WHO Pipeline review / Roadmap for susceptibility testing developers

Dear All: Two useful papers have just been released — see titles and abstracts below my signature. Both are Open Access so please do download & read! And just for full disclosure, know that I’m a co-author on both.

First, a working group organized by WHO has produced a comprehensive review of the clinical antimicrobial pipeline for both bacteria and TB (Theuretzbacher et al. Analysis of the clinical antibacterial and antituberculosis pipeline. Lancet Infect Dis DOI:https://doi.org/10.1016/S1473-3099(18)30513-9, 2018). An important feature of this paper is its analysis by candidate of spectrum and novelty. Noted added 30 Mar 2019: There is a supplemental table (link) that provides a somewhat more user-friendly version of the key summary tables.

Second, a working group organized by JPIAMR has written a detailed analysis of the barriers to timely development and implementation of novel and rapid AST (Antimicrobial Susceptibility Test) platforms. As explained in the linked editorial, this paper’s goal is to facilitate a dialog between AST developers and users about the features that would facilitate uptake and usage of AST devices.

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog/

WHO review: Theuretzbacher, U., S. Gottwalt, P. Beyer, M. Butler, L. Czaplewski, C. Lienhardt, L. Moja, M. Paul, S. Paulin, J. H. Rex, L. L. Silver, M. Spigelman, G. E. Thwaites, J.-P. Paccaud and S. Harbarth (2018). “Analysis of the clinical antibacterial and antituberculosis pipeline.” Lancet Infect Dis DOI:https://doi.org/10.1016/S1473-3099(18)30513-9.

Abstract: This analysis of the global clinical antibacterial pipeline was done in support of the Global Action Plan on Antimicrobial Resistance. The study analysed to what extent antibacterial and antimycobacterial drugs for systemic human use as well as oral non-systemic antibacterial drugs for Clostridium difficile infections were active against pathogens included in the WHO priority pathogen list and their innovativeness measured by their absence of cross-resistance (new class, target, mode of action). As of July 1, 2018, 30 new chemical entity (NCE) antibacterial drugs, ten biologics, ten NCEs against Mycobacterium tuberculosis, and four NCEs against C difficile were identified. Of the 30 NCEs, 11 are expected to have some activity against at least one critical priority pathogen expressing carbapenem resistance. The clinical pipeline is dominated by derivatives of established classes and most development candidates display limited innovation. New antibacterial drugs without pre-existing cross-resistance are under-represented and are urgently needed, especially for geographical regions with high resistance rates among Gram-negative bacteria and M tuberculosis.

AST Roadmap (and, see also the associated editorial): van Belkum, A., T. T. Bachmann, G. Lüdke, J. G. Lisby, G. Kahlmeter, A. Mohess, K. Becker, J. P. Hays, N. Woodford, K. Mitsakakis, J. Moran-Gilad, J. Vila, H. Peter, J. H. Rex, W. M. Dunne, J. A. M. R. R. D. T. W. G. o. A. R. the and T. Rapid Diagnostic (2018). “Developmental roadmap for antimicrobial susceptibility testing systems.” Nature Reviews Microbiology https://doi.org/10.1038/ s41579-018-0098-9.

Abstract: Antimicrobial susceptibility testing (AST) technologies help to accelerate the initiation of targeted antimicrobial therapy for patients with infections and could potentially extend the lifespan of current narrow-spectrum antimicrobials. Although conceptually new and rapid AST technologies have been described, including new phenotyping methods, digital imaging and genomic approaches, there is no single major, or broadly accepted, technological breakthrough that leads the field of rapid AST platform development. This might be owing to several barriers that prevent the timely development and implementation of novel and rapid AST platforms in health-care settings. In this Consensus Statement, we explore such barriers, which include the utility of new methods, the complex process of validating new technology against reference methods beyond the proof-of-concept phase, the legal and regulatory landscapes, costs, the uptake of new tools, reagent stability, optimization of target product profiles, difficulties conducting clinical trials and issues relating to quality and quality control, and present possible solutions.

