Gr cph life science sept'17 by Nem Media

SEPTEMBER 2017

THEME:

CLINICAL TRIALS IN DENMARK

— MEDICON VALLEY ALLIANCE - 20 years anniversary

— GOVERNMENT’S GROWTH TEAM FOR LIFE SCIENCE DELIVERED 17 RECOMMENDATIONS - How they are viewed by the industry

— LEGAL UPDATE - Experiencing the first consequences of BREXIT!

Secti on Page 23

LabDays 2017

CONTENTS September 2017 Publisher:

THE COLUMN

MVA ANNIVERSARY

NEWS 8 THEME: CLINICAL TRIALS

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

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:

ISSN: 2446-1776

Clinical trials in Denmark – 2016 at a glance

Four phases of clinical trials in humans

Clinical trial activity improves health care, employment, and learning

Raised application fees and overhead costs put strain on clinical trial budgets

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LabDays 2017

Overview

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GOVERNMENT’S RECOMMENDATIONS

LEGAL UPDATE

CALENDAR 38 SUPPLIERS 39

LIF UDDANNELSE HAS CHANGED ITS NAME TO ATRIUM But we still oﬀer a wide range of training courses for professionals in GCP. Sign up for our courses in the fall of 2017 and the spring of 2018 now:

ADVANCED COURSES: Certiﬁcate in Advanced GCP - December 2017 Site Audit and inspections - November 2017 Clinical Trial Management and Risk Based Monitoring - May 2018

DIPLOMA PROGRAMMES: Diploma in ICH-GCP managed trials for monitors and investigators / study nurses - March and September 2018

BASIC COURSES: Certiﬁcate in Basic GCP - November 2017 Introduction to Clinical Drug Research - November 2017

Find your course at www.atriumcph.com We now communicate in English, but some of our courses will still be in Danish. Check out which on our website.

FREMTIDENS LABORATORIER ER FLEKSIBLE (OG DANNER RAMME OM DET GODE ARBEJDSMILJØ) Vi sætter den menneskelige faktor, trivsel og arbejdsglæde højt, når vi skaber bæredygtige laboratorieløsninger. Læs mere på ramboll.dk/pharma

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COLUMN

Clinical trials – key to innovation, better patient treatment and a strong life science sector Foreword by Ida Sofie Jensen, CEO at LIF

ver the past 5-7 years, increased political attention and strategic actions have changed the environment for clinical trials in Denmark. This was urgently needed – and now we see the first positive results. Establishment of NEXT partnership and Clinical Trials Office Denmark, branding by Invest in Denmark and a revision of the Act on Research Ethics Review are some of the specific initiatives that have made it easier for companies to attract clinical trials to Denmark. Faced with an international and very competitive environment we need to continue and to develop this effort in order to keep clinical trials as a Danish stronghold. From 2007 to 2010, the number of industry-initiated trials dropped by more than 35% affecting not only industry activities in Denmark but also jeopardising the uptake of scientific progress and the development of quality in the public health sector coming from public-private collaboration on clinical trials. The decline in number of trials was a joint societal problem. From 2011 to 2014, the political focus and initiatives introduced led to the first results, the steep decline in numbers of trials stopped, and in 2015 we saw an increase. The latest figures covering 2016 show that members of Lif and Dansk Biotek had a total of 309 ongoing trials of which 92 were new trials initiated in 2016. The positive development in 2015 observed among Lif and Dansk Biotek members has been maintained. In Europe, Denmark is having the highest number of clinical trials per capita. To keep this position we have to prepare for and make the most out of the current trends within clinical trials. The new EU clinical trial regulation is very soon to become reality, clinical trials are vital for develop-

ment of personalised medicine, new technologies are used for support of clinical trials and active use of health data and health registries have the potential to strengthen both the conduct and outcome of clinical trials. With a new Life Science strateg y coming up this fall the Danish Government has the opportunity to incorporate the recommendations from the Life Science Growth Team – recommendations involving further strengthening of the framework conditions for clinical research. Key elements are development and expansion of the NEXT partnership success, better use of health data to support clinical trials and increased focus on incentives stimulating public-private research collaboration. Being a very small country and having a decentralised hospital sector, it is important to coordinate and streamline local research initiatives and local administrative practices. NEXT partnership and Clinical Trials Office Denmark have shown with convincing success how this can be done – more of that is needed. Last but not least, world-class regulatory authorities are vital for efficient case handling, inspections and quality of clinical trials. With a more centralised European procedure for clinical trial applications and assessments, companies will look for those countries where regulatory authorities can facilitate efficient, predictable, service-minded and transparent processes. In a highly competitive regulatory environment, the speed and quality of authorities are

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

seen by industry as the main performance indicators – fees above European average will stand out negatively. Denmark has all it takes to stay in the European top when it comes to clinical trials. However, the negative development that we saw a decade ago also tells us that we can lose ground very fast. Therefore, continued political focus and concrete actions are still needed.

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MVA ANNIVERSARY

Medicon Valley Alliance celebrates 20 years anniversary overlooking Greater Copenhagen Members, life science collaborators, and academia joined the 20 years anniversary reception of Medicon Valley Alliance on 17 August. The spectacular view from the top of the Maersk Tower of Copenhagen, the coast line, and the bridge to Sweden, circled back the storytelling about where and when it all began: The inauguration of the Øresundsbron. By Charlotte Strøm, MD PhD Journalist Network. Since the begin-

Three pillars of MVA

ning in 1997 the life science

Søren Bregenholt, Chair-

organization, Medicon Valley

man of the MVA Board and

Alliance, has watched the

Corporate Vice President at

cluster thrive and grow into

Novo Nordisk highlighted

the largest life science cluster

that the MVA as organization

in the Nordic. CEO at MVA,

has three equally important

Petter Hartman, welcomed

pillars: Strong academic insti-

the guests and on a running

tutions, cutting edge health

basis introduced the speakers

care sector and a vibrant life

who were invited to put into

science environment. He

few words what the scientif-

furthermore pointed out that

ic perspectives are for this

MVA has already, and is on an

Danish-Swedish connection.

ongoing basis, working hard

Talking together across

to provide the data that can

borders and across bridges

convince the EU to place the

appear to be durable and the

European Medicines Agency in

reception allowed adequate

Copenhagen. A recent report

of the cluster further into

MVA once again in 2017 qual-

time for networking for all the

by MVA on research Medicon

perspective. Finally, Søren

ified for the prestigious gold

same reasons.

Valley 2017 puts the strengths

Bregenholt, highlighted that

label of the European Cluster

CEO at Medicon Valley Alliance, Petter Hartman, welcomed members, collaborators, and guests who joined the MVA 20 years anniversary on 17 August 2017 at the top of the Maersk Tower (Photo: News Øresund - Johan Wessman).

MVA ANNIVERSARY

"NEXT partnership has only been around since 2014, but has already proven to be a successful way to attract the early phase clinical trials to the region." Excellence Initiative (ECEI),

improve the scientific possi-

which is a European certifica-

bilities and potential within a

tion set up to monitor, control,

range of different disciplines.

and inspire best practice as

The NEXT public-private

regards the work of cluster

partnership is yet another

organizations.

example of how joining forces takes science one step further.

Joining forces

Thomas Kongstad Petersen,

Lars Gaardhøj (So-

Chairman of NEXT Partner-

cialdemokratiet), Chairman

ship and Vice President at LEO

of the Business and Growth

Pharma highlighted that the

Committee in the Capital Re-

NEXT partnership has only

gion of Denmark puts effort on

been around since 2014, but

the high ambitions for collab-

has already proven to be a

orations, not only across the

successful way to attract the

bridge but also across sectors,

early phase clinical trials to

in the political community,

the region. Albeit there is still

establishment of a regional,

midst of Copenhagen. She

academia, and the industry as

a lot of work to be done in or-

cross-country network in

pointed out that the tower

drivers of growth.

der to improve the framework

oncology facilitated by MVA

holds 12 floors of cutting

conditions, he pointed out

has already resulted in new

edge laboratories along with

Senior Adviser, enthusiastical-

that he is convinced that the

projects by allowing for a crit-

their scientists who have just

ly told the audience about the

puplic-private partnerships

ical mass of patients, funding,

recently moved in. Like the

vision and ambitions for the

are here to stay.

innovative ideas and scientific

ambitions for the output of

talent.

research of the Maersk Tower

Sindra Peterssson Årsköld,

European Spallation Source

Professor at Lund University,

Professor at University of Copenhagen, Niels Brunner (left) and professor at Lund University, Carl Borrebaek, took the initiative to start an oncology network in the Medicon Valley region (Photo: News Øresund - Johan Wessman).

