Around the world, a critical and often overlooked gap in healthcare persists – determining the right drug, at the right dose, for pregnant women, and children, who require treatment. This gap stems from the long-standing and systemic exclusion of these vulnerable populations from clinical trials, originally intended to protect, but now widely recognised as a barrier to informed, equal care. The result is a lack of evidence-based dosing guidelines for many medications commonly given during pregnancy and childhood. Consequently, almost all drugs are prescribed off-label, with healthcare providers relying on their clinical judgement as well as therapeutic monitoring to assess safety and efficacy. Across countries and continents, rich or poor, this increases the risk that patients may be over-treated, under-treated, or left untreated altogether due to ethical, legal or liability concerns – not out of negligence, but because healthcare practitioners have yet to modernise their approach to maternal and paediatric pharmacology.

Project Madam seeks to address this global blind spot. By using physiologically-based pharmacokinetic (PBPK) modelling it offers a science-based pathway towards safer, more effective drug dosing.