Greater Copenhagen Life Science November 2018

NOVEMBER 2018

FOODTECH 2018 FOODTECH OFFERS PLENTY TO SEE AND DO

— KNOWLEDGE SHARING BRINGING THE BEST IDEAS AND TALENTS INTO PLAY

— LEGAL UPDATE PATENTING NATURE-BASED PRODUCTS IN THE US

— THEME SCIENTIFIC & CLINICAL COLLABORATIONS

Secti on Page 21

NOVEMBER 2018 Publisher:

Høffdingsvej 34 2500 Valby Denmark E-mail: nem@nemmedia.dk Web: www.nemmedia.dk

CONTENTS THE COLUMN

By Copenhagen Health Science Partners

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KNOWLEDGE SHARING

6

Bringing the Best Ideas and Talents into Play

FOODTECH 2018

10

Activities and Events Gathering the Food Industry in Herning

10

IFC World Congress, an International Conference

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Editors: Karin Jensen Charlotte Strøm Arne Nielsen Clara Holm-Hansen Signe Walther Mørck and Mohammed Ali Wachah.

ScanStar, the United Nordic Packaging Competition

12

Graphics & Layout: Kapteina Reklame

BIO-EUROPE 2018

21

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Advertisement: Mohammed Ali Wachah +45 23238082

Venue Overview

24

Highlighted Events

26

mw@nemmedia.dk

RECRUITMENT & EDUCATION

Magnus Andersen +45 4281 1110 ma@nemmedia.dk

Photo: www.ty-stange.dk

Print: Green Graphic & Signtec Reklame

THEME 14

Scientific & Clinical Collaborations

14

Clinical Academic Groups on Asthma, Cancer, Osteoarthritis, and Childhood Infections

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Welcome to BIO-Europe 2018 in Copenhagen

28

Graduates and Further Education of Life Science Employees

NEWS FROM THE INDUSTRY

34

LEGAL UPDATE

40

Patenting Nature-Based Products in the US

In cooperation with:

Cross-cultural management, cooperation and communication We help life science organisations succeed in an international multicultural working environment. Our activities include: Management and cooperation in the multicultural team

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Knowledge-sharing

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•

Negotiation techniques

Feedback techniques (DIDS method)

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Presentation techniques

Scientific and business English

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Translation and proofreading

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ISSN: 2446-1776

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www.global-denmark.dk +45 33 86 29 30

global@global-denmark.dk

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THE COLUMN

COPENHAGEN HEALTH SCIENCE PARTNERS – New Research Collaborations Promoting Health and Growth

By Per Jørgensen, director at Copenhagen Health Science Partners

T

hese years the Danish healthcare system is very focussed on solving the growing challenges within the health sector. We are faced with an ageing population, more patients suffering from chronic diseases, increasing medicine and treatment expenses, a need for more coherent continuity of care across sectors and increased expectations from citizens. Political measures and structural changes of various kinds are part of the solution. But without research and innovation combined with fast and efficient implementation of new knowledge we will not succeed. In Denmark we must utilise our strong position within the health and medical sciences, health technology and the entire life science industry.

A lot of the health challenges that research must help to solve are highly complex. They can no longer be solved by the researcher alone and one or two PhD students. We need large research collaborations

across universities and hospitals, where basic, translational, clinical and health technological research together contribute to finding, developing and implementing solutions. Though Danish researchers are already doing this, we need to be even better.

Copenhagen Health Science Partners (CHSP) is a framework aiming to make it easier to do research and collaborate across the University of Copenhagen and the hospitals in the Capital Region of Denmark. We do this by initiating and supporting a series of cross-sectoral research collaborations called Clinical Academic Groups (CAGs). Each CAG is headed by a chairmanship consisting of one researcher from the university and one researcher from the region. In addition to the chairmanship, each CAG can have up to 10 key members, who may come from other organisations, including private enterprises.

Within the framework of the CAG

the researchers and clinicians must cooperate on developing new methods for prevention and treatment and ensure that new knowledge will benefit the patients as fast as possible.

Through excellent research and effective implementation of new knowledge CHSP helps improve the outcome for Danish patients. Furthermore, CHSP seeks to contribute to the Danish life science ecosystem through productive collaborations with the life science industry.

The next chapter will look at the upcoming expansion of the group of partners with the Technical University of Denmark and Region Zealand. We hope the expanded partnership and the even more complete Greater Copenhagen Health Science Partners will strengthen Denmark as an interesting collaborator to universities and international companies within the life sciences.

"A lot of the health challenges that research must help to solve are highly complex. They can no longer be solved by the researcher alone and one or two PhD students."

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

Per Jørgensen, director at CHSP

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BRINGING THE BEST IDEAS AND TALENTS INTO PLAY

HOW TO BRING THE BEST IDEAS AND TALENTS INTO PLAY

By Signe Walther Mørck, Journalist

A silo mentality, internal competition and personal barriers can stand in the way of knowledge sharing, without managers and employees even being aware of it. However, through culture-neutral work tools that create trust and enable cross-cultural communication, organisations and people can transcend substantial barriers and bring the best ideas and talents into play, according to a communications expert.

M

ulti-cultural working groups can greatly contribute to innovation in an organisation. Nevertheless, many businesses and managers are unaware that, irrespective of the organisational set-up, employees sometimes tend to withhold information and ideas, and this can obviously harm the organisation’s internal learning and ability to bring good ideas and talents into play.

An American research study conducted by the Academy of Management and published in 2017 reported on the reactions on feedback from almost 2,000 employees.

The results showed that, unlike employees who only cared about improving their own performance, employees who were curious and motivated to receive feedback attracted more and higher-quality feedback from their surroundings.

If you want motivated employees who are willing to share information internally in their department or with the entire organisation, it is crucial that the company culture is based on trust and cross-cultural communication. This should be the organisation’s DNA, according to Claus Adam Jarløv, CEO of the consultancy firm GlobalDenmark.

“From a psychological point of view, feedback is a sensitive process, because we not only comment on a person’s performance; we also, implicitly, assess the person’s right to be part of the group. Professionals are often ambitious and competitive individuals, and many people live in fear

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of their incompetence being displayed.

Moreover, employees also avoid engaging in colleague-to-colleague feedback, either because they are afraid to hurt other people’s feelings, or because they fear that their feedback will lead to frustration and a thirst for revenge”, said Claus Adam Jarløv, explaining that feedback is therefore often reduced to an unstructured and superficial response that does not create real value.

ments, but rather a factor that contributes to creativity and cooperation”, said Claus Adam Jarløv, adding that: “At GlobalDenmark, we work with a special feedback model that maps out opportunities, allowing a valuable exchange of ideas to take place by virtue of cultural differences, and not despite cultural differences”.

Culture-neutral work tools enhance constructive generation of ideas However, if conducted in the right way, feedback can serve as an important catalyst for stimulating the best ideas and talents in an organisation.

Consequently, feedback is a crucial element in the organisation’s toolbox.

GlobalDenmark offers courses on how to promote the use of culture-neutral tools that are quick and easy to implement, while at the same time reflecting a number of psychological and cognitive processes that break down the silo mentality and cultural barriers in an organisation.

“By using tools that are culture-neutral, cultural differences are no longer disturbing ele-

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

BRINGING THE BEST IDEAS AND TALENTS INTO PLAY

Feedback across professional groups and nationalities GlobalDenmark’s feedback model, DIDS (Describe, Identify, Discuss, Summarise) is a catalyst for learning and ideas. The model is culture-neutral and steers clear of irrelevant psychological speculation.

GlobalDenmark has been using the model for the last ten years and has tested it on PhD students from all over the world, as well as on researchers and senior researchers from private life-science companies and public-sector research organisations. According to Claus Adam Jarløv, the feedback model makes it possible to focus on a performance or an idea without letting assumptions and psychological guesswork interfere in the process.

“The DIDS model may seem simple, but it’s actually more complex than that.

When used correctly, the model steers clear of a large number of psychological and cultural mechanisms, while at the same time enhancing knowledge sharing

and generation of ideas,” said Claus Adam Jarløv, adding that the model paves the way for dialogue across cultures, professional backgrounds and hierarchies.

“The model is a key tool for knowledge-intensive, multi-cultural organisations who want to base their existence on developing ideas and talents. A subordinate employee can give feedback to his or her manager so that both parties will learn

FACTS GlobalDenmark a Danish consultancy firm with more than 35 years of experience in international and cross-cultural management, collaboration and knowledge-sharing.

One of the primary fields of activity

from the process; a researcher can give

at GlobalDenmarks is training and

feedback on a colleague’s sketch of ideas

education of researchers from all

without this causing jealousy or fear of

over the world. More than 2,500

the researcher stealing the idea. Simi-

PhD students and a large number of

larly, a Chinese researcher can provide

researchers and senior researchers

valuable feedback to a Danish colleague, and the Danish researcher can subsequently provide feedback to the Chinese colleague. This enables the two colleagues to learn from each other on an ongoing

have attended GlobalDenmark’s courses over the past ten years.

