PRECISION MEDICINE The Swedish Industry Guide 2018 - SwedenBIO
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PRECISION MEDICINE The Swedish Industry Guide 2018 Mapping the Swedish Precision Medicine Industry Landscape COLLABORATION MIKAEL DAMBERG, 5 HOT SPOT FOR SUCCESS MINISTER FOR ENTER REGIONS This report is published by SwedenBIO with financial support from PRISE AND INNOVATION IN SWEDEN Business Sweden and Vinnova and How AstraZeneca, in collaboration with Arthur D. Little. Pfizer and Thermo “Contemporary life science A vibrant start-up Fisher Scientific are is data and technolgy- scene across Sweden collaborating with driven. Therefore, with R&D driven small Swedish companies infrastructure and sized companies in and universities to enabling technologies close connection advance precision are national priorities for to Sweden’s major medicine. resource allocation”. universities.
“Swedish precision medicine is a real area of growth and home to a vibrant start-up scene.” Thank you! We would like to express our special thanks to Special thanks go to the following people SwedenBIO project team everyone who helped and contributed to making this Carina Schmidt, CEO at Athera Biotechnologies, Nicole Hanzon, MSc, Project Leader report a reality, without whose contribution it would Elisabeth Nielsen, Programme Manager, International Susanne Baltzer, PhD, Senior Advisor not have been possible to assemble the companies Division at Vinnova, Karin von Wachenfeldt, CEO at Sara Gunnerås, PhD, Editor, and content presented in the report. Thanks are due Truly Translational, Karl Bergman, CEO at Elypta, sara.gunneras@swedenbio.se to, by no means exclusively, to all the science parks, Markus Thor, Investment Advisor at Business Sweden, incubators, regions, other supporting organizations Patrik Hidefjäll, Senior Researcher at the Bioentre- SwedenBIO – The Swedish and individuals who shared their valuable knowledge preneurship Unit at the Karolinska Institutet, Per Life Science Industry Organization and insights. Rydberg, CEO at Adduct Analys, Sara Malcus, CEO at Wallingatan 24, 111 24 Stockholm, Sweden Metabogen, Sirisha Adimatyam, CEO at Innovosens Tel: +46 8 21 66 20, info@swedenbio.se Special thanks go to the following organisations and Ulrica Sehlstedt, Partner at Arthur D. Little. www.swedenbio.se Business Region Göteborg, Invest in Skåne, Medicon Village, Sahlgrenska Science Park, Stockholm Science Special thanks to our students from the Master’s Graphic design: Andreas Hallbert, Greatland City, Swelife, Umeå Biotech Incubator and Biotech Programme in Bioentrepreneurship at Karolinska Editorial support, proofing and copy: Umeå, UppsalaBIO, Uppsala Innovation Centre. Institutet: Mengjing Ke, Bing Vu and Rosa Willock Angela Scott, COHELIX Ltd Share the knowledge. Please cite as Precision Medicine – The Swedish Industry Guide 2018 (SwedenBIO). Download the report at www.swedenbio.se/reports The content of this report is based on information gathered in good faith and is believed to be correct at the time of publication. SwedenBIO can however provide no guarantee regarding the accuracy of this content or any misprints that may occur.
| Precision Medicine – The Swedish Industry Guide 2018 SwedenBIO The Swedish precision medicine industry landscape at first glance This report, published by SwedenBIO – the Swedish Life Science Industry Organization, presents the results of the first mapping of the Swedish precision medicine industry landscape. It is a guide to 76 companies, all of which are developing innovative products and services with the potential of advancing the field. At the end of the report, there is a listing of their relevant R&D projects as well as launched products. T he precision medicine landscape is complex and integrating multidisciplinary research areas will have the consists of overlapping and intersecting elements, potential to really transform precision medicine in the future. including biomedical research, clinical informa- Many global enterprises have a significant presence in tion, and lifestyle parameters, plus the enabling Sweden with both R&D and manufacturing sites, as well tools of digital health, “-omics” technologies, and as through their many collaborations with academia and computational health sciences. How are Swedish companies innovative Swedish companies. For this report, we asked active in this field and contributing to realizing the promise AstraZeneca, Pfizer and Thermo Fisher Scientific about their of precision medicine? To gain more knowledge about this perspective on precision medicine and how they take an active SwedenBIO initiated a project mapping the Swedish industry part in advancing the field through Swedish collaborations. and the result is presented in this report. Finally, we have included a description of selected research in- Using our considerable network of organisations and indi- frastructures, such as Science for Life Laboratory – a national viduals around Sweden, we invited a wide selection of com- resource for “-omics”-based research and development – to panies to participate in a survey by describing their business complete the picture by including a view of public sector effort and research programmes. In parallel, we identified a range in this field. of additional companies through database searches and these Our conclusion is that Swedish precision medicine is an were also invited to participate. Details of this process can be area of substantial growth and home to a vibrant start-up scene. found in the methods section on the last page. In the last four years, 26 companies were established within In this first edition, we focused on Swedish companies this area. The vast majority (97%) of companies are small with a business-to-business model. Therapeutic projects were with 50 employees or less. These companies are strongly excluded as these are regularly presented in “The Swedish connected to academia, with 72% having been spun out from Drug Discovery and Development Pipeline” report1. Sweden the academic sector. The spin-off clusters are located around is also home to many high quality service providers and Sweden’s larger cities with the majority originating from business-to-consumer companies, also part of the precision Karolinska Institutet in Stockholm, Lund University and medicine landscape. In the future, we intend to revisit and Uppsala University. Linköping, in the heart of southern report on these latter groups of companies to complement the Sweden, has developed into a national arena for analysis of present picture. medical imaging using for example, artificial intelligence. We have primarily focused on companies developing research tools suitable for stratification of patient subpopu- Our report encompasses the following topics: lations, diagnosis and/or prognostication of disease progress. • A map of technologies used by the companies Examples of such tools are: new validated biomarkers, • Description of areas of rapid technology advancement companion