IDSA’s 10×20 could be 20×20 and yet not enough! / Harvard course on FDA and prescription drugs

Dear All: Two things on a Friday:

First, I just learned of IDSA’s release of its latest paper (link) in the Bad Bugs/No Drugs and 10×20 series. Officially entitled “The Infectious Diseases Society of America’s 10 × ’20 Initiative (Ten New Systemic Antibacterial Agents FDA-approved by 2020): Is 20 × ’20 a Possibility?”, I think a better title might be “20×20 might not be enough!”. The abstract says it all:

  • Results: Since our 2013 pipeline status report, the number of new antibiotics annually approved for marketing in the US has reversed its previous decline, likely influenced by new financial incentives and increased regulatory flexibility. Although our survey demonstrates progress in development of new antibacterial drugs that target infections caused by resistant bacterial pathogens, the majority of recently approved agents have been modifications of existing chemical classes of antibiotics, rather than new chemical classes. Furthermore, larger pharmaceutical companies continue to abandon the field, and smaller companies face financial difficulties as a consequence.
  • Conclusions: Unfortunately, if 20 x ’20 is achieved due to efforts embarked upon in decades past, it could mark the apex of antibiotic drug development for years to come. Without increased regulatory, governmental, industry, and scientific support and collaboration, durable solutions to the clinical, regulatory and economic problems posed by bacterial multidrug resistance will not be found.

And on a separate but related note, Harvard is offering an interesting online course: “The FDA and Prescription Drugs: Current Controversies in Context.” The course theme is to help you understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing, and testing. If you’ve wanted to learn more about pharmaceutical regulation in general, this looks like a great place to start! The course itself is free, and a certificate of completion is available for $99. The course starts next week on 26 March.

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://13.43.35.2/blog/

Upcoming meetings of interest to the AMR community:

  • [NEW] 26 Mar 2019 (everywhere): First day of Harvard-sponsored course entitled “FDA and Prescription Drugs: Current Controversies in Context.” Register here.
  • 26 Mar 2019 (London, UK): Sponsored by The Economist, a 1-day symposium entitled “Antimicrobial Resistance: Preventing an antibiotic apocalypse.” Register here.
  • 28 Mar 2019 (everywhere, 4-5.30p GMT): GARDP-sponsored webinar entitled “Clinical development for non-developers Part 3: Antibacterial Drug Enhancer Combinations and Non-traditional Products.” Register here.
  • 1 Apr 2019 (University of California, Los Angeles): Longitude Prize AMR Diagnostic Workshop and evening Lecture on the Longitude Prize. Details here.
  • 8 Apr 2019 (FDA White Oak Campus): Workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease”. Register here.
  • [NEW] 9 Apr 2019 (everywhere, 17:00-18:30 CEST): GARDP-sponsored webinar entitled “Mining Chemical Libraries for New Antibacterials.” Register here.
  • 11-12 Apr 2019 (Amsterdam): ESGAPSWAB (European Study Group for Antibiotic Policies – Stichting Werkgroep Antibioticabeleid) Technical Workshop on measuring quantity and quality of antimicrobial use. Register here
  • 13-16 Apr 2019 (Amsterdam): Annual ECCMID meeting
  • 16-18 Apr 2019 (Utrecht): ICOHAR, International Conference on One Health Antimicrobial Resistance. Organized by the ESCMID Study Group for Veterinary Microbiology (ESGVM).
  • 24-26 Apr 2019 (Boston): Annual SHEA (Soc. for Hospital Epidemiology of America) Spring meeting
  • 6-11 May 2019 (Ljubljana, Slovenia): 37th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Details here.
  • 20 May 2019 (everywhere): Application deadline for NIAID solicitation (HHS-NIH-NIAID-BAA2019-1) for proposals to support new vaccine or therapeutics candidates targeting antibiotic-resistant bacterial infections. Go here for more details.
  • 3-6 Jun 2019 (Philadelphia): Annual BIO meeting
  • 10-11 June 2019 (Research Triangle Park, NC): AMR Action Summit on R&D and Commercialization. Sponsors include the British-American Business Council, the UK Gov’t, CARB-X, the NC Biotechnology Center, and others. Details here.
  • 20-24 June 2019 (San Francisco): Annual ASM Microbe meeting.
  • [Mark your calendar now!] 3-6 Sep 2019 (Boston). Annual ASM-ESCMID Conference on Antibiotic Development. The Bootcamp series will continue on 3 Sep with the main meeting on 4-6 Sep. Mark your calendar now and check back here for details.
  • 6-8 Sep 2019 (Bilbao, Spain): 5th ESCMID conference on Vaccines. Check back here for details.
  • 2-6 Oct 2019 (Washington, DC): IDSA’s annual IDWeek meeting.
  • 19-27 Oct 2019 (Annecy, France): International Course on Antibiotics and Resistance (ICARe) – A soup-to-nuts intensive residential training program on all things AMR, especially R&D for new antibiotics. See this link for details.
  • [Mark your calendar now!] 1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): GRC on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Not yet online, but the date is firm. Will share a link when it becomes available.

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EPA (part 5): Interagency Framework on AMR Risks of Antibacterial and Antifungal Pesticides

This is the fifth of a 5-part newsletter series. There is an initial 27 Sep 2023 newsletter introducing the EPA concept note, a second (28 Sep 2023) newsletter that expands on the EPA concept note, a third (12 Jan 2024) newsletter about ending the use of streptomycin spray on citrus crops, and a 4th newsletter (27 Jan 2024) containing some additional resources. Dear All, Excitingly, the US EPA

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Without action, AMR costs go from $66b to $159b/yr by 2050

Dear All, A new paper from Anthony McDonnell and a team led by the Center for Global Development extends estimates of the health-related impact of AMR (e.g., death) to a consideration of the economic ($) cost of AMR. To follow the plot, here are the links you will need: The new paper: “Forecasting the Fallout

UN TV: You can watch the AMR High-Level Meeting at UNGA

Dear All, The AMR HLM (High-Level Meeting) at the UN General Assembly starts at 10a ET today.  You can watch it here on UN TV: https://webtv.un.org/en/asset/k11/k11knc6w2t Addendum: It’s available for replay at that same link. See also the 1 Oct 2024 newsletter for a review of the HLM. All best wishes, –jr John H. Rex, MD

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