Pediatric drug development
Ever since the introduction of the Best Pharmaceuticals Act for Children (‘pediatric exclusivity’) and the Pediatric Research Equity Act (‘the pediatric rule’) in the US, and the introduction of the European legislation in 2007, resulting in the formation of EMEA’s Pediatric Committee (PDCO), drug developers are forced to design Pediatric Investigational Plans (PIP) and consider pediatric development for each new drug to be registered.
Pediatric drug development requires very specific expertise in all disciplines involved, including clinical, PK/PD modeling and simulation, non-clinical, regulatory affairs and CMC, and many pharmaceutical development companies are struggling to find optimal ways to implement pediatric development in their overall development programs.
Kinesis Pharma considers pediatric development a key focal point of its drug development service offering. Over the past years, Kinesis Pharma has amassed expertise and experience in pediatric development.
Skilled people in all drug development disciplines (i.e. non-clinical, CMC, clinical, Modeling and Simulation, regulatory and project management) position Kinesis Pharma as a multi-disciplinary centre of excellence for pediatric development. This unique centre of excellence can support the complete pediatric drug development process from drafting of the PIP and regulatory discussions, development of suitable pediatric formulations, responsibility for the actual conduct of juvenile animal and clinical studies, and reporting and interpretation of the results.
To support specific clinical knowledge and to increase the possibilities for the conduct of pediatric clinical studies, Kinesis Pharma has established close collaborations with the Dutch Medicines for Children Research Network (MCRN link) and a number of Key Opinion Leaders.
In summary, Kinesis Pharma has a track-record of success in pediatric development - which includes PIP procedures and PDCO and FDA decisions gained by hands-on experience