LifeSciences Insight - No 3 - 2011
No 3 - 2011
The Magazine about Life and Science in Medicon Valley
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
Animation of the European Spallation Source in Lund
20: ESS will boost
future R&D in medicon valley
3: Give inventions back to the inventors Merck Millipore is a division of
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24: IPR – potential and pitfalls
42:
New vaccine construct opens up exciting new vistas
Contents
LifeSciences Insight no. 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 Frydendalsvej 3 DK-1809 Frederiksberg C Denmark +45 3326 9520 info@raskmedia.com www.raskmedia.com
The column - Give inventions back to the inventors Research highlights from Medicon Valley
Building Strong Ties between Strong Universities Cooperation 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 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. Biotech marketing must be razor sharp Claus 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 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.
Partners: Medicon Valley Alliance www.mva.org
IPR – potential and pitfalls Professional guidance is necessary to work out the do’s and the don’ts in IPR.
EBD GROUP www.ebdgroup.com
Allocate time and resources to patenting Patience and resources such as money and manpower are required when patenting life science inventions.
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.
The biotech industry’s storytellers The 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.
Advertising: Sales Manager: Mads Elgstrøm +45 2887 0776 sales@raskmedia.com
People - A man out of the box Researcher, chairman of the board, scientific director of 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.
Cover photo: ESS, Lund, Sweden Photographer: Christian Hjorth Øhlenschlæger www.hjorth-photo.dk Layout and print: artegrafix and PE Offset, Varde
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. New vaccine construct opens up exciting new vistas In 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.
Next issue: November 2011 ISSN: 1904-4755
Upcoming events and new members of Medicon Valley Alliance XXX-XXX Printed matter
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Give inventions back to the inventors 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 university researchers no longer owned their own inventions. Instead 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 themselves whether they want to attempt to commercialise a project, they were now duty-bound to report new inventions to their institution. The brand new technology transfer unit would take care of any patenting and licensing requirements. Critics called this change in legislation 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 salaries 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
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 invention 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 community 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.
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Research highlights from Medicon Valley
By Susanne Bergstrøm Translation: CLS Communication A/S
Maternal smoking during pregnancy In collaboration with Finnish researchers, the Department of Growth and Reproduction at Copenhagen University Hospital – Rigshospitalet, has studied more than 3,000 young men with a view to shedding light on the possible 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 produce the male hormone testosterone. Maternal smoking reduces the active and available share of testosterone, resulting in boys starting puberty earlier and subsequently 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 concentration. 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.
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Lactobacillus plantarum HEAL 19 is a beneficial bacterium 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 researchers and the pharmaceutical industry with enormous 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 deficiency Menkes 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 gene A 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 motivated to quit smoking, according to one of the resear
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 followed 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 smokers 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 babies Researchers at the Department of Health Sciences, Lund University, who discovered HAMLET (Human Alfalactalbumin Made LEthal to Tumour cells) in 1994, a component 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 attention 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 cell For 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. In this way, the cells have proven to be particularly
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receptive to instructions. The discovery is a significant step towards the goal of creating nerve cells for transplants that come directly from the patient. The vision is to be able to do a biopsy, generate new cells and transplant 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 SLE The 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 University, 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 twothree 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 way With the creation of synthetic biomolecules, a chemist from the Department of Chemistry, University of Copenhagen, 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. However, this substance is so fragile that it has been impossible 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 exactly 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 organism Nature’s plants have potent toxins that not only protect 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 Sciences, University of Copenhagen, now have a new technique 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 metabolism of a drug through an organism, in this case laboratory 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 drugs Today, 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 effective 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 proteins. Today, it is unclear whether this process effectively 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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The scout molecules of the immune system Our 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 Clinical Immunology, Copenhagen University Hospital – Rigs hospitalet, have discovered that under certain conditions, 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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manipulating how the scout molecules cooperate in order to boost or suppress the immune system.
Breast cancer gene Hereditary 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 braking mechanism is vital as cells containing damaged DNA can develop into cancer if they are permitted to divide unchecked. Researchers at the Biotech Research and Innovation Centre (BRIC), University of Copenhagen, have now uncovered the mechanism behind the process. Using new technology to screen known cancer genes, researchers 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 mutations 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 clots A coronary thrombosis produces scar tissue which can subsequently cause heart failure and increased mortality. The Heart Centres at Copenhagen University Hospital – Rigshospitalet and Aarhus University Hospital – Skejby 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 patients who received injections of Byetta had 19 per cent more heart muscle left. In the future, international patient trials will be carried out, funded by the pharmaceutical industry. How ever, it will take between three to five years to determine whether the method will become a standard part of the treatment of blood clots in Denmark.
