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.
Bibliographical noteFunding Information:
R. F. has provided consultative advice Destiny Pharma, GlaxoSmithKline, Menarini Recherche and Novartis. R. B. is currently a senior partner at Tran-scrip partners LLP and works with several large and small pharmaceutical companies in the area of antibiotic development. He is also a non-executive director of Helperby therapeutics Ltd. F. B. is an employee of Eli Lilly and Company Ltd. I. C. is a member of the Scientific Advisory Board of Destiny Pharma Ltd, and has recently received research funding from Cubist, Destiny, Galapagos, Leo, Pfizer, Novartis and Novacta. D. L. has received conference, speaking and research support from numerous pharmaceutical companies. He holds shares in AstraZeneca, Merck, Pfizer, Dechra, and GlaxoSmithKline, and, as executor, manages further holdings in GlaxoSmithKline and Eco Animal Health. He is an employee of the UK HPA and is a UK taxpayer. T. W. is an independent consultant, a retired employee and shareholder of GlaxoSmithKline, and in the past 5 years has received financial remuneration for consultancy or presentations from GSK, and Chiron/Novartis. The remaining Members of the Working Party have none to declare.
- Antibiotic resistance
- Clinical trials
- Drug licensing