Hot meetings x 3! FDA Microbiome AdComm, Diagnostic devices, ASM-ESCMID developer meeting

Dear All, I think it’s worth a newsletter to call your attention to several upcoming meetings. In addition to the 30 Aug CDC-FDA webinar on “Drug Development Considerations for the Prevention of Healthcare-Associated Infections” and PACCARB’s 12-13 Sep 2022 pandemic wargaming event, we have these 3 meetings. The first two just now hit my radar and the 3rd is worth a shout-out: 

  • 15 Sep 2022 (virtual, 2-4p ET): Duke-Margolis webinar entitled “Advancing Bacterial Diagnostic Development.”
    • Mark McClellan’s team at Duke-Margolis consistently assembles instructive webinars and this one will focus on strategies for regulatory clearance of new diagnostics. Don’t miss it!
    • Go here for more details and to register.
  • 22 Sep 2022 (virtual, 8.30-5.00p ET): FDA Advisory Committee discussing an application for approval of Rebyota (Fecal Microbiota, Live) with a requested indication to “reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent Clostridioides difficile infection.”
  • 4-7 Oct 2022 (Dublin, Ireland): The 2022 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance.
    • This series has been one of my favorite meetings since its start … this year it is back and in-person.
    • The scientific program looks excellent and the meeting has lots of opportunity for networking. 
    • I strong encourage attendance! Go here for all the details..

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://13.43.35.2/blog/. All opinions are my own.

Draft EMA antibacterial guidance: Analysis

Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft

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