Source: www.videnskab.dk Experimentarium News Politiken [Danish daily newspaper] Lund University University of Copenhagen Technical University of Denmark
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Building Strong Ties between Strong Universities With 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. By Steven Kjeld Christensen Translation: CLS Communication A/S Both the UBC and KU are universities with strong faculties within the pharmaceutical sciences; however a joint venture can significantly strengthen their profiles. At least
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. Tectra has three main functions: 1. Business-related utilisation of inventions, including patenting and commercialisation 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 following main focus areas: · Evaluation of new inventions, including preparation of market analyses. ·
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that is the motive behind a new Statement of Cooperation signed by both faculties. The Statement of Cooperation marks the beginning of a collaboration in which both faculties expect not only to exchange knowledge, but also develop collaborative research projects and exchange students, scholars, faculty and post-doctoral fellows. Even though the initial agreement is for five years, Professor Sven Frøkjær, Dean of the Faculty of Pharmaceutical 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 Steps A 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 professors 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 Facilitator The Life Science Ambassador Program has been the
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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
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 introductions, 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 further 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 Cooperation The Faculty of Pharmaceutical Sciences, University of British Columbia, and the Faculty of Pharmaceutical Sciences, University of Copenhagen, will explore areas of potential collaboration with respect to the following activities:
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Second-cycle degree project at Lund University The 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. By Eva Tiwe Translation: 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
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the opportunity to be a supervisor for these degree projects,” says Bo Ahrén, Dean of the Faculty of Medicine, in a newsletter. “By involving ourselves in supervising clinical or experimental 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 motivated 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.
“And it’s not only students for whom this is an opportunity,” 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 students 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
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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 supervised 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.
Martin Garwicz, professor of neurophysiology at Lund University and coordinator of the development of the new course
New project database
Bo Ahrén, Dean of the Faculty of Medicine
The 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 scientific 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-
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2C will go the entire way from concept to production including testing and production facilities.
Photo: Lund University
A circulating cancer cell found by CytoTrack, the rare cell detection instrument invented and developed by 2C. A breakthrough in cancer research.
Test equipment for development of medical devices.
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Lund University
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Flying high in Business and Research
sors can assist students with their projects. Experienced supervisors emphasise the importance of finding the projects they are supervising interesting, so that the work does not feel tedious. “A project database will be set up to facilitate contact between students and prospective supervisors,” says Garwicz. Supervisors will be able to add project descriptions, 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 Garwicz. 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 programme in future.
BIOTECHNICA 2011 The focus themes at BIOTECHNICA 2011 are BioServices Biotechnological Innovation in Food Industrial Biotechnology The exhibition program includes: Bioprocessing Technology, Bioengineering, Bioinformatics, Bioanalytics, Services, Biotechnological Applications
Europe’s No. 1 Event for Biotechnology and Life Sciences
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biotechnica.de
Responsible officers in Lund and Malmö respectively: Elisabet.Holst@med.lu.se, Peter.Svensson@med.lu.se
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
Business Profile
Joint forces and competences yield synergy with a larger outreach 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. By Charlotte Strøm, MD Phd Journalist In July 2010 Merck KGaA acquired Millipore and in doing so Merck Millipore, the new division arising out of Millipore and elements of Merck KGaA’s life science products and services businesses, became a global supplier of innovative products used in research, formulation, and production by the life science industry. “The two product ranges combined within Merck Millipore are very complimentary. 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 Millipore 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 pharmaceutical products, in formulation,
upstream or downstream processing of raw materials through to API or drug product. The Millipore legacy is the hardware part of the business. The products are often customer specific solutions that are created to meet the challenges of a particular production.
Drug delivery system – new kid on the block Merck 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 Millipore 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 ahead On 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 solutions 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 employee I think it is very exciting times because I actually see the synergies 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.”
• Merck Millipore is the result of the Merck KGaA acquiring Millipore 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
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Biotech marketing must be razor sharp By Birgitte Aabo Translation: CLS Communication A/S
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.