Among other things, this has provided them with specific tools to

basis and to build a relationship based on

stimulate knowledge sharing and

trust. Thereby, their cultural differences

generation of ideas across profes-

become a value-creating factor. The basis

sional and national cultures.

for the best idea has been established”.

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PROFILE

Interpreting scientific data to meet regulatory demands Getting the full overview and understanding of how to incorporate regulatory demands into the development plans or the production may be a challenge to life science. The insights and toxicological expertise at DHI help life science companies tackle these challenges in order to stay on top of patient safety.

Medicines are heavily reg ulated having to meet high standards for product quality and safety. The medtech industr y faces equally high reg ulator y demands with the implementation of the new medical device reg ulation.

-Clearly, patient safety goes beyond any other consideration when it comes to medicinal products or medical devices. And that is the position and the motivation from the reg ulator y authorities, says Senior Toxicologist, ERT Brian Svend Nielsen, at DHI.

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-The more we learn and understand about the effects of the compounds known as CMR, i.e. carcinogenic, mutagenic, or toxic for reproduction, and endocrine disruptors, the more critical control and documentation of product safety becomes, he says.

Knowing what the future may bring An increasing amount of research provides new evidence on compounds that were believed to be safe when they were initially introduced.

-The reg ulation is obviously coming into

action somewhat slower than the scientific evidence is published. We make an effort, however, to know the science indepth. As a result, we are also able to advise our clients on how they can avoid problematic compounds or excipients that may not currently be subject to reg ulation but are likely to become reg ulated in the near future, Brian Svend Nielsen explains.

Strategic advice Poul Bo Larsen is Chief Toxicologist at DHI and along with 25 colleag ues he provides expert

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

assistance to life science companies. As the area is of high focus with the reg ulator y authorities, it is important for the life science industr y to be on the alert.

-The larger companies may have sufficient manpower and expertise in-house to meet the demands on documentation, but small or midsize life science companies may not. But this is not something you would want to overlook.

Hence, we offer strategic advice on selecting the right materials that comply with the reg ulator y demands for

PROFILE

product safety. It could

the threshold level. In

Poul Bo Larsen

Brian Svend Nielsen

also include advice on

case of the latter, the

Chief Toxicologist, DHI. Poul has more

Senior Toxicologist, European Regis-

finding substitutes in

documentation needs to

than 25 years of experience in hazard

tered Toxicologist (ERT), DHI. Brian’s

case certain elements of

be in place and followed-

and risk assessment of chemicals

focal point is his in-depth expertise

a production give rise to

up with monitoring and

and chemical pollutants for industry

in human toxicology coupled to the

a safety concern, Poul Bo

quality control, ads

and authorities. His background also

regulatory requirements for use of

includes serving as the national expert

chemicals in industry and in pharma-

continues,

on health risk assessment of chemicals

ceuticals and medical devices. Another

in numerous working groups in the

area of interest is the use of computer

-In case a contamination

EU and the OECD, and he has been

modelling, such as in silico and QSAR,

requires a change of

the national representative in the Risk

to model pharmacologic or physiologic

process DHI can advise

Assessment Committee, RAC, at the

processes in order to avoid testing on

clients about potential

Euro-pean Chemicals Agency, ECHA.

animals.

Larsen explains.

He gives another example: -In case a minor change in processes have been applied, such as a new method of sterilization, an increase in production temperature, or a change

Brian Svend Nielsen and

alternatives based on our large chemical knowledge

in hoses where migrating

and insights.

softeners may be found

Problem solving

in the final product, this

FACTS about DHI

As the toxicologists

To the life science industry, DHI offers regulatory and

the end user.

at DHI are experts

toxicological expertise for documentation of safety and

Meticulous risk assessments

in pinpointing the

regulatory compliance.

problems related to

may potentially expose

How is the actual risk

product safety when it

assessment performed?

comes to problematic

W hile the toxicological and chemical analyses are performed by contract laboratories, the data

chemical properties, it is a key driver also to help clients identify and find solutions.

interpretation and

- We are a bit like

evaluation are performed

investigating detectives.

at DHI.

We look carefully for any

-We evaluate both the final and preliminar y products that are under suspicion of being contaminated somewhere in the production line. And doing so we document the origin and further assess whether the contamination is problematic or is below

potential problems, and once identified we use our knowledge to g uide the companies in a new and lasting direction that complies with the reg ulator y demands.

This enables our clients to proactively ensure product and patient safety

Regulatory and toxicological services

• • • • •

Safety assessment of materials, constituents and impurities Biocompatibility, documentation and ISO standardization Chemical characterization, leachables and extractables Global registrations

Testing and risk assessment

• • • •

QSAR (quantitative structure-activity relationship) and read-across Testing strategies Exposure scenarios and risk assessments Health-based exposure limits – OEL (Occupational Exposure Levels) and PDE (Permitted Daily Exposure.

For more information: www.tox.dhigroup.com

on a continuous basis.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

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FoodTech 2018 offers a wide variety of activities, including the innovation competition FoodTech Challenge & InnovateFood.dk, which will be held in the new concept hall Tech City. The photo shows the 2016 winners. Photo: MCH/Torben Worsøe

FROM A WORLD CONGRESS TO AN INNOVATION COMPETITION: FOODTECH OFFERS PLENTY TO SEE AND DO Source: FoodTech, MCH A/S

Northern Europe’s largest food technology expo, FoodTech, would like to invite you to MCH Messecenter Herning, Denmark for three days of exhibitions and new knowledge, from 13–15 November 2018. Among the new attractions this year are Tech City, an innovative new meeting place for the food industry, and the IFC World Congress.

W

hen FoodTech gathers the entire food industry in Herning for the twelfth time, the programme will once again offer plenty of new things to see and do. In addition to the nearly 300 exhibitors presenting the latest ideas and product groups in the field of food and technology, visitors can look forward to discovering a wealth of activities – including the 5,000 m2 concept hall Tech City in Hall F, where technology and knowledge converge.

“Tech City invites you to a wealth of activities, all of which will focus on the concept of ‘tech’. Whether you are attending a conference or exhibition, exhibitors and visitors will experience a clear recurring theme related to technology and industrial food production,” said John Dørr Jensen, Project Manager at FoodTech.

World Congress at FoodTech One of the many new experiences waiting in Tech City is the IFC World Congress, which will include a series of Danish and international speakers from, among others, Danish Crown, Arla Foods and Grundfos, all focusing the sustainable use and reuse of water in the food industry.

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The IFC World Congress will be held from 14–15 November, and the programme has been designed to introduce participants to the food industry’s goals and strategies for sustainability – while also reviewing various future scenarios with regard to water and water consumption.

In addition, a number of selected experts will present the latest new knowledge about water treatment, food safety and measurement methods.

Popular innovation competition As in 2016, the innovation competition FoodTech Challenge & InnovateFood.dk is again part of the FoodTech programme.

This time, the competition has been moved to Tech City, where 50 selected students from all over the world will have three days to develop the best idea in food technology. Here, the students will work in small teams where each team receives a specific task from a major Danish company; and the students must then come up with the best possible solution for the given case. This year’s case companies are among the industry’s largest and most well-known companies and include Arla, KMC, Marel, Chr. Hansen and Tulip, among others.

FoodTech Challenge & InnovateFood.dk will conclude on the final day of the expo, 15 November, when a panel of judges will select a winning team.

A wealth of activities at FoodTech In addition to Tech City, the IFC World Congress and FoodTech Challenge & InnovateFood.dk, visitors can also look forward to experiencing a wide variety of activities, including the International Food Contest in Hall M, where food and dairy products from all over the world will be exhibited and evaluated; FoodLab in Hall L, where laboratory equipment manufacturers will be demonstrating their food products and solutions; FoodTech Product News, where a number of exciting products have been awarded stars for their innovation value; as well as the ScanStar stand in Hall F, where visitors can see the eight Nordic packaging solutions that have been honoured with a ScanStar.

FoodTech will be held on 13–15 November 2018 at MCH Messecenter Herning.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

This year, FoodTech is playing host to a major international conference. The IFC World Congress focuses on water reuse in the food industry. Photo: MCH/Tony Brøchner

FOODTECH STRENGTHENED BY INTERNATIONAL CONFERENCE ON WATER REUSE Source: FoodTech, MCH A/S

When FoodTech opens its doors from 13 to 15 November 2018 at the MCH Messecenter Herning, the trade fair will be complemented by the IFC World Congress, an international conference that focuses on the reuse of water in the food industry.

W

ater is fast becoming an expensive commodity – it is expensive to buy in the first place and wastewater treatment is also costly. In many places around the world, there are serious shortages of clean drinking water, so there is good reason to save water to safeguard clean drinking water for future generations.

The food industry uses large amounts of water and therefore both the Danish and global food industry are very interested in saving water and reusing their process water and wastewater.

In fact, it is possible to reuse wastewater – and that is precisely the focus of the international conference that is being held at the same time as FoodTech. The conference is called the “IFC World Congress” and will be presenting the latest developments and opportunities related to sustainable water use and reuse in the food industry.

