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:

Share

Share on twitter
Share on facebook
Share on linkedin
Share on email
Share on whatsapp
Share on reddit

AMR Action Fund ($1b for P2-3): Video chat with new CEO! New committed funds!

Dear All, I’ve written before about the AMR Action Fund (9 Jul 2020 newsletter): In brief, it is ~$1b pledged by over 20 leading pharmaceutical companies to support the Phase 2-3 studies needed to bring 2-4 new antibiotics to approval by 2030 Stated differently, the AMR Action Fund provides Push incentives for Phase 2-3 to complement the Push Incentives

UK Antibiotic Subscription Pilot: Updates from a webinar

Dear All (and with thanks to Kevin Outterson for co-authoring), We’ve written and talked before from various perspectives about the groundbreaking UK NHS England-, NHS Improvement-, and NICE-sponsored antibiotic subscription pilot project: 10 Feb 2021: Fabulous 5-minute video explainer on the economics of antibiotics by Andrew Jack of Financial Times Superb discussions of Push/Pull, the role

Brilliant 5-minute video explainer of the AMR problem!

 Dear All, Andrew Jack of the Financial Times (FT) has produced a superb 5-minute video explainer of the AMR challenge! Featuring cameos from Kevin Outterson (CARB-X), Christine Ardal (Norwegian Institute of Public Health), and Manica Balasegaram (GARDP), the video deftly illustrates the economic challenge, the way that delinked Netflix-like models provide a solution, and the

Job with global impact: Director, CIDRAP Antimicrobial Stewardship Program

Dear All, Launched in 2016, the Antimicrobial Stewardship Program (ASP) at the Center for Infectious Disease Research and Policy (CIDRAP) of the University of Minnesota works to provide support globally to the the infectious disease community via such diverse activities as ASP-oriented podcasts, webinars, journal clubs, and other resources. CIDRAP itself is directed by the

Scroll to Top