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IN FOCUS<br />

INSPIRING LIFE SCIENCE BUSINESS & INNOVATION NO 03 <strong>2019</strong><br />

Q&A<br />

COLUMN<br />

CELLINK Developing the<br />

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CERENION A quartet with<br />

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CORIPHARMA Bringing<br />

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CONTENTS NORDIC LIFE SCIENCE<br />

108<br />

PHOTO NNF<br />

PHOTO JENNY ÖHMAN<br />

PHOTO HEINZ TROLL


Your Nordic Partner Within Life Science<br />

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NORDIC<br />

LIFE SCIENCE<br />

EDITOR IN CHIEF: MALIN OTMANI<br />

ART DIRECTOR: ANNIKI SKEIDSVOLL EDÉN<br />

REPORTERS: ELLEN R. DELISIO, PIA ANDREA,<br />

CHRIS TACHIBANA, AMY BROWN<br />

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ANDRES@NORDICLIFESCIENCE.ORG<br />

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01. FOUR PRINTED ISSUES OF THE BUSINESS<br />

MAGAZINE<br />

02. ALL ISSUES O<strong>NL</strong>INE, READABLE ON YOUR<br />

PREFERRED DEVICE<br />

03. WEEKLY NEWS UPDATES FROM OUR<br />

NEWSLETTER NORDIC LIFE SCIENCE NEWS<br />

CALL: +46 8 588 941 52<br />

OR SIGN UP AT: NORDICLIFESCIENCE.ORG<br />

PARTNERS:<br />

ARE TWO HEADS, or brains, better than one? Well, perhaps not always but diversity has<br />

been shown to fire imagination and stimulate people to come up with new ideas,<br />

while studies have shown that if the collaborators communicate, are competent and<br />

confident they perform better and make more sensible decisions (Bahrami et al.,<br />

Science, 2010). Even the lone genius Albert Einstein supposedly collaborated with<br />

his fellow students.<br />

Within life science we also have a lot of successful historic examples, duos like<br />

Watson & Crick and Charpentier & Doudna, and let’s not forget one of the world’s<br />

largest collaborative biological projects, the Human Genome Project. Not convinced<br />

yet? Take a look at the last slide of every Nobel Laureate’s Nobel lecture – the list of<br />

colleagues they want to acknowledge is usually very long.<br />

REGARDLESS IF A discovery is made by a single person, the importance of a collaborative<br />

environment should not be underestimated. We need environments that encourage<br />

researchers to build cross-border and interdisciplinary teams and attack problems<br />

that no person alone, or no country or discipline alone, can solve.<br />

An atmosphere where you share the larger goals could also encourage a young<br />

scientist to continue follow his or her calling. Recurrent advice from the young<br />

talented researchers we spoke to in this issue was the importance of networking;<br />

talking to others in order to open up your perspectives, beeing a team player and<br />

discussing your findings.<br />

THIS DOESN’T just apply to the scientific community. In order to build successful businesses,<br />

collaboration is also the key. According to our profile in this issue, venture<br />

capital specialist Eugen Steiner, “you need both the geniuses who invent stuff and<br />

very smart people who can turn the discovery into products, as well as the business<br />

developers who create the network, and the investors.” So, more than one brain.<br />

In our interviews with up-and-coming Nordic life science companies they also all<br />

agree; building a good team around your technology is key and you can’t do everything<br />

yourself!<br />

So, if two heads are better than one when building a business I think it is also true<br />

that two hearts are better than one. If you share a common passion you are more<br />

likely to succeed and it won’t take long until the due date for your baby, ... I mean<br />

your company.<br />

MALIN OTMANI<br />

EDITOR IN CHIEF<br />

FOR DAILY UPDATES OF THE NORDIC LIFE SCIENCE<br />

INDUSTRY, VISIT: NORDICLIFESCIENCE.ORG.


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PHOTO THOMAS RØNN<br />

ACQUISITION<br />

AMGEN HAS AGREED TO BUY THE BIOPHARMACEUTICAL COMPANY<br />

NUEVOLUTION TO BOOST ITS POSITION IN DRUG DISCOVERY.<br />

HE OFFER FROM Amgen follows a<br />

collaboration between Nuevolution<br />

and Amgen which started<br />

in October 2016. Amgen had<br />

exercised opt-in rights for two<br />

cancer treatment approaches that<br />

have emerged from the alliance.<br />

“Going forward, and provided that the transaction<br />

goes through, Amgen wishes to keep<br />

Nuevolution in its strongest setup, and Nuevolution<br />

will play a key role together with our many<br />

coming colleagues at Amgen. We will join efforts<br />

in discovery of small molecule-based (tablet)<br />

medicines, where Nuevolution will continue<br />

its operations from Copenhagen, where about<br />

50 people from about 10 countries are working<br />

today,” says Alex Haahr Gouliaev, CEO of<br />

Nuevolution. “Personally, I am excited about this<br />

opportunity, and I think that we should collectively<br />

be proud about this. It is the result of many<br />

people’s effort and professional and private<br />

investors’ support over many years.”<br />

Alex Haahr Gouliaev,<br />

CEO, Nuevolution


TEXT<br />

b y M A L I N O T M A N I<br />

SARA MANGSBO<br />

IS ENTREPRENEUR<br />

OF THE YEAR<br />

PHOTO KENNET RUONA<br />

IDOGEN HAS ESTABLISHED A NEW<br />

METHOD FOR ITS CELL THERAPY<br />

THE COMPANY HAS ESTABLISHED A NOVEL METHOD FOR PREPARATION OF THEIR<br />

TOLEROGENIC CELL THERAPY.<br />

DOGEN ANNOUNCED IN<br />

January <strong>2019</strong> that analyses<br />

performed in a scientifically<br />

improved evaluation<br />

model showed that<br />

the company’s technology so<br />

far, based on zebularine as a<br />

tolerance inducer, did not give<br />

the effect that earlier preclinical<br />

experiments had indicated. An<br />

evaluation of a number of alternative<br />

tolerance inducers was<br />

initiated in order to identify a<br />

more effective method to generate<br />

dendritic cells that educate<br />

the body to tolerate drugs,<br />

endogenous molecules and<br />

cells. It has led to the establishment<br />

of a new method for the<br />

development of the company’s<br />

cell therapy projects in the areas<br />

of hemophilia (IDO 8), kidney<br />

transplant (IDO T) and autoimmune<br />

diseases (IDO AID).<br />

The new method is based on<br />

a selected combination of tolerance-inducing<br />

substances that<br />

will replace zebularine. The next<br />

sub target is to initiate a clinical<br />

study of IDO 8 in hemophilia patients<br />

who have developed immunity<br />

against their treatment.<br />

Idogen has also started work on<br />

compiling patent applications<br />

for the new method.<br />

“The last few months have<br />

been a test of strength for the<br />

company’s employees and with<br />

the promising results achieved<br />

we can now look back on<br />

our efforts with pride,” says<br />

Idogen’s previous CEO, Lars<br />

Hedbys. During the summer<br />

it was announced that Lars<br />

Hedbys has resigned as CEO,<br />

after five years in the position.<br />

Anders Karlsson took over the<br />

role on August 19th.<br />

RESEARCHER AND ENTREPRE-<br />

NEUR SARA MANGSBO HAS<br />

WON THE FIRST PRIZE IN THIS<br />

YEAR’S SWEDISH MAGAZINE<br />

VECKANS AFFÄRER SUPER<br />

TALENT COMPETITION.<br />

ARA MANGSBO WORKS<br />

both in academia<br />

and business. She is<br />

an Associate Senior<br />

Lecturer at Uppsala<br />

University and Chief Development<br />

Officer at Ultimovacs, a<br />

Nordic cancer vaccine company.<br />

Almost a year ago, the company<br />

bought a subsidiary of Immuneed<br />

AB, an immunotherapy company<br />

that Mangsbo had co-founded.<br />

“It was extremely interesting<br />

and exciting to be involved in an<br />

acquisition. I learned a lot from that<br />

experience. I enjoy working at full<br />

speed and with lot of things going<br />

on. As an entrepreneur you have<br />

the opportunity to influence and<br />

discover new treatments for cancer<br />

patients. You also have the opportunity<br />

to help create new jobs, work for<br />

diversity and inspire others to forge<br />

their own path,” says Mangsbo.<br />

“Sara is so worthy of this prize<br />

and it’s a testament to her entrepreneurship.<br />

Her background and expert<br />

research skills are in high demand.<br />

Sara’s work is not only important<br />

for the work at Ultimovacs, but her<br />

expertise is also needed in the growing<br />

field of cancer research,” says<br />

Gunilla Ekström, Managing Director<br />

at Ultimovacs.<br />

THE NORWEGIAN BIOINFORMATICS COMPANY WILL NOW BECOME A SUBSIDIARY OF NEC AND<br />

OPERATE UNDER THE NAME OF NEC ONCOIMMUNITY AS.<br />

Sara Mangsbo,<br />

CDO, Ultimovacs<br />

ONCOIMMUNITY, FOUNDED IN 2014, is dedicated to<br />

the development of software solutions that facilitate<br />

the effective selection of patients for cancer<br />

immunotherapy, and identify optimal neoantigen<br />

targets for personalized cancer vaccines and cell<br />

therapies in a clinically actionable time frame.<br />

NEC announced its business strategy surrounding<br />

its AI-driven drug discovery business in May<br />

<strong>2019</strong>. This acquisition is integral for enhancing<br />

the resources and capabilities that support the<br />

development of its individualized immunotherapy<br />

pipelines, it states. NEC will maintain its focus<br />

on drug discovery, while NEC OncoImmunity AS<br />

continues its neoantigen prediction services.<br />

“These synergies will positioning NEC Onco-<br />

Immunity as the leading neoantigen prediction<br />

service provider in the field,” says Richard Stratford,<br />

CEO and co-founder of OncoImmunity.<br />

PHOTO MARTINA SJAUNJA<br />

NORDICLIFESCIENCE.ORG 9


TOP STORIES BUSINESS<br />

BUSINESS<br />

ADDLIFE<br />

ACQUIRES<br />

2 DANISH<br />

COMPANIES<br />

Peter Simonsbacka, Business Area<br />

Manager Labtech, AddLife<br />

ADDLIFE HAS SIGNED<br />

AN AGREEMENT FOR<br />

THE ACQUISITION OF<br />

ALL SHARES IN THE<br />

DANISH COMPANIES<br />

LAB-VENT CONTROLS<br />

AND KOLDT & RYØ EL.<br />

NEW MARKET<br />

Rajan Chaudhary and Ingvild<br />

Soenstegaard Chaudhary<br />

THE COMPANIES ARE leaders<br />

on the Danish market in<br />

ventilation solutions for<br />

laboratories and clea<strong>nr</strong>ooms.<br />

They will be a<br />

complement to AddLife´s<br />

operations in the company<br />

Holm & Halby, a<br />

laboratory equipment<br />

provider specialist in<br />

clea<strong>nr</strong>ooms on the Danish<br />

market, states AddLife.<br />

The companies typical<br />

end customers include the<br />

pharmaceutical industry<br />

and academic research<br />

institutions.<br />

“The acquisitions<br />

means that we more<br />

clearly establish AddLife<br />

as a complete supplier<br />

of advanced solutions in<br />

clea<strong>nr</strong>oom technology<br />

in the Danish market,”<br />

says Peter Simonsbacka,<br />

Business Area Manager<br />

Labtech, AddLife.<br />

The company currently<br />

has 20 employees and<br />

sales of DKK 36 million,<br />

on the Danish market. The<br />

deal was closed on 15<br />

August <strong>2019</strong>.<br />

THE INDIAN CONSULTING COMPANY HAS OPENED AN OFFICE IN MEDICON<br />

VILLAGE, THE LIFE SCIENCE RESEARCH PARK IN LUND.<br />

HE COMPANY AIM is to help Scandinavian<br />

healthcare and medtech<br />

companies enter the Indian market<br />

and to support Indian companies<br />

that seek collaborative partners in<br />

Scandinavia. It intends to have five<br />

employees at their Swedish affiliate within the next<br />

1-2 years, as a compliment to their office with 22<br />

employees in India. One of their clients is Glycorex<br />

Transplantation, of which Wayinia is a main distribution<br />

partner for Indian hospitals.<br />

The team behind Wayinia, Ingvild Soenstegaard<br />

Chaudhary and Rajan Chaudhary, formerly country manager<br />

of Gambro in India, see potential in using their<br />

expertise from the life science industry and knowledge<br />

of business relations between India and Scandinavia.<br />

”In my opinion, Nordic companies should<br />

enter the Indian market because India and South<br />

East Asia (SEA) offer the power of scaling the<br />

business, which many countries in Europe doesn’t.<br />

India has today a population of over 1.4 million,<br />

and as we know, by 2050, over half of the world’s<br />

population will be concentrated in nine countries,<br />

out of which three are in SEA,” says Chaudhary.<br />

“Today India has 12 million people coming to<br />

the workforce every year, it has an average age of<br />

29 years and has had an economic growth of seven<br />

percent plus for many years. India is the right<br />

choice for investors and companies to start thinking<br />

toward SEA, since it has untapped potential and it<br />

is the single biggest economic growth driver the<br />

world has ever seen.”<br />

ayinia reached out to Invest<br />

in Skåne and Copenhagen<br />

Capacity in 2018 requesting<br />

assistance in establishing<br />

their company in Greater<br />

Copenhagen. They arranged<br />

a visiting program that included meetings with<br />

relevant stakeholders and potential customers, as<br />

well as assisted Wayinia with the process of registering<br />

their Swedish company.<br />

“Thanks to the large number of life science<br />

companies in the Medicon Valley cluster and the<br />

proximity to Copenhagen Airport, with direct flights<br />

to the rest of the world, Lund and Medicon Village is<br />

the perfect location for us,” says Chaudhary.


TOP STORIES<br />

FINANCING<br />

ULTIMOVACS<br />

ENTERS THE<br />

OSLO STOCK<br />

EXCHANGE<br />

PHOTO JENNY ÖHMAN<br />

Christoffer Lorenzen,<br />

CEO, Karo Pharma<br />

BUSINESS DEAL<br />

KARO PHARMA ACQUIRES TRIMB<br />

THE COMPANY HAS ACQUIRED ALL THE SHARES OF TRIMB HOLDING AB FROM<br />

AVISTA CAPITAL PARTNERS AND OTHER SHAREHOLDERS FOR SEK 3,400 MILLION.<br />

HE TRANSACTION IS expected to<br />

contribute positively to Karo<br />

Pharma’s market position and<br />

create a strong platform for Karo<br />

Pharma’s continued growth. The<br />

combined company had annual<br />

sales of approximately SEK 2,640 million for 2018.<br />

“Trimb is a distinguished company within<br />

over-the-counter pharmaceuticals and consumer<br />

healthcare products. Over the past years, the<br />

company has successfully built a Nordic business<br />

and a growing presence in Northern Europe. Trimb<br />

complements Karo Pharma well, both in terms of<br />

geographical presence, distribution channels and<br />

product offering. I look forward to continuing this<br />

THE COMPANY<br />

ANNOUNCES<br />

the addition<br />

of Nobel<br />

Laureate<br />

Dr James<br />

Allison and<br />

Oncologist<br />

Dr Padmanee<br />

Sharma from the MD Anderson<br />

Cancer Center to its SAB and as<br />

Company Strategic Advisors.<br />

Dr James (Jim) Allison (PhD) is<br />

Regental Professor and Chair of<br />

Immunology and Executive Director<br />

of Immunotherapy at the MD<br />

Anderson Cancer Clinic, University<br />

of Texas. He is also a director<br />

of the Cancer Research Institute<br />

scientific advisory council.<br />

His research elucidated the<br />

mechanism behind T cell activation<br />

and pioneered the first immune<br />

checkpoint blocker drug<br />

journey in a combined company,” comments<br />

Christoffer Lorenzen who took over as Karo<br />

Pharma’s new CEO 1 July <strong>2019</strong>.<br />

ARO PHARMA ESTIMATES that the<br />

transaction will bring synergy<br />

potential for the company in<br />

the form of both sales and cost<br />

synergies. The company has<br />

an ambition to achieve annual<br />

synergies of SEK 50 million in 2021 when fully<br />

realized. Achieving these synergies implies<br />

estimated integration costs of approximately SEK<br />

30–40 million in total, which will be taken during<br />

the period <strong>2019</strong> and 2020.<br />

NOBEL LAUREATE<br />

JAMES ALLISON JOINS LYTIX BIOPHARMA’S<br />

SCIENTIFIC ADVISORY BOARD<br />

for the treatment of cancer. His<br />

work has radically transformed the<br />

landscape for cancer treatment,<br />

shifting it away from targeting a<br />

tumour to instead using the<br />

immune system to destroy<br />

cancer cells. His current research<br />

is focused on improving the<br />

utility of checkpoint blockade and<br />

identifying new targets to unleash<br />

the immune system to eradicate<br />

cancer.<br />

The Norwegian cancer<br />

vaccine company has<br />

raised NOK 370 million<br />

and entered the Oslo<br />

Stock Exchange on June<br />

3rd <strong>2019</strong>.<br />

SEVERAL INTERESTED PARTIES<br />

have now become shareholders<br />

in the company, totaling<br />

approximately 1500<br />

shareholders.<br />

“It is good for the Norwegian<br />

health industry and<br />

for Ultimovacs when national<br />

and international investors<br />

show the company this kind<br />

of trust. In today’s uncertain<br />

market, it is especially nice<br />

with such a large interest,<br />

from both international<br />

investors and small savers. I<br />

look forward to following the<br />

company further,” says Jonas<br />

Einarsson, Chairman of the<br />

Board in Ultimovacs and Managing<br />

Director in Radforsk.<br />

The funds that Ultimovacs<br />

has raised will go to<br />

financing the development<br />

of their universal cancer<br />

vaccine, UV1. A large clinical<br />

study will document the<br />

effect of the vaccine. UV1<br />

will be combined with other<br />

immunotherapies in patients<br />

with malignant melanoma (a<br />

type of skin cancer) at around<br />

30 hospitals in Norway,<br />

Europe, USA and Australia.<br />

Ultimovacs has already run<br />

two successful clinical trials of<br />

the vaccine on patients with<br />

lung cancer, prostate cancer<br />

and malignant melanoma.<br />

“I am very happy that<br />

we now have entered the<br />

Oslo Stock Exchange. It<br />

means that the practical<br />

conditions are in place to<br />

put our development<br />

program into action,” says<br />

Øyvind Kongstun Arnesen,<br />

CEO of Ultimovacs.<br />

NORDICLIFESCIENCE.ORG 11


TOP STORIES BUSINESS<br />

PHARMA<br />

ASTRAZENECA’S<br />

CALQUENCE<br />

GRANTED BREAK-<br />

THROUGH THERAPY<br />

DESIGNATION<br />

THE FDA HAS GRANTED THE<br />

DESIGNATION AS A MONOTHERAPY<br />

TREATMENT FOR ADULT PATIENTS<br />

WITH CHRONIC LYMPHOCYTIC<br />

LEUKAEMIA (CLL).<br />

BUSINESS DEAL<br />

QUANTERIX CORPORATION WILL ACQUIRE PRIVATELY HELD UMAN-<br />

DIAGNOSTICS FOR $22.5 MILLION, COMPRISED OF $16 MILLION IN CASH<br />

PLUS $6.5 MILLION IN QUANTERIX COMMON STOCK.<br />

HE MERGER<br />

BETWEEN<br />

the companies<br />

holds<br />

great promise<br />

for<br />

unlocking<br />

the value of Neurofilament<br />

Light, says Niklas Norgren,<br />

CEO of UmanDiagnostics.<br />

UmanDiagnostics, based<br />

in Umeå, Sweden, supplies<br />

Neurofilament Light (Nf-L)<br />

antibodies and ELISA kits,<br />

widely recognized by researchers<br />

and biopharmaceutical and<br />

diagnostics companies worldwide<br />

as the premier solution<br />

for the detection of Nf-L to<br />

advance the development<br />

of therapeutics and diagnostics<br />

for neurodegenerative<br />

conditions. Nf-L has seen a<br />

dramatic growth in the last<br />

three years since Quanterix<br />

developed the first assay using<br />

Uman’s antibodies that could<br />

reliably measure Nf-L in blood.<br />

Nf-L has demonstrated<br />

utility in the diagnosis, prognosis,<br />

and monitoring of a wide<br />

range of conditions including<br />

Alzheimer’s Disease, Multiple<br />

Sclerosis, Parkinson’s Disease,<br />

traumatic brain injury (TBI),<br />

ALS, Huntington’s Disease.<br />

“We believe that the ability<br />

to measure Nf-L in blood is<br />

one of the most significant<br />

advances in diagnosis and<br />

monitoring of a wide range<br />

of neurodegenerative conditions<br />

and has the potential<br />

to dramatically improve the<br />

The UmanDiagnostics team<br />

lives of people suffering from<br />

some of the most debilitating<br />

diseases impacting society,”<br />

says Kevin Hrusovsky, CEO of<br />

Quanterix. ”The acquisition<br />

will allow us to better support<br />

growing research with Nf-L<br />

and ultimately has the potential<br />

to accelerate the availability<br />

of diagnostic tests.”<br />

“We greatly look forward to<br />

further advancing the field as<br />

part of Quanterix. We are compelled<br />

by Quanterix’ vision,<br />

mission, and strategy for disrupting<br />

the field of neurodegeneration<br />

research and diagnostics<br />

and are confident in the<br />

management team’s ability to<br />

continue its superb execution<br />

against this substantial opportunity,”<br />

says Niklas Norgren.<br />

THIS IS AN important regulatory<br />

milestone for our work in<br />

haematology and for patients<br />

living with chronic lymphocytic<br />

leukaemia, a life-threatening<br />

disease, states José Baselga,<br />

Executive Vice President,<br />

Oncology R&D, AstraZeneca.<br />

”The Breakthrough Therapy<br />

Designation (BTD) acknowledges<br />

the growing body of evidence<br />

that supports Calquence<br />

as a highly-selective Bruton<br />

tyrosine kinase inhibitor with<br />

the potential to offer patients a<br />

new, differentiated, chemotherapy-free<br />

treatment option<br />

with a favourable safety profile,”<br />

says Baselga.<br />

The FDA granted the BTD<br />

based on positive results from<br />

the interim analyses of the<br />

ELEVATE-TN and ASCEND<br />

Phase III clinical trials. Together<br />

the trials showed that Calquence<br />

alone or in combination significantly<br />

increased the time<br />

patients lived without disease<br />

progression or death, with<br />

safety and tolerability that was<br />

consistent with its established<br />

profile.<br />

This is the 10th BTD that<br />

AstraZeneca has received from<br />

the FDA since 2014.<br />

José Baselga<br />

12<br />

NORDICLIFESCIENCE.ORG


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BUSINESS<br />

ENTERS LICENSE AGREEMENTS<br />

Together with Everest Medicines the company will<br />

develop and commercialize Nefecon in Greater China<br />

and Singapore and it has also in-licensed Budenofalk<br />

for the US market from Dr. Falk Pharma.<br />

NDER THE TERMS<br />

of the agreement<br />

with Everest, Calliditas<br />

will receive an<br />

initial upfront payment<br />

of MUSD 15 on signing of<br />

the agreement, as well as future<br />

payments linked to pre-defined<br />

development, regulatory and<br />

commercialization milestones<br />

up to an additional MUSD 106,<br />

including an option worth up to<br />

MUSD 20 for the development<br />

of Nefecon in other potential<br />

indications. Everest will also pay<br />

typical royalties on net sales.<br />

Calliditas is currently running<br />

a global Phase 3 clinical trial with<br />

Nefecon for the treatment of patients<br />

with IgAN. The agreement<br />

gives Everest exclusive rights<br />

to develop and commercialize<br />

Nefecon in China, Hong Kong,<br />

Macau, Taiwan and Singapore<br />

and may, depending on the<br />

outcome of consultation with the<br />

relevant regulatory authorities,<br />

lead to the inclusion of Chinese<br />

study centers in the ongoing<br />

study, NefIgArd, with the result of<br />

achieving registration approval<br />

for the Chinese market on an<br />

accelerated basis. Following<br />

potential registration approvals,<br />

Everest will be responsible for<br />

the commercialization of Nefecon<br />

in the relevant territories.<br />

HE AGREEMENT WITH<br />

Dr. Falk covers all<br />

indications for the<br />

US market, excluding<br />

orphan indications<br />

outside of liver targets. Initially,<br />

Calliditas will leverage Dr. Falk’s<br />

clinical trial data and expertise in<br />

liver indications, such as autoimmune<br />

hepatitis with a view to<br />

accelerate approval and market<br />

access. The deal has an initial<br />

upfront payment of M€1.5 and<br />

foresees additional regulatory<br />

related payments, subject to<br />

market approval from the FDA.<br />

The total deal value amounts<br />

to M€40, including future sales<br />

milestones and comes with<br />

typical royalties.<br />

Calliditas initially aims to<br />

leverage positive clinical trial<br />

data from Dr. Falk to support discussions<br />

with the FDA, focused<br />

on receiving guidance on the<br />

clinical program necessary to<br />

obtain an approval to market the<br />

product in the US.<br />

ANETTE ROMARE<br />

M.Sc. Chem. Eng. & Biotechnology<br />

European Patent Attorney<br />

Anette has a chemical background<br />

with particular expertise in<br />

absorbent products. She has vast<br />

experience of EPO opposition and<br />

appeal proceedings as well as<br />

patent evaluations and opinions.<br />

www.valea.eu


TOP STORIES BUSINESS<br />

PHOTO LARS OWESSON/GAMBRO<br />

Guido Oelkers, CEO, Sobi<br />

REORGANIZATION<br />

Swedish Orphan Biovitrum (Sobi) will acquire, from Novimmune’s<br />

shareholders, a newly established company owning emapalumab<br />

and related assets. It has also announced a reorganization and<br />

90 employees will be laid off.<br />

in orphan drugs a cost reduction for the<br />

application fee for future products and<br />

shortens the review period. The voucher<br />

can be used or sold by Sobi.<br />

“This will allow us to realize the full<br />

potential of emapalumab as an important<br />

treatment in the area of Immunology and<br />

address a significant unmet medical need.<br />

Immunology is one of our key focus areas<br />

where we can make a significant difference<br />

to patients’ lives. We look forward<br />

to welcoming our new colleagues to join<br />

us in this mission and create an even<br />

stronger Sobi,” says Guido Oelkers, Sobi<br />

President and CEO.<br />

The company has also announced that<br />

it intends to carry out a reorganization<br />

to increase the focus of R&D resources<br />

to support its two core therapeutic areas:<br />

Haematology and Immunology. The<br />

company intends to establish two centers<br />

of excellence, for Haematology in Sweden<br />

and for Immunology in Switzerland.<br />

Sobi also intends to discontinue<br />

discovery/early research and partner<br />

R&D programs outside its core focus<br />

areas. This includes the intention to<br />

divest the SOBI-006 project and the<br />

SOBI003 project. The new focus of the<br />

R&D organization is expected to lead to<br />

annual savings of SEK 200–<strong>300</strong> million<br />

on a full-year basis in 2020, which will<br />

increase the company’s financial flexibility<br />

to reallocate future investments into<br />

late-stage development projects.<br />

Restructuring costs of around SEK<br />

100–200 million relating to the reorganization<br />

and redundancies corresponding<br />

to approximately 90 positions will be<br />

charged in <strong>2019</strong>.<br />

the acquisition is CHF 515 M (SEK 4,897<br />

million), of which CHF 400 M was previously<br />

committed in the exclusive license<br />

agreement for emapalumab. The acquisition<br />

is expected to be earnings neutral in<br />

<strong>2019</strong> and completed during Q3 <strong>2019</strong>,<br />

subject to customary closing conditions.<br />

Through the acquisition of emapalumab,<br />

Sobi gains access to: all assets relating<br />

to emapalumab including intellectual<br />

property, patent rights, data and knowhow,<br />

all relevant and highly experienced<br />

employees involved in the clinical and<br />

biopharmaceutical development of<br />

emapalumab, options for the shared<br />

financial rights to NI-1701 and NI-1801,<br />

two product candidates in the field of<br />

immuno-oncology, a priority review<br />

voucher within the US Food & Drug<br />

Administration’s priority review program,<br />

which offers companies investing<br />

Sobi headquarters<br />

14 NORDICLIFESCIENCE.ORG


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Contact: +45 6593 2920 • dblab@dblab.dk • dblab.dk<br />