Wastewater can be cleaned and reused Among the keynote speakers already listed on the programme are the CEO of the Danish Food & Agriculture Council, Karen Hækkerup, and the Chairman of the Carlsberg Group, Flemming Besenbacher.

A group of experts with special knowledge of water treatment and reuse is responsible for implementing the conference.

Among them is Søren Nøhr Bak, Segment Director at Grundfos BioBooster, who explains: “The goal of the conference is to provide participants with insight into the technical and economic opportunities for reusing water, including how to reuse their water without compromising food safety. In addition, the conference will reveal how far we have come with regard to the sustainable use of water in the food industry. What can we do here and now?

And what challenges are we facing?”

Sustainable use of water The programme has been designed to introduce delegates to the food industry’s sustainability goals and strategies. The conference will also examine various future scenarios with regard to water and water use. Selected experts will present the latest knowledge about water treatment, food safety and measurement methods.

sentatives from the food industry will give specific relevant examples of sustainable water use, including water reuse and recycling in the food industry.

One of the members of the congress working group is Jan Dalsgård Johannesen, Environment and Climate Manager at Arla Foods. He points to a wide range of areas where technology can help businesses in the food industry to improve the sustainability of their water use. Jan Dalsgård Johannesen says: “There is a constant need for new knowledge and new technology in the field of water. However, it is also important to implement new water treatment techniques in production as quickly as possible, and ensure that we lead the way in the sustainable development of water.”

Similarly, process suppliers will present the latest technical solutions, and repre-

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

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FoodTech offers a wealth of exciting new products on 13–15 November 2018 at MCH Messecenter Herning, Denmark. You will find the ScanStar winners in Hall F. Photo: MCH/Tony Brøchner

EXPERIENCE THIS YEAR’S SCANSTAR WINNERS AT FOODTECH Source: FoodTech, MCH A/S

FoodTech will feature an exhibit of the packaging solutions that have been honoured with a ScanStar prize for their outstanding design and functionality. You can see the exhibit at ScanStar’s stand in Hall F.

S

canStar is a united Nordic packaging competition that is hosted annually by the Scandinavian Packaging Association (SPA). The competition is open to all packaging solutions that are designed, constructed or produced in one of the Nordic countries. This year, ScanStar was organised by the Danish Technological Institute, Plastics and Packaging, in Taastrup, where the panel of judges also gathered. The judges received a total of 23 different packaging solutions for their review, and eight of them were awarded a ScanStar prize.

All of the ScanStar prize winners will be on display at the ScanStar stand in Hall F, where FoodTech’s many visitors can experience these new and exciting packaging solutions. On 13 November at 2 p.m., you can attend the awards ceremony at the ScanStar stand, where the winners will receive their ScanStar prize.

Sustainable packaging is on the rise Sustainability and convenience remain important trends in the packaging market. This year, fibre-based packaging dominated, while there were only a few plastic solutions compared to previous years. The trend is to replace more traditional plastic packaging with fibre-based packaging, which can be easily recycled, making it a more sustainable alternative.

In general, the judges look at the level

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of protection and functionality provided by the packaging, the quality of the user experience, the information provided, and how sustainable and easy to discard it is.

an additional advantage overall. Multivac has given thought to sustainability, food waste and the environment in the design and use of this packaging.

Among the eight ScanStar winners that you can experience at FoodTech, you will find a cardboard tray from Finnish Jospak Oy and newly developed packaging for cold cuts from Multivac.

A ScanStar paves the way for a potential WorldStar

Cardboard tray from Jospak Oy The design of the cardboard tray from Jospak Oy takes into account visual communication, material applications and recycling. The clear instructions on the bottom of the packaging make it easier for the consumer to sort the packaging for recycling. The effortless separation of the film and fibres makes sorting easy, and the overall design supports the impression of a sustainable packaging solution.

Double-layer packaging for cold cuts from Multivac This innovative plastic packaging from Multivac has been designed with two separate layers to reduce food waste by allowing the consumer to keep their cold cuts fresh for longer. After opening the first layer, the sliced meat has a shelf life of five days, while the second layer maintains its full shelf life of 30 days. The benefits of preventing food waste significantly outweigh the disadvantages of using extra plastic, giving this packaging

Søren R. Østergaard of the Danish Technological Institute, Plastics and Packaging, chaired the ScanStar panel of judges this year. He says: “I can definitely recommend that all visitors to FoodTech stop by the ScanStar stand in Hall F to see the eight Nordic packaging solutions that have been honoured with a ScanStar. They are all newly developed packaging solutions that offer great value to both the manufacturer and the consumer.”

The eight ScanStar winners have automatically progressed to the global WorldStar competition, where the world’s newest and most innovative packaging will be competing to receive a WorldStar – the highest accolade that packaging can receive. The WorldStar competition was held earlier this year in Australia. A total of 194 packaging solutions from all over the world received a WorldStar Award.

This year’s ScanStar panel of judges comprised Lasse Lavrsen of Toms Gruppen, Sandra Pousette of RISE Bioeconomy, Ole Anton Bakke of Jotun A/S and Markus Joutsela of Aalto University.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

R

R

R

THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

THEME

SCIENTIFIC & CLINICAL COLLABORATIONS COPENHAGEN HEALTH SCIENCE PARTNERS - A joint initiative from The Capital Region and Copenhagen University, which aims at shortening the distances between the researchers at the laboratories and the clinicians by strengthening the translational collaborations between researchers.

14

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

FROM PETRI DISH TO BEDSIDE IMPLEMENTATION

By Charlotte Strøm, MD PhD Journalist

In late June 2018 four scientific/clinical collaborations were announced as Clinical Academic Groups (CAGs) by Copenhagen Health Science Partners (CHSP), highlighting a stronger focus on bringing ideas and results from the laboratories into clinical practice for improved patient care.

Usually it takes years from

it brings together scientists

a basic research finding is

who normally would have

done till it is implemented

never met if it was not for

in clinical practice to the

this specific collaboration.

benefit of patients. A joint

I believe that both basic

initiative from The Capital

researchers and clinicians

Region and Copenhagen

gain new insights and

University, CHSP, aims at

inspiration from these col-

shortening the distances

laborations, says Director

between the researchers

at CHSP, Per Jørgensen.

at the laboratories and the clinicians by streng thening the translational collaborations between researchers.

The initiative was inaug u-

The Clinical Academic Groups represent an initiative of bringing scientists together in new collaborations. It’s an opportunity for both basic

rated in 2017 and the first

researchers and clinicians to gain new insights

four CAGs were announced.

and inspiration, says Director at Copenhagen

In late June 2018 another four CAGs were announced.

The set-up of the CAGs with a strong management focus is inspired by similar initiatives in the U K. -The structure and management of the hospitals and the universities represent different mindsets that tend to be carried over into thinking a bit in silos.

The CAGs create forums where the ref lections and ideas of the researchers and the clinicians enrich each other. And certainly,

Health Science Partners, Per Jørgensen. Photo

by Pernille Hollerup.

THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

International panel of peers select the CAGs He explains how the selection of this year’s CAGs within asthma, cancer immunotherapy, osteoarthritis, and childhood infections was done.

money. Each CAG receives

sions of the traditional

-We are currently nego-

0.5 million Danish kroner

research networks – also

tiating with The Danish

each year for two years,

for the established research

Technical University and

and in addition the costs

groups, Per Jørgensen says,

The Region of Zealand to

of enrollment of 3 ph.d.

continuing,

join the CHSP. We will have

students equivalent of 1.35 million Danish kroner. In total the research grant amounts in an estimat-

-We have established an

ed value of 2.35 million

independent, international

Danish kroner. Some would

panel of experts to evalu-

arg ue that these are small

ate the applicant projects,

amounts compared to the

in acknowledgement of

considerable size of the

the importance of having

research projects outlined

competent peers review the

in the CAGs.

project plans. The panel of experts have understanding of both basic, translational, and clinical research, and moreover research management.

-Some of the research groups, both at the hospitals and at the university, may be somewhat isolated.

The CAGs aim to facilitate the f low of information and also possibly solve practical issues, such as the need for access to blood samples for the basic researcher.

to change the name accordingly to accommodate the larger geographical reach of the partnership. It is an important achievement to enclose more hospitals and thus more patients and clinical researchers along with technical expertise and scientists with different perspectives and

Long-term commitment

approaches on the problem

ers in the new CAGs are

Per Jørgensen highlights

solving from the DT U, Per

well established with

that both Copenhagen Uni-

Jørgensen says.

long standing tradition of

versity and the politicians

fundraising. The money is

at The Capital Region have

-Most of the research-

not what makes the biggest

committed themselves to

A total of 13 projects had

difference here. It helps,

use CHSP for a continued

applied to become a CAG

obviously, but I do think

focus on streng thening the

this year and four of these

that the most important

cross-sectional research

were selected as this year’s

aspect is that the CAGs

for improved patient care.

CAGs. With the announce-

manage to establish new

In fact, CHSP is about to be

ment comes also a bag of

collaborations and exten-

expanded.

