Marcel Hoefnagel

Marcel Hoefnagel has been an Assessor of Biopharmaceuticals since 2002, with expertise in vaccines, allergens, biosimilars, immunogenicity, and cell and gene therapy products. Since 2023, they have chaired the EMA Quality Innovation Group (QIG), which facilitates the translation of innovative approaches in the design, manufacture, and quality control of medicines. The QIG serves as a key contact point for industry, developers, academics, and other stakeholders to discuss scientific and regulatory aspects of CMC innovation. In addition, they have chaired the HMA Substance Validation Group (SVG) since 2020, contributing to the development and maintenance of the EU Substance Registration System (EU-SRS)—a comprehensive database of medicinal product substances and their molecular structures. This system supports substance experts in SmPC review and helps provide relevant information to healthcare professionals. Alongside regulatory work, they are actively involved in academic research projects focused on the assessment of biopharmaceuticals and related areas. Trained as a biologist, they hold a PhD in Plant Biochemistry from Leiden University (1993) and held several postdoctoral positions in plant biochemistry and biotechnology from 1993 to 2002.