent, but allows for a novelty search and ini-tial examination of whether the invention can be patented by an international patent authority

EP application: A European patent application covering more than 30 European countries.

Evaluation of the application is handled centrally by the European Patent Of-fice which will eventually grant the patent. The countries in which the patent is intended to be upheld require a translation of, e.g., the claims of the patent into local languages, which is referred to as the National Phase

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paper work and translation,” says Anne Schouboe.

Major mistake to miss out on BRICHowever, in some cases filing appli-cations in English has been a pitfall.

“For years, many inventors have filed their patent applications in English in the US, in Europe where English was possible, and having done that Canada, Australia and New Zealand seemed very obvious to go for as well. However, few really gave Brazil, India and China much thought, which I think many regret dearly today,” Anne Schouboe says.

She regularly sees pharma-ceutical companies that discover their products are being copied, produced, and sold in the BRIC-countries and there is absolutely nothing they can do about it with-out IPR. The patent holder only can enforce his rights if the drug or API is imported in a geographical area in which the company has patent protection.

Seek professional guidanceIPR has a complex area that is very difficult to understand in depth, implying that obtaining professional guidance and advice is required in most cases.

“Some small or mid-sized compa-nies or solo inventors may think for a while they can do without paten-ting. They can, but surely not for very long. My best advice is to get professional IPR guidance as soon as possible in order to optimise the protection of the invention for your own benefit,” Anne Schouboe concludes.

tin (lowers cholesterol) and sidenafil (treats impotence) to show for it. At the expiry of the original pro-ducts (Prosacâ/Fontexâ, Zocorâ and Viagraâ, respectively) generic pro-ducts took over large parts of the market, but until then each product made millions.

IPR strategy The advice to conduct continuous research activities in any life sci-ence business is to develop an IPR strategy.

“Research-based companies can benefit from having thought through from the beginning which direction they want to take their research activities, where inven-tions can be patented and where there is sufficient freedom to ope-rate,” Anne Schouboe says, stress-ing that there is a bottom line loss if these things are left to chance.

Freedom to operate applies to, say, a treatment regimen which can be used without infringing existing patents. It often goes unnoticed that promising inventions may in-fringe existing patents that where unknown before the IPR specialist started looking for them.

“It makes sense to prepare a map

showing the landscape of where you are going before starting your journey, even if you have to further investigate how to get to your des-tination,” she says. European trendsAnne Schouboe has taken a spe-cial international education in IPR. Foreign non-European life science companies must file for patents in Europe through a European Patent Attorney, like Anne Schouboe. And the European focus of the company, Plougmann & Vingtoft, is reflected in a number of offices across the European continent.

“IPRs obviously cross borders, and very rarely, if ever, are life sci-ence patents filed only nationally,” the European patent attorney says.

At the moment, there is a discus-sion about establishing an EU patent court of law, and in accordance with that creating an ‘EU-patent’ in Eng-lish. This is not currently the case. Patents may be filed centrally, but in order to uphold its protection the patent must be filed in most coun-tries in the local language.

“Clearly, an EU harmonisation would benefit innovation as a whole. Today, too many hours are lost on

Patrawin® gives you instant control of your IPR families divided into product categories or business areas. This easily

installed application simplifies everything from control of deadlines to mass-updating and document management. A web

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I P R R E N E W A L M A N A G E M E N T & S O F T W A R E S O L U T I O N S

IPR has a complex area that is very difficult to understand in depth, implying that obtaining professional guidance and advice is required in most cases.

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search after 18 months. This also marks the point in time when your invention is published and is thus no longer confidential. The preliminary examination comprises one or two so-called Written Opinions on the patent-ability to which you can respond and is concluded about 2.5 years after the priority date of your invention with an International Preliminary Report on Patentability.

Country selection At this point you have to decide in which specific countries you are going to apply for a patent. The number of countries determines the cost from here on out. In most countries, you need to provide a translation of the application into the local language, with most European countries gene-rally only requiring a translation of the application into English, German or French. This is called the National Phase.

Following grant, which may take several years, any competitors or any-

By Charlotte Strøm, MD, PhD, JournalistTranslation: CLS Communication A/S

Patience and resources such as money and manpower are required when patenting life science inventions. Developments within biotechnology, medical treatment or software may be patented if they are objectively novel, possess inventive step, have industrial applicability and are not exempt from patenting. An example of the latter could be a method of per-forming eye surgery. In practice, it is novelty and inventive step that decide the patentability of a given invention.

Let’s follow the timeline of how you obtain patent protection for your invention.

Day 0 – 18 months The priority date is the earliest ap-plication to a patent office describing your invention. It can be the provi-sional filing date of e.g. a US provi-sional patent application. A patent application describes the invention and the area within which it has a perceived usability. The priority date is the day the priority year starts. For 12 months you can gather additional information justifying the invention and before the year ends you can file an updated application in the coun-tries where you are going to apply for patent protection. Of course you would want to know if your invention is patentable worldwide, which may be assisted by a novelty search per-formed using the Patent Corporation Treaty (PCT) if you file an international application. While this is ongoing (18 months) your invention remains confi-dential. Up until this date, the cost is approximately EUR 15,000-25,000.

18 months – 2.5 yearsThe preliminary examination may be initiated in continuation of the novelty

Allocate time and resources to patenting

one else for that matter may object to your patent. Under the European Patent Office the opposition period is nine months, and the deadline is absolute.

