The Medicines Evaluation Board (MEB) assesses and monitors the efficacy, risks and quality of human and veterinary medicines, and the safety of novel foods for human consumption. The MEB is an independent administrative body residing under the Government of the Netherlands. The MEB independently decides about the authorisation and monitoring of human medicinal products.
Role of MEB in VAC2VAC
MEB will contribute to the application and optimization of cellular assays based on analysis of vaccine-induced activation of antigen presenting cell (APC) and reporter cell lines and development of cell- or cell line-based assays for assessment of novel biomarkers identified. In these projects the MEB will work on assays for DTaP vaccine in collaboration with the RIVM.
Furthermore the MEB will contribute by proposing rational arguments for regulatory acceptance based on analysis and comparison of information obtained from the animal testing and the information from proposed set of alternative tests. Also a meta analysis will be performed of the information that the current testing (including in vivo test) yields and that the proposed testing will yield. The meta analysis is expected to reveal the different gaps in relevant information that the current (in vivo) and proposed testing strategies will have. This is expected to contribute to the argumentation for accepting the replacing testing strategy
Marcel H.N. Hoefnagel Ph.D. Senior Assessor Biopharmaceutical: Marcel Hoefnagel is a biochemist/biotechnologist who has been working as assessor of chemical-pharmaceutical assessment biologicals (with a focus on vaccines, allergens and cell-based therapies) since 2002. He is involved as an expert in several) working groups of the European Medicines Agency (EMA).
He has led several research projects including:
- development of a in vitro assay for immunogenicity of biologicals;
- 5-year PhD student project at University of Utrecht (UU Group of W. van Eden) on immunological activity testing of vaccines and cell-based therapies.
He has (co-) authored 39 peer-reviewed papers, including a paper on in vitro testing of vaccines.