John Jensen, PhD, Senior Scientist, Deputy Head of Department, Department of Bioscience, Aarhus University
What is your field of expertise?
Senior researcher within ecotoxicology and ecology with special interest in pharmaceuticals, having most practical experience in soil ecotoxicology and veterinary medicines, but also aspects of human medicinal products. Furthermore, I have 15+ years of experience in regulatory aspects as external expert for the Danish Medicinal Agency and member of one of EMA’s permanent working parties on ecological risk assessment of pharmaceuticals.
What do you expect from PREMIER?
As one of the largest research projects within recent years and an assembly of highly qualified partners, I expect the PREMIER project to on the one hand move science forward and on the other hand form the platform for a better and smoother procedure for assessing medicinal products in a regulatory context by for example, compiling data in an accessible database for future marketing authorization holders (MAH), helping to minimizing repetitive testing.
Why did you agree to be part of the SAB?
To keep up with the scientific field and to help linking the science with regulatory needs. The project has a huge potential and if my contribution can help just the slightest, I would be more than satisfied.
What do you think are the current gaps in the/your field that PREMIER could fulfil?
For example, many active substances have a mode of action, which the current base test systems cannot capture properly. These may, for instance, be the Selective Serotonin Reuptake Inhibitors (SSRI) products or beta-blockers, which are very common anti-depressants and heart disease drugs, respectively. PREMIER cannot and should not develop Standard (OECD – Organisation for Economic Co-operation and Development) ecotox test, but they may be able to elucidate the challenges and evaluate the limitations in the current test system regime and recommend alternative endpoints for such active substances.
How could society at large benefit from the PREMIER products?
If an updated accessible database is created where companies can get access for a reasonable fee it can help medicine availability, it can save money for the MAH and reduce unnecessary testing promoting the 3Rs (Replacement, Reduction and Refinement).