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Pregnancy and breastfeeding considerations within long-acting therapeutics research

Posted on: 7 August 2025 by Rebecca Derrick in LONGEVITY Blog

Members of CELT's Community of Practice are stood in a light, spacious raise in The Spine in Liverpool. The blog title is written over the top

The Centre of Excellence for Long-acting Therapeutics (CELT) have begun a global conversation, and started international actions, towards better medication safety for people of reproductive age and breastfed children in the sphere of newly emerging long-acting therapeutic technologies.

What is World Breastfeeding Week?

Set up by the World Health Assembly, World Breastfeeding Week is supported by the World Health Organisation (WHO), UNICEF and many others. The first week of August was designated World Breastfeeding Week to promote enabling environments that support breastfeeding through community work and education.

The 2025 theme announced on the WHO 2025 event page is ‘Invest in breastfeeding, invest in the future’. The hope is this will “shine a particular spotlight on the ongoing support women and babies need from the healthcare system through their breastfeeding journey.” This includes making sure there is ample access to the support and information to breastfeed for as long as one wishes to. The belief is that we can achieve this through empowerment at home, in healthcare and at work.

Breastfeeding is a key consideration for all medicines, including long-acting therapeutics

To put people’s minds at rest about how the medications they are taking could have an impact on the children they are carrying or breastfeeding, we must include them in our pharmacological research. If pregnant participants are included in clinical trials, health care providers can confidently reassure patients of their safety. If lactating participants are included in trials, then we can reassure patients around the safety of their milk for their children.

With funding from global health agency Unitaid, The Centre of Excellence for Long-acting Therapeutics (CELT) are overseeing a Community of Practice for long-acting therapeutics for maternal and paediatric health. While CELT is Co-Directed by Professor Andrew Owen and Professor Steve Rannard, the Community of Practice sits within the Perinatal Pharmacology Group, led by Dr Adeniyi Olagunju.

Within clinical trials for new medicines there are many groups that are underrepresented. It is understandable that people may be sceptical about medication when they cannot see themselves in the research. This scepticism is understandably greater in people who are pregnant or breastfeeding. Last year, we published a guest blog from Professor Catriona Waitt, a member of the community of practice, for the International Day for Universal Access to Information that explains this further.

CELT's community of practice for long-acting therapeutics for maternal and paediatric health

The Community of Practice is a truly international group set up to bridge the significant gaps that currently exist in the development of new medicines for people of child-bearing potential and children, compared with the general adult population. CELT exists to grow the availability of long-acting therapeutics and new drug delivery systems are always in research. With constant medical development, this gap could expand further.  

A large focus of the Community of Practice is engaging key stakeholders to facilitate safe use of long-acting therapeutics during breastfeeding. This includes better understanding of the extent of breastfed infants’ exposure to long-acting therapeutics that have been taken by their breastfeeding parent. Non-exclusion of lactating participants in clinical trials is being discussed more, such as in an equity of access to research paper from Professor Waitt’s team that focuses on pregnancy and breastfeeding participants in clinical trials. However, much more research is needed in this area.

The Community of Practice aims to catalyse the development and availability of long-acting therapeutics of value for maternal and paediatric health globally, including in low- and middle- income countries.

The first in-person meeting of the Community of Practice

Organised by Rachel Daley, the Community of Practice has been coming together since October 2024 and first convened in January 2025 via online meetings. Tuesday 1 July was the first in-person meeting of the Community of Practice for long-acting therapeutics for maternal and paediatric health. Stakeholders came from all over the world to discuss how we start to action our concerns around maternal and paediatric health in global pharmacology research. They included regulators, researchers, health care providers, pharmacologists, chemists and more, providing a wide breadth of people to make sure the conversation covered as many areas of importance as possible.

While the day was made up of sessions exploring paediatric health and global health, that we’ll explore at a later point, the first session really resonated with the the message of World Breastfeeding Week. The starting plenary of the day was ‘Long-acting therapeutics in maternal health’. It included speakers Professor Sharon Nachman from IMPAACT Network, Dr Rachel Scott from MedStar Health Research Institute and IMPAACT Network, and Dr Adeniyi Olagunju representing CELT’s perinatal pharmacology work. Within this session, maternal health included discussion of pre-pregnancy, the three trimesters, birth, postpartum and lactation. 

A call to action

This World Breastfeeding Week, let’s advocate for a future where maternal health is no longer an afterthought in research. Pregnant and lactating individuals deserve access to safe, effective treatments—and the peace of mind that comes with knowing those treatments have been tested with them in mind.

Several speakers throughout the day emphasised the growing importance of pregnancy and breastfeeding modelling in preclinical trials, which could play a vital role in reassuring participants and improving maternal recruitment to clinical trials.

There was a strong sense within the Community of Practice that meaningful community outreach is essential—listening to what people want, ensuring patients feel supported, and equipping healthcare providers with the knowledge to build trust in long-acting medication options.

Trust is crucial to improving adherence to treatment regimens, especially for conditions that are preventable or treatable. The day felt like a pivotal moment—a shared recognition that decisions about medication have profound impacts, particularly for those who are pregnant or breastfeeding. Without diverse representation in clinical trials, it’s difficult for patients to feel confident in their choices, especially when those choices affect not only their own health but also that of their child. Pregnant and breastfeeding people are present in every community worldwide, yet they remain among the most underserved.

This event marked the beginning of a collective commitment to change.

 

#WorldBreastfeedingWeek #WBW2025


CELT's Community of Practice has a project page including a video of the full maternal health session. Our Community of Practice is funded by global health agency Unitaid.

The Unitaid logo is the organisation name written above the words