TEDDY - Task-force in Europe for Drug Development for the Young

The Task-force in Europe for Drug Development for the Young (TEDDY) is a Network of Excellence funded under the Sixth EU Framework Programme for Research and Technological Development (FP6).
The project started in June 2005 and is expected to run until 2010. It involves 19 partners from 11 countries.

Today, no more than 30% of marketed drugs in Europe can be considered safe and effective with respect to their paediatric use, as a consequence of insufficient efforts in dedicated biomedical research.
This gap is rooted, on the one hand, in the complexity of scientific and ethical issues linked to the design and execution of clinical trials involving children, and on the other hand, on a perception of poor profitability which seems to prevent pharmaceutical companies from investing significantly in this sector.

However, along with other age groups, children as well should benefit from breakthroughs in genomics, biotechnology, pharmacology and therapeutics.

The European Legislator has developed and is implementing a Regulation on medicinal products for paediatric use which is likely to improve significantly the current situation.

Within this general institutional framework, and in synergy with other processes and actors, TEDDY wish to dwell on the development of a new research matrix that integrates scientific domains, assesses the impact of findings and monitors policy implementation.

The overall aim of TEDDY is promoting the availability of safe and effective medicines for children in Europe by integrating existing expertises and good practices, as well as stimulating further developments.

To fine-tune paediatric research, it focuses on incorporating pharmacogenetics applications, sharing guidelines for better practice, and implementing dedicated tools. Attention will be paid to variability in response, especially with respect to the role of gender factors and time-dependencies associated with the development from prenatal period to adolescence.

An integrated framework will be devised to characterise adverse drug reactions (ADRs) and to optimise dosing regimens, by resorting also to research projects on pharmacogenetic variants. Harmonised databases and possible guidelines will be investigated for marketed medicines. Training programmes on ethical, scientific and clinical skills will be set up to build research capacity and to promote social awareness. To do this TEDDY incorporates 7 Objectives and 12 Working Packages.

In order to achieve these aim the following OBJECTIVES have been identified


1- To establish a rationale for the safe and efficacious use of medicines in male/female children based on an understanding of developmental biology, pharmacogenetics and pharmacogenomics.

2- To identify unmet needs for the development and use of medicinal products and orphan drugs in male/female children.

3- To develop, validate and harmonise pre-clinical and clinical methods for assessing the safety and efficacy of current and new drugs in male/female children.

4- To explore, validate and consolidate the existing data sources containing information on medicines used in male/female children before setting up a harmonised, integrated and reliable European database (or system of databases) to provide an information centre service.

5- To increase awareness of, and contribute to the debate on the ethical issues arising from paediatric drug research and use (including off-label and unlicensed use), and the extended use of biotechnology for diagnostic and therapeutic purposes.

6- To bring together industries and other relevant stakeholders to encourage the development of new drugs, to optimise paediatric formulations and provide labelling recommendations for current drugs.

7- To build critical mass capacity by means of training and education activities, the dissemination of information and the development of guidelines.