A significant barrier to improving global maternal and perinatal health is underinvestment in pharmaceutical research and development of medicines for pregnancy-specific conditions like pre-eclampsia. To address this, we're working on a new target product profile.
A target product profile (TPP) is a well-recognised strategy to promote development of innovative medical products, such as devices, diagnostic tests and therapeutics.
The World Health Organization defines a target product profile as a document that describes the minimum and preferred (or optimal) characteristics of a target product, aimed at a particular disease or diseases. They specify the key characteristics that the intervention must address, such as (but not limited to) clinical indication, target population, desired efficacy, safety, formulation/presentation and stability and storage. Target product profiles are an important resource for multiple stakeholders in the research and development pathway, including funders, researchers, product developers, manufacturers and regulators.
A research paper released in October 2022 describes the development of the first ever target product profiles for preterm birth medicines. It’s the first peer reviewed publication on the development of target product profiles for any pregnancy condition.
Pre-eclampsia is the most common hypertensive disorder of pregnancy, affecting an estimated 4.6% of pregnant women globally, and it's a leading cause of maternal mortality. The only cure for pre-eclampsia is initiated by the birth of the baby and delivery of the placenta, and there's lack of effective medicines for preventing and treating pre-eclampsia.
Gates Foundation