After 5-10 years Within 5 to 10 years after the priori-ty date, you should be ready to claim patent protection for your inven-tion. The total cost of the process is approximately EUR 270,000-400,000 for obtaining a patent in, e.g., 10-15 countries. Maintaining the patent costs about EUR 20,000 on a yearly basis. The standard period of protec-tion of a patent is 20 years from the filing date. However, for patents for products which require investigation into, e.g. the safety of its usage, and for which commercialisation may take a considerable amount of time (e.g. pharmaceuticals), an extension of up to five years can be granted upon re-quest to cover maintenance fees.

Source: Plougmann & Vingtoft

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company, which was established in the autumn of 2010, was founded by an experienced film expert, Bjørn Vidø, and biochemist and head of research Jesper Eugen-Olsen, PhD. They aim to communicate to the world knowledge of the many exciting companies in the biotech industry through the medium of film. Their bal-last from the research world and over 20 years in the film industry provides BioLogicMedia with some unique competences. Something which has already been dis-covered by players in the market and BioLogicMedia’s

By: Journalist Hans Henrik LichtenbergTranslation: CLS Communication A/S

A challenge for the biotech industry’s marketing is that any exposure of a brand or product results in vulnerability. The problem is particularly evident in the biotech industry where many restrictions are in force – political, ethical and legal. There has therefore been a tendency to restrict communication to cut risks to a minimum.

Research and film in unique combinationBioLogicMedia has addressed this challenge. The

The biotech industry’s

storytellersThe concentration of biotech and medico companies in the Øresund region has provided fertile soil for a number of specialist service companies providing services targeted to suit the industry’s needs. One of these companies is BioLogicMedia, which in just a few months has had success offering professional video production to companies in the life science industries.

Photo: BioLogic Media

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customers include names such as Abbott (US), Novo A/S (Denmark) and BGI (China).

The route to new target groups“A scientific article can take a year to be produced and can cost one million Danish kroner. The results might be pioneering but how many people will read it?” asks Bjørn Vidø.

“If you present the research as a story on film, you can suddenly reach an audience that could be a hundred times bigger. We can help companies with this – and for a price that many of our customers find surprisingly low. The significant difference between us and advertising agencies and production compa-nies is our specialist knowledge of the world where our customers work. In other words, we have in-depth knowledge of our customers and the elements which it is important to communicate,” says Bjørn Vidø.

Major market for communication in the bio industryTo highlight its approach, BioLogicMedia has hired se-veral specialists among its staff with backgrounds in science. For example, there is a 3D expert who specia-lises in visualising phenomena at cellular and molecular level. BioLogicMedia now has a total of eight employ-ees and has equipped itself with top-professional studios, an editing suite topped off with a cinema in the heart of Copenhagen with a view over the Royal Garden.

BioLogicTube: Anytime, anywhere and on all platforms We have made a platform that makes it pos-sible to access movies where ever there is an internet access. With BioLogicTube, we have solved the problem of film formats and viewing platforms. Our films can be seen on all plat-forms, from smartphones to iPAD, from PC to Mac. With HD quality, our movies can bee seen on the big screen, e.g. as part of a conference presentation.

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Left: Bjørn Vidø, CEO BioLogic Media. Right: Jesper Eugen-

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“It’s an exciting market because it is so incredibly complex. The logistics for a film are extreme and combined with the challenges related to communicating about new drugs, for example, the task reaches a magnitude that few companies are able to take on successfully. That’s why when we meet our customers they are relieved to have found someone who finally understands them,” explains Bjørn Vidø.

Creative storytelling in a science-intensive industryThe combination of creativity and knowledge is a balance that BioLogicMedia masters, and the company has already received its first price for a creative project in which a 14-metre blood vessel was built in the Town Hall Square in Copenhagen during a campaign. As you can see, BioLogicMedia has nothing against taking on spectacular projects provided the focus is on precise information for the right target group. This also applies on the Internet:

“A digital revolution has occurred and regardless of the industry you work in, it’s often a case of who comes first on Google’s hit list. Meanwhile, people are less patient on the net and few people now bother to read through wordy material. That’s why we often produce series of short films that are only a couple of minutes long and deal with a specific subject. That way the films are seen and when several films are involved, a company can manage its communication better. With a series of films, a particular user is more likely to see the company’s films rather than clicking on other perhaps negative material about the company,” says Bjørn Vidø.

Film can influence share pricesCommunication with stakeholders within the industry and end users, e.g. through patient associations, is one thing. Reaching investors is quite another story. Bjørn Vidø is expecting lucrative new markets to open up in the years ahead. “Communication via print and the traditional media still works well for B2B, but we have already gained some interesting experience with film as a medium for investor relations. Investors also need a fast, accurate picture and we can see that this commu-nication channel can be extremely effective in connec-tion with pricing limited companies,” says Bjørn Vidø.

See more at www.biologicmedia.dk

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People

Dr. Jesper Eugen-Olsen, PhD, is having taken a suPAR test. SuPAR-nostic has a unique value as biomarker. The test is scientifically developed by Jesper Eugen-Olsen.

In 2007, Jesper Eugen-Olsen was sitting in a bar in Tokyo with his band, Dansk Fløde (literally “Danish Cream”). They had just finished one of the first concerts on a tour which would bring them from Japan across Africa to Berlin and New York. The tour was organised in part by the Danish Ministry of Foreign Affairs, and in the

midst of their euphoric revelry after the first success-ful concert in Tokyo, Dansk Fløde learned that the Da-nish Arts Agency had thrown an additional DKK 250,000 in funding their way.“There was a bit more champagne and whisky flow-ing that time. We’d applied for the funding, but never

A MAN OUT OF THE BOXBeing a researcher, chairman of the board, scientific director BioLogic

Media and musician on world tour all in one go may sound like an odd combination, but happens to be exactly what Jesper Eugen-Olsen has realised. If you follow your passion and dare to follow things through,

you become a man without boundaries.By Mikkel Ais Andersen, JournalistTranslation: CLS Communication A/S

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People

thought we’d actually get it. And we are the only ones, along with Tue Vest, to receive such a large dona-tion.”On the face of it, you would not think we were talking about a biochemist with a PhD and several companies to his name, but Jesper Eugen-Olsen has never been one to turn away from new opportunities – driven by a passion and a desire to try new things, his energy and impatience have fuelled an innovative combina-tion of projects. He has an excellent reputation in the research community, with results that have even been called pioneer-ing. For instance, his research was recently highlighted at a conference in Australia for 20,000 researchers.