“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 Affairs’ innovation centre in Shanghai, which works to attract Chinese investments, 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 November, he takes on his new role as managing director of Copenhagen Capacity, the capital region’s official investment and business promotion 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
made where the best and cheapest 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 opportunities. 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 marketing 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 refuse In actual fact, Claus Lønborg’s contract covered a longer stay in China: “But when a headhunter called me and I heard more about this
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 International 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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job, it sounded so interesting that I couldn’t say no. So now we’re uprooting 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 experience 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 Lønborg on his mobile from Shanghai.
Along the same lines At Copenhagen Capacity, they will not notice any major changes, however, 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, Copenhagen 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
managed to create more than 1,000 jobs, according to their own calculations. Claus Lønborg has defined some special focus areas. In addition to marketing, he points to, for example, 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.
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Business Profile
Think eCTD and get regulatory documentation right from the start Pharmaceutical businesses face different requirements with electronic drug product registration applications at international regulatory authorities. It is worthwhile to do things right from the beginning.
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 applications 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-application. 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 applications they are experts in the field. “We often assist small and midsize 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 Consulting operates globally with their main focus in Europe.
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.
Quality, safety, and efficacy The three cornerstones in a drug product application are the drug quality documentation, non-clinical, and clinical documentation of safety, and efficacy. At IWA Consulting they have made it their company pay-off. “We focus on quality in everything we do, and our clients can rest
Facts About IWA Consulting: • offers Medical and Regulatory 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 medicines 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 experts as employees • is located in Ølby nearby Køge, just off the highway connecting to Copenhagen from the South www.iwaconsulting.dk
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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 certification, 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 substance.” 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 demonstrate strong e-competences. Apart from putting together an application file for a drug product registration, the services of IWA
Consulting cover all regulatory activities during development and life cycle management of a medicinal 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 Copenhagen or they may work temporarily as in-sourced consultants at the client’s office.
Is paper out? As an applicant for a drug product 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 establish 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.
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The Baton
Medicon Valley, the natural place to be for ESS With 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 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 AllEngland championships, but for many years I held the distance record at this event for the county of Westmorland in the North-West of England. My active involvement 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-
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 importantly, 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 gathering 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
Photo: Animation ESS
Animation of the European Spallation Source in Lund. Scheduled plant opening 2019.
The Baton
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 science
CEO Colin Carlile at The ESS Industry Day in Copenhagen 2010
our budget and we want to have delivered on specification. And of course the finishing line is but the beginning for ESS. The long period of delivering scientific 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.
Neutrons 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 possible 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 assembly highlights those structures for study. Equally, neutrons can elucidate the crucial role of water molecules and hydrogen atoms in biological processes.
Why do we need the ESS? Currently, Europe has two major international neutron facilities – the Institut Laue-Langevin in Grenoble, France and ISIS near Oxford in the UK. Although
A tool for advanced science ESS 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? Before 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 materials, down to the scale of atoms. One of these techniques 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 biological molecules including proteins. When neutrons are scattered off an array of biomolecules, they pinpoint the spatial positions of the atoms to give a threedimensional structure of the molecular assembly. Measuring the accompanying changes in the energy of the neutrons can even detect atomic and molecular movements. In this way, researchers can probe biological mechanisms that are the basis of life.
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The Baton
regularly upgraded, both are several decades old. Requests 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 construction 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 research With 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 neutron 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 function Living 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. • Infection Many 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 passage 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.
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• Surgical treatments Neutron-scattering methods are essential for studying 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 health Neutron studies help in optimising the properties of many materials to improve health and safety – for example by reducing the toxicity of paints, cleaning-up contaminated soil, and improving the quality of food. In conclusion, ESS will provide unique research opportunities 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 discoveries and 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 scientists involved in the planning of the future ESS science. 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!
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-shapers 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 questions 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 Valley’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, innovation 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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Statistical discovery speeds up clinical trials Getting, 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. “Speeding up the process or enhancing the value creation 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 researchers, 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 cornerstone 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 approval 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 audience 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 horsepower 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
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 Nedbal 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 assessing 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 consultant Kasper Munck from NNE Pharmaplan speaking about how JMP supports cycles of learning within Quality by Design initiatives. The efficient exploration of opportunity 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 carefully 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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IPR – potential and pitfalls Patent 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, Journalist Translation: CLS Communication A/S
In the life sciences, as in any other business, it is value creating to spot potential and get inventions patent protected in a timely fashion. However, the discipline of Intellectual Property Rights (IPR) is also a matter 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.
