This past spring I worked at the Medicines Evaluation Board (MEB) doing my thesis project, which was the final part of my MSc in Pharmaceutical Sciences studies at the University of Copenhagen. This project was carried out in collaboration with the Copenhagen Centre for Regulatory Science (CORS) and MEB. My daily supervisors were Didier Meulendijks and Marc Maliepaard from the MEB and Professor Marieke de Bruin from CORS.
Timi Toiviainen
I'm 25 years old and live in Helsinki, Finland. I graduated as a pharmacist last August from the university of Copenhagen.
I chose to do my project at the MEB because I thought the work done in regulatory science there seemed interesting. Living in the Netherlands was a nice experience.
Optimalisation of pharmacogenetic-pharmacokinetic (PG-PK) issues
The aim of this study project was to determine how pharmacogenetic-pharmacokinetic (PG-PK) issues were addressed by the European Medicines Agency (EMA) in centralised procedures, and if the regulatory assessment of PG-PK issues could be optimised in the EU. EMA’s "Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products" from 2012 was used to determine when PG-PK studies should be included in the initial marketing authorisation application (MAA).
Results
This study shows that evaluation of pharmacokinetics-related drug-gene interactions in the centralised procedures is often, but not always, done in line with what is required in the EMA’s PG-PK guideline. E.g., in a number of cases, CYP3A4/5 was not considered to be a clinically relevant polymorphic enzyme, which is not fully justified based on current knowledge. Overall, based on this research, a more harmonised approach to the assessment of pharmacogenetics in the EU seems warranted. This could help to further improve the benefit/risk–balance of genetic subpopulations.