diagnostics, diagnostic assays based on “-omics” • Presentation of Swedish research infrastructures including technologies, sequencing technologies or software programs Science for Life Laboratory for analysis of complex and large datasets. • AstraZeneca, Pfizer and Thermo Fisher Scientific views on Secondly, we decided to highlight the outstanding Swedish precision medicine and their presence in Sweden research and development happening in complex data-com- • The list of companies and their projects puting, bio-imaging, bioinformatics, and large databases. It is becoming increasingly apparent how these technologies This report has been published with support from Business are being transformed into companies developing new methods Sweden, the Swedish Trade and Investment Council, and based on machine learning and artificial intelligence. These Vinnova, the Governmental Agency for Innovation, and in col- IT-intensive companies are developing advanced imaging laboration with management consulting firm, Arthur D. Little. techniques using CT, MRI, PET or microscopy, or developing advanced bioinformatic programming and decision support 1. L earn more about Swedish Drug Discovery and Development at www.swedenbio.se/reports software programmes. We envisage that these efforts of 3
CONTENT FOREWORDS BY 6 5 SwedenBIO, the life science industry organization 6 Mikael Damberg, Minister for Enterprise and Innovation 7 Business Sweden, the Swedish Trade and Investment Council Foreword by Mikael Damberg 7 Vinnova, the Governmental Agency Minister for Enterprise and Innovation for Innovation “Contemporary life science is data and technology-driven. Therefore, infrastructure and enabling technologies are WHAT IS PRECISION MEDICINE? national priorities for resource allocation” 8 Introduction by Arthur D. Little 16 Stratification of patients and development of new technologies Learn more about the first PRECISION MEDICINE IN mapping initiative of the SWEDEN AT A GLANCE Swedish precision medicine 12 Strong academic connections 12 industry landscape! 13 Five Swedish hot spots 14 Small companies driving innovation THERAPEUTIC AND Highlight: Biomedical imaging TECHNOLOGY HIGHLIGHTS Linking basic molecular 20 Oncology studies with phenotypic clinical 24 The fight against infectious diseases manifestations of disease to 26 26 Imaging in the era of precision medicine promote an accurate diagnosis. 32 Cutting-edge technologies in biopsy NATIONAL RESOURCES An exclusive list of 76 companies AND PLATFORMS developing innovative products 40 Science for Life Laboratory and services that have 40 Human Protein Atlas the potential of advancing the 42 National biobanks and quality registers 18 precision medicine sector. GLOBAL COLLABORATIONS 30 Pfizer Highlight: Oncology 34 Thermo Fisher Scientific The increased understanding of 43 AstraZeneca the biology of different cancers is now leading to the development COMPANIES AND PROJECTS/PRODUCTS of new diagnostic methods. 20 18 Companies A-Z 44 List of more than 200 projects 4
| Precision Medicine – The Swedish Industry Guide 2018 SwedenBIO SwedenBIO – the life science industry organization We are always open to collaboration and we hope this report will serve as an invaluable source of information for companies, investors and other parties seeking collaboration and business opportunities in Sweden in this exciting area. S weden is ranked as one of the and growth to our life science industry. most innovative countries in the To accomplish this, SwedenBIO is active in world. Our strong academic base the public debate and represents the industry and world-leading infrastructure in a continuous dialogue with authorities for research form the basis for a and politicians. We facilitate the building of successful and innovative life science industry professional networks and hold several inspi- accounting for nearly ten percent of our rational and educational meetings, round table net export. The sector is highly prioritized, discussions, workshops and informal get-to- and the government recently established a gethers throughout the year. SwedenBIO’s permanent office for life sciences within the investor-only meeting – vc2vc – encourages Government Offices in order to generate a investors in life sciences to co-invest in each coordinated policy, clearer priorities and a other’s portfolio companies. Nordic Life higher pace in working towards a competitive Science Days, SwedenBIO’s international in- life science sector in Sweden. vestor and partnering meeting, held annually As outlined in this report, the tradition of in September, has rapidly grown to become Jonas Ekstand, PhD innovation development continues to thrive the largest business meeting in the Nordic Director General SwedenBIO in precision medicine, an area where Swedish region. This event will next take place on companies are developing novel products and September 10-12, 2018 in Stockholm technologies for a global market. Accessible (www.nlsdays.com) and is by far the most biobanks, quality registers and well-developed efficient way to meet the Swedish life science platforms for interaction between academic community and its many innovative companies. scientists, clinicians and companies together We are grateful to our partners for making with our early-adopter mindset, all contribute the production of this report possible and wish to making Sweden an ideal location for R&D you, as a reader, an informative and enjoyable in precision medicine. insight into how Swedish companies contrib- SwedenBIO is the national association for ute to advancements in precision medicine. the life science industry in Sweden with close to 250 member companies. Our mission is to Visit us at www.swedenbio.se and www.nlsdays.com promote an environment which brings success 5
| SwedenBIO Precision Medicine – The Swedish Industry Guide 2018 “The Swedish government is strongly committed to supporting continued rapid development in the life science sector” S Photo: Kristian Pohl weden is a major player Contemporary life science is data- and on the life science arena, “In February 2018, an technology-driven. Therefore, infra- offering a thriving life structure and enabling technologies are science environment which Office of Life Science national priorities for resource alloca- is technology-driven and was established in the tion. A state-of-the art e-infrastructure characterised by close collaboration Government Offices” is being created to facilitate coordinated between academia, health care, in- and efficient use of the unique biobanks Mikael Damberg dustry and patient organisations. As a Minister for Enterprise and Innovation and national registers. The Science for logical consequence of this, life science Life Laboratory is a leading national is a dominating line of business and a and international infrastructure and cornerstone of the Swedish economy. a national strategy for life science. research environment for molecular Supporting research, innovation and The digitalisation revolution has biosciences