Ready, set, (get ready to) go! I just today learned of this really important US government pre-solicitation notice (lightly reformatted excerpt follows, see here for the whole thing):
- “The Government seeks an FDA-approved antibiotic(s) for a biothreat indication (Y. pestis, B. anthracis, F. tularensis, B. mallei and/or B. pseudomallei) for delivery to the Office of the Assistant Secretary for Preparedness and Response (ASPR)/Strategic National Stockpile (SNS).
- “The antibiotic(s) must be FDA-approved or in Phase 3 clinical development and eligible for Emergency Use Authorization (EUA) pre-approval by FDA for a biothreat indication.
- “If the antibiotic is not FDA approved for a pneumonic indication, the Offeror must seek development and FDA approval for a pneumonic indication that could support approval of a biothreat indication.
- “The oral or parenteral antibiotic(s) must have demonstrated efficacy against drug resistant pathogen(s) to include demonstrated in vitro efficacy against one or more of the aforementioned biothreat pathogens.”
While it’s not yet an official Request for Proposal (RFP), it certainly looks like ASPR (presumably, BARDA) is serious about purchasing one or more biothtreat-active antibiotics (note the use of the plural) for the Strategic National Stockpile.
The pre-solicitation notice was posted on 14 Feb 2019 (and I missed it before today), but its indicative timeline is that the RFP would run for 60 days during the window March to May. Obviously, this has not happened! If you assume a goal of awarding the RFP during this fiscal year (that is, on/before 30 Sep 2019, consistent with the date on the pre-solicitation notice), an RFP running May-June would give the agency three months to get to done.
Very exciting to see!
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:
- 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
- 20-24 June 2019 (San Francisco): Annual ASM Microbe meeting.
- 10-11 Jul 2019 (Madison, WI): Tiny Earth Symposium, a teaching consortium that uses crowd-sourcing of antibiotic-producing microbes to improve undergraduate education. Details here.
- [NEW] 12 July 2019 (FDA, White Oak Campus): Public workshop to discuss the 2018 LPAD guidance. Register here.
- [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 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.
- 12-13 Mar 2020 (Berlin?): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-, ENABLE-supported (among a long list!) Conference on Novel Antimicrobials and AMR Diagnostics. Final location is TBD, details will appear here, and you should mark your calendar now.
- 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
- 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)