Coordination with the regulatory authorities

The long-term perspective of the joint project Phage4Cure is the approval of bacteriophages for the treatment of bacterial infections. Although bacteriophages have been used as therapy for more than one hundred years, there are many different aspects to be considered when compared with traditional drugs. Until now, drug approval procedures have been based on classical chemical and biotechnological substances and can therefore not simply be translated to phages. In order to pave the way for the approval of phage therapy, the project members aim to discuss the necessary steps regularly with the regulatory authorities. Already at the end of September 2017, the Paul Ehrlich Institute (PEI) hosted a meeting in Langen near Frankfurt. In February 2018 the first meeting took place at the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn. Meanwhile, the responsibility of the authorities has been clarified: the BfArM will be in charge.

The project team visiting the BfArM (Febr. 2018) F.l.t.r.: Prof. Dasenbrock (ITEM), Dr. Rohde (DSMZ), Dr. Hüser (CRO), Dr. Roß (ITEM), Dr. Hertrampf (CRO), Fr. Lehmann (CRO), Dr. Ziehr (ITEM), Prof. Witzenrath (Charité)
The project team visiting the PEI (Sept. 2017) F.l.t.r.: Dr. Rohde (DSMZ), Dr. Uhle (CRO), Dr. Hertrampf (CRO), Dr. Seitz (ITEM), Prof. Witzenrath (Charité), Prof. Dasenbrock (ITEM), Dr. Ziehr (ITEM), Dr. Roß (ITEM), Dr. Hüser (CRO).