In mid-January, WHO published two reports analysing the current development of new antimicrobial agents. In relation to the clinical pipeline one of the reports highlighted insufficiencies in tackling the challenge of increasing emergence and spread of antimicrobial resistance. The second report acknowledges that the pre-clinical pipeline is looking better, but underlined that it will still take years before these developments will reach patients.
The publication on ‘Antibacterial agents in preclinical development’ outlined the diversity of the pipeline, with more than 250 antimicrobial agents seeking to target pathogens on the priority list. However, despite these positive advancements WHO also noted that these are still in a very early stage, meaning that effectiveness and safety still needs to be proven. In relation to the 50 antibiotics that are currently in the clinical phase, it was pointed out that these products are going to bring little benefit over existing treatments and that only half of these are going to be effective against WHO’s priority pathogens. The report on “Antibacterial agents in clinical development—an analysis of the antibacterial clinical development pipeline” also brought forward evidence showing a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1). Out of the 50 products in the pipeline only three are seeking to target NDM-1.
EMA’s views on big data
The joint task force of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) on Big Data has moved to phase two and released recommendations for the European medicines regulatory network. Their work tries to shed light on the changing data landscape which requires regulators to look at new mechanism for accessing, managing and analysing data.
In the first phase the group looked at the landscape of Big Data and identified opportunities which included for example filling knowledge gaps. The report “Evolving Data-Driven Regulation” provides further …