and drug development that co-creation in the life science sector has been a prerequisite for efficient handling receives long-term government support. been a long-standing strategic priority of ‘big data’ arising from the new MAX IV and the European Spallation of the Swedish government. technologies and will continue to speed Source (ESS), two major investments in The threats to human health are up progress in life science and clinical high-resolution imaging, support a wide escalating rapidly across the globe, medicine. Here, Sweden has compet- range of scientific areas and have been rendering human health a major global itive advantages. Our public health set up as core national and European challenge. Accordingly, in 2015, our care system, along with the personal infrastructures. National Innovation Council, which is identification numbers introduced in Precision medicine targets diagnosis chaired by the Prime Minister, launched 1947, has made generation of unique, and treatment tailored to the individual. an innovation partnership programme comprehensive patient registers and Joint efforts in this area will result in life science to further accelerate functional biobanks possible. Sweden in improved health, strengthened progress in research and innovation, is also internationally lauded for international competitiveness for all and promote co-creation involving all its performance in information and stakeholders, increased export and new major stakeholders. And, in February communication technology, including investments in Sweden. The Swedish 2018, an Office of Life Science was technologies for managing big data and government is strongly committed to established in the Government Offices, mobile technologies that hugely benefit supporting continued rapid develop- a first assignment of which is to develop the Swedish life science sector. ment in the life science sector. 6
Business Sweden The gateway to business in Sweden Expect great things of Sweden! In Sweden you will find a proven, business friendly envi- ronment that is characterized by forward thinking, sharp brains and open minds. Sweden is considered to be one of the world’s most prominent research nations and provides full access to Europe. It is a place where not only will you Elisabet Nielsen, Programme Manager, International Division. Laurent Saunier, Head of Department, Health Division. get quality and efficiency beyond your expectations, but also stability and sustainability by default. Life sciences is a sector of high strategic importance to Vinnova Sweden – Sweden. The foundation that underpins innovation in the Swedish life sciences sector is the fruitful collaboration an innovation between academia, industry and healthcare, where all stake- holders demonstrate an open-minded and boundary-span- ning approach. Our long track record of investing heavily in leader research and development has borne fruit and is yet another reason to choose Sweden for life science business develop- ment, licensing, partnerships or direct investments. About Business Sweden Business Sweden’s purpose is to help Swedish companies to According to the Global Innovation Index1, Sweden is rated grow their international revenues and international compa- as the second most innovative country in the world. It offers nies to invest and expand in Sweden. For Swedish companies, an environment where you can find entrepreneurship, strong we provide strategic advice, sales execution and operational R&D clusters, and a thriving start-up scene. support. For international companies we ensure that they can rely on our knowledge, experience and extensive network Supporting innovation to identify new business opportunities and achieve an accel- Vinnova, the governmental agency for innovation, funds erated return on investment. Business Sweden is present in innovation and research projects. Every year, the agency 50 of the world’s most promising markets and owned by the invests around SEK 3 billion (> USD 371 million) in pro- Swedish Government and commercial sector, a partnership moting innovation. Funds are generally allocated using a that provides access to contacts and networks at all levels. “calls for proposals” system. Visit us at www.business-sweden.com Precision medicine is an interdisciplinary field that is expected to drive the health research and innovation agenda for years to come. To continue enabling advances in this sector to be made, Vinnova stimulates collaboration be- tween companies, universities, higher education institutions, public services and civil society, as well as working to strengthen international cooperation. Vinnova is a member of the EC-funded network “The International Consortium for Personalised Medicine” (ICPerMed)2. In addition, we fund projects in this field via our national programmes such as the Strategic Innovation Programmes (SWELife and Medtech4Health) and Chal- lenge Driven Innovation. We are also engaged in promoting international calls for propsosals under the Horizon 2020 framework, as well setting up a Nordic call for proposals within Personalised Medicine. Visit us at www.vinnova.se Photo: Patrick Trägårdh Ulrika Cederskog Sundling 1. Global Innovation Index 2017 Report, www.globalinnovationindex.org Executive Vice President Invest & Region Sweden 2. ICPerMed www.icpermed.eu 7
| SwedenBIO Precision Medicine – The Swedish Industry Guide 2018 PRECISION MEDICINE Providing the right treatment to the right patient at the right dose and the right time. T he advent of “precision medi- announced the Precision Medicine Initiative, cine” has long been predicted launched with a $215 million governmental – essentially ever since, when in backing in the presidential 2016 Budget to 1990, scientists began decoding advance precision medicine in the USA. In the the human genome. There is no EU, the European Commission has invested ‘single’ definition of the concept of precision heavily into precision medicine within the FP7 medicine, but one that has gained strong and Horizon 2020 frameworks, alongside support is that precision medicine is defined as other several major national initiatives such the stratification of patients into groups based as Genomics England, France Medécine on biological information and biomarkers at Genomique and the Danish National Strategy the molecular level as a result of our increased for Personalized Medicine. And in Asia, understanding of disease pathways and within countries like South Korea have declared that the fields of genomics, proteomics, metabo- the government will establish obligatory data lomics, epigenomics and pharmacogenomics, platforms and ease regulations to encourage thus allowing doctors and drug makers to Ulrica Sehlstedt, PhD innovation in precision medicine. In Sweden, match a patient to a drug that is likely to Partner, Arthur D. Little initiatives such as Genomic Medicine Sweden work. That is, precision medicine aims at are in progress, aimed at building a new type improving the targeting of drug treatment to of