“What a nerd!”It was not written in the cards that biochemistry was the path for Jes-per Eugen-Olsen, and in order to find out how things turned out the way they did, we need to travel further back in time. And like most of the other choices Jesper Eugen-Olsen

had made in his life, it was again pas-sion that was the motivating factor.“Towards the end of sixth form, I was just so fed up with school. I just didn’t feel like going, and I wasn’t doing that well academically either. Then one day I visited a friend who hadn’t been to school for a couple of weeks. When I got to his place, I found him sitting in candle light reading a pile of thick books,” he says. They turned out to be books on biochemistry, and Jesper Eugen-Olsen’s first thought was “What a nerd!”, as he put it.“He was fascinated by these books and talked me into reading a couple of them, and that’s when a light went on in my head. I remember thinking it was like exploring the inner universe.

When you look inwards and start ex-ploring the body, it’s like looking up at the stars. It’s just as big a universe that goes on and on,” he explains. From here, the path to studying biochemistry at university was set in stone, and even though Jesper Eugen-Olsen has been a dedicated and passionate researcher, he is far from the stereotype – more like the opposite.

It takes at least 10 yearsLife as a researcher requires a great deal of patience. It can easily take 10 years to go from a result to actually implementing it, work-ing with it and seeing its effects in reality. This came as a surprise for Jesper Eugen-Olsen, who had imagined a completely different way of applying the results from research that could help people in the real world. So when he achieved brand new results 14 years ago, he ran down to his professor and PhD supervisor, Jens Ole Nielsen, threw open the door and shouted enthu-siastically that this could really help

people. He clearly recalls his profes-sor’s reaction:“He patted me quietly on the back and said, it looks fine, and we could continue researching it. He explained to me that implementation was at least 10-15 years way, and I couldn’t believe it. But he turned out to be right.”What Jesper Eugen-Olsen had dis-covered at the time was a protein in the body that reveals our pre-disposition to disease and also our life-expectancy. He invented the so-called suPAR test, which meas-ures the suPAR protein and can give an indication of a person’s genetic predisposition. The test can be used in connection with diseases like AIDS and tuberculosis because it is pos-sible to measure whether specific types of medications will work and then target the treatment accord-ingly. This inspired him. He wanted to use his knowledge to help people all over the world, and Africa was particularly close to his heart.

Finally in Africa“The objective of my research has always been to help people who are less well off. Just imagine how much it could help people in developing coun-tries to know what medications work for the individual and, especially, which don’t. This could save a lot of money as well as saving lives,” he says.

Jesper Eugen-Olsen on stage at the concert “blood in bredgade-friday the 13th”.

“We’d applied for the funding, but never thought we’d actually get it.

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People

Jesper Eugen-Olsen had a mission. He wanted to use his research findings to help people, but the pharmaceuti-cal industry is not exactly an aid organisation, so he had to patent his research to ensure that it was not picked up by some giant corporation and used for monetary gain. Ten years ago, patenting research results was not customary and prohibitively expensive, so Jesper Eugen-Olsen had to think creatively to generate the capital he needed. One of Jesper Eugen-Olsen’s mottos has always been to make sure to have the best possible team, and so he found two people who knew all about applying to foun-dations and generating capital for research projects. He managed to obtain the patent, and it ultimately formed the basis for Jesper Eugen-Olsen’s company, ViroGates, which today works with the suPAR test. Today, the test he developed 12 years ago through his research is a reality, so Jesper Eugen-Olsen’s professor was correct in his prediction that it would take at least 10 years. The company is very successful, and he has managed to uphold his ideal of helping the less fortu-nate. He will shortly be returning to Kenya, where he will be supervising trials of the suPAR test at two hospitals.

Do whatever you want Think outside the box. This is Jesper Eugen-Olsen’s ap-proach to life as the way to make things happen. And as a living example of this philosophy, he currently owns several companies that deal with very different things. For example, he joined forces with Bjørn Vidø to estab-

lish the company BioLogicMedia when he grew tired of the long academic reports that his research is inevita-bly associated with.“You can spend hours and hours on such reports, which will only be read by a handful of other researchers. I want to bring exciting research findings to the people and communicate things so anyone can understand them. There is storytelling in everything – also in bio-chemistry, and that’s what I want to share,” he says. So the natural step – at least for Jesper Eugen-Olsen – was to start a media company that produces short vid-eos on research, both for his own company, ViroGates, but also for many other biotech and pharmaceutical companies. Today, their customers include Abbott, Novo Nordisk and the Chinese company BGI. Musician on world tour, trailblazing researcher, PhD fel-low, entrepreneur, filmmaker, we could go on and on. It is difficult to put a label on Jesper Eugen-Olsen, and it is probably best not to try. For as he puts it, he is just a guy who does what he wants without harming others.

Jesper Eugen-Olsen: “I gave a talk on suPAR, we played a punk-rock concert and audience were offered suPARnostic testing”.

