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 meeting. The 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.
- Podcast: Antibiotic Resistance: When Drugs Don’t Work Anymore
- Q&A: One Doctor’s Fight to Stop Superbugs and Save Lives
- Q&A: Answers to Common Questions About the Use of Antibiotics in Animal Agriculture
- Patient story: Parents Remember Army Vet’s Battle with Antibiotic Resistance
- Patient story: A Superbug Survivor Shares His Struggle with Antibiotic Resistance
- Patient story: “My Worst Fear”: A Doctor Faces Antibiotic Resistance
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:
- 24-27 Nov 2017 (Taipei): 30th International Congress of Chemotherapy & Infection (ICC)
- 7-8 Dec 2017 (Birmingham, UK): Antibiotic Resistance and Mechanisms Workshop (BSAC)
- 12-14 Feb 2018 (Baltimore): ASM Biothreats Conference
- 11-16 Mar 2018 (Ventura Beach): Gordon Research Conference on Antibacterial Discovery
- 21-24 Apr 2018 (Madrid): ECCMID
- 7-11 Jun 2018 (Atlanta): ASM Microbe
- 22-27 Jul 2018 (Bryant University, Smithfield, RI): Gordon Research Conference on Drug Resistance for Cancer, Infectious Disease and Agriculture
- 4-7 Sep 2018 ESCMID-ASM Conference (#3) on Drug Development for AMR (initial flyer)