Greater Copenhagen Life Science July/August 2017

JULY/AUGUST 2017

THEME:

THE EUROPEAN MEDICINES AGENCY - Looking for a new host - The Danish candidacy - Business continuity is a top priority

— THE ANNUAL STAKEHOLDER EVENT, FOLKEMØDET: - Life science as a major growth driver - Patients’ involvement in innovation - Big data, telemedicine, and healthcare robots

— UPCOMING EXHIBITIONS: - MEDICA and COMPAMED 2017 - LabDays 2017

— GENERIC DRUGS AND BIOSIMILARS - When medicinal products come off patent

CONTENTS July 2017 Publisher:

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

Editors: Karin Jensen Charlotte Strøm Arne G. Nielsen and Mohammed Ali Wachah

THE COLUMN

4

BRAIN PRIZE - CALL FOR NOMINATIONS

5

ANNUAL POLITICAL FESTIVAL, FOLKEMØDET

6

THEME: EMA POST BREXIT

8

EMA is looking for a new home

10

EMA in copenhagen – a realistic candidate?

12

Business continuity is a top priority

17

How to handle centralized procedures post brexit

18

UPCOMING EXHIBITIONS

20

LABDAYS 2017

22

NEWS FROM THE INDUSTRY

24

MAGNIFYING LOUPES 26 GENERIC DRUGS AND BIOSIMILARS

28

CALENDAR 30

Graphics & Layout: Kapteina Reklame

Advertisement: Mohammed Ali Wachah +45 23238080 mw@nemmedia.dk Rasmus Andersen +45 42811110 ra@nemmedia.dk

Print: Green Graphic & Signtec Reklame

In cooperation with:

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THE COLUMN

Denmark – a candidate for hosting the European Medicines Agency Foreword by Lars Rebien Sørensen, Special envoy of the government

W

ith a strong Danish tradition for focusing on patient safe-

there is a highly competent and professionally skilled workforce

ty, an important research environment, and a flourish-

for the European Medicines Agency to tap into at any given time.

ing and innovative pharmaceutical industry, we firmly believe that Copenhagen is equipped to provide all the conditions nec-

A well-developed infrastructure is vital for the flexible and ef-

essary to enable the European Medicines Agency to operate as

fective operation of the European Medicines Agency, as well as

effectively as today once it will

for the agency’s employees and

have to relocate after Brexit.

their

Furthermore, Copenhagen is

Airport,

well-connected, easy to reach,

ed best Northern European

and offers a range of hotels

Airport, is the largest hub in

ready to accommodate the

Northern Europe and is situ-

many visitors to the Europe-

ated only 8 km from Copenha-

an Medicines Agency. Last but

gen city centre. Copenhagen

not least, Copenhagen is one

also offers a well-developed

of the world’s most liveable

local infrastructure system,

cities and family friendly.

ensuring easy access and swift

families.

Copenhagen

repeatedly

award-

transportation. In regards to The

European

Medicines

digital infrastructure, Den-

Agency and Denmark share a

mark is likewise on top.

ceaseless, strong dedication to protect public and animal

Copenhagen is furthermore

health. The Danish health-

highly attractive for the em-

care system is characterised

ployees of the European Med-

by a strong commitment to

icines Agency and their fami-

patient safety and patient in-

lies with its well-functioning

volvement. The Danish com-

institutions,

mitment and tradition in this

public services, safe environ-

regard, and a continued Dan-

ment and large number of in-

ish contribution to the Euro-

ternational schools including

pean activities, create a good

a European school. High living

setting for the activities of the

standards, a healthy work-life

European Medicines Agency

balance, an informal work and

to ensure that all medicines

business culture, as well as a

available on the EU market

great mix of entertainment,

are safe, effective and of high

urban green spaces and sandy

quality.

beaches further add to this.

high

level

of

The Danes have strong lanCopenhagen offers a world-class research environment, where

guage skills, making it easy for the employees of the agency and

expertise and easy access to both researchers and professional

their families to work and live in Denmark.

research collaborations provide an excellent setting for the activities of the European Medicines Agency. Copenhagen is also

In conclusion, Copenhagen provides the ideal opportunities and

home to an innovative and vibrant life science industry with

conditions to ensure a successful relocation and further devel-

Danish and international companies that will provide a high-

opment of the European Medicines Agency. We will do every-

ly professional work environment. Close collaboration between

thing in our power to facilitate a smooth and efficient transition

companies, universities and the public health sector provides an

in order to ensure full operational continuity for both the agen-

ideal ecosystem for innovation and it furthermore ensures that

cy and the large number of employees involved.

4

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THE BRAIN PRIZE

CALL FOR NOMINATIONS - THE € 1 MILLION PRIZE Edited by Arne Nielsen

T

he time for identifying

The Prize may be awarded to

Nominations under active

For more information and

candidates for the € 1

one or shared by two or three

consideration by the Selection

nominations:

million prize, The Brain Prize,

scientists who have distin-

Committee will be retained

www.thebrainprize.org

which is awarded by the Lund-

guished themselves through

for a further 2 years, unless

beck Foundation, is present

publication of outstanding

specifically withdrawn by the

and the call for Nominations is

results in the field of brain

nominator. Re-nomination of

open until the 15th of Septem-

research. The prize may in

previous nominees is possible

ber 2017.

extraordinary cases be award-

and encouraged.

SOURCE: THEBRAINPRIZE.ORG

ed to four or more researchThe Brain Prize recognizes

ers. Nominees can be of any

highly original and influential

nationality and working in any

advances in research on the

part of the world.

nervous system, covering all aspects from fundamental

It was awarded for the seventh

studies to research related to

time this year, to Peter Dayan,

understanding and treatment

Ray Dolan and Wolfram Schul-

of diseases of the brain and

tz all based in UK.

other parts of the nervous system.

The Lundbeck Foundation

the brain pr1Ze 2017 1 million € is jointly awarded to

Peter dayan

ray dolan

wolfram schultz

Gatsby Computational neurosCienCe unit, uCl, united KinGdom

max planCK uCl Centre for Computational psyChiatry and aGeinG researCh and WellCome trust Centre for neuroimaGinG, uCl, united KinGdom

department of physioloGy, development and neurosCienCe, university of CambridGe, united KinGdom

‘for their multidisciplinary analysis of brain mechanisms that link learning to reward, which has far-reaching implications for the understanding of human behaviour, including disorders of decision-making in conditions such as gambling, drug addiction, compulsive behaviour and schizophrenia.’

the award ceremony will take Place on 4 may in coPenhagen all nominations were reviewed by the distinguished selection committee: anders björKlund, sWeden, viCe-Chairman Colin blaKemore, united KinGdom, Chairman joseph Coyle, usa

Geoffrey donnan, australia tom jessell, usa story landis, usa

philip sCheltens, the netherlands irene traCey, united KinGdom

The Brain Prize recognizes and rewards outstanding contributions to European neuroscience, from basic to clinical

ANNUAL POLITICAL FESTIVAL, FOLKEMØDET

LIFE SCIENCE HIGHLIGHTS FROM FOLKEMØDET 2017 More than 100.000 visitors over four days at the annual political festival, Folkemødet, 15-18 June at Bornholm participated in around 3.200 different event. Among them were a long list of events related to life science. Here are a few highlights.

