Journal
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
Volume 66, Issue 9, Pages 1945-1947Publisher
OXFORD UNIV PRESS
DOI: 10.1093/jac/dkr259
Keywords
antibiotics; antibiotic resistance; diagnostics; drug licensing; clinical trials
Funding
- Cubist
- Destiny
- Galapagos
- Leo
- Pfizer
- Novartis
- Novacta
- GSK
- Chiron/Novartis
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Regulatory agencies play a critical role in the licensing of new antimicrobial agents. To address the pivotal role played by regulatory agencies, particularly in the context of a paucity of new drugs active against bacteria resistant to currently available drugs, the BSAC formed the 'Urgent Need' Working Party to address the regeneration of antibacterial drug discovery and development. The Working Party identified a number of issues, including: increased application of pharmacokinetic/pharmacodynamic principles to expedite drug development; the need to prioritize licensing of drugs (including 'orphan' drugs) active in life-threatening infections; and expansion of the use of surrogate markers and rapid point of care diagnostics to facilitate drug development.
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