– more than a lab


BUSINESS<br />

INTERVIEW<br />

NanoZolid enables the<br />

controlled, long-term<br />

and personalized release<br />

of drugs for up to six months


The last few months have been very eventful for LIDDS; the last<br />

patient has been e<strong>nr</strong>olled in their localized treatment of prostate<br />

cancer study and they are evaluating a possible listing on Nasdaq<br />

Stockholm’s Main Market. The CEO of LIDDS, Monica Wallter,<br />

gives us an update.<br />

TEXT<br />

b y M A L I N O T M A N I<br />

hat’s next for LIDDS<br />

and what results can<br />

we expect during<br />

<strong>2019</strong>?<br />

“LIDDS will report<br />

the Phase IIb study<br />

very soon. Also, the Phase I study where solid<br />

tumors are injected with NanoZolid combined<br />

with docetaxel is ongoing and the first patient is<br />

treated. We have a preclinical program ongoing<br />

with STING agonists and additionally have very<br />

interesting other immune-oncology projects in<br />

the feasibility stage. Other highlights this year<br />

include the hiring of Charlotta Gauffin as Head<br />

of Clinical Development, and Markus Thor as<br />

Head of Business Development.<br />

We have also been invited to present the<br />

possibilities with the NanoZolid technology at<br />

recent conferences. Associate Professor Niklas<br />

Axén, Inventor and Head of Technology and<br />

Patents, attended the Pharma R&D Conference<br />

in Paris in March, and Stefan Grudén, Director<br />

of Pharmaceutical R&D, presented at the Formulation<br />

& Drug Delivery Congress in London in<br />

April.”<br />

What are your hopes and expectations<br />

for the future?<br />

“That LIDDS will be able to out license the<br />

clinical projects in prostate cancer and local<br />

cytostatic treatment of solid tumors after results<br />

are available. Additionally, that new projects will<br />

enter into clinical stage in the coming years.”<br />

You are evaluating a possible listing, what<br />

are the advantages?<br />

“A listing on Nasdaq Stockholm’s Main Market<br />

is a natural next step in the company’s development.<br />

Hopefully it will contribute to increased interest<br />

from a broader investor base as well as increased<br />

visibility, both in Sweden and globally.”<br />

In April, you initiated a novel TLR9 agonist<br />

project and announced a plan for a phase I<br />

clinical trial. Tell me more?<br />

“The NanoZolid technology addresses key<br />

issues in developing TLR agonists, as repeated<br />

intratumoral injections are needed using standard<br />

formulations. We will be focusing our project<br />

on TLR9, one of the most promising targets for<br />

increasing response and reversing resistance to<br />

immunotherapies. TLR9 agonists have been<br />

shown to be most effective when injected directly<br />

into a tumor. A preclinical program is ongoing to<br />

broaden the results obtained to date and we are<br />

now preparing for a Phase I clinical trial using<br />

NanoZolid combined with a TLR9 agonist. The<br />

first human study is planned to commence in<br />

2020. There is significant commercial potential<br />

in this area of research and drug development<br />

and the market for TLR agonists is expected to<br />

be worth hundreds of millions of dollars over the<br />

coming years.” <strong>NL</strong>S<br />

Monica Wallter<br />

FACTS<br />

NANOZOLID<br />

LIDDS AB<br />

develops<br />

injectable drugs<br />

for cancer and<br />

other diseases<br />

based on a<br />

NanoZolid<br />

technology.<br />

NanoZolid<br />

helps solve<br />

some of the<br />

main problems<br />

with the way<br />

drugs work in<br />

the body and<br />

which affect<br />

patient quality<br />

of life. NanoZolid<br />

enables the<br />

controlled,<br />

long-term<br />

and personalized<br />

release<br />

of drugs for up<br />

to six months.<br />

NanoZolid can<br />

be combined<br />

with traditional<br />

small molecules,<br />

as well as with<br />

larger molecules.<br />

In March this<br />

year the United<br />

States Patent<br />

and Trademark<br />

Office issued<br />

a Notice of<br />

Allowance for<br />

the NanoZolid<br />

technology<br />

patent. The<br />

same patent<br />

was approved<br />

by the European<br />

Patent Office in<br />

2018. With this<br />

new US patent,<br />

the NanoZolid<br />

technology will<br />

be protected<br />

until 2037 in<br />

both Europe<br />

and the US.<br />

NORDICLIFESCIENCE.ORG<br />

17


PHASE III<br />

THE COMPANY HAS ANNOUNCED POSITIVE OVERALL SURVIVAL (OS) RESULTS FROM<br />

THE PHASE III CASPIAN TRIAL WITH IMFINZI IN 1ST-LINE EXTENSIVE-STAGE SMALL<br />

CELL LUNG CANCER (SCLC).<br />

A PLANNED INTERIM analysis conducted by an Independent<br />

Data Monitoring Committee concluded<br />

that the trial has met its primary endpoint by showing<br />

a statistically-significant and clinically-meaningful<br />

improvement in OS in patients treated with<br />

Imfinzi in combination with standard-of-care etoposide<br />

and platinum-based chemotherapy options<br />

vs. chemotherapy alone. The safety and tolerability<br />

for this Imfinzi combination was consistent with the<br />

known safety profiles of these medicines.<br />

“The Phase III CASPIAN results offer<br />

new hope for patients who are facing the<br />

devastating diagnosis of small cell lung<br />

cancer, and for whom new medicines are<br />

urgently needed. This is the first trial offering<br />

the flexibility of combining immunotherapy<br />

with different platinum-based regimens in<br />

small cell lung cancer, expanding treatment<br />

options,” says José Baselga, Executive Vice<br />

President, Oncology R&D, AstraZeneca.


PHASE I/IIA<br />

NEW CLINICAL<br />

DATA FROM<br />

BIOINVENT<br />

Team Targovax<br />

COMBINATION TRIAL<br />

Martin Welschof,<br />

CEO, BioInvent<br />

Clinical responses were observed in three out of nine patients in<br />

part 1 of the ONCOS-102 and Keytruda combination trial in anti-PD1<br />

checkpoint inhibitor (CPI) refractory advanced melanoma.<br />

HE PRIMARY AND<br />

secondary<br />

endpoints of<br />

the trial are to<br />

assess safety,<br />

immune activation<br />

and clinical responses of<br />

ONCOS-102 and Keytruda<br />

combination treatment. The<br />

main scientific aim is to test<br />

the hypothesis that ONCOS-102<br />

can immune activate anti-PD1-<br />

resistant patients to respond<br />

to re-challenge with an anti-<br />

PD1 CPI.<br />

Part 1 safety data now shows<br />

that the sequential ONCOS-102<br />

and Keytruda treatment regimen<br />

is well tolerated. The efficacy<br />

is also very encouraging, with<br />

three of nine patients demonstrating<br />

a clinical response<br />

(33% ORR).<br />

The data also confirms the<br />

hypothesis that ONCOS-102<br />

is able to immune activate<br />

treatment-resistant tumors to<br />

respond to re-challenge with<br />

an anti-PD-1 CPI. ONCOS-102<br />

was also seen to induce profound<br />

innate and adaptive immune<br />

activation.<br />

Part 2 of the trial is currently<br />

e<strong>nr</strong>olling patients, where safety<br />

and efficacy of a more intensive<br />

treatment regimen of<br />

twelve ONCOS-102 injections<br />

will be evaluated.<br />

TARGOVAX HAS NOW also<br />

initiated an expansion part in<br />

their phase I/II trial with ON-<br />

COS-102 in combination with<br />

durvalumab. All safety reviews<br />

during the dose escalation<br />

phase have been completed<br />

with no Dose Limiting Toxicities<br />

(DLT) reported and the five<br />

US hospital sites are now open<br />

for further recruitment.<br />

This trial investigates the<br />

safety, biologic and anti-tumor<br />

activity of ONCOS-102 in<br />

combination with Imfinzi<br />

(durvalumab, anti-PD-L1) in<br />

patients with advanced peritoneal<br />

malignancies who have<br />

failed prior standard chemotherapy<br />

and have histologically<br />

confirmed platinum-resistant<br />

or refractory epithelial ovarian<br />

or colorectal cancer.<br />

Magnus Jäderberg,<br />

CEO, Targovax<br />

THE COMPANY HAS announced the<br />

publication of the first data from<br />

two parallel Phase l/lla clinical<br />

trials of its lead product candidate<br />

BI-1206 as a single agent and/or in<br />

combination with rituximab,<br />

currently being conducting in the<br />

UK and the US/EU, respectively.<br />

In the UK trial, 10 patients have<br />

received single agent therapy<br />

with up to 100 mg BI-1206 once<br />

weekly for a period of 4 weeks.<br />

In the US/EU study, five patients<br />

have received up to 100 mg<br />

BI-1206 in combination with<br />

rituximab.<br />

Receptor occupancy is dose<br />

proportionate and anticipated<br />

to yield high levels of receptor<br />

blockade at clinically relevant doses<br />

of BI-1206. While target-mediated<br />

drug disposition has not yet been<br />

overcome, as the optimal dose has<br />

still not been reached, pharmacodynamic<br />

analysis at the current doses<br />

showed depletion of peripheral B<br />

cells, including circulating mantle<br />

cell lymphoma cells during the first<br />

week of induction therapy.<br />

“These are exciting results that<br />

further support the development of<br />

BI-1206 as a potential first-in-class<br />

therapeutic with a unique mechanism<br />

of action. Circumventing<br />

rituximab internalization by FcγRIIB<br />

blocking means it will potentially<br />

enhance rituximab’s efficacy,” says<br />

BioInvent’s CEO, Martin Welschof.<br />

NORDICLIFESCIENCE.ORG 19


sheds light on<br />

inventors whose pioneering findings have<br />

provided answers to some of the biggest<br />

challenges of our times. In the medical<br />

technology sector, in the category research,<br />

the French immunologist Jérôme Galon<br />

was the winner.<br />

Galon has developed a diagnostic tool that helps medical<br />

staff predict the chances of recovery and risks of relapse in cancer<br />

patients based on the strength of their immune response. The<br />

test, Immunoscore, uses digital images of tumor samples and<br />

advanced software to measure the number of positive immune<br />

cells found at tumor sites, and is already in use at clinics around<br />

the world to improve the accuracy of prognosis for patients with<br />

colorectal cancer.<br />

“Jérôme Galon’s invention has had a major impact in the<br />

field of oncology,” said EPO President António Campinos. “It<br />

has already prompted the re-examination of cancer classification<br />

schemes and could ultimately give rise to new treatments.<br />

By launching a start-up and successfully using patents to commercialize<br />

his invention, Galon is bringing the technology to<br />

market so that his research efforts can make a difference where<br />

it counts most – in helping people.”<br />

EFFECTIVE THERAPIES WITHOUT OVER-TREATING<br />

Jérôme Galon broke new ground in cancer diagnostics in 2006.<br />

He showed that the strength of each patient’s immune system<br />

plays a key role in successfully fighting the condition. Galon<br />

patented his invention, an in-vitro diagnostic tool that quantifies<br />

the immune response of colon cancer patients at the site of the<br />

tumor. Independent researchers have since found that Immunoscore<br />

provides the most reliable prognostic to date for the risk<br />

of recurrence in solid cancers.<br />

“When I started working on cancer, the field was mostly<br />

focused on tumor cells,” Galon says. “But as an immunologist<br />

it was clear to me that the immune system plays a major role as<br />

well. By knowing how active his or her immune system is, we<br />

can predict if a cancer patient is at high risk or low risk of recurrence.<br />

This enables doctors to not only classify cancers more<br />

precisely, but also to give patients the most effective therapies,<br />

without over-treating them.”<br />

analyzing a<br />

small tissue sample that is surgically removed from the<br />

primary tumor of a patient. It monitors the cancer site,<br />

counting immune ‘cytotoxic’ T cells, which destroy<br />

cancerous or virally-infected cells. The more of these<br />

immune cells present in the tumor, the better the<br />

patient’s chances of survival. To conduct the test a<br />

specialized scanner takes digital images of the tumor<br />

sample on which the software counts the number of positive immune<br />

cells. An algorithm then calculates an overall Immunoscore<br />

for the patient based on T cell concentrations. This provides doctors<br />

with greater insight into both the severity of the cancer, and the risk<br />

of patients relapsing and dying in different stages of treatment.<br />

The test has been approved for use in colorectal cancer, where<br />

it has shown a 95% likelihood of predicting the overall survival<br />

of cancer patients, and has also reduced the unnecessary exposure<br />

of low-risk patients to toxic drugs.<br />

TRANSFORMING BASIC RESEARCH INTO REAL LIFE<br />

To bring his invention to market, Galon co-founded the<br />

Marseille-based company HalioDx in 2014. Over the past five<br />

years the company has grown to around 160 employees and<br />

raised more than EUR 26 million in financing. The company has<br />

partnered with medical distributors, including Philips, to share<br />

the benefits of Galon’s patented invention with more patients.<br />

“It is very rewarding to transform basic research into real<br />

life,” Galon says. “The company was supported by venture<br />

capital from the start, and investors looked hard at how deep<br />

and broad their patents were. Without the patents I would not<br />

have been able to raise the capital needed.”<br />

an immunologist<br />

at the Pasteur Institute and the<br />

Curie Institute in Paris and he received his<br />

PhD in immunology from Jussieu University<br />

in Paris in 1996. After working as a<br />

postdoctoral researcher at the National<br />

Institutes of Health in the US, Galon returned<br />

to Paris in 2001 to run a research<br />

group funded by INSERM. Today he is Director of Research at<br />

INSERM and Head of the Laboratory of Integrative Cancer Immunology<br />

at the Cordeliers Research Center. <strong>NL</strong>S<br />

22 NORDICLIFESCIENCE.ORG


ADVERTORIAL<br />

BUSINESS PRESENTATION<br />

RegSMART<br />

Life Science AB<br />

She understands that working with these<br />

kinds of projects requires changes to the<br />

regulatory mindset, as well as increased<br />

interaction between regulators, health<br />

technology bodies and payers.<br />

“Considering the type of products in<br />

the pipeline today, there will be a limited<br />

amount of data for the authorities and<br />

payers to evaluate. This puts pressure on<br />

both authorities and companies.”<br />

Marie Gårdmark, CEO,<br />

RegSmart Life Science<br />

REGSMART LIFE SCIENCE<br />

Center for Translational Research (CTR) has established a new regulatory<br />

company, RegSmart Life Science, with a focus on pharmaceuticals and medical<br />

devices. To meet today’s regulatory challenges, Marie Gårdmark (CEO), sees the<br />

need for a closer relationship between companies and authorities.<br />

EGSMART’S AIM is to help<br />

scientists and companies<br />

navigate through a complex<br />

regulatory landscape. “The<br />

conditions for the development<br />

of pharmaceuticals and medical devices<br />

are rapidly changing and to find the most<br />

successful way forward, profound regulatory<br />

competence is needed. We understand how<br />

the authorities reason and that regulatory<br />

guidelines do not always give you a straight<br />

answer. There are hardly simple yes or<br />

no’s,” Marie Gårdmark says.<br />

A CHANGE IN CLINICAL RESEARCH<br />

Marie Gårdmark has extensive regulatory<br />

experience as Director of Licensing at the<br />

Swedish Medical Products Agency and has<br />

had several regulatory strategic roles within<br />

the pharmaceutical industry. She sees a<br />

change in clinical research with, for example,<br />

much focus on treatments targeting small<br />

but urgent need patient populations.<br />

“The patients understand their own<br />

needs and are important in the development<br />

of new products, for example to determine<br />

what endpoints are most important to them.”<br />

CENTER FOR TRANSLATIONAL<br />

RESEARCH AB is a holding company<br />

that was founded in 2016. CEO is<br />

Mats Lindquist. The company partly<br />

owns RegSmart Life Science AB and<br />

CTC Clinical Trial Consultants AB.<br />

WWW.REGSMART.SE<br />

MAKE SURE WE ARE PREPARED<br />

Together with CTR, Marie Gårdmark wants<br />

to contribute to competency development<br />

within Life Science in Sweden. She believes<br />

that the positive collaboration climate and<br />

strong scientific heritage supports an expanding<br />

Swedish Life Science.<br />

“I sometimes meet those who see regulatory<br />

experts as naysayers. In my experience<br />

we are the opposite. Guidelines and regulations<br />

are constantly emerging, driven by<br />

research from the pharmaceutical and medical<br />

device industries.”<br />

Marie Gårdmark believes that the development<br />

of advanced therapies (ATMPs) will<br />

continue in the future.<br />

“As a society, we are challenged by these<br />

types of products and we may need to review<br />

both regulations and business models<br />

to make sure that we are prepared.”<br />

Medical devices such as digital apps<br />

and diagnostics tools are also an emerging<br />

market. RegSmart will help identify gaps<br />

in the development of pharmaceuticals and<br />

medical devices and suggest how to move<br />

forward.<br />

“We will guide companies in understanding<br />

the current view of the regulators.<br />

We will help in risk and opportunity assessment<br />

and in the development of the project<br />

strategy.”<br />

KNOW THE CHALLENGES<br />

Marie Gårdmark believes that the regulatory<br />

plan is an important part of a product’s<br />

developmental plan. With her scientific<br />

background and experience from both big<br />

and small sized pharma, she knows the<br />

challenges.<br />

“It’s important to understand the scientific,<br />

regulatory and commercial issues at an<br />

early stage. My role as a regulatory expert<br />

is to read between the lines and visualise the<br />

perspectives of the authorities.” <strong>NL</strong>S<br />

24 NORDICLIFESCIENCE.ORG


FINANCING<br />

PHOTO SALSS<br />

PHOTO UP THERE, EVERYWHERE AB<br />

PHOTO JENNY ÖHMAN<br />

Eugen Steiner has worked<br />

in venture capital for 23 years,<br />

but his roots as a medical<br />

doctor still influence the way<br />

he nurtures start-ups as<br />

a venture partner.<br />

read more on page 26<br />

Five different Nordic venture<br />

capitalists share their thoughts<br />

on the Nordic life science<br />

capital landscape and give<br />

advice to companies looking to<br />

raise capital.<br />

read more on page 34<br />

Two Nordic life science<br />

companies, Athera<br />

Biotechnologies and<br />

Forendo Pharma, have<br />

recently raised capital<br />

and we highlight their stories.<br />

read more on page 47<br />

At SALSS D.C. <strong>2019</strong> Swedish<br />

life science companies gained<br />

valuable insight into how they<br />

could gain entry into the US<br />

pharmaceutical market, the<br />

largest in the world.<br />

read more on page 50<br />

NORDICLIFESCIENCE.ORG<br />

25


26<br />

NORDIC LIFE SCIENCE


a venture partner [at HealthCap – a family<br />

of venture capital funds investing globally in life sciences]<br />

is like a company doctor. I deliver companies and help them<br />

grow until they can stand on their own feet,” Steiner says.<br />

“People think of venture capital as a source of money. But<br />

it is so much more than that. It’s like a marriage. You’re an<br />

outspoken partner. There will be friction in the relationship,<br />

but you have to be able to sit down together and discuss the<br />

issues that come up. The company is like a baby. There will<br />

be problems along the way raising it, but you work it out.”<br />

With his years of executive management experience, Steiner<br />

has helped deliver many companies. He has served as CEO<br />

for HealthCap portfolio companies including Affibody,<br />

Biostratum, Creative peptides, Eurona Medical, Melacure<br />

Therapeutics, Nordic Vision Clinics, PyroSequencing and<br />

Visual Bioinformatics.<br />

It was not the career he imagined for himself when he became<br />

a medical doctor at the Karolinska Institute, where he earned<br />

a PhD in Clinical Pharmacology. Until 1987, Steiner practiced<br />

medicine at Karolinska Hospital. He became a specialist in<br />

clinical pharmacology and was active in pharmacogenetic<br />

research at the Karolinska Institute.<br />

“I never thought about doing anything other than medicine,”<br />

Steiner says, as he sits in the well-appointed, handsome<br />

conference room at HealthCap’s headquarters in Stockholm,<br />

a far cry from the hustle and bustle of a hospital.<br />

28<br />

NORDIC LIFE SCIENCE


Eugen Steiner has for example<br />

served as CEO of Affibody,<br />

Biostratum, Creative peptides,<br />

Eurona Medical, Melacure<br />

Therapeutics, PyroSequencing<br />

and Visual Bioinformatics.<br />

NORDICLIFESCIENCE.ORG<br />

29


Then, one day, an unexpected opportunity came his way.<br />

“I was invited to be CEO of a clinical lab company called<br />

Calab. They had invented the first large-scale laboratory robots<br />

and were pioneers in building automated computerized analytical<br />

machines. They were keen that a doctor and researcher should<br />

be in the lead. The offer came out of the blue really. It was not<br />

something I was looking to do. I was happy with my career,<br />

after my PhD.”<br />

The offer, he reflects, is not one he could refuse. “It was<br />

basically a door that opened. In academia it would take ten<br />

or more years to have your own lab, but here I was being<br />

invited to do just that,” Steiner says. “And it was there that<br />

I learned about running a business.”<br />

When he left his position at Calab in 1996 after the company<br />

was sold to the healthcare company Capio, Steiner says, “I started<br />

to look around for something else to do.”<br />

At the time HealthCap had just been started by Björn<br />

Odlander and Peder Fredrikson. “They were sitting on boxes<br />

with borrowed furniture,” Steiner recalls when he met with<br />

them. “They started something unique in Sweden: venture<br />

capital in life sciences. A lot of large pharmaceutical companies<br />

like AstraZeneca [formerly Astra AB] and Pharmacia had<br />

been investing in medical research but at the time there was<br />

no venture capital.”<br />

Steiner was intrigued and agreed to come on board. Today<br />

HealthCap is one of the largest life sciences venture capital<br />

firms in Europe. It has invested in 113 companies, with 22<br />

approved drugs, $40 billion in accumulated sales, 50 medical<br />

technology products, and over two million treated patients.<br />

Some 50 to 70 clinical trials are usually ongoing at any time<br />

with its portfolio companies, Steiner says. There have been<br />

over 66 exits.<br />

His preference, he says, is working with start-ups. “I have<br />

worked with a dozen companies. Some are public companies<br />

today, others unfortunately failed, while still others were<br />

acquired.”<br />

The journey, he explains, is always interesting, even when<br />

a promising idea or company doesn’t pan out in the end. “We<br />

focus on the companies, to reach breakthrough rather than<br />

finances. It’s about recruiting the right people as well as raising<br />

money and building the infrastructure of the company. We<br />

not only invest money, we invest a lot of our time and our<br />

soul into the companies we work with.”<br />

Like an ambitious child, these companies often yearn to<br />

spread their wings far from home. For many, that means<br />

becoming a successful life sciences company in the US. It is<br />

the biggest pharmaceutical market in the world, valued at<br />

around $446 billion in 2018, and representing over 45 percent<br />

of the global pharmaceutical market.<br />

Steiner agrees it is important for a Swedish company to<br />

have a physical presence in the US. “Once you start large<br />

clinical trials it is good to have a location in the US,” he says.<br />

30<br />

NORDIC LIFE SCIENCE


”När människor tänker på ”framtiden” tycks<br />

den ofta upplevas som väldigt långt borta. Därför<br />

har vi döpt museet till ”imorgon”. Det ligger närmare<br />

i tiden och påverkas av vad vi gör idag.”<br />

HUGO BARRETO, GENERALSEKRETERARE FÖR ROBERTO MARINHO FOUNDATION<br />

NORDICLIFESCIENCE.ORG<br />

31


32<br />

NORDIC LIFE SCIENCE


To help their portfolio companies get a foothold in the US,<br />

HealthCap often co-invests with companies in the US.<br />

“It is easier for Europe to invest in the US than for US<br />

investors to do the same here. There is ample opportunity to<br />

invest in the US. Swedish companies are known to have very<br />

good quality and a high valuation.”<br />

He notes that the investment landscape in the US moves<br />

much more quickly and it is most likely the larger American<br />

investment or venture capital firms that will invest in Swedish<br />

companies.<br />

But whether the initial market is in Sweden, Europe or the<br />

US, the challenges of becoming successful are often significant<br />

for a life science start up, Steiner explains. HealthCap, for<br />

instance, receives some <strong>300</strong> to 400 proposals each year and<br />

can only accept a few.<br />

“For those companies we do choose to work with, the sky’s<br />

the limit for helping them reach their potential. Once we<br />

decide to invest, the next day we are a company’s best friend<br />

and will open our networks for them and do everything we<br />

can to help them succeed. We are also very respectful and try<br />

to be helpful in other ways when we have to say no,” he says.<br />

He lists all of the expertise a successful life science start-up<br />

must possess, especially to break into the US market: an<br />

understanding of the disease area in which the company is<br />

focused; and knowledge of the drug development process and<br />

the regulatory environment.<br />

“We look for people who can manage all these complexities,”<br />

he says. “There’s a difference between the geniuses who<br />

invent stuff and very smart people who can turn the discovery<br />

into products. You need both, as well as the business developers<br />

who create the network, and the investors.”<br />

“We also encourage companies not to build too large fixed<br />

cost structures, but to use consultants for efficiency. It is important<br />

to find out quickly if the technology works or doesn’t<br />

work, so it doesn’t cost investors so much money as opposed<br />

to failing late at the clinical stage,” he says.<br />

That is because the world yearns for the solutions that<br />

science and medicine can offer, he adds.<br />

“Society wants the solutions that healthcare can provide.<br />

The new drug that has taken years to develop may seem<br />

expensive but if it will reduce the total cost of care for a<br />

disease, or reduce the number of days in the hospital, the<br />

economics are often beneficial,” Steiner says. “We are always<br />

looking at that. We understand the medical needs. We’re<br />

looking for companies that really solve medical needs – not<br />

an improved mousetrap but which offer innovations that in<br />

a fundamental way tackle a medical problem.”<br />

Would he turn back the clock and return to his days in the<br />

research lab or as a practicing medical doctor? Not a chance,<br />

Steiner says.<br />

“What’s incredible is the close interaction I have with<br />

all these very smart people who do brilliant work. And yes,<br />

sometimes they fail. But even then, we try to help them find<br />

positions where they can do good. They are really passionate<br />

people. It’s a privilege to work in this environment.” <strong>NL</strong>S<br />

As for mistakes to avoid, Steiner advises start-ups that before<br />

there is any real revenue, “make sure there is money to pay<br />

the bills. And don’t plan clinical trials that aren’t designed to<br />

really answer the questions you need to answer. If you take<br />

shortcuts, it is seldom profitable. And if you’ve done everything<br />

right, and you still don’t succeed, the ethical thing is to<br />

close down the company. Otherwise it’s a waste of investors’<br />

money, resources and people.”<br />

Steiner knows all too well the barriers that face even the<br />

most promising start-up. “Even though times have been<br />

good, it is difficult to raise capital for them. And very few<br />

life sciences companies actually make money today, with<br />

real sales. But good companies who have good people and a<br />

novel, well-thought-out product and strategy will always find<br />

capital – even when times are not so good.”


