R&D Insight

Brilliant 5-minute video explainer of the AMR problem!

 Dear All, Andrew Jack of the Financial Times (FT) has produced a superb 5-minute video explainer of the AMR challenge! Featuring cameos from Kevin Outterson (CARB-X), Christine Ardal (Norwegian Institute of Public Health), and Manica Balasegaram (GARDP), the video deftly illustrates the economic challenge, the way that delinked Netflix-like models provide a solution, and the

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AMR Action Fund ($1b for P2-3): Video chat with new CEO! New committed funds!

Dear All, I’ve written before about the AMR Action Fund (9 Jul 2020 newsletter): In brief, it is ~$1b pledged by over 20 leading pharmaceutical companies to support the Phase 2-3 studies needed to bring 2-4 new antibiotics to approval by 2030 Stated differently, the AMR Action Fund provides Push incentives for Phase 2-3 to complement the Push Incentives

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JPIAMR call: 25m Euro for interventions to reduce/prevent AMR

Dear All, JPIAMR is today launching an international call entitled “One Health interventions to prevent or reduce the development and transmission of AMR.” The call, with financial support from the European Commission, includes 30 funding organisations from 21 JPIAMR member countries and has a total estimated call budget of 24.9 million Euro. Here’s the description of

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FDA offers 2 fellowships and 3 RFPs! Endpoints, breakpoints, PROs & more!

Dear All, Our colleagues at FDA are planning some serious AMR-related research during 2021-22 with the following fellowships and RFPs. Extended details are available via the links — you can also find brief summaries below my signature or via FDA’s research webpage. Wow! FDA Fellowship #1: A study of ordinal endpoints for antibiotic trials using

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Sunday 10 Jan: UCSF-Stanford regulatory conference with FDA

Dear All, New on the meetings calendar today is the 10 Jan 2021 UCSF-Stanford Innovations in Regulatory Science Summit. Per the meeting website: “It is a gathering of leaders in the academia, industry and regulatory sectors to discuss the role of regulatory science in medical product development.   “The 2021 Summit will have a major focus on

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Jan-Feb meetings; CDC releases Healthcare Epidemiology RFP

Dear All: Happy New Year! I hope everyone was able to take a least a brief break over the holidays. Two things for today. First, there are two meetings in January and one in February that have just popped onto my radar. See the meetings calendar for a pair of Keystone Symposia on the microbiome,

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UK Pilot Antibiotic Subscription Model: Two candidate antibiotics chosen!

Dear All, Breaking news! Prior newsletters (initial and follow-up) have discussed the UK’s innovative antibiotic subscription pilot (aka, “Netflix for antibiotics”). In brief, the UK intends to identify two innovative antibiotics suitable for being purchased via a delinked model in which the payment to the innovator is a fixed annual fee rather than a per-use

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CDC call for AMR-related proposals: 13 Jan 2021 deadline for white papers

Dear All, Just out is a Broad Agency Announcement (BAA 75D301-21-R-71738) from CDC with a 13 Jan 2021 deadline for white papers. The webpage for the BAA is here and you’ll need to look at the .pdf of the solicitation to understand all the possibilities. The AMR-related research areas include calls for proposals that would: Improve identification of bacteria

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EMA Network Strategy to 2025: Action on AMR / Comments due 4 Sep

Dear All, We learned today during the BEAM AMR conference (link) that EMA released a call on 7 June 202 for comments on their draft Network Strategy to 2025 that considers how “the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges

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WAAW: Impact investing, podcasts, reports, and logos!

Dear All, Today we have a bit of a potpourri for WAAW (World Antibiotic Awareness Week). Lots of good stuff… In the new meetings category, we have two meetings for investors seeking social impact: 23 Nov 2020 (online, 6-7p CET): Webinar sponsored by Access to Medicine Foundation (ATM) entitled “The Materiality of Superbugs: Investor Action

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