1. Strongholds, key figures and facts about clinical trials in Denmark
January 2014

2. Having clinical trials is important
Clinical trials – investigator-driven as well as company initated – create the basis for a quick and correct introduction of modern therapy which benefit the patients.
Engagement in clinical research improves scientific knowledge, practical skills and focus on structured patient treatment.
Adds quality and efficiency to the healthcare sector and to the treatment of patients.
Plays a key role in having a research-oriented, growing and exporting pharmaceutical industry.

3. Number of ongoing trials in Lif’s member companies
Source: Survey – clinical trial activities 2012, Lif and Dansk Biotek,

4. The total number of clinical trial applications to Regulatory Authorities
Source: Lif/Nordic Medicines Authorities

5. The number of clinical trial applications from commercial sponsors to Regulatory Authorities
Source: Lif/Nordic Medicines Authorities

6. The number of clinical trial applications from academic sponsors to Regulatory Authorities
Source: Lif/Nordic Medicines Authorities

7. Ongoing clinical trials 2007-2012 conducted by members of LMI, PIF, LIF Sweden and LIF DK
Source: Lif DK, Lif SE, LMI and PIF

8. Number of clinical trials 2012 – Global Top 20 (All trials - industry and investigator initiated)
Denmark is ranked 17 on a global Top 20
Source: (search and analysis made by Lif DK, October 2013)

9. Clinical trials per million capita i Global Top 20 (All trials - industry and investigator initiated)
Per capita, Denmark is the country in the world that conducts the most clinical trials
Source: (search and analysis made by Lif DK, October 2013)

10. Number of new industry funded trials registered “first time” in clinicaltrials.gov (phase I-IV), comparison, selected countries
Europe total (-8%): 2008: 6408 new trial registrations (summing up national figures), 2011: 5899
Source: (search and analysis made by Lif DK, February 26, 2013)

11. Number of new industry sponsored clinical trials taking into account the size of population
Source: Danske regioner, Én indgang for industrien til kliniske forsøg i Danmark, April 2012

12. Distribution of the number of trials on therapeutic areas
The listing is based on data extracted from

13. number of drug trials and number of trial subjects
Distribution of the
number of drug trials and
number of trial subjects
on therapeutic areas in
2012
Source: Danish Health and Medicines Authority,
Annual Report 2012 – Clinical trials of medicines in
humans

14. Danish strongholds Complex trials that require a lot of coordination
Trials that require a lot of technical equipment – e.g. scanners
Denmark has a very good infrastructure
The Danish Healthcare sector is well-organised and of very high quality
Efficient and very competent medicines authorities
Very competent investigators (internationally recognised Key Opinion Leaders)
Very competent and highly trained study staff
Danish patients can easily be identified and followed by use of unique registries
Danish patients are very willing to participate in clinical trails
Danish patients are very compliant when participating in clinical trials

15. World-class patient registries, civil registries and biobanks create an unique foundation for clinical research
In 2013 the Danish Government has initiated development of a National Strategy for Access to Healthcare Data. The aim is to improve access and use of data for research purposes.

16. Oncology Phase I Clinical Trials in Denmark - Fast start-up

17. Oncology Phase I Clinical Trials in Denmark - Fast start-up

18. A strong political ambition to make Danmark attractive for clinical trials
Healthy Growth / Smart Health - Better Lives. A government initiative to increase health and wealth in Denmark. A series of nine initiatives launched november 2010 that aimed at improving the conditions for public-private partnerships in the area of health research and innovation.
Single-point-of-entry for clinical trials in Denmark. In 2011, the Danish regions and Danish industry organisations established a joint project to create a simple and efficient portal for concluding agreements on clinical trials for the whole of Denmark. The “single-point-of-entry” (SPOE) system facilitates corporate access to preparing and planning clinical trials in Denmark and recruiting trial subjects.
A new National Strategy for Clinical Research – to be launched spring 2014
A National Strategy for Access to Healthcare Data – to be launched in 2014
“Denmark as the preferred country for early clinical testing of new medicines” – one of five INNO+ projects to be initiated in 2014.

19. Danish strongholds in science

20. Private investments in R&D is a Danish/Nordic strength position
Source: Forsknings- og Innovationsstyrelsen, 2010: Kortlægning af lægemiddelforskning,based on OECD R&D-statistics

21. Denmark ranks 1st when it comes to size of clinical pipeline
Denmark ranks 1st when it comes to size of clinical pipeline* of new drugs in Europe measured by number of inhabitants DK
* Clinical (phase I, II and III)
Source: Ernst & Young, Beyond borders 2012

22. Denmark ranks top 3 when it comes to size of pipepline
Denmark ranks top 3 when it comes to size of pipepline* of new drugs in Europe measured by number of inhabitants DK
* Preclinical and Clinical (phase I, II and III)
Source: Ernst & Young, Beyond borders, Biotechnology Industry Report 2013

23. High quality research in Denmark
Publications per million inhabitants among OECD- and BRIC countries
Citations per publication among OECD- and BRIC countries.
Source: Ministeriet for Forskning, Innovation og Videregående Uddannelser – Forskningsbarometer 2012

24. Denmark ranks 3rd internationally by the number of articles (per inhabitants) in top scientific health journals
Source: Ministeriet for Forskning, Innovation og Videregående Uddannelser – Forskningsbarometer 2012

