Time to Unite A Greater Medicon Valley
a journal about Life Science in Greater Copenhagen
Suppliment to Affärstidningen Näringsliv nr 1 - 2017 PharmaRelations Meets Shortage of Staff
Region Skåne, Lund University and Medicon Village Science Park plan to create opportunities for advanced cell and gene therapies at the frontiers of the field. Page 5
Precision medicine and diagnostics. Page 5-13
17 ReproUnion Strengthens Capacity in Infertility Research
2 Medicon Village joins forces with Region Skåne and Lund University to plan an ATMP centre
5 ESS Provides Unique Insights in Drug Target and Drug Candidate Interaction
3 Expres2 Platform Solves Tough Protein Expression Challenges
Mapping Medicon Valley – the life science cluster of Greater Copenhagen
EVERY STEP OF THE WAY
Your global clinical development partner
time to Unite A greAter medicon vAlley
Creating opportunities Building a successful life science cluster in Medicon Valley, the life science region and brand of Greater Copenhagen, is all about creating opportunities. Consequently, creating opportunities has been the tagline of Medicon Valley Alliance for years. To insiders it is obvious that the historically separate Danish and Swedish life science ecosystems can create more opportunities for successful life science innovation when working together. The strengthened life science collaboration in the Medicon Valley region and our ability to actually build bi-national clusters of excellence within selected therapeutic areas proves this point every day. The most recent example is the Danish-Swedish public-private ReproUnion project which is contributing significantly to putting Medicon Valley on the global map when it comes to R&D and the treatment of involuntary childlessness. The regional strongholds within dermatology, diabetes and Central Nervous System (CNS) are wellestablished, and when it comes to for instance oncology, extremely promising research from a patient as well as a business perspective is growing out of the regions private and public sector laboratories. Private as well as public sector investments also have an increasingly regional dimension, which can be illustrated by for instance the number of Danish life science companies being listed in Sweden and the extensive joint investment in the European Spallation Source, which is currently under construction in Lund, Sweden, and will have the Data Management and Software Centre
Postal Adress Box 2079, 433 02 Sävedalen Tel 031-340 98 00 Fax 031-340 98 01 Homepage www.naringsliv.se Publisher Peter Fridén
Time to unite A greater Medicon Valley Editor in Chief Anders Lindgren Editor/Project manager Håkan Oltander Layout Tidningsbyrån www.tidningsbyran.se Print V-TAB Västerås 2017 ISSN: 0281-698 Distribution 34 000 copies
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(DMSC) based in Copenhagen. At Medicon Valley Alliance we encourage such joint initiatives which will help place the region on the global life science map and attract cutting edge R&D groups from all over the world. We actively support and engage in the bi-national teamwork being done to attract scientific conferences to the region, and we are particularly happy to be able to welcome all interested companies, academia and hospital personnel to the Nordic Life Science Days 2017 in Malmø-Copenhagen next autumn. An important general precondition for this Danish-Swedish cross-fertilization of life science R&D and innovation is the free movement of labour and talent. We need to be able to attract the best and the brightest scientist and engineers to sustain the clusters success and we need to ensure that everybody can settle down in one part of the region and work in another. The current, ho-
pefully temporary, identity control at the border which causes substantial delays and de facto makes it increasingly difficult commute from Sweden to Copenhagen and back with public transportation, is a costly barrier to the realization of our ambition to become the most competitive and vital life science cluster in northern Europe. In my view it is time to unite and call for solutions that don t interfere significantly with the free flow of labour in the region. I think the regional life science industry deserves a voice in the matter. In terms of tax revenue, export earnings and the creation of jobs of the future, no other industry is contributing more to the building of our economies and the creation of wealth. Let s continue to pave the way for success and create opportunities together! Petter Hartman, CEO, Medicon Valley Alliance.
ReproUnion Strengthens Capacity in Infertility Research In an effort to find new, more efficient, personalised and cost efficient treatment regimens for reproductive medicine, Medicon Valley Alliance has launched the threeyear project ReproUnion, funded by the EU Interreg V programme.
More than 10% of couples have fertility problems and more than 50% of those seek some form of medical care. Infertility is as common as, for instance, diabetes (15-20%) and WHO has classed infertility a disease. Despite revolutionary developments in the techniques for assisted reproduction (ART), the ’baby take home rate’ is still below 30%, with declining success rate with increasing age. In an effort to find new, more efficient, personalised and cost efficient treatment regimens, Medicon Valley Alliance has teamed up with a number of stakeholders and launched the three-year project ReproUnion, funded by the EU Interreg V programme. ReproUnion encompasses a network of 14 clinical and research units within the Capital Region of Denmark, Region Zealand of Denmark and Region Skåne. Key clinical competences include: High standard IVF and ICSI treatment including use of recent methods for embryo selection; Extended evaluation of the male partner in order to find the best treatment options for the couple and prevent long term squeal of infertility; Sperm DNA analysis; Andrological surgery
and treatment of ejaculatory dysfunction; Gonadal cryopreservation; Gamete donation; Assessment and counselling regarding environmental reproductive risks at the individual and the group level. 20 New CrossBorder Projects
The overall aim is to establish a common, multi-disciplinary, Reproductive Medicine Centre including R&D, education and career development as well as treatment and prevention. The objective of the science part of the centre, called ReproScience, is to strengthen the region’s research capacity within infertility. Approximately 30 senior researchers and more than 50 PhD students are engaged in over 20 new cross-border projects with more
than 20 new research positions. The business partner of ReproUnion is Ferring Pharmaceuticals, a company with a strong focus on innovation in Reproductive Health. "Treatment of infertility is one of Ferring’s key areas of interest and therefore our R&D efforts are firmly committed to progress in the field of ART. We're always looking for new ways of improving existing products as well as finding interesting leads and ideas for novel therapies in this field," says Marcel van Duin, PhD, Senior Director, Therapeutic Area Head Reproductive Health & Endocrinology Research at Ferring’s Research Institute in San Diego. ”Together with our Development colleagues at the International PharmaScience Center in Co-
penhagen we see the importance of external opportunities to help expand our R&D portfolio. So, it is attractive for us to partner in this project,” he adds. ”Not all of the ReproUnion research projects are equally interesting to Ferring, but engaging external experts is important for us. Discussing and interacting with these scientists can help us generate new ideas or design new studies. We highly value the opportunity to tap into ReproUnion’s critical mass and hope that some of the projects will turn into Ferring projects. It's also a way for us to get in contact with young talents who may become future employees or collaboration partners in Ferring projects,” Marcel van Duin comments.
time to Unite A greAter medicon vAlley
ESS Provides Unique Insights in Drug Target and Drug Candidate Interaction
Model of the European Spallation Source in front of Science Village Scandinavia and the MAXIV synchrotron.
To actually see the structure of the drug target protein and the candidate drug and how they interact with each other will make it possible to develop compounds with greater effect.
The European Spallation Source (ESS), organised as a European Research Infrastructure Consortium (ERIC), is a multi-disciplinary research facility based on the world’s most powerful neutron source. The unique capabilities of this new facility being built in Lund, Sweden, will both greatly exceed and complement those of today's leading neutron sources, enabling new opportunities for researchers across the spectrum of scientific discovery, including life sciences, energy,
environmental technology, cultural heritage and fundamental physics. Neutrons have special properties which means that they can give researchers unique information. They are, for instance, very sensitive to hydrogen and water. Water plays a major role in medical applications and biological and medical molecules consists of approx. 50% hydrogen. Information about where the hydrogen atoms point to and the positions of the water molecules is valuable for structure-based pharmaceutical development. "Being able to actually see the structure of the drug target protein and the drug candidate under investigation and how they interact with each other will make it possible to develop compounds with greater effect. We'll have an instrument exclusively dedicated to this application," says Sindra
Petersson Årsköld, Scientific Advisor at ESS. The neutron sources available today are too weak to generate a signal strong enough to produce high-resolution crystal structures of most biologically interesting systems. Then there are systems which you cannot crystallise, like large, multi-component complexes, aggregates and materials. Deuterium labelling in combination with neutron techniques provide unique insights into these elusive systems, both structural and dynamic. ”With these applications and many others gaining ground, life science is a growing field of the neutron domain,” she adds. Relevant for People’s Everyday Lives
ESS is a tool for scientists to study materials, the atoms and molecules that make them up and
how they interact. There are many areas where you need a greater understanding of molecular properties. It could be used to generate and store energy more efficiently, create metals that are lighter and are more energy-efficient to produce, compounds as catalysts as well as scientific and industrial improvements of materials. ”In contrast to CERN and instruments like big telescopes, we study areas that are relevant for people’s everyday lives like biological structures, energy sources, transportation systems, in order to make improvements for the benefit of people and society,” says the Director General of ESS, John Womersley. The total construction budget of ESS is EUR 1.8 billion and the annual operations budget is estimated to EUR 140 million. Test runs of the accelerator is planned
to commence in 2020 and in 2023 the facility will initiate the research programme. ESS will comprise 22 separate experimental stations. ”ESS will provide a capability that doesn’t currently exist. Scientists will be able to study smaller objects and at shorter timescales. It’s beyond what similar facilities can do in Europe today and about five times better than anything else in the world,” he adds. University and industry research groups have the opportunity to propose experiments on any of the instruments and it’s estimated that approx. 3,000 scientists will use the ESS each year. The data generated in these experiments will be analysed and stored at the ESS Data Management Centre (DMSC) in Copenhagen, Denmark.
time to Unite A greAter medicon vAlley
Making the invisible visible MAX IV produces the most intense x-ray light in the world and there are great hopes, both in the research community and the business sector, that it will deliver results the world has never seen before.
MAX IV has three accelerators – a linear accelerator and two storage rings. The large ring has a circumference of 528 metres, comparable with the Coliseum in Rome. It is estimated that 2,000 researchers from around the world will visit MAX IV every year to conduct experiments at the facility. The linear accelerator increases the velocity of electrons almost to the speed of light. The electrons are then directed into the storage ring, where magnets bend their path. In this bending process the electrons emit synchrotron light, which is an extremely intense light spanning wavelengths from ultraviolet to hard X-rays. The light is directed to the research stations through special beamlines, which is where experiments are conducted. When fully developed, MAX IV will have the capacity to accommodate 26‒28 beamlines in the two storage rings and in the extension of the linear accelerator. Deeper Understanding of How Things Work
The various techniques of ima-
ging, spectroscopy and scattering are often combined in the experiments. In the life sciences, MAX IV can be used to study and develop new drugs and healthy and diseased cells and tissue can be analysed as a basis for developing new treatments. Tomographic imaging could depict living structures in extreme detail. X-ray crystallography and powder diffraction can be used to identify how atoms or molecules are positioned in relation to each other, which is important for the characteristics – mechanical, magnetic, electronic, etc. – of the matter or material. ”When we’re able to see the actual structure of things, like proteins, in a resolution of a few tenths of a nanometre we get a much deeper understanding of how they function and interact with other molecules. Apart from increasing our knowledge through basic research it can also facilitate drug developers in their search for suitable drug candidates,” says Dr. Thomas Ursby, BioMAX Project Manager, MAX IV. He’s also active in establishing the MicroMAX beamline, that can be used for studying extremely small crystals. ”40% of all pharmaceuticals are targeted at membrane proteins. These proteins are hard to crystallise into large crystals, so MicroMAX will greatly contribute to new developments in this
MAX IV was inaugurated in June, 2016, in the presence of Sweden’s Prime Minister Stefan Löfven (left) and King Carl XVI Gustaf. Photo: Kennet Ruona.
The laboratory enables researchers to study atoms and molecules that are only a few tenths of a nanometre in diameter, which provides completely new knowledge about the world and how it works. Photo: Kennet Ruona.
important field of drug discovery. Also the formulation of drugs
can be studied in great detail, utilising the different techniques provided by the different beamlines,” he adds. Great Asset for Life Science Companies
When fully developed, about 250 people will work at MAX IV that consists of some 20 buildings occupying an area of approx. 50,000 m2. Photo: Leif Jansson.
”The facility is a great asset for life science companies who can study their samples here. Companies can come here and get access to the research equipment but we also encourage them to collaborate with academic research groups with the know-how and competence to perform these kinds of experiments. In the future we will provide a service so that only their samples need to be sent to us and the researchers can
perform their experiments by accessing the equipment via a webbased interface,” says Magnus Larsson, Industrial Liaison Officer, MAX IV. The MAX IV facility is based on new technology and scientific theories that have been developed at the Lund-based MAX Lab since the early 1980s. MAX Lab was the forerunner with the MAX I, II and III accelerators. So far, investment in MAX IV amounts to EUR 470 million, the biggest ever investment in national research infrastructure in Sweden.
WntResearch The focus and aim of WntResearch is to develop novel anti-metastatic therapies for the treatment of cancer patients and thereby meet a large medical need. WntResearch AB · Medeon Science Park, SE-205 12 Malmö · Sweden www.wntresearch.com
precision medicine And diAgnostics
Medicon Village joins forces with Region Skåne and Lund University to plan an ATMP centre Region Skåne, Lund University and Medicon Village plan to create opportunities for advanced cell and gene therapies at the frontiers of the field. The three partners will tie existing infrastructure to cutting edge academic and industrial competence. The aim is to establish an Advanced Therapy Medicinal Product (ATMP) Centre at Medicon Village Science Park – to drive the transition from bench to clinic faster.
Cell and gene therapies are Advanced Therapy Medicinal Products (ATMPs) and have the promise to deliver cure to terminal and disabling diseases, such as Parkinson’s, cancer, Alzheimer's and muscular dystrophy. These novel drugs have the potential to halt or even reverse symptoms of diseases that have previously been untreatable. ATMPs are one of today’s hottest medical research fields, although most of the products are still in an early phase of development. In an effort to speed up the R&D process from bench to bedside, Region Skåne, Lund University and Medicon Village have jointly announced that they plan an ATMP Centre that will gather all necessary facilities, equipment and competences needed to develop, manufacture and store ATMPs in one place. Challenging Paradigm Shift
The paradigm shift to ATMPs creates challenges in terms of
Medicon Village is home to researchers, innovators and entrepreneurs ñ in all some 1600 of them in 120 companies and organisations ñ and all working in life science.