Lars Petersen, CEO, CapDelta Group
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 access 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 perspective this could turn into a nightmare, because it can mean that the invention does not fulfil the novelty criteria, and as an inventor it is difficult to control. The best advice is to avoid disclosing anything prematurely, and only to do so after getting the appropriate confidentiality agreements signed,” Anne Schouboe says.
Avoid buying a pig in a poke She 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 companies go down because they didn’t perform careful due diligence in the patent situation. In one case, the patent legally belonged to a different 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 demands An invention must be novel. Se
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Getting the invention over the hurdle
Anne Schouboe, MD, European Patent Attorney, Plougmann & Vingtoft
condly it must have inventive step, meaning it should not be something that is obvious to a person of ordinary 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
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 commercialisation could be too difficult or costly. It takes money and this is usually a major hurdle. “Inventors have to find investors, 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 specifically assists inventors to shape inventions as business proposals and present them to investors and potential partners.
CapDelta Group typically enters 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 partners,” 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.
Inventors are often researchers or clinicians with a good idea that solves a clinical problem they face regularly. “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 sharing One could argue that the whole idea of IPR goes against the bold but strong research spirit which embraces sharing knowledge, leaving ideas available in open source, letting them flow freely benefit more people. Lars Petersen, CEO at CapDelta Group comments:
“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 invention 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 sharing even precedes inventions. The complete genome sequence of Mycobacterium tuberculosis was published in Nature by Cole and co-
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workers in 1998. And even though the word on the genome sequence was out and made publically avail able, researchers from SSI (Statens 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.
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, implying that it remains a good business case to do it,” Anne Schouboe says, continuing , “In such cases the larger companies have an advantage. Generally, it takes a lot of effort to control and enforce second medical use patents.”
When the party ends Pharma companies struggle to differentiate 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-
Pricy patents Filing 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 maintaining the patents. This depends
on how many and in which countries patent protection is sought but can amount to EUR 20,000 on a yearly basis and can be construed 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 ongoing issue,” says Anne Schouboe who acknowledges that most inventors at some stage are in need of business 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 vocabulary
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 concluded 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 initial 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 Office 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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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. tin (lowers cholesterol) and sidenafil (treats impotence) to show for it. At the expiry of the original pro ducts (Prosacâ/Fontexâ, Zocor â 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 science 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 inventions can be patented and where there is sufficient freedom to ope rate,” Anne Schouboe says, stressing 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 infringe existing patents that where unknown before the IPR specialist started looking for them. “It makes sense to prepare a map
enterprise
showing the landscape of where you are going before starting your journey, even if you have to further investigate how to get to your destination,” she says.
European trends Anne Schouboe has taken a special 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 science patents filed only nationally,” the European patent attorney says. At the moment, there is a discussion about establishing an EU patent court of law, and in accordance with that creating an ‘EU-patent’ in English. 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 countries in the local language. “Clearly, an EU harmonisation would benefit innovation as a whole. Today, too many hours are lost on
paper work and translation,” says Anne Schouboe.
Major mistake to miss out on BRIC However, in some cases filing applications 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 pharmaceutical companies that discover their products are being copied, produced, and sold in the BRICcountries and there is absolutely nothing they can do about it without 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 guidance 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. “Some small or mid-sized companies 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.
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Allocate time and resources to patenting By Charlotte Strøm, MD, PhD, Journalist Translation: 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 performing 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 application to a patent office describing your invention. It can be the provisional filing date of e.g. a US provisional 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 countries 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 performed using the Patent Corporation Treaty (PCT) if you file an international application. While this is ongoing (18 months) your invention remains confidential. Up until this date, the cost is approximately EUR 15,000-25,000.
18 months – 2.5 years The preliminary examination may be initiated in continuation of the novelty
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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 socalled Written Opinions on the patentability 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
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 invention. 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 protection 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 request to cover maintenance fees. Source: Plougmann & Vingtoft
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Photo: BioLogic Media
The biotech industry’s
storytellers The 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. By: Journalist Hans Henrik Lichtenberg Translation: 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 combination BioLogicMedia has addressed this challenge. The
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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 ballast from the research world and over 20 years in the film industry provides BioLogicMedia with some unique competences. Something which has already been discovered by players in the market and BioLogicMedia’s
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 companies 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 industry To 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 employees 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 possible 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 platforms, 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.