With the courtesy of Copen-

are high, the ambitions at the

(ESS), a true example of what

Carl Borrebaek, and professor

Region Skåne and Capital

at University of Copenhagen,

hagen University, the Vice

MVA also remain high. For an

Region Denmark is capable of

Niels Brunner, rounded off the

Dean, Trine Winterø, co-host-

afternoon, the organization

when joining forces, resourc-

series of brief speeches or life

ed the anniversary reception

took time to see things from

es, man power, and talent. The

science pep-talks. They gave

at the top of the Maersk Tower

the top.

ESS will open in 2023 and will

their own example of how the

at the Panum Institute in the

The spectacular view from the top of the recently inaugurated Maersk Tower at the Panum Institute, where MVA celbrated the 20 years anniversary (Photo: News Øresund - Johan Wessman).

NEWS

Short news LEO PHARMA LEO Pharma ranks in second position out of 50 pharmaceutical companies evaluated in the AllTrials audit on clinical trial transparency. â&#x20AC;&#x153;The AllTrials rankings are a robust overview which, while grounded in empirical data, casts new light on the attitudes and approaches to transparency across our industry,â&#x20AC;? said Kim Kjoeller, Executive

Vice President Global Research and Development, LEO Pharma. LEO Pharma has made its clinical trials results dating back to 1990 available to the public and will share individual patient-level data upon request from qualified third-party researchers.

Kim Kjoeller, Executive Vice President, Global Research and Development

GENMAB On 24. August, Genmab announced topline results from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) versus VMP alone as front-line treatment for newly diagnosed patients who are not considered candidates for autologous stem cell transplantation (ASCT).

"The interim results of the ALCYONE study yet again illustrate the potential of daratumumab in multiple myeloma in combination with existing treatment regimens; this time with VMP in the front-line setting," said Jan van de Winkel, CEO of Genmab.

Jan van de Winkel, CEO at Genmab

H. LUNDBECK

Anders Gersel Pedersen. Executive Vice President, Research & Development

On 28. July, H. Lundbeck and Otsuka Pharmaceutical Co announced that Abilify Maintena (aripiprazole) for extended-release injectable suspension was approved by the FDA for the maintenance monotherapy treatment of bipolar I disorder in adults. "Receiving Abilify Maintena each month as prescribed and administered by a healthcare professional, provides patients an opportunity to be free from taking their daily antipsychotic for bipolar I disorder," said Joseph Calabrese, MD, Director of the Mood Disorders Program at University Hospitals Cleveland Medical Center, and Professor of Psychiatry at Case Western Reserve University School of Medicine. -----------------On 2. August, Lundbeck announced that it will join personal genetics company 23andMe, Inc. and think tank the Milken Institute in a large new study

to increase the understanding of the underlying causes of Major Depressive Disorder (MDD/unipolar depression) and Bipolar Depression. The study will also explore how these disorders and brain functions such as attention and decision-making are related to genetics. "We expect the study to provide detailed insights into the interaction of mood symptoms, cognitive processes and environmental factors, and to link these factors to genetic data," said Anders Gersel Pedersen, Executive Vice President, Research & Development at Lundbeck. The study will recruit a total of 25,000 participants (15,000 with MDD, 10,000 with Bipolar Depression) who will have their DNA tested and complete cognitive tests and surveys over nine months.

NOVO NORDISK

Doug Langa, executive vice president

Novo Nordisk has announced two changes to its Executive Management Team. With effect from 1. October, Camilla Sylvest, senior vice president in charge of operations in Region China, has been appointed executive vice president in charge of Commercial Strategy & Corporate Affairs. She will be responsible for the company's corporate functions within marketing, market access, strategy, communication, stakeholder relations and sustainability. Effective 1. August, Doug Langa, senior vice president, head of North America Operations and president of Novo Nordisk Inc, is promoted to executive vice president. His responsibilities remain unchanged. -----------------

Novo Nordisk announced on 1. August that new data shows that once-weekly Semaglutide is superior to dulaglutide on glucose control and weight loss in people with type 2 diabetes. The 40-week SUSTAIN 7 trial, investigated the efficacy and safety of 0.5 mg semaglutide compared with 0.75 dulaglutide and 1.0 mg semaglutide compared with 1.5 mg dulaglutide, when added to metformin. ----------------On 25. August, the U.S. Food and Drug Administration (FDA) approved a new indication for Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease. The FDA's decision is based on the results from the landmark LEADER trial.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

WORLD FORUM FOR MEDICINE 13 – 16 NOVEMBER 2017 DÜSSELDORF GERMANY www.medica-tradefair.com

Verden af forbrugsartikler med ét blik: Soeren-Ulrik Rolsted Fangholm,

www.medica.de/MWCF2

Director & Head of Department

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THEME

CLINICAL TRIALS Clinical trials are often the result of a public-private collaboration. The business area engages a series of life science partners. From pharmaceutical companies, over contract laboratories, logistics, and contract research service partners along with doctors and nurses, testing both new and readily licensed medicinal products and devices in patients to the benefit of society. This series of articles assesses the status of clinical trial activity in Denmark.

THEME CONTENT 12 | Clinical trials in Denmark â&#x20AC;&#x201C; 2016 at a glance 14 | Four phases of clinical trials in humans 16 | Clinical trial activity improves health care, employment, and learning 18 | Raised application fees and overhead costs put strain on clinical trial budgets

Moving day for heavy metals analyses

PROFILE

- This is what we are really good at, namely tailoring our services specifically to the

From January 1st 2017, the heavy metal analysis described in the European Pharmacopeia chapter 2.4.8 has been deleted from all human monographs. Instead, heavy metal testing will be performed with atomic absorption spectrometry (AAS) and inductively coupled plasma (ICP) spectrometry. DB Lab, a GMP contract laboratory, has extensive experience in providing these analyses to the pharmaceutical industry. - Currently, we are dealing with a change of methods that have been applied for over 100 years. I consider this an improvement for our clients, as the ICP is a more specific and sensitive analysis, says Michael Wamberg, Sales Manager at DB Lab. An ICP analysis still requires many individual assessments where the real asset is our extensive experience. He points to the fact that the changes that currently apply to the European Pharmacopoeia will also apply to the US pharmacopoeia as of January 1st 2018. The conversion of methods has implications which clients need to take into account during drug manufacturing. - ICH Q3D ‘guideline for elemental impurities’ applies to tests for heavy metals on the final product. When it comes to API and excipients, manufacturers can either perform the test to eliminate any potential risk or perform a risk assessment. This puts a new demand on the subcontractor of the raw materials who now has to supply their customers with documentation regarding the heavy metals, Michael Wamberg explains.

needs of our client at all times.

About testing for heavy metals

•

As of January 1st 2017, the heavy metals tests described in the European Pharmacopoeia chapter 2.4.8 were

Michael Wamberg, Sales

Ulrika Rosdahl, Sales &

deleted from all human monographs,

Manager at DB Lab

Business Development

affecting 753 monographs and the

at DB Lab

same will apply to the US Pharmaco-

ICP screening by classification His colleague Ulrika Rosdahl, Sales & Business Development at DB Lab carries on, - Whereas AAS is a technique that handles one metal at a time, ICP can perform a total screening of all the metals that the product contains. ICH Q3D has classified the metals according to their toxicity: Class 1, 2A, 2B, 3 and ‘other elements’. We can do a quantitative or a qualitative screening based on the classification as well as on individual metals. Having both ICP-OES and ICP-MS, we can accommodate sample material of both high and low concentrations.

Method validation required Ulrika Rosdahl acknowledges that some drug manufacturers have already enclosed the new requirements regarding heavy metal testing by purchasing ICP equipment of their own. In these cases, DB Lab remains a qualified partner in the process. - At DB Lab, we have a range of specialist chemists who offer their expertise regarding ICP when it comes to method optimisation and validation, she says and ends:

poeia from January 1st 2018.

