Module232025

5/7/2025

The Benefits of integrated paediatric drug development

Prioritization within early portfolio on paediatric needs:  increase revenue from a wider initial licensed indication.  Bigger claim window for patent (SPC) reward.  Niche, less competitive areas i.e. neonates and congenital diseases

Integrated operational models for paediatrics across enterprise/TAs  to reduce duplication and burden

Benefits on global alignment of paediatric trials :  cost and time efficiency,  reduction of number of trials,  increased feasibility

Delivering for patients and families through innovation and science

31

31

International, efficient, patient focused trial designs to meet global regulatory requirements Collaborative and constructive dialogue between children, patients/parents’ representatives, academics, industry and regulators to facilitate and accelerate treatment development. More emphasis to research opportunities for data sharing across different medicines (or groups of drugs), for example supporting extrapolation. Collection of data for future trial preparation in a culture of lessons-learned, Dissemination of good practice across paediatric clinical research networks Lobby for greater recognition and awareness amongst healthcare professionals and across society.

Future of paediatric clinical research

32

16