“There is storytelling in everything – also in biochemistry, and that’s what I want to share

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suPARnostic® - the risk status marker

The novel biomarker soluble urokinase Plas-minogen Activator Receptor (suPAR), which is found in every individual, forms the basis of the suPARnostic® product.from Danish ViroGates A/S.

suPARnostic has a unique value as biomarker: Independent of the respective condition, an elevated suPAR level carries a negative prog-nostic value and is thus a master alarm forpatient risk status.

Jesper Eugen-Olsen is joint owner of Viro-Gates, an international Medtech company headquartered in Copenhagen, Denmark who has developed and distributes suPARnostic.

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Manufacturers of medical devices are responsible for the quality and safety of the products they market. This also applies to any single component that is used in the device, as well as in cases where particular components are supplied by subcontractors. Henrik Kvistgaard from Medical Device Consult (MDC) has specialised in provid-ing technical advice on obtaining and maintaining certifi-cations in the medtech industry.

“There is definitely a trend towards subcontractors trying to get a competitive edge by establishing diligent quality management systems (QMS) that live up to the standards that are applicable to their customers, the medtech manufacturers,” says Henrik Kvistgaard, CEO at MDC.

He adds:

“It is a competitive advantage to have taken up the challenge and hard work of for instance obtaining the applicable ISO certifications. It attracts more business, and is thus an investment for the subcontractors.”

Projecting responsibilityAt the Danish Notified Body, DGM, which provides cer-

tifications of medtech companies, the trend has been spotted, but as such it does not change how they work.

“Patient safety is what is at stake here, and clearly that is what the law reflects. It’s only natural that the requirements of the law are projected into the de-mands a medtech manufacturer has to its subcontrac-tors,” according to DGM.

Peter Carlfors, Swedish Standards Institute, adds:

Medtech subcontractors with a competitive head start In a highly competitive environment, the trend is for subcontractors to document quality management systems at the same level as medtech manufacturers. By Charlotte Strøm, MD, PhD, Journalist . Translation: CLS Communication A/S

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“In principle it’s easier for a manufacturer to ensure the quality and safety of the end product with a selec-tion of subcontractors who can document compliance with an applicable QMS.”

The name of the gameHence, subcontractors have a head start compared to competitors if they can document that the QMS systems are in place. Scalae, an MVA-based product development company, offers a full range of services in product development and production, and QMS is an incorporated part of the business.

“It’s about making the customer and the customer’s customer feeling safe. Even if we, as a subcontractor, are far from the end-user, his or her safety remains the focus of our efforts on keeping up QMS,” explains Peter Arndt, co-founder and Marketing Director, Scalae.

Peter Arndt continues:“I would go so far as to say that if you are a medtech

subcontractor and not certified, it is really difficult to be a serious partner in the match, because the custo-mers are growing used to only selecting subcontractors that can document their QMS and compliance with the standards.”

Peter Arndt has worked in the medtech and life sci-ence industry for about 10 years. He points out that

there is also a downside to the increasing demands that are placed on manufacturers and projected downwards.

“It takes more time to ensure the ultimate goal of safety, and it gives less freedom in the process. Time is money, so the result is production at a slower rate and higher cost but with a continuously high standard and focus on safety,” says Peter Arndt.

Changes ahead There is an ongoing discussion about the differences between CE labelling of medical devices in the EU versus the US, respectively. The trend is that products are more rapidly being approved for marketing in the EU; however, some argue that the FDA (the American Food and Drug Administration) conducts a more thorough and thus safer assessment of medical devices before

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It takes more time to ensure the ultimate goal of safety, and it gives less freedom in the process.

38

they are marketed. A recast of the European medical devices directives has been in the works for some time now and is likely to affect manufacturers as well as their subcontractors.

The Danish association of the medtech industry, Medicoindustrien, is very happy about this outlook for the EU.

“We have been waiting for this recast of the direc-tives for some time now. The industry’s concern is that a tightening will raise the bar considerably for the medtech industry,” says Morten Rasmussen, Communi-cation Officer, Medicoindustrien.

According to the Notified Body, DGM, the legislation is being revised by the EU in order to reduce risk and reflect past experience. An example of this is the revi-sion of the classification of breast implants because it became clear from vigilance reports that there had been problems in the past.

Henrik Kvistgaard at MDC is certain that any upgrad-ing or tightening of the rules and regulations that apply to the medtech industry will simultaneously affect the layer of subcontractors:

“A tightening of the demands is likely to give compa-nies with certifications and QMS in place an even bigger head start, because getting there is a time-consuming and laborious process.”

Upgrading knowledgeMorten Rasmussen at Medicoindustrien confirms that overall the development, manufacturing and marketing of medical devices has become more complex over the years.

“For some time now, we have successfully organised courses for our members for training in regulations and guidelines, including those that are applicable to over-view subcontractors. And we see an increase in demand for upgrading employee competencies in this field,” says Morten Rasmussen.

The Notified Body, such as DGM, that provides the manufacturer or subcontractor with the specific cer-tification maintains a dialogue with their clients on this subject, however counselling is not their business.

“DGM is willing to discuss with the applicant which focus areas they should concentrate on, also among subcontractors. However, DGM can only point the organisation in a certain direction. They cannot offer any advice or consultancy on how to obtain the QMS,” according to DGM.

Henrik Kvistgaard at MDC confirms that both medtech companies and subcontractors are heading down the road of increasing focus on certifications.

“It takes a while to learn how to navigate this field of expertise and to understand fully how to implement the QMS and operate it as well-known and familiar proces-ses. So implementation of QMS is just as important as aiming for establishing a QMS,” Henrik Kvistgaard says.