By Charlotte Strøm, MD PhD Journalist

P

oliticians and people,

ness, and Financial Affairs

little on entrepreneurship.

and improve patient safety

representing private

presented 17 recommenda-

While Dean Ulla Wewer from

and quality assurance within

companies, public organiza-

tions to support and further

Copenhagen University agreed

the health sector. Nordic

tions, NGO’s, and the media

develop life science growth.

to the need for stepping up the

Healthcare Technology pre-

gathered to discuss and debate

Stakeholders representing the

private-public partnerships,

sented the Minjapp, a patented

all kinds of topics during the

Growth Team, Copenhagen

she underlined that providing

device that clicks onto all ma-

major annual stakeholder

University, start-ups, and

competent candidates and a

jor brands of insulin pens and

event, Folkemødet. Events

politics discussed whether

highly educated work force

comes with an app. The device

related to life science enclosed

life science growth is in fact

remains the key delivery of the

automatically registers the po-

topics such as patient safety,

realistic or illusionary.

universities. Structural ob-

sition of the injection site and

medical innovation and

Anders Thelborg from the

stacles on public listing at the

the app registers the data and

growth, clinical trials, health-

Growth Team on Life Science

stock exchange in Denmark is

guides the user to the correct

care technology, personalized

pointed to the need for an

also a major challenge, which

the injection site, allowing the

medicine, big data, education,

office to govern, coordinate,

is evident when comparing to

patient to comply with alter-

impartiality in healthcare

and provide assistance for life

Sweden, where 80 new start-

nating injection sites.

decisions, transparency, and

science in the same manner

ups were listed compared to 7

much more.

as what is seen in agricul-

in Copenhagen last year.

tural and maritime business

Two start-ups had three min-

How are patients involved in innovation?

Life science as a major growth driver

areas as top of the wish list.

utes to pitch their business

Representatives from the

Christian Vintergaard from

idea to the panel. Poros Health

Danish Medicines Agency,

By end March 2017 the Growth

The Danish Foundation for

Tech has developed an auto-

Kræftens Bekæmpelse as a

Team on Life Science under

Entrepreneurship stressed

mated tablet dispenser solu-

major NGO, Siemens Health-

the Ministry of Industry, Busi-

that the universities focus too

tion to reduce medicine errors

care, and Neurescue discussed

6

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

ANNUAL POLITICAL FESTIVAL, FOLKEMØDET

important tool in patient safe-

care robots are already in use

ty surveillance and treatment

at many hospitals in the oper-

of speech? A topic of discussion between key

benefits in large populations.

ating theaters, while making

stakeholders at Folkemødet 2017."

And while a series of tele-

use of diagnostic power from

medicine solutions in chronic

super computers is currently

obstructive lung disease, dia-

only being tested. Still, human

betes, congestive heart failure

healthcare professionals are

etc. have readily demonstrated

unlikely to be superseded any

patient benefits, it remains to

time soon as underlined by

be seen whether the invest-

Camilla Rathcke, representing

ments prove to be a return on

the younger physicians.

"Do healthcare professionals truly have freedom

how patient involvement

trials drives improved health

drives innovation in life

and prognosis as stated by Leif

science. Siemens Healthcare

Vestergaard, CEO at Kræftens

outlined how customized

Bekæmpelse. Neurescue is a

patient applications and

start-up working to provide

changes in existing equipment

solutions to improve surviv-

are readily based on patient

al after cardiac arrest. The

feedback. Patient involvement

founder of the company, Habib

is still of the utmost impor-

Frost is a medical doctor, got

tance in order to enable rapid

the idea for his innovation

clinical development of new

bedside. He saw the incorpora-

medicines, alongside an agile

tion of life science innovation

Bornholm after inspiration from the Swedish

and competent regulatory

into the medical education as

’Almedalsveckan’ a political festival taking place

process. Nikolaj Brun from

a major up-side that remains

at the island of Gotland in Sweden

the Danish Medicines Agency

to be explored.

pointed out that any interacthe pharmaceutical industry

Big data, telemedicine, and healthcare robots

is highly transparent to the

Several events discussed the

public, which is a foundation

opportunities and inborn po-

of the work of the Agency. And

tential ethical concerns relat-

from a patient perspective,

ed to the use of big data. Real

the involvement in clinical

world evidence has become an

tion that the Agency has with

investment financially. Health

ABOUT FOLKEMØDET •

•

Is taking place in week 24 annually at Allinge,

Has taken place since 2011 with increasing success; this year’s Folkemøde had more events and visitors than ever.

•

Visitors participate in events free of charge

•

For more information https://folkemoedet.dk/

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

7

THEME

EMA POST BREXIT “Copenhagen harbours one of the strongest life science industries in the EU, and as Chairman of Copenhagen University and CSO of Novo Nordisk I’ve seen first-hand how the excellent collaboration between academia and private sector in the Greater Copenhagen life science cluster changes people’s lives by turning breakthrough basic research into innovative medicines.

If the European Medicines Agency relocates to Copenhagen the cluster will become stronger – for the benefit of patients all over the European Union.”

Mads Krogsgaard Thomsen, Novo Nordisk Chief Science Officer.

THEME CONTENT 10 | EMA IS LOOKING FOR A NEW HOME 12 | EMA IN COPENHAGEN – A REALISTIC CANDIDATE? 17 | BUSINESS CONTINUITY IS A TOP PRIORITY 18 | HOW TO HANDLE CENTRALIZED PROCEDURES POST BREXIT

EMA is looking for a new home One of the consequences of the United Kingdom’s vote to leave the European Union comes into act by 1 April 2019 when the European Medicines Agency (EMA) will open in a new location. The big question is where. The answer is expected in October or November 2017.

By Charlotte Strøm, MD PhD Journalist

O

fficially, the European

2017 at the latest and so the list

Medicines Agency (EMA)

of candidate cities is steadily

has no opinion on its re-lo-

growing.

cation; however, a series of specifications describing the

From the European Council it

requirements of a new location

was officially announced 22

for EMA has been delivered to

June that the Heads of State

the EU Commission. The EMA is

or Government of 27 Member

being relocated along with the

States endorsed the procedure

European Banking Authority

for the decision of relocating the

(EBA), which is also currently

two agencies:

located in London because of

“The decision on where the

the UK’s activation of the Arti-

two agencies should have their

cle 50 of the Treaty on European

future seat should be taken on

Union notifying of its intention

the basis of a fair and transpar-

to leave the European Union.

ent decision-making process

All interested Member States of

with an organised call for offers,

the EU have the opportunity to

based on specified objective

submit their offer to host one or

criteria.”

both of the Agencies by 31 July

It is expected that an assess-

"It is expected that an assessment of the candidate cities will lead to a shortlisting. The assessment will be based on a series of objective criteria."

10

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

EMA POST BREXIT

ment of the candidate

Official criteria on relocation of EMA

What does it mean?

will be taken by a vot-

The assurance that the agency can be set up on site and take up its functions at the date of the United Kingdom’s withdrawal from the Union.