Christian Elling,<br />

Managing Partner,<br />

Lundbeckfonden<br />

Emerge


hat kind of companies<br />

are you and<br />

your colleagues<br />

focusing your<br />

investments on?<br />

And what stages?<br />

“We seek to identify and initiate development<br />

of scientific opportunities that could<br />

solve significant unmet medical needs and<br />

that have substantial commercial impact<br />

and value. We also make Exploratory<br />

Investments – investments in exciting and<br />

promising projects that have no or very<br />

limited data to support the investment<br />

hypothesis. It is high risk and we only invest<br />

less than two million EUR to begin with,<br />

but later – if the idea turns out to be as<br />

amazing as we thought – we can make follow<br />

up investments and provide substantially<br />

more capital to further develop the company.<br />

The Lundbeck Foundation also has a<br />

philanthropic side, where we grant more<br />

than 500 million Danish kroner in academic<br />

research grants every year – more than<br />

half of that is given to brain research.”<br />

What are some of your basic criteria<br />

to invest capital in a company? What<br />

factors do you consider especially<br />

important?<br />

“To put it simply, we are looking for great<br />

science and great people. We often invest in<br />

early stage companies. The Lundbeckfonden<br />

Emerge is about translating exciting new<br />

science and less about late stage clinical phase<br />

2 or 3, unless in niche indications. We invest<br />

in early stage companies or even in an amazing<br />

idea with not much data that we find exciting.<br />

But it can also be a project that has been<br />

around for some time, e.g., growing from<br />

pre-clinical to clinical.<br />

The intention is to stay with the company<br />

from the initial investment until an exit, which<br />

typically would require clinical phase 2<br />

data. That means we can own companies<br />

for quite a number of years. We are quite<br />

picky in what companies we invest in. They<br />

have to fit us, our strategy and what we are<br />

trying to achieve. We make fewer investments<br />

than some other investors. However, that<br />

enables us to ensure we have enough cash<br />

reserves to allow companies to truly test<br />

their hypothesis.<br />

We are active owners. That means<br />

engaging with the company and founders<br />

to help them mature their plans and execution,<br />

ranging from as early as defining a<br />

professional business plan to how to make<br />

proper strategic choices later on. Quite<br />

a lot of the people we invest in are just<br />

out of university and don’t have a mature<br />

management team yet. We help them grow<br />

and build the company – sometimes we step<br />

in as interim CEO or COO and establish a<br />

good management team. But most of our<br />

later work is done from the board level, as<br />

a company over time needs to develop a<br />

strong management team.”<br />

Could you give an example of a common<br />

mistake among startups?<br />

“Underestimation. In many shapes and<br />

forms. Classical biotech drug development<br />

projects, and generally speaking new startups,<br />

underestimate what it takes to raise money.<br />

They don’t see clearly what investors are<br />

looking for to invest in their companies.<br />

They are great scientists but don’t have the<br />

experience it takes to build a company and<br />

that often makes them too optimistic with<br />

regards to what you can do and how the<br />

investors will react.<br />

The people we invest in have to show us<br />

their business plan and often those business<br />

plans require substantial revision. But as<br />

long as the idea is right, we can re-write the<br />

plan together and come up with something<br />

that we believe in – and eventually help get<br />

additional investors on board.”<br />

Could you mention a current strength<br />

or trend among Denmark’s life science<br />

companies?<br />

“Well, in recent years some local companies<br />

have successfully built international<br />

venture capital syndicates with their existing<br />

investors and raised substantial funds<br />

in early financing rounds. We have seen<br />

that in our portfolio of companies and that<br />

is very encouraging. Importantly, it reflects<br />

that there are local investors, such as<br />

Lundbeckfonden Emerge, who are willing<br />

and able to invest substantial amounts early<br />

to share the risk with new international<br />

investors. It is very important that this<br />

trend continues for the further development<br />

of local biotech.”<br />

What advice do you have for small<br />

and mid-sized life science companies<br />

looking to raise capital?<br />

“You are trying to develop a commercially<br />

valuable product, so focus on the product!<br />

What exactly is your product? What difference<br />

does it make for the patients and for<br />

the payers? Is there a need for it? US biotech<br />

companies are often more successful in<br />

building products because they understand<br />

that the product is key and focus on that<br />

early on.<br />

My second piece of advice is think long<br />

term, e.g., ask yourself when you want to<br />

reach the market. Any investor will look<br />

at your project and try to determine if it is<br />

thought through. Does your future product<br />

have merit – when it reaches the market<br />

in more than 10 years? Investors need to<br />

exit with a profit, they have to provide a<br />

return on investment, and they need to have<br />

a commercial product that makes sense for<br />

patients and payers when it reaches the<br />

market. My third piece of advice is think<br />

long and hard about your team. Are you<br />

employing the right people? Any investor<br />

is in the human resource business and<br />

invests in teams. What does your team look<br />

like and where will it take the company?<br />

And lastly, think about the syndicate<br />

of investors you are trying to build. Are<br />

you aligned with the investors? How can<br />

the investors help you get to where you<br />

need to go? Who will add value – money,<br />

knowledge, network, experience – to your<br />

company?” <strong>NL</strong>S<br />

NORDICLIFESCIENCE.ORG<br />

35


team to be complete – we often help recruit<br />

to the team through our network, as the<br />

growth and development of a start-up<br />

requires different types of skillsets.”<br />

hat kind of companies<br />

are you and<br />

your colleagues<br />

focusing your<br />

investments on?<br />

And what stages?<br />

“Hadean Ventures is a Nordics-focused,<br />

European life science VC fund manager.<br />

We invest broadly in the life science space,<br />

including pharma/biotech, medtech,<br />

diagnostics, and digital health. We are a<br />

typical Ser A investor, but we also mix in<br />

some later stage investments.”<br />

Ingrid Teigland Akay,<br />

Managing Partner,<br />

Hadean Ventures<br />

Ingrid Teigland Akay is Managing Partner at Hadean Ventures, a life<br />

science fund manager that invests in life science companies across<br />

Europe, with a particular focus on the Nordic region.<br />

What are some of your basic criteria<br />

to invest capital in a company? What<br />

factors do you consider especially<br />

important?<br />

“We look for companies that can solve<br />

an unmet medical need, and a solid market<br />

potential needs to be present. The asset<br />

needs to be protectable, typically through<br />

patent protection. We furthermore look<br />

for management teams/founders whom we<br />

believe we can work well with for many<br />

years to come – through “thick and thin”.<br />

That doesn’t mean we expect a management<br />

Could you give an example of a common<br />

mistake among start-ups?<br />

“Many start-ups underestimate the<br />

challenge and time it takes to raise capital<br />

and start this process to late. You should<br />

start initial conversations with investors<br />

early, preferably long before you need any<br />

money – such conversations help to understand<br />

what kind of aspects the investors<br />

focus on.”<br />

Could you mention a current strength<br />

or trend among Norway’s life science<br />

companies?<br />

“There are a number of areas of<br />

strength, not only in Norway but across<br />

the Nordic region. These areas include oncology,<br />

immunology, medtech and digital.<br />

We have seen a strengthening of a number<br />

of life science hubs and clusters across the<br />

region that help grow interesting start-ups<br />

on the basis of very strong science.”<br />

What advice do you have for small and<br />

mid-sized life science companies looking<br />

to raise capital?<br />

“There are a couple of things I would<br />

highlight. First of all, as mentioned, don’t<br />

delay your fundraising process. These<br />

processes take a lot of time. Furthermore<br />

– know your audience and prepare well.<br />

Remember to adjust your presentation,<br />

your terminology and the level of details<br />

based on who you are speaking to. And<br />

ideally, try to team up with investors who<br />

can assist you with more than just the<br />

capital. The ideal investor is a long-term<br />

partner who understands your industry<br />

and is prepared to support you throughout<br />

the development.” <strong>NL</strong>S<br />

36 NORDICLIFESCIENCE.ORG


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PHOTO MARGARETA BLOM SANDBAECK<br />

Jonas Jendi,<br />

Investment Manager,<br />

Industrifonden<br />

hat kind of companies<br />

are you and your colleagues<br />

focusing your<br />

investments on? And<br />

what stages?<br />

“As a foundation and VC fund we have<br />

a split focus on life science and technology.<br />

On the life science side our current focus<br />

lies on pharmaceuticals/biotech, medical<br />

devices, and digital health. We invest in early<br />

stage companies with global potential, and<br />

a first ticket is normally between 10–50<br />

million SEK.”<br />

What are some of your basic criteria<br />

to invest capital in a company? What<br />

factors do you consider especially<br />

important?<br />

“Obviously, the science and the team<br />

are key factors. We also seek out opportunities<br />

where there is a great unmet medical<br />

need, as well as a willingness to pay for<br />

innovation.”<br />

Could you give an example of a<br />

common mistake among startups?<br />

“We often see entrepreneurs underestimating<br />

the challenges in the transition<br />

from relying on soft funding to relying<br />

on equity funding. Another thing we see<br />

is unstructured cap table (crowded, too<br />

many owners and owners unaware of<br />

large upcoming funding needs).”<br />

Could you mention a current strength<br />

or trend among Sweden’s life science<br />

companies?<br />

“Sweden has a large pool of experienced<br />

experts and executives, and in addition to<br />

that many risk-taking early stage investors,<br />

also with a deep expertise within the area.”<br />

What advice do you have for small and<br />

mid-sized life science companies looking<br />

to raise capital?<br />

“Invest in the early, pre-clinical work,<br />

even when that work is not appreciated<br />

by all funding sources. It will pay off later<br />

when pitching to international equity<br />

investors. Also, compare yourself directly<br />

to international peers, also in terms of<br />

fund raising, and aim high. And finally,<br />

build a strong team, with skillsets that<br />

complement each other.” <strong>NL</strong>S<br />

NORDICLIFESCIENCE.ORG<br />

39


CRS.<br />

Experts.<br />

Early Phase.<br />

www.crs-group.de<br />

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Concept in Patients.<br />

Hannu Rautanen<br />

Director<br />

Business Development<br />

hannu.rautanen@crs-group.de<br />

+358 400 75 20 07<br />

Dr. Volker Menschik<br />

Chief Business Officer<br />

(CBO)<br />

volker.menschik@crs-group.de<br />

+49 151 52 64 16 33<br />

CRS. Your number one CRO<br />

for Early Phase in Europe.<br />

More than 2.000 successfully completed trials.<br />

Five clinical research units. 260 beds.<br />

Fourty years of experience (Phase I – IIa).<br />

Reliable access to various patient populations and<br />

healthy volunteers.


What are some of your basic criteria<br />

to invest capital in a company? What<br />

factors do you consider especially<br />

important?<br />

“We want to see solid science and<br />

research behind the project that usually<br />

also entails that the teams – we always<br />

invest in teams instead of one wo(man)<br />

projects – have good networks in their<br />

professional field. Syndication is also important<br />

for us. Good syndicates increase<br />

the likelihood of success.”<br />

Petri Laine, Managing<br />

Partner, Innovestor Ventures<br />

ould you give an example<br />

of a common mistake<br />

among startups?<br />

“Underestimating costs.<br />

You should always budget<br />

for unseen delays or extra costs. Stakeholder<br />

management is also important. It is<br />

much easier to go for additional funding<br />

if you have kept your stakeholders and<br />

investors informed transparently about<br />

where your company is. Especially about<br />

the bad news.”<br />

hat kind of companies<br />

are you and your<br />

colleagues focusing<br />

your investments<br />

on? And what stages?<br />

“Innovestor invests in all fields of<br />

technologies. Life science, medtech and<br />

health are some of the areas we are active,<br />

and the current portfolio is approximately<br />

25 companies. We have in our portfolio<br />

hardcore drug development as well as<br />

diagnostics and medical devices. Our initial<br />

investments have always been relatively<br />

early phase investments, but not seed.”<br />

Could you mention a current strength<br />

or trend among Finland’s life science<br />

companies?<br />

“Universities have invested a lot in<br />

developing their business support systems.<br />

New novel treatments e.g., in oncology<br />

are interesting. A good example of that is<br />

Tenboron.”<br />

What advice do you have for small and<br />

mid-sized life science companies looking<br />

to raise capital?<br />

“Go out early. Go to events and meet<br />

people. Fund raising requires a lot of leg<br />

work and you ought to reserve enough<br />

time and resources for that.” <strong>NL</strong>S<br />

NORDICLIFESCIENCE.ORG<br />

41


Jonas Hansson,<br />

Venture Partner,<br />

HealthCap<br />

hat kind of companies<br />

are you and your<br />

colleagues focusing<br />

your investments on?<br />

And what stages?<br />

“We invest in companies/assets in the<br />

precision medicine (right medicine for the<br />

right patient) space. We like to be early<br />

into the equity meaning that we often<br />

invest in seed or Series A financings. We<br />

also like to start companies ourselves<br />

around certain assets we identify. On the<br />

asset side, we like to invest in assets that<br />

have at least generated strong pre-clinical<br />

data in relevant disease models, or assets<br />

that are in early clinical development.”<br />

What are some of your basic criteria to<br />

invest capital in a company?<br />

“The criteria we look for are significant<br />

unmet medical need, where the product(s)<br />

we invest in has the potential to significantly<br />

improve the life of the patient it addresses,<br />

well-understood disease biology and<br />

mechanism of action for the drug(s) that<br />

the company is developing, and a strong<br />

team and IP. We also make sure we see a<br />

development plan forward (all the way to<br />

approval of NDA/BLA/MAA) that is possible<br />

to finance in the VC community, i.e.,<br />

we should not be dependent on the public<br />

market or having to do a deal with large<br />

pharma/biotech. As I mentioned, we want<br />

to be early into the equity but invest in assets<br />

that are a bit more advanced.”<br />

Could you give an example of a common<br />

mistake among startups?<br />

“That they have a very optimistic view<br />

on timelines, and hence capital needs, and as<br />

a result they are often under financed.”<br />

PHOTO DAN COLEMAN<br />

Could you mention a current strength<br />

or trend among Sweden’s life science<br />

companies?<br />

”They have become better at attracting<br />

also international investors. We always<br />

syndicate with other VC’s when we invest<br />

in a company, and we often invite international<br />

investors into the deals we work on.”<br />

What advice do you have for a small or<br />

mid-sized life science company looking<br />

to raise capital?<br />

“Make sure you get the right investors<br />

onboard, i.e., those who can add more<br />

than just money, for example experience<br />

and networks.” <strong>NL</strong>S<br />

42 NORDICLIFESCIENCE.ORG


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ADVERTORIAL<br />

POTTERCLARKSON.COM<br />

BY STEPHEN MCNEENEY PHD, UK AND EUROPEAN PATENT ATTORNEY,<br />

PARTNER AT POTTER CLARKSON LLP<br />

started in the<br />

pharmaceutical<br />

industry, as an<br />

in-house patent<br />

attorney in the early 1990s, I figured<br />

that it was a fairly “safe“ environment<br />

in which to be employed. An apparently<br />

recession-proof business where IP, and<br />

patents in particular, were critical to<br />

profitability. The business was global<br />

and powered by huge research-based<br />

companies (“Big Pharma”), who took<br />

drugs all the way from preclinical<br />

research, through clinical development<br />

to commercialization. Drugs commanded<br />

high prices in the developed<br />

world, which represented almost the<br />

entire market in terms of value, with<br />

the US market being by far the most<br />

lucrative. Although the Hatch-Waxman<br />

Act, a US federal law designed to<br />

encourage generic drug manufacture<br />

and sale with a view to lowering prices,<br />

had been around for just a few years,<br />

generics companies were still somewhat<br />

smaller, often local organizations that<br />

tended not to enter the market until at<br />

least the basic patent covering a drug<br />

expired.<br />

Fast-forward 25 years and the pharmaceutical<br />

industry is still global, but it<br />

has had to evolve in response to everchanging<br />

healthcare and regulatory<br />

environments, on both a local and a<br />

global level. In first-world countries,<br />

ever-increasing demands on healthcare<br />

providers are coupled with downward<br />

pressure on drug pricing and more stringent<br />

regulatory environments imposed<br />

by national governments. Greatly enhanced<br />

generic competition has come<br />

from companies that are now themselves<br />

global players. The pharmaceutical<br />

market in developing markets is on a<br />

rapid upward trajectory. Despite these<br />

obvious opportunities, traditional<br />

western Big Pharma players have found<br />

such markets (particularly China)<br />

difficult to penetrate, given that they<br />

represent a somewhat uneven playing<br />

field, often having scant regard to<br />

intellectual property rights. Despite<br />

a degree of naivety, local companies,<br />

who are often subject to lower ethical<br />

and safety standards than is the case in<br />

the developed world, find it easier to<br />

meet local demand, and local governments<br />

and courts tend to assist further<br />

in that process.<br />

A response of Big Pharma to these<br />

pressures has been well-documented<br />

consolidation, with the inevitable<br />

consequence of job losses and facility<br />

closures. Things have quickly become<br />

fragmented, particularly in Sweden, with<br />

less fundamental, ground-breaking research<br />

being performed in-house. Larger<br />

pharmaceutical companies have moved<br />

towards becoming drug development<br />

houses, increasingly looking to smaller<br />

R&D-focused companies to fill their<br />

ever-shrinking pipelines. One might<br />

conclude that such a relationship should<br />

be a win-win, symbiotic one.<br />

he problem that so many<br />

of these innovative<br />

companies tell me that<br />

they experience is a lack<br />

of funding. In Sweden, investment<br />

is hard to come by at all stages<br />

of the development process. Although<br />

start-up money is often available to get<br />

things off the ground (target validation<br />

and/or lead identification), there is an<br />

absence of organizations that are willing<br />

to invest heavily in the next stage of<br />

development (e.g. up to candidate drug<br />

identification). This is less of an issue in<br />

Denmark, where large local pharmaceutical<br />

companies and associated investment<br />

arms are naturally more inclined<br />

to invest with the long game in mind.<br />

That said, it can still be very difficult<br />

to secure investment at the right<br />

time. Pharmaceutical R&D by its very<br />

nature is a risky business, and Big<br />

Pharma companies, the very organizations<br />

that are both able to commit<br />

both the necessary financial resource<br />

and have the technical competence in<br />

drug development to invest in the long<br />

term, are typically unwilling to take<br />

on big risks that were not “invented in


ADVERTORIAL<br />

POTTER CLARKSON<br />

house”, without conducting extremely<br />

rigorous due diligence. A pharmaceutical<br />

company is thus more likely to show<br />

interest in a project that has been taken<br />

at least some way into clinical development.<br />

Although it is tempting to conclude<br />

that pipelines will dry up unless smaller<br />

innovative companies are supported<br />

by large drug development companies<br />

in a less risk-averse way, I repeat that<br />

these companies are increasingly being<br />

squeezed on all sides in markets such<br />

as the US. It is no longer the case that<br />

products can necessarily be sold at a<br />

premium and pharmaceutical companies<br />

often pay rebates to health insurance<br />

companies, which can mean that,<br />

for some products, the net price can be<br />

lower than it is in Europe. In my view,<br />

Big Pharma applying such a high level<br />

of scrutiny is not them wanting to have<br />

it both ways.<br />

own rigorous due diligence, asking<br />

the same questions that a Big Pharma<br />

company would do.<br />

At some point, often early on, in a<br />

small company´s life, its patent estate<br />

will be scrutinized with a view to ascertaining<br />

whether effective protection for<br />

a product has been, or in all likelihood<br />

will be, obtained.<br />

THEY WILL ASK:<br />

01. How easy would it be for a competitor,<br />

such as generics company, to<br />

circumvent by designing around what is<br />

covered by a patent?<br />

02. Is the patent likely to stand up to<br />

scrutiny if challenged by a competitor?<br />

03. Does the technology infringe any<br />

third party’s legal rights?<br />

Stephen McNeeney<br />

urthermore, although the<br />

Hatch-Waxman Act was intended<br />

to level the playing field<br />

as between large multinational<br />

pharmaceutical concerns<br />

and smaller, US generics businesses,<br />

the tables have turned. Generic drug<br />

companies have seized the initiative created<br />

by the new law, which allows them<br />

to challenge patents without the risk of<br />

having to put a product on the market.<br />

The realization that they have so much<br />

to gain and relatively little to lose has<br />

empowered them to become more<br />

aggressive in their approach. Generics<br />

have themselves become multinational<br />

pharmaceutical companies, and often<br />

originator companies are not the big<br />

organizations they once were.<br />

If Big Pharma is unwilling to invest<br />

in early stage companies, it may therefore<br />

be necessary to sell a project´s<br />

potential to sophisticated private investors,<br />

or to secure funding via an IPO.<br />

Inevitably though, such investment<br />

comes at a price. It can be very hard to<br />

secure given that such investors will<br />

themselves naturally be looking for a<br />

lucrative exit when a Big Pharma player<br />

eventually does come on board. Such<br />

investors will thus often conduct their<br />

n view of this, it is critically<br />

important for small innovative<br />

companies to ensure that appropriate<br />

measures are taken to<br />

properly protect products at the<br />

outset. Ensuring that the protection afforded<br />

to a product has real commercial<br />

value is a balance between staking out<br />

what a company is legally entitled to<br />

versus what will stand up to legal scrutiny,<br />

either at a patent office or in court.<br />

This process cannot happen by itself<br />

and requires dialogue between inventors<br />

and their patent attorney. A clear<br />

overview of the prior art landscape is<br />

essential, as is a good patent attorney<br />

who, despite not necessarily having all<br />

the answers, will know what to ask to<br />

secure those answers.<br />

innovations<br />

coming out of small biopharmaceutical<br />

organizations across Scandinavia, it is<br />

vital that these enterprises “think big“<br />

and behave like a Big Pharma company<br />

would when it comes to protecting their<br />

valuable ideas. A good invention is a<br />

good start but, in order to stand any<br />

chance of successfully bringing an idea<br />

ABOUT THE<br />

AUTHOR<br />

Stephen McNeeney PhD<br />

is an experienced UK and<br />

European Patent Attorney<br />

at Potter Clarkson, where<br />

he is a partner. Stephen<br />

completed his degree in<br />

chemistry and obtained a<br />

master’s degree in organic<br />

chemistry, before further<br />

achieving a PhD in the subject.<br />

He joined Potter Clarkson<br />

in 1996, specialising in<br />

pharmaceutical industryrelated<br />

inventions.<br />

Today, Stephen acts for a<br />

variety of clients, ranging<br />

from Big Pharma, through<br />

SME drug discovery and<br />

drug development companies,<br />

to start-ups and university<br />

spin-outs, many of which<br />

are based outside the UK,<br />

particularly in Scandinavia.<br />

to market, it is only the start. <strong>NL</strong>S NORDICLIFESCIENCE.ORG 45


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FINANCING<br />

LIFE SCIENCE<br />

EXAMPLE<br />

NEW SHARE ISSUE<br />

Athera Biotechnologies announced the closing of a new share issue in May, raising in total SEK<br />

55 million from current major shareholders including Industrifonden and Östersjöstiftelsen,<br />

together with new shareholders from the Sciety network of investors.<br />

Carina Schmidt, CEO, Athera<br />

PHOTO UP THERE, EVERYWHERE AB<br />

developing a candidate<br />

for indications within cardiovascular<br />

disease, where current treatment is insufficient.<br />

Following completion of three Phase<br />

1 studies, it has now raised the capital for<br />

completion of a clinical Proof-of-Concept<br />

Phase 2 study, with the aim to close an<br />

agreement with a larger pharmaceutical<br />

company once the study is complete.<br />

Current major shareholders Industrifonden,<br />

Linc AB and Östersjöstiftelsen<br />

participated in the issue of new shares to<br />

finance the study.<br />

Sciety, a corporate finance firm specializing<br />

in life science, supported the process<br />

to raise the capital with the introduction of<br />

new investors from the Sciety-network.<br />

“We want innovations that make a<br />

difference to reach their full potential.<br />

We select promising companies and fund<br />

them for further growth,” says Andreas<br />

Lindblom, CEO at Sciety when describing<br />

their work.<br />

“Athera Biotechnologies is targeting<br />

a niche indication with high unmet need,<br />

while enabling further development for<br />

several broader cardiovascular disease<br />

indications. The first-in-class potential,<br />

strong IP protection, and drug development<br />

experience of the management and<br />

major shareholder is what attracted us to<br />

fund Athera,” he says.<br />

“Athera decided to work with Sciety for<br />

their effective process to raise capital, combined<br />

with their competence in life sciences<br />

and a strong investor network. With the help<br />

of Sciety we could complete the new issue of<br />

shares in a short time. Both management and<br />

major shareholders are very pleased with the<br />

collaboration,” says Carina Schmidt, CEO at<br />

Athera Biotechnologies. <strong>NL</strong>S<br />

NORDICLIFESCIENCE.ORG 47<br />

PHOTO


WOMEN´S HEALTH<br />

In July Sunstone Life Science Ventures made a EUR 5 million investment into the Finnish<br />

women’s health company Forendo Pharma to finance clinical studies in endometriosis.<br />