About Copenhagen Health Science Partners •

Copenhagen Health Science Partners is a partnership between The University of Copenhagen and The Capital Region of Denmark. The partnership is established to strengthen the cooperation between researchers in basic laboratories and clinical researchers in the hospitals.

•

University researchers and clinical researchers can use CHSP to learn from each other and develop new ideas, resulting both in faster scientific results and better treatment of patients.

•

A strong collaboration between university and hospitals aim to create breakthroughs within near-patient health research and facilitate increased cooperation with the business community, creating more jobs in the healthcare industry. At the same time, the research result will raise the level of education among university graduates employed in the healthcare system.

•

The Capital Region of Denmark provides a number of health services to its 1,8 million citizens and attends to an average of 13.000 patients each day in hospitals and clinics. More than 4.000 scientists conduct innovative research at the University of Copenhagen and the hospitals.

16

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

PROFILE

NIRAS to strengthen Life Science foothold in Nordic region NIRAS will strengthen its focus on Life Science even further and the aim is to increase the number of industry specialists employed in the Nordic region by 2020.

After the merger with Alectia in 2017, consulting engineering group NIR AS now employs around 2,200 people worldwide, though predominantly in the Nordic region. The Life Science business area is set to become much bigger in coming years.

“The ambition is to grow this business area strongly so that by 2020 we’ll have even more specialists employed and an even stronger foothold in the Nordic region, especially Sweden and Nor way,” says Bo Vestergaard, Market Director at NIR AS. NIR AS’ Life Science employees are highly experienced with specialist insight in the industr y, just as they know the requirements in GMP production (Good Manufacturing Practises) and what it entails to work in a hugely reg ulated market.

“Requirements in the Life Science industr y are sk y high, not least for documentation, and this can seem rather over whelming for some

companies,” says Bo Vestergaard.

A unique feature at NIR AS is its ability to draw on different competencies from different ser vices and industr y segments.

“We have lots of experience from the process industr y and are extremely good at combining knowledge from different industr y segments. For example, when working with logistics, we can draw on our employees in the Food & Beverage segment, who are highly experienced with logistics solutions and lean f low production,” says Vestergaard.

NIR AS helps Life Science companies that are subject to reg ulator y authority requirements, help them address these requirements and make sure they are in place before production start-up.

“We help with both the reg ulator y requirements, but also consultancy ser vices and investment projects such as new production lines,” says Vestergaard.

About half of NIR AS’ work in Life Science is specialist consultancy ser vices within GMP production and design and together with the customer, it helps define the right level for new production, whether this be an entirely new production line or upgrade of an existing production line to make it compliant with new reg ulator y requirements.

“We do audits, feasibility studies, develop business cases, work with GA P analysis and much more.

All to provide the company with a sufficient basis for decisions, which again will ensure that the right level of quality is being kept throughout the process,” says Vestergaard.

After that initial work, NIR AS makes investment forecasts, designs the plant, layout and optimises processes ongoing.

“We are involved from the raw material comes in and till we have a finished product at the other end of the production line,” says Vestergaard.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

Bo Vestergaard, Market Director at NIRAS

Focus on sustainability, increased competitiveness, higher efficiency and lower costs are other areas which NIR AS helps its Life Science customers address.

But higher efficiency at a time when medicines are increasingly being customised for each patient, resulting in smaller production batches, may provide a real challenge.

“It requires innovation and creativity,” says Vestergaard.

www.niras.dk

17

THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

CAGS 2018 ON ASTHMA, CANCER, OSTEOARTHRITIS, AND CHILDHOOD INFECTIONS

By Charlotte Strøm, MD PhD Journalist

Four new research collaborations were presented at the announcement of CAGs 2018. The projects cover a wide range of common diseases with major impact on patient health in both children and adults. Read on and learn more about this year’s CAGs and what questions the researchers are trying to find the answers to.

CAG Modulating the Infant Microbiome for Disease Prevention CAG Modulating the Infant Microbiome for Disease Prevention is looking into improved prevention of chronic inf lammator y diseases and treatment of paediatric asthma. Imbalance in the bacterial composition and maturation of the intestines and air ways can affect children’s risk of developing asthma later in life. The overall aim of the CAG is therefore to understand the connection between

data collected from a moth-

immunotherapy are rapidly

require greater knowledge

er-child group within the

being approved for treat-

exchange and collabora-

COPSAC2010 project. Over

ment of still more forms of

tion between clinicians

the last eight years the

cancer. The new treatment

and researchers. CAGci

project has followed chil-

options indicate that far

has established a strong

dren with an imbalance in

more patients, even where

research-clinical partner-

the bacterial compositions

the disease has spread, can

ship organization between

and thus increased risk of

become sur vivors of cancer.

universities and hospitals

developing diseases. The

Immunotherapy is based

in the Capital Region of

mother-child group data

on the immune system’s

Denmark. By streng thening

offers a unique opportu-

ability to approve and kill

the cross-institutional and

nity to outline the mecha-

cancer cells and will lead to

cross-disciplinar y knowl-

nisms that link the infant

changes in most, if not all,

edge exchange between

microbiome – before the

forms of cancer treatment

clinicians and researchers

emergence of disease – to

over the next few years.

within cancer immuno-

the development of common chronic inf lammator y diseases.

285,000 Danes live with a cancer diagnosis. In Denmark the one-year sur vival

therapy CAGci will be able to explore the potential of immunotherapy of benefit to patients, relatives and

the infant microbiome and

The CAG Modulating the

rate for cancer is 75% for

the development of chronic

Infant Microbiome for

men and 77% for women.

inf lammator y diseases.

Disease Prevention involves

The implementation of new

CAGci enclose 12 research

a total of 29 research part-

forms of immunotherapy

partners across universities

ners across universities and

has been so rapid that many

and hospitals.

hospitals.

clinicians face pressing

In the Western world the prevalence of asthma and other chronic inf lammator y diseases has more than doubled over the last 50 years. Between 250,000 and 300,000 adult Danes have been diagnosed with asthma, and a total of 7-10 per cent of all schoolchildren in Denmark suffer from asthma.

CAG in Cancer immunotherapy (CAGci)

questions and challenges with regard to the treatment. The overall aim of

society.

CAG Host Infections Laboratory research Drugs (CAG CHILD)

CAGci aims to improve

CAGci is to develop evi-

CAG CHILD aims to improve

treatment with immuno-

dence-based clinical solu-

prevention and treatment

therapy for cancer patients

tions to these challenges

of the large number of

to ensure that more cancer

and to offer evidence-based

children affected by infec-

patients sur vive. Immuno-

training of health staff in

tions each year. There is a

therapy represents a major

cancer immunotherapy.

need for fast and reliable

and significant break-

Further development

The studies will be based

through in cancer treat-

on a large amount of unique

ment, and new forms of

18

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

within immunotherapy will

diagnostics and effective prevention of infections.

This lack causes 50% of all

THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

children to be treated un-

ers and clinicians, including

knowledge in practice, thus

to rarer, life-threatening

necessarily with antibiotics

all four paediatric wards in

reducing the consequences

infections such as menin-

during the first two years of

the Capital Region of Den-

of these diseases.

gitis.

their life and 30% to be hos-

mark. This makes it pos-

pitalized with an infection

sible to collect biological

Infection is the most

The CAG will contribute to

during childhood. This has

material from children suf-

frequent cause of disease

the implementation of the

significant socio-economic

fering from infections and

among Danish children

latest new knowledge on

and human costs and con-

infection-like inf lammation

and responsible for 10% of

prevention and diagnosing

tributes to the antibiotic

and to apply it in basic

all deaths among children

in the healthcare system’s

resistance crisis.

research. The research col-

below the age of one. In-

handling of infections in

fections include ever y thing

children and employs a to-

from common air way infec-

tal of 60 research partners

tions not requiring treat-

across universities and

ment seen in all children

hospitals.

CAG CHILD consists of an ambitious group of highly committed basic research-

Photograph www.ty-stange.dk

laboration will contribute with new evidence-based strategies and streng then the implementation of new

THEME: SCIENTIFIC & CLINICAL COLLABORATIONS

CAG Research OsteoArthritis Denmark – Prevention and treatment through the lifespan of patients (CAG ROAD) It hurts and it is wide spread. Osteoarthritis (OA) is increasing in prevalence and CAG ROA D aims to im-

without OA. Similarly, persons with OA who are active in the work force have 3.3 million more sick days a year than other workers. In total, OA-related expenses cost society 11.5 billion Danish kroner in 2010.

prove the quality of life of

CAG ROA D focuses on pre-

persons with OA, which is

vention and development

the second most widespread

of better treatment for pa-

condition in Denmark

tients. Based on the latest

next to allergies. Around

new research-based knowl-

900,000 Danes suffer from

edge CAG ROA D will shed

At the launch of the 2018 CAGs representatives from each CAG made a short

OA, and the costs of the

light on the risk factors

presentation of the aim of the CAG, while Per Jørgensen (Director CHSP), Ulla Wever

condition both with regard

and disease mechanisms

to treatment and loss of

affecting the development

production are substantial.

of OA. In light of the demo-

In Denmark persons with

graphic development with

OA pay their general prac-

increased life expectancy

titioners 2.7 million more

and an expected increase

visits a year than people

in the number of persons with obesity, the number of persons with OA is likely

(Dean Copenhagen University) Diana Arsovic Nielsen, (Director at The Capital Region), and regional politician, Lars Gaardhøj explained on the motivations behind establishing the partnership and the CAGs. Photo by Simon Skipper Christiansen.

significant socio-economic

and other professionals

consequences in the form of

within the field of OA.

treatment costs, handicap,

Together they will translate

reduced quality of life and

basic and clinical research

lost earnings.

into improved quality of life for persons with OA.

to grow possibly leading

CAG ROA D is a streng th-

to great human and social

ened cross-disciplinar y

CAG ROA D holds 29 re-

costs. In addition, OA has

partnership between

search partners across uni-

researchers and clinicians

versities and hospitals.

