Greater Copenhagen Life Science Yearbook 2020

YEARBOOK 2020

THE ME DICON VA LLE Y

YEARBOOK

2020

BIOTECH

CANCER IMMUNE THERAPY

INTERNATIONALISATION

LAUNCHING A NEW PRODUCT

CLINICAL DEVELOPMENT

- EXPORTS

FOR THE FIRST TIME

AND CHALLENGES

- CLUSTER COLLABORATION

LEGAL UPDATE

RECRUITMENT AND EDUCATION

DIGITALISATION AND AI

- BREXIT UPDATE

- INTERNATIONAL TALENTS

- HEALTH DATA

- PATENT/IP STRATEGY

- SOLVING THE RIGHT NEEDS

- PROCESSING PHARMA COVIGILANCE ACTIVITIES

YEARBOOK 2020

CONTENTS

Publisher:

Høffdingsvej 34 DK-2500 Valby E-mail: nem@nemmedia.dk Web: www.nemmedia.dk Editors: Karin Jensen Charlotte Strøm Arne Nielsen Lotte Overbjerg Karin Absalonsen and Mohammed Ali Wachah Contact the editors at

THE COLUMN

BY SØREN BREGENHOLT, MEDICON VALLEY ALLIANCE

3

CANCER IMMUNE THERAPY CLINICAL DEVELOPMENT AND CHALLENGES

5

DIFFERENT CANCER IMMUNOTHERAPY APPROACHES

5 10

LAUNCHING A NEW PRODUCT FOR THE FIRST TIME

14

PATIENT RECRUITMENT IN CLINICAL TRIALS

16

TRIAL SUBJECT GDPR CONSENT - A DO OR A DON'T

19

DIGITALISATION AND AI

24

nem@nemmedia.dk Graphics & Layout: Kapteina Reklame Advertisement: Mohammed Ali Wachah +45 2323 8082 mw@nemmedia.dk

INTERNATIONALISATION 30 EXPORTS 30

CLUSTER COLLABORATION

RECRUITMENT AND EDUCATION INTERNATIONAL TALENTS

33

36 36

Magnus Andersen

THE GLOBAL TALENT COMPETITIVENESS INDEX

38

ma@nemmedia.dk

BIOMEDICAL DESIGN’S NOVO NORDISK FOUNDATION FELLOWSHIP PROGRAMME

40

Print: Green Graphic & Signtec Reklame In cooperation with:

LEGAL UPDATE BREXIT UPDATE

PATENT/IP STRATEGY

COMPANY INDEX

50 50 52

76

CALENDAR 90 90 HIGHLIGHTED FAIRS & EVENTS

ISSN: 2446-1776

2

HIGHLIGHTED COURSES AND EDUCATION

93

THE COLUMN

Culture and strategy should dine together

By MVA Chairman of the Board of Directors, Søren Bregenholt The American management consultant, educator, and author of several books, Peter Drucker, told us that “Culture eats strategy for breakfast” and we all recognize the truth in that! When speaking of life science in the Medicon Valley, or the Greater Copenhagen region, our ambition should be to have culture and strategy eat breakfast together.

Despite the differences in history, structure and financing infrastructure, the culture of the Danish and Swedish life science has come a long way since the beginning of the millennium.

Today, both countries are successfully hatching and nurturing new generations of life science students, with an impressive entrepreneurial mind-set and global outlook. When looking at new initiatives like The Pipeline incubator at University of Copenhagen, and the number of spin-outs from DTU (the Technical University of Denmark) and the other universities in the Medicon Valley region, there is reason for substantial optimism.

This optimistic feeling is reinforced when following organisation like the student-driven life science organisation “Synapse – life science connect”.

As a consequence, the science parks in Copenhagen and Lund are both expanding and Ballerup municipality is planning an entire new science city, and all this put together testifies to a mindset and level of ambition rarely seen 20 years ago. Supported by Medicon Valley Alliance, Synapse is by the way in the process of establishing a permanent foothold in Lund, which bodes well for the next generation of life science innovation cross-fertilization in the region. This impressive bottom-up activity resulting from a new mind-set and a new culture of life science entrepreneurship is probably the single most important success factor for the future of Medicon Valley based life science. It is, in my view, even more important than the specific nature of the national life science strategies in Denmark and Sweden, which, despite a lack of understanding and acknowledgement of current and potential regional life science collaboration in the Danish-Swedish Greater Copenhagen region, should nevertheless be welcomed as an attempt to get on the offensive and improve some of the important framework conditions for life science in both countries. It would be wrong to say that the national life science strategies are being eaten by culture.

Søren Bregenholt, Medicon Valley Alliance chairman of the Board and Chief Business Officer, IO Biotech

However, the execution of national life science strategies should aim to align, optimize and support the innovation and entrepreneurial culture in the region and supplement it with a truly international outlook not hampered by national blinkers.

The big pharmaceutical companies are of course already global by nature.

But for an increasing number of new micro-, small- and medium-sized life science companies, hands-on innovation, international R&D collaboration and fundraising can very well start with connecting the dots in the Medicon Valley region thereby creating the foundation for global outreach and expansion. This of course already happens, a fact that unfortunately seems to have eluded national policy makers in both Stockholm and Copenhagen not familiar with the day-to-day activity in this bi-national region.

Furthermore, any political aspirations of a Nordic region as a centre of gravity for life science innovation, production and commercialization such as it is presented and explicitly, mentioned in the Swedish national life science strategy, must rest on two pillars – a Danish and a Swedish. This basic point and its logic consequence, to increased Danish-Swedish collaboration, still need to grab the attention of the national governments of both countries.

Whereas politicians in Stockholm can perhaps be somewhat excused for their lack of in-depth knowledge about life science in Skåne some 600 km away from the political centre of gravity, one could wonder why national policymakers in Copenhagen do not listen more carefully to the voices of their regional counterparts and the growth layer of the local life science community.

But perhaps that requires a change of culture too?

3

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Og vores rekrutteringskonsulenter taler dit sprog.

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With focus on Patient safety and Employee welfare we design State of the Art controlled environments in full compliance to support the objectives of Hospital Pharmacies.

CANCER IMMUNE THERAPY

Finding the way in the maze of developing novel cancer immunotherapies A growing number of biotech companies work on technologies that overall aim to enable the body’s own immune system to fight back cancer cells. Clinical development of cancer immune therapy (CIT) has specific challenges to be addressed.

By Charlotte Strøm, MD PhD Journalist

I

mmunotherapy is becoming a fastgrowing area of new medicinal products in oncology. The European Medicines Agency (EMA) and The Food and Drug Administration (FDA) in the US have approved immunotherapy agents in more than 10 cancer types. These new agents have brought important advances in patient care and have considerably changed the landscape of treatment options in cancer and among others for melanoma and lung cancer patients. However, there are still many challenges on how to bring these agents through regulatory approval and into clinical practice.

Appropriate patient population selection, new clinical trials designs, rationale for the mechanism of action in different tumour types, innovative immunological-based products used in combination and assessing relative efficacy of these novel immunomodulating therapies are some of these key issues.

Lars J. Petersen, MD DMSc CBA, Director at ljpmedical and Professor of Nuclear Medicine at Aalborg University has more than 20 years of experience in clinical development in biotech and pharma.

As a consultant he identifies the critical early phases as the key hurdles to overcome for small biotech companies in pursuit of exits. He points to the stronghold often being the science behind the lead technology of the biotech company, however, the early clinical development is critical to reflect and plan for.

"CIT provides a series of opportunities by indication, as monotherapy or in combination with existing cancer therapies etc. Hence, a clear strategy for the clinical and regulatory development is warranted and important to align this with the business strategy," Lars J. Petersen says.

“Orphan drug indications may be a plausible route to take. Moreover, the validity of a novel anti-cancer compound increases with little or no treatment options available.”

The challenge of filling the gap Orphan drug indications may be a plausible route to take. Moreover, the validity of a novel anti-cancer compound increases with little or no treatment options available. Despite approval of a series of cancer immunotherapies over the past 5-6 years, a clear unmet medical need is still very real in some cancer types, among others the aggressive brain cancer, glioblastoma, and pancreatic cancer, and some rare blood cancers.

Opportunities may also exist in more common cancers that are refractive to existing therapies, such as prostate or breast cancer.

"There is more to it than having an indication with a clear unmet medical need. It is essential to identify the gap to fill. Finding this unique place implies at least three considerations: 1) the emerging drug candidate is expected to benefit the patients with the medical need, 2) the clinical benefit must be documented so it satisfies the requirements from the regulatory agencies, and importantly, 3) the proposed development is in line with the company’s business strategy.

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Lars J. Petersen, MD DMSc CBA, Director at ljpmedical and Professor of Nuclear Medicine at Aalborg University

CANCER IMMUNE THERAPY

Even though the combination of an emerging product with an existing therapy may generate the best response, combinations have downsides regarding documentation of superior efficacy over the existing agent, more adverse events, added price from both products etc.," Lars J. Petersen says.

Further, he sees a shift in the anti-cancer development area with increasing focus on the functionality of a tumour, typically identified by a gene mutation rather than its physical location in the body. Patient selection by expression of a specific target may improve the direct anti-cancer effect but may also be used to increase the sensitivity of the tumour from other therapies e.g. radiation or chemo.

Advanced diagnostic tests will likely improve the prediction of response to expensive, advanced biologics in the future.

This information feeds into how to design the clinical trials and how to carefully align them with the exit strategy of the company.

"In principle, you need to look for early trial designs that can suggest an ‘effect’ in the early development stages in addition to identifying the optimal dosing and the frequency of the dosing. Clinical development experts must also have a business view, so early clinical trials not only show safety and tolerability but provide early signs of efficacy to improve stakeholder value."

Lars J. Petersen points to advanced trial designs such as accelerated trials being employed more often in development of CIT already from first-in-man in addition to adaptive

trial designs allowing for an ongoing adaption of the trials according to the collected data. The studies may have additional or new treatment groups. Trials with seamless designs are meant to improve the transition from phase 1 through phase 3 – in what can be perceived as a single, long study, aimed for rapid development and quick approval.

Different safety profile "CIT often tend to be well tolerated and quite safe compared to traditional chemotherapeutics.

However, the safety profile of CIT is very different from what is known from chemotherapeutics, and adverse effects tend to have a latency. This is a major challenge in the development phase regarding dose escalation, because choosing the right dose and dosing frequency is essential. It makes the situation complex that the relation of dose to efficacy and dose to toxicity vary among CIT agents," he says.

Adverse events generally seen with CIT reflect immune reactions and count cases such as of colitis, pneumonitis, adrenal insufficiency, and hypophysitis. As some of these sometimes quite severe adverse effects may occur at a late stage and even be fatal, Lars J. Petersen advocates a strong focus on pharmacokinetics and pharmacodynamics for optimal dose finding.

"In early clinical trials with CIT, in the absence of classical signs of biological activity, dosing may be supported by pharmacodynamic studies of the effect on a cellular level in the blood or in the tumour combined with pharmacokinetic

assessments of the drug concentration in the blood or the number of cells in CITs based on active cells."

Changing standards for imaging in oncology Within imaging, CIT have proven to warrant new standards for the assessments and evaluation of effect.

"Tumour imaging may demonstrate growth in the early course of CIT, which we have learnt may be, in fact a reversible pseudo progression. CIT has required the development of an updated set of imaging reporting standards specifically designed to assess the anti-cancer effect from CITs. The regulatory authorities in both the US and Europe is currently looking into this – and I suspect that they will employ the demands for assessing both systemically administered CIT and therapies that are injected directly into the tumour," Lars J. Petersen says.

He points to the relevance of the sponsors’ need for developing specific imaging manuals up-front in order to guide the investigators.

"Moreover, it is important to pay close attention to the fact that imaging experts and central reading centers mush have documented relevant experience and skills to show for."

"Altogether, this area is developing very rapidly; we are building up the competences to design and report CIT trials with new imaging classification systems. The devil is in the details", he ends.

"Adverse events generally seen with CIT reflect immune reactions and count cases such as of colitis, pneumonitis, adrenal insufficiency, and hypophysitis."

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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PROFILE

PROVIDING CLINICAL PROOF OF CONCEPT Scandion Oncology is a Danish Biotech Company listed on the Swedish Stock Market Spotlight (SCOL).

In 2018, 43 Danes died every day from cancer and most of these lethal outcomes were due to the cancer cells developing resistance to the anti-cancer drugs used. Scandion Oncology’s mission is to introduce novel and innovative drugs that combat anti-cancer drug resistance and thereby increase survival of cancer patients.

with advanced or metastatic pancreatic cancer where the patients will be randomized to receive standard chemotherapy or standard chemotherapy plus SCO-101. Scandion Oncology develops companion diagnostics to facilitate selection of the right patients for SCO-101 treatment. Our goal is to provide clinical Proof of Concept for our drugs and then to partner with a larger pharma company in order to bring our drugs to cancer patients.

We have three drugs/compounds in our pipeline.

The most advanced of these is SCO-101, which is approved for phase II clinical studies. Our first clinical study with SCO-101 is in patients with chemotherapy resistant colorectal cancer. The patients will continue with their chemotherapy but now in combination with SCO-101. Our second phase II trial will enroll patients

Scandion Oncology’s current cash position is DKK 15.4 million as of December 31, 2019 together with DKK 5.0 million recently granted from Innovation Fund Denmark and an expected additional capital injection of SEK 12.4 million, if all outstanding warrants are fully exercised in Q3, 2020.

For additional information, please contact: Nils Brünner, MD, DMSc CEO, Scandion Oncology Phone: +45 26144708 E-mail: nb@scandiononcology.com Web: www.scandiononcology.com

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CANCER IMMUNE THERAPY

Different cancer immunotherapy approaches Current days readily available cancer immunotherapies span over a variety of different approaches and mechanisms of action. Among others, they work by targeting growth factor receptors in order to inhibit the tumour cell growth, by activating the immune response through complement mediated cytolysis and antibody dependant cellular cytotoxicity; by blocking of T-cell receptors (checkpoint-inhibition), or by binding an anti-cancer drug to an antibody and hence delivering the drug directly to the tumour.

In addition, local biotech companies that are dedicated to oncology therapy strive to deliver innovative compounds specifically designed to specific immune targets. Although far from exhaustive, here is a small selection:

Adoptive cell therapy Cytovac focuses on developing a cancer treatment that use the immune cells from the patient to fight the cancer after reinjection of the cells. The technology is referred to as adoptive cell therapy and implies that the patient’s lymphocytes are isolated, then modified, or ‘educated’, outside the body to recognize and kill tumour cells. The cells are subsequently cultivated and expanded to a very large number of active cancer fighting cells and finally reinjected to the patient. A critical factor to this approach in anti-cancer treatment is the turnaround. The ALECSAT therapy by Cytovac can be manufactured in only 20 days upon harvesting a small blood donation from the patient.

The clinical pipeline of Cytovac

• • •

The ALECSAT therapy is currently investigated for the treatment of the brain tumour, glioblastoma multiforme (orphan drug designation), in a phase 2 study.

Two phase 1 studies have been completed in prostate cancer One phase 1 study has been completed in pancreatic cancer

Source: https://cytovac.com/

Allogeneic dendritic cells as immune primers Immunicum’s technology is based on allogeneic (i.e. the patient’s own) dendritic cells which are potent immune primers that both recruit and activate the patient’s own immune cells, and stimulate them towards a cytotoxic immune response.

The allogeneic dendritic cells are explored in different ways to educate the immune system to recognize the cancer cells. The concept of neoantigens is used to describe the specific mutated proteins for each patient’s cancer cells. Moreover, neoantigens which are specific mutated proteins for each patient’s cancer cells are considered as important targets for immune system activation and is also a key focus area of Immunicum.

The clinical pipeline of Immunicum

• • •

Ilixadencel is currently investigated in combination with kinase inhibition in a phase 2 study in renal cell carcinoma.

Also, in combination with kinase inhibition Ilixadencel is tested in liver cancer and gastrointestinal stromal tumours, both indications in phase I. In combination with checkpoint inhibition, Ilixadencel is also investigated in head and neck cancer, non-small cell lung cancer, and gastric cancer – currently in phase 2.

Source: https://immunicum.se/

Dual mode of action in immune modulation IO Biotech has demonstrated the value of targeting cells expressing immune regulating proteins.

The dual mode of action approach enables recognition and elimination of tumour cells as well as immune suppressive cells.

The technology, T-win®, targets tumour cells and the tumour micro environment while simultaneously activating the host immune system.

The clinical pipeline of IO Biotech Two lead immune modulating anti-cancer therapies targeting

IDO (Indoleamine-pyrrole 2,3-dioxygenase) and PD-L1 (programmed death-ligand 1) both expressed by various cancers, are in clinical development.

• •

IO102, targeting IDO, is currently in phase 2 for the treatment of non-small cell lung cancer (NSCLC) IO103, targets PD-L1 and three clinical trials are ongoing in multiple myeloma, follicular lymphoma and malignant melanoma.

Source: https://iobiotech.com/

Targeting the metastases The vast majority of cancer immunotherapies are targeting the primary tumour. RhoVac has a different approach and is focusing on preventing or eliminating metastatic cancer cells, irrespective of cancer type with the aim of preventing relapses and progression after the primary tumour has been treated.

Metastatic cancer cells over-express a protein called RhoC, increasing cancer cells’ ability to migrate and infiltrate other tissue. RhoVac’s antigen-based cancer therapy is an immunooncologic drug that is presented to the immune system as an

antigen, stimulating T-cells to identify and destroy cells that carry this protein, i.e. metastatic or metastatic potential cells.

The clinical pipeline of RhoVac

•

RV001 is currently studied in a large randomized placebo-controlled double-blind clinical phase 2b study in preventing and treating disease progression after surgery or radiation to the primary tumour in prostate cancer.

Source: https://www.rhovac.com/

The modular vaccine format The Vaccibody technology platform attracts and targets antigen presenting cells (APCs), which are known to be essential to initiate an effective immune response. Binding by the vaccine’s targeting module to receptors on APCs leads to rapid internalization of the vaccine and mediates maturation of the APC. Vaccibody vaccines consist of three modules; the targeting module, the dimerization module, and the antigen module.

The modular format of the Vaccibody vaccines facilitates a modification of the vaccine structure to create individualized compounds as well as off the shelf treatment for specific disease.

The clinical pipeline of Vaccibody

•

New!

• •

•

In collaboration with Roche the same compound, VB.10.16, is being investigated in combination with Roche’s checkpoint inhibitor atezolizumab (TECENTRIQ®) in advanced cervical cancer, currently in phase 2.

VB10.NEO is targeting tumour specific antigens, neoantigens, arising from somatic gene mutations in malignant cells during neoplastic transformation and is currently studied in patients with locally advanced or metastatic solid tumours.

VB10.NEO is further being investigated in combination with a CD-122-biased agonist, NKTR-214 by Nektar Therapeutics in head and neck cancer.

Source: https://www.vaccibody.com/

VB10.16 investigated in HPV16-induced precancerous cervical lesions in a clinical phase 1/2a study. The study has been completed with positive 12 months results.

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PROFILE

IDENTIFYING THE COMPETITIVE EDGE Small enterprises (SME) and start-ups within biotechnology, pharma, and medtech benefit from expert regulatory advice at a remarkably early stage. IWA Consulting act as a local partner for global development, knowing what it takes to take the biotechnological innovation all the way to regulatory approval and the market.

When biotech innovative compounds and products are taken from the laboratory and applied to both quality development and clinical development, there are an abundance of knowledge that needs to be documented and submitted. Preparing for and keeping track of all the documentation to be ready for regulatory submissions, inspections, and due diligences are essential for survival of the projects.

The start-ups and SMEs are mainly driven by scientists and business developers.

Regulatory expertise is rarely represented.

However, the strengths of working out a regulatory strategy from the very beginning, are tangible. Just think about it, knowing where you are going and what you are aiming at makes quite a difference, says Lillan Rejkjær, Managing Director at IWA Consulting.

What characterizes a regulatory strategy at this very early stage?

Well, firstly it is highly relevant to know what the competitive edge of your lead compound is; therefore, we recommend doing a target product profile. It takes more than an unmet medical need and a molecule with potential to succeed as a biotech company. The data gaps need to be uncovered – and you need to get an understanding of what your edge is compared to competitors, she says and continues: An outline of this information highlights what is required from the quality, preclinical and clinical development, and notably it is the information from the development phases that any labeling is based on once you make it to the marketing authorization application, says Lillan Rejkjær, and stresses that if the target product profile proves highly unfavorable, the best advice may be to abort the mission.

The best advice is sometimes not to continue with the compound in question.

That may not be comfortable news, but if there is no competitive edge, then the company is better off knowing it from the beginning. Most importantly you need to know how to be competitive and use

investments in the most beneficial way with the ultimate aim of improving diseased patients’ life.

Electronic clinical trial documentation Notably, both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) only accept marketing authorization applications in the eCTD format. Additionally, the FDA only accepts electronic Investigational New Drug Applications (IND). IWA Consulting provides the platform and the regulatory knowledge for building the eCTD in a global format.

As it is accepted in the EU to provide the quality part of a Clinical Trial Application (CTA) in CTD format the electronic global format ensures easy preparation of the quality part of a CTA. There is no longer any ways around doing eCTDs. So, when you start compiling your eCTD, we advise to create a common eCTD from the very beginning which is applicable on both continents, says Connie Lyngbek Thestrup, Managing Director at IWA Consulting.

EU vs US – or both Often the US market is attractive from an investor’s point of view, being much larger and with less restrictions to pricing compared to many European countries.

From a regulatory aspect, there are different ways of working in the US and Europe, and if your business development strategy mainly focuses on the US, it may at first glance seem less relevant to walk the extra mile for a common Dossier. However, the easy solution may not always be the best one, Connie Lyngbek Thestrup says.

Often, the start-ups and SMEs are keen on meeting with the FDA and EMA pushed forward from investors. Lillan Rejkjær recognizes this as a major challenge from a regulatory perspective: We’re in favour of consulting with the regulatory authorities, and we handle this on behalf of both our EU and US clients, however, it is paramount to know your compound in depth. Otherwise, it is not money and time well spent; she ends.

in managing Global Regulatory Affairs

12

Lillan Rejkjær,

Connie Lyngbek Thestrup,

Managing Director

Managing Director

About IWA Consulting • Is a consultancy company with

core competences, expertise, and decades of experience within regulatory science • The company employs 23

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regulatory science specialists expert services to international private and public clients • The IWA Consulting Team assists

biotech, pharma, and medical device companies in achieving major regulatory milestones timely • IWA Consulting is owned by Voisin

Consulting Life Sciences (VCLS), a leading global HealthTech product development consultancy company • Learn more about IWA Consulting

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LAUNCHING A NEW PRODUCT FOR THE FIRST TIME

CRO’s at hand for biotechs planning to launch a new product for the first time Being a young biotech company about to embark on its first pre-clinical or clinical trials, or about to launch its first product on the market, can be an overwhelming task.

But many CRO’s offer services that help at each stage of the process.

By Karin Jensen Discovering and developing a new drug is a very long process that requires multiple resources and the success rate of getting a new product to market is very low.

However, with the right consultancy services, the chances of obtaining approval for a new drug can be increased many times over.

BioXpedia is a contract research laboratory active in preclinical trials, working with both small biotech companies and large pharma groups. Preclinical trials are trials carried out prior to clinical trials in humans, and where feasibility, iterative tests and drug safety data are collected.

Mogens Kruhøffer, CEO and founder of BioXpedia.

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

LAUNCHING A NEW PRODUCT FOR THE FIRST TIME

“I have worked with clinical researchers, large pharma and biotech companies over many years. We may not necessarily have the answer to all questions, but we know how to find the answers” BioXpedia’s consulting service always starts with a discussion of the project and the goals the life science company plans to reach.

“Together with the client we determine what the best methods are, the best technology platform to use, how many tests are needed to obtain sufficient statistical power in the analytical work but also try to establish what obstacles we may encounter during testing,” says Mogens Kruhøffer, CEO and founder of BioXpedia.

If a company orders clinical tests such as animal tests or cell culture samples, BioXpedia helps establish how these samples should be carried out and how to make sure the samples are reproducible and standardised from beginning.

“Minimising pre-analytical variation in samples is very, very important. You also need sufficient standardisation in the way you do the samples and how you store them,” says Kruhøffer.

Working with a contract research laboratory provides a biotech company with access to the most advanced and up-to-date technology but also to a network of very experienced people in the industry, who apart from experience with clinical trials also have in-depth knowledge of regulatory affairs in various markets.

“I have worked with clinical researchers, large pharma and biotech companies over many years.

We may not necessarily have the answer to all questions, but we know how to find the answers,” says Kruhøffer.

The Scandinavian contract research organisation, LINK Medical, offers a service for young biotech companies about to enter clinical trials with their compound. An initial meeting is held to discuss the business model as well as the parties go through the trial protocol and design.

“Our clients get the safety profile of the product evaluated just as we

evaluate the market for this type of product and which markets to focus on, which patient group to start with, how to design the trials,” says Ola Gudmundsen, CEO at LINK Medical.

Gudmundsen says LINK Medical is a multi-disciplinary company with many different competencies inhouse, including several doctors and an experienced oncology team, who can help a small biotech company getting ready to go to market.

“Perhaps it’s a small company with just two employees and an excellent product that may be in need of a broader evaluation of the product,” says Gudmundsen.

A clear strategy and well thought out target profile are also essential if a biotech company is looking for new investors.