25. High quality pharmaceutical research
Second most scientific publications per inhabitant
after Switzerland*.
Second most quoted after Switzerland*.
* Pharmaceutical research specifically
Source:
Rapport vedrørende bibliometrisk kortlægning af dansk lægemiddelforskning , Forsknings- og Innovationsstyrelsen 2010

26. Rapid assessment of clinical trials by Danish Health and Medicines Authority
30 working days (according to agreement with industry)
14 working days (Type A trials)
60 days (EU directive)

27. Medicon Valley

28. Medicon Valley – the primary location of the pharmaceutical industry
Approx employees in the private life science sector
Companies with R&D and/or production:
Approx. 80 (red) biotech companies
20 pharma companies
100 medtech companies
International companies with affiliates:
More than 200 pharma companies
Approx. 170 medtech companies

29. Public private research initiatives
Funding partners:
The Danish State
Novo Foundation
University Hospital, Rigshospitalet, DK
Novo Nordisk A/S
Uppsala University, SE
When fully developed, the center will have approx. 100 researchers

30. Novo Nordisk Foundation Center for Protein Research
Promote basic and applied discovery research on human proteins of medical relevance.
Donation of 79 million EUR from the Novo Nordisk Foundation and through significant contributions from the University of Copenhagen for the renovation of the Center laboratories.
Currently >130 employees have been recruited (out of an expected ~150, at complete staffing).

31. The Novo Nordisk Foundation Center for Basic Metabolic Research
The center will be established at the Faculty of Health Sciences, University of Copenhagen and will employ between scientists and technical staff.
Donation of 117 million EUR from the Novo Nordisk Foundation.
Research will work in close collaboration with research groups in the region as well as leading research groups from top ranking universities in the USA, Europe, China.

32. European Spallation Source (ESS)
ESS will be located in Lund, Sweden, co-hosted by both Sweden and Denmark with the data management center in Copenhagen.
ESS will be funded and operated by a partnership of 17 European countries (total investment of expected EUR 1.6 – 2.0 billion)
ESS will be the brightest source of neutrons in the world for scientific research.

33. Danish National Biobank – Register research
One of the worlds largest biobanks with more than 15 million samples.
Scientists will have the possibility to link information about biological samples from individuals with the large amount of information contained in Danish administrative registries.
The Danish National Biobank will become one of the world’s largest biobanks and a unique resource that will take Danish biomedical research another step forward.

34. Science City North Copenhagen
> 1,3 billion EUR to be invested in new research facilities, buildings and hospital facilities.
One of Europe’s largest concentration of education, basic research and applied research within health science, pharmaceutical science and natural science.
students and scientific personnel, science parks and facilities for companies that wants to be located close to and cooperate with public research.

35. The Danish pharmaceutical industry

36. The pharmaceutical industry’s key figures
130 companies
directly employed in the industry.
jobs in total including employment in subsupply branches.
USD 2.78 billion annually – income tax and company tax to the Danish state
USD 0.21 million – annual value added per employee per year (2.6 times industry average in Denmark).
One out of three industries in Denmark that have a higher productivity growth than the same industries have in other countries.
One of Denmark's largest export goods

37. Segmentation of industry
Four different types of companies
Companies that just sell drugs i.e. generic companies and parallel traders = 70
Sale of drugs + research i.e. affiliates of foreign R&D based companies with clinical research activities in Denmark = 46 (original producers)
Sale of drugs + research + production i.e. national Danish companies with R&D HQ in Denmark and clinical research, production and sale of drugs in Denmark = 4
Just research i.e. small biotech companies with no production and sale = 80

38. Export of pharmaceutical products
DKK 67 billion in 2012, 11% of total exports, Denmark’s largest export commodity

39. The largest Danish export commodities in 2012 (Euro, million)
Medicinal And Pharmaceutical Products
Petroleum, Petroleum Products And Related Materials
General Industrial Machinery And Equipment
Meat And Meat Preparations
(11,76 billion USD)

40. Denmark is highly specialised in pharmaceuticals
2010
Export of pharmaceuticals
per capita USD
Pharmaceutical export’s share of
total export
Value added per employee in pharma-industry USD (labour productivity)
Denmark
1.621
9.4 %
216
Finland
242
1.9 %
213
Norway
146
0.4 %
204
Sweeden
967
5.8 %
151
Germany
794
5.2 %
172
France
530
6.7 %
145
Source: EFPIA and Eurostat

41. 70% increase in the number of employees in the Danish pharmaceutical industry between 2000 and 2012

42. Read more here…..
New Official Report Presents Opportunities in the Danish Life Science Industry

43. 10 good reasons for choosing Denmark as the location for pharmaceutical research activities
Unique framework conditions for the pharmaceutical industry
Denmark ranks 3rd internationally by the number of articles (per inhabitants) in top scientific health journals and 2nd internationally by the number of publications based on clinical trials and pharmaceutical research
Tradition for close public-private partnerships
State investments in public-private research partnerships
Highly qualified labour
Heavy investment in new research infrastructure creates unique frameworks for pharmaceutical research in Denmark
World-class patient registries, civil registries and biobanks
The best clinical trial subjects
Health service of high international standard
Efficient public authorities