CDC – AMR.Solutions

WHO Vaccine pipeline review; CDC on impact of COVID on AMR

John Rex — Fri, 15 Jul 2022 01:56:33 +0000

See also

This related newsletter: 29 Mar 2021, entitled “Vaccines to turn back the tide of antimicrobial resistance.”
This 20 Oct 2024 report from WHO: “Estimating the impact of vaccines in reducing antimicrobial resistance and antibiotic use: technical report”
This 25 Apr 2024 paper in Lancet Global Health by Hausdorff and colleagues: “Facilitating the development of urgently required combination vaccines” DOI https://doi.org/10.1016/s2214-109x(24)00092-5

Dear All, WHO continues to crank out those pipeline reviews … now we have one for bacterial vaccines! Go here for the press release and here for the report. The report considers data from 2010 forward and (interestingly) provides data on both active and failed projects. The review identified 94 active preclinical candidates and 61 projects in the clinic. The distribution of clinical projects is instructive:

In the figure, BPPL = Bacterial Priority Pathogen List (go here if you need to see the current priority pathogen lists). You can thus see that we have reasonable coverage of Medium and High priority pathogens, but Critical pathogens are not well served.

Unfortunately, that gap in vaccine spectrum is unlikely to be fixed. As the report notes, “six pathogens from the WHO priority pathogens list (A. baumannii, P. aeruginosa, Enterobacter spp., E. faecium, S. aureus, and H. pylori) … were found to have low feasibility for vaccine development due to biological and other product development challenges.” Sad, but true! A real strength of the report is its discussion of the likelihood of success of the various types of projects; for more on feasibility issues, see also this 29 Mar 2021 newsletter on WHO’s Immunization Agenda 2030: A Global Strategy to Leave No One Behind.

—
CDC has just released a review on the impact of COVID-19 on AMR. Go here for the press release and here for the report. The key finding can be stated briefly: “resistant hospital-onset infections and deaths both increased at least 15% during the first year of the pandemic.” The results varied somewhat by pathogen (see table at the top of report page 6) with the sharpest increase being a 78% rise in the incidence of carbapenem-resistant Acinetobacter. Ugh!

Sadly, this result would seem predictable based on a prior CDC NHSN report (Weiner-Lastinger 2021, doi:10.1017/ice.2021.362) showing significant increases during 2020 in rates of central-line-associated bloodstream infections, catheter-associated urinary tract infections, ventilator-associated events, and MRSA bacteremia.

Many thanks to our colleagues at CDC for compiling and sharing these data! Now is the time for action at levels of the AMR ecosystem. Prevention, stewardship, new diagnostics, new therapeutics are needed! Let’s get the PASTEUR Act passed!

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)

The AMR Industry Alliance has announced their 2022 Stewardship Prize! The program offers 10,000 CHF to recognize established, innovative approaches to AMR stewardship in low- and middle-income countries (LMICs). The 2021 prize went to the Infectious Diseases Institute (IDI) in Kampala, Uganda for their best practices in diagnostic stewardship and for their patient awareness campaigns dedicated to decreasing inappropriate use of antibiotics in their specialist HIV clinic in Kampala. Applications for the 2022 prize are due August 31, 2022. Thinking in terms of stewardship, WHO have recently released a pair of courses through the OpenWHO platform:
- Course 1 provides training on the WHO Policy Guidance on Integrated Antimicrobial Stewardship Activities
- Course 2 focuses on the WHO practical toolkit for antimicrobial stewardship programmes in health-care facilities in low- and middle-income countries
- The online training courses can be found on the dedicated channel: https://openwho.org/channels/amr
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 a newly launched early-stage funding vehicle. Details are still coming into focus, but per comments on 25 Aug 2021 at the BIOCOM conference, their goal is to support ~4 companies per year with about $250k/company. Contact details are on their website (https://www.incate.net/).
New funding rounds from CARB-X are expected soon now that funding for the next 10 years has been announced! For the most current update, watch this 30-minute video from the June 2022 kick-off webinar.
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):