“The new biotech companies that succeed and get investments, are those who know where they want to go and who have a clear strategy of how to get there,” says Gudmundsen.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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PATIENT RECRUITMENT IN CLINICAL TRIALS

Bridging the gab between people and clinical trials In 2019 we saw a record high number of new clinical trials being registered (32,524), which is more than a 60% increase in the last seven years (20,436). The number of new clinical trials being registered is a result of incredible advancements in biotechnology, healthcare and the efficiency of research and development, but the reality

is that all new therapies and all the advances we make in developing them must be tested and approved. This is where one of the biggest blockages of bringing faster access to new treatments to billions of people lies – the recruitment of eligible patients in time.

New registered clinical trials per year.

Source: clinicaltrials.gov

Year

Today, nearly 80% of all clinical trials fail to meet their enrolment timelines and up to 50% of research sites enrol only one or no patients at all. Further, some studies are seeing dropout rates of up to 30%, which is a result of insufficient patient retention, in turn resulting in additional delays, and even leading to clinical trials being shut down.

Registered

Total

2000

2,119

2,119

2001

1,773

3,892

2002

1,379

5,271

2003

3,588

8,859

2004

3,166

12,025 24,824

2005

12,799

2006

10,917

35,741

2007

12,549

48,290

2008

17,566

65,856

2009

17,011

82,867

2010

17,350

100,217

2011

17,821

118,038

2012

19,466

137,504

2013

20,436

157,940

2014

23,311

181,251

2015

24,113

205,364

2016

27,797

233,161

2017

29,188

262,349

2018

30,978

293,327

2019

32,524

325,851

Nearly 80% of all clinical trials fail to meet their enrolment timelines The lack of eligible patients in clinical trials is a result of fundamental problems: 1. Access and visibility for the patient. It is extremely difficult for people outside of the industry to find information about potential clinical trials. The patient or their families often need to find the information themselves, because they are not informed by their physician.

2. The registries that are available are poorly designed and create a real struggle to identify clinical trials that could be a match for a patient.

3. Complex medical protocols and increased number of inclusion and exclusion criteria.

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4. Lack of information about the study itself, the patient journey and how it affects the daily life of the patient.

Jonas Spott is the Chief Product Officer at Patiro, which is a data-driven patient recruitment company.

"Since more than 80% of the population aren’t aware that clinical trials could be a care option for them, we need to start focusing on education and awareness. Digital tools can help spread the message way faster and much more efficiently with targeted outreach – and at the same time present an easier way of joining studies for both the patient or a caregiver," says Jonas Spott.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

PATIENT RECRUITMENT IN CLINICAL TRIALS

Smarter ways to reach patients Many clinical trials rely on physician referrals, very formal letters, traditional marketing tactics like poster at hospitals and clinics or mass media advertising. In fact, more than 85% of studies don’t use non-traditional tactics of recruitment. Placing digital patient outreach advertisements on search engines, social media, affiliate networks and other digital channels help sponsors and CROs recruit patients who are active, engaged and already looking and searching for treatment options.

Digital channels can utilise highly-targeted audiences, including demographics, to reach and identify potential matching patients or caregivers faster and more effectively.

Patiro’s goal is to dramatically accelerate the recruitment process through digital tools, allowing for faster and more efficient access to life-saving medication.

“A consumer brand would never present information to consumers that is difficult to understand. So why is it being done for clinical trials and healthcare – which are far more important than consumer products. This is not a patient-first approach. The industry needs to do better," says Jonas Spott.

“Public opinion shows that most agree that clinical trials are important and would consider participating if they knew about them. The biggest challenge is finding the right people at the right time. By shifting the focus from a scientific approach to a more consumer oriented approach we can present the information in a much more engaging and simpler way. Patients are the heart of a clinical trials – and we need to make it work for them. Not the other way around," says Jonas Spott.

More than 53% of patients are finding information about clinical trials online, which affects sponsors and CROs who don’t engage in digital patient recruitment and risk missing out on valuable ways to engage with potential study candidates. Using digital advertisements and EHRs can boost patient recruitment and retention – and clinical trials can take a significant step towards decreasing missed clinical trial deadlines. Not only will this save a lot of money in fines and lost revenue, but it will also result in what is most important: bringing better and important treatments closer to those who need it – the patients.

Eliminate medical jargon Not only can it be difficult to understand the official descriptions of some clinical studies that are presented on many of the registries, but in many cases the description and details are only presented and explained in English.

Patiro is a Danish patient recruitment company that utilises their innovative technology to both translate unstructured clinical criteria and match patients to trials in a matter of minutes. This helps both the clinical studies and patients find each other much faster and effectively.

Jonas Spott, Chief Product Officer at Patiro

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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Sweden – Denmark – Norway – Finland

Enabling Future Health Scandinavian CRO is a full-service CRO with team players that really love what we do. We provide expert support that meets your unique needs and enables you to succeed in your clinical studies.

Our vision?

To enable future health solutions that meet the needs of tomorrow.

Contact details +46 18 100 550 – www.scro.se – info@scro.se Scandinavian CRO AB – Skolgatan 8, P.O 150 27 – SE-750 15 Uppsala

TRIAL SUBJECT GDPR CONSENT

TRIAL SUBJECT GDPR CONSENT - A DO OR A DON'T?

By Jan Bjerrum Bach, Attorney-at-Law

C

ongratulations on your appointment as project manager of a pre-submission multinational clinical trial to be carried out at sites in, inter alia, the EEA and the UK for the purpose of generating IMP* data eventually enabling submission of a marketing authorization application for a medicinal product now to be tested.

Your employer is a private forprofit operating special purpose biotech company being run by a few CXO’s* and staff, such as yourself, engaged on short term consultancy terms, and interacting digitally at a distance. Due to the limited amount of in-house resources, your responsibilities include all operational, logistical and legal aspects of the trial, often reflecting GCP* and data protection requirements.

Biotech Company GDPR Need-to-Knows: 1. The legal basis for the processing of trial derived health data.

2. The GDPR qualification of sponsor, investigators and other interests involved.

3. The need for DPA’s - Who are required to enter into and sign a DPA with whom?

4. Consent required for (purpose specific) processing of protocol mandated health data?

5. GDPR de minimis data processing standards.

6. Data Protection Officer Must sponsor have a DPO? 7. Data retention periods.

Fortunately, the trial budget authorizes engagement of a CRO*, including - on a country-by-country basis - local CRO sub-contractors, so following completion of a relatively informal tender process; you have contracted the bidder that you believe to be the most cost-effective and internationally experienced CRO available. The chosen CRO has offered to render the trial related services required on basis of a CRO developed “standard” MSA* and bilingual GCP (CTA*, ICF*) and GDPR* (DPIA*, DPA*) templates regulating relationships among sponsor, CROs, sub-contractors, sites, investigators, patients and EC’s*, and GDPR risk assessments. The CRO expects the templates to be acceptable more or less on an “as are” basis to everybody to be contracted. So, with everything being on track for initiation of site recruitments, EC submissions, kick-off meetings, subject enrolment and initiation of the trial, you may now lean back, right?

Well, first of all your expectations that you (and sponsor) may rely on CRO templates and CRO professionals conducting the trial without involving you in the finer time-consuming details, is an illusion. The GCP requirement that CRO’s may only act on specific authority and delegation implies that the negotiation process can only be executed by the CRO on basis of detailed instructions received from you on all sorts of contractual details – the templates, which sounded so promising, are no longer a solution, but merely a check

list comprising a starting point for the negotiations to be concluded.

With respect to personal data processing you should, to secure regulatory consistence, implement a GDPR position policy, which addresses, among other issues, the questions raised in the appetizer above of this article, and which is consistently implemented vis-à-vis all parties involved securing that e.g. controller* and processor* roles have not been varied from site to site just to accommodate individual sites’ individual institutional policies. If the GDPR roles are not consistently implemented on all sites, investigators, CROs, etc. involved, the data package ultimately compiled will comprise a GDPR patchwork vesting different GDPR rights in different trial subjects. Such end result would be a nightmare to administrate as some data may have been obtained on a no consent basis, as research data should be, and other on a trial subject consent made to the site as controller which the site should not be, implying that transfer to sponsor would be consent based and hence subject to withdrawal risks and reconsent procedures being neglected, potentially jeopardizing the entire data bank.

Considering the vast amount of GDPR advice available from a comprehensive number of sources, including the EU Data Protection Board* and national data protection agencies, it should be straightforward to agree on a GDPR interpretation paving the way

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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TRIAL SUBJECT GDPR CONSENT

for a smooth implementation of template-based contracts. However, experience has shown that involved interests often take different views on what is the right answer to a variety of GDPR related questions, such as those raised above, and especially on GDPR consents, the need for a Data Protection Officer, DPA closing and retention periods.

GDPR Consents: Some sites insist that the sponsor – side by side with the GCP required consent comprising the ICF - must obtain a GDPR consent from the trial subjects in order for the health data generated as per the protocol to be processed. When challenged, the argument sustaining this requirement is “better safe than sorry”. Ironically, the policy does the opposite – rather than being safer and better-off, such policy actually and unnecessarily vests (some) control over the health data in the trial subject and moreover

a need for the subject to re-consent every one or two years. Hence, nothing is achieved, but an increase of the risk of losing data due to, e.g., withdrawal requests.

DPO* / Data Protection Officer: As per GDPR Art. 37 a data protection officer must be designated when the core activities of an enterprise consist of processing operations which, by virtue of their nature, their scope and/or their purposes, require regular and systematic monitoring of trial subjects on a large scale or where the core activities consist of processing on a large scale of health data. In this case sponsor’s core activity does not comprise processing operations requiring regular and systematic monitoring on a large scale basis, nor processing on a large scale of health data. Partly sponsor’s core activity is not data processing, but IMP development and partly the trial subject cohort is traditionally very limited in terms of number of trial subjects. Moreover the duration of the trial will be limited and the processing taking place thereafter comprise archiving of pseudonymised* data only, which does not add on to the risk for personal data breaches as such risks are already in place by the mere fact that each trial subject has a medical record with the investigator, whose share of the trial cohort may often be counted on one hand.

Jan Bjerrum Bach, Attorney-at-Law, Jusmedico Law Firm / BioLawEurope

20

DPAs / Investigator Processing: Not infrequently, sites refuse to sign Data Protection Agreements otherwise called for as per Art. 28 (3) of the GDPR on the basis that the site has to adhere to an institutional policy stipulating that investigator – by site definition – will not be “processing” data, merely “transferring” same, in spite of the CTA and the protocol requiring investigator to, inter alia, collect, record, organise, structure, store and retrieve health data.

Apparently, the position reflects a kind of wishful thinking that if we call “processing” something else, then it will not be “processing” and no GDPR obligations will be vested in the processor or at least they will be less onerous. In our perspective such policy is nothing more than exactly wishful thinking, which has no bearing.

Health Data Retention Periods: Health data controlled by sponsor, i.e. data generated as per the protocol, comprise Essential Documents* as per GCP. However, the trial subject’s medical record will be maintained by investigator, who as per the CTA – considering both medical confidentiality* and data minimisation* principles – will only be required to transfer pseudonymised data to sponsor.

Considering that sponsor will only be in a position to cause trial subjects to be (re-)identified via the investigator’s own records, sponsor is required to impose data retention periods on the investigators, which enable sponsor to comply with GCP. Hence, the CTA must impose an obligation for the investigator to keep on record the health data, including the codes required to identify a trial subject, for as long as required by GCP. The retention period duration depends on whether a marketing authorization is eventually obtained or not, but as

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

TRIAL SUBJECT GDPR CONSENT

a general principle the investigators should be required to keep the data on file for at least 25 years after study completion, it being noted that sponsor is obligated to inform investigator, when the data may be erased. Were investigator to erase data, including the re-identification codes, prior to elapse of the retention period, such action may jeopardize sponsor’s ability to comply with the CTR, when taking effect presumably later this year.

Even in cases where the parties have been capable of finding pragmatic solutions to inconsistencies between an institutional policy and sponsor’s GDPR obligations, the mere disagreement on the positions will impose a severe delay on sponsor’s trial execution and in effect sponsor needs to consider upfront if sites raising the above or similar objections, which may clearly be rejected on basis of the GDPR, should simply be excluded from the site selection process at a very early stage, as it may be quicker for the CRO to find alternative sites than for sponsor to try to fight institutional policies the result of which fight is likely to assemble the result of Don Quixote’s fight against windmills.

Seven Need-to-Knows - Answers 1. The legal basis* for the processing of i) pre-submission trial data related to e.g. safety (legal obligation vested in sponsor) comprises Article 6(1)(c) in conjunction with Article 9(1)(i) of the GDPR, and ii) Article 6(1)(f) - Sponsor’s legitimate interests - in conjunction with Article 9(2)(j) supplemented by 89(1) of the GDPR, when the data comprise other data.

2. GDPR consent as per Article 6(1)(a) and 9(2)(a) of the GDPR should under no circumstances be used as legal basis for the processing.

3. GDPR qualification: For data required to be collected and processed as per the protocol, sponsor is controller, whereas the investigator, and other parties handling the data as per sponsor’s protocol derived instructions, are processors.

4. DPAs between sponsor on the one side and each processor on the other, e.g. the CRO, the CRO sub-contractors, the investigators (or sites) and laboratories handling biological samples.

5. Irrespective of GDPR consents being superfluous, GDPR de minimis data processing standards comprising DPIA completion, data minimisation, data security and the communication of a suitable privacy statement in the ICF must be observed.

6. Biotech companies will seldom have to appoint a DPO, and may name any CXO or the project manager, irrespectively of professional GDPR qualifications, in case of personal data breaches.

7. The investigators must undertake to store all health data generated as per the protocol for the shorter of 25 years after study completion and sponsor confirming that erasure may take place.

*References: See http://www.jusmedico.com/

Disclaimer: This article is of a general nature

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news-and-publications.

only and not intended to address the specific

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provided herein is authorised, subject to source

Acknowledgements: With special thanks of gratitude to Messr. Francis Davey, Barrister and Associate, & Mark Anderson, Solicitor and Managing Partner, both of Anderson Law LLP, who on basis of their valuable insights into the subject matter hereof, kindly provided helpful feedback and proof reading of this article.

acknowledgement.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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PROFILE

LINK Medical offers strategic partnership for effective development of new life science products Getting a new drug or medical device to market is a challenging process, potential risks need to be limited and costs addressed thoroughly. LINK Medical offers life science companies a strategic partnership that will help them reach the desired market more quickly and with the most optimal use of resources.

As a full-service contract research organisation (CRO), LINK Medical offers more than just the traditional product development services for life science companies.

Its in-house team of experts offer services that span from early development through to clinical development and market access.

“We primarily work with clinical development but in addition, we have a rather large regulatory team, a highly skilled medical device team, a growing market access team and a pharmacovigilance team operational in both pre- and post-marketing services,” says CEO Ola Gudmundsen.

The LINK Medical teams work with clients in all the phases required to bring a new product to market.

• LINK Medical is a full service CRO

for biotech, pharma, and MedTech in Northern Europe • Has 175 employees, servicing

customers from offices in Oslo, Stockholm, Malmö, Uppsala, Copenhagen, Berlin and London • Provides services within all

aspects of life cycle management from preclinical to post-market https://linkmedical.eu Contact information: LINK Medical Research Gjerdrums vei 19, 0484 Oslo

development in oncology and related areas such as inflammation and immunology.

A Target Product Profile (TPP) document outlines the strategy of product development, planning of clinical trials, liaisons with health authorities, and compliance with regulations.

Life science companies, from small biotech to large established pharma and medical device manufacturers, use the market access expertise offered by LINK Medical.

“The pharma industry needs to prepare a business model that ensures that they reach the goals set out to reach. A lot of excellent ideas never materialise because you have not prepared properly or you keep running into errors that could have been prevented with proper planning,” Gudmundsen says.

“We have an excellent team working with strategic oncology trials,” says Gudmundsen.

“We view ourselves as a strategic partner more than a service provider, in that way we can establish a strong collaboration.

We cooperate, talk together and work things out jointly – and in our experience, this makes a huge difference,” says Ola Gudmundsen.

Bringing a medical device to market, for example, requires that health economic models be prepared in order to compare the product to standard treatments and devices already on the market. Obtaining reimbursements for a new drug can be a time-consuming process and will depend on various terms and regulations, while the reimbursement application must adhere to all requirements and submission deadlines.

About LINK Medical

• For more information

“It’s important to have a solid understanding of the market being entered and what characterises this market, so we build a Target Product Profile at the earliest stage possible,” Gudmundsen says.

“It’s also important that life science companies target the right group of patients and get the right product into the right market. This requires a wide range of resources,” says Gudmundsen.

In particular, the field of oncology is a minefield; more than 2,000 products are currently under active development.

“Only a small fraction of those products will reach the market, and those who put the most thought into this and have a clear strategy will come the furthest. It’s not just a question of biology, the strategy is equally important,” says Gudmundsen.

LINK Medical’s expert oncology team includes medical specialists with a substantial knowhow of product

info@linkmedical.eu +47 22 58 90 00

22

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

Ola Gudmundsen

EXPRES ION 2

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DIGITALISATION AND AI

New health cluster focuses on health data Denmark is the leader within the gathering of personal data on citizens' health. A new joint cluster for life science and welfare technology will, among other things, work for better application of health data when the information is to be used to take advantage of the potential of artificial intelligence in the healthcare sector.

By Lotte Overbjerg, Welfare Tech

A

rtificial intelligence and machine learning will become some of the most important tools to use for health innovation in the future of the care and healthcare sector. There is a need for large volumes of personal data in order to develop intelligent solutions.

Fortunately, Denmark has the world's best health data, which will be the basis for the artificial intelligence. We also have a long and solid tradition in which citizens feel secure when their data is used for research and improvement of the healthcare system. We will hold onto that tradition when companies and the public sector use the latest technologies in the future.

That is what Troels Bierman Mortensen, CEO of Welfare Tech believes. Welfare Tech is a business cluster where 200 companies, knowledge institutions and public sector parties collaborate on welfare technology.

“Denmark is in tough international competition within the gathering of personal data and development of artificial intelligence. The ownership of data is different in other countries – for example, many companies like Google and Amazon own large volumes of citizen data in the USA. Therefore, it is important that we focus on security in connection with personally sensitive data when we use data for development,” believes Troels Bierman Mortensen.

New joint health cluster on the way In future, it will become easier for stakeholders in the healthcare sector to work together on secure access to citizens' health data, among other things.

In 2020, all stakeholders in the field of life science and welfare technology will gather in a new joint cluster organisation.

Troels Bierman Mortensen, director of Welfare Tech, works with other stakeholders to develop a national cluster for life science and welfare technology. Photo: Ard Jongsma.

24

Secure access to data is the foundation for the development of artificial intelligence for the healthcare sector. The photo is from WHINN (Week of Health and Innovation in Odense) 2019. Photo: Ard Jongsma.

This new structure is part of the 2020–2023 strategy of Denmark's Erhvervsfremmebestyrelse (Promotion of Trade and Industry Board), where ten Danish positions of strength have been identified.

The new national cluster for life science and welfare technology will function as a one-stop-shop, with regional hubs where private companies, investors, research and educational institutions as well as healthcare providers such as hospitals and municipalities can meet and collaborate on developing and implementing new, innovative solutions. This may be decisionsupporting tools for healthcare professionals and patients as well as solutions that can ease the work of healthcare professionals and support safe treatment.

Projects must improve work with data Welfare Tech already works with data and machine learning in, for example, the project VIND -

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

DISCHARGE 22% MORE PATIENTS

VelfærdInnovation med Nyttige Data (Welfare Innovation with Useful Data). A second cluster, Copenhagen Healthtech Cluster, facilitates the project Data Redder Liv (Data Saves Lives), where more than 25 public and private partners collaborate on the improved use of health data.

With the new joint cluster, innovation projects focusing on data will be prioritised further, explains director of Copenhagen Healthtech Cluster, Henning Langberg.

1

“The new super cluster for life science and welfare technology provides the possibility for closer collaboration on ambitious projects. Improved use of data is the path to improved personal treatment by, for example, using the latest technologies and artificial intelligence. So this will become one of several focus areas in the coming cluster," says Henning Langberg.

REDUCE LENGTH OF STAY BY 6%

Data is the path to personal treatment The joint cluster for life science and welfare innovation will have a better opportunity to attract funding for new data projects.

"The cluster provides new opportunities to collaborate on ambitious projects where there is a convergence across pharma, medtech, health tech and welfare technology. Here, in close collaboration with the medico and pharma industry, we will develop solutions that will make the access to data more flexible without compromising citizens' rights. On the whole, the cluster will improve the work on developing artificial intelligence and personal treatment in the Danish healthcare sector," believes Troels Bierman Mortensen.

Improve patient care and reduce healthcare costs suPARnostic® is the only CE-IVD product applied for clinical determination of suPAR, and reflects the level of activation of the human immune system. It allows you to classify 34%1 more patients into low-risk category and reduce hospital length of stay by 6%2 per patient.

Henning Langberg, director of the Copenhagen Healthtech Cluster, which facilitates the project Data Saves Lives, among others.

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This is where more than 25 public and private partners work together on the improved application of health data.

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1 Schultz et al. Scand J Trauma Resusc Emerg Med, 2019, 27:43 2 Schultz et al. Disease Markers, 2019, 10;1-8

DIGITALISATION AND AI

NAVIGATING IN A COMPLEX GLOBAL WORLD Globalisation and ever more legislation and strict regulations are a real challenge for many life science-companies. Insife has developed a software platform that helps Pharmacovigilance organisations with the processing of their PV activities.

By Karin Jensen In January 2019, Insife launched its new software platform, Halo PV, which helps life science companies process their Pharmacovigilance (PV) activities more efficiently.

PV is the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drugrelated problem, according to the World Health Organisation (WHO).

“When a company buys our software, they can use the platform for their network, external partners, affiliates globally, enabling the entire network to work with the global process set up,” says Martin Holm-Petersen, founder and CEO of Insife.

The Halo PV platform integrates with the traditional safety case

Martin Holm-Petersen, founder and CEO of Insife.

management system and delivers global processing of PV activities.

It handles local processes and legislation and distributes information to the right sources. For example, reports on side-effects of a drug, which the system can translate and send to the right destinations.

“The logic behind our system is that life science organisations are complex entities that have to handle multiple sets of rules and regulations.”

“Generally, life science companies are excellent at being compliant and live up to the high standards

DIGITALISATION AND AI

in the industry. But they are struggling because of the multitude of requirements, and more and more requirements globally,” says Holm-Petersen, who has more than ten years of experience working with safety surveillance systems in the life science industry.

Traditionally, PV activities have been centred at the head quarter and focused on the European and North American markets. The head quarter ensured that all reporting was filed with the right authorities, such as EMA and FDA, but with increasing globalisation, organisations have also become much more complex.

The company operates on many more markets and often have hundreds of partnerships.

“Most reported side-effects don’t come from the home market and with new, giant markets such as China, India, Indonesia and Brazil, you also see new legislations and requirements that have to be met.

It’s a global coherent process that requires reporting to many different places.”

“Many life science companies today are a matrix of different affiliates and partners around the world,

hundreds of partnerships, and they all need information,” says Holm-Petersen.

Insife has partnered with Amazon to use some of their Artificial Intelligence (AI) tools, for example a tool that can automatically translate reports.

“Our aim is to be faster in sending information around the world and automatic translation will help ensure that. Our claim is that automatic translations have developed so much that it is now on par with human translations. It is enabling life science companies to move data from one country to the right partners and affiliates around the world” says Holm-Petersen.

When it comes to AI, Insife still takes a conservative approach and only uses AI in places where it makes the most sense. Collaboration and speed of interaction are still key issues for Insife Another Amazon tool being applied soon, is a tool that can detect errors and help the organizations determine whether a follow-up report should be made and detect which data may be missing.

”Follow-ups of information or insufficient data is something that many life science companies are struggling with and can be very time-consuming. We aim at raising the quality and remove some of the manual steps in the process,” explains Martin Holm-Petersen and adds a report on side-effects typically needs at least one followup on average.

PV activities have been at the core of the Halo PV platform, but Insife is now looking into regulatory affairs and medical devices. New EU legislation in May this year, the EU Medical Device Regulation, will see more challenges for the pharma industry.

“A lot of pharma products such as a prefilled syringe or a medical patch will now be labelled a device too.

A string of new rules needs to be handled and our platform can do that” says Holm-Petersen.

Customers of the Halo PV platform are medium sized to big pharma and include Novo Nordisk and ALK. Insife is currently in talks with several large global pharmaceutical enterprises and Martin HolmPetersen expects to sign with 10-15 new customers this year.

“Many life science companies today are a matrix of different affiliates and partners around the world, hundreds of partnerships, and they all need information”

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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INTERNATIONALISATION

Record-high life science exports 2018 was a record year for both the Danish and Swedish life science industry’s exports. The export of medical products and devices was responsible for 15.4% of Denmark’s total exports. Exports were valued at nearly 106 billion DKK – more than double what they were ten years ago. Life science exports were also record-high in Sweden in 2018, having risen 10.6% compared to 2017. The life science industry is responsible for 6.2% of Sweden’s total exportation of goods. The Swedish life science industry’s exports in 2018 were worth a total of 89 billion SEK (approx. 65 billion DKK).

LIFE SCIENCE EXPORTS IN DENMARK AND SWEDEN IN 2018 Millions DKK

Export share 2018

Growth (one year)

Annual growth 2008-2018

Denmark

105 876

15.8%

7.7%

8.7%

Sweden

64 786

6.2%

10.6%

2.9%

Source: Statistics Denmark and SCB/Statistics Sweden and Riksbanken.

