Literature DB >> 25918147

Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals.

Esther Bettiol1, Jeffrey D Wetherington2, Nicola Schmitt3, Stephan Harbarth4.   

Abstract

As the number of antibacterial medicines in the pipeline remains low, we anonymously surveyed pharmaceutical industry professionals on challenges and solutions for clinical development of these agents. Challenges were reported primarily as financial and regulatory. For multidrug-resistant organisms, there are needs for rapid diagnostic tests, new regulatory guidance, and adaptation of endpoints/trial designs. Regulators and public/private initiatives are addressing these challenges to help ensure that proposed solutions have the support of all involved stakeholders.
Copyright © 2015, American Society for Microbiology. All Rights Reserved.

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Year:  2015        PMID： 25918147      PMCID： PMC4468719          DOI： 10.1128/AAC.00638-15

Source DB:  PubMed          Journal:  Antimicrob Agents Chemother        ISSN： 0066-4804            Impact factor:   5.191


  16 in total

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Journal:  Curr Opin Microbiol       Date:  2003-10       Impact factor: 7.934

2.  The critical impact of time discounting on economic incentives to overcome the antibiotic market failure.

Authors:  Brad Spellberg; Priya Sharma; John H Rex
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3.  White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens.

Authors: 
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Review 4.  Antibiotics: the changing regulatory and pharmaceutical industry paradigm.

Authors:  Richard Bax; Samantha Green
Journal:  J Antimicrob Chemother       Date:  2015-01-28       Impact factor: 5.790

Review 5.  A long and winding road; evolution of antimicrobial drug development - crisis management.

Authors:  Roger M Echols
Journal:  Expert Rev Anti Infect Ther       Date:  2012-11       Impact factor: 5.091

6.  A comprehensive regulatory framework to address the unmet need for new antibacterial treatments.

Authors:  John H Rex; Barry I Eisenstein; Jeff Alder; Mark Goldberger; Robert Meyer; Aaron Dane; Ian Friedland; Charles Knirsch; Wendy R Sanhai; John Tomayko; Cindy Lancaster; Jennifer Jackson
Journal:  Lancet Infect Dis       Date:  2013-01-15       Impact factor: 25.071

7.  10 x '20 Progress--development of new drugs active against gram-negative bacilli: an update from the Infectious Diseases Society of America.

Authors:  Helen W Boucher; George H Talbot; Daniel K Benjamin; John Bradley; Robert J Guidos; Ronald N Jones; Barbara E Murray; Robert A Bonomo; David Gilbert
Journal:  Clin Infect Dis       Date:  2013-04-17       Impact factor: 9.079

8.  First QIDP drug approved, but designation may fail urgent needs.

Authors:  Amanda B Keener
Journal:  Nat Med       Date:  2014-07       Impact factor: 53.440

Review 9.  The challenge of antimicrobial resistance: new regulatory tools to support product development.

Authors:  J F Tomayko; J H Rex; D M Tenero; M Goldberger; B I Eisenstein
Journal:  Clin Pharmacol Ther       Date:  2014-05-13       Impact factor: 6.875

Review 10.  Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health.

Authors:  George H Talbot; John H Powers; Thomas R Fleming; Judith A Siuciak; John Bradley; Helen Boucher
Journal:  Clin Infect Dis       Date:  2012-06-28       Impact factor: 9.079
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  10 in total

Review 1.  Antibiotic Potentiators Against Multidrug-Resistant Bacteria: Discovery, Development, and Clinical Relevance.

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Journal:  Front Microbiol       Date:  2022-07-01       Impact factor: 6.064

2.  PROPHETIC: Prospective Identification of Pneumonia in Hospitalized Patients in the ICU.

Authors:  Stephen P Bergin; Adrian Coles; Sara B Calvert; John Farley; John H Powers; Marcus J Zervos; Matthew Sims; Marin H Kollef; Michael J Durkin; Badih A Kabchi; Helen K Donnelly; Ana Cecilia Bardossy; Claire Greenshields; Daniel Rubin; Jie-Lena Sun; Karen Chiswell; Jonas Santiago; Peidi Gu; Pamela Tenaerts; Vance G Fowler; Thomas L Holland
Journal:  Chest       Date:  2020-06-29       Impact factor: 9.410

3.  Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis.

Authors:  Thomas L Holland; Stephen Mikita; Diane Bloom; Jamie Roberts; Jonathan McCall; Deborah Collyar; Jonas Santiago; Rosemary Tiernan; Joseph Toerner
Journal:  BMJ Open       Date:  2016-11-10       Impact factor: 2.692

4.  Reversing resistance to counter antimicrobial resistance in the World Health Organisation's critical priority of most dangerous pathogens.

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Journal:  Biosci Rep       Date:  2019-04-12       Impact factor: 3.840

5.  PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts.

Authors:  Stephen P Bergin; Sara B Calvert; John Farley; Jie-Lena Sun; Karen Chiswell; Willem Dieperink; Jan Kluytmans; Juan Carlos Lopez-Delgado; Rafael Leon-Lopez; Marcus J Zervos; Marin H Kollef; Matthew Sims; Badih A Kabchi; Daniel Rubin; Jonas Santiago; Mukil Natarajan; Pamela Tenaerts; Vance G Fowler; Thomas L Holland; Marc J Bonten; Sebastiaan J Hullegie
Journal:  Open Forum Infect Dis       Date:  2022-05-09       Impact factor: 4.423

Review 6.  Metallotherapeutics development in the age of iron-clad bacteria.

Authors:  Garrick Centola; Fengtian Xue; Angela Wilks
Journal:  Metallomics       Date:  2020-12-23       Impact factor: 4.526

7.  Lipidation of Temporin-1CEb Derivatives as a Tool for Activity Improvement, Pros and Cons of the Approach.

Authors:  Paulina Kosikowska-Adamus; Emilia Sikorska; Dariusz Wyrzykowski; Aleksandra Walewska; Anna Golda; Milena Deptuła; Michał Obuchowski; Adam Prahl; Michał Pikuła; Adam Lesner
Journal:  Int J Mol Sci       Date:  2021-06-22       Impact factor: 5.923

8.  Retrospective analysis of relationships among the dose regimen, trough concentration, efficacy, and safety of teicoplanin in Chinese patients with moderate-severe Gram-positive infections.

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Journal:  Infect Drug Resist       Date:  2018-01-05       Impact factor: 4.003

9.  Cost Drivers of a Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Phase 3 Clinical Trial.

Authors:  Stella Stergiopoulos; Sara B Calvert; Carrie A Brown; Josephine Awatin; Pamela Tenaerts; Thomas L Holland; Joseph A DiMasi; Kenneth A Getz
Journal:  Clin Infect Dis       Date:  2018-01-06       Impact factor: 9.079

10.  Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE's STAT-Net.

Authors:  Marlieke E A de Kraker; Harriet Sommer; Femke de Velde; Isaac Gravestock; Emmanuel Weiss; Alexandra McAleenan; Stavros Nikolakopoulos; Ohad Amit; Teri Ashton; Jan Beyersmann; Leonhard Held; Andrew M Lovering; Alasdair P MacGowan; Johan W Mouton; Jean-François Timsit; David Wilson; Martin Wolkewitz; Esther Bettiol; Aaron Dane; Stephan Harbarth
Journal:  Clin Infect Dis       Date:  2018-11-28       Impact factor: 9.079
  10 in total

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