A fast developing pharmaceutical environment should benefit from research at the intersection of academia, regulatory authorities and industry. Being at the centre of this intersection, I hope that my research can contribute to improvements in the regulatory area.
Education and experience:
Kevin Klein has studied Bio-Pharmaceutical Sciences at the University of Leiden, which he finished with a Master Specialisation in Science Based Business in 2013. After his studies, Kevin started working for Exon Consultancy in Amsterdam for which he was involved in various projects in the field of pharmaceutical regulation. In the Escher project ‘Pharmacovigilance of biologics’ his research focused on the traceability of biological medicinal products in clinical practice and adverse drug reaction (ADR) reporting. Since 2015, he works for TI Pharma on the IMI project ADAPT SMART, which is an enabling platform for Medicinal Adaptive Pathway to Patient (MAPPs) activities in Europe. Kevin started his professional PhD at Utrecht University in 2015.
Title PhD project:
Pharmaceutical regulation in the EU: exploring (dis)connections between science, regulation and clinical practice.
PhD project description:
Regulation in the pharmaceutical area has to protect public health, support patient access to medicines and provide appropriate incentives for innovation. Regulations have to achieve their goals by maximizing benefits while minimizing negative effects. Rapid technological and scientific developments ask for regulations to be continuously assessed and have the possibility to adapt to changing environments. This is particularly challenging in innovative and developing pharmaceutical areas, such as areas of high medical need and new treatments approaches. Due to the novelty of these pharmaceutical areas and the limited regulatory experience, regulations should be constantly reviewed by evaluating their impact on practice, to assess whether regulations are achieving their goals or how they should be improved to do so.
The aim of this research is to get a better understanding of the crossroads of science, regulation and clinical practice in innovative and developing pharmaceutical areas, by identifying key drivers for the designing of new regulations, evaluating the impact of regulations in the area of practice and assessing how we can learn from regulatory evaluations in order to improve current and future regulations.
Teammembers and other people involved:
Klein K, De Bruin ML, Broekmans AW, Stolk P. Classification of recombinant biologics in the EU: divergence between national pharmacovigilance centres. Accepted for publication in BioDrugs (2015)
Klein K, Scholl JHG, Vermeer NS, Broekmans AW, Van Puijenbroek EP, De Bruin ML, Stolk P. Traceability of biologics in the Netherlands – an analysis of information-recording systems in clinical practice and spontaneous ADR reports. Accepted for publication in Drug Safety (2015)