Medicon Village provide an open, innovation-rich environment that actively promotes wide-ranging cooperation between researchers and between large and small companies.
how to make these therapies commercially available. Independently of the type of product or indication, the production of regenerative medicines is highly complex and there is therefore a need for an ATMP centre. There are many issues that must be addressed. For instance, manufacturing capacity and costs, including flexibility and scalability. Other issues concern regulatory and quality programmes. In addition, all work has to be performed in laboratories and cleanrooms with special classifications. Finally, there are important ethical questions to be considered. Much of the development is carried out by academic scientists and clinicians affiliated with university hospitals or small to medium size enterprises. Many of these however lack the regulatory expertise, experience and resources to establish and operate Good Manufacturing Practice (GMP) compliant manufacturing processes.
but also collaboration with partners and CRO-companies with the right knowledge and technologies. Collaboration is the cornerstone when developing novel therapies and diagnostics. In most cases, involving the right expert at the right time will save both time and money. “One of the centre’s goals is to offer competence in how to bring these products from lab to market by promoting interaction and collaboration between academic research groups, clinicians, biotech companies and service providers," explains Kerstin Jakobsson, Vice President of Medicon Village.
We have 17,000 m2 of laboratories at Medicon Village ñ from the simple to the advanced. They include labs for chemistry and biochemistry, climate rooms, cell biology labs, clean rooms and pharmaceutical labs. There are also labs for pre-clinical testing, analysis and much more.
Access to Cleanrooms and Competence
The ATMP centre will be located at Medicon Village Science Park comprising of a number of cleanrooms with different classifications and necessary supporting infrastructure. Medicon Village Science Park is a thriving life science community that has the potential to emerge to the forefront in the field of advanced therapies, both within academia and in companies, such as Idogen and Xintela. The close proximity between such companies and Skåne University Hospital, as well as cleanrooms, advanced equipment and regulatory expertise benefit all parties. Through collaboration with clinicians, academic scientists and CROs, ATMP-developing companies will have access to the necessary knowledge and expertise in order to manufacture these advanced therapies in line with European GMP and other stringent national and European regulations. ”The conditions to succeed with the establishment of the ATMP centre are very good in Skåne and, additionally, include big opportunities to develop life science in Skåne and all of Sweden. Region Skåne is a co-financer and fully supports the venture,” says Hannie Lundgren, Research Director at Region Skåne. Navigating the R&D process from lab bench to patient bedside requires both skills and creativity,
A Thriving Life Science Community
At Medicon Village Science Park there are more than 70 experienced service providers and CRO companies. The science park provides access to state-of-the art lab services and equipment. In addition, there are many internationally competitive preclinical and clinical research programmes in hematology, diabetes, neuroscience and cancer at Lund University and Skåne University Hospital.
“By bringing together scientists from Lund University with clinicians from the University Hospital and companies in the field of advanced therapies, we create a strong life science community at Medicon Village,” adds Kerstin Jakobsson. There are also many researchers here working in other life science areas, as well companies within biotech, pharma, medical devices etc. Today more than 1,600 people from research, innovation and commercialisation work in more than 120 different organisations at Medicon Village Science Park. It’s close to Lund University, the University’s BioMedical Centre (BMC) and the University Hospital (SUS), as well as the European Spallation Source (ESS) and the MAX IV Laboratory. Furthermore, Copenhagen Airport is reached in about 60 minutes by train and Copenhagen is just across ’The Bridge’. In other words, Medicon Village Science Park is an excellent place to be when it comes to R&D and commercial use of products and services for people’s health and wellbeing.
Fact Medicon Village Science Park Number of member organisations: more than 120 Member employees: more than 1,600 Space: 80,000 m2 Laboratories: 40,000 m2 Owner: Mats Paulsson’s Foundation for Research, Innovation and Social Benefits. The terms of the foundation stipulate that all profits must be re-invested in research and innovation.
precision medicine And diAgnostics
Cell Therapy for Immune Diseases The biotech company Idogen develops tolerogenic vaccines which is a new treatment method for autoimmune diseases, organ rejection and antibodies towards biological therapeutics, based on reprogramming the immune system. The company’s CEO was one of the initiators of the new Cell and Gene Therapy Centre at Medicon Village.
Idogen is a company in Medicon Village who develops tolerogenic vaccines. The term 'tolerogenic' refers to that the immune system will tolerate the selected molecule after treatment, and are thus like inverted versions of conventional vaccines. ”It offers a new treatment method for autoimmune diseases, organ rejection after transplantation and for patients having developed antibodies against biologi-
cal therapeutics," says Lars Hedbys, co-founder and CEO of Idogen. The company’s treatment method comprises cells from the patient’s blood being reprogrammed to dendritic cells with the capacity to specifically counteract the adverse immune reaction. The technology platform has the potential to develop longacting treatment of autoimmune diseases that currently cannot be
Idogen develop tolerogenic vaccines which reprogram the immune system. The term “tolerogenic” refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for autoimmune diseases, organ rejection after transplantation, and for patients having developed antibodies against standard treatment. Idogens first product will treat patients with severe hemophilia A affected by neutralising antibodies against its vital coagulation factor VIII-treatment. Photo: Kennet Rouna.
cured. In addition, Idogen has the potential to change the transplantation market by reducing the need for immunosuppressive therapy after transplantation. The company was founded in 2008 based on an immunological discovery at Lund University and is listed on Aktietorget. Cell and gene therapy is the ultimate treatment of personalised medicine since it’s possible use of the patient's own cells as product batch. But there are challenges. Cells are complex products, hard to characterise and very sensitive. Since they're fresh there are logistical and storage issues to consider. And if the treatment is based on autologous cells, each batch only works on a single patient, which is challenging in terms of cost-effectiveness. In addition, the medical issues are unique for each product. Initiator of the New Cell and Gene Therapy Centre
Lars Hedbys has over 20 years experience in senior and executive roles within the life science industry. Previous assignments in-
The technology in Idogen’s treatment concept comprises that cells from the patient’s blood are reprogrammed outside the body to dendritic cells with capacity to specifically counteract the adverse immune reaction. Thereafter, the dendritic cells are transferred back to the patient and creates a tolerance to the antigen without affecting the rest of the immune system. Illustration: Lena Lyons.
clude CEO roles in public and private companies and Vice President and Site General Manager roles in AstraZeneca. He was also one of the initiators of the new Cell and Gene Therapy Centre at Medicon Village and sees great potential in the new centre. ”From our perspective, who develop a cell therapeutic product it's key to be able to go from lab scale to GMP scale for clinical trials, i.e. the translational step, and later to commercial production of our cell-based therapies. We lack that competence, inhouse, and it's hard to find in Sweden,” he says, and adds: ”I know that there are research
groups at Lund University with similar problems. I therefore contacted Medicon Village and suggested that we use the cleanrooms from AstraZeneca for production of cell and gene therapy products.” Lars Hedbys thinks that each player at the centre will have its own GMP room, but share some of the instruments and process development infrastructure. Idogen is currently negotiating with Medicon Village as part of a business case. If things work out well they may very well be running their first project at the centre in the first quarter of 2017.
A Hope for Cure of Osteoarthritis Xintela is a Swedish biomedical company working in the fields of regenerative medicine and cancer, with particular focus on osteoarthritis and the brain tumour glioblastoma.
Osteoarthritis is a disabling and often very painful chronic joint disease that involves a gradual degeneration of the cartilage. It is estimated that 630 million people worldwide suffer from osteoarthritis and the total global market for osteoarthritis therapy is expected to grow from the current USD 3.6 billion (2014) to USD 9.2 billion (2024). Xintela’s patented marker technology, XINMARK™, makes it possible to identify and select a certain type of stem cells which can develop into cartilage cells and thus have the potential to repair cartilage and cure osteoarthritis. The product market for horses with osteoarthritis is also big and veterinary products can reach the market faster than therapeutic products for humans. Xintela’s recently completed a six-month study on horses with a type of cartilage damage that mimics post-traumatic osteoarthritis. The study was conducted at Cornell University in Ithaca,
Xintela focuses on osteoarthritis and glioblastoma, areas with substantial need for better treatments.
New York and demonstrated that Xintela’s allogeneic (donated) mesenchymal stem cells are safe and did not cause pain or other adverse events. Furthermore, Xintela’s selected stem cells can protect joint cartilage from further damage after injury and also prevent damage to the underlying bone. ”The results give us confidence to take the next step in the development of a horse stem cell product. The results are also very important in our efforts to obtain regulatory approval to support clinical trials in humans. Our goal is to demonstrate Proof-ofConcept in humans and then identify a partner for further development and commercialisation,” says Evy Lundgren-Åker-
lund, CEO and founder of Xintela. “The company is currently in a phase where we're about to scale up production of cells for clinical trials on horse and man. The new cell and gene therapy centre in Medicon Village will be of great benefit to Xintela’s clinical and commercial operations,” says Evy Lundgren-Åkerlund. Novel Treatment of Brain Tumour
The XINMARK™ technology also makes it possible to identify certain tumour cells in order to target an effective treatment to those cells to slow down or even stop tumour growth. ”In our cancer project we focus on glioblastoma, a very aggressi-
“Xintela’s fantastic progress the last year demonstrates the strength of our technology platform and our result-focused team”, says CEO Evy Lundgren-Åkerlund.
ve and deadly brain tumour with an average life expectancy of only 15 months with current treatments,” says Evy LundgrenÅkerlund. Xintela has developed an antibody that can deliver a drug to the tumour. Recent results from cell studies and animal model have shown that Xintela’s antibody drug conjugate (ADC) can bind to the glioblastoma cells and has a killing effect on the cells. “These exciting results demonstrate that the concept works. Our
next step will be to find a development and commercialisation partner to speed up the work of taking the product to market and to the patients,” says Evy Lundgren-Åkerlund. The company has a broad and strong patent portfolio, in important markets such as Australia, Europe, USA, Canada and Japan. It has several international collaborations running in Sweden, the EU and the US and is planning for clinical studies in both horse and man.
precision medicine And diAgnostics
Tumour Inflammation Targeted in Novel Cancer Treatment The biotech company Cantargia at Medicon Village in Lund focuses on treating pancreas- and lung cancer by targeting the tumour inflammation, as a complement to traditional therapies.
”A single therapy will never solve this problem.” The words are from Göran Forsberg, CEO of the biotech company Cantargia. ”One must remember that cancer is a collective term for over 200 diseases, where each patient, in principle, has his or her own unique disease,” he further explains and adds: ”Hence, what you need
is a toolbox wherewith you can tailor the treatments to the needs of each individual patient.” Several compounds in combination are therefore needed to create an effective treatment and Göran Forsberg compares the operations with a military assault where you need airborne attacks, as well as artillery and troops on the ground to be successful. ”We focus on the tumour inflammation. It’s a part of the disease which is not treated with targeted therapies today. We thereby enter the battlefield from a new flank as it were. The therapy is unique in that it combines activa-
tion of the immune system with blocking of signals that promote tumour growth.” Upcoming studies in patients
In the last ten years, antibodybased therapies have emerged. They hit the tumour more directly than chemotherapy and are now a proven and verified, lowrisk, technology that is utilised by Cantargia. ”Our lead candidate CAN04 is an antibody that specifically targets the molecule IL1RAP (Interleukin-1 receptor accessory protein) with the potential to treat a
number of different cancers. Initially, we focus on non-small cell lung cancer (NSCLC) and pancreatic cancer. In the initial toxicity study no signs of toxicity have been detected and in the first half of 2017 we’ll initiate clinical trials in patients with these diseases. On the back of the results in this study, we will then also initiate studies in patients with leukemia.” Cantargia is a virtual company and does not have own labs. Instead Cantargia collaborates with academic groups as well as specialized commercial labs thereby getting access to their exper-
Cantargia’s lead candidate has a dual mechanism of action. CAN04 stimulates the immune system to attack the cancer cells and blocks signaling that promote inflammation and tumour growth.
Göran Forsberg, CEO Cantargia.
tise and latest technologies. An example being antitumor effects which are studied in so called PDX models based on human tumour tissue specific for the studied indications. Another example is engineered cell lines used for production of antibodies with optimized features. The company also has another project in its pipeline. It focuses on inflammatory diseases and is in an early phase. ”The plan is to select a product candidate by the end of 2018 or beginning of 2019,” Göran Forsberg comments. This means that Cantargia with a strong focus on the platform has created two independent legs to stand on.
A healthy slim Thylabisco AB is a biopharmaceutical research and development company focused on developing novel therapies for prevention and treatment of obesity. The Company is based on research carried out at Lund University, Lund, Sweden. Components of green leaves, called thylakoids are in the focus of the research and development. Appetite and weight control Clinical investigations on the eﬀect of thylakoids have demonstrated an enhanced satiety, a suppressed hunger and a suppressed urge for sweet and salt. We have also demonstrated a stabilization of blood glucose levels and a reduction of insulin secretion. In overweight women a reduced body weight, reduced fat mass, coupled to reduced blood glucose levels, and reduced blood lipid levels, including LDL-cholesterol have been demonstrated after two months of a daily shot with 5 grams of thylakoids, taken in the morning. Gut satiety hormones are activated Studies are going on to explain the mechanism of action. So far we have demonstrated an increased release of satiety hormones like CCK and GLP-1 from the gut, which could explain the satiety eﬀect and an improved appetite control. We have also demonstrated that thylakoids are pre-biotic and create a healthy microﬂora in the intestine, including an increased production of Lactobacillus reuteri. A correct intestinal microﬂora is important for achieving optimal energy and body weight balance. Increased fat oxidation Thylakoids also activate fatty acid oxidation, leading to decreased fat mass relative to fat-free mass. The abdominal fat is speciﬁcally reduced. The speciﬁc targeting of abdominal fat is important, since this fat is the harmful fat. The mechanism is being investigated Read more: www. thylabisco.com at Lund University. Charlotte Erlanson-Albertsson, professorAptitkontroll, Inst för Experimentell medicinsk vetenskap Lunds Universitet, BMC, B11, 221 84 Lund, 046-222 85 89
precision medicine And diAgnostics
New Technology Finds Early Biomarker Signatures for Cancer The technology platform IMMray™ of Immunovia finds early biomarker signatures for several forms of cancer and autoimmune diseases, which gives it the potential to significantly increase the survival rate and quality of life of many patients.
