1. National Experimental Therapy Partnership
Britta Smedegaard Andersen
Project Director

2. When Partnerships
To solve complex issues that cannot be solved at once “It is no longer possible to assign responsibility for any fundamental problem to a single government agency – and no single agency can control or manage any problem that matters” - public administration expert Donald Kettl, The Next Government of the United States, W.W. Norton, 2009, p. 34

3. When Public-Private Partnerships?
To combine the resources of government with those of private agents in order to deliver societal goals The forms taken by public-private partnerships include contracting out of services, business management of public utilities, and the design of hybrid organizations for risk sharing and co-production between government and private agents - Chris Skelcher “Public-Private Partnerships and Hybridity”.

4. Parts of a Public-Private Partnership
Collaboration between public and private organisations
Committed collaboration over time
Goal to create common results
Shared ressources and time

5. Public-Private Partnerships
A globally popular strategy for governments to deliver public infra-structure. Important factors to success:
Governance
Acountability
Performance
The PPPs deliver innovative approaches to infrastructure by bringing the public sector and the private sector closer together to create results for both parties

6. NEXT Budget
Innovation Fund Denmark

7. CLINICAL TRIALS IN DENMARK
CLINICAL TRIALS APPLIED FOR IN DENMARK,
Danish Medicines Agency Annual Report 2016
ABOUT NEXT I

8. To Turn The Curve

9. NEXT is a Contribution to the Danish Government’s Innovation Strategy
Politically priority to make Denmark a country where innovative solutions to Danish and global challenges are converted into growth and employment by establishing societal partnerships
NEXT is a public-private partnership funded by Innovation Fund Denmark
NEXT was established in 2014 and will in 5 years make Denmark a country of choice for early clinical research
By establishing centres for experimental research and ”Proof of Concept” trials
Based on organisational innovation

10. NEXT – A Unique Public Private Partnership
Denmark as a country of choice for early clinical trials of new drugs in patients
Based on a close collaboration across hospitals ensuring national recruitment of patients
Involving research activities in universities and hospitals within precision medicine
NEXT experiences a fast start with remarkable interest from industry and hospitals
Partnership combined with huge political intereset and support from government
Oncology & haematology & bioinformatics Dermatology, Respiratory Medicine & Infectious Diseases

11. NEXT NEXT CENTERS Respiratory Oncology & Hematology Medicine
Infectious
Diseases
Dermatology
NEXT Link 1
NEXT Link 2
ABOUT NEXT I

12. WHY NEXT WORKS
PUBLIC-PRIVATE PARTNERSHIP Continous dialogue between the regions, hospitals and companies
FOCUS Clinical trials and the value stream
RESSOURCES TO BUILD THE INFRASTRUCTURE Investment from The Innovationsfond Denmark – money to hospitals
ABOUT NEXT I

13. WHY NEXT WORKS IIII. DISEASE SPECIFIC INITIATIVE
One point of contact to selected disease areas with the Danish top researchers
IV. NATIONAL ORGANISATION
One anchorage
ABOUT NEXT I

14. How do we Manage National Collaboration?
A neutral NEXT Core facility which ensures national collaboration across the hospital departments
In each NEXT disease area, a Medical Lead is assigned as a medical ambassador to ensure medical aspects are handled nationally

15. NEXT Organisation 28.11.2018 STEERING COMMITTEE ADVISORY BOARD
PROJECT DIRECTOR
NEXT CORE
NEXT CENTER FOR DERMATOLOGY
NEXT CENTER FOR ONCOLOGY & HEMATOLOGY
NEXT BIOINFORMATICS
ADVISORY BOARD
Center Coordinator
NEXT CENTER FOR RESPIRATORYDISEASES
NEXT CENTER FOR
INFECTIOUS DISEASES
NEXT LINK 1
Coordinator
NEXT LINK 2
Coordinator

16. The requester evaluates the response2
Center for Oncology & Haematology evaluates the request in the Coordination Group
Aarhus
Odense
Aalborg
Herlev
Rigshospitalet 1 3
Request for
feasibility for an early clinical study in Denmark is send to the Center Coordinator at Rigshospitalet
Compiled response to requester is sent from Center Coordinator: fast high quality excecution of clinical study in Denmark
Requester
The requester evaluates the response 4

