Biosimulation: a new tool in drug development

Brussels, 20 Sep 2005

The EU is funding the BioSim Network of Excellence in order to structure efforts to develop simulation models for the design, selection and testing of drugs.

Thanks to the biosimulation approach, the lengthy and costly development process for a drug could be reduced by two to three years in time, and lead to a significant reduction of the use of laboratory animals and test persons.

Expert reports from the European Federation for Pharmaceutical Sciences (EUFEPS) and from other European organisations have repeatedly stressed the need for a targeted effort to speed up the development of new and safe drugs. The area of pharmaceutical products is characterised by highly increasing development costs, but worryingly the number of resulting new medicines is slowing down.

The current approach to drug discovery and development, based mainly on trial-and-error processes, is largely inefficient, extremely lengthy and risky for pharmaceutical industries and much too costly for society. Development projects on new drug substances are often stopped due to too many adverse reactions or the fact that efficacy is less than expected as a consequence of the extraordinary complexity of living systems. Such failed projects can run to 100 million euro or more. One of the many reasons behind such failures is that testing, including clinical trials, often does not result in a sufficient amount of knowledge at an early enough stage.

In view of the enormous progress that has been achieved over the last decade in information technology, systems biology, and complex systems theory, many feel that this situation is no longer acceptable. A completely new approach must be developed in which information is handled in a more rational manner and the enormous potential of more systematic approaches is taken into account.

Biosimulation is a relatively new discipline, which uses many of the advanced methods of chaos research to describe and explore biological systems by means of computer models. A simulation model translates our knowledge about the biological system into mathematical equations. In the initial stage of the drug development process, one can use the simulation model to test any hypothesis and change the product in order to optimise its function, or estimate the likelihood that a given agent will function as a drug, even before the first molecule is produced.

During the trial phase, the simulation model can be used as a vehicle to define an effective test protocol and to check that information obtained from tests is consistent. Many academic institutions in Europe already have significant expertise in biomedical modelling, and several groups are at the forefront of research in their specific areas. However, efforts are strongly fragmented both because of the enormous diversity within the field and because of the absence of a common purpose and an organising structure. The European tradition for collaboration between academic institutions and the pharmaceutical industry is also relatively weak.

BioSim (Biosimulation - a new tool in drug development) is an EU funded research project that will run for five years (2004-2009), receiving 10.7 million euro under the 'life sciences, genomics and biotechnology for health' priority of the Sixth Framework Programme (FP6). The overall objective of the BioSim project is to establish a European Network of Excellence, creating broader contacts between the many research groups working in this field throughout Europe.

The research project brings together researchers from 26 EU universities, nine small and medium sized enterprises (SMEs) and one large pharmaceutical company. Four regulatory authorities (medicines agencies) from Spain, the Netherlands, Sweden and Denmark are also participating. The Danish Medicines Agency has been asked to coordinate the activities of the regulatory agencies, which also includes keeping informed all other EU agencies informed.

The BioSim Network commands a wide range of biomedical expertise. At the same time, the network involves leading experts in pharmacokinetics, computer simulation, and complex systems theory. The purpose of the network is to develop in silico simulation models of cellular, physiological and pharmacological processes to provide a deeper understanding of the associated biological processes, as well as maintaining the competitiveness of the pharmaceutical industry. The BioSim partners believe that the development time for a drug can be reduced by two to three years as the industry adopts and becomes accustomed to the simulation approach. Hence, there is a strong economic motive for industry in pursuing the use of simulation models. At the same time, the industry will be able to reduce its use of laboratory animals (and test persons) significantly.

Besides the specifically clinical studies, the network will also engage in a wide range of educational activities, including the training of PhD students, specialized courses for industry and regulatory experts, and communication with the public.
For further information, please visit the following website:
http://chaos.fys.dtu.dk/biosim/index.jsp

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