Constanze Blume, Ph.D., is Senior Vice President Global Regulatory Affairs at BioNTech. She joined the company in 2018 to provide regulatory support to its growing oncology pipeline and to build the Regulatory Affairs department which she co-leads with Ruben Rizzi.
Constanze works on the regulatory strategy for all of BioNTech’s product candidates and BioNTech’s proprietary BioNTainer concept, particularly contributing her expertise on regulatory CMC (pharmaceutical quality) aspects. Further, she is responsible for the regulatory aspects of artworks for commercial products, regulatory policy, and regulatory intelligence.
Together with Ruben, Constanze has played a pivotal role in the development of the Pfizer-BioNTech COVID-19 vaccine. She co-led the regulatory team defining and executing the global regulatory strategy, focusing on registrational CMC aspects and, in the later stages of clinical development, on the commercial artworks, thus securing regulatory approvals for the vaccine and for subsequent variant-adapted versions as well as the expansion of the EU-relevant manufacturing network. She therefore has contributed heavily to the success of the collaboration with Pfizer, while establishing trust-based exchanges with global regulators.
Constanze holds a Ph.D. in Biology from the University of Basel. Before joining BioNTech, Constanze set up and headed the regulatory department at Ganymed. In addition, she established and temporarily headed the company’s CMC department. In these roles, she was responsible for the developed monoclonal antibodies and companion diagnostics for oncology indications and supported the transfer after the acquisition by Astellas.