Opportunities of interest for the AMR community

  • 24 Oct 2018 deadline: IMI AMR Accelerator programme Pillar A within IMI Call 15: Capability-building network to manage the whole accelerator and strengthen AMR science. This is a two-stage call, with letter of intent from applicants expected on 24 Oct 2018.
  • 24 Oct 2018 deadline: IMI AMR Accelerator programme Pillar B: Tuberculosis drug development network within IMI Call 15: Tuberculosis drug development network to collaboratively progress TB compounds and validate new tools for TB drug development. This is a two-stage call, with letter of intent from applicants expected on 24 Oct 2018.
  • 24 Oct 2018 deadline: IMI Call 16: A series of individual programs where a single EFPIA partner works with a consortium to progress compounds for for TB, non-tuberculous mycobacteria, and Gram-negatives. This is a one-stage call, with full proposal from the EFPIA and applicant consortium expected on 24 Oct 2018.

Upcoming meetings of interest to the AMR community:

  • 23 Oct 2018 (online webinar): Introduction to Pew’s SPARK platform (Shared Platform for Antibiotic Research and Knowledge)
  • 23 Oct 2018 (New York City): New York Academy of Sciences workshop entitled “New Therapeutic Strategies to Combat Antibacterial Resistance
  • 26 Oct 2018 (London): EMA information day for SMEs: “Regulatory toolbox for medicines and combined devices developers”. Here is the current agenda. Webcast will be available. More details from sme@ema.europa.eu.
  • [DATE CORRECTED] 29-30 Oct 2018 (Washington): BARDA Industry Days, a 2-day conference on countermeasure development for the US Government
  • 7-9 Nov 2018 (Seville, Spain): Better Methods for Clinical Studies in Infectious Diseases and Clinical Microbiology: A Hands-on Workshop
  • 8 Nov 2018 (Alderley Park, UK): Bionow’s 1-day Bioinfect conference
  • 12-18 Nov 2018 (everywhere): WHO (and US CDC) Antibiotic Awareness Week. Events now being planned … see the WHO and CDC links for ideas, fact sheets, and graphical materials.
  • 12-13 Nov 2018 (London): Joint SCI– and Royal Society of Chemistry-sponsored 2nd annual Symposium on Antimicrobial Discovery. Online materials here.
  • 13 Nov 2018 (London): All-Parties Parliamentary Working Group on AMR meeting. Online materials here
  • 16 Nov 2018 (Berlin): Max Planck Institute for Innovation and Competition is organizing a conference on life sciences and innovation. Online materials here.
  • 19-20 Nov 2018 (Accra, Ghana): Call to Action on Antimicrobial Resistance. Latest agenda here. To attend, contact AMRCalltoAction@wellcome.ac.uk.
  • 21 Nov 2018 (London): NICE- & APBI-sponsored masterclass: “Using non-randomised data to estimate treatment effects in NICE submissions”. Details here.
  • 29-30 Nov 2018 (Birmingham, UK): BSAC (British Society Antimicrobial Chemotherapy): Antibiotic Resistance Mechanisms Workshop for Researchers
  • 7 Dec 2018 (Boston, MA): BAARN, Boston Area Antimicrobial Resistance Network 2018 symposium, 8:30am to 7pm at The Starr Center (185 Cambridge Street, Boston, MA). This is an excellent networking opportunity, especially for those based in the Boston area. Details not yet online.
  • 15 Jan 2018 (London): BSAC’s Antimicrobial Chemotherapy Conference 2019: “An ABC for everyone involved in developing new antimicrobials.” Details here.
  • 14-15 Mar 2019 (Berlin): BEAM– and ND4BB-ENABLE-sponsored Berlin Conference on Novel Antimicrobials and AMR Diagnostics. Details here.
  • 21-22 Mar 2019 (Birmingham, UK): BSAC Spring Conference.

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