Life Science 2019 by Business Insights

LIFE SCIENCE DENMARK

A new Danish-Swedish alliance has positioned oncology to become Denmark's next life science blockbuster

p. 36

Robert Langer: Biotech Advances by Finding Talent Who Can Walk through Walls

p. 12

The Next Life Science Successes are Being Waylaid by Funding Constraints

p. 19

“Denmark Will Not See a New Novo Nordisk”

p. 42

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About Life Science Denmark is produced by Reach Media in close cooperation with Medicon Valley Alliance, Medicoindustrien, Copenhagen Capacity, Welfaretech, COBIS and SmiLe Incubator. This magazine is distributed with Børsen on December 17, 2019. We thank the partners, sponsors, sources and the editorial team for contributions.

Colophon: Editor in Chief: Jakob Lindmark Frier Journalists: Sebastian Kjær, Karin Jensen, Kasper Ørkild and Jakob Lindmark Frier Project managers: Alexander Christensen and Jesper Krogen Layout: Kristoffer Lohse Published by Reach Media: Stian Faber, sf@reach-media.dk

Content 08-09

Well Begun Is Half Done – but Only Half Done!

Biotech Advances by Finding Talent Who Can Walk through Walls

08-09

Denmark’s Stronghold in the Life Sciences

10-11

Combining Strongholds Will Carry Denmark’s Life Sciences Forward

The people who are most successful doing research are the ones who know how to deal well with failure

12-15

“We Want to Become a European Innovation Hub within the Life Sciences” It Takes an Ecosystem to Build a Successful Life Science Company

16-18

Up-and-Comers Are Finding Success on Swedish Stock Exchange

19-21

The Next Life Sciences Successes Are Being Waylaid by Funding Constraints

22 23 24-25

Greater Copenhagen Is Going to Be a Global Hub for Microbiome Research 26-27 Academic Spinout Pushes New Diabetes Treatment to the Clinic

Denmark’s Life Science Cluster Invites to Collaboration

30 31

CRISPR Technology: Assassinating Superbugs and Creating a New Paradigm The Danish start-up SNIPRBiome used CRISP technology to kill seemingly untreatable bacterial infections with surgical precision Agilent Technologies and Dako Denmark: A Shared Appetite for Innovation

Oncology Research Is Done in Vain If It’s Not Transferred to Patients

32-33

Figthing Cancer through Technology Innovation

34-35

Immunotherapy Is Fast Becoming A Major Treatment Of Cancer

In Denmark alone, we do not have the capacity and competencies to build the next large oncology company

36-40

Stronger Collaboration Only Way Forward for Danish Health Sector Longboat Amniotics Takes the Next Step in Cell Therapy

42-43 44

“Denmark Will Not See a New Novo Nordisk” Merger of Danish Health Clusters Will Strengthen the Sector

45 46 48-49

Speed Is Becoming a New Parameter in the Conservative Industry 50-51 New Tools Improve Patients’ Ability To Take Control Of Own Treatment

Infertility Can Be Solved by Tech, but Not in the Way You Think

54 56-57

Denmark Has the Best Health Data in the World,We Just Have a Hard Time Using It Over the past five decades, the massive dataset collected by the Danish healthcare system has become extremely valuable Denmark’s Talent Pool Must Secure Positions of Strength in the Life Sciences

Transplant Treatment Start-up Aims at Billion-Dollar Market

A Danish Start-Up Is Engineering Mucus at the Molecular Level

Daiichi Sankyo Builds up a Strong Nordic Presence

Synklino is developing an innovative drug to combat a virus that causes troubles for patients following organ and stem cell transplantation

When Universities Turn Their Patents into Start-Ups Everybody Wins

New Assessment Council Promises to Foster Holistic Procurement

How Life Science Start-ups Can Harness Intellectual Property Strategies

Strong IP Strategy Ensures Investor Capital for Danish Biotech Firm 64-65 66-67 Clinical Tests Are Based on Artificial Reality and Yield Suboptimal Results 68-69 Smart, Profitable Start-ups Are Growing in SmiLe’s Winning Community

Is Denmark’s National Life Sciences Strategy Making a Difference? Denmark’s life science industry is heavily regulated. Success and growth isn’t just a matter of securing qualified talent in great companies

Editorial

Well Begun Is Half Done – but Only Half Done! By: Søren Bregenholt, Chairman of the Board of Directors, Medicon Valley Alliance

hen it comes to life science, the partners in the Danish-Swedish Medicon Valley region, Denmark and Sweden, are both well-positioned to become first class life science nations in the future. Both countries are innovation leaders within Europe. Both countries have and share a long tradition of successful academia-industry partnerships within life science. Both in the Swedish eastern and Danish western part of our region we have high ranking universities such as University of Copenhagen, Technical University of Denmark and Lund University helping to create and maintain a well-trained, highly skilled and very experienced work force, of which as sub-

stantial part is absorbed and further educated by the region´s successful and future-oriented life science companies. In addition to that, the major Danish life science companies have a rather unique ownership structure which not only prohibits companies such as Novo Nordisk, Leo Pharma and Lundbeck from being acquired and having their R&D activities relocated, but also ensures a continuous and crucial flow of new investment s into the life science start-up eco-system from these companies´ foundations. Furthermore, we have top research facilities relevant to life science in operation and under construction in Lund. The European Spallation Source, which will be world’s most powerful neutron source, enabling scientific breakthroughs in material

research, is planned to open in 2023, and with the Data Management and Software Centre located in Copenhagen, this is an excellent example of regional and bi-national teamwork. In sum, we have a favourable point of departure positioned literally “on top of Europe” with a relatively attractive business and R&D climate and well-functioning societies allowing for a comparable good quality of life. There is, however, still room for improvement, and we do need to make it even more attractive for certain highly demanded and highly qualified profiles to relocate to Denmark and Sweden with their families, if we want to keep the engine running and sustain innovation and growth. Talented and innovative people are the key raw material for this industry, and although the life science industry is unique in many ways, just like any other industry, it will not function with insufficient raw material supply. What we need to be aware of is that although “well begun is half done”, it is exactly that, half done! Our current success does not guarantee future success. We cannot rest on our laurels. Yesterday´s national strategy will not necessarily suffice for tomorrows challenge. To optimise the likelihood of future success – there are no guarantees - we need to scrutinize, strengthen and, finally, coordinate our current national life science strategies. Just like team mates in a game of tennis doubles are less likely to succeed with individual and uncoordinated strategies, Denmark and Sweden are less likely to succeed and successfully compete internationally with individual and uncoordinated national life science strategies. The fact that the international competition is stronger than ever and that new nations and companies from around the world are working dedicatedly to catch-up and close the innovation gap, just emphasizes the need for us to get our act together, together. Any meaningful notion of a strong Nordic life science cluster serving as an attractive destination for life science industry, talents and academic R&D starts with Denmark and Sweden joining forces. The good news is that we are still ahead in the game and we still have time to come up with better, more comprehensive and more aligned national strategies. But will we?

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Denmark’s Stronghold in the Life Sciences Restructuring and growth set the tone for Danish and Swedish life science, particularly in the Medicon Valley region that crosses Øresund. In recent years, the supporting structure for the life sciences, which is both innovative and promotes exportation, has undergone important developments.

Capital Region of Denmark

32700

Rest of Denmark

4200

Journalist: Jakob Lindmark Frier Source: State of Medicon Valley Analysis

Region Zealand

6300

he conditions are ripe for the life sciences to become a sector with a stabilising effect through the next recession. In fact, employment and job security in Medicon Valley is on the rise. The latest statistical evidence (2017) shows that there were 44.000 employees in Medicon Valley. Its main life science municipality is Gladsaxe, where 8.600 citizens are currently employed in the industry. This is home to Novo Nordisk’s headquarters and large facilities, as well as its sister company, Novozymes. The second largest municipality is Copenhagen, where there are 6.400 employees in companies including H. Lundbeck, Ferring Pharmaceuticals, and Genmab. Closely following Copenhagen – with 6.000 employees – is Ballerup, where the headquarters for Leo Pharma and Novo Nordisk facilities are located. Regarded as a life science hub, Ballerup’s ambition is to attract more companies to their ecosystem. The aim is for

it to grow continuously and to tap into the federal government’s ambitions for the entire Danish landscape. According to Jette Margrethe Rau, director of business development in Ballerup Municipality: “The last bit of land will be established as a new business and residential area, where we want to attract different kinds of co-working spaces and lab facilities. There will be a co-existence with universities and venture capital with this particular focus. We want to recruit start-ups and SMEs globally, in cooporation with med- and biotech companies

and accelerator programs, and to provide close access to the ecosystem for investors.” Rau points out that there are already highly qualified personnel in the area, and that this is valuable for both the labour force and networking efforts: “With all the bridging work that will take place in the years to come, now is the time for companies to move to Ballerup – to be part of a still-growing network and funding system.” It is worth noting that Ballerup Municipality is heavily investing in a new business zone west of the city, Kildedal.

9 Stockholm Uppsala region

16600 Rest of Sweden

4500

Value of exports in life science, in millions (DKK) 110.000 100.000 90.000 80.000 70.000

Västra Göteland

7400

60.000 50.000 40.000

2008

2009

2010

2011

2012

Denmark

2013

2014

2015

2016

2017

2018

Sweden

Source: Statistics Denmark and SCB/Statistics Sweden and Riksbanken

Medicon Valley

44000 Skåne

5000

Novo Nordisk is among the companies to move offices to the new Kildedal area. Going forward, Ballerup is poised to establish a life science stronghold by analysing what is already present in Greater Copenhagen’s ecosystem. In Raus words: “We are able to fill in gaps that can make Denmark an even stronger nation within the life science domain. That is why we are spending a lot of time forming networks and partnerships with the right institutions and companies. Although the exact details are still shaping up over the coming months, a strong international profile and strategic partnerships are critical.

Denmark’s Life Sciences Exports Achieve Record High Levels Denmark and Sweden’s life sciences exports are at an all-time high. Doubling over the past 10 years, Danish life sciences exports are now worth close to 106 billion DKK. The country’s life sciences exports now account for more than 15 per cent of Denmark’s total exportation of goods; this is the highest share recorded between 2008-2018. Keeping pace, Swedish life sciences exports achieved a record high after rising 10.6 per cent in 2018 alone. This trend is expected to continue into 2019, as new figures from Statistics Denmark show that the pharmaceutical industry's share of industrial production is hovering at 20 per cent. And, exports of medicinal products, especially in the second quarter of 2019, have grown almost twice as fast as other European countries. After a rather weak 2017, marked by little growth, Danish life sciences exports rose significantly in 2018 – increasing by 7.7 per cent. As Denmark’s largest export market, life sciences

Life science exports in Denmark and Sweden in 2018 Millions DKK

Export share 2018

Growth (one year)

Annual growth 2008-2018

Denmark

105.876

15.4%

7.7%

8.7%

Sweden

64.786

6.2%

10.6%

2.9%

Source: Statistics Denmark and SCB/Statistics Sweden and Riksbanken

exports to the United States in 2018 were valued at 28 billion DKK, a 21 per cent increase compared to 2017. After the US, China is the industry’s largest export market. Medicinal products and devices worth 8.7 billion DKK were exported to the Chinese market, albeit the increase from 2017 – 1 per cent – was minimal. Yet, when viewed from a long-term perspective, exports to China have risen substantially. The average annual growth between 20082018 was 23 per cent.

Beacons of Medicon Valley Pharmaceutical companies with existing or former headquarters in the Capital Region of Denmark dominate Medicon Valley’s largest groups of pharmaceuticals and biotechnologies. The four major players – Novo Nordisk, Lundbeck, Ferring, and LEO Pharma – and the foundations that own them, have acted as venture capital investors and the bedrock for many researchers in the region. Since the 1990s, a number of biotechnology companies have emerged, including Genmab, Zealand Pharma, Bavarian Nordic, and Symphogen in Denmark, as well as Alligator Bioscience and Camurus in Skåne.

Combining Strongholds Will Carry The field of life sciences is in a state of constant development. However, according to Morten Sommer – who leads a laboratory at the Novo Nordisk Center for Bio-sustainability at DTU – Denmark shouldn’t strive to invent the wheel anew. Rather, we should build upon our strong foundation. Journalist: Sebastian Kjær

he life sciences are playing a crucial role in the Danish business environment, as evident from the stronghold of industry leaders like Novo Nordisk, Chr. Hansen, Leo Pharma, and Lundbeck. According to Morten Sommer – who leads a research laboratory at the Novo Nordisk Center for Bio-sustainability at DTU – Denmark has several positions of strength and an immense skill base thanks to these huge companies. As one of the industry talents who is expected to carry the field forward, Sommer is focusing on what Denmark does best – i.e., bacteria, biopharma, and dermatology – and has set his sights on transforming them. In his own words: “It’s important to build upon existing strongholds and find new applications for it. Our region already has various positions of strength that we can build upon to create next-generation approaches.” The stronghold is company-made Denmark’s life science hub of experts have one thing in common: they are each the offspring of big, successful companies. This has contributed to their strength by heightening interest in their research from local universities. Although Sommer is an academic, he attributes most of his success in the field to companies that have been around for decades. In more detail: “The ecosystem is a stronghold in itself, as we have several huge, fund-owner companies – Lundbeck, Novo, Leo – who have managed to keep their business Danish. In turn, they keep giving back to the ecosystem to a smaller or larger degree through research and grants to both universities and new start-up companies.” Crossovers: the key to success Although cancer research has not carried the same weight as, for example, diabetes in Denmark, it is on the rise following the launch of successful new companies. Sommer points to the emergence of Genmab and Y-mabs as sites of home-grown knowledge and skills in biologics and proteins. Their research has been used in new settings within antibodies and oncology thanks to these companies. In fact, Sommer believes oncology is “on its way to becoming a strong field in the region, separate from the established industry.”

Denmark’s Life Sciences Forward Sommer anticipates similar developments in microbiome research, which is becoming increasingly recognised in Denmark: “Knowledge of bacteria is one of the core skills which will become really important when we get a better understanding of what bacteria and microbiomes mean for human health. And we are in a really good spot thanks to the strength we have in this field already.” Sommer forecasts the same for applying digitalisation and big data to the equation: “We have been the first movers when it comes to big data analysis in microbiome research. This, combined with our microbial manufacturing experience and Denmark’s public databases, provides some very interesting possibilities in using microbiomes as new targets for the treatment of a wide range of diseases.” A framework of trust Infusing the knowledge and skills from Denmark’s life sciences throughout the public and private sector will carry us into the future. But that will only be possible if stakeholders trust each other. Optimistically, Sommer points out the “trusting way” of doing business and partnerships in the Nordics, and its power to facilitate cooperation. He describes how “this makes it possible to bring different competencies together, which in other cultures is quickly slowed down by legal issues and distrust.”

We have been the first movers when it comes to big data analysis in microbiome research. This, combined with our microbial manufacturing experience and Denmark’s public databases, provides some very interesting possibilities in using microbiomes as new targets for the treatment of a wide range of diseases Photocredit: Medicoindustrien

Morten Sommer

Biotech Advances by Finding Talent Who Can Walk through Walls As one of the most accomplished engineers in history, Robert Langer has spent most of his career in biotech â&#x20AC;&#x201C; spinning companies out of the Massachusetts Institute of Technology. This past November, he joined the Scientific Advisory Board of BioInnovation Institute. Journalist: Jakob Lindmark Frier

Photocredit: Langer Lab, MIT Department of Chemical Engineering

hroughout his distinguished career, Dr. Robert Langer has faced a lot of ‘no's’. As a chemical engineer who was eager to work on drug delivery systems, his ideas cut against the grain of conventional wisdom: “It was tough. As a newly-minted chemical engineer, people wrote insulting things about my knowledge of biology and medicine. Many critics thought my ideas were crazy, a number of professors even wanted me to leave the university, and my first nine grant proposals were turned down.” Despite his rough start as a chemical engineer, Langer kept his sights set on transitioning into medical research. Steadfast, he eventually landed a job as a postdoctoral fellow with the cancer researcher Dr. Judah Folkman at the Children's Hospital in Boston. Folkman became a role model and a mentor who embodied the values and drive that Langer now looks for in talented researchers and business people. Over time, Langer’s research that combined synthetic polymers and mammalian cells led to the creation of FDA-approved artificial skin, new blood vessels, and spinal cords. Currently, he’s running clinical trials to use these innovations to treat hearing loss. Along the way, Langer’s entrepreneurial mind-set and unshakeable confidence helped him to become a rock star in the field of biotech, who is frequently referred to as the ‘Edison of our time’. As a serial entrepreneur, he holds over 1,000 patents, has published over 1,000 articles, and is affiliated with numerous university spinouts that benefit from the depth and breadth of his expertise. This past November, the star researcher at the Massachusetts Institute of Technology (MIT) accepted to chair a group of scientific experts who will advise Novo Nordisk Fonden's biotech incubator, Bioinnovation Institute.