Export markets Denmark Danish life science exports are now worth close to 106 billion DKK, having more than doubled over the past ten years.

Swedish life science exports have also reached a record high after rising 10.6% in 2018.

The US is Denmark’s largest export market. China is also a growing market for the Danish life science industry and is the country’s second largest export market. Exports to Germany, Sweden, the UK and Italy decreased in 2018. The four countries are among the top-ten export markets for the Danish life science industry. Exports to France and Canada rose however, and the two countries are now 6th and 10th respectively on the top-ten list. The Danish life science industry’s exports in 2018 were worth a total of 106 billion DKK.

THE PRINCIPAL EXPORT MARKETS FOR SWEDISH LIFE SCIENCE Exports in millions (DKK) 2018

Annual growth 08-18

China

9 010

29%

Germany

8 347

4%

US

8 174

1%

Japan

4 484

22%

Norway

3 865

4%

France

3 080

-4%

Australia

2 795

3%

Belgium

2 620

-3%

Great Britain and Northern Ireland

1 917

-3%

Netherlands

1 714

10%

Source: SCB/Statistics Sweden and Riksbanken

Exports per capita Sweden and Denmark are both important export countries for medical products and devices; in relation to the population, Denmark holds 4th and Sweden 10th place on the list of countries with the most life science exports per capita. The country with the highest exports in the life science sector is Germany, which is responsible for 15.2% of global sales.

Following Germany are Switzerland and the US. Ireland is the largest exporter in terms of population size, followed by Switzerland, Belgium and Denmark.

“The life science industry is important for the Danish economy, both in terms of jobs, productivity and tax revenues.

If we want to retain the standard of today’s welfare system, then we have to focus on industries where we have core competencies and where we can generate growth, create jobs, tax revenues and so on. I am absolutely convinced the new government fully understands this,” says Petter Hartman, CEO at MVA.

THE PRINCIPAL EXPORT MARKETS FOR DANISH LIFE SCIENCE

TOP 10 COUNTRIES WITH THE MOST LIFE SCIENCE EXPORTS PER CAPITA

Exports in millions (DKK) 2018

Annual growth 08-18

US

27 899

15%

China

8 689

23%

Ireland

12 578

8.3%

Germany

5 786

3%

Switzerland

9 769

11.3%

Export per capita USD

Percentage of global life science export

Japan

4 992

6%

Belgium

4 944

7.7%

Sweden

4 802

2%

Denmark

2 895

2.3% 1.8%

France

3 642

2%

Singapore

2 362

Great Britain

3 581

6%

Netherlands

2 303

5.4%

Norway

2 915

10%

Slovenia

1 894

0.5%

Italy

2 684

6%

Germany

1 354

15.2%

Canada

2 632

11%

Austria

1 301

1.6%

Sweden

999

1.4%

Source: Statistics Denmark

Source: UN Comtrade Database, World Bank and Danmarks Nationalbank.

Export markets Sweden Sweden’s largest export market for life science products is China. Germany used to be the largest, but where overtaken by China in 2018. In 2018, the exports to China increased by 21% compared to 2017. As in Denmark, Swedish life science exports to the Chinese market have risen markedly in the past decade.

From 2008 to 2018, the average annual growth was 29%. In the past decade exports to Germany and the US slightly increased, however exports to France, Belgium and the UK have fallen.

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Brexit The expected combined Danish and Swedish life science exports have long been estimated to rise to more than 200 billion DKK in 2021, but there are uncertainties ahead.

Especially about the consequences of Brexit for the Danish and Swedish life science industries. The UK has finally withdrawn from the EU and this will have consequences for the Danish and Swedish exports, but a transitional agreement will secure current conditions until 1 January 2021. What happens next is still uncertain.

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At BioMedical Design Novo Nordisk Foundation Fellowship Programme we invite the brightest minds from different professional backgrounds to go through a challenging learning journey that will shape them to become health innovation leaders.

Medical technology development, qualitative and quantitative research, design thinking and commercial strategy are core learning elements acquired hands-on.

The ten months long programme gives the participants indispensable skills to be used in life science companies or in hospitals to find and deeply understand the right needs and make great solutions to help patients and health professionals globally.

Find out more at biomedicaldesign.dk

INTERNATIONALISATION

The path to the world goes through cluster collaboration Together we are stronger. Companies that work with life science and welfare technology have better possibilities to have an impact on new foreign markets if we collaborate in a cluster.

By Lotte Overbjerg, Welfare Tech

I

t is far easier for companies to enter a new international market if several companies do so together.

Studies show that the degree of internationalisation increases significantly for small and mediumsized companies that participate in activities through business clusters.

Suppliers to the care and healthcare sector, in particular, have a greater probability of getting a foot in the door in a new country if they are part of a group or delegation. Project Manager of Cluster Excellence Denmark, Kaspar Nielsen explains: “It is a huge job taking on a new market which perhaps has a whole other structure than what you are used to. The care and healthcare sector, in particular, often have a different structure in countries other than in Denmark. Therefore, it is a clear advantage to make use of others' experience and to work together with a cluster in relation to the new market," explains Kaspar Nielsen, who has more than ten years' experience with internationalisation. Cluster Excellence Denmark is the national support function for innovation networks and clusters in Denmark.

A cluster is a group of companies that collaborate with other companies, organisations and knowledge institutions to create development, innovation and value.

The South Denmark European Office recommends collaboration as the path to international markets. The office assists companies, public authorities and other institutions to create international development

projects, partnerships, competencies and networks.

“It is clear to us that small and medium-sized companies in the healthcare sector that want to cultivate an international market, receive added value when they collaborate with the Danish business clusters,” says Allan Nordby Ottesen, EU consultant at the South Denmark European Office.

Groups open doors The Danish division of Prolog Development Center (PDC) A/S can confirm that the care and healthcare sector is certainly different in other countries. PDC A/S develops and delivers planning and optimisation solutions to the healthcare sector, among others.

In 2019, Ole Grønskov participated in an internationalisation programme with Welfare Tech, which is a business cluster wherein 200 public and private members collaborate on the development and implementation of health technology.

“If we had been on our own, it would have been even more difficult to get a foot in the door in the German healthcare sector. Here, the welfare area is research-based and there was a mountain of knowledge on the organisation and contacts which we only obtained on the strength of our visit to Germany, in collaboration with a business cluster," explains Sales Director of PDC A/S, Ole Grønskov.

The company Wellness Nordic, which works with assistive devices

such as the therapy rocking chair, has achieved extra sales, networks and knowledge by being a part of an international cluster project.

“In any event, we have sold at least ten sensory chairs to German care centres as a direct result of participating in an internationalisation project.

Moreover, by way of the project, we have gained contact to a German dementia professor who can give us the latest knowledge. By way of Demantec, we have also joined a German network which has contacts to the care centres we want to do business with," explains Bent Bonde, director of Wellness Nordic.

Find the right stage Among other things, the Danish clusters organise match-making, knowledge sharing collaboration and internationalisation projects.

In 2018, a total of 4,758 companies participated in the most important Danish clusters' international activities.

Kaspar Nielsen from Cluster Excellence Denmark applauds the internationalisation process in several stages, which clusters such as Welfare Tech offer companies within care and welfare technology.

“It's not enough to go on a study trip or to have a contact or two in a country. Companies that want to expand internationally need a broad partner like a cluster, which can offer knowledge, contacts and perhaps even development projects," says Kaspar Nielsen.

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33

INTERNATIONALISATION

For a number of years the technology cluster Welfare Tech has specialised in a three-stage rocket model within internationalisation in the field of care and healthcare.

International coordinator, Karen Lindegaard, explains that the cluster ensures that members obtain, in part, advanced knowledge on international markets and, in part, can participate in match-making and networking trips. Finally, Welfare Tech manages a number of innovation projects where the goal is to develop welfare technological solutions across national borders.

function," remembers Andreas Melson, partner in Applikator. He literally went from participating in the function to jumping onto a plane to Stavanger.

“Before you throw yourself into a new market, there is a need for thorough analysis of both your own company and the healthcare sector in the country in which you want to do business. Therefore, we recommend that you participate in a clarification process or a pre-seminar before you go on a study trip or invest in expensive consultancy hours," explains Karen Lindegaard.

Prior to market validation with German experts and networks for other Nordic companies, the participants were also given direct contact to decision-makers when they visited a German hospital.

Directly from pre-seminar to meeting in Norway The company Applikator is a good example of how a pre-seminar can create value. Applikator participated when Welfare Tech and the Norwegian Smart Care Cluster, in collaboration, invited the company to a pre-seminar on Norway's healthcare sector as a lead up to the Danish-Norwegian cluster collaboration, NorDen 3C, in 2017. Applikator develops app-based welfare technology for communication to municipalities, regions and citizens.

The meeting regarding the Norwegian market for health and care technology became the kickoff for Applikator's entry into the Norwegian market. At the pre-seminar, a tender that was in progress in Stavanger Municipality was presented and Andreas Melson, a partner in Applikator, immediately saw the opportunity.

“It was so relevant that I booked a flight while I was still at the

34

Hospital visit gave new possibilities The project Digital Health & Care 4.0, in which PDC participated, is a Nordic cluster-to-cluster collaboration under Welfare Tech.

The goal was to support SMEs in bringing Nordic health and care technology into the German market by way of market insight, networks and product presentations.

As a result of the meeting, PDC was invited to several follow-up meetings in Germany where they demonstrated their digital planning solution.

In Digital Health & Care 4.0, more than 150 Nordic companies have actively participated in activities and, in doing so, clarified their opportunities in the German care and healthcare market.

The project Demantec, of which Wellness Nordic was a part, was a Danish-German dementia collaboration. Here, more than 400 people from companies and public institutions participated for over three years in networking activities and conferences.

International focus can provide a lead It is important that the Danish business clusters continue to have a keen eye on foreign countries.

The international focus of the Danish clusters can also help to make Denmark a leader in new technological fields, believes Allan Nordby Ottesen from the South Denmark European Office.

“Previously, telemedicine and health-promoting apps were some of the new technological fields in the healthcare sector. Today, artificial

intelligence, for example, is an exciting field with great potential.

But it can be difficult, for smaller companies especially, to gain an overview of their possibilities to participate in innovation projects and to get funding," believes Allan Nordby Ottesen.

"Business clusters can boost this task by, for example, communicating knowledge, holding events, matchmaking, etc. A good example is the AI Conference in September 2019 in Odense. Besides plenty of knowledge sharing, there was also advice on funding and innovation projects from, e.g. the projects VIND (Welfare Innovation with Useful Data) and the South Denmark OPI pool, which are both under Welfare Tech. In addition, participants could also obtain knowledge about EU funding options from us at the South Denmark European Office," says Allan Nordby Ottesen.

In 2020, Welltech Tech is inviting participants for internationalisation projects aimed towards the care and healthcare sector. The project Access & Acceleration is aimed towards Germany, while the project Danish Healthtech is holding several activities that will assist SMEs to get into the Scottish market, as well as activities that focus on the Nordic region, the Netherlands and the USA. Digital Health & Care 4.0 will continue the strong Nordic/German cluster-to-cluster collaboration.

Facts •

Every year more than 18,000 Danish companies participate in activities in Danish clusters and innovation networks.

•

Companies that participate in the clusters' activities achieve four times higher innovation power and 3.6% increased productivity in comparison to other companies.

Source: Cluster Excellence Denmark.

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RECRUITMENT AND EDUCATION

"For Denmark, the life science industry is a major industry and thus it deserves a dedicated focus from the government, securing workplaces and income to Denmark. A healthy competition between companies, sensible framework conditions and an educational strategy securing new and well-educated employees to the businesses are some of the key elements."

Henrik Christensen, chairman at DiaLab and Henrik Lundgaard Sedenmark, head of secretariat, DiaLab

Danish and Swedish governments’ initiatives to attract international talents Source: The State of Medicon Valley 2019 – MVA

A

lready in 2018, changes were made to make the Danish tax relief scheme more attractive, with the maximum period for which it could be used extended from five to seven years. At the same time, the fixed tax rate rose one percentage unit, from 26% to 27%. An agreement between the new Danish government and the parties that support it made following the 2019 elections stipulates that employers with a concrete shortage of qualified

36

personnel should be able to recruit qualified workers from abroad more easily.

The 1st of January 2020 the Swedish government introduced new rules for residency permits given to international researchers and students. This means that researchers and students at higher learning institutions will be able to e.g. remain in Sweden for up to one year after completing their

studies or research in order to seek employment or start a company of their own. In addition, those with residency permits that allow them to study or do research in another EU-country may be able to study or do research in Sweden. In 2018, the number of international researchers who were approved for the Swedish tax relief scheme increased slightly, going from 740 in 2017 to 786 in 2018.

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RECRUITMENT AND EDUCATION

Denmark and Sweden amongst the best countries for talent Each year the comprehensive annual benchmarking, the Global Talent Competitiveness Index (GTCI), measures how countries and cities grow, attract and retain talent. This year, the index covers 132 countries worldwide, which are ranked according to their competitiveness. Sweden is ranked fourth best, closely followed by Denmark in fifth place. The two Scandinavian countries are surpassed only by Switzerland, USA and Singapore.

Denmark’s workforce is future proof Addressing the theme of global talent in the age of artificial intelligence (AI), the 2020 edition of the GTCI explores how the development of AI is changing the nature of work and forcing a re-evaluation of workplace practices, corporate structures and innovation ecosystems.

Danish businesses have a long tradition for lifelong learning, employee involvement, freedom and flexibility and a high degree of autonomy and empowerment at work, as well as early technology adoption. This creates a strong foundation for reskilling and making the most of new AI technologies.

Amongst Denmarks achievements are the following:

Top 10 talent countries:

No. 1 in talent impact

1. Switzerland

No. 1 in delegation of authority

2. USA

No. 3 in ease of doing business

3. Singapore

No. 4 in labour-employer cooperation

4. Sweden

No. 4 in new product entrepreneurial activity

5. Denmark

No. 5 in sustainability

6. Netherlands

No. 7 in lifelong learning

7. Finland

No. 8 in technology utilisation

8. Luxembourg

No. 8 in lifestyle

9. Norway 10. Australia Denmark performs particularly well in retaining talent (3rd), as a result of strong performances in both the sustainability and lifestyle sub-pillars. Sweden’s best scores are in fields such as technology utilisation (2nd), investments in emerging technologies (3rd), social inclusion (3rd) and leadership opportunities for women (4th). Both countries scored high on global knowledge and language skills, where a high degree of entrepreneurship and innovation makes them amongst the global leaders in terms of talent impact.

“Denmark has an excellent pool of global knowledge skills, where a high degree of entrepreneurship and innovation makes it the global leader in terms of talent impact.”

- GTCI 2020

“At all levels of qualifications, workers will need training on adaptability, social intelligence, communication, and problem-solving. Lifelong learning will increasingly play a key role in developing skills to foster empathy, creativity, imagination, judgement and leadership, which are likely to continue to be human-only activities.”

- GTCI 2020

About the Global Talent Competitiveness Index 2020 This index is published by INSEAD, the Business School for the World, in partnership with the Adecco Group and Google.

The Global Talent Competitiveness Index 2020 is a comprehensive annual benchmark, measuring how countries and cities grow, attract and retain talent, providing a unique resource for decision makers to understand the global talent competitiveness picture and develop strategies for boosting their competitiveness.

38

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RECRUITMENT AND EDUCATION

THE NEED FOR SOLVING THE RIGHT NEEDS Couldn’t this be done in a better way? Being in a hospital, you may have had such a brief thought while waiting in line for treatment, trying to get hold of staff or when treatment is inconvenient or doesn’t fit into your everyday life. Many people who get in contact with the health care system have.

By Katrine Lind At BioMedical Design’s Novo Nordisk Foundation Fellowship Programme those situations are considered as needs. A need is defined as a gap between what one does, and what one wishes to obtain as a clinical outcome. In that sense, you can view needs as possibilities for creating new value. The fellowship programme invites the brightest minds from professional backgrounds like health care, engineering, business development, design, IT and the like to join a learning journey in interdisciplinary teams. For 10 months fellows go through a boot camp and a threestep innovation process containing clinical immersion, creative skills and commercial skills development.

In short, BioMedical Design is training the participating fellows in a needs-led approach to innovation.

The needs-led approach It has its roots in design thinking methodology and was first developed and tested with the Biodesign programme at Stanford University. Since then, more and more universities around Europe and lately also in Asia have adapted the approach and created their own Biodesign programmes.

The needs-led approach is particularly well suited when innovating for healthcare.

“There is so much sticky information that literally walks around on two legs in the sector and in patients’ homes, not to mention the life science innovation ecosystem. There is simply no other way to harvest that information than to get out, observe and talk with people,” says managing director, Dr. Sys Zoffmann Glud.

According to her the needs-led approach ensures a validated problem understanding and impact potential assessment before moving on with the innovation process.

“I usually say – there is not a lack of exiting technology, but there is a lack of people who can make a proper problem/needs-description for solutions/technology. The BioMedical Design Fellowship aims to foster that kind of talent.”

40

What is design thinking?

Design thinking is a non-linear, iterative process which seeks to understand users, challenge assumptions, redefine problems and create innovative solutions to prototype and test. The method consists of 5 phases: empathise, define, ideate, prototype and test, and is most useful when you want to tackle problems that are ill-defined or unknown.

In fellows’ own words Two fellows from the first cohort of the Danish BioMedical Design programme are deeply involved in a series of creative workshops, the socalled Creative Skills phase. Fellow Lene Ladegaard has a background in business with international sales and marketing for a broad range of products, from medical devices to carpets. She applied for the fellowship programme because it appealed to her to be close to product development and also to help products that can make an impact in people’s lives get to market.

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RECRUITMENT AND EDUCATION

“My skills are not technical,” she says. “I totally rely on somebody else for the technical side of making a solution, and that’s why the interdisciplinarity in our teams is great. I like to communicate and understand problems. Often people think that sales is only talking, but it actually is about understanding problems and selling the right solution which fits into people’s needs.”

off company or collaborate with industry, which enables you to bring new technology to the patient and make a difference for him or her”.

An international fellow’s perspective

The final needs

Jasper Nijkamp is Dutch and already had a foot in the Danish academic world when he applied for a seat in the innovation fellowship programme. He worked as a visiting scientist at Aarhus University Hospital’s Oncology Department where he was pointed in the direction of the programme.

He immediately saw it as a great opportunity to improve both his research and commercial skills.

Both fellows have narrowed their hundreds of observed needs down to two in each of their respective teams. Jasper’s team is working on a solution to diagnose sleep apnoea, which is a busy field. Lots of people are already working in this area and lots of solutions are available.

“It provides a different entry to research,” Jasper explains, “science is mostly evaluated on impact factors and number of published papers, but not on patient impact, and I think this is totally wrong. It’s often a little bit dirty to talk about the commercial aspects of research – mainly because it might challenge your independence. But if you have the skills from this programme you are better equipped to set up a spin-

He states that the money made from the commercial aspect can flow back into research, where you can become less depending on external funding.

In this way he hopes to more directly make an impact for patients and create solutions which become more valuable to society.

“The problem is that only about 20% of the actual patients know they have the problem,” he says.

“Sleep apnoea progresses so slowly that you don’t notice you have a problem until your wife tells you one morning: 'you stopped breathing a couple of times last night, and I’m a little worried’. It’s a tough field to find your niche,” continues Jasper.

Another need in Jasper’s team is about the eustachian tube – the tube running from behind your ear to your nose. It is used to equalise the pressure in your ear, to make sure that you can hear properly.

“Around 1–5% of all adults have problems with this but there’s actually no good tool to find out if it’s properly functioning or not,” Jasper explains. “The challenge here is that there is little competition.

This makes it much harder to position a diagnostic tool for Eustachian tube dysfunction within healthcare.”

Final needs in Lene’s team “We have two needs on the table now,” says Lene. “The first one is about hearing loss – if you have a complicated hearing loss you need a mould of your inner ear to get a customised ear plug. There’s an oldfashioned way to do it with foam, but you have to sit absolutely still for five minutes to get it done well.

For adults it’s not a problem, but for kids it’s almost impossible. And they need it from when they are 14 days old – and then a new mould should be made up to every two weeks, depending on the fit. This means that parents might need to take a day off every two weeks - and the kids still can’t sit still – so we are trying to figure out a way to make a smarter mould of the ear”.

The second need Lene and her team work on concerns thyroid biopsy.

“If you suspect you have cancer of the thyroid you get a biopsy taken.

But taking a thyroid biopsy can be difficult as you might not get

Lene Ladegaard trying the weight and challenges of being old at Praksis- og Innovationshuset, a testing environment in central Copenhagen.

41

RECRUITMENT AND EDUCATION

As a part of the boot camp fellows get a crash course in medicine. Here fellows, dressed up as surgeons, had to watch an operation and holding their hands above their waist to try the feeling of being a surgeon.

enough cells and of good enough quality. About 30% of all biopsies need to be redone as the cell material is not sufficient for the laboratory. And you only get the results of the test after a few days.

Patients often need to return to the hospital for new biopsies. It’s costly to arrange new appointments, and it’s painful for the patients too, so they would prefer to only visit once.

We are thinking about a better way to evaluate the blood test.”

New kids on the block When asked how they feel about facing the huge health tech market with already existing solutions and start-ups and companies, they nod at the challenge they might face. But it doesn’t frighten them off.

“You have to look into the market and then it mainly helps you select which needs you should not go into.

There are enough needs to choose from. With the upcoming machine learning tools there is a very high potential to solve currently existing needs. However, very often you need huge amounts of patient data to train these solutions. If you don’t have access to data, or if there are no obvious partners to work with, you can better leave it to the big players,” says Jasper.

Future output On the question of whether she believes in a commercial future for the solutions fellows are working on, managing director Sys Zoffmann Glud, who initiated the BioMedical Design programme, answers: “I feel quite confident that the rigours with which we guide the fellows through the complexity of factors to be considered will for sure help them to develop the right

product-market fit for their ideas.

I will say it is almost impossible that they end up with ideas with no commercial potential. But whether they choose to pursue the projects afterwards will depend on their personal passion and drive. If we look at the number of start-ups fostered in our sister-programmes in Europe and at Stanford then we should expect at least two future start-ups out of every fellowship cohort”.

If you would like to know more about the BioMedical Design Novo Nordisk Foundation Fellowship Programme please visit our website at biomedicaldesign.dk, where you can get further information about the structure of the programme, and in the insights section you can read articles by our fellows about their learning experience.

The eight fellows allocated to the BioMedical Design Aarhus office visiting the Copenhagen office in September 2019.

42

Kurser til life science industrien Marts 2020

Maj 2020 (fortsat)

September 2020 (fortsat)

EU-GMP-regler – krav og fortolkninger GDP for ledelsen Kvalificering af udstyr NYT Parat til IT-inspektion Pharmacovigilance – an introduction QA-rollen

Miljømonitorering i klassificeret område Procesvalidering Stability documentation NYT

GMP – sidste nyt Krav og metoder til intern træning Quality Oversight Regulatorisk Life Cycle Management SOP-skrivning – workshop Steril/aseptisk fremstilling

April 2020 GDP 1 – grundlæggende GDP-regler – krav og fortolkninger GMP-uddannelsen QP´er – Qualified Person Validering af analysemetoder

Maj 2020

Juni 2020 GDP – workshop Validering af IT-systemer Variationer i tabletproduktionen

August 2020 Risikobaseret tilgang til GMP ledelse NYT

September 2020

Gå hjem-møder • • •

Sådan tænker en Lead Auditor Krav til rengøring i life science industrien Udvælgelse og udvikling af lægemiddelemballage: Guidelines og relation til Drug-Device Combination Products Brexit in a Regulatory perspective

EU-GMP-regler – krav og fortolkninger Find den rigtige root cause Forstå statistikken GDP 1 – grundlæggende GDP-krav til transport af lægemidler

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Derudover tilbyder vi GMP kurser i AMU-regi, hvor vi er en godkendt udbyder af kurser indenfor GMP.

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Kontakt os: kursusinfo@pharmakon.dk 4820 6073

GMP-uddannelsen GMP-uddannelsen er for ledige akademikere og varer 9 uger.

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Læs mere: pharmakon.dk/kurser/life-science/

PUBLIC/PRIVATE COOPERATION

The welfare sector must be developed through collaboration with the business community Regions and municipalities cannot meet the challenges of the healthcare area themselves – private companies and knowledge institutions must provide assistance. Cooperation between the public sector and the business community is necessary in order to maintain and develop the Danish welfare system. Several stakeholders in the healthcare sector believe so.

By Lotte Overbjerg, Welfare Tech

G

ood collaboration is required to maintain welfare in Denmark.

Hospitals and municipalities, together with the business community and universities, need to be able to develop solutions that can improve treatment, quality of life and care. The path to developing the Danish healthcare system is publicprivate innovation collaboration – also called OPI. This is the opinion of Welfare Tech, among others, who manages the digital OPIguide. dk, which has between 1,000 and 2,000 page displays every single month. The guide helps companies, public organisations and knowledge institutions to achieve success with public-private innovation collaboration.

"If we are to meet the many challenges the healthcare sector is facing, it is necessary to have more collaboration across the public sector, the companies and the educational institutions. OPI is an advantageous way in which to

develop welfare in Denmark because we have a strong public sector which provides the majority of the care and healthcare offers together with the private general practitioners.

