EMA Network Strategy to 2025: Action on AMR / Comments due 4 Sep

Dear All,

We learned today during the BEAM AMR conference (link) that EMA released a call on 7 June 202 for comments on their draft Network Strategy to 2025 that considers how “the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.”

The call for comments is here and I encourage you to take a look now … comments are due 4 Sep 2020. The strategy has 6 goals:

  1. Availability and accessibility of medicines
  2. Data analytics, digital tools and digital transformation
  3. Innovation
  4. Antimicrobial resistance and other emerging health threats
  5. Supply chain challenges
  6. Sustainability of the Network and operational excellence

All of the goals are obviously relevant to product innovation but you can see that goals 1 and 4 are particularly pertinent to the AMR community. The detailed elements of these two goals are found below my signature — please read the document for the full story. I’m pleased to see the call for Pull incentives and the call to streamline incentives, but I need to spend some time with nuance.

I’m pushing this out tonight because the deadline for comments is 4 Sep — please take a look at this! Follow-up note: Kevin Outterson and I submitted comments — here they are as a .pdf.

I hope to “see” you tomorrow at the BEAM meeting — the sessions feature an all-star cast! All best wishes, –jr

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.

Goal 1: Availability and accessibility of medicines

  • Strengthen the availability of medicines to protect the health of European citizens, via:
    • efficient and targeted regulatory measures, made possible through an in-depth understanding the root causes of unavailability of patented and off-patent products;
    • identification of possible challenges in implementing legislation, removal of national barriers, increased coordination of the EMRN, sharing and implementation of best practices including by thestakeholders and increased transparency are the essential steps towards this goal.
  • Optimise the path from development, evaluation through to access for innovative and beneficial medicines through collaboration between medicines regulators and other decision makers in the areas of:
    • evidence planning, including post-licensing evidence;
    • engagement in review of evidence and methodologies, respecting remits of the various players;
    • collaboration on horizon scanning.
  • As a result of this work, medicines that address unmet medical needs should have broader and earlier access coverage.

Goal 4: Antimicrobial resistance and other emerging health threats

  1. Provide high quality information on antimicrobial consumption and surveillance data on antimicrobial resistance in animals and humans in support of policy development.
  2. Contribute to responsible use of antibacterial agents and effective regulatory antimicrobial stewardship in human and veterinary sectors by putting in place strategies to improve their use by patients, healthcare professionals and national authorities
  3. Ensure regulatory tools are available that guarantee therapeutic options (with a focus on veterinary medicines) while minimising impact of antimicrobial resistance on public health and the environment
  4. Define pull incentives for new and old antibacterial agents, including investigating support for new business models and not-for-profit development
  5. Foster dialogue with developers of new antibacterial agents and alternatives to traditional antimicrobials, to streamline their development and provide adequate guidance in both human and veterinary medicine
  6. Improve regulatory preparedness for emerging health threats

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:

  • 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.
  • [NEW] 2 Oct 2020 (online meeting): 7th annual Boston Area Antimicrobial Research Network (BAARN) meeting. Go here for details.
  • 21-25 Oct 2020 (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.
  • 9-12 Jul 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.
  • 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.
  • 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.


CDC-FDA webinar: Developing drugs to prevent healthcare-associated infections (30 Aug 2022)

Dear All, A quick note today to call your attention to an upcoming webinar that will be of wide interest. Substantial new details have been added to the online agenda materials for the 30 August 2022 (virtual, 8.30a-5.00p ET) webinar sponsored by CDC and FDA entitled “Drug Development Considerations for the Prevention of Healthcare-Associated Infections.” This is very

US Senate and House / Call for Pull incentives in FY23 budget

Dear All, The US Government is now building its budget for FY23 (Federal Year 2023, really runs 1 Oct 22 to 30 Sep 23). We had proposals from the House for the Department of Health and Human Services (DHHS) budget in late June;  and the proposal from Senate was released on 28 Jul 2022. Each

WHO Vaccine pipeline review; CDC on impact of COVID on AMR

Dear All, WHO continues to crank out those pipeline reviews … now we have one for bacterial vaccines! Go here for the press release and here for the report. The report considers data from 2010 forward and (interestingly) provides data on both active and failed projects. The review identified 94 active preclinical candidates and 61

IDWeek 2022: New pipeline sessions seek presentation of therapeutics and diagnostics!

Dear All: I have learned that the program for IDWeek 2022 will have specific dedicated pipeline sessions for therapeutics and diagnostics. The online details are relatively scant, but my understanding is that the therapeutics of interest for these sessions include antibacterials, antifungals, and non-HIV, non-COVID antiviral agents. There do not appear to be any constraints

Scroll to Top