PHOTO THOMAS ROENN<br />

Claus Andersson, Sunstone<br />

General Partner who will<br />

join Forendo’s Board of<br />

Directors<br />

has announced its first<br />

investment from its Life<br />

Science Ventures Fund IV<br />

into Forendo Pharma, a<br />

Finnish clinical stage drug development<br />

company focusing on novel treatments<br />

in women’s health. The investment is<br />

designated for financing the continuation<br />

of Forendo Pharma’s positive Phase Ia<br />

study in post-menopausal women into<br />

Phase Ib in pre-meno-pausal women,<br />

and later Phase II for the treatment of<br />

endometriosis.<br />

In March <strong>2019</strong>, Forendo Pharma<br />

successfully completed a Phase Ia study of<br />

its lead program FOR-6219, a novel oral<br />

formulation of a tissue-specific treatment<br />

for endometriosis. FOR-6219 was found<br />

to be safe and well tolerated.<br />

Sunstone will be joining a syndicate<br />

of reputable active international investors,<br />

including Novo Seeds, Novartis<br />

Venture Fund, Vesalius Biocapital III and<br />

M Ventures (Merck).<br />

“Sunstone sees women’s health as an<br />

area with immense need of investments<br />

and with trending popularity. Endometriosis<br />

is a perfect example as approximately<br />

8% of all pre-menopausal women<br />

are affected with moderate to severe pain,<br />

infertility, and impaired quality of life<br />

as a consequence. We are very pleased<br />

to make this first investment under our<br />

new Fund IV, which earlier this year had<br />

its first closing at €80 million, with a<br />

target of €150 million at final closing,”<br />

says Claus Andersson, Sunstone General<br />

Partner, who will join Forendo Pharma’s<br />

Board of Directors. <strong>NL</strong>S


50


Barbro Ehnbom,<br />

the Founder of<br />

SALSS<br />

SALSS D.C. <strong>2019</strong><br />

“WHEN YOU PUT THE RIGHT BUSINESS PEOPLE TOGETHER<br />

AND THEY BECOME FRIENDS, THEY WILL END UP DOING<br />

BUSINESS TOGETHER,” SAYS BARBRO EHNBOM, THE<br />

FOUNDER AND CHAIRMAN OF SALSS.<br />

TEXT<br />

b y AMY BROWN PHOTO b y S A L S S


52<br />

Ann Rose, CEO Regulatory, ViCro and<br />

Steven Eror, Strategic Investor, Hill Top<br />

Group, shared valuable advice to companies<br />

looking to enter the US market<br />

Anna Maroney, Vice President<br />

of Alliance Management,<br />

AbbVie, emphasized the importance<br />

of having a clear idea<br />

of where your innovation rests


the intention Ehnbom has had since<br />

she founded the Swedish-American Life Science Summit<br />

(SALSS) in 2005, an initiative to increase the level of crossborder<br />

business between one of the largest markets in the<br />

world, the United States, and one of the most important life<br />

science industry centers in Europe, Sweden.<br />

In April <strong>2019</strong>, the invitation-only SALSS conference at the<br />

Swedish Embassy in Washington, DC brought together some<br />

of the most renowned life science executives, scientists, entrepreneurs<br />

and investors in both Sweden and the US. The aim<br />

is to build strategic and collaborative relationships between<br />

academia, industry and funders to enhance the life science<br />

business. SALSS also holds a three-day event in Stockholm<br />

annually with the same aim.<br />

The event is the brainchild of Ehnbom, a pioneer in the<br />

life science industry throughout her career. She was one of the<br />

first female executives in several US pharmaceutical companies,<br />

a top analyst on Wall Street, followed by many years of<br />

investment banking. She has played a particularly strong role<br />

in mentoring women in the life sciences industry as well as in<br />

business in general.<br />

great drugs but only a handful of these companies have good<br />

management.”<br />

Eugen Steiner, partner at HealthCap, a family of life<br />

science venture funds in Sweden, added that his firm actively<br />

tries to get American investors to invest in their portfolio<br />

companies and that co-investment is often a successful route<br />

for entry into the US market. “Otherwise you are competing<br />

with a lot of interesting investments in the life science and<br />

tech clusters around Boston and parts of California.”<br />

Maroney said that in the end, the ability to attract an<br />

investor “comes down to the science and the innovation, not<br />

necessarily the location.” From that perspective, a Swedish<br />

life science company with a truly novel idea has the same<br />

chance in the US market as any other start-up.<br />

“The Swedish brand is one of the finest brands in life science<br />

you can find today,” said Steven Eror, Strategic Investor<br />

with the Hill Top Group. “There are weaknesses in some of<br />

the companies that come over but these are the same weaknesses<br />

of any company today. I think there is a preference for<br />

giving a chance to a company from Sweden.”<br />

Swedish life science companies in attendance gained valuable<br />

insight into how they could gain entry into the important US<br />

pharmaceutical market, the largest in the world, during one<br />

of the panel discussions during the two-day event.<br />

“In terms of engaging with future partners, and with<br />

eventual entrepreneurs and pharma, you must have innovative<br />

science. Big pharma depends on the innovation that occurs in<br />

small companies,” said Dr. Anna Maroney, Vice President of<br />

Alliance Management, AbbVie, a US-based biopharmaceutical<br />

company. “Our pipeline is over 50 percent partnered in our<br />

firm. It is very important when entering into a discussion to<br />

have a clear idea of where your innovation rests and to be able<br />

to communicate that innovation in a way that is very compelling<br />

and concise and will engage us in further discussions.”<br />

Venture capital shouldn’t be the only source of funding that<br />

Swedish life science companies consider, according to Peter<br />

Kash, an entrepreneur and investor in the biotechnology sector,<br />

and Partner at the Kash Family Office. With over 25 years in the<br />

pharma industry, he has co-founded more than a dozen companies<br />

and co-raised over $800 million in private and financings.<br />

“Companies seeking money shouldn’t just go over to<br />

venture capital but also try family foundation offices. If<br />

you want to nail a disease, no one is more passionate than<br />

someone who has a personal stake in it. Most family offices<br />

diversify, no one needs to make more than eight percent on<br />

investments and in nine years you can double your capital.<br />

The most important thing is the management. There are<br />

Dr. Alexander Nuyken, Partner & Head of Life Sciences,<br />

Transaction Advisory, EMEIA at EY, spoke about the growing<br />

trend of financing life science start-ups through crossborder<br />

mergers & acquisitions (M&A).<br />

“Approvals from the Food & Drug Administration (FDA)<br />

are increasingly coming from smaller companies which<br />

creates opportunities for big pharma to source innovation<br />

externally, which is driving M&A and licensing deals.”<br />

Big pharma, he noted, is accessing innovation via dealmaking<br />

with an increase in early-stage deals and overall deal<br />

volume. “You have to be fast, place more bets and take more<br />

risks,” he said.<br />

Among the hot areas he noted are novel modalities that<br />

“are becoming personalized and curative disease treatments<br />

tailored to the individual patient in oncology and rare<br />

diseases. Cell therapy is another hot area, as well as gene<br />

therapy. I see these as being very hot in terms of investment.<br />

This trend is expected to continue, with novel technologies in<br />

high demand and attracting large capital.”<br />

“The option of cross-border M&As and other alternative<br />

means of funding may be better suited for our smaller cap<br />

Nordic companies,” noted Ylva Santesson, Senior Director of<br />

SALSS. “We must also seek opportunities to have US venture<br />

capital adapt to the conditions facing Nordic corporations in<br />

a realistic way, which would likely result in better return to<br />

venture capital investors and most importantly, stronger international<br />

companies and hence increased value for society.”<br />

NORDICLIFESCIENCE.ORG<br />

53


54<br />

Barbro Ehnbom, the<br />

Founder and Chairman<br />

of SALSS<br />

The companies in attendance also benefited from a range of<br />

expertise including advice from Ann Rose, CEO and President,<br />

Regulatory for ViCro, a medical products company, on how to<br />

approach the FDA, and from Helén Waxberg, partner with the<br />

law firm Mannheimer Swartling, providing a legal roadmap on<br />

how to enter the US market and engage with the FDA. US Rep<br />

Diana DeGette (D-CO) shared insights into the Affordable Care<br />

Act.<br />

A select number of Swedish companies were invited to make<br />

presentations for the investors and other gathered. These were<br />

Affibody, Elypta, Cellink, BioArctic, Immunicum and Ziccum.<br />

For Ehnbom and Santesson, the <strong>2019</strong> conference achieved<br />

their aims of bringing Swedish life science to the attention of<br />

American investors.<br />

Maria Tufvesson Shuck, Partner,<br />

Mannheimer Swartling,<br />

and her colleagues provided<br />

a legal roadmap on how to<br />

enter the US market<br />

investors are starting to realize there are a<br />

lot of business opportunities they are missing out on because<br />

they are not looking at these smaller companies from Sweden,”<br />

Santesson said. “We need to find ways to enhance their interest<br />

and shift their attitudes. Obviously, the US is a huge market,<br />

with a totally different dimension of capital and a different way<br />

of doing business but there’s no reason why our Swedish companies<br />

can’t compete with the best.” <strong>NL</strong>S<br />

PHOTO COURTESY OF THE SWEDISH-AMERICAN LIFE SCIENCE SUMMIT


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ADVERTORIAL<br />

UNITED HEALTH FI<strong>NL</strong>AND<br />

LIFE SCIENCES ARE THRIVING IN FI<strong>NL</strong>AND AND IN THE FIVE REGIONS, OULU,<br />

KUOPIO, TAMPERE, TURKU AND HELSINKI, EACH OF WHICH HAVE UNIQUE<br />

STRENGTHS, YOU WILL FIND THE PERFECT PLACE FOR R&D, INNOVATION AND<br />

BUILDING A LIFE SCIENCE-BUSINESS.


BUSINESS PRESENTATION<br />

HELSINKI / OULU / TURKU / TAMPERE / KUOPIO<br />

Finland’s capital is home to a top-ranked<br />

university and hospital, as well as several<br />

successful life science companies, but is<br />

also home to initiatives that bring together<br />

the best Helsinki has to offer.<br />

One such example is the Health Capital Helsinki<br />

(HCH) alliance, formed in 2015 with the purpose<br />

of developing the region into a Northern<br />

European hub for life science and health tech<br />

innovations and business development.<br />

Since then HCH has facilitated commercialization<br />

of scientific research, increased<br />

the number of business ideas, startup companies<br />

and jobs, and has supported business<br />

growth and accelerated export.<br />

A key focus areas for HCH is the development<br />

and promotion of a unique ecosystem,<br />

possessing living labs and test environments<br />

such as the Clever Health Networks for<br />

digital health innovations, the HUS Testbed<br />

for testing an developing products and<br />

services in the Helsinki University Hospital<br />

environment and the Innovation House for<br />

the development of mobile applications and<br />

services in collaboration with healthcare<br />

professionals. It also focuses on business<br />

development, advice for startups, research<br />

services and offers communities and workspaces.<br />

Contact: healthcapitalhelsinki.fi<br />

Oulu is one of Europe’s leading health<br />

and ICT centers and is widely recognized<br />

as a city of innovation and business<br />

opportunities.<br />

The innovative ecosystem OuluHealth<br />

strengthens collaborations among the city,<br />

universities, research organizations and the<br />

private sector to stimulate economic growth,<br />

spur health innovations and provide a supportive<br />

test and development environment,<br />

OuluHealth Labs, for health tech businesses.<br />

OuluHealth Labs is composed of three<br />

testbeds that are equipped with cutting<br />

edge pilot facilities: OYS TestLab, an authentic<br />

hospital testing facility at Oulu University<br />

Hospital; Oamk SimLab, a versatile simulation<br />

and studio environment and Oulu Welfare-<br />

Lab, which allows testing to be carried out<br />

throughout the city of Oulu’s social and<br />

health service network, including in citizens’<br />

homes.<br />

The region’s core expertise lies in health<br />

and information technologies, especially<br />

in medical imaging, robotics, printed electronics,<br />

artificial intelligence and 5G/6G<br />

that enables digitalization of the social and<br />

healthcare sectors. Oulu is also one of the<br />

first cities to test the 5G network in the hospital<br />

environment.<br />

The health and life science sector in Oulu<br />

is one of the best places to carry out research<br />

and develop successful businesses. You can<br />

come here with an idea and leave with a<br />

market ready product in your hand.<br />

Contact: ouluhealth.fi<br />

Turku has recently grown into an expertise<br />

center for developing and manufacturing<br />

biological drugs. Drug development and<br />

diagnostics are also common research<br />

profiling areas at the University of Turku<br />

and Åbo Akademi University.<br />

It is also expected that Finland’s new<br />

National Drug Development Centre will<br />

be located in Turku, serving researchers<br />

from all over the country and improving<br />

the commercial potential of findings at<br />

universities.<br />

Another important area in Turku’s life<br />

science sector is the evolving of real-worlddata<br />

where the city has initiatives through its<br />

biobank, as well as, for example Auria Clinical<br />

informatics, which is an EU-recognized<br />

DIH (Digital Innovation Hub).<br />

For entrepreneurs the city has a lot to<br />

offer, such as the life science accelerator program<br />

(Finland’s first), which generated nine<br />

new companies and attracted EUR 4 million<br />

in financing over a period of two years.<br />

It started with ERDF funding and will<br />

continue in the autumn of <strong>2019</strong> with an<br />

improved concept under the new name<br />

ProHEALTH ACCELERATOR.<br />

The program has enabled both startup<br />

companies and university projects to develop<br />

their business plans, get important end-user,<br />

business and funding contacts and thus prepare<br />

for a global breakthrough.<br />

Contact: turkubusinessregion.com<br />

Be it a large multinational company, a researcher<br />

or an entrepreneur, Tampere has the world<br />

class expertise and functional infrastructure<br />

to make things happen.<br />

The collaboration between research, business<br />

and clinics is strong and offers a fertile ground<br />

for health care and medical related players to innovate<br />

and grow. Numerous health tech start-ups<br />

with remarkable potential have also emerged<br />

from Tampere. For example, the biotechcompany<br />

Vactech has announced a partnership with<br />

Provention Bio, a US-based corporation listed on<br />

Nasdaq. The biomedical laser company Modulight<br />

has also announced collaboration with Bausch &<br />

Lomb to develop a new photodynamic laser.<br />

“Our start-ups and scale-ups are utilizing<br />

technologies, especially AI, imaging and sensor<br />

expertise in health care and medical solutions,”<br />

says Director Harri Ojala, Business Tampere. If<br />

you’re interested in the opportunities we have to<br />

offer in life sciences, Business Tampere is your<br />

first point of contact.<br />

Contact: businesstampere.com<br />

The Kuopio region is a global leader in the<br />

health and life sciences sectors, offering<br />

companies a unique industry ecosystem<br />

that stimulates innovation, supports research<br />

and development, and offers access to experts<br />

and talents to bolster business success.<br />

At the heart of Kuopio’s health sciences cluster<br />

is the KuopioHealth open innovation ecosystem,<br />

which promotes development, research and<br />

innovations based on customer needs and acts<br />

as a platform for new products and services. It<br />

is a network committed to promoting wellbeing,<br />

food industry and health care technology competence,<br />

research and business life as well<br />

as health care industry awareness locally,<br />

nationally and internationally. For companies<br />

developing health and wellbeing technologies,<br />

Kuopio Living Lab offers a product development<br />

and testing platform in collaboration with<br />

Kuopio University Hospital, the City of Kuopio,<br />

and Savonia University of Applied Sciences.<br />

Contact: businesskuopio.fi


TRONDHEIM<br />

Cilia in the nose of a zebrafish.<br />

Cilia are present in many other organs<br />

of the body of vertebrates. Here is shown<br />

the nose, cilia are in red, some cells are<br />

indicated in green and the nuclei are in blue.<br />

(Reiten et al., Current Biology, 2016)


CLINICAL SCIENCE TRIALS REPORT<br />

RESEARCH NEWS FROM THE NORDIC REGION<br />

These hairs, or cilia as they are called, have been poorly understood but if they are<br />

not functioning a person can develop neurological conditions like hydrocephalus and<br />

scoliosis. In an article in Current Biology researchers at NTNU have now provided<br />

more insight into how these cilia work and why they are so important.<br />

found that groups<br />

of cells with cilia are<br />

organized in different<br />

zones of the ventricles<br />

(the fluid cavities in the brain), which<br />

together create a stable, directional flow of<br />

the cerebrospinal fluid.<br />

“We found surprisingly little exchange<br />

of fluid between the ventricles as long as<br />

the fish were at rest, even though the heartbeat<br />

pulsations caused some flow between<br />

them,” says Emilie Willoch Olstad, first<br />

author of the article. “But when the animal<br />

moves, locomotion leads to a great degree<br />

of fluid exchange between the different<br />

ventricles.”<br />

To assess the function of motile cilia the<br />

researchers used mutant lines in which genes<br />

essential to either ciliary motility or cilia<br />

assembly are knocked out. In their study they<br />

found that in larval zebrafish mutants lacking<br />

cilia altogether, parts of the ventricular system<br />

were larger than in control siblings. However,<br />

in mutants where the cilia still assembled,<br />

but were immotile, the duct between two of<br />

the cavities appeared occluded.<br />

“In addition to genes supporting the assembly<br />

and motility of cilia, additional<br />

factors are suggested to impact other features<br />

of the cilia, such as their beating frequency.<br />

For instance, both neuropeptides and<br />

neural states are proposed to impact the ciliary<br />

beating (Conductier et al., 2013, Faubel et al.,<br />

2016). Yet, such influences on the cilia and on<br />

the fluid flow remain poorly understood, and<br />

we are excited to further investigate this,” says<br />

Olstad.<br />

To Olstad’s knowledge no one has<br />

reported any specific numbers of motile<br />

cilia within the human brain. “However,<br />

they are suggested to cover a large surface<br />

area of the ventricles (Coletti et al., 2018).<br />

It is important that you have a sufficient<br />

number of motile cilia, as these contribute<br />

to the movement of cerebrospinal fluid<br />

along the ventricular walls. Several studies<br />

in both rodents, amphibians and fish suggest<br />

that the lack of functioning motile cilia<br />

along the ventricles causes hydrocephalus<br />

(enlarged ventricular cavities) and/or occlusion<br />

of the ducts connecting the ventricles.<br />

Although less frequent, humans with<br />

dysfunctional motile cilia (e.g. patients<br />

with primary ciliary dyskinesia) do also<br />

sometimes develop hydrocephalus.”<br />

led by Dr Jurisch<br />

-Yaksi (Department<br />

of Clinical<br />

and Molecular<br />

Medicine) are<br />

interested in further<br />

studying fluid circulation in the brain<br />

using better analytical tools and computer<br />

models. For example, new nerve cells are<br />

born near the wall of the ventricles and from<br />

here they might migrate to different areas<br />

of the brain. The differentiation of these<br />

new cells was suggested to be influenced<br />

by nutrients and molecular signals that are<br />

distributed by the flow of the cerebrospinal<br />

fluid near the ventricular walls (Sawamoto<br />

et al., 2006). The next step is now to see if it<br />

is possible to influence the brain functioning<br />

of the zebrafish by manipulating the<br />

cilia and vice versa. <strong>NL</strong>S<br />

A 4 DAYS OLD LARVAL ZEBRAFISH HEAD<br />

AN ILLUSTRATION OF THE BRAIN VEN-<br />

TRICLE OF A 2 DAYS OLD ZEBRAFISH<br />

(LEFT) AND AN ADULT HUMAN (RIGHT)<br />

REFERENCE<br />

OLSTAD ET AL., CILIARY BEATING<br />

COMPARTMENTALIZES CERE-<br />

BROSPINAL FLUID FLOW IN THE<br />

BRAIN AND REGULATES VENTRIC-<br />

ULAR DEVELOPMENT, CURRENT<br />

BIOLOGY, <strong>2019</strong><br />

ILLUSTRATION OLSTAD ET AL, CURRENT BIOLOGY, <strong>2019</strong> AND VARTAN KURTCUOGLU/<br />

INTERFACEGROUP.CH & CHRISTA RINGERS/ WWW.YAKSILAB.COM


SCIENCE REPORT<br />

RESEARCH NEWS FROM THE NORDIC REGION<br />

PHOTO NATIONAL INSTITUTE OF ALLERGY AND<br />

INFECTIOUS DISEASES (NIAID)<br />

MYCOBACTERIUM TUBERCULOSIS IS A HUMAN<br />

PATHOGEN THAT HAS HAD A STAGGERING GLOBAL<br />

IMPACT. THE BACTERIUM MYCOBACTERIUM TUBER-<br />

CULOSIS CAUSES TUBERCULOSIS IN HUMANS. ONCE<br />

INSIDE THE BODY IT MORPHS INTO A TOUGHER<br />

FORM THAT CAN WITHSTAND MORE STRESS AND IS<br />

HARDER TO KILL.<br />

PHOTO MATTIAS PETTERSSON<br />

Fredrik Almqvist,<br />

Professor, Umeå University<br />

UMEÅ<br />

Scientists at Umeå University have found a molecular compound that prevents<br />

and even reverses resistance to the most widely used antibiotic for treating<br />

tuberculosis – isoniazid.<br />

TUBERCULOSIS IS CAUSED BY<br />

the bacterium Mycobacterium<br />

tuberculosis. Once<br />

inside the body, it morphs<br />

into a tougher form that<br />

can withstand more<br />

stress and is harder to<br />

kill. Rather than look for new and better<br />

antibiotics, researcher Christina Stallings,<br />

together with her fellow researchers<br />

at Washington University School of<br />

Medicine and Umeå professor Fredrik<br />

Almqvist, decided to look for molecular<br />

compounds that could prevent bacteria<br />

from becoming resistant.<br />

When put in a low-oxygen environment<br />

to mimic the stressful conditions that<br />

tuberculosis bacteria encounter inside the<br />

body, the bacteria come together and form<br />

a thin biofilm. This biofilm is resilient to<br />

not only low-oxygen conditions but also<br />

to antibiotics and other stressors.<br />

The researchers found one compound,<br />

called C10 that did not kill the tuberculosis<br />

bacteria but prevented them from<br />

forming a biofilm. “The molecule may<br />

also bolster the antibiotic’s power to<br />

kill tuberculosis bacteria – even those<br />

sensitive to drugs. This could mean<br />

that doctors could start thinking about<br />

cutting down the onerous six-month<br />

treatment regimen they prescribe today,”<br />

says Almqvist.<br />

Further experiments showed that<br />

blocking biofilm formation with C10<br />

made the bacteria easier to kill with<br />

antibiotics and even curbed the development<br />

of antibiotic resistance. In addition,<br />

one out of a million tuberculosis bacteria<br />

spontaneously become resistant to isoniazid<br />

when grown under typical laboratory<br />

conditions. But when the researchers grew<br />

tuberculosis bacteria with isoniazid and<br />

the compound, the drug-resistant mutant<br />

bacteria never arose. Most surprisingly, the<br />

compound even reversed drug resistance.<br />

“This could mean that by using a<br />

molecule like C10, we can give all those<br />

millions of people worldwide who carry<br />

isoniazid-resistant tuberculosis the option<br />

of using isoniazid again,” says Stallings.<br />

“Now we’re working on improving<br />

the compound itself so we can start<br />

testing it in animals. We are also trying to<br />

figure out how it prevents biofilm formation<br />

so that we can develop other drugs<br />

that target the pathway.” <strong>NL</strong>S<br />

60 NORDICLIFESCIENCE.ORG


SUSTAINING LAUNCH SUCCESS AS ORPHAN MEDICINES COME OF AGE<br />

IN 2018, BOTH THE AMERICAN FDA and the European<br />

Medicines Agency approved a greater number of<br />

new medicines for rare diseases than for mainstream<br />

conditions for the first time. The dream of<br />

making more medicines available for patients with<br />

very rare diseases, started decades ago with the US<br />

Orphan Drugs Act and the EU Orphan Regulation,<br />

has succeeded.<br />

Although there remains huge untreated and<br />

unmet need, more patients with rare diseases<br />

have pharmacotherapies available, and there are<br />

a growing number of disease-focussed registries,<br />

increasing public and policy maker awareness,<br />

and significant R&D investment in pharmacotherapies<br />

and in digital technologies to support<br />

trials and treatment. However, for the pharmaceutical<br />

companies behind them, not just bringing<br />

orphan medicines to approval, but launching<br />

orphan medicines excellently will become even<br />

more challenging and important over the next 5<br />

years.<br />

A new frontier of challenge faces orphan<br />

medicines companies as the gap between orphan<br />

medicines and mainstream specialty products<br />

narrows. To understand how to succeed in<br />

launching an orphan medicine in the coming<br />

years, companies must learn from past launches<br />

and apply an orphan medicines-focused Launch<br />

Excellence framework for success.<br />

Huge advances in therapies are enormously<br />

promising, but even though the total sales of<br />

individual Orphan Medicines are mostly modest,<br />

payer concern on costs has risen, and with it the<br />

number of negative market access outcomes.<br />

Orphan medicines companies must not only get<br />

an optimal label, they must successfully address<br />

market access in a more challenging environment,<br />

with the right data, stakeholder relationships,<br />

insight and flexibility.<br />

Orphan Medicines companies face substantial<br />

challenges of patient identification and recruitment<br />

for clinical trials, and support on the path<br />

to effective treatment, sometimes even when<br />

a product is available and budget is agreed.<br />

Patients suffering from rare diseases are likely<br />

to be geographically spread, and in many cases<br />

may have experienced mis-diagnosis and lack of<br />

awareness of their symptoms which means that<br />

they can spend an average of 4.8 years presenting<br />

symptoms before an accurate diagnosis is made.<br />

Clinical trials for rare disease patients can<br />

be hampered by slow recruitment due to slow<br />

diagnosis, or due to the inability of patients to<br />

reach scarce treatment centres. More effective<br />

use of Human Data Science to understand and<br />

identify patients using real world, genomic and<br />

other information, will underpin the next step in<br />

Orphan Medicine evolution.<br />

TO READ THE full whitepaper on this topic and to<br />

learn more about IQVIA and our presence in the<br />

Nordics, visit www.iqvia.com. <strong>NL</strong>S<br />

FACTS IQVIA<br />

IQVIA (NYSE:IQV) is a<br />

leading global provider<br />

of advanced analytics,<br />

technology solutions<br />

and contract research<br />

services to the life sciences<br />

industry dedicated<br />

to delivering actionable<br />

insights.<br />

IQVIA is a leading authority<br />

on Launch Excellence,<br />

publishing a white paper on<br />

global Launch Excellence<br />

every two years since 2007,<br />

and establishing many key<br />

concepts used to manage<br />

pharmaceutical launches,<br />

including the importance<br />

of the six-month window.<br />

IQVIA has also published<br />

widely on specific launch<br />

issues, including launch<br />

and multichannel, medical<br />

affairs, emerging markets<br />

and orphan medicines.


