Dear All (and yes, back-to-back newsletters … lots of action this week!):
BARDA have today released a new version of their long-running BAA (Broad Agency Announcement, formerly BAA-18-100-SOL-00003) that seeks medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases. The new BAA is BAA-23-100-SOL-00004 and has been completely reorganized and updated. Do be sure to read through the entire document to see how to take full advantage of the updated BAA. In particular, there is now a BARDA BAA Toolkit where you can learn about the BAA process as well as access tools and templates that would help you develop your Quad Chart, write your Market Research Abstract, and write your full proposal. There is also a good discussion of the TechWatch program by which you can have quite a wide-ranging conversation with BARDA staff and their interested colleagues from across the US government.
The full list of Areas of Interest (N = 12!) is found below my signature and includes vaccines, antitoxins, diagnostics, and therapeutics for viruses, bacteria, and fungi. Of particular interest to the AMR community who read this newsletter would be the following (lightly formatted by me for ease of reading, including some use of bold face to highlight):
The full list of Areas of Interest (N = 12!) is found below my signature and includes vaccines, antitoxins, diagnostics, and therapeutics for viruses, bacteria, and fungi. Of particular interest to the AMR community who read this newsletter would be the following (lightly formatted by me for ease of reading, including some use of bold face to highlight):
- Area 3.1. MDR Bacteria and Biothreat Pathogens
- “The Antimicrobials Program is interested in drug candidates that are active against biothreat pathogens and/or can be used to treat secondary infections during a CBRN, pandemic influenza, or emerging infectious disease incident. Infections of greatest interest are the following:
- hospital-associated/community-acquired bacterial pneumonia (HABP/CABP),
- bloodstream infections (BSI),
- complicated intra-abdominal infections (cIAI),
- acute bacterial skin and skin structure infections (ABSSSI),
- and complicated urinary tract infections (cUTI).
- “Relevant biothreat pathogens include Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia mallei, and Burkholderia pseudomallei.
- “Preference will be given to candidates that combat infections caused by the MDROs identified by the Centers for Disease Control and Prevention (CDC) as serious and urgent threats.”
- “The Antimicrobials Program is interested in drug candidates that are active against biothreat pathogens and/or can be used to treat secondary infections during a CBRN, pandemic influenza, or emerging infectious disease incident. Infections of greatest interest are the following:
- Area 3.2. MDR Fungal Infections
- “The Antimicrobials Program seeks to support the development of first-in-class, broad-spectrum antifungal drug candidates with novel mechanisms of action that target Candida species, including Candida auris, and Aspergillus species.
- “Drug candidates that also demonstrate activity against rare molds, such as Mucorales, are of interest.”
- Area 7.2. Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens
- “BARDA is providing support to advance innovative, rapid, and improved diagnostics to detect bacterial pathogens that cause hospital-associated and community-acquired drug-resistant infections (HAI/CAI), particularly those identified by the Centers for Disease Control and Prevention (CDC) as serious and urgent threats and to characterize their resistance profiles for biological threats and/or routine clinical use. Assays must support clinical decision points.”
- Area 7.2.1. Bacterial Antimicrobial Resistance (AMR) Testing Direct from Specimen
- “BARDA seeks advanced development, clinical evaluation, and FDA clearance/approval of direct-specimen diagnostic tests for priority bacterial pathogens that identify the pathogen(s) and their resistance or susceptibility to relevant antibiotics within 24 hours.
- “The workflow is preferred to be integrated from sample to answer with no intermediate hands-on time or transfer steps. Inclusion of external commercial specimen preparation and/or blood culture instruments in the workflow would factor into the 24-hour time frame. The assay must have clinically relevant sensitivity and specificity from whole blood and must be able to accept multiple specimen types (e.g., urine, sputum, CSF, and nasal secretions).
- “Molecular or phenotypic tests are acceptable.
- “It is highly preferred that pathogen identification be available in less than 30 minutes from initiating testing.
- “Priority will be given to antimicrobial susceptibility test (AST) solutions with reduced time to results, a small footprint, high throughput, and fully automated compared to current standard of care. TRL 4 or greater required.”
