R&D Insight

Beyond Pull: Maximizing availability + (appropriate!) use / Help needed!

Dear All, Today we have two interwoven topics to consider: An analysis of research priorities (not all technical!) and a triad of related initiatives, each of which comes with an opportunity for you to starting working on some of those priorities! First up, we have an excellent new paper summarizing the perspective of 32 experts

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Stewardship & Access Guide from CARB-X, Wellcome, and partners: Analysis, video chat

Dear All, Novel antibacterial agents, vaccines, and diagnostics will do little if they are not widely available and used responsibly. CDDEP’s recent report entitled “The State of the World’s Antibiotics in 2021” makes this very clear: “… more people in LMICs (low-middle-income countries) die from lack of access to antimicrobials than from resistant infection.” Hence, CARB-X has

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Pull incentives in the EU / Statements by Commissioner Kyriakides

Dear All (and note the related 28 Nov 2020 newsletter), Stella Kyriakides, the European Commissioner for Health and Food Safety, made some really interesting statements before the European Parliament’s health committee (ENVI) on Thursday of last week (22 April). Per this Exchange of Views on the EP’s multimedia center and this news report, here are some

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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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Lessons in Discovery from Lynn Silver + Pro-con on alternatives to antibiotics

Dear All: “Good decisions come from experience, and experience comes from bad decisions … and paying attention.” You’ve probably heard the first part of that before, but the “… and paying attention” is my addition and reflection upon reading Lynn Silver’s most recent commentary in the Springer Series Topics in Medicinal Chemistry, edited by Jed Fisher, Marvin

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Final FDA Unmet Need Guidance!

Dear All:  Just out in the last 24h is the announcement that FDA’s 2013 Unmet Need Guidance has now been released in final form. The associated FR guidance is also worth reading as it provides a summary of what has been updated: “This guidance finalizes the draft guidance of the same name issued July 2, 2013 (78 FR

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Using Real-World Evidence: FDA Workshop on 13 Sep 2017

Dear All:  There is a newly announced FDA workshop on 13 Sep on using real-world evidence. Here is the link and I’ve also reproduced the key background text below my signature. This is of interest to the antibacterial community as our reliance on non-inferiority trials for the majority of our data means that we are often going to want

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