Dear All,
BARDA is interested in hearing from antibiotic developers about antibiotics which could be used under Emergency Use Authorization (EUA) or marketing authorization for the treatment and/or PEP (post-exposure prophylaxis) of a biothreat indication, specifically: Y. pestis, F. tularensis, and/or B. pseudomallei.
Here’s the core message from the pre-solicitation notice:
- Topline: “The U.S. Government may seek an antibiotic which could be used under Emergency Use Authorization (EUA) or marketing authorization for the treatment and/or PEP of a biothreat indication, specifically: Y. pestis, F. tularensis, and/or B. pseudomallei.“
- More detail:
- “This notice seeks information from small businesses with regard to their qualifications, experience, and capability to support late-stage development of an antibiotic to treat biothreat infections and potential delivery of the antibiotic to the ASPR/SNS.
- “The U.S. Government may seek an antibiotic which could be used under Emergency Use Authorization (EUA) or marketing authorization for the treatment and/or PEP of a biothreat indication (specifically Y. pestis, F. tularensis, and/or B. pseudomallei).
- “The product would need to be FDA-approved within the last 10 years or in Phase III clinical development.
- “Potential proposals would be required to include sufficient data to support a Pre-EUA package for a biothreat indication with no further comments from FDA and a supplemental New Drug Application (sNDA) package for a biothreat indication.”
Reading between the lines, I think BARDA is trying to identify the availability and capabilities of potentially qualified businesses that could respond to a formal request for proposal (RFP) for a new antibiotic targeting biothreats. By responding to this pre-solicitation notice, sponsors can help BARDA (i) conduct market research on potential products responsive to a full RFP and (ii) evaluate the feasibility and impact of the requirements in such a request (e.g., is manufacturing on US soil achievable).
The deadline for initial responses is 10 AM EST on 20 Oct. There are separate request pathways if the responding company is a small business (link) and “other than a small business” (link).
Could this be you and your company? I hope so … we do need more fire extinguishers! 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.
Current funding opportunities (most current list is here):
- 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.
- It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
- You might also be interested in the most current lists of R&D incentives (link) and priority pathogens (link)
Upcoming meetings of interest to the AMR community (most current list is here):
- 8 Oct 2020 (online, 16.30-18.30 CEST; 10.30a-12.30p EST); Bootcamp #2 entitled “Exploring safety issues in antimicrobial drug development”. Moderated by Claire Sadler (Apconix), this webinar is jointly sponsored by GARDP, CARB-X, Novo REPAIR, JPIAMR, Wellcome Trust, ASM, and ESCMID. Since we can’t the ASM-ESCMID meeting, we’re still going to have the bootcamps! Go here to register.
- 15 Oct 2020 (online, 9-10.30am EST) webinar chaired by Andrew Morris entitled “Prevention is Stronger than Cure”, the second webinar in a 4-part series sponsored by Wellcome Trust entitled “AMR in the Light of COVID-19 Webinar Series; From hypothetical to reality: How COVID-19 foretells a world without antibiotics.” Go here to register.
- 21 Oct 2020 (online, 9:00-10:30 CEST): GARDP-sponsored webinar entitled “Building better breakpoints: data and methods needed to determine breakpoints for new agents” moderated by Gunnar Kahlmeter. Go here to register.
- 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, 9a-5p EST): FDA Workshop entitled “Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.” Go here to register.
- 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.
- 3-27 Nov 2020 (online, 4-week course, 10 sessions, 2-3h/session): First WHO Training Course in Infodemic Management. Infodemic = “information” + “epidemic” = rapid and far-reaching spread of both accurate and inaccurate information making it difficult to learn essential information about an issue. This is a training program for country-level preparedness. Application deadline is 18 Oct 2020. Go here for more.
- 5 Nov 2020 (online, 9-10.30am EST) webinar entitled “Aiming in the dark: what happens when disease spreads without diagnosis”, the third webinar in a 4-part series sponsored by Wellcome Trust entitled “AMR in the Light of COVID-19 Webinar Series; From hypothetical to reality: How COVID-19 foretells a world without antibiotics.” Go here to register.
- 17 Nov 2020 (online, 17:00-18:30 CET): GARDP-sponsored webinar entitled “Discovery of new antibacterials using artificial intelligence (computational chemoinformatics)” moderated by Laura Piddock. Go here to register.
- 18-24 Nov 2020 (everywhere): World Antimicrobial Awareness Week. For resources, go here for WHO’s home page for the week. The focus will be on two messages: “Antimicrobials: handle with care” and “United to preserve antimicrobials.”
- 19 Nov 2020 (online, 9-10.30am EST) webinar chaired by Jeremy Knox entitled “Responding to difficult-to-treat infections: Role and responsibilities of governments, researchers, clinicians, industry and patients”, the final webinar in a 4-part series sponsored by Wellcome Trust entitled “AMR in the Light of COVID-19 Webinar Series; From hypothetical to reality: How COVID-19 foretells a world without antibiotics.” Go here to register.
- 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.