•

AAS and ICP-OES/ICP-MS are the techniques that are now in use for heavy metals testing.

About DB Lab • DB Lab is a qualified contract laboratory providing chemical and microbiological analyses after Good Manufacturing Practice (GMP) standards with a longstanding experience regarding ICP analyses. • DB Lab is working with pharmaceutical clients all over Europe, primarily the Nordic countries. • The company has more than 20 years of experience with GMP analyses, a staff of 42 employees, and is located in Odense. • www.dblab.dk

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

CLINICAL TRIALS

Clinical trials in Denmark – 2016 at a glance In total 286 applications for new clinical trials were submitted with the Danish Medicines Agency in 2016. This was a slightly lower number compared to 2015. Cancer trials remain a major driver of trial activity. By Charlotte Strøm, MD PhD Journalist

ystematic investigations

There was a remarkable drop

2014 (13.088 study subjects).

The annual report showed a

in humans are undertak-

in commercial clinical trials

According to the DKMA this

rise (29%) in non-commercial

en in order to collect data

from 2006- 2010. Clinical

increase was due to initiation

phase II clinical trials com-

about new or already licensed

trials with non-commercial

of large scale phase IV trials

pared to 2015, and a decline

medicinal products, and the

sponsors have been on the rise

that typically enroll large

in non-commercial phase

clinical trials must comply

or steady since 2010.

numbers(> 500) of

IV trials. The report stated

with certain scientific and

The vast majority, 67%, of

study subjects.

that DKMA anticipates an

ethical standards. In order to

clinical trials undertaken in

meet these requirements, in

Denmark in 2016 was part

The commercial clinical

the label phase II, and not IV,

Denmark, all clinical trials

of multinational trials, and

trials were typically phase I

to clinical trials investigating

must be approved upfront by

the number of Danish study

and phase III trials, although

new indications of already

the regional ethical commit-

subjects appeared to be on the

both type’s commercial phase

licensed medicinal products to

tee and the Danish Medicines

rise. The DKMA annual report

I (31%) and phase III (17%)

be the reason to this change.

Agency (DKMA). The level of

showed a 16% increase in the

declined heavily in 2016

clinical trial activity in Den-

number of Danish patients

compared to 2015.

mark is reported by the DKMA

participating in clinical trials

annually.

in 2016 (21.965 study subjects)

With the DKMA the clinical

Type of trials conducted

compared to 2015 (18.922

trial activity is registered ac-

study subjects); this was an

cording to the sponsor: com-

ongoing trend since

mercial or non-commercial. The total number of clinical trial applications submitted with the DKMA in 2016 was 286, which was slightly less than the number submitted in 2015. Historically, the global financial crisis did not leave the business area untouched.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

increased focus on assigning

CLINICAL TRIALS

The total number of clinical trial applications submitted to the Danish Medicines Agency Year

Commercial

Non-commercial

Total

2012

153

106

259

2013

165

129

294

2014

162

122

284

2015

190

139

329

2016

158

128

286

Source: Danish Medicines Agency Annual report on clinical trials, 2016. https://laegemiddelstyrelsen.dk/da/nyheder/2017/kliniske-forsoeg-med-laegemidler-aarsrapport-2016

Cancer trials remained a key

2016, albeit not reflected in

rology, genetic diseases, and

attracted the majority (56%) of

driver of clinical trial activity.

the number of study subjects.

metabolic disorders each gave

clinical trials in 2016, followed

This therapeutic area account-

The 99 trials only accounted

rise to 7% of the total number

by the Central Denmark Re-

ed for 99 (35%) of the new clin-

for 18% of the total number of

of clinical trials.

gion (18%), and the Region of

ical trial applications that were

Danish study subjects in 2016.

submitted with the DKMA in

Clinical trials within neu-

Spectrum-Labs-KR2i-System-Life-Science-Ad.indd 1

Geographically, by far the

Southern Denmark (16%).

Capitol Region of Denmark

8/31/17 9:18 AM

CLINICAL TRIALS

Four phases of clinical trials in humans Medicinal products are funnelled through a series of different types of studies and tests. The series of clinical trials also represent a selection process. As the exposure of patients increases, so does the demand for proving a favourable benefit / risk ratio. The overall likelihood of approval of a drug from Phase I for all developmental drug candidates is only around 10%. Rare disease programmes and clinical trial programmes utilizing biomarkers tend to have higher success rates at each phase of clinical development. By Charlotte StrĂ¸m, MD PhD Journalist Phase I studies assess the

one group of patients receives

the effectiveness of the drug,

effectiveness and impact on

safety of a drug or device and

the experimental drug, while

the benefits, and the range

patientsâ&#x20AC;&#x2122; quality of life, or c) to

represent an initial phase of

a control group receives a

of possible adverse reactions.

determine the cost-effective-

testing, only including a small

standard treatment or placebo

70% to 90% of drugs that enter

ness of a drug relative to other

number of healthy volunteers.

in a double-blinded manner,

phase III studies successfully

traditional and new therapies.

The study determines the

allowing for comparative

complete this phase. Appli-

Phase IV studies can result

effects of the drug or device

information about the relative

cation for marketing authori-

in a drug being taken off the

in humans including how it is

safety and effectiveness of the

zation is applied for after the

market or restrictions of use

absorbed, metabolized, and

new drug. About 33% of ex-

completion of phase III.

could be placed on the product

excreted in addition to side

perimental drugs successfully

effects that occur as dosage

complete both phase I and II

Phase IV studies, often called

the study. Regulatory author-

levels are increased. About

studies.

post marketing surveillance,

ities may approve a medicinal

are conducted after a drug

product for the market, while

Phase III studies involve ran-

or device has been approved

connecting the sustained mar-

domized and blinded testing

by the national or interna-

keting authorization to the

Phase II studies test the

in several hundred to several

tional regulatory authorities.

results of post approval phase

efficacy of a drug or device and

thousand patients. Large-scale

The objective may be a) to

IV studies.

involves up to several hundred

investigation that may last

compare a drug with other

patients. Most phase II studies

several years provides a more

drugs already in the mar-

are randomized trials in which

thorough understanding of

ket; b) to monitor long-term

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

70% of experimental drugs pass this phase of testing.

depending on the findings in

PROFILE

Prepare for the future legal framework for clinical trials in Europe The current voluntary harmonization for approval of clinical trials within the European Union (EU) will take a step further when the new legal frame Work comes into effect around 2019. Starting right –regulatory documentation is more important than ever. Any type of testing in humans bears significance to the marketing authorization of the medicinal product or device, as the documentation is part of the regulatory file. Lillan Rejkjær, Managing Lillan Rejkjær, Partner and Head Managing Partner and Head Regulatory Regulatory & Medical & Medical Development Development at IWA Consulting is keeping an eye on the progress of putting clinical trials into a new legal framework within the EU. The law is expected to come into act in 2019. -At IWA Consulting we stress the urgency of starting the clinical documentation in a correct manner, ensuring that the study protocol, the data collection, the description of the study conduct etc. are all in compliance with the requirements, Lillan Rejkjær says and continues, -In particular the small or midsize biotech and pharma companies or the non-commercial sponsors who may run clinical testing before a university spin out or divestment of the compound may have difficulties in overlooking the full process from the first-in-man phase I trial to the submission of an electronic marketing authorization application (MAA) with the European Medicines Agency (EMA) or a national authority. It takes a thorough regulatory understanding to do it all right from the very start of the clinical development process.

More than words The future clinical trial legal framework will be based on an approval procedure similar to the assessment of a decentraliced marketing authorization procedure. However, the choice of words appears to slightly differ. -Some may argue that it is just about words, the point is that an applicant for a clinical trial, is helped by being aware of this similarity, which eases the understanding of the new clinical trial approval process., Lillan Rejkjær says and refers to a tabulated overview from IWA Consulting. Aim for the MAA -The aim of a clinical trial result being a part of an MAA is important, irrespective of the origin of the sponsor, says Lillan Rejkjær. She’s hoping that the centralisation and harmonization within a legal framework for clinical trials in Europe will enable a smooth and rapid work flow to the benefit of the life science industry and to patients to whom the new medicines will hopefully become available sooner than what is the case today. Moreover, she believes it will strengthen the pharmacovigilance and overall surveillance of adverse effects and also hopes that the understanding of the need of thinking ahead will settle. -In general, the harmonization is likely to create a greater awareness of the close connection between clinical trials and the regulatory set up among the different stakeholders of the life science industry. The simple advice is, to aim for the MAA.