Founded on the research of Professor Carl Borrebaeck at Lund University, Immunovia has developed a technology platform, IMMray™(Immunovia Antibody Microarray), for early diagnosis, prognosis and monitoring of cancers and autoimmune diseases. ”Complex diseases leaves footprints in the immune system. With a simple blood sample we can measure many proteins simultaneously in the immune response and thereby identify clinically relevant biomarker signatu-
res for several forms of cancer, as well as autoimmune diseases like rheumatoid arthritis, Sjögren’s Syndrome, Lupus etc. that are hard to diagnose early,” says Mats Grahn, CEO of the molecular diagnostics company Immunovia. The company’s first and main product is aimed for early diagnosis of pancreatic cancer. ”It’s a cancer that develops slowly over a longer time-period with no or very vague symptoms. Then, in the last 6-9 months of
Mats Grahn, CEO of Immunovia AB. Photo: Andreas Offesson
the patient’s life, it becomes very aggressive. So, when it’s detected it’s metastatic to an extent that 80% of the patients do not answer to any treatment currently available. And the survival rate after five years is only 5%. Clinical data show that if, on the other hand, it’s discovered in the first stage, the survival rate could increase to 50%,” he adds. The company has concluded a retrospective study with 1,300 blood samples that resulted in an accuracy of 96% in pancreatic cancers stages 1 and 2. The result has been validated in a second study in collaboration with the Knight Cancer Institute in the USA and was presented in May 2016. Now, the company is launching prospective studies, which must show good results in order to secure future reimbursement. ”It will take approx. three years before these studies are completed. However, we can start selling our tests commercially already before that through our own lab once it is accredited, as well as through a certified lab in the USA that we’re partnering with,” Mats Grahn comments.
Staff at Immunovia’s laboratory in Lund are able to diagnose pancreatic cancer using a drop of blood on a microarray. Photo: Lars Strandberg Many Projects in Pipeline
Immunovia has in collaboration with Professor Carl Borrebeack at Lund University and others several projects in its strong pipeline and many of the company’s 25 employees have worked 25-30 years in the business. Situated at Medicon Village, it has access to a great infrastructure that AstraZeneca left when they moved out 2012. ”It’s a fantastic environment for a company like ours with access to both advanced facilities and highly-skilled people.” In December 2015, Immunovia was launched at Nasdaq First North and it has recently received the prize as the most innovative
small and medium size listed company in Europe, ’Stars of Innovation’, by the stock exchanges in the EU. Last autumn, it received additional financial reinforcement when leading funds, such as Swedish Heart-Lung Foundation and Handelsbanken Fonder, together with other institutional and private investors invested MSEK 190 in the company in a directed issue. They’ve also successfully completed a preferential rights issue to existing share holders of MSEK 28.7 making the total capitalisation 218 MSEK.
At the Forefront of Immuno-Oncology The biotechnology company Alligator Bioscience in Lund specialises in tumour-directed immunotherapies for cancer treatment. The signing of a MUSD 700 deal, plus royalties, with Johnson & Johnson is a sure sign of their pole position in the hot field of immuno-oncology.
In 2014, it was as if all pharmaceutical companies suddenly decided to go for immuno-oncology, following positive study results concerning a group of new promising compounds, PD-L1 inhibitors. They act to inhibit the association of Programmed death-ligand 1 (PD-L1) with its receptor Programmed cell death protein 1 (PD-1), thereby preventing cancer from evading the immune system responses. Several PD-L1 inhibitor antibodies are being successfully trialled for different cancer types. Alligator Bioscience in Lund has been active in this field since 2008. Their long experience puts them at the forefront and gives them a great advantage. The company’s technology platform consists of ALLIGATORGOLD® – an antibody library comprising over 60 billion different human antibody variants and FIND® – a technology for opti-
Photo: Lars Strandberg
mising the characteristics of antibodies and other proteins. The company has a strong pipeline of five antibody-based products, all with the potential to become first-in-class or best-inclass. By leveraging on their leading and differentiated research position of tumour-directed immunotherapy they avoid head-tohead competition with big pharma. Their most advanced project, the antibody ADC-1013, activates dendritic cells by the stimulation of the co-stimulatory receptor CD40. Dendritic cells activated in this way can effectively instruct T-cells to find and kill tumour cells in the whole body. Since some tumour cells express
CD40 on the surface, ADC-1013 may also act through a secondary mechanism of action by directly killing such tumour cells. Record Deal with Johnson & Johnson
The fact that Janssen Biotech, a company within Johnson & Johnson Innovation will pay MUSD 700, up-front and milestones, plus significant royalties for an exclusive, worldwide, licence to ADC-1013 demonstrates Alligator’s edge over its competitors. ”The agreement with Johnson & Johnson, in August 2015, is one of the greatest ever concerning a single product in early clinical phase I,” Per Norlén, CEO and Chief Medical Officer of Al-
Per Norlén, CEO. Photo Andreas Offesson
ligator Bioscience, comments. The deal has naturally caused great interest in the company, both among investors and potential employees. And, they deservedly won the SwedenBIO Award 2016. ”It’s not just about the J&J deal. People notice that we’re in the frontline in the hottest field on the market, immuno-oncology. We’ll continue to keep our position even though all the big
pharma companies are now in this game. It’s unique for a small company as Alligator.” Since the signing with Johnson & Johnson, Alligator Bioscience has increased their staff by 50% we are today 40 employees, and in November 2016 Alligator was listed on Nasdaq Stockholm including a successful share issue that added almost 350 million SEK to the Company’s cash position.
precision medicine And diAgnostics
A Small Peptide Inhibits Tumour Metastasis Innovative research by one of the founders of WntResearch has shown that a small peptide can interact with cancer cell motility and thereby inhibit cancer from metastasising.
Most people that die from cancer, die from metastases. So, there’s an urgent need for a treatment that specifically counteracts metastasis. WntResearch develops a new type of cancer pharmaceutical, based on innovative research that indicates that the endogenous protein Wnt-5a plays an important role for the tumour cells’ ability to move and spread to other places in the body (metastasis). Professor Tommy Andersson and his research group at Lund University has discovered that in some cancer diseases low levels of Wnt-5a protein in the primary tumour indicates high level of motility and metastasis. Tommy Andersson co-founded WntResearch based on his research, and patented peptides that could interfere with the Wnt-5a signalling. ”In pre-clinical test models our lead candidate, the agonist Foxy-5, has been able to reduce the tumour cells’ ability to move, thereby inhibiting metastasis. A completed phase I study indicates a positive safety profile and pharmacokinetics as well as early indications of biological activity. The project is currently in a phase 1b study on patients with colon, prostate or breast cancer. So far, the results are promising and we’re planning to launch a phase II study during 2017,” says Henrik Lawaetz, MD and CEO of the company. ”Foxy-5 is the first substance of its kind in this class of pharmaceuticals and presents a new mode
of action. Wnt-5a is a complex protein with 360 amino acids, whereas Foxy-5 is a hexapeptide with only 6 amino acids. It seems to have a very low toxicity and this makes it easy to combine with other pharmaceutical cancer therapies,” he adds. Looking for Business Partners
The company is also developing Box-5, which has an antagonistic effect to Wnt-5a. "The most extensively studied example of a tumour that could be treated by blocking Wnt-5a signalling is malignant melanoma. We will therefore further characterise the mechanisms by which the Box-5 antagonist functions and explore its ability to impair malignant melanoma cell migration and metastasis in vivo." Wnt Research has quite an extensive patent protection covering many applications of their substances and is currently looking for business partnerships. ”We are especially interested in partnering with pharmaceutical companies to develop therapeutic products from our platform to address the common cancer types previously mentioned,” says Henrik Lawaetz, CEO of WntResearch. WntResearch is a very virtual and flexible organisation working closely with their CRO and regulatory consultants, as well as manufacturing and laboratory functions all over Europe. WntResearch was established in 2007 and is since 2011 listed at Aktietorget. Henrik Lawaetz, CEO of WntResearch AB.
We work to understand, explain and improve our world and human health FACULTY OF MEDICINE AT LUND UNIVERSITY After over 300 years of medical research at Lund University, the Faculty of Medicine is now one of the most research-intensive university environments in Europe. Over the years our researchers have made many significant medical discoveries that have led to improved treatment methods, new drugs and better diagnostics.
Our cutting edge research includes innovative forms of treatment for neurodegenerative diseases, identifying the genetic factors responsible for the development of diabetes, stem cellbased therapy, stroke and haematological diseases, as well as development of advanced brain-computer interfaces.
Lund University was founded in 1666. Today, the University is ranked as one of the world’s top 100 and is Sweden’s most international higher education institution. The University has 47 000 students and 7 200 staff based in Lund, Helsingborg and Malmö. We are united in our efforts to understand, explain and improve our world and the human condition. www.med.lu.se
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RhoVac Eliminates Metastatic Cancer Cells The research team behind the company RhoVac AB has developed a concept for eliminating metastatic cancer cells by knocking out cells, which have an overexpression of the RhoC protein .
RhoVac AB conducts research and development of immune therapeutic medicines. The company’s main focus is the development of a therapeutic cancer vaccine with the potential of preventing or limiting the metastasis of cancer. The company is headquartered at Medicon Village in Lund and the research is primarily conducted at the University Hospital in Herlev, Denmark. ”Our research team, active at the Center for Cancer Immune Therapy, has more than 20 years of experience from cancer vaccines and are among the best in the world in their niche,” states Anders Ljungqvist, CEO, CSO and co-founder of RhoVac AB at Medicon Village in Lund. In metastatic cells of all cancer types there’s a high concentration (overexpression) of the RhoC protein. Overexpression of this protein is necessary for the cancer cells’ ability to move to another part of the body. Extensive research has demonstrated that down regulation of the expression of RhoC correlates with a radical reduction in cancer cell metastases. ”The overexpression of the protein RhoC can be identified as a kind of fingerprint on the outside of the cancer cell wall. Following treatment with our product, the patient’s T-cells can identify this fingerprint and eliminate the cancer cells. So, it’s actually the body’s immune system that takes care of the treatment, which is the principle in a therapeutic cancer vaccine,” Anders Ljungqvist explains. It’s a different way of targeting
Anders Ljungqvist, CEO RhoVac.
cancer. There are other players that have used RhoC as biomarker, but Anders Ljungqvist and his colleagues haven’t come across anyone else who run RhoC projects in clinical phase or any pre-clinical development of RhoC for treatment of metastatic cancer either. Clinical Phase I/II Study Initiated
At this time, the company pursues only one product candidate, RV001. ”We focus solely on this project. Potentially, if the concept works as we think it will, we’ll potentially be able to treat more or less all types of metastasising cancer forms. It’s a huge market and it would be fantastic to be able to treat so many patients. One of the fine things with cancer vaccines is that they have very few side-effects. Apart from very positive safety profiles, it means patients can use them for long time-periods. This in turn
makes them suitable for combination with other therapies,” says Anders Ljungqvist. By the end of 2016, RhoVac initiated a phase I/II study of their product candidate RV001. The study is conducted in Copenhagen and will be completed by mid 2018. During 2017, they will through their established research collaborations with universities in Europe prepare for the next clinical study. ”We’re able to conduct phase IIb studies ourselves, but not phase III studies. That demands purchase or out-licensing,” he comments. Since RhoC is not overexpressed in the primary tumour, the product developed by RhoVac will be used in combination with other therapies focussing on the primary tumour. ”The primary tumour will be removed by e.g. surgery, radio- or chemotherapy and the metastases will be prevented or limited using our therapeutic cancer vaccine.”
precision medicine And diAgnostics
Tumour Immune Response Activated by Precision Laser Therapy Heating up tumour tissue with high-precision laser beams, activates the body’s im22mune system to attack the tumour cells.
Immunostimulating Interstitial Laser Thermotherapy (imILT) is developed and marketed by Clinical Laserthermia Systems AB (CLS). It works by using laser beams to generate lower, not coagulating, temperatures in the area of the tumour border, which has the effect that intact tumour antigens are released while the tumour cells are killed. The antigens are exposed to the immune system, which, in turn, creates a specific immune response against the remaining tumour, including disease at other sites. The laser light is delivered by an optic fibre applicator placed in an introducer of slightly more than 2 mm in diameter. In addition, a temperature probe, of slightly more than 1 mm in diameter, is also inserted in conjunction with the fibre applicator and is used for precise control of the temperature during imILT. ”The therapy is minimally invasive, image guided and is developed for treating patients with late stage and metastasised cancer. Often, these patients don’t answer to existing therapies due to the advanced progression of their cancer disease. This is especially true for patients with late stage pancreatic cancer, which is one of our primary target groups,” says Dan J. Mogren, CCO of CLS, whose head office is located next door to the Lund University Cancer Research Center at Medicon Village in Lund. ”That said, the technology could also be used for patients with non-metastasised cancer. It has basically no dose limitation and it can be combined with surgery, radiation therapy, vascular occlusion therapies and cytostatic, angiostatic and immunomodulating drugs,” he adds. Based on extensive research
The probe and fibre introducer come in lengths of 10-35 cm for
The laser light is delivered into the cancer tumor by an optic fibre applicator, placed in an introducer.
Dan Mogren, Chief Commercial Officer at CLS.
flexible working angles. The optic fibre is 3 or 12 metres long and connected to the system’s mobile laser unit. The other instruments are operative, sterile and disposable, instruments
packaged in patient kits. ”Our technology and products are based on research, performed by Professor Karl-Göran Tranberg and his team at Lund University during the two last de-
cades. Similar technology has formerly been used on non-metastasised cancer only, but with relatively low precision,” Dan Mogren comments. CLS is currently conducting
clinical studies at several sites in Europe. Three of these studies are financed by EU and the Horizon2020 program by EUR 2.3 million, and are targeting pancreatic cancer and breast cancer. ”We’ve also initiated the market entry process in the USA and have, as a first step, started a collaboration with University of Texas Medical Branch (UTMB) focusing on treatment for prostate cancer,” says Mogren.
