A CRO perspective on what would
attract more Clinical Trials to the Nordic
Region
Jan Hellqvist
Regional Managing Director Northern Europe, TFS
Chairman of the board, Red Glead Discovery
TFS General Overview
Founded in 1996 in Sweden, TFS has built one of the largest, independent global
clinical CROs with focus on serving the biopharmaceutical sector
§
Headquartered in Sweden with global
operations and offices in 21 countries
§
Regional US Headquarters in Princeton, NJ
§
~700 employees
§
Operations inspected by U.S. FDA, EMA
(Europe), MHRA (U.K.) and MPA (Sweden)
§
Revenue of $85 (€75) million in 2015
§
Experience, track record and reputation has
engendered strong references among the
leading life science sponsors and SMEs
TFS Revenue Distribution 2016
Business Area
Client Segment
4%
TFS Develop
30 %
6%
9%
Biotech
TFS People
70 %
Big Pharma
43%
14%
Pharma SME
Medical Device
24%
Government/Academia
Other (Generics, CRO, Functional
Food, Diagnostics
TFS in the Nordic area
Market Leader in the Nordic area
§ ~210 Employees
§ From first in man to post launch
§ All Development services in house
§ Approx 140 customers and increasing
§ Currently working with:
§
Big Pharma
§
SMEs
§
Biotechnology
§
Medical Device
§
Functional Food
§
Aestetics
§
Oslo
Espoo
Gothenburg
Stockholm
Lund (HQ)
Copenhagen
www.tfscro.com
©2011
What´s the problem?
0.4%
6.8%
What is important to a CRO?
1.
Quality Assurance
2.
Predictability
3.
Timelines
4.
Key Competence
5.
Cost
What hurdles do we see?
1.
Time & willingness to take part in clinical research
2.
Predictability in recruiting patients
3.
Infrastructure could be improved
4.
Cost is an issue (especially in Finland and Norway)
5.
Time to start can be shortened
6.
Some cherry picking
7.
Better coordination and cooperation over the boarders
8.
Unique competence should be more developed and utilized better
in research centres
Now is the time to act
Long
approval
times,
receding
market
Not cheap
any more,
patients are
treated
better than
before
Issues with
study
related
deaths,
credibility,
time
Market Trends
Where should we focus?
Observational Research
Time of trial and start up
times
Ready to start within 30 days in Canada
•
Well organized regional
stuctures with SMOs/Research
hubs
•
Maximum 30 days Regulatory,
and ethical approval in
parallell.
•
Site contract negotiations in
parellell.
•
Tax deductions for Canada
based Companies performing
early clinical research i
Canada.
Predictability
Poland
•
Poland went from a huge issue to a
significant strength. They can now see
the number of trials increasing rapidly.
•
Site contracts negotiations has
decreased from approx. 4-5 months to
two weeks and recruitments has
become really predictable by assigning
private SMOs attached to University
Hospitals.
•
Government led campaigns to increase
the willingness of patients to take part
in clinical trials fuel the recruitment
capacity..
Learn from Denmark
•
Significant infrastructure
improvements
•
A culture of collaboration over
regions and between hospitals.
•
No need for ethical or regulatory
approval in observational research
•
A willingness to bring in support
when needed
•
A long term collaborative business
sense
•
A committment to early clinical
research. (NEXT)
A Nordic approach for Clinical reserach
1.
Act as one strong area
2.
Shorten timelines
3.
Learn from US on need for Regulatory
approvals. Do we really need new
Regulatory approvals for all trials?
4.
One ethical application for the whole
region.
5.
Learn from Canada on Speed
6.
Learn from Poland and Denmark on
Infrastructure and change management
7.
With SMOs coordinating and facilitating
research in the regions the infrastructure
will be better.
8.
Focus on early and late phase clinical
research
9.
Develop unique competence even further.
What hurdles do we see?
1.
Time & willingness to take part in clinical research
2.
Predictability in recruiting patients
3.
Infrastructure could be improved
4.
Cost is an issue (especially in Finland and Norway)
5.
Time to start can be shortened
6.
Handling of site contracts
7.
Cherry picking
8.
Better coordination and cooperation over the boarders
9.
Unique competence should be more developed
www.tfscro.com