Clinical Trials Why Norway? · Aftenposten February 3rd 2015: Norway world leading in treatment of...
Transcript of Clinical Trials Why Norway? · Aftenposten February 3rd 2015: Norway world leading in treatment of...
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Clinical Trials – Why Norway?
NRI 4. mai 2015
Siri Kolle, VP Clinical Inven2
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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
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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!
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Moving forward together
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2014 – many initatives
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Promotion group
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Mission
• Increase international awareness about Norwegian expertise
• Increase the number of clinical trials in Norway
Starting point:
• Promote Norway «as is» today
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Process
• Challenges
• Facts vs myths
• Looked to other countries
• Mapped initatives
• Defined «uniqueness»
• Aligned message
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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
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Lipidklinikken - Oslo University Hospital
Excellent track record
Inclusion according to or above goal
High compliance
Professional organization
Facilities
Expertise
Dedication
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”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
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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
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30.04.15
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Starting today – starting with you!
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From plan to action
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Plan for the future
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Building culture
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Need for change
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Focus
• Prosess flow
– Rolles and responsibility
– Deadlines
• Standardisation
– Agreement templates/master agreements
– Budgeting/invoicing
– Increased transparency
• Information
= Simplification
Efficiency Predictability
Quality
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Electronic signature
Past:
Now:
4-8 weeks
24 hours
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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
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So…..
Why not Norway?
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@inven2as