ISO certificationsISO 9001 and ISO 13485 are the most common and relevant certifications among medtech manufactu rers and hence their subcontractors. ISO 13485 is an ISO standard published in 2003 that represents the re-quirements for a comprehensive management system for the design and manufacturing of medical devices. ISO 13485 is generally harmonised with ISO 9001. A fun-damental difference, however, is that ISO 9001 requires the organisation to demonstrate improvement on a continuous basis, whereas ISO 13485 only requires that they demonstrate the implementation and maintenance of the quality system.

Certified CSRCertifications in other areas like CSR (Corporate Social Responsibility) reflect that CSR is increasingly acknow-ledged as a management tool. The designation for cer-tifications in CSR is DS 26001 or ISO 26000. DS26001 is a further development of ISO 26000 and is applicable across business areas. As something new in ‘the jungle of doing good’ the DS 26001 set up a framework for what CSR is and allows for a certification of an organi-sation in order to document that their CSR work is seri-ous and trustworthy. However, as DS260001/ISO 26000 have been introduced only recently (December 2010) the effects on the industry and potential subcontractors remain to be seen in the years to come.

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DGM is willing to discuss with the applicant which focus areas they should concentrate on, also among subcontractors.

3939

He explains that the benefits of seeking professional advice on these matters are that the trademark is thought into a strategy that is inter-cepted with the business plan.

The services rendered by DELA-COUR DANIA thus comprises build-ing a trademark strategy, searching databases globally on potential name inflictions, applying for trademark registration, overseeing the mar-ketplace regarding violations of the client’s IP rights, and furthermore react and prosecute when necessary.

Think trademark registration upfrontThe best advice that lawyer and IP rights expert Johnny Petersen at DE-LACOUR DANIA can give to entrepre-neurs in life science is to think about trademark registration from day one.

“You don’t want to miss this boat. There are way too many examples of how damaging it can be to either ig-nore the trademarks of your business or postpone the handling of them, perhaps thinking that it can wait a few years until you have established the business further. At that time it may be too late,” Johnny Petersen concludes.

how a trademark is acknow ledged in one country from another.

“In some cases making use of the name and being able to document it will in itself grant a trademark pro-tection. Often, however, you have to apply for a registration of a trade-mark,” Johnny Petersen explains.

Relatively small investmentHe points out that the investment, eg around DKK 10.000 for a European trademark registration including the fee for the lawyer, remains very small compared to how costly and dam-aging for any business, trademark, brand violation, or even theft is.

“Businesses that have worked hard to build their success in the market on a particular quality of the pro-duct and brand are almost inevitably exposed to copying and trademark violation,” Johnny Petersen says.

He carries on, “Currently China is the place in

the world where most companies in all industries experience trademark violation and theft. Some run into problems that are self inflicted be-cause they have ignored the Chinese market and not sought trademark registration here in due time. Others are clearly victims of extortion.”

Trademark strategyThe examples from above serve as a reminder to Johnny Petersen’s clients on carefully assessing their business now and some years down the road.

“Trademark registration should be anchored in the commercial reality of the company and hence it is valuable to take a closer look at the business plan. What is product now – are more coming? What is the current market – and what are the future markets?” Johnny Petersen says.

By Charlotte Strøm, MD PhD Journalist

Protection of IP rights is not pre-cluded large companies. Startup businesses ought to pay carefully attention to the trademark situa-tion and the life science industry is no exception in this context.

Johnny Petersen is a lawyer and partner at the law firm DELACOUR DANIA. He has worked with IP rights for thirteen years and as an expert within this area he advises small and midsize startup businesses. He ex-plains why these companies have his particular interest and focus.

“Very few small startup companies have the in-house capacity to oversee the trademark situation in an Euro-pean and even less so a global setting. So this is where my advice really makes a difference,” Johnny Petersen says.

European registration Trademarks are hardly ever re gistered nationally. In the EU a central registra-tion provides trademark protection in 27 countries in one go, whereas outside the European continent, trademarks are generally registered by each nation. Furthermore it varies

Business Profile

® - A small but significant difference for protection of IP rights

ABOUT DELACOUR DANIADELACOUR DANIA Limited partnership law company has offices in Aarhus, Copenhagen, Nuuk, Tórshavn, Moscow, Kiev and Warsaw and some 200 employees, of whom approxi-mately 80 are lawyers. More information about DELA-COUR DANIA and its services may be found on:www.delacourdania.dk.

Startup companies should pay attention to and invest into their trademarks right from the early beginning. It pays off.

Johnny Petersen, lawyer and partner

40

By Charlotte Strøm, MD, PhD, Journalist

The medtech is facing increasing challenges with regard to meeting regulations, standards and require-ments for international certifications and marketing approval of medical devices and in vitro diagnostics (IVD). MVA-based Medical Device Consult (MDC) has specialised in providing technical advice on ob-taining and maintaining certifications in the medtech industry.

In addition to general requirements and practical issues related to setting up, managing, and maintaining a qual-ity management system (QMS), the medtech company must also meet certain demands concern-ing the type of device in question.

“Electrical devices, diagnostic kits, implantable devices etc. – they each face specific require-ments in addition to the general international specifications per-taining to medical devices,” explains Henrik Kvistgaard, owner of Medical Device Consult.

A jungle without short cutsHe realises his expertise is highly specific and that his success is partly driven by the difficulties his customers have finding their way around the laws, regulations and standards.

“For many customers this is something

of a jungle, and that’s actually quite understandable,” Henrik Kvistgaard says.

However, acknowledging that there is no shortcut provides the foundation for fruitful collaborations:

“MDC provides very specific competencies and years of experience that we hope to be able to match at

some point. Presently, a successful and efficient model for us has been to in-source the exper-tise provided by MDC,” says Bjarne Bo Jensen, CEO at HertART

Customers come from all over the world and the assignments vary greatly, ranging from minor

issues that need to be resolved over acute pre-audit or pre-inspection evaluation and assessment

to setting up, implementing and maintaining a full quality management system.