MIT and Stanford – they have engineering and entrepreneurial cultures in the fields of computer technology and biotechnology. They celebrate and embrace the entrepreneurial spirit. At some universities, academia and business are too far apart, when the two are actually interdependent and often require close collaboration to find real value,” Langer remarks. The optimal conditions for a successful entrepreneurial environment include: university environments that can provide trainees with the right skills; access to risk capital;

You just have to keep trying and never give up. This is based, in part, on personality, but it also requires believing in what you are building and creating Dr. Robert Langer

Learning to deal with failure Every entrepreneur is told that failure is necessary on the road to success. This mantra is alive and well throughout American entrepreneurial ecosystems in Silicon Valley and MIT alike. According to Langer: “The people who are most successful doing research are the ones who know how to deal well with failure. It’s ok to fail, if you are able to turn it into a real opportunity to do something different, or can make the necessary adjustments. I believe in the power of positive reinforcement to encourage people that almost anything is possible. This, of course, is easier if you do something that you love and are truly passionate about.” Failure can also push entrepreneurs out of their comfort zones, stretching towards what is possible. It’s about exploring all sorts of avenues for solutions and doing so in a very rigorous, disciplined way. But it can be a gruelling process. In an interview with Forbes, Langer spoke to how he guides others to a point where they’re asking good questions – whether in science or in business. Be bold An ecosystem requires that several conditions be present for something to take root and grow. This applies outside of the natural sciences, especially to start-ups and entrepreneurs who are making businesses out of great research. However, the reality is that researchers-turned-entrepreneurs are still frowned upon, and this only causes barriers for impact: “Looking at the two most attractive ecosystems for research in the United States – the areas adjacent to

the opportunity to interact with legal advisors who have insight into patent law; and collaborations with established companies that can either dedicate employees to specific entrepreneurial projects or acquire successful start-ups. These conditions give rise to a rich ecosystem that can help life sciences start-ups to develop and ship their products to the market. Another key stakeholder is the government. As Langer sees it, the Danish government should look more closely at providing funding to universities because very often entrepreneurship and innovation starts at the university level, and better funding can attract superstar faculty and junior scientists to the country. “You have to be ambitious – not about money for lucrative salaries – but with funding for facilities and resources for professors and researchers. They want to work in places where they can carry out their research under the most optimal conditions available. And if that is in Denmark, they will no doubt come here,” Langer explains. Drawing a recent parallel to MIT, he points out that the university wants to establish the world’s best research centre for artificial intelligence and is looking to hire 50 of the best professors in the field. Such bold moves can only come with significant funding. Companies are like children growing up Since the 1980s, MIT’s Langer Lab has spun out companies whose products treat cancer, diabetes, schizophrenia, and even thicken hair. He also serves as a board member for several of his companies and devotes a lot of his time to men-

15 toring. Based on his observations over many years, Langer describes companies as children when they are growing up. When they are babies, they need a lot of nurturing. Later on, they need less. And, in the end, they may not even listen to you, but at least you hope they will love you. In seeking out individuals to run his companies, Langer looks at those who are the best overall as opposed to specialists: “I rely heavily on advisors. If they say that this person is the best, that he or she would walk through walls to accomplish things and is a nice person, I work with them. I have been lucky in choosing people, and MIT has been a good environment for them to flourish.” That being said, it is more challenging to recruit CEOs for his companies: ‘Many people are not going to be a great CEO no matter what, and those who are great will only be so at a certain time in their life. If you get someone too early, they may make mistakes because they do not have the experience. And if you get them too late in their life, they might not have the fire in their belly. So somehow you have to be fortunate enough to judge people as you find them and that is awfully hard’. Although Langer is quick to point out that there is no one type of personality that is most suited for success, he emphasised the importance of vision, hard work, never letting up, and – especially in the world of biotech – patience: ‘You just have to keep trying and never give up. This is based, in part, on personality, but it also requires believing in what you are building and creating. That is what I mean when I say that people can walk through walls: someone who can create something that is almost unbelievable’.

The Edison of our time: Robert Langer holds over 1,000 patents; has published over 1,000 articles; oversees a lab at MIT that has served as an incubator for 40 companies; and he is the most quoted engineer in history. He has received 220 awards, including the United States National Medal of Science and the United States National Medal of Technology and Innovation, the Charles Stark Draper Prize (considered the Nobel Prize in engineering), the Albany Medical Center Prize, the Wolf Prize for Chemistry, the Millennium Technology Prize, the Priestley Medal (highest award of the American Chemical Society), the Gairdner Prize, and the Lemelson-MIT prize, for being ‘one of history’s most prolific inventors in medicine’. He holds 34 honourary doctorates and is one of the very few individuals ever elected to the National Academy of Medicine, the National Academy of Engineering, the National Academy of Sciences, and the National Academy of Inventors. The Langer Lab at MIT is the largest biomedical engineering lab in the world, and maintains over $10 million in annual grants and houses over 100 researchers. Photocredit: Langer Lab, MIT Department of Chemical Engineering

If we had the same rules and opportunities in Denmark, we might not have moved to Sweden. We only did that because the investment environment is much better there Nils BrĂźnner

Photo: Kasper LĂ¸ftgaard

Danish Life Science: Up-and-Comers Are Finding Success on Swedish Stock Exchange Several Danish life science companies have taken to Sweden’s Spotlight Stock Market to raise capital for their developments. Here, investors are more willing to bet on smallergrowth companies – propelling business innovations forward. Journalist: Sebastian Kjær

ather than develop a shiny new app or a fancy gadget, the young Danish company – Scandion Oncology – is developing a drug to help people living with cancer to win the fight. According to Nils Brünner, the company’s CEO: “The biggest challenge in cancer treatment today is resistance. It’s a known challenge for antibiotics, but few people know that cancer cells also develop resistance to treatments. Our goal is to develop a drug that can block that resistance.” The building blocks of the company’s drug emerged from basic research undertaken at the University of Copenhagen. This drug is expected to be used in a phase II trial on patients later this year. Of course, the journey from basic research to commercial medicine is long and expensive – very expensive. Saddled with the challenges of raising capital from private Danish investors, the company turned to the Swedish Spotlight Stock Market last November and has since raised 26 million Swedish kronor. Scandion Oncology isn’t the only Danish company to do so. To date, 10 up-and-comers in the field of life sciences have turned to the Swedish stock exchange to help make their ambitious projects come to life. Life science researchers are looking to Sweden The consultancy, Sedermera Fondkommission – based in Sweden – has helped close to 100 growing companies raise capital since the company’s inception in 2003. Back then, the company decided to offer start-ups with a full-service solution to make their transactions and IPOs as seamless as possible. Fredrik Rahl, director of sales and capital markets at Sedermera, explains: “We saw the same problem everywhere: a lack of growth capital. At the end of the day, that's a pretty big problem, as it slows down growth in all countries. One way to help solve this problem is by making it easier for growth companies to raise capital from the stock market.” Following their initial success in Sweden, Sedermera looked beyond the border and saw a lot of interesting growth-companies in Denmark facing the same challenges as domestic businesses. In Rahl’s words: “The key was to give Danish companies access to the Swedish ecosystem to get more liquidity. As

a result of that, start-ups would be in a good position to raise more growth capital as a listed company. From a global standpoint, we have a unique ecosystem in Sweden for growth companies.” Back in 2014, the first Danish company Sedermera helped to secure its IPO on Spotlight was the medical startup, Saniona. Since then, Sedermera has been the financial advisor for 15 Danish companies – 10 of which are life science companies. These companies have raised approximately 200 million SEK from their IPOs and approximately 900 million SEK in total. Rahl is careful to point out that “an IPO on Spotlight isn’t like a large IPO in the United States, which looks more like the founders selling their company. On Spotlight, it’s all about access to capital – both in the short and long term.” Lured by the Swedish investment culture Scandion Oncology is the third company that Nils Brünner has taken to the Swedish stock market. For Brünner, “It has been a viable way forward when we didn’t want to raise venture capital. My two previous experiences raising capital in Sweden demonstrated that the liquidity is high, in stark contrast to the Danish First North exchange. Specifically, we have been able to raise an additional 29 million Swedish kronor this summer.” He attributes much of their success to Sweden’s investment culture, which is fueled by the ‘Investingsparkskonto’ – a special new account that gives investors favorable tax breaks when investing in growth companies. Investing in growth is now an appealing option for many people who would not have considered it even a decade ago. And, for Scandion Oncology, this has resulted in successfully raising money from somewhere between 1500-1600 investors. No silver bullet According to industry analysts, a lack of risk-capital is slowing the development of life science start-ups in Denmark. While Sweden offers a viable framework for this problem, it cannot be replicated overnight. Rahl explains: “A lot of different components came together to create Sweden’s ecosystem and trust in the market. It wasn’t like this when we started in 2003, but over Continues

the years the investment culture in Sweden has shifted. There is much more liquidity now, and companies have to follow the liquidity to be well-positioned for further capital injections.”

...almost everyone is actually investing in the small growth companies, and they are getting covered and analysed in a way that was traditionally reserved for big companies Fredrik Rahl

More broadly, competition between stakeholders has raised the quality of start-ups across the investment landscape. Larger investors are now daring to bet on new start-ups, and, thanks to the introduction of the ‘Investingsparkskonto’ in 2012, smaller retail investors now have a better opportunity to follow initial investments in growth companies. Rahl compares this to a ‘Folkesport,’ where “almost everyone is actually investing in the small- growth companies, and they are getting covered and analysed in a way that was traditionally reserved for big companies.”

To stave this off, Brünner envisions “a mechanism that makes sure the companies stay in Denmark. Today they are moving out of the country or getting bought once they achieve success. As a country, we can’t be satisfied with that. The initial funding and the company ending up somewhere outside Denmark is very much 2 sides of the same coin. The next Novo Nordisk will never come, if all the small companies are being moved out of the country.”

A Better Danish Ecosystem Small start-ups may be incentivised to move substantial parts of their business out of Denmark, given their deep involvement with the Swedish market early on. Despite the fact that Scandion Oncology is successful in the Swedish stock market, they still think the Danish ecosystem needs to be developed. Brünner remarks: “If we had the same rules and opportunities in Denmark, we might not have moved to Sweden. We only did that because the investment environment is much better there. But how you handle investments is a political decision. In Sweden they make the rules to create jobs and growth, but in Denmark I feel a resistance toward what we are trying to do.” Denmark’s stock market rejection may have severe consequences in the long run, once start-ups take off and become really successful.

Fredrik Rahl, director of sales and capital markets at Sedermera

Photo: Neurescue team. Habib Frost is second from the right

The Next Life Science Successes Are Being Waylaid by Funding Constraints Although the Danish life science ecosystem produces a wealth of viable product ideas, there is a huge disproportion between the possibilities and the capital available to convert them into reality. Journalist: Sebastian KjĂŚr

he computer-aided aortic occlusion catheter developed by the Danish start-up Neurescue is the first of its kind in the world. It is a sophisticated balloon that can be safely inserted into the blood vessel of a cardiac arrest victim

without the need for imaging. And Neurescue hopes it can help more than 1 out of 10 people to survive a cardiac arrest, which is the current statistic. After four years of development and 600 tests performed on the product, the company has secured more than

20 patents and is now ready to launch their first product to the market. Even though four years to market is relatively fast, when youâ&#x20AC;&#x2122;re developing a highly advanced, innovative medical product in a highly-regulated space, the road to market could have been faster with access to more capital. Continues

20 According to Habib Frost, the founder and CEO of Neurescue: “You often have to choose between doing it good, fast, or cheap – and you only get to pick two. We have always prioritised safety and quality, so we could not do as many things as fast as we necessarily wanted from an international standpoint.” With the three rounds of funding secured from life science business angels and equity-free funds – e.g., €1,6 million from the European Commission Horizon 2020 and investments from the Danish Innovation Fund – Neurescue is product-ready and are moving towards a successful launch. Still, the company represents one of the biggest challenges the Danish ecosystem is facing: The number of talented people with good ideas isn’t matched by the amount of capital needed to reap their full potential. Greater potential than yield Stephan Christgau was one of the founders of Novo Seeds back in 2007 – a venture fund for life science start-ups initiated by Novo. Recently, when he left Novo Seeds it was to establish a new Nordic life science venture fund, which he thinks is crucially needed in the Nordic funding landscape: “Right now, there is a screaming disproportion between all the great opportunities in the ecosystem and the venture capital available. More and more compelling opportunities are emerging, which obviously creates an even bigger demand for venture capital.” Research from Denmark’s universities is increasingly commercialized – which is what makes a difference for patients in the end. After all, a discovery or a new invention only becomes a product that can benefit patients if it is developed. And while most start-ups require capital to make their ideas reality, that is even truer for life science start-ups. Christgau explains: “Life science start-ups require deep expertise and a wide range of competencies and networks to succeed. In turn, this sets demands for investors. If they are investing in a new cancer drug, they need to understand the medical candidate, how to test it on patients, how to sell it, and so forth.”

New ideas often come from young people with limited financial resources who need external funding from investors to realise their ideas Ricki Boye

is finding knowledgeable investors who can help the business grow without taking so much equity early on that it becomes impossible to raise bigger rounds down the road. Boye points out: “Founders don’t always understand the extent of what they’re taking on with investors.

The wrong capital can kill a start-up Ricki Boye, a partner at the lawyer firm Bach Advokaterne, knows just how crucial it is for a start-up’s success to secure the “right” investors from the beginning. In his own words: “New ideas often come from young people with limited financial resources who need external funding from investors to realise their ideas. And unless they know the funding landscape beforehand, it can be hard to put together a group of investors who can help the company grow now as well as in the long run.” Although there is investor money in the market, for life science start-ups it can be hard to find investors who understand their technology and have the necessary patience to invest in the industry. In this domain, regulatory requirements are significant and time-consuming, compared to other tech start-ups. If a team decides to take on an investor who doesn’t know the landscape, it can backfire later on, Boye explains: “There are multiple business angels who are ready to jump into life science, but it can be dangerous to get investors aboard who don’t know what they’re signing up for or understand the risk involved.” Typically, life science start-ups need a lot of money before their product is ready for market. Part of the challenge

Habib Frost, founder and CEO, Neurescue

Once they take in outside money, they also accept giving up some of their power. The goal is to leverage the founders’ right to run and develop the company and the investors’ desire to safeguard their investment. If they are not aligned it can be devastating to the development of the company, as the founders lose focus on the project as they spend their time engaging in discussions with investors. Overall, this can derail the company before it’s even started.” The Nordics need more life science VCs Start-ups need all the capital opportunities they can get – from soft funding and grants to business angels and family offices. That is especially the case in their early development phases. On this point, Christgau is careful to point out that start-ups require better access to competent venture capital once they are prepared to develop and commercialise their products. In this way, venture capitalists can participate with larger financing, in addition to bringing domain knowledge and commercial expertise to the table: “In all the Nordic regions there’s only 5 dedicated life sciences investors. And as more people from the industry succeed and start thinking more internationally, the lack of capital is really becoming the limiting factor.” In fact, even when life sciences start-ups attract international venture capital, Christgau thinks it’s crucial to have

Ricki Boye, partner, Bach Advokaterne

Nordic funds. His rationale is that foreign funders will want to see a local investor if they are to invest as an international syndicate, or alternatively they may consider moving the start-up to their own region. More capital is required for a new Novo Nordisk Neurescue is ready to generate clinical evidence for the commercially-relevant clinical pathways of their device. Consistent with this, they are preparing for a larger investment from venture capitalists next year – most likely this will include targeting foreign investors. The group’s founder, Habib Frost prefers not to make any predictions as to whether a foreign investment will mean that Neurescue will be sold to a bigger company, or that they will establish themselves as a successful company in Denmark. One thing that he is clear on is that Denmark needs more capital if more start-ups, in general, are to stay in the country. The leap from a start-up with a finished product to an established company which sells globally is simply too big of a stretch without more venture capital. In Frost’s words: “For a small Scandinavian start-up like us, it’s very difficult to sell and distribute in the US without a larger partner. It requires much more capital to establish distribution to the bigger markets yourself, and we do not see that as the right pathway for us. If we want the next Novo Nordisk and Coloplast to stay in Denmark, we need larger invest-

Right now, there is a screaming disproportion between all the great opportunities in the eco-system and the venture capital available

“Danish start-ups get a lot of respect internationally, as we have a large talent pool and can come a long way with small investments. But we are ready to take off as a world-leading life science nation. However, in order to really take off and substantially increase our growth, more capital is needed.”

Stephan Christgau ments. Right now, the landscape indirectly promotes early exits after development.” Frost remarks that the Nordics are very good at early-stage research and development, but he also hopes for more start-ups to become sustainable companies headquartered in Denmark:

Stephan Christgau, one of the founders of Novo Seeds

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The start-up Synklino is a part of the Creation House program in BioInnovation Institute

“We Want to Become a European Innovation Hub within the Life Sciences” BioInnovation Institute is poised to become the epicentre for entrepreneurial scientists within the life science sphere. This is all the more promising considering one of their first start-ups just closed a Series-A investment round of 20 million euro.

n describing the BioInnovation Institute’s (BII) mission, their CEO, Jens Nielsen, points to the ambitious task of bridging the gap between universities and society. The idea is to inject research ideas into companies that create socially-beneficial products and services. With this mandate and a capital injection of about 470 million Danish kroner from the Novo Nordisk Foundation for the three-year establishment phase, Nielsen and the team at BII are well on their way to accomplishing their ambitious target. Their platform is an incubator where scientists are given time and 10 million kroner to prepare their technology for the market. A select few Eight companies are currently participating in the incubator program that is known as “Creation House.” By the beginning of 2020, 4 more companies are expected to join the cohort – following a rigorous selection process. In more detail: “Applications are accepted twice a year. Applicants are assessed by a committee of industry insiders, venture capitalists, and serial entrepreneurs. In the end, we host a pitch event, where 7-8 companies present,” Nielsen explains. This screening process enables the group to identify the most promising companies who are the right “fit” to enter the incubator. In other words, the team can assess

Jens Nielsen, CEO of the BioInnovation Institute the likelihood of a specific business moving forward with an injection of money and mentorship. “We can help them build a solid team, where they can bring experienced, business-developing forces on board. Along the way, we support their journey in making a clear business case out of research by having a strong market focus,” says Nielsen. Capital alone does not constitute a good business case Typically, BII’s Business Acceleration Academy programme accepts companies that are at a relatively early stage of development, ones that are not yet ready to secure capital

from traditional investors. This is due, in part, to Nielsen’s contention that, capital alone should not be the sole focus when starting a business. “Capital alone does not determine whether businesses will be sustainable. That's why we focus not only on getting them ready for the next round of investments but on helping them to become a business,” Nielsen explains. The road to becoming a European innovation hub for life science Their formula has been validated through one of the first participants, Stipe Therapeutics. Recently, the start-up closed a Series-A investment round with 20 million euros. Having a ripple effect, their experience can benefit other companies in the incubator. At the helm of BII, Nielsen’s ambitions extend further. The organisation is scheduled to become an independent funder as of January 2021. Looking ahead, Nielsen envisions: “In 10 years, we will have created thousands of new jobs in Denmark. We will have become the natural destination for ambitious researchers, who come here because they believe that the environment we provide gives them the greatest chance of succeeding with their business. In this way, we can become a European hub for innovation within the life sciences. That is our vision.”

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It Takes an Ecosystem to Build a Successful Life Science Company COBIS, the hub for 120 research-based biotech and life science start-ups, offers the ideal framework to foster Denmark's next successful business.

