Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The
Dear All (with thanks to Kevin Outterson for co-authoring this newsletter), Last week’s announcement of the AMR Action Fund was both exciting and sobering: $1b from 20+ pharma companies to fund antibacterials through Phase II-III to approval, with a goal 2-4 high quality new agents by 2030. If you missed it, please go here to
This newsletter is part of a series — here are the links to Part 1, (this one is Part 2), Part 3, Part 4, and Part 5. Also relevant is the 5 April 2024 newsletter entitled “48,015 → 0: Antibacterial Discovery Is Hard. Really, Really Hard.“ Dear All (wonkish note alert!), The recent newsletter on chemicals, drugs, and halicin (link, see
Dear All (and with thanks to Kevin for co-authoring), The UK NHS England Pilot is known to us all as the first real attempt at an antibiotic subscription model and now it will be undergoing a major overhaul. In case you are a new reader or would like a refresher on the pilot, here are the links
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 The current draft guidance is here and the meeting agenda is found here.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
Dear All (wonkish alert … get your coffee!), EFPIA have recently released a report estimating the value of a Transferable Exclusivity Extension (TEE, report, press release) that provides new generalized insights into ways to think about the value of new antibiotics and the appropriate size of the Pull rewards needed to bring that new antibiotic
Dear All (wonkish alert … coffee up!), FDA held a workshop on 25 Sep 2020 on development of inhaled antifungal (AF) therapies with a focus on (i) therapies for allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitization (SAFS), (ii) prophylaxis in lung transplantation, and (iii) adjunct therapy in invasive fungal lung infections (link to
Dear All (wonkish alert, but the details are fascinating … and with thanks to Kevin Outterson for co-authoring!), Two related items of note for today. First, the PASTEUR Act was introduced today (press release from Rep. Doyle; press release from Rep. Ferguson) into the US House of Representatives by the bipartisan team of U.S. Representatives
Dear All (Wonkish alert! Coffee-up!), Today we have something special: A deep-dive into the future trajectory of AMR-related work developed by Wellcome Trust. The newly released report is here and there is a webinar discussing the report on Wednesday of this week (1500-16:00 GMT on 18 Nov 2020, go here to register). The back story
Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the ideas here are VERY confusing, I suggest you make the time to watch the video, read the newsletter, and then watch the video one more time. I have yet to