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Multifocal approach in Cancer Research Based on the insight that many different areas of expertise are needed to fight cancer, the Strategic Research Centre for Translational Cancer Research (CREATE Health for short) at Lund University integrates clinicians with researchers from the Faculties of Medicine, Natural Sciences, Social Science and Engineering at Lund University.
The centre, which is mainly located at Medicon Village, has been around for eleven years and has been funded mainly by the Swedish Foundation for Strategic Research, Knut and Alice Wallen-
berg Foundation and VINNOVA. ”Within CREATE Health we have projects that focus on the tumour microenvironment, the psychological impact on cancer and its treatment, as well as immunooncology. Another major focus area is early diagnosis and improved diagnostic methods. As for the different types of cancer investigated, we focus in particular on breast, pancreas and prostate cancer, which are three cancer with unmet clinical need,” says Ulrika Axelsson, PhD, Research Coordinator and Deputy Director at CREATE Health. Tumours, an organ itself
Nowadays, cancer tumours are no longer seen as only a collection of cancer cells but are rather viewed as an organ with a microenvironment that consists of many cells other than cancer cells. There’s an immediate interest in investigating this microenvironment in relation to target non-canA biomarker signature for early diagnosis © Copyright 2017 Immunovia.
cer cells for therapeutic purposes – a novel treatment strategy. ”Within one of CREATE Heaths main program, the MAD (Make A Difference) for Cancer programme Professor Kristian Pietras and his research group, look at these different cell types and has identified promising target molecules to investigate further,” says Professor Carl Borrebaeck, Center Director. Psychological Resilience
”SCAN-B Resilience is an novel project combining expertise from many different areas represented by professors Lisa Rydén, Ingalill Rahm Hallberg, Carl Borrebaeck and Per Johansson ”The aim of the project is to map the molecular background of Psychological Resilience and to see how this can impact how a patient copes with cancer and the treatment. We want to know if there are psychological aspects that can increase the quality of life as well as the survival rate. We also want to connect it to the e-health platform Digital Oncology, to be able to follow the patients when they’re not at the clinic. SCAN-B Resilience is a project that has been very well-received by clinics and patients alike,” Ulrika Axelsson tells. Early Diagnosis
Professor Carl Borrebaeck leads
Dr Ulrika Axelsson, Deputy Director and Research Coordinator of CREATE Health.
Prof. Carl Borrebaeck Director of CREATE Health.
a very promising research project on early diagnosis of pancreas cancer. ”It is based on a biomarker signature in a blood sample. In this case the test can detect pancreas cancer already at stage I and II, before the patient has developed any clinical symptoms. It can also distinguish cancer from other pancreatic disease, such as inflammation (pancreatitis). Resection of early stage pancreatic tumors radically increases the patient survival rate,” says Ulrika Axelsson. In prostate cancer, we have together with Professor Anders Bjartell started a project to identify a biomarker signature as a complement to the PSA tests available today. The aim is to deve-
lop a much more accurate diagnosis, thereby relieving both healthcare providers and patients of a heavy burden. Immuno-oncology
Immuno-oncology is currently one of the hottest fields in cancer research with very promising results for the patients. Using immuno-onology the body´s own immune system is activated to fight the tumor. Professors Thoas Fioretos and Carl Borrebaeck have recently initiated a research project in this field funded by philanthropic donation involving an extensive collaboration with Swiss Cancer Center in Lausanne. The aim is to identify new therapeutic targets in immunooncology.
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New Contrast Agent Improves MRI The Swedish biotech company Spago Nanomedical has developed a unique nanomaterial that may serve as a new platform for diagnosis and treatment of cancer.
A product candidate, SN132D, was recently appointed for the lead project SpagoPix which means the company will enter regulatory GLP studies sometime during the first half of 2017. ”This is a great step forward for the company. Having a material ready for regulatory development is a considerable risk reduction for the SpagoPix project,” states Mats Hansen, CEO of Spago Nanomedical. SpagoPix is a contrast agent for tumour selective MRI, based on manganese. It significantly increases the contrast between solid tumours and the surrounding non-tumour tissue. Sharper contrast between tumours and surrounding tissue gives more accurate diagnoses and, in the end,
better and more cost-effective cancer treatments. Magnetic resonance imaging (MRI) is most commonly used for detecting and diagnosing cancer. A problem with MRI is that the contrast agents used are not tumour selective, which leads to relatively poor contrast between tumours and non-tumour tissue. The risk of false positive findings (tumour findings that are not malignant) is therefore high. It not only leads to anxiety and suffering for the patient, but also to significant costs for unnecessary subsequent examinations. ”Our particles utilises the Enhanced Permeability and Retention (EPR) effect, which is manifested in many tumors that are surrounded by leaky blood ves-
sels,” says Oskar Axelsson, CSO of Spago Nanomedical, and adds: “SpagoPix will accumulate in tumors and provide better contrast toward healthy tissue.” Radionuclide Therapy
In addition to SpagoPix, the company is also developing Tumorad. It’s a project where nanoparticles are loaded with radionuclides (radioactive isotopes) allowing internal, tumour selective, radiotherapy. ”The advantage of radionucli-
de therapy over external beam radiation treatment is the possibility to selectively deliver the radioactive substance to tumours and thereby irradiate several soft tissue tumours or metastases simultaneously. The mechanism of action for Tumorad is based on passive accumulation in tumors by means of the EPR-effect, and Tumorad is thereby applicable in several tumour types. Since the radionuclide is locally accumulated in tumours, a lower total radiation dose is needed to achieve a
Life Science Days Nordic Life Science Days is fastest growing and the largest Nordic partnering conference for the global Life Science industry.
Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech but also from investors and finances, academic research, policy and regulatory authorities. Based on cutting-edge and advanced partnering and networking tools, Nordic Life Science Days showcases the best the Nordic region has to offer. The Nordic way of doing life science business
NLSDays offers networking and knowledge for anyone interested in the Nordic life science, biotechnologies, pharmaceuticals, medical devices and e-health bu-
siness. We offer plenty of opportunities to connect.
vious events, NLSDays 2017 expecting 1000 to 1200 international delegates.
Meetings on your terms
Every meeting is an opportunity. At NLSDays, we focus on meeting quality, not quantity. We provide ample time for you to meet your fellow delegates in a stressfree environment. The Nordic region is proud to host some of the world’s most innovative biotech, medtech and pharma companies. It also has the 12th strongest economy, making it the perfect place to invest. The conference offers an amazing program consisting of Super Sessions, Workshops, Company Presentations, Exhibition, Faceto-Face meetings and unique Receptions, providing so many opportunities to network with peers, potential partners and investors. NLSDays 2017 will take place at Malm¨Mässan, in the MalmöCopenhagen region, in the heart of the Medicon Valley on September 12-14. Based on attendance at pre-
Highlights from NLSDays 2016: 1070 Participants 36 Countries 12,000+ Meeting requests 2,200+ Scheduled Meetings Partnering at NLSDays is powered by partneringONE®, the leading conference solution for helping Life Science delegates meet efficiently and effectively. partneringONE® has the unique ability to manage the complex interactions among thousands of executives from many different companies. NLSDays is a SwedenBIO event, produced by Bionordic Services AB. Contact: Olivier Duchamp Managing Director, Nordic Life Science Days CEO, Bionordic email@example.com Tel: + 33 (0) 608 804 515
Olivier Duchamp, Managing Director
therapeutic effect. Furthermore, radiation to non-tumour tissue can be minimised,” Oskar Axelsson comments. ”Our business model is to bring the projects to clinical phase. By then we expect to have added good value for all our stakeholders and will seek a licensing partner for further development to the market,” says Mats Hansen. Spago Nanomedical AB is listed on Aktietorget since 2013 and is situated in Lund.
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Mapping Medicon Valley – the life science cluster of Greater Copenhagen Medical Valley Alliance has commissioned and recently published the first comprehensive mapping of the Medicon Valley life science cluster. The analysis has been prepared by Øresundsinstituttet. The reason for doing so is threefold. Firstly, we need to know the facts and get overview of the cluster in order to identify strongholds, shortcomings and positive and negative trends and challenges that affect the regional life science eco-system. Secondly, we need to make sure that private as well as public sector decisionsmakers in both Sweden and Denmark have a thorough understanding of the nature of the eco-system, the benefits it brings and the necessary preconditions for its continued development. Thirdly, we need to be able to showcase the life science cluster of Greater Copenhagen convincingly internationally, in order to attract talent, new business and – perhaps - even an institution such as the European Medicines Agency currently located in London, but scheduled to relocate because of Brexit. The analysis itself highlights some interesting facts. Did you for instance know that; • “In the past 10-15 years, Medicon Valley has grown to be by far the strongest Nordic life science cluster employing 35700 persons or 53 % of the total number of employees in the life science industry in Denmark and Sweden”
• “22 billion Swedish crowns are being invested in the two facilities for material research ESS and MAX IV in Lund” • “Denmark is the fourth largest exporter of life science products per capita, while Sweden is the tenth largest, and both countries have USA, Germany and China as their primary export markets, in that order” • “10,4 % is the annual growth in Danish life science export from 2008-2015. Swedish exports has grown 2.6 % annually” • “Medicon Valley filed more than twice as many patent applications to the European Patent Office (EPO) within medical or veterinary science then the competing Stockholm-Uppsala region. Novozymes and Novo Nordisk are among the top-25 applicants to EPO” • “There are more than 3000 international students studying life science programs in Medicon Valley of which approximately a third are studying in Skåne” Download the free analysis from www.mva.org. A limited number of copies can also be picked up from our office at Arne Jacobsens Allé 17, 2., 2300 Copenhagen S. By David Munis Zepernick, Head of communication and Public Affairs, Medicon valley Alliance
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ExpreS2 Platform Solves Tough Protein Expression Challenges ExpreS2ion Biotechnologies specialises in solving the toughest protein expression challenges using a tailormade Schneider 2 (S2) system, derived from one of the most commonly used Drosophila melanogaster (fruit fly) cell lines.
The highly experienced scientists at ExpreS2ion Biotechnologies are driven by the idea that they can solve uniquely difficult protein challenges that no one else can. They are specialised in developing cell lines and processes based on a non-viral Drosophila S2 cells expression system. ”Over 250 proteins have so far been expressed by using our proprietary non-viral insect cell expression system, ExpreS2. It has demonstrated a success rate of 90% even for proteins where other systems have failed,” says Steen Klysner, PhD, CEO of ExpreS2ion Biotech Holding AB and ExpreS2ion Biotechnologies ApS in Hørsholm, Denmark. One of the advantages of their system is that it’s very robust, which means that their products are easier to handle and more harmonious up-stream. The stable cell lines also contribute to higher yields and the system is generally faster than mammalian systems. ”Our platform perfectly supports all phases of drug disco-
very, R&D and manufacturing,” he adds. The system has been developed since 2002 and has been commercially available since 2010. Recently, some of the projects using the ExpreS2 platform have entered clinical phase. In October 2016, ExpreS2ion Biotechnologies for instance announced that its collaboration partner, the Jenner Institute of the University of Oxford, initiated a Phase I/IIa clinical study to assess the safety, immunogenicity, and efficacy of the blood-stage Plasmodium falciparum malaria antigen RH5.1, which is produced with ExpreS2. ”In this particular case the Jenner Institute faced recombinant protein challenges which could not be solved before they applied our protein expression platform ExpreS2,” Steen Klysner comments. Process and Production Tool
ExpreS2ion Biotechnologies sell
research licences to both companies and academic research labs and they want ExpreS2 to be identified as a process and production tool and to enter their customers’ processes at an early stage. ”Market wise, Europe and the US are closest to where we are and our most recent licence was
signed with the American company VaxInnate. However, Asia is clearly rising and emerging as an interesting market. In Asia, good entry points to the individual markets are the many fine science parks that have been established throughout the continent, offering both state-of-the-art equipment as well as good contacts.”
The entry point doesn’t necessarily have to be a company or a university. Organisations like the Bill & Melinda Gates Foundation, WHO and others offer grants to companies fighting Zika, malaria and other diseases. ”As soon as there’s an indication relevant to what we do, we apply for grants,” says Steen Klysner.
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A Gateway to Inspiring Meetings Housed in the tallest building in Lund, the 19 storeys high, Ideon Gateway, Elite Hotel Ideon is in many respects a new landmark for the entire Öresund region and an important addition to Medicon Valley. At the heart of Ideon Science Park and in close proximity to some of the world's leading life science companies, Elite Hotel Ideon offers great opportunities for visitors to mingle and make contact with new, prospective business partners throughout the entire Öresund region and not least in Medicon Valley. A public bus line also links the hotel with the new area in Brunnshög that’s being developed, with ESS and MAX IV as well as a science village with office space and homes for 10,000 citizens. The municipality plans for a future tram line that will stop at the hotel on its way to Brunnshög. Sustainability at the Core Ideon Gateway is in many respects a symbol of sustainable business through its low environmental imprint, modern technology and efficient use of resources. Since 2017, the Elite Hotel Ideon is Green Key certified by the Swedish Society for Nature Conservation. Achieving this certification demands that not only the building is certified in terms of building material, energy efficiency etc., but also that products used in the hotel and restaurants are eco friendly and fair-trade marked and that the hotel is managed in a sustainable way. ”In addition, we invite our guests to act in a way that entails a lower environmental imprint,” says General Manager of Elite Hotel Ideon, Nina Lund. Four Star Business Hotel Elite Hotel Ideon is a distinguished conference centre with generous facilities for all types of business meetings, including nine conference rooms. The hotel caters to the needs of all, including
The tallest building of Lund, Ideon Gateway, is home to Elite Hotel Ideon.
the small group of about ten people to the large international conferences gathering several hundred participants. The hotel has two restaurants, the Italian lunch bistro Paolo's and the full-service restaurant NorthEast, inspired by both Nordic and Asian culinary influences, open in the evenings and at business hours. "The culinary experience is a very important aspect of a conference and we constantly improve
our range by experimenting with new ideas. Most importantly is that our conference guests will remember their visit as a positive experience of Lund and the culinary experience is a very important part of that," says Nina Lund. Being housed in the tallest building in Lund many of the 178 air-conditioned rooms offer magnificent views over the southern part of Skåne.