OBIS is the collaborative breeding ground for startups, investors, academics, and service providers, who gather to share the latest knowledge and industry resources in biotech and the life science. Life science start-ups are generally under-resourced and are constantly on the hunt to secure funding, attract talent, build their presence, and gain international exposure. According to Morten M. Jensen, CEO of COBIS, ”A healthy ecosystem requires a physical framework where stakeholders can meet and share resources.” For its part, COBIS fosters relationships with international investors, pharma companies, and public institutions in other countries to help them boost their sales and scale globally. Fertile conditions Biotech companies employ more highly-educated people than any other industry. As an international heavyweight, Denmark boasts the lion’s share of exports in the field and is a highly attractive platform to launch life science companies: “In Denmark we have large fund-owned pharma companies that have a permanent presence in the region. This generates a wealth of knowledge and attractive jobs. In addition, we have the political backing and government support, which have contributed to the growth of the biotech sector. Combining this with the excellent research conducted at the universities and growth capital it has helped to create the position of strength we enjoy today,” Jensen explains. COBIS is a strong player in the ecosystem because of the cooperative relationships it forges between the private business community, the public sector and the academic environment. In Jensen’s words: ”COBIS is a great example of a successful triple helix collaboration. We have a great cooperation with the University of Copenhagen and Danish Technical University, DTU. At the same time, we have had support from both the government and the region, which has been involved from the very beginning 10 years ago. Finally, we are standing

Morten M. Jensen, CEO of COBIS

on the shoulders of 3 highly-experienced science parks, Symbion, DTU Science Park, and Incuba Science Park, which has been in operation for more than half a century” Seeking global growth opportunities To succeed and ensure sustainability, it is crucial for the future of Denmark’s biotech and life science industry that the ecosystem become better at entering the international landscape. For Jensen, the reason is simple: “By being internationally linked to other regions to the greatest extent possible, you can be much more informed about the latest trends and technologies, how the competition is shaping up, where venture capital flows, and where human resources and competencies are embedded.” That’s why, whenever COBIS invites new start-ups on board, they are always aware of the specific needs of each company and offer tailored services to meet those needs. Jensen explains: “Instead of only offering laboratories and offices, we try to fulfil each company's next important steps. It is usually by providing contacts and going through our networks to solve their problems – especially our international networks.”

Facts According to Jensen, these are the 4 main components of a healthy ecosystem: 1. Stakeholders must be committed to continuing their activities for 10+ years. 2. An ecosystem must be open to anyone who has an interest in it, rather than exclusive to specific actors. 3. An ecosystem must be driven by an entrepreneurial mindset. That is why COBIS draws on company founders, so that they can help to shape the ecosystem of the future. 4. Access to networks is hugely important. It's about storytelling and exposure to the right people at the right time

CRISPR Technology: Assassinating Superbugs and Creating a New Paradigm The Danish start-up SNIPRBiome used CRISPR technology to kill seemingly untreatable bacterial infections with surgical precision. And that is just the first use case of the comprehensive, patent-fueled platform they’re building. Journalist: Sebastian Kjær

t’s a rare thing for a new biotech to hit the front page or go viral. But that was the case a few years back when the molecular scissors ‘CRISPR’ were used to edit rabbit genes to make them glow in the dark. While most of the initial hype surrounding the gene-editing technology was spent discussing the possibilities and ethics of editing human beings, a small Danish start-up used their time patenting the use of the technology in bacteria instead. According to Dr. Christian Grøndahl, co-founder and CEO of the start-up SNIPRBiome: “CRISPR is a gene-editing tool that allows you to cut all kinds of genes – mine,

yours, and in wheat or zebrafish. But we have decided to use it exclusively to cut the genes in bacteria.” Deoxyribonucleic acid (DNA) is the same in mice, men, and bacteria, and that is precisely what the company is editing with the technology. Specifically, SNIPRBiome is using the technology to combat the multi-resistant superbugs currently killing approximately 50.000 people in the West each year. Grøndahl explains: “We want to use the technology to get rid of life-threatening and untreatable bacterial infections – superbugs and multi-resistant bacteria which can’t be treated using regular antibiotics. So we’re looking to

find the replacement for antibiotics for the 1 out of 100 incidences where antibiotics don’t work.” This is just the first use-case for their patented technology. With 60 patents pending all over the world and a hefty investment of 350M DKK, the company is giving us a glimpse into what we can expect from this hyped technology in the near future. A sniper rather than a hunter Most people associate bacteria with something bad, but that explanation is much too simple for Grøndahl. Our bodies contain more bacteria than human cells, and they are

25 crucial for us to survive – albeit we didn’t really appreciate this until 10-15 years ago. There is a cost to cure a bacterial infection, as the medicine typically attacks a broad collection of bacteria – including the goods one. And that’s where the CRISPR medicine developed by SNIPRBiome sets itself apart: It only targets the bacteria it is designed to attack. In Grøndahl’s words: “Using broad antibiotics is like using a harvester. It’s a chemical substance that influen-

We are aiming at curing incurable, multi-resistant diseases and helping patients with inflammatory bowel disease by altering the bacteria in their stomachs Christian Grøndahl

ces all of the bacteria in your body. We want to introduce a drug that is just as accurate as the doctor's scalpel, so we only target one bacteria instead of aiming at them all.” The targeted approach does, however, include some additional steps for the drug to work. First of all, it requires a precise diagnosis to know exactly what type of bacteria should be targeted. Following this, the medicine must be programmed to identify the bacteria (literally programmed). For this, SNIPRBiome uses a supercomputer to calculate the features in the DNA of the target bacteria, as well as the bacterium the drugs should avoid. This way, the drug “knows” which bacteria to attack and kill by cutting its DNA. From hype to big business The ambitious biotech start-up was founded just four years ago by two scientists and a patent lawyer. This arrangement allows for both the development and legal protection of the new drug, paving the way to its patent as the first CRISPR-drug in the United States. As Grøndahl describes it: “We spent the first 2,5 years in stealth mode, while we used our own savings to get research results and apply for patents.” Since then, the company has moved from Cambridge to Copenhagen, secured a 1200 square meter combined office and lab space, raised 350M DKK, and hired 25 researchers (a number they predict will grow to 35-40 by next year). Though research and patents remain at the core of building the company’s platform, they also have the first two drugs on the way. Grøndahl shares: “We currently have two research projects we hope will turn into drug candidates within the next year or two. We are aiming at curing incurable, multi-resistant diseases

SNIPRBiome teamet

and helping patients with inflammatory bowel disease by altering the bacteria in their stomachs. But we also have new drug types planned for the long term, including a drug to alter the immune system.” The CRISPR paradigm shift As the CEO of SNIPRBiome, Grøndahl has been developing drugs for the past 25 years in both pharma and biotech.

Christian Grøndahl, Dr. Med, co-founder and CEO of the start-up SNIPRBiome

And he has huge confidence in, the CRISPR technology, and how it is about to fundamentally alter the nature of medicine: “Our business model is based on a brand new approach to making drugs. CRISPR-based drugs aren’t in the pipeline in any of the big pharma-companies right now.” With 60 patents pending worldwide, their patent position is unusually strong for such a young company. Paired with Denmark’s biggest Series A-investment in the country’s history, they have managed to hire some of the best talent in the ecosystem, and are well on their way to building a solid platform for their new drug type. With a platform that includes proprietary technology that is well-protected, the company has some very valuable product candidates in the pipeline that can be commercialised. The question becomes: What happens if they succeed in this huge endeavour? According to Grøndahl: “It will result in a paradigm shift. Some of the big pharma-companies saw CRISPR and microbiomes as overhyped until 6-12 months ago. Now, they have acknowledged that they will need their own people who know these technologies. In reality, the technology is able to kill any given bacteria – we just need to know its genetic code.”

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Copenhagen Capacity: Ambition Is to Make Greater Copenhagen a Global Hub for Microbiome Research A new three-year project seeks to establish Greater Copenhagen as a global leader and hub for research in the up-and-coming field of microbiomes.

he field of microbiome has in recent years been linked to a plethora of conditions such as diabetes and neurological diseases, which has made it emerge as one of the hottest topics in life science research. The Greater Copenhagen region - with its established strengths in the life science industry - has the potential to become a global leader in this new field. For that reason, Copenhagen Capacity, the official Danish investment promotion agency for Greater Copenhagen, has recently kicked-off a three year EU Interreg funded initiative together with Medicon Valley Alliance and Invest in Skåne

By attracting R&D and strategic partnerships, our present microbiome cluster both in industry and academia will grow – thus reinforcing Greater Copenhagen as a global hub for Microbiome research and development Anette Steenberg

with the ambition to catapult Greater Copenhagen to the top of Centres of Excellence when it comes to research within the microbiome. If not globally, then at least in Europe. Anette Steenberg, Director of Investment Promotion, sees a great potential in making the microbiome area a stronghold for the region: “We focus on attracting foreign direct investors to strengthen the Greater Copenhagen

strongholds where we are already- or ought to be - in top 3-5 globally, but we also focus on finding new areas with an untapped potential. The microbiome area is very interesting, and we know we already have several strongholds within this area, though it is still virgin ground for many companies.” Copenhagen Capacity has a 25-year long history of attracting companies, investments and talent to existing and successful clusters but also to provide support and promote new up-and-coming industries. The work of identifying microbiome as a new stronghold started three years ago, when Copenhagen Capacity asked Copenhagen Economics to conduct a study on Denmark’s research strengths. Twelve research areas were identified in which Denmark is particularly strong. It turned out that five of those areas were related to microbiome, tells Nikolaj Lubanski, the Director of Talent Attraction in Copenhagen Capacity: “For example, diabetes, immunology, ingredients and enzymes. There is strong scientific reason to say that if we combine these areas of strength, then we can lift microbiome research to a global success.” Even though microbiome fits the bill perfectly, it doesn’t automatically become a stronghold. Greater Copenhagen microbiome cluster needs to come together and be positioned internationally in order to attract both companies, investors and talent to the highly specialised field. “Quadruble Helix Strengths” Creating a global microbiome hub in Greater Copenhagen requires a high level of internationalisation. International investors, talent and businesses are prerequisites for strengthening the present existing base of companies and talent in order to build a strong international microbiome research environment. Steenberg and her team are working on attracting international companies and investors to Greater Copenhagen but are also reaching out to the foreign life science companies already present here in order to get them engaged in the microbiome initiative. ”Foreign life science companies already present here are also incredibly important to this process. They know of

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their companies’ initiatives world-wide which may involve expanding their research in the microbiome area”, says Steenberg and continues: “What we are looking to attract is primarily research and development initiatives or units within the microbiome fields. By attracting R&D and strategic partnerships, our present microbiome cluster both in industry and academia will grow – thus reinforcing Greater Copenhagen as a global hub for Microbiome research and development.” When attracting international life science companies and investors, Copenhagen Capacity focuses on what they call a “Quadruble Helix strengths”. Steenberg elaborates on this unique approach: “The good cooperation between t h e

authorities, industry, academia but also patient organisations – a unique selling point and something that impress most foreign direct investors when visiting Greater Copenhagen.” The large cluster of life science companies in Greater Copenhagen coupled with core stronghold areas such as diabetes, cancer, metabolism, neurology, dermatology and proteins are incredibly interesting for foreign companies. “The accessibility and digitalisation of the public system and the access and dialogue with authorities are so much easier in Denmark and Southern Sweden compared with other countries,” Steenberg says. Attracting talent - but what talent? Microbiome is a very specialised field, and in the context of Greater Copenhagen the talent needed to drive the journey toward an international hub remains unmapped. Copenhagen Capacity therefore encourage those companies and research environments interested in this field to reach out to the agency. Lubanski and his team will be working to attract international talent to do so, they need a thorough dialogue with the industry and academia: “Microbiome is an even more specialised area than other research areas we work with, which is why we in all humbleness say we need a close dialogue with the industry and academia.” According to Lubanski the life science industry and academia must provide the input which enables Copenhagen Capacity to be precise and clear when reaching out to potential companies and talent that may be interested in coming to in Greater Copenhagen: “In relation to talent attraction, we will use this process to find out what type of profile the companies are looking for and to get a clear picture of the jobs being offered.” The first task is to determine where these highly specialised talent are and how to reach them through a targeted digital strategy. “The strategy focuses on place branding as well as employer branding, why the talents should choose Greater Copenhagen, why the life science industry and its companies and research environments here are attractive for them and how it can help boost their careers,” Lubanski says. A part of the strategy is making sure there are jobs available for the talent to apply for: “Usually, we help companies screen talent, but we are considering working even closer with the life science industry here because the microbiome area is so highly specialised.”

and how far they are but also to identify world conferences and events that should be targeted. “Once mapping is done, we will start to look at value proposition. Basically, we need to establish which unique value propositions we have that can attract foreign life science

Microbiome is an even more specialised area than other research areas we work with, which is why we in all humbleness say we need a close dialogue with the industry and academia Nikolaj Lubanski

companies to come here and do research and development in microbiome,” Steenberg says and adds this part of the process is expected to be completed in the spring of 2020. In 2020-21, Copenhagen Capacity will also run a global digital campaign, which will focus on creating awareness of microbiome research in Greater Copenhagen and aim to market and promote the Danish cluster. The campaign is targeted the top global life science companies, and at the same time Lubanski and his team are visiting companies and research environments to get a better idea of the profiles being sought and questions needed to be answered as part of the screening process. “In 2021 the peak of the initiative will be creating an international event putting Greater Copenhagen on the global microbiome map. By then our ambition is that the first matchmakings and interested foreign direct investors will start surfacing in Greater Copenhagen,” says Steenberg.

First matchmakings and investors in 2021 The initiative to boost microbiome research in Greater Copenhagen is in its start-up phase. The first stage consists of mapping and analysing, determining which life science companies are working with microbiome research

Anette Steenberg, Copenhagen Capacity

Nikolaj Lubanski, Copenhagen Capacity

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Academic Spinout Pushes New Diabetes Treatment to the Clinic The scientist-driven start-up, Pancryos is working on getting important cell therapy discoveries out to patients who have Type 1 diabetes.

ranslating scientific breakthroughs to the public involves a long and winding road that is filled with a variety of obstacles. Perhaps the most effective way to make the transition is for startups to have deep roots in the scientific community. This is the case for Pancryos, which was spawn from the Novo Nordisk Foundation Center for Stem Cell Biology (or “DanStem”). The simple concept behind the start-up is to market the use of stem cells to treat patients with diabetes. Although this work was formalized in 2012, when Jacqueline Ameri joined DanStem as a postdoc in Henrik Semb’s research group, it began before that. Ameri explains: “I started working on this as a PhD student in 2004. After making it half-way through my thesis, I wasn’t able to make the insulin producing cells. So, I continued improving the protocol as a postdoc.” Now, she’s the CEO and co-founder of Pancryos. Patients avoid injections

Pancryos’ goal is to market a product that was created based on discoveries from DanStem. The solution, PanINSULATM, is a stem cell derived beta cell therapy that is used to treat patients with Type 1 diabetes. According to Henrik Semb, professor and executive director of DanStem, “Nothing compares to the real cells. Beta cells can sense exactly when to start and stop secreting insulin.” Adding to his list of accomplishments, Semb is also a co-founder of Pancryos and the scientific advisor on the collaboration between the start-up and the center at University of Copenhagen. He sees a bright future thanks to the treatment: “Through donor islet transplantations we have the proof of concept that cell therapy works. After islet transplantation, patients do not need to inject insulin for several years. We think we can achieve similar, or perhaps even better results, with stem cell-derived beta cells.” The research group at DanStem has already reached a point where the commercial side of the discovery is critical, but a big step towards reaching the market – bridging research and commercialization – was the establishment of Pancryos in 2015. Semb believes the collaboration between centers like DanStem and companies will be an important link in

the future of biopharmaceutical development. “This is a relevant discovery that can impact the quality of life for patients. While there is still some way to go, we have an obligation to pursue this,” Semb points out. Making a difference The transition from a scientific discovery to a commercial product is equally important to Jacqueline Ameri. After all, she began her career in research after one of her family members fell ill. She wanted to make a difference: “I started because I wanted to cure a disease that cannot be cured – exactly like Type 1 diabetes. I learned that if I wanted to be at the frontline and learn about the latest discoveries I had to join the scientific community and become a researcher. And now it is clear to me that if I want to make a difference in patients’ lives, our research has to be commercialized. So, I'm fulfilling my dream.” Moving her discoveries from the lab to the clinic was Ameri’s strongest motivation to join the corporate sphere, and she is encouraged by the results of her efforts: “After 15 years of working in this field, I’ve reached a point where we’re able to create insulin- producing cells and move them into the clinic. This wouldn't have been possible without the discoveries we made that addressed basic

scientific questions. But now we need to push further and take these discoveries into the clinic, otherwise they will never reach the market.” To be sure, Ameri took a big step in moving from a researcher at DanStem to leading Pancryos. One of her less scientific tasks is pitching the product for funding in order to reach the next step. The start-up aims to initiate clinical trials in the end of 2022. Giving Ameri the last word: “We’re at an exciting point in the company, and, with sufficient funding, we will be in a good position to reach our goal.”

Jacqueline Ameri, CEO and co-founder of Pancryos

Henrik Semb, professor and executive director of DanStem

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CEO and founder of GlycoDisplay Claus Kristensen and researcher Weihua Tian. Foto: Søren Bidstrup/Ritzau Scanpix

Denmark’s Life Science Cluster Invites to Collaboration

s part of the Danish innovation infrastructure, the national innovation network Biopeople has operated since 2005 from universities and university hospitals in Copenhagen, Aarhus and Aalborg. Based on the national focus on personalised medicine the network provides a framework for knowledge sharing, matchmaking and collaboration between research groups at hospitals and universities and the research based bio- and life-science industry. Among other activities, this has resulted in working groups relating to personalised medicine, autoimmune diseases, bio imaging, x-omics and clinical research. Through membership of about 100 life-science companies Biopeople has a close connection to the Danish life science community, offering members to participate, co-organise or present at Biopeoples’ events. Exposure and financial incentives Biopeople continually focus on the exposure of small and medium sized life science companies and is happy to publish news about activities and the companies’ latest results in its newsletter, at the website and social media like LinkedIn. Biopeople participates in several EU projects including the recent Boost4Health project. These projects have offered an international network of expertise and minor financial incentives, to help Danish life science companies explore their international growth potential. The story about GlycoDisplay GlycoDisplay, a spinout company from the Danish National Research Foundation Excellence Center, Center for Gly-

comics at the University of Copenhagen, is an example of a company that Biopeople have supported through exposure. Biopeople published news about GlycoDisplay in 2016 before the company was even established, and again when it moved into the 10th floor at the bright new Maersk Tower, University of Copenhagen, in 2017. GlycoDisplay initially offered its technology – to modify sugar structures on glyco proteins – to the pharmaceutical industry for the development of new medicines. Now three years after the establishment, the company, supported by Innovationsfonden, has identified a new concept, Long-Acting Glycodesign (LAGD), to improve enzymes for the treatment of rare genetic lysosomal diseases. In spring 2019 GlycoDisplay, together with researchers at the University of Copenhagen, published the first results of the LAGD concept for the treatment of Fabry disease in Nature Communications.

