The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 821520. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
What: Webinar presenting the ConcePTION European Breast Milk Collection
When: Tuesday, May 24, 14-15 CEST
Organisers: ConcePTION & BBMRI-ERIC
To provide evidence for how a medicine transfers to breastmilk, we need to test milk from mothers who use medicines during the post-partum period. We know that there are both short- and long-term benefits of breastfeeding for both mothers and infants. Data is missing because robust clinical lactation studies are rare, and the existing data cannot be confidently translated into evidence-based clinical practice. As a response, the ConcePTION project is developing a research infrastructure to collect, store and analyse samples of breast milk and blood.
The ConcePTION European Breast Milk Collection is supported by both public and private partners, including the Biobanking and BioMolecular resources Research Infrastructure, BBMRI-ERIC. We are working on five demonstration projects, studying how five different compounds transfer to breastmilk. Carried out by different partners in the project, the studies are intended to provide more information about the strength and feasibility of different methodological approaches. The first study from the University of Oslo will soon be finalized, including over 30 breast feeding participants using levocetrizine donating over 300 milk samples. During this webinar, the team will provide an overview of the study design, recruitment, lessons learned, and present the first results.
The main focus of the webinar is on the infrastructures developed in the project. In a joint effort, standardized documents for the informed consent, pre-analytical processes and storage have been developed. Together with BBMRI-ERIC, ConcePTION is developing a comprehensive Quality Management System (QMS) in order to secure and control all operations associated with conducting clinical trials, biobanking activities, and downstream analysis procedures at multiple process levels. This infrastructure will become a platform for lactation studies performed by both universities and pharmaceutical companies, with the objective to evaluate the possible transfer of medicines into breast milk, helping to bridge the knowledge gap on medical treatments for women who want to breastfeed. We are also developing an infrastructure for analysis of medicine residue in both breast milk and blood, applying bioanalytical methods, developed and validated according to regulatory authorities’ requirements. The bioanalytical platform is managed by the UDOPP at the department of Pharmacy, Uppsala University. UDOPP (Uppsala Drug Optimization and Pharmaceutical Profiling platform) is a research infrastructure, which provides modern laboratory and fore-front research helping drug discovery and development projects to characterize, analyze and deliver candidate drugs of the highest possible quality.
The ConcePTION approach also includes the final step: data analysis in the post-analytical phase, where laboratory test results are evaluated, and data is processed and fed back to support clinical data analysis, particularly critical results and the modification, annotation or revocation of results as necessary to support clinical data analysis. The major objectives are to understand drugs’ disposition within mothers’ population and identify covariates contributing to the population variability.