Decentralised Procedure (DCP)

Clinical trial

Reference member state (RMS)

Reporting member state

Concerned member states (CMS)

Member states concerned

Common documentation

Scientific part (Part I)

National documentation

National part (Part II)

Preliminary assessment report Final assessment report

Draft part I of the assessment report Request of additional information

About IWA Consulting The IWA Consulting Team is a

•

dedicated group of regulatory affairs specialists providing expert services to a range of international private and public clients. We do that based on our long

•

term regulatory experience, in-depth knowledge, and expertise. We assist biotech, pharma,

•

and medtech companies in achieving their major regulatory milestones, knowing and thoroughly understanding the sense of urgency that applies to this business area. Regulatory affairs – in every aspect of the discipline – are our core competence.

That is – at the end of the day – the goal. And my job is to ensure that our clients understand enough about the process to choose a regulatory pathway that is well thought through from the very beginning, Lillan Rejkjær ends.

Phone: +45 56 66 04 90 E-mail: info@iwaconsulting.dk Web: www.iwaconsulting.dk

Final part I of the assessment report Part II of the assessment report

RMS approval

Conclusion of part I of the assessment report

National phase

Decision phase

in managing Global Regulatory Affairs

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

CLINICAL TRIALS

Clinical trial activity improves health care, employment, and learning A report based on questionnaires among health care professionals (HCP) documents the local effects of industry initiated clinical trial activity on education, improved care, research activities, and jobs. By Charlotte Strøm, MD PhD Journalist

hen a medicinal

Invest in Denmark released a

The motivation among health

product is investi-

report provided by Copenha-

care professionals to join

gated in Sweden, Estonia,

gen Economics quantifying

clinical trials as investigators

and Slovakia, or elsewhere

the value of industry initiated

covers a professional interest

on the globe, it will – if the

clinical trials in Denmark.

in being part of the most re-

data attributes licensing – be

The report puts into num-

cent pharmaceutical develop-

Thomas Kongstad Petersen, Chair of

available as well to Danish

bers the effects that may

ment as well as an interest in

patients in due time. However,

appear difficult to quantify

strengthening the scientific

clinical trial activity initi-

properly, such as the learn-

network. Moreover, clinical

ated by the industry implies

ings and knowledge sharing

trials tend to implicate clinical

distinct local benefits in the

among HCP from working with

improvements at participat-

quently resulted in increased

health care system that should

a clinical trial. More than 53%

ing hospitals e.g. by changes

scientific activity taking

be taken into account when

of respondents agreed that

made to daily clinical practice,

place at the institution, i.e.

estimating the added value of

they felt working with clinical

treatment guidelines, changes

attracting more clinical trials

this activity. In January 2017

trials had improved their clin-

made to national guidelines

or other research activities,

The Danish Association of the

ical skills, and 61% responded

etc. Furthermore, the respon-

publication of scientific results

Pharmaceutical Industry (Lif),

that their knowledge had been

dents pointed to a trend that

directly or indirectly related to

the NEXT Partnership, and

shared with colleagues.

clinical trial activity subse-

the clinical trial etc.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

the NEXT Partnership and Vice President at LEO Pharma

CLINICAL TRIALS

Clinical trials initiated by

-For the patients, the health

physician and nurse, who are

Partnership demonstrates

the life science industry tend to attract millions in invest-

care system, and for society, it

doing the practical assign-

how it can be done, as NEXT

is hard to find any downsides.

ments, related to the industry

has helped build clinical trial

ments, improving capacity

The HCP learn more from

initiated trials.

competences and manpower at

and qualifications with the

working with clinical trials,

-One side of the story is

the partnering departments.

staff. Investments made by the

and the capacity and quality

that the industry pays the

-I believe it is essential that

pharmaceutical industry in

of the health care system

hospitals to conduct the trials,

the hospitals prioritize clinical

the Danish health care system

increases because the industry

but if this does not materialize

research. Clinical trials take

in 2015, were estimated to be

pays for the time, medicine,

into more head counts then

human resources, professional

around 37 million EUR. More-

and equipment used during

it definitely puts a strain on

commitment, and engagement

over, the industry initiated

the clinical trials, says Thom-

the staff that will have even

among the staff to contrib-

clinical trials also create jobs

as Kongstad Petersen, Chair

more chores and assignments

ute to a trial. Itâ&#x20AC;&#x2122;s possible

and improve the gross nation-

of the NEXT Partnership and

to fill into a day that was busy

to encourage and stimulate

al product.

Vice President at LEO Pharma.

already. Clearly this is unsus-

that through more part-time

He agrees, however, that lo-

tainable, Thomas Kongstad

research positions, education

the industry initiated trials in

cally â&#x20AC;&#x201C; and bedside â&#x20AC;&#x201C; it may be

Petersen explains.

in clinical trial conduct, and

the public health care system?

a challenge for the individual

Are there any downsides to

He envisions that the NEXT

possibly by setting goals for clinical trial activity that are

"The report puts into numbers the effects that may appear difficult

aligned with goals measuring

to quantify properly, such as the learnings and knowledge sharing

the hospitals, Thomas Kongs-

among HCP from working with a clinical trial."

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

patient treatment and care at tad Petersen concludes.

Ida Sofie Jensen, CEO at Lif

CLINICAL TRIALS

Raised application fees and overhead costs put strain on clinical trial budgets Clinical trials already engage a large proportion of budgets in pharmaceutical companies. Remarkable increases in fees with the Danish Medicines Agency and overhead costs at hospitals may jeopardize the current level of activity. By Charlotte Strøm, MD PhD Journalist

hrough an executive order the Danish Medicines Agency (DKMA) raised the fees to be paid to the agency for applications on clinical trials of medicinal products as of 01 July 2017. The fees apply to all, irrespective of the origin of the trial sponsor.

to the actual costs of assessing them. Hence, we improved the registration tools, allowing us to assess the actual time consumption, and ended up with this new level of fees.

During the public hearing prior to the decision made by the Minister of Health, Ellen Trane Nørby, several stakeholders raised their concerns on the remarkable raise in the fees. An application involving new medicinal products from 01 July 2017 costs 6.087 EUR, applications involving already marketed products cost 3.066 EUR. Additionally, as a new item, an annual fee of 1.711 EUR applies to every trial for every ongoing year. Amendments to the protocol cost 635 EUR. Overall, the fees have been raised considerably.

-Some fees have been raised quite a lot, others have been lowered. But overall the level of the fees now reflects the real cost of assessing the applications, Henrik Bendixen says.

He points to the reflection of the real cost.

The fees relate to the administration costs of assessing and approval of clinical trial applications and continuously conduct inspections at clinical sites, manufacturing facilities etc. The revenues of fees related to clinical trials represent 6% of the total turnover of the DKMA according to Henrik Bendixen.

In the association’s hearing response to the executive order, it says: “A lot non-commercial research is taking place partly unpaid in the physician’s spare time, and rarely the grants cover all studies. With the proposed increase in fees, it will be difficult – if not impossible – for medical doctors to initiate trials on their own in areas such as medicine interaction or adverse effect studies, because there is no money to pay for the fees.” The Danish Association of the Pharmaceutical Industry (Lif) also raised concern regarding the increase in fees. -The fees related to approval of, and ongoing control with clinical trials ought not to be above the average level of fees in countries for comparison, when the EU act on clinical trials is issued. This is expected to happen in 2019, says Ida Sofie Jensen, CEO at Lif.

Henrik Bendixen, Chief Adviser at the DKMA explains on the increase of fees:

Risk of fewer trials Critics of the raise of fees at DKMA claim that the increase

Lif has compared the level of fees with the National

-A national audit earlier stressed that the fees of clinical trial applications and other fees subject to The Danish Medicines Act with the DKMA must be closely related

in costs may jeopardize the activity on clinical trials. The Danish Medical Association worries on the raised fees particularly concerning the investigator initiated trials.

