Dear All, First up today is a very interesting new workshop from FDA on 1-2 Sep entitled “Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.” In brief: “The Complex Innovative Trial Design Pilot Meeting Program (CID Program) facilitates and advances the use of complex and innovative trial designs that have the potential
Dear All, Deadline: 15 August 2021: The World Health Organization (WHO) is seeking experts to serve as members of the Advisory Group on the Bacterial Priority Pathogen List (AG BPPL). A “Call for experts” document provides information about the advisory group and the expert profiles being sought for the group. The document also provides information on
Dear All, This webinar merits a standalone newsletter! If you are thinking (or working on) phage, then please mark your calendar for an FDA (CBER; Center for Biologics Evaluation and Research) workshop entitled: Science and Regulation of Bacteriophage Therapy: August 30, 2021—September 1, 2021 The purpose of the public workshop is to exchange information with the
Dear All, A view from Cambodia: “If we lose this antibiotic, there is no oral treatment left for typhoid here.” Good data drives good policy … it’s a lesson that I’ve really grown to appreciate. With this in mind, Wellcome Trust has just released a report entitled “How drug-resistant infections are undermining modern medicine –
Dear All, Two brief items today: First, a survey on OneHealth research priorities from WHO/FAO/OIE: “The Tripartite collaboration between World Health Organization (WHO), Food and Agricultural Organization of the United Nations (FAO), and World Organization for Animal Health (OIE)) is joining efforts to develop a One Health priority research agenda on antimicrobial resistance (AMR). “This
Dear All, Today we have two interwoven topics to consider: An analysis of research priorities (not all technical!) and a triad of related initiatives, each of which comes with an opportunity for you to starting working on some of those priorities! First up, we have an excellent new paper summarizing the perspective of 32 experts
Dear All (and with thanks to Arjon van Hengel for co-authoring), As was discussed in newsletters dated 28 Nov 2020 (a general announcement) and 29 Apr 2021 (comments by Stella Kyriakides), the EU has announced an ambitious Pharmaceutical Strategy with initiatives that includes development of Pull incentives for antimicrobials among a number of other topics (see the 28
Dear All, Building on the success of the 21st Century Cures Act passed in 2016 and springboarding from a concept paper published in Science, U.S. Reps. Diana DeGette, D-Colorado, and Fred Upton, R-Michigan, have today introduced the 21st Century Cures Act v2.0! Here are the links you need: Discussion draft of the Cures 2.0 bill Cures 2.0
Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Woot, woot! Woot, woot! US Senators Michael Bennet (D-Colo.) and Todd Young (R-Ind.) and Representatives Mike Doyle (D-Pa.) and Drew Ferguson (R-Ga.) have today reintroduced the PASTEUR (Pioneering Antimicrobial Subscriptions to End Up surging Resistance) Act! Here are the links you need: The text of
Dear All, On the theme of global health security, today’s note covers 3 exciting, overlapping items. Here we go… First, the G7 leaders have agreed to sign the Carbis Bay Declaration covering global health, economic stability, climate and more. Specifically related to health in a section entitled “End the pandemic and prepare for the future”, we have