R&D Insight

FDA-NIAID-CDC: Developing drugs for gonorrhea, 23 Apr 21 workshop

Dear All, FDA, NIAID and CDC have announced a public workshop on development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will cover both nonclinical (preclinical) and clinical trial design considerations: Animal models Clinical pharmacology considerations Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.

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Developing antibiotics for children: There are no easy answers

Aside: If you’ve enjoyed the prior discussions of movies to inspire antibiotic R&D and very apropos given the theme of today’s newsletter, please check out the newly released 4-minute YouTube discussion of a scene from Master and Commander in which antibiotics could have saved a young man’s arm! Dear All (Wonkish alert! There’s a lot of

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Amended Indian PPL slide / SUPERBUGS Act / Novo REPAIR Global Call

Dear All, Three bits of news you can use… First, when I wrote yesterday about the new Indian Priority Pathogen List (PPL), I said that it was similar to the WHO PPL list except for the addition of Staphylococcus epidermidis (and speculated that this relates to the role of S. epidermidis in neonatal sepsis). Well, it

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Pew infographic: Antibiotic R&D needs economic incentives

Dear All, I hope you have been enjoying the excellent new pipeline analysis from Pew Trusts (10 Mar 2021 newsletter) and in particular their clever animated graphic showing pipeline evolution from 2014 to 2020. To build on this, Pew Trusts have now posted a webpage entitled “Antibiotic Development Needs Economic Incentives” that features a pair of

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Where’s the innovation? / Indian Priority Pathogen List / DTR video explainer

Dear All, Three things briefly this evening: First, the observation about the limited degree of innovation across products in Phases 1-3 in the recent newsletter about the Pew Pipeline review (only 1 in 4 are novel classes or novel mechanisms; none are potentially active against Gram-negative ESKAPE pathogens or WHO critical threat pathogens) generated queries along

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Updated global antibacterial pipeline review from Pew Trusts

Dear All, Pew Charitable Trusts have released an excellent update to their long-running series of pipeline reviews. Here are the links you need: (link) Pipeline of traditional products (classical small molecules) (link) Pipeline of non-traditional products (vaccines, immunotherapies, and other out-of-the-box ideas) (link) An infographic that you can use for sharing the key points (link)

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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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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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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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