ConcePTION: ‘Building a pan-European ecosystem for generating, monitoring, and providing robust information on medication safety in pregnancy and breastfeeding’

15 June 2019

In April of this year, a landmark public private partnership called ConcePTION, jointly led by Novartis and the University Medical Center Utrecht, was awarded a five-year grant by the Innovative Medicines Initiative (IMI2) to tackle many of the research gaps related to medicine used by pregnant and breastfeeding women.

The project unites 88 organisations from 22 countries, including the European Medicines Agency, drug manufacturers, academia, public health organisations, and teratology networks to innovate new solutions to a decades-long public health issue. With a shared vision that there is a societal obligation to radically and rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding, the ConcePTION team will work to create sustainable solutions to the problem. Through better use of existing health data from routine, daily practice together with enhanced methods to collect patient-reported data, and with new research capabilities to predict and measure maternal medication in breast milk, the team hopes to close the information gap.

Today, only about 5% of medications have adequate safety information on use in pregnant or breastfeeding women. Obtaining reliable safety information can take 20 or more years to collect after a medicines on the market. ConcePTION aims to change this paradigm by improving and unifying currently uncoordinated approaches to data collection, and through the re-use of existing and de-identified health data that is generated during the routine care of patients, this is also called ‘Big Data’. These data can be systematically and securely analysed to provide useful information about the effects of medicines on pregnancy outcomes in real life. ConcePTION does this by forming a networked system bringing together the major data sources dispersed across Europe.

ConcePTION researchers also aim to create new pathways and methods for understanding medication transfer to breastmilk by creating the first Europe-wide breast milk biobank for research purposes. The team will also develop new models that can predict medication transfer into human breast milk.

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