“On average, it takes an estimated 27 years to determine if a novel medication can be used by pregnant women without risking adverse effects on the fetus or child. This just can’t continue any longer”, says Professor Hedvig Nordeng at the University of Oslo’s Department of Pharmacy.
“We have even less knowledge about the effects of drug use in the subsequent breastfeeding period! We don’t even know if most medications are transferred from mother to child via breastfeeding, and this is something that can’t be tested in animal models. The contents of the milk is very different between animals and humans”, adds Nordeng.
Under the auspices of ConcePTION, the participants are going to develop European standards for the study of the transfer of medicines through breastfeeding.
“There are a lot of different steps in this kind of research, and each step must be performed in a defined manner. How are we going to obtain samples of milk? How to store them? How to analyse them? And so on. Today, most researchers have their own way of doing things, and the result is that it becomes very difficult to compile the results and draw conclusions”, Nordeng emphasizes.
Bringing out the big guns
Professor Hedvig Nordeng is enthusiastic about the ConcePTION project because it demonstrates the ability of the EU research and innovation program, Horizon 2020, to bring out the “big guns” when important societal problems need to be solved.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. EFPIA members spent almost two years discussing their way to a thought-through research programme, before the call for projects and applications became public in 2017. The project is funded with 13 million euros from the EU program innovative medicines initiative (IMI) and an equivalent amount from the EFPIA members.
The University of Oslo (UiO) is currently investing heavily in life sciences; so heavily that UiO: Life Sciences is the university's largest initiative ever. Professor Hedvig Nordeng emphasizes that the ConcePTION program and the entire IMI initiative fits very well with UiO's commitment to life science and innovation.
“This EU initiative offers many exciting opportunities for life science researchers at UiO. In the years to come, we are going to work really hard in order to give pregnant women the information and the safety that they deserve”, Nordeng concludes.
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