Many of the 178 modern and air-conditioned rooms offer magnificent views over the southern part of Skåne. Photo: Sandra Birgersdotter
Photo: Sandra Birgersdotter
Quality, Tradition and Flair The Suites are located at the top of the building on floors 13 and 14, with great views. They have a separate living room, bedroom with 200 cm wide beds and a large bathroom with bath amenities from Missoni. The suits on floor 13 are also equipped with a rooftop terrace. ”In the Suites, we also offer capsule coffee machine, bathrobes and slippers.” Elite hotels truly cares about their guests and Elite Hotel Ideon is no exception. There’s a pro-
gramme for members that give them those great benefits that people associate with the hotel brand. ”As a member you get added values like discounts on our rooms, and vouchers in our restaurants, for instance,” comments Nina Lund who invites all their guests to fill in the digital questionnaire sent to them. ”For us, it’s very important to get that feedback and for the guest it’s a way of influencing our offer and what we deliver.”
The hotel has a large conference area consisting of nine rooms with a capacity of up to 220 participants. Photo: Sandra Birgersdotter
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PharmaRelations Meets Shortage of Staff With its vast network of competent professionals and tailor-made recruitment services offering, PharmaRelations meets the shortage of academic specialists currently experienced on the Nordic life science market.
PharmaRelations provides temporary staffing and recruitment services for companies and organisations within the life sciences. All of their consultants have a background, including leadership and management experience, in the life science industry. ”We do traditional recruitment of all levels within life science and our services are individualised and tailor-made, based on the customer’s needs and price expectation,” says Kim Raabymagle, Country Manager Denmark, PharmaRelations. “But in addition to that we offer temporary staffing in both Sales & Marketing and Medical & Scientific areas where our talented consultants work for our customers for a shorter or longer period.” The recruitment team covers
the entire process in-house, including search, interviews, tests, references and contracts, as well as follow-up after 6 months. ”If the candidate has left the position during the first 6 months, we compensate our client with a new candidate,” he adds. In Denmark, PharmaRelations conducts more than 100 interviews with candidates as well as 2-
300 pro-active interviews with could-be candidates per year. In addition to that many customer visits each year contribute to PharmaRelations deep knowledge of the Life Science industry. “It is critical for our customers that we really know the industry and the trends in the therapeutic areas. That helps us understand our customers needs and be able to meet them,” says Kim Raabymagle. ”Key to our business process is that we prioritise our customers, candidates and consultants equally high. It’s because today we may interview a candidate that tomorrow might be a customer or a customer that becomes one of our consultants in the future,” comments Kim Raabymagle. Try and hire is another of the company’s concepts that’s appreciated by their customers. In that
case they employ the consultant that works for their customer for an agreed time-period. After the period, and if all parties agree, the consultant is hired by the customer. Increased Mobility Across the Öresund
PharmaRelations was established in Stockholm 20 years ago and covers all four Nordic countries since several years. During this time is has built up a huge network across the region. ”We established a physical office in Lyngby, Copenhagen, in 2015. But, we’ve been working on the Danish market through partners for five years,” says Kim Raabymagle and informs that they currently have 2 recruitment consultants on the Danish market and 12 in the Nordic countries in total.
Many Danish life science companies experience a shortage of specialists with academic degrees, such as product developers, health economists and sales and marketing professionals. However, PharmaRelations finds it relatively easy to attract highly educated and skilled candidates for contract employment. ”Many candidates contact me, asking for an unconditional interview, and I receive approx. 25 new relevant resumés per week from people looking for a new job. I believe it’s our concept of prioritising all three roles: customer, candidate and consultant equally high that makes us attractive. That makes sense for what we’re doing. The mobility has also increased in the last years, so candidates are more willing to travel across the Öresund as long as it’s within driving distance.”
Innovation Facilitates Regional Growth Lund University plays a significant role in stimulating economic growth in Skåne. Not only by providing high competence in terms of graduates and scientists, but also by translating the knowledge generated at the faculties into new products, services and modes of operation.
To facilitate the transition of scientific discoveries into actual innovations that can be marketed and managed by a company,
Lund University (LU) has established a hub for innovation and commercialisation, LU Innovation. LU Innovation has two sections: one a part of the public authority and the other a holding company, LU Holding AB. Together they function as one unit with a joint mission and joint management, but are responsible for different parts of the innovation process. ”Together, our bodies can support a business through the entire value-chain, from the initial idea to a company being investible by venture capital,” says Christine Widstrand, Vice President and Portfolio Manager of LU Holding AB. Funding for Commercialisation Projects
Olov Sterner, Professor and Dean of the Faculty of Science, founded Gedea Pharma together with Professor Helena Strevens, Specialist Physician at the Faculty of Medicine, as well as Professor Ulf Ellervik and Assistant Professor Sophie Manner, both chemists at the Faculty of Engineering. Photo: Mats Nygren
Every year LU Innovation meets hundreds of researchers and receives around 120 innovative ideas. A great part of them are taken on and developed by teams comprising researchers, business developers and patent and legal advisors. To identify and support new ideas in the early stages is fundamental to LU Innovation and the organisation has various ways in which it can help fund researchbased commercialisation pro-
jects. Ideas that seem promising may for example get verification funding, a part of a Vinnova programme. “In 2016, we also launched a Pre-Seed Program within Life Science, with the purpose of strengthening the entrepreneurial drive among scientists and stimulate commercialisation of their research. You may call it support for early proof-of-concept. The response has been very positive and we’ve received a high number of applications,” Christine Widstrand comments. LU Holding, on the other hand, can invest money in promising ideas and pay for costs unrelated to the actual verification or validation. “We invest in projects with significant international market potential and a unique concept that competitively solves a clear customer need. And we do it at an early stage when the risk is considerable,” says Christine.
Finding the Right People
LU Holding typically assists a company in legal matters and accounting, as well as active involvement in the form of board expertise. ”We usually become active board members of young companies and help them with experience, contacts and strategic decisions during the first years. When they attract external investments we exit our active engagement and sell when possible, to be able to invest in new startups,” says Christine Widstrand. Approx. 50% of LU Holding’s portfolio of 45 companies is life science businesses. One example is Gedea Biotech AB that started in 2016, founded by scientists from three faculties at Lund University. Their basic scientific findings suggested that women suffering from vaginal fungal infections could be cured by a local treatment with a safe, natural and non-antibiotic product.
Fact: LU Innovation’s mission is to contribute to increased growth in Sweden by ensuring that knowledge and research from Lund University benefit society. The organisation provides support services to students and researchers with business ideas and research findings that can be converted into innovations. Since 1999, it has invested in over 80 new research companies, which together have generated over 3,000 man-years employment and close to SEK 900 million in tax revenue.
Christine Widstrand, Vice President and Portfolio Manager of LU Holding AB. Through the holding company, Lund University can work operationally to bring new innovations to the market, by becoming the part-owner of research-based companies or helping to license research results to established companies.
“For us, LU Holding offered vast experience with startups and a broad contact network. But foremost, they were able to understand the potential of our project and managed to connect the right people to it, completing the team with critical skills,” says Olov Sterner, Professor and Dean at the Faculty of Science and one of the founders of Gedea Biotech AB.
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Nanomaterial för diagnostik och behandling av cancer Spago Nanomedical AB utvecklar unika funktionella nanopartiklar för passiv ansamling i tumörer. Bolagets projekt inom diagnostik och terapi har förutsättningar att avsevärt förbättra framtidens cancervård.
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Pharmaceutical P harm rmaceuti a tical Deve Development velop pment C p Co Consultancy onsulta tancy cy ""S Scciiieence ce and C Co oomp mplia iance" "Science Compliance" www.sciuspharma.se
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Scandinavian CRO Celebrates 10 Years of Success as a Company This year, the full-service contract research organisation Scandinavian CRO (SCRO) celebrates its 10th anniversary. The company has over the years succeeded with a steady, organic and strategic growth and is now represented in all four Nordic countries.
Scandinavian CRO is a full-service contract research organisation headquartered in Uppsala. The company has years of experience in running, as well as staffing, clinical trials in many therapeutic areas. ”We offer tailored solutions designed to address each customer’s specific needs. We’re a thriving company that takes pride and joy in helping customers be successful,” says Ulrika Hammarström Lüllmaa, CEO of Scandinavian CRO (SCRO), which she founded in 2007. Being represented in Sweden, Denmark, Norway and Finland the company has reached one of its milestones and will from now on focus on strengthen all four countries separately, but also as one unit. ”The expansion shall rather be on the number of assignments and to grow as an organisation. Not only in the number of employees, but also in terms of competence and experience. In the last year, we’ve recruited several strategic key roles in the company. We have a new CFO and several new project managers with strong backgrounds in their respective fields. We also continue to strengthen our statistics and data management department and will recruit more strategic positions to continue to advance the company,” she adds. Operating Procedures Cover All Segments
Be sure. sure. Anytime. Anywher Anywhere. e. www.lifeassays.com www.lifeassays.com
The Nordic market is currently experiencing a growth within
Medical Device, especially in Sweden and Denmark. ”We’ve raised our staff’s competence in this field in order to meet the increased demand for studies of medical devices and of products combining medical devices and active pharmaceutical ingredients. We’ve also adapted our Standard Operating Procedures so that they cover all segments,” Ulrika Hammarström Lüllmaa comments. With the regulatory and monitoring demands constantly getting tougher and stricter, they also see an increased need of their services in investigator initiated studies. ”We happily work with academic research groups. One example is the Beta-JUDO – Beta-cell function in Juvenile Type 2 Diabetes and Obesity – project initi-
ated by Uppsala University within the EU Seventh Framework Program. The aim is to identify novel strategies reducing insulin hypersecretion in young obese individuals and we’re proud of being a part of this important project,” says Ulrika Hammarström Lüllmaa. A tendency in the CRO market is that risk based monitoring is increasing, which demands more of soft skills among the CRO staff. ”Our ambition is to be a partner to our customers, not just a supplier of services. Hence, communication, feedback and risk analysis are all important aspects of what we do and what we deliver. Our long-lasting customer relations prove that our personal engagement gains our customers as well.”
Improving early-stage drug discovery Supporting drug discovery teams in pharma, biotech and academic organisations, our Discovery Services provide cutting-edge phenotypic insight to help shorten lead times and reduce costs. • Fully collaborative services • Advanced discovery platform • Biologically relevant disease models • Specialists in CNS and pain diseases
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Insight from life science consultant and thought leader Pharma Global Consulting – supporting Sweden’s export strategy with market-entry strategies for companies in the Middle East and North Africa region Insight from life science consultant and thought leader Pharma Global Consulting – supporting Sweden’s export strategy with market-entry strategies for companies in the Middle East and North Africa region.
The Swedish life science sector is seeing fresh growth and, with local government’s export drive, many life science companies are looking to the Middle East for new business opportunities however the route to market can be complex. Swedish life science business consultant Global Pharma Consulting uses its vast local knowledge and skills to eliminate the pain points and ensure a quicker entry for clients. Global Pharma Consulting’s team has a clear understanding of the business landscape and needs of this market, and has developed a comprehensive turn-key business offering that is unparalleled in Sweden. “We’re unique in as much as we have solutions and support for the entire spectrum of services required by the typical life science company operating in the MENA region. We know what it takes to do business in this territory both from a regulatory and cultural point of view, and our team is made up of skilled professionals who have worked with some of the sector’s biggest global brands. Combine all this and you have a solid platform for successful and rapid market entry, sometimes even faster than starting operations in our own Nordic countries!” says Paula Hassoon, CEO at Global Pharma Consulting. “The region has extensive medical and infrastructural requirements and a high demand for professional management of hospitals. Our clients are mostly interested in the Gulf States as they
have substantial financial resources to cover healthcare costs however; MENA is a big region with several interesting markets. An extensive benchmarking and research exercise, and a solid understanding of local legislation is the best starting point. From there, the most suitable point of entry quickly emerges,” Hassoon advises. Sweden and even Scandinavia are recognised for leading innovation and Sweden’s healthcare system is often considered one of the best in the world. Swedish health products are favoured for their simplicity and pricing advantage compared to the more complicated and costly medtech products from other countries/regions. Another interesting aspect is the world-famous Swedish know-how in the quality register area, especially for the challenges areas such as diabetes and cardiovascular problems. Many countries in the MENA-region are starting to discuss how to introduce this valuable tool to improve the quality of care and patient outcomes. “Registering a CE-marked Medtech Class II product usually takes six to eight months in Saudi Arabia, just to give an example. During that period, we search for a local partner, and we oversee every element of the market entry strategy based on a needs assessment, from elements such as price analyses and research, export processes, logistics, product registrations, local networking and introductions, to translation services and cultural advice. On average, the entire process can take eight to 12 months, from the start of the strategy to the client’s first order in the new country.” “If you're going to work with a distributor, invest some time in finding one that matches your expectations and fits your values. It goes without saying that back-
ground checks are critical. Never let a distributor select you – you should be the one selecting a distributor in line with your needs and requirements!” According to Hassoon, the obstacles to entering a new territory often results in lost opportunities when the process becomes too drawn out or frustrating and the MENA-region expansion plans are dropped. This doesn’t just affect the individual company but Swedish exports and other areas of the local economy are impacted. As a Swedish business, Global Pharma Consulting are members and also works closely with the Swecare Foundation, a semi-governmental non-profit organization where academia, public and private sector join forces on enhanced export and internationalization of Swedish health care. “We have a clear understanding of what Sweden is trying to achieve and we fully support the focus on export strategies aimed at emerging economies. The mandate to support enterprises offering high quality and afforda-
ble life science products and services, especially those with a strong focus on innovation, is presenting some really exciting opportunities right now. Life science companies can make a real difference to the MENA countries’ health care infrastructure and the implementation of international best practice and standards for patient care,” says Hassoon. As part of Global Pharma Consulting’s own communications strategy in the MENA region, in late January the company will be active at the Arab Health Congress and Exhibition, the key international networking event on the region’s calendar. “We didn’t want to be just another exhibitor, we wanted to go bigger and give our clients’ region a greater visibility. After months of preparation and with high level support from Swedish government, Global Pharma Consulting will be the only independent consultancy to host its own pavilion focusing on life science from a single region. So, at Arab Health this year, 16 Swedish companies and representati-
ves from the Swedish Ministry of Health and Swecare Foundation will join us in Global Pharma Consulting’s Anglo Nordic Pavilion. We couldn’t be more excited to be showcasing some of Sweden’s top life science innovators!” Watch out for more international life science networking events hosted by Global Pharma Consulting in 2017.
