Marcel Hoefnagel
MEB-Medical Evaluations Board
- Biochemist with a PhD in molecular plant biology
- Since 2002 at the agency
- Specialised in vaccines, allergens, biosimilars, and ATMP.
- Since 2012 involved in ATMP, contributed to several EMA ATMP guidelines
- Published papers on potency tests for cell-based products.
- Involved in quality (CMC) assessment of COVID-19 vaccines as (Co)Rapporteur
- Contributed to several EMA quality guidance documents for Accelerated access
- Current research includes :
- impact of regulation on quality and costs of ATMPs
- in vitro assays to replace in vivo potency testing of vaccine