- Area 7.2.2. Bacterial vs. Viral Infections: Point-of-Care
- “BARDA seeks advanced development, clinical evaluation, and FDA clearance/approval of CLIA-waivable/waived, rapid platforms and assays for use in point-of-care settings that will reliably distinguish between viral and bacterial infections to inform appropriate use of antibacterials and antivirals.
- “The assay must be highly sensitive and specific, and useful with multiple specimen types (e.g., respiratory, whole blood).
- “Results should be available in less than 30 minutes.
- “Priority will be given to solutions on platforms that are FDA cleared for other diagnostic applications. TRL 4 or greater required.
Interestingly, the next deadline for proposals to this edition of the BAA is 25 Sep 2028. Yes, that’s right … 2028. Previous versions of the BAA had a rolling quarterly process but it now appears that the BAA is simply open for the next 5 years. And as with the prior BAA, the program is open to applicants regardless of location: BARDA seeks the best science from anywhere in the world … so please get busy with your application(s)!
Well done, Team BARDA! With best wishes to all, –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.
Full list of areas of interest … these start on page 41 of the BAA
- CBRN Vaccines
- CBRN Antivirals and Antitoxins
- Antimicrobials
- Radiological/Nuclear Threat Medical Countermeasures
- Chemical Medical Countermeasures
- Burn and Blast Medical Countermeasures
- Diagnostics
- IEID Vaccines (IEID = Influenza and Emerging Infectious Diseases)
- IEID Therapeutics
- ImmuneChip+
- COVID-19 Immune Assay(s) Development and Implementation
- Flexible and Strategic Therapeutics (FASTx)
Current funding opportunities (most current list is here)
- BARDA’s long-running BAA (Broad Agency Announcement) for medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases is now BAA-23-100-SOL-00004 and offers support for both antibacterial and antifungal agents (as well as antivirals, antitoxins, diagnostics, and more). Note especially these Areas of Interest: Area 3.1 (MDR Bacteria and Biothreat Pathogens), Area 3.2 (MDR Fungal Infections), and Area 7.2 (Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens). Although prior BAAs used a rolling cycle of 4 deadlines/year, the updated BAA released 26 Sep 2023 has 5-year application period that ends 25 Sep 2028 and is open to applicants regardless of location: BARDA seeks the best science from anywhere in the world!
- HERA Invest was launched August 2023 with €100 million to support innovative EU-based SMEs in the early and late phases of clinical trials. Part of the InvestEU program supporting sustainable investment, innovation, and job creation in Europe, HERA Invest is open for application to companies developing medical countermeasures that address one of the following cross-border health threats: (i) Pathogens with pandemic or epidemic potential, (ii) Chemical, biological, radiological and nuclear (CBRN) threats originating from accidental or deliberate release, and (iii) Antimicrobial resistance (AMR). Non-dilutive venture loans covering up to 50% of investment costs are available. Applications are accepted on a rolling basis; go here for all the details.
- The ENABLE-2 consortium has announced a call to support hit-to-lead compound development by researchers at publicly-funded European universities. The call is focused on molecules with the potential to be direct-acting therapies for one or more of the following priority pathogens: ESBL-producing/carbapenem-resistant Enterobacteriaceae (E. coli, K. pneumoniae), P. aeruginosa, A. baumannii, methicillin-resistant S. aureus, or vancomycin-resistant E. faecium. The Call is open continuously, applications are reviewed at intervals, and funding is non-dilutive. Expressions of interest received before 30 Sep 2023 would be considered in November 2023. Applications received after this date will be evaluated in the spring of 2024 (date to be decided). Go to https://www.ilk.uu.se/enable2/apply/ for further details.
- The AMR Action Fund is now open to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to contact@amractionfund.com.
- INCATE (Incubator for Antibacterial Therapies in Europe) is an early-stage funding vehicle supporting innovation vs. drug-resistant bacterial infections. The fund provides advice, community, and non-dilutive funding (€10k in Stage I and up to €250k in Stage II) to support early-stage ventures in creating the evidence and building the team needed to get next-level funding. Details and contacts on their website (https://www.incate.net/).
- These things aren’t sources of funds but would help you develop funding applications
- 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.
- Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-X, C-CAMP, and FIND, it pulls together real-life insights into a succinct set of tutorials.
