ConcePTION

Studies of medicines safety and breastfeeding often involve animals. Now IMI’s CONCEPTION project has a plan that could deliver better results while also using fewer animals.###

One of the aims of the CONCEPTION project is to deliver knowledge, tools and resources so that breastfeeding women and their doctors can take an informed decision about whether or not it is safe to breastfeed while taking a given medication. As part of this effort, the project is collecting samples of milk from breastfeeding women. However, on its own, this is not enough, and so the project is investigating other ways of studying which medicines are likely to make it into breast milk.

Currently, three types of models are used to help answer this question. In vitro models consist of cells in a dish or test tube, while in silico models are computer based. CONCEPTION is working to improve in vitro and in silico models. Finally, there are animal (in vivo) models, which are useful for analysing the mechanics of how a medicine makes it into the breast milk. CONCEPTION researchers recently published an extensive review of the pros and cons of different animals as models for research on breastfeeding.

Ultimately, the CONCEPTION team believes that the best way of studying which medicines get into breast milk is to combine in vivo, in vitro and in silico models.

How would combining approaches work in practice? ‘The approaches used are directly connected through a continuous flow of information,’ explains Alberto Elmi of the University of Bologna. ‘Moreover, both in vitro and in vivo data feed the mathematical approaches of the in silico platform, and this will further strengthen the other models. In addition, use of the human lactation data collected elsewhere in the project will allow us to validate the in silico, in vivo and in vitro platforms.’ 

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The EHDEN and ConcePTION projects plus the ADVANCE/VAC4EU initiative will help the European Medicines Agency (EMA) gather real world data on COVID-19 vaccines and treatments once they are approved and being used in day-to-day clinical practice.###

EHDEN is already working with 25 data partners across Europe, to help them map COVID-19 data to a common data model. Now, it is set to collaborate with the EMA on the creation of a framework for multicentre cohort studies on the use of medicines in COVID-19 patients.

ConcePTION will collaborate with the EMA on a project that will collect data on the impact of COVID-19 in pregnancy and follow up the baby to monitor long-term outcomes in order to guide decision-making about vaccine indications, vaccination policies and treatment options for COVID-19 in pregnant women.

The international association VAC4EU (Vaccine Monitoring Collaboration for Europe) is set to work with the EMA to prepare for the monitoring of the benefits and risks of COVID-19 vaccines in Europe. VAC4EU was born out of IMI’s ADVANCE project.

‘The inclusion of EHDEN, ConcePTION and VAC4EU in the EMA’s work is testament not only to their scientific excellence but to their ability to adapt to the challenges posed by the COVID-19 pandemic,’ said IMI Executive Director Pierre Meulien. ‘I am confident that the projects will make a valuable contribution to this important initiative which is a key part of the global fight against the disease.’

The outcomes of the projects will feed into the work of EMA’s COVID-19 EMA pandemic Task Force (COVID-ETF) and EMA’s scientific committees, to ensure that the evidence is translated into scientific opinions on the optimal use of the medicines and vaccines concerned.

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Evidence suggests that up to 95 % of the five million women who get pregnant in the EU every year will reach for a prescription drug at some point. And yet, only about 5 % of the medication they take comes with pregnancy and breast-feeding-related safety information. Now, IMI’s ConcePTION project is working to fill the data gap. ###As a first step, they are running a survey to gather as much information as possible about how women who are pregnant or breastfeeding are currently making choices about medication.

Elsewhere, the project aims to establish new and better ways to collect digital data and samples; create a Europe-wide breast milk biobank for research; develop tools to predict transferability of drugs medicines into breastmilk; and build a web-based drug info bank, presented in a way that women have a reliable single source and don’t need a medical degree to understand.

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