Quality can’t waitHenrik Kvistgaard is some-times urgently involved in late-stage projects but he prefers timely involve-

ment. “Very often it’s easier –

and cheaper I might add – to reflect on quality management

systems and the establish-ment of the required technical

dossiers upfront,” he says and continues,

Competent navigation ofstandards and certificationsCompliance with the regulations for medical devices and diagnostic kits can be somewhat of a maze. Medical Device Consult has specialised in helping the medtech industry meet international requirements for approval of medical devices in the EU and USA.

Business Profile

Photo: ScanStockPhoto

41

“When I don’t get involved until a late stage, we may have to find temporary solutions that will require more work later.”

His point is that quality can’t wait. In his opinion it is time saving and much more efficient to ensure that QMS is in place at an early stage of the production process.

Staying updated in the nicheHenrik Kvistgaard has more than 18 years of experi-ence from the medtech industry. He has successfully been in charge of MDC for four years, since he took over the business from the founder, Vivi Thulstrup. He is a mechanical engineer by trade and staying up-to-date is part of his job. Henrik Kvistgaard continuously educates himself within his area of expertise, keeps track of news from regulatory authorities and certi-fication bodies on an international basis and attends courses and conferences.

“Working in a niche area allows me to dig deeper and provides a fundamental insight into the challenges of my customers,” Henrik Kvistgaard concludes.

About Medical Device Consult (MDC) MDC is s a Danish based and globally operating consulting company that has specialized in as-sisting Medical Device and In-Vitro Diagnostic companies in meeting US & European regula-tory and Quality System requirements

MDC can assist through interpretation of the regulatory requirements relevant for the product in question and a range of services to facilitate the CE marking process in Europe or the 510(k) & PMA process with US FDA

MDC was founded in 1995

For more information: medecon.dk

Business Profile

42

A group of researchers at the University of Copenhagen’s De-partment of International Health, Immunology and Microbiology, led by Professor Allan Randrup Thom-sen, has found a new strategy for controlling viruses—a vaccine that can be kept in readiness to fight any influenza or impending virus pandemic whatsoever.

In addition to Professor Allan Ran-drup Thomsen, the research group consists of associate professor Jan Pravsgaard Christensen and Peter Johannes Holst, a post-doctoral student. It was Peter Johannes Holst who, back in his study days, had the idea, which has proved to have exciting prospects. The University of Copenhagen has obtained a patent on the vaccine construct, and further research has shown that, in principle, it can also be used to fight cancer and

provides scope for developing indi-vidual vaccines.

Conventional vaccineAn ordinary, conventional vaccine consists of antigens, which induce antibodies aimed at a particular antigen. It is difficult to manufac-ture a vaccine for multiple viral diseases, as viruses have a ten-dency to change, or mutate. So developing a new influenza vac-cine, for example, always takes a certain amount of time because the influenza virus is a virus that changes, so it is not always known exactly what the virus looks like. The new vaccine construct is based on an altogether different principle, which stimulates our own immune defences to fight infec-tions.

The reverse principle ”The reason for us having to be vaccinated against flu every year is that the protection offered is based on antibodies against par-ticular molecules on the surface of the virus structure, but these molecules are constantly changing. Once the population has become immune to a variant, a new vari-ant crops up, so there will always be new virus variants to vaccinate against, year after year,” says Pro-fessor Allan Randrup Thomsen. What Professor Allan Randrup Thomsen and his group want is to try and reverse the entire pro-cess: instead of making an anti-body-based vaccine, which con-stantly has to be adapted to new variants of virus, they are making a vaccine that induces T-cell medi-

42

New vaccine constructopens up exciting new vistasIn future, perhaps we can avoid the world panicking about new virus infections like swine flu, as happened in the summer of 2009, or diseases like SARS, bird flu or other new viruses.

From left: Peter Johannes Holst, Prof. Allan Randrup Thomsen and Jan Pravsgaard Christensen. Department of International Health, Immunology and Microbiology, University of Copenhagen

By Jorun Christophersen, JournalistTranslation: CLS Communication A/S

“ In principle, we could make a

vaccine that would work on all

strains of influenza

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“ Firstly, a cell-mediated

immune response to the

influenza virus is not

quite as effective as the

antibody-based one.

ated immunity. That is to say that the organism’s own im-mune defence is stimulated to fight the infection. T-cells, unlike antibodies, are able to recognize any gene product whatsoever in a virus – virus molecules, both those on the cell surface and those on the interior. The inter-nal molecules have not been subject to the same selection pressure as those on the sur-face targeted by conventional antibody vaccine. As a result, they are more alike, anything up to 80-90% identical in fact, whereas the surface molecules are right down there at 15-20%, which in principle means they are absolutely nothing like one another.”If we can raise a powerful T-cell response to the internal virus molecules or genes, then at least we’ll have a period until the virus has learned to adapt to this process, assuming it is even capable of doing so. We have a head start. In principle, we could make a vaccine that would work on all strains of influenza,” says Allan Ran-drup Thomsen, adding the words ”in principle”, because it’s not without its problems, of course. But all the indications are that they have devised what is called a naked DNA vaccine, which can probably be used for many different illnesses, right from cancer to malaria. At the same time it also offers possibilities for devel-oping individual vaccines.