Quality Excellence
Photo: BioLogic Media
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Left: Bjørn Vidø, CEO BioLogic Media. Right: Jesper EugenOlsen, Scientific Director BioLogic Media
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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 scienceintensive industry
Film can influence share prices Communication 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 communication channel can be extremely effective in connection with pricing limited companies,” says Bjørn Vidø. See more at www.biologicmedia.dk
Photo: BioLogic Media
The 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.
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Photo: Michael Hjort alias no.1.
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.
A MAN OUT OF
THE BOX
Being 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, Journalist Translation: CLS Communication A/S 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 successful 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 flowing that time. We’d applied for the funding, but never
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People
When you look inwards and start exploring 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.
thought we’d actually get it. And we are the only ones, along with Tue Vest, to receive such a large donation.” 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 combination of projects. He has an excellent reputation in the research community, with results that have even been called pioneering. For instance, his research was recently highlighted at a conference in Australia for 20,000 researchers.
It takes at least 10 years Life as a researcher requires a great deal of patience. It can easily take 10 years to go from a result to actually implementing it, working 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 enthusiastically that this could really help
“What a nerd!” It was not written in the cards that biochemistry was the path for Jesper 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 passion 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 EugenOlsen’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.
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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 countries 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.
Photo: Michael Hjort alias no.1.
“
We’d applied for the funding, but never thought we’d actually get it.
people. He clearly recalls his professor’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 discovered at the time was a protein in the body that reveals our predisposition to disease and also our life-expectancy. He invented the so-called suPAR test, which measures 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 possible to measure whether specific types of medications will work and then target the treatment accordingly. This inspired him. He wanted to use his knowledge to help people all over the world, and Africa was particularly close to his heart.
Jesper Eugen-Olsen on stage at the concert “blood in bredgade-friday the 13th”.
Photo: Michael Hjort alias no.1.
People
Photo: Michael Hjort alias no.1.
“ Jesper Eugen-Olsen: “I gave a talk on suPAR, we played a punkrock concert and audience were offered suPARnostic testing”.
Jesper Eugen-Olsen had a mission. He wanted to use his research findings to help people, but the pharmaceutical 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 foundations 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 fortunate. 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 approach 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-
There is storytelling in everything – also in biochemistry, and that’s what I want to share
lish the company BioLogicMedia when he grew tired of the long academic reports that his research is inevitably 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 biochemistry, 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 videos 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 fellow, 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.
suPARnostic® - the risk status marker The novel biomarker soluble urokinase Plasminogen 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 prognostic value and is thus a master alarm for patient risk status. Jesper Eugen-Olsen is joint owner of ViroGates, an international Medtech company headquartered in Copenhagen, Denmark who has developed and distributes suPARnostic.
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Photo: ScanStock Photo
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 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 providing technical advice on obtaining and maintaining certifications 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:
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“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 responsibility At the Danish Notified Body, DGM, which provides certifications 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 demands a medtech manufacturer has to its subcontractors,” according to DGM. Peter Carlfors, Swedish Standards Institute, adds:
“In principle it’s easier for a manufacturer to ensure the quality and safety of the end product with a selection of subcontractors who can document compliance with an applicable QMS.”
The name of the game Hence, 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 science industry for about 10 years. He points out that
S T O C K H O L M
O S L O
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.
It takes more time to ensure the ultimate goal of safety, and it gives less freedom in the process. 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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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 directives for some time now. The industry’s concern is that a tightening will raise the bar considerably for the medtech industry,” says Morten Rasmussen, Communication 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 revision 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 upgrading 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 companies with certifications and QMS in place an even bigger head start, because getting there is a time-consuming and laborious process.”
Upgrading knowledge Morten 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 overview 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 certification 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.
DGM is willing to discuss with the applicant which focus areas they should concentrate on, also among subcontractors. ISO certifications ISO 9001 and ISO 13485 are the most common and relevant certifications among medtech manufactur ers and hence their subcontractors. ISO 13485 is an ISO standard published in 2003 that represents the requirements for a comprehensive management system for the design and manufacturing of medical devices. ISO 13485 is generally harmonised with ISO 9001. A fundamental 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 CSR
Photo: ScanStockPhoto
Certifications in other areas like CSR (Corporate Social Responsibility) reflect that CSR is increasingly acknow ledged as a management tool. The designation for certifications 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 organisation in order to document that their CSR work is serious 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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Business Profile
®
- A small but significant difference for protection of IP rights Startup companies should pay attention to and invest into their trademarks right from the early beginning. It pays off. By Charlotte Strøm, MD PhD Journalist
Protection of IP rights is not precluded large companies. Startup businesses ought to pay carefully attention to the trademark situation 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 explains why these companies have his particular interest and focus.
