WP6

It is the aim of all developments within WP6 to provide new tools to facilitate Model-Based Drug Development (MBDD) in the pharmaceutical industry. Indeed, demands for MBDD go beyond the facilitation of interactions between existing software tools.

The demands include:

• The building of mechanistic models that combine existing knowledge on the disease and the project level with new data from a recent experiment or study. New methodologies for parameter estimation in complex models will be developed.
• The initial focus is on complex models for diabetes. Specific plans include: visual diagnostics for time-to-event models, guidance for model building with correlated covariates, and new types of normalised prediction distribution errors.
• The simulation of future experiments or studies in order to support development decisions that lead to an optimal portfolio management. A second prototype of a Clinical Trial Simulator has been distributed for testing to interested EFPIA participants in the work package.
• The optimal design of future experiments or studies. These are not just designs that increase the probability of success, but designs that deliver results within a reasonable timeframe and within a predefined budget.

Each of the four tasks within WP6 addresses one of these four demands. The specific challenges of WP6 are:

• To develop new tools that will fit into a framework that itself is evolving during the lifespan of DDMoRe.
• To develop new tools which meet the expectations of the customers, i.e. the EFPIA members in the consortium.
• To develop new tools not from scratch but from existing tools which are already in use among the customers.
• To find a balance between what is doable within the budget of DDMoRe and what is expected by the customer.