The rise in antimicrobial resistance can be attributed to multiple factors: the misuse and overuse of antibiotics, the spread of infectious diseases through poverty, inadequate water supply and poor sanitation, and a lack of access to quality primary health care, among other factors. Equally challenging is the context in which drug development, that could lead to new treatments for resistant infections, is taking place. Failure rates in antibiotic drug development are high, and the costs incurred in research and development stand against limited potential revenues from taking a new antibiotic to market. As a result, most major pharmaceutical companies have left the antibiotic research and development space and many smaller antibiotic companies are struggling to survive. In light of these challenges, discussions have taken place within the G7, the G20 and many other international fora, which have since led to the creation of a number of new publicly funded research initiatives.
In 2017, WHO published the list of priority pathogens for which new treatments are urgently needed, to help ensure that the work undertaken by these new research initiatives, as well as the private sector, is targeted at priority public health needs.
WHO has now published four Target Product Profiles (TPPs) – addressing enteric fever, gonorrhoea, neonatal sepsis and urinary tract infections – to provide further detailed guidance for the research and development community.
Much more is needed to ensure that the antibacterial drug pipeline does not dry up completely, but these TPPs represent an important step in supporting and stimulating the development of drugs and products that are urgently needed to redress the impact of antimicrobial resistance now and in the future.
The publication
This publication contains four Target Product Profiles (TPPS) for antibacterial treatments for enteric fever, gonorrhoea, neonatal sepsis and urinary tract infections, together with the report of the meeting of the scientific advisory group that developed the TPPs.
The TPPs provide companies and other product developers, regulatory agencies, and research funders with a list of the specific characteristics of a future treatment that the drug developer should aim for in the development process. Each TPP comprises an introduction, rationale, and summary of the preferred characteristics of the proposed product with a minimal and preferred target product profile. The TPPs were developed according to the WHO standard methodology for the development of TPPs.
Related links:
Global Observatory on Health R&D: Target product profiles
Antibacterial agents in clinical development – an analysis of the antibacterial clinical development pipeline Antibacterial agents in preclinical development
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