Breastfeeding mothers who need medication are making decisions based on guesswork, not data. The MILK-CENTRE aims to fix that by building a dedicated research centre in Uganda to study how drugs pass into breast milk and affect infants. This matters because regulators and clinicians currently lack the evidence to advise breastfeeding women on medication safety. Lactation pharmacokinetic studies—which track drug levels in both mother and milk—are rare, methodologically weak, and rarely include vulnerable groups like adolescent mothers or women in outbreak settings. The centre will fill this gap by running systematic reviews, developing a bioethical framework for including breastfeeding pairs in trials, and conducting new studies on antidepressants and anti-infectives in Ugandan mother-infant pairs. If successful, the centre will produce physiologically based pharmacokinetic models that predict drug exposure in breastfed infants, giving clinicians a practical tool for prescribing. It will also create a ready-to-activate protocol for studying vaccine safety and drug transfer during viral haemorrhagic fever outbreaks, so that infants are not left unprotected during emergencies. Over five years, the work should shift global regulatory guidance and establish a sustainable, policy-influencing hub for lactation pharmacology.
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Background and Aims Breastfeeding mothers who require medication lack access to the evidence necessary to make truly informed choices for themselves and their infant. Lactation pharmacokinetic studies are few, and often have methodological limitations. There is demand from regulators that research must become more inclusive, and that lactation studies should be done in a timely manner, but such studies are still rare. The complexity of the population makes the design, delivery and interpretation of lactation pharmacokinetic studies challenging. I plan to leverage my work in Uganda over the past decade to build a globally-relevant, internationally credible centre of excellence for lactation pharmacology, the MILK-CENTRE. The centre will have capability to respond to changing epidemiology and global threats, provide capacity building and support for partners, foster increasing industry relationships and influence global policy. Specific Aims and Methods This multi-disciplinary project bridges strategic gaps and meets specific research priorities which have been established through community and stakeholder consultation. It will create the necessary infrastructure and expertise to meet the scientific objectives: Refine ongoing and future research priorities through systematic reviews and a research prioritisation exercise Define a bioethical framework for the fair inclusion of breastfeeding mother-infant pairs in clinical trials, focussing on areas of increased vulnerability including adolescent mothers, outbreak settings and mental health in Uganda Undertake lactation pharmacokinetic studies on antidepressants and anti-infectives in Ugandan mother-infant pairs Build physiologically based pharmacokinetic models to predict drug exposure to the breastfed infant for anti-infectives and antidepressants Develop an ethically approved protocol ready for activation during the next viral haemorrhagic fever outbreak to study vaccine safety and breastmilk drug transfer Cross-cutting all the activities of the MILK-CENTRE will be our three synthesising objectives: Engage communities for co-creation and understanding changing priorities Build capacity and extend capabilities in pharmacokinetic modelling Build policy-making engagement ensuring current and future work of the lactation programme responds to priorities and influences practice Anticipated Impact Establishment of research priorities will lead to a 'roadmap' for lactation pharmacology. The bioethical framework and infrastructure will ensure that we are positioned to do such studies in the safest and most methodologically rigorous manner. Over the course of this five-year professorship the MILK-CENTRE will deliver physiologically-based and population pharmacokinetic models relating to the use of antibiotics and antidepressants in lactation together with novel clinical data. Findings will be shared with community healthcare workers and policy makers for direct benefit of breastfeeding women. We will also develop - and if conditions are appropriate - test a protocol for understanding the safety of breastfeeding during filoviral outbreaks, ensuring that infants are not 'protected to death'. These impacts will cement the MILK-CENTRE as a leading centre for lactation pharmacology. This in turn will increase our influence on regulatory guidance and attract global collaboration from both academia and industry to enable a sustainable programme of work beyond the duration of this grant.
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