No matter if a company has no specific portfolio interest in paediatric medicines new EMA and FDA regulatory requirements demand that paediatric studies are performed on new products in order to obtain marketing authorisation for all patients.
This obligation may not be set aside without strong cause. Consequently all companies will have to consider means to perform studies in children for their new products. Paediatric clinical development however is much less advanced than traditional study designs as very few products in the pharmacopoeia have been studied in children.
There is thus an urgent need for pharmaceutical companies to understand and overcome the challenges presented by this area of medicine. The core competencies needed to rise to this challenge are:
- Paediatric Pharmacology – addressing the differences in body size, physiological maturation and metabolism between neonates, infants, children and adolescents.
- Clinical Development Planning – designing studies that can be recruited and run by paediatricians with experience of the development process.
A key constituency in this community are paediatric pharmacologists. Knowledge of the pharmacokinetics and pharmacodynamics involved in dose calculation allied to pharmacometric analysis and adverse event monitoring at different stages of life is fundamental to successful drug development. Much remains to be discovered about normal variations among these largely understudied groups of patients.
The European Society for Developmental Perinatal and Paediatric Pharmacology Congress 2019 to be held in May at the Congress Centre in Basel Switzerland offers the ideal opportunity to meet with many of the world’s leading Paediatric Pharmacologists. They represent the source of innovation in the field as well as being the arbiters and advisors to industry and regulators alike.
The ESDPPP Congress is accompanied by a Convention and Exhibition where pharmaceutical companies and service providers will be able to exchange information between the delegates and colleagues from other disciplines focused on the specific challenges of the Paediatric markets.