EMA needs a building with sufficient space for offices (current 27.000 m2), meeting rooms, auditorium (300 people) and off-site archiving (around 600 m2), high-performing telecommunication and data storage networks as well as appropriate physical and IT security standards.

ing process between the

Accessibility of the location

A well-connected airport nearby with frequent flights to all the capitals of the EU is important and so is public transportation to and from the airport. Quality and quantity of accommodation facilities are equally important as EMA is expected to continue the volume and intensity of current meeting activities (around 30.000 hotel rooms / year).

Business continuity

Given the critical nature of the services provided by the EMA and the need to ensure continued functionality at the existing high level, business continuity relates to the timeframe required to fulfil the four criteria above. It concerns amongst other things the ability of the EMA to maintain and attract highly qualified staff from the relevant sectors, notably in case not all current staff should choose to relocate. Furthermore, it concerns the capacity to ensure a smooth transition to the new location to guarantee the business continuity of the agency which should remain operational during the transition.

Geographical spread

There is an agreed desirability of geographical spread of the agencies' seats that were set in December 2003 by the representatives of the Member States and confirmed in 2008.

cities will lead to a shortlisting. The assessment will be based on a series of objective criteria. From here on, the decision

Member States. According to the EU Commission the final decision must ensure and allow for a smooth and timely relocation of the two agencies, hence the objective is to reach a decision on the new locations in the autumn of 2017. It is envisaged that the decision will be taken in the margins of the General Affairs Council in November 2017.

Source: The European Council http://www.consilium.europa.eu/en/press/press-releases/2017/06/22-euco-agencies-relocation/

CELGENE NORDIC HJÆLPER MENNESKER TIL ET BEDRE LIV Samarbejde er nøglen til succes. Ved at lytte og opbygge gode relationer til patienter, sundhedspersonale, forskere og beslutningstagere stræber vi efter at udvikle løsninger, som succesfuldt forandrer fremtidens sundhedsbehandlinger.

Sammen kan vi arbejde for at forbedre menneskers sundhed, så alvorlige sygdomme kan forebygges, diagnosticeres tidligt, behandles og måske endda helbredes.

Celgene ApS | Kristianiagade 8, 3. sal | 2100 København Ø | +45 352 716 00 | www.celgene.dk

NS-CELG170002

De nordiske lande er vigtige for Celgene. Her har vi igangsat en række initiativer, som styrker forskning og innovation, og som fremmer udbredelsen af nye behandlinger. I Norden er der dataregistre af høj kvalitet, og det skaber gode muligheder for at udføre klinisk forskning. Forskning er Celgenes fundament, og vi investerer mere end en tredjedel af vores overskud i forskning og udvikling. Formålet er at udvikle nye behandlinger til en række alvorlige sygdomme. Det gælder eksempelvis blodkræft og andre former for kræft samt inflammatoriske- og immunologiske sygdomme.

EMA POST BREXIT

EMA in Copenhagen – a realistic candidate?

Copenhagen is an official candidate city as is a long list of other European cities. We know by now what the official criteria are. But what are the odds and what are the potential unofficial parameters which may or may not influence the decision in the end.

By Charlotte Strøm, MD PhD Journalist

W

hen the Danish Govern-

(EMA), it sent the intended

developed by the European

scores for all parameters.

ment earlier this year

signal that this is highly a

Federation of Pharmaceutical

The report evaluates and

appointed former CEO at Novo

prestigious matter.

Industries and Associations

compares Rome, Lisbon,

Nordisk, Lars Rebien Sørensen

In March 2017, Novo Nordisk

(EFPIA) were categorized

Milan, Madrid, Barcelona,

as Denmark’s official delegate

had KPMG work out an assess-

into several parameters and

Brussels, Dublin, Bonn, Lyon,

lobbying in matters con-

ment report on comparison of

sub-parameters, and the

Vienna, Berlin, Amsterdam,

cerning the relocation of the

candidate locations. The crite-

candidate cities were ranked

Munich, Stockholm, Copen-

European Medicines Agency

ria for a new location for EMA

according to the sum of the

hagen, and Paris. However, as the deadline for submission of

Ranking the cities - Total points per city

a candidacy ends 31 July the number of cities is likely to

70

8

11

10

14

13

14

15

12

8

10

8

6

7

11

8

9

10

8

and size of life sciences clus-

9

8

ter, b) research and scientific

16

16

16

17

19

17

environment c) connectivity

7 8

The criteria that the rankings are based on cover a) dynamic

ag nh

r is

Co

pe

Pa

en

h

ol

ic

kh

da

in rl

st

m

and infrastructure d) national Am

na

13

er

18

15

Be

9

12

un

5 8

11

oc

5

11

St

9

15

57

m

13

13

grow even further.

57

M

12

en

bl

se

on el rc

Ba

52

12

Vi

14

52

8

n

16

50

nn

15

in

6 7

Bo

5 6

ls

7 5

a

r id

n

11

10

Du

14

ad

on

15

11

13

7

us

6 7 5

il a

Ro

m

e

0

9

M

10

sb

20

6 6 4 6

Li

30

48

8

12

9 5 8 5

M

32 5 6 7 5 9

Br

38

37

40

41

Ly o

48

46

50

63

56

55

60

62

Dynamic and Size of Life Sciences Cluster Research & Scientific Enviroment Connectivity / Infrastructure National Competent Authorities/ Political Stability/ Absence of Violence/ Terrorism/ Corruption Quality of Life - Attractiveness for Families and Spouses and Affordability of Housing

Total points per city as sum of the points for each parameter. Each parameter consists of 3-6 sub-parameters. Max points = 80

competent authorities/ political stability/ absence of violence/ terrorism/ corruption e) quality of life - attractiveness for families and spouses and affordability of housing. In the KPMG report Copenhagen is ranking second, just one point below Paris and with Stockholm in a third place.

In the overall ranking based on a series of predefined parameters KPMG concluded in March 2017 that Paris, Copenhagen, and Stockholm have the three highest scores pertinent to a new location of the European Medicines Agency. Source KPMG.

EMA POST BREXIT

Greater Copenhagen includes Southern Sweden

of the equation puts Copenha-

recruit from, more housing

Agency to keep the wheels

gen in a favourable position,

opportunities, more interna-

running the recruitment of

The Medicon Valley Alliance is

Petter Hartman explains, and

tional schools, and more hotel

highly qualified employees is

a non-profit membership orga-

carries on,

rooms, Petter Hartman says.

critical. For that a strong life

nization in the Danish-Swed-

-Furthermore, there is a clear

ish life science cluster Med-

upside to the report that has

-At the end of the day, this is

icon Valley, which is a part

not been enlightened so far.

all more of an advantage to

of Greater Copenhagen. The

The KMPG report only takes

Copenhagen as a candidate

Still, in his opinion, the KMPG

organization counts 245 mem-

the numbers into account that

city rather than Stockholm.

report clearly understates the

bers, who together employ

are sourced out of Denmark.

approximately 140.000 people.