Paula Hassoon, CEO Global Pharma Consulting. Photo: Jennie Kumlin
TECHNOGARDEN LIFE SCIENCE Technogarden has a national team of consultants who have extensive experience in the pharmaceutical industry, biotechnology, medical device and food production. WE OFFER RESOURSES WITH EXPERTISE The team has expertise in areas such as qualiﬁcation/validation of classiﬁed facilities, cleanrooms and equipment, validation of software and processes, compliance against standards and directives and layout/design of laboratory. Project Management and Quality Management. THE TEAM OF CONSULTANTS We can help you with missions where you need advice, longer assignments when you need to increase the resources in a project or need to bring in an interim manager. The expertise of our consultant team reinforces by external cooperating consultants/partners with experience within Life Science. Technogarden support you through your entire business, from product development to production.
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LifePod Prioritises the Right Patients Learn about the Øresund investor climate Get your free copy of the report at: G www.nyconsulting.se/en/reports w
CREATE Health Strategic Centre for Translational Cancer Research, Lund University Medicon Village, Sheelevägen 8 Lund www.createhealth.lth.se www.madforcancer.lu.se
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Cross Technology Solutions has developed a platform that connects patients with healthcare providers to identify the patients with the greatest needs and ensure that they get the right treatment when they need it best.
"How do we evolve the healthcare system while keeping the patients' needs and priorities at the forefront?" The rhetorical question is asked by Thomas Bergqwist, Co-founder and CEO of Cross Technology Solutions AB in Lund. His business idea is to drive the treatment of patients with chronic and multiple diseases from being calendar-based to being based on each patient’s current medical needs. For ten years, the company he co-founded has been working on its patented ehealth platform to accomplish this mission. It's an open, cloud-based, application programming interface (API) platform that prioritises treatment for those in most need. It collects data from medical records, sensors and from the connected patients who use an application on their smart phones, tablets or pc/mac to report important parameters to the clinics. The action data generated from theses multiple sources is facilitated, prioritised and visualised in one interface used by the healthcare professionals. ”LifePod, as we call it, is both a decision support system for healthcare professionals at the clinics and a tool for patients to report their current health status to the clinics. Apart from the most basic data such as health condition, pulse, blood pressure, waist circumference and physical activity other more unique and special data coupled to the patient’s chronic condition is collected,” he explains further. Makes the Patient Feel Acknowledged and Safe
The data is compiled, cleaned and structured before it’s interpreted by algorithms and presen-
LifePod – patient interface.
LifePod interface for advisors.
Thomas Bergqwist, CEO.
ted to the healthcare professionals in a user-friendly interface. The patient with the greatest medical needs is automatically moved to the top of the priority list. The patient receives a confirmation notice when the healthcare provider reviews patients’ parameters. ”Reporting back to the patient is very important to make the patient feel acknowledged and safe,” states Thomas Bergqwist.
Studies on patients at the university hospitals in Malmö, Lund and Umeå have shown that the platform successfully identifies deviating values among connected patients who’ve had myocardial infarction and that it’s led to medical interventions to prevent their problems from escalating. ”It proves that we can move from calendar-based to needs-based healthcare, which is a huge gain for both patients and healthcare providers in terms of quality of life as well as time- and costsavings.” More money has recently been invested in Cross Technology Solutions and the company is now ready to launch LifePod on the market in earnest. ”We recently received a SEK 5 million investment from our biggest shareholder, Dendera Venture, and aim to launch a rights issue of SEK 40-50 million this summer.”
Vem har ditt drömjobb? Troligen vi. Vi rekryterar åt några av Sveriges mest spännande företag. Även om du trivs på ditt nuvarande jobb får du gärna höra av dig och berätta vem du är. Många nya karriärer har börjat på det sättet.
dfind.se/science-engineering 0775-700 900
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Invest in Market Validated Start-Ups NY Consulting is specialised in life science and ICT and offers a range of productified consultancy services that facilitates business development and implementation for the benefit of start-ups and their investors.
Today, many small biotech companies to a large extent constitute the development pipeline of the big pharma companies. This is especially true in Sweden. There is a willingness among investors to invest in companies with a high risk. But, they need to know where, i.e. in which projects, to place their money for best results, both for themselves and the portfolio company they decide to invest in. NY Consulting offers a range of consultancy products that facilitates a successful start-up – investor relation. ”We see an increased demand for qualified validation of early phase business projects. Our offer covers establishment of market potential, commercial due diligence, go-to-market strategy, as well as business development
management and implementation. The products are developed based on the most common needs of our main clients – university innovation offices and investors. Each product has fixed deliverables, fixed price and fixed timeframe after agreed scoping. This makes our customers confident and reassured in relation to project results, cost and timings,” says NY Consulting’s CEO Johan Ny, who founded the company in 2013. The firm focuses solely on customers with interest and investments within life science and ICT (Information and Communication Technology) and is consulted by the leading research groups and portfolio companies from Scandinavian universities and venture capital funds. ”We use a validated user-cen-
Johan Ny, CEO. Photo: Sofie Björner
tric project process based on scientific methodology that has been validated in more than 30 projects, and for each case our process improves,” he comments. Cross-Öresund Focus Could Accelerate Growth
Last autumn, NY Consulting published their Öresund Investor Climate Report in which they, among other things, concluded that there are many pharma related Corporate Venture Capital funds interested in the regional companies, and they are actively seeking ways to build their pipe-
NY Consulting develops, refines and implements business development strategies for Life Science and ICT companies. Photo: Precious People
line through both acquisitions and syndication deals. However, there is a need for more crossborder coordination and collaboration, with a focus on market validation of early phase companies that will qualify them for later stage investment. ”Based on the input gathered in our survey, it seems that life
science in Öresund is doing well and that the region has potential. However, a cross-Öresund focus on creating venues to promote the promising companies and clusters could do a lot to accelerate the growth of the Öresund region and improve the investor climate,” states Johan Ny.
New Concept for Diabetes Treatment The virtual biotech company Apoglyx in Lund develops a new therapeutic concept for treatment of type 2 diabetes patients with reduced kidney function.
Patients with advanced kidney disease, which is a common complication in diabetes, cannot make proper use of current therapies. Normal kidney function is needed for many of the available therapies to keep risks of side-effects low. Even though diabetes care is individualised, using combinations of pharmaceuticals, the options for this patient group are limited. Still, these patients need effective therapies for lowering elevated blood sugar levels to avoid complications. ”Our solution is to target a mechanism on a molecular level that has not been addressed before, namely inhibitors of the protein aquaporin-9 (AQP9). This protein transports glycerol into the liver cell, where it gets turned into glucose and released into the plasma,” says Martina Kvist Reimer, CEO of Apoglyx, a virtual biotech company in Lund that develops a new therapeutic concept for treatment of type 2 diabetes. Initial in vivo tests have shown promising results. ”Improved glucose control has been observed in tests on knockout mice, where AQP9 has been removed. Since less amounts of glycerol, which functions as a fuel for the glucose production of the liver, is transported to the liver, the concentration of glycerol increases in the mice’s plasma. This demonstrated that glycerol transport is effectively inhibited,
with no observed side effect in such animals. Our concept also eliminates the risk of dangerously low glucose levels, which insulin-based therapies might cause. Of course, the concept needs to be proven in patients in order to validate its benefit,” Martina Kvist Reimer comments. Out-License Before Clinical Phase
In 2016, Apoglyx received SEK 5 million from business angels to
take the pre-clinical development further and hopefully reach proof-of-concept in relevant translational animal models in the first quarter of 2017. The goal is to create an orally administrated pharmaceutical in tablet form, and the company is also exploring additional indications where AQP-9 inhibition might have a therapeutic benefit. ”We’re the only company with patents covering selective and potent inhibitors of AQP9. We
have a solid IP strategy which gives us competitive advantage, as our patents precludes other parties to use our compounds,” says Martina, who has presented the concept to various players within Pharma companies, whom have shown great interest in novel compounds with a first-in-class potential. ”Since our primary business strategy is to out-license our projects before clinical phase, we’ve listened to their advice and have,
to a certain extent, adjusted our pre-clinical development programme based on their feedback. However, out-licensing at a preclinical stage is difficult, as Pharma companies rather partner at a clinical stage to minimise risk. As an alternative back-up strategy we are considering to progress AQP-9 inhibitors towards the clinical phase by partnering with a venture capital firm or by raising the required capital by an IPO.”
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• • • • •
Statistical advice Statistical analysis Pharmacokinetics Scientific and regulatory All phases of development
StatMind AB, Scheelevägen 2, 223 61 Lund Thomas +46709131995, Stefan +46727320332
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Inflammation Detected by magnetism LifeAssays® in Lund has developed a technology that detects increased levels of, for instance, the C-reactive protein (CRP), an indicator of inflammation/infection, using the company’s proprietary magnetic detection technology.
The unique point-of-care technology platform, which the diagnostic company LifeAssays® was founded upon, was developed at Lund University. It’s composed of nano-size magnetic particles and a detector system for the identification of biological markers. By mixing the target biological substance, i.e. the ’marker’, with target-specific antibodies on the magnetic nanoparticles an immune complex is formed as a solidphase pellet. Since the pellet contains magnetic particles it possesses magnetic properties, which are measured quantitatively with the VetReader by detecting the change in inductance of the internal coil. The obtained signal is converted into a target marker concentration unit (μg/ml), by the system’s computer chip, using a mathematical algorithm. The chip contains all of the data specific to the analysis. The VetReader is a desktop unit that has been developed in-house by LifeAssays. LifeAssay’s has had a strong focus on companion animals. Today the company has canine (dog), feline (cat) and equine (horse) Acute Phase Protein (APP) test systems on the market. APPs are important and early markers for inflammation/infection and a valuable tool in the initial diagnosis and follow up of treatment. ”We deliberately opted to focus on the veterinary applications made possible by this technology. We have developed applications for humans as well, but veterinary applications face lower regulatory demands making it a shorter route to market. In addition, the veterinary market is growing faster than the human diagnostic
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and the technology is currently being miniaturised to the size of today’s pregnancy test, but unique as it gives a quantitative result. It requires only a single drop of blood and it’s easy for the veterinarian to administer the test, which can be used as a disposable,” he adds. Magnetism vs Light
Anders Ingvarsson, CEO of Life Assays AB.
market,” says Anders Ingvarsson, CEO of Life Assays AB. ”That said, we did acquire the Finnish company Magnasense Technologies Oy, which gave us access to a CRP test for the human point-of-care market and a broadening of our patent portfolio. The acquisition was made by the turn of the year 2015/2016
There are CRP tests on the market that use light to measure the CRP level in the blood plasma or serum. ”To use light in these tests has some draw backs. Our technology requires no calibration by the customer, has fewer sources of interference and gives a greater range between the lowest and highest levels of concentration that we can measure, making it more accurate,” Anders Ingvarsson explains. LieAssays was founded in the year 2000 and is listed on the Nordic Growth Market stock exchange in Stockholm since 2002.
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The Art of Storing Sensitive Material Ali Ismail is a chemical engineer who became expert at solving problems around the storage and transportation of sensitive material and used this experience as a basis for a new business concept. And so Birka BioStorage saw the light of day.
”Logistics and storage were always bottlenecks and sources of risk of losing sensitive material and project progress. I worked as a process developer at BioInvent and during my eleven years with the company I gained a lot of experience of solving such problems,” says Ali Ismail, founder of Birka BioStorage, and adds: ”In those days (1997-2008) everyone did their own storage and logistics. But after making a thorough needs analysis I concluded that companies needed an external partner that could handle
all these issues and in 2008 I decided to leave BioInvent to become that partner. I took a position at BioReliance, to learn more about the market. In 2010, the timing was perfect.” Being an entrepreneur at heart, he had tried out various enterprises while still in his teens and so this idea was quickly turned into a viable business concept. ”My initial capital covered a rental contract and some equipment, and in July 2010, Birka BioStorage moved into the incu-
bator in Lund and to its current facilities in 2011. It took exactly two years to get the necessary approval. At first, the Medical Products Agency (MPA) didn’t believe in my setup. For one thing they questioned my ability to solve the conflict between the regulatory classifications for storing different types of material in the same facility. But after inspecting my facility they approved the concept without further ado, and Birka BioStorage received its Good Manufacturing Practice (GMP) permit.” He already knew a number of companies interested in testing the concept and they became good references. ”In the following years, we added door to door transportation, as well as urgent recovery of our customer´s in-house storage. Our cost-effective services are based on one contact and one platform even if you store several different substances. In emergency situations we can provide ade-
quate space that meets the regulatory demands within 24 hours.” Natural Business Partner from Day One
The business continued to grow and in 2014, Birka BioStorage signed contracts with their first customers in Finland and Denmark. In 2016 they got customers from the USA and the Netherlands as well. Today, the company has become the main Scandinavian GMP certified repository for the storage of crucial biological and pharmaceutical material such as cell banks, API & drug products, clinical trial product samples, reference material, stem cells and biobanks. Furthermore, Birka have just started the planning to set up the largest repository hub in the world. ”Now we’re a natural business partner from day one when some-
The Science and Compliance of Pharmaceutical Development Scius Pharma Support AB is a privately owned independent consulting firm, supporting pharmaceutical product development initiatives of life science companies of all sizes.