Johnny Petersen, lawyer and partner
“Very few small startup companies have the in-house capacity to oversee the trademark situation in an European 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 registered nationally. In the EU a central registration provides trademark protection in 27 countries in one go, whereas outside the European continent, trademarks are generally registered by each nation. Furthermore it varies
how a trademark is acknowledged 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 protection. Often, however, you have to apply for a registration of a trademark,” Johnny Petersen explains.
ABOUT DELACOUR DANIA DELACOUR DANIA Limited partnership law company has offices in Aarhus, Copenhagen, Nuuk, Tórshavn, Moscow, Kiev and Warsaw and some 200 employees, of whom approximately 80 are lawyers. More information about DELACOUR DANIA and its services may be found on: www.delacourdania.dk.
Relatively small investment He 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 damaging 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 because they have ignored the Chinese market and not sought trademark registration here in due time. Others are clearly victims of extortion.”
Trademark strategy The 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.
He explains that the benefits of seeking professional advice on these matters are that the trademark is thought into a strategy that is intercepted with the business plan. The services rendered by DELACOUR DANIA thus comprises building a trademark strategy, searching databases globally on potential name inflictions, applying for trademark registration, overseeing the marketplace regarding violations of the client’s IP rights, and furthermore react and prosecute when necessary.
Think trademark registration upfront The best advice that lawyer and IP rights expert Johnny Petersen at DELACOUR DANIA can give to entrepreneurs 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 ignore 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.
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Business Profile
Competent navigation of standards and certifications Compliance 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. By Charlotte Strøm, MD, PhD, Journalist The medtech is facing increasing challenges with regard to meeting regulations, standards and requirements 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 obtaining and maintaining certifications in the medtech industry. In addition to general requirements and practical issues related to setting up, managing, and maintaining a quality management system (QMS), the medtech company must also meet certain demands concerning the type of device in question. “Electrical devices, diagnostic kits, implantable devices etc. – they each face specific requirements in addition to the general international specifications pertaining to medical devices,” explains Henrik Kvistgaard, owner of Medical Device Consult.
A jungle without short cuts He 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
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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 expertise 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 preaudit or pre-inspection evaluation and assessment to setting up, implementing and maintaining a full quality management system.
Quality can’t wait Henrik Kvistgaard is sometimes urgently involved in late-stage projects but he prefers timely involvement. “Very often it’s easier – and cheaper I might add – to reflect on quality management systems and the establishment of the required technical dossiers upfront,” he says and continues,
Photo: ScanStockPhoto
Business Profile
“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 niche Henrik Kvistgaard has more than 18 years of experience 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-todate is part of his job. Henrik Kvistgaard continuously educates himself within his area of expertise, keeps track of news from regulatory authorities and certification 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 assisting Medical Device and In-Vitro Diagnostic companies in meeting US & European regulatory 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
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New vaccine construct opens up exciting new vistas In 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. By Jorun Christophersen, Journalist Translation: CLS Communication A/S
A group of researchers at the University of Copenhagen’s Department of International Health, Immunology and Microbiology, led by Professor Allan Randrup Thomsen, 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 principle, we could make a vaccine that would work on all strains of influenza
Photo: Private
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In addition to Professor Allan Randrup Thomsen, the research group consists of associate professor Jan Pravsgaard Christensen and Peter Johannes Holst, a postdoctoral 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
From left: Peter Johannes Holst, Prof. Allan Randrup Thomsen and Jan Pravsgaard Christensen. Department of International Health, Immunology and Microbiology, University of Copenhagen
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provides scope for developing individual vaccines. Conventional vaccine An ordinary, conventional vaccine consists of antigens, which induce antibodies aimed at a particular antigen. It is difficult to manufacture a vaccine for multiple viral diseases, as viruses have a tendency to change, or mutate. So developing a new influenza vaccine, 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 infections. 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 particular 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 variant crops up, so there will always be new virus variants to vaccinate against, year after year,” says Professor 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 antibody-based vaccine, which constantly has to be adapted to new variants of virus, they are making a vaccine that induces T-cell medi-
ated immunity. That is to say that the organism’s own immune 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 internal molecules have not been subject to the same selection pressure as those on the surface 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 1520%, which in principle means they are absolutely nothing like one another. Figure 3-19 The Immune System, 2/e (© Garland Science 2005) ”If we can raise a powerful Tcell 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 MEASURE MONITOR AND head start. In principle, we could make a vaccine that would work on all strains of influenza,” says Allan RanVALIDATE IN CONTROLLED drup Thomsen, adding the words ”in principle”, because ENVIRONMENTS it’s not without its problems, of course. But all the indications are that they have devised what is called HUMIDITY - TEMPERATURE - CO2 - dP ... 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 develWe can help you with oping individual vaccines.