[NEW] 20 Jul 2022 (virtual. 11a-noon ET): Pfizer– and CQ Roll Call-sponsored webinar entitled “Superbugs: Policy Solutions to Tackle an Emerging Health Threat.” This webinar will feature Senators Todd Young (R-IN) and Michael Bennet (D-CO), the senate sponsors of the PASTEUR Act! Don’t miss it! Go here to register.
26 July 2022 (virtual, 10a-11.30a ET): REVIVE webinar entitled “New approaches for antibiotic discovery”. Go here for details.
24-27 July 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.
28-31 July 2022 (Singapore): 10th International Congress of Asia Pacific Society of Infection Control is a hybrid event for professionals in the Asia Pacific region. Go here for details and to register.
10 Aug 2022 (virtual, 11a-12.30p ET): REVIVE webinar entitled “Animal models to study the activity of antibiotics.” Go here for details.
10 Aug 2022 (virtual, 10a-4.30p ET): USDA ‘s APHIS (Animal and Plant Health Inspection Service) will host a public meeting on Antimicrobial Resistance. Co-hosted with USDA’s FSIS (Food Safety Inspection Service) and REE (Research, Education and Economics) mission area, the webinar will review lessons learned since the first AMR workshop 2012 as well as discuss plans for the future. Go here to register.
23 August 2022 (virtual, 11a-12.30p ET): REVIVE webinar entitled “The Challenges and options in developing antibiotic combinations.” Go here for details.
30 August 2022 (virtual, 8.30a-5.00p ET): Webinar sponsored by CDC and FDA entitled “Drug Development Considerations for the Prevention of Healthcare-Associated Infections.” This is very timely as developing products for prevention is surprisingly hard. As just one example, see this 20 Dec 2018 newsletter about a valiant (but failed, sadly) effort to develop a S. aureus vaccine. Go here for additional details and to register.
12-13 Sep 2022 (virtual, 9a-5p ET): This meeting of PACCARB is going to “identify key issues and critical policy gaps through a series of facilitated discussions examining a hypothetical large-scale disease outbreak scenario based on historic examples and estimates of future AMR outbreaks.” Sounds like pandemic wargaming (Center for Health Security; pre-COVID 19 May 2020 NPR article) to me! Go here for details.
20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
4-7 Oct 2022 (Dublin, Ireland): The 2022 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent meeting, especially for developers … and if you’ve missed it, the recordings from the 2021 meeting are online. Go here for details on the 2022 meeting.
19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
- [NEW] IDWeek has opened pipeline sessions for antibacterials, antifungals, and non-HIV, non-COVID antivirals as well as for diagnostics (no limitations). Go here to submit your abstract; this 14 July 2022 newsletter contains some additional details.
15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6^th edition of Patrice Courvalin’s fabulous ICARe residential training course covering all things AMR is on for 2022! This is a soup-to-nuts training in AMR: it is very intense, very detailed, and always gets rave reviews from attendees. Registration is open 21 Mar 2022 to 21 June 2022 and is limited, so book your slot as soon as you can. Go here for details.
19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
[NEW] 23 Oct 2022 (Cape Town, South Africa): Symposium entitled “Tackling AMR: How implementation research is vital in a One Health approach” that is sponsored by the AMR knowledge hub of TGHN (The Global Health Network). Go here for details.
25-28 Oct 2022 (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.
17-20 Nov 2022 (Kuala Lumpur, Malaysia): The International Congress on Infectious Diseases will take place for the first time as a hybrid event. Go here for details.
27-30 Nov 2022 (Perth, Australia): 32nd International Congress of Antimicrobial Chemotherapy is the biennial congress of the International Society of Antimicrobial Chemotherapy (ISAC). Go here for details.

FDA-NIAID-CDC: Developing drugs for gonorrhea, 23 Apr 21 workshop

John Rex — Tue, 13 Apr 2021 20:30:58 +0000

Dear All,

FDA, NIAID and CDC have announced a public workshop on development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will cover both nonclinical (preclinical) and clinical trial design considerations:

Animal models
Clinical pharmacology considerations
Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.

The workshop is being held virtually on 23 Apr 2021 from 9a-5p EST. The workshop’s webpage is here and provides details on how to attend, how to make an oral presentation, etc. Registration is here.