infrastructure in the Swedish healthcare boost the efficacy of drugs and to reduce their system by the introduction of new genetic adverse reactions. It is not just about devel- screening technologies to enable implemen- oping new drugs but also about identifying tation of precision medicine throughout the those patients who are most likely to respond country. A further example is the recent to existing products, and therefore aimed at significant investment in precision medicine reducing the number of ineffective therapies in oncology by the Sjöberg Foundation in clinicians may need to test on a patient before “The opportunities collaboration with the Swedish Regional finding the right one. Although the term within precision Cancer Centers. ’personalized medicine’ is also sometimes used medicine have Delivering on promises with precision to describe this process, it actually denotes a medicine is inextricably linked to technolog- unique treatment designed and manufactured attracted much ical advancement of biomarker technologies, for an individual patient, as for example, the interest, not only digitalization and big data management. Novartis chimeric antigen receptor therapy The steep decrease in the cost of sequencing (Car-T). from scientists, a genome has played, and still does play an The opportunities within precision med- drug makers and important part in advancing the field, as do icine have attracted much interest, not only patients but also the high speed development and application from scientists, drug makers and patients but of data mining, artificial intelligence (AI) and also from funders and decision makers. In from funders and machine-learning to predict which patients 2015, former US President Barack Obama decision makers” will respond to specific therapies. The in- 8
New paradigm shift in treatment Transitioning from the ”One-size-fits-all” to ”Precision Medicine” model with multi-level patients stratification. One-size-fit-all Precision medicine medicine Patients are grouped by: Individual patient level: • Disease Subtypes • Genomics and Omics • Risk Profiles • Lifestyle preferences • Demographics • Health History • Socio-economic • Medical Records • Clinical Features • Compliance Precision medicine is about the stratification • Biomarker • Exogenous Factors • Molecular of patients into groups, based on biological sub-populations information and biomarkers at the molecular level – to match a patient to a drug that is likely to work. creasing availability and selection of devices drugs and associated diagnostic tools. Being “Sweden, with its and wearables for collecting “real-world” able to prove the value of the associated data from patients means that biomarker improvement in care quality or health out- long tradition in bio- information can be combined with data about comes will become increasingly important for molecular research individual differences in lifestyle and environ- drug and diagnostic suppliers if they are to and its comprehen- ment to provide researchers with further tools obtain approval for their precision medicine to discover paths towards delivering precision solutions, and also have them reimbursed and sive biobanks and medicine. implemented in the market. quality registers, is Precision medicine has the potential to Sweden, with its long tradition in bio- fundamentally alter the existing business molecular research and its comprehensive very well positioned logic in the healthcare landscape in several biobanks and quality registers, is very well as a front runner in ways – by creating a more segmented market positioned as a front runner in the field of pre- the field of precision through increased interdependency between cision medicine. In this report, we highlight industrial partners and by the expected tran- Swedish companies that currently innovate, medicine.” sition from volume-based payment towards develop and supply researchers and drug mak- outcome-based payment. One of the major ers with all the important tools and technol- determining factors which will either drive or ogies that are a prerequisite for the discovery, hinder the broader uptake of precision med- development and implementation of precision icine is whether or not healthcare providers medicine for the benefit of patients in Sweden will be adequately reimbursed for using the and elsewhere. 9
The future of tailored treatment is about HAVING A BETTER UNDERSTANDING OF BIOLOGICAL MECHANISMS AND ENVIRONMENTAL INTERACTIONS 10
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| SwedenBIO Precision Medicine – The Swedish Industry Guide 2018 An initial map of the Swedish precision medicine industry In this report, we have prepared a guide to 76 companies developing innovative products and services that have the potential of advancing the precision medicine sector. The companies are clustered in five major regions, where the capital region Stockholm-Uppsala is home to almost 50%. The vast majority has been spun out of academic institutions. Commercialisation of academic Karolinska Institutet Strong association to incubators research – 72% of companies are Adduct Analys, Affibody, Athera and science parks university spin-offs Biotechnologies, AroCell, Chundsell In close connection to the universities, Nearly three out of four companies in Medicals, Clinical Gene Networks, the incubators and science parks provide this report have been founded based on CyberGene, DoubleStrand start-ups with relevant business tools research and innovative technologies Bioinformatics, iCellate Medical, in the commercialisation process. It is developed at academic institutions. InDex Pharmaceuticals Holding, therefore no surprise that about 50% of Sweden has the second highest R&D Pelago Bioscience and VLVbio. the companies are associated with an expenditure in Europe as a percentage incubator or science park. The densest of GDP1 and a well-established academ- Lund University innovation hubs are naturally collocated ic and corporate research culture. The Akuru Pharma, Diaprost, Immunovia, with Sweden’s most populated regions proximity between the universities and Medviso, Qlucore, Reccan Diagnostics, and largest universities, with the princi- the healthcare sector, as well as the pub- Respiratorius, SAGA Diagnostics, pal ones being the SMILE incubator and lic research infrastructures, are plausible SensoDetect, SenzaGen, Spectronic Medicon Village Science Park in Lund, reasons why so many academic inno- Medical. and the Karolinska Institutet Incubator vations are now being commercialised. and Science Park in Stockholm. Below is a list of companies spun out of Uppsala University the major universities. Astrego Diagnostics, BioArctic, Biovica, CADESS Medical, CRAY Innovation, Gradientech, Olink Bioscience, Olink Proteomics, Q-linea. Chalmers Technical University and Gothenburg University How did 1928 Diagnostics, Alzinova, Eigenvision, the company Elypta, Medfield Diagnostics, start? Metabogen, Multid Analyses, PExA and TATAA Biocenter. Linköping University AMRA Medical, BioReperia, ContextVision, Glycobond and Sectra. Spin-off from academia, 55 Umeå University 1. B usiness Sweden, Why Sweden leads the Independent, 17 AcureOmics, HiloProbe, InfiCure and innovation game (www.business-sweden.se/en/ Other, 4 UmanDiagnostics. Invest/industries/Manufacturing/innovation) 12