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installation and validation. Call at +46 8 7509420
Firstly, a cell-mediated immune response to the influenza virus is not quite as effective as the antibody-based one.
Conventional vaccine versus cell-mediated immunity ”Firstly, a cell-mediated immune response to the influenza virus is not quite as effective as the antibodybased 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 3-20 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 people 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 Randrup 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 vaccine 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 conducted 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 mixture of variable and more constant genes, in principle,” says Professor Allan Randrup Thomsen. New vaccine principle The 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
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linked molecule presents the antigens to the cellmediated immune apparatus. It has proved to have a great effect on the immune defence and the immunological memory. At cell level the process takes place with the invariant chain acting as a locomotive and ensuring that the linked antigen molecule is transported around, functioning optimally inside the cell. In graphic terms, the cell can be compared with a high-rise block containing 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 plastered 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 expression, 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, unexpected 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 surface 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).
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
B U I L D I N G VA L U E T H RO U G H PA RT N E R S H I P S
BIO-EUROPE
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17TH ANNUAL INTERNATIONAL PARTNERING CONFERENCE
2011
OCTOBER 31–NOVEMBER 2, 2011 DUESSELDORF, GERMANY BIO-Europe® is Europe’s largest partnering conference, serving the global biotechnology industry. The conference provides an excellent opportunity to find potential partners for your products, initiate strategic alliances or tap into the international financing network. Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain. In addition to productive partnering, BIO-Europe offers high level workshops, panels, company presentations and a lively exhibition. For further information, please view our conference website at www.ebdgroup.com/bioeurope
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Upcoming Events and new members Events by Medicon Valley Alliance october 2011 October 6 Webinar: A Picture is worth a Thousand Words - Optimize your Communication with Investors, Customers and Public Stakeholders The 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 computer Time: 15.00 More information: www.mva.org/calendar november 2011 November 2 Good Morning Meeting, Ideon, Lund The 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, Lund Time: 8.00-10.30 More information: www.mva.org/content/us/initiatives
November 9 Good Morning Meeting, COBIS, Copenhagen The 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, Copenhagen Time: 8.00-10.30 More information: www.mva.org/content/us/initiatives November 10 Introductory Meeting At this meeting we welcome both members and nonmembers 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, Denmark Time: 15.30-18.00 (Join us for coffee and networking already at 15.00) More information: www.mva.org/calendar November 24 Boost seminar: Outsourcing to the East, Ørestad This 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/Copenhagen Time: 9.00 – 14.00 More information: www.mva.org/content/us/initiatives November 25 Boost 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 decided Time: 9.00 - 14.00 More information: www.mva.org/content/us/initiatives
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december 2011 December 1 Annual Meeting, Lundbeck, Valby Medicon Valley 2020: The Attractiveness of Medicon Valley and the Challenges Ahead The 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/Copenhagen Time: 13.30 – 19.30 More information: www.mva.org/AM2011
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Latest members of Medicon Valley Alliance Oracle Danmark ApS www.oracle.dk Oracle 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 Europe www.spartasystems.com Sparta 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 ApS www.iwaconsulting.dk IWA 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 ApS www.bucky.dk The 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 AB www.swedbank.se Swedbank´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 ApS www.unigroup.dk Unigroup 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 Aps www.irwcro.com IRW 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 fullresponsibility partner or provider of in-sourced expertise. Kommunicera Communications AB www.kommunicera.se Kommunicera 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 LLP www.millerrosenfalck.com Miller 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.
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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 EMPROVEŽ 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