Clinical Trials – Why Norway?

NRI 4. mai 2015

Siri Kolle, VP Clinical Inven2

Clinicial trials – why Norway?

• High costs

• Small population

• Emerging markets

• No focus or priority

• Downward spiral

PI/Hour cost: 2005: 1 200 NOK 2015: Inflation: 1 406 NOK

9% lower

Population 26 mill

1 333 NOK

What really matters

Aftenposten February 3rd 2015: Norway world leading in treatment of Lymphoma 1990: 7 of 10 died 2015: 9 of 10 survives

Clinical research and explorative treatment is the key to progress and patient safety!

Moving forward together

2014 – many initatives

Promotion group

Mission

• Increase international awareness about Norwegian expertise

• Increase the number of clinical trials in Norway

Starting point:

• Promote Norway «as is» today

Process

• Challenges

• Facts vs myths

• Looked to other countries

• Mapped initatives

• Defined «uniqueness»

• Aligned message

Why Norway?

• Governmental initatives for clinical trials and medical innovation

• Unique resources for medical research

• Well organized and transparent infrastructure

• Health registries and biobanks

• Excellent medical expertise

• Oncology and Immunology

• Translational medicine

• Neuroscience

• Cardiology and environmental diseases

• Medical Imaging

Lipidklinikken - Oslo University Hospital

Excellent track record

Inclusion according to or above goal

High compliance

Professional organization

Facilities

Expertise

Dedication

”Personligt vil jeg rigtigt gerne bidrage til at vi får flere forsøg i Norge – det har været en stor succes for de forsøg jeg har været involveret i.”

Dorthe Iversen, Medpace 28.04.15

The Clinical Trial Unit Department of Oncology, Oslo University Hospital

• Advanced study management

• Fast translation of new therapies

Department of Cellular Therapy

Immuno therapy

World leading

30.04.15

Starting today – starting with you!

From plan to action

Plan for the future

Building culture

Need for change

Focus

• Prosess flow

– Rolles and responsibility

– Deadlines

• Standardisation

– Agreement templates/master agreements

– Budgeting/invoicing

– Increased transparency

• Information

= Simplification

Efficiency Predictability

Quality

Electronic signature

Past:

Now:

4-8 weeks

24 hours

Result

• Single point of contact – Agreements One negotiation

• Number of clinical studies increasing

• Agreement timelines halfed

• Number of sponsors with new studies increased

• Norwegian pharma companies doing studies in Norway

So…..

Why not Norway?

@inven2as