Long and wonkish note alert — please refresh your coffee before you start reading! Dear All: I was able to attend and speak at the 12 July 2019 Public Meeting organized by FDA on the LPAD (Limited Population Antibacterial and Antifungal Drug) pathway. The current draft guidance is here and the meeting agenda is found here. The meeting
(15 Apr 2021 update: WHO have today released a 2020 update to the report discussed in this newsletter.) Dear All, WHO has today released two exhaustive reviews of the antibacterial R&D universe (and by way of full disclosure, let me say upfront that I participated in the clinical pipeline discussion). Based on a cut-off date
Dear All, First up for today, WHO’s GLASS (Global Antimicrobial Resistance and Use Surveillance System) have released an update to their ongoing work that provides global data through 2020. Here the links you need: The GLASS dashboard The GLASS report An insightful LinkedIn post on the way(s) that the data can now be used: you
Dear All, Based on a 2020 RFP, we’ve known that WHO was building a fungal priority pathogen list (PPL). Well, now the list has been released. Here’s what you need to understand the new PPL: Webpage where you can get the report My PowerPoint .pptx that summarizes all the PPLs to date My webpage that provides
Dear All: The new WHO priority pathogen list for R&D has been released! It’s entirely focused on bacteria both otherwise has a lot of similarity the CDC list. FYI, CARB-X will use both lists going forward. Links to WHO materials are below. I have also prepared a short slide deck (updated on 22 Dec 2017) that shows
Dear All, A quick note today to call your attention to an upcoming webinar that will be of wide interest. Substantial new details have been added to the online agenda materials for the 30 August 2022 (virtual, 8.30a-5.00p ET) webinar sponsored by CDC and FDA entitled “Drug Development Considerations for the Prevention of Healthcare-Associated Infections.” This is very
Dear All, We have a 3-part discussion today on the theme of “I want a new drug … so how do I find it?” Off we go! First, the 14 June 2022 newsletter entitled “Leaky Pipe(lines) / When Is A Molecule A Drug” generated further discussions that are worth sharing: It was noted the microdosing
Dear All (Wonkish alert! Get some coffee and settle in!), Almost in parallel, EMA and FDA have released updates to key antibacterial guidance documents! Here are the links you’ll need and I’ve highlighted the key documents. To go deeper, you’ll need to pick through everything and I provide a tour further below in this newsletter: EMA’s
Dear All: I have learned that the program for IDWeek 2022 will have specific dedicated pipeline sessions for therapeutics and diagnostics. The online details are relatively scant, but my understanding is that the therapeutics of interest for these sessions include antibacterials, antifungals, and non-HIV, non-COVID antiviral agents. There do not appear to be any constraints
Dear All, In a report entitled Understanding the Antibiotic Manufacturing Ecosystem: A view of global supply chains, pressure points, and implications for antimicrobial resistance response, the Boston Consulting Group and Wellcome Trust have examined at length the questions of (i) how the #FireExtinguishersOfMedicine are made and (ii) how they can be made with the least impact