62 NORDICLIFESCIENCE.ORG


SCIENCE ARTICLE Q3 <strong>2019</strong><br />

OXYCODONE<br />

OXYCODONE HYDROCHLORIDE<br />

IS PART OF A GROUP OF DRUGS<br />

KNOWN AS OPIOIDS.<br />

OXYCODONE IS MORE<br />

COMMO<strong>NL</strong>Y PRESCRIBED BY<br />

DOCTORS TO RELIEVE<br />

MODERATE TO SEVERE PAIN.<br />

OXYCODONE COMES IN A<br />

NUMBER OF FORMS INCLUDING<br />

CAPSULES, TABLETS, LIQUID AND<br />

SUPPOSITORIES. IT ALSO COMES<br />

IN A VARIOUS OF STRENGTHS.<br />

THE UNITED STATES HAD MORE<br />

THAN 200 000 DEATHS IN 1999-<br />

2016 FROM PRESCRIPTION<br />

OPIOID-RELATED OVERDOSES.


PHOTO AKSEL K.HENRIKEN<br />

Ashley Muller<br />

REFERENCE<br />

MULLER AE, CLAUSEN T, SJØGREN P,<br />

ODSBU I, SKURTVEIT S. PRESCRIBED<br />

OPIOID ANALGESIC USE DEVELOP-<br />

MENTS IN THREE NORDIC COUNTRIES,<br />

2006–2017. SCAN J PAIN.<br />

at the Norwegian<br />

Institute of Public Health, is aware of the risks of offering<br />

opioids for chronic, noncancer pain. She is American and knows<br />

that the United States had more than 200 000 deaths in 1999 – 2016<br />

from prescription opioid-related overdoses.<br />

Muller recently published work on opioid prescribing that<br />

she did at the Norwegian Centre for Addiction Research,<br />

University of Oslo, with collaborators at the University of<br />

Copenhagen and Karolinska Institutet.<br />

Denmark, but lower mean doses, except for oxycodone. Sweden<br />

had the lowest mean oxycodone doses but wider prescribing,<br />

to 3% of the population.<br />

Based on these and other findings, Muller says, ”People<br />

in public health are worried.” No one is sure of the reason<br />

for the prescribing patterns. Oxycodone isn’t advertised in<br />

Europe and because of regulations, the cause doesn’t seem to<br />

be industry related, Muller says. However, the aging Nordic<br />

population means patients may be reporting more pain.<br />

The study confirms that Norway, Denmark, and Sweden do<br />

not have an opioid crisis like North America. However, the<br />

report contains troubling findings.<br />

”The biggest concern,” Muller says, ”is that oxycodone<br />

use increased in all three countries.” Oxycodone is a potent<br />

opioid drug linked to the American overdose epidemic. Other<br />

research shows increasing deaths in Norway and Sweden<br />

related to the drug.<br />

Muller and colleagues analyzed publicly available data<br />

from Norwegian, Danish, and Swedish prescription drug<br />

registries. The data were for 2006–2017 and an impressive 21<br />

million people. For each year, the researchers looked at opioid<br />

prevalence, meaning the percent of the population with at<br />

least one dispensed opioid drug.<br />

The countries had different prescribing patterns. Norway<br />

had consistently higher opioid prevalence than Sweden and<br />

Muller and a collaborator are now analyzing data from<br />

Norway on people aged 50-80 years. Older people are also<br />

receiving increasing amounts of opioids, they find. In general,<br />

Muller says, ”Opioids are important for people with acute<br />

pain, for example after operations.” One factor in rising<br />

opioid use might be that short-term prescriptions turn into<br />

long-term use. However, many studies show that opioids are<br />

not effective for chronic pain.<br />

A bright spot is that Nordic health officials, clinical<br />

leaders, and policymakers have an excellent resource – the<br />

national prescription drug registries – to help prevent a U.S.-<br />

type opioid problem. Muller says the drug data she used in her<br />

study were easy to use and high quality. Some patients have<br />

already developed a use disorder, though, and here’s where the<br />

life science industry might help. Muller says: ”There’s room<br />

for innovation in ways to help with addiction.” <strong>NL</strong>S


BUSINESS<br />

PRESENTATION<br />

MILTENYIBIOTEC.SE<br />

American politician Anna Eshoo once described innovation as the calling card of<br />

the future. With that in mind, a good case could be made for listing the Nordic region<br />

as the address on that card. The cutting-edge biomedical research that takes place<br />

in its plethora of prominent institutions and renowned biotech firms attests to that.<br />

Although not a native Scandinavian firm, Miltenyi Biotec sits comfortably nestled in<br />

arguably the heart of all that activity, Lund.<br />

FROM ITS FOUNDATION, Miltenyi Biotec has<br />

focused on thinking differently, whether<br />

through pushing forward new frontiers or<br />

simply seeing minor adjustments to existing<br />

processes. Often, this has led the multidisciplinary<br />

team around the founder to create<br />

products for previously unthought of applications.<br />

Based on the then revolutionary MACS ®<br />

Technology, the firm’s 14,000+ products<br />

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helpful counsel. Such an output of innovation<br />

is possible through continual interaction<br />

and collaboration with the scientific<br />

community, reflecting Miltenyi Biotec’s fundamental<br />

belief that new ideas are created by the<br />

The MACSQuant Tyto Sorter makes<br />

use of very low–pressure filtered air<br />

for exceptionally gentle cell treatment,<br />

resulting in never-before-seen<br />

viability and functionality in a sterile,<br />

GMP-compliant, fully closed setup.<br />

sharing of experiences between some of the<br />

world’s most brilliant and creative minds.<br />

More recently, this deep-rooted understanding<br />

of, and appreciation for, the real-life<br />

challenges faced in the research environment<br />

led to one of our most revolutionary products<br />

yet; the MACSQuant ® Tyto ® Sorter. Traditional<br />

cell-sorting techniques are droplet-based, which<br />

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charges. Not only can all of these factors<br />

potentially impact on the viability and functionality<br />

of the cell population of interest,<br />

the droplet method can lead to the formation<br />

of biohazardous aerosols, endangering the<br />

researcher and requiring both additional time<br />

and capital to offset. Finally, sample-to-sample<br />

carry-over and external contamination are<br />

always of concern in traditional cell sorting,<br />

necessitating laborious cleaning protocols.<br />

The MACSQuant ® Tyto ® Sorter eliminates<br />

all of these concerns. Samples are kept<br />

in sterile, disposable, fully closed cartridges,<br />

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Cells to be sorted are driven through this system<br />

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a charge. This exceptionally gentle cell treatment<br />

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reproducible research findings. The entire<br />

process is plug-and-play, requiring minimal<br />

operator training, and nine times less<br />

hands-on time with the instrument in total<br />

compared with conventional droplet-based<br />

cell sorters.<br />

But such an innovative new technology<br />

doesn’t just improve existing processes with<br />

added convenience; it opens up entirely new<br />

applications. For example, because cell sorting<br />

takes place entirely within the closed system<br />

of the MACSQuant ® Tyto ® Cartridge, cells<br />

remain sterile. And since there is no sheath<br />

fluid, using the system with MACS ® GMP<br />

Tyto Consumables means the cells only ever<br />

come into contact with MACS ® GMP products.<br />

This makes Miltenyi Biotec the first company<br />

ever to offer sterile, GMP-compliant multiparametric<br />

cell sorting in a fully closed setup,<br />

opening up entirely new possibilities in translational<br />

and clinical research settings.<br />

It is our belief that this sort of breakthrough<br />

concept is the result of an authentic adherence<br />

to the scientific mindset; to always<br />

question how things are done, and how they<br />

can be done better; through collaboration,<br />

and through the free and frank exchange of<br />

challenges, successes, and ideas. <strong>NL</strong>S<br />

MILTENYI BIOTEC NORDEN AB SCHEELEVÄGEN 17, 223 70 LUND, SWEDEN, +46 46 280 72 80, MACS@MILTENYIBIOTEC.SE


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Science Q&A. The Novo Nordisk Foundation (NNF) has awarded postdoctoral fellowships<br />

to 16 talented researchers from the Nordic countries. The fellowships provide the recipients<br />

the opportunity to carry out research at some of the world’s best laboratories, which will<br />

hopefully boost their skills and strengthen their independent research careers. We asked<br />

four of them about their research and about being a young scientist today.<br />

TEXT b y M A L I N O T M A N I P H O T O b y N N F<br />

NORDICLIFESCIENCE.ORG 67


SCIENCE<br />

YOUNG<br />

TALENT<br />

CEMRE MANAV PERFORMS BASELINE SCIENTIFIC RESEARCH IN RNA<br />

PROCESSING THAT PAVES THE WAY FOR NEW TREATMENTS OF MANY<br />

DISEASES, SUCH AS HEART FAILURE, AS WELL AS FOR THERAPEUTIC<br />

PROCESSES, FOR EXAMPLE GENE SILENCING.


PHARMACOVIGILANCE<br />

FACTS<br />

MANAV’S PROJECT<br />

I HAVE<br />

FOUND my<br />

CALLING<br />

was one of the recipients of the Novo<br />

Nordisk Foundation’s postdoctoral fellowships <strong>2019</strong> for research<br />

abroad in the field of Bioscience and Basic Biomedicine. Cemre<br />

Manav will receive DKK 3,998,207 over four years.<br />

What does this grant mean to you and your research?<br />

“I have been studying and working as a researcher in Aarhus/<br />

Copenhagen for the last six years. I have always appreciated the work<br />

ethics here in Denmark. There are also so many good opportunities for<br />

scientists when it comes to networking and funding. That is why I would like to contribute<br />

to the Danish research environment and develop my life and career here in<br />

Denmark. For a postdoc, having your own funding is an amazing thing. Having huge funding,<br />

such as the NNF funding, is a blessing for me because it is very, very convenient and it helps<br />

me come back to Denmark, which is just perfect for me.<br />

For my research career I am very certain that this postdoc will improve my skills tremendously.<br />

I will be working with very brilliant people who contribute to the area amazingly and<br />

some of whom are Nobel Laureates. Being in such a work environment will help me become<br />

an independent and good scientist.”<br />

Where will you conduct your postdoc?<br />

Anna-Leena Saarela is an expert in pharmacovigilance<br />

and she sees it as a privilege<br />

to work in the front line of this fast developing<br />

environment for the benefit of patient safety.<br />

“I will be working at the Medical Research Council – Laboratory of Molecular Biology<br />

(MRC-LMB) in Cambridge, England, with the group of Lori Passmore.”<br />

What applications could your research have?<br />

“My research focuses on RNA processing. This is directly related to health diseases,<br />

bone marrow diseases and gene expression. If we can control this process, we can control<br />

which genes are expressed. This means that if we know a specific gene is causing a specific<br />

disease, we can just stop that gene from being translated from the very beginning.”<br />

What is the best thing about being a scientist TEXT and b y about M A Lyour I N area O T Mof Aresearch?<br />

N I<br />

TITLE: Cryo-electron<br />

microscopy and functional<br />

studies of targeted<br />

deadenylation<br />

complex: Insights into<br />

mRNA deadenylation<br />

at the molecular level<br />

mRNA turnover is a<br />

fundamental aspect<br />

of gene regulation. In<br />

the nucleus, eukaryotic<br />

mRNAs are polyadenylated<br />

at the 3’-end<br />

[poly(A) tail] and the<br />

poly(A) tail is crucial for<br />

gene regulation. In the<br />

cytoplasm, mRNAs are<br />

de-adenylated, where<br />

the length of the<br />

poly(A) tail is gradually<br />

shortened. After the<br />

poly(A) tail is removed,<br />

the mRNA is degraded,<br />

which makes<br />

deadenylation a critical<br />

step in determining<br />

the lifetime of mRNAs.<br />

The tail is protected by<br />

Pab1 and shortened by<br />

Ccr4-Not. This process<br />

is further regulated<br />

by the RNA-binding<br />

protein tristetraprolin,<br />

promoting targeted<br />

deadenylation.<br />

Understanding how<br />

these proteins work in<br />

such a large assembly<br />

will reveal in greater<br />

detail how mRNAs<br />

are regulated through<br />

“The best thing is the idea of helping people! What we do is very baseline scientific research,<br />

which paves the way for the clinical researchers to develop treatments for diseases such as<br />

infections, heart failure etc. Knowing that I might be helping humanity feels amazing and<br />

it is the driving force for me to just keep working and learning.”<br />

their 3′-end. This will<br />

ANNA-LEENA Do you have SAARELA any advice for IS students today working out there as a wanting to pursue “A typical a career day at work in varies depending on lay the stage groundwork of the projects for<br />

Pharmacovigilance science? Expert at Crown CRO, a Finnish CRO with Crown CRO PV are working on at the time. the Right treatment now of I am many involved<br />

offices in “It the might Nordic feel and overwhelming Baltic area and with tiring. operations Their lab mainly work will not always in developing yield good new results. Standard Operating Procedures diseases, such in close as heart collaboration<br />

look with for our a Quality reason Assurance department, while at the same time<br />

failure, as well as for<br />

in Europe. Most of She the is a time part we of get a team negative of pharmacovigilance results, but we never experts give up. Always<br />

therapeutic processes,<br />

and her and respons-ibilities look for a different cover way a wide of doing range it. of There tasks, is from always overall a way of getting planning the a results, controlled it’s change to our electronic for example safety database, gene Argus<br />

maintenance just a matter and development of hard work of and the reading company’s what pharmacovigilance<br />

other people are doing. Safety, And always with the discuss system vendor.” silencing.<br />

(PV) your system, studies to management with other people, and coordination see what they of PV think projects about and it.<br />

tasks, and daily PV operations, such as safety case processing.<br />

Science is A fun!” clinical trial in the start-up phase is also keeping Saarela busy<br />

as she and her colleagues are setting up the<br />

“In this role, no day is the same as the previous one,” she says.<br />

NORDICLIFESCIENCE.ORG 69


SCIENCE<br />

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INTERVIEW LIDDS<br />

CAGLA SAHIN’S RESEARCH focuses on expanding our knowledge of how the human<br />

memory is formed and stored. She will investigate molecular interactions inside<br />

cellular structures formed by memory proteins and her findings might lead to a<br />

better understanding of the relationship between normal brain function and<br />

disease.<br />

FACTS<br />

SAHIN’S PROJECT<br />

was one of the recipients of<br />

the Novo Nordisk Foundation’s<br />

postdoctoral fellowships<br />

<strong>2019</strong> for research<br />

abroad in the field of<br />

Bioscience and Basic Biomedicine.<br />

Cagla Sahin will<br />

receive DKK 3,640,073 over four years.<br />

What does this grant mean to you and<br />

your research?<br />

”Thanks to the NNF grant, I get to spend<br />

three years at the Karolinska Institutet, Stockholm,<br />

where I will deepen my knowledge<br />

of mass spectrometry (MS), a really cool and<br />

advanced technique that enables the measurement<br />

of molecular weights, leading to insight<br />

of complex molecular assemblies. In particular<br />

I will use native MS and hydrogen-deuterium<br />

exchange MS to understand how molecular<br />

interactions and structural and conformational<br />

changes affect the function of amyloid-like proteins.<br />

This has never been done before, and I’m<br />

really looking forward to it! It is really exciting to<br />

get my own funding that supports my ideas and<br />

research, and gives me the opportunity to grow as<br />

a scientist this early in my career.”<br />

Where will you conduct your post-doc?<br />

”The first three years I will be doing my<br />

postdoctoral research at the department of<br />

Microbiology, Tumor and Cell Biology at the<br />

Karolinska Institutet, in the group of Assistant<br />

Professor Michael Landreh and Professor Sir<br />

David Lane. Thereafter and for the last year<br />

of the project, I will join the group of Associate<br />

professor Kaare Teilum at the department of<br />

Biology at Copenhagen University, where<br />

another technique, nuclear magnetic resonance<br />

(NMR), will be used for structural characterization<br />

of amyloid-like proteins.”<br />

What applications could your research have?<br />

”My research qualifies as basic science and<br />

focuses on expanding the knowledge of how the<br />

human memory is formed and stored. Specifically,<br />

I will investigate molecular interactions inside<br />

cellular structures formed by what are known<br />

as memory proteins, using native and hydrogendeuterium<br />

exchange MS. At the same time,<br />

studying such molecular interactions may lead to<br />

a better understanding of the molecular mechanisms<br />

involved in neurodegenerative diseases,<br />

such as Alzheimer’s and Parkinson’s and even<br />

cancer. Furthermore, this technique can be<br />

applied to understand molecular interactions in<br />

many other contexts, ranging from basic science<br />

to drug development and to protein formulation<br />

in industry.”<br />

What is the best thing about being a scientist<br />

and about your area of research?<br />

”In general I love science and being a scientist.<br />

I like to develop new methods and protocols<br />

that can help shed light on a problem in a new<br />

way. Once you make any discovery – even tiny<br />

findings – they are a part of a bigger question, and<br />

I just find it thrilling and exciting to understand<br />

the everyday life – in nature, health and disease.”<br />

Do you have any advice for students out<br />

there wanting to pursue a career in science?<br />

”If I were to give some general advice, one<br />

aspect would be to remember the life outside the<br />

science world, and really focus on finding that<br />

balance – it will make the road of the scientific<br />

career easier and more fun. Another piece of<br />

advice is to talk with the people in your network;<br />

supervisors, fellow-students, colleagues, nonscientist<br />

friends. Talking with others can open up<br />

your perspectives, whether it is regarding your<br />

career, for feedback on your development as a<br />

scientist/colleague/friend, or for a specific problem<br />

related to an experimental setup. Finally, find<br />

a good balance of optimism and realism. One will<br />

(most often) meet a lot of failure, before achieving<br />

that one positive result, which others might<br />

not even find as exciting as you do. Prepare your<br />

self by lowering your expectations, while striving<br />

for the best.” <strong>NL</strong>S<br />

FACTS<br />

LIDDS<br />

TITLE: The superstructural<br />

biology<br />

of RNA-binding<br />

amyloid-like proteins<br />

in neurodegeneration<br />

and memory<br />

formation<br />

Inside cells, proteins<br />

are busy fulfilling specific<br />

tasks by binding<br />

to other molecules,<br />

and wrong interactions<br />

can LIDDS lead AB to disease.<br />

When develops the brain injectable<br />

information, drugs for<br />

stores<br />

certain cancer proteins and selfassemble<br />

diseases together based<br />

other<br />

with other on a molecules NanoZolid<br />

into large technology. scaffolds Nanothat<br />

bind Zolid copies helps of solve<br />

different some genes. of the main<br />

These problems scaffolds with<br />

resemble the protein way drugs<br />

assemblies work called in the body<br />

“amyloid” and that which are affect a<br />

hallmark patient of diseases quality of<br />

such as life. Alzheimer’s. NanoZolid<br />

Despite enables being the controlled,<br />

one protein long-term<br />

similar,<br />

family forms and personalized<br />

“good” release struc-<br />

of<br />

functionaltures,<br />

and drugs the for other up<br />

pathogenic, to six months. “bad”<br />

ones. Sahin NanoZolid will use can<br />

mass spectrometry, be combined a<br />

technique with that traditional allows<br />

her to small weigh molecules, proteins,<br />

and nuclear as well magnetic as with<br />

resonance larger spectro- molecules.<br />

scopy that In March gives this<br />

structural year information, the United<br />

to follow States their Patent interactions<br />

to Trademark understand Office<br />

and<br />

what makes issued protein a Notice of<br />

assemblies Allowance in the for the<br />

brain bad NanoZolid or good. technology<br />

parts patent. of<br />

Which<br />

the proteins The same bind patent<br />

together? was Can approved we<br />

interfere by with the European these<br />

interactions? Patent Answering<br />

these 2018. questions With this<br />

Office in<br />

will help new us US to better patent,<br />

understand the NanoZolid the relationship<br />

technology between will<br />

normal be brain protected function until<br />

and disease. 2037 in both Europe<br />

and the US.<br />

NORDICLIFESCIENCE.ORG<br />

NORDICLIFESCIENCE.ORG<br />

71


SCIENCE<br />

YOUNG<br />

TALENT<br />

Kaja Plucinska’s research focuses on the brown and beige fat secretome<br />

and the discovery of novel endocrine factors regulating insulin<br />

sensitivity and energy balance. Her findings might lead to new therapeutic<br />

strategies to combat insulin resistance in Type 2 Diabetes.


was one of the recipients of the<br />

Novo Nordisk Foundation’s<br />

postdoctoral fellowships <strong>2019</strong><br />

for research abroad in the field<br />

of Endocrinology & Metabolism.<br />

Plucinska will receive DKK 3,985,865 over<br />

four years.<br />

What does this grant mean to you and<br />

your research?<br />

“Primarily, it tells me that the research we<br />

proposed is novel and has a true potential to<br />

uncover previously unknown and clinically relevant<br />

biology within metabolism and (brown<br />

fat) endocrinology. This grant will allow me to<br />

explore a new research environment abroad<br />

and work alongside top tier scientists in the<br />

field to develop new thinking strategies and use<br />

cutting-edge technology, e.g. click-chemistry<br />

and gene editing in vivo. I am a senior postdoc<br />

at Copenhagen University (UCPH), so this International<br />

& Homecoming (3+1 years) NNF<br />

grant will hopefully allow me to establish my<br />

FACTS<br />

I HAVE<br />

FOUND my<br />

CALLING<br />

own research group in Denmark, or another<br />

European country in 2024.”<br />

Where will you conduct your postdoc?<br />

“I will be based at the Rockefeller University,<br />

NYC (US) in the Laboratory of Molecular<br />

Metabolism led by Asst. Prof. Paul Cohen for<br />

the initial three years of the fellowship, and will<br />

return to Denmark for my fourth year, at the<br />

NNF Center for Basic Metabolic Research<br />

(CBMR). During this fellowship, I will be using<br />

what is called the ‘bio-orthogonal non-canonical<br />

amino-acid tagging’ (BONCAT) technique<br />

These areas of research are brand new in the<br />

Anna-Leena Saarela<br />

field, and<br />

is<br />

I feel<br />

an<br />

lucky<br />

expert<br />

to be able to embark<br />

in pharmaon<br />

it<br />

with this fellowship.”<br />

covigilance and she sees it as a privilege<br />

Do you have any advice to students<br />

to work in the front out there line wanting of this to pursue fast a career developing<br />

science?<br />

environment for the “Think benefit ahead of your of next patient steps, know safety.<br />

recently employed by the Cohen Lab to label<br />

and trace newly synthesized proteins released<br />

from fat in order to establish: why is burning<br />

fat through cold exposure (e.g. 5ºC) healthy for<br />

us? Does brown fat secrete (yet unidentified)<br />

We and others suggested that brown fat<br />

may produce potent circulating hormones,<br />

which have the potential of improving insulin<br />

sensitivity, but the identity of these hormones<br />

remains unknown. We recently discovered a<br />

number of such circulating factors and propose<br />

to identify their sites of actions and delineate<br />

their potential against metabolic disorder in<br />

mice to hopefully open new therapeutic strategies<br />

to combat insulin resistance in PHARMACOVIGILANCE T2D.”<br />

What is the best thing about being a<br />

scientist and about your area of research?<br />

“As an academic, I am primarily fascinated<br />

by how much there is to be discovered in biology<br />

in order to understand how we function<br />

and adapt to the environment. Since 2010,<br />

I have been pursuing basic disease-oriented<br />

research and developed a particular interest in<br />

normal physiology and pathophysiology, such<br />

as metabolic disease. The biggest ‘kick’ for me<br />

in science is the ability to pose a hypothesis<br />

and figure out the best ways to tackle it. The<br />

outcome is always exciting; it gives you a lead<br />

and it is broadening knowledge.<br />

The best thing about my current research<br />

area is that brown fat was only discovered in<br />

adult humans a decade ago (2009), and despite<br />

enormous research efforts, still little is known<br />

about its endocrine function. It burns calories<br />

and defends core body temperature during<br />

cold, but is it, similarly to white fat, also an<br />

endocrine organ? Does it crosstalk with other<br />

tissues such as brain, muscle and liver to orchestrate<br />

whole body metabolic homeostasis?<br />

PLUCINSKA´S<br />

PROJECT<br />

TITLE: Brown<br />

and beige fat<br />

secretome –<br />

discovery and<br />

characterization<br />

of novel endocrine<br />

factors regulating<br />

insulin<br />

sensitivity and<br />

energy balance<br />

in vivo<br />

Obesity, a major<br />

cause of T2D,<br />

is linked with<br />

many health<br />

complications.<br />

Fat tissue plays<br />

a fundamental<br />

role in T2D development,<br />

as its<br />

functions to<br />

store excess calories<br />

(white fat)<br />

or burn them<br />

during ‘thermogenesis’<br />

(brown<br />

fat) become<br />

impaired. These<br />

events give rise<br />

to ‘insulin resistance’,<br />

a condition<br />

of poor<br />

sugar clearance<br />

from blood.<br />

Recent data<br />

suggest that<br />

brown fat may<br />

produce potent<br />

hormones, which regulate insulin sensitivity,<br />

circulating horand<br />

if so, can they become therapeutic targets what you want to do and make a feasible plan<br />

mones that regulate<br />

insulin sensitivity,<br />

but the<br />

against obesity or diabetes?”<br />

TEXT to bachieve y M Ait. L IThis N Orule T Mis Atrue N Ifor both lab work<br />

What applications could your research and career choices. Find your strengths and<br />

identity of these<br />

have?<br />

weaknesses – work on your ‘areas for improvement’<br />

whilst using your strengths productively. mains unknown.<br />

hormones re-<br />

“Obesity, a major cause of Type 2 Diabetes<br />

(T2D), is linked with many health complications,<br />

as well as increased SAARELA mortality. IS today We know working as a it, find friends “A at typical work. Attend day at work conferences, varies depending on the factors stage was of the projects<br />

