A new document providing guidelines on the ideal regimen process for TB treatment was launched last week (4 September, 2016) during the ERS International Congress.
The document, entitled Target Regimen Profiles for TB Treatment, was launched in an official WHO document signing ceremony on Sunday, 4 September as part of the ERS and TB symposium, which highlighted some of the core achievements in tuberculosis prevention and control.
The document aims to guide the drug/regimen process by enabling important drug and regimen features which respond to the needs of end-users, care providers and policymakers. The document specifically targets the pharmaceutical industry, research institutions and product development partnerships and donors.
Dr Mario Raviglione, Director of the WHO Global TB Programme, noted: “These profiles, which go beyond the current standard of care, represent ideal product attributes and priorities to be considered early and coherently during the TB drug research and development process. The goal of candidate regimens must be to be more effective, less toxic, shorter and less-burdening on patients and health systems.”
The profiles were developed in consultation with a wide range of stakeholders including national TB programmes, civil society, partners, regulatory authorities and drug developers. The process was led by the WHO Task Force on New TB Drug Policy Development.
Dr Giovanni Battista Migliori, past ERS Secretary-General and Director for the WHO Collaborating Centre for TB and Lung Diseases in Italy, noted, “While the landscape of TB drug development has evolved dramatically in recent decades, one major obstacle continues to be the length of time to find optimal drug combinations and also the time to obtain regulatory approvals for new products. These target regimen profiles support regimen development rather than individual drug development. These profiles have the potential to cause a paradigm shift by urging drug developers to direct their efforts towards identifying optimal drug combinations from the very beginning of the TB drug R&D process.”
The profiles will now be monitored by the WHO and its Task Force on New TB Drug Policy Development and feedback will be collected by working with developers, end users and patients to ensure they are useful and that they reflect any new developments.
Listen to the interview recorded for Live@ERS featuring Dr Giovanni Battista Migliori (ERS), Dr Mario Ravigilione (WHO), Dr Dennis Falzon (WHO), and Dr Christian Lienhardt (WHO).