This is a timely meeting given that emergence of resistance has created a powerful global need for new products for gonorrhea. That noted, developing for this infection has some unusual aspects that will make this a very informative workshop: in particular, the human specificity of N. gonorrhoeae has made animal models (and hence, PK-PD work to guide dose selection) difficult. It will be interesting to learn the updates on work (e.g., transgenic models) intended to help with this issue.

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 will open its next global call on 1 April 2021. Go here for current details.
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.
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):

20-22 April 2021 (online, 1-5p CET): JPIAMR-sponsored workshop entitled “Feeding the Antimicrobial Therapeutics Pipeline.” JPIAMR, the collaborative global effort of 28 countries (much of the EU and also Argentina, Canada, Egypt, Israel, Japan, Korea, South Africa, and Turkey), is organizing a mixture of keynote talks, abstract presentations, and discussion panels designed to encourage collaborative antibiotic R&D. Go here for more details and registration. Abstract deadline is March 17^th 2021; no previous JPIAMR funding required.
21-22 April 2021 (online, 9a-5p UK): 2021 BioInfect Conference sponsored by BioNow, the Northern England business support group. Go here to register.
23 Apr 2021 (online, 9a-5p EST): FDA-NIAID-CDC workshop entitled “Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.” The workshop’s webpage is here; go here to register.
29 April 2021 (online, 5-6.30p CEST): GARDP-sponsored webinar entitled “AMR R&D efforts in the CMC and formulation arena: Do it right the first time!” Go here to register.
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.
[NEW] 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 (online 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.
20-24 June 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)
[NEW] 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.

CDC BAA: Surveillance, endpoints for decolonization, and more…

John Rex — Thu, 12 Jan 2023 02:07:07 +0000

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.

Jan-Feb meetings; CDC releases Healthcare Epidemiology RFP

John Rex — Sun, 03 Jan 2021 02:28:12 +0000

Dear All:

Happy New Year! I hope everyone was able to take a least a brief break over the holidays. Two things for today.

First, there are two meetings in January and one in February that have just popped onto my radar. See the meetings calendar for a pair of Keystone Symposia on the microbiome, a National Academies project meeting on AMR, and a meeting of PACCARB.

Second, CDC’s Division of Healthcare Quality Promotion has a new Request For Proposals (RFP) entitled “Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD)” that is available online at https://beta.sam.gov.

Proposals are due for this substantial RFP by 3 Mar 2021. The shortest online version I found begins on page 7 of this .pdf from the RFP’s home page. Quoting from an email announcing the program:

“This funding opportunity will help CDC to continue partnering with external experts to address questions over the next 5 years related to healthcare-associated infection (HAI) prevention research, including antibiotic resistance and work across healthcare settings.

“This indefinite delivery, indefinite quantity (IDIQ) contract is for healthcare systems, academic, and other research partners. Awardees will perform quality improvement projects, HAI prevention research, and other healthcare epidemiology studies in the following five domains to improve healthcare quality:

“Develop and implement research protocols to prevent HAIs and other adverse healthcare events, including study design, statistical support, literature review, and data management and analysis.
“Implement research projects in multiple healthcare sites to improve quality of care and prevent HAIs and other adverse healthcare events.
“Conduct formative research, guidance development, and research translation to improve healthcare practices, a new opportunity to contribute to the evaluation and dissemination of products aimed at improving healthcare practices and bridging the public health and healthcare divide.
“Develop and implement research projects focused on HAIs and other adverse healthcare events in low- and middle-income countries.
“Review, recommend, and accelerate the development and use of surveillance protocols for the National Healthcare Safety Network (NHSN) that extend or enhance the use of information technology and healthcare data in electronic form for surveillance purposes.”

Wow! And while you’re looking at this, don’t forget about CDC’s call for AMR-related proposals (newsletter) that has a 13 Jan 2021 deadline.

Stay safe … and all best wishes for 2021, –jr

PS: I am experimenting with a YouTube channel that provides short video discussions of AMR-related topics. Feedback would be gratefully received as would suggestions for discussion topics!