76 companies within precision medicine 50% associated with incubators or science parks 72% spin-offs from academia 7% Umeå Region Five Swedish hot spots for precision medicine development in Sweden The capital region of Stockholm together with its northern neighbour Uppsala, are home to almost half of the 76 companies included in this report. More than one 47% fourth of the companies are located in the southern Malmö-Lund region, followed by 14% in the Gothenburg region and Stockholm/ 7% in the Umeå region. Linköping region Uppslala also hosts 5% of the companies, mainly Region within imaging technologies. Göteborg Region 14% 5% Linköping Region 26% 1% Other Malmö/Lund Region 13
Small companies – driving innovation 14
| Precision Medicine – The Swedish Industry Guide 2018 SwedenBIO A ll but two of the 76 companies swer to the question as to which competencies As many as 77% presented in this report, Elekta were being sought, the response was that the and Sectra, have less than 50 highest demand is for expertise in bioinfor- of the companies employees (n=74) and most of matics and software skills, and interestingly plan to recruit more these can be classed as micro- or also, several companies are looking for skills staff, and 47% plan virtual companies (n=61). These small research in artificial intelligence. based companies, are part of the vibrant Swedish to increase their start-up scene, which is further fuelled by a 26 companies founded over number of special- well-established network of funding organisa- the last four years tions, support organisations such as incubators The high activity within the area of precision ised consultants/ and science parks, contract research organiza- medicine is manifested by the significant num- contractors tions and other expert service providers. This ber of newly founded companies measured all contributes to Sweden’s well-established over the last four years. On average, more position as a global innovation leader, which is than 6 new companies were founded each year due to the country’s attractive research infra- (2014: +7; 2015: +5; 2016: +10; 2017: +4). structure, high-level of competence and skills, as well as a flourishing, cross-disciplinary learning and testing environment.1 2014 2015 2016 2017 Elekta and Sectra are the two largest Swedish 1928 Diagnostics Bionamic Data Consulting Akuru Pharma Astrego Diagnostics companies active in the field of precision Antaros Medical BioReperia CADESS Medical CartaNA medicine. These two companies employ about CRAY Innovation Eigenvision Doctrin DoubleStrand 250 people each in Sweden, and 3581 and Bioinformatics 616 worldwide, respectively. Together, the 76 Gnosco EMPE Diagnostics HiloProbe Elypta companies mentioned in this report employ the equivalent of 1000 FTEs in Sweden. Life Genomics Neodynamics InDex Pharmaceuticals Holding We asked the companies how they see their company developing over the next three years, PExA Liv Diagnostics and more specifically if they plan to recruit Reccan Diagnostics Medsens within their R&D departments. As many as Olink Proteomics 77% of the companies plan to recruit more Oncosignature staff, and 47% plan to increase their number Saga Diagnostics of specialised consultants/contractors. In an- N. B. Companies InDex Pharmaceu- The majority of the 76 companies have less than 50 employees ticals Holding and Olink Proteomics were registered in 2016, but existed previously in the form of other company structures. 61 13 0 2 1. B usiness Sweden, Why Sweden leads the innovation game 0–10 11–50 51–200 >200 Micro Small Medium Large (www.business-sweden.se/en/ Invest/industries/Manufacturing/ innovation) 15
| SwedenBIO Precision Medicine – The Swedish Industry Guide 2018 Stratification of patients and development of new technologies is on the agenda for Swedish companies We are all unique. Our health is determined by our inherent genetic differences combined with our lifestyles and environment. Precision medicine is about having a better understanding of biological mechanisms and environmental interactions that govern health and disease. V arious diagnostic meth- Based on the data provided by the com- technologies are also placed in this ods and instrumentation panies participating in the survey, it can group. platforms serve to facili- be concluded that Swedish companies The companies were asked if their tate our ability to identify in the field are numerous and work technological sectors are typical for changes in the human across a broad spectrum of research and precision medicine. The top five tech- body. It is the combination of the infor- methods. For purposes of this report, nologies listed were bioinformatics, mation we observe or diagnose by these they have been divided into groups data management (big data), machine means, and our increasing knowledge with the focus being on two groups of learning, patient monitoring and predic- of human biology (through ongoing companies: tive analytics. For more information, advances in “-omics” technologies) that – Those working with stratification see page 18-19. enables us to determine our individual of patients based on genetic and pheno- Sweden is home to outstanding risk of developing disease, detect illness typic patterns. research and development in complex earlier, and to choose the most effective These include companies developing data computing, bioinformatics and interventions to help improve our methods and products for: companion large databases, and these technologies health, be it through medicines, lifestyle diagnostics, biomarker discovery and are now being translated into compa- choices, or even simple changes in diet. validation, molecular diagnostics, muta- nies developing new methods based A model for describing the over- tion analysis by sequencing, expression on artificial intelligence or machine lapping and intersecting elements that profiling, bioinformatics, genomics, learning. These IT-intensive companies make up the field of Precision Medicine proteomics, pharmacogenomics, are developing advanced imaging are shown in the diagram in this sec- metabolomics, translational imaging techniques using CT, MRI, PET or tion. The figure depicts these individual with PET-ligands, or next generation microscopy, or developing advanced bi- elements, which include biomedical sequencing (NGS) of whole genomes. oinformatics programming and decision research, clinical information, and life- – Those working on development of support software programmes. style parameters, plus the enabling tools new technologies and instrumentation. Big data analytics, based on the of digital health, “-omics” technologies, These companies are primarily devel- wealth of information held in Sweden’s and computational health sciences. oping new diagnostic methods such as: large and numerous databases, is be- When integrated, these elements can sampling techniques (biopsies), patient coming an important area of research inspire the development of new research monitoring, bio-imaging and medical in precision medicine. Handling large and technologies which eventually can imaging and clinical-decision support amounts of data requires the type lead to more precise and predictive systems. Companies developing new of new software development that is healthcare. software and advanced programming needed for artificial intelligence (AI) 16
