Dear All: The ~150 of us who gathered in Washington yesterday and today for the NIAID’s PK-PD workshop enjoyed a very rich conversation. It’s really hard to capture the full debate, but here is a brief slide set and as well a written summary of the meeting that provide the main points. More materials can be found online at this
Dear All: FDA today hosted their eagerly awaited workshop on animal models in support of narrow-spectrum agents for A. baumannii (Abau) and P. aeruginosa (Pae). It was a really full & interesting day at the end of which my confidence that we can actually register narrow-spectrum agents for these two pathogens (and others that are even less frequent) is
Dear All: An article by Gassman, Nguyen, and Joffe in today’s NEJM entitled “FDA regulation of prescription drugs” caught my eye because of its emphasis on structured benefit-risk (B-R) analyses as a core part of regulatory thinking. See links below along with the core paper from the FDA’s website on benefit-risk (oddly, the NEJM paper is not
Dear All: OK, I’ll say that I’m sending this around because the title was so intriguing and reminded me of the debates we’ve had about why fever is not part of endpoint definition for clinical trials of new drugs. But, this article (see weblink & abstract below) is an excellent, in-depth survey of how salicylic acid and
Dear All: This one appears to have been released on 7 Mar but it just crossed my desk today. In brief, IDSA has assembled 13 patient stories into a well-written and illustrated .pdf. The centerpiece of the paper is this graphical history of AMR shown below. Well done to IDSA for pulling these stories together
Dear All: There’s a very comprehensive review of the polymyxins by Poirel, Jayol, and Nordmann just out in Clin Micro Reviews (http://cmr.asm.org/cgi/content/long/30/2/557). If you’re a fan of good quality graphics as way to tell the story of AMR, their Figure 4 is worth capturing! Ditto their Figure 5 of outbreaks of colistin-resistant, carbapenemase-producing K. pneumoniae.
Dear All: The attached EU Parliament resolution on Access to Medicines was released today. Broadly, it calls for greater transparency in price setting for medicines and for harmonization of HTA processes. Along the way, AMR gets a couple of specific mentions as does the Adaptive Pathway concept that provides some of the logic behind registering antibiotics with
Dear All: Just in case you missed the 30 March annoucement, see at right a snapshot of the first 11 Powered by CARB-X funded companies. Initial funding is $24m, with potentially a further $24m if the companies hit their milestones. With the funds provided by the companies themselves, the total potential investment is $75m. This is just the start:
Dear All: Just hitting my inbox today is this report from OHE. The paper reviews in detail the incentive proposals in the 2016 O’Neill Report on incentives from the UK AMR Review commissioned by UK government and the 2017 GUARD Report entitled “A Call for Concerted Action on Antibiotics Research and Development” commissioned by the German government. This well-written and detailed paper is a welcome
G20 Health Minister’s declaration / Calls for push, pull, avoiding price/volume mechanisms, and support of global partnerships!
Dear All: Adding to the continued forward momentum of calls for support of antibiotic R&D, this week’s meeting of the G20 Health Ministers has led to the attached declaration. After some very sound recitations of the importance of health communities and the importance of good infrastructure, we also have calls for R&D preparedness (Para 15), workforce building (Para 22),