Display for 60 Danish and international companies. The result for us was useful contacts and a new collaboration partner.” GlycoDisplay’s technology now attracts international awareness. Most of the Company’s partner agreements are with American companies, and Weihua Tian, researcher at the University of Copenhagen and at GlycoDisplay, just received a Young Investigator Award to present the Long-Acting Glycodesign concept at WORLDSymposium 2020 in Orlando, USA. WORLDSymposium organise research within lysosomal diseases. Together with three academic groups, GlycoDisplay recently applied for a H2020 Synergy Grant, and the Company and a large European partner currently prepare a Eurostar application, which they will submit in 2020. Read more about Biopeople and Biopeople events at Biopeople.EU

Relevant target group ”The collaboration with Biopeople has from the very first day been for the benefit of GlycoDisplay,” says Claus Kristensen, CEO and founder of GlycoDisplay. ”Biopeople has proven to provide a good platform for exposure when we have published new results and news as for instance the Nature Communications article in spring 2019. Coverage in Biopeoples’ newsletter has reached the desired target group. In 2018, we furthermore attended a large Boost4Health event, organised by Biopeople at the Maersk Tower. We got an opportunity to give the participants a tour of our facilities and to present Glyco-

Claus Kristensen, CEO and founder of GlycoDisplay

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Agilent Technologies and Dako Denmark: A Shared Appetite for Innovation Agilent Technologies had built a strong appetite for acquiring Dako Denmark due to a strong cultural fit and leading focus on research and innovation. Now, Agilent Technologies is developing and commercialising leading Dako branded diagnostic solutions as part of its Diagnostics and Genomics Group.

or more than 10 years, Dako Denmark was the missing piece of the puzzle for the American giant, Agilent Technologies. The California business, specialised in measurement instruments applied for a wide variety of applications and sectors, waited for the right moment time to expand into the diagnostics market. In 2012, Agilent acquired Dako, which, at that time, was held by the Swedish equity fund EQT, which in 2007 had bought 100 per cent of the business from the family of the founder, Niels Harboe and Novo Nordisk A/S. Reflecting on its history, Simon Østergaard, Vice President of the global Pathology business and CEO of Agilent Technologies Denmark said: “Back then, the company made antibodies for a wide range of applications. We raised antibodies for a broad variety of applications within research and diagnostics. But once Dako was acquired by EQT, the company focused on cancer diagnostics and became very specialised in the area of tissue-based cancer diagnostics.” Both Agilent and Dako have a long history as pioneers in scientific development and a culture focused on research and innovation. In fact, Agilent Technologies dates back to 1939. The company was spun out of Hewlett-Packard, whose founders David Packard and William Hewlett wrote the first codes in a garage in what we now know as Silicon Valley. In 1999, Hewlett-Packard set their sights on the field of life sciences, and Agilent became listed on the Stock Exchange for $ 2.1 billion – the highest listing in Silicon Valley back then. A shared appetite for innovation Agilent and Dako shared a desire for innovation, feeding off a healthy culture that welcomed curiosity and experimentation. With just over a thousand employees before the acquisition, Dako was a large player in the Danish landscape. Today, Agilent Technologies has more than 15,000 employees worldwide, and their Danish counterparts have become accustomed to being part of a truly global organisation and environment. According to Østergaard, “We entered the new ownership embracing Dako’s culture. Agilent is a huge global machine and, working together we knew we could offer solutions that benefit many people worldwide. Our shared values meant a lot to both companies. We have a unique opportunity to sustain our strong position within cancer diagnostics offering conventional tissue-based diagnostics in addition to new offerings like DNA sequencing, which we would not have happened if we had been operating alone." Of course, to maintain the pace of their technological developments, investments must be made in new techno-

Simon Østergaard, Vice President of the global Pathology business and CEO of Agilent Technologies Denmark

logies while also meeting regulatory requirements. After all, the political sphere poses strict and rigorous demands on businesses. In Østergaard’s words: “It would have been difficult if we were the old Dako, while today we leverage capital and benefit from a large pool of competences within the entire company.” Diversity and culture go hand-in-hand While Dako remains an independent brand under Agilent Technologies, the culture of the new owner and management is different. As the research and development manager at Agilent Technologies, Signe Bagge Nielsen explains: “There is a healthy culture where we work on establishing cross-functional collaboration. Just because I work at R&D, it does not mean that I’m locked in a lab most of the time. I also work with my colleagues in other functions with a common goal of delivering the best results as one team. As an employee, you feel that you are part of a big cross-functional collaboration and the company’s development.”

The acquisition meant that around 1,000 Dako employees had to get used to working with 14,000 new colleagues. Now, Dako has been a part of Agilent Technologies for over 7 years, and Nielsen still feels that she is developing personally while working globally. Echoing this, Østergaard points out: “We are focusing a lot on diversity. We are a global company, so we think of diversity at all levels. It is important for everyone to think about including diversity for a successful company to grow.” From a business standpoint, it is essential to demonstrate the value of diversity in the workplace. Otherwise, you risk the culture being biased and overlook its nuances. Life sciences companies cannot afford this, according to Østergaard. Adding to the discussion, Nielsen remarked: “When you bring people together it affects the culture. Something will happen in the way you communicate and collaborate. You create better results, the more nuanced you get because you benefit from quality dialogue and can discuss subjects expansively with people from broad backgrounds.”

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Fighting Cancer through Technology Innovation Humans are now living longer than ever, and the natural lifespan is only expected to increase into the future. Cancer will become a growing threat to public health systems worldwide, and there is an urgent need for effective treatment solutions. As a global pioneer in oncology, Agilent Technologies uses companion diagnostics to identify which patients stand to benefit most from specific cancer treatments.

pproximately 38,000 Danes are diagnosed with cancer each year. While chemotherapy remains the most common treatment, only 25 per cent of cancer patients respond to it. Given that it is broad-spectrum, chemotherapy damages not only cancer cells but also the body's healthy cells. Its most common side-effects are hair loss, nausea, and mucosal problems. Moreover, a treatment process without clear benefits can be mentally degrading to a patient, just as it costs the state approximately 300,000 Danish kroner per patient annually. Ultimately, 75 per cent of the treatments are both harmful to patients and expensive to the state. Better diagnostics are needed to ensure precision treatments and improved outcomes for individual patients and the system.

According to Simon Østergaard, Vice President of the global Pathology business and CEO of Agilent Technologies Denmark, “It is critical to identify the patient's specific type of cancer as this increases the likelihood of treating the right patients successfully. That is why companion diagnostics are key to identifying who can benefit from a given treatment. With the help of targeted diagnostics on tissue samples, we can assess whether or not the individual patient benefits from specific cancer treatment.” In 2012, Agilent Technologies acquired Dako Denmark A/S, which was the first company worldwide to begin to conduct tissue diagnostics to the identification of the body proteins via tissue staining. In 1998, Dako launched HercepTestTM, the world's first companion diagnostic kit to identify HER2 breast cancer patients. More

recently, in 2016, Agilent Technologies launched the companion diagnostic PDL1 kit a tool for oncologists and pathologists to identify targeted treatments for patients with specific types of lung cancer who can then be treated with Keytruda® (pembrolizumab) from Merck & Co. Valuable collaborations As a genetic disease, one cannot cure cancer without understanding the complicated relationships between the multiple genes and proteins that control the cell cycle and which, through random mutations, can lead to malignant cancerous tissue. As the research and development manager at Agi-

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lent Technologies, Signe Bagge Nielsen explains: “We are assessing whether the specific patient holds immune cells that can be used in cancer treatment. We do this through tissue diagnostics and biomarkers because we know from clinical studies which patient profiles can benefit from the medicine. From tissue sections, pathologists can assess whether each patient will respond to treatment.” Over the past 7 years, Agilent Technologies has made great strides in building on Dako's pioneering spirit, leading to the establishment of several collaborations throughout the pharma industry worldwide. In Østergaard’s words: “We were the first to demonstrate the link between treatment and diagnostics. We have been at the forefront of developing diagnostic kits and establishing collaborations with most of the largest pharma companies in the field of oncology. Innovation in the industry is characterised by those who are skilled at collaborating with the pharma industry, and those who have staining solutions and instruments placed in the pathology laboratories worldwide – and, in this domain, we have been a leader.”

Photo: Simon Østergaard (right) and Signe Bagge Nielsen (left)

Increasing demands The number of people living with cancer has increased significantly over the past 50 years, primarily because humans are living longer and cancer is most prevalent among those who are aged 65+. Agilent's methods are particularly useful in diagnosing for example lung and breast cancer. Within the foreseeable future, Østergaard expects that the group will be able to diagnose even more types of cancers: “The regulatory landscape is putting pressure on the industry as a result of the increasing need for targeted treatment; hence more cancer patients are expected to benefit from our diagnostics and the corresponding cancer medicine. The more indications we can include on our labels, the more people will benefit.” He credits collaborations with the pharma industry as increasing the impact of their work and reducing the large number of people who have gone through chemo courses in vain. Evolving from a small company on a global scale, which offered a wide range of antibodies and routine diagnostics, to now also being the world leader in companion diagnostics creates value for all stakeholders: “In the future, we can help even more people with this awful disease. We are doing something good, and we are shaping an industry,” Signe Bagge Nielsen explains. According to Simon Østergaard, companies must prove that they can link cancer medicine to the companion diag-

nostics as a matter of regulatory pressure. In other words, every drug company that supplies cancer drugs must have a biomarker strategy for each drug. Expanding on this point, Østergaard claims: “Twenty years ago it was not possible to sequence DNA of individuals. Today solutions are developed with fast pace to the point where it starts becoming a commodity, and it will also impact cancer diagnosis gradually over time as its clinical utility is getting adopted in clinical settings at the hospitals.” Digital solutions overcome a lack of resources Within years, the industry will likely see a shortage in the number of pathologists, so we must think differently in planning for the inevitable future, which can also help pathologists generate accurate and consistent diagnostic results According to Østergaard, “We, like the entire industry, need to figure out a solution to bridge the competencies gap that will arise. We are looking at the opportunities that digital pathology can provide as a supplement to the shortage of pathologists. For this, we are investigating how we can translate tissue assessments into a diagnosis and

how we can apply algorithms as part of the process. More broadly, there is no doubt that the Internet of Things is appealing when you have a large installed base of instruments that can be serviced and monitored in the event of a crash. Remote services are particularly interesting.” Overall, this industry is on the rise – armed with data and algorithms. For their part, Agilent Technologies is working to prepare for the digital transformation under the concept of 'digital pathology'. Østergaard suggests this is a global trend in the industry and is encouraged by the competent colleagues he has in Copenhagen, Carpinteria, Santa Clara and Tel Aviv. Of course, it is easy to be overwhelmed by new data, new technology, new methods, and new goals, let alone new social paradigms. It is a challenge not only for oncologists and pathologists, but also researchers, developers, and marketing new targeted cancer therapies. Having the last word on the matter: "We are looking for a wide range of profiles within business, science and technology to develop our global biotechnology business, but it will also be important that we have the right skills on board to build new digital solutions," Østergaard explains.

Immunotherapy Is Fast Becoming a Major Treatment of Cancer

Over the past 10 years there have been major advances in immunotherapy. Although still in the early stages of development, it is quickly becoming one of the most significant forms of therapy to treat cancer. Given the huge potential of immunotherapy, Big Pharma and biotech are heavily invested in R&D, tracing the next breakthrough. Journalist: Karin Jensen

ajor strides have been made within the area of immunotherapy since 2010, when promising results showed remarkable effects in patients with advanced melanoma skin cancer. In fact, several patients even showed signs that their cancer had disappeared. As of 2010, immunotherapy was approved to treat patients with widespread melanoma. Later research showed that the antibody has a much broader effect for patients with many different forms of cancer. According to Inge Marie Svane, professor and head of the Centre of Cancer Immunotherapy at Herlev Hospital: “Immunotherapy is fast becoming one of the biggest forms of cancer treatment. Obviously surgery, chemotherapy, and radiation remain the major treatments in hospitals, but immunotherapy is developing incredibly fast. Right now, immunotherapy is used as a treatment for around 15 different forms of cancer.” Prior to these advances, an efficient treatment for advanced melanoma had been lacking as this form of cancer is not particularly responsive to chemotherapy. Moreover, the immune systems of patients with melanoma are less compromised. A leading hypothesis was that there may be an interaction between melanoma cancer cells and the immune system that could be taken advantage of. Enthusiastically, Svane shares: ”It turned out to be true and melanoma is the type of cancer where we see the most effect.” 2018 Nobel Prize In 2018, the Nobel Prize in Physiology and Medicine was jointly awarded to James P. Allison (from the United States) and Tasuku Honjo (from Japan) for their discovery of an effective cancer treatment that inhibits

negative immune regulation. Through their research, the Nobel laureates established an entirely new form of cancer treatment by stimulating the inherent ability of the immune system to attack tumor cells. “The breakthrough came after a change of strategy. Previously, researchers had tried to accelerate reactions of the immune system with some effect in patients with melanoma and kidney cancer,” explains Svane. Instead of accelerating reactions in the immune system, Allison and Honjo began to study proteins that function as a brake. Whereas Allison studied the T-cell protein CTLA-4, Honjo studied the PD-1 protein expressed on the surface of T-cells. Although CTLA-4 and PD-1 operate through different mechanisms, they both function as a kind of brake in the immune system. Elaborating on this process, Svane explains: “Cells in the immune system, primarily T-cells, attack and eliminate the cancer, but can be blocked by immune checkpoints. The antibodies that were developed allow immune cells to stay activated and respond more effectively to the cancer cells.” Now, less than 10 years after Allison and Honjo’s breakthrough, most major pharmaceutical companies have an immunotherapy pipeline and are heavily involved in the research and development of new compounds. For her part, Svane has initiated more than 15 phase I, II, and III immunotherapeutic trials as a principal investigator since 2001, and points to the growth of the field: “More than 3,000 different compounds are under development, covering more than 60 different mechanisms.” Clinical trials that are currently in progress include established antibodies being tested on new patient groups, in combination with standard treatments (such as chemotherapy, CTLA-4, and PD1) as well as a whole wave of new immune-regulating proteins. From Svane’s perspective: ”The pharmaceutical industry has realised that immunotherapy represents a huge market potential if they develop a really effective immunotherapy compound, just as it has major benefits for cancer patients.” Compared to other therapies, immunotherapy can offer long-term survival among advanced-stage patients who show good treatment effects. According to Svane, these patients continue to benefit from immunotherapy for years without the relapse that is common with more traditional therapies like chemo. It is important to emphasize that research and development in immunotherapy remains in its infancy and will continue to grow in the coming years. In Svane’s words: “Right now, roughly 15 forms of cancer can be treated with immunotherapy, including solid forms of

cancer and different types of blood cancer. I don’t think all forms of cancer can be treated with immunotherapy, but we will see a rather high number of cancer forms being treated with immunotherapy in the future.” Side effects Last year, the first approval was granted to use the PD-1 antibody as a preventive treatment against relapses for patients with melanoma. Svane is careful to point out that this is for situations where patients do not have a widespread disease but may have had, say, a birthmark removed: ”Perhaps the cancer spread to local lymph nodes, which will then be removed and further treated with PD-1 to prevent a relapse. In those cases, we have seen that the risk of relapse was reduced by almost 50 per cent. This is quite remarkable.” These results do not come without a cost, however. Just like chemotherapy and radiation, immunotherapy comes with its share of adverse side effects. According to Svane, ”Some side effects are rather serious, or even life-threatening, so it’s important for the patient to get the right care. Life-threatening side effects are very rare but may happen if the immune system becomes too active, too aggressive, and attacks the body’s different organ functions.” To gain more insights, large clinical trials are being conducted to identify which patients stand to benefit the most from immunotherapy. They are also seeking to establish when immunotherapy is better - or worse - than other leading therapies, and the extent of side effects. Giving Svane the last word: “Many factors, or patterns of factors, will determine whether immunotherapy is effective, but not all factors have been established. The number of mutations present in cancer cells may also play a role. The more mutations, or genetic faults, the greater the likelihood for an effective immunotherapy.”

Inge Marie Svane, Professor and head of Centre of Cancer Immunotherapy at Herlev Hospital

Oncology Research Is Done in Vain If Itâ&#x20AC;&#x2122;s Not Transferred to Patients Armed with a wealth of research and teaching experience in oncology, Nils BrĂźnner is now taking his third company to the Stockholm Stock Exchange. In this article, he describes the challenges Denmark faces when it comes to creating the next big life sciences company, including the tendency to sell life sciences competencies and knowledge to large international companies and how a new network will help solve those challenges. Journalist: Jakob Lindmark Frier

n 2015, the Danish company EpiTherapeutics was sold and merged with the United States biotech, Gilead. Prior to its acquisition by the American giant, the company emerged from the University of Copenhagen and researched epigenetics. Their research was lauded for contributing to the treatment of a variety of diseases, especially cancer. But with the merger, the research and findings fell into American hands. And that's a shame, according to Nils Brünner – a former professor at Copenhagen University, current CEO of the biotech company Scandion Oncology, and previously doctor at both Bispebjerg Hospital, Rigshospitalet and Herlev Hospital: "It happens almost every time we see a promising oncology company built on solid research; they are bought by international mastodons. And, most often, the companies close down the Danish operations because the new owners want total control over what they have just bought. This happens in ninety per cent of cases". Taking a proactive approach, in 2017 Brünner and his Swedish colleague at Lund University, Carl Borrebeck (professor in the Department of Immunotechnology), formalised an oncology network to tighten the relationships across Øresund to exchange knowledge between Denmark and Sweden. In Brünner's words: "In Denmark alone, we do not have the capacity and competencies to build the next large oncology company at the size of the largest Danish life science companies. That is why we must bring the Swedes along. But we will never succeed if the most promising companies are sold as soon as they achieve good results. Therefore, the network must spread the knowledge of Danish oncology research throughout Sweden and vice versa". Given that smaller biotech companies usually lack funding, merging competencies in Denmark and southern Sweden can create larger companies with more stable funding and research foundations. This has the added advantage of enabling companies to stand firmer when foreigners want to buy them out and transport them abroad, Brünner explains. Losing the largest source of income In Denmark, the four largest life science companies are Novo Nordisk, LEO Pharma, Lundbeck, and Ferring. Relationships must be strengthened between life science disciplines and their operations to enable the fifth major Danish company to focus on oncology. The reality is that there is a clear need for a highly specialised workforce in this domain, and to have the capacity to commercialise new research. As Brünner sees it, "If a smaller company is capable of producing and researching pharmaceuticals, joining a company that makes biomarkers, and then teaming up with a third company that can conduct clinical trials, then the company suddenly consists of three functions and three-times as many employees instead of a small company between five to ten employees with only one main competence". It is also worth pointing out the high tax contributors. According to Brünner: "In Sweden they lost the two big tax contributors in Astra and Pharmacia. They simply disappeared to the United States when they were acquired. In Denmark we have to remember that Novo Nordisk is our biggest contributor to the tax system, and that the whole life science ecosystem is the biggest source of tax contributions to the Danish state – by far. And they lost it in Sweden". Failing to realise potential Denmark and southern Sweden differ in several areas of the oncology sector. In Denmark there are advantages for conducting clinical studies, since there are more patients who have