Information Discovery Knowledge INDIVIDUALS RESEARCH ENABLING TOOLS INTEGRATE, INTERPRET AND VISUALIZE COLLECTED DATA Basic Clinical Digital Omics Discovery Discovery Health Technologies Social/Behavioral Computational Discovery Health Genomics Microbiome POPULATIONS Exposures Behaviors Clinical Tests MORE PRECISE Patient Contributed Data DIAGNOSTICS, TREATMENTS AND PREVENTION Adapted from Precision Medicine at UCSF. and machine learning programs. AI and machine learning algorithms are now also being applied to practices such as diagnostic processes, treatment protocol development, patient monitoring and care. We also asked the companies about their projects and products. The major- ity have applications in specific therapy areas. The strongest area is by far on- cology followed by infection. New diag- nostic tools for Alzheimer’s disease and cardiovascular diseases are also in focus for several companies. In addition to disease specific tools, several companies are developing new instrumentation for improved bio-imaging techniques as well as technologies within biopsy instrumentation. All the projects and This “wordle” captures and measures products reported by the companies, the words used by the companies totalling more than 200, are listed on when describing the applications of the last pages. their products. 17
| SwedenBIO Precision Medicine – The Swedish Industry Guide 2018 COMPANIES A-Z S) G A (N N a) D ng ng at g ci in ci D g en at en is in g ys qu Bi ul ag g qu e in g s rc t( s al se nc is im ic ic lin se g ag ci en an ys ng om rin yt ge n ofi s e of m e em al io ic al n ni ul i to s s m lli en li pr sy io an m n ic at an ic s ar ec te no na ag t io ic on at at to s om og op er on rs le in ll ol ic om e ut ge t io an m ip ca ce m en so tiv ac bi m m ne si ol al m or cr m la en tifi nt es en eo tg le ic le ab ci m id le hi er nf ns e ns t ie a ho ed tifi ng en ar pr ig qu ng os ot ac en ex et th oi at a a Ep Ph Ex Pa Pr Ar W Pr Tr Id Si Li Bi Bi M O Tr M Si D N G Company 29 28 25 23 23 17 14 13 13 11 11 10 9 9 7 6 6 6 6 5 4 20 1928 Diagnostics AcureOmics Adduct Analys AMRA Medical Affibody Akuru Pharma Alzinova Antaros Medical AroCell Ascelia Pharma Astrego Diagnostics Athera Biotechnologies Atlas Antibodies Axcentua Pharmaceuticals BioArctic Biomotif Bionamic BioReperia Biovica CADESS Medical Calmark Sweden CartaNA Chundsell Medicals Clinical Gene Networks ContextVision Corpus Data & Image Analysis CRAY Innovation CyberGene DanPET Diaprost Doctrin DoubleStrand Bioinformatics Eigenvision Elekta Elypta Emotra EMPE Diagnostics Glycobond 18
We listed a selection of technologies typical for precision medicine and asked the companies to mark relevant areas for their business. The result is outlined below. The following companies did not participate in the web- based questionnaire, but do touch upon precision medicine and are therefore also briefly mentioned in the report: Alpha Biotech, Apodemus, BiBBInstruments, Cavidi, Chromalytica, Hermes Medical Solution, ImaGene-iT, Molecular Fingerprint Sweden, Phase Holographic Imaging, Sensabues, SyntheticMR. S) G A (N N a) D ng ng at g ci in ci D g en at en is in g ys qu Bi ul ag g qu e in g s rc t( s al se nc is im ic ic lin se g ag ci en an ys ng om rin yt ge n ofi s e of m e em al io ic al n ni ul i to s s m lli en li pr sy io an m n ic at an ic s ar ec te no na ag t io ic on at at to s om og op er on rs le in ll ol ic om e ut ge t io an m ip ca ce m en so tiv ac bi m m ne si ol al m or cr m la en tifi nt es en eo tg le ic le ab ci m id le hi er nf ns e ns t ie a ho ed tifi ng en ar pr ig qu ng os ot ac en ex et th oi at a a Ep Ph Ex Pa Pr Ar W Pr Tr Id Si Li Bi Bi M O Tr M Si D N G Company 29 28 25 23 23 17 14 13 13 11 11 10 9 9 7 6 6 6 6 5 4 20 Gnosco Gradientech HiloProbe iCellate Medical Immunovia InDex Pharmaceuticals Holding InfiCure Bio Life Genomics Liv Diagnostics Lytics Health Medfield Diagnostics Medsens Medviso MetaboGen Multid Analyses Neodynamics Olink Bioscience Olink Proteomics OncoSignature Pelago Bioscience PExA Q-linea Qlucore Reccan Diagnostics Redhot diagnostics Respiratorius SAGA Diagnostics Sectra SensoDetect SenzaGen Single Technologies Spago Nanomedical Spectronic Medical Symcel TATAA Biocenter Truly Translational Sweden UmanDiagnostics VLVbio 19
| SwedenBIO Precision Medicine – The Swedish Industry Guide 2018 ONCOLOGY The inceased understanding of the biology of different cancers is now leading to the development of new diagnostic methods. A ccording to the World Health The future is approaching Organization (WHO) cancer is, The arrival of next-generation sequencing Since no after ischemic heart disease and (NGS) has accelerated the implementation of stroke, the second leading cause genomic profiling in the care and management validated serum of morbidity and mortality of patients with cancer. Initial efforts have fo- biomarkers for worldwide. Cancer was responsible for 8.8 cused on target identification in patients with breast cancer million deaths in 2015. The number of new advanced cancer. Prognostication, resistance have yet been cases of cancer is expected to rise by about detection, disease monitoring, and early detec- 70% in two decades, from 14 million in 2012 tion efforts are also underway. identified, to 22 million by 2030. Our increased understanding of the biology there is a great Lung, prostate, colorectal, stomach and of different cancers is now leading to the clinical need liver cancer are the most common types of development of new diagnostic methods for cancer in men, while breast, colorectal, lung, detecting biomarkers specific for certain can- for a better cervix and stomach cancer are the most com- cers and different stages of the cancer. non-invasive mon among women. test that allows Improved diagnostics in breast cancer correct Finding and treating cancer at an Breast cancer is one of the most common early stage can save lives cancers with more than 1,300,000 cases and diagnosis Cancer mortality can be reduced if cases are 450,000 deaths occurring annually world- detected and treated early. Screening pro- wide.1 Breast cancer diagnostics today include grammes and early diagnosis are two major the diagnostic management of the breast as components of early detection. Figures from well as the axillary lymph nodes. Since no Cancer Research UK suggest that more than validated serum