Conventional vaccine versus cell-mediated immunity”Firstly, a cell-mediated immune response to the in-fluenza virus is not quite as effective as the antibody-based one. That is to say that the antibodies prevent you from even becoming infected, and hence ill—whereas with T-cell mediated immunity, virus has to get into the cells before they can attack. I.e., you get poorly rather than sick,” says Allan Randrup Thomsen.

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Figure 3-19 The Immune System, 2/e (© Garland Science 2005)

If you are familiar with the influenza virus that is coming, therefore, it is better to make a conventional vaccine with an antibody response that prevents peo-ple becoming infected in the first place. But in those instances where the virus is not actually known, it is better to be slightly ill than to be very ill and possibly even die from it.”This is where our new vaccine can enter the picture. In principle, it could be kept on hand, in stock, ready for a situation where a hitherto unknown virus crops up, when we can experience a pandemic. That was what happened, for instance, in Mexico in 2009, with the advent of an entirely new influenza variant from pigs. There was no way of predicting that,” Allan Ran-drup Thomsen says.In cases like that, we’re already losing the race to produce a vaccine that matches the new virus. In such instances the new vaccine offers a great advantage, even though it is not quite so effective as a classic antibody-based vaccine. But in these cases, no such vaccine exists anyway. So in the case of the new vac-cine principle, where the immune apparatus and the T-cells are battling the infection at an early stage, people do fall mildly ill, but it is possible to prevent drastic mortality from occurring.”On the basis of the trials that have so far been con-ducted on experimental animals, that can be predicted at any rate. The vaccine principle also appears to have a positive effect on controlling cancer cells, which we are well underway investigating. Although the principle is not supposed to work for flu, for some reason or other, the concept is relevant to all viruses with a mix-ture of variable and more constant genes, in principle,” says Professor Allan Randrup Thomsen.

New vaccine principleThe new vaccine construct is based on a linkage between a gene sequence from a virus and a protein, called invariant chain, found naturally in the cells. The

linked molecule presents the antigens to the cell-mediated immune apparatus. It has proved to have a great effect on the immune defence and the immuno-logical memory. At cell level the process takes place with the invari-ant chain acting as a locomotive and ensuring that the linked antigen molecule is transported around, func-tioning optimally inside the cell. In graphic terms, the cell can be compared with a high-rise block contain-ing lots of apartments. The invariant chain is used to yank the antigen into precisely the right apartment to ensure that the facade – the cell wall – gets plas-tered with antigen, Professor Allan Randrup Thomsen explains. ”We piggy-back, as it were, along the transport routes that already exist, of which the invariant chain forms part. That leads to increased antigen expres-sion, without our fully knowing the molecular details. Whereas the antigen will normally traffic somewhere random in the cell, our linked antigen now follows the same route as the chromosomes’ invariant chain and, bound to an MHC class II molecule, it is presented on the cell surface,” explains Professor Allan Randrup Thomsen (Figures 3-19 and 3-20).This process stimulates what is called CD4+ help for the so-called CD8+ T-cells, popularly referred to as ”killer cells”, as they ’dissolve’ the infected cells. The CD4+ help appears to be a determinant of the quality of immunological memory with which one is endowed.As sometimes happens in biological research, un-expected results materialize. Apart from the fact that the experiments show a marked increase in the CD4+ response, an even better CD8+ response also occurs—that is to say, an increase in the cytotoxic T-cells, which express the protein CD8 on their sur-face and are those that kill virus-infected cells or cancer cells. The CD8 + cells bond with the MHC class I molecules and fight the intracellular antigens (Figure 3-19).

44

Figure 3-20 The Immune System, 2/e (© Garland Science 2005)

45

The graph shows how CD4+ and the CD8+ response increase in experiments with mice following vaccination with the new vaccine construct. The response falls off after a couple of months but remains at a higher level than before the vaccination.Holst et al, ©J. Immunol. (2008) 184:3339

OCTOBER 31–NOVEMBER 2, 2011DUESSELDORF, GERMANY

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OCTOBER 2011October 6Webinar: A Picture is worth a Thousand Words - Optimize your Communication with Investors, Customers and Public StakeholdersThe webinar will help you understand how state of the art digital content can help you communicate with investors, customers and public stakeholders in a reliable, easy to understand and value-based manner. Venue: Your personal computerTime: 15.00More information: www.mva.org/calendar

NOVEMBER 2011November 2Good Morning Meeting, Ideon, LundThe objective of the Good Morning Meetings is to improve knowledge and competences among Medicon Valley’s companies and organisations. The theme is to be decided by Høiberg A/S. More information on this event will be available soon online.Venue: Agora/Forum conference room, Ideon, Scheelevägen 17, LundTime: 8.00-10.30More information: www.mva.org/content/us/initiatives

Events by Medicon Valley Alliance

November 9Good Morning Meeting, COBIS, CopenhagenThe objective of the Good Morning Meetings is to improve knowledge and competences among Medicon Valley’s companies and organisations. The theme is to be decided by Høiberg A/S. More information on this event will be available soon online.Venue: COBIS, Ole Måløesvej 3, CopenhagenTime: 8.00-10.30More information: www.mva.org/content/us/initiatives

November 10Introductory MeetingAt this meeting we welcome both members and non-members who would like to know more about how to benefit from a membership of Medicon Valley Alliance. If you are considering membership and would like to get more details, this is also an excellent opportunity to find out more and discuss the various opportunities with us.Venue: Arne Jacobsens Allé 15, 2300 Copenhagen S, DenmarkTime: 15.30-18.00 (Join us for coffee and networking already at 15.00)More information: www.mva.org/calendar

November 24Boost seminar: Outsourcing to the East, ØrestadThis Boost seminar is organised by MVA in partnership with our member Pharmacosmos Cro and is free of charge for members. More information on this event will be available soon online.Venue: Main Auditorium, Edvard Thomsens Vej 14, Ørestad/CopenhagenTime: 9.00 – 14.00More information: www.mva.org/content/us/initiatives