Photograph www.ty-stange.dk

20

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

BIO-EUROPE 2018

WELCOME TO 24TH ANNUAL INTERNATIONAL PARTNERING CONFERENCE

NOVEMBER 5–7, 2018 ‍ ‍ ‍ / /‍ ‍ ‍ ‍ COPENHAGEN, DENMARK

Photo by Martin Heiberg, Copenhagen Media Center.

Source: EBD Group

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BIO-EUROPE 2018

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BIO-Europe is produced by EBD Group, the leading partnering firm for the global biotechnology industry, with the support of the Biotechnology Innovation Organization (BIO).

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

25

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Breakfast, Grab & Go Lunch, Coffee Breaks

CATERING

EXHIBITING COMPANIES

EXHIBITING SPONSORS

NOVEMBER 5–7, 2018 BELLA CENTER COPENHAGEN, DENMARK

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BIO-EUROPE 2018

BIO-EUROPE 2018

PARTNERING AREA & EXHIBIT, HALL C

NOVEMBER 5–7, 2018 BELLA CENTER COPENHAGEN, DENMARK

ACCESS TO: HALL E

HALL B

• Exhibit • Catering

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G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

25

BIO-EUROPE 2018

HIGHLIGHTED EVENTS AT BIO-EUROPE 2018 IN COPENHAGEN Monday, 5 November 2018 07:45 - 18:00:

Registration and Exhibition Open Exhibition - Hall E and Hall C

09:00 - 10:30:

Workshop, Pediatrics: Searching new drug solutions for the people we love most - Room B1

The panel of high-profiled executives will explore the challenges and opportunities for drug development, clinical studies and new formulations for children including a review of the regulatory context both in the US and Europe.

10:45 - 11:15:

Presentation: Welcome and Opening Remarks – Room C1

11:15 - 12:30:

Opening Plenary Discussion: Europe: The global innovation trailblazer - Room C1

The panel will examine success stories from Europe, and highlight strategies to help invigorate entrepreneurs by nurturing partnerships, share best practices from external resources, and intelligently secure funding in order to expand research within Europe and beyond.

13:30 - 14:30:

A panel discussion about partnering trends in the pharma world - Room B3–B4

How does big pharma expand pipeline opportunities?

13:30 - 14:30:

Panel discussion: AI's implications for the future of drug discovery - Room B1–B2

In this panel discussion, we bring together thought-leaders in machine learning and artificial intelligence to delve into the opportunities, capabilities, future trends and challenges of using AI to speed up drug discovery, decrease failure rates in drug trials and create more affordable and better treatments for patients.

17:15 - 18:15:

Panel discussion: How are geopolitics affecting biopharma’s future prospects? - Room B3–B4

How has pharma adapted to the new geopolitical landscape? What challenges lie ahead and what should pharma do to manage any risks involved?

Tuesday, 6 November 2018 09:00 - 10:00:

Panel discussion: Commercialization of cell and gene therapies - Room B4

Hear experts discuss the infrastructure needed to develop best practices for manufacturing and providing the safe and effective delivery of cell and gene therapies.

09:00 - 10:30:

Presentation: University of Copenhagen – Building value out of curiosity: How basic research leverages the biopharmaceutical industry - Room B3

10:45 - 11:45:

Presentation: Spotlight on Denmark - The place to conduct clinical trials - Room B5

14:00 - 15:00:

Panel discussion: Using new business models to forge stronger partnerships in today’s biopharmaceutical industry - Room B4

What is the optimal strategy for different commercialization scenarios? Panelists will share their perspectives on solutions across the lifecycle of a product.

15:00 - 18:00:

Startup Slam Copenhagen - Room C1

Startup Slam is a pitching competition offering emerging entrepreneurs a chance to pitch their company.

Selected companies will present their innovative technologies to a panel of judges comprising business development executives, venture capitalists and industry experts.

Wednesday, 7 November 2018 10:00 - 11:00:

Presentation: Is the ecosystem of translational metabolic research in greater Copenhagen sustaining a competitive biotech industry? - Room B4

10:30 - 12:00:

Panel discussion: Harmonization of Health Technology Assessment in Europe - Room B5

-

This panel will discuss the impact of a stronger collaboration on Health Technology Assessment within the EU.

16:00 - 17:00:

CLOSING RECEPTION: Reception to welcome BIO-Europe 2019, November 11-13 in Hamburg, Germany - Hall E, Booth #97

26

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

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28

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

RECRUITMENT AND EDUCATION

CALL ON DANISH LIFE SCIENCE COMPANIES TO TAKE ON MORE DANISH GRADUATES

By Karin Jensen

Young academics struggle to get a job after graduation and companies often require many years of experience or pick graduates from abroad. Recruitment agency calls on the Life Science industry to take on more Danish graduates and give them a chance to prove themselves.

TEMP-TEAM, the Danish

Unemployment among

large generation of ageing

recruitment and temporar y

Danish graduates has been

employees who are getting

employment agency, is

a consistent problem since

close to retirement.

swamped with job appli-

the financial crisis. Howev-

cations from graduates,

er, many large Danish Life

who wish to work in the

Science companies are at-

Life Science industr y but

tractive to work for and are

do not even get invited to

often in a position where

a job inter view. And that

they can pick and choose

is a shame, because the

from top graduates from

graduates possess many

both Danish and interna-

Another idea could be to

qualities despite their lack

tional universities.

think in a more untradi-

of experience, according to the agency.

“It’s a problem that Danish companies pick foreign

Training at Atrium At Atrium, focus is on training and further edu-

“So why not hire more

cation in the Life Science

graduates and train them.

industr y, offering courses

They don’t have ten years of

for people who works in

experience, no, but expe-

all aspects of life science,

rience must be acquired,”

including pharmaceutical

says Kjær.

companies, the public sec-

tional way, for example train a graduate with an academic background to work

tor and medical agencies.

“Our prime goal is to ensure that employees in life science are well-qualified, both in relation to their

“They are clever, fast and

graduates before Danish

adaptable, have an ac-

graduates,” says Kjær, who

ademic approach, good

would like to see Danish

lang uage skills, know IT

Life Science companies take

“We have to be a bit more

careers. We offer ever y-

and social media. There

on more Danish graduates

open and perhaps change

thing from introductor y

are so many competencies,

and help them gain expe-

the culture somewhat.

courses to Masters’ pro-

rience. Training a foreign

The graduate may be a bit

grammes,” said Søren-Ulrik

job inter view,” says Margit

graduate costs money and

overqualified for lab work

Rolsted Fangholm, Director

Kjær, who is responsible for

time too, she says.

but it’s also about getting

and Head of Department at

a chance, create a network

Atrium.

but they don’t even get to a

recruiting academics in the Life Science industr y.

Furthermore, the Danish labour market has a

in a laborator y as is often seen in other countries.

and gain some experience,” says Kjær.

ever yday work in a ver y restrictive industr y but also in relation to their personal

Examples of people taking courses at Atrium could be a pharmacist who has to learn the discipline of pharma-

"... the Danish labour market has a large generation of ageing employees who are getting close to retirement."

covigilance, or a business graduate finding employment in sales and marketing in the Life Science industr y.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

29

RECRUITMENT AND EDUCATION

“There is a ver y special

“We also have courses for

After graduating, Harting

“It’s a great opportunity to

ling uistic code you need to

those with fifteen years of

was unemployed for almost

show a company what you’re

learn before getting a job

experience and two Masters’

six months and, like many

made of. During the eight

in the industr y. And the

degrees,” says Fangholm.

other graduates, struggled

weeks, Boehringer Ingel-

to get a break. He then

heim saw my potential and

decided to take the course

offered me a job,” says Søren

“Pharma Understanding,”

Harting.

more experience you gain, the more specialised you’ll have to be, and the higher

From unemployed to international job at GN Hearing

the requirements will be,”

A one-day course at Atrium

where he met people from

Fangholm says.

kick-started Søren Harting’s

the Life Science industr y.

career in the Life Science

Introductor y courses

industr y. Søren Harting

provide newcomers in the Life Science industr y with knowledge on for exam-

graduated from the Copenhagen Business School in 2015 and during his studies,

ple anatomy, physiolog y

he worked at Novo Nordisk

and medical understand-

and wrote his Masters’ the-

ing but other wise Atrium

sis at Pfizer.

offers courses at all levels to match the entire value

“I have always been fasci-

chain in life science, from

nated by the pharmaceu-

research, clinical trials,

tical industr y” says Søren

reg ulator y work, authority

Harting.

approval and market

Harting worked for Boehringer Ingelheim for around

“I spoke with someone from

two years and a few weeks

Boehringer Ingelheim and

ago, he started a new job at

we agreed that I should send

GN Hearing.

my CV over. After a while, I was invited to an informal job inter view,” says Harting.

