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Debut of FDA Susceptibility Test Interpretive Criteria (STIC) website

Dear All: I knew that the idea of an online and frequently updated website for FDA-recognized Susceptibility Test Interpretive Criteria (STIC) was brewing based on the 21st Century Cures Act … and now it has happened! Check this out: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm There is also a short URL link that remaps to the longer URL just above: https://www.fda.gov/STIC

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13 December 2017 No Comments

(Another!) FDA trial design workshop: Complex innovative designs

Dear All: Adding to the 19 Mar 2018 (Designs for Rare Diseases) and 16 Apr 2018 (Inclusion/Exclusion criteria) workshops already announced (see list below), FDA has now announced a 20 Mar 2018 workshop on complex innovative designs (CID) in clinical drug trials. From the Federal Register notice, we are told that the workshop seeks to (1) facilitate

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24 February 2018 No Comments

Duke-Margolis & FDA: Workshop on stats & methods for rare diseases

Dear All: Duke-Margolis and FDA have now announced a 19 Mar 2018 workshop entitled Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Drug Development (FR notice). Here’s the teaser from the web: “Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will

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14 February 2018 No Comments

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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8 September 2017 No Comments

Novo’s $165m REPAIR fund seeks to support projects from LO to Phase 1

Dear All: Just announced today (press release, website), Novo Holdings has created a $165m impact fund that seeks to support novel therapies from Lead Optimization (LO) through Phase 1. The fund specifically targets “first-in-class therapies, covering small molecules, biologics, and new modalities.” Similar to the focus of CARB-X, REPAIR (Replenishing and Enabling the Pipeline for Anti-Infective Resistance) will focus on priority pathogens from the

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28 February 2018 No Comments

Looking forward: The global pre-clinical antibacterial pipeline / How will we care for these precious jewels?

​Dear All, Long note alert! There are two deep and deeply connected topics to share today. Refresh your coffee and settle in… Today’s first topic: Adding to the recent reviews of the clinical stage pipeline for both traditional products (link to the Sep 2019 Pew Charitable Trusts summary), and non-traditional products (link to an Aug 2019 newsletter summarizing

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24 November 2019 No Comments

An apple a day (used to) keep the doctor away

Dear All: OK … enough with bad news, at least for today. In today’s edition of XKCD (link), we learn about resistance to apples and the need to use good apple stewardship. Image reproduced with permission from https://xkcd.com/2161/ If you don’t read XKCD, you should! All best wishes, –jr John H. Rex, MD | Chief Medical

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11 June 2019 No Comments

AMR stays on the G20’s to-do list with calls for Push and Pull mechanisms

Aside: Please look closely at the forward calendar. In addition to two new webinars from GARDP’s REVIVE project, there is a meeting in Thailand in December that focuses on alternatives to antibiotics. I’m told that the program is primarily focused on veterinary and agricultural uses, but previous year’s attendees have found the discussion to have broad application

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5 July 2019 No Comments

Commissioner Gottleib (New FDA initiatives, need for Pull incentives) + updated Pew pipeline analyses

Dear All: It was a HUGE day at the Pew Charitable Trusts today! First, Commissioner Scott Gottleib gave a superb and very exciting speech. You can either read or listen to the entire speech. There is also a panel discussion after his talk that is worth replaying. Here are some highlights from Commissioner Gottleib’s talk: FDA is working to coordinate

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14 September 2018 No Comments
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