Y2017

Preclinical pipeline overview / Help fund a movie about AMR!

Dear All: Two things today. First, Ursula Theuretzbacher, Miloje Savic, Christine Ardal, and Kevin Outterson have published in Nature Reviews Drug Discovery a brief but instructive snapshot of the global preclinical antibacterial pipeline. This report nicely complements the recent WHO analysis of the clinical pipeline that concluded that “the world is running out of antibiotics.” You’ll want to read the paper yourself (it’s

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EMA-FDA-PMDA action + Podcasts (CDD, Pew) + NEJM on non-inferiority

Dear All: Several updates today, all on the theme of good things to know or share! First, EMA, FDA, and PMDA are continuing to meet and have released a summary of their third tripartite meeting. The key message is alignment: alignment on trial designs for key indications, alignment on pediatric programs, and alignment on single global development programs! This is

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4-7 Sep 2018: ESCMID-ASM Conference #3 on AMR (initial flyer)

Dear All: Now available is the initial flyer for next year’s ESCMID-ASM Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This third meeting will be 4-7 Sep 2018 in Lisbon and will follow the prior (and excellent!) meetings #1 (Vienna, 2016) and #2 (Boston, 2017). Although you can’t register for it yet (and I’ll let you know as soon

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Summary of funding initiatives (Simpkin et al.) + E9(R1) Statistical methods update (FDA)

Dear All: Two updates today. First, our colleagues at London School of Economics have just published a review of antibiotic innovation incentives that includes a detailed review of some of the currently available sources of funding (Simpkin VL et al., Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps. J Antibiot, 1 Nov 2017). As

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Incentives for antibiotics: Recent papers, with an emphasis on Pull

Dear All:  For your weekend reading list, I have some papers on the topic of (mostly pull) incentives for antibiotics. First, I previously wrote about the survey from TATFAR (Transatlantic Task Force on Antimicrobial Resistance) of 6 possible pull models (higher reimbursement, diagnostic confirmation, market entry rewards both fully and partially delinked, tradable exclusivity vouchers, and an options market).

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CDC funds more than 20 AMR-focused projects!

​Dear All:  CDC has today announced $9m in funding for more than 20 new projects focused on slowing or combating antimicrobial resistance. Part of the CDC’s Antibiotic Resistance Solutions Initiative, these projects span a broad range that includes surveillance (C. auris, antibiotic resistance in a watershed, antibiotic resistance in poultry farms), diagnostics (POC tools, what’s in hospital sewage

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International AMR Action! 21 Sep Wellcome Trust-UNGA event / 12-13 Oct Call to Action (Berlin)

Dear All:  The international conversation continues apace following the recent DRIVE-AB meeting on antibiotic incentives. There are two further important meetings coming up that you may wish to know about. First, Wellcome Trust is co-hosting a side-event with the UN Foundation during the UN General Assembly on 21 Sep (yes, this week!). The side event is from 8a-10a in

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Updates from EMA, FDA, and UK NICE at the 6-8 Sep 2017 ASM-ESCMID Antibiotic Development Conference

Dear All: On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology assessment (HTA) landscape. The speakers (Marco Cavaleri, PhD, Head of Anti-Infectives and Vaccines, EMA; Sumati Nambiar, MD, Director, Division of Anti-infective Products, FDA; and Colm Leonard, MD, Consultant Clinical Adviser,

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