Marcel Hoefnagel Medicines Evaluation Board

Marcel Hoefnagel, Senior Assessor Quality (CMC) of Biopharmaceuticals Medicines Evaluation Board (CBG-MEB), The Netherlands. Chair EMA Quality Innovation Group. Chair HMA Substance Validation Group • Assessor of Biopharmaceuticals (since 2002): Specialised in vaccines, allergens, biosimilars, immunogenicity, and Cell and Gene therapy products. • CMC Expert in Cell Therapy products Involved in Research on Cell therapy products. (Publications on Immunotherapeutic Cell potency assays). • Chair of the EMA Quality Innovation Group (QIG; since 2023). The EMA QIG supports the translation of innovative approaches to the design, manufacture and quality control of medicines. The QIG is the entry point for pharmaceutical industry, developers, academics and other stakeholders to discuss scientific and regulatory issues on innovation in CMC. • Chair of the HMA Substance Validation Group (SVG; since 2020). The SVG is involved in development and maintenance of EU-SRS (EU- Substance Registration System; a database with all substances in medicinal products with their molecular structure). EU-SRS supports substance experts in SmPC review and in providing nationally relevant information to health care professionals. • Involved in various academic research projects to support the assessment of (bio)pharmaceuticals and other regulatory activities. • Trained as Biologist, with a PhD in Plant Biochemistry (Leiden University, 1993) and held several post-doc positions in plant biochemistry and biotechnology (1993-2002)