Medication Safety In Pregnancy And Breastfeeding – The ConcePTION Big Data And Biobank Project

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A landmark public-private partnership called ConcePTION was recently awarded a 5-year grant by the European Innovative Medicines Initiative (IMI2) to tackle many of the research gaps related to medicine used by pregnant and breastfeeding women.

ConcePTION is a 5-year, €28.6 million project supported by the Innovative Medicines Initiative (IMI), a public-private partnership between the European Union and the European pharmaceutical industry. The pharmaceutical industry contributes €13.3 million to the project through in-kind contributions, whereas the European Commission funds €15.3 million in cash. The consortium, comprising close to 200 researchers, is governed and managed by a balanced 50/50 split of public and private partners, and is jointly led by Novartis and the University Medical Center Utrecht.

Up to 90% of women are exposed to a prescription medication at some point during their pregnancy. Women and their healthcare providers face difficult choices before, during, and after pregnancy, due to a widespread lack of information. Physicians help women to select the safest medication, but they seldom have robust evidence to allow them to make informed decisions.

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Today, only about 5% of medications have adequate safety information on use in pregnant or breastfeeding women. Obtaining reliable safety information after a medicine is on the market can take 20 or more years to collect.

ConcePTION will form a networked system bringing together the major data sources dispersed across Europe to curate big data from routine patient care. ConcePTION will also create the first Europe-wide breast milk biobank for research purposes. From this the team will develop new models that can predict medication transfer into human breastmilk.

In this way, ConcePTION will create a trusted biomedical ecosystem that can efficiently, systematically, and ethically, generate reliable evidence-based information regarding the safety of medications used during pregnancy and breastfeeding. ConcePTION aims to provide that information in a form that is usable by both healthcare providers and women to facilitate informed decision making.