biomarkers for breast cancer 90% of women diagnosed with breast cancer have yet been identified, there is a great clin- at the earliest stage survive their disease for ical need for a better non-invasive test that at least 5 years compared to around 15% for allows correct diagnosis as well as prognosis women diagnosed with the most advanced and recurrence. stage of the disease. Prediction of the risk of the cancer reoc- The promise of precision medicine is that curring, especially in parts of the body distant treatments will one day be tailored to the to the breast, is difficult using current clinical genetic changes in an individual’s cancer. and histopathological parameters. Conse- Information about genetic changes in a quently, a number of patients are over and/ tumour will help decide which treatment will or non-optimally treated, resulting in largely work best for that person. However, it is now unnecessary side-effects for patients and known that cancer is an extremely hetero- increased costs for healthcare providers. Thus, geneous disease, which explains differences tools for predicting the metastatic migration not only between cancer cells from different behaviour of cancer cells are needed. patients, but also between cancer cells within A number of Swedish companies are currently a single patient. This calls for new and better engaged in this race to fight breast cancer. The sampling technologies, an increased under- methods they are developing span a variety of standing of the genetics behind cancer devel- technologies – from improved biopsy methods, opment and better screening and diagnostic analysis of cancer specific enzymes and bio- methods. markers to cell migration assays and diagnostic tools based on machine learning. 1. WHO, GLOBOCAN 2012 20
Photo: AcureOmics Company Technology Application/s A number of Swed- Affibody HER2 PET imaging agent. Imaging in metastatic breast cancer. ish companies are In clinical validation. AroCell TK1 serum biomarker ELISA analysis Monitoring treatment efficiency and survival currently of serum. in stage 2 breast cancer. engaged in this Biovica Analysis of TK enzyme activity in blood. Monitor and predict treatment response in stage 2 breast cancer therapy. In clinical validation. race to fight ContextVision Digital diagnostics / machine learning. Analysing tumour proliferation speed as a breast cancer. decision support tool/treatment plan. Immunovia Panel of breast cancer biomarkers on Early detection of breast cancer. Possible prediction microarray platform /software algorithm. of development of distant metastases. Liv Diagnostics Lab-on-a-chip, analysis of cells Diagnosis and follow-up of breast cancer. from biopsy. Measure of tumour invasiveness. Neodynamics Biopsy system with ultrasound Tissue sampling of small lesions and axillary guided imaging with end sampling. lymph nodes. Product launched. 21
| SwedenBIO Precision Medicine – The Swedish Industry Guide 2018 The challenges of prostate cancer do not have prostate cancer.3 In the future There is no question that screening can help Once the prostate cancer is diagnosed there find many prostate cancers early. Until recently, are other challenges in the treatment regime of precision PSA (prostate specific antigen) tests for pros- that need to be addressed. Androgen depriva- medicine, tate cancer were considered to be exemplary tion therapy (ADT) is generally the first choice treatments for successful early cancer detection leading for the management of advanced prostate will be tailored to improved treatment outcomes. But over the cancer. Unfortunately, after an initial response last few years, a series of studies has suggested to ADT, prostate cancer eventually loses to the genetic that the tests are not sensitive enough: frequent responsiveness to the androgen blockade and changes in an false positives lead to too many unnecessary progresses into castration-resistant prostate individual’s medical procedures, and false negatives give cancer (CRPC). Again, the way to successfully men a false sense of security. Even if screening targeting CRPC lies with the advancement of cancer detects prostate cancer, doctors are often precision medicine i.e. analyse gene mutations unable to tell if the cancer is truly aggressive. and expressed genes in tumour samples and Because of an elevated PSA level, some men combine these with patient data. may be diagnosed with a prostate cancer that A promising on-going research project in would otherwise have gone unnoticed, not Sweden is the combination of the “Stock- caused any symptoms nor led to their death. holm3 test” with magnetic resonance imaging As a result, most healthcare authorities in Eu- scans to further improve the identification of rope, including Sweden and around the world, aggressive prostate cancer. The “Stockholm3 do not recommend introducing screening for test” is a blood-based prostate cancer test that prostate cancer with the PSA test.2 predicts the risk for aggressive prostate cancer Consequently, there is a need for more at biopsy by analyzing five protein markers, accurate diagnostic tests than are presently more than 100 genetic markers and clinical available. In the future of precision medicine, data. The hope, now, is that the combinations treatments will be tailored to the genetic of different biomarkers and imaging tech- changes in an individual’s cancer, but they niques will lead to better detection and predic- will also be taking account of the normal tion of prostate cancer. variations seen in healthy individuals. Indeed, In Sweden, there is a growing number in a recently published paper, a genome-wide of companies developing new methods and association study suggested that 40 genetic re- analysis tools for more accurate diagnosis of gions could together predict nearly 10 percent prostate cancer. of normal variation in PSA levels in men who Company Technology Application/s AroCell TK1 serum biomarker ELISA analysis. Prognostic and monitoring treatment efficiency in prostate cancer. CADESS Medical Cloud-based decision support system based Identification of malignant glands in tissue images on digital imaging analysis of biopsies. and prognosis of the prostate cancer development. Chundsell Combination of gene expression, of IGFBP3, Decision support Medicals F3 and VGLL3, with clinical parameters. Prognosis of aggressive prostate cancer and survival for various treatment options. Product launched. ContextVision Digital diagnostics / machine learning. Analysing tumour proliferation speed as a decision support tool/treatment plan. CRAY Innovation Genetic analysis of loss of chromosome Y Predict risk for all-cause mortality of prostate (LOY) in blood cells. cancer in men. Diaprost Mab-PET-ligand (anti-hK2) in combination with In vivo screening for identification and detection anatomical imaging (CT/MR). of prostate cancer. Elypta Platform based metabolic profiling analysis Early detection, differential diagnosis, surveillance (machine learning algorithms) of 20 cancer-type of recurrence and monitoring or prediction of specific metabolites in blood or urine. treatment response. iCellate Medical Whole genome sequencing (of CTC and ctDNA) Analysis of aggressive prostate cancer. Risk profiling and germ-line DNA, from normal blood samples. in hereditary investigation. In clinical validation. Immunovia Panel of prostate cancer biomarkers on microar- Early detection of prostate cancer. 2. T he National Board of Health ray platform /software algorithm. and Welfare (Socialstyrelsen) 3. W itte, & Van Den Eeden, 2017. Spectronic Software that provides AI driven technology Treatment planning for MRI only radiotherapy Nature Communications Medical to enhance radiotherapy by enabling MRI. planning. Ongoing registration of the product. 22
