What is GAP-f?
Global accelerator for paediatric formulations
GAP-f is a coordinated response to the lack of appropriate paediatric medicines. Through a global collaborative framework set-up to deliver fit-for-purpose solutions to provide better medicines to children in low and middle-income countries, the project promotes a faster, more efficient, and more focused approach to paediatric formulation development.
The Penta Foundation, as lead of the Clinical Research Working Group, is responsible, together with other paediatric clinical research networks from the group, for establishing when needed dosing, safety, and efficacy across all relevant weight bands for each product in the GAP-f portfolio. The Working Group members combine their strengths and experiences as they lead new studies related to the GAP-f portfolio and provide technical support for studies performed by the pharmaceutical industry. Penta relies on a fully functional network with expertise in multiple-disease areas, which clearly provides an advantage in terms of completion time frame and high standards.
Why is GAP-f needed?
Several challenges hamper the rapid development of paediatric formulations for children. The biology of children and differences in drug metabolism in pharmacokinetics, the different doses needed based on age and weight of children and the lack of data on drugs even those that have been used for a long time have been based on studies done on adults and not children all hinder the development of medication for children. GAP-f was created to respond to these and other influences on the paediatric treatment gap.
What is GAP-f’s goal?
The global HIV health community has made substantial progress to accelerate the development and uptake of better paediatric products for children living with HIV. To keep this momentum going, GAP-f has formalized cross-sector collaborations to enable accelerated development and availability of optimized treatment options for paediatric infectious diseases, such as HIV, tuberculosis, and viral hepatitis, ensuring children have accelerated access to optimal drug formulations.