Current funding opportunities (most current list is here):

CDC has released a Broad Agency Announcement with that includes multiple opportunities for AMR-related work. See this newsletter for details. The deadline is 13 Jan 2021.
The US Department of Defense is funding pre-clinical research on small molecules vs. P. aeruginosa. See this newsletter for details. The deadline is 18 Feb 2021.
The National Institute of Allergy and Infectious Diseases (NIAID) Applicant Assistance Program (AAP) provides no cost support for companies planning to apply for a Phase II, Fast Track, or Direct-to-Phase II SBIR or STTR Award. Go here for details.
Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (75 total awards, and counting and they conclude contracting on prior rounds), including future options on those awards. New rounds from CARB-X will occur only after new funding is obtained in 2021.
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.
Finally, 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):

[NEW] 5-8 Jan 2021 (online, from 11a EST each day): Meeting #3 of the project entitled “Examining the Long-term Health and Economic Effects of Antimicrobial Resistance in the United States” sponsored by the National Academies of Science, Engineering, and Medicine. This project was described in a previous newsletter and appears to be part of the run-up to creating the next iteration of the US National Action Plan (NAP) for Combatting Antimicrobial Resistant Bacteria (CARB). Go here for more details and to register.
14 Jan 2021 (online, 5-6.30p CET): GARDP-sponsored webinar entitled “Manipulating the host response to treat infections,” moderated by Neeloffer Mookherjee. Go here to register.
[NEW] 18-20 Jan 2021 (online, 10.00a EST to ???): A pair of virtual Keystone Symposia entitled “Harnessing the Microbiome for Disease Prevention and Therapy” and “The Microbiome: From Mother to Child”. Not a lot specifically on infection, but the deep biology typical of Keystone’s programs looks fascinating. Go here and here to register.
26-28 Jan 2021 (online, runs ~7.30a-5.00p Central each day): 4th Annual Texas Medical Center Antimicrobial Resistance and Stewardship Conference. Sponsored by McGovern Medical School, ARLG, and the Gulf Coast Consortia, the agenda includes both poster sessions and keynotes. The call for abstracts closes 18 Dec 2020. Go here for more details.
2-3 Feb 2021 (online, 1-5p GMT): Antimicrobial Chemotherapy Conference 2021 sponsored by BSAC and in collaboration with the Helmholtz Institute for Pharmaceutical Sciences (HIPS), the German Center for Infection Research (DZIF) and the International Research Alliance for Antibiotic Discovery and Development (IRAADD, a JPIAMR-funded network). Go here for details and to register.
[NEW] 10-11 Feb 2021 (online, 10a-4p EST): Virtual public meeting of PACCARB (US Presidential Advisory Council on Combatting Antimicrobial Resistant Bacteria). Go here for details.
25 Feb 2021 (online, 5-6.30p CET): GARDP-sponsored webinar entitled “Manipulating the host response to treat infections,” moderated by Michael Mourez. Go here to register.
10-12 Mar 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; abstract deadline is 15 Nov 2020.
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.
24-29 May 2021 (online 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.
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. 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.
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.

CDC call for AMR-related proposals: 13 Jan 2021 deadline for white papers

John Rex — Wed, 16 Dec 2020 21:40:42 +0000

Dear All,

Just out is a Broad Agency Announcement (BAA 75D301-21-R-71738) from CDC with a 13 Jan 2021 deadline for white papers. The webpage for the BAA is here and you’ll need to look at the .pdf of the solicitation to understand all the possibilities. The AMR-related research areas include calls for proposals that would:

Improve identification of bacteria plasmids to understand AR epidemiology and ecology
Build the ability to perform whole genome sequencing in PulseNet regions, including Asia Pacific and Middle East, to improve detection and surveillance of emerging multidrug-resistant enteric (gut) bacteria
Estimate the prevalence of antifungal-resistant Aspergillus fumigatus in low- and middle-income countries
Evaluate samples for colonization and relatedness with multidrug-resistant organisms
Evaluate IPC Iinfection Prevention and Control) metrics among patients colonized with carbapenem-resistant Enterobacteriaceae (CRE)
Assess antibiotic stewardship practices internationally
Review IPC guidelines, policies, and practices implemented in healthcare facilities
Develop operational guidance for hospital IPC committees
Develop a curated, international antibiotic-resistant gonorrhea sample bank

Other possibilities in the solicitation include work on infant and maternal health surveillance, strengthening the Laboratory Response Network (LRN), and work on both influenza and COVID-19.

