Let’s make a pull incentive happen in the US during the 116th Congress!

Dear All:

I’ve written a lot about the need for pull incentives, preferably delinked (some papers to read, comments by TATFAR, highlights from Davos 2018, and the UK commits to trying delinkage). 

Now, I am delighted to report that a really serious effort is underway in the US to make something happen during the 116th Congress.

The essential document can be found here. This is a letter that has been sent with appropriate adjustments to all the relevant legislative committees: the Senate Committee on Health, Education, Labor & Pensions (HELP), the Senate Committee on Finance, the House Committee on Ways & Means, and the House Committee on Energy & Commerce.

After explaining the background and the need for a fundamental fix via a package of incentives, the letter reads as follows:

“Key principles of a pull incentive package:

  1. Incentives should be paid after FDA approval, rewarding only successful development of novel antibiotics that address the greatest public health need.
  2. A package of incentives should aim both to stabilize today’s novel antibiotic market and to ensure the viability of future development – meaning they must be substantial and viewed as highly valuable to private markets.
  3. Economic incentives should provide predictability for drug developers – assurance that the company can commit R&D funds today, knowing that the economic incentive will be available if the new drug meets eligibility criteria.
  4. Incentives must be aligned with appropriate antibiotic stewardship and surveillance.

“We commit to working with Congress and the Administration to further develop and advance a package of antibiotic incentives, at least some of which must be enacted in 2019 to meet growing patient needs and help mitigate a public health crisis. Such a package could, for example, include a mix of tax incentives, novel pull incentives, reimbursement changes, and even a low-interest loan program, along with continued investment in NIAID and BARDA.”

The letter is signed by a very broad coalition of stakeholders who are now working closely together:

  • Achaogen
  • Antimicrobial Innovation Alliance
  • Antimicrobials Working Group – (Amplyx Pharmaceuticals, Aridis Pharmaceuticals, Cidara Therapeutics Inc., ContraFect Corporation, Entasis Therapeutics Inc., Iterum Therapeutics Ltd., Melinta Therapeutics Inc., Motif Bio plc, Nabriva Therapeutics US Inc., Paratek Pharmaceuticals Inc., Qpex Biopharma Inc., SCYNEXIS Inc., Summit Therapeutics plc and VenatoRx Pharmaceuticals Inc.)
  • Biotechnology Innovation Organization
  • GlaxoSmithKline
  • Infectious Diseases Society of America
  • Merck
  • Pfizer Inc.
  • Shionogi Inc.
  • Spero Therapeutics
  • Tetraphase Pharmaceuticals
  • The Pew Charitable Trusts
  • Trust for America’s Health

There is active progress even now on a bipartisan bill that would be introduced to the House and Senate simultaneously in which a fundamental DRG fix is proposed as an initial step. In parallel, we are going to seek to explain and develop support for a delinked reward model to follow the initial DRG-focused fix.

Cross your fingers!

Now is the time for all people of good will to support this effort, with time, energy and money. We can’t afford to wait until the 117th or 120th Congress!.

If we fail, it won’t be for lack of trying. And if your company wants to join in, please let me know and I’ll connect you appropriately. 

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: http://amr.solutions/blog/

Upcoming meetings of interest to the AMR community:

  • 7 Feb 2019 (London): Opportunity to comment in person on the IACG draft recommendations. See this tweet for more details.
  • 21 Feb 2019 (everywhere, 17:00-18:30 CET): GARDP-sponsored webinar entitled “NIAID Resources to Facilitate Discovery & Development of Anti-Infectives.” Register here.
  • 5-6 Mar 2019 (Washington): NIAID-sponsored workshop: Vaccine strategies for endemic fungal pathogens. Register here.
  • 14-15 Mar 2019 (Berlin): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-ENABLE-sponsored (among a long list!) Berlin Conference on Novel Antimicrobials and AMR Diagnostics. Details here. Poster submissions are being accepted through 9 Jan (details here).
  • 18 Mar 2019 (everywhere): Deadline for responding to the WHO call for data on preclinical antibiotic programs. Details here.
  • 21-22 Mar 2019 (Birmingham, UK): BSAC Spring Conference.
  • 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.
  • 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.
  • 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.

Dear All,
 
The IDWeek 2024 program committee is again seeking programs on novel antimicrobial agents and novel diagnostics for presentation in pipeline sessions! Here’s what is sought:

  • “Industry partners are invited to submit antimicrobials that are in preclinical stages of development (Phase II and III preferred) or recently approved after January 2024.
  • “The pipeline sessions will include antibacterials, antifungals, and antivirals (excluding COVID-19 and HIV).
  • “The committee also invites companies developing novel diagnostic technologies with a minimum of some preliminary proof of concept data to submit.” 

This is a great opportunity to tell the story of your development project! The deadline to submit is Wednesday, June 26 via the application portal. Any questions should be directed to program@idsociety.org. Please share this email with anyone you think might be interested in applying!
 
