EMA-FDA-PMDA action + Podcasts (CDD, Pew) + NEJM on non-inferiority

Dear All: Several updates today, all on the theme of good things to know or share!

First, EMA, FDA, and PMDA are continuing to meet and have released a summary of their third tripartite meetingThe key message is alignment: alignment on trial designs for key indications, alignment on pediatric programs, and alignment on single global development programs! This is excellent to see and I look forward to hearing more about this during the 2018 meetings.

Second, CDD (Collaborative Drug Discovery) has released a podcast by Lynn Silver and Johannes Zuegg in which they survey ways to think about finding molecules for Gram-negatives that both penetrate and have reliable activity. CDD will also host a webinar on 13 Dec 2017 on BMGF’s TB Drug Accelerator program.

Third, a recent paper in NEJM by Mauri & D’Agostino provides a good survey of non-inferiority trial designs. you haven’t already done so, read as well the May 2017 Rex, Talbot, et al. paper in CID on non-inferiority designs specifically for antimicrobial agents. If you’re going to work in this area, you need an in-depth understanding of strengths and weaknesses of these trials and these papers provide the background you need.

Finally, our colleagues at Pew Trust have released a variety of materials that you may find useful personally or to share. These include a podcast, two Q&A documents, and a trio of patient vignettes. All these materials are suitable for helping tell the story of AMR to interested colleagues — the patient vignettes are brief (~5 minutes) and especially compelling.

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/

Upcoming meetings of interest to the AMR community:


Leaky pipe(line)s, Part 2 / CARB-X reboot / WHO 2021 pipeline review

Dear All, We have a 3-part discussion today on the theme of “I want a new drug … so how do I find it?” Off we go! First, the 14 June 2022 newsletter entitled “Leaky Pipe(lines) / When Is A Molecule A Drug” generated further discussions that are worth sharing: It was noted the microdosing

Antibiotic procurement models for LMICs / G7 Leaders call for Pull!

Dear All, Two stops on our tour today: (i) an excellent survey of incentive models and (ii) a final communique from the recent G7 meetings. First up, CGD (Center for Global Development) have released a report (link) entitled “Leveraging Purchasing Systems to Ensure Access, Stewardship, and Innovation: A Landscape Review of Current and Potential Market Structures

Leaky pipe(lines) / When is a molecule a drug? (Part 1 of 2)

Dear All, I was fascinated by this recent paper in AAC: Neha K. Prasad, Ian B. Seiple, Ryan T. Cirz, and Oren S. Rosenberg. Leaks in the Pipeline: a Failure Analysis of Gram-Negative Antibiotic Development from 2010 to 2020. Antimicrob Agents Chemother. 2022 May 17;66(5):e0005422. doi:10.1128/aac.00054-22. (Addendum: This newsletter has a follow-up newsletter.) In brief,

FDA/CVM: Antimicrobial use in companion animals

Dear All, Post-newsletter addendum: I’ve learned that USDA will host a 10 Aug 2022 (virtual, 10a-4.30p ET) workshop on AMR in food agriculture. See the meetings calendar for more details; go here to register. I’ll confess to having missed entirely the request back in February 2022 from FDA’s Center for Veterinary Medicine (CVM) for comments on antimicrobial

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