Establish your network and actively cultivate<br />

A number of<br />

such circulating<br />

ANNA-LEENA<br />

Pharmacovigilance that fat tissue plays Expert a fundamental at Crown CRO, role a Finnish the CRO with communicate Crown your discoveries, CRO PV are be working curious on at the time. Right recently now discovered.<br />

Their in close mole-<br />

collabora-<br />

I am involved<br />

offices development in the Nordic of and T2D, Baltic because area its and functions with operations to mainly about other people’s in developing work, new be a Standard team player. Operating Procedures<br />

in Europe. store excess She is a calories part of (white a team fat) of pharmacovigilance or burn them experts No-one has ever tion achieved with our a Quality ground-breaking Assurance department, cular while mechanisms<br />

and sites<br />

at the same time<br />

and her during respons-ibilities the process called cover a ‘thermogenesis’<br />

wide range of tasks, from overall discovery on their planning own. a controlled Take initiative change and to our electronic safety database, Argus<br />

of action will<br />

maintenance (brown fat) and become development compromised, of the company’s giving rise pharmacovigilance never let go of Safety, your ambition. with the system If you vendor.” love<br />

now hopefully<br />

(PV) to system, what to is called management ‘insulin and resistance’, coordination a condition<br />

and of daily poor PV sugar operations, clearance such from as safety blood. case processing. switch jobs.” as <strong>NL</strong>Sshe and her colleagues are setting up the<br />

of PV projects science, and you will A be clinical able to trial live in it. the If you start-up don’t, phase is also be keeping identified. Saarela busy<br />

tasks,<br />

“In this role, no day is the same as the previous one,” she says.<br />

NORDICLIFESCIENCE.ORG<br />

73


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YOUNG<br />

TALENT


SARAH MCGARRITY’S RESEARCH FOCUSES on endothelial cells, which are important<br />

for blood pressure and clotting, and her findings might give us a better understanding<br />

and lead to treatments for conditions including cardiovascular disease, diabetic vascular<br />

damage and acute vascular problems due to shock.<br />

ARAH MCGARRITY, PHD, was one of<br />

the recipients of the Novo Nordisk<br />

Foundation’s postdoctoral<br />

fellowships <strong>2019</strong> for research<br />

abroad in the field of Endocrinology<br />

& Metabolism. McGarrity<br />

will receive DKK 3,992,447<br />

over four years.<br />

What does this grant mean to you and<br />

your research?<br />

“This grant will provide me with the opportunity<br />

to continue to explore the links between endothelial<br />

cell function and metabolism. I will be<br />

able to work in a group that has expertise in vascular<br />

nitric oxide production and reactive oxygen<br />

species scavenging, and their links to vascular<br />

health. The knowledge I gain and the techniques<br />

that I learn will enable me to build on a project<br />

about endothelial metabolism that I have begun<br />

at the University of Iceland in collaboration with<br />

a clinical group at Rigshospitalet in Copenhagen.<br />

Also working in a new research environment,<br />

particularly one as active and prestigious as<br />

Harvard Medical School, will allow me to explore<br />

a broad range of scientific ideas and how<br />

to plan, communicate and improve my research<br />

career. The final year of the grant will allow me<br />

to bring the techniques I learn at Harvard back<br />

to the University of Iceland, where I will also<br />

continue to grow the collaboration with Rigshospitalet.”<br />

Where will you carry out your post-doc?<br />

“For the first three years I will carry out<br />

research at Harvard Medical School, under the<br />

supervision of William Oldham and Joseph<br />

Loscalzo. I will be able to learn from their expertise<br />

in vascular biology, particularly redox biology<br />

in the vasculature. Professor Loscalzo is<br />

a leader in the development of the application<br />

of systems biology to clinical problems in the<br />

form of network medicine. In my final year I will<br />

return to the University of Iceland in Reykjavík<br />

where I will continue to work in Óttar Rolfsson’s<br />

group as part of the Biomedical Centre and the<br />

Centre for Systems Biology there.”<br />

What applications could your research have?<br />

“Endothelial cells line blood vessels and are<br />

important to control blood pressure and clotting.<br />

They are covered by a proteoglycan-rich layer,<br />

the endothelial glycocalyx, which is important to<br />

this control. This layer houses enzymes that produce<br />

nitric oxide (which controls blood pressure)<br />

and remove damaging reactive oxygen species<br />

(ROS). My research investigates the effects of<br />

various stimuli on the glycocalyx layer covering<br />

vascular endothelial cells and how this, in turn,<br />

affects the activities of enzymes that are housed<br />

in this layer. The enzymes are NO forming and<br />

ROS scavenging enzymes that are important to<br />

cardiovascular health, both in the long term and<br />

during acute conditions such as trauma.<br />

By better understanding how the glycocalyx<br />

and its enzymes are affected by inflammatory<br />

and other stimuli I hope that we will be able to<br />

better understand and eventually treat conditions<br />

including cardiovascular disease, diabetic<br />

vascular damage and acute vascular problems<br />

due to shock.”<br />

What is the best thing about being a<br />

scientist and about your area of research?<br />

“I am fascinated by the process of investigation,<br />

of finding out about how things, endothelial<br />

cells in this case, work; how they break and how<br />

they affect other things. My job as a scientist<br />

enables me to pursue these investigations and<br />

to work with other people to apply any findings<br />

to create useful solutions to human health<br />

problems. As a scientist each day presents new<br />

challenges so my job is always interesting and<br />

varied.”<br />

Do you have any advice to students out<br />

there wanting to pursue a career in science?<br />

“Students who would like to pursue a research<br />

career should explore as wide a range of science<br />

as they can in order to find a research area that<br />

stimulates them. I have found that my research<br />

career has opened up a range of life experiences<br />

to me but also presents challenges that can sometimes<br />

be frustrating; being interested in my work<br />

has made the challenges worthwhile.” <strong>NL</strong>S<br />

FACTS<br />

MCGARRITY’S PROJECT<br />

TITLE: The effect of<br />

the endothelial glycoclayx<br />

on superoxide<br />

dismutase, glutathione<br />

peroxidase and<br />

nitric oxide synthase<br />

activities during<br />

stimulation<br />

Endothelial cells (EC)<br />

line blood vessels<br />

and are important<br />

to control blood<br />

pressure and clotting.<br />

ECs are covered by<br />

a proteoglycan-rich<br />

layer, the endothelial<br />

glycocalyx (EGL),<br />

which is important to<br />

this control. The EGL<br />

houses enzymes that<br />

produce nitric oxide<br />

(which controls blood<br />

pressure) and remove<br />

damaging reactive<br />

oxygen species (ROS).<br />

Hyperglycemia, inflammation,<br />

blood flow and<br />

adrenal hyperactivity<br />

affect the EGL and are<br />

known to contribute to<br />

cardiovascular disease<br />

development.<br />

This fellowship will<br />

try to better understand<br />

the mechanisms that link<br />

changes in the makeup<br />

of the EGL, after<br />

interventions in glucose<br />

levels, adrenaline and<br />

blood flow, with the<br />

activity of EGL-housed<br />

enzymes to better understand<br />

vascular health<br />

and disease.<br />

NORDICLIFESCIENCE.ORG 75<br />

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PHOTO PÅL K SELBO<br />

PHOTO LINDA KASTRUP<br />

05<br />

Timo Koskela, Eero<br />

Väyrynen, Ilkka Juuso<br />

and Jukka Kortelainen<br />

are devloping AI tools<br />

for the analysis of brain<br />

function in intensive<br />

care.<br />

read more on page 78<br />

Coripharma has taken<br />

the positive lessons<br />

learned from its country’s<br />

excellence in pharma<br />

manufacturing and<br />

adds a competitive edge<br />

to this solid heritage.<br />

read more on page 84<br />

PCI Biotech in Oslo is<br />

refining three different<br />

applications for this<br />

technology that could<br />

make differences in<br />

cancer treatments and<br />

vaccine effectiveness.<br />

read more on page 90<br />

Engineering students<br />

Casper Slots and Martin<br />

Bonde Jensen turned<br />

their undergraduate<br />

research into an Odense<br />

medical device startup<br />

company, Particle3D.<br />

read more on page 96<br />

Fueled by his passion<br />

for biotechnology,<br />

marketing and facilitating<br />

change, Erik<br />

Gatenholm co-founded<br />

the world’s first bioink<br />

company.<br />

read more on page 102<br />

NORDICLIFESCIENCE.ORG 77


A QUARTET WITH A


Timo Koskela, Eero Väyrynen,<br />

Ilkka Juuso and Jukka Kortelainen<br />

Dr Jukka Kortelainen was doing<br />

his residency at the Department of Clinical Neurophysiology<br />

at Oulu University Hospital. His work included research with<br />

intensive care patients and he realized how little we knew<br />

about the brain function of these patients. Brain monitoring<br />

has been complicated and not well-suited to the intensive care<br />

area where clinical evaluation might be difficult due to the<br />

disease, or sedation, and where no reliable laboratory tests are<br />

available to measure brain function.<br />

In addition, the information provided by imaging, such<br />

as CT or MRI, is also limited and transferring the patient for<br />

these examinations is time consuming and laborious. One of<br />

the few and best ways to measure brain function in an intensive<br />

care unit is electroencephalogram (EEG), but its application<br />

here is limited. One reason is the practical difficulties in<br />

carrying out the measurement, but this part of the problem is<br />

about to be solved as several easy-to-setup solutions suitable<br />

for intensive care with minimal training have entered the market.<br />

Another reason is that intensive care personnel usually are<br />

inexperienced in interpreting the EEG, and getting an opinion<br />

from an EEG expert might be difficult or impossible, leading<br />

to compromised treatment of the patient.<br />

Together with his colleague, Eero Väyrynen, an artificial<br />

intelligence specialist also from the University of Oulu, Kortelainen<br />

started to develop a solution to this problem. The goal<br />

was to create a technology that would provide EEG measurements<br />

in an easy-to-interpret form.<br />

The two researchers carried out a pilot study with comatose<br />

cardiac arrest patients, in collaboration with Oulu University<br />

Hospital. They found that specific EEG features revealed<br />

healthy brain function despite the patients being unconscious<br />

and sedated.


The long-term goal for Cerenion is<br />

to make C-Trend a globally adopted<br />

solution for continuous brain<br />

monitoring in intensive care<br />

the spark for an invention that was<br />

further investigated in a commercially-oriented research project, called<br />

BrainICU, which was funded by Business Finland (at that time, Tekes).<br />

“During this project it became evident that there is a clear<br />

end-user-driven need for a practical brain monitoring solution in<br />

the intensive care environment. The invention also raised a strong<br />

interest in the companies providing equipment for intensive care.<br />

These two things, together with our strong belief in our unique<br />

technology and our team, formed the basis for the decision to<br />

establish Cerenion,” says Timo Koskela, CEO and co-founder of<br />

Cerenion.<br />

The company’s patent-protected solution utilizes artificial<br />

intelligence to compress the complex EEG signal into a single<br />

parameter, C-Trend, revealing the status of the brain. This easyto-interpret<br />

parameter (ranging from 0 to 100) helps doctors in<br />

utilizing EEG in their everyday work to provide the best possible<br />

care to the patients.<br />

All four co-founders of Cerenion have research experience from<br />

the University of Oulu, and some of them have spent<br />

almost two decades at the university, so in many ways the<br />

founding of Cerenion was a big but an exciting change,<br />

according to Koskela.<br />

“First of all, everything is now more dynamic. We<br />

have a lot of freedom to choose how we run the company<br />

and how we conduct our daily work. But we also have a greater responsibility<br />

for ourselves, our employees, our investors and other<br />

stakeholders that we do it well,” he says.<br />

Some of the co-founders possessed previous entrepreneurial<br />

experience, for example from the company MetaVisual, founded<br />

in 2005. MetaVisual still exists and provides centralized, full-stack<br />

online publishing solutions to SMEs, organizations and discerning<br />

private customers. “This company has provided us with good<br />

practical experience in running a small company. Some of the<br />

founders have also worked for some other startup companies for<br />

short periods of time,” says Koskela.<br />

Nonetheless he says that the learning curve has been very steep<br />

over the past two years. “But this has mainly been a positive thing,<br />

if you take the right attitude. Of course, a small team is also much<br />

more flexible, so implementing a change is much faster (and easier)<br />

compared to the university. I also feel very privileged that we have<br />

been given a chance to build the company from scratch, including<br />

the team, the company culture and the processes. You can experience<br />

some of this at the university, but not all of it.”<br />

Jukka Kortelainen is still working half-time at the university<br />

as an academic research fellow, so he is still involved in<br />

research on a daily basis. The co-founders also conduct<br />

research at Cerenion,but they are currently commercializing<br />

their first product, so research has not been the highest<br />

priority, but will have more emphasis in the future,<br />

according to Koskela.


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,<br />

Founding a company of course teaches you a lot and you gain<br />

important insights. Timo Koskela advises that if you are planning<br />

to spin-out from a university, start the negotiations for the<br />

IPR transfer in time.<br />

“It may be that your home university does not have a clear<br />

process for the IPR transfer, or you may enter into difficult<br />

negotiations about the valuation of your company (which affects<br />

the percentage of shares the university will get once the IPR is<br />

transferred, and further, may affect the investors’ interest in your<br />

company), and therefore it may take a lot of time – reserve at least<br />

half a year. Luckily for us, the IPR transfer from the University of<br />

Oulu was rather smooth.”<br />

Also, try to attract the interest of several potential VCs, angels,<br />

etc., to create some healthy competition, is Koskela’s advice. This<br />

may help optimizing your valuation and speeding up the process<br />

in general. “If you are raising your first funding round, I would recommend<br />

that you reserve 6 to 12 months’ time depending on the<br />

maturity of your investor materials (business plan etc.) and your<br />

current connections with the VCs, angels, etc.,” he advises.<br />

When you draft your roadmap, Koskela would also recommend<br />

leaving room for delays. It is always better to “under-promise”<br />

and then “over-deliver” than be delayed.<br />

Koskela says he thinks Finland provides good conditions for<br />

a high-tech medical start-up when you apply for the seed funding.<br />

However, the challenge is that it takes a lot of time and effort<br />

to develop a medical device and bring it to the market due to all<br />

standards and regulations to be followed, which are of course<br />

definitely needed.<br />

“Therefore, I believe that the seed funding is rarely enough<br />

for the commercialization of a medical invention, and therefore<br />

typically another funding round (late seed/pre-A) is required. This<br />

is much more difficult to get, as you do not yet have any revenue,<br />

and consequently any proof that the upcoming product will actually<br />

sell,” he says.<br />

Cerenion’s solution utilizes AI to compress<br />

the complex EEG signal into a single parameter,<br />

revealing the status of the brain<br />

Another important aspect of founding a company is networking,<br />

he continues. “It is a must for every founder or co-founder. If<br />

people know you or know at least a (trusted) person who knows<br />

you, it is much easier to start discussions on collaboration or other<br />

business activities. Even in B2B, it is still people who make the<br />

deals.”<br />

Koskela also emphasizes the composition of the team. You<br />

must have all the essential pieces in place, or you need to recruit<br />

the missing talent and/or buy the services. “Also take good care of<br />

your team, both the co-founders and particularly the employees,<br />

because you have extremely talented and motivated people, but<br />

they are only a few and you cannot afford to lose any of them.”<br />

Koskela and his colleagues are currently finalizing their upcoming<br />

C-Trend software product and will soon start the certification<br />

process. The first C-Trend enabled EEG product is expected to be<br />

out on the European market this year.<br />

“Our long-term goal is to make C-Trend a globally<br />

adopted solution for continuous brain monitoring in<br />

intensive care. But before we get there, let’s enjoy the<br />

journey!” states Koskela. <strong>NL</strong>S


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84<br />

NORDIC LIFE SCIENCE


Coripharma aims to take the<br />

positive learnings from Actavis,<br />

such as excellence in quality and<br />

customer service<br />

Iceland<br />

has proven successful in the field of R&D<br />

development and manufacturing of<br />

pharmaceuticals and generics. Invest in<br />

Iceland reports that investments in R&D<br />

manufacturing within the pharmaceutical<br />

industry are continuing to increase in<br />

the country.<br />

“As a result of all the infrastructure,<br />

as well as the knowledge that has been<br />

built over the past few years, there<br />

are unprecedented opportunities for<br />

strengthening and enhancing knowledge<br />

in the Icelandic biotech and pharmaceutical<br />

industries,” states Jakob Falur<br />

Garðarsson, Managing Director of<br />

Frumtok, the Icelandic Association<br />

of the Pharmaceutical Industry.<br />

New companies have also sprung<br />

from this excellence. One such example<br />

is Coripharma, a pharmaceutical<br />

manufacturer based in Hafnarfjordur,<br />

outside Reykjavik.<br />

“Our idea is to ensure the continuation<br />

of the manufacturing of pharmaceuticals<br />

in Iceland, and to do so with a<br />

competitive edge, based on the experience<br />

of the team, our strategic location<br />

and high quality of the site,” says Björn<br />

Aðalsteinsson, Director of Business<br />

Development at the company.<br />

The founding of Coripharma began with<br />

the acquisition of a production facility<br />

with a long and successful history. The<br />

plant was first built by Actavis and it<br />

played an important role in the growth<br />

story of the company when the business<br />

expanded from a local manufacturer<br />

in Iceland to one of the biggest generics<br />

players in Europe and the world.<br />

It was later acquired by Teva, as<br />

part of its global acquisition of Actavis’<br />

generics business, and subjected to a<br />

planned closure in 2016.<br />

However, a group of local Icelandic<br />

investors and members of the management<br />

team of the plant and the commercial<br />

units came together with the aim of<br />

buying the facility and re-opening it.<br />

“In mid-2018 the team finalized the<br />

acquisition, after lengthy negotiations<br />

with Teva. The investors behind the<br />

project are a collection of private equity,<br />

including some former top managers of<br />

Actavis, as well as institutional Icelandic<br />

investors,” says Aðalsteinsson.<br />

During 2018 the new company managed<br />

to get its production facility up and running,<br />

it was re-inspected by the Icelandic<br />

Medicine Agency and production began.<br />

In addition, in <strong>2019</strong> Teva decided to<br />

divest its R&D site in Iceland. This site<br />

was adjacent to Corpiharma’s facility<br />

and the company saw the opportunity<br />

to invest – making the jump from a<br />

86<br />

NORDIC LIFE SCIENCE


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pure contract manufacturing organization<br />

(CMO) to establishing its own R&D<br />

and selling its own developed products.<br />

“Now we are a fully-fledged CDMO.<br />

We offer our partners a full range of<br />

production of tablets and capsules at an<br />

internationally GMP approved site and<br />

we also offer our own range of in-house<br />

developed generic products, most of<br />

them coming off patent in the coming<br />

few years,” Aðalsteinsson says.<br />

The majority of the team behind<br />

Coripharma have previously worked at<br />

Actavis, being part of a journey where<br />

they have grown and evolved with a<br />

company growing from a small local<br />

entity to be a part of a multi-national<br />

organization.<br />

“We aim to take the positive learnings,<br />

such as excellence in quality and<br />

customer service, while avoiding the<br />

pitfalls of the big top-heavy corporate<br />

beasts that companies can grow into if<br />

left unchecked,” says Aðalsteinsson.<br />

“The contract manufacturing market<br />

is quite competitive today and to gain<br />

an advantage you need to focus on what<br />

you are good at,” continues Aðalsteinsson.<br />

“Our strength lies in our ability to<br />

offer high customer service, quick turnaround<br />

times and good cost of goods for<br />

the medium sized products. We are not<br />

trying to compete with companies offering<br />

billions of tablets but instead to offer<br />

production and packaging to clients that<br />

need flexibility and quality.”<br />

“Official support is very limited,”<br />

he continues, “But the local investment<br />

environment in Iceland has been very<br />

receptive of our project and funding the<br />

company has gone very well. All commercialization<br />

is done the “old school”<br />

way – knocking on doors – beginning<br />

with those we knew from previous jobs<br />

and cold-calling. Participating in trade<br />

events has also generated good results.”<br />

“The long-term plans for Coripharma<br />

are to bring the R&D projects to market<br />

and build a future on their own in-house<br />

developed products, while continuing to<br />

build a strong CMO operation which<br />

will serve as an important revenue generator,”<br />

says Aðalsteinsson.<br />

“We will also aim to work closely<br />

with selected development partners in<br />

order to maximize our portfolio reach.<br />

Going forward we are not planning to<br />

sell under our own brand directly to<br />

the market, but rather out-license our<br />

products to international customers.”<br />

As a final piece of advice to other<br />

Nordic life science entrepreneurs-to-be<br />

out there, Aðalsteinsson recommends<br />

to nurture your network and believe in<br />

your team! <strong>NL</strong>S<br />

Aðalsteinsson states that among the<br />

advantages of being located in Iceland<br />

is access to great employees. “We have<br />

been extremely fortunate in the fact<br />

that the pool of ex-Actavis workers has<br />

been deep enough to sustain our needs<br />

well, and people really have jumped at<br />

the opportunity to join our company<br />

on this journey.”<br />

Another advantage, he says, is the<br />

green energy they utilize for their operations.<br />

“Iceland is also located very<br />

strategically, close to both Europe and<br />

America, and being inside the European<br />

Economic Area makes us a natural<br />

EU-GMP site.”<br />

Coripharma has been fortunate in<br />

the fact that the pool of ex-Actavis<br />

workers has been deep enough to<br />

sustain their needs well<br />

88<br />

NORDIC LIFE SCIENCE


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91


Per Walday, CEO, PCI Biotech


photochemical internalization<br />

(PCI) technology, an intracellular<br />

delivery method, comes in. Norwegian<br />

biopharmaceutical company PCI Biotech<br />

AS in Oslo is refining three different applications<br />

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differences in cancer treatments and vaccine<br />

effectiveness.<br />

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of the two, it is going to open up so many new possibilities that it is<br />

difficult to imagine the consequences.”<br />

BEEN IN THE INDUSTRY IN DIFFERENT WAYS<br />

Per Walday, 58, joined PCI Biotech in 2008, bringing with him<br />

more than 20 years of experience in the biotechnology field. Prior<br />

to joining PCI Biotech, Walday served as the Global Head of<br />

project management at GE Healthcare and in management positions<br />

at Nycomed Imaging/ Amersham Health. Early in his career<br />

he worked for the Norwegian Defence Research Establishment,<br />

researching potential treatments against nerve gas poisoning.<br />

A celebrity marine explorer and conservationist and scuba<br />

diving were Walday’s primary inspirations to study<br />

biology. An avid scuba diver and admirer of wellknown<br />

French marine expert Jacques Cousteau,<br />

Walday moved from his native Sweden to study biology<br />

at the University of Oslo. There he decided the<br />

most compelling aspect of the field was the workings<br />

93<br />

of the human body and focused on physiology, in which he earned<br />

a doctorate. Walday also studied toxins and how they enter and<br />

effect cells. “I’ve been in the industry in different ways since then.”<br />

APPLICATIONS FOR THE PCI TECHNOLOGY<br />

Now PCI Biotech is working on three applications for the PCI<br />

technology, which was invented at Oslo University Hospital; using<br />

it to increase the effectiveness of chemotherapy for certain cancers;<br />

enhancing the effectiveness of vaccines by improving cellular immune<br />

responses and in collaborations with companies interested in<br />

using the intracellular delivery method.<br />

PCI<br />

technology to treat bile duct cancer have<br />

been promising, Walday noted. “My goal<br />

is to make this company succeed and<br />

make sure we can deliver what we said we<br />

would.”<br />

In the coming years, Walday expects to<br />

see PCI technology in use across different<br />

disciplines. “It will be more like precision medicine, more than just<br />

a drug delivered for one indication.”<br />

THE CHALLENGE OF RECRUITING<br />

Among the challenges of starting a biotech company in<br />

Norway is having a small number of pharmaceutical and<br />

biotechnology companies with whom to work, because the<br />

main focus has been on other industries such as fishing and


PHOTO PÅL K SELBO<br />

ILLUSTRATION OF THE PCI PRINCIPLE:<br />

LEFT IMAGE: DRUG (ORANGE) TRAPPED IN ENDOSOMAL CAPSULES WITHIN CELLS<br />

RIGHT IMAGE: DRUG RELEASED INTO THE CELL CYTOSOL AFTER PCI TREATMENT<br />

oil and gas extraction. The small biotech industry base can make it<br />

difficult to fill key positions.<br />

“Finding an experienced chief medical officer in Norway is<br />

difficult,” Walday said. While interest nationally in the biotechnology<br />

field continues to grow, recruiting specialty investors to invest<br />

in Norwegian biotech, can also be difficult, he added.<br />

SUPPORT THAT MAKES A DIFFERENCE<br />

Support from the Oslo Cancer Cluster has made a difference for<br />

PCI Biotech and other cancer focused biotech companies getting<br />

off the ground, according to Walday. Among the cluster’s<br />

initiatives are bringing small companies together for forums and<br />

networking and building an innovation park. Educating the public<br />

and government officials about the importance of the biotechnology<br />

industry is another initiative that is showing results.<br />

“Since I’ve been in the biotech startup area, over the past 10 years,<br />

things have changed dramatically,” Walday said. “They [people at the<br />

cluster and the pharmaceutical industry association] are influencing<br />

politicians; it is important for politicians to understand that there is<br />

very good research going on, and a lot of that can become technology<br />

that can be commercialized.The cluster has contributed well<br />

in making sure politicians understand that. The atmosphere<br />

has changed with improved interaction between healthcare<br />

providers, researchers and the industry.”<br />

are good for industry<br />

growth. “I think it [the industry outlook]<br />

is very positive,” said Walday. “The people in<br />

the Nordic countries are very well-educated,<br />

there is a highly-organized healthcare system<br />

with well-developed health registries and a<br />

lot of industry organized around life sciences.<br />

Denmark and Sweden have more of a history<br />

in biotechnology, but now Norway is getting more interested in the<br />

potential of this industry. Biotech companies need highly-competent<br />

and highly-educated people. There is a good supply here compared<br />

to many other countries and a growing need for this type of work.”<br />

AN OPEN ENVIRONMENT<br />

The advice Walday would pass on to biotech entrepreneurs is to<br />

have patience and persistence.<br />

“There will be a lot of ups and downs in what you are doing, so<br />

you have to have stamina. Make sure you have the right people;<br />

and not only the right people, but also the right competences. You<br />

need people who thrive with challenging work and want to make it<br />

happen. People who want it to succeed. Also ensure that<br />

you have team members who function well together, that<br />

you have an environment that is open and where you can<br />

share everything.” <strong>NL</strong>S<br />

94


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Currently, implants for<br />

reconstructive surgery are<br />

made of bone taken from<br />

the patient that must then<br />

grow back or from foreign<br />

materials such as metal.<br />

P article3D prints implants<br />

using calcium phosphate-fatty<br />

acid bioink with a composition<br />

similar to bone


DENMARK<br />

Casper Slots and<br />

Martin Bonde Jensen<br />

97<br />

PHOTO LINDA KASTRUP


-<br />

TEXT<br />

b y C H R I S T A C H I B A N A<br />

N 2015, Martin Bonde Jensen and Casper<br />

Slots were University of Southern Denmark<br />

engineering students with a smart research<br />

project. Today, they are cofounders and<br />

executives of Particle3D, moving the technology<br />

from their project to market. The<br />

company is developing medical implants that<br />

are 3D-printed from biomaterials similar to<br />

natural bone.<br />

”When Martin and I decided to write a bachelor’s thesis<br />

together,” Slots says, ”we thought 3D printing was exciting<br />

and we wanted to work on a real-life problem.” They<br />

developed their project with Professor Morten Ø. Andersen<br />

and Odense University Hospital surgeon Torben Thygesen,<br />

also Particle3D cofounders.<br />

98<br />

BUILDING A SOLID ORGANIZATION<br />

Already in 2015, prompted by the university, the team filed<br />

its first patent. Within a few years, Slots and Jensen earned<br />

master’s degrees, won the VentureCup pitch competition,<br />

receiving 100 000 DKK toward their startup, and got intense<br />

entrepreneurial training in the Accelerace incubator program.<br />

Particle3D is now funded by 5 million DKK from business<br />

angels and the early stage investor PreSeed Ventures.<br />

Jensen, 28 years old in 2018, was on the Forbes 30 under<br />

30 list for Europe Science and Healthcare. In March <strong>2019</strong>,<br />

experienced executive Thea Wulff Olesen joined Particle3D<br />

as CEO. The company is still in ”very early days,” she says,<br />

”but we’re reviewing our strategy and looking at the best<br />

paths for us.” Her primary goal right now is building a solid<br />

organization based on the Particle3D technology.<br />

TAILORED, BONELIKE IMPLANTS<br />

Currently, implants for reconstructive surgery are made<br />

of bone taken from the patient that must then grow back<br />

or from foreign materials such as metal. Particle3D prints<br />

implants using a calcium phosphate-fatty acid bioink with<br />

a composition similar to bone. Experiments with stem cells<br />

show the implants support activities that should lead to their<br />

eventual integration into a patient’s body through normal,<br />

physiological bone remodeling.<br />

Slots explains that getting to the right technology took biological<br />

understanding and engineering instincts. The bone-like<br />

bioink they formulated is dense, like toothpaste, and has to be<br />

kept warm because it solidifies quickly. That required some<br />

technological hacking. ”We started with a cheap printer,<br />

like hobbyists use,” Slots says, ”and stationed a blow<br />

dryer in front to keep it at the right temperature.”