Cancer of the pancreas HCC diagnosis is usually achieved using According to WHO, hepatocellular pancreatic biomarkers and early diagnosis is critical for cancer is probably the most lethal tumour, successful treatment. Today, only 10% of forecast to become the second most fatal HCC patients are diagnosed at an early stage cancer by 2020 in developed countries. Pan- and there is a significant unmet need for diag- creatic cancer often does not cause any signs nostic markers enabling early detection. or symptoms in the early stages, making early AroCell is developing a screening test based diagnosis difficult. Detection at a curable on measuring TK1 levels to monitor cancer stage demands screening intervention for early therapy with activated T-cells for liver cancer. detection and differential diagnosis. However, This project is currently in clinical validation. to date, no successful strategy or image tech- Ascelia Pharma, detection and localization nology has been found to offer an effective of primary liver cancer. Clinical validation of approach. Currently, the hope for this cancer this project is on-going. is to be able characterise relevant non-invasive Glycobond has developed an ELISA-based biomarkers. assay that detects aberrant and cancer-specific Axcentua Pharmaceuticals is developing spe- glycosylation on alpha-1 acid glycoprotein. cific biomarkers for stratification of pancreatic The protein is secreted into the blood stream cancer patients. This project is currently in where analysis can be performed on a simple clinical validation. blood sample. This product is launched. Elypta is developing a blood- and urine-based liquid biopsy platform for detection and clas- Kidney or renal cancer sification of multiple cancer indications, one The two most common types of kidney cancer of which is pancreatic cancer. are renal cell carcinoma and transitional Immunovia is working on a diagnostic cell carcinoma. The different types of kidney multiplexing serum test for early detection cancer have different long-term outcomes and of pancreatic ductal adenocarcinoma. need to be staged and treated in different ways. Reccan Diagnostics is investigating a serum Akuru Pharma is using a bioinformatics biomarker panel for pancreatic cancer. platform for identification of novel surface This project has reached clinical validation. molecules that can serve as biomarkers for renal cancer. This project has reached clinical Liver cancer validation. Hepatocellular carcinoma (HCC) is responsi- Elypta is developing response monitoring and ble for causing over 700,000 deaths annually. recurrence detection of renal cell carcinoma. 23
| SwedenBIO Precision Medicine – The Swedish Industry Guide 2018 THE FIGHT AGAINST INFECTIOUS DISEASES S weden is deeply committed to the A benefit of adopting precision medicine for global fight against the development bacterial and viral infection is that improved A number of multidrug resistant pathogens. diagnostics will help drive new drug develop- In 2016, the Swedish government ment for novel antimicrobials and antivirals, of Swedish presented the Swedish strategy to combat anti- particularly agents to be reserved for resistant companies biotic resistance. The Public Health Agency of pathogens or agents that are intended for use are developing Sweden contributes to the Global AMR Sur- only against a limited range of pathogens. New, new tests and veillance System through both the WHO and rapid diagnostics can support development of bilateral cooperation with e.g. India, China narrow spectrum agents and targeted therapy platforms to push and EU. The Unit for Antibiotics and Infec- that will generate new business models for an- diagnostics to tion Control of the Agency has in fact been tibacterial and antiviral agents, to focus treat- the next level. designated as a WHO Collaborating Centre ments to the right patients at the right time. for Antimicrobial Resistance Containment. The development of transformational Serious bacterial infections need to be diagnostics and biomarkers that can easily treated rapidly to maximize a patient’s chance be used to diagnose infections directly from of survival. In some infections, such as venti- clinically relevant specimens should focus on lator associated pneumonia and sepsis, and in features such as being inexpensive, simple, certain critical situations, minutes can matter. rapid and having a high degree of accuracy. Traditional bacterial identification relies Furthermore, being able to distinguish both primarily on culture-based methodologies bacterial and viral etiologies as well as colo- requiring 12 to 24 hours for isolation and an nizing organisms from infecting pathogens is additional 24 to 48 hours for species identi- also crucial to future developments. fication. In the absence of rapid diagnostics, A number of Swedish companies are empiric therapy, based on an “educated guess” developing new tests and platforms to push as to the causative agent of the infection, has diagnostics to the next level. These are shown become the standard. in the table below: Company Pathogen Methods Application 1928 Bacteria Software platform for whole Antibiotic resistance detection Diagnostics genome sequencing data. and surveillance. Alpha Biotech Bacteria PCR Detection of Rickettsia bacteria in cerebrospinal, bronchial lavage, synovial fluid. Apodemus Virus PCR, NGS, Immunology. Presence of different viruses. Astrego Bacteria Microfluidics, real time imaging. Antibiotic susceptibility. Testing Diagnostics in urinary tract infections. CAVIDI AB Virus Reverse Transcriptase assay. Automated drug resistance test- ing in near-patient HIV viral load. EMPE Bacteria Padlock probe-dependent Antibiotic susceptibility testing; Diagnostics DNA rolling circle amplification Detection of bacteria, virus, and lateral flow biosensors. fungi, and other microbes. Gradienttech Bacteria Microfluidics, real-time imaging. Rapid antibiotic susceptibility testing. Q-linea Bacteria Padlock probes and circle-to- Fully automated multiple antibiotic circle isothermal nucleic acid susceptibility testing. amplification technology (C2CA). Symcel Bacteria Real-time cell calorimetry. Multiple antibiotic resistance testing. 24
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