November 25Boost seminar: Outsourcing to the East, Sweden This Boost seminar is organised by MVA in partnership with our member Pharmacosmos Cro and is free of charge. More information on this event will be available soon online.Venue: To be decidedTime: 9.00 - 14.00More information: www.mva.org/content/us/initiatives

DECEMBER 2011December 1Annual Meeting, Lundbeck, ValbyMedicon Valley 2020: The Attractiveness of Medicon Valley and the Challenges AheadThe theme of the Annual Meeting 2011 is about ensuring the attractiveness of Medicon Valley in the years to come. The keynote speaker will be Mr Jan Leschly, Chairman and partner of Care Capital. Presentations will also be given by representatives from Merck Serono Ventures and LEO Pharma. The Annual Meeting is also an excellent opportunity to network with other life science professionals in Medicon Valley.Venue: Main Auditorium, H. Lundbeck A/S, Ottiliavej 9, Valby/CopenhagenTime: 13.30 – 19.30More information: www.mva.org/AM2011

Upcoming Events and new members

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Expand your network:Latest members of Medicon Valley Alliance

Oracle Danmark ApSwww.oracle.dkOracle provides the world’s most complete, open, and integrated business software and hardware systems, with more than 370,000 customers—including 100 of the Fortune 100—representing a variety of sizes and industries in more than 145 countries around the globe. Oracle’s product strategy provides flexibility and choice to our customers across their IT infrastructure.

Sparta Systems Europewww.spartasystems.comSparta Systems TrackWise® Enterprise Quality Management System helps pharmaceutical & biotechnology industries address complex challenges by providing centralized and consolidated tracking, workflow management and regulatory reporting for all critical business processes affecting global pharmaceutical and biotechnology manufacturing operations.

IWA Consulting ApSwww.iwaconsulting.dkIWA Consulting provides healthcare companies with assistance in regulatory affairs and expert advice and assistance on all European procedures. IWA Consulting has more than 30 years’ experience in medical and regulatory affairs based on previous corporate experience in both Europe and the USA, making the company eminently qualified in drug development, submission strategies and eCTD filing in the EU and the USA. Within the last three years IWA Consulting has run more than 100 EU procedures and prepared more than 1200 eCTD sequences including life-cycle management. In 2009 the Company was ISO certified (DS/EN ISO 9001:2008).

BUCKY’o’ZUN ApSwww.bucky.dkThe BUCKY’o’ZUN company relies on the invention of a new technology, which as the first product in the world is able to protect 99.99 % against UVA-, -B-, -C- and –D-radiation. One of the problems caused by UV-radiation is the development of skin cancer hence the primary goal of BUCKY’o’ZUN is to provide complete protection against skin cancer. The decomposing and fading of various materials are also caused by the UV-radiation. The BUCKY’o’ZUN technology solves these problems due to its ability to protect humans and materials fully and continuously against all UV-radiation.

Swedbank ABwww.swedbank.seSwedbank s Healthcare Sector is situated within the Division Large Corporates and Institutions(LC&I). We are 3 Client Executives and 2 Analysers. Our Sector Head is Conny Granelli. Our customers are preferably listed companies in the Healtcare Sector. We are situated in Stockholm and Malmö.

Unigroup ApSwww.unigroup.dkUnigroup ApS develop and market indication based medical devices, primarily within dermatology. We focus our development activities within non-prescription OTC and market our brands towards pharmacies. Unigroup ApS bridge the gap between science and the market, using our knowledge to fast track new products from idea to the end-user. Our in-licensing activities span a number of partners, which we represent in the Nordic countries. Indication areas includes: Chicken Pox, Labial Herpes, Throat Infection; Pediculosis, Verruca and Nail Fungus. We are based at Scion DTU, Lyngby, DK).

IRW Consulting Apswww.irwcro.comIRW is a Nordic full-service Clinical Research Organization with more than ten years experience and local offices in Sweden, Denmark, Finland and Norway. We offer solid know-how and experience of clinical research, data management, biostatistics and pharmacovigilance for global and small pharma, biotech and the medical devices industry. We are experts in interacting with Nordic regulatory authorities. IRW covers the full range of CRO services throughout your products’ lifecycle, for studies of all sizes and all phases, acting as a full-responsibility partner or provider of in-sourced expertise.

Kommunicera Communications ABwww.kommunicera.seKommunicera Communications Group is a leading provider of language services and content development services to the European business community. Kommunicera and Lingtech in Denmark have supplied specialized translations and other services to the life science industry for more than 15 years. Kommunicera Communications Group work with all different kinds of documents and content including protocols, product résumés, SOP, IFU, patents, web-sites, reports and internal and external communications for pharmaceutical companies, medical device companies and others within the industry.

Miller Rosenfalck LLPwww.millerrosenfalck.comMiller Rosenfalck is a full service English law firm specialising in international trade and business migration within Europe and beyond.We offer guidance and advice on company set ups, corporate structures, inward and outward investments, commercial contracts, dispute resolution, intellectual property and employment law with in-depth knowledge of cross border issues.With our headquarter in London, our experienced multilingual team is on hand to advise you and your business.

Raw materials. Service. Expertise.The fine art of pharmaceutical composition.It takes outstanding raw materials and great skills to create something unique. Which is what Merck Millipore does for you: by striking the balance between innovation and supply chain security, with services like EMPROVE® and extensive regulatory support. It’s how we find solutions together with you that contribute to the big picture: your success.

www.merck4pharma.com

Merck Millipore is a division of

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