Competent Authorities in 17 European countries. The key concern with the numbers is that the fees in Denmark are now in the high end.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

Need for evaluation When executing the order, the Minister of Health, Ellen Trane Nørby, suggested that the raised fees will be subject to evaluation after some time. Ida Sofie Jensen comments on this point: -It makes sense to ensure that the fees for clinical trials are not an independent barrier obstructing the attraction of clinical trials to Denmark. We tend to agree with the Minister of Health that the new level of fees should be thoroughly evaluated in due time. Once the damage is done, and Denmark gets the reputation of being expensive, it can be difficult and take a long time to recover from. Thomas Kongstad Petersen, Chair of the Board at the NEXT (National Experimental Therapy) Partnership and Vice President at LEO Pharma dares to put an actual estimate on this risk. -For sure this will have an impact. The fees were fairly low, I admit to that and more realistic fees are fair, however, the increase we see here is out of the ordinary, and likely to have a prohibitive effect, he says and carries on,

CLINICAL TRIALS

"A national audit report stressed that tax money cannot be used in support of private companies" -I’m afraid we will see the impact quite soon, within six months or so.

decided to synchronize the level of overhead across the country. This decision came into act in the spring of 2017, and the overhead for any research conducted on behalf of external partners was raised to 18%. The overhead is to cover indirect costs such as administration, management, finance and control, facility management, purchases of IT etc.

Overhead costs increased He stresses that not only has the DKMA raised the fees for clinical trial applications considerably over the summer, the Capital Region of Denmark in early 2016 also raised the overhead cost on all research activity performed with external sponsors at the region’s hospitals. The overhead cost is a fee in percentage of the revenue, generated by the trial, in order to cover indirect costs. -Previously, the overhead across the regions varied, from a few percent to 5%. Within the Capital Region of Denmark, the overhead was increased to 15% in 2016 overnight, he says.

A national audit report stressed that tax money cannot be used in support of private companies. Hence, any type for research that is conducted at the public hospitals for external parties must be self-financed to comply with the law. According to Jeppe Hedegaard Munck, team leader at Economic Affairs, Danish Regions, that is why the overhead has been applied and set to a fixed rate of 18 % across the country. Jeppe Hedegaard Munck explains further:

But there is more to come. Based on a national audit report, the Danish regions that own the hospitals have

-The national audit found that the hospitals and regions did not in an adequately way separate the budget for research from the regular budget for patient treatment. This means that potentially money allocated to patient treatment, against the law, has been used for conducting research for private companies. -However, the national audit did not conclude that this was the case, as hospitals to some extent already charged a sufficient payment to cover both direct and indirect costs. This is also why the application of overhead of 18% will not imply that the costs of research projects will rise by 18%, says Jeppe Hedegaard Munck.

Overhead in most European countries The work group at Danish Regions has investigated the level of overhead in Europe and found that overhead is commonly applied in most other countries; some places even more than 18% is charged according to Jeppe Hedegaard Munck. Overlooking the continent from a pharma headquarter office in Boston, Chicago,

Paris, or Zürich during the planning of large scale global clinical trials involving millions of Euros, the overhead of 18% may need some explaining, including the fact that it is legally required at Danish hospitals. Whether the fixed national overhead rate of 18% for external research at hospitals will dampen the clinical trial activity in Denmark remains to be seen. However, in part this tends to go against the Life Science Growth Team’s 17 recommendations for the government on a stronger life science sector. The report was presented in March 2017, stressing the strengthening of clinical research as the first recommendation. -Altogether, the increased costs of overhead at hospitals and increased fees with the DKMA appear to be counterproductive. The pharmaceutical companies are hardly counting pennies; however, it would be unwise to make the mistake to assume that price is not at all an issue. It is, Thomas Kongstad Petersen concludes.

FACTS •

On 01 July 2017, an executive order on fees for applica-

•

The Capital Region of Denmark issued new rules on determination of overhead costs in 2016 applied to research

utive order covers the determination of fees for applica-

performed at the region’s hospitals with external partners.

tions regarding clinical trials submitted with the Danish

The overhead was subsequently set to 15%.

Medicines Agency (DKMA).

•

tions concerning clinical trials came into act. The exec-

•

The hospitals owners, the regions of Denmark, have alto-

Read more about the fees for clinical trials with the DKMA

gether in 2017 decided to set the overhead to a fixed rate

at https://laegemiddelstyrelsen.dk/en/licensing/clini-

of 18% for research activities performed in collaboration

cal-trials/fees/

with external partners.

The overhead is to cover indirect costs such as administration, facility management, IT etc.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

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Spectrum-Labs-TFDF-System-Life-Science-Ad.indd 1

8/31/17 9:22 AM

LabDays 2017 Fagmesse for laboratorieteknik

n LSB TemamĂ¸de n Laboratorieudstyr n Diagnostik n Bioteknologi n Forskning n Kvalitetskontrol n Fagkonferencer n Over 90 udstillere

Ă&#x2026;rhus 20. - 21. september labdays.dk

LABDAYS 2017

WELCOME TO LABDAYS 2017 G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

LABDAYS 2017

LABDAYS 2017 The 20th and 21st of September, the second version of the LabDays fair takes place in Aarhus, Denmark. At the premiere fair – in 2015 - there were 79 exhibitors, greeting the many visitors from the life science industry. Edited by: Arne Nielsen. According to J.B. Exhibitions,

with more than 90 exhibitors

fair in 2015 – with the smallest

can either be done by pre-

the organizer of LabDays, all

registered for the event, the

booth being 4 m² and biggest

registering on the website

experience has shown that

expectations are that LabDays

booth 50 m².

(Labdays.dk) or at the

there is a correlation between

2017 will beat all records. The

the number of exhibitors and

booth area is approximately

the number of visitors and

20 % bigger than at the first

All visitors have to register,

entrance of the fair.

when visiting the fair, which

ACTIVITIES Exhibitors FREE Lab Theater The exhibitors will execute smaller seminars from the open stages. Wednesday, September 20th Thursday, September 21st

DiaLabs’ Purchasers Day Danish Diagnostics & Laboratory Association (Dialab) will hold a meeting for purchasers from both the public and private sectors. Tuesday, September 20th

LSB's Annual Meeting Laboratory Medical Society for Bioanalysts executes their annual meeting for members (no costs) – non-members can attend for the price of 400 Dkk. Wednesday, September 20th

LSB’s NGS (Next-GenerationSequencing) theme day Laboratory Medical Society for Bioanalysts executes the NGS theme day for members (no costs) – non-members can attend for the price of 400 Dkk. Thursday, September 21st

Registration is not required.

Invitation only.

Registration is required.

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.

and other stuff in the staffed wardrobe for the price of DKK 25.

FACTS: Venue: Scandinavian Congress Centre Margrethepladsen 5, 8000 Aarhus C Opening hours Wednesday, the 20th of September: 9:00 pm to 4:00 am

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

Wardrobe You can store clothes, bags

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

For further information visit: www.labdays.dk

• • • • •

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High-end køle- og fryseprodukter til klinisk produktion og forskning.

Besøg os på stand nr. 98.

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Premium Håndbåren forsendelse Maksimal overvågning og sikkerhed Dokumenteret ubrudt kølekæde Worldwide transport med proaktiv opfølgning og track & trace Det sikre valg GdP compliance Temperatur datalogger og reguleret temperatur til modtager Vejledning/udarbejdelse omkring tolddokumentation Worldwide transport med proaktiv opfølgning og track & trace

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LABDAYS 2017

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

LABDAYS 2017

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

SEE YOU AT LABDAYS 2017

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

Med 25 år i branchen, ISO 9001 certificeret, egen serviceafdeling, eget lager og særdeles dedikeret specialister, er vi altid klar til at supportere dig! Download gratis billetter på www.labdays.dk og kom og hils på os. Vi vil blandt andet vise: GEM5000 – Nyeste indenfor blodgas analyse INDIKO – Fuldautomatisk, åbent fotometri instrument STERI-7 – Produkter til sterilisering og renrum Vi glæder os til at se jer!

JRV offers a wide range of innovative quality ventilation solutions based on high performance-oriented experience and a reliable staff. Visit us at LabDays and you are one step closer to some of the most demanded air handling products existing at laboratories, hospitals and universities. Among the best sellers such as point exhaust and fume cabinets, you will have the opportunity to ask questions or have your curiosity gratified about what JRV has developed and manufactured since 1968.

Website: www.ilsdk.dk / Mød os på stand nr. 6.