However, the Medicon Valley

He would have liked to see one

-The numbers stated in the

Petter Hartman, CEO at Med-

is a life science cluster that

joint Scandinavian proposal

report reflect the Danish side

icon Valley Alliance is happy

has an outreach across the

for relocation of EMA.

of the cluster. Considering

to discuss the key findings

border between Sweden and

of the KPMG report, which

Denmark, enclosing both

-In a perfect world, Sweden

penhagen it includes Southern

ranks Paris, Copenhagen, and

Southern Sweden and Greater

and Denmark had probably

Sweden, and is a clear upside

Stockholm as top 3 on the list

Copenhagen.

raised the odds in their favour,

to the candidacy, he says and

if they had put in a joint can-

ends.

of feasible candidate cities for

science and academic environment is very important.

advantages of Copenhagen.

Copenhagen as Greater Co-

relocation of EMA. He points

The official spokesperson,

didacy. Still, both countries

to two major points that needs

Henrik Fritzon, from Region

appear to be ranking quite

-If the politicians play their

to be taken into consideration

Skåne has previously an-

high on the list.

cards well, I actually do think

when discussing the findings

nounced the region’s support

of the KMPG report that com-

of Copenhagen rather than

pares the candidate cities.

that the odds are quite good in favour of Copenhagen.

Stockholm as the favourite

Report understates the Danish candidacy

location for EMA post Brexit.

Based on the official crite-

part of a political drama at the

ria, Petter Hartman thinks

highest levels.

-By the time the report was is-

However, it is likely to become

sued in March 2017, Paris was

-This was obviously a source

Copenhagen has quite a good

still in the game. But France

of great debate internally in

chance. Additionally, a vibrant

The list of candidate cities is

has now officially announced

Sweden, but I think it stresses

and highly active life science

expected to be shortlisted in

Lille to be the French can-

that Southern Sweden and

environment appears to be an

October in order to reach a

didate city to house EMA in

Copenhagen is connected

obvious upside.

final decision by November

the future. I cannot put exact

through the life science

numbers on the advantages

cluster. Additionally, Medi-

-Some of the 900 employees

and drawbacks of Lille, but I

con Valley as a cluster adds

will relocate – but obviously

do think that leaving Paris out

yet a greater work force to

not all. In order for the

2017.

"In a perfect world, Sweden and Denmark had probably raised the odds in their favour, if they had put in a joint candidacy."

Petter Hartman, CEO at Med­icon Valley Alliance

13

WHY COPENHAGEN According to “Relocation of the European Medicines Agency� the top five reasons why Copenhagen provides the optimal conditions for the European Medicines Agency are:

1: World-class research environment Copenhagen offers a world-class research environment.

Denmark is the leading country in the EU in terms of number of clinical drug trials per capita.

2: Innovative and vibrant life science cluster Copenhagen is home to an innovative and vibrant life science cluster with Danish and international companies that will provide a highly professional work environment for the European Medicines Agency. Close collaboration between companies, universities and the public health sector provides an ideal ecosystem for innovation.

3: Strong focus on patient safety The Danish healthcare system is characterized by a strong commitment to patient safety and patient involvement.

This commitment creates a good setting for the activities of the European Medicines Agency to ensure that all medicines available on the EU market are safe, effective and of high quality.

4: Efficient infrastructure Copenhagen is easily accessible with efficient infrastructure and direct flights to all capitals and major commercial cities of the EU Member States from Copenhagen Airport.

5: High liveability Copenhagen has well-functioning institutions, a high level of public services, a large number of international schools, and the Danes have strong language skills. These conditions make it highly attractive for the employees of the European Medicines Agency and their families to live and work in Denmark.

Source: http://emacph.eu

READ MORE The KMPG report on comparison of locations for EMA: http://www.greatercph.com/a-way-of-life/about/location-comparison The website of the Danish candidacy: Relocation of the European Medicines Agency - http://emacph.eu

university of copenhagen

f a c u lt y o f h e a lt h a n d m e d i c a l s c i e n c e s

MASTER OF INDUSTRIAL DRUG DEVELOPMENT Get insight into the entire drug development process from molecule to market access Developed in close collaboration between University of Copenhagen and the pharmaceutical industry Courses combine outstanding academic-based research with an extensive contribution from leading experts from the pharmaceutical industry Enroll in the full programme or take individual courses

det sundhedsv

kø b e n h av n s u n i v e

Courses in 2017 Deal-making in the Pharmaceutical Industry Pharmacology Biopharmaceuticals Drug Development Quality by Design (QbD) in Pharmaceutical Development Market Access for Pharmaceutical Products – trends and challenges QA, QC, GXP for Pharmaceutical Production Clinical Pharmacology and Biostatistics Discovery and Development of Medicines

Read more at mind.ku.dk or e-mail master@sund.ku.dk

MASTER OF MEDICINES REGULATORY AFFAIRS Become the expert that can help secure a safe, coherent and successful regulatory process The Master will give you Thorough insight into the regulatory process at all stages during the development of medicines An overview of the differences in regulatory demands globally The competencies to analyse, predict and advise on medicines regulations and directives The Master programme is offered in collaboration with Medicademy – part of Lif Education.

Enroll in the full programme or take individual courses

Read more at mra.ku.dk or e-mail master@sund.ku.dk

Courses in 2017 Global Medicines Legislation and Guidelines Clinical Development – Efficacy of Medicines Regulatory Science Perspectives on Clinical Development Safety of Medicines – From Non-clinical Development to Pharmacovigilance Ethical, Societal and Assessment Aspects of the Regulation of Medicines Regulatory Affairs in the USA Regulatory Affairs in the EU Biopharmaceuticals – Quality Development and Documentation Quality – Active Substance and Medicinal Product

FACTS Key figures on EMA’s activities in 2016

•

EMA recommended 81 medicines for marketing authorization, including 27 new active substances, 11 new veterinary medicines for marketing authorization; six of these medicines contain a new active substance.

•

EMA received 84 PRIME (Priority Medicines) applications, a new scheme providing early and enhanced support to medicines that have the potential to address patients’ unmet needs.

•

The total number of applications for initial evaluation received was 114.

•

EMA received 118 notifications of withdrawn products from pharmaceutical companies.

•

EMA received 672 inspection requests for Good Manufacturing Practices and 121 for Good Clinical Practices.

•

EMA received 1843 requests for information.

Source: The European Council - http://www.consilium. europa.eu/en/press/press-releases/2017/06/22-euco-agencies-relocation/

EMA POST BREXIT

BUSINESS CONTINUITY IS A TOP PRIORITY As a strong national authority, the Danish Medicines Agency plays an important role in the attempts of having EMA relocate to Copenhagen.

By Charlotte Strøm, MD PhD Journalist

T

he relocation of EMA is

only without the UK, and at a

is likely to be the most import-

a highly complex matter,

different location than Canary

ant criterion.

and is likely also to become a

Wharf, says the Director Gen-

political hot potato as several

eral at the Danish Medicines

-The aspect of geographical

of the 27 Member States of the

Agency, Thomas Senderovitz.

spread, which is stated as

European Union have aired

desirable, is in my mind of

their interest and expectations

He continues,

less importance compared to

on the new home of EMA.

- Of course, it matters where

the need to ensure busi-

Thomas Senderovitz, Director General

EMA is located, because it

ness continuity, which also

at the Danish Medicines Agency.