39 diverse needs and greater access to hospitals that have the necessary facilities. A further advantage is that it is illegal to have a private practice in oncology, meaning all cancer patients who show up at the hospital will be registered. Brünner points out: "The Danish cancer registry is the oldest in the world, and we also have the oldest prescription registry in the world. It means a lot to our research that we can extract and analyse the right numbers. In the near future, when new technologies make it easier and more efficient to work with large volumes of data, we will see big leaps in data processing and the speed at which we can create new solutions and research results". He also hopes that machine learning and artificial intelligence will help commercialise lab results and advance treatments for patients with cancer. This may be overly optimistic, however considering the major medical challenges the field of oncology confronts in Denmark. Healthcare research cuts deeply into the public purse, and the largest share goes towards cancer treatments. While the most effective treatment is surgery, in cases where the damaged cells cannot be removed, doctors often turn to chemotherapy. According to the Danish Cancer Society, only one in every four Danes responds to chemotherapy. This nods to the need for precision medicine and companion diagnostics, as there is much to gain in this field. Adding to this narrative, Brünner claims: "We are still losing around fifty per cent of the patients who are diagnosed with cancer and this is primarily due to resistance. We are not strong enough in this field and effective enough when it comes to treating the right patient at the right time with the right medicine". Even so, Brünner acknowledges that Denmark"s treatment approaches and outcomes are on par with other developed countries. In fact, as soon as treatments and drugs are approved in other parts of Europe, Danish patients will benefit from them as well. Contributing to the field, Brünner has his sights set on biomarkers, precision medicine, and immuno-oncology: "Perhaps we are a bit more restrictive than other countries. And for good reason. We have to be careful, but we also have to commercialise products for the market, and if new technology can accelerate that process, then we need to embrace it. Solid research is being undertaken in vain if we don"t know how to make it beneficial to patients". The art of commercialisation

Photo: Kasper Løftgaard

Although Brünner no longer teaches at the University of Copenhagen, commercialising public research remains close to his heart: "At the university, we must show that we are both capable of educating talented people, and that we can create an impact on the world around us. That's ultimately what we get paid for. We can"t make an impact if we do not understand how to commercialise research findings. Today, there is no medical pharmaceutical product or instrument at a hospital that has not been through a commercialisation process. It spans everything from the curtains to the instruments doctors use to operate". Brünner is careful to point out that it is not only the universities that need to focus on commercialising research. From 2013 to 2018, he was head of a division of the Danish Cancer Society. Despite the fact that the association had existed for 100 years, as of 2013 not a single product from the institution had reached patients. "When I joined in 2013, my primary task was to improve this. The researchers spent most of their time in the labo-

ratories and many were concerned as to whether their inventions would work when tested on cancer patients. We did manage to send some research to market, but it took a lot of convincing researchers that their findings were sufficient", Brünner explains. In general, he calls for more engagement from public stakeholders who have expertise in innovation. Their advice and coaching would also benefit new companies. Brünner's insights are based not only on his experiences as a professor, but as a seasoned entrepreneur who is readying to take his third company to the Stockholm Stock Exchange: "We mostly never hear anything from them. No one has offered us a service and we have to go out and search for them while they are not looking for us. They should host seminars and be present in the ecosystem, because that's where the small businesses that need their skills are located. Most often people at the universities do not have the knowledge to commercialise their product. So many startups and small companies could benefit from their knowledge of business development and commercialisation". Friends become enemies From Brünner's standpoint, if we are to see a change in oncology and research in Denmark, it must come from enthusiasts who want to create new businesses and jobs from ground-breaking research: "Every day, forty-three Danes die from cancer. If we are to change that, it must come from start-ups and the knowledge they generate. This is reinforced by the many large companies we are seeing close their research departments

Every day, forty-three Danes die from cancer. If we are to change that, it must come from start-ups and the knowledge they generate Nils Brünner

to exploit the findings of start-ups. Over the past 15 years, new pharmaceuticals that have been commercialised from start-up mergers have increased significantly. That's why the big companies cut costs on their own R&D and instead scout start-ups around Europe". As an accomplished researcher and CEO of the biotech company, Scandion Oncology Brünner has sat on both sides of the table at the university's Tech Transfer office – linking universities with businesses that can work with their results. While this office is nice in theory, in Brünner"s experience the funds are drowned in administrative red tape: "The Tech Transfer system needs to be redesigned. Instead of requiring collaboration between universities and businesses, they shut down the funding resources. The Danish

40 tech trans offices that I know of are usually rigid systems where there is a fundamental lack of understanding of the needs of researchers and the interests of companies.â&#x20AC;? In Denmark, universities own their researcher"s inventions, whereas in Sweden the inventor owns them. This means that a Danish university researcher who has made an invention is entirely subject to the universities' tech-trans offices, while a Swedish university researcher can decide how the invention is to be commercialised. This is compounded by the fact that the Danish ecosystem lacks capital and financial incentives for private investors, as the shares in Danish startup companies are taxed unfavourably for investors. Concluding, BrĂźnner remarks: "It goes without saying that it is very motivating even to stand at the helm of one's own inventions. Perhaps in Denmark one could find a model that better meets the needs of public researchers to set the course for developing their own inventions".

In Denmark alone, we do not have the capacity and competencies to build the next large oncology company at the size of the largest Danish life science companies

Photo: Kasper LĂ¸ftgaard

DK/CORP/P/19/0007, November 2019

“Denmark Will Not See a New Novo Nordisk” The life science industry is seeing a paradigm shift, where newly established production companies are no longer taking the traditional approach. Instead of insisting on creating Danish jobs, we must create success on our own terms. Journalist: Jakob Lindmark Frier

he companies of the future will be more virtual, requiring the best skills and resources available. Globally speaking, that talent will be secured by outsourcing all the activities you can get away with. According to Morten Mølgaard Jensen, the CEO of COBIS, which houses 120 Danish start-ups and smaller life sciences companies: “Today, a successful life science company often consists of a small core group of really strong employees with very specific skills. They have a large number of agreements with talented external players and service providers who are involved in their business development. The most important task is to gather the threads and follow the development plan that the company has laid down”. Once such a company gets to the next step – where there is clinical evidence for their idea and it has passed developmental phases – it requires scale-up at an accelerated pace to yield a sustainable business that will create thousands of jobs. Here, Denmark has a big problem: ‘We are generally not competitive enough. It's about the lack of highly specialised human resources and it's also about wage pressures’, Jensen explains. Attracting the next generation of life science start-ups When it comes to creating jobs in Denmark, the life sciences companies are challenged to meet the expenditures. Although it may seem promising that the life sciences industry

has experienced growth in the number of Danish production workplaces, Jensen points out this is only because of: “Very few employers, like Ferring, Genmab, and Novo Nordisk, who still offer blue collar jobs in Denmark. The next generation of life sciences companies will not have the same preconditions as those that are already established. There will be massive pressure from investors and markets to lower the expenses on production, and you can do that significantly cheaper in many other places than in Denmark. Therefore, I don’t think that we are going to see a new Novo Nordisk.” Instead, Jensen believes that the next generation of life science companies built in Denmark must be the best in the world to innovate and think new, while identifying and developing the latest technologies and actively bringing them into use in novel ways. This can create a foundation for the next generation of life sciences companies that gets to that level where it will be attractive for foreign companies or investment funds to build partnerships or take over Danish companies. That is precisely what we just saw with Veloxis and the former EpiTherapeutics, which got sold to Japanese and American life sciences mastodons, respectively. A balanced ecosystem is a healthy ecosystem Granted, there are always new companies emerging. Some die while others are on the pathway to becoming the big companies of the future. In fact, the companies that are less than 20 years old account for 50 per cent of the value created in Denmark, according to the 2014 figures from Dansk Industri (while other studies show that start-ups deliver more net jobs than large industrial players). As Jensen sees it, the major players create growth and stability in the Danish economy, and serve as a valuable link to the ecosystem. That is because they can take on new inventions that emerge in the grassroots environment among start-ups. He points to Novo Nordisk's significance for the Danish life sciences scene to demonstrate how big and small mutually benefit each other. For Denmark to remain at the forefront in developing new therapies, vaccines, or treatments, it requires a well-fun-

ctioning ecosystem with active participation by research institutions, research parks and incubators, venture capital and industry, that – when combined – can rise to the task. Drawing attention to the political landscape, Jensen remarks: “I wish that the Danish Minister of Industry would take specific action on creating new incentive structures to create and withhold jobs within the high-tech industries. We generally have favourable terms for doing business in Denmark, but as long as you are challenged on pay conditions from low-income countries around the world, you will have stakeholders that don’t understand why you would put a production link in Denmark when the same benefit is 50 per cent cheaper other places. And it is hardly in Denmark’s interest to participate in a race towards the bottom.” Refusing to rest on laurels Minister of Industry, Simon Kollerup acknowledges the intense international competition, but he also emphasises the positive developments of the Danish life sciences sector over the last 10 years: “Life sciences is an industry with strong international competition, so it is important that we continuously ensure good growth conditions. Fortunately, many stakeholders are indicating that things are going well. The life sciences industry delivers impressive numbers on many parameters. This applies, for example, to exports, which doubled from 2008 to 2018. These are Danish products – produced and sold out of Denmark. But of course, we are listening to input on how we support this sector now and into the future”. The government is working to create a business climate that provides jobs and ensures healthy Danish companies: “From 2008 to 2016, we can see that employment in life sciences companies increased by almost 20 per cent and we can see that increase in research and production halls. Of course, we should not rest on our laurels. That is why we are also very concerned about how we can strengthen Danish companies' competitiveness in the long run,” Kollerup concludes.

Photocredit: Adobe Stock

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Merger of Danish Health Clusters Will Strengthen the Sector Five Danish Health Clusters will merge in to one National Health Cluster for Life Sciences and Welfare Technology. The new organisation must strengthen collaboration between businesses, universities and health care providers on innovative products and solutions to ensure growth, export and better health care for all. Written by: Lotte Overbjerg, Welfare Tech

ife science and welfare technology is 1 of 12 national focus areas for Danish industry development. A new national cluster will replace the five existing regional clusters in Aalborg, Aarhus, Odense and Copenhagen. By joining forces, they intend to become a driving force for world-class innovation within health care and welfare technology. Today Denmark is lagging behind other countries in areas like sharing of health data and artificial intelligence (AI). That is one of the reasons why stakeholders in the life sciences have decided to create a strong national organisation that can accelerate the collaboration between organisations and companies in the health care space. According to Troels Bierman Mortensen, CEO of Welfare Tech, one of the largest health clusters in Denmark: “The Healthcare sector is very important to Denmark. We have many small and medium sized companies and some large global players within pharma, biotech, world class researchers and an efficient health care system. But advances in digitisation, sharing of health data and personalised

medicine are fundamental challenges for all players in the industry. Innovation Fund Denmark estimates in a recent report that AI alone has the potential to improve the welfare of Danes by approximately DKK 9 billion annually through better and more efficient and personalised medicine. They recommend strengthened collaboration between research organisations and SMEs as the road to success. A strong national cluster for Life Sciences and Welfare Technology can play a key role in facilitating such collaborations.” Life sciences and welfare technology: Strengthening industry collaboration The new cluster for Life Sciences and Welfare Technology will serve as a national one-stop-shop with regional hubs where private companies, investors, research and educational institutions, and health care providers like hospitals and municipalities can meet and work collaboratively on developing and implementing new innovative solutions. Two of the existing clusters, Medtech Innovation Consortium (MTIC) and Welfare Tech are working closely to build the national cluster for Life Sciences and Welfare Technology. According to Jørgen Bardenfleth, Chairman of the Board of Directors of MTIC: “Creating a national cluster in life sciences and welfare technology is the right move. This will give Denmark an improved position on the global market and provide better opportunities for Danish manufacturers of digital, technological, biotechnological, and medical solutions.”

sectors working together to improve the health sector. One example of such collaboration is drones for public health services, another is a Internet of Things laboratory where new solutions can be tested in a real life setting. At MTIC, 9 out of 10 innovation projects are based on the use of data from across the health care space. For instance, the project “The ambulatory care clinic of the future” combines 2 digital solutions in a digital outpatient clinic course. And the project “Cross-sectoral diet registration” supports the registration and calculation of the weekly dietary intake of elderly people, among other things. Cooperation yields knowledge and evidence The entire healthcare sector is facing significant challenges, making the creation of a national cluster very timely. As Tenna Korsbek Andreasen, CEO of MTIC, explains: “New opportunities for optimised solutions arise when data sharing and AI generate breakthroughs. Companies of all sizes require the latest clinical evidence, and hospitals and the public sector require collaboration with businesses. So now we have to join forces to help build better health systems for all.”

Business development opportunities Both the public and the private sector stand to benefit from one strong national cluster. Companies will have easier access to research, and hospitals and municipalities can enter in to partnerships to develop new solutions that meet existing and new demand for health and care. Both MTIC and Welfare Tech are facilitating projects that see several

Tenna Korsbek Troels Bierman Mortensen, Andreasen, CEO of MTIC CEO, Welfare Tech

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Stronger Collaboration Only Way Forward for Danish Health Sector The Danish health sector lags behind that of many other countries in its application of advances in personal health and artificial intelligence (AI) technology solutions. “In order to address this gap, our hospitals, universities, and companies need to work together towards one clear vision to improve the efficiency and responsiveness of the healthcare system in Denmark”, says Peder Jest, Medical Director at Odense University Hospital. Written by: Lotte Overbjerg, Welfare Tech

his prescription for stronger collaboration across these sectors will require a powerful handmaiden. Luckily, such a unifying force is emerging in the shape of the newly formed national cluster for Life Sciences and Welfare Technology. In order to secure its place among Denmark’s future positions of strength, the healthcare sector is undergoing a major restructuring. This new cluster dedicated to life sciences and welfare technology is a critical part of that restructuring with the goal of bringing a common framework for the systematic application of innovation, research, and development across the field. Strong precedent for what can be achieved through collaboration Thomas Lethenborg, CEO of Monsenso, believes that a joint cluster is the right path forward. Monsenso is already a member of the health clusters Welfare Tech, HealthTech Nordic, and Health Tech Hub Copenhagen. In Lethenborg’s words: “A unified life sciences cluster will benefit to everyone by making it easier to get Danish health solutions on the political agenda. Just look at how much focus there has been on cancer – which is thanks to the Danish Cancer Society successfully bringing together all of the stakeholders to ensure sustained focus, donations, and research funding for cancer. The same principle of focusing and combining forces to improve the Danish healthcare system has led to clustering of our life sciences and welfare technology sector.” Monsenso develops digital solutions to improve mental health outcomes through prevention, early intervention, and treatment. The company has participated in 13 research projects — each of which has been cross-sectoral and collaborative, benefitting from the involvement of leading researchers and health professionals in Denmark and abroad.

A unified life sciences cluster can be of benefit to everyone, making it easier to get Danish health solutions on the political agenda

healthcare and precision medicine. We need input and solutions from businesses and researchers that think outside of the box,” proclaims Peder Jest, Medical Director and Chairman of the Innovation Council at Odense University Hospital. Odense University Hospital has a successful track record with development projects that involve both companies and research institutions. The latest example of such an initiative is the Center for Clinical AI or CAI-X, which is a collaboration with the University of Southern Denmark that brings together research-based evidence in AI with clinician point-of-care needs. CAI-X is working on algorithms to track intestinal cancer through the use of camera capsules. The group is also using AI to detect early signs of diabetes and pregnancy complications through facial video sequences. “These projects exemplify the value of combining the skills and experience of universities and companies in order to bring AI advance that increase the value and success of healthcare interventions.” Solutions through research and evidence A core mandate for the new National Life Sciences and Welfare Technology Cluster will be to ensure that the knowledge built up in research institutions and university hospitals is translated and applied directly to patient care. The Danish company, Chromaviso, which develops health-promoting lights for hospitals and nursing homes – serves as an excellent example of the benefit to health outcomes that can be achieved by applying evidence-based insights. “There is a massive amount of research, knowledge, and technical skills behind Chromaviso’s lighting protocol, which was developed in collaboration with Aarhus University Hospital and Rigshospitalet,” asserts Torben Skov Hansen, Chromaviso’s head of innovation and quality. “Solid research and evidence are indispensable for a technology company like ours.” Mobilising efforts, the Danish Executive Board for Business Development and Growth has announced that clusters must be consolidated by the end of 2020.

Thomas Lethenborg

One ecosystem for mutual gain: Why hospitals need the business community and vice versa “The healthcare system is facing major changes. Innovation is essential to fulfilling our ambition of personalised

Peder Jest, Medical Director and Chairman of the Innovation Council at Odense University Hospital.

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Longboat Amniotics team, Kåre Engkilde is third from left

Longboat Amniotics takes the Next Step in Cell Therapy The Swedish company, Longboat Amniotics sees great potential in the mesenchymal stem cells derived from amniotic fluid. Their planned clinical trials in 2020 may lead to a break-through in the future of cell therapy.

we see a wide range of diseases that can potentially be treated using MSCs and/or surfactant’, Engkilde remarks. The company’s work is based on research from Lund University in Sweden, and was founded by two clinicians and a stem cell scientist.

Sustained focus on premature birth

surfactant and need to be supplemented in order to survive and to prevent lung complications, including respiratory disease syndrome later in life. Lung surfactant from amniotic fluid could provide premature babies with advantages over current animal-based surfactant products. In fact, medical products of human origin can improve treatments in general. According to Engkilde, MSCs from amniotic fluid have several advantages. The cells are not only more potent and tissue-relevant, they are also eliminated by the body after the therapeutic process. In some respects Longboats’ MSC development program can be regarded as a platform, as the cells may be the pathway to treating patients with kidney diseases, urinary tract disorders, non-alcoholic steatohepatitis, and even lower back pain. ‘While our technologies are especially targeted at diseases with no current successful treatment modality,

Longboat has already developed a device that can safely and easily collect amniotic fluid during planned cesarean deliveries. The collection itself takes between thirty and ninety seconds, and from a single donation they can treat 200-300 patients. Currently, the team is focussed on cultivating lung-like MSC from amniotic fluid to treat respiratory diseases. This is a medical condition with high unmet needs. Although several companies (e.g., AstraZeneca) have tried to develop therapies for respiratory diseases, there is still a high need to offer substantial improvements for quality of life. Complementing this, Longboat is developing a lung surfactant therapy which is also derived from amniotic fluid. In order for newborn babies to take their first breaths, they require surfactant that is naturally produced in the lungs. However severely premature babies often have limited lung

MSC’s from amniotic fluid staind with acting and Ki67, showing the highly proliferative capacity of these cells

he biopharmaceutical company, Longboat Amniotics is taking a patient-centered approach to cell-therapy – using mesenchymal stem cells (MSC) derived from amniotic fluid. The Swedish company hopes to offer life-changing treatments through MSC therapy, and has reason to be optimistic considering stem cell therapies are on the verge of disrupting both academic and industrial settings. In particular, amniotic fluid provides the ideal tissue-specific neonatal cells for cell-based medical treatments. According to Kåre Engkilde, CEO of Longboat Amniotics, ‘We want to offer treatments for a broad range of diseases with high unmet medical need, to maximise human health outcomes’.