In addition, I’ll also note that those with a more general story to tell should look at the BugHub Stage (and the Global BugHub stage). Both BugHub variants seek “presentations that touch on your experience of working in infectious diseases and presentations that ultimately lead to a greater understanding of our diverse field” via a TED Talk-esque speech about your work. The deadline for applications is 26 June, the same as for the pipeline sessions.

I look forward to seeing you there! 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.

John’s Top Recurring Meetings

Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details. 
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here for the meeting’s general website. You can’t register (yet) for the 2024 event, but save the date!
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Save the date! More details to come!
  • 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. Go here to register

Upcoming meetings of interest to the AMR community:

  • [NEW]  9 Apr 2024 (virtual, 830a-10a ET): GARDP’s next REVIVE webinar entitled “Progressing a discovery project – Criteria and challenges.” Register here.
  • [NEW] 9 Apr 2024 (virtual, 10a-1130a ET): CDC webinar “Impacts of Antimicrobial Resistance on Cancer Care.” Click here for details and to register.
  • 10-11 Apr 2024 (virtual): Sepsis Alliance AMR Conference, a 2-day conference focused on “Practical technologies to manage sepsis and counteract the expanding challenge of antimicrobial resistance.” Go here for details and to register.
  • 26 Apr 2024 (Barcelona, Spain): ESCMID workshop entitled “Using Data Science and Machine Learning for Infection Science: A Hands-on Introduction.” Click here to register or here for more details. 
  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
  • 26-31 May 2024 (Montreal, Canada): EDAR7, the McGill AMR Centre’s 7th edition of their Environmental Dimension of Antimicrobial Resistance conference. Go here for details; final abstract deadline is 21 Dec 2023.
  • 28-29 May 2024 (in person, Uppsala, Sweden): Uppsala Antibiotic Days, a broad-ranging 2-day program hosted by the Uppsala Antibiotic Center. Go here for details and to register.
  • [NEW] 30-31 May 2024 (face-to-face in Rockville, Maryland as well as online, 8.30-5.30p ET on 30 May, 9-2.40p on 31 May): NIAID-sponsored workshop entitled “Towards realizing the promise of adjunctive immune therapy for invasive fungal infections”. The agenda covers host immunity to invasive fungal infections, immune modulators in the context of fungal infections; and strategies for testing immune modulators as adjunctive therapy. Go here for more details and to register.
  • 9-13 June 2024 (in person, Ascona, Switzerland): “New Approaches to Combat Antibiotic-Resistant Bacteria, 2nd Edition” is a Sunday-Thursday residential workshop focused on the deep biology of AMR. Sponsored by NCCR AntiResist (a Swiss National Science Foundation consortium), the scientific program has the feel of a Gordon Conference. Space is limited, so you are encouraged to apply promptly — go here for details.
  • 13-17 June 2024 (Atlanta, Georgia): ASM Microbe, the annual meeting of the American Society for Microbiology. You can’t register yet, but you can go here for general details.
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. See Recurring Meetings list, above.
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above. 
  • 19-27 Oct 2024 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance). Now in its 8th year, Patrice Courvalin directs the program with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Seating is limited, so mark your calendars now if you are interested. Applications open in March 2024 — go here for more details.
  • 4-5 Dec 2024 (in person, Washington, DC): “Fungal Dx 2024: Fungal Diagnostics in Clinical Practice” is a 2-day in-person workshop organized by ISHAM‘s Fungal Diagnostics Working Group. The program and registration links are available at https://fungaldx.com/; the agenda is comprehensive and features an all-star global list of speakers.

Share

48,015 → 0: Antibacterial discovery is hard. Really, really hard.

Dear All (and with thanks to Patricia Bradford for co-authoring this newsletter), When you are seeking novelty, antibacterial discovery is hard … really, really, REALLY hard. And it gets even harder if you want activity vs. Gram-negative bacteria. As the latest proof of this, a paper from GARDP’s Blasco et al. describing use of an

Call for Pull: Swiss Roundtable on Antibiotics

Dear All, To end the week, we have a really lovely paper from the Swiss Roundtable on Antibiotics (a multidisciplinary, non-profit Swiss association). Here are the links you need: The new (25 March 2024) paper entitled “Effective antibiotics for the Swiss health care system: today and in the future.” A prior (7 Feb 2023) paper

Help PASTEUR cross the finish line: Action Alert from IDSA!

Dear All, Today’s news is that the House PASTEUR sponsors (Drew Ferguson [R-GA-3], Scott Peters [D-CA-50], Jake LaTurner [RKS-2] and Mike Levin [D-CA-49]) are urging House leadership to authorize the PASTEUR Act without initially having funding attached. Although this may seem counterintuitive, initial passage as a $0 bill is a solid strategy — it is common

Scroll to Top