Website: www.jrv.dk / Meet us at booth number 52

Svanholm.com is a supplier of High-End Analyzers, Sensors and Equipment for biotech, biofuel, crystallization, stem cells, tissue engineering and tablet manufacturing areas. We distribute products of 25 suppliers in the Nordic countries, and we cover from raw material identification with Raman over solvent drying control with mass spectrometers to fermentation pH, DO, OD and Viable Cell Density sensors.

Bioneer is a Danish R & D based service company in biomedicine and biotechnology. Services comprise protein manufacturing (up- & downstream), pharmaceutical development (drug candidate analysis and formulation), stem cell based models for disease (neuronal, immune and skin), biomarkers and histology (HTP molecular in situ and qPCR). Bioneer is also contributing with R & D in a number of national and international R & D programs (IF, IMI, H2020).

Website: www.svanholm.com / Meet us at booth number 75

Website: www.bioneer.dk / Meet us at booth number 88

Køl- og frys til klinisk produktion og forskning er der, hvor et kølefirma, viser om det er opgaven voksen.

Mød din landsforening – fortæl os hvad vi kan gøre for dig.

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Dansk Laborant-Forening organiserer laboranter, laboratorieteknikere, miljøassistenter, miljøteknikere, miljøteknologer og professionsbachelorer. Er du i gang med uddannelsen i et af disse fag, er du også meget velkommen. Vores medlemmer er ansat på både private og offentlige arbejdspladser, det kan være i kontrol -og produktionslaboratorier eller forskningslaboratorier på universiteterne.

Website: www.scotsman.dk / Besøg os på stand nr. 98

Website: www.hk.dk/dl-f / Mød os på standnr. 53

For the ultimate in automated chemical analysis, visit FOSS at stand 48. We can help you to save resources with solutions covering every stage of the analysis process, from sample preparation to chemical preparations based on Digestion, Distillation and Extraction, all the way to final analysis. More than 50.000 FOSS analysis instruments are in operation in laboratories worldwide, including Commercial, Public & Industry laboratories.

Techtum Lab AB focus on NGS in the Nordic region. Smarter automation of NGS – lower tip consumption, lower investment and user programmable setup of library prep kits and clean-ups etc. We also supply widest range of IVD certified NGS kits for cancer (Swiss manufacturer). Our competitive proven platform for automatic sample preparation for screening of MRSA is the fastest and has lowest cost/prep. Used by Karolinska Hospital since 10 years.

Website: www.fossanalytical.com / Meet us at booth number 48.

Website: www.techtum.se / Meet us at booth number 76.

Det har vi været i 30 år, og derfor indgår vores produkter i kølekæden på de fleste sygehuse og i mange medicovirksomheder. Giv os jeres køleudfordring så kvitterer vi med en gennemtænkt løsning.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

SEE YOU AT LABDAYS 2017

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

EcoOnline ApS er en IT-virksomhed, som er dedikeret til at udvikle software til nem håndtering af kemikaliedokumentation. Med vores system ChemiControl får I adgang til mere end 50.000 sikkerhedsdatablade, som holdes opdateret. I kan nemt oprette autogenerede arbejdspladsbrugsanvisninger, samt til kortlægge jeres kemikalier og autogenerer etiketter. ChemiControl er webbaseret og kan bruges på både computer, tablet og smartphone.

Ultra rent vand er grundlæggende i alle effektive laboratorier, der arbejder med følsomt apparatur og kemiske og molekylærbiologiske analyser. Krüger Aquacare forhandler en række af ELGAs vandanlæg.

Website: https://public.chemicontrol.dk/ / Meet us at booth number 19

Website: http://www.kruger.dk/industri/loesninger/laboratorievand/

Skanlab ApS provides solutions and products to laboratories. -Crushers, Mills, Sieves and Sieves Shakers as well as Sample Dividers from Retsch GmbH (DE). -Equipment for optical size and shape analysis of solids from Retsch Technology GmbH (DE). -Ovens & furnaces from Carbolite-GERO (GB) with a tempature range from 30 to 3000 Cº. -Counseling, service and sales of the world-renowned quality product from the the above mentioned companies in Greenland, Iceland, The Faroe Islands and Denmark.

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.

Website: www.retsch.dk / Meet us at booth number 83

Website: www.bionordika.dk / Meet us at booth number 59

Dorte Egelund ApS er et højt specialiseret firma, der leverer løsninger til mikrobiologiske- og biotech laboratorier. Etableret i 2008 og har i dag tilknyttet nogle af de førende producenter inden for området.

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.

Vi tilbyder salg-service og support. Men beliggenhed i Roskilde og lagerførende med forbrugs artikler fra vores leverandører, er der altid hjælp at hente.

Vi tilbyder et bredt spekter af helhedsorienterede løsninger til laboratorier, der stiller høje krav til deres leverandører. Meet us at booth number 27

- PCR/qPCR - Antibodies - NGS library prep - Restriction enzymes - Cloning - Endotoxin detection - Electrophoresis - Molecular diagnostics - FISH probes - Assay kits for biomedical research - Custom services - Primary cells and cell culture media

Website: www.dorteegelund.dk / Meet us at booth number 17

Website: www.steelcospa.com / Meet us at booth number 29

Representatives of the magazine Greater Copenhagen Life Science will be present at the exhibition, where we will walk amongst the visitors and exhibitors handing out free magazines.

Greater Copenhagen Life Science is the primary mouthpiece for the Medicon Valley region’s many companies and organizations within biotech, medtech and pharma as well as companies who have this segment as their customers or suppliers. Website: www.nemmedia.dk

Website: www.eticalls.EU / kj@etisoft.dk / +45 86867733

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

LABDAYS 2017

New feature for etiCALLS The development of the laboratory industry has made etiCALLS get a new face, adapting to the needs of the demanding market. It’s not just a new logo, a website dedicated to etiCALLS, but also a much wider product range. By Joanna Heler-Kończakowska etiCALLS is the result of our many years of experience, supported by cooperation with leading laboratories. The solution consists of specialized labels, a matching thermal transfer ribbon, software, printing devices, and code readers. The solution allows you easily and quickly create labels using text, barcodes, 2D codes and graphics (warning signs, chemical symbols etc.). It also allows you to insert numbers and the current date and time. The special labels and thermal transfer ribbons guarantee legibility and durability even under extreme conditions of storage, as well as excellent adhesion to a variety of surfaces. etiCALLS system brings many value-added benefits such as ease of identification, elimination of errors, and the introduction of good practices

to improve the quality and productivity of laboratories. With the use of etiCALLS, the cost of operating the laboratories decreases as only the requested quantities of appropriately selected materials are printed. The etiCALLS system will therefore work in those institutions where cost optimization goes hand in hand with quality, precision and reliability. The labels within etiCALLS can be used for samples, straws, tubes, histopathological slides and cassettes, multi-grain plates and petri dishes, blood bags, cryogenic shelves, laboratory equipment, documentation and more. Print and paste in a workflow is now possible on small round tubes LabDays 2017 is the place where Etisoft presents the solution that allows fast, safe

and consistent printing and applying labels on tubes and round bottles all the way from Ø 120mm down to a diameter of only Ø 10mm.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

It is the result of own developed labels for both cryo and freeze storage environments and a small Italian developed Print and Apply solution. The etiCALLS label solution is products of different materials and adhesive that fix attachment on surfaces to be frozen to - 196 or -80 degrees +150 degrees. Etisoft now combines the Italian developed Print and Apply solution Pk-50-M with their specialized label solution etiCALLS. Take your pipes or bottles with you on LabDays and get test results applied for later test at home to your own freezer. Source: Etisoft

In this movie at the minute 4:00 there are some little vial shown: https://www.youtube.com/ watch?v=JMxjmK9ebV0&t=38s Or search for: Pk 50 M Applicatore etichette semi-automatico Or scan the QRcode:

LabLog+ er udviklet omkring to principper - at give indkøberen overblik, og at forstyrre personalet mindst muligt!

