Unravelling biofilm complexity: a regulatory science perspective

Biofilms are a substantial problem across many sectors, with a frequently cited estimated global economic cost of >$5 trillion. In the healthcare setting, biofilm-associated infections have a significant impact on patient management and quality of life. They are difficult to eradicate and treat and contribute to escalating antimicrobial resistance. There are a multitude of methods for investigating biofilms, most designed to mimic in vivo conditions in an in vitro environment, but without standardisation, assay reproducibility and confidence is lost. The community needs validated, reproducible and harmonised approaches to support research and innovation underpinned by physical reference materials and written standards. Furthermore, clarity around the type of evidence needed to make and substantiate antibiofilm claims is needed; despite growing innovation in antibiofilm research, regulatory pathways remain unclear. This review discusses challenges and opportunities for biofilm innovation and highlights where regulatory science can aid and support progress.