The implementation of model based approaches in the Drug Development process will efficiently aid in bringing new, safe and effective medicines to the patients who need them.

Specifically, Exprimo offers:

  • Value regarding decision-making. Our use of advanced PK/PD and drug-disease modelling can form the basis on which fast and well-informed decisions in drug devlopment can be made.
  • Value regarding communication. We can collaborate with you in the implementation of new model-based approaches which will facilitate communication within both the project team and the organisation as a whole.
  • An inspirational and visionary long term relationship.

Exprimo believes that the objectives of any Modelling & Simulation (M&S) project implemented during the course of the Drug Development process should focus on the next phase(s) of that process.

Pre Clinical

The objectives during Discovery and Pre-clinical are:

  • A feasibility assessment of the mechanism of action.
  • Perform combined meta-analyses and objectively review all discovery and pre-clinical data.
  • To define metrics for candidate compound selection.
  • To assess the safety margin of candidate compounds.

Implementation of M&S during this stage will contribute to:

  • The evaluation and selection appropriate of biomarker(s).
  • Optimization of the designs of early Phase I studies with biomarkers.

Phase I and Phase IIa

The objectives during Phase I and Phase IIa are:

  • Evaluate the dose-response relationship of the biomarker(s).
  • Evaluate the relevance of the biomarkers with respect to the clinical endpoints.
  • Optimize the design of POC trials.
  • Evaluation of the ‘Target Product Profile'.
  • Provide feedback to the Discovery and Pre-clinical departments.

Implementation of M&S during this stage should be focussed on:

  • Definition of metrics for dose selection (for example, how much response for how much side effect).
  • The assessment available public information (e.g. SBA's).
  • The development disease progression models.
  • Optimization of the design of Phase II dose-range finding trials.

Phase IIb, Phase III and through-out post-marketing

The objectives during Phase IIb, Phase III and through-out post-marketing are:

  • To develop more descriptive type models to predict clinical response.
  • To employ model-based for selection of Phase III dose(s) levels.
  • To quantify the likelihood of success in Phase III.
  • To optimize the design Phase III trials.

Implementation of M&S during these stages should contribute to:

  • Aiding in better positioning your compound relative to competitor compounds.
  • Optimizing the design of Phase IV trials.
  • Optimizing the designs of special patient population studies (e.g. children).
Home | Vision | Services | Courses | Personnel | Contact | Academic Info | Regulatory Info
© Exprimo NV. Web Design by Digital Turtle