2 prove by dirk de herdt
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❷Prove The Concept of Proof Expertise in Early Clinical Development 19 September 2012 – Presentation BioVille 1
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LTL presents at BioVille: CRO solutions, Six contract research organisations present their services
Transcript of 2 prove by dirk de herdt
❷ProveThe Concept of Proof
Expertise in Early Clinical Development
19 September 2012 – Presentation BioVille 1
❷ProveThe Concept of Proof
The Market Pain
19 September 2012 – Presentation BioVille 2
Pre-clinical Early Development Late Development Approval
POCPOC
❷ProveThe Concept of Proof
Bio-Plus 3- 6 years 6- 7 years
Discovery Preclinical Clinical trials Market
20-100 100-500 1000-5000
Number of Volunteers
0.5 – 2y
Approval
2Prove
Phase II Phase III
Phase I
Discovery POC Development
“Early Clinical Development”
19 September 2012 – Presentation BioVille 3
❷ProveThe Concept of Proof
Today’s Landscape
19 September 2012 – Presentation BioVille 4
❷ProveThe Concept of Proof
The Concept of Proof
Phase I Phase II Phase III Phase IVPreclinicaIConcept
Concept PreclinicaI First in Man/POC
Pivotal Post-marketingCE
Challenge: Pre-clinical through Clinical
19 September 2012 – Presentation BioVille 5
❷ProveThe Concept of Proof
Our Focus
• Translate and accelerate from Pre-clinical to Clinical Development Phase
• Design AND execution of Early Development Studies
• Focused on science (“2 understand”)
• In compliance with industry standards2Prove =
excellence in transitioning “compound to treatment” through early clinical trials
19 September 2012 – Presentation BioVille 6
❷ProveThe Concept of Proof
The Concept of Proof
“End-to-End” approach of Early Development Studies
•Study design and protocol development
•Implementation and co-ordination
•Site selecting and monitoring
•In house /on-site quality assurance & control
•Analysis and study report
•Medical writing and publication
Our Services
19 September 2012 – Presentation BioVille 7
❷ProveThe Concept of Proof
The Concept of Proof
Partnership
Knowledge
Ownership
Our Approach
19 September 2012 – Presentation BioVille 8
❷ProveThe Concept of Proof
The Concept of Proof
Partnership
• Communication
• Experience
• Client focus
Our Approach
19 September 2012 – Presentation BioVille 9
❷ProveThe Concept of Proof
The Concept of Proof
Ownership
• Cost efficiency
• Accountability
• Lean organisation with strong network
Our Approach
19 September 2012 – Presentation BioVille 10
❷ProveThe Concept of Proof
The Concept of Proof
Knowledge
• Focus on science
• “End-to-End”: from design to reporting
• Integrate early pre-clinical to clinical
• Pharmaceuticals, Biotech and Medical Devices
Our Approach
19 September 2012 – Presentation BioVille 11
❷ProveThe Concept of Proof
Jo Lissens MD• > 30 years of experience• Pharma & medical
devices• R&D management• Liaison clinical –
regulatory – health economics – marketing
Who
19 September 2012 – Presentation BioVille 12
Dirk De Herdt, PharmD• > 20 years of experience• Pharma & biotech• Compound Development• Clinical Operations• Quality Management &
Regulatory Compliance
❷ProveThe Concept of Proof
Summary
• Translate and accelerate from Pre-clinical to Clinical Development Phase
• End-to-end approach
• Focused on science
• In compliance with industry standards
19 September 2012 – Presentation BioVille 13
❷ProveThe Concept of Proof
❷ProveThe Concept of
Proof
Questions?
19 September 2012 – Presentation BioVille 14
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