3d-pharmaxchange by ronald van der geest

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September 2012 Company presentation Dr. Ronald van der Geest

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Page 1: 3D-PharmaXchange by Ronald van der Geest

September 2012

Company presentationDr. Ronald van der Geest

Page 2: 3D-PharmaXchange by Ronald van der Geest

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

Page 3: 3D-PharmaXchange by Ronald van der Geest

Better medicines, badly needed

Continuous re-invention of the process

Page 4: 3D-PharmaXchange by Ronald van der Geest

Our focus

Provide innovative development solutions for small to full-size life science companies,

scientific and government institutes

Page 5: 3D-PharmaXchange by Ronald van der Geest

Operational model

Network & expertise

IP, Capital,

Management

Project team• Project lead• Clinical• Formulation• Regulatory• Toxicology• Ad hocs

3D-PXC:Development

expertise

Page 6: 3D-PharmaXchange by Ronald van der Geest

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

Page 7: 3D-PharmaXchange by Ronald van der Geest

Differentiating factors

Focus on creation of added value in 3 Dimensions: Time, Cost & Risk

Page 8: 3D-PharmaXchange by Ronald van der Geest

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

Page 9: 3D-PharmaXchange by Ronald van der Geest

• 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

Page 10: 3D-PharmaXchange by Ronald van der Geest

Clients - examples

Page 11: 3D-PharmaXchange by Ronald van der Geest

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

[email protected]