The healthcare sector also needs new knowledge in order to develop the service level,” explains Welfare Tech's deputy director, Søren Parmar-Sielemann.

Welfare Tech is a business cluster where 200 private and public stakeholders collaborate on the development of welfare technology.

External partners play an important role in public sector innovation.

According to the Centre for Public Innovation, 79% of public innovations have occurred in collaboration with external partners.

Users and developers must collaborate Aabenraa Municipality has participated in a number of OPI projects within e.g. the elderly area, and the municipality has good experiences of involving citizens and employees when new methods and solutions are to be developed together with private companies.

Karen Storgaard Larsen, director for Social & Sundhed (Social & Health), Aabenraa Municipality, explains:

Søren Parmar-Sielemann, deputy director, Welfare Tech. “If we are to meet the many challenges the healthcare sector is facing, it is necessary to have more collaboration across the public sector, the companies and the educational institutions.”

Lena Brogaard, lecturer at RUC, predicts that in the future there will be even more focus on how OPI projects achieve success.

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“When we co-develop new technology in Aabenraa Municipality, there are two aspects that are crucial to our creating actual and lasting value. The one aspect is that citizens and employees play a key role in the development process together with innovative companies. The best solutions are achieved when developers and users work together in the reality where the solutions are to be used. The second aspect is that the companies' new products, in themselves, create value. The value comes about when the new solutions make sense and are used in the citizens' and employees' daily lives,” states Karen Storgaard Larsen.

OPI provides soft values Figures from the Centre for Public Innovation show that there is a 76% probability of higher quality if public innovation takes place together with a private company.

If the public sector collaborates with a knowledge institution, the probability for higher quality is 79%.

PUBLIC/PRIVATE COOPERATION

Lena Brogaard, lecturer at RUC, has analysed and evaluated the benefits of OPI projects in the welfare sector. She has studied 260 Danish innovation projects and is a little surprised about the many soft values and benefits which OPI projects add to the participants in the short term.

“More than half of the companies, regions and municipalities that have responded to the survey, have gained new knowledge by being part of an OPI project. For example, OPI can give the companies knowledge about needs and operations in the public sector and a project can also be an entry point to a public sector customer, which would otherwise be difficult to get into contact with. Moreover, the successful collaboration provides a validation of the company's products. On the other hand, the public parties can learn more about the technological potential, for example, and in some cases this leads on from one project to more,” says Lene Brogaard.

She predicts that in the future there will be even more focus on how OPI projects achieve success. Among other things, she assesses that there will be additional needs for the scaling up of the developed solutions so that they can be used in more municipalities or at more hospitals, for example.

Denmark is a good test country

Facts •

79% of public innovations have occurred in collaboration with one or more external partners.

•

There is a 76% probability of higher quality if public innovation takes place in collaboration with an external company.

•

There is a 79% probability of higher quality if public innovation takes place together with a knowledge institution.

The public-private collaboration has good conditions in Denmark.

“We have a great demand from companies that want support to develop technological solutions for the healthcare and care sector.

Among others, we manage the South Denmark OPI pool and the project VIND - Welfare Innovation with Useful Data, which builds on publicprivate innovation. Almost a third of the country's municipalities are members of Welfare Tech and even more have participated in testing new solutions in our OPI events,” says Søren Parmar-Sielemann.

Source: Center for Offentlig Innovation, coi.dk

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A small company with a big vision One in five children does not have access to the most basic vaccines, and every year approximately 1.5 million people die from diseases that could be prevented with the help of vaccines.

A major reason for this situation is the difficulty in getting vaccines to those who need them most: It is incredibly difficult to set up the cold chain from the factory to the children, who are most in need and live the farthest distance away.

Z

iccum, a company based in Lund, Sweden, is currently working at the Testa Center and has high hopes for its new way of preparing vaccines and biological drugs in the form of temperature-stable powders.

Ziccum is developing new formulations of vaccines, as well as other biological drugs. LaminarPace is their patented technology that develops dry formulations of products that are currently in liquid form only.

“Transporting powder is considerably easier and more costeffective. The powder remains stable at 40 degrees for several weeks and does not require a cold chain, which is extremely important in warm countries such as those in Africa,” says Louise Egeblad, project manager at Ziccum.

Together with a colleague, Louise is using the Biosafety Level 2 (BSL2) Laboratory at the Testa Center.

“Everything is possible here. It is a flexible, well-equipped lab that makes it easy for us to work with viruses when we need a BSL2 lab,” says Fabrice Rose, the company's newly hired formulation expert.

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“It is a gentle drying done at room temperature and it is good for vaccines. We are experts with the machine, but method development is still underway to optimize the drying process, and it has been extremely instructive to come here to the Testa Center,” says Louise.

According to Louise, the next step is to develop a large-scale system for production in GMP environments and to scale it up for larger volumes.

Louise also explains that vaccines are stable in a different way and can be stored for longer periods of time when they are in the form of powder.

The powder form does not take up as much space, which is an advantage if you have to store vaccines prior to an outbreak. In theory, any powder that is manufactured can be used, and therefore you do not have to throw away materials that don’t meet the criteria, such as after a broken cold-chain transport. WHO has estimated that about half of all vaccines are destroyed during transport and handling, which is an enormous waste of resources and money. Other advantages of the powder formulations include being able to develop new inhalation

routes, such as nasal vaccines— something Ziccum is also looking into.

"We hope that, within a year, we will have a commercial contract with a large vaccine manufacturer and another new patent application for a temperature-stable formulation," concludes Louise.

About Testa Center Testa Center is a non-profit company by GE Healthcare.

Co-founded in 2018 by the Swedish agency for innovation, Vinnova, for the growth of the life science industry and its manufacturing capabilities.

The company offers a modern, pilot-scale test bed for commercial, research and educational projects in production of biological products e.g. monoclonal antibodies, recombinant proteins, vaccines and viral vectors, in mammalian or microbial (non-GMP, up to Bio-safety level 2 and 500 liter).

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

Spider silk for organ reconstruction T

he spider web’s strength and elasticity make it a fantastic material with many desirable properties. It is made up of proteins, which make it useful for repairing damaged tissue in the body. For example, it is known that the cardiac musculature is often destroyed during a heart attack.

Spider silk can, in this case, be used as a supporting network to which one can attach cardiac muscle cells to repair the damaged area.

The use of silk proteins for tissue reconstruction has a wide-ranging potential, including for example wound healing and repair of nerve injuries.

“The biomaterial we produce is a recombinant spider silk protein with a variety of unique, desirable properties. Here at the Testa Center we have purified the recombinant protein and our goal is to investigate the possibility of scaling up our current process,” says Jenny Rönnmark, Production and Quality Manager of the company Spiber Technologies.

Jenny and two researchers from the company, Wojciech Kazmierczak and Martin Östberg, have now been at the Testa Center for three weeks to scale up the process. They have optimized their time by doing solid groundwork prior to their arrival and are currently very satisfied with their experience, not the least of which is the expertise they encountered and participated in at the Testa Center.

“It has been very easy to come in to the Testa Center, and we have received very good support from the GE team, such as getting help with packing large columns for the various chromatography steps. The main advantage of the Testa Center is that we have been able to use instruments that we do not have ourselves. We have now succeeded in scaling up the process ten-fold, which is of enormous value to the company. The weeks here have been important. It’s a big step forward for our continued development,” says Jenny Rönnmark.

The company, established in 2008, is based on Professor My Hedhammar's research on spider silk proteins. The company develops, produces and commercializes products based on recombinant spider silk proteins.

The main application areas are in medical technology, particularly cell culture and regenerative medicine.

market, BioSilk521,” says Jenny Rönnmark.

There is a great interest in Spiber's technology because they offer a way to grow primary cells, including stem cells, in a 3D environment in order to make complex tissue models. The company currently has several partnerships with worldleading academic research centers around the world.

“There are other companies that produce recombinant silk, but we are the only one able to bioactivate spider silk. Now that we have seen that we can produce the protein in a larger scale, we are moving toward an exciting future,” says Jenny Rönnmark.

Earlier this year Spiber started a collaboration with BioLamina, a company that has also been working at the Testa Center. Combining Spiber's recombinant silk protein with laminins from BioLamina provides stem cells with a favorable 3D environment.

“This is a new technology in order to imitate the extracellular matrix (ECM). We get the 3D support from the silk and bio-relevance by adding laminins. This was an important collaboration for us that has led to our first product reaching the

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LEGAL UPDATE

Brexit update Consequences for the life science sector

By Karin Absalonsen, Attorney and Partner at Nyborg & Rørdam Lawfirm The UK has left the EU According to the Withdrawal Agreement of 17 October 2019, the United Kingdom of Great Britain and Northern Ireland (together “UK”) has left the European Union (“EU”) as of 31 January 2020 and has become a third country. There is now a transition period until 31 December 2020 while UK and EU negotiate additional agreements.

The current EU rules on trade, travel and business will continue to apply during the transition period.

The new rules will take effect on 1 January 2021. This leaves EU and UK with just 11 months to negotiate new trade and collaboration agreements. If EU and UK are unable to come to such agreements before 31 December 2020 a hard Brexit through the backdoor will be the reality1.

The life science sector is a highly regulated industry with a comprehensive EU-derived legislative framework concerning testing, approval, production and distribution of pharmaceutical and other products. EU has provided much of the scientific, regulatory and trade infrastructure for the life science industry in the EU through the European Medicines Agency (EMA). This ensures that all medicines available on the EU market are safe, effective and of high quality. Securing cooperation between EU and UK on the regulation of pharmaceuticals

and other products will be critical to ensure that EU and UK life science businesses are able to continue to market these products post-Brexit.

Regulatory Marketing of medicinal Products within the EU requires a marketing authorisation. After the transition period, the UK Medicines and Health Care Product Regulatory Agency (MHRA) will not be recognized as an EU/EEA regulator and marketing authorisations issued by the MHRA may not be valid for sales on the EU/ EEA market after Brexit. Companies that rely on UK authorisation should therefore prepare for transfer to EU of their ownership and/or regulator.

However such transfer may require additional permissions and there is a risk of triggering tax charges on exit.

It is therefore necessary to prepare for the relocation of Qualified Persons for delivery of pharmacovigilance activities across the EU to another EU member state.

Medicinal products imported into the EU must undergo quality control testing (batch testing) in the EU/ EEA 2 . However, after the transition period products that have been batch-tested in the UK will no longer be accepted for release to the EU market 3.

The UK is a major location within the EU for clinical trials. Clinical trial authorisation requires an EU registered Qualified Person.

Post-Brexit, Qualified Persons registered in the UK will no longer be recognized as EUQualified Persons and instead an EU legal Representative will be required for clinical trial authorization. UK Qualified Persons will also be unable to deliver pharmacovigilance activities outside UK. Karin Absalonsen, Attorney and Partner at Nyborg & Rørdam Lawfirm

1 The Transition period can be extended one time with up to one or two years by mutual agreement between EU and UK no later than on 30 June 2020 but UK has in its national legislation adopted the Withdrawal Agreement Bill that prevents any extension of the transition period. An extension of the transition period therefore requires that amended legislation in the UK is adopted prior to 31 December 2020.

2 European Directive 2001/83/EC, article 51(1)(b) and European Directive 2001/82/EC, article 51(1)(b).

3 https://ec.europa.eu/health/sites/health/files/files/documents/brexit_batchtesting _ medicinalproducts_en.pdf

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

LEGAL UPDATE

establish a designated authorised representative in EU and relabel the devices to indicate the new authorised representative.

Manufacturers of medical devices outside the EU with an authorised representative within the UK will need to designate an authorised person in the EU market. Following any change of authorised representatives, the quality management system must also be updated.

Organisations must therefore plan for the transfer of testing and release of equipment, materials and people from the UK to another EU member state after Brexit.

In order to market medical devices across EU/EEA manufacturers of medical devices in medium- and high-risk classes must perform an assessment of conformity with the involvement of a notified body in the EU/EEA. However, certificates issued by UK notified bodies are no longer valid in the EU after Brexit.

Holders of UK-issued certificates must require a new certificate issued by a notified body in the EU/EEA in order to ensure the continued marketing and use of the medical device in the EU/EEA post-Brexit.

Supply Chain Life Science organisations must analyse post-Brexit impacts of the reduced harmonised environment and potential introduction of border controls for their current products as well as products in development.

This is also important in respect of the new EU Falsified Medicines Directive where the UK is expected to lose access to the European Medicines Verification System.

After Brexit authorised representatives in the UK will no longer be acknowledged in the EU and vice versa. Manufacturers of medical devices must therefore

If a new trade agreement is not in place by the end of 2020, border delays and reduced access across borders are very likely to have a significant impact on supply chains.

Import of pharmaceutical products into the UK post-Brexit is likely to continue to be zero-rated. However, ancillary products associated with the production are liable to customs duty, e.g. packing. If/when the UK loses access to the benefits of free trade agreements due to Brexit, duty rates and market access arrangements between the UK and third countries could also change.

Life Science businesses should also consider tax implications due to activities being transitioned from the UK to the EU, and there could be impacts because EU VAT simplifications no longer apply.

Recovery of import VAT etc. will need to be assessed.

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LEGAL UPDATE

Life science companies must have firm patent strategy at very early stage of development Developing a new drug is a time-consuming and costly business and many life science companies often leave the patent application too late and may therefore miss the opportunity to protect the product longer term

By Karin Jensen

I

t is a long process getting a new drug to market and requires a lot of resources and capital. Quite often life science companies work very hard on product development in the early stages of development and they forget to pay attention to Intellectual Property (IP) and applying for a patent of the drug.

“And in the later product development stages that may put you in a difficult position if your product is not protected,” says Claudia Ulrich Hjørringgaard, patent attorney within life science at Patentgruppen.

Leaving a patent application until clinical trials begin is too late.

“You need to consider a patent application at the very beginning.

Before you start cooperating with partners, before you begin to tell the world about the uniqueness of your product, you need to have control over IP,” says Claudia Ulrich Hjørringgaard.

Getting a patent can take several years and depends entirely on the authorities in the market where the patent has been submitted. A patent is needed in each market where the drug is expected to be launched, but since a patent application is costly it is important that the company carefully consider where to apply and avoid spending time and money on needless applications.

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“We encourage life science companies to have a clear business plan in place, and a clear strategy for their patent applications. There’s no need to spend money applying for a patent in a market you’re not planning to enter,” says Claudia Ulrich Hjørringgaard.

“It’s important that the life science company is fully aware that it may cost DKK 800,000 over eight, ten years. There may be more than one patent family in which case you have to multiply the cost with the number of patents families you require,” says Lene Nørby Nielsen, patent attorney within life science at Patentgruppen.

Quite often the life science company will need external funding to finance development of the drug and having a clear strategy, including a complete overview of the patent application process, will make it much easier to attract investors.

“If the investor can see a business case, a clear strategy, then it will lower the barrier to get an investment,” Lene Nørby Nielsen says and adds it may also be difficult to raise capital for the development of the drug if the rights to the drug has not been protected with a patent application.

“We engage in a cooperation with the life science company to get to the core of the product and to fully understand the essentials.

But it is equally important that we understand the company, the market, to get as broad a patent as possible,” says Jørgen Møller, patent attorney, partner and CEO at Patentgruppen.

To get to there, Patentgruppen takes a very methodical and analytical approach and the process often involves several of Patentgruppen’s patent consultants to get a wider picture of the company and products, just as it carries out interviews with the company’s management, R&D and even sales people, who can provide valuable feed-back on the market.

“It’s important to do a thorough job and make use of all the competencies we have in-house and cooperate with the company because one person does not know everything,” says Jørgen Møller who adds that a broad patent is vital for the company and its ability to protect its business strategy longer term. It is costly to obtain a patent but will pay off in the end if your IP approach is aligned with your business, he says.

An important element of the patent strategy is to know exactly what and how much should be included in the patent applications.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

Lene Nørby Nielsen (left) and Claudia Ulrich Hjørringgaard (right)

LEGAL UPDATE

PROTECT YOUR IP

– WHY HAVING AN IP STRATEGY IS KEY As patent litigators, we often see the consequences of the lack of an IP strategy when it is too late; when a legal action or the threat hereof has arisen. We also see the negative consequences during due diligence processes where the lack of an (adequate) IP strategy can ultimately lead to loss of financial investments or a merger or acquisition. Often, simple measures could have made the difference.

By Rasmus Vang (Director, Attorney-at-Law) and Emilie Lerstrøm (Attorney-at-Law) both IP experts at Lundgrens Advokatpartnerselskab

W

hen considering the

directives harmonizing the legal

Hence, non-disclosure agreements

importance of an IP strategy,

framework and seeking to strike

and adequate IP clauses securing

it is relevant to understand the

a fair balance between interests

the transfer of the rights to the

mechanism of IP rights and IP

of innovators against the general

intended entity should be considered

policy. Danish IP law is to a broad

public interest. For example, patents

incorporated in employment

extent governed by multilateral

enjoy 20 years protection against

contracts, consultancy agreements

treaties1, EU regulations and

the disclosure of how the invention

etc. If the company is doing research

works for free utilization upon

in collaboration with e.g. a research

patent expiry.

institution or university, it is

2

It all starts with a good idea However, it doesn’t start with a patent application. It starts with a good idea or a work of creativeness. The first element of an IP strategy is to secure that potential IP based on this work legally vests in the right entity.

equally important to consider the distribution of IP rights developed as part of the collaboration.

Additionally, implementing standard processes are important to ensure that employees notify the company when a potential invention has been made to secure the assignment and filing of such invention. Otherwise, the risk is that the invention vests in the wrong entity, is never discovered by

Rasmus Vang (Director, Attorney-at-Law), Lundgrens Advokatpartnerselskab

the company or that it is eventually is discovered by competitors and – worst case – that competitors are granted a patent covering the One of the most important treaties is the TRIPS Agreement (“Trade-Related Aspects of Intellectual Property Rights”) which entered into force in 1995 and sets out global minimum standards for protecting and enforcing nearly all forms of IP rights.

1

2 And even longer for certain pharmaceutical patents eligible for a supplementary protection certificate (“SPC”).

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LEGAL UPDATE

“... it may be relevant to “patent around” the core invention creating “patent clusters” or “thickets” to block potential competitors.” invention. This can ultimately

be assessed. Given the strength, it

We see companies realizing at

lead to an injunction against the

may be relevant to “patent around”

a mature stage the importance

company restraining the company

the core invention creating “patent

of implementing a strategy, for

from utilizing its “own” invention as

clusters” or “thickets” to block

instance during a due diligence

it can be difficult to establish “prior

potential competitors. Relevant

process as part of a merger or

use”.

geographic markets must also

acquisition. While the lack of a

be considered. Another way of

strategy can negatively impact a

securing a strong market position

purchase price or an investment,

is considering registering other

a due diligence process can be the

types of IP such as trademarks or

wake-up call for a proper IP “clean

designs. Particularly in relation

up”.

Freedom to operate Conducting a freedom-to-operate analysis (“FTO-analysis”) is also a corner stone in an IP strategy - and is often an important

to pharmaceuticals, timing is

tool for commercial success in industries of extensive patenting.

It involves an analysis of pending and granted patents highlighting third parties’ rights in the relevant field and jurisdictions – in order for the company to limit the risk of infringing third party rights. If such risk exists, it may be relevant

relevant as premature registration of a drug name may risk revocation due to lack of genuine “trademark use”3. This cannot be overcome by early advertising as this may contravene advertising regulation.

Is timing everything?

to consider obtaining licenses or

Even though an

consider work-arounds.

early strategy is

Taking your strategy to the next level When the contractual work in relation to the ownership of IP is in order and an FTO-analysis

the best strategy, it is never too late to incorporate an IP strategy.

might have been conducted to clear market entry, the company may be ready to file a patent application.

Patent application filings is a

Emilie Lerstrøm (Attorneyat-Law), Lundgrens Advokatpartnerselskab

strategy on its own and the strength of a product or technology both technically and commercially must

3 See the CJEU’s reasoning in the recent BOSWELAN decision (C-668/17 P).

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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VIROGATES SUPARNOSTIC® TURBILATEX PRODUCT – A DISCHARGE DECISION AID FOR HOSPITALS EMERGENCY DEPARTMENTS – NOW CE IVD APPROVED FOR THE ADVIA® CHEMISTRY XPT SYSTEM FROM SIEMENS HEALTHINEERS The prognostic biomarker suPAR (soluble urokinase Plasminogen Activator Receptor) is a strong measure of chronic inflammation and underlying risk of negative outcomes including short-term mortality, and is highly suited for risk evaluation in hospitals Emergency Departments. suPAR can now easily be measured in the hospital laboratories, as ViroGates has completed the development and regulatory approval (CE-IVD) of its suPARnostic® TurbiLatex product for the ADVIA® Chemistry XPT System from Siemens Healthineers. The approval for the ADVIA XPT platform complements the previous approvals for the Roche Diagnostics cobas systems.

This way, the healthcare systems can improve patient care and reduce healthcare costs.

In the figure is shown the guideline for suPAR in acute medical patients. A low suPAR (<3 ng/ml, 56% of patients) supports the decision to discharge the patient – and a high suPAR (>6 ng/ml, around 12% of the patients) calls for immediate clinical attention and further investigation.

For more information, visit www.virogates.com

Thereby suPAR can be implemented in clinical routine use at hospitals, and can automatically be determined simultaneously with other blood parameters at the central laboratories. The result will automatically be reported into the laboratory information system. suPAR is an unspecific biomarker elevated by most diseases and correlated to disease severity, and is superior to other biomarkers in risk prediction.

A low suPAR level is a safe indicator for a good prognosis and can therefore be used for discharge decisions, leading to reduced hospital length-of-stay and reduced crowding.

The suPARnostic® TurbiLatex product from ViroGates – now approved for the ADVIA® Chemistry XPT System from Siemens Healthineers as well as the Roche Diagnostics cobas systems

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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Siden 1985 har Prevas assisteret førende virksomheder indenfor Life Science-sektoren i udviklingen af livreddende medicinsk udstyr og apparater, der bidrager til en mere effektiv behandling af patienter indenfor mange områder. Der stilles høje krav til medicinsk udstyr hvor brugervenligheden og kvaliteten skal være i top - og det er netop dér, vores specialister har deres spidskompetencer.

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Live probiotic bacteria for eczema patients Danish biotech company, Lactobio, has recently launched a new series of products that put live probiotic bacteria back onto the skin of patients who lack the natural defences against pathogens.

T

rillions of microorganisms live and thrive on our skin - primarily bacteria, but also various fungi and

virus species - which together form the ecosystem we call our microbiome. There are so many of them that they outnumber our own, human cells.

Some bacteria cause infections and make painful conditions such as atopic dermatitis (eczema) worse.

Others don’t hurt us. Instead, they help us by taking up space and by producing toxins and peptides that are helpful against invading pathogens.

For Lactobio it’s all about bacteria Current treatment of eczema often includes antibiotics and steroid creams, which kill off both good and bad bacteria and have a variety of side effects. Lactobio takes a new approach by topically applying live bacteria directly on the skin.

Probiotic bacteria are naturally present on the skin and form an important part of its microbiome. Therefore, they are also very safe to use. When applied to the skin, they support and complement the natural bacterial

Eczema patients often lack the good probiotic bacteria

diversity of the microbiome and help to improve and

that would typically fight off pathogens such as

restore its natural balance and health.

Staphylococcus aureus. Colonisation with S. aureus is, in most cases, non-symptomatic, but it can cause infections when the skin’s protective barrier function is breached - making people with eczema especially susceptible to Staphylococcus infections.

The company’s new line of cosmeceuticals, Bak Probiotic Skincare, contains the live probiotic bacteria, Lactobacillus plantarum LB244R, selected specifically for its ability to counter S. aureus and for its healthpromoting properties.

Infobox •

•

•

Lactobacillus plantarum is listed as GRAS (Generally Regarded as Safe) in the US and as QPS (Qualified Presumption of Safety) in the EU. Lactobacillus plantarum LB244R, the bacterium used in our products, has shown very promising activity against Staphylococcus aureus, Methicillin Resistant Staphylococcus aureus (MRSA) and other pathogens.

Staphylococcus aureus has been associated with a variety of skin diseases, including atopic dermatitis, perioral dermatitis, carbuncle, cellulitis, rosacea, psoriasis, diaper rash, impetigo and breast infections.

If you want to read more about Lactobio or our upcoming projects such as acne treatment and methane reduction, please go to www.lactobio.com.

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Transforming Pathology Labs in the Fight Against Cancer Agilent is a global leader in life science, diagnostics, and analytical laboratory technologies. The Pathology Division has a site in Carpinteria, California, and a large site located in Glostrup, Denmark with more than 600 employees.

worldwide make accurate tissue-based diagnoses and determine the most effective treatment for cancer patients.

Join our passionate team and help us provide solutions for our customers in the fight against cancer. www.agilent.com

Our comprehensive portfolio of Dako reagents, instruments, software, and expertise helps hospitals and laboratories

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Protect your business & Gain value from your IPR investment Patentgruppen provides counselling on all matters of IPR (Intellectual Property Rights), i.e. on all matters relating to patents, utility models and designs. Patentgruppen wants to simplify the client’s ways to protect his business, products and innovation through a proactive and strategic approach to IPR. By working as a team, we will let you exploit our expertise both as regards IPR and technical knowledge.