Kom og se Svanholm.com celledyrkning DreamTeam! Massespektrometre til offgas

LabLog+ er et uafhængigt stand-alone system, der ikke kræver integration til indkøbssystem, eller andre IT-systemer. Digitalisering af følgende arbejdsgange:

• • • • • • • •

Indscanning af forbrugsvarer og kemikalier, der indleveres til depot og lagre. Registrering af udløbsdato og LOT. nr. Modtage varer der skal i karantæne. Samt frigivelsesprocessen. Udscanning af forbrugsvarer, personalet plukker fra lagre og depoter. Herunder registrering på konti, projekter, id. Automatisk varsling af indkøber, når defektpunktet nås (i realtid). Automatisk varsling om varer der udløber om XX dage. Lagerstyring, foretages i database med fuld historik. Udtræk af alle data til Excell.

LabLog+ erstatter:

• • • •

Online måling af levende celle densitet med kapacitans

Regneark med oplysninger om produkter og leverandører.

Lineær OD sensor, stor range, der ikke forstyrres af bobler

Lagerstyring via regneark. Regneark med økonomioplysninger. Laminerede Kanban-/Defektkort.

Source: Scotsman

Optisk Densitet (OD) med høj følsomhed

Physoxia Workstations. Optimalt arbejde med celler

Lucullus PIMS software styrer alle fabrikater af fermentere. Numera automatisk prøveudtagningssystem sampler 24/7

LABDAYS 2017

QR codes keep track of your certificates DRIFTON A/S introduces an innovative player in the laboratory glass industry Glassware manufacturer GLASSCO prints – as the first company in the world – QR codes on their volumetric glass. The QR code makes it significantly easier to keep track of your certificates, standards and manuals, etc. Simply place your mobile phone close to the product - and you are instantly presented to all the data sheets that may otherwise get lost. DRIFTON A/S is introducing GLASSCO to the Danish market, but the company is far from being a new player in the laboratory glass industry. GLASSCO is a family business that has managed to gain status as a leading and worldwide brand in laboratory glass and equipment in two generations. Based in Manglai in northern India, GLASSCO has specialized in producing high quality glass for 45 years, and today exports exclusive laboratory glass at highly competitive prices to more than 75 countries worldwide.

Intelligent pumps Participants at LabDays 2017 will be able to see a small selection of GLASSCO's products at DRIFTON A/S´ stand (No. 50), where a selection of laboratory pumps will also be presented. For example, we demonstrate the LabV6 peristaltic pump from Shenchen. It is an intelligent flow rate pump of high quality, which is particularly distinguished by being extremely fast and efficient. It operates at a speed range of 0.1 - 600 rpm and a flow rate range of 0.000067 - 2280 ml/min. It is very easy to use with a digital touch screen that intuitively guides you through the features. It also boasts a smart, streamlined design - and an attractive price tag.

Visitors to DRIFTON A/S´ stand (No. 50) at LabDays in Aarhus will, among other things, be able to see a selection of GLASSCO's high-quality laboratory glass and get a demonstration of the latest development in laboratory pumps.

Finest quality GLASSCO specializes in volumetric glass and filtration glass, but is capable of delivery in all laboratory glass - and has a wide range of other laboratory equipment, such as dispensers, magnetic stirrers, heaters, etc. The glass is manufactured from ASTM E-438, Type 1, Class A (BORO 3.3) glass, which the company imports from Germany. The laboratory glass is manufactured with high precision and in sizes that comply with applicable DIN EN ISO, ASTM and USP standards. GLASSCO's calibration laboratory is accredited with ISO 17 025: 2005 and is also ISO 9001 and 18 001 certified.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

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

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Courses in 2017/2018 QA, QC, GXP for Pharmaceutical Production Clinical Pharmacology and Biostatistics Discovery and Development of Medicines Drug Discovery Non-Clinical Safety and Toxicology

Enroll in the full programme or take individual courses

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 2017/2018 Regulatory Science – Perspectives on Clinical Development Global Medicines Legislation and Guidelines Regulatory Affairs in the EU Ethics in Regulatory Affairs of Pharmaceutical Products – Dilemmas in Decision-makings Safety of Medicines – From Non-clinical Development to Pharmacovigilance Quality – Active Substance and Medicinal Product Biopharmaceuticals – Quality Development and Documentation Clinical Development – Efficacy of Medicines Regulatory Affairs in the USA

GOVERNMENT’S RECOMMENDATIONS

What the Life Science industry says E

arlier this year, the government’s growth team for Life Science delivered 17 recommendations on how to improve the framework conditions so that the industry can create growth, develop new innovative treatments, strengthen research and innovation and increase exports.

We asked Medicoindustrien, the Danish industry association for medical device developers and manfacturers, Medicon Valley Alliance, the Danish-Swedish life science networking organisation and Dansk Biotek, the Danish biotech industry association.

So how do the main players in the Life Science industry view the recommendations?

Hans Schambye, member of the board at Dansk Biotek: “The 17 recommendations are right and they are important if we are to maintain a powerful biotech industry. “Unfortunately, the proposals just published by the ministries of taxation and industry & business are diluting the recommendations. For example, the share account savings scheme and deductions on investments are very modest. It’s the political reality but one could argue that it pays to be more proactive because supporting the Danish biotech industry is a good investment. ”The government’s proposal for further

Petter Hartman, CEO Medicon Valley Alliance (MVA): ”Overall, it’s a really ambitious job that’s been done here with some strong recommendations. If these are implemented the right way, then it can have real significance but it’s now up to politicians to create the right conditions. ”For MVA, what we’re especially interested in is access to qualified labour. This is the key issue. We have to work really hard in the region to attract international talents but also to make sure that the educational system can deliver the right competencies in future. Politicians, universities and industry must work closely together. “Investments in research is another

investments in Danish research is only a fraction of what we believe it should be. We do a lot of world class research at Danish universities but we are not very good at transforming this into new companies and new products. We lack the support from the state. In France, for example, the state has made it attractive for pension funds to invest in French biotech companies. ”The 17 Life Science recommendations are really good, though, and covers the entire life cycle of the sector. One thing we’re excited about is the proposal for a Life Science office under the ministry of industry and business which will help ensure that new draft bills and initiatives involving Life Science are being taken care of properly.

important area, also investments on the Swedish side of Oresund. I think Denmark can benefit from investments in Sweden, for example the ESS (European Spallation Source), MA X IX Laboratory at the Lund University, where ground-breaking research is being done. “The third important part of the recommendations is the entire banding aspect, to visualise the position of strength we have and become even better at marketing the region and make it attractive for international talents and investors to look towards Denmark. For Greater Copenhagen to be perceived as a leading Life Science hub, marketing and internationalisation are enormously important.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

GOVERNMENT’S RECOMMENDATIONS

Peter Huntley, CEO Medicoindustrien:

extremely high level that we already have.

“The recommendations are spot-on and

proposals for a new tax reform included

cover the Life Science industry in full.

a share savings account scheme and tax

“There are particularly three elements, which we put great emphasis on. Firstly, that we get a life science office which will entrench the development targets and framework conditions of the industry. Secondly, it is immensly important that the Danish health care system and the industry have a close interaction with regards to development, testing of products and market access. And thirdly, that we maintain innovation at the

”The government’s newly published

deductions for investors who invest in small start-ups. The medico industry is very good at establishing small start-ups but so far, there’s been a lack of growth incentives, which can help a start-up turn into a growth company. In Sweden and the UK, for example, there are much better conditions for start-ups, that is ways to channel private funds into start-ups. I think the share savings account system will be a good instrument.

The 17 recommendations are 1

Denmark should allocate more resources to and target the public research as well as increase the private research, which form the basis of innovation within Danish Life Science. At the same time, the education of highly qualified researchers to the private and the public sector should be reinforced.

The coordination of clinical research in Denmark should be gathered in one unifying place under the existing NEXT cooperation which should be expanded into a national organization covering all clinical areas. The new NEXT 2.0 is anchored between state, regions and companies, and the possibilities of clinical research at the hospitals are enhanced.

Efforts to create the framework for transparency and trusting public-private cooperation between healthcare sector and companies should be enhanced.

It should be possible to use IT and health data in a secure manner in order to develop and research in new and innovative forms of treatment and to contribute to a better, more secure and coherent healthcare sector.

The Danish Medicines Agency should be reinforced to be one of the top medicines agencies in Europe.

There should be more notified bodies (bodies that certify medical devices) in Denmark with the relevant top quality capacity to meet demands.

Denmark should be a pioneering country within personal health technology.