The core competences of Scius Pharma Support AB revolve around the activities that in the end will support the Chemistry, Manufacturing and Controls (CMC) section of the regulatory package for a new medicinal product. The company was founded in 2013 by Fredrik Nicklasson, a pharmacist with a PhD in Pharmaceutics and extensive experience of product development within the pharma industry. Scius is currently a one-person operation with Fredrik as the owner as well as the operative consultant. In early 2016, the company moved to Medicon Village in Lund in order to be closer to the
many small size virtual and startup companies thriving in ’the Village’. “What Scius aims for is ‘Science’ and ‘Compliance’. Those two words sums it up,” says Fredrik Nicklasson. “Whether your immediate objective is proof of concept or an application for registration approval,” he continues, “you need to prove the technical viability of your project. The Compliance part deals with finding out what you need to prove, whether it’s to a potential financial backer or to a regulatory authority. The Science part is all about how to prove it.” Can Quickly On-Board Projects
Assignments can be as diverse as preclinical formulation work and tech transfer for commercial production. “Being a small firm with no in-house laboratory or manufacturing capabilities, the ability to collaborate and coordi-
nate is key,” Fredrik observes. “And with being small comes great flexibility and the ability to quickly on-board projects.” Often, client companies need assistance with scientific writing or review of regulatory submission packages. “Again, Science and Compliance,” says Fredrik. “The content must be scientifically sound and needs to cover the regulatory requirements. And if you can present a concise and coherent narrative, a lot of misunderstanding can be avoided.” And the company name? Scius is latin, meaning knowledgeable person or someone with expertise. “The name is more of an aspiration than a statement of fact,” Fredrik concludes, “in this line of business you need to always be up-to-date if you want to stay relevant.” Fredrik Nicklasson.
one outlines a new development project, clinical study or manufacturing process. And authorized bodies are actually consulting us when setting up new guidelines for pharmaceutical logistics. It’s an example of how we influence new standards. We have learnt a lot and gladly share our knowledge. That way everyone wins,” he says. But Ali Ismail didn’t stop there. He has recently launched three new business projects at Ideon: Canopus Medical, Insolidex and Resanitec. ”Canopus Medical focuses on pharmaceutical manufacturing, Insolidex on robotic milling of medical metals for industrial tools, knee-caps, hip balls etc, and Resanitec will provide cleaning, testing, mapping of risks in connection with facilities classed as hygiene zones,” he explains.
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Statistical Expertise Promotes Accurate Study Management Founded by former AstraZeneca statisticians, StatMind offers companies statistical expertise regarding design of study programmes and data mining, as well as retrospective analyses and modelling of PK/PD relationships.
StatMind was founded in 2011 by former AstraZeneca colleagues, and is now co-owned by Thomas Bengtsson and Stefan Peterson. The company, which is situated in Medicon Village since 2013, provides statistical competence to pharma and medical device projects. At AZ, Thomas and Stefan gained comprehensive expertise in respiratory R&D, but they have also been involved in projects concerning diabetes, pain relief, haemophilia and oncology. ”We help our customers to design their study programmes, as well as with retrospective analyses, data mining and communicating with regulatory authorities. We also provide high-quality analyses of pharmacokinetic and pharmacodynamic studies, as well as modelling of PK/PD rela-
tionships,” says Thomas Bengtsson. Apart from their strong base in PD studies, their customer cases also involve bioequivalence, therapeutic equivalence and regulatory aspects. ”We’re unique in the sense that we can supply both PK computations and perform the statistical analysis of the parameters. We have the additional insight gained by strong statistical methods and experience” he adds. They’ve also been engaged in register studies. ”Sweden has a veritable goldmine with its high-quality and comprehensive records,” Stefan Peterson comments. Provides Project Risk Reduction
When a company comes to StatMind it may already have started to conduct a regulatory study. But StatMind advises companies to involve a statistical expert earlier in the process to ascertain that the proposed study can answer the primary objective as intended, for instance a proper sample size calculation is needed.
Statisticians Stefan Peterson and Thomas Bengtsson joined AstraZeneca in the mid-90s. In 2011 they co-founded StatMind AB and have established their business at Medicon Village.
”Otherwise, parts of a study may have to be re-run due to criticism from regulatory authorities. In that sense our services provide risk reduction for a project,” says Stefan Peterson. StatMind can also be a complement to a traditional CRO, and act as project statisticians and advisors to the sponsor while the CRO analyse the data. In some projects they’ve also been a sci-
entific support for medical advisors. ”We’re flexible and work with different tools to find effective solutions for each customer. Our primary focus is on small studies in early phase trials, but also explorative studies. By visualising our results we make them more accessible,” he adds. StatMind is also a member of the Medicon Valley Inhalation
Consortium (MVIC), a registered company jointly owned by its 24 member companies. It acts as a full service CRO specialised in inhalation product development. ”For each project, MVIC forms a project team with members allocated from the various member companies as appropriate and in a way that is fully seamless to the client,” Thomas Bengtsson concludes.
A new treatment in the growing field of cancer immunotherapy
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Growing Together To better assist the many small life science companies in Sweden, the recruitment and engineering consultancy company Technogarden has developed a range of services especially targeting the challenges faced in the early stages of development.
Technogarden Engineering Resources AB offers recruitment and consultancy services in a number of technologically advanced business areas, including life science. ”Our range of consultant services covers anything from solving specific technical tasks to managing entire projects, as well as interim manager solutions. We also arrange courses and seminars on GMP and GLP etc, both public and tailored to the specific needs of our customers. We have a strong focus on life science since 2015 when it became one of our core business areas,” says Sandra Larsson, Consultant and Life Science Manager at Technogarden Engineering Resources AB, a company in the Norconsult Group. The business area life science is represented in the company’s offices in Malmö, Lund and Gothenburg. It will, however, expand
to the rest of their eight offices in Sweden, starting with Stockholm and Karlstad in 2017. ”The aim for the next couple of years is to maintain its growth rate of 50% per year,” she adds. Technogarden currently has approx. 15 life science consultants in Sweden and 3-5 in Copenhagen with wide and deep technical expertise and/or regulatory competence within medtech, biotech and pharma. In addition, the company often hires sub-consultants to reinforce their team with the extra competence that a project demands. By regularly meeting new candidates Technogarden continuously expand their vast network of competent engineers and other specialists. ”We work with well-established methods and tools to find and validate the best candidates for our customers, wether it’ll be for consultant services or for ap-
Life Science business area at Technogarden Engineering Resources run by Therese Lindquist (researcher), Ulrika Ydse (consultant manager), Birgitta Andreasson (consultant manager) and Sandra Larsson (consultant manager and business area manager). Photo: Sandra Larsson
pointing vacant positions,” says Sandra Larsson. Strong Demand for Meeting Regulatory Standards
She sees a strong demand for automation engineers within the pharma industry, as well as for quality engineers covering pur-
chasing and quality assurance of manufacturing and product development, especially within medical devices. Since the life science market in Sweden consists of many small businesses, Technogarden has developed a range of services tailored for these, many times virtual, companies.
TOGETHER EVERY STEP OF THE WAY If you are looking for a committed clinical development partner with a global reach that can fulﬁll your needs for speedy delivery, ﬂexible solutions, senior consultants and cost eﬃciency, then look no further. TFS can cover both your insourcing and outsourcing needs from early clinical development to post launch.
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”We call the concept ‘Growing Together’ since the idea is that we shall join them on their journey of creating, designing and launching a new product. These services especially target the challenges faced in the early stages of development.”
Clinical development planning Regulatory aﬀairs Feasibility Global Clinical Operations Study and Site Coordination Patient Reqruitment Services Clinical Data Management Biostatistics Pharmacovigilance/Safety Medical Writing Quality Assurance
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Nordic CRO with Strong Presence in Öresund The contract research organisation IRW Consulting sees a strong demand for clinical trial management, not least in Denmark and Southern Sweden, and plans for several new projects in Lund and Malmö in 2017 and 2018.
IRW Consulting is a premium, full-service, contract research organisation (CRO) that has worked with outsourced clinical research for over 17 years. The company has a strong Nordic presence with regional offices in Denmark, Finland, Norway and Sweden. Their experienced locally-based staff can assist their customers conducting clinical trials as per country specific laws and regulations. ”We cover all the stages of clinical development, from phase I to phase IV, including paediatric and non-interventional studies
and medical device investigations. Our customers range from virtual biotech companies and medtech companies to big pharma and other CROs. Depending on the customer’s requirements, our staff is either outsourced or works with in-house projects,” says Ola Jeppsson, Vice President Nordic, IRW Consulting AB, headquartered in Stockholm. The company has a strong presence in the Medicon Valley region with their second largest office located in Copenhagen. There’s a strong demand in Denmark and Southern Sweden and IRW Consulting plans for several new projects in Lund and Malmö in 2017 and 2018. 40% of Trials are in Oncology
”The number of projects is growing in a wide range of therapeutic areas, not least in oncology. Approx. 40% of the trials we manage are in oncology. We’re plan-
ning to recruit more people in 2017, especially in Denmark and Sweden, and are constantly in search of new highly skilled professionals experienced in conducting clinical trials,” Ola Jeppsson adds. IRW Consulting is increasingly performing clinical trials outside the Nordic countries. Primarily in Germany, France, the UK and Poland, but also in the US and other non-European countries. After some years of decline in clinical trials, the Swedish market is witnessing an increase both in the number of companies and in the number of projects entering clinical development. ”The conditions for performing trials in Sweden are very good and many companies, both from Sweden and abroad, choose to conduct their studies here. With our engagement and extensive network of clinics we can overcome the bottlenecks regarding time and access to patients
Ola Jeppsson, IRW Consulting AB.
that sometimes occur. By showing this we’ve attracted companies from other parts of EU to ex-
pand their trials to Sweden as well,” says Ola Jeppsson.
It's All About Trust! Through their deep knowledge and extensive experience from the industry, Dfind Science & Engineering is a trusted partner in recruitment and lease of scientists and engineers to many life science companies.
Dfind Science & Engineering specialises on recruitment and lease of scientists and engineers, with a strong commitment to its business areas, customers and consultants. By finding the right match between their customers and candidates, Dfind helps companies become more successful and to grow, while supporting people in their search for a new rewarding career position in line with their ambitions and dreams. One of the key aspects of establishing successful, rewarding and profitable partnerships is trust. And trust runs like oxygen through Dfind's organisation, vitalising all parts of Dfind's business. ”Our customers’ trust in us is earned through our deep knowledge and extensive
experience from the industry. And the fact that we keep what we promise, are open and honest, and communicate in a straightforward way make us credible. It applies to our customers, as well as our consultants and candidates,” says Karin Christiansson, Consultant Manager at Dfind Science & Engineering in Malmö, who has graduated in Biomedicine and worked in different Ideon companies before joining Dfind. ”Here, my curiosity gets much scope and I can make use of my ability of creating a good collaborative environment between different parties, in an industry where I have both qualified education and experience,” she adds. Attentiveness Ensures Effectiveness
Knowing that details are of fundamental importance to establish a good match Dfind puts a lot of effort in getting to know their customers and candidates in order to get a good picture of their current situation and where they're striving at.
”Our attentiveness ensures effectiveness. By basing our offering on our customers’ real needs we maintain credibility and trust from them. It also helps that we strive for perfection and often exceed expectations,” she says with a smile. Through their knowledge and experience, Dfind sometimes challenge their customers who search for a certain profile by suggesting a candidate with complementary competences relevant to their upcoming needs. ”When someone has left an organisation, the best solution isn't always to find another person with exactly the same qualifications,” Karin Christiansson comments. Having achieved a good match is the most rewarding part of her job. The customer is happy, the candidate is happy and Dfind is actively part of their customer’s progress and success. ”I feel privileged to work in a company that shapes the world of work and contributes to all the interesting technology
Karin Christiansson. Photo: Elin Mårtensson
being developed by our customers to enhance people's lives, not least in the life sciences. And we would never have been here without their trust."
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I-Mind Turns Data into Knowledge I-Mind Consulting is a service provider of highquality data management and analysis of drug development projects and clinical trials. The company is growing and is actively searching for talented statisticians and statistical programmers, especially with experience from the pharmaceutical industry.
I-Mind Consulting, based in Lund, Sweden, supports life science companies and organisations with statistical expertise and statistical programming since 2010. ”We have medtech, pharma and functional food companies as customers and handle all phases from experimental methods and methodology studies (pre-clinical), through clinical phases I-IV to post marketing studies across a large number of therapeutic areas. Everyone working here has at least 16-17 years of experience in the business and quality is the most important aspect of what we deliver,” says Mats Hindefelt, Senior Consultant at I-Mind Consulting. I-Mind’s statistical services cover all the statistical activities related to clinical trials from study design to preparing deliverables for the final integrated clinical report, as well as writing the statistical sections. Their programmers have extensive knowledge within CDISC and put a lot of effort on examining the data from CROs and
Christina Johansson and André Albrup, I-Mind Consulting AB.
make them up-date it to common data standards such as SDTM and ADaM. ”What we do most is statistical programming and our greatest expertise is management and analysis of clinical data,” comments André Albrup, Senior Consultant and Chairman of IMind Consulting. The big pharma companies handle these issues in-house, but small biotech companies often have problems with this. In their procurement of CRO services
they sometimes miss certain components. ”But the greatest shortcoming is on quality. It’s important to set up requirement specifications, i.e. the standard, for how they need the data delivered from the CRO so that they can reuse it in meta analyses,” he adds. Offers Good Economic Terms
Today, I-Mind Consulting has 11 employees, but Mats and André would like to have 15-20 people
working at the company. So, they’re actively searching for new employees. ”We’re especially in need of statisticians and statistical programmers with experience from the pharmaceutical industry,” states Mats Hindefelt. Working at I-Mind Consulting means that you work quite independently towards the customer in a freedom based on trust approach. ”We want our employees to feel a joy on delivering results
and to have fun at work. The working hours are flexible and there’s no need to stay fixed to our office in Lund. Apart from the occasional client and project meetings, there’s plenty of opportunity to work from home. We offer very good economic terms and all our employees are offered training and education to maintain and advance their expertise, so we can continue to deliver top-notch results in each project,” he concludes.
