TOOL TO REDUCE USE OF LABORATORY ANIMALS

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Biosimulation: a new tool in drug development

 

[2005-09-20]

 

 

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

 

 

 

Category: Programme implementation

Data Source Provider: BioSim project

Document Reference: Based on information from BioSim

Programme or Service Acronym: FRAMEWORK 6C; FP6-INTEGRATING; FP6-LIFESCIHEALTH

Subject Index : Medicine, Health; Biotechnology; Information Processing,

Information Systems; Industrial Manufacture; Evaluation; Social Aspects;

Economic Aspects

 

RCN: 24445