For centralized procedures

should be in a new host city,

includes a strong host city and

during the marketing applica-

completely fulfilling the

national medicines agency,

tion procedure, the marketing

official criteria, i.e. assurance

who is willing to, and has the

authorization holder must

that the agency can be set up

capability of taking on more

demonstrate Copenhagen as a

be located in the EU as per 1

in time, accessibility to the

regulatory tasks. Furthermore,

serious candidate.

April, but other than that the

location etc. The regulatory

a geographical consideration

assessments and procedures

procedures at EMA are like a

may or may not meet the

-As a national medicines

are business as usual:

highly complex assembly line.

criteria on logistics, in terms

agency, and member of

In order to keep it running,

of location and capacity of the

international regulatory

-From a regulatory point of

we cannot allow the different

airport, hotel rooms etc. And

community we do our best to

view and from the view of an

stations to be unmanned at

moreover, the relocated EMA

maintain business continuity

applicant, the geographical

any time - even during a relo-

must be able to have a highly

in the European regulatory

location of EMA is not the

cation. Hence, the continuity

qualified work force to recruit

network, and through this and

key issue. The main challenge

of business is what is most

from. This is possible in some

our already ongoing increase

for the European regulatory

important.

of the cities that are among

in capacity and scientific ex-

the candidates, but hardly in

pertise, we demonstrate that

all of them, he explains.

we are able to keep the plates

network is to ensure continued operations even without

Business continuity is among

the English medicines agency

the official criteria as stated by

MHRA. We have to carry on

the European Council. Thomas

Thomas Senderovitz and his

period, which is a very critical

the business exactly as it was

Senderovitz stresses that this

colleagues are working hard to

point in time, he says.

spinning during the transition

"The aspect of geographical spread, which is stated as desirable, is in my mind of less importance compared to the need to ensure business continuity"

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

-I sincerely hope that the heads of states will take due consideration to the criteria in their decision making process.

That would definitely be key for the ongoing operations of our world-class European regulatory network.

17

EMA POST BREXIT

How to handle centralized procedures post Brexit The EMA has established an elaborated Q&A addressing the questions that life science businesses inevitably ask themselves these days in matters of central marketing authorization procedures of medicinal products.

By Charlotte Strøm, MD PhD Journalist

B

y 1 April 2019 the United

Commission and the EMA are

undisrupted supply of their

The Coordination Group

Kingdom will become a

currently issuing Q&A’s on

medicines in the EU after 30

for Mutual Recognition and

‘third country’ concerning the

a series of matters pertinent

March 2019. It furthermore

Decentralized Procedures

European Union. Brexit has

to pharmaceutical companies

addresses questions con-

- Human (CMDh) has also

consequences in that market-

and other stakeholders within

cerning the location of an

published information for

ing authorization holders of

life science.

applicant in the context of

marketing authorization

the centralized procedure, in-

holders of nationally autho-

centrally authorized medicinal products for human and

The first one was published 31

cluding the location of orphan

rized products for human use.

veterinary use, implying that

May 2017 and outlines a list

designation holders, qualified

The EMA advise companies to

the UK’s withdrawal from

of questions relating to the

persons for pharmacovigilance

check the webpage regularly

the EU is not just a matter for

establishment requirements

(QPPVs), and companies' man-

for further guidance on the

European and national ad-

within the European Union,

ufacturing and batch release

consequences of Brexit, as the

ministrations and politicians,

aiming to ensure that the

sites that all must reside with-

agency is preparing a series of

but indeed also for private

companies are ready to take

in the European Union.

further guidance documents.

companies. The European

the necessary steps to enable

"The European Commission and the EMA are currently issuing Q&A’s on a series of matters pertinent to pharmaceutical companies and other stakeholders within life science."

regulatory network.

FACTS For more information

•

EMA’s webpage: http://www.ema.europa.eu

•

About United Kingdom’s withdrawal from the European Union ('Brexit'): http://www.ema.europa.eu/ema/ index.jsp?curl=pages/news_and_events/general/general_content_001707.jsp&mid=WC0b01ac0580a809a7

•

Q&A related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure http://www. ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500228739.pdf

18

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

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"COMPAMED, the leading international suppliers’ forum which is held parallel with MEDICA, provides added value in terms of medical developments. " PHOTO Messe Dßsseldorf GmbH

UPCOMING EXHIBITIONS

MEDICA and COMPAMED the 13th – 16th of November 2017 Once a year, the biggest international trade fair for medicine, MEDICA, sends out powerful stimuli for the medical technology industry around the world. The event is a networking and communication platform for all medicine related markets, and is a place where a lot of groundbreaking business relationships originate - relationships, which have an impact in all areas of the health sector and the world.

Edited by: Arne Nielsen.

M

ore than 128,000,

Numerous conferences

mostly international

and forums stand for a top

trade visitors, attended

quality transfer of know-how

MEDICA in 2016, and learnt

between experts from the

about the latest news and

field of politics, commerce and

developments from over 5,000

science, exhibitors and trade

exhibitors. One important

visitors, and have become

quality feature of the audience

established as crowd-pullers

was that more than 80 per cent

for the discerning public.

had decision-making power.

These special attributes

COMPAMED, the leading

make MEDICA a firm part of

international suppliers’ forum

the development process for

which is held parallel with

tomorrow’s medicine. Messe

MEDICA, provides added

Düsseldorf is investing heavily

value in terms of medical

in the future to maintain this

developments. This concept

status: 2017 will see the start

leads to fruitful synergies

of construction work for the

between both industries.

new South Entrance and an

In 2016, 774 COMPAMED

adjacent hall, which with more

exhibitors from 37 countries

than 12,000 square metres

guaranteed a lively exchange

will replace the old Halls 1

between the people involved

and 2. In this way, exhibitors

in both trade fairs.

will profit from a wide and bright exhibition area in two

Source: Messe Düsseldorf GmbH

MAIN PRODUCT CATEGORIES • • • • • •

Electromedicine, medical technology Information and communication technology Laboratory equipment/diagnostics Physiotherapy/orthopaedic technology Single-use and consumer items Medical services and publications

Photo: Messe Düsseldorf GmbH

years’ time – up to the latest

1 and 2 will be accommodated

technical standard, with more

in modern, temporary halls

presentation options and

at strategically favorable

a direct connection to the

locations on the trade fair

CCD South. For this reason,

ground until its completion in

MEDICA exhibitors from Halls

2019.

VISITOR TARGET GROUPS • • • • • • • • • • •

General practitioners Hospital doctors Hospital managers Hospital nursing staff Hospital technical managers Laboratory managers Physiotherapists Medical trade Medical industry Medical assistants (hospital, doctor’s surgery, laboratory) Cost units

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

21

LABDAYS 2017 PHOTO: J.B. Exhibitions

Expectations are high as the laboratory industry prepares for the second version of the LabDays fair in September.

Edited by: Arne Nielsen.

