Dear All,
It’s been a busy day! Hot on the heels of today’s Duke-Margolis webinar on combatting AMR during which Senator Bennet said that he expects the PASTEUR Act to come to legislative approval this year based on strong bipartisan support (Senator Bennet is working with Senator Young), we have an announcement this afternoon that BARDA are going to fund another 10 years of antibacterial R&D via an Antibacterial Accelerator.
I can’t (yet) find a press release, but you can see the new announcement here: https://sam.gov/opp/5476c9122a554ac1a8d3341a5cbf0ea8/view
From that webpage, look in list of attachments for: BAA-18-100-SOL-00003_Special Instructions AOI 3_4_20210512.pdf
And that should take you to a .pdf document in which you will learn that
- “These Special Instructions under BARDA BAA-18-100-SOL-00003 Area of Interest #3.4 Antibacterial Accelerator aim to identify and support an accelerator capable of managing a portfolio of antibacterial candidates and overseeing the development of these candidates.
- “From 2016-2021, BARDA funded Boston University’s (BU) Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) program to build a diverse early-stage development portfolio of innovative antibiotics, non-traditional therapeutics, vaccines, diagnostics, and other products to treat, prevent, and diagnose antibiotic-resistant infections.
- “The period of performance for BARDA’s existing Cooperative Agreement supporting BU ends in 2022.
- In an effort to continue driving innovation, BARDA intends to award an Other Transaction (OT) to support an accelerator responsible for managing the preclinical and early clinical development of a pipeline of antibacterial candidates.
And a bit further on (Section 3.4), we learn that:
- “BARDA anticipates making one award under these Special Instructions using an Other Transaction (OT).
- “BARDA anticipates the Base Period of the OT will have a targeted ceiling of up to $20 million of USG funding (based on the availability of funds) …
- “Multiple Option Periods … may be exercised under the OTA to support continued activities, based on the availability of funds … It is anticipated that the total OT period of performance, inclusive of the Base plus any Option Periods, will be up to 10 years with a total targeted ceiling of up to $175 million exclusive of cost sharing.“
—
My translation? BARDA jumped into the AMR effort with an initial $180 million investment in CARB-X that has done very well indeed: CARB-X has substantially exceeded the five-year program targets set out in the 2015-2020 U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) by generating a portfolio totaling over 85 projects (including nine first-in-human clinical studies). And as you know, BARDA’s money was matched by an additional $300 million in funding and in-kind services from other donors.
With this template for success and with the 2020-2025 U.S. National Action Plan for CARB calling for the US government to continue support of early-stage development of innovative antibacterial products, BARDA has secured funding to drive another 10 years of investment through a similar type of Antibacterial Accelerator. One can only speculate, but I’d assume that this Accelerator would be able to attract further funding and in-kind services from interested donors, thus further amplifying its impact.
And in case you wonder what this means for CARB-X itself, my guess is that as the incumbent, it would be a strong contender in this full and open competitive procurement call.
—
Fabulous! With the extension of BARDA’s support for an Accelerator from pre-clinical to Phase 1 and the AMR Action Fund providing further push funding for Phase 2-3, we have a 10-year plan that really should bring some innovative new drugs to registration.
Get busy! Per Section 4.5 of the announcement, full proposals may be submitted until 4:30 PM Eastern Time on Monday, June 28, 2021. BARDA will also provide written responses to inquires received by 4:30 PM Eastern Time on Wednesday, May 19, 2021.
—
And as one more small thing in support of the value to society of new fire extinguishers/antibiotics, please check out this 5-minute thought experiment in which we contemplate the world with and without a fire extinguisher for COVID-19:
What a day! 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):
- NIAID’s 2021 Broad Agency Announcement for product development is entitled “Development of Medical Countermeasures for Biothreat Agents, Antimicrobial-Resistant Infections an Emerging Infectious Diseases” and is now live with a 24 May 2021 deadline. Research areas include Vaccines, Therapeutics, and Sequencing-Based Diagnostics.
- GNA NOW (part of the IMI AMR Accelerator) has an open call to identify a novel mechanism antibacterial to add to its portfolio. The selected project would receive resources equivalent up to several million € (to be defined according to project needs); see also this 11 May 2021 newsletter for details. Expressions of interest are due by 18 June 2021.
- CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (more than 80 total awards, and counting, as they include contracting from prior rounds). New rounds from CARB-X will occur only after new funding is obtained in 2021.
- It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
- The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
- In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my 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):
- 10-12 May 2021 (virtual): UK-focused Virtual AMR Innovation Mission sponsored by Innovate UK in collaboration with AMR Insights and Oxford innovation. This free 3-day virtual event seeks to connect AMR-focused start-ups, SMEs and Multinationals, Academia, Research Institutes, Regional Development Companies and other interested stakeholders in the UK, Europe and other parts of the world. It will be followed (COVID-willing!) by a face-to-face mission scheduled for 11-15 Oct 2021. Go here for more details.
- 12 May 2021 (virtual, 11a-12.30p EST): Duke-Margolis-sponsored webinar entitled “Combating Rising Antimicrobial Resistance (AMR) & Advancing Public Health Preparedness.” Including discussions by two former FDA Commissioners (Scott Gottleib, Mark McClellan), the webinar will focus on the policy issues around AMR. Go here for the agenda and to register.
- 13 May 2021 (virtual, 9.30-11.00a EST): CDC-sponsored webinar entitled “AMR in a Changed World: Building Resilient Systems for Today and Tomorrow.” Moderated by CDC’s Michael Craig, an international panel will discuss “where we go from here to address AMR after the COVID-19 pandemic.” Go here to register.
- 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.
- 24-29 May 2021 (virtual and in Geneva): ESPID 2021, the 39th Annual Meeting of the European Society for Paediatric Infectious Diseases. Save-the-date announcement is here, details to follow.
- 27 May 2021 (virtual, 9.30a-11.00 CEST): GARDP-sponsored webinar entitled “New clinical trial designs for evaluation of antimicrobial agents.” Go here to register.
- 7-9 Jun 2021 (virtual, various times): 5th International Conference on Responsible Use of Antibiotics in Animals. This conference runs only every few years … the 4th instance was in 2016. Go here to register.
- 20-24 Jun 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
- 20-24 Jun 2021 (virtual, various times): World Microbe Forum sponsored by the American Society for Microbiology (ASM) and the Federation of European Microbiological Societies (FEMS). Go here for more details and to register.
- 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.
- 9-12 Jul 2021 (virtual): Annual ECCMID meeting (#31)
- 26 Jul-30 Jul 2021 (online): Small World Initiative Instructor Training Workshop – training for undergraduate professors in the wet lab techniques, parallel curricula, & pedagogical instruction to engage students in the hunt to find new antibiotic-producing soil microbes. Go here to register.
- 14-29 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.
- 11-15 Oct 2021 (physical, somewhere in the UK): UK-focused Innovation Mission sponsored by Innovate UK in collaboration with AMR Insights and Oxford innovation. This free event seeks to connect AMR-focused start-ups, SMEs and Multinationals, Academia, Research Institutes, Regional Development Companies and other interested stakeholders in the UK, Europe and other parts of the world. Go here for more 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. Bonus feature: For obvious reasons, the course didn’t happen in 2020! But as a celebration of the course’s 5th year, a webinar version was held on 29 Oct 2020: go here to stream it.
- 25-28 Oct 2021 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.
- 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.