Dolf Seilacher (1925–2014)

Reading meeting, John Hardcastle from the company discussed the commercial and regulatory challenges attached to such endeavours. Christine Rohde and Johannes Wittmann at the German Collection of Microorganisms and Cell Cultures in Braunschweig are in the process of expanding their arsenal of medically useful phage strains. Most recently, they reported the characterisation of phages against the opportunistic bacterial pathogen Achromobacter xylosoxidans, which causes complications in patients with cystic fibrosis and often carries multiple antibiotic resistance traits (PLoS One (2014) 9, e86935; Virology Journal (2014) 11, 14). While research aimed at medical application of phages is making rapid progress, a key problem remains the mismatch between the biological properties of phages and the established regulatory frameworks for drugs and medical procedures. As mentioned above, the success of phage therapy may depend on rapid change to the recipe, outrunning the evolution of the targeted bacteria. This need for change and for efficient use of the natural diversity of phages runs against the grain of the established drug regulations and guidelines which aim to pin down the precise and unchangeable composition of a given treatment and require timeintensive testing of this very specific product. Therefore, Gilbert Verbeken and colleagues at Leuven and Brussels have argued that adaptation of existing drug rules for phages would be impractical (Arch. Immunol. Ther. Exp. (2014) 62, 117–129). The authors call on the European Union to set up new guidelines specifically for phage therapy, based on the ecological knowledge accumulated in recent years. The important message to regulators as well as to future users of phage therapies is that, even though they may one day replace antibiotics, they don’t behave like antibiotics, and we, as a civilisation, definitely don’t want to repeat the mistakes we made with antibiotics.