R&D Insight

Weekend reading: HABP-VABP study design; Overview of AMR initiatives

Dear All: Two papers (one with an editorial) that are worth your time. First, we have publication of the long-awaited FNIH (Foundations for the NIH) paper on trial designs for studies of HABP-VABP (Hospital-Associated Bacterial Pneumonia and Ventilator-Associated Pneumonia). The paper also comes with an editorial: Talbot, G. H., A. Das, S. Cush, A. Dane, M.

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Ouch! Pfizer terminates S. aureus vaccine trial due futility (Part 3 of 3)

Addendum: This is the third in a 3-newsletters series on this topic. I need to do a specific newsletter on the challenges of vaccines but for now this is the place where I am accumulating relevant papers. Go here and here for the prior newsletters.  5 Feb 2023 addendum: A GSK Staphylococcus aureus vaccine candidate (GSK3878858A) was reported

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Initiatives for addressing AMR in the environment: Reports from a joint WT, CDC, and UK-SIN project

Dear All: The United Kingdom Science and Innovation Network (UK-SIN), the United States Centers for Disease Control and Prevention (US-CDC), and the Wellcome Trust (WT) have recently released a white paper highlighting the potential for the environment (e.g., soil and water) to be a source of antimicrobial-resistant microbes that can affect human health: Executive Summary: Initiatives

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Lord O’Neill’s 10 steps to control AMR, two years on / G20 calls for action

Dear All: About two years ago, Lord Jim O’Neill led the UK AMR review to its 7th and final report and proposed these 10 steps as the fundamental basis for controlling AMR: A massive global public awareness campaign Improve hygiene and prevent the spread of infection Reduce unnecessary use of antimicrobials in agriculture and their dissemination into the environment Improve global surveillance of drug resistance and antimicrobial consumption in humans and animals

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Three $10k prizes for initiatives that improve access / create demand for diagnostics in LMICs

Dear All: Following the precept (often attributed to Osler, but I can’t find it in his Principles and Practice 1892) that the 3 core elements of treatment are “diagnosis, diagnosis, and diagnosis,” FIND (Foundation for Innovative New Diagnostics) is an international non-profit organization that enables the development and delivery of diagnostic tests for poverty-related diseases, including TB, malaria,

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PACCARB wants to hear from you! Deadline, 7 Jan 2019

Dear All: The US Presidential Advisory Council on Combating Antimicrobial Resistant Bacteria (PACCARB) has released a request for information (RFI) in which it seeks comments on priority actions for the future. Here is the link to the Federal Register notice: https://www.federalregister.gov/documents/2018/11/23/2018-25435/notice-of-request-for-information-a-notice-by-the-presidential-advisory-council-on-combating In brief, PACCARB has pursued these 5 goals from the first US National Action

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Public opinion poll (US): 70%+ agree need for government intervention addressing AMR, including support for AMR R&D

Dear All: IDSA and Research!America have worked together to conduct a broadly representative opinion poll in the United States regarding AMR. The project was supported by Pfizer and surveyed 1,004 adults in the US during October 2018. Key results: Less encouraging but probably an improvement from the past, 1/3rd of respondents thought antibiotics were effective

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33,100 deaths in EU/EEA during 2015 attributable to resistant bacteria

Dear All: Cassini et al. have just published a truly scary paper. Here’s the bulk of the abstract … I can’t improve on it. Methods: We estimated the incidence of infections with 16 antibiotic resistance–bacterium combinations from European Antimicrobial Resistance Surveillance Network (EARS-Net) 2015 data that was country-corrected for population coverage. We multiplied the number of bloodstream

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FDA-approved surrogate endpoints for developers

Dear All: As requested by Congress as part of the 21st Century Cures Act, the US FDA has now released for public comment a table of surrogate endpoints that can be considered for use by developers: The public docket soliciting comments is here. The web page providing an overview of surrogate endpoints and biomarkers is here. The surrogate

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