Meet our Life Science Patent Attorneys, Lene Nørby Nielsen and Claudia Ulrich Hjørringggaard at our office in Copenhagen Bio Science Park

Patentgruppen A/S Ole Maaløes Vej 3, 2200 Copenhagen N +45 86192000 patent@patentgruppen.com

06-03-2020 13:25:09

Recombinant Factor C testing as a fulfilment of paradigms established

by Limulus amoebocyte lysate

By Kevin Williams, bioMerieux

T

he recombinant Factor C (rFC) assay has been developed to help alleviate the pressures of a growing demand for the Limulus amoebocyte lysate (LAL) assay. Here, given the recent pending recognition by the European Pharmacopoeia of rFC as a compendial test, the advantages of rFC testing will be explored, and a discussion of rFC as an extension of the LAL paradigms will be presented.

In November of 2019, the European Pharmacopoeia (Ph. Eur.) Commission adopted 13 new monographs and four new general chapters. Among the new chapters is Chapter 2.6.32, entitled “Test for bacterial endotoxins using recombinant factor C”. This will be published in the coming weeks in Ph. Eur. Supplement 10.3 and become available on the European Directorate for the Quality of Medicines (EDQM) website. The chapter will be effective at the start of next year (January 1, 2021). rFC testing will thus be a compendial test in Europe very soon. Tests for bacterial endotoxins using recombinant factor C will therefore not have to be validated per se, other than in consideration of their use for a specific substance or product in a specific analytical environment, which is referred to as a verification in USP terminology. USP <85>, for example, is a verification whereas USP <1225> is a full validation. rFC advantages: improvements on the LAL paradigm (or 3S’s to supplement the 3R’s) The advantages of the rFC test revolve around the most recent

paradigm: the difficulty associated with sustaining and improving modern endotoxin test methods in light of diminishing horseshoe crab populations. The rFC test is recognised as possessing several distinct advantages over the LAL assay, here referred to as the “3S’s”: (a) Scientific characterisation i. Reproducibility ii. Quality (b) Sustainability i. Availability (c) Specificity These advantages will be briefly discussed.

Scientific characterisation, reproducibility and quality The lack of characterisation of LAL has never been an acknowledged problem. However, LAL was used for a decade before an alternative activation mechanism was discovered (the Factor G pathway).

It was a shocking revelation at the time that materials other than endotoxin could activate the Limulus cascade to produce a positive reaction when little or no endotoxin was present. RFC consists of just the recombinant protein and a small fluorescent peptide, and thus no Factor G. The protein content of rFC can be measured to perfection whereas the proteins in LAL consist of at least eight different ones (Factor C, Factor B, proclotting ezyme, coagulogen, Factor G, and serine protease inhibitors 1, 2, and 3), including some proteins denatured through

processing, and it is likely that more unspecified proteins exist in LAL. The LAL formulation process that differs between LAL manufacturers contributes to the lack of scientific characterisation, as they are all different. Some LAL formulations are chloroform extracted, leaving denatured proteins (inhibitors) whereas some contain zwittergent (the concentration added can have a large effect on endotoxin detection levels ), and each LAL is paired with an LPS that is alternatively prepared (relative to RSE) and formulated with various excipients.

Characterisation suggests that one should know exactly what is contained in a product, which is impossible for LAL. There is some irony in the fact that current attempts to correlate a highly characterised material (rFC) with a less characterised material that is used as the gold standard, and that varies widely from supplier to supplier, is made difficult given the lack of specificity of LAL to endotoxin.

Classical LAL assays are sourced from horseshoe crabs and thus subject to underlying natural variability from lot to lot.

Production lot to lot, rFC has been shown to maintain its quality attributes in terms of standard curve values and obtained reaction parameters. The biotechnological production of rFC allows users to source a consistent product that is not subject to the variables of naturally harvested proteins. This is important for reproducible and reliable testing. Product variability that occurs with pooled batches

Roslansky and Novitsk, Sensitivity of Limulus amebocyte lysate (LAL) to LAL-reactive glucans, Jour. Clin Microbiol. 1991 Nov; 29(11): 2477–2483.

Cooper, Levin, Wagner. New rapid in vitro test for pyrogen in short-lived radiopharmaceuticals. Jour. Nuclear Med. 1970; 11:310.

1 3

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of harvested animals includes age, gender, size, environment, etc.

Global companies prefer uniformity and standardised platforms as applied across global supply chains.

Thus, a recombinant produced product can better meet these criteria. rFC is a product of biotechnology; thus, as opposed to being harvested from a sea creature that is undergoing survival pressures, it can be produced “at will” in cell culture. The genus Limulus is listed as “vulnerable” in the US and in Asia the genus Tachypleus is listed as “endangered” on the IUCN Red List (www.iucnredlist.org).

The global availability of LAL has to date been met with a supply chain that depends upon geographically isolated production and subsequent transatlantic or transpacific export from the US East Coast. On a smaller scale, the use of Tachypleus amebocyte lysate (TAL) produced locally in Asia, has also been used. The “at will” production of a recombinant reagent can help meet the logistical demands to support global supply chains. rFC is not licensed by the US Food and Drug Administration (FDA), as LAL has historically been, because it is not a blood derived product, and therefore more localised production of rFC may provide advantages in terms of pharmaceutical auditing and oversight of production quality.

Specificity If LAL was to be approved today it would have to contend with USP specificity requirements. In this regard it has been accepted, yet this should not be confused with an optimum situation. In contrast to rFC, LAL contains Factor G, which is the beta-glucan zymogen (biosensor for beta-glucan). Beta-glucan has been commonly found as a

breakdown product of cellulosic filters in drug manufacturing processes, as well as a ubiquitous contaminant of natural waters (lakes, rivers and sewers) as a byproduct of plant, algae and fungal growth. The activation of LAL by beta-glucans is referred to as a false positive as there is no beta-glucan standard in the endotoxin test. Even when masked with a beta-glucan blocking buffer (a high concentrated solution of beta-glucans), it has been shown to affect the variability of LAL assay results. Activity of LAL may also be affected by synergistic effects of small amounts of endotoxin, exaggerated by the presence of trace levels of betaglucans. The lack of false positive results from rFC testing removes a sometimes confounding element of LAL detection.

In recent years, many scientific studies have been published showing reliable detection of a wide variety of Gram-negative bacterial endotoxins using rFC-based assays.

In comparison, the performance of equivalency of the rFC and LAL methods has been demonstrated by many pharmaceutical users. Multiple pharmacopoeia are today beginning to include the rFC in their official texts.

In terms of validation requirements for pre-compendial comparison testing (though regulators have expressed the policy of accepting the pending compendial status that now applies to rFC), water from various natural sources including the Sea of Cortez, Japan’s Lake Biwa or the Bay of Bengal, for example, could be used. However, natural water may contain specific impurities from local flora that interfere with either rFC or LAL and should thus not be used for equivalence testing. Users should use purified water, as neither USP <85> or USP <1225> requires the testing of any water but that actually used as purified for drug manufacturing purposes. It would be exceedingly difficult to reproduce testing from uncharacterised water sources. rFC as a continuation of historical LAL paradigms Any envisioning of the future of testing contains elements extrapolated from the past. There are three main elements that predict a positive global outcome for rFC that require very little extrapolation: (i) The advent of biotechnology and the replacement of animal proteins

Naturally sourced waters such as those from lakes, rivers or sewage should not be used for comparison purposes in testing rFC versus LAL. For pharmaceutical water testing, purified water spiked with endotoxin (natural or standard) is used for equivalence testing (rFC vs.

LAL). The potential contaminants from purified water systems have been shown to come from biofilm rather than passed through from natural sources which are uncharacterised and expected to contain beta-glucans.

Kevin Williams has spent 30 years at Eli Lilly & Company developing endotoxin assays and detection technology in the QC lab. After retiring from Lilly he has worked at Hospira (now Pfizer), Lonza, GE Water, and now bioMerieux. He has authored several books on endotoxin (Endotoxins 2nd and 3rd ed.-Informa) including, most recently “Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems” (2019, Springer Nature). He is a frequent speaker at endotoxin related industry events.

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“Each paradigm change has aided the pharmaceutical industry by helping make product contamination events very rare" via the cloning of the necessary animal genes (insulin, growth hormone, etc.) and production in bioreactors via single-celled organisms has given us advanced medicines and cures for many diseases and thus serves as a successful paradigm for replacement. (ii) The specificity, sensitivity and expanded utility of using rFC methods has been repeatedly demonstrated. The paradigm change of testing a coagulation output (Limulus) versus an original fever output (rabbit pyrogen) was a much bigger change than changing from a natural to recombinant protein version where both are inherent coagulation measures. Note that the horseshoe crab has no fever reaction and the assumption that fever reaction equals coagulation reaction is seldom discussed. For practical purposes of contaminant detection the two are accepted as synonymous. (iii) The continued use of horseshoe crabs as harvested from limited geographical locations is not sustainable, and pharmaceutical manufacturers will want to prepare for such a change.

It is important to view rFC as a continuation of the LAL testing paradigm Since the initial exploratory use of LAL for radiopharmaceutical testing, the past 50 years have established several widespread paradigms that will be enhanced by rFC testing, including: (a) The use of the LAL test to supplant the rabbit pyrogen test (RPT) as a method of precluding fever reactions in patients subject to injectable drug treatments.

The detection of “all pyrogens” was not a particularly sensitive or relevant target for injectable 4

drugs as drugs are a product of water-based manufacturing where GNB are the predominant contaminant. (b) Initially, quality control consisted of the end-product testing of finished drugs only.

With the advent of a convenient in vitro test, LAL has rapidly taken over the task of testing; over the years testing has expanded from end-point only to raw material, in-process, purified waters as well as end-point release testing. The increased test coverage of the entire manufacturing process has brought about a vast increase in the microbiological safety of drug products. (c) The rise of test volume (both domestically and globally) has been paralleled by the demise in the reagent source. Horseshoe crabs on the US Eastern Seaboard (Limulus) are listed as “vulnerable” and those in Asia (Tachypleus) are now listed as officially “endangered”. While most agree that biomedical bleeding has not been the cause of such a demise, industry must still contend with the fact that sustainable methods are needed to replace LAL testing. (d) More recently the advent of “ease of use” testing has greatly benefited users. The LAL test began as a fairly user-intensive effort that included manually inverting reaction tubes for gel clot testing and has transitioned to, first, semi-automated kinetic testing where absorbance is monitored over time without further user intervention, and finally, to configurations in which test standards and reagents are combined in a single prepackaged unit (cartridge and precoated

plate testing). There are already “ease of use” improvements in the rFC assay, including pre-spiked plates (Go Plate®, bioMerieux).

Each paradigm change has aided the pharmaceutical industry by helping make product contamination events very rare. Today, there is an expectation that, for sustainability reasons, global pharmaceutical companies should explore the use of rFC in routine testing of purified water, raw materials and components as well as finished drug products.

The US FDA has been receptive to such a change, as seen in the recent approval (2019) of the first drug to be released using rFC testing. Many global companies also continue to pursue raw material, water and component testing as well as finished product testing using rFC. There are some in the industry who worry about the legacy of LAL; however, the uptake of recombinant methods should be viewed as a fulfilment of that legacy rather than an affront to it, just as the change from animal-sourced medicinal proteins, such as recombinant human insulin, was not an affront to early efforts (animal-derived insulin) to treat disease. Indeed, the biotechnological revolution is a direct response to the recognised utility of natural proteins. There are also some who would delay and defer the development of approved rFC methods for commercial purposes with the intent of continuing the regulated monopoly that now exists on Limulus harvesting. This is imprudent as it places the entire supply chain of medicinal products at risk. When the final horseshoe crab is bled and there is no more supply from which to make LAL, what will the detractors of rFC propose then?

Endotoxin-like reactions associated with intravenous gentamicin- California, Morb. Mortal. Weekly Report, 1998, 47(41); p. 877-880.

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We Translate Science into Treatment Clinical Trial Consultants AB is a full-service CRO with focus on Phase 0-IIa studies and innovative techniques. In contrast to many other CROs, CTC provides in-house clinical conduct at our First-in-Human (FIH) and Phase 0-IV research units in Sweden.

We perform approximately 5 FIH studies a year.

CTC was founded in 2011 and has successfully performed 260+ industry-sponsored clinical trials for start-up companies as well as for international pharmaceutical companies and CROs. Besides FIH studies with single and multiple ascending dose parts, our track record includes food effect, drug interaction, bioequivalence, bioavailability, microdose and biosimilar studies, new drug delivery systems, ATMP, medical device, PET/MRI and expert precision QT studies.

Biometrics, all supported by independent quality assurance management.

Our mission is to facilitate clinical and translational research by providing our customers with cost-effective advice, conduct and reporting of clinical trials. We have four different departments contributing to our full-service offering: Clinical Research Units, Clinical Operations, Pharmacovigilance and

Our scientific experts with extensive experience from drug development aim to build maximum value in the first studies of your candidate drug. They will suggest a tailor-made design of your early phase study based on a compilation of preclinical data for allometric scaling and prediction of human

We have in-house medical experts, including in-house Principal Investigators, and a close collaboration with consultant physicians at Uppsala University Hospital who cover most therapeutic areas. We offer counselling in various medical areas, ranging from intensive care and plastic surgery to gastroenterology and cardiology.

PKPD properties, a thorough risk assessment and an in-depth consideration of the study objectives and endpoints.

CTC has experience in setting up adaptive FIH umbrella protocols including single and multiple ascending dose cohorts, food and drug-drug interaction parts, and patient cohorts. Regardless of the complexity of the study, safety is always the key focus.

ctc-ab.se

ProPharma Group Complex challenges.

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ProPharma Group is your global life science consultancy company with a strong Nordic presence. We offer EMA, FDA, and local Health Authority support with global pharmacovigilance and compliance services, through one organization. From concept development to commercialization, and any point in between, we partner with pharmaceutical, biotechnology, and medical device clients to tackle their complex business challenges, helping to ensure regulatory expectations are met, business goals are achieved, and patient health and safety are improved. www.ProPharmaGroup.com

LAB AUTOMATION

UNILABS INCREASED PRODUCTIVITY BY 40% WITH LAB AUTOMATION At Unilabs in Copenhagen, blood samples from sclerosis patients from all over the world are being screened for antibodies against a virus, and the results are being used for diagnostic analysis.

“Every day we screen a minimum of 470 samples from patients. For this we use the pipetting robot flowbot ONE of which we have five in our laboratory. In a specific pattern, the robots dilute the samples and dispenses them onto microtiterplates. The process for one assessment takes a little less than 30 minutes and we are completing 10-12 assessments every day. It’s an improvement of 40% more samples screened,” says Dana Svraka, Medical Laboratory Technologist at Unilabs, Copenhagen.

Being an international company, Unilabs performs diagnostic services in large scale, with more than 120,000 cases of pathology diagnostic services, 3.8 million imaging examinations and 195 million analyses made annually, in more than 250 laboratories spread globally.

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Unilabs provides diagnostic services to different patient groups.

For Unilabs in Copenhagen, the implementation of five flowbot ONE robots in their workflow resulted in significantly shorter turnaround time for incoming patient samples.

Dana Svraka is enthusiastic about this efficiency improvement: “Now, the sclerosis patients get answers 30% faster than before. The time from we start the tests until we can conclude on results has been significantly shortened and it is really satisfying to me. We could not have done this without the flowbots.”

Prior to automating their screening process, they had some concerns regarding training and the general use of pipetting robots. “We were a little concerned about losing the manual know-how of pipetting. But the bottom line is that our lab team still fully controls the pipetting, only now we avoid aching hands and shoulders due to locked work positions and repetitive procedures.

This is really important to us.”

It took little effort for the laboratory technologist at Unilabs to become familiar with flowbot ONE. The Danish company Flow Robotics has designed flowbot ONE to be intuitive for new users. “We are really happy with how user-friendly flowbot ONE is. You quickly get started in the morning - a push on the button and it is ready to start running the predefined programs,” describes Dana Svraka, “It’s great that you don’t have to learn a lot of new procedures. It’s simple to use since you can setup programs with a few clicks, and everyone in our lab understood how to use it right away.”

“We are happy that we decided to automate our dilution series with flowbot ONE. We have increased our productivity, reduced injuries and, in the bigger picture, we give the answers of the samples quicker, so that medical staff can provide the right care for the patients sooner,” concludes Dana Svraka, and returns to the lab, where one robot already finished a run and is ready for the next batch of samples.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

©2020 bioMérieux, Inc. • BIOMERIEUX a nd the BIOMERIEUX logo and ENDONEXT, ENDOZYME and GOPLATE are used pending and/or registered trademarks belonging to bioMérieux, or one of its subsidiaries, or one of its companies Patents: www.biomerieux-usa.com/ pate nts • PRN 18-0375-00

WE’RE MAKING ENDOTOXIN TESTING FASTER, EASIER AND ECOLOGICALLY FRIENDLY.

Rapid ENDOZYME® II GO is the latest member of bioMérieux’s ENDONEXT™ range of endotoxin detection assays based on recombinant horseshoe crab Factor C (rFC).

Not only does ENDOZYME II GO eliminate the need to harvest horseshoe crab blood, it ushers in a new era of smarter, more efficient quality control testing. ENDOZYME II GO features GOPLATE™, an innovative microplate pre-loaded with required Control Standard Endotoxin (CSE) for standard curves and internal controls: • Less processing time - over 50% time-saving compared to conventional kinetic chromogenic LAL • Provides exceptional accuracy, precision and 100% endotoxin-specificity • Significant reduction of invalid results and OOS biomerieux-industry.com/Endotoxin

Nyborg & Rørdam har lang erfaring med rådgivning til virksomheder indenfor life science og biotech. Vores rådgivning fokuserer på resultatorienterede og praktisk anvendelige løsninger, der bygger på et indgående kendskab til branchens strategiske og kommercielle forhold samt forretningsmodellen hos det enkelte selskab. Vi lægger vægt på at opbygge tætte og tillidsfulde relationer til vores klienter. Vi rådgiver blandt andet om:

Etablering og opstart af nye virksomheder Tilførsel af ny kapital og finansiering af drift Fusion, opkøb og salg / exit Aktieincitamentsprogrammer Licens-, forsknings- og udviklingsaftaler Persondata Skat - selskabs- og personbeskatning Læs mere på www.nrlaw.dk

DATA AND ACCESSIBILITY ARE ESSENTIAL TO MODERN LABORATORIES A newly developed mobile platform seeks to revolutionise the way users interact with data.

The platform – developed by LabWare and naturally named LabWare Mobile - is a configurable application that builds on 30+ years of development and runs natively on any device. It allows users to easily connect to their existing LabWare systems, see their data and perform customer-defined tasks.

Security features apply throughout the platform, making it easy for administrators and end users alike to get the data they need, whether optimising an existing process or creating an entirely new workflow.

The power of configuration LabWare Mobile fully integrates with the LabWare LIMS/ELN platform and utilises the same, proven configuration tools that have made LabWare the lab informatics market leader for over 20 years.

This groundbreaking technology places the power of app development into the hands of LabWare administrators without the need for mobile-specific programming skills. LabWare Mobile can be configured to match specific business workflows, and can interact with anything in the LabWare LIMS system: samples, standards and reagents, instrument calibration and maintenance, clinical patients and more. This extensible, robust approach allows Android and iOS users to leverage the same configuration.

LabWare Mobile: Examples of Tasks

Sample Locations, Result Trends and more

Updating instruments, patients, etc.

Reports and statistics can be viewed on a phone

Native device application Unlike some mobile apps that render via device web-browsers, LabWare Mobile is a native application that harnesses the true power of the device and utilises device-specific capabilities. This makes it easy for users to locate samples with GPS, dictate notes, read barcodes and even take photos, whether in the field or the laboratory.

Accessibility LabWare Mobile works within the traditional laboratory, as well as making it easier for nonlaboratory users to perform mobile tasks. It can be downloaded from the Apple App Store or Google Play Store, and devices are easily managed with the new LabWare Device Registration Manager. This feature allows the customer to register, use and update any device that will access LabWare Mobile for their company.

The app allows you to enter and access data whenever you want and wherever you are.

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LabWare Mobile features include: • • • • • •

Over 300 device commands plus access to 500+ server-based commands Native device controls (dictation, autocorrect, date spinners, etc.)

Camera photos and barcode scanning, including QRcodes GPS/Location Services and Mapping app interfaces Available on Android and iOS devices Compatibly with new and existing LabWare systems

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

INTRODUCING NEW 3D IMAGING CAPABILITIES WITH WATER IMMERSION TECHNOLOGY Scientists can now capture greater physiologically-relevant phenotypic data for 3D and thick tissue samples, improving workflow.

Molecular Devices, a leading provider of highperformance instruments and software for life science applications, recently introduced a new automated water immersion imaging technology for their ImageXpress® Micro Confocal High-Content Imaging System. This innovative technology builds on the company’s existing 3D cell imaging capabilities and will enable both acquisition and analysis of 3D cell model assays such as spheroids, organoids, and organ-on-a-chip biology.

Scientists often experience difficulties screening complex models and obtaining better data quality.

With water immersion objectives on the ImageXpress Micro Confocal system, they can increase signal up to four times, improve z-resolution, and decrease optical aberrations for sharper, crisper images.

To address 3D image analysis workflow challenges, Molecular Devices MetaXpress® 3D analysis software module enables scientists to generate greater phenotypic data within a single interface without compromising throughput or data quality, giving scientists confidence in their discoveries.

Angiogenesis in 3D: culture of human umbilical vein endothelial cells (HUVEC) forming angiogenic sprouts in the OrganoPlate®3-lane. PHOTO: MIMETAS B.V.

“We’re excited to invest in innovative technologies that build on our recent capabilities and address 3D imaging challenges for our customers,” said Susan Murphy, President of Molecular Devices. “ By integrating robotics and incubation, we are able to provide a fully automated workflow for high-throughput organoid screening that helps deliver drugs to market faster.”

Molecular Devices continues to lead the cellular imaging community towards new discoveries utilizing a comprehensive portfolio of powerful yet easy-to-use high-content imaging systems.

For more information, please visit moleculardevices.com/water

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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Looking forward to the largest Nordic partnering conference in 2020 The Nordic conference, Nordic Life Science Days 2020, offers conference super sessions, seminars, company presentations, exhibition, face-to-face meetings and unique receptions, providing so many opportunities to network with peers, potential partners and investors.

Nordic Life Science Days (NLSDays) is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, and providing inputs and content on the most recent trends. NLSDays attracts leading decision makers from the Life Science sector, not only from Biotech, Pharma, and HealthTech, but also from finances, research, policy, and regulatory authorities.

Based on cutting-edge and advanced partnering and networking tools, NLSDays showcases the best the Nordic region has to offer.

Network with peers, potential partners and investors The Nordic region is proud to host some of the world’s most innovative biotech, medtech and pharma companies. It also has the 12th strongest economy, making it the perfect place to invest. Set in the vibrant Malmö-Copenhagen region, the conference offers conference super sessions, seminars, company presentations, exhibition, face-to-face meetings and unique receptions, providing so many opportunities to network with peers, potential partners and investors.

The 2020 conference design will feature a new exhibition layout creating more interactions with the exhibitors, an enriched program featuring a first Nordic Life Science Investment Day (by invitation only), 8 Super Sessions, 4 fireside chats, the Nordic Life Science

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Awards, selected 6mn and 15mn company presentations, partnering areas allowing more comfort and privacy, extended informal networking opportunities.

Partnering at NLSDays is powered by One-on-One the leading BIO conference solution for helping Life Science delegates meet efficiently and effectively. Oneon-One has the unique ability to manage the complex interactions among thousands of executives from many different companies. This sophisticated web-based partnering system enables delegates to screen potential partners, pre-arrange meetings and manage the entire conference partnering process. Delegates can log in and connect with the conference community, anytime, anywhere.

Will take place in Malmö on September 9-10 Based on attendance at previous events, NLSDays 2020 is expecting 1300+ international delegates.

Highlights from NLSDays 2019 • • • •

1200+ participants 40+ countries 780+ companies/organizations 2800+ scheduled face-to-face meetings

For more visit www.nlsdays.com

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

Life science events in 2020 Global Engage meetings are at the forefront of life science and health research. With internationally renowned speakers from academia, industry and finance sectors, our conferences cover cutting-edge advances in genomics and personalised medicine, drug discovery, human health and technology, as well as commercialisation strategies.

To find out more about our events, visit: www.global-engage.com/#upcoming-conferences

3RD GLOBAL BIOPROCESSING, BIOANALYTICS & ATMP MANUFACTURING CONGRESS 18-19 MAY 2020 DUBLIN, IRELAND

MICROBIOME & PROBIOTICS R&D & BUSINESS COLLABORATION FORUM 18-20 MAY 2020 ROTTERDAM, THE NETHERLANDS

6TH DIGITAL PATHOLOGY & AI CONGRESS 25-26 JUNE 2020: NEW YORK, USA 2-3 DECEMBER 2020: LONDON, UK

5TH MEDICINAL CHEMISTRY & PROTEIN DEGRADATION SUMMIT 16-17 NOVEMBER 2020 LONDON, UK 4TH PHARMA R&D INFORMATICS & AI SUMMIT 16-17 NOVEMBER 2020 LONDON, UK

@lifesciences_GE

IDENTIFY. PREDICT. ACT.

hsTnI Physician Pathway

A STEP BY STEP PHYSICIAN GUIDE TO HELP MORE ACCURATELY IDENTIFY PATIENTS THAT MAY BE AT RISK OF A FUTURE CARDIAC EVENT. TM

Join the HeartAsure movement by adding Abbott’s High Sensitive Troponin-I cardiac specific blood test to your patient’s health check. And help change lives.

