Dear All (long note alert ... there's a lot of material below my signature):
Just published today is an IDSA White Paper entitled “Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-spectrum Indications, and Unmet Needs.” The paper is accompanied by an editorial by George Drusano. As the papers are free to download (links below).
The white paper reviews the output from the July 2016 FDA workshop entitled “Facilitating Antibacterial Drug Development for Patients with Unmet Need and Developing Antibacterial Drugs that Target a Single Species” and has the goal of presenting for a pragmatic approach to feasible trial designs for antibacterial agents.
If you were at the July 2016 workshop, you’ll recall that the group worked in detail through the problem of organism-specific clinical trials and identified a group of potential solutions. The discussion was then advanced again during the 1 Mar 2017 workshop. And, we've also had since then the 13 April 2017 FDA AMDAC on this topic.
There’s a lot in these various documents … you’ll need to spend some time with them. The briefing book from the 13 Apr 2017 AMDAC is an excellent way to get an overview of whole problem. As a supplemental rough guide, I provide a summary of the core logic below my signature.
As noted before, I suspect (hope!) that FDA is going to turn all this into a guidance document in the near future.
Heady times! See you soon, --jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Chief Strategy Officer, CARB-X | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx
Boucher et al. White Paper:
18-19 July 2016 FDA workshop: Facilitating Antibacterial Drug Development for Patients with Unmet Need and Developing Antibacterial Drugs that Target a Single Species
1 Mar 1017 FDA workshop: Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa
13 Apr 1017 FDA AMDAC: Developing Single-Pathogen agents for Acinetobacter baumannii and Pseudomonas aeruginosa
John’s summary of the core ideas