Beyond the AMR Action Fund: PBS NewsHour and Things for us all to do!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter),

While we’re all thrilled with the announcement of the AMR Action Fund (newsletter), we’ve also had in parallel a demonstration of why the fund alone is insufficient to solve the antibiotic innovation crisis (newsletter on withdrawal of plazomicin’s marketing application in Europe).

Thus, it’s a good time to talk about next steps. AMR is complex but actions that would matter are within the grasp of our community. As a start for today, let’s consider 2 powerful themes that are open to immediate action by us all:

#1: Tell the story!

  • As one idea, we can start with the recent excellent 2-part PBS News Hour story on AMR hosted by Paul Solman. Please watch and then share these clips:
    • 29 Jul 2020: “As a virus ravages the world, antibiotic makers are in disarray”: link
    • 30 Jul 2020: “How a crumbling antibiotics infrastructure could yield catastrophe”: link
  • And in case you missed the prior video reports by PBS:
    • 22 Oct 2013 (PBS Frontline): “Hunting the nightmare bacteria” (link)
    • 2 Aug 2017 (PBS NewHour): “We are running out of effective antibiotics”: link
    • 3 Aug 2017 (PBS NewHour): “The financial barrier” (link)
    • 4 Aug 2017 (PBS NewHour): “Is there an economic cure for the problem?” (link)
    • 9 Aug 2017 (PBS NewHour) “How industrial farming techniques can breed superbugs” (link)
    • 10 Aug 2017 (PBS NewHour): “The economic reason this chicken producer gave up antibiotics” (link)
  • In short, share the story widely (and in non-technical language) with folks outside our AMR bubble!
    • A great place for ideas is the data from Wellcome Trust’s exploration of language that really works (link).
    • The key idea is to talk about how AMR impacts your life and work, what you’re doing to address it, and what specific efforts are needed by others.
  • You can do this by…
  • For more detailed ideas to share, look also at the list in the 5 May 2019 newsletter about the collapse of Achaogen (link):
    • Timely guideline updates from professional societies
    • Updated health technology assessment approaches (the UK continues to lead here; link)
    • Action by political leadership
  • If nothing else, let’s all start using #FireExtinguishersOfMedicine in our tweets … it’s such a simple but powerful meme! 

 

#2:  Support calls for substantial post-approval Pull Incentives from the G7, if not (most of) the G20

  • Making Pull Incentives happen is the most efficient way to drive the overall ecosystem!
    • Without lifetime Pull Incentives of $1-$4b for really innovative new drugs (see this newsletter for the math), private investment and expertise in antibiotic development will disappear
    • We’re already seeing this: companies with approved products are already going bankrupt. In effect, you will be able see new drugs but not have them.
    • The G7 countries could deliver the bulk of the needed Pull Incentives, but adding the G20 countries (India, China) would make a powerful difference.
  • These Pull Incentives are especially needed to provide the funding after initial approval that supports the costs of keeping a drug on the market and of the additional data packages needed to inform appropriate use.
    • Initial approval is at most the half-way point in a drug’s development and we must make it possible (indeed, desirable) for the developer to generate those data that make a difference (e.g., pediatrics).

 

Get to it, use that #FireExtinguishersOfMedicine hashtag, and stay safe!

All best wishes, John & Kevin

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

Kevin Outterson, JD, Professor of Law, Boston University & Executive Director, CARB-X (these views are personal and do not necessarily reflect the views of CARB-X or any of its funders) @koutterson  

Current funding opportunities:

  • Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
  • 2020 funding rounds for CARB-X have not been announced.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.


Upcoming meetings of interest to the AMR community:

  • 4 Aug 2020 (Silver Spring): FDA workshop entitled “Development Considerations of Antifungal Drugs to Address Unmet Medical Need.” Go here to register.
  • 5 Aug 2020 (Silver Spring): FDA workshop entitled “Developing Antifungal Drugs for the Treatment of Coccidioidomycosis (Valley Fever) Infection.” Go here to register.
  • [NEW] 7 Aug 2020 (online, 3-7.30p BST): The Longitude Prize Sprint Workshop entitled “Navigating MedTech Regulation Pathways in Developed and Emerging Markets”. Register here for this deep-dive into regional variations in the rules for devices.
  • 17 Aug 2020 (online, 1-2.30p EST): ASM Microbe 2020, Industry & Science program. Go here for details.
  • 24-28 Aug 2020 (online, 9.45a-18.30p CEST daily): BEAM Alliance-sponsored AMR Conference. Go here for details.
  • September 2020. University of Sheffield (UK). Applications are being taken for a new 1-year (full-time) or 2-year (part-time) Masters of Science course in Antimicrobial Resistance. The program runs annually from September and covers microbiology, clinical practice and policy. The course webpage is here.
  • 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • 21-25 Oct 2019 (online meeting), IDWeek 2020. Go here for details.
  • 26-29 Oct 2020 (online meeting), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 27 Oct 2020 (online meeting), BARDA Industry Day, a discussion of U.S. Government medical countermeasure priorities. Mark your calendar now and watch this website for details.
  • 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)
  • 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
  • [NEW] 27 Jun-2 Jul 2021 (Ventura, CA): Gordon Research Conference entitled “Antimicrobial Peptides”. Go here for details, go here for the linked 26-27 Jun Gordon Research Seminar that precedes it.
  • 5-21 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
  • 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
  • 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students.
  • [NEW] 6-11 Mar 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.

Share

Share on twitter
Share on facebook
Share on linkedin
Share on email
Share on whatsapp
Share on reddit

In Praise of Non-Inferiority

Dear All (wonkish but intended for everybody to read and absorb): There’s been a lot of recent discussion about “lessons learned from COVID-19.” Indeed, there are many valuable points: global cooperation, preparedness, supply chains, and so forth. As an example, I note the 17 Sep 2020 communique from the G20 Health Ministers (link): it was heavily

FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The

Treating resistant Gram-negatives: IDSA provides pragmatic expert advice

Dear All, IDSA (Infectious Diseases Society of America) have today released an eagerly awaited new guidance document on treating infections due to resistant Gram-negative bacteria (link). The thing that makes this document unusual is that it is an expert guidance rather than a formal guideline. Although there is value in formal guidelines that carefully review

New antibiotics are not being registered or sold in Europe in a timely manner

Dear All (and with thanks to Kevin for leading the charge on this newsletter), While listening to last week’s BEAM-sponsored AMR Conference (really a wonderful conference, thank you Team BEAM, go here to listen to the sessions), we tumbled onto a really, really disturbing trend: New antibiotics are not being registered or sold in Europe in

Scroll to Top