CHOOSE TRANSFORMATIONTM

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

High Sensitive Troponin-I for use in Asymptomatic Patients Abbott’s High Sensitive Troponin-I is a cardiac specific blood test, the first CE marked cardiac specific biomarker for risk stratification of the apparently healthy population. Abbott’s high sensitive Troponin-I may be used, in conjunction with clinical and diagnostic findings, to aid in stratifying the risk of cardiovascular disease, including cardiovascular death, Myocardial Infarction (MI), coronary revascularization, heart failure, or ischemic stroke in asymptomatic individuals.1 Abbott’s High Sensitive Troponin-I blood test is a tool for use by physicians to more accurately predict among asymptomatic individuals who is likely to be at low, moderate or elevated risk for future adverse cardiac events. It allows prioritization of care for those at higher risk to help prevent adverse outcomes, and potentially avoid unnecessary investigations and treatments in those at lower risk.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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Abbottâ&#x20AC;&#x2122;s hsTnI Physician Pathway By offering your patients a cardiac specific biomarker that is a direct signal from the heart, you can help motivate them to strive for better heart health.

S TE P 1 PATIENT BLOOD DRAW S TE P 7 DISCUSSION WITH PATIENT ON LIFESTYLE & MEDICATIONS

S TE P 2 PHYSICIAN SENDS SAMPLES TO THE LAB

PHYSICIAN PATHWAY S TE P 6 PHYSICIAN APPLIES CLINICAL JUDGEMENT

S TE P 4 S TE P 5 RESULT GOES FROM LAB TO PHYSICIAN

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S TE P 3 TROPONIN RESULT IS GENERATED

RESULT IS APPLIED TO RISK STRATIFICATION TABLE

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

RISK STRATIFICATION OF ASYMPTOMATIC INDIVIDUALS Various CV risk prediction models are currently available. Most CV risk prediction models estimate CV risk by taking into account the presence of CV risk factors. This method of stratifying CV risk poses challenges in their applicability in the local setting, especially between patients of different ethnicities.2,3 Furthermore, the various models each have specific limitations, such as applicability only in certain populations and the ability to measure only a limited number of CV outcomes.

How does hsTnI risk stratification compare with the current tools used by the physicians?

The current tools like Framingham 2008 and SCORE (ESC) involve measures that are not specific to the heart and are heavily dependent on age which may not necessarily provide the true cardiac risk status of a patient. Since Troponin-I is specific to the heart, it can more accurately categorize patients’ risk compared to the above-mentioned tools, as demonstrated in several publications, when used in conjunction with clinical and diagnostic findings.4-8

LIMITATIONS OF VARIOUS CV RISK SCORING SYSTEMS RISK SCORING SYSTEM

LIMITATIONS

European SCORE risk chart2

• Estimates only fatal CV risk • May not be applicable in non-European populations • Limited to the major determinants of risk • Limited to age range (40-65 years)

ASCVD risk score calculator (AHA/ACC)

• May overestimate CV risk in both men and women.3

Framingham Risk Score10

• May overestimate CV risk in both men and women.9

• Was inferior to the Framingham Risk Score in identifying high CV risk individuals when evaluated in Asian population.9

• May not be accurate in those with markedly elevated risk factors (e.g. those with markedly elevated LDL levels).7

Compared to above mentioned tools, Abbott hsTnI more accurately categorizes a patient into low, moderate or elevated risk categories when used in conjunction with clinical and diagnostic findings.4-8

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What do you do with the hsTnI risk stratification results?

1. Abbott’s hsTnI results are to be reported in the same way as the current hsTnI results.

2. Then, results should be applied to the risk stratification table as shown below (Risk Stratification of Asymptomatic Individuals).

3. Identify the risk categories (low/moderate/elevated) with the corresponding Troponin-I level.

An accompanying statement interpreting these results, may be provided.

• It is critical to evaluate Troponin-I concentrations within the clinical context of all supporting parameters, including all classical cardiovascular risk factors (blood pressure, lipids, smoking, diabetes, family history) and all clinical and diagnostic findings.

• Any condition resulting in myocardial injury can potentially increase cardiac Troponin-I levels.11

Risk Stratification of Asymptomatic Individuals: The following cut-off points may be used to aid in stratifying the risk of cardiovascular disease in asymptomatic individuals.1

TROPONIN LEVEL RISK

MALE (pg/mL)

FEMALE (pg/mL)

LOW

<6

<4

MODERATE

≥ 6 – ≤ 12

≥ 4 – ≤ 10

ELEVATED

> 12

> 10

4. Healthcare providers should use clinical judgement and follow their recommended cardiovascular prevention guidelines to determine the standard of care based upon their patients’ level of risk.

For example, if a patient falls into a low-moderate risk category, and the clinician is following 2016 European Guidelines on Cardiovascular Disease Prevention in clinical practice, section 2.3.5 offers guidance on apparently healthy people, and recommends “offering lifestyle advice to maintain their low-moderate risk status” using SCORE tables.2

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To implement Cardiac Risk Stratification of the Apparently Healthy Population using Abbott’s High Sensitive Troponin-I in your practice please contact your local Abbott Diagnostics representative.

For more information go to www.corelaboratory.abbott See “Offerings,” then scroll to “Solutions by Segment” and select “Cardiac”.

TM

Join the Abbott’s High Sensitive Troponin-I movement by adding Abbott’s High Sensitive Troponin-I cardiac specific blood test to your patient’s health check. And help change lives.

REFERENCES 1.

ARCHITECT STAT High Sensitive Troponin-I Package Insert 2. Piepoli MF, et al. Eur Heart J 2016;37:2315–2381.

3. DeFilippis AP, et al. Ann Intern Med. 2015;162(4):266-75.

4. Sigurdardottir FD, et al. Am J Cardiol 2018;121(8):949 – 955.

5. Ford I, et al. J Am Coll Cardiol. 2016 Dec 27;68(25):2719-2728.

6. Blankenberg S, et al. Eur Heart J. 2016 Aug 7;37(30):2428-37.

7.

Everett BM, et al. Circulation. 2015 May 26;131(21):1851-60.

8. Omland T, et al. Clin Chem. 2015 Apr;61(4):646-56.

9. Garg N, et al. Indian Heart J. 2017;69(4):458-463.

10. Blom DJ. S Afr Fam Pract 2011;53(2):121-128 11. Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial infarction. Eur Heart J 2012;33(20):2551-2567.

ABBOTTDIAGNOSTICS.COM © 2019 Abbott Laboratories. ADD-00067020

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COMPANY INDEX

INDEX

78 | Academic Institutions and Support Structure Organisations 80 | Contract Research Organisations 82 | Contract Manufacturing Organisations 82 | Business Service Providers 86 | Laboratory, Medical & Pharmaceutical Suppliers

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COMPANY INDEX

Rapid ENDOZYME® II GO is the latest member of bioMérieux’s ENDONEXT™ range of endotoxin detection assays based on recombinant horseshoe crab Factor C (rFC).

Not only does ENDOZYME II GO eliminate the need to harvest horseshoe crab blood, it ushers in a new era of smarter, more efficient quality control testing. ENDOZYME II GO features GOPLATE™, an innovative microplate pre-loaded with required Control Standard Endotoxin (CSE) for standard curves and internal controls: bioMérieux Europe, Middle East, Africa North- and South America, Asia, Oceania W: www.biomerieux.com

ExpreS2ion Biotechnologies Agern Allé 1 DK-2970 Hørsholm T: (+45) 2222 1019 E: info@expres2ionbio.com W: www.expres2ionbio.com

Mercodia Sylveniusgatan 8A SE-754 50, Uppsala T: +46 18 57 00 70 E: services@mercodia.com W: www.mercodia.com

• Less processing time - over 50% time-saving compared to conventional kinetic chromogenic LAL • Provides exceptional accuracy, precision and 100% endotoxin-specificity • Significant reduction of invalid results and OOS

ExpreS2ion Biotechnologies is a Denmark-based biotech company focusing on new vaccines and immunotherapy products. The company has a discovery platform, ExpreS2 TM, made especially for fast, efficient production of complex proteins required for innovative vaccines, immunotherapy and diagnostics. ExpreS2 is CMC-fit and regulatory validated for clinical supply. ExpreS2 also includes functionally modified glycosylation variants of the ExpreS2 cell line.

ExpreS2ion co-owns a novel plug-&-play virus-like particle (VLP) platform through AdaptVac, a joint venture founded in 2017 targeting a.o. cancer and cardiovascular diseases.

ExpreS2ion is publicly listed on NASDAQ First North Stockholm through ExpreS2ion Biotech Holding AB (Ticker: EXPRS2).

Mercodia is a company focused on bioanalysis that was established in 1991. Through its long-standing expertise in measurement quality and life cycle management, Mercodia has become an appreciated bioanalytical service provider. The company offers high-class bioanalytical services for large molecule and ligand binding assays (LBAs). With over 100 years of combined experience in immunoassay development, validation, production and sample analysis, it can guide and support clients from exploratory research to clinical studies. The company’s flexibility allows it to tailor assays or specific runs to the client’s needs, while maintaining the highest quality standards.

Scandion Oncology is a Danish Biotech Company listed on the Swedish Stock Market Spotlight (SCOL).

In 2018, 43 Danes died every day from cancer and most of these lethal outcomes were due to the cancer cells developing resistance to the anti-cancer drugs used. Scandion Oncology’s mission is to introduce novel and innovative drugs that combat anti-cancer drug resistance and thereby increase survival of cancer patients.

Scandion Oncology Nils Brünner, MD, DMSc CEO T: +45 26144708 E: nb@scandiononcology.com W: www.scandiononcology.com We offer you a modern, pilot-scale test bed for commercial, research and educational projects in production of biological products e.g. monoclonal antibodies, recombinant proteins, vaccines and viral vectors, in mammalian or microbial (non-GMP, up to Bio-safety level 2 and 500 liter).

Testa Center Björkgatan 30 SE-75323 Uppsala, Sweden T: +46 (0)18 612 0000 E: contact@testacenter.com W: www.testacenter.com

In our flexible facility, and with some helping hands of our experienced staff, you can perform a wide variety of projects, including process development of cultivation, clarification, and purification or scaleup of a complete process from frozen cell bank vial to purified protein.

We serve companies, institutes and academia worldwide.

Testa Center is a non-profit company by GE Healthcare. Co-founded in 2018 by the Swedish agency for innovation, Vinnova, for the growth of the life science industry and its manufacturing capabilities.

We partner with the best in their fields to deliver better patient care.

Zealand Pharma is a biotechnology company focused on the discovery and development of innovative peptide therapeutics. We are advancing medicines for specialty gastrointenstinal and metabolic diseases, with several late-stage Phase 3 programs and potential to launch into major markets beginning in 2021.

Zealand Pharma T: +45 8877 3600 E: info@zealandpharma.com W: www.zealandpharma.com

Partner with us to change the lives of people living with severe unmet medical needs.

Connect with us at partnering@zealandpharma.com, or find out more at www.zealandpharma.com.

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COMPANY INDEX

Academic Institutions and Support Structure Organisations Atrium is a living, dynamic space where life lcience professionals come to learn, connect and network.

Atrium is a place rich in tradition, insights and inspiration – an environment where opinions and knowledge are shared. We’re passionate about offering valuable learning experiences that help you advance professionally.

Atrium Lersø Parkallé 101 DK-2100 Copenhagen T: +45 39 27 60 60 W: www.atriumcph.com

Copenhagen Capacity is the official organisation for investment promotion and economic development in Greater Copenhagen. The organisation supports foreign companies, investors and talent in identifying and capitalising on business opportunities in Greater Copenhagen - from initial considerations to final establishment.

Copenhagen Capacity is the leading expert on developing and implementing business opportunities in Greater Copenhagen.

Copenhagen Capacity Nørregade 7B DK-1165 Copenhagen T: +45 3322 0222 E: info@copcap.com W: www.copcap.com

Copenhagen Capacity’s services are free of charge for all foreign-owned companies, who want to establish or invest in Greater Copenhagen, and provided in full confidentiality.

DiaLab is the Danish Trade Association for companies engaged in the trade and/or production of products used by laboratories.

The laboratory sector includes hospital laboratories and research laboratories - both public and private practitioners and laboratories in a number of other sectors including pharma, food, environmental sector and Biotech.

The association is a member of Dansk Erhverv (The Danish Chamber of Commerce) and works to strengthen the member companies’ competences within ethics, environment and CSR and raise industry standards in general.

DiaLab For more information, Visit www.dialab.dk

DTU Science Park is Denmark’s leading community for deep tech companies.

We are the place where new standards are set, and the future is built. We create a space where deep tech ideas are developed and shaped, so they can be realized more quickly and turned into business.

We assume the responsibility in boosting the connections between the companies who choose to be part of DTU Science Park, as we believe that close connections pave the way from science to business.

DTU Science Park A/S Agern Allé 24 DK-2970 Hørsholm T: +45 29 26 12 22 E: sh@dtusciencepark.dk W: www.dtusciencepark.com

DTU Science Park is made up of 290 companies and more than 4.000 employees who work side by side nurturing each other, because all recognize the value of collaboration and knowledge sharing.

Our deep tech community takes your company to the next level.

INNO-X Healthcare offers courses and continuing education programs based on need-driven innovation.

A common feature of the courses is that we want to sharpen participants' ability to integrate innovation as a natural part of their work. Thus, we give the participants qualified to create and develop innovative solutions to existing needs in the health sector.

INNO-X Healthcare Aarhus University, Department of Clinical Medicine Hedeager 3, DNU 03 8200, Aarhus N Tel. +45 4041 2536 E-mail: Info@innox.dk Web: www.innox.au.dk

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COMPANY INDEX

Faculty of Health and Medical Sciences University of Copenhagen Blegdamsvej 3b 2200 Copenhagen N Tel. +45 3532 7900 E-mail: email@sund.ku.dk Web: www.healthsciences.ku.dk

The Faculty of Health and Medical Sciences is an important part of a dynamic interaction with the surrounding community. The purpose of this interaction is to use our knowledge to create value for citizens and improve general health. For this reason, our core task is to educate talented students who can go on after their graduation to devote their strong skills to their working lives. The faculty constantly discovers valuable new insights that can contribute to growth and employment in the community.

Lundbeckfonden awards anually the 1 mio. € Brain Prize. Lundbeckfonden is an active industrial foundation established in 1954. Its main objective is to maintain and expand the activities of the Lundbeck Group, and to provide funding for scientific research of the highest quality. The Foundation annually grants DKK 400 - 500 million to support medical research of the highest quality and supports educational and communication activities related to science.

Lundbeckfonden, The Brain Prize Scherfigsvej 7 DK-2100 Copenhagen Ø Tel. +45 3912 8000 E-mail: info@thebrainprize.org Web: www.thebrainprize.org

Medicon Valley Alliance Arne Jacobsens Allé 15, 2. Ørestad City DK-2300 Copenhagen S Phone: +45 70 20 15 03 Email: mva@mva.org www.mva.org

Pharmakon Milnersvej 42 DK-3400 Hillerød T: +45 48 20 60 00 E: info@pharmakon.dk W: www.pharmakon.dk

Welfare Tech Forskerparken 10 H DK - 5230 Odense M And: SOHO, Flæsketorvet 68 DK - 1711 København V T: +45 3177 8078 E: info@welfaretech.dk W: www.welfaretech.dk

Medicon Valley Alliance (MVA) is a non-profit membership organization in the Danish-Swedish life science cluster Medicon Valley. Our approx. 230 members, who together employ approximately 140.000 people, represents the region’s triple helix and include universities, hospitals, human life science business, regional governments and service providers. We create value for our members by co-hosting, launching and driving meetings, working groups, seminars, conferences and projects, that strengthen the collaboration, networking and knowledge-sharing in the regions life science community, create critical mass and help realizing the full potential of Medicon Valley.

Pharmakon is based in the city of Hillerød in the Greater Copenhagen region. Offering more than 200 life science related courses each year, most of which are offered in Danish, but there are also courses conducted in English. Some of the courses offered are: - Pharmacovigilance – An Introduction - Stability Documentation - Quality Oversight - Regulatory Life Cycle Management - Brexit in a Regulatory Perspective For more courses, further information and enrolment, visit www.pharmakon.dk

Welfare Tech is the largest Danish member-based cluster organisation for health and welfare technology with members representing small entrepreneurs and large private companies, public organisations, municipalities, regions and leading research and educational institutions.

Welfare Tech acts as a catalyst for business development and innovation in partnership with the actors within the sector.

The goal is to accelerate the development and introduction of new health and welfare technology products and services and pave the way for better public services, higher quality of life and higher efficiency in society.

Welfare Tech is a Gold Label cluster under the European Commission’s quality assurance system.

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COMPANY INDEX

Contract Research Organisations

A+ Science AB Luntmakargatan 22 111 37 Stockholm SWEDEN T: +46 (0)73 67 441 22 F: +46 (0)8 564 352 60 E: info@a-plusscience.com W: www.a-plusscience.com

ChemPartner Europe 2 Kogle Allé DK-2970 Horsholm T: +45 4586 9000 E: europe@chempartner.com W: www.chempartner.com

Clinical Trial Consultants AB / CTC Dag Hammarskjölds väg 10B Uppsala, Sweden T: +46 18-30 33 00 E: rfp@ctc-ab.se W: www.ctc-ab.se

CroxxMed ApS Agern Allé 24 DK-2970 Hørsholm Mobile: +45 2015 1221 E-mail: bte@croxxmed.com Web: www.croxxmed.com

A+ Science is a Contract Research Organization (CRO) run by its employees. We provide services in clinical trials for pharmaceuticals (phase I-IV) and medical devices. We also offer broad expertise in pharmacovigilance services during clinical trials and post marketing.

Our core expertise is in the Nordic countries, however through our close collaboration with CRO partners, we cover several other countries. We offer customized, flexible and cost-efficient solutions to our clients.

Earn Trust- Make Difference.

ChemPartner is a world-class Contract Research Organization (CRO/CDMO) with exceptional scientists and experienced leaders. The company’s extensive services offering includes discovery chemistry, biology and pharmacology, biologics discovery, DMPK, and exploratory toxicology as well as small and large molecule CMC. As more and more pharmaceutical and biotech companies look for alliance partners to provide intellectual contributions and exceptional technical expertise, ChemPartner is uniquely positioned to not only be a CRO/CDMO but be a true pharmaceutical alliance partner. ChemPartner serves a diverse global client base with laboratories, business offices, and representatives in the US, Europe, China, and Japan.

Clinical Trial Consultants AB is a full-service CRO with focus on Phase 0-IIa studies and innovative techniques. In contrast to many other CROs, CTC provides in-house clinical conduct at our First-in-Human (FIH) and Phase 0-IV research units in Sweden.

CTC was founded in 2011 and has successfully performed 260+ industry-sponsored clinical trials for start-up companies as well as for international pharmaceutical companies and CROs. Besides FIH studies with single and multiple ascending dose parts, our track record includes food effect, drug interaction, bioequivalence, bioavailability, microdose and biosimilar studies, new drug delivery systems, ATMP, medical device, PET/MRI and expert precision QT studies.

At CroxxMed we are a team of experienced personnel striving to make your experience as smooth as possible. Nordic by nature, we provide complex knowledge built on a solid foundation of years in clinical research within many different therapeutic areas. CroxxMed offers services in all phases (I-IV); clinical operation, regulatory affairs, data management, statistics, medical writing, pharmacovigilance, and consulting services for all types of medical device studies. We are at all times updated on the market. At any time, fully in tune with the regulatory requirements and trends in the industry. We are less boring than average and you are our top priority.

DB Lab is a GMP contract laboratory with more than 25 years of experience. We offer chemical, physical and microbiological analyses on raw materials, intermediates, finished products, and process samples to the pharmaceutical and biotechnological industries. We value ongoing dialogue with our partners in order to provide the best service possible. Quality and credibility are core values to both our partners as well DB Lab. DB Lab A/S Lille Tornbjerg Vej 24 5220 Odense SØ T: +45 65 93 29 20 E: dblab@dblab.dk W: www.dblab.dk

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COMPANY INDEX

IRW is a Nordic Contract Research Organization (CRO) with more than 20 years of experience in conducting clinical trials and with offices in Sweden, Denmark, Norway and Finland.

We are offering our solid experience with all aspects of Clinical Research, Pharmacovigilance, Data Management and Biostatistics as well as Outsourcing based on experienced, well qualified, and flexible resources within clinical operations.

IRW Consulting AB Svärdvägen 5, NB Box 703 SE-182 17 Danderyd T: +46 879 166 40 E: info@irwcro.com W: www.irwcro.com

IRW Consulting is contributing to excellence in clinical research and thus enhancing people’s health and quality of life with a Global Reach and Local Expertise, and we all act with Respect, Responsibility, Loyalty, Integrity and Passion for excellence.

IWA Consulting is a consultancy company with core competences, expertise, and decades of experience within regulatory affairs. The company employs 20 regulatory experts. The IWA consulting team provides regulatory affairs specialists expert services to international private and public clients. The IWA consulting team assists biotech, pharma, and medical device companies in achieving major regulatory milestones timely.

IWA Consulting ApS T: +45 5666 0490 E: info@iwaconsulting.dk W: www.iwaconsulting.dk

LINK Medical Research Gjerdrums vei 19 NO-0484 Oslo, Norway T: +47 2258 9000 E: info@linkmedical.eu W: www.linkmedical.eu

LINK Medical is a full-service contract research organization (CRO) providing product development services for the pharmaceutical and medical device industries across Northern Europe. We offer a well-integrated local presence in the Nordics, UK, and Germany. Reaching from early phase development to post-marketing, we have over 180 employees providing expert guidance across every aspect of a project – all from ONE source. Our specialized oncology team thrives with complex oncology studies due to our broad multidisciplinary knowledge and long experience overcoming the associated challenges at every step.

Our promise is to improve and accelerate your product development through transformative methods, active communication and optimal solutions. As a strategic partner, we provide expert competence and technology to enable evidence-based decision-making that supports the delivery of superior clinical outcomes.

NCK A/S was founded in 1956 to conduct research and development in synthetic organic chemistry on a contract basis.

NCK has worked for more than 200 customers world-wide. Most of the products which NCK develop are APIs for pre-clinical or clinical studies and are produced in accordance with cGMP. NCK routinely develops and validates analytical methods for release testing of APIs. Important core values are timely delivery, quality and communication.

NCK A/S Rugmarken 28 DK-3520 Farum T: +45 4495 1881 E: nck@nck.dk W: www.nck.dk Scandinavian CRO is a privately held clinical CRO headquartered in Uppsala, Sweden. Covering the Nordic area, the company performs complete studies or parts of projects within the field of clinical studies Both pharma and med tech. We facilitate clinical trial conduct in a wide variety of therapeutic areas and conduct trials in Sweden, Finland, Norway, and Denmark.

Scandinavian CRO AB Skolgatan 8, P.O 150 27 SE-750 15 Uppsala T: +46 18 100 550 E: info@scro.se W: www.scro.se

Zelmic AB Sankt Lars väg 45 B SE-222 70 Lund David Sagna, CEO T: +46 4616 1240 E: David.Sagna@zelmic.se W: www.zelmic.se

The company is a full-service CRO that helps manage trial aspects such as feasibility studies, study design, medical writing, submissions, monitoring and pharmacovigilance, as well as study documentation, data management, and statistics. All to ensure clinical studies comply with national and international regulations.

The company has an outstanding track record. We are confident that it is because we are agile, dedicated, and experienced, driven by our belief in building long-term relationships with our clients Zelmic AB is a Contract Research Organisation (CRO) in Lund – Sweden, founded in 2003 and has vast expertise in the development of pharmaceutical formulations for topical drugs. Zelmic’s have a strong track record of bringing topical products from idea to clinical testing. We have inhouse formulation, GMP analytical, and in vitro capability to bring value to the drug development companies and can handle small molecules, peptides, and proteins. Moreover, Zelmic’s team members have been working with drug delivery technologies and have put both oral, parental, and dermatological products on the market. The profound expertise in the topical-formulation niche is a strong differentiating factor to larger competing CRO’s.

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COMPANY INDEX

Contract Manufacturing Organisations Cambrex is an innovative life science company with a refreshingly human approach. Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world.

With over 35 years of active pharmaceutical ingredient (API) development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets.

Cambrex has facilities in the US (Corporate), Sweden, Germany, Italy, Estonia. Cambrex is also active in the Danish market.

Cambrex Björkborns Industriområde 691 33 Karlskoga Sverige Tel. +46 586 78 30 00 Web: www.cambrex.com

Recipharm is a leading contract development and manufacturing organisation (CDMO) headquartered in Stockholm, Sweden. We operate development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and are continuing to grow and expand our offering for our customers. Employing around 6,000 people, we are focused on supporting pharmaceutical companies with our full-service offering, taking products from early development through to commercial production. For over 20 years we have been there for our clients throughout the entire product lifecycle, providing pharmaceutical expertise and managing complexity, time and time again. Despite our growing global footprint, we conduct our business as we always have and continue to deliver value for money with each customer’s needs firmly at the heart of all that we do. That’s the Recipharm way.

Recipharm AB (publ) (HQ) Box 603, SE-101 32 Stockholm T: + 46 8 602 52 00 W: www.recipharm.com

The PolyPeptide Group is a World Leading Contract Development and Manufacturing Organization supplying peptides for the cosmetic, pharmaceutical and biotechnological markets employing more than 800 people at six manufacturing sites located in Belgium, France, India, Sweden and the USA. Whether your need is gram quantities or 100’s of kilograms of peptide or peptide-like API’s, PolyPeptide’s experience, focus and established regulatory track record offers Global Support for a Quality Solution.

