presentation/223 1st BioSim Conference - Presentation

1st BioSim Conference


Models and the licensing process of medicinal products

Author: Martin Olling, Medicines Evaluation Board, The Netherlands.

Names and affiliation of other authors:
Per Helboe, Danish Medicines Agency, Denmark
Steffen Thirstrup, Danish Medicines Agency, Denmark
Tomas Salmonson, Medical Products Agency, Sweden

Oral or poster: Oral presentation

Modelling of biological processes is an important tool in the development of medicinal products and the elucidation of pharmacological and toxicological mechanism.
As we are not able to investigate the whole population for which products will be used, animals, in vitro experiments, healthy volunteers and a selected patient population are used as models for the intended patient population.
In the development of medicinal products, quantitative mathematical models are used currently more and more. However, in the licensing process of new products these models do not play an important role. The limited use of models in this process is partly due the fact that authorities want to see ’hard evidence’ of efficacy and safety. This ‘hard evidence’ can differ between the products mainly depending on the practical use (indication, patient population, etc.). Therefore interpretation of the results of the studies may differ from one product to another.
In this lecture we will discuss the role of models used in the different stages of the drug development process (pre-clinical and in the phase I, II and III ), as well as the value of these models and their impact on decision making. Further, we will discuss the development in the use of new models and the role of the Biosim Network in this. Especially the requirements licensing authorities may have on models and how modellers should anticipate these demands, already at the start of the development of the model, will be discussed.

1st BioSim Conference. October 6th to October 8th, 2005. Palma de Mallorca, Spain.