Wow! Get busy! 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):

The US Department of Defense is funding pre-clinical research on small molecules vs. P. aeruginosa. See this newsletter for details. The deadline is 18 Feb 2021.
The National Institute of Allergy and Infectious Diseases (NIAID) Applicant Assistance Program (AAP) provides no cost support for companies planning to apply for a Phase II, Fast Track, or Direct-to-Phase II SBIR or STTR Award. Go here for details.
Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (75 total awards, and counting and they conclude contracting on prior rounds), including future options on those awards. New rounds from CARB-X will occur only after new funding is obtained in 2021.
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.
Finally, 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):

14 Jan 2021 (online, 5-6.30p CET): GARDP-sponsored webinar entitled “Manipulating the host response to treat infections,” moderated by Neeloffer Mookherjee. Go here to register.
26-28 Jan 2021 (online, runs ~7.30a-5.00p Central each day): 4th Annual Texas Medical Center Antimicrobial Resistance and Stewardship Conference. Sponsored by McGovern Medical School, ARLG, and the Gulf Coast Consortia, the agenda includes both poster sessions and keynotes. The call for abstracts closes 18 Dec 2020. Go here for more details.
2-3 Feb 2021 (online, 1-5p GMT): Antimicrobial Chemotherapy Conference 2021 sponsored by BSAC and in collaboration with the Helmholtz Institute for Pharmaceutical Sciences (HIPS), the German Center for Infection Research (DZIF) and the International Research Alliance for Antibiotic Discovery and Development (IRAADD, a JPIAMR-funded network). Go here for details and to register.
25 Feb 2021 (online, 5-6.30p CET): GARDP-sponsored webinar entitled “Manipulating the host response to treat infections,” moderated by Michael Mourez. Go here to register.
10-12 Mar 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; abstract deadline is 15 Nov 2020.
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.
24-29 May 2021 (online 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.
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. 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.
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.

CDC funds more than 20 AMR-focused projects!

John Rex — Mon, 23 Oct 2017 16:47:08 +0000

Dear All:

CDC has today announced $9m in funding for more than 20 new projects focused on slowing or combating antimicrobial resistance. Part of the CDC’s Antibiotic Resistance Solutions Initiative, these projects span a broad range that includes surveillance (C. auris, antibiotic resistance in a watershed, antibiotic resistance in poultry farms), diagnostics (POC tools, what’s in hospital sewage discharge?), fellowship training in stewardship, and much, much more. The full list with some details can be be found online at the link above and I’ve produced a high-level summary just below my signature in which I broadly classify the projects for ease of review.

Combined with the 2016 investments, CDC’s AR Solutions Initiative has awarded more than $24 million to investigators through a broad agency announcement. There’s a neat online map that shows how this has been spread across the US — I show here the map with California highlighted:

It’s great to see our US Gov’t partners so deeply and well engaged in addressing the challenge of AMR. I’m particularly impressed by the breadth of projects … from microbiome to clinical investigations, CDC has really cast a broad net. Go CDC!

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: https://13.43.35.2/blog/

List of projects newly funded by CDC:

Microbiome

Baylor College of Medicine: Cross-validation of human fecal minibioreactor arrays and humanized microbiota mice as complementary pre-clinical models of the GI (gastrointestinal) microbiome
Regents of the University of Michigan: Microbiome disruption and Enterobacteriaceae dominance as a risk factor for sepsis in intensive care patients

Diagnostics & Bioinformatics

Children’s Hospital Oakland Research Institute (CHORI) at the University of California San Francisco: Rapid assays to detect Neisseria gonorrhea antibiotic resistance at the point of care
Emory University: Computational methods for culture-independent disambiguation of wgMLST types in biological samples with multiple related bacterial strains
J. Craig Venter Institute (JCVI): Improved bioinformatics tools for detection and characterization of antimicrobial resistance in public health
University of Mississippi Medical Center: Comparison of methods for detecting recombination in bacterial whole genome sequences

