Dear All,
Greetings in the new year! I just tonight picked up on this fascinating BAA (Broad Agency Announcement) from CDC:
- BAA 75D301-23-R-72545 as described on this general overview webpage: https://sam.gov/opp/15229982f7c348f69fd35e9a0add8aba/view
- The BAA itself
- Timeline: Initial white papers (max 4 pages, see page 76 of the BAA for details) are due by 3 Feb 2023; Invitations for a full proposal would follow after review of the white papers
- Anticipated Award Date: Aug/Sep, 2023
- Approximate Total Funding for the entire BAA: $75,000,000.00 (The BAA notes that this amount is an estimate, is not intended to be a ceiling, and is subject to availability of funds.)
This is quite a broad call that seeks proposals on topics as diverse as Ebola, malaria, folate-sensitive birth defects, and diabetes management! For the readers of this newsletter, the following topics caught my eye:
- Topic 12.2: “Develop models and software tools to predict the source or geographic origin of pathogens or to identify anomalous patterns that may signify the emergence, re-emergence, or persistence of strains over time using whole genome sequencing and epidemiological data.”
- Topic 14. “Determining effective multimodal strategies for improving environmental cleaning in low-resource healthcare settings in low- and middle-income countries (LMIC)”
- Topic 17.1 “Development of an electronic surveillance definition, national burden estimate, and hospital toolkit for pediatric sepsis” (under the broader title of “Novel methods to derive sepsis estimates in pediatric populations”)
- Topic 19.1 “Identify Nursing Homes at Increased Risk of Health Inequities to Focus Strategic Interventions”
- Topic 22.3 “Feasibility of providing ‘waterless’ care in the Neonatal Intensive Care Unit in an attempt to limit neonatal exposure to Gram-negative bacteria from the environment”
- Topic 22.4 “Develop and propose studies needed to define clinical and/or surrogate endpoints that can be used for the regulatory approval of decolonizing agents, microbiome therapies, or similar products that can prevent the transmission of pathogens (especially those that are antimicrobial resistant) in and across healthcare setting.”
- This one is especially fascinating to my eye. It appears to be a follow-on from the 30 Aug 2022 webinar sponsored by CDC and FDA entitled “Drug Development Considerations for the Prevention of Healthcare-Associated Infections.”
- Topic 23.2 “Research to understand the distribution of antifungal-resistant Aspergillus fumigatus in outdoor environments”
… and that’s just a few of the bacterial/fungal themes from this very eclectic BAA! Jump to the bottom of page 5 / top of page 6 of the BAA for an easily reviewed list of the topics and subtopics.
Impressive! Sharpen your pencils and submit those white papers by 3 Feb 2023! 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)
- FDA have announced five RFPs spanning antifungal animal models, usability of antimicrobial drug labeling, urine PK-PD, and interpretive breakpoints. Applications are due dates of 23 Jan 2023 — see this newsletter for more details.
- Current funding rounds from CARB-X are as described in this newsletter!
- 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.
- BARDA’s long-running BAA-18-100-SOL-00003 offers support for both antibacterial and antifungal agents. This BAA has offered 4 deadlines/year since 2018 … check the most current amendment for details.
- 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/).
- 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):
- 1-2 Feb 2023 (virtual): Antimicrobial Chemotherapy Conference by GARDP and BSAC in collaboration with ReAct Africa and Africa CDC. Go here for details.
- 16-17 Mar 2023 (timings suggest hybrid EU-US): 7th AMR Conference, hosted by the BEAM Alliance with many co-sponsors. This has historically been a very good networking event. Go here for details.
- 14 Apr 2023 (Copenhagen, Denmark; 3-6.30p CEST): ECCMID and the Global Leaders Group on AMR will jointly sponsor a symposium entitled “Forging partnerships between science and policy in Antimicrobial Resistance (AMR).” Go here to register.
- 15-18 Apr 2023 (Copenhagen, Denmark): 33rd ECCMID. Go here for details and to register.
- 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.
- 14-22 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.
- [NEW] 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.