Aiming for the stock market Following the clinical trials on the MSC product for respiratory disease, Longboat Amniotics plans to license or co-develop the product. In this way, the team can generate the financing required to bring the human surfactant and other products from their pipeline into clinical trials for several therapy areas with unmet medical needs. In Engkilde’s words: ‘We need funding to reach our clinical studies and to generate the right amount of turnover to follow our current plans’

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Denmark Has the Best Health Data in the World, We Just Have a Hard Time Using It Over the past five decades, the massive dataset collected by the Danish healthcare system has become extremely valuable. But researchers, companies, and clinicians require an easier entrypoint to access data for patients and society at large to reap its benefits. Journalist: Sebastian Kjær

urrently, there are too few radiologists in Danish hospitals and the number of routine X-rays conducted is growing steadily. While scans are being outsourced to radiologists in other countries for analysis, patients are left waiting for an answer. In an effort to fill this gap and improve health outcomes, the Danish start-up Radiobotics is helping hospitals by training computer software to analyse and prioritise the X-rays before doctors review them. This enables doctors to focus on high-value activities, ensures higher accuracy, and, in the end, saves patients from waiting unnecessarily long to receive their diagnoses. Gaining access to the "right" data has been crucial for the company to train the software"s algorithms. According to Henning Langberg, director of the Data Saves Lives initiative and professor at the University of Copenhagen, this has been possible thanks to Denmark"s unique healthcare data: "In Denmark, we have digitised scans and X-rays for the past 20 years. This has created a unique data bank, which isn"t currently being exploited. Radiobotics saw the opportunity to create a tool based on artificial intelligence and used the data as a basis for training the algorithm". Radiobotics showcases how Danish data can be refined into a new tool that has global potential. And this is just one of the health data projects that is being supported by the Data Saves Lives initiative, which aims to promote the use of Danish healthcare data for the benefit of researchers, companies, and patients alike. Oversight is required The Danish healthcare system holds a wealth of valuable data that is stored in more than 160 registries. According to Langberg, the healthcare system collects data about every citizen in Denmark from the cradle to the grave: "We have done so since the introduction of CPR numbers 50 years ago. Everyone is included – rich and poor, sick

and healthy – which makes the dataset unique and gives it the potential to develop novel solutions". But to unleash that potential, the data must be used, connected, and refined rather than scattered in siloes and registries across different public entities. That's why the first challenge Data Saves Lives is trying to resolve is making the data coherent and accessible. They are doing this through a private-public partnership between 30 stakeholders, including Rigshospitalet, Novo Nordisk, and the University of Copenhagen. In describing their methodical process, Langberg claims they "have made a data-map with an overview of the many Danish health data registres where researchers, clinicians, and stakeholders can search across all registres to see which variables are available and where they are located. Before getting access to the actual data, the researchers still have to apply to each registry, but in parallel, we're suggesting a new public service concept where stakeholders only have to apply to one place for access". Easy access is key Data-driven transformations are all-encompassing – spanning the pharmaceutical industry, tech companies, the start-up environment, and research departments. Although Denmark possess all the criteria to stand at the forefront of this growing industry, without access to data the opportunity might be missed. From Langberg's perspective; "It is complicated and takes a lot of time to get approval and access to data – which limits the possibilities to create the new solutions we need. Collaboration between public and private partners is needed to make it faster and more seamless to develop and implement these new solutions across the healthcare system". Today, a lot of data is being collected without ever being used to benefit patients. The technology to use the data in a more sophisticated way is already there, it just needs

Mads Jarner (front) and Mikael Boesen (Back) from the Department of Radiology at Frederiksberg Hospital

to be harnessed: "We have to solve this in order to make a better healthcare system in Denmark, but also because it can become an export product which other countries will benefit from", Langberg explains. Exporting collaboration Greater access to and use of data holds the promise of attracting more companies and industries to Denmark. That being said, Langberg is careful to point out that Danish health data will never be "for sale" to either foreign companies or governments. Of course, there will be a balancing act between giving access to data while securing privacy and safety for Danish patients and citizens. In Langberg's words: "There is an enormous need to build a system as transparent as possible, so citizens and patients are informed and confident about how their data is being used and how it is being protected. Hopefully Danes will be proud if their data is being used to help other patients and to build novel, life-changing solutions". To succeed with this agenda, private-public partnerships need to be formed and this is exactly what the team behind Data Save Lives is trying to do. After all, this is something that we have a long cultural tradition of in Denmark. Concluding, Langberg shares: "The approach we have to data in Denmark means that most citizens feel confident that their data is being collected for a good reason. The way we handle and use data has the potential to be used by other countries as a new standard for how it's done â&#x20AC;&#x201C; as an alternative to the American or Chinese way. And we have to see that as a huge export opportunity".

Henning Langberg, director of the "Data Saves Lives" initiative and professor at the University of Copenhagen

Photocredit: LEO Pharma

Speed is Becoming a new Barometer within the Heavily Regulated and Conservative Pharma Industry In the past they hunted the ideas themselves, now colleagues are proactively proposing innovative use cases for LEO Pharma's R&D department as they see the value of technology innovation. Journalist: Jakob Lindmark Frier

igitalisation and globalisation creating both new business opportunities and challenges. Now, companies have to keep track of the rapidly developing industry to maintain their competitive advantage. Gone are the days where the company with the highest market share was tomorrow’s leader by default. Taking the lead requires company executives to understand how to innovate and adapt to the broader market. Innovation comes in many forms whether at the production and product level, process, or business model. At LEO Pharma, their new research and development department plays a crucial role in the company’s efforts to innovate. According to Troels Ravn Bærentzen, vice president of LEO Pharma and head of the newly established R&D data and analytics department: “We need to be able to innovate across the board and follow the market, as well as be flexible about the business models we see today to help define what opportunities

The short-term goals are to attract the right people with the right skills Troels Ravn Bærentzen

exist in the future. You cannot fail to innovate on any part of the business, but we naturally want to focus on creating new products.” Alongside his colleagues, Bærentzen is looking for opportunities to innovate LEO Pharma's business by identifying how to effectively use data to optimise and streamline processes. In the end, refining their practices will help to get the company's products to the market faster and benefit patients. Different markets demand different solutions Of course, it is essential to keep the external factors that affect business models in mind. After all, there is a big difference between whether products are shipped to the American or Danish market. As Bærentzen explains: ‘The insurance industries dictate a patient’s treatment options and the medications available, so the health sector in each country has a major impact on how business models can be designed. In this, we must focus on what the patient journey looks like’.

51 The tendency in Denmark is to turn to ‘Dr. Google’ if we are experiencing any negative symptoms. Then we usually visit the doctor, who might refer us to a skin doctor or other specialists before we end up at the pharmacy to collect medication. However, in the future, these consultations will change, especially phone consultations. They will become more frequent and online pharmacies will be a more common option. This will result in a different ecosystem – not only in Demark but worldwide there will be greater access to medicine. Bærentzen envisions that the ecosystem will also change the way they engage with stakeholders: “They are becoming innovative, so we have to be that way as well. We are turning to new directions as we develop our drugs in our clinical studies. It is no longer enough for us to take it slow, because our competitors are also in the market and they are constantly thinking about how to make their processes smarter and faster.” New solutions demand new competencies If LEO Pharma is too conservative and takes too much time to get their latest products to market, they run the risk that hospitals will not partner with them on their clinical tests. This applies equally to data collection and processing. In other words, it’s essential for teams to learn how to use artificial intelligence to make faster and better data-driven decisions. That is why speed is a new barometer in the heavily regulated and conservative industry: “When dealing with large amounts of data, we need to understand how artificial intelligence, the Internet of Things, and other new technologies can make multiple processes smarter while remaining within regulations. To be clear, the models and algorithms don’t make the decisions themselves, but they do support human decision-making. We put data on the table faster, so that we can make the right decisions faster,” Bærentzen explains. It’s not only about research, then but also about information technology infrastructure. Mobilising this calls for the right competencies to use the right kind of data in the

Photocredit: LEO Pharma

areas that most need it. For this, LEO Pharma is looking to attract the right people with the right skills in the short term: “We will start out by building a competency base which will end up being the driving force for the projects. However, when we do that, we will do it together with other business areas on specific projects, so our team never sits alone. They will always work with other parts of the business,” Bærentzen points out. One use case at a time From Bærentzen’s vantage point, the company has an appropriate size to innovate and their goals are clear. Theirs is

a healthy innovation culture, one where it is okay to make mistakes. In fact, it is expected in building machine learning models you haven’t seen before. LEO Pharma's innovation strategy consists of building new solutions one use case at a time. The successful cases are implemented while the less successful ones are analysed to find out why they did not work out as hoped. Offering an inside look, Bærentzen explains: “We are very transparent about our use cases, and they don’t necessarily have to create value measured in crowns and pennies. There can also be value in the quality and the speed of what we build. It can return value in many ways. If an algorithm for machine learning for some reason doesn’t work, we have to be open to asking: “why isn’t it working?” but of course, we need successes once in a while too”. After all, successes are what puts the wind in the company’s sails to mobilise innovation: “It's not that the team necessarily has to understand the technologies, but rather that they start to see what you can use them for. Initially, we hunted for ideas ourselves, but with the more success we achieved our colleagues started to come to us. When you can see what the technologies are capable of, employees are buoyed by the goodwill.”

Troels Ravn Bærentzen, Vice President of LEO Pharma

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New Tools Improve Patients’ Ability to Take Control of Own Treatment As a result of the technical evolution, patients with chronical diseases will be able to improve their disease management. New digital health solutions and related apps will provide new opportunities for patients and health care professionals.

he life science industry has witnessed an acceleration in applied technologies such as the Internet of Things, wireless connectivity, cloud computing and AI. In combination, these advancements have the potential to transform healthcare processes. Recent developments in digital health technology such as connected drug delivery devices and dedicated disease management software can give patients and health care professionals an improved overview of treatment related data and improve the ability to adjust and control treatment. ”The development in technology and the opportunity to build an ecosystem that can help structure a patient’s health related data is an important step towards individualised treatment and medicine. The technology can help the patient take the right medicine and dosage at the right time. Over time, I expect further additions to the ecosystem that will allow the patients to understand the impact of additional factors such as nutrition, sleep and exercise in a structured way.” says Søren Krogh Knudsen, Head of Nordics, at PA Consulting. Mobile applications and software that is a medical device on their own – Software as a Medical Device (SaMD) – can become an integrated part of the patient’s daily life. In combination, and subject to patient consent, these products can potentially facilitate data collection across patient groups with the view to increase understanding of diseases, treatments and patient behaviour. This insight can be used to improve treatment options and guidance to patients. ”Mobile applications can help patients with chronic diseases, such as diabetes, to manage their treatment and take preventive actions by keeping track of, for example, nutrition, sleep and exercise. In this connection, a key enabler for development of good digital solutions is the willingness for patients to share data and for solution providers to use data responsibly to the benefit of the patients. This requires that the authorities ensure that legal and regulary governance both supports the development in this space and safeguards the patient’s interests” Søren Knudsen says. An integrated universe Soon, medical systems may be connected by integrating sensors in the drug delivery devices that send data to an

application and communicate with a drug- and user platform. “Over time the platform should become the focal point that combines data from several input sources. In the case of diabetes, you could for instance combine data on blood sugar and medicine dosage with nutrition, exercise and sleep. It's about creating a system that is coherent and easy to manage, so you as a patient can monitor your treatment and lifestyle in a broader sense,” Søren Knudsen says. When the many data points are gathered, the patient is empowered with insight into his or her condition and the disease management can help the patient monitor treatment and effect continuously. “Longer team, one can create a huge data imprint where a coalition can be formed to analyse data across groups of patients to understand, for example, nutrition implications better,” Søren Knudsen says. A trend to follow A report from The Danish Diabetes Association shows that 66 percent of the 300.000 Danish diabetic patients are fearing a diabetes chock caused by an overuse of insulin. And it is still difficult for patients with a chronic disease to maintain the right dose. “It is my understanding, that patients with diabetes may have lower quality of life because the treatment is demanding to manage and the potential side effects of not being in control are severe. If the digital solutions can help patients get in better control and understand the impact of their life style choices better, it will be a help to patients and as well as their families that are often closely involved in the daily disease management,” Søren Knudsen explains. The new digital solutions can facilitate nudging techniques and, thereby, increase treatment adherence with

great benefits for individual patients, their relatives and society at large as chronic diseases have a huge impact, including high financial costs. “With the expected future offering of many competing SaMD products and other healthcare and lifestyle apps, a challenge for patients will be to choose which products to trust to give good guidance and whom to share their personal treatment and health data with. The life science companies have a big responsibility in this connection but is also important that authorities and patient organisations look across the ecosystem help ensure the right balance across the opportunities as well as dilemmas that the new digital products will bring,” Søren Knudsen says. There is no doubt that this will be an interesting market to follow in the coming years. Currently, the trend is new platforms being launched by the largest companies in the world gathering immense data sets. At the same time, small businesses are launching apps and new patient support systems almost weekly. The ecosystem will emerge as the result of the combination of these trends.

Søren Krogh Knudsen, Head of Nordics, at PA Consulting

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Infertility Can Be Solved by Tech, but Not in the Way You Think Exseed Health is helping couples to win their fight with infertility through a medical device that enables at home sperm testing. It has the further advantage of nudging users to make lifestyle changes. Journalist: Sebastian Kjær

hile the causes of infertility remain largely unknown, leading researchers agree that infertility has become a widespread disease and a pervasive problem for couples worldwide who want to conceive. In Denmark, somewhere between 15-20 per cent of couples who are at child-bearing age experience infertility. In fact, a study from 2017 showed that sperm count has decreased by 50 per cent over a 40-year period. Even so, infertility treatments still tend to focus on women. ExSeed Health wants to change that. The Danish startup has spent the past three years developing a medical device that can be used at home to test the quality of sperm. According to Morten G. Ulsted, the CEO and co-founder of ExSeed Health: "Our medical device can provide highly reliable results to a user"s phone in a matter of minutes. And if you"re among the third of the population who have low-to-moderate sperm quality – making it harder to become pregnant – we help you to do something about it." Their survey shows that 18 per cent of the male respondents who were asked whether they wanted to get their sperm count tested claimed that the biggest barrier was that they didn"t want to visit a clinic. For now, the help the company offers comes in the form of using the technology to nudge users to make lifestyle changes. Male involvement is often overlooked, even in clinics "We see a downward trend in sperm count, and we know a lot of couples need help to get pregnant. Still, the male's contribution to infertility is grossly neglected", Ulsted observes. While women are often treated with hormones and have a variety of guidance at their disposal, there is not much available for men. According to Ulsted, 40 per cent of the fac-

tors contributing to infertility are associated with the male, but not much is done about it because it's not a part of the traditional treatment paradigm. In other words, in order to support infertile couples on a national scale, researchers and clinicians can't afford to overlook the 40 per cent. With their medical device, Exseed Health wants to make it easy and reliable for users to conduct tests in the comfort of their own homes. This lowers the barrier of being tested significantly. Not surprisingly, this product also holds great appeal for fertility clinics, who want to use Exseed Health's technology platform to integrate it into their fertility treatments. From Ulsted's perspective, this is a sign of their device's potential. After all, the platform is reliable enough for the clinics because they use the same algorithms and software; they just have to store it on the Cloud. The power of tech to foster lifestyle changes

Morten G. Ulsted, CEO and co-founder of ExSeed Health

Evidence shows that lifestyle changes affect the quality of sperm. A study from 2018 has shown that 24 weeks of resistance training undertaken three times a week increased sperm. While only 2.9 per cent of the control group got pregnant, the number for the 203 men doing the program was 36.2 per cent. Exseed Health is basing the second part of their solution – consultation and guidance – on similar studies. Essentially, after running the diagnostics, the platform combines

the results with other user data to tailor a program targeted at increasing sperm count. The app offers targeted suggestions regarding weight, stress, and alcohol consumption. In Ulsted's words: "There are a lot of motivated men who want to do something about their fertility, and for that reason, we see the guidance that allows users to improve their situation as half of the value of what we're developing. When the user indicates a certain lifestyle pattern, our algorithms choose a guide for them and divide it into 4, 8, or 12-week programs."