I

n September, the second

experience to exhibit at

all experience has shown

The venue, in which the

version of the LabDays fair

LabDays 2015. We welcomed

that there is a correlation

fair will be conducted the

will take place in Aarhus,

many of our existing

between the number of

20th and 21st of September

Denmark. At the premiere

customers; and we also met

exhibitors and the number

2017, is located in Aarhus

fair – in 2015 - there were

new potential prospects.

of visitors and with more

-the second biggest city in

79 exhibitors, greeting

We, and our customers, are

than 85 exhibitors already

Denmark.

the many visitors from the

happy that we with LabDays

registered for the event, the

laboratory industry.

has created a Lab Forum in

expectation is that LabDays

Jutland." said Ole Jakobsen,

2017 will beat all records.

CEO at Axlab A/S.

The booth area is expected

The overall statements from the exhibitors and visitors were positive after the LabDays fair in 2015.

"It's been a really good

to be 20 % bigger than at the According to J.B.

first fair in 2015 – with the

Exhibitions, the organizer

smallest booth being 4 m²

of LabDays and Cph LabMed,

and biggest booth 50 m².

All visitors have to register, when visiting the fair, which can either be done by preregistering on the website (Labdays.dk) or at the entrance of the fair.

FACTS:

22

Venue: Scandinavian Congress Centre Margrethepladsen 5, 8000 Aarhus C

Registration Pre-register on Labdays.dk or register at the entrance of the fair.

Opening hours Wednesday, the 20th of September: 9:00 pm to 4:00 am Thursday, the 21st of September: 9:00 pm to 4:00 am

Parking Scandinavian Congress Centre has 1.100 near-parking lots which can be used against payment.

Wardrobe You can store clothes, bags and other stuff in the staffed wardrobe for the price of DKK 25.

For further information visit: www. labdays.dk

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

SEE YOU AT LABDAYS 2017

AARHUS - SCANDINAVIAN CONGRESS CENTER, the 20th and 21st of September 2017

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Dorte Egelund ApS er et højt specialiseret firma, der leverer løsninger til mikrobiologiske- og biotech laboratorier.

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Steelco Denmark er et dansk A/S og datterselskab til Steelco SpA, der udvikler og producerer vore produkter til anvendelse indenfor Infection Control. Indenfor LifeScience, LAB og Pharma er der et omfattende program af autoklaver, vaskemaskiner og automation, herunder animal research.

Steelco DK har ansvar for at sælge og servicere Steelcos totale program i DK. Vor hovedafd. har adresse på Lottenborgvej 24, 2800 Lyngby. Henvendelse på e-mail steelco-denmark@steelcospa.com eller tlf. 69136040.

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We offer a wide and unique selection of products and services within the areas of Celland Molecular Biology. Our extensive knowledge about advanced life science applications gives us the opportunity to guide you to the right products for your research.

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NEWS FROM THE INDUSTRY

News From the Industry Edited by Arne Nielsen

Particle Measuring Systems Celebrates 45th Anniversary

leading products enabled industry advances in cleanliness and smaller feature sizes. In 2000 the company made the

Particle Measuring Systems has been providing

decision to expand into life sciences, which is now a very

contamination monitoring solutions for 45 years.

significant part of the business. While the name “Particle

Dr. Robert Knollenberg founded the company shortly after inventing the world’s first laser particle counter. Since then, Particle Measuring Systems (PMS) has continued the course of being first when it comes to engineering new particle

Measuring Systems” is a nod to its start as a particle counting company, PMS now also provides microbial and molecular monitors as well as complete services including consulting, GMP, and training.

counters, including the recent Chem20™ – the world’s only

“We started out as a small business in a garage and have

20 nm chemical particle counter.

expanded to several hundreds of employees, with almost

PMS started building instrumentation that f lew on the wings of aircraft to study the atmosphere, than applied its technolog y to cleanroom applications, first focused largely on micro-electronic manufacturing. The sensitivity

two thirds outside the U.S., over 35 distributors, and local sales and services in more than 70 countries, with over 60 patents”’, said John Mitchell, President of PMS. SOURCE: PA RTICLE MEASURING SYSTEMS

NEWS FROM THE INDUSTRY

Medicon Valley Alliance has once again been gold label certified

TA Instruments Introduces 3 New Discovery DSC Systems

Two year´s ago, Medicon Valley Alliance, qualified for the

TA Instruments is pleased to introduce a new line of

first time for the prestigious gold label of the European

Differential Scanning Calorimeters, the Discovery

Cluster Excellence Initiative (ECEI), which is a European

DSC2500, DSC250, and DSC25. These instruments feature

certification set up to monitor, control and inspire best

enhanced sensing technologies resulting in unprecedented

practice as regards the work of cluster organizations.

performance in baseline f latness, sensitivity, resolution, and

The summer of 2017 Medicon Valley Alliance, has once again been gold label certified. It is the explicit policy of among

reproducibility, reaffirming TA’s position as the technolog y and global leader in thermal analysis.

others Region Skåne that their cluster collaboration partners

At the core of every new Discovery DSC is the exclusive

shall all be ECEI-certified. In Denmark, Medicon Valley

TA Fusion Cell™, which incorporates design concepts that

Alliance, BioPeople and Welfare Tech are currently ECEI-

“fuse” together the best features of the world’s bestselling

gold label certified cluster organizations.

Q-Series and first generation Discovery DSC, patented

SOURCE: M VA.ORG

Tzero® technolog y, and new proprietary manufacturing processes. Additionally, an app-style user interface is standard with each new model and combined with powerful

Executive Summary of the Report “The Value of Clinical Trials in Denmark” Available NEXT, The Danish Association of the Pharmaceutical Industry (Lif ) and Invest in Denmark published a report made by Copenhagen Economics in March 2017 in Danish.

The report quantifies the value generated by clinical trials in Denmark, and main conclusions are that clinical trials by pharmaceutical companies deliver value to the Danish society. On average, a clinical trial improves GDP by DKK 0.9m and the public budget by DKK 1.2m.

new TRIOS software, automated calibration and verification routines work seamlessly to dramatically improve laboratory work-f lows and productivity.

The Discovery DSC measures the change in energ y in a sample as the temperature is raised or lowered. It is used for a wide range of applications, including material science, pharmaceuticals, chemistry and studies of biomaterials. It excels in both research environments and production control processes.

SOURCE: TA INSTRUMENTS

The positive economic effects arise from trials conducted in Denmark through several drivers: More and better healthcare, highly productive jobs and new research in Life Sciences. The report can be found on nextpartnership.dk.

SOURCE: NEXTPA RTNERSHIP.DK

New Danish National Super Hospitals Ready for the Future The construction of five new national super hospitals with state-of-the-art health IT infrastructure is well underway in Denmark. This is a unique opportunity for companies to do business and develop new solutions.

In the near future Denmark will have fewer, larger and more specialised hospitals and the use of health IT will be intensified. The objective of the new hospital structure is to meet increasing demands to the public healthcare system and to improve the quality of patient care, while reducing public spending.

To face this challenge, the hospitals are being developed and built in close cooperation with a range of relevant stakeholders, including international companies with specific know-how, not least within health IT and medical technolog y.

