A chapter dedicated to the future perspectives  of the paediatric drug discovery and development and  written by the experts from Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) and TEDDY – European Netwrok of Excellence for Paediatric Clinical Research, Angelica Intini, Donato Bonifazi and Giovanni Migliaccio, has just been published on-line and will be included in the book entitled “Drug Discovery and Development – New Advances”, published by IntechOpen, one of the world’s leading publisher of open access books.

The chapter, entitled “Challenges and New Frontiers in the Paediatric Drug Discovery and Development”, provides an overview on the drug discovery and development path for children highlighting challenges and new frontiers of each phase from the discovery to the preclinical and clinical development as well as we will provide a slightest hint about paediatric biomarkers discovery, age-appropriate formulation, pregnancy, and perinatal pharmacology and in silico pharmacology.

Drug discovery and development path represents the long process starting with the identification of new target molecules (discovery phase), going through studies on microorganisms and animals (preclinical development) and finally testing the new medicines in the target population (clinical development) to bring them to the market (authorization and commercialization). As the author have strongly underlined, paediatricians routinely give drugs to children ‘off-label’ (drug not specifically approved for use in children), although it is known that children respond to drugs in a very different way than adults in terms of safety and efficacy, so that a new drug to be used in children should be specifically tested in children themselves in controlled clinical studies.

The gap in the availability of proper medicines for children can be traced back to ethical, practical and economic reasons. Many initiatives have been taken over the years, also at institutional levels, to promote a ‘good research’ in the paediatric field, in order to involve children and at the same time preserve them by unnecessary risks. CVBF and TEDDY Network have always been proactive in this sense, promoting initiatives and studies for the integration of the paediatric pharmacological research activities and contribute to the promotion of safe and efficacious medicines for children.

The chapter is available at this link.