Lourens Bloem

Class of:

2016

Current affiliation:

Utrecht University & MEB

Contact:

L.T.Bloem@uu.nl

Motivation:

Being trained as a pharmacist, I am especially interested in innovation and improvement of pharmacotherapy and drug regulation. Through this project I hope to contribute to timely patient access to innovative therapies where possible and acceptable, while ensuring links with the daily regulatory practice through my position of pharmacovigilance assessor at the Dutch Medicines Evaluation Board (CBG-MEB).

Education and experience:

Lourens obtained his PharmD in 2016 at Utrecht University. As part of his studies he has done several internships, including a placement at the Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital and an 8-month research placement at the Centre for Health Economics Research and Evaluation (CHERE) of the University of Technology Sydney in collaboration with the University of New South Wales, in Sydney, Australia.

Next to his studies, Lourens worked for three years at a community pharmacy. In addition, he was board member and founder of several organisations, for which he was nominated for the university’s 2015 Prize for Exceptional Extra-curricular or Social Achievements. 

Title PhD project:

Adaptive licensing, a changing role for pharmacovigilance

PhD project description:

The adoption of a life-cycle approach to drug assessment and the introduction of new licensing pathways (e.g. conditional marketing authorisation) have considerably changed the European regulatory landscape in the past years. The changes follow a continuing trend to build an increasingly adaptive system for marketing authorisation (MA), which satisfies both wishes of patients for early access to medicines and the need to generate data about drug performance under real-world circumstances. However, adaptive approaches also require behavioural changes by regulators, especially with regard to decision-making under greater uncertainty, tools and instruments for requesting post-marketing studies and the life-cycle monitoring and assessment of B/R profiles. Given the specific need to decrease uncertainties about the B/R balance of products licensed under adaptive pathways, additional evidence needs to be generated on what tools are most efficient in this respect.

This project therefore aims to:

-Understand differences in level of knowledge and uncertainties between products that follow new (adaptive) pathways vs standard MA at time of authorization.

-Describe methods used by regulators to determine the level of uncertainty and to decide upon ways to decrease uncertainties in the post-marketing phase

-Assess the effectiveness of these methods, to decrease uncertainties through systematic follow-up of the outcomes of proposed post-marketing activities.

Teammembers and other people involved:

Prof. Dr. Bert Leufkens, Prof. Olaf Klungel (supervisors), Dr. Aukje Mantel-Teeuwisse, Dr. Jarno Hoekman (daily supervisors)

 

Publications:

Bloem LT, De Abreu Lourenço R, Chin M, Ly B, Haas M. Factors Impacting Treatment Choice in the First-Line Treatment of Colorectal Cancer. Oncol Ther. 2016;1–14.