LTL presents at BioVille: CRO solutions, Six contract research organisations present their services

1. Company presentation
Dr. Ronald van der Geest
September 2012

2. The Long Road to a New
Medicine...
NDA/MMA
Clinical Data
Analysis
Full Development Registration
Studies in 100-300 Candidate Medicine Tested in
Patients (Phase II)
3-10,000 Patients (Phase III)
Large Amounts of
Candidate Medicine Extensive
Studies in Healthy Synthesized Safety
Volunteers (Phase I)
Studies
Exploratory Development Formulations
Developed Candidate
Early Safety
Studies
Synthesis
Project Team Screening
and Plans of Compounds
Discovery

3. Better medicines, badly needed
Continuous re-invention of the process

4. Our focus
Provide innovative development solutions for
small to full-size life science companies,
scientific and government institutes

5. Operational model
Project team
• Project lead
3D-PXC: • Clinical
IP,
Development • Formulation Capital,
expertise • Regulatory Management
• Toxicology
• Ad hocs
Network & expertise

6. Project models
Model 1 Model 2 Model 3
Stand-alone projects, based on Full project management from Insertion of lacking expertise
prior and mutually agreed input start-to-finish, often in parallel in on-going projects, both
and output requirements to in-house projects temporary and medium term

7. Differentiating factors
Focus on creation of added value in 3 Dimensions:
Time, Cost & Risk

8. Differentiating factors
Program II (1996) Program I (2002) Program III (2008)
4 phase I trials 6 phase I trials 2 phase I trials
1 phase II trial 0 phase II trials 1 phase II trial
2 phase III trials 2 phase III trials
2 open label trials
development duration: development duration: development duration:
Est. 5-6 yrs Est. 4 yrs Est. 2 yrs
Est. budget: Est. budget: Budget:
105 M 60 M 15 M

9. Project examples
• 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
aI LS
• Development of a new chemical entity
against incontinence
S
• Full coordination of approval-to-launch process for
early-stage biologics Biotech

10. Clients - examples

11. Contact details
Visiting Address:
Maidstone 48A, 5026 SK Tilburg
Tel: +31 (0)13 534 8272
Website: www.3d-pxc.com
Ronald van der Geest, PhD
+31 6 523 901 30
Ronald@3d-pxc.com