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
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
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
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
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
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
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
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
Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the ideas here are VERY confusing, I suggest you make the time to watch the video, read the newsletter, and then watch the video one more time. I have yet to
Dear All (Wonkish alert! Get some coffee and settle in!), Almost in parallel, EMA and FDA have released updates to key antibacterial guidance documents! Here are the links you’ll need and I’ve highlighted the key documents. To go deeper, you’ll need to pick through everything and I provide a tour further below in this newsletter: EMA’s