SOURCE: IN V ESTINDK.COM

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

25

MAGNIFYING LOUPES

A BESPOKE SOLUTION Winning multiple Red Dot Design Awards, the product range exudes Nordic simplicity and elegance

By Arne Nielsen

T

oday, ExamVision is

million different possibilities in every optical correction, so

Complex subject, simple choice

The Kepler Kompakt was

known as one of the

world’s most exclusive brands

you need to know what you are

ExamVision offers two main

designed to give a crystal

of magnifying loupes sold

doing, both in measurement

ranges – HD Galilean or Kepler

clear edge-to-edge image in

to physicians and dentists

and in production. A doctor

Kompakt loupes, with LED

high magnifications, yet be

all over the world. Specially

might be able to wear a poorly

light systems to complement

lightweight, comfortable and

trained dealers in over 30

fitting loupe for 10 minutes,

them.

ergonomically adaptable.

countries advise ExamVision

but after only a few hours

customers, based on an

the eyes are strained and the

assessment of their individual

loupe will end up shut away in

needs. Working practices,

a drawer.”

The HD Galilean is best suited for lightweight, low

launched in 2014, and is

Kepler Kompakt is available in 3.5, 4.6 and 5.7 magnification.

magnification, and the unique

An ExamVision dealer will

lens system designed by

always advise the customer

All ExamVision loupes are

ExamVision gives optimal

on the best choice for

manufactured using only the

light transmission with no

their situation. As Tamsin

highest quality components

colour separation. Angles and

Fabricius, Sales and Marketing

available. The frames are pure

working distances are also

manager, points out, “Our

titanium, allowing them to be

ordered individually for the

unique selling point is the

adjusted to fit facial features.

best ergonomic position, and

bespoke nature not only of

Premium lenses and coatings

for customers with back or

the product, but of the advice

from the world’s best optical

neck problems it is possible to

and service that we give. Our

companies are incorporated

build in a Prisma Lens System

specialist dealers either have

ExamVision optometrist

into the final product. Bifocal

TM which moves the image,

optometrists on the team or

Lise Wigard explains, “It is

or multifocal lenses can easily

allowing a straighter sitting or

specialist optical knowledge

surprisingly difficult to make

be built in, allowing the

standing position.

that enables them to give the

a good loupe! There are over a

customer to focus on exactly

best advice, and troubleshoot

what they need to see.

problems should they arise.

ergonomics, prescription and the working environment are all factors to be considered before selecting a loupe. The order is sent to the factory on the Danish island of Samsø, once the perfect bespoke solution has been agreed upon.

Our customers are experts in their chosen field and we are experts in ours.”

Individual yet rebuildable ExamVision products are built to last. So they can be rebuilt when a doctor’s prescription changes, or for a new doctor, if they are owned by a hospital

Readers of Greater Copenhagen Life Science are welcome to contact ExamVision with suggestions for worthy projects or charities that could benefit from a loupe in the field.

26

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

department or a particular clinic.

Many ExamVision customers come back for their 2nd or 3rd pair of loupes; one low magnification for general consultation or incision/ suture, one for specialized surgery and that last one as a back-up… because they realize they can’t work without them!

In the clinic or in the field ExamVision loupes are used by many different professions, but the company also tries to make a difference. A project to rebuild old demo loupes for charity work has, among others, resulted in this feedback from Dr Uta Froschl, who received a pair of rebuilt ExamVision Galilean loupes, through UK charity Soundseekers, dedicated to helping deaf people, particularly children, in the poorest communities of the developing world “…they are all the time with me in clinic, theatre and on outreach clinics and are a great help! It is unbelievable how much more I can do with the glasses especially on the outreach clinics - no need for bulky microscope - just the loupes and I can work. They are also so helpful if we have (an) uncooperative child (moving a lot) to suction the ears or remove foreign bodies in the ear or nose - I already had some kids who did not need to go under general anesthesia to theatre because I could sort their problem out with the loupes!”

Dr Uta Fröschl ENT surgeon Zambia

GENERIC DRUGS AND BIOSIMILARS

THE NAME OF THE GAME Some 10 years post marketing authorization, medicinal products come off patent. And when they do that generic products stand ready to take major market shares. While original medicines provide innovation, generic drugs and biosimilars first and foremost provide increased access and lower costs.

By Charlotte Strøm, MD PhD Journalist The patent protection

Biosimilar Medicines

product was granted market

provide data to support

of innovative original

Industry Association (IGL).

authorization. Generic

that there is no clinically

and biosimilar medicinal

meaningful difference to

products provided to the

the original product. But

Danish market have all

with the introduction of

been granted marketing

biosimilars the definition

authorization based on

of similarity had to be

the regulations outlined

revisited. Even for original

centrally by the European

biological medicines there

Medicines Agency or locally

are minor differences from

by the Danish Medical

one batch to another, and

Agency. Peter Jørgensen

manufacturers must be able

medicines provide

-As society, innovation is

exclusivity to the market.

of the utmost importance,

This is obviously of great

and clearly, that’s what the

importance to the society,

patent protection is there

and is duly ref lected in

for. But I dare say, once

revenues. However, on the

the patent is no longer in

other side of the ‘patent

effect, sustainable costs

fence’, generic medicines

of medicines are of equal

and biosimilars have

importance. It is the name

equally demonstrated value

of the game.

to society by providing

points to the requirements

to document that these

increased access as well

Hence, as a rule of thumb

being put in place and

differences do no impact the

as lower costs, says

generic medicines enter

described thoroughly by

safety and efficacy of the

Peter Jørgensen, CEO at

the market some 10 years

the authorities. The generic

product.

The Danish Generic and

after the original medicinal

small molecules must

FACTS •

Patent protection is 20 years, and in general for medicinal products this implies exclusivity around 10 years post marketing authorization.

•

The turnover of medicines in Denmark is app. DKK 20 billion / year

•

The proportion of the yearly turnover of medicines in DK pertinent to generic medicinal products amounts to more than 50% at the hospitals and close to 70% at the pharmacies – in volume. This reflects app. 20% in value of the total turnover.

Source: The Danish Generic and Biosimilar Medicines Industry Association (IGL).

28

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

GENERIC DRUGS AND BIOSIMILARS

"For biosimilars a comparability exercise is required, implying that the manufacturer of biosimilars can ascertain that the original and biosimilar drug product is comparable in terms of quality, safety, and efficacy."

message also to the patients in order not to cause unnecessary confusion or delay in treatment due to uncertainty. Patients who have taken a specific type of medicine for many years may feel uncertain about the introduction of a generic

-For biosimilars a

attributes, Peter Jørgensen

acknowledged by physicians,

comparability exercise is

explains.

national advisory boards,

required, implying that the manufacturer of biosimilars can ascertain that the original and biosimilar drug product is comparable in terms of quality, safety, and efficacy. To reach this

This may entail evaluating

payers, and politicians.

or biosimilar medicinal product. But that is a challenge that surely can be overcome with information

the product at multiple

What about the patients?

and the Danish Medicines

stages, and implies that

How do they feel about having

Agency has done a great

additional testing and

to change medicine?

job in order to provide all

quality control may be required.

-Well, in fact they don’t really have their medicine

goal, the product should be

-Still, the biosimilars have

changed. It is mainly a

evaluated at the process step

managed to overcome the

change in supplier – and at

most appropriate to detect

initial skepticism upon their

a much lower cost. I think it

a change in the quality

entry, and are now duly

makes sense to convey that

the relevant information to patients as well as to the health care persons involved, Peter Jørgensen ends.