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Denmark’s Talent Pool Must Secure Positions of Strength in the Life Sciences Despite its industry stronghold and reputation throughout Europe, Denmark’s life sciences industry is ever-changing. This calls for dedicated efforts and strategic discussions on training and building the capacity of new talent, so that they can become tomorrow’s leaders in the field.

enmark’s life sciences field is alive and well. World-class research continues to inform the development of life-changing products that are some of the country’s top exports. At the same time, the industry is changing. If the Danish life science ecosystem wants to maintain their global stronghold, it requires new talent. According to Søren-Ulrik Rolsted Fangholm, the head of Atrium and the director of marketing and business development at DLI Market Intelligence: “If you look at the industry right now, it’s going really great – both locally in Denmark and as an export business reaching 100 billion Danish krone. But the demands for the industry are changing. Across Europe, and in Denmark as well, governing bodies are tightening regulations for clinical testing, regulatory approval, and market access. Both

patients and society as a whole expect the industry to find new solutions for severe diseases. Some of these are very niche-oriented; sometimes as few as 5-10 Danish patients require very complex and expensive treatments.” Atrium is the life sciences educational unit. As part of LIF, the Danish Association of the Pharmaceutical Industry, each year Atrium educates 2500 employees in the life sciences sector. New competency requirements are felt across the value chain – from research and development to regulatory affairs and market access. Seasoned experts, as well as newly-minted graduates from universities and business schools, need to understand the changing regulations and mechanisms that are now being applied industry-wide. Rolsted Fangholm explains: “We need more focus on lifelong learning in order to create the best possible conditions to drive research. This can keep the industry innovative, effective, and attractive.”

learning to stay on top of this ever-evolving industry. As Rolsted Fangholm points out: “There has to be a balance between expertise in the professional field, such as clinical development or regulatory affairs, and understanding the surrounding market. Not just in a financial sense, but also in regards to the complex healthcare system the solution is going to be a part of.” New skills for the future of the field It is one thing to keep employees up to speed on changes in the market. It is quite another to meet the increased demand for new competencies and expertise. In Rolsted Fangholm’s words: “There is a problem in Denmark and that is the lack of candidates for the life sciences sector. There is a huge de-

Complexity drives the need for talent One of the biggest changes in the industry over the past years is that the blockbuster companies are diversifying from the primary sector – the practitioner – to producing hospital products. This is in an effort to develop complex and advanced treatments for diseases like cancer. The costs and diversification – combined with the governing body’s increased demands for justifications of the clinical effectiveness and cost-benefit ratios across the value chain – have increased the demands for personnel across the board. While the sector’s employees are highly educated, even those who possess 2 master’s degrees need to keep

The lack of qualified labour is already an issue now, and if we don’t solve it it’s going to turn into a problem which will affect Denmark’s competitiveness as a leading European life science nation Søren-Ulrik Rolsted Fangholm

mand for competences, such as data scientists and health economists. They have not traditionally been a core part of the life sciences industry, but now those skills are becoming increasingly crucial.” It is no surprise that the life sciences field, like all other industries, is becoming increasingly data-driven. This bears not only on development, where big data and artificial intelligence play a role in streamlining the time it takes to get a new drug to market, but also collecting real-world evidence about the drug after it’s been launched. More broadly, Rolsted Fangholm points out: “Research-wise we’re an industry with a huge margin of uncertainty. If we’re able to solve the puzzle of eliminating

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Søren-Ulrik Rolsted Fangholm, Head of Atrium, and Director of Marketing & Business Development in DLI Market Intelligence

some of that risk using algorithms and artificial intelligence to find that one molecule among 10.000 worth betting on, there’s a lot to be gained. For that reason, developers and IT-personnel are being hired like never before.” The sheer number of professionals entering the industry who possess a depth and breadth of expertise is creating an urgent need to bridge the gaps between knowledge systems. For example, Atrium has created a new project management education program for the life sciences in order to make clinical trial units in the hospitals, clinical research organisations, and the pharma industry work seamlessly. As Rolsted Fangholm sees it: “In order for the 3 parties to work efficiently they need a common language and an understanding of each other’s interests – which is what the project manager brings to the table.” Understanding systemic changes The widespread change throughout the industry has shifted the provider’s role from explaining and promoting a product to a practitioner to being a partner in the healthcare system with many stakeholders involved. This means that, before they can design the right solution for the right problem, developers must understand not only patients, spe-

cific disease entities, and hospital processes, but also the entire life sciences ecosystem. Sharing his “insider” perspective, Rolsted Fangholm explains: “We already have great treatments for many of the large, common diseases, and are now focusing on smaller disease areas – such as severe types of cancer and neurological diseases such as Alzheimer’s. This requires highly specialized treatments for smaller populations. Although the products are developed for fewer people, the development cost is essentially the same. And this calls for an understanding between society, the public healthcare system, regions, hospitals, and the industry. We all have to agree on how to prioritize responding to such questions as: Which product is the optimal solution for the individual patient, in balance with costs and the treatment effect of using it?” Competitiveness is at stake The good news is that Denmark has all of the prerequisites in place. What’s needed is a fulsome discussion about the next steps required to fulfil the potential. For Rolsted Fangholm: “We’re evolving for the patients’ sake. The industry secures the patients the best possible treatment and helps

doctors do it in the most optimized way. At the same time, the life sciences is a huge export industry securing lots of jobs in Denmark.” The takeaway is clear: new talent is required in order for Denmark to maintain its stronghold as one of Europe’s most renowned life sciences nations.

Atrium Atrium is a living, dynamic space where life science professionals come to learn, connect and network. We offer lifelong learning from basic to expert level help to you advance professionally - because we know that the need for upgrading competences changes throughout your career. Our course and educational programmes cover the medicinal product lifecycle – from molecule to patent expiry - and are divided into the subject areas: Clinical development, Regulatory Affairs, Pharmacovigilance, Market Access, Marketing Compliance and our marketing and sales diploma programme Pharma Consultant.

Shifting the Paradigm of Birth Control: A Danish Start-Up Is Engineering Mucus at the Molecular Level Cirqle Biomedical is developing a contraceptive that promises to leverage the natural properties of the female body, without any negative side effects. Journalist: Jakob Lindmark Frier

ince the birth control pill was introduced over 60 years ago, there has not been much innovation in this niche area. Of course, there are other types of delivery methods, but they are all based on the same hormonal principles. The paradigm shift began because of his girlfriend’s dissatisfaction with ”the pill.” Frederik Petursson Madsen, the CEO of Cirqle Biomedical, went on to investigate the hormone-free alternatives available on the market. According to Madsen: “It has been well-established that birth control pills have negative side effects. Many of us saw that at the individual level through discussions. This has been confirmed on a larger scale over the last few years by data from more than 1 million pill users, showing an increased risk of depression and reduced well-being.”

effects. This is particularly timely considering 9/10 women using a modern contraceptive rely on hormonal therapy. After 2 years of searching for a solution or a technology that could do what the market was clearly demanding, Madsen visited The Royal Institute of Technology in Stockholm. There, he was introduced to Thomas Crouzier, who researches mucus. French-born Crouzier started researching mucus during his postdoc fellowship at the Massachusetts Institute of Technology. He then established a research group in Stockholm that developed the technology that Madsen had been looking for. Describing their dynamic, Madsen remarks: “Thomas was looking for an application or problem where his research could be applied. I came up with the problem. In fact, ours is a very typical innovation process.”

Problem meets solution

Shifting the paradigm through molecular mucus engineering

This is the origin story for Cirqle Biomedical. Dispensing with incremental innovation, the company investigates whether a product can be created free of unwanted side

The cervix is naturally filled with a mucus gel that functions as a natural contraceptive. Throughout most of a woman's cycle, it is thick and serves as a barrier to sperm, but around

ovulation, hormonal changes make the barrier more watery and penetrable. Knowing this, the core of their solution is to leverage this natural barrier: ”Our product is a vaginally-inserted capsule containing a unique biopolymer. The biopolymer crosslinks the ovulatory cervical mucus so that the sperm cannot swim through it,” Madsen explains. In fact, the product does so well that they are now testing the solution on large animals whose reproductive systems resemble human beings. Their early successes indicate that the technology may be ready for human trials within two years. Cirqle Biomedical has already secured funding from a US fund that specializes in reproductive health. Earlier this year, they were also admitted to the biotechnology innovation hub incubator, BioInnovation Institute (BII), in the Creation House incubator programme. For Madsen, becoming part of BII has made a really big difference: ”They have managed to build a bridge between research and venture capital. It has helped us attract talented people and put in place a solid plan that we are now executing, so we can create a new paradigm in contraception.”

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Daiichi Sankyo Builds up a Strong Nordic Presence Japanese pharmaceutical company, Daiichi Sankyo was drawn to Denmark and the Nordics’ life sciences ecosystem. Now they’re a thriving part of the scientific environment.

n a bid to drive science and foster sustainable partnerships across the Nordics, last year Daiichi Sankyo settled into Denmark. The global pharmaceutical company, which focuses on oncology and haematology, has its origin in Japan and is present in more than 20 countries worldwide. Their Nordic headquarters is located in the Copenhagen Bio Science Park (COBIS), in the heart of Greater Copenhagen and the epicenter of Medicon Valley. As Patrik Grandits, General Manager & CEO, Daiichi Sankyo Nordics, explains: “Denmark and the Nordic region generally is appealing to us because of the scientific infrastructure and the thriving ecosystem of universities, hospitals, authorities, and industries.” The move to the Nordics was a strategic step for the internationally-focused company. Gaining a foothold required a number of factors, particularly their innovative edge: “Innovation is at the core of how we address patient’s needs, pursue new medicines and methods of drug discovery, and how we attract talent and build our organization,” Grandits points out.

We want to be an active partner and contribute to the Nordics’ life sciences ecosystem. We can offer a lot, but the region offers a lot to us as well Patrik Grandits

Strengthening Nordic scientific engagement Science is a strong part of Daiichi Sankyo’s DNA. In Grandits’ words: “We are passionated about science. Whether our team is based in Japan, New York, or Copenhagen. We are committed to creating first-in-class and best-in-class therapies to address high unmet medical needs. Our ambition is to be a global pharma innovator with a competitive advantage in oncology by 2025. Realizing this vision will require a global effort, and building a sustainable Nordic presence

with a strong scientific foothold is a cornerstone of Daiichi Sankyo’s strategy to achieve that.” “A key priority for us in that process is to strengthen our Nordic scientific engagement. Not only will it demonstrate our commitment to the region - it is also central for our core ambition of transforming science into the benefit of patients in areas with high unmet medical needs.” A strong step in the right direction is the organization’s collaborative partnerships in the Nordic life sciences

cluster. “We want to be an active partner and contribute to the Nordics’ life sciences ecosystem. We can offer a lot, but the region offers a lot to us as well,” Grandits acknowledges. The organization has initiated collaborations with research institutions, patient associations, and commercial partners across the Nordics and will continue to expand their engagements. Thanks to their efforts, the team became part of the pharmaceutical industry association in Denmark, securing seats on several committees, and are now exploring potential partnerships that can help drive their aspiration to advance the science to improve patient outcomes. Getting the right people on board According to Grandits, “The Nordics have a big talent pool and many people with in-depth knowledge about life sciences, but in order to have a well-functioning team it is also important to find people with the right growth-mindset.” Eager to set a new standard in customer-centricity, the company measures the impact made on the entire value chain in healthcare and focuses on team targets rather than individual targets. In terms of their recruitment process: “We value team players and the ability to listen, ask the right questions, and engage. One year has gone by since opening our office, and we now have a multicultural, highly-experienced, agile team in the Nordics,” Grandits says with pride. Over the next 8 years, Daiichi Sankyo aims to deliver 7 new treatments in the following domains: investigational antibody drug conjugates, acute myeloid leukemia, and scientific breakthroughs. “Our focus is on oncology and hematology and our mission is to leverage our innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer,” Grandits concludes.

Facts about Daiichi Sankyo A Japanese pharmaceutical company with more than 100 years of scientific expertise More than 15.000 employees worldwide A strong pipeline within oncology and haematology A strong scientific focus: 21,9% revenue investment in R&D Nordic HQ established in October 2018 in Copenhagen, Denmark Patrik Grandits, General Manager & CEO, Daiichi Sankyo Nordics

60 Fortunately, the medical world – and its requirements – have changed since then. Adding to this, Kledal points out: ”We now know that our drug has much more capability than we knew back then. It can kill both latent virus-infected cells as well as active ones.” The drug can also be used to cure organs housed in organ care systems outside the body (ex vivo). They are currently testing the treatment on lungs that are deemed unfit for transplant in Toronto, Canada. Discovering and developing within a billion-dollar market This August, Novo Nordisk Foundation’s innovation initiative, BioInnovation Institute (BII) injected 10 million Danish kroner into Synklino. Their acceptance into the notoriously-selective incubator came at the right moment, as they

...it was possible to target this virus protein due to its very particular way of acting

Start-Up for Transplant Treatments Has Set Its Sight on Billion-Dollar Market Synklino is developing an innovative drug to combat a virus that afflicts patients who receive organ and stem cell transplants. A recent investment from the BioInnovation Institute is moving the start-up from the discovery phase into development. Journalist: Jakob Lindmark Frier

“W

e are developing a biopharmaceutical drug to treat a herpes virus infection called cytomegalovirus (or CMV). Most people are carriers and, just like other herpes viruses, once you get it, you can’t get rid of it” Thomas Kledal, CEO of Synklino, says. Well-known strains of herpes are apparent through common symptoms like cold sores. By contrast, most people with CMV will never know that they have it. That is, unless their immune system is suppressed after receiving a stem cell or an organ transplant. Kledal views this as a huge problem, considering it manifests in people who’ve been sick for a prolonged period, with either leukaemia or organ failure: “People wait for a long time to receive an organ that increases their chances of survival. But if they get CMV infection during the transplantation process, their mortality rate increases significantly. For some high-risk groups it even doubles and the healing process following transplantation

is complicated and slowed. In other words, CMV is a serious condition that increases costs and suffering connected to transplants.” “The timing is right” Combining their expertise, Synklino’s three founders represent a lifetime – or three – of research and academic achievements within basal molecular pharmacology and these special receptors. Describing their relationship, Kledal remarks: “We’ve done research together as a group for years within this field. During that time various ideas have arisen based on what we’ve discovered. For instance, it was possible for us to target this viral protein due to its very particular behavior.” The three started a company in 2008 and worked on what has now become part of Synklino’s intellectual property. However, the regulatory requirements for phase III drug testing stifled their early attempts.

Thomas Kledal

were transitioning from a discovery to a development company. Kledal is quick to point out that this transition ”requires huge knowledge and financial resources.” Drug development is a long and winding road. Most likely, transplant patients will not benefit from Synklino’s innovations until the mid-to-late 2020s. Still, the company is highly motivated to advance their development based on market research in the US and Europe, as the need is clear: “The market that is the most attractive from a commercial angle would be to position our drug as a preventative treatment for transplant patients. That segment alone in the US and Europe presents an annual revenue opportunity of more than 1 billion USD. But beyond that, the drug can benefit anyone who is immunosuppressed,” Kledal concludes.

Thomas Kledal, CEO of Synklino

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New Assessment Council Promises to Foster Holistic Procurement and Strengthen Innovations The new Danish Health Technology Assessment Council must assess whether the cost of new treatments and health technologies is in line with their potential impact and reach. Medicoindustrien welcomes the new council and hopes that they can create a new culture to assess the value of long-term procurement.

hroughout its three-year lifespan, the Medicines Council has worked to ensure a balance between purchasing price and the return on investment for hospital medicine. Seeking the same for medical equipment, Danish Regions have voiced plans for a new Health Technology Assessment Council. While this type of screening already takes place prior to purchasing medical equipment, there is a need to assess the value of treatments that involve new technology. In other words, the Council is looking to create an evidence-based screening process to determine what is most useful in emerging technologies. According to Peter Huntley, director of the Medicoindustrien: “the Danish Health Technology Assessment Council must foster a new healthcare culture – one where we take a more value-based approach to what future technology can do in terms of treatments and whether the outcome is equal to what we pay for it. It is crucial that we also have an eye on the long-term impact.” Offering a behind-the-scenes look, when new technology is purchased today, the public institution often looks at the first year's purchase price. Going forward, health administrators must get used to looking at the overall value and adopt a long-term perspective in terms of the years the technology is expected to be used. For this, Huntley suggests: “You have to look at the link between purchasing, operations, and processing. All levels must be included in a value-based consideration, and we hope that it will remain in the assessment council.” Strenghtening innovation In an ideal world, new and exciting technology would be tested, evaluated, and analysed to determine whether the conditions are ripe for scaling. Danish regions, with their ambitions for the new Assessment Council, have paved the way for new technology to yield economic savings. However, Huntley cautions that this should not be the Council’s sole purpose, because it would lose some of its potential. His rationale is that if the focus is only on reducing costs, then new treatment opti-

You have to look at the link between purchasing, operations, and processing. All levels must be included in a value-based consideration Peter Huntley, director of Medicoindustrien

ons and technologies that have the potential to create opportunities for many patients in the long term will not come to market. In Huntley’s own words: “The Assessment Council will be a great stepping stone on our journey, where we need to look at what creates value, rather than what it costs. Their activities must influence the way the public sector handles procurements. Simply put, we need to be more holistic when we evaluate a product's abilities and the Assessment Council can be a platform for systematic screening.” More broadly, Huntley points to innovations in healthcare – how they often happen sporadically among passionate entrepreneurs. His hope for the Assessment Council is to foster a systematic assessment of new technology and create better conditions for citizens across the country to benefit from new technology. Huntley goes on to explain that: ”To be at the forefront, we must ensure that Denmark becomes a country where we work with the latest technology and create powerful innovations. The Treatment Council will not solve this issue, but it will help us move in the right direction.” The role of municipalities It is important to note that although Danish regions have not yet issued a concrete proposal, it does not appear that municipalities will be involved in the Danish Health Technology Assessment Council. Huntley regards this as problematic: “There are many treatments that range from the regional level to the municipal level. As such, there are many technologies that need to be evaluated overall. If the municipalities are cut off, you cannot get the full picture of a specific treatment.” While it has yet to be revealed who will get a chair at the round table, Huntley points to the Medicines Council for inspiration – given its composition and breadth of professionals: “It is important that council members can assess whether the technology is relevant, so the industry needs to be heavily represented. That is why I also expect the Medicoindustrien to get a seat in the new assessment council.”

Getting Products to Market: How Life Science Start-ups Can Harness Intellectual Property Strategies It often takes very large and very long-term investments to develop products in the life science industry. Intellectual property rights (IPR) are critical to securing investments and getting products to market. Journalist: Jakob Lindmark Frier

ccording to Finn Strøm Madsen, CEO of the full-service intellectual property rights (IPR) consultancy, Plougmann Vingtoft: “IPR must be a fundamental part of the business strategy and plan from day one.” Over the past years, he has witnessed first-hand how the development from industrial to digital society has increased the importance of IPR within the life science industry. Echoing this, his colleague Christian L. Christiansen – who is the head of biotech and pharma at Plougmann Vingtoft and a European patent attorney – claims that start-ups can accelerate their time to market if they create the right strategy around their IPR: ‘A strong IPR strategy can support the process of acquiring the right investments from investors or larger companies. It shows the investor that the start-up company is on top of things and takes IP protection seriously. A lack of patent protection or dominating competitor rights can be a complete show-stopper’. There is more to it than the initial patent Generally speaking, there are several factors that make up a strong IP strategy – from patents, trademarks, and design registrations to a combination of several types of IP: ‘First of all, it is important to analyse the IP landscape among possible competitors to identify whether there is a ‘freedom to operate’ in relation to the product. You also need to consider the possible competitive patent rights and take steps to secure your freedom to operate in the long run. Surveillance of close competitors’ IP rights are also part of a strong strategy’, Christiansen cautions. More than a patent on a particular product, IPR concerns all the processes surrounding development and use. Protecting all of the essential aspects of a commercial product is also a matter of timing: ‘Timing is an essential consideration in order to ensure the longest possible protection of a firm’s commercial products’, Christiansen points out. IPR is a continuous process Life science start-ups don’t hold assets in buildings or production facilities. Because their most important as-

sets are ideas, it’s vital to maintain a strong IP strategy. Neglecting this will likely result in issues that delay time-to-market or perhaps even kill the business, Christiansen explains: ‘In the life science industry, businesses are often built around a few successful products. Therefore, a weak IP position can be detrimental to the commercialisation of these products’. Investors in the life sciences field, including larger life sciences companies, are highly aware of these issues and are more inclined to invest if the start-up company is on top of their IP. This does not mean applying for as many patents Christian L. Christiansen, European Patent attorney & Head of Biotech & Pharma at Plougmann Vingtoft

Timing is an essential consideration in order to ensure the longest possible protection of a firm’s commercial products Christian L. Christiansen

Finn Strøm Madsen, CEO of the full service IPR consultancy, Plougmann Vingtoft as possible. It means doing the necessary market research and making a conscious decision about IPR and its strategic use-value. Concluding the point, Madsen explains: ‘When you set up an IP strategy, you are forced to consider whether you need to protect your brand, the functionality of your product, or the particular design. IP rights may not even be necessary in your market position. But if you want a strong business plan you should, at the minimum, be able to argue for your choice or dismissal of IP rights’.