The Danish education system should be organized so it can, to a higher degree, deliver world-class employees with the right skills for the entire value chain within the Danish Life Science industry.

Danish Life Science is global - and the conditions for attracting and keeping international talents and qualified labour should be at the European top.

Denmark should increase the focus on entrepreneurship and innovation within the Life Science research and education environments as well as improve the conditions for this.

Denmark should pave the way for more Life Science companies through better access to early financing.

Opportunities for attracting investments for Danish Life Science companies should be enhanced.

The tax incentives for research-intensive companies and for investors should be improved.

In Denmark Life Science companies should have a favorable framework for manufacturing with research and development as a basis.

Continuous work has to be done to support a flexible, stable, rational and innovation-boosting home market that can work as an international show window.

A national exporting strategy for Life Science should be prepared and this should be supported by new earmarked funds for exportpromoting activities with the aim that the export of Danish Life Science solutions should be doubled towards 2025. Moreover, an action plan should be prepared to form the basis of increased targeted efforts to attract foreign investments to the Danish Life Science group.

A growth plan for Life Science should be prepared based on the Growth Team's recommendations and a permanent Life Science office referring to the Danish Minister for Industry, Business and Financial Affairs should be established.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

123

We are now experiencing the first consequences of BREXIT! Photo: Bech-Bruun

By Martin DrĂŚbye Gantzhorn, Partner at Bech-Bruun

t requires an unusual degree

obligations of the contract/

will thereby acquire third

BREXIT for holders of centrally

of escapism if the claim

rights apply to the territory

country status, such as e.g.

authorised medicinal products.

is made that BREXIT has

designated as the "EU" or its

Switzerland or the USA. From

not had or will have further

equivalent. In the future, will

that date, pharmaceutical

consequences for the Life

such agreements also apply to

substances and finished

Marketing authorisation after BREXIT

Science sector. Naturally

activities in Britain? Perhaps.

medicinal products produced

there will be consequences

Companies should as soon as

in Great Britain will be treated

for the United Kingdom,

possible in each case deal with

like other medicinal products

but certainly also for the

business-critical contracts so

that are imported onto the EU/

remaining Member States

that there is clarity. Perhaps

EEA from a 'third country'.

who will lose a significant

it would also not be a bad

After BREXIT, pharmaceutical

member of the Community.

idea to consider whether it

manufacturers in the United

The consequences will also

would be advantageous to

Kingdom who want to sell

impact Life Science companies

move production/research

medicinal products to the

to varying degrees, both

and development activities

EU/EEA will be met with

pharmaceutical manufacturers

from, or even to the United

a number of important

and manufacturers of medical

Kingdom? In this area it will be

regulatory requirements. This

equipment established in

essential that companies have

applies among other things to

the United Kingdom, as well

an overview of the regulatory

applications for, or the transfer

as those companies in the

and fiscal pros/cons. It may be

of a marketing authorisation

industry that conduct research

difficult to get a full overview

for an EU/EEA country, as

and development as well as

at the present time, but no

well as to documentation

maintain production in the

company can afford to sit by

that the products live up to

United Kingdom. This does not

passively and wait for the

EU standards and quality

come as a shock.

situation to develop?

requirements.

Are contracts under control?

The United Kingdom will become a third country

In this way, BREXIT has led

A relatively simple example consists of the many contracts

The immediate consequence

European Medicines Agency

(e.g. concerning case files,

of BREXIT is that the United

(EMA), and in its response,

licensing or distribution),

Kingdom from March 30, 2019,

the EMA has just published

which parties have concluded,

will no longer be subject to EU

an opinion concerning the

where it is stated that

legislation, and the country

immediate consequences of

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

to a flurry of questions to the

Marketing authorisations for human and veterinary medicinal products issued by the EU Commission on the basis of an EMA approval are valid throughout the EU. The marketing authorisation is as a starting point valid for five years but may be extended. The holder of the marketing authorisation (MAH) for a medicinal product for both human and veterinary use, must be established in an EU/EEA country. BREXIT therefore means that holders of centrally authorised medicinal products, where the MAH has been established in the United Kingdom, must transfer current marketing authorisations to a stakeholder established in an EU/EEA country or appoint a representative in the Community. This also applies to medicinal products authorised for the treatment of rare diseases (orphan drugs).

LEGAL UPDATE

Documentation of the quality of medicinal products As a starting point, production of medicinal products in the EU/EEA follows the GMP standard, "good manufacturing practice". Medicinal products and active substances produced in the United Kingdom and intended

for the import of medicinal

QPPV who is already a

achieved via a legal entity (e.g.

products and semi-finished

resident within the EU/

a subsidiary) established in

products into the Community,

EEA. The Danish Medicines

the EU/EEA, that will act as a

in order for the importer

Agency expects that a QPPV

link between the MAH and the

to be able to release the

is routinely present in the

EMA.

products for sale. This imposes

company, is familiar with all

requirements to the importer’s

of its premises, and is present

quality assurance and control,

for a minimum of 10 hours per

as well as his organisation,

week.

staff, facility and equipment, etc.

BREXIT also contains possibilities. There is a tendency that stakeholders in the industry establish

European Union support for small pharmaceutical companies

themselves in close proximity

The SME regulation provides

the EMA may relocate, there is

to the EMA. The causes are

must therefore in the future be

Qualified Person for Pharmacovigilance

accompanied by a valid GMP

The pharmaceutical company’s

for the possibility of economic

the expectation of an indirect

certificate that documents

"Qualified Person for

and administrative assistance

boost to the Life Science

that the product lives up to EU

Pharmacovigilance" (QPPV)

from the EMA in the form of

industry of the host country.

quality requirements.

must be a resident in the EU/

a discount on fees and the

Nothing - as we all know - is

EEA. As a consequence of

translation of such documents

so bad that it is not good for

BREXIT, the QPPVs who are

as are necessary in order to

something else. Let us hope

connected to MAHs situated

be able to issue a marketing

that our struggle to get the

in the United Kingdom, will be

authorization. After 2019,

EMA to Denmark will "pay off"

forced to move to an EU/EEA

companies situated in the

later in the year.

country to be able to continue

United Kingdom can no

their work tasks. Alternatively,

longer apply for SME status.

a MAH may appoint a new

Such a status can however be

for sale in an EU/EEA country

For finished medicinal products, an importer must be appointed in the EU/ EEA country in which the manufacturer wishes to sell and distribute its medicinal products. The importer must comply with existing rules

many, and regardless of where

Vi tilbyder dedikeret juridisk bistand af høj kvalitet. Vores mål er at skabe resultatorienterede og langsigtede løsninger for vores klienter. Vi har et solidt kendskab til biotekbranchen, som vi kombinerer med vores spidskompetencer bl.a. indenfor:

etablering og opstart af nye virksomheder tilførsel af ny kapital og finansiering af drift fusion, opkøb og salg / exit aktieincitamentsprogrammer rekonstruktion persondatabeskyttelse og opfyldelse af EU’s persondataforordning skat - selskabs- og personbeskatning Læs mere på www.nrlaw.dk

Karin Absalonsen kab@nrlaw.dk

Henriette la Cour hlc@nrlaw.dk

123 CALENDAR

HIGHLIGHTED FAIRS AND EVENTS IN 2017 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 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.

Upcoming Issue

Life Science companies are constantly bombarded with new regulations, new technology and new business initiatives. They must find the optimal balance between risk and efficiency so regulatory compliance does not block digitalization, analytics, patient centricity, and more. The industry is asking serious questions about compliance:

•

Do we overspend on time and resources, hampering efficiency and our bottom line?

•

Do we underspend – running the risk of our compliance getting out of control?

www.medica-tradefair.com

In the next issue of Greater Copenhagen Life Science, read about a study of pharma, biotech and medical device companies conducted by Epista Life Science: Compliance Maturity in the Danish Life Science Industry. The study examined a wide range of compliance topics from QMS systems and documentation to perceptions of quality and culture. Quality and IT professionals from 38 different companies participated. The resulting report provides insight and recommends concrete actions to help companies balance their compliance efforts between risk and efficiency. The optimal balance is critical, for it is here that compliance begins to create real business value. Read more about the study in the next issue.

G R E AT ER CO P EN H AG EN L I F E S CI EN C E | S E P T E M B E R 2017

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