Y2020

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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CC4CARB solicitation is out (16 Mar 2020 deadline) / Superb WSJ podcast on antibiotic economics

Dear All, I wrote on 3 Jan 2020 (link) about the NIAID contract intended to establish an innovative Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB). The formal solicitation has now gone live and can be found here. The deadline for applications is 16 Mar 2020. Get to it! In parallel, there is a superb Wall Street Journal podcast dated 13 Jan 2020 about

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NIAID/DMID seeks contract proposals for AMR / 9 Apr 2020 deadline

Dear All, As part of a NIAID Omnibus Broad Agency Announcement (BAA) posted on 31 Dec 2019, NIAID’s Division of Microbiology and Infectious Diseases (DMID, link) has three research areas (RAs) soliciting contract proposals for preclinical and clinical development of vaccines, therapeutic, and diagnostics for microbial pathogens. The entire BAA can be found here. The three RAs

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Melinta goes bankrupt / Never let a good crisis go to waste

Dear All (long-ish, wonk-ish note alert … lots of details to absorb): This newsletter has a followup here. Sadly, Melinta Therapeutics, Inc. declared bankruptcy just before the end of 2019 (link). Formerly known as Rib-X (link), Melinta went public in 2017 through a reverse merger with Cempra (link); and via a series of deals had four

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NIAID to fund a Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB)

Dear All, Warm up your chemistry set! NIAID has just released a pre-solicitation notice of their intent to request applications for a new NIAID contract intended to establish an innovative Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB). NIAID anticipates awarding a single CC4CARB contract funding 28,000 direct labor hours per year for up to 5 years. The core

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FDA workshop: Revising the process for importance-ranking of human antimicrobials to guide their use in animals

Dear All, FDA have announced that they will hold a virtual public workshop on 16 Nov 2020 (9.30a-4.00p EST) entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” Go here for the FR notice, here for extended details, including registration, and here for

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Nature publishes superb 10-paper collection on all things AMR

Dear All,  Released on 21 Oct 2020, Nature has published an Outlook series on AMR. The papers are 2-4 pages long and provide an excellent survey of all things AMR from the perspective of R&D in support of new therapies and vaccines (diagnostics are not covered). See below the list of papers with brief comments

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FDA workshop: Insights on inhaled antifungals and antibacterials

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

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