PolyPeptide Group Limhamnsvägen 108 PO Box 30089, SE- 200 61 Limhamn T: +46 40 366 200 E: scandinavia@polypeptide.com W: www.polypeptide.com

Business Service Providers NUMBER 1 PROVIDER OF HUMAN TALENT WITHIN TECHNOLOGY & LIFE SCIENCE

Best Talent A/S Strandvejen 724 STOKKERUP DK-2930 Klampenborg T: +45 4556 5300 E: info@besttalent.dk W: www.besttalent.dk

Best Talent is specialized in Executive Search and Recruitment within Engineering, Pharma and Life Science.

Best Talent has quickly grown to become the favorite collaborative partner as a result of our experience, background and network.

We solve international projects on both a tactical and strategic level. We “speak the language”, know the market and attract highly qualified candidates. We possess the largest and most desired talent database in the field with over 20,000 life science candidates.

Looking for a safe place to store your samples?

Birka BioStorage is the biggest Biorepository in Europe.

Birka BioStorage Odarslövs Gård 332, SE-225 92 Lund T: +46(0)46 540 3930 E: safesamples@birkabiostorage.com W: www.birkabiostorage.com

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The cGMP & GDP storage services include: - Cell Banks - API & Drug Product - Reference & Retention - Clinical Samples - Dry Ice Production - Stability Studies - Disaster Recovery Backup - Storage Facility Management - Documentation Archive - Worldwide Distribution

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COMPANY INDEX

With 30 years of business experience and expertise knowledge of the pharma/biotech industry Centrum Personale can contribute as your HR partner. We can provide different types of services that can give your company financial and resource benefits. We work on many levels within the field of recruitment and HR and can help you with e.g.: • Recruitment of employees to permanent positions • Temporary Assistance – shorter and longer periods • Outplacement processes • Payroll service

Centrum Personale A/S Frederiksberg Allé 35 DK-1820 Frederiksberg C T: +45 3324 4080 www.centrum-personale.dk

Chart Bio is with you from science to market. With over 30 years of scientific and commercial experience Chart Bio together with its wide network of experts will prepare your scientific discoveries for commercial success. Not only does Chart Bio have a strong ability to translate and safeguard your science innovation but also identify new innovations and find a way for business growth. Chart Bio has global clients within bioproduction in a range of health applications, with products in early phase of development. We're with you.

Chart Bio DENMARK T: +45 31 17 22 46 E: contact@chartbio.eu W: www.chartbio.eu GET STRATEGIC, VALUE-ADDING IPR ADVICE Chas. Hude A/S is one of the leading IPR firms in Denmark. We offer professional, strategic advice on the commercialization of knowledge and technology.

We advise on all aspects within IPR and we can provide you with the total IPR expertise needed for clever and quick solutions by combining knowledge from e.g. patents, trademarks, and design in one dedicated team. Give us a call today on (+45) 33 19 34 00!

Read more about our services and meet our trusted advisors at chashude.com.

Chas. Hude A/S H. C. Andersens Boulevard 33 DK-1780 Copenhagen V T: +45 33 19 34 00 E: chashude@chashude.com W: www.chashude.com

DFD Cleanroom – specialists in documented solutions of cleanroom garment and cleaning solutions • • • De Forenede Dampvaskerier - DFD Cleanroom V. Henriksens Vej 6 DK-4930 Maribo T: +45 4422 5560 / +46 406 566 500 E: cleanroom@dfd.dk W: www.dfd.dk

All our processes are traceable and validated and based on innovative cleanroom technology.

We specialize in on-site training of operators in correct use of cleanroom clothes and cleaning articles.

We provide full-service solutions of garments, cleaning and logistics within all cleanroom areas and in accordance to ISO and GMP compliance.

The pulse of life sciences Trust a reliable partner who helps you achieve operational excellence Endress+Hauser A/S Poppelgårdvej 10-12 DK-2860 Søborg T: +45 70 131 132 E: info.dk.sc@endress.com W: www.dk.endress.com

insife

Insife Automatikvej 1, 3. Floor DK-2860 Søborg, Copenhagen E: info@insife.com W: www.insife.com

You can count on our world-class instruments, designed to ASME-BPE standards and rely on our experienced engineering and support services. We partner with you to help you reach your goals of process optimization, increased plant availability and continuous improvement.

Trusted by the biggest pharmaceutical companies in Scandinavia, we are here to help you make Pharmacovigilance processes and technology deliver efficiently and in regulatory compliance. We can help you across clinical and post-market scenarios on ICSR CRO /affiliate/ partner intake, case processing and submission, aggregate reporting, signal and risk management, compliance tracking and oversight, PSMF, SDEA and literature monitoring management etc. Our experience spans across working for global enterprises as well as small biotechs. We also have a broad network of partner companies e.g. for process outsourcing, so whatever challenge you may face, we can offer a solution. + Argus Safety Insife is a Danish company with divisions in India and USA Read more on insife.com and halopv.com

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JKS is the leading temp and recruitment agency in Denmark with 38 branches located across the country. We will find the temp, freelancer or employee you need at any level in your organisation.

JKS A/S Rødkløvervej 2 DK-6950 Ringkøbing T: +45 7015 0750 E: info@jks.dk W: www.jks.dk

Jusmedico Advokatanpartsselskab Klampenborgvej 248, 1. m.f.

DK-2800 Kgs. Lyngby T: +45 4029 4124 E: jbb@jusmedico.com / mbl@jusmedico.com W: www.jusmedico.com

Jusmedico is a specialist law firm providing legal services to the biotech, pharmaceutical, medical device, food supplement & dentistry industries, life science investors and to suppliers and service providers thereto. Internationally Jusmedico is co-founder and member of BioLawEurope F.m.b.A. a network of independent law firms from EEA countries, UK and Switzerland, specialized in the rendering of legal services to clients facing life science related legal challenges. Moreover Jusmedico operates a representative office in New York, USA. In 2017, 2018, 2019 and 2020 Jusmedico has been awarded the Corporate INTL Global Award Price as Biotech Law Firm of the Year in Denmark.

Kelly Scientific Resources Nordics has recruitment and staffing solutions for all your needs within the life/science industry. We are specialists that recruit specialist. All our consultants have a scientific academic background, and experience in how to match the best life/science talents with the most exciting companies in the entire Nordic region. If you are looking for your next employee, or if you want to discuss your own career opportunities please do not hesitate to contact us.

Kelly Scientific Nordics Contact: Thomas Lund, Branch Manager T: +47 40108070 E: Thomas.lund@kellyservices.no W: www.kellyservices.dk Velkommen til Danmarks eneste landsdækkende vikar- og rekrutteringsbureau specifikt for laboratoriebranchen. Med over 20 forskellige laboratorierelaterede faggrupper indenfor alt lige fra fødevareområdet til pharma, biotek, medicinal, dentalområdet med flere.

Vi har mere end 10 års erfaring og speciale i vikar- og rekrutteringsløsninger til laboratorier.

LabVikar ApS Avernakøvænget 4 DK-5000 Odense C E: kunde@labvikar.dk W: www.labvikar.dk

Lactobio ApS Lersø Parkallé 42 2100 København Ø E: info@lactobio.com W: www.lactobio.com

LIFE SCIENCE PLUS Advokater Ole Maaløes Vej 3 DK-2200 Copenhagen N Claudia Blomgren-Hansen M: +45 2548 2448 E: cbh@lspadvokater.dk W: www.lifescienceplusadvokater.dk

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In Lactobio we focus on the creation of new probiotic and microbial solutions to target and fight the problem of increasing infections caused by microorganisms being resistant to antibiotics. We work with the gut, oral, vaginal and skin microbiota to treat a variety of diseases – with projects spanning a variety of diseases including most bacterial pathogens.

Lactobio have obtained very promising results, with newly isolated lactic acid bacteria having a significant antibacterial activity against Methicillin Resistant Staphylococcus aureus (MRSA) and other pathogens.

LIFE SCIENCE PLUS Advokater provides specialized and business oriented legal advisory based on more than 15 years of hands-on experience from the Life Science industry - both from an operational and strategic level: * General Legal Services - full spectrum of general commercial & R&D specific contracts, IP aspects as well as commercially oriented legal and strategic advice and compliance work. * Business Development/Licensing activities - coordination and structuring of licensing and other transactional activities, incl. due diligence processes, deal structures, drafting and negotiation and anchoring/ integration. * Partnerships - structuring, drafting, negotiation and management of partnerships & alliances with e.g. academia, institutions and commercial partners; R&D outsourcing.

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COMPANY INDEX

Lundgrens Advokatpartnerselskab Tuborg Boulevard 12 DK-2900 Helleup T: +45 3525 2535 E: info@lundgrens.dk W: www.lundgrens.dk

Nyborg & Rørdam Store Kongensgade 77 DK-1264 København K T: +45 33 12 45 40 E: info@nrlaw.dk W: www.nrlaw.dk

Patentgruppen A/S Ole Maaløes Vej 3 DK-2200 Copenhagen N And: Aaboulevarden 31, DK-8000 Aarhus T: +45 86192000 E: patent@patentgruppen.com W: www.patentgruppen.com

Prevas Sweden, Denmark, Norway and India T: +45 3315 9090 W: www.prevas.com

ProPharma Group Europe North America Asia-Pasific W: www.ProPharmaGroup.com

Ramboll Group A/S Hannemanns Allé 53 DK-2300 København S T: +45 5161 1000 E: info@ramboll.com W: dk.ramboll.com

Lundgrens is a leading firm in Denmark with a strong client base comprising domestic and international clients, including institutional investors, banks, financial institutions, private equity funds and investors, listed and non-listed companies, public bodies, multinational corporates and insurance companies. The firm has around 80 lawyers, including 25 partners. In addition to Denmark the firm covers Greenland and the Faroe Islands.

Nyborg & Rørdam har lang erfaring med rådgivning til virksomheder indenfor life science og biotech.

Vores rådgivning fokuserer på resultatorienterede og praktisk anvendelige løsninger, der bygger på et indgående kendskab til branchens strategiske og kommercielle forhold samt forretningsmodellen hos det enkelte selskab. Vi lægger vægt på at opbygge tætte og tillidsfulde relationer til vores klienter. Vi rådgiver blandt andet om: - Etablering og opstart af nye virksomheder - Tilførsel af ny kapital og finansiering af drift - Fusion, opkøb og salg / exit - Aktieincitamentsprogrammer

- Licens-, forsknings- og udviklingsaftaler - Skat - selskabs- og personbeskatning - Persondata

GAIN VALUE FROM YOUR IPR INVESTMENT Patentgruppen provides counselling on all matters of IPR, i.e. on all matters relating to patents, utility models and designs. Patentgruppen wants to simplify the client’s ways to protect his business, products and innovation through a proactive and strategic approach to IPR. By working as a team, we will let you exploit our expertise both as regards IPR and technical knowledge. No matter who you are or which requirements you have for either technical counselling or IPR knowledge, we will proactively match your needs.

Ved du hvor stor en forskel avanceret elektronik og software kan gøre for vores helbred?

Siden 1985 har Prevas assisteret førende virksomheder indenfor Life Science-sektoren i udviklingen af livreddende medicinsk udstyr og apparater, der bidrager til en mere effektiv behandling af patienter indenfor mange områder. Der stilles høje krav til medicinsk udstyr hvor brugervenligheden og kvaliteten skal være i top - og det er netop dér, vores specialister har deres spidskompetencer.

Læs meget mere om Prevas på www.prevas.dk eller følg os på de sociale medier.

ProPharma Group is your global life science consultancy company with a strong Nordic presence. We offer EMA, FDA, and local Health Authority support with global pharmacovigilance and compliance services, through one organization. From concept development to commercialization, and any point in between, we partner with pharmaceutical, biotechnology, and medical device clients to tackle their complex business challenges, helping to ensure regulatory expectations are met, business goals are achieved, and patient health and safety are improved.

ProPharma Group - Complex challenges. Exceptional solutions.

SAFE MEDICINE MANUFACTURING (CLOSE TO THE PATIENT) New Medical Treatments and Advanced Therapies involves restricted requirements to facility design, technology and equipment of Hospital Pharmacies.

Advanced Therapy Medicinal Products (ATMPs) based on cells and genes requires increased focus on product quality, controlled aseptic conditions and the risk of contamination as such the manufacturing chain must comply with GMP-ATMP regulations.

With focus on Patient safety and Employee welfare we design State of the Art controlled environments in full compliance to support the objectives of Hospital Pharmacies.

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COMPANY INDEX

Laboratory, Medical & Pharmaceutical Suppliers

Agilent Technologies Inc. Produktionsvej 42 DK-2600 Glostrup W: www.agilent.com

Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences, diagnostics, and applied chemical markets. Now in its 20th year as an independent company delivering insight and innovation toward improving the quality of life, Agilent instruments, software, services, solutions, and people provide trusted answers to customers' most challenging questions. The company generated revenue of $5.16 billion in fiscal 2019 and employs 16,300 people worldwide. Information about Agilent is available at www. agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.

Apodan is the leading supplier of pharmaceutical packaging items in the Nordic. Our main activities are development, production and sale of a wide range of pharmaceutical packaging items. Our products are sold worldwide, and the Nordic countries is the primary market area. We are specialists in standard packaging solutions as well as in customized packaging solutions, which is developed in close cooperation with the customer.

ApodanNordic PharmaPackaging A/S Kigkurren 8M DK-2300 København S T: +45 32 97 15 55 E: packaging@apodanpharma.dk W: www.apodanpharma.dk

BioSense Solutions ApS Hirsemarken 1 DK - 3520 Farum T: +45 26 28 19 43 E: info@biosensesolutions.dk W: www.biosensesolutions.dk

Buch & Holm A/S Marielundvej 39 DK-2730 Herlev T: +45 4454 0000 E: b-h@buch-holm.dk W: www.buch-holm.dk

Visit us at www.apodanpharma.dk

BioSense Solutions develops automated scanning microscopes, for pharma, food and biotechnology.

Based on the patented scanning technology Fluidscope, BioSense Solutions currently market the oCelloScope an automated live-cell imaging system designed for analyses and monitoring of microbial growth.

By combining continuous real-time imaging and powerful image analysis software, oCelloScope enables researchers to capture and analyze microbial growth and morphological changes simultaneously in standard microtiter plates. oCelloScope’s enhanced imaging technology provides greater operational flexibility, with use in current applications: Antimicrobial Susceptibility Testing (AST), Co-aggregation studies, Spore Germination, Microbial cell morphology, Material degradation studies, Sterility QC testing, Anti-Fungal peptide screening, Probiotic screening, Fermentation optimization, Solubility studies, Food Mold inhibition and Preservative screening.

Over the years Buch & Holm has developed into a company that adapts quickly to dynamic market conditions. This is achieved through know-how, consulting and competent personnel. In recent years, Buch & Holm has experienced strong growth, and today the company is one of the market leaders as a total supplier of equipment, inventory and consumables to laboratories, quality control and the industry.

It’s all about adding value to the things we do.

WE KNOW WHAT IT TAKES.

Diatom is an engineering & trading company, which since 1964 has represented international contacts in Denmark with market leading products where we have a commitment to achieving customer satisfaction by providing innovative, total system solutions that add value to our customer by improving manufacturing efficiency, reliability and quality.

Diatom A/S Avedøreholmen 84 DK-2650 Hvidovre T: +45 3677 3600 E: info@diatom.dk W: www.diatom.eu

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COMPANY INDEX

Drifton A/S Avedøreholmen 84 DK-2650 Hvidovre T: +45 3679 0000 E: info@drifton.dk W: www.drifton.eu

Flow Robotics A/S Glentevej 70A 2400 København NV T: +45 40185935 E: info@flow-robotics.com W: www.flow-robotics.com

HaemoMedtec ApS Granlyvej 4 DK-6920 Videbaek Contact information: Bue Svendsen (Managing Director) T: +45 3116 6727 E: bue@haemomedtec.dk W: www.haemomedtec.dk

Krüger Aquacare Fabriksparken 50 DK-2600 Glostrup W: www.aquacare.dk

Drifton A/S offers a wide range of laboratory pumps, dispensing devices and precision balances for use in laboratories. Our range of laboratory pumps includes peristaltic pumps, micro gear pumps and syringe pumps. We offer a wide range of ancillary products for the peristaltic pumps e.g. peristaltic pump tubing, dispensing nozzles, weights for tubing, luer lock adapters and tube connectors.

Our laboratory products include laboratory glassware, pipettes, bottle-top dispensers, hotplates and magnetic stirrers. Our balances are very sensitive and some of them can measure down to 5 decimals.

Flow Robotics creates flexible, user-friendly liquid handling robots for lab automation. The lab robot flowbot ONE with two pipette modules will replace repetitive, time-consuming and burdensome manual pipetting tasks yielding more consistent results. The intuitive user interface of flowbot ONE enables setup within minutes and no previous experience with robots or programming is required. The flexibility of the robot makes it possible to use a wide range of tubes, vials and plates in an unlimited range of procedures. Ease of use is the life blood of Flow Robotics.

HaemoMedtec ApS has, in cooperation with Danish bioanalysts and other Danish companies, developed the SBCSystem – a new cart for phlebotomy near the patient, including a preanalytical robot HENm for prelabelling of the tubes.

SBCSystem - Safety Blood Cart System - is built on our SBQIntercom-software which is used in the SBQSystem (Safety Blood Queue System) which deliver bags with prelabelled tubes directly to the patient (outpatients) together with a queue number.

The cart is built around the preanalytical robot HENm, which prepares the correct sample tubes with the correct barcode labels.

SBCSystem makes it possible to do this locally, where the barcode on the patient's bracelet is scanned, and then LIS/HIS automatically delivers the information about the order.

And in seconds the sample tubes are printed and delivered in a tray, where after the phlebotomy is performed as usual.

With the help of several extra features (automated tube mixing as an example), we have focused on making the workflow as optimal as possible, both besides the patient when performing the phlebotomy, during transport and at the laboratory.

Ultra rent vand er grundlæggende i alle effektive laboratorier, der arbejder med følsomt apparatur og kemiske og molekylærbiologiske analyser. Krüger Aquacare forhandler en række af ELGAs vandanlæg.

Vi tilbyder et bredt spekter af helhedsorienterede løsninger til laboratorier, der stiller høje krav til deres leverandører.

Læs mere om vores professionelle løsninger her: http://www.kruger.dk/industri/loesninger/laboratorievand/

LabWare is the clear industry leader in laboratory automation software with LabWare LIMS ™ (Laboratory Information Management System) and LabWare ELN ™- a fully integrated Electronic Laboratory Notebook application.

LabWare’s Enterprise Laboratory Platform is a unique and proven suite of product capabilities that encompass LIMS, ELN and LES method execution in an integrated and enterprise ready solution.

LabWare Nordic Landskronavägen 25A SE-Helsingborg 252 32 T: +46 4237 5860 E: infoNordic@labware.com W: www.labware.com

LabWare has delivered powerful lab automation solutions to many different industries, and our single core product strategy benefits every LabWare customer because it enables all of our development, support and implementation resources to focus on a common solution. The LabWare technical architecture facilitates easy upgrades and functionality enhancements, so our customers are always current and remain well supported.

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COMPANY INDEX

Molecular Devices – we are one of the world’s leading providers of innovative instrumentation & software for protein & cell biology in life science research & drug discovery & development.

Our portfolio includes: Anja Mathiesen, Senior Account Manager BioResearch | Anja.Mathiesen@moldev.com M: +45 2966 8684 Maja Hoi, Account Manager Drug Discovery and Bioprocessing maja.hoi@moldev.com | +45 2966 0741 W: www.moleculardevices.com

• • • • • • •

Microplate readers & washers Automated microscopy/cellular imaging systems High-content imaging systems High-throughput screening systems Conventional electrophysiology systems Protein & cell biology reagents & assay kits Automated workflows

With over 140,000 placements in laboratories worldwide, our instruments have contributed to remarkable scientific research as described in over 150,000 peer reviewed publications.

A/S Ninolab Cordozasvinget 6 DK-2680 Solrød Strand T: +45 4491 1007 E: info@ninolab.dk W: www.ninolab.dk

OLYMPUS DANMARK Tempovej 48-50 DK-2750 Ballerup M: +45 4070 6590 F: +45 4473 4801 E: allan.hemmingsen@olympus.dk W: www.olympus-lifescience.com

Parker Hannifin Danmark Industriparken 35-37 DK-2750 Ballerup T: +45 4356 0400 W: www.parker.com

Phase Holographic Imaging PHI AB Scheelevägen 22 SE-223 63 Lund T: +46 46 38 60 80 E: info@phiab.se W: www.phiab.com

Med kunden i fokus - Hos Ninolab har vi fokus på høj kvalitet og sætter dine behov i centrum. Vi hjælper dig med at skræddersy en løsning, hvad enten det gælder enkelte produkter eller hele systemer. Vi leverer altid et korrekt tilpasset produkt, med de rigtige funktioner, til aftalt tid og pris.

Tryghed når du vælger Ninolab - Som kunde kan du være tryg, at når du vælger Ninolab som leverandør, da du altid vil blive tilbudt de bedste produkter. Du får god support i kraft af veluddannet personale, og vi er meget bevidste om, at vores ansvar strækker sig længere end til leveringen af selve produktet.

Produkter fra verdens bedste leverandører - Vi udvælger produkter løbende og skaber kontakter med de producenter der er kendte for deres seriøsitet og ansvarlighed i fremstillingen af laboratorieprodukter i højeste kvalitet. Ninolab forhandler produkter fra ca. 30 nøje udvalgte producenter fra hele verden.

Kvalificerede og engagerede medarbejdere - Vi tager ansvaret. Vi har specialister indenfor alle områder og samlet giver det den styrke der kræves for at tage et aktivt ansvar for avanceret laboratorieudstyr.

Understand your samples better with unprecedented flexibility and image quality in slide scanning. The SLIDEVIEW VS200 features Olympus’ revolutionary X Line objectives delivering confidence in quantitative analysis.

The VS200 is equipped with five observation modes (brightfield, fluorescence, darkfield, phase contrast and polarization) and supports fluorescence multiplexing up to Cy7. This combined with the ability to handle a variety of slide sizes enables you to see more details across multiple applications, such as: Brain Research Get the full picture with crisp details from single cells to whole-slide images.

Cancer and Stem Cell Research Gain deeper insights with a clear view on tissue composition and morphology.

Drug Discovery Accelerate understanding of your target molecules’ interactions.

Parker develops solutions specific to life sciences, focusing on the pharmaceutical, medical and diagnostics industries, where there are especially tough demands for quality and precision.

Quality control, reliable delivery and know-how are key when Parker supplies made-to-measure solutions to the leading companies in the life sciences industry. Parker’s expertise covers a wide area, and the product portfolio basically takes in everything from filters that purify insulin to miniature components that go into hearing aids, dentists’ tools or other medical equipment.

Phase Holographic Imaging PHI AB (Lund) provides an innovative tool, HoloMonitor® M4, for continuous imaging and monitoring of cultured cells directly inside the incubator. HoloMonitor is a small and convenient microscope designed to operate 24/7, inside the cell incubator. Our technology, digital holography, is non-invasive and enables recording of cells in real time without any labels or stains. The result is real 3D images and quantitative data on cell cultures, all the way down to single-cell level, easily collected with the user-friendly HoloMonitor App Suite software.

Promega products are used by life scientists who are asking fundamental questions about biological processes as well as by scientists who are applying scientific knowledge to diagnose and treat diseases, discover new therapeutics, and use genetics and DNA testing for human identification.

Promega Biotech AB Finnboda Varvsväg 16 pl 4 SE-131 72 NACKA T: +46 (0)8 452 2450 E: sweorder@promega.com W: www.promega.com

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Our local teams in Denmark and Sweden support scientist through providing the highest quality products, the best possible customer service, unsurpassed technical support.

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COMPANY INDEX

Siemens Healthineers offers a wide selection of diagnostic solutions for effective testing in in-vivo and in-vitro diagnostic.

Siemens Healthineers Borupvang 9 DK-2750 Ballerup T: +45 4477 4477 W: www.healthcare.siemens.dk

Soltech ApS Maaloev Vaerkstedsby 69-73 DK-2760 Maaloev, Denmark Phone: +45 44972532 E-mail: info@soltech.dk Web: www.Soltech.dk

TA Instruments Denmark A Division of Waters A/S Dybendalsvaenget 2 DK-2630 Taastrup Claus Larsen T: +45 4657 4100 E: denmark@tainstruments.com W: www.tainstruments.com

Triolab AS Vallensbækvej 35 DK-2605 Brøndby T: + 45 4396 0012 F: + 45 4396 4312 Service: +45 72 300 431 E: triolab@triolab.dk W: www.triolab.dk

ViroGates Banevænget 13 DK-3460 Birkerød T: +45 2113 1336 E: info@virogates.com W: www.virogates.com

An estimated five million patients globally everyday benefit from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

We are a leading medical technology company with over 170 years of experience. With about 50.000 dedicated colleagues in over 70 countries, we will continue to innovate and shape the future of healthcare.

Soltech is your partner in contract Product Development.

Our team of specialists can assist in the stages between getting an idea to having a finished product. We can take wild and visionary ideas and turn them into tangible solutions.

