CELT's Community of Practice for long-acting therapeutics for maternal and paediatric health

The Centre of Excellence for Long-acting Therapeutics (CELT) has developed and is hosting Community of Practice for long-acting therapeutics in maternal and paediatric health. This is part of the scope within CELT’s costed extension, funded by global health agency Unitaid.

Project overview

The Community of Practice sits with our Perinatal Pharmacology group and is led by Dr Adeniyi Olagunju. The Community of Practice has brought together a globally representative group of stakeholders with interest in long-acting therapeutics development and use in pregnant and lactating people.  

Significant gaps currently exist in the development of new medicines for people of child-bearing potential and children, compared with the general adult population. This gap could expand further with new treatment modalities like long-acting therapeutics.

For instance, there is currently no guidance on possible changes in drug exposure from long-acting therapeutics due to the physiological changes associated with pregnancy.

Additionally, the extent of breastfed infant exposure through breast milk is largely unknown. The dynamic nature of paediatric physiology has implications for transferability of adult-appropriate long-acting technologies to paediatric use.

Objectives

1. Catalyse the development and availability of long-acting therapeutics of value for maternal and paediatric health globally, including in low- and middle- income countries via online focus group discussions, workshops, webinars, surveys, an annual in-person meeting and other innovative strategies, through:
   • Engaging relevant stakeholders in academia, clinical practice, pharmaceutical industry, regulators, women and patient groups
   • Synthesising evidence-based perspectives on best practices for long-acting therapeutics
   • Disseminating outputs from the community of practice for uptake by the wider community through white papers, peer-reviewed publications, workshop presentations, and open access web resources
2. Improve design and conduct of clinical trials of long-acting therapeutics in women during the perinatal period and paediatrics
3. Facilitate new studies to address key questions on the use of long-acting therapeutics in women during the perinatal period and paediatrics
4. Identify research gaps that could be addressed with targeted funding opportunities from national and global funding bodies
5. Improve guidance and policies on the development and use of long-acting therapeutics for women and children’s health.

Joining the Community of Practice

There are several planned meetings for the Community of Practice (mostly occurring online with one in-person workshop taking place annually).

While the community of practice was launched in January 2025 and we’re happy for new members to join us at any point. To ensure the energy and impact of the Community of Practice is reflective of a wide range of stakeholder groups, we are keen to work with: 

• Subject matter experts from industry 
• Regulatory bodies 
• Patient groups 
• Governments
• Community members.

We are also developing a stream of work focused on co-developing training resources for non-expert members of the public to facilitate their membership of the Community of Practice. 

If you are interested in joining, please fill out this short expression of interest form. We will then be in touch with further information and the next steps if your interests align with the project. 

If you have any further questions before registering your interest, please contact us on askcelt@liverpool.ac.uk. 

Upcoming sessions

22 October – Webinar –Technology innovations in LATs – Laxman Cherkupally, Medicines for Malaria Venture

Previous sessions

23 January – Launch

The meeting marked the official launch of the CELT's Community of Practice for long-acting therapeutics for maternal and paediatric health. During the meeting the key objectives for the Community of Practice were set:

• Collaboration:
  Bringing together diverse stakeholders—academics, regulators, NGOs, and healthcare professionals—to drive innovation in LATs.
• Knowledge Sharing:
  Facilitating the exchange of best practices, research findings, and clinical insights.
• Innovation:
  Encouraging novel approaches and solutions to improve LATs for maternal and paediatric populations.
• Access & Equity:
  Ensuring LATs are accessible and appropriate for all populations, especially in low- and middle-income countries (LMICs).
• Improved Outcomes:
  Enhancing the safety and effectiveness of treatments for pregnant, lactating women, and children.

Discussion highlights:

• Scope & Inclusivity:
  Members emphasised the need for inclusive language and representation, particularly regarding gender diversity and regional equity. The CoP aims to be disease-agnostic but currently has strong representation from infectious disease experts.
• Governance & Membership:
  A light-touch governance model was proposed, with potential for rotating leadership roles and thematic leads. Members discussed balancing broad participation with effective coordination.
• Outcomes & Impact:
  Proposed outcomes include white papers, peer-reviewed publications, increased web engagement, and influence on policy and funding. Dissemination strategies beyond web presence were encouraged.
• Themes for Future Work:
  Six thematic areas were identified for deeper exploration:
  • Dynamic maternal and paediatric physiology in LAT development
  • Formulation design and innovation
  • Accessibility and implementation in LMICs
  • Stakeholder engagement and community participation
  • Policy advocacy and dissemination
  • Health systems and ethical considerations
• Rapid Insight Session
  Participants contributed real-time feedback on the six themes to help shape future webinars, workshops, and in-person meetings.

January session recording

19 March – Webinar

The webinar provided a comprehensive exploration of the unique physiological considerations in paediatric and maternal populations that influence the pharmacokinetics (PK) and pharmacodynamics (PD) of long-acting therapeutics.

Professor Edmund Capparelli highlighted the intricate developmental changes in children that affect drug absorption, distribution, metabolism, and excretion. His presentation underscored the importance of age-specific dosing strategies and the variability in drug exposure across paediatric age groups, especially for biologics and monoclonal antibodies. The data presented reinforced the need for tailored approaches in paediatric drug development to ensure safety and efficacy.

Professor Robert Bies expanded the discussion to maternal health, emphasising how pregnancy-induced physiological changes alter drug behaviour. His focus on physiologically-based pharmacokinetic and population pharmacokinetic modelling illustrated the power of computational tools in predicting drug exposure and optimizing therapeutic strategies during pregnancy. The case study on long-acting cabotegravir demonstrated how modelling can inform clinical decisions and regulatory pathways, especially in populations where direct sampling is challenging.

Together, the presentations emphasised the critical role of precision pharmacology in vulnerable populations. As long-acting therapeutics continue to evolve, integrating physiological insights with advanced modelling techniques will be essential for developing safe, effective, and equitable treatments for both children and pregnant individuals.

1 July – In-person meeting

The first in person meeting was held at The Spine in Liverpool, UK. Around 40 delegates attended in person and just under 20 online. They spanned the globe and represented many industries and patient groups, but all of us had a common interest in keeping pregnant and lactating people, and children, safe during this time of newly developing drug delivery modalities.

The agenda for the day was packed with four different sessions considering the impact of long-acting therapeutics;

Maternal health

Paediatric health

Global health

Awarding body

CELT's Community of Practice for long-acting therapeutics for maternal and paediatric health is funded by global health agency Unitaid.