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. 2019 Mar 15;6(Suppl 1):S5-S13.
doi: 10.1093/ofid/ofy345. eCollection 2019 Mar.

Antimicrobial Resistance Surveillance and New Drug Development

Helio S Sader  1 , Paul R Rhomberg  1 , Andrew S Fuhrmeister  1 , Rodrigo E Mendes  1 , Robert K Flamm  1 , Ronald N Jones  1
Affiliations

Antimicrobial Resistance Surveillance and New Drug Development

Helio S Sader et al. Open Forum Infect Dis. .

Abstract

Surveillance represents an important informational tool for planning actions to monitor emerging antimicrobial resistance. Antimicrobial resistance surveillance (ARS) programs may have many different designs and can be grouped in 2 major categories based on their main objectives: (1) public health ARS programs and (2) industry-sponsored/product-oriented ARS programs. In general, public health ARS programs predominantly focus on health care and infection control, whereas industry ARS programs focus on an investigational or recently approved molecule(s). We reviewed the main characteristics of industry ARS programs and how these programs contribute to new drug development. Industry ARS programs are generally performed to comply with requirements from regulatory agencies responsible for commercial approval of antimicrobial agents, such as the US Food and Drug Administration, European Medicines Agency, and others. In contrast to public health ARS programs, which typically collect health care and diverse clinical data, industry ARS programs frequently collect the pathogens and perform the testing in a central laboratory setting. Global ARS programs with centralized testing play an important role in new antibacterial and antifungal drug development by providing information on the emergence and dissemination of resistant organisms, clones, and resistance determinants. Organisms collected by large ARS programs are extremely valuable to evaluate the potential of new agents and to calibrate susceptibility tests once a drug is approved for clinical use. These programs also can provide early evaluations of spectrum of activity and postmarketing trends required by regulatory agencies, and the programs may help drug companies to select appropriate dosing regimens and the appropriate geographic regions in which to perform clinical trials. Furthermore, these surveillance programs provide useful information on the potency and spectrum of new antimicrobial agents against indications and organisms in which clinicians have little or no experience. In summary, large ARS programs, such as the SENTRY Antimicrobial Surveillance Program, contribute key data for new drug development.

Keywords: NDA; antimicrobial agents; antimicrobial resistance; new drug development.

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Figures

Figure 1.
Figure 1.
Carbapenem-resistant Enterobacteriaceae (CRE) rates in the United States (SENTRY Program, 1999–2017).
Figure 2.
Figure 2.
Carbapenem-resistant Enterobacteriaceae rates among nations surveyed by the SENTRY Program in 2017.
See this image and copyright information in PMC

References

    1. Boucher HW, Talbot GH, Benjamin DK Jr, et al. . 10 x ‘20 Progress–development of new drugs active against Gram-negative bacilli: an update from the Infectious Diseases Society of America. Clin Infect Dis 2013; 56:1685–94. - PMC - PubMed
    1. Núñez-Núñez M, Navarro MD, Palomo V, et al. . The methodology of surveillance for antimicrobial resistance and healthcare-associated infections in Europe (SUSPIRE): a systematic review of publicly available information. Clin Microbiol Infect 2018; 24:105–9. - PubMed
    1. Langley G, Schaffner W, Farley MM, et al. . Twenty years of active bacterial core surveillance. Emerg Infect Dis 2015; 21:1520–8. - PMC - PubMed
    1. Centers for Disease Control and Prevention (CDC). Fatal and nonfatal injuries involving fishing vessel winches--Southern shrimp fleet, United States, 2000–2011. MMWR Morb Mortal Wkly Rep 2013; 62:157–60. - PMC - PubMed
    1. Weston EJ, Wi T, Papp J. Surveillance for antimicrobial drug-resistant Neisseria gonorrhoeae through the enhanced gonoccal antimicrobial surveillance program. Emerg Infect Dis 2017; 23:S47–52. - PMC - PubMed