At Soltech we also perform all bench tests needed to be compliant with your pre-clinical test plan and other relevant standards.

Soltech has an ISO-class 8 clean room. We make small scale production for in vivo testing, clinical studies or for the market entry.

We have a well-equipped in-house tool shop and raw materials in stock.

Soltech also design and construct high end laboratory equipment for the pharmaceutical industry.

TA Instruments (– A Division of Waters) has its focus on Material Characterization and are offering highend instrument solutions within thermal analysis, rheology, thermophysical properties and microcalorimetry.

TA Instruments is leading the way when it comes to performance, robustness and ease-of-use.

In addition the solutions from TA Instruments holds many patents, an un-precedented 5-years warranty on key elements of the DSC/TGA/DMA/Rheometer and maybe most importantly: an impressive track record of delivering the best support from highly skilled service engineers and a group of very knowledgeable application specialist who are assuring the best after-sales support possible (underlined by well over 5.000 Nordic users/operators, who in the recent 14 years) have participated in the courses offered.

Check-up on the current courses: www.tainstruments.com/training/course-schedule

Triolab AS is a professional sales organization, founded in 1991. We offer products and services to hospital laboratories, general practitioners, pharmaceutical industry, public industry, research labs, and universities. We are specialized in the fields of POC, coagulation, hematology, microbiology, molecular diagnostics, clinical chemistry, immunology, genetics, pathology and microscopy. More info at www. triolab.dk

ViroGates is an international Medtech company headquartered in Denmark.

ViroGates develops and sells prognostic products to the healthcare sector.

The products are used in hospital emergency services to make a clinical decision on hospitalization or discharge of patients in hospitals Emergency Departments, which can lead to better clinical decisions, faster discharge, improved patient care and significant cost savings.

ViroGates test suPARnostic® measures the protein suPAR (Soluble urokinase Plasminogen Activator Receptor) in the bloodstream. With the suPARnostic® TurbiLatex test, hospital staff will get the result together with other blood parameters with no additional steps involved – a help to reduce Emergency Room crowding.

The prognostic value of suPARnostic® is validated by more than 600 clinical trials and studies which included more than 300,000 blood samples.

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HIGHLIGHTED FAIRS AND EVENTS IN 2020 The Future of Swedish & Danish Life Science Date: 2nd of April 2020, Lund, Sweden

For further information, visit: www.swedishdanishlifescience.se The international partnering-event started in 2012 and includes a combination of partnering (pre-bookable oneon-one meetings), presentations, exhibition and informal networking. The 9th edition of the international partnering event The Future of Swedish & Danish Life Science will showcase the regionâ&#x20AC;&#x2122;s strengths and look at the key factors behind the success of Swedish/Danish life science collaboration. One of the themes will cover the hot topic Immuno-oncology. In other sessions, panels with experts will discuss critical factors for continued, international competitiveness such as how to create value through the unique research

infrastructure including Max IV and ESS, how to attract (and keep) competence and how to maintain and further improve the conditions for innovation and product development.

The event attracts 400-500 leading decision makers every year from all over the world from pharma, biotech and medtech as well as research, the healtchcare sector, policy, regulatory authorities and finance. The exhibition with about 30 exhibitors provides a platform for partners and vendors to engage and discuss collaborations and do business.

Global Engage â&#x20AC;&#x201C; International Life science events in 2020 Global Engage meetings are at the forefront of life science and health research. With internationally renowned speakers from academia, industry and finance sectors, our conferences cover cutting-edge advances in genomics and personalised medicine, drug discovery, human health and technology, as well as commercialisation strategies.

3RD GLOBAL BIOPROCESSING, BIOANALYTICS & ATMP MANUFACTURING CONGRESS When & where: 18-19 May 2020, Dublin, Ireland

MICROBIOME & PROBIOTICS R&D & BUSINESS COLLABORATION FORUM When & where: 18-20 May 2020, Rotterdam, The Netherlands 6TH DIGITAL PATHOLOGY & AI CONGRESS When & where: 25-26 June 2020, New York, USA, and 2-3 December 2020, London, UK 5TH MEDICINAL CHEMISTRY & PROTEIN DEGRADATION SUMMIT When & where: 16-17 November 2020 London, UK 4TH PHARMA R&D INFORMATICS & AI SUMMIT When & where: 16-17 November 2020 London, UK To find out more about these and other events, visit: www.global-engage.com/#upcoming-conferences

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LabDays Copenhagen Date: 2-3 September 2020, Copenhagen, Denmark

For further information, visit: www.labdays.dk The fair had its premiere in 2014, under the name Cph. LabMed. The name was later changed to LabDays Copenhagen. The last fair, conducted in 2018, had nearly 100 exhibitors and close to 3.000 visitors.

The expectations for LabDays Copenhagen 2020 are huge, based on the successfully conducted event in 2018.

BioPeople, the Danish life science cluster is one of the congress partners. The cluster participated at the event LabDays Aarhus in 2019 where they had a panel discussion and two mini seminars at the fair. Pleased with the outcome, they have decided to repeat the success at the upcoming LabDays Copenhagen 2020. This time BioPeople will also have a small booth.

Interesting conferences, seminars and meetings with be conducted in parallel with the fair, as the laboratory industry meets in Øksnehallen, the venue where the event will take place.

EUROTOX 2020 Date: 6–9 September 2020, Copenhagen, Denmark

For further information, visit: www.eurotox-congress.com The Danish Society for Toxicology and Pharmacology organises EUROTOX 2020 in Copenhagen. The venue is The Tivoli Congress Center, located in the City Center.

The congress theme is “combined efforts in quest of safer chemicals and medicines” and reflects the congress pro-

gramme including a variety of topics dealing with safety of drugs and environmental chemicals, new and emerging technologies, personalized medicine, human health effects caused by exposure to chemicals as well as safety issues arising from climate changes.

Nordic Life Science Days Date: 8-10 September 2020, Malmö, Sweden

For further information, visit: www.nlsdays.com Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector,

not only from biotech, pharma and healthtech but also from finances, research, policy and regulatory authorities. Based on cutting-edge and advanced partnering and networking tools, Nordic Life Science Days showcases the best the Nordic region has to offer.

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DiaLabXpo Date: 29 SEPT. – 1 OCT. 2020, Herning, Denmark

For further information, visit: www.dialabxpo.com DiaLabXpo is the diagnostic and laboratory industry’s new exhibition that brings product innovation into sharp focus, along with the newest trends and developments within the industry. There will be several opportunities for being inspired through exciting and professional presentations, debates, workshops and lectures, in order to generate knowledge and insight into new trends and developments.

DiaLabXpo has been developed in close collaboration with the trade association DiaLab and MCH Messecenter Herning, and gathers the diagnostic and laboratory industry.

DiaLabXpo was conducted at Lokomotivværkstedet in Copenhagen the first time (in 2019), but in 2020 it will be held at MCH Messecenter Herning together with the big food technology expo FoodTech 2020.

EUSEM – The European Society of Emergency Medicine Congress Date: 19-23 September 2020, Copenhagen, Denmark

For further information, visit: www.eusem.org The next EUSEM annual meeting is held in Copenhagen. This years’ host is the Danish Society for Emergency Medicine.

This year the organising and scientific committees have introduced new aspects that will make this congress a memorable event. The scientific program has been expanded with more tracks orientated to nurses and paramedics. A new dedicated educational track focused on ETR Curriculum

review will prepare you for exams and will lead you to be the best EMD. More than 120 speakers including 3 keynote speakers will form the scientific backbone of the congress, with excellent professionals, up-to-date topics and vibrating discussion panels.

BIO-Europe 2020 Date: October 26–28, 2020, Munich, Germany

For further information, visit: www.ebdgroup.com BIO-Europe is the largest biotechnology partnering conference held in Europe. More than 4000 attendees from more than 60 countries from biotechnology, pharma and finance annually attend BIO-Europe to identify new business opportunities and develop strategic relationships. Business development executives and dealmakers consider BIO-Europe a must-attend event and an effective business strategy enabling them to meet and present to numerous potential partners. BIO-Europe features the industry’s most advanced web-based partnering system enabling delegates from all parts of the biotechnology value chain to quickly identify, engage and enter into strategic relationships that drive their

business successfully forward. BIO-Europe's world-class workshops, panels and active exhibition along with thousands of prescheduled one-to-one meetings make this event an unrivaled forum for companies across the biotech value chain to meet and do business.

The congress is also the opportunity for European collaborators to meet in groups, present study results and discuss new projects. This is an essential objective of our scientific society, creating a venue where clinical science is molded and giving more members an opportunity to get involved.

MEDICA Date: 16-19 November 2020, Düsseldorf, Germany

For further information, visit: https://www.medica-tradefair.com/ MEDICA is where the world of medicine meets. Join the largest international communication and networking platform in the industry. And it offers a lot: take advantage of this combination of the world’s largest trade fair for medicine, the leading supply market event for the associated production sector and a dynamic atmosphere to drive forward your success. The entire process chain at a glance: at COMPAMED,

92

discover the current innovations that could shape your future innovations. The MEDICA START-UP PARK matches ideas and investors. A wide range of forums, conferences and events celebrate the topics and trends of tomorrow. All this at the same time in the same place – for the synergy that will make MEDICA 2019 as successful as previous editions.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

COURSES AND EDUCATION

HIGHLIGHTED COURSES AND EDUCATION Master of Medicines Regulatory Affairs For further information and enrolment visit www.mra.ku.dk Master of Medicines Regulatory Affairs is a continuing education programme targeted at professionals in the pharmaceutical industry.

Enrol in the part time master’s programme and: •

Achieve a thorough insight into the regulatory process at all stages during drug development

•

Become competent in analysing, predicting and advising on drug regulations and directives

•

Learn to critically examine legislation in regulatory science

•

Get an overview of the differences in regulatory demands globally

•

Understand how to organise the regulatory work across the classic safety, clinical and quality disciplines to prevent delays in the innovation process

The course is lectured in Copenhagen, Denmark. It is possible to sign up for a single course or enroll in the full master's programme. The 60 ECTS credits master’s programme (equivalent to 1 year of full-time study) is designed to be completed within 2 to 6 years of part-time study.

The congress is also the opportunity for European collaborators to meet in groups, present study results and discuss new projects. This is an essential objective of our scientific society, creating a venue where clinical science is molded and giving more members an opportunity to get involved.

Master of Industrial Drug Development For further information and enrolment visit www.mind.ku.dk Master of Industrial Drug Development is designed to meet the need for managers to coordinate the many elements involved in order to accelerate the drug development process and smooth the transition of candidate drugs to market.

•

Learn about the latest developments and trends in toxicological assessments

•

Get an overview of pharmaceutical in- and out licensing processes, including due diligence cases from pharma industry, CROs and biotech

•

Be introduced to the new advances in our ability to develop macromolecules into effective biopharmaceuticals

Enrol in the part time master’s programme and: •

Get good insight into the processes, regulations and options for the production of both small molecule and biopharmaceutical drugs

•

Understand the transition process of drug candidates from the preclinical stage to clinical evaluation comprising selection of special patient populations, PK/ PD methodology, clinical trial designs, and regulatory aspects

•

Get a comprehensive overview on how drugs are discovered and developed in the pharmaceutical industry

The course is designed with a minimum of class-room attendance in order to fit into the busy schedule of working professionals. Lectured in Copenhagen, Denmark. The 60 ECTS credits master’s programme (equivalent to 1 year of full-time study) is designed to be completed within 2 to 6 years of part-time study.

CRISPR technology For further information and enrolment visit www.zealand.dk Zealand Institute of Business and Technology has started a collaboration with several external teachers who, as Associate Professor, MSc, Dr.med. Eric Paul Bennet from the Copenhagen Center for Glycomics at the University of Copenhagen can provide the latest in current topics. Eric Paul Bennet teaches the use of CRISPR. Short about the course: •

Review of gene targeting before and after the "CRISPR craze" era of 2013

•

Review of the principle of using CRISPR / Cas9 as a gene editing technique

•

Methods for identifying Cas9 induced genome changes

•

Review of CRISPR specificity and security, including the “off target” concept

•

Review of the biotechnological and therapeutic application options for CRISPR

The course is held once a year in the Maersk tower at the University of Copenhagen.

CRISPR is the latest genetic tool of scientists that enables them to accurately and inexpensively modify the genes of different organisms, GMOs. CRISPR is a method with endless perspectives.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

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COURSES AND EDUCATION

Quality Systems Regulations (QSR) For further information and enrolment visit www.medicoindustrien.dk The course has been designed for staff in the medical device industry who need to gain insight into FDA QSR/GMPs and people about to take part in planned FDA inspections.

The course will present and assist understanding of the differences between the US and European medical device standards, including a review of FDA Quality System Regulations and comparison with the ISO 13485 standard.

Here are some of the subjects from the course: •

Background of the U.S. FDA regulations

•

Preparing and surviving to a FDA inspection: the FDA

QSIT Guidance and other useful guidance documents •

The USA FDA QSR and comparison with ISO 13485:2016

•

QSR: From Subpart A to Subpart O, including discussion of the USA FDA Medical Device Reporting (MDR) and Corrections and Removals Regulations

Examples of FDA Warning Letter for each subpart of the regulation The course will be conducted in English, alternating between lectures, case studies and discussion of participants’ own issues.

•

Devices: Recent FDA Guidance Documents For further information and enrolment visit www.medicoindustrien.dk In order to avoid extremely costly delays, it is essential to understand the laws, regulations, processes and guidance for medical devices in order to be successful in getting medical devices into the US marketplace. There are several recent guidance documents which are key to effectively navigating FDA. The course provides insight to several recently critical guidance documents relating to regulation of medical devices in the US. Here are some of the subjects from the course: •

De Novo 510(k)s

•

Evaluating Substantial Equivalence for 510(k)s

•

Balancing Premarket and Post Market Data for PMAs

•

Regulation of Mobile Apps

•

Communication During FDA’s Review of Submissions

•

Pre-Submissions

•

FDA IDE Decisions and Procedures

•

Design of Pivotal Clinical Studies

•

Emergency Research

•

Clinical Trials Outside the US

•

Fundamentals of Animal Studies

The course is beneficial for anyone who has an interest in development of medical devices intended for the US market.

Pharmakon - Offering more than 200 life science related courses each year For more courses, further information and enrolment visit www.pharmakon.dk Pharmakon is based in the city of Hillerød in the Greater Copenhagen region. Most of the courses offered are in Danish, but there are also courses conducted in English. Some of the courses offered are: •

Pharmacovigilance – An Introduction

•

Stability Documentation

•

Quality Oversight

•

Regulatory Life Cycle Management

•

Brexit in a Regulatory Perspective

INNO-X Health For further information and enrolment www.innox.au.dk INNO-X offers courses and education where the participants acquire methods and competencies that enable them to develop and integrate solutions that makes a real difference for patients, colleagues and collaborators and thus contribute to developing the healthcare area as a whole. Courses are offered in collaboration with Central Denmark Region and Aarhus University. INNO-X also offers customized courses.

The participants at the customized courses learn new competencies within need-driven innovation and develop their ability to establish productive and thriving interdisciplinary teams. The customized courses vary from shorter workshops, where the participants learn specific tools they can apply in

94

their daily work, to longer educations where the participants become experts in need-driven innovation. The basis of INNO-X’s courses are methods and theories that is practically proven in an international context. Their approach to innovation and competency development is Stanford University’s successful Biodesign program, D-Schools’ Design thinking-method, Berkeley University’s Lean Launch Pad program, and last but not least our own specialized Mixed Methods Innovation Model. A customized course from INNO-X Health gives the participants methods, tools and competencies that enables them to create organizational value through a need-driven approach.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | Y E A R B O O K 2020

TA Instruments Taking MATERIAL CHARACTERIZATION to a NEW LEVEL

Training courses, technology tours* and seminars in thermal, rheology and microcalorimetry: • Sign up and increase your application knowledge.

• Balanced content between theory and practical hints.

• You are welcome to bring samples for analysis (pre or post) or any experimental data for consultation.

• Participation is free Be up-to-date with the latest news and join these fine seminars, annual meetings, technology tours*/user meetings:

When

Description

Where

13th - 14th Feb

31st Thermal Symposium by FinTAC and FyFa

10 - 11 March

Rheology Technology Tour*

23rd - 26th March

Microcalorimetry - TAM IV & TAM Air Training Course (Theory & Practical) Microcalorimetry - ITC & DSC Training Course (Theory & Practical)”

Stockholm

28th April

Differential Scanning Calorimetry (DSC) Training Course (Theory & Application)

Stockholm

29 April

Dynamic Mechanical Analysis (DMA) Training Course (Theory & Application)

Stockholm

th

th

th

Helsinki Stockholm/Uppsala

6 - 7 May

Rheology Training Course (Theory & Practical)

CPH/Malmö

19th May

Thermal Technology Tour*

CPH/Malmö

3 - 5 June

57 Nordic Polymer Days & 29 Nordic Rheology Conference

10 - 12 June

Scandinavian Society of Biomaterials 2020

24th - 27th Aug

Microcalorimetry - TAM IV & TAM Air Training Course (Theory & Practical) Microcalorimetry - ITC & DSC Training Course (Theory & Practical)

25th August

Differential Scanning Calorimetry (DSC) Training Course (Theory & Application)

th

th

rd

th

th

th

th

Espoo

th

Jurmala, Latvia Stockholm Turku

26 August

Thermogravimetric Analysis (TGA) and Simultanous DSC & TGA (SDT) Training Course

7th - 8th Oct

Rheology Training Course (Theory & Practical)

Stockholm

15th Oct

Thermal Technology Tour*

Stockholm

10 - 11 Nov

Rheology Technology Tour*

24 Nov

Differential Scanning Calorimetry (DSC) Training Course (Theory & Application)

CPH/Malmö

25th Nov (½-day)

Modulated Differential Scaning Calorimetry (MDSC) Training Course (Theory & Application)

CPH/Malmö

25th Nov (½-day)

Thermogravimetric Analysis (TGA) Training Course (Theory & Application)

CPH/Malmö

th

th

th

th

Turku

Helsinki/Tamp.

* There will be a number of additional TA Technology Tours (this is where TA Application Specialists will visit selected users to discuss applications, technical matters, instruments and/or software. Please come back if you would like to learn more about this).

For additional information please email: sweden@tainstruments.com, denmark@tainstruments.com, norway@tainstruments.com or finland@tainstruments.com.

By telephone: +46 (0)8 555 521 or +45 46 57 41 00.

www.tainstruments.com

tainstruments.com

Claus Dansk Kemi 2020.indd

1/23/20 7:15 AM

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Analytical services

Udstyr og forbrugsartikler

Buch & Holm, celledyrkning - september 2020

Celledyrkning

Alle priser gĂŚlder frem til 31. december 2020

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7930403 25 ml uden reservoir 150 stk. kr. 535,- Tilbud kr. 345,94525 25 ml med reservoir 60 stk. kr. 295,- Tilbud kr. 220,94550 50 ml med reservoir 50 stk. kr. 445,- Tilbud kr. 330,Kontakt os for flere størrelser

Sterile

KOLBER TIL CELLEKULTURER

Optimum Growth™ kolberne har specialdesignede bafler, som giver en signifikant højere beluftning og et meget højere udbytte. Kolberne kan erstatte såvel Fernbach-flasker som Wave Bags (5 og 10 liter). Kan bruges med transfer-låg, der f.eks. kan benyttes til inokulering. Er pakket enkeltvis og sterilt.

4880105 4880106 4880104 4880103 4880101 4880100

125 ml 250 ml 500 ml 1,6 liter 2,8 liter 5 liter

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25 stk.

12 stk.

6 stk.

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kr. 4.120,- kr. 5.670,- kr. 4.450,- kr. 3.940,- kr. 1.620,- kr. 2.625,-

Tilbud kr. 3.626,Tilbud kr. 4.990,Tilbud kr. 3.916,Tilbud kr. 3.467,Tilbud kr. 1.426,Tilbud kr. 2.310,-

Hør ogås på transfer caps flaskerne til Optimum Growth™

UNIVERSAL BORDCENTRIFUGE Specielt designet til at modstå det korrosive miljø i CO2-inkubatoren.

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Sigma universal bordcentrifuge i topklasse for krævende brugere der har brug for udvidede funktioner. Nu med g-lock system, så du kan skifte rotor uden brug af værktøj. Hastighed op til 18.000 o/min. og kapacitet op til 4 x 400 ml.

4950090 Celltron rystebord til inkubatorer kr. 26.990,- 23.995,4960085 Plade 400 x 330 mm m/klæbemat. kr. 2.875,- 2.570,-

221037002 / Sigma 3-18KS med g-lock rotor Listepris kr. 75.860,- Tilbud kr.

RYSTEBORD TIL INKUBATORER

Inkl. udsvingsrotor til 36 x 15 ml og 16 x 50 ml falconrør - ekskl. skab

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32.995,-

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61.600,Pakketilbud

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CELLEDYRKNINGSFLASKER

CELLEDYRKNINGSPLADER Brøndgeometrien er et vigtigt kriterium på en 96-brønd celledyrkningsplade. TPP tilbyder plader med både rund og flad bund: F-bund (flad) er velegnet til præcise, optiske målinger - idet lyset ikke distraheres af geometrien og for mikroskopi-applikationer (bundlæsning).

U-bund (rund) uden kant er velegnet til pipettering. Kan bl.a. anvendes til agglutinationstest og "+/-" evalueringer. 126 stk. pr. pakke.

92006 92012 92024 92048 92096 92097

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kr. 2.110,- kr. 2.110,- kr. 2.110,- kr. 2.110,- kr. 2.510,- kr. 2.510,-

Tilbud kr.

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1.685,1.685,1.685,1.685,1.995,1.995,-

Gratis sterile TPP vareprøver!

Kontakt os for at høre om flere TPP produkter

Vi fører et bredt sortiment af celledyrkningsflasker. Vi har bl.a. flasker med genlukkeligt låg og peel-off, som giver let adgang til dyrkningsarealet. Flaskerne findes med to forskellige former for skruelåg: Filter, som giver permanent ventilation og VENT, som kan drejes en kvart omgang for beluftning.

90025 m/vent. låg 360 stk. 25 cm² kr. 2.365,- Tilbud kr. 1.890,90026 m/filterlåg 360 stk. 25 cm² kr. 2.600,- Tilbud kr. 2.080,90075 m/vent. låg 100 stk. 75 cm kr. 1.255,- Tilbud kr. 995,90076 m/filterlåg 100 stk. 75 cm² kr. 1.365,- Tilbud kr. 1.090,90150 m/vent. låg 36 stk. 150 cm² kr. 970,- Tilbud kr. 775,90151 m/filterlåg 36 stk. 150 cm² kr. 1.050,- Tilbud kr. 840,90300 m/vent. låg 18 stk. 300 cm² kr. 1.055,- Tilbud kr. 835,90301 m/filterlåg 18 stk. 300 cm² kr. 1.115,- Tilbud kr. 890,-

Kontakt os også vedr. celledyrkningsflasker med ”peel off” og ”genlukkelig” front

SCREENING OG SCALE-UP Inden for bioprocesområdet har vi i mange år repræsenteret en af verdens førende producenter: Infors HT. Infors er leveringsdygtig i rysteborde, rysteinkubatorer og bioreaktorer til ethvert formål.

Kontakt os og hør om dine muligheder

Find vores komplette sortiment på www.buch-holm.dk

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InIn April 2018, 2018, our our Biomedical Biomedical Business Business Brand Brand InApril April 2018, our Biomedical Business Brand will will change change toto PHCbi will change toPHCbi PHCbi

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Intelligent Intelligent Intelligent Inverter Inverter Inverter Listepris kr. 123.600,- Tilbud kr.

Buch & Holm har et stort udvalg i både skabs- og Efficient Efficient Efficient kummefrysere. Kontakt os for mere information.

Refrigeration Refrigeration Refrigeration Naturally Naturally occurring occurring Naturally occurring hydrocarbon hydrocarbon (HC) (HC) hydrocarbon (HC) refrigerants provide provide more more refrigerants provide more KRYOBOKSE I COATEDrefrigerants PAP efficient efficient cooling cooling due tototo their their efficient due their Vandafvisende og kan tåle nedfrysning.

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Inverter Inverter compressors compressors provide provide Important Important information information such such Inverter compressors provide Important information such optimum optimum stability, stability, while while quality quality optimum stability, while quality asasas freezer freezer temperature, temperature, door door freezer temperature, door ofofdesign ensures ensures reliability. reliability. ofdesign design ensures reliability. opening opening times times and and alarm alarm opening times and alarm Ideal Ideal for for samples samples that that are are Ideal for samples that are history history isislogged for for monitoring monitoring history islogged logged for monitoring sensitive sensitive tototemperature sensitive totemperature temperature ininGLP applications. applications. inGLP GLP applications.

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lav kr. 1.620,- Tilbud kr. 1.295,-

4929010

30 x 1,0/2,0 ml

Buch & Holm A/S - Marielundvej 39 - 2730 Herlev - tlf.: 44 54 00 00 e-mail: b-h@buch-holm.dk - www.buch-holm.dk IRONME NV

ISO

14001:2015

TH & SAF AL

ISO

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4929016 12 x 1,0/2,0 ml

Uniform Uniform Sample Sample Storage Storage Uniform Sample Storage

NT

Alle priser er nettopriser ekskl. moms og gældende frem til 31.12.2020. Der tages forbehold for trykfejl.

rabat på racks v. køb af ny fryser

45001:2018

kr. 4.420,- Tilbud kr. 3.535,-