17.
NEXT Partners

18. NEXT STEERING COMMITEE
NEXT PROFILE I

19. What does Denmark gain from NEXT?
Patients: Access to new medical treatment and possibility of personalised patient treatment, involvement in drug development processes
Precision medicine
Industry: Easy access to excellent research environments in Denmark, fast clinical trials, access to unique health data, closer public-private collaboration
Healthcare System: Experiences with new medical treatments, education of staff, increased possibilities for patient treatment, income

20. If Industry is to place early clinical trials in Denmark:
Clinical quality & standard processes
Predictability in clinical trials
Structured set-up of clinical units
Quality
A national mindset with:
One entrance – disease specific
One entrance other relevant areas
Access
Marketing of NEXT in DK and abroad
Partnership in NEXT
Visibility
28 November 2018

21. Key Characteristics for Succesful Performance in Clinical Trials Industry Needs
Focus on performance in clinical trials
Flexibility in the hospital system
Fast start up of clinical trials
Committed investigators & nurses
Easy access to investigators

22. Key Characteristics for Succesful Performance in Clinical Trials Investigators need
Staff support resources especially in the start-up process of clinical trials, Clinical Trial Units
Jobs combining research and care
Incentives to engage in clinical
trials
Dedicated time to perform clinical trials
Training & education, eg. GCP

23. DELIVERABLES DELIVERABLES
Disease specific national centers with one point of entry
National collaboration
Optimized processes for clinical trial conduct
Improved frame work conditions for clinical research
Patient databases for optimized patient recruitment
Implementation of genomic profiling in the clinic
Awareness of NEXT center capabilities
ABOUT NEXT I

24. NEXT Expands Establishment of research networks – NEXT Link
Associated partners
Associated hospital departments

25. SUGGESTIONS FROM LIFE SCIENCE GROWTH TEAM TO THE GOVERNMENT – MARCH 2017
LIFE SCIENCE GROWTH TEAM, RECOMMENDATION Coordination of all Danish clinical research to be anchored with NEXT. Focus on infrastructure to support and optimise the conduct of clinical trials.
SUPPORT FROM THE REGIONS The regions support the life science suggestions to the government.
THE FUTURE I

26. THE WAY AHEAD
NEXT will exist as the future national support of Danish clinical trial infrastructure
A stipulation of the Innovation Fund from the time of the investment to become self-finansed
The NEXT Office remains point of contact
Incentives for clinical research must be clear in the healthcare system
Keep the partnership idea in the set-up
NEXT will cover all major disease areas and all clinical phases of drug and medical device development
THE FUTURE I

27. CONCLUSIONS

28. Formation of NEXT – Key Do’s
Joint initiative between the Danish regions and the pharmaceutical industry
A national approach to ensure all regions are interested
Industry commitment in early phase trials in specific disease areas
Regional commitment of co-financing of staff manpower
Efficient governance model

29.
Challenges
Clinical readiness to start clinical trials fast – staff time / ressources
Incentives in the hospitals for doctors and nurses to engage in commercial clinical trials
Hospital acknowledgement of local clinical trial units performance in commercial clinical trials
Local Authority & Ethics Committee approval time
Administrative hurdles in the hospitals eg. time spent with legal negotiations of clinical trial contracts

30. Key Learnings – governance & model
Partnership as a model is unique
Preferably the board consists of public representatives and private representatives and chairman is private
A neutral Project Director
A neutral co-ordinationg facility to ensure a national approach in the set-up
Hospital in-kind is a challenge – staffing is to be prioritised

31. For more information:
WWW. nextpartnership.dk, E: M:

32. Back-up

33. NEXT is just the start...
NEXT
NEXT
NEXT
NEXT

34. For more information:
WWW. nextpartnership.dk, E: M:

35. Back-up

36. Clinical Trial Services in Denmark
Respiratory medicine
Oncology and haematology
Infectious diseases
Dermatology
NEXT Partnership
Britta Smedegaard Andersen
Client with a
clinical trial
request
Paediatric Research Network, DanPedMed
Marie Louise S. Nilsson
Paediatric diseases
All other areas of diseases
Clinical Trials Office Denmark
Ole Ravnholt Sørensen

37. Clinical Trial Services in Denmark

38. Industry: A National Approach is needed in the Global Competition – even Nordic?
Three political levels
Government
Five regions:
Capital Region of Denmark
Region Zealand
Region Southern Denmark
Central Denmark Region
North Denmark Region
98 municipalities