3d-pharmaxchange by ronald van der geest
DESCRIPTION
LTL presents at BioVille: CRO solutions, Six contract research organisations present their servicesTRANSCRIPT
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September 2012
Company presentationDr. Ronald van der Geest
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The Long Road to a New Medicine...
Registration
Discovery
NDA/MMA
Full Development
Exploratory Development
Project Team and Plans
Project Team and Plans
Synthesis of Compounds
Synthesis of Compounds ScreeningScreening
Early Safety Studies
Early Safety Studies
Formulations Developed
Formulations Developed
Studies in Healthy Volunteers (Phase I)Studies in Healthy
Volunteers (Phase I)
Studies in 100-300 Patients (Phase II)
Studies in 100-300 Patients (Phase II) Candidate Medicine Tested in
3-10,000 Patients (Phase III)Candidate Medicine Tested in
3-10,000 Patients (Phase III)
Clinical Data Analysis
Clinical Data Analysis
Large Amounts of Candidate Medicine
Synthesized
Large Amounts of Candidate Medicine
SynthesizedExtensive
Safety Studies
Extensive Safety Studies
CandidateCandidate
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Better medicines, badly needed
Continuous re-invention of the process
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Our focus
Provide innovative development solutions for small to full-size life science companies,
scientific and government institutes
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Operational model
Network & expertise
IP, Capital,
Management
Project team• Project lead• Clinical• Formulation• Regulatory• Toxicology• Ad hocs
3D-PXC:Development
expertise
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Model 1 Model 2 Model 3
Stand-alone projects, based on prior and mutually agreed input
and output requirements
Stand-alone projects, based on prior and mutually agreed input
and output requirements
Full project management fromstart-to-finish, often in parallel
to in-house projects
Full project management fromstart-to-finish, often in parallel
to in-house projects
Insertion of lacking expertise in on-going projects, both
temporary and medium term
Insertion of lacking expertise in on-going projects, both
temporary and medium term
Project models
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Differentiating factors
Focus on creation of added value in 3 Dimensions: Time, Cost & Risk
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Differentiating factors
Program II (1996) Program I (2002) Program III (2008)
4 phase I trials1 phase II trial2 phase III trials
2 open label trials
6 phase I trials0 phase II trials2 phase III trials
2 phase I trials1 phase II trial
development duration:
Est. 5-6 yrs
development duration:
Est. 4 yrs
development duration:
Est. 2 yrs
Est. budget:
105 M
Est. budget:
60 M
Budget:
15 M
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• Nasal spray development for conscious sedation and epilepsy
• Develop novel companion diagnosytic strategy for high-end diagnostic company
• Social Innovation in Life Sciences (SaILS) for Midden-Brabant
• Development of a new chemical entityagainst incontinence
• Full coordination of approval-to-launch process for early-stage biologics Biotech
Project examples
SaILS
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Clients - examples
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Visiting Address:Maidstone 48A, 5026 SK Tilburg
Tel: +31 (0)13 534 8272Website: www.3d-pxc.com
Contact details
Ronald van der Geest, PhD+31 6 523 901 30