R&D Insight

Updating WHO’s Bacterial Priority Pathogen List: Call for advisors

Dear All, Deadline: 15 August 2021: The World Health Organization (WHO) is seeking experts to serve as members of the Advisory Group on the Bacterial Priority Pathogen List (AG BPPL). A “Call for experts” document provides information about the advisory group and the expert profiles being sought for the group. The document also provides information on

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UK Antibiotic Subscription Pilot: Updates from a webinar

Dear All (and with thanks to Kevin Outterson for co-authoring), We’ve written and talked before from various perspectives about the groundbreaking UK NHS England-, NHS Improvement-, and NICE-sponsored antibiotic subscription pilot project: 10 Feb 2021: Fabulous 5-minute video explainer on the economics of antibiotics by Andrew Jack of Financial Times Superb discussions of Push/Pull, the role

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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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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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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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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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