“It’s a dream job for me.

I get to work with international responsibilities,

Initially there were no spe-

which was always my goal,”

cific job openings, but Søren

says Harting.

Harting and Boehringer Ingelheim agreed that he should do an eight-week internship.

access and launch.

Margit Kjær, Senior Recruitment Specialist at Temp-Team and Søren-Ulrik Rolsted Fangholm, Director and Head of Department at Atrium

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BIOTIN INTERFERENCE IN IMMUNOASSAYS

Recent studies and case reports are driving awareness that Biotin can interfere with laboratory testing. Patients, laboratories and physicians may not know about the presence of Biotin, so education and awareness can help reduce the potential for diagnostic errors.

Biotin beware – why?

GORDON AVERY MSC, SCIENTIFIC LIAISON MANAGER IN ABBOTT, GIVES A BRIEF OVERVIEW OF BIOTIN INTERFERENCE IN SOME IMMUNOASSAYS In 2015 a 55-year-old man with multiple sclerosis was referred to a hospital thyroid unit because the screening thyroid function tests showed markedly elevated FT4 and FT3 results and low (apparently suppressed) levels of TSH 1, this pattern of results typically suggests a severe form of Graves’ disease. However a thyroid scan with 123-Iodine showed a normal thyroid gland with normal radioiodine uptake. The patient showed no symptoms of hyperthyroidism. As the biochemical results were discordant with the patient’s clinical assessment, investigations for assay interference from drugs or other compounds were conducted.

It emerged that the patient had taken very high doses of biotin (300 mg daily, roughly 1,000 times the recommended daily intake) as a study had suggested that biotin might be beneficial for multiple sclerosis patients. The discontinuation of biotin supplements resulted in the FT4, FT3 and TSH results returning to within reference range values in just a few days.

BIOTIN INTAKE AND ASSAY INTERFERENCE Biotin interference in immunoassays from several manufacturers has been described by other authors, with clear examples of potential clinically misleading test results 2.

The mechanisms for biotin interference in immunoassays have also been described 3. Biotin (vitamin B7) is a hydrophilic compound that acts as a coenzyme in carboxylase reactions, and is therefore an essential nutrient. Biotin is readily available in many foods and the recommended daily intake (about 30 μg per day) is easy to achieve.

Although initially only very high levels of biotin have been considered as a cause of “incorrect” laboratory results, further studies demonstrated that even at moderately elevated biotin concentrations, some assays may be affected, causing either a falsely elevated or a falsely decreased test result 4, 5.

The mechanism of biotin interference differs depending on the format of the assay 5. When biotin-streptavidin binding is used as part of a sandwich assay format, for example for some TSH assays, excess biotin in the sample can displace biotinylated antibodies resulting in falsely low results. In contrast in competitive immunoassays, for example some FT4 assays, excess biotin in the specimen can compete with the biotinylated analog for the binding sites on streptavidin resulting in falsely high results.

Patients may not realize they are taking supplements that contain biotin, labs will not know if specimens contain biotin and physicians could make decisions based on inaccurate lab results.

Immunoassays involving streptavidin-biotin interaction are used by many reagent manufacturers and have the potential to show interference from biotin by one of the mechanisms described above. Patients not taking biotin supplements would not be expected to show any assay interference.

However, people taking biotin supplements may have much higher biotin intakes, with daily oral doses of up to 40 mg per day. Supplements, often described as “good for nails and hair”, containing very high doses of biotin are readily available, even on supermarket shelves, and are becoming increasing popular. Some studies, in patients with multiple sclerosis and demyelinating pathologies, show patients receiving very high doses of biotin (300 mg per day). In the presence of high biotin concentrations there is potential for competitive and sandwich assays using the streptavidinbiotin format to generate misleading test results 5. It is therefore important that the laboratory considers its choice of assay, and recognises the possibility of biotin interference if test results do not fit with each other or with the clinical picture. Where biotin interference is possible or expected, the biochemical results should be obtained or checked with assays that are not affected by biotin interference.

Abbott has recently conducted an evaluation and no on-market ARCHITECT assay formulations use the free capture streptavidin/biotin assay format referenced in recent articles that have been associated with interference from ingested high dose biotin.6

5 STEPS

TO HELP REDUCE LABORATORY ERRORS CAUSED BY BIOTIN

ADD-00061021_EN_WIRED_Issue 4_Biotin May 2018

1. Raise Awareness 2. Know your assays and the impact biotin can have on them 3. Educate your health care providers and patients 4. Have a contingency plan for acute care settings 5. Recognize there are laboratory methods that are not impacted by biotin that can provide an alternative option for your patients

ABOUT: BIOTIN Biotin, also referred to as Vitamin B7 or H, is a water-soluble B-complex vitamin that helps the body metabolize proteins, fats, carbohydrates and process glucose. Biotin is a safe and essential vitamin for supporting overall health and plays a role in medicine and the beauty sector.

SUMMARY • Biotin (vitamin B7) is an essential nutrient for which an intake of 30 μg per day is recommended. Supplementation is normally not necessary since biotin is ubiquitous in common foods.

• As well as being available as a “beauty” supplement, biotin may be administered to patients with multiple sclerosis, myopathies and with some inherited metabolic diseases.

• Though biotin is considered non-toxic even at high dosage, the potential clinical issue is that these doses have the potential to generate misleading results in some immunoassays.

• Biotin has been demonstrated to impact assays that use biotin–streptavidin binding as part of the assay format, including thyroid function tests, other endocrine assays, assays for cardiac biomarkers and other analytes.

• Some immunoassay formats are not affected by biotin and may be used to check unexpected results from assays that are affected, and/or may be preferred if the patient is known to be receiving biotin supplementation.

References: 1. Barbesino G. Misdiagnosis of Graves’ disease with apparent severe hyperthyroidism in a patient taking Biotin megadoses. Thyroid 2016, 26: 860 – 863.

2. Elston MS, Sehgal S, DuToit S, Yarndley T, Conaglen JV. Factitious Graves’ disease due to biotin immunoassay interference – a case and review of the literature. J Clin Endocrinol Metab 2016, 101: 3251 – 3255.

3. Wijeratne NG, Doery JC, Lu ZX. Positive and negative interference in immunoassays following biotin ingestion: a pharmacokinetic study.

Pathology 2012, 44: 674 – 675.

4. Kwok J S-S, Chan I H-S, Ho-Ming M. Biotin interference on TSH and free thyroid hormone measurement. Pathology 2012, 44: 278 – 280.

5. Piketty ML, Polak M, Flechtner I, Gonzales-Briceño L, Souberbielle JC. False biochemical diagnosis of hyperthyroidism in streptavidinbiotin-based immunoassays: the problem of biotin intake and related interferences. Clin Chem Lab Med 2016. DOI: 10.1515/cclm-2016-0606.

6. Product Information Letter PI1011-2017.

INDUSTRY NEWS

NEWS FROM THE INDUSTRY Edited by Arne Nielsen

State-of-the-art flow cytometry CRO ImmuMap expands to offer cellular therapy safety package Numerous companies within immune-oncolog y have been founded in the past years, while also existing large companies increasingly have turned their attention to this field, aiming at manipulating patients’ immune system to fight cancer in different ways. The treatments most advanced in the clinical process are the checkpoint inhibitor antibodies and the chimeric antigen receptor (CAR) T- or T cell receptor (TCR)-transduced cell therapies. For the CAR T and TCR-transduced cell therapies a huge concern is cross-reactivity and safety issues related to this.

Previously, several of these treatments induced fatal side effects due to cross-reactivity of the TCR to unrelated tissues. We recently established several assays based on f low cytometry and next-generation sequencing for measuring alloreactivity and the TCR fingerprint to overcome this.

ImmuMap CEO Thomas M. Frøsig in front of the highend LSR Fortessa II f low cytometer.

“We are now established on the market with several returning customers. We look forward to applying our expertise for new clients by moving into this area, in addition to our previous work within immune monitoring, phenotyping, activation and antigenspecificity”, says ImmuMap CEO Thomas M. Frøsig.

For more information visit w w w.immumap.com

DUKADA® Trio – Unique add-on for insulin pens ¬DUK ADA Trio® is a unique Smart Cap especially designed for the insulin pens Novo FlexPen® from Novo Nordisk and Sanofi Solostar® from Sanofi. The coverage of other insulin pens is considered. The base is thinking on how to make insulin pens meet daily life needs of users of insulin pens. It is one of the most innovative insulin pen add-ons in Europe which was designed and is produced in Denmark. The high quality Danish design is elegantly blended with functionality.

