Marcel Hoefnagel, PhD Dutch Medicines Evaluation Board

Marcel Hoefnagel, Senior Assessor Biopharmaceuticals, Medicines Evaluation Board (CBG-MEB), The Netherlands.

• Senior Assessor of Biopharmaceuticals for the Medicines Evaluation Board (MEB) and
• Specialised in ATMPs, vaccines, allergens, biosimilars, immunogenicity assays -
• Since 2012 involved in regulation of CGTP (cell and gene therapy products) and drafting of guidance for CGTP and in drafting of several guidance documents for ATMPs.
• Co-organiser of EMA/FDA Work on support to quality development in early access approaches. This was the start of drafting Toolbox guidance to support quality data packages for products for an unmet medical need. This approach was also used to support accelerated development and assessment of COVID-19 vaccines. Dr. Hoefnagel published several papers on potency testing for cell-based products. Current research includes impact of regulation on quality and costs of CGTP and the development of in vitro assays to replace in vivo potency testing of vaccines (IMIproject VAC2VAC).

As Chairman of the Substance Validation Group he is involved in development of an international Substance Registration System (with EMA in collaboration with FDA: EU-SRS and G-SRS).