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
Dear All, Three things briefly this evening: First, the observation about the limited degree of innovation across products in Phases 1-3 in the recent newsletter about the Pew Pipeline review (only 1 in 4 are novel classes or novel mechanisms; none are potentially active against Gram-negative ESKAPE pathogens or WHO critical threat pathogens) generated queries along
Dear All, FDA, NIAID and CDC have announced a public workshop on development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will cover both nonclinical (preclinical) and clinical trial design considerations: Animal models Clinical pharmacology considerations Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.
Dear All, I hope you have been enjoying the excellent new pipeline analysis from Pew Trusts (10 Mar 2021 newsletter) and in particular their clever animated graphic showing pipeline evolution from 2014 to 2020. To build on this, Pew Trusts have now posted a webpage entitled “Antibiotic Development Needs Economic Incentives” that features a pair of
Dear All, Pew Charitable Trusts have released an excellent update to their long-running series of pipeline reviews. Here are the links you need: (link) Pipeline of traditional products (classical small molecules) (link) Pipeline of non-traditional products (vaccines, immunotherapies, and other out-of-the-box ideas) (link) An infographic that you can use for sharing the key points (link)
26 Aug 2020 update: The committe has been named and some additional project commentary posted. Go here for details. — Dear All, Following on from the AMR-related funding in the legislation that funded the US government through Sep 2020 (link), the National Academies of Sciences, Engineering, and Medicine (NASEM) is now seeking nominations for an
Dear All, As has been discussed in recent newsletters (link), the UK National Institute for Health and Care Excellence (NICE) and NHS England launched a joint project July 2019 to test a payment model for antibiotic products, based on a product’s value to the NHS, rather than how much is used. This goal of the
Dear All, The June issue of ACS Infectious Diseases (link) is entirely devoted to the perspectives on how we can restore and maintain the antibiotic ecosystem. Check it out … we have perspectives from major groups driving policy, groups doing active R&D, and the major funders. Here’s the table of contents, re-organized slightly to group
Dear All (and with thanks to Damiano for taking the lead on this newsletter): In advance of Italy assuming the G7 Presidency for 2024, The European House – Ambrosetti (an Italian think tank and management consulting firm) published a new report on 15 November 2023 entitled “Value and sustainability of antibiotics as essential tools for the healthcare
Note: Be sure to take advantage of the BARDA Industry Day(s) event that occurs Monday-Tuesday of this coming week … see newsletter and forward calendar for details. Dear All, In what could be called Part 2 of Excellent 2023 ASM/ESCMID Talks (read the newsletter on Jen Cohen’s talk on how manufacturing underpins both access and