Epidemiology

Rutgers, the State University of New Jersey: Rapid identification and analysis of transmission of the emerging pathogen Candida auris
The Ohio State University: Preventing the dissemination of CRE from healthcare facilities into surface waters in the US (continuation request)
The Rector and Visitors of the University of Virginia: Understanding the microbiologic dynamics of Carbapenemase-producing organisms in hospital wastewater premise plumbing
The University of Georgia: The prevalence and diversity of antibiotic resistant bacteria in a mixed-use watershed
University of Alabama at Birmingham: Sentinel surveillance for Macrolide-resistant Mycoplasma pneumoniae at select sites in the United States

Food agriculture

Georgia Tech Applied Research Corporation (GTARC): Antibiotic resistance in concentrated poultry feeding operations: Impacts on environmental waters
University of Georgia Research Foundation, Inc.: Azole resistance in agricultural settings

Training

Infectious Diseases Society of America (IDSA): Infectious Diseases Fellowships to drive innovative education and approaches in antibiotic resistance, antibiotic stewardship and public health (AR/AS Public Health Innovation Fellowships)
OpGen, Inc.: Highly accessible system for infection control and antimicrobial stewardship in resource limited settings
The Children’s Hospital of Philadelphia (CHOP): Perinatal antibiotics and weight gain in childhood
Translational Genomics Research Institute (TGen): Considering homologous and non-homologous recombination in outbreak analysis

Clinical investigations

Cleveland VA Medical Research and Education Foundation: Natural history of Clostridium difficile colonization
Department of Research & Evaluation, Kaiser Permanente Southern California: Prenatal antibiotic use and body weight in children
Georgia Tech Applied Research Corporation (GTARC): Optimization of therapeutic strategies to manage polymicrobial CF lung infections: Clinical assessment
University of Arizona: Reducing antibacterial use in patients with coccidioidomycosis
University of Maryland, Baltimore: Implementation of a novel strategy to prevent Staphylococcus aureus (SA) acquisition and hence invasive SA infection in community-based nursing homes: Feasibility and pilot to guide a multicenter stepped wedge cluster trial
Washington University: Double blinded, randomized controlled Trial of Oral vancomycin versus placebo in hospitalized patients with diarrhea and stool toXin NEGative but nucleic acid amplification test positive for toxigenic Clostridium difficile (TOX NEG trial)

Upcoming meetings of interest to the AMR community:

29 Oct-1 Nov 2017 (Santa Fe): Keystone Symposium – Antimicrobials and Resistance: Opportunities and Challenges
3 Nov 2017 (no specific location): One Health Day
6 Nov 2017 (Boston): BAARN (Boston-Area Antimicrobial Resistance Network), Annual Meeting for 2017
[NEW] 7 Nov 2017 (Washington, DC): FDA VRBPAC (Vaccines & Related Biologic Products) AdComm on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical population
7-8 Nov 2017 (Washington, DC): BARDA Industry Days
11-19 Nov 2017 (Annecy, France): International Course on Antibiotics and Resistance (ICARE)
13-19 Nov 2017 WHO’s World Antibiotic Awareness Week
15 Nov 2017 (London): BSAC: AMR Market Lounges. Networking day.
20 Nov 2017 (week of, China): UK-China Newton Fund Workshop: Antimicrobial Resistance Centre Partnerships Initiative.
20 Nov 2017 (London): Early Career Researcher Workshop on Diagnostics for Antimicrobial Resistance.
24-27 Nov 2017 (Taipei): 30th International Congress of Chemotherapy & Infection (ICC)
12-14 Feb 2018 (Baltimore): ASM Biothreats Conference
11-16 Mar 2018 (Ventura Beach): Gordon Research Conference on Antibacterial Discovery
21-24 Apr 2018 (Madrid): ECCMID
7-11 Jun 2018 (Atlanta): ASM Microbe
22-27 Jul 2018 (Bryant University, Smithfield, RI): Gordon Research Conference on Drug Resistance for Cancer, Infectious Disease and Agriculture

CDC’s 2019 update to its