R&D Insight Archives • Page 2 of 37 • AMR.Solutions

Two things: WHO’s looking GLASS + FDA’s advances with PDUFA VI

Dear All: Two things today. Unrelated, but both relevant! WHO’s GLASS: WHO’s Global Antimicrobial Resistance Surveillance System (GLASS) was created during October 2015 and seeks to obtain coordinated and consistent global estimates on resistance rates. In a major report released on 29 Jan 2018, GLASS now provides provides official national AMR data for the period 2016-17 from 40 countries

6 February 2018 No Comments

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

22 March 2021 No Comments

WHO: Draft TPPs for MDR bacterial infections

Dear All, Back in 2019-2020, WHO developed a set of TPPs (TPP = Target Product Profile = A description of the desired attributes of a drug) for products for enteric fever, gonorrhea, neonatal sepsis, and urinary tract infections as guides for developers (see the 1 Sep 2019 newsletter for the original call for input and the link

13 August 2025 No Comments

WHO wants your input on its draft TPPs for needed antibacterial agents

Dear All, Addendum: This project ultimately led to publishing in May 2020 of a set of TPPs for enteric fever, gonorrhea, neonatal sepsis, and urinary tract infections as guides for developers. You can find those TPPs at https://www.who.int/publications/i/item/9789240003897. WHO has developed a set of draft TPPs (target product profiles) for needed new antibiotics. As part of the

1 September 2019 No Comments

WHO Collaborating Centres for AMR: A rapidly growing group!

Dear All, I recently learned about the designation of Stanford as a WHO Collaborating Centre (WHOCC) for AMR and Stewardship. This caused me to dig a bit more into the way that WHO has created a global network of Collaborating Centres. WHOCC designation represents a sustained and productive collaboration with WHO (link). As an example, Stanford’s

9 December 2019 No Comments

18-19 Nov 2019 FDA-IDSA-NIH-Pew Workshop: Enhancing Antibacterial Trials in the US

Dear All, Long note alert: Set aside at least 30 minutes for this one … there’s a lot of important material here. Last week’s workshop entitled “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States” was an unusual and unusually instructive meeting. You can go here for the meeting materials but as there are

27 November 2019 No Comments

BARDA RFP: Antibiotic for HABP/VABP or Bloodstream Infection

Dear All, BARDA have published an RFP (Request for Proposals) under which it would support clinical development and then stockpiling of an antibiotic for “treatment of bacterial pneumonia or bloodstream infections.” Here are the data you need to get started: RFP #: 75A50125R00005 https://sam.gov/opp/494fc05d7c4940abad0273cdb465079a/view Submission deadline is 26 Aug 2025 Quoting liberally from the online

22 July 2025 No Comments

Vaccination to prevent AMR: Insights from Wellcome

Dear All (and with thanks to Vega Masignani for co-authoring this newsletter), Waaaay back in 2019 (pre-COVID … remember that?), Wellcome put out a call for grants focused on understanding the value of vaccines in combatting AMR (4 June 2019 newsletter entitled “Why vaccines for AMR? What is their value? Grant opportunity for research on

21 July 2025 No Comments

Updated FDA Q&A on Antibacterials for Unmet Medical Need

Dear All, An updated version of FDA’s very helpful Q&A entitled “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers” has just been released. Here are the links you need to get started: The new June 2025 guidance itself The webpage about the guidance

8 July 2025 No Comments

Jan 2025 PACCARB meeting cancelled as new administration takes the reins

Dear All, Sadly, I must report that the 27th meeting of PACCARB (the US Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria) planned for 28-29 Jan 2025 has been cancelled “as the new Administration considers its plan for managing federal policy and public communications.” This 22 Jan 2025 article in the New York Times provides additional details

23 January 2025 No Comments

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