It includes distinctive features that facilitate diabetes life with insulin pens.

•

Timer

•

Needle Light

•

Flex-Grip

•

Sun-Light protection

The unique sun-light protection (useful all year round but especially in summer time) protects the insulin container of the insulin pen when the insulin pen is used.

The timer provided on DUK ADA Trio records the time since the latest insulin injection, and it can be easily retrieved. The needle light allows diabetics to take insulin in the dark, while the Flex-Grip is dedicated to diabetics that have shaking hands – or inject insulin on the go - and it has been proved a highly helpful

34

means that stabilizes the hands during the insulin injection.

DUK ADA ApS has developed a network of distributors and retailers in Europe. Recently, DUK ADA ApS started the distribution of their products in Amazon all over Europe.

Source DUKADA ApS - For more visit www.dukada.com

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

INDUSTRY NEWS

Lactobio is developing a new screening platform The new screening platform consists of new probiotic isolates collected from multiple different sources and donors. The new strain collection is the foundation for screening and identification of new lactic acid bacteria with specific characteristics suitable for modulation of the microbiome to prevent or manage different diseases. Screening technologies include various antimicrobial assays and a new project focus on the fight against antibiotic multi-resistant bacteria has obtained very promising results. Lactobio has isolated and identified new probiotic strains being able to inhibit growth of Methicillin Resistant Staphylococcus aureus (MRSA). MRSA is a major concern and currently one of the most common nosocomial pathogens, thus a leading cause of a variety of hospital-acquired infections. The isolated lactic acid bacteria have antimicrobial activity and inhibit the growth of MRSAs.

Source Lactobio ApS For more visit www.lactobio.com

ViroGates announces the first suPARnostic® TurbiLatex product.

The prognostic biomarker suPAR (soluble urokinase Plasminogen Activator Receptor) is a strong measure of chronic inf lammation and underlying risk of negative outcomes including short-term mortality, and is highly suited for risk evaluation in Emergency Departments.

Now it will be even easier to measure suPAR in the hospital laboratories, as the first suPARnostic® TurbiLatex product has just been launched – validated for Roche Cobas analyzer. Thereby suPAR can be automatically determined simultaneously with other blood parameters at the central laboratories, and the result automatically 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.

This way, the healthcare systems can allocate resources more effectively.

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.

Source ViroGates - For more visit www.virogates.com

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

35

INDUSTRY NEWS

New generation of single-use bags reduces the risk of process loss and contamination The utilization of single-use systems continues to grow, and so does the concern about the purity levels of the single-use components and their potential impact on high-value final products. From the high cost of losing product due to assembly failures at fill/ finish, to ever-increasing scrutiny from regulatory bodies, every angle requires protective measures.

With a product design that incorporates the purity, integrity and performance standards of the microelectronics industry with the regulatory and quality requirements for life sciences, the new Aramus single-use 2D bags from Entegris allow you to protect and store your high-value process solutions with reduced risk of process loss, contamination or compromised quality and efficacy.

The Aramus single-use 2D bags are made of a

high-grade, gamma-stable f luoropolymer (Tef lon), providing higher purity, greater compatibility and increased safety for critical process f luids and final products.

With a new single-layer technolog y that contains no curing agents, antioxidants, plasticizers or adhesives, the number of potential contaminants is greatly reduced.

These single-use bags offer the widest operating temperature range, making them more durable in frozen applications (down to -85° or lower without going brittle or porous). This groundbreaking quality offers a safer process, reducing the risk of product loss.

Source: Alf low – For more www.alf low.dk

Xvivo System - X3 Hypoxia Hood and Culture Combo Xvivo X3 is the world's first incubation and handling system designed exclusively for meeting the needs of cells. Unlike traditional CO2 incubators and BSCs, the CytoCentric® Xvivo X3 platform features several design attributes to accommodate a Cell’s need for: •

Full Time Protection: closed incubators, closed hoods, medical grade gases, and continuous internal HEPA filtration ensure that cultures are never exposed to room borne contaminants

•

Full Time Optimization: every cell incubation, cell handling, and cell analysis step occurs within a controlled, cell optimized workf low that prevents exposure to randomly varying and non-optimal room air

•

Physiologic Simulation: all incubator and hood modules are programmable for matching in vivolike levels of O2, CO2, pH, and Temp

•

Protocol: since different cell cultures require different conditions, independently control multiple cell experiments at the same time under different cell protocols of O2 and CO2

•

36

Dynamics: since the cellular microenvironment isn’t static, program any incubator chamber or hood module with controlled changes of O2 and CO2 to match metabolic state, cell expansion requirements, or pathological modeling

•

Fit: the f lexible design of Xvivo X3 provides configurations for any application, any budget, and any space with plenty of future upgrade options to avoid equipment dead-ends

Source Ninolab - For more visit www.ninolab.dk

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

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INDUSTRY NEWS

Evotec and Ferring form strategic research alliance In October, Evotec and Ferring

Dr Mario Poly wka, Chief Operating

historical expertise in peptides

Pharmaceuticals announced a

Officer of Evotec, commented:

and tackling molecular targets

strategic research alliance to

"The integration of our industry-

that are best addressed using small

discover and develop new small

leading small molecule discovery

molecule therapeutics. Evotec is a

molecule therapies to treat

and development platform with

highly regarded company in this

patients living with fertility and

Ferring's deep disease expertise

field, and this alliance offers the

g ynecological conditions.

in reproductive medicine and

prospect of significant innovation

women's health will create a

for patients. Together, we have

powerful combination that we hope

the potential to make a difference

will create a difference for patients

for both men and women who

suffering from infertility and

are struggling to start a family,

g ynecological disorders. We very

and for women suffering from

much look forward to working with

g ynecological conditions."

Evotec will apply its drug discovery platform to design novel, safe and efficacious treatments in partnership with Ferring.

The multi-target, multi-year collaboration aims to deliver small molecule pre-clinical development

such an innovative partner."

(PDC) and investigational new

Per Falk, Chief Science Officer,

drug (IND) ready candidates. As

Ferring, added: "To achieve

part of the alliance, Evotec is

leadership in reproductive

eligible for undisclosed research

medicine and women's health,

funding and milestones.

we are expanding beyond our

Source: Evotec AG

Universal ergonomical tool for the lab Mikrolab ErgoSkru reduces wrist twist and effectively reduces EBA when screw caps are to be closed and opened on bottles and vials.

Automation of routine tasks ErgoSkru from Mikrolab is designed so that both the vial and the screwdriver are fixed in the direction of rotation. This prevents twist in wrists and hands when tightening and loosening of the screw caps. ErgoSkru ensures consistent screwing and unscrewing, and eliminates sources of error caused by manual closing.

The torque of the screwdriver can be adjusted to suit different types of glass, tubes and bottles.

Intuitive operation and setup Special training is not required to operate Mikrolab ErgoSkru. Quick installation and setup: Connect

Pneumatic equipment creates safe working conditions

compressed air and mount suitable rack and screw

ErgoSkru can be used in and out of fume cupboards

head and the device is ready for use. Pressing the

or LAF benches and is 100% powered by compressed

button on the screw motor quickly selects between

air, which allows it to be used in explosion hazardous

screwing and unscrewing. It can be customized to

areas (ATEX).

any size or type of lid. The base plate is not fixed and

Mikrolab offers a free three weeks trial.

can easily be moved around in the laboratory. Can be purchased with a screw head that holds the lid if it

Source: Mikrolab â&#x20AC;&#x201C; For more visit www.mikrolab.dk

needs to be re-screwed shortly after.

38

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

Welcome to the future 13-15 November 2018

The entire food industry meets at FoodTech, and you are invited.

Come and join thousands of colleagues when more than 300 Danish and international exhibitors give you insight into the future food industry.

You can experience many exciting activities at FoodTech 2018: FoodLab area where suppliers of laboratory equipment present the latest products and solutions for the food industry and several other events.

Read more and get your free ticket at uk.foodtech.dk

PROCESSING & PACKAGING | 13 - 15 NOVEMBER 2018

Photo: Aaron Burden

PATENTING NATURE-BASED PRODUCTS IN THE US

By Andreas Lauge Christensen, Patent Attorney at Plougmann Vingtoft and Jan Mondrup Pedersen, European Patent Attorney & Partner at Plougmann Vingtoft - www.pv.eu

Life science and pharmaceutical companies seeking patent protection of nature-based products are increasingly challenged by strict and complex US patent laws. Here, we highlight a key element that should be considered before filing a patent to the US authority.

Until recently, the bar for patentable

occurring equivalents, are more frequent-

subject-matter in the US was defined by

ly challenged by objections under the new

“anything under the sun that is made by

strict and complex interpretation of 35

man”. Two recent decisions from the US

USC § 101.

Supreme Court has done away with this mantra, in a way that affects products that are nature-based. With Mayo Collaborative Servs. vs. Prometheus Labs.

Inc. (2012) and Ass. Mol. Pathology vs.

