The project unites 88 organizations from 22 countries, including European Medicines Agency, drug manufacturers, academia, public health organisations, and teratology networks
ConcePTION, a public-private partnership project jointly led by Novartis and the University Medical Center Utrecht, has been recently awarded a 5-year grant by the Innovative Medicines Initiative (IMI2) to tackle many of the research gaps related to the medicine used by pregnant and breastfeeding women.
The project unites 88 organizations from 22 countries, including the European Medicines Agency, drug manufacturers, academia, public health organizations, 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,” stated a press release issued by UMC Utrecht .
Up to 90 per cent of pregnant and breastfeeding women are exposed to 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.
According to Utrecht, today only about 5 per cent 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 medicine hits the market.
“ConcePTION aims to profoundly 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,” stated the press release.
“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 breast milk by creating the first Europe-wide breast milk bio-bank for research purposes. The team will also develop new models that can predict medication transfer into human breast milk,” it added.
ConcePTION will create a trusted biomedical ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate reliable evidence-based information regarding the safety of medications used during pregnancy and breastfeeding. The project aims to provide that information in a form that is usable by both healthcare providers and women to facilitate informed decision making.