Dear All, On Friday, 20 Dec 2020, legislation was signed to fund the US government through Sep 2020. Relevant to AMR: The bill provides a $50 million increase in funding to NIAID for antimicrobial resistance. NIAID will also have to report to Congress on the success rate for these particular grants. The bill provides funding for
Dear All, Two important new research calls are now out. First, FDA is offering research funding of up to $1m to support creation of rabbit models of ventilator-associated bacterial pneumonia (VAP or VABP, depending on your preferred abbreviation) due to carbapenem-resistant strains of A. baumannii and P. aeruginosa. The call for proposals is via FDA Broad Agency Announcement (FDABAA-20-00123N, link), an ongoing
Dear All, As part of a NIAID Omnibus Broad Agency Announcement (BAA) posted on 31 Dec 2019, NIAID’s Division of Microbiology and Infectious Diseases (DMID, link) has three research areas (RAs) soliciting contract proposals for preclinical and clinical development of vaccines, therapeutic, and diagnostics for microbial pathogens. The entire BAA can be found here. The three RAs
Dear All, I realized after sending the note about Melinta’s bankruptcy that I’d failed to be clear on what comes next for the company. (If you missed it, you can go here for a copy of that prior note.) In brief, a 27 Dec 2019 press release (link) states that the bankruptcy filing exchanges $140 million of secured claims
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: Verbatim comments from interviews with 12,000 people in Germany, India, Japan, Kenya, the UK, the USA and Thailand: India: “[Antimicrobial resistance] is quite normal, no big thing, like malaria. It’s on a personal level, if you take antibiotics, your resistance will be on [the] lower side. If you are fit, your body resistance is more.” Germany: “Air pollution
Dear All: I had the opportunity today to share an updated version of my “Funding, Filing, and Finance” talk with the attendees of Superbugs & Superdrugs in London. Topics covered were: Funding: What are the global initiatives? Where can you find information on how you could apply? Filing: What are the must-read background documents for developers? What
Please be sure to look closely at the events calendar: Q&A with Scott Gottlieb, Lipinski on Lipinski, and more! Dear All: FDA’s 21-22 Aug 2018 workshop on the development of non-traditional antibacterial agents was an excellent discussion of core challenges in this area. The agenda plus all the meeting materials (including the public comment slides and
Dear All: ISHAM 2018, the meeting of the International Society for Human and Animal Mycology, is now happening in Amsterdam. I was given an opportunity to talk today on antifungal R&D and I thought I would share the slides with the broader community. It was really interesting to think about the parallels between antibacterials and
Dear All: Given our collective interest in finding oral antibiotics, a recent article in J Med Chem on the evolution of our understanding of Lipinski’s Rule of 5 (Ro5) prompts me today to share it along with a recent webinar and links to both Lipinski’s original paper as well as his 2016 commentary: The original