Dear All, No, EMA has not decided to set up shop on the beach! Rather, the point of this newsletter is that I heard a fascinating talk on the idea of “regulatory sandboxes” during the recent BEAM-AMR meeting. I had not previously heard of this idea, but it turns out that the concept of regulatory sandbox
Dear All, A very senior and globally significant leadership opportunity has appeared: CARB-X is seeking to recruit a new Chief of Research & Development! Given CARB-X’s role as the world’s leading public-private partnership accelerating the early-stage development of innovative products to treat, prevent, and diagnose life-threatening bacterial infections, and its current investment levels (approx. USD 100 million a
Dear All (a wonkish guide to something you may have thought was obvious AND with thanks to Aaron Dane for co-authoring this newsletter), In a position paper recently released in the New England Journal of Medicine, we have notice of a shift in FDA policy from a default expectation of two pivotal trials to a
Dear All (and with thanks to Robert Skov for co-authoring this newsletter AND with a wonkish alert for this complicated topic for which a compelling narrative is only now starting to unfold … so, get your coffee and be ready to follow the links as you read on!), While we often talk in this newsletter about
Dear All, I’m delighted to be able to say that PASTEUR 2026 was (re)introduced into the US Congress this week! It’s an improved version relative to the version introduced into the prior 3 sessions of the US Congress (see below for discussion of that), so I think we can safely call it “PASTEUR v2.0” as
Dear All, In a thoughtful companion to WHO’s preclinical and clinical pipeline reviews, we now have an instructive analysis of the global funding pipeline for 2017-2023! Here are the links you need: The new paper and its primary data source: Paper: Czaplewski L, Lamichhane U, Sudbrak R, Hennessy A, Ogilvie LA, and Piddock LJV. An
Dear All, I just today learned that FDA has posted two antimicrobial resistance-related (AMR-related) FY 2026 funding opportunities. The titles for the RFPs are very good descriptions of each and I’ve added a few details from the RFPs: Request for Proposals to Facilitate Development of Susceptibility Test Interpretive Criteria (STIC or Breakpoints) for Candida auris
Dear All (wonkish … but worth it … get ready to follow the links!), Greetings in the new year! As a marvelous way to end the last year, the US FDA announced on 12 Dec 2025 its approval of two new oral therapies for gonorrhea, thus addressing the priority pathogen lists of both WHO (High
Dear All, Happy New Year! As a great start for January, Team CARB-X have announced (i) that they will have two funding calls during 2026 (April and then Q4) and (ii) that a theme focused on finding new chemical scaffolds will be part of both calls. Applications to these target-based therapeutics funding calls will require defined chemistry
Dear All, Regular readers will be aware of the global conversation now happening around the threat arising from the potential to create viable organisms that are (at a molecular level) the mirror images of existing organisms. If this is new to you (or, if you’d like a refresh), here are the links you need: 18