MultiHelix AB works in co-opertion with Life Sciences, ICT and Foodtech in: MultiHelix Think Tank Twin’s International MultiHelix Science Skills You can find more about us at MultiHelix.se If you want to join, mail us at info@multihelix. se or meet us at Medicon Village, Lund
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Clinical Trial in a Plate Cellectricon AB and Censo Biotechnologies Ltd. are introducing a joint technology access programme for a fully humanized phenotypic screening platform targeting preclinical neuroscience and chronic pain research.
The approach is based on human induced pluripotent stem cells (HiPSC) sourced and produced by Censo, combined with Cellectricon’s proprietary screening platform, IP and know-now. The joint technology access programme will enable high quality phenotypic screening of medium throughput compound libraries in customized human IPSC-derived diseased and healthy control models. The power of HiPSC technology includes reduced risk of late stage failures by encompassing increased biological relevance and by bridging the gap between preclinical and clinical data. The HiPSC technology also makes it possible to generate isogenic control lines from disease-bearing individuals thereby creating
a genetically corrected control. A phenotypic approach directly interrogates physiologically relevant biology in a target and pathway agnostic manner, increasing the probability of finding/targeting novel mechanisms. ”Primary screening of drug candidates, hit validation, optimisation, toxicology can be efficiently followed by clinical trials in a plate testing the drug candidates in many patient lines to capture more genetic diversity and get a better sense of the robustness of the compound effects,” says Dr. Mattias Karlsson, CEO of Cellectricon, a leading provider of highly differentiated cell-based discovery services to enable faster drug discovery with reduced costs and failure rates. The company is situated in Mölndal, Sweden. Discovery of First-in-Class Medicines
Currently, there are no ways to model sporadic disease in nonhuman systems that offer a way forward for diseases of the central nervous system and chronic
pain. This programme, on the other hand, enables discovery of first-in-class medicines using phenotypic screening both on the cellular and network level. “Differences in target composition and neuronal processing between humans and model organisms may lead to poor translation between animal studies and the clinical setting. By gaining access to human cells from virtually any disorder, our collaboration with Censo has significantly enhanced our discovery services offering for CNS and chronic
pain research,” says Paul Karila, VP Discovery Services at Cellectricon. “There is an excellent alignment between Censo and Cellectricon. Our extensive expertise in the production of ethically approved human iPSCs and derivatives adds further value to Cellectricon’s proprietary discovery services. We are very excited that this program will enable clients to access highly relevant screening cascades,” comments Aidan Courtney, CEO of Censo, a stem cell technology company provi-
ding human cells and contract research services for drug discovery, toxicity testing and cell banking. The company is based in Cambridge, UK. ”The programme provides massive cost savings for our clients by avoiding the need for capital expenditures and personnel investments in stem cell production, assay development, and screening,” says Mattias Karlsson, who also points to the benefits of reduced risk and shortened lead times in the discovery phase by up to more than two years.
MVIC – A Strong Partner in Developing Inhalation Products Together, the 24 member companies of the Medicon Valley Inhalation Consortium (MVIC) constitute one of the world’s greatest concentrations of expertise and advanced equipment for developing inhalation applications.
The Medicon Valley Inhalation Consortium AB (MVIC) started as a consortium of inhalation experts that had worked at AstraZeneca in Lund until 2012, when the company moved out from its premises. ”Many of us have more than 30 years of experience within inhalation R&D. And since we’ve worked together we know each other quite well and have the
same way of thinking and working, which is a great advantage in a collaborative environment like ours,” says Ola Nerbrink, CEO and co-founder of MVIC AB, a CRO specialising in inhalation and respiratory applications, both as compounds and medical devices. The companies of MVIC span a wide range of expertise and contract services. ”We can take a project from early development up to phase II. We can also assist with optimisation in the discovery phase. We have both the expertise and the equipment necessary to perform the actual tests, validation and documentation including phase I clinical studies,” Ola Nerbrink comments.
”No other CRO in the world is as comprehensive in terms of knowledge and infrastructure in the field of inhalation products, I should say. It’s shown by our many customers from abroad, not least from Asia and by the fact that the Medicon Valley Inhalation Symposium, which we arrange in Lund in October every year since 2012, is Europe’s third largest inhalation symposium,” he adds. Increased Demand for Developing Generic Products
With many patents about to expire, there’s an increased demand for generic inhalation products, where companies want to copy existing products. ”We’re for instance working with tech transfer in this field for a couple of big companies now. Then there are a number smaller companies that want to develop new concepts as well.” Apart from being the CEO of MVIC, Ola Nerbrink also runs his own company, Respiron Consulting, that specialises in the development of inhaled products from pre-clinical to CMC, offering services within device and device/formulation interaction, product/patient interaction, sys-
tem characterisation, inhalation toxicology system optimisation and evaluation, as well as documentation. ”I deliver services for both liquid- and powder-based inhala-
tion products. I, for instance, offer investigations of particle size distribution through laser diffraction and spray pattern/plume geometry,” he concludes.
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End-to-End Patent Management Ström & Gulliksson is a top-tier European patent firm, offering end-to-end patent management, including searches, strategic advice, filing and prosecution, validation, opposition and appeal, and litigation. Staying focused on their client’s business model, they create Intellectual Property Rights (IPR) that carry real commercial value, leveraging money spent.
Though patent protection is and remains their core business, the business mindedness of the patent attorneys of Ström & Gulliksson enables them to see beyond the patent application and take a holistic approach from the perspective of their client’s business model. ”To investigate the IP guided by the business concept with the invention in focus is our way of doing business and it’s appreciated among our customers. We experience that they don’t find this competence in many places elsewhere. It’s also been acknowledged by companies abroad who come to us for EPO applications, which has contributed to our good growth over the last years,” says Rikard Roos, Senior Partner,
CEO and European Patent Attorney at Ström & Gulliksson, headquartered in Malmö and with local offices in Lund, Stockholm and Gothenburg. Live Watch Based on Business Model
To facilitate their analyses, Ström & Gulliksson uses their cost-effective business intelligence tool ‘WatchOut’, which gives the clients insight into the whereabouts of their competitors. ”We set up a live watch, based on their business model, which gives the client an overview of the current situation, covering market trends and potential threats from competing rights. Then we analyse the results most relevant to the client’s business. This
is perfectly in line with our focus on our client’s business model,” Rikard Roos adds. It can also be used by investors, with a range of companies in their portfolio, who need to evaluate the real potential of a business project in order to decide whether to invest in it or not. Thorough Experience of Litigations
For a successful life science company, there'll always come a time when someone risking to infringe their patents wants to buy or license them. In situations of potential infringements or breaches of contracts, they can rely on Ström & Gulliksson’s extensive experience of major litigations to help them out. ”We’ve been involved in litigations to an extent quite unique among Swedish patent firms. These experiences also benefit smaller companies, since the attorneys who counsel in the major litigations are the same attorneys who give advice to the firm’s smaller clients,” says Dr Magnus Berglund, Partner and European Patent Attorney at Ström & Gulliksson and head of their Life Science team. In legal processes, they will also benefit from the patent firm’s long-standing cooperation with Gulliksson, a top-tier Swedish law firm. ”The lawyers at Gulliksson are specialised in IPR and together we successfully counsel clients in national and international patent litigations,” he adds. With their deep knowledge of advanced technologies, the patenting process, IPR and viable business models, Ström & Gulliksson offers true end-to-end patent management. However, their work doesn’t stop with the creation of the client’s patent portfolio, but also involves assisting in getting them financing, representation in their Board etc., in collaboration with Gulliksson law firm.
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Connecting Users and Technology Good design facilitates smooth interaction between technology and its users and increases the chances of making a profitable return.
Without a functional and appealing design it's hard to commercialise new technology and develop distinct selling points, even if you've come up with a fantastic technical solution. Medical devices must also appeal to two very different group of users: 1) healthcare professionals and 2) patients and their relatives. This poses a challenge in itself. Trying to guess the needs of each category of your users and how they react to different design features is not a good starting point for a commercially successful product design. Better then to partner with experts in the field with years of experience from user needs and expectations, as well as the entire design process from the initial paper sketches to prototypes and mass production. For a designer it’s important to have a thorough understanding of the situation in which a product is
RayPilot® is an electromagnetic real time positioning system that is used in prostate tracking in radiotherapy. Photo: Micropos Medical
used, and Shift Design & Strategy has a long experience of working with life science products for both young innovative startups and well-established, global players. "Medtech innovation companies can leverage on our experience of design projects for global clients like Wellspect (formerly Astra Tech). It has given us extensive knowledge about the users of medical equipment and assistive
RayPilot® from Micropos Medical took an early market position through its relevant design. Photo: Micropos Medical
devices,” says Per Bergström, Product Designer and Partner at Shift Design & Strategy. Contributes to Profitable End-Results
For medtech products it’s important to look and feel genuine and give the healthcare professionals pride in using them. However, the features also have to be as friendly looking as possible to convey safety to patients and their relatives. “For Micropos Medical the design development from patient focused technical prototype to user relevant product was crucial to reach market,” says CEO Tomas Gustafsson at Micropos Medical. ”Technology focused companies are not always, and in detail, conscious about how people interact with their products functionally as well as emotionally. We’re the link filling that knowledge gap and can facilitate for the whole project group to make
Sippi® is a unique, single use, digital urine meter by Navamedic Medtech. The design has helped the product to gain acceptance in a very conservative market. Photo: Navamedic Medtech
design decisions that give the product competitive edges,” Per Bergström comments. ”In addition, we’re a small and flexible organisation and can easily harmonise the design process to the bigger overall product development process.” he adds. To successfully contribute to profitable end-results, the company has developed its own strategic design tool, which incorporates the client’s company, the product’s users and the product’s
expression. "Through good design, we do the technology justice and increase the chances of making a profitable return for companies developing products where the interface between advanced technology and people is a core issue. The outcome should always be the easiest, clearest and most pragmatic way of communicating brandand product values," says Carl Hampf, Co-founder of Shift Design & Strategy AB.
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The new generation of cancer treatments Cantargia's CAN04 antibody treatment fights cancer by activating the immune system, and by blocking signals that lead to tumour growth.
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A Comfortable and Generous Stay in Lund With its comfortable, modern rooms, nice surroundings, generous meal offerings and good communications, Hotel Planetstaden is a very good starting point for a visit in the Medicon Valley area, be it for business or leisure.
In 2017, the four star Clarion Collection Hotel Planetstaden was awarded Travellers’ Choice TripAdvisor – Top 25 hotels in Sweden for the third year in a row. Perhaps not so surprising since the hotel is committed to give its guests a high level of comfort, quality and personal service and provides them added value in a number of ways. Every evening, for instance, Hotel Planetstaden invites all its guests to share an evening meal including hot meals, homemade vegetarian soup, salads, cheese platter, dessert, fruit platter etc. It’s just to grab in, it’s all included in the room fee. Coffee and tea are always readily available in the lounge and in the afternoon they serve homebaked pastries. Of course, the room fee also includes a generous breakfast buffet. The hotel is
passionate about food and the restaurant kitchen cooks the food from scratch, using local ingredients as far as possible. Art Gallery and Generous Parlours
Everyone should be able to find their own little place in the hotel’s generous parlour. You could, for instance, relax in one of the comfortable armchairs by the fireplace, or read a good book in the library. In the summertime, the hotel garden offers fine opportunities to relax in the sun. According to Hotel Planetstaden, a good day is a day with fine experiences. The hotel has a great passion for art and the guests are welcomed to take an art walk in the hotel’s gallery and current exhibitions. As a guest, you have access to the hotel’s own gym with a wonderful view over the nearby allotment gardens. Here are workout machines for exercises to improve both strength and fitness. If you rather prefer a soothing sauna bath, that’s also available. Jogging and walking in the area is also recommended. Just ask the receptionist for a map with marked out jogging trails.
S T O C K H O L M
Good Starting Point for Company Visits
Hotel Planetstaden also offers top-modern conference rooms, the biggest has room for 42 people. There’s also conference rooms with two connected rooms in a row. The conference rooms are bright and airy with guestcontrolled climate unit and carbon-controlled ventilation. Hotel Planetstaden is a good starting point for company visits or leisure activities in the region.
The guests are welcomed to take an art walk in the hotel’s gallery and current exhibitions.
Lund’s town-centre is within walking distance and the hotel offers free parking space. By car, Malmö is reached in 15 minutes and
Copenhagen in 50. Local, regional and express busses to Malmö stops right outside the hotel’s entrance.
Everyone should be able to find their own little place in the hotel’s generous parlour. Why not relax in one of the comfortable armchairs by the fireplace?
G O T H E N B U R G
O S L O
C O P E N H A G E N
H E L S I N K I
Premium Full-Service CRO Global Reach and Local Expertise
Clinical Trials Pharmacovigilance Data Management
Patient Recruitment Services Non-Interventional Studies Quality Assurance Biostatistics
Medical Writing Feasibility Studies
Please don’t hesitate to contact us. IRW Consulting AB · Svärdvägen 3A · Box 703 · SE-182 17 Danderyd · Sweden · 08-791 66 40 · www.irwcro.com
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anlĂ¤ggningen i Lund tom. 2012 startade vi Medicon Village i de tomma
representerad â€“ prevention, diagnostik, behand-
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effektivt sĂ¤tt skapa en vĂ¤rdekedja â€“ frĂĽn tanke
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och idĂŠ till stĂśd och utveckling av en fĂ¤rdig pro-
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Building a successful life science cluster in Medicon Valley, the life science region and brand of Greater Copenhagen, is all about creating...
Published on May 21, 2018
Building a successful life science cluster in Medicon Valley, the life science region and brand of Greater Copenhagen, is all about creating...