P4G på DTU Skylab 2019

When Universities Turn Their Patents into Start-Ups Everybody Wins According to Marianne Thellersen, the senior vice president of entrepreneurship and innovation at DTU, universities should feel an obligation to consider whether the knowledge that is generated in their academic departments can benefit individuals and societies. And start-ups are often the most viable way to ensure knowledge gets translated to practice. Journalist: Jakob Lindmark Frier

ore often than not inventors take out patents to protect the investment that established companies and start-ups made to bring the technology to market. Most universities file a number of patents every year based on the research undertaken in their departments and its real-world applicability. In fact, by Danish law universities have a role to play in the commercialisation of the patents they take out. According to Marianne Thellersen, the senior vice president of innovation and entrepreneurship at DTU, ’From our point of view, [researchers and the university] have a responsibility to get our knowledge out in the world and create jobs and value in society’. Even though investing in filing patents and running start-up programs to turn patents into commercial products impacts the university’s bottom-line, for Thellersen this is entirely worthwhile, even necessary:

’There would be no reason for us to build start-ups if established companies brought new technology to the market directly, but the technologies are often too immature for that. We are really good at research, but we can’t mature and commercialise patents on our own’. Start-ups are bringing inventions to the world While it’s necessary to embed entrepreneurship into the university’s walls, it takes years of experience working within and outside of academia to provide the training and build the capacity needed for the next generation of researchers. Now, after many years in the making, DTU has role models who have done it before, and they have helped the university to build a wide and open ecosystem for start-ups. Despite the wealth of knowledge and opportunities available, it is also necessary to make students and researchers aware of how they can capitalise on this. As

Thellersen sees it, this is a matter of changing the culture by encouraging researchers to constantly consider whether their research has value outside of the univesity’s walls. Over time, DTU has become more selective in terms of the stages of the patents they are filing, appreciating that they need to have a viable pathway to the market. Of course, what that path looks like – from knowledge to product – is different in each case. Although the university cannot always be the driving force behind it, they have a strong role to play in facilitating the commercialisation of their patents. In describing DTU’s process, Thellersen points out: ’At the moment we file a patent we make a plan for it. We talk with investors about the best way forward, and sometimes it is through launching a start-up. The technology is often so early that established companies can’t immediately put in on their shelves’. Commercialisation leads to better research outcomes

Photocredit: Kaare Smith

DTU runs a series of programs and offers targeted grants to help research entrepreneurs get started and accelerate their projects. Even though this doesn’t generate profits by itself, it opens up research for funding by commercial partners. The effort also creates value in other ways. ’I think it’s healthy to actually look at how the research you’re doing can be applied to the real world. Theoretically, you can have a lot of assumptions about its potential, but it’s an entirely different story when it meets the real world. The findings become more concrete, and, in the end, I actually think we get better research because it is put into the perspective of everyday use-value’, Thellersen concludes. Those start-ups that are spun out of patents filed by DTU are often led by a professor or a doctoral student associated with the research.

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If entrepreneurs develop products without developing a strong IP strategy and ensuring proper patent protection, they create a huge capital risk Christian L. Christiansen, Partner, Plougmann Vingtoft

Strong Ip Strategy Ensures Investor Capital for Danish Biotech Firm Danish entrepreneurs miss important funding opportunities if they lack a strong IP strategy. That is the key message from Plougmann Vingtoft — one of Scandinavia’s leading consulting firms within Intellectual Property Rights. Firms in the Life Science field operating without IP rights can have an especially hard time going to market, Plougmann Vingtoft says, which is why they should incorporate IP from the beginning, just as biotech pioneer Curasight did.

urasight is one of the success stories of the Danish Life Sciences field, and much of its success is rooted in its initial focus on IP, which gave it a head start in the fast-growing industry. Developing an IP strategy was one of the first things on the agenda when CEO and co-owner Ulrich Krasilnikoff and his team began their business journey. They are behind the development of uTRACE®, which is a pioneer product in improving brain and prostate cancer diagnosis. When uTRACE® was just an early-stage idea, Curasight sought ways to protect its IP. Together with consultants at Plougmann Vingtoft, the company created a bulletproof strategy, which helped it attract investors and accrue enough funding to develop its idea further. “It is both expensive and complex to apply for a patent if you don’t know how. That’s why it is so important to find

an IP partner you can trust to do the job,” says Ulrich Krasilnikoff from Curasight. He adds: “The research development within Life Science is extremely competitive, and the many skilled people in the industry will likely upset your game if you don’t have a strong IP strategy.” A battle for capital For most Life Science firms, the need for capital investment starts early in the product-development phase. The fight for capital is tough, and without acquiring your position through patents, design protection or trademarks, you run the major risk of encountering a copycat or another party blocking your IP before you even enter the market. Among IP consultants such as Plougmann Vingtoft, who are familiar with the Life Science industry, there is no

doubt that getting a head start is the name of the game. “Developing a Life Science product requires substantial investments and a whole lot of time. If entrepreneurs develop products without developing a strong IP strategy and ensuring proper patent protection, they create a huge capital risk. The best way to protect your Life Sciences capital and pave the way for future investments is by protecting your products and securing freedom to operate,” says Christian L. Christiansen, European Patent Attorney and a Partner at Plougmann Vingtoft. Freedom to operate In meetings with Danish entrepreneurs, consultants at Plougmann Vingtoft often experience that most new firms acknowledge the importance of protecting ideas and products. However, not all of them are aware that it is just as

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About Plougmann Vingtoft Plougmann Vingtoft is an award-winning consulting firm that specializes in handling, protecting, and commercializing IPR (Intellectual Property Rights), as well as the strategic use hereof. The firm offers top-level expertise within all aspects of IPR, which includes services such as IPR administration, the formulation of patent claims, trademark applications and design protection, and it provides strategic advice on how a company can develop its business and achieve a competitive edge by working strategically with IPR. Contact: 33 63 93 00, www.pv.eu

As a startup, you need to get familiar with the market analysis before you spend all of your funding on a product that might never go to market Ulrich Krasilnikoff, CEO, Curasight

important to ensure that their product does not infringe on others’ IP rights. As a starting point for their IP strategy, Plougmann Vingtoft and Curasight made sure that Curasight had so-called “freedom to operate”, meaning that it was able to launch a new product without infringing another party’s IP rights, whether through trademarks, copyright, designs or patents. “As a startup, you need to get familiar with the market analysis before you spend all of your funding on a product

that might never go to market. There is no use in developing a good product if there is no market in which this particular product can live,” Ulrich Krasilnikoff explains. He emphasises that it can be difficult to navigate the world of intellectual property — which is where the IP consultant comes in. “Our job as IP consultants is to create space for the entrepreneurs to focus on what they do best. Meanwhile, we turn complex regulations into a strong IP strategy and valuable IP assets that support and develop the business,” says Christian L. Christiansen, who has more than 15 years of experience within Life Science and IPR. According to Curasight, its IP strategy was a crucial part of raising capital for further development. It sends a strong signal to investors when the start-up has made a conscious decision about their IP rights and are aware of

how to defend them. Further, it helps investors to discover which part of the particular product is unique, says Ulrich Krasilnikoff.

Christian L. Christiansen, Partner, Plougmann Vingtoft

Ulrich Krasilnikoff, CEO, Curasight

Photocredit: Adobe stock

Is Denmark’s National Life Sciences Strategy Making a Difference? Hans Schambye was among the first members in Denmark’s “growth team” to offer suggestions for a national growth plan for the life science. Almost two years after the plan was announced, he has received both praise and criticism for the implementation efforts to date. Journalist: Sebastian Kjær

enmark’s life science industry is heavily regulated. Success and growth isn’t just a matter of securing qualified talent in great companies. It calls for the right framework for the country to operate and develop solutions. This has been articulated in a national growth plan for life science. According to Hans Schambye, CEO of Galecto Biotech: “We have a large industry filled with skilled people, and universities doing really strong research. Our strategies strive to ensure research findings keep being turned into innovative new products that can benefit patients and that can be exported.” As a member of the “growth team,” Schambye proposed a life science strategy several years ago, which was formalised as 36 suggestions in 6 central areas where Denmark could improve. As international competition in the life science increases, Schambye explains: “The challenge is that everybody wants a strong life science industry. It generates good jobs and a lot of money; it doesn’t create much pollution; and it is dedicated to improving public health, so it serves a great purpose. For that reason, a lot of countries are constantly improving their frameworks, which makes it dangerous to rest on our laurels.” One entry point to the life science Given the comprehensiveness of the field, a lot of ministries have traditionally been involved in the industry – such as the ministries of health, education, business, and foreign affairs. This plurality of stakeholders left the field untethered in the official bodies. However, that has changed with the establishment of a life science office. While this might sound like a relatively small and simple thing to implement,

a lot of companies are warmly welcoming the initiative. Schambye explains: “While we have ministries for fishing and farming – the traditional industries – it’s important that we also have someone who deeply understands the life science industry. The life science office has provided the industry with one entry point to all the central ministries, which, in the end, provides an entrance to the parliament.” Capital and entrepreneurship wanted Although the need to bring more researchers and key talent to Denmark has been universally agreed upon, Schambye would still like to see more being done to promote entrepreneurship and investments in new life science companies: “We would like to see more effort in stimulating the stock market, making it more attractive to invest in start-ups, and we’re still very far from that goal. Similarly, new benefits for investing in research and development are far from being as competitive as in some of our neighboring countries.” He points to Swedish investors, who have been given attractive tax breaks. In fact, it has worked to such an extent that Danish life science start-ups are crossing the Øresund to make their initial public offering on the Swedish stock exchange. According to Schambye, this approach has nourished an early biotech ecosystem in Sweden, one that “stands in stark contrast to how it was only a few years ago, when Denmark was roaring while Sweden was growing a little slower.”

Schambye would like to see the two markets become harmonized for the cooperation to flow more easily: “Overall, it would be beneficial to ensure a lot of rules and regulations are the same. One small thing would be making sure it’s not hard for commuters. I’m currently recruiting a Swede living in Sweden, and the 20 minutes extra he must spend each way on border control is a hurdle to overcome.” At the same time, he understands why it makes sense to frame the strategy in a Danish context, as the life science have a huge impact on Danish jobs, exports, and taxes: “It doesn’t matter to patients if the new treatment is being developed in one country or the other. But it’s an advantage for Danish taxpayers if the development stays in Denmark, and the industry gets to grow here instead of aboard. Oftentimes, companies are moving where it makes the most sense for the business, so we have to continue the work to make Denmark an attractive place to carry out life science business.”

Danish strategy in an international landscape While the growth strategy for the life science is Danish, a lot of innovation is happening in the Greater Copenhagen region between Denmark and Sweden. For that reason,

Hans Schambye, CEO of Galecto Biotech

Illustration of a toxic smoke in Lung. Credit: Adobe Stock

Clinical Tests Are Based on Artificial Reality and Yield Suboptimal Results Clinical medical tests are developed in an artificial reality and can’t be effectively applied in the clinical setting, says Morten Sodemann. That’s why he’s encouraging doctors to swallow their pride and start researching alongside social- and human science professionals. Journalist: Sebastian Kjær

etween 2003 and 2017, 396 of the 3.000 drugs that had passed FDA approval were withdrawn. This is the conclusion of a 2019 meta-study on the randomized clinical trials featured in 3 leading medical journals. Their conclusion isn’t just that the clinical studies are being conducted in a poor fashion. According to Morten Sodemann, a clinical professor of infectious diseases at the University of Southern Denmark, the entire approach to clinical tests – from inception to implementation in the hospital setting – is faulty: “What’s being tested is an artificial reality. Researchers are testing healthy young men in their prime – not pregnant women, the elderly, children, or people with multiple diseases or mental illnesses. Real patients are being left out of the studies, and this has created an artificial reality, one where the results are measurable in a lab but not applicable to the real world.” While this approach to clinical testing makes it easier for authorities and white-collar workers to justify the economics of their choices, most of the research doesn’t make a difference to patients, according to Morten Sodemann: “As long as we’re focusing on how the study benefits the scientist’s credentials, we won’t get studies which are really changing things. Patients won’t feel a difference between 2 pills that can only be measured in a lab.” And this isn’t just an isolated issue bearing on the drugs that are being withdrawn from the market after their clinical tests. It is a symptom of what’s going on in health research generally.

We know how hard it is to move the behaviour of obese and smokers, and the study shows, that it might be because of something else than we thought Morten Sodemann

Advancing the field requires swallowing pride Clinical scientists tend to operate as though they are best positioned to know what patients need, often without meaningfully engaging them. This makes it difficult, if not impossible, to apply the solutions in practice. For Sodemann, the solution is to cross the medical professions with other professionals from human- and social sciences: “Doctors hate to collaborate with other professionals, and so do anthropologists, but maybe we should meet in the middle and explore the interdisciplinarity of our respective fields. It sometimes pays off, but we have to swallow our pride to do this – and that might be the hardest part.”

After all, doctors have a craftsman-like approach to their research and practice. Generally speaking, if an answer or a result doesn’t fit the predefined box – or questionnaire – it is challenging to navigate. On the other hand, intersectional collaborations can help them to negotiate and balance several truths at once. Data is a valuable resource – but not on its own Adding human- and social sciences into this equation will not resolve the problem on its own. Data must be used in the right way, combined with proper clinical testing and

new discoveries from the research. On that note, Sodemann highlights a study that combined the big data from Facebook networks and social science skills with data from the Danish healthcare system and knowledge about health behaviour from medical scientists: “The results show that obese people have obese friends, and even their friends-friends weigh more than the average person. The same goes for smokers. This indicates that lifestyle diseases spread in a different way than we thought: through networks.” In other words, both productive and counterproductive traits are spread in social networks, and this could alter our understanding of how to fight lifestyle diseases. This would have been hard to recognize without professionals pooling their knowledge from different fields. Moreover, it may inspire researchers to work constructively instead of continuing to “knock people in the head with the obvious health advice that they shouldn’t overeat and smoke,” Sodemann explains. Optimistically, he points out that research funds play a pivotal role in defining agendas and areas of inquiry, and he sees a change from funding basic research deep underground to something that can actually be applied to the real world.

Human Health, University of Southern Denmark Human Health is a research strategy that aims to bring professionals together across human, social, and health sciences to identify evidence-based solutions for future healthcare challenges. As part of the project team from the University of Southern Denmark, Sodemann is quick to point out that project applicants must make it clear how their work will add value by bringing a variety of professions together in undertaking the research.

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cess to 10 fully-equipped labs which give early companies a powerful running start and significantly reduce their financing needs. And the model is working. Since SmiLe’s launch in 2007, 14 of the 70 companies participating in the incubator program have completed successful initial public oferings achieving a current market cap of approximately €690 million. A small circle is crucial There is a huge diference between a normal tech start-up buying an online marketing platform and a life science startup reaching market approval through clinical trials managed by a larger organization. The transactional costs and demand for successful strategy are simply much higher. For that reason, it’s a huge advantage for the start-ups to be located in the incubator, as part of a larger life science cluster. According to Fåhraeus: “There is on-site, peer-to-peer knowledge transfer between the companies. They support each other, and actually buy services from each other, which helps them to develop faster. Serial entrepreneurs come back when they start all over again because they understand the value of our community.” Becoming international

Smart, Profitable Start-ups Are Growing in SmiLe’s Winning Community There are names making news, like Cantargia and SAGA Diagnostics in cancer therapy, Gedea Biotech in microbial resistance and Speximo with green-wave cosmetics. These represent SmiLe Incubator’s focus on results and expertise in Lund, Sweden.

miLe Incubator is where health product start-ups begin as lean, market-focused teams who consistently attract capital, meet product milestones, and achieve successful initial public oferings and transactions. SmiLe is the life science start-up hub based at Medicon Village in Lund, Sweden, where entrepreneurs build product market value in a community of expertise and support. According to Ebba Fåhraeus, CEO of SmiLe Incubator: “We’re on a mission to support life science start-ups to make the world a better place for humankind. Essentially, we catalyze ambitious entrepreneurs to transform their

There is a lot of know ledge transfer bet ween the companies that happens onsite Ebba Fåhraeus, CEO of SmiLe Incubator

innovations into revenue generating products and services that actually reach patients.” Today, about 70 companies have completed, or are currently part of, SmiLe’s incubator program. Over the last 5 years, these companies have notably secured €290 million in funding and operate in fields such as medtech, drugs, diagnostics, e-health, probiotics, and contract research services. What’s more, 50 “very early” health tech companies have attended SmiLe’s intensive accelerator program, Health2B. Industry experts Successful life science start-ups navigate challenges best when surrounded by the right competence for their business objectives. This is why the SmiLe team brings extensive knowledge from their careers in the life sciences industry and start-ups. They are well-positioned to help the small companies streamline their time to market by avoiding mistakes and making the right strategic decisions at the right time. Fåhraeus explains: “In the incubator program, our coaches and experts work closely with each company to help them attract venture capital. In the first 6 months of this year alone, the companies received close to €60 million in financing.” The incubator’s formula for success includes tapping into international networks of industry partners and investors who can power-up the start-ups. It also includes ac-

In particular, Fåhraeus and her colleagues are helping companies through a growing presence in an international sphere: “We take an active part in several of the EU innovation programs, in a Russian accelerator held by AstraZeneca and others, and we plan to further develop our footprint in Europe.” When investors look for the best new tech start-ups in Silicon Valley, they turn to leading accelerators like Y Combinator. SmiLe aims to fill that role for life science start-ups throughout Europe. Fåhraeus adds: “We want to top the list. It’s all about bringing investors and corporate market leaders within the life sciences together with high-potential start-ups to create great market value.”

Some of the successes from SmiLe Cantargia (alumni): Cantargia develops new drugs in the field of immunotherapy for cancer treatment. The company was founded in 2010, completed its IPO in 2016 on Nasdaq Stockholm and currently has a market cap of €110 million. Gedea Biotech (incubator company): The company developed the first antibiotic-free treatment that is expected to cure bacterial vaginosis and to prevent the infection from recurring. SAGA Diagnostics (incubator company): SAGA Diagnostics is a personalized cancer medicine and disease monitoring company. The company provides molecular genetic tests and services, using its ultra-sensitive analysis of circulating tumour DNA and tissue mutations. Speximo (alumni): Speximo’s new generation emulsifiers, derived from nature, allow for stable formulations, protect active ingredients, and enable controlled release. The company was recently acquired by a major enterprise in the field of cosmetics for an undisclosed amount.

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