WE OFFER TEMPORARY AND PERMANENT STAFF WITH SPECIFIC KNOWLEDGE WITHIN:

Quality Control Quality Assurance Medical affairs

Research & Development Pharmacovigilence Regulatory affairs 29

Tel. +45 33 36 09 44 l www.temp-team.dk

CALENDAR

HIGHLIGHTED FAIRS AND EVENTS IN 2017 NORDIC LIFE SCIENCE DAYS 2017 Date: 12.09.2017 to 14.09.2017 - Malmoe, Sweden

www.nlsdays.com

Nordic Life Science Days is the largest Nordic partnering conference dedicated

created a space for meaningful encounters, with one-on-one meetings being one

to the life science industry. Since its inception in 2013, the event has nurtured a

of the main features of NLS Days. Additionally, the high quality of topics and

community of people from the world of life science, and created a unique place

presenters provide insight into the most recent trends in science and business.

to do business.

NLS Days attracts leading decision makers from biotech, pharma and medtech as

Most attendees express their delight in the informal atmosphere, combined with

well as finance, research, policy and regulatory authorities.

an organized approach to meeting highly relevant people. The conference has

LABDAYS 2017 Date: 20.09.2017 to 21.09.2017 - Aarhus, Denmark

www.labdays.dk

In September 2015 the first LabDays event was conducted, and with 79 exhibitors

isfied with the venue, Scandinavian Congress Center. So LabDays 2017 will again

and close to 1,500 visitors the premiere was considered a success. This marked

be held in Scandinavian Congress Center in Aarhus. Similarly, a lot of exhibitors

that pleased to present all the details concerning how LabDays 2017 is expected

was satisfied with the exhibition concept with fixed turnkey stands. And thats

to be implemented. A large majority of the exhibitors and visitors (from 2015)

why we also stuck to the concept with fixed turnkey stands for all exhibitors.

felt that Aarhus was the right location. And at the same time was everyone sat-

THE SCANDINAVIAN MEDICAL DEVICE PACKAGING CONFERENCE 04.10.2017 to 05.10.2017 - CPH, Denmark

www.smdpc.com

The conference will give an insight into how some of the best performing compa-

You will be able to network with your peers and the conference offers you the

nies in this field have managed to incorporate complex requirements into their

opportunity to book a one-to-one session with leading specialists and organiza-

production planning and process handling.

tions in their field. The main audience will be designers & developers, engineers

The speakers will provide you with the latest knowledge on design, packaging

within packaging and processing, regulatory affairs, purchasers, management

technology & packaging process, integrity, test and validation, sterilization,

and quality assurance staff.

regulatory issues, quality assurance and UDI compliance.

SWEDISH LABDAYS 2017 Date: 18.10.2017 to 19.10.2017 - A arhus, Denmark

www.labdays.se

The new trade fair will take place Wednesday the18th and Thursday the 19th of

The ambition is to bring together the leading laboratory companies to this new

October in the Victoria Hall at Stockholmsmässan - the goal is to make the fair

trade fair, as well as some of the leading annual meetings within the industry,

an annual event.

creating a dynamic platform beneficial for the Swedish laboratory industry.

BIO-EUROPE 2017 Date: 07.11.2017 to 09.11.2017 - Cologne, Germany

www.ebdgroup.com

The event offers powerful opportunities for you to network with the right

attracted 3,692 attendees, 1,982 companies from 63 countries. 20,833 one-to-

partners, and brings together hundreds of the world’s most innovative leaders

one meetings were held, 4,734 licensing opportunities were posted, 153 company

across biotech, finance and pharma for high-level networking, pre-scheduled

presentations held and 105 Exhibitors were present.

partnering meetings, strategic panel discussions and more. Last year the event

MEDICA and COMPAMED Date: 13.11.2017 to 16.11.2017 - Düsseldorf, Germany

30

www.medica-tradefair.com

More than 128,000, mostly international trade visitors, attended MEDICA in

leading international suppliers’ forum that is held parallel with MEDICA, pro-

2016, and learnt about the latest news and developments from over 5,000 exhibi-

vides added value in terms of medical developments. 774 COMPAMED exhibitors

tors. MEDICA is the biggest international trade fair for medicine, and has a huge

from 37 countries guarantees a lively exchange between the people involved in

impact on the medical technology industry around the world. COMPAMED, the

both trade fairs.

G R E AT E R C O P E N H A G E N L I F E S C I E N C E | J U LY/A U G U S T 2 0 17

HIGHLIGHTED SUPPLIERS

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 are the primary market areas. We are specialists in standard packaging solutions as well as in customized packaging solutions, which is developed in close cooperation with the customer. Visit us at www.apodanpharma.dk

LBKPATENT is focusing on providing IP, in particular, Patent consulting to Pharmaceutical companies, Biotechnology companies having focus within the therapeutic area as well as start-up companies having focus within the therapeutic area.

packaging@apodanpharma.dk - +45 32 97 15 55

http://www.lbkpatent.dk/ Lbk@lbkpatent.dk

Strenometer ApS has specialized in test equipment – mainly for test and characterization of all kinds of surfaces. For more than 50 years, we have provided instruments and chambers to a wide range of applications, including:

Leading the way for vacuum sales and service

- Color measurements - Stability test: o Temperature and/or humidity o According to ICH Guidelines Q1B + Q5C - Plant growth chambers o Chambers o Walk-in - Mixing

www.strenometer.dk

At Studieskolen we help employees break down the language barrier in order to get them comfortably settled into Danish culture and work life.

We offer both customised courses and regular group courses.

Location: In the centre of Copenhagen or at your company.

Read more at studieskolen.dk/life-science.

DANISH FOR FOREIGNERS

LBKPATENT is also able to provide patent consulting within the broader life science area and the chemistry area, as well as mechanical area.

in Denmark: - Small dry/oil sealed vacuum pumps - Mass Flow Controllers, Pressure Controllers, Verifiers & Calibration units - UHV Motion & Manipulation, Deposition Stages & Heating

- FTIR/NDIR Infrared Gas Analysis Instruments & Residual Gas Analysers - HV Vacuum Chamber Manufacture & Design - Industrial/Chemical dry pumps & boosters - Vacuum Measurement, Controllers & Vacuum Valves - Standard Vacuum Components, Feedthroughs & Accessories

- Turbomolecular MAGLEV & hybrid pumps

www.vacpro.dk - info@vacpro.dk - +45 70 26 88 05

THIS IS STANDARDIZED OPERATION SciLog® Filter and Dispense System

Automated system for performing final bulk filtration and dispensing.

Fully disposable single-use flow path

The SciLog® Filter and Dispense System offers closed and automated single-use processing for bulk fill applications. Combining unique and innovative SciLog® sensing and control technologies with renowned filtration expertise our integrated automated single-use systems can be configured to provide built-in flexibility for bioprocessing.

www.parker.com/filter-and-dispense • Parker Hannifin Danmark • tel. +45 4356 0400 • parker.dk@parker.com