Marcel Hoefnagel

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 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). • Involved in various academic research projects on regulatory aspects of (bio)pharmaceuticals (incl. cell & gene therapy) 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)