- 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):
- General note: Virtual meetings are easy to attend, but regular attendance at in-person events is the key to networking and deeper insight. My personal favorites for such in-person meetings are marked below as HIGHLY RECOMMENDED and are the BEAM Alliance’s AMR Conference (March, Europe), ECCMID (April, Europe), the ASM-ESCMID Developer’s meeting (September, alternates sides of the Atlantic), and ID Week (October, USA). Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!
- [DON’T MISS THIS ONE!] 27 Sep 2023 (virtual, 10a-11a ET): Milken Institute webinar entitled “What’s Next for the UK’s Subscription Model in the Fight Against Antimicrobial Resistance”. Based on the announcement email from Milken, this will be a deep dive from key UK experts (Sophie Cooper from NICE and David Glover from NHS England) who have been integral to the UK’s thinking. Note also that Milken has published (2022) an excellent deep dive into this area. Go here to register.
- 26 Sep 2023 (virtual or in-person, 1.00-1.50p ET): Webinar entitled “When antibiotics fail: Solving the deadly superbug threat” sponsored by the Harvard School of Public Health. Go here for details and to register.
- 27 Sep 2023 (in-person at BBC Studios, 1120 Avenue of the Americas, New York City 5p ET): Screening (with panel discussion) of “Race Against Resistance: The life and death struggle to save antibiotics”, the fabulous new BBC Storyworks film. Go to https://www.youtube.com/watch?v=5U3k9ruszxI to see the film online; go here to register for the in-person screening.
- 27 Sep 2023 (virtual, 2-3p CET, 8-9a ET): GARDP-sponsored webinar entitled “Antibiotic shortages: causes, consequences and solutions.” Go here to register.
- 4 Oct 2023 (Museum of Science, Boston, MA; in person, 11.30a-2.30p ET): Co-sponsored by the Boston’s Museum of Science and the Rijksmuseum Boerhaave (Netherlands), you can attend a luncheon and panel discussion entitled “Celebrating 300 Years of Innovation and Beyond: How van Leeuwenhoek’s Discovery of the Microworld Sparked a Medical Revolution, with a Focus on Antimicrobial Resistance.” Go here for details and to register. I knew about Boston’s MOS but did not know about the exceptional collection of the Rijksmuseum Boerhaave which seeks to “… show what science is all about: curiosity, guts, creativity and perseverance.” Fascinating!
- 7-15 Oct 2023 (residential, Annecy, France): ICARe, the Interdisciplinary Course on Antibiotics and Resistance. Now in its 7th year, this course is a deep-dive into the world of antibiotic development. Intense, rigorous, and HIGHLY recommended. Seats are always limited … apply sooner rather than later! Go here for details.
- 11-15 Oct 2023 (Boston, USA): IDWeek 2023, the annual meeting of the Infectious Diseases Society of America. Go here for details and to register. HIGHLY RECOMMENDED.
- 12 Oct 2023 (virtual, 2-3p CET) GARDP-sponsored webinar entitled “Market interventions to improve access to antibiotics for resistant infections.” Go here to register.
- 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.
- 6-7 Feb 2024 (online): Antimicrobial Chemotherapy Conference. This is an annual, free of charge conference that is co-organized by GARDP and the British Society for Antimicrobial Chemotherapy (BSAC). Details to follow — for now, just mark your calendar.
- 6-7 Mar 2024 (Basel,[NEW] 6-7 Mar 2024): Sponsored by the BEAM Alliance, the AMR Conference is now in its 8th year and is consistently an excellent meeting for developers. You can’t register yet but you can mark your calendar and signup for notifications about the meeting. HIGHLY RECOMMENDED.
- 17-22 Mar 2024 (Ventura Beach, CA, in person): Gordon Research Conference (GRC) entitled “New Antibacterial Discovery and Development” with a 16-17 Mar 2024 pre-conference Gordon Research Seminar (GRS) for young doctoral and post-doctoral researchers. An intensive residential meeting, GRCs are highly recommended for networking and deep research insights. Apply here for the GRC and here for the GRS.
- 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. HIGHLY RECOMMENDED.
- 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.
- 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. Go here for the meeting’s general website. You can’t register (yet) for the 2024 event, but you can mark your calendar. HIGHLY RECOMMENDED.
