International partnership to tackle research gaps in medication safety for pregnant and breastfeeding women’

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

On 1 April 2019 a landmark public private partnership called ConcePTION was awarded a 5-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 an unprecedented 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 breastmilk, the team hopes to close the information gap.

Pregnant and breastfeeding women have long been overlooked in the medical research community because there have been few avenues available for conducting research; the fear of legal liability has overshadowed the need for reliable information to benefit these women and their families.

Nonetheless, 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.

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 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. 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 breastmilk.

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. ConcePTION aims to provide that information in a form that is usable by both healthcare providers and women to facilitate informed decision making.

ConcePTION is a €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.

The Management team comprises representatives from Novartis, UCB Biopharma and University Medical Center Utrecht. The Management Board (work package leaders) has representatives from: European Institute of Innovation through Health Data, European Institute of Women's Health (non-voting contributor), GSK, Janssen Pharmaceutica, LAREB, Katholieke Universiteit Leuven, Novartis, Sanofi Aventis, Takeda, UCB Biopharma, University Medical Center Utrecht, University of KwaZulu-Natal, Ulster University and Uppsala Universitet.