-<br />

Odense


-<br />

article3D now has a more advanced printer<br />

with specialized components. The company<br />

moved in 2017 from the university,<br />

which initially employed Jensen and Slots<br />

to develop their idea, to office and lab space<br />

in central Odense. Particle3D holds U.S.<br />

and European patents and are applying in<br />

South America and Asia, including India.<br />

The company is testing the implants in pigs, with results<br />

expected soon, and plans for clinical trials, if all goes well.<br />

Eventually, Jensen says, they envision making individually<br />

tailored implants for hospitals and surgical centers to use<br />

with patients having facial reconstruction because of cancer<br />

or accidents.<br />

LEARNING BY DOING<br />

Jensen and Slots barely have time to reflect on how<br />

they went from an idea to Particle3D in a few quick<br />

years. It was a learn-by-doing experience, in any case. Every<br />

process from registering the company to paying their own<br />

salaries was new. ”We’re engineers,” Jensen says. ”We didn’t<br />

have experience with starting or running a company.”<br />

onetheless, Olesen is impressed with<br />

what the entrepreneurs built. ”Martin<br />

and Casper did a great job of not<br />

rushing into things but figuring them<br />

out first,” she says. Although they are<br />

just four full-time employees now, Slots<br />

says an early lesson has been the importance<br />

of building a good team around your technology.<br />

Particle3D has benefitted from mentors and advisors they<br />

met through Accelerace, for example. ”You learn you can’t<br />

do everything yourself and you need experts,” Slots says.<br />

MAKING THIS IDEA FLY<br />

Both Slots and Jensen are committed to moving the company<br />

forward to market launch, although this career path is<br />

somewhat surprising to them. Both originally thought they<br />

would work in R&D, including getting engineering PhDs.<br />

Slots has a nursing degree and says, ”My perspective is, this<br />

is such a good cause. I’m first and foremost a nurse, drawn<br />

to technology and working on medical devices. I see how<br />

our company can help patients who have difficulties with<br />

cranial-facial reconstructions. Although they appreciate<br />

their surgeons, many have depression because they don’t<br />

recognize themselves in the mirror. I want to get a product<br />

on the market that helps patients improve their lives.”<br />

ensen says that he might someday go back<br />

to doing engineering labwork or he could<br />

launch another startup in the future based on<br />

his entrepreneurial experience with Particle-<br />

3D. But right now, he says, the work is fun<br />

and exciting and ”our full focus is on commercializing<br />

our lead product and scaling our<br />

company and making this idea fly.” <strong>NL</strong>S<br />

100


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102


GROWING UP IN AN ACADEMIC ENVIRONMENT WITH PARENTS WHO ARE<br />

SCIENTISTS AND ENGINEERS, ERIK GATENHOLM SAW HOW TRANSFORMATIVE<br />

SCIENTIFIC DISCOVERIES COULD BE AND WONDERED HOW MUCH MORE<br />

GOOD THEY COULD DO IF O<strong>NL</strong>Y MORE PEOPLE KNEW ABOUT THEM.<br />

TEXT<br />

b y E L L E N R . D E L I S I O


iotechnology,<br />

marketing and facilitating change, Gatenholm co-founded<br />

and is the CEO of Cellink, the world’s first bioink company,<br />

with its U.S. headquarters in Boston, Massachusetts and<br />

European office in Gothenburg, Sweden. Using bioink<br />

technology, researchers can print three-dimensional human<br />

organs and tissue; the biomaterial enables human cells and<br />

tissue to grow as if they were in a body.<br />

Bioink and the printer technology stem from work by<br />

researchers such as Paul Gatenholm, Erik’s father, a professor<br />

of biopolymer technology and chemistry at Chalmers University<br />

in Gothenburg. Cellulose from Swedish forests and alginate<br />

from seaweed native to the Norwegian Sea are among the<br />

bioink’s ingredients.<br />

The applications for the bioprinted materials are endless,<br />

including pharmaceutical and preclinical testing; scientists can<br />

print out small sections of cancer tumors, for example, and use<br />

them for testing different drugs and print liver, cartilage and skin<br />

tissues. Cellink also sells the bioprinters used in the process.<br />

Five years ago, bioink was not available commercially,<br />

and Erik Gatenholm decided that needed to change. In the<br />

three years since Cellink was founded, business has grown<br />

rapidly and the company has customers in about<br />

50 countries and employs approximately 100<br />

people. Married with an apartment in Sweden,<br />

Gatenholm said he still travels frequently, spending<br />

most of his time on the east coast of the U.S.<br />

105<br />

Erik’s other love is music production, but the passion<br />

for Cellink have put those activities on hold. “I truly enjoy<br />

music production and actually had plans of becoming a<br />

professional House music producer,” he said. “Back in<br />

2013, I received my first record deal with a record label<br />

and then kept producing for a few years after that. It’s been<br />

a while since I produced music now. I miss it.”<br />

MAKING AN IMPACT<br />

Gatenholm, 29, met some of his future business partners<br />

while working on his MBA at Gothenburg University. He<br />

was born in Sweden, but moved to the U.S. at a young<br />

age when his father accepted a job at Virginia Polytechnic<br />

Institute and State University (more commonly known as<br />

Virginia Tech) in Blacksburg, Virginia.<br />

Paul Gatenholm’s area of expertise was bioengineering,<br />

and he worked with biomaterials and tissue engineering.<br />

While Erik also was interested in science, he earned a degree<br />

in business management from Virginia Tech. He learned about<br />

interesting discoveries and developments in bioengineering and<br />

science, but also saw the difficulties scientists and entrepreneurs<br />

had in bringing discoveries to market and getting<br />

patents. “You have to do that if you want to make an<br />

impact,” Gatenholm said. “I saw that was missing<br />

and wanted to focus on that aspect. What a lot of<br />

companies in the science field are lacking is a focus<br />

on the management, marketing, and sales.”


A FACE-TO-FACE INDUSTRY<br />

One of the challenges for new companies in Sweden and other<br />

Nordic countries is they are not as comfortable marketing products<br />

as businesses elsewhere, particularly the U.S., Erik Gatenholm<br />

said. “The environment is different [in Sweden]; I made a point<br />

that they could excel if they showcased their products. The U.S.<br />

has different ways of marketing. So many companies here are<br />

developing great technologies, but they don’t reach out far.”<br />

In May, Gatenholm had recently completed a “world tour”<br />

traveling to different research labs to explain bioink. “The life sciences’<br />

