Regulatory opportunities to encourage technology solutions to antibacterial drug resistance

Roger Finch; Martin Blaser; Otto Carrs; Gail Cassell; Neil Fishman; Robert Guidos; Stuart Levy; John Powers; Ragnar Norrby; Glenn Tillotson; Rick Davies; Steven Projan; Mike Dawson; Dominique Monnet; Marcus Keogh-Brown; Kieran Hand; Sarah Garner; David Findlay; Chantal Morel; Richard Wise; Richard Bax; Frances Burke; Ian Chopra; Lloyd Czaplewski; Roger Finch; David Livermore; Laura J.V. Piddock; Tony White

doi:10.1093/jac/dkr259

Regulatory opportunities to encourage technology solutions to antibacterial drug resistance

Roger Finch^*, Martin Blaser, Otto Carrs, Gail Cassell, Neil Fishman, Robert Guidos, Stuart Levy, John Powers, Ragnar Norrby, Glenn Tillotson, Rick Davies, Steven Projan, Mike Dawson, Dominique Monnet, Marcus Keogh-Brown, Kieran Hand, Sarah Garner, David Findlay, Chantal Morel, Richard WiseRichard Bax, Frances Burke, Ian Chopra, Lloyd Czaplewski, Roger Finch^*, David Livermore, Laura J.V. Piddock, Tony White

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

19 Citations (Scopus)

Abstract

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.

Original language	English
Article number	dkr259
Pages (from-to)	1945-1947
Number of pages	3
Journal	Journal of Antimicrobial Chemotherapy
Volume	66
Issue number	9
DOIs	https://doi.org/10.1093/jac/dkr259
Publication status	Published - Sept 2011

Bibliographical note

Funding 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.

Keywords

Antibiotic resistance
Antibiotics
Clinical trials
Diagnostics
Drug licensing

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1093/jac/dkr259

Cite this

Finch, R., Blaser, M., Carrs, O., Cassell, G., Fishman, N., Guidos, R., Levy, S., Powers, J., Norrby, R., Tillotson, G., Davies, R., Projan, S., Dawson, M., Monnet, D., Keogh-Brown, M., Hand, K., Garner, S., Findlay, D., Morel, C., ... White, T. (2011). Regulatory opportunities to encourage technology solutions to antibacterial drug resistance. Journal of Antimicrobial Chemotherapy, 66(9), 1945-1947. Article dkr259. https://doi.org/10.1093/jac/dkr259

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title = "Regulatory opportunities to encourage technology solutions to antibacterial drug resistance",

abstract = "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.",

keywords = "Antibiotic resistance, Antibiotics, Clinical trials, Diagnostics, Drug licensing",

author = "Roger Finch and Martin Blaser and Otto Carrs and Gail Cassell and Neil Fishman and Robert Guidos and Stuart Levy and John Powers and Ragnar Norrby and Glenn Tillotson and Rick Davies and Steven Projan and Mike Dawson and Dominique Monnet and Marcus Keogh-Brown and Kieran Hand and Sarah Garner and David Findlay and Chantal Morel and Richard Wise and Richard Bax and Frances Burke and Ian Chopra and Lloyd Czaplewski and Roger Finch and David Livermore and Piddock, {Laura J.V.} and Tony White",

note = "Funding 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.",

year = "2011",

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doi = "10.1093/jac/dkr259",

language = "English",

volume = "66",

pages = "1945--1947",

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Finch, R, Blaser, M, Carrs, O, Cassell, G, Fishman, N, Guidos, R, Levy, S, Powers, J, Norrby, R, Tillotson, G, Davies, R, Projan, S, Dawson, M, Monnet, D, Keogh-Brown, M, Hand, K, Garner, S, Findlay, D, Morel, C, Wise, R, Bax, R, Burke, F, Chopra, I, Czaplewski, L, Finch, R, Livermore, D, Piddock, LJV & White, T 2011, 'Regulatory opportunities to encourage technology solutions to antibacterial drug resistance', Journal of Antimicrobial Chemotherapy, vol. 66, no. 9, dkr259, pp. 1945-1947. https://doi.org/10.1093/jac/dkr259

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T1 - Regulatory opportunities to encourage technology solutions to antibacterial drug resistance

AU - Finch, Roger

AU - Blaser, Martin

AU - Carrs, Otto

AU - Cassell, Gail

AU - Fishman, Neil

AU - Guidos, Robert

AU - Levy, Stuart

AU - Powers, John

AU - Norrby, Ragnar

AU - Tillotson, Glenn

AU - Davies, Rick

AU - Projan, Steven

AU - Dawson, Mike

AU - Monnet, Dominique

AU - Keogh-Brown, Marcus

AU - Hand, Kieran

AU - Garner, Sarah

AU - Findlay, David

AU - Morel, Chantal

AU - Wise, Richard

AU - Bax, Richard

AU - Burke, Frances

AU - Chopra, Ian

AU - Czaplewski, Lloyd

AU - Finch, Roger

AU - Livermore, David

AU - Piddock, Laura J.V.

AU - White, Tony

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PY - 2011/9

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N2 - 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.

AB - 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.

KW - Antibiotic resistance

KW - Antibiotics

KW - Clinical trials

KW - Diagnostics

KW - Drug licensing

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M3 - Article

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AN - SCOPUS:80051705390

SN - 0305-7453

VL - 66

SP - 1945

EP - 1947

JO - Journal of Antimicrobial Chemotherapy

JF - Journal of Antimicrobial Chemotherapy

IS - 9

M1 - dkr259

ER -

Regulatory opportunities to encourage technology solutions to antibacterial drug resistance

Abstract

Bibliographical note

Keywords

UN SDGs

Access to Document

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