A White Paper on Advancing Long-Acting Therapeutics for Maternal and Pediatric Health by Bridging Gaps in Clinical Research, Access and Regulation.

As use cases for long-acting therapeutics expand across clinical indications, there is a critical need to ensure the inclusion of women who are pregnant or breastfeeding, infants and children-populations with a historical gap in the availability of interventions already approved for use in adults. This White Paper synthesizes insights from a special session during the 1st of July 2025 workshop of the Community of Practice for Long-Acting Therapeutics for Maternal and Paediatric Health. It was hosted by the University of Liverpool Centre of Excellence for Long-acting Therapeutics. Attendees included stakeholders drawn from clinical practice, patient advocacy groups, academia, pharmaceutical industry, regulatory agencies, product development partners, and public health organizations. Four focus groups-centered on maternal health, pediatric health, access, and regulation-addressed three key questions: (i) What are the most urgent gaps that could hinder the adoption of long-acting therapeutics for maternal and pediatric health indications? (ii) What critical actions are needed to address these gaps? (iii) What partnerships must be initiated or strengthened to enable or accelerate these actions? Actionable strategies to accelerate progress were identified. Key themes that emerged from the discussion included the need for inclusive and context-sensitive research designs, harmonized regulatory frameworks, culturally responsive implementation strategies, and sustainable funding mechanisms. Platforms for fostering interdisciplinary collaboration, amplifying diverse stakeholder voices, and promoting transparency in innovation are needed. Partnership models that support inclusive development and equitable deployment will be central to successful integration and to realize the full potential of long-acting therapeutics in advancing maternal and pediatric health.