Help update the WHO clinical antibacterial pipeline analysis

Dear All:

As you know, WHO produced a pipeline update with a cut-off date of 1 July 2018. It’s now published both as a manuscript (Theuretzbacher et al. Lancet ID 2018, link) and a set of summary tables (link).

Team WHO would like to update this analysis with a cut-off date of 1 Aug 2019. They will of course do the usual searches for products in the clinic, but they would also be grateful for direct contact from developers with products in the clinic. 

The scope includes both traditional and non-traditional products and as noted is limited to products in / beyond Phase 1.

See further details just below my signature. For questions or to send data on your project for inclusion (and do note that there is a form to use for data submissions), please write to Sarah Paulin (paulins@who.int). 

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/

==  6 June 2019 Note from Pipeline Central at WHO ==
It is that time of the year again! WHO is in the process of updating the clinical antibacterial pipeline analysis for 2019 gathering information on new products that have entered the pipeline or changes/movement of products in the pipeline after 2 July 2018 through 1 Aug 2019.   

Here is the link to the most recent 2018 clinical pipeline update: https://apps.who.int/iris/bitstream/handle/10665/275487/WHO-EMP-IAU-2018.06-eng.pdf?ua=1

We would greatly appreciate if you could share with us any additions and changes that you are aware of within the current scope of the methodology (antibiotics and combination with a new chemical entity (NCE), new antibiotic combinations without NCE, polyclonal and monoclonal antibiotics and phase endolysins) with supporting documents by 22 July 2019. Please send changes using this form.

Data wanted for the pipeline analysis:

  • Developer
  • Name (and/or synonym) of the antibacterial
  • Phase (I-III, NDA)
  • Antibiotic class
  • Route of administration
  • Expected activity against the WHO priority pathogens list including which one/s
  • Innovation (new class, target, mechanism of action, no cross resistance to other antibiotic classes?)
  • Supporting data from the clinical trials including clinical trial numbers

In addition a broader discussion on non-traditional products in the clinical pipeline will also be included in the 2019 report as we see that these are beginning to play a larger role. WHO will undertake a formal expansion of the clinical pipeline methodology for the 2020 update with a full analysis of all non-traditional products targeting the PPL (priority pathogen list). In view of this future expansion you are also invited to include data on any non-traditional products being developed that fall more broadly under: antibodies (already included in the pipeline), virulence inhibitors, microbiome modulators, peptide immunomodulators, antibiotic inactivators, lysins, and probiotics.

Upcoming meetings of interest to the AMR community:

  • 10 June 2019 (everywhere): Application deadline for NIAID solicitation (HHS-NIH-NIAID-BAA2019-1) for proposals to support new vaccine or therapeutics candidates targeting antibiotic-resistant bacterial infections. Go here for more details.
  • ​11 June 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Models for antimicrobial R&D: Development and use of in vivo models for infectious disease research”. Go here to register
  • 11 June 2019 (webinar, 11.00-12.00 EST): CARB-X and CFF (Cystic Fibrosis Foundation) webinar on CFF’s new infection research initiative. Go here to register.
  • 20-24 June 2019 (San Francisco): Annual ASM Microbe meeting.
  • 9 July 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Infection models for antimicrobial R&D: Intracellular models”. Go here to register.
  • 10-11 Jul 2019 (Madison, WI): Tiny Earth Symposium, a teaching consortium that uses crowd-sourcing of antibiotic-producing microbes to improve undergraduate education. Details here.
  • 12 July 2019 (FDA, White Oak Campus): Public workshop to discuss the 2018 LPAD guidance. Register here.
  • [Mark your calendar now!] 3-6 Sep 2019 (Boston). Annual ASM-ESCMID Conference on Antibiotic Development. The Bootcamp series will continue on 3 Sep with main meeting on 4-6 Sep. Mark your calendar now and check back here for details.
  • 6-8 Sep 2019 (Bilbao, Spain): 5th ESCMID conference on Vaccines. Check back here for details.
  • 2-6 Oct 2019 (Washington, DC): IDSA’s annual IDWeek meeting.
  • 19-27 Oct 2019 (Annecy, France): International Course on Antibiotics and Resistance (ICARe) – A soup-to-nuts intensive residential training program on all things AMR, especially R&D for new antibiotics. See this link for details.
  • 1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): GRC on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Go here for details.
  • 12-13 Mar 2020 (Berlin?): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-, ENABLE-supported (among a long list!) Conference on Novel Antimicrobials and AMR Diagnostics. Final location is TBD, details will appear here, and you should mark your calendar now. 
  • 16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details. 
  • 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
  • 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)


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