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Designing development programs for non-traditional antibacterial agents

Author

Listed:
  • John H. Rex

    (F2G Limited, Eccles
    McGovern Medical School at The University of Texas Health Science Center at Houston)

  • Holly Fernandez Lynch

    (University of Pennsylvania Perelman School of Medicine)

  • I. Glenn Cohen

    (Harvard Law School
    Petrie-Flom Center)

  • Jonathan J. Darrow

    (Harvard Medical School)

  • Kevin Outterson

    (Boston University School of Law, CARB-X)

Abstract

In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and non-traditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits that would benefit from extension of current paradigms. Discussion of such potential paradigms should be undertaken by the development community.

Suggested Citation

  • John H. Rex & Holly Fernandez Lynch & I. Glenn Cohen & Jonathan J. Darrow & Kevin Outterson, 2019. "Designing development programs for non-traditional antibacterial agents," Nature Communications, Nature, vol. 10(1), pages 1-10, December.
    • Handle: RePEc:nat:natcom:v:10:y:2019:i:1:d:10.1038_s41467-019-11303-9
    DOI: 10.1038/s41467-019-11303-9
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