At the end of 2024, the IMI ConcePTION consortium formally disbands after five years of progress to improve medicine safety in pregnancy and breastfeeding. On Thursday 21 November, we are hosting an event in Brussels to mark the end of the project, and plan for the future: presenting 10 proposals for policy that can improve access to accurate and reliable information about medicine safety in the coming ten years!

When the Innovative Medicines Initiative funded ConcePTION project first launched in 2019, we brought a consortium of 88 different organisations together under a joint mission: to drastically improve the evidence and access to trusted and reliable information on medicines in pregnancy and breastfeeding. Together, we have built an ecosystem that can provide health care professionals and pregnant and breastfeeding women with the evidence and information they need to make informed decisions about medicines.

On our closing-event this Thursday, consortium members and key stakeholders come together to reflect and celebrate our achievements of the past five years. But we will not stop there. During the meeting, the project will share 10 policy proposals that can make lasting difference in the following 10 years, through:

1. Global alignment of methods, data sources and tools
2. Investment in existing medicines
3. An accessible network for evidence generation
4. Europe-wide breast milk biobank
5. Knowledge bank for medicines during pregnancy and breastfeeding
6. Qualification of methods and data sources
7. Education for health care professionals
8. Global collaborations & alignment of methods and tools
9. Tools to monitoring progress
10. Platform for dialogue, discussion & priority setting

Do you want to play a part in the next phase of IMI ConcePTION? Contact project managers d.smith-3@umcutrecht.nl or jerina@collaborate.eu.

Access to good quality data is essential for assessing medicine safety in pregnancy. The ConcePTION project has developed an app to collect information from expecting mothers in the United Kingdom. The Meds4Mums2B app will allow women in the United Kingdom to both report the medicines they use and receive information on medicine safety through the app.

By using the app, women and healthcare providers in the UK can help future mothers, by providing information about how their children develop. On Monday 18 November 2024 at 11:20 AM (CET) Amalia Alexe from the ConcePTION project will present some of the features of the Meds4Mums2B app to pharmacovigilance leaders of the world at the European Pharmacovigilance Congress.

Want to know more about the European Pharmacovigilance Congress 2024? The congress is held virtually on 18-19 November, and face-to-face in Milan on 22 November. Take a look at the programme and sign up to the conference on their website.

Are you concerned about your own pregnancy? The app can only handle information from the UK. The reason for this is the fact that different countries have different systems for collecting data for pharmacovigilance in pregnancy and breastfeeding. If you are not living in Great Britain or Northern Ireland, and have used medicines during pregnancy and breastfeeding, you can report to the company that makes the medicine (the Marketing Authorization Holder), or your doctor. In some European countries, there are also specialised, country-specific centres called Teratology Information Services. There is also the equivalent of the UK MHRA in every country that can receive your report.

Do you want to know more about the app? Take a look at the Meds4Mums2B result page.

Breastfeeding has a lot of health benefits for both mothers and infants. But there is often limited information on how safe a particular medicine is for infants when taken by their breastfeeding mothers. The ConcePTION project has developed an in vitro model to predict how medicines transfer to breast milk. The results provide data that that can improve in vivo study design.

The model is based on human mammary epithelial cells to represent the blood-milk barrier in the mammary gland. Researchers used two types of cells for the model: either primary cultures of human breast cells, or immortalized cell lines derived from breast tissue, to see how these cells transport specific chemicals. The results show that the primary human breast cell model is superior, and retains features such as cell shape and connections, and formed a strong and consistent barrier.

The model can be used to study medicine partitioning in milk, and has the potential to generate evidence to support the use of certain medicines during lactation already at early stages of drug development. Debora La Mantia, PhD student at the University of Bologna, is co-lead author of the study, published in the International Journal of Molecular Sciences.

“Our in vitro model allows the prediction of human milk drug distribution, providing quantitative data that informs researchers for better in vivo study designs, reducing the animal use. It will also help mothers and physicians make evidence-based decisions about the use of medicines during lactation,” says Debora La Mantia.

Do you want to know more? Read the publication: La Mantia D, Nauwelaerts N, Bernardini C, Zannoni A, Salaroli R, Lin Q, Huys I, Annaert P, Forni M. Development and Characterization of a Human Mammary Epithelial Cell Culture Model for the Blood–Milk Barrier—A Contribution from the ConcePTION Project. International Journal of Molecular Sciences. 2024; 25(21):11454. DOI: https://doi.org/10.3390/ijms252111454