R&D Insight

Language matters: CRE vs. CPE; SDD vs. I; and MDR, XDR, PDR, UDR vs. DTR

Note: See also these related newsletters: 13 Jan 2019 (link) on DTR as part of the language of resistance and 7 June 2020 (link) on using DTR to estimate antibiotic value. Dear All (wonk-ish note alert!), Three technical points for your consideration today. All focus on the subtleties of language, something I always find fascinating

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FDA workshop: Animal models to support antibacterial development (5 Mar 2020)

Dear All (moderately long note alert; be sure to note the new list of funding opportunities just below my signature), FDA have announced a public workshop on 5 Mar 2020 to discuss progress and challenges in the development and advancement of various animal models for serious infection. The Federal Register notice is here and registration is here.

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New economic models for antibiotics: Are we there yet? No, but we ARE on the road

Dear All, The Duke-Margolis team hosted an excellent full-day workshop on 16 Jan 2020. Entitled “Exploring Opportunities to Reform Antimicrobial Payment and Post-Market Incentives” and chaired by Mark McClellan, the workshop’s outstanding cast of presenters and discussants provided a thorough discussion of both the need for new payment models and and the many ongoing activities focused

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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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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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12 July 2019 FDA public meeting for comments on the 2018 LPAD guidance

Dear All: Apologies for the back-to-back emails, but this one just came across the transom. In brief, FDA will hold a public meeting on Friday 12 Jul 2019 (9a-3p EDT, FDA White Oak Campus) at which FDA is soliciting public comment on the 2018 LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) guidance. You can register

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