Myriad Genetics Inc. (2013) has come a new paradigm with the aspiration of the US Supreme Court to prohibit monopolizing patents that tie up future use and innovation. This concept is known as pre-emption and has been the primary motivation for the USPTO to draw up new guidelines (Interim Guidance on Patent Subject Matter Eligibility) for their Examiners to follow when deciding whether a patent claim related to a nature-based product is patent eligible or amounts to a judicial exception under 35 USC § 101.

Under this new paradigm, life science and pharmaceutical companies seeking to protect products, processes or uses that in some aspects may be related to naturally

40

THE MAYO-TEST A principal set of questions, schematically illustrated on the next page (fig.1), determines if a patent claim to a nature-based product is deemed patent eligible or not.

Steps 2A-B are known as the Mayo-test

STEP 2A – “MARKEDLY DIFFERENT” FROM THE NATURALLY OCCURRING EQUIVALENT? The first step of the Mayo-test boils down to whether the nature-based product can be categorized as markedly different from the closest naturally occurring equivalent. Only those limitations of the patent claim relating to the naturally occurring equivalent are evaluated in step 2A.

and are used to evaluate e.g. compounds

Practice of the USPTO is largely formed

from natural extracts, food products, or-

by the jurisprudence of the courts, where

ganisms such as bacteria and plants, and

markedly differences may for instance be

proteins and peptides.

found in:

According to the guidelines, the Exami-

•

ners are obliged to present prima facie evidence (such as a court decision) to justify a 35 USC § 101 objection. However, the reality is that the burden of proof to

• •

pass the Mayo-test for patentability often lies with the applicant. Consequently, it is important to act proactively in prosecution opposite the USPTO.

•

Biological or pharmacological functions or activities Chemical and physical properties Phenotype, including functional and structural characteristics Structure and form, whether chemical, genetic or physical

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

LEGAL UPDATE

Only if the natural equivalent is not considered markedly different will the nature-based product be further evaluated in step 2B.

STEP 2B – “SIGNIFICANT MORE” THAN THE NATURALLY OCCURRING EQUIVALENT? In the second step, the Examiner evaluates if further elements are sufficient for the patent claim to constitute significant more than a judicial exception according to step 2A. In contrast to the markedly different-analysis of step 2A, the patent claim is evaluated as a whole in the significant more-analysis of step 2B. This part of the Mayo-test is relative vague, but amongst others the USPTO provides the following examples from the Supreme Court that qualify as significant more:

• • •

Improvements to another technology or technical field Effecting a transformation or reduction of a particular article to a different state or thing Adding a specific limitation other than what is well-understood, routine and conventional in the field

The additional features of a patent claim must be evaluated both individually and in combination with each other. Individual elements, which do not amount to significant more, may in combination represent significant more than a judicial exception.

LEGAL VALIDITY OF INTERIM GUIDANCE

Fig. 1: This infographic shows how the United States Patent and

According to the USPTO, patent claims re-

Trademark Office (USPTO) assess patentability under 35 USC § 101.

lated to nature-based products that clearly do not tie up future use and innovation will not be evaluated by the Mayo-test, but will be prosecuted under streamlined analysis. As the USPTO has emphasized that the new guidelines are by no means binding to the US courts, questions concerning the validity of such patents pertains. Thus, future opponents will likely

USPTO Patent Trial and Appeal Board or

to the interpretation of the individual

in district court with the argument that

Examiners. At Plougmann Vingtoft we

the patent claims are not valid under a

have experience with objections raised

complete Mayo-test.

under the new paradigm and recommend

PATENT CLAIMS IN THE US PROSPECTIVELY

to focus on solid fallback options containing structural limitations. This recommendation is corroborated by the fact that

challenge the validity of patents granted

At present, handling of objections under

the US courts appear also to prefer struc-

under the streamlined analysis at the

35 USC § 101 is unpredictable and subject

tural limitations.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

41

HIGHLIGHTED COMPANIES

HIGHLIGHTED COMPANIES NOVEMBER 2018

Lactobio has built a proprietary discovery and screening platform of new isolated probiotic strains. We are dedicated to the development of innovative microbial products and concepts to fight bacterial infections or microbiome dysfunctions associated with specific diseases.

In Lactobio we focus on creation of new microbial solutions, we work with the gut, oral, skin and vaginal microbiota to create new products targeted to specific needs.

For more information visit www.lactobio.com

Mikrolab Aarhus A/S has been serving customers in Denmark and abroad for almost 50 years. The product range extends widely and includes everything in equipment and consumables for analysis in pharma, food, environment and industry.

Latest news is a large range of sampling equipment for product control. Mikrolab also produces both standard and customer-specified equipment for optimization and prevention of work related injuries in the laboratory.

For more information visit www.mikrolab.dk

Alflow Scandinavia A/S offers a wide range of single-use products and solutions for the pharmaceutical and biotech industries. With 20 yearsâ&#x20AC;&#x2122; experience and our one-stop-shop concept, we provide state-of-the-art, high-quality single-use products and solutions to help our customers secure and optimize their valuable single-use processes.

For more information visit www.alflow.dk

DUKADA ApS was first established in 2012 and started the development of the add-on for insulin pens, DUKADA Trio which was presented to the market in 2015.

DUKADA Trio combines innovative solutions and Danish design for people living with diabetes. The company is focused on innovation in the field on injection delivery systems based on user experiences.

Today DUKADA ApS has an important number of distributors, as well as presence in Amazon all over Europe.

For more information visit www.dukada.com

42

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | N OV E M B E R 2018

HIGHLIGHTED COMPANIES

Mode-of-action cellular analyses using multiparameter flow cytometry • We are a contract-research organization generating data for customers needed in the decision-making process • We provide customer-tailored solutions in the field of immune-oncology and autoimmune diseases • We help biotech companies of all sizes, primarily the middle- and large-sized ones, and companies in the pharma industry • We offer state-of-the-art cellular immune analyses using multiparameter flow cytometry and cell culturing • Our agility and flexibility are highly appreciated by our clients Visit www.immumap.com or contact CEO Thomas M. Frøsig, tmf@immumap.com/+45 61781882 for further information.

For Axlab gælder det om at være et skridt foran, læse den teknologiske udvikling, forstå morgendagens udfordringer, og ikke mindst fornemme de nye politiske og forskningsmæssige vinde.

Vi arbejder for løsninger, der sikrer kunderne effektivitet langt ind i fremtiden. I den forbindelse råder vi ikke bare over det mest avancerede teknologiske udstyr, men er også udstyret til fremtiden gennem vores innovative tænkning og rådgivning.

Resultatet er tidsbesparelser, bedre arbejdsmiljø og ikke mindst bedre service for både nutidens og fremtidens brugere og patienter. Hvis ikke vi forandrer verden, forandrer den os. I vores verden handler det at tænke fremad samt at formidle ny energi i alle vores kunderelationer.

For more information visit www.axlab.dk

LABEX offers system solutions for logistics, quality assurance, diagnostic analysis and production to blood banks, clinical laboratories, biotech and pharmaceutical industry.

LABEX offers system solutions for logistics, quality assurance, diagnostic analysis and production to blood banks, clinical laboratories, biotech and pharmaceutical industry.

By challenging today's routines and standards, by being curious and creative, we help our LABEX offers system solutions logistics, production to blood banks, clinical By challenging today's routines and standards, by being curiousfor and creative, we help our quality assurance, diagnostic analysis and customers succeed better with what matters to them. customers succeed better with what matters to them.

Together with our customers, we save lives.

Together with our customers, we save lives . laboratories, biotech and pharmaceutical industry.

Website: www.labex.dk / Meet us at booth no 108

Website: www.labex.dk / Meet us at booth no 108

By challenging today's routines and standards, by being curious and creative, we help our customers succeed better with what matters to them. Together with our customers, we save lives.

For more information visit www.labex.dk

MSCi: All kinds of complete solutions for GC – GCMS – HPLC. We deliver instruments and support for analytical chromatography and work with all aspects: Sale of complete, fully automated and unique solutions - Service and support - Training/workshops and applications.

MSC: We have access to a modern and comprehensive selection of instruments, and offer: Consulting and contract analysis work. Training courses, chromatography and biotechnology.

For more information visit www.msconsult.dk

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IS YOUR LABORATORY REACHING ITS TRUE POTENTIAL? Performing labs deliver results that drive better patient outcomes and improve healthcare value

Recognizing the challenges facing healthcare and clinical diagnostics, we at Abbott have been on a journey to deliver solutions that are personalized to your goals. Alinity is Abbottâ&#x20AC;&#x2122;s next-generation holistic family of systems, designed to simplify diagnostics and deliver unprecedented integration across key laboratory disciplines, helping you achieve measurably better healthcare performance.

For more information, please visit Alinity.com, ask your local Abbott Ambassador, or send an email: wired@abbott.com

Clinical Chemistry Alinity c

Immunoassay

Informatics

Alinity i

Alinity PRO

Hematology

Point of Care

Alinity hs Alinity hq

i-STAT Alinity

Molecular Alinity m

Transfusion Alinity s

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