industry is still a face-to-face industry,” he said. “You have to<br />

spend time in labs and bring researchers up to speed, you have<br />

to build up relationships with customers and get to know them.<br />

I really enjoy that.”<br />

WANT TO BE READY<br />

Recruiting high-quality people is another challenge of starting any<br />

company. “Finding good colleagues and coworkers is hard and finding<br />

people who are willing to put everything into the company, willing<br />

to put their entire lives into the company, is hard,” Gatenholm<br />

said. “You need to motivate them for the long-term perspective and<br />

provide incentives.”<br />

Bioink’s uses likely will expand and diversify over the next few<br />

decades, according to Gatenholm, and he wants to be<br />

ready. “The first 10 years will be focusing heavily on the<br />

pharmaceutical and preclinical industries, then we will<br />

see it working into clinical work,” he said. “We are starting<br />

with the easy tissues, the single-cell ones. After 10 years, we<br />

will see researchers working it into clinical fields. We will be<br />

providing the pickaxe and shovels so they can print skin, a<br />

meniscus or blood vessels.”<br />

THE GROUNDWORK FOR A SUCCESSFUL<br />

BUSINESS<br />

Looking ahead, Gatenholm’s goal is to create “massive” life sciences’<br />

companies that can supply the best added-value technologies.<br />

“I want to build companies comparable to Facebook and<br />

Google in the life sciences field.”<br />

He would advise other entrepreneurs to publicize their names<br />

and ideas as much as possible as soon as possible. “It’s important<br />

to stand out; use advertising and marketing to stand out and<br />

always think about sales opportunities,” Gatenholm said.<br />

“By the time your product is approved, you will have laid the<br />

groundwork for a successful business.”<br />

The Nordic countries also have the key ingredients to grow<br />

life science companies. “The outlook is quite positive, the field is<br />

going to grow very rapidly,” Gatenholm said. “There are a lot of<br />

new companies popping up; the risks are low and the advantages<br />

high. When you look at the cost of scientists and programmers,<br />

salaries are lower [than the U.S.], you have a highly-educated<br />

workforce and the ability to start something very<br />

rapidly.” <strong>NL</strong>S<br />

106


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<strong>NL</strong>S<br />

INSIGHT<br />

LEGAL ADVICE


almost identical<br />

to a drug manufactured by another<br />

company whose patent has expired. In<br />

many cases, however, a single original<br />

medication can have as many as 200<br />

patents and exclusivities attached to<br />

it, according to Julie Maréchal-Jamil,<br />

director of Biosimilar Policy & Science,<br />

Medicines for Europe, who is raising<br />

the question of whether this is in keeping<br />

with the intent of the patent system.<br />

“A particular concern is the increasing<br />

number of patents protecting indications<br />

that can be used to delay the access<br />

for patients, as our pharma industry<br />

has experienced with certain cancer<br />

medicines in Eastern Europe,” says<br />

Maréchal-Jamil. “This extensive patent<br />

landscape adds to the risk of developing<br />

biosimilar medicines.”<br />

The quality pre-clinical and clinical<br />

comparability exercises needed to<br />

develop biosimilars also requires<br />

extensive amounts of time and money,<br />

according to Maréchal-Jamil. What<br />

this means for drug devel-opers is<br />

intense discussions with regulatory<br />

authorities, such as the U.S. Federal<br />

Drug Administration (FDA) and the<br />

European Medicines Association<br />

(EMA), about regulatory issues to<br />

understand in detail their requirements<br />

for a specific development program.<br />

This includes the analytical methods<br />

to apply for analytical biosimilarity<br />

exercises and the design of clinical trials,<br />

says Martin Åmark, CEO/IR of Xbrane<br />

Biopharma AB, a Swedish biotechnology<br />

company that is developing biosimilars.<br />

To get the necessary advice, “We have<br />

engaged with specialist consulting<br />

groups and also participated with a<br />

scientific advisory group,” notes Åmark.<br />

“We are targeting the European and<br />

U.S. markets.”<br />

Xbrane expects to launch its first biosimilar<br />

in 2022. “You need to have the<br />

scientific know-how to develop these<br />

products and the financial resources to<br />

push them through the trials,” he says.<br />

As a good omen for the biosimilar industry,<br />

companies in Finland, Denmark<br />

and Sweden prevailed in the first patent<br />

dispute in Finland and Denmark. In<br />

March, the Finnish Market Court ruled<br />

against a motion for a preliminary<br />

injunction against MSD Finland Oy<br />

filed by F. Hoffman-La Roche AG,<br />

Roche Oy and Genentech Inc., and in<br />

Denmark, the Maritime and Commercial<br />

High Court in Copenhagen denied<br />

Roche and Genentech preliminary<br />

injunctions against MSD Danmark,<br />

Samsung Bioepis and Biogen (Denmark)<br />

Manufacturing.<br />

F. Hoffman-La Roche and Genentech<br />

argued that MSD Finland Oy<br />

infringed upon Roche and Genentech’s<br />

rights, according to the Finnish part of<br />

a European product patent, by marketing<br />

and selling a biosimilar drug in<br />

Finland. According to the court, it was<br />

unlikely MSD Finland would infringe<br />

on the rights of the companies that produced<br />

the original drug and was free<br />

to continue selling its drug to Finnish<br />

hospitals.<br />

In Denmark, Genetech and Roche<br />

claimed MSD Danmark, Samsung Bioepis<br />

and Biogen were infringing on their<br />

rights, according to the Danish section<br />

of a European product patent.<br />

NORDIC LIFE SCIENCE<br />

109


Swedish company Xbrane expects to<br />

launch its first biosimilar in 2022.<br />

Union accounts for more than 90 percent<br />

of the global cumulative experience<br />

with biosimilar medicines, according<br />

to Maréchal-Jamil. “In the EU, every<br />

country uses biosimilar medicines,<br />

however there remains variability among<br />

countries and also within countries,<br />

depending on the biologic molecule and<br />

the therapeutic area.”<br />

Payers and customers in the Nordic<br />

countries have been especially accepting<br />

of biosimilars, according to Pfizer Sweden<br />

Country Manager Malin Parkler.<br />

Pfizer’s current portfolio includes four<br />

approved biosimilars in the U.S. and<br />

EU for the treatment of cancer or supportive<br />

care, and approved biosimilars<br />

for the treatment of inflammatory<br />

conditions. In terms of guidance during<br />

production, “We work with a range<br />

of stakeholders including researchers,<br />

physicians, patients and policymakers<br />

to inform our development pipeline<br />

and bring these important therapies to<br />

the market,” Parkler informs.<br />

In September 2017, Pfizer filed a suit<br />

in U.S. District Court for the Eastern<br />

District of Pennsylvania against Johnson<br />

& Johnson, arguing that Johnson &<br />

Johnson is preventing U.S. patients<br />

from using a biosimilar produced by<br />

Pfizer. No trial date has been set.<br />

“We filed this lawsuit to challenge<br />

practices that block access, choice<br />

and price competition for patients,<br />

so that U.S. patients have access to a<br />

wide range of treatment options at a<br />

competitive price,” says Andy Widger,<br />

Senior Director, Global Media Relations,<br />

for Pfizer.<br />

The lawsuit alleges that Johnson &<br />

Johnson’s anti-competitive practices<br />

concerning Remicade® (infliximab)<br />

have denied U.S. patients and the<br />

broader healthcare system the benefits<br />

of price competition and therapeutic<br />

options in the biologics marketplace<br />

in violation of federal antitrust laws,<br />

according to Widger. The suit maintains<br />

that Johnson & Johnson said it<br />

would withhold significant rebates to<br />

insurers for both current and future<br />

patients unless the insurers agreed to<br />

block coverage for Inflectra and other<br />

infliximab biosimilars, Widger noted.<br />

Despite the cost and numerous patent<br />

and legal issues, interest in biosimilars<br />

remains high. Currently the European<br />

Other barriers to biosimilar use are fears<br />

that they will not be as effective as the<br />

original drugs and there are insufficient<br />

inducements to develop and prescribe<br />

them, according to experts.<br />

“The lack of incentives and benefitsharing<br />

schemes, which require specific<br />

national policy interventions and<br />

measures [are issues],” says Maréchal-<br />

Jamil.<br />

Among the potential solutions she<br />

cites making sure the framework is<br />

patient-centric and the market mechanisms<br />

are supportive of healthy competition;<br />

the pricing, reimbursement and<br />

tendering processes and timelines enable<br />

timely biosimilar medicine launches, and<br />

the treatment guidelines are revised to<br />

include improved cost-efficiency where<br />

biosimilar medicines are available.<br />

“A competitive and sustainable<br />

European marketplace that supports<br />

both originator biologics and oncology<br />

biosimilars is necessary to obtain the<br />

110 NORDICLIFESCIENCE.ORG


<strong>NL</strong>S<br />

INSIGHT<br />

LEGAL ADVICE<br />

The Xbrane Biopharma<br />

management team<br />

Malin Parkler, Country<br />

Manager, Pfizer Sweden<br />

Julie Maréchal-Jamil, Director<br />

of Biosimilar Policy & Science,<br />

Medicines for Europe


Martin Åmark, CEO, Xbrane Biopharma<br />

in crafting policies that facilitate<br />

biosimilar production. “One of the<br />

fundamental pillars for the successful<br />

uptake policies in Norway has been the<br />

government leadership in designing a<br />

biosimilar policy framework, involving<br />

multi-stakeholder engagement and an<br />

active roadmap for policy interventions<br />

supporting their ambition for biosimilar<br />

medicines’ role in the healthcare system,”<br />

says Maréchal-Jamil. “In the Nordic<br />

region, Sweden can certainly be showcased<br />

as an active-learning example,<br />

factoring experience in the design<br />

of the framework. Swedish officials<br />

recently outlined the implementation<br />

of a tiered tendering approach, which<br />

supports multi-actors in the market<br />

and healthy competition, as well as<br />

implementing benefit-sharing schemes<br />

where the benefits of the introduction<br />

of biosimilar medicines in clinical practice<br />

are re-invested in tangible improvements<br />

for the healthcare community.”<br />

benefits that these important medicines<br />

offer for patients, physicians, payers<br />

and healthcare systems in the longterm,”<br />

adds Parkler.<br />

Additional incentives to drive the<br />

use of biosimilars over more expensive<br />

originator biologics could include<br />

regulators accepting interchangeability<br />

of medications and automatic substitution,<br />

says Åmark.<br />

Communicating the safety, effectiveness<br />

and lower cost of biosimilars to<br />

patients and healthcare providers also<br />

helps, according to Maréchal-Jamil,<br />

including disseminating real-world data<br />

about the value and benefits seen across<br />

the healthcare community through the<br />

use of biosimilar medicines.<br />

112 NORDICLIFESCIENCE.ORG<br />

In terms of production, some experts<br />

maintain that revising the regulations<br />

for clinical trials could eliminate redundancy<br />

in testing. Lowering the primary<br />

requirements for Phase III trials and<br />

relying more on evidence from analytical<br />

data and phase I studies would help<br />

manufacturers get biosimilars to market<br />

faster, says Åmark.<br />

Maréchal-Jamil agrees, “The regulatory<br />

science advances also need to factor in<br />

the experience for optimal efficiency in<br />

both the development and registration<br />

of biosimilar medicines.”<br />

The Nordic countries, especially<br />

Sweden and Norway, have been leaders<br />

The savings from using biosimilars are<br />

going to become increasingly critical as<br />

healthcare costs continue to rise.<br />

“The value and benefits of biosimilar<br />

utilization in terms of re-investment<br />

in health and patient care are very clear<br />

and documented,” notes Maréchal-<br />

Jamil. Among these are more patients<br />

receiving treatment earlier because of<br />

the lower costs of the medications, and<br />

allowing the savings to be invested in<br />

other areas of care, such as expanding<br />

a hospital’s nursing staff, she notes.<br />

“Biosimilars are one of the most<br />

promising things to reduce healthcare<br />

costs in the coming decades,” adds<br />

Åmark. “They are the key to reducing<br />

costs and the key to making drugs accessible<br />

to broader populations.” <strong>NL</strong>S


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CAREERS<br />

INTERVIEW<br />

Anna-Leena Saarela,<br />

Pharmacovigilance<br />

Expert, Crown CRO


PHARMACOVIGILANCE<br />

TEXT<br />

b y M A L I N O T M A N I<br />

today working as a<br />

Pharmacovigilance Expert at Crown CRO, a Finnish CRO with<br />

offices in the Nordic and Baltic area and with operations mainly<br />

in Europe. She is a part of a team of pharmacovigilance experts<br />

and her responsibilities cover a wide range of tasks, from<br />

overall maintenance and development of the company’s<br />

pharmacovigilance (PV) system, to management and coordination<br />

of PV projects and tasks, and daily PV operations,<br />

such as safety case processing.<br />

115<br />

“In this role, no day is the same as the previous one,” she says.<br />

“A typical day at work varies depending on the stage of the projects<br />

Crown CRO PV are working on at the time. Right now I am involved<br />

in developing new Standard Operating Procedures in close collaboration<br />

with our Quality Assurance department, while at the<br />

same time planning a controlled change to our electronic<br />

safety database, Argus Safety, with the system vendor.”<br />

A clinical trial in the start-up phase is also keeping<br />

Saarela busy as she and her colleagues are setting up the


safety reporting processes for that particular project together with<br />

the clinical team and other stakeholders.<br />

“Other daily tasks involve processing and reporting any adverse<br />

event reports that may come in from the other ongoing projects<br />

and other similar unpredictable tasks,” Saarela adds.<br />

A TEAM EFFORT<br />

Working at a CRO with different customers and projects requires an<br />

ability to understand and accommodate the needs and expectations<br />

of both customers and regulatory bodies to provide a service that<br />

exceeds customer expectations and meets industry standards, Saarela<br />

describes. “This makes the job constantly changing and interesting.”<br />

CRO work is a team effort involving communication with<br />

customers and authorities but also with various internal stakeholders,<br />

as different functions work together to achieve common project<br />

goals. “My work involves a lot of meetings, calls with colleagues from<br />

different functions, delegating tasks, solving problems, and negotiating<br />

with stakeholders to find good solutions. Efficient communication is<br />

the key, and I believe any problem can be solved by clear, timely and<br />

honest communication with everyone involved,” states Saarela.<br />

IN THE FRONT LINE<br />

Anna-Leena Saarela first came to work in the pharmaceutical industry<br />

in 2002, as an administrator in clinical trials. “Right away I felt I<br />

had found my calling.”<br />

Over the past 17 years she has worked in different companies<br />

within the industry as a Language Services Specialist,<br />

Project Management Assistant, Clinical Supplies Manager,<br />

IxRS and Medication Manager, and now as a Pharmacovigilance<br />

Expert at Crown CRO for the past three years.<br />

116<br />

She started off by studying translation at the University of<br />

Helsinki in Finland, and she also has an Authorized Translator’s<br />

certificate specialized in medicine and biology. “It was my first job<br />

as a medical translator two decades ago that led me to the pharmaceutical<br />

industry and clinical trials, and later on I studied further<br />

and now I have a Master’s Degree in Pharmacy from the University<br />

of Helsinki.”<br />

During her pharmacy studies she specialized in industrial pharmacy,<br />

and now she is planning to start PhD studies as a kind of<br />

extracurricular activity alongside her day job, she says.<br />

The field of pharmacovigilance caught her interest quite early<br />

in her pharmacy studies, as PV was clearly an area where working<br />

for the benefit of patient safety was the top priority. “I see it as a<br />

privilege to be able to work in the front line of the fast developing<br />

pharmacovigilance environment.”<br />

VERSATILITY – A CHALLENGE AND AN OPPORTUNITY<br />

The best part of her job, Saarela describes, is the versatility. “In a<br />

company of this size it is possible to bring out the best competencies<br />

in everyone and try your wings in areas you would not have<br />

the opportunity to see in a large company, where there may often<br />

be less room for movement outside your own role. This job offers<br />

a wide range of opportunities for professional growth.”<br />

Versatility is also the most challenging part of the job, she<br />

says. Crown CRO is a consulting company aiming to provide its<br />

customers excellent service, and when customer expectations vary<br />

Saarela and her colleagues have the challenging and exciting role<br />

of meeting and exceeding those expectations, while also meeting<br />

regulatory expectations in a highly regulated industry. “Every day<br />

at the office is different, and part of my job is to adopt new information<br />

quickly in a changing environment,” she describes.<br />

EXTENSIVE REGISTRIES AND DIGITALIZATION<br />

The regulatory environment around clinical trials, drug development<br />

and marketing is rapidly changing, and staying up to date<br />

to comply with global laws, regulations and guidance is very<br />

important for a life science company entering these phases. Both<br />

the pharmaceutical industry and the regulatory environment are<br />

changing constantly, and the clinical trials field will change with<br />

the upcoming adoption of the new EU Clinical Trial Regulation<br />

next year, believes Saarela.<br />

“In pharmacovigilance, the adoption of medical device and<br />

in-vitro diagnostic device regulations in 2020 and 2022 will have<br />

a marked impact on the safety reporting of medical devices and<br />

also on clinical trials concerning medical devices overall. Also real<br />

world data is a hot topic that will affect the way we look at safety<br />

information as well. On a more general level, digitalization is a<br />

global phenomenon, which we at Crown CRO see as an opportunity<br />

to improve the quality of data and streamline projects.”<br />

Finland is known for its high-standard medical research and a<br />

stable industry environment, and this holds true for Finnish CRO<br />

services as well, says Saarela. One aspect where Finland especially<br />

stands out, even on a global level, she says, “is the extensive health<br />

databases and registries that will certainly be utilized<br />

more and more in future. The registries allow for efficient<br />

collection of information, such as real world data.”<br />

“Finland is also a forerunner in the adoption of digital<br />

solutions, which gives us a stronger position in the midst<br />

of global digitalization,” Saarela concludes. <strong>NL</strong>S


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CAREERS<br />

IN A NEW JOB<br />

THE LATEST CAREER NEWS FROM THE NORDIC LIFE SCIENCE INDUSTRY<br />

TEXT<br />

b y M A L I N O T M A N I<br />

PHOTO LENA BECK<br />

ANKI MALMBORG HAGER MALIN PARKLER KLAUS ABEL CATHERINE MAZZACCO<br />

NEW CEO OF PAINDRAINER<br />

NEW CHAIR OF LIF SWEDEN<br />

NEW GENERAL MANAGER<br />

NEW CEO OF LEO PHARMA<br />

NORDICS, LEO PHARMA<br />

ANKI MALMBORG HAGER has a<br />

long-standing experience of<br />

leading life science companies in<br />

their early start-up phases, with<br />

SenzaGen being the most recent<br />

achievement. At SenzaGen she<br />

took the company from a market<br />

cap of 5 to 500 million SEK. Prior<br />

to SenzaGen, she was acting<br />

CEO of Cantargia and Diaprost.<br />

She holds a doctorate degree in<br />

Immunotechnology from Lund<br />

University as well as a Pharma-<br />

MBA from Falconbury.<br />

“PainDrainer is a very interesting<br />

start-up company that has<br />

developed an absolutely unique<br />

web-based application for selfmanagement<br />

of chronic pain.<br />

Artificial intelligence and eHealth<br />

are two of the latest and most<br />

promising technologies that will<br />

rule much of our future, and I am<br />

excited to explore the potential<br />

of this type of business. I very<br />

much look forward to being part<br />

of this exciting company and<br />

build value in the coming years,”<br />

says Malmborg Hager.<br />

She started on September 1,<br />

focusing on the commercial development<br />

of PainDrainer, using<br />

its evidence based clinical data.<br />

MALIN PARKLER, CEO of Pfizer<br />

Sweden, has been appointed<br />

new Chair of the Board of the<br />

Research-based Pharmaceutical<br />

Industry in Sweden (LIF). Parkler<br />

was elected to the Board of LIF<br />

in 2014, and elected Vice Chair<br />

of the Board of LIF in 2018. Since<br />

February <strong>2019</strong> she has been the<br />

Chair of the LIF Board since the<br />

previous Chair, Niklas Karlberg,<br />

Novartis, left the Board for an<br />

international assignment.<br />

“I am very excited to be able<br />

to carry on the development work<br />

that LIF successfully has conducted<br />

during the last couple of years.<br />

LIF is a very important and reliable<br />

partner within Swedish healthcare<br />

and that is a position that we need<br />

to manage well. Sweden needs<br />

an international competitive life<br />

science strategy, where all actors<br />

collaborate and interact with each<br />

other to develop and ensure that<br />

patients quickly and safely have<br />

access to effective treatments. A<br />

well-functioning ecosystem for<br />

research, development and production<br />

means both better treatments<br />

for patients, development<br />

of scientific skills and investments<br />

in production,” says Parkler.<br />

KLAUS ABEL has been appointed to<br />

lead LEO Pharma across the Nordic<br />

region. Abel moves into the new<br />

role from Lundbeck, where he was<br />

for 19 years. While at Lundbeck<br />

he held senior roles in Global<br />

Marketing and in Commercial<br />

Operations, in addition to Managing<br />

Director positions in Australia/New<br />

Zealand from 2007–2011,<br />

and Italy from 2016–2018.<br />

As Managing Director for the<br />

Nordics Organization, Abel will<br />

lead operations in Denmark,<br />

Sweden, Norway, Finland and<br />

Iceland. He will be responsible<br />

for driving LEO Pharma’s Dermatology<br />

business, developing<br />

talent and ensuring a successful<br />

implementation of LEO Pharma’s<br />

2025 strategy. Abel will also be<br />

part of the Cluster Europe North<br />

Australia New Zealand Leadership<br />

team.<br />

“Being a foundation-owned<br />

company, LEO Pharma has no<br />

shareholders and is committed<br />

to reinvesting its profits into<br />

R&D. These aspects really stand<br />

out to me. I am inspired by the<br />

opportunity to improve the<br />

quality of life of the people living<br />

with skin conditions,” he says.<br />

CATHERINE MAZZACCO is an<br />

accomplished executive with<br />

more than 25 years of experience<br />

in international business management,<br />

strategy, marketing and<br />

sales in the pharmaceutical and<br />

life science industry, including in<br />

launching and expanding biologics<br />

in immunology.<br />

Her wealth of professional and<br />

business experience includes<br />

positions as head of Global<br />

Commercial Operations for GE<br />

Healthcare’s BioPharma<br />

division, and, before that,<br />

numerous leadership positions<br />

at Abbott in the pharmaceutical,<br />

diagnostic and medical devices<br />

divisions. Mazzacco has lived in<br />

the United States since 2011. She<br />

received her engineering degree<br />

from the Université de Technologie<br />

de Compiègne (France).<br />

She plans to relocate from<br />

Boston to Denmark in connection<br />

to her new position.<br />

Gitte Aabo will step down<br />

as President and CEO after 27<br />

years in the company, and 11 of<br />

these as CEO, and the Board of<br />

Directors has appointed Catherine<br />

Mazzacco as new President<br />

and CEO.<br />

118<br />

NORDICLIFESCIENCE.ORG


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COLUMN<br />

HELENA STRIGÅRD, CEO SWEDENBIO<br />

SWEDENBIO<br />

– HARNESSING THE FULL POTENTIAL OF THE NORDIC LIFE<br />

SCIENCE HOTBED<br />

Lately we have discovered a trend, or more accurately a trend<br />

within a trend.<br />

T IS ALREADY WELL KNOWN how international<br />

big pharma and big biotech<br />

companies are looking to smaller and<br />

younger companies to vitalize their<br />

pipelines, since they are dependent<br />

on external innovation. This phenomenon<br />

has developed over many years, and now<br />

we are seeing some interesting and logical<br />

consequences of this, such as the increasing<br />

physical openness of larger international<br />

companies.<br />

In Sweden, for instance, it was already in<br />

2014 a deliberate strategy of AstraZeneca to<br />

open up to the surrounding life science community,<br />

resulting in the launch of Bioventure<br />

Hub, an arena where start-ups are located<br />

within AZ premises. Testa Center at the<br />

GE Healthcare site in Uppsala is another<br />

example where a global life science-company<br />

is exposed to more innovation and science.<br />

The insight of the necessity of external<br />

innovation, and with that opening up<br />

your own assets to brilliant minds outside<br />

your organization, is currently gaining full<br />

momentum in every vein of the big life science<br />

companies, and those who understood<br />

this many years ago are now reaping the<br />

benefits. It´s a paradigm shift.<br />

For the Nordic countries, which year after<br />

year excel at the top of global innovation<br />

indexes, this is a potential jackpot-situation.<br />

Many of the international companies whose<br />

Nordic presence previously mainly consisted<br />

of sales offices to gain market access are<br />

now increasingly seeking interfaces with the<br />

vibrant Nordic life science community of predominantly<br />

smaller companies to gain access<br />

to their innovative power. Some of the former<br />

are literally moving into the heart of our innovation<br />

hotbeds at university campuses.<br />

This local trend, within a much larger<br />

global trend, could be described as moving<br />

from market access to also looking for<br />

innovation access. In Sweden, as well as<br />

in the rest of the Nordics, we should meet<br />

this opportunity with intelligence. In order<br />

to create a proper win-win situation, we<br />

can be neither protectionist nor naïve.<br />

he growing international<br />

interest in harnessing Nordic<br />

life science innovation should<br />

truly be embraced. I am<br />

genuinely convinced that<br />

business opportunities and collaborations<br />

early on between innovation start-ups and<br />

large companies will help build stronger<br />

homegrown Nordic companies. Not only<br />

does the interface funnel innovative power<br />

into big pharma, big biotech etc., it also<br />

provides newcomers with crucial know-how<br />

on what it actually takes to meet the global<br />

market and get it right from the beginning.<br />

At the same time, for this encounter to be<br />

beneficial for the young company, it needs<br />

to have a strong voice in the negotiations.<br />

Entering into collaborations and business<br />

agreements is surrounded by pitfalls.<br />

The innovation system has a role to play<br />

here, to ensure that strong voice. This requires<br />

providing critical early stage funding that<br />

enables various options to be explored<br />

and weighed against each other, and also<br />

providing platforms where knowledge and<br />

know-how can generously be exchanged<br />

business-to-business, no strings attached.<br />

After all, you learn best from those who are<br />

or have been in the same situation.<br />

This is where we, the Swedish Life science<br />

industry organization, come in. I´m proud<br />

to say that building networks, spreading<br />

knowledge and providing industry with a<br />

strong voice is our mission. For seven years<br />

we have provided the largest partnering<br />

meeting in the Nordics, the Nordic Life<br />

Science Days (www.nlsdays.com), which<br />

this year will take place in Malmö on<br />

10–12th September. The goal is to enable<br />

such win-win encounters and encourage<br />

companies of all sizes and origins to share<br />

their know-how. Openness is the path<br />

forward.<br />

Nordic life science should aim high.<br />

Now more than ever, considering what<br />

a powerhouse of innovations it is and how<br />

the world is looking for this resource, let´s<br />

be bold enough to ask what it would take<br />

for international companies to engage here,<br />

with production facilities and long-term<br />

research investments, adding to the existing<br />

marketing offices. Then with the question<br />

asked – policy makers ought to listen to the<br />

answer. Only then will the Nordic society<br />

fully harness the full potential of this innovation<br />

hotbed of ours. <strong>NL</strong>S<br />

120 NORDICLIFESCIENCE.ORG


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Meet leading decision makers within<br />

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SO IT’S OVER FOR ANOTHER YEAR – THE <strong>2019</strong> BIO INTERNATIONAL CONVENTION,<br />

WHERE THE WORLD’S BIOTECH COMMUNITY GATHERS FOR FOUR DAYS OF<br />

MEETINGS, PRESENTATIONS AND DISCUSSIONS, DESIGNED, ACCORDING TO<br />

THE ORGANIZERS, TO “ADVANCE BIOTECHNOLOGY INNOVATION AND<br />

SOLUTIONS TO THE WORLD’S TOUGHEST CHALLENGES TODAY”.<br />

122 NORDICLIFESCIENCE.ORG


EVENT<br />

HIGHLIGHTS<br />

TEXT<br />

b y R I C H A R D H A Y H U R S T<br />

– 65 companies<br />

had pavilions last year. Perhaps the most<br />

unexpected was Uruguay with a couple<br />

of signed Sanchez soccer shirts and an<br />

interesting range of veterinary and food<br />

diagnostic start-ups. More low key – i.e.,<br />

no Zlatan shirts – but according to many<br />

of the 17 000 plus BIO visitors, deeply<br />

missed and welcomed back was the first<br />

major Nordic Pavilion for four years.<br />

Hanne Mette Kristiansen from Innovation<br />

Norway says her goal has been to reestablish<br />

a strong and sustainable Nordic<br />

visibility and presence at the BIO International<br />

Convention.<br />

“BIO is an important meeting place,<br />

witness the 95 Nordic companies/organizations<br />

and about 160 delegates who attended<br />

this year. Supporting them with visibility<br />

and regional branding helps them to stand<br />

out in an extremely competitive market<br />

place. Also, there are additional benefits; the<br />

pavilion provides a connection point and<br />

meeting place for the Nordic regional players.<br />

It’s very seldom that the Nordic clusters<br />

and support organizations are in the same<br />

place for three days and so BIO makes the<br />

venue the perfect place to review and discuss<br />

Nordic collaborative efforts. However, the<br />

main focus is always on supporting the<br />

companies and optimizing the value of their<br />

participation in the conference,” she says.<br />

NORDICLIFESCIENCE.ORG 123


acked by Sweden-<br />

BIO’s Jonas Ekstrand<br />

and Helena<br />

Strigård.<br />

“For this year’s<br />

conference, it was<br />

great to see the<br />

Nordic countries<br />

jointly branded for the first time as The Nordics – Global Hub for<br />

Life Science Innovation with our value proposition to international<br />

companies and investors packaged in one set of messages,<br />

building upon common denominators. By joining forces<br />

with our neighbouring countries in this way, we believe that we<br />

can be even more successful in attracting intelligent capital and<br />

business-to-business collaborations to our life science sector. This<br />

is imperative for the continuous growth of Swedish life science,”<br />

says Helena Strigård, CEO, SwedenBIO.<br />

Both also agreed that the Pavilion was a success worth repeating.<br />

“The Pavilion attracted a steady stream of visitors from<br />

the global life science community asking about investment and<br />

collaboration possibilities in the Nordic region. Project scouts<br />

typically asked about companies active in specific therapy areas<br />

and investors were keen to learn about the strong life science sector<br />

and what are the specific Nordic USPs. Also, there was quite<br />

some curiosity about the Nordic countries’ cultural features and<br />

traditions,” informed Strigård.<br />

According to Nadja Kronenberger of Healthcare Denmark, the<br />

Danes joined the Nordic Pavilion to strengthen ties to the other<br />

Nordic countries and promote Denmark as a leading life science<br />

nation, in accordance with The Danish Growth Plan for Life<br />

Science, which was published last year.<br />

“BIO fulfilled our expectations – we found the conference<br />

inspiring and had many interesting conversations, for example<br />

about new joint Nordic projects. We also got the chance to<br />

promote Denmark as the leading nation in terms of clinical trials<br />

per capita in the European Union and attract further trials and<br />

research to Denmark,” says Nadja Kronenberger.<br />

Many longterm BIO visitors also<br />

remembered the DeCode story and were<br />

pleased to see Iceland present in the pavilion<br />

according to Erna Björnsdóttir of<br />

Promote Iceland.<br />

”By participating in the Nordic booth at<br />

BIO for the first time, we got an opportunity<br />

to connect with Nordic colleagues and further<br />

discuss future common promotional activities.<br />

Sharing information with them and<br />

other national clusters and organisations will help Promote Iceland<br />

develop promotional material and stories to support our messages.”<br />

The sense of community was strengthened by an evening<br />

reception on June 4th. Altogether, over one hundred delegates<br />

were welcomed by Ulf Åkerblom, Swedish Honorary Consul in<br />

Philadelphia and Roger Franklin, Partner at Hadean Ventures,<br />

who pointed out that Philadelphia was one of the main points of<br />

entry to the US for early Swedish settlers and celebrated in the<br />

monument to Penn, which dominates the city skyline.<br />

The conference programme itself was interesting, with the acceleration<br />

of innovation and convergence of biological and digital<br />

technologies a recurring theme. The general consensus seemed to<br />

be that the future for biotechnology is bright, but as a sector it will<br />

continue to face hurdles, such as funding and affordability of treatments,<br />

especially with the growth of cell and gene therapies.<br />

investment the idea that the innovation<br />

hub models of Boston and San Francisco<br />

cannot exist anywhere given the lack of venture<br />

capital was challenged by other US regions,<br />

including the hosts Philadelphia. They emphasized<br />

the importance of people and patients and offered<br />

the Spark Therapeutics’ partnership with the<br />

Children’s Hospital of Philadelphia as an example<br />

of how to be successful without following the<br />

traditional model of VC funding. They also encouraged countries<br />

across the globe developing domestic biotech sectors that don’t<br />

have access to large amounts of capital to creatively leverage their<br />

existing institutions and expertise.<br />

124<br />

NORDIC LIFE SCIENCE


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2877 BT_halvside_200x126_NordicScience.indd 1 21/08/<strong>2019</strong> 15.05


EVENT<br />

HIGHLIGHTS<br />

The Nordic countries were jointly<br />

branded for the first time as The<br />

Nordics – Global Hub for Life<br />

Science Innovation<br />

However, the key question, particularly for many readers of this<br />

magazine, will always be whether BIO is worthwhile from a business<br />

point of view. Never mind the countless receptions, extravagant<br />

pavilions and star-studded keynotes, will you meet key potential<br />

collaborators, customers and investors? BIO certainly thinks so.<br />

According to the pressrelease, “The Convention<br />

continued to demonstrate that it is the<br />

premiere networking event for the biotechnology<br />

industry. BIO hosted more than 48 500<br />

partnering meetings.”<br />

A snapshot of Nordic attendees seems to<br />

say yes. Two long standing BIO supporters<br />

are Gunnar Gardemyr, CFO of Follicum and<br />

Martin Welschof, CEO of BioInvent.<br />

“BIO is one of the most important partnering<br />

events we have. It is a great platform<br />

for a small biotech like Follicum to explore<br />

high-quality partnering opportunities. I had<br />

more than 30 meetings this year with companies<br />

from the USA, EU, Japan, China and<br />

Korea. BIO also provides excellent networking<br />

opportunities every day through the various<br />

receptions,” says Gardemyr.<br />

“BIO is always useful for me to do face-toface<br />

follow-ups and/or to generate potential<br />

new partnering leads,” adds Welschof.<br />

From another perspective, and picking up on Gardemyr’s observation,<br />

Ralph Inforzato, CEO of JETRO Chicago, the Japan External<br />

Trade Organisation, said that Japanese biotechs see Scandinavia as<br />

one of the leading hubs in Europe, and BIO as providing a perfect<br />

meeting place, being a global meeting that just happens to be held<br />

in the US.<br />

BIO will return to San Diego for the fourth<br />

time from June 8–11 in 2020. According to<br />

Kara Nelson, Manager, International Relations,<br />

BIO was thrilled to welcome back the<br />

Nordic Pavilion to the BIO Exhibition floor.<br />

“Nordic companies made a significant<br />

impact, seen throughout BIO’s exhibition<br />

and partnering programs at the event. The<br />

Nordics Pavilion highlighted the strength of<br />

its vibrant life sciences community and why<br />

it is one of the leading biotechnology hubs in<br />

Europe,” she says.<br />

Already this year’s team are planning for<br />

a stronger presence in San Diego, as well as<br />

looking to provide more input into the official<br />

programme and build on the success of<br />

associated events, such as the International<br />

Cancer Showcase organized by Jutta Heix<br />

of the Oslo Cancer Cluster. <strong>NL</strong>S<br />

126<br />

NORDIC LIFE SCIENCE


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UPCOMING EVENTS NORDIC LIFE SCIENCE<br />

NORDIC LIFE SCIENCE<br />

UPCOMING<br />

EVENTS<br />

LIFE SCIENCE EVENTS, MEETINGS AND CONFERENCES<br />

TEXT<br />

b y M A L I N O T M A N I<br />

26 SEPTEMBER <strong>2019</strong>: PARK ANNUAL<br />

SAHLGRENSKASCIENCEPARK.SE/<br />

PARK-ANNUAL<br />

This 14th year of the event will, as always, showcase seminars,<br />

one-to-one meetings, exhibitions and lots of networking opportunities.<br />

11-13 NOVEMBER <strong>2019</strong>:<br />

BIO-EUROPE<br />

This event celebrates 25<br />

years this year, and Hamburg<br />

Messe will offer three<br />

days of biotech, pharma<br />

and finance.<br />

HE SPOTLIGHT<br />

WILL be turned<br />

on women’s<br />

health, workable<br />

AMR financial<br />

models, CNS, digital health<br />

and clinical trials, gene therapy<br />

valuation and deal trends and<br />

funding trends and how to<br />

break them.<br />

Last year the event attracted<br />

4 354 attendees, 26 092 oneto-one<br />

meetings took place,<br />

and 5 203 licensing opportunities<br />

were posted. In addition,<br />

2 325 companies participated,<br />

there were 139 company presentations,<br />

131 exhibitors, and<br />

60 countries were represented.<br />

A pre-event course in advanced<br />

business development<br />

has also been organized. It is an<br />

intensive three-day workshop<br />

for professionals who want to<br />

learn, develop and practice<br />

their business development<br />

skills, working in teams with the<br />

guidance of an expert faculty.<br />

BDGROUP.KNECT365.COM/BIOEUROPE<br />

THE EVENT, WHICH gathers<br />

more than 500 representatives<br />

from industry, academia and<br />

the healthcare sector sets out<br />

to create inspiring ideas and<br />

interesting business opportunities.<br />

For example, the day will<br />

include presentations from<br />

both startup-companies and<br />

more recognized life science<br />

organizations. The theme The<br />

Future of Health embraces<br />

cross-collaboration and humane<br />

technology and reflects the<br />

ongoing paradigm shifts within<br />

healthcare and life science,<br />

attracting pioneering entrepreneurs<br />

and venture capital willing<br />

to back them.<br />

Speakers include Almira<br />

Thunström, organizational<br />

developer and researcher at<br />

Psychiatry of Affective Disorders<br />

at Sahlgrenska University Hospital,<br />

Andres Strasser, Investment<br />

Director EMEA at Volvo Car<br />

Corporation, and Johan Hyllner,<br />

Senior Director and Head of<br />

Cell and Gene therapy at CVRM<br />

at AstraZeneca.<br />

The day will also include<br />

the announcement of the<br />

winner of the Arvid Carlsson<br />

Award by Sahlgrenska Science<br />

Park. The award goes to an<br />

entrepreneur who drives development<br />

forward for human health<br />

and wellbeing and previous<br />

winners include Erik Gatenholm<br />

(highlighted in this issue)<br />

and Hector Martinez and their<br />

company Cellink, and Susanne<br />

Staaf and Kristina Lagerstedt<br />

and their company 1928 Diagnostics.<br />

128<br />

NORDIC LIFE SCIENCE


EVENTS NORDIC LIFE SCIENCE<br />

CALENDAR<br />

26 SEPTEMBER<br />

GOTHENBURG<br />

4-5 OCTOBER<br />

NEW DELHI<br />

9 OCTOBER<br />

PACIFICO YOKOHAMA<br />

11-13 NOVEMBER<br />

HAMBURG<br />

19-21 NOVEMBER<br />

ODENSE<br />

10 DECEMBER<br />

MARSEILLE<br />

Park Annual<br />

InnoHealth<br />

Bio-Japan<br />

BIO-Europe<br />

Week of Health and<br />

INNovation<br />

BioFIT<br />

19-21 NOVEMBER <strong>2019</strong>: WEEK OF HEALTH AND INNOVATION<br />

10 DECEMBER <strong>2019</strong>:<br />

BIOFIT<br />

WWW.WHINN.DK<br />

This European partnering<br />

event focuses on early-stage<br />

deals and investment rounds<br />

in the life sciences field.<br />

This conference showcases future innovation and technology in healthcare.<br />

WHINN, THE WEEK OF HEALTH AND<br />

INNOVATION Is a health tech and<br />

health innovation conference<br />

that attracts business people,<br />

decision makers, policy makers,<br />

clinicians, end-users and people with a general<br />

interest in healthcare and health innovation.<br />

The exhibition gathers private companies,<br />

private-public organizations, municipalities,<br />

regions, innovation labs, country pavilions,<br />

students, academia and many more.<br />

The program includes topics such as robots,<br />

AI and drones of the future, digital therapeutics,<br />

improving access for all citizens, the sundhed<br />

technology, and virtual reality/augmented reality<br />

in healthcare.<br />

BIOFIT IS a leading<br />

partnering event<br />

in Europe for technology<br />

transfer,<br />

academia-industry<br />

collaborations, early-stage<br />

innovation deals, and is the<br />

European marketplace for<br />

pre-seed, seed and Series<br />

A investment rounds in the<br />

life sciences field. This year’s<br />

event is held in Marseille.<br />

The three tracks in the<br />

program are Best practices<br />

and academia-industry R&D<br />

collaborations, Nurturing and<br />

licensing early-stage assets,<br />

and Early-stage innovation:<br />

identify the right funding<br />

sources.<br />

WWW.BIOFIT-EVENT.COM


UPCOMING EVENTS<br />

INNOHEALTH<br />

… Parthvee Jain, Head of Market Access and Partnerships at Inno-<br />

HEALTH, an annual conference for influencers, investors, startups,<br />

young innovators and media in health innovation.<br />

hat have been the<br />

outcomes from your<br />

previous events?<br />

“Previous events have<br />

generated for example 35 panel discussions,<br />

over 200 partnering meetings, and<br />

have attracted over 1500 participants.”<br />

Testimonials include a comment from<br />

Dr Katja Heikkinen from Turku AMK<br />

in Finland, saying “The program of the<br />

week was spectacular and we got really<br />

good and valuable contacts.” Dr Rahil<br />

Qamar Siddiqui, co-founder of Eventus<br />

in India said that last year’s conference<br />

was very productive and informative and<br />

“It was a pleasure being associated with<br />

it and meeting some fantastic people.”<br />

What are you most looking forward<br />

to in the program?<br />

“I am looking forward to the session<br />

sponsorships, the exhibition booths and<br />

the young innovators award, where the<br />

finalists will give their presentations in<br />

the presence of our jury and over 500<br />

healthcare stakeholders who will evaluate<br />

the innovations.”<br />

Why is this event important for<br />

the life science industry?<br />

“The event comprises nine high powered<br />

sessions, inclusive of an inaugural session.<br />

The discussions and presentations in<br />

these sessions are all focused primarily<br />

towards the celebration of innovation.<br />

Since life sciences deal with the branches<br />

of science that involve life, all the sessions<br />

can be relatable in some degree or other<br />

and be related to life sciences involving<br />

innovation. More closely, the sessions on<br />

the following topics are directly related<br />

to life sciences. The conference highlights<br />

innovations for hospitals and insurance<br />

companies, innovations in medical devices<br />

and diagnostics and the task of fighting<br />

diabetes with technological innovations.<br />

In the above mentioned sessions, influencers<br />

from different walks of life collaborate,<br />

deliberate and place a study before<br />

industry leaders and decision makers so<br />

that the provision of more scope towards<br />

the research segments can be easily and<br />

cumulatively administered.”<br />

Something you would like to add<br />

about the upcoming event that visitors<br />

should not miss?<br />

“Do not miss the company pitches<br />

and the InnovateHER session, highlighting<br />

inspiring women entrepreneurs<br />

in healthcare.” <strong>NL</strong>S<br />

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