R&D Insight

PASTEUR action; Wellcome convenes Global R&D discussion!

Dear All, Two items for your attention today: an immediate action for you to take to support PASTEUR plus a launch event for a major Wellcome Trust project for your calendar.  First, as you may recall, the Oversights & Investigations Subcommittee of the US House Energy & Commerce Committee recently held a hearing about the impact of AMR.

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Notable webinars: Pediatric drug development; Drug delivery systems

Dear All, The high-value webinars below have just crossed my radar.  First up, we have a very important 2-part webinar on pediatric antibacterial drug development entitled “Improving the Investigation of New Antibacterial Agents for Use in Children: Ensuring That Our Youngest Patients Also Benefit from Innovative Treatments of Infections Caused by Multi-Drug Resistant Bacteria.” Here are the

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LPAD/Limited Use insights; NI margins for TB and candidiasis

Dear All,  I want to call your attention to next week’s AMDAC (Antimicrobial Drugs Advisory Committee) for rezafungin. This meeting is Tue 24 Jan 2023, 9a-4.30p ET and the meeting materials are provided here.  Rezafungin is an antifungal but please don’t let that dissuade you from attending: this AMDAC promises to be an important discussion

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Public meeting on the LPAD Pathway: Post-meeting thoughts (wonkish)

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 The current draft guidance is here and the meeting agenda is found here.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

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WHO 2019 Review of the Preclinical and Clinical Antibacterial Pipeline

(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

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2022 GLASS report / JPIAMR survey on 2025-2032 funding plan

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

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WHO releases its Fungal Priority Pathogen List (PPL)!

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

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WHO 2017 Priority Pathogens List

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

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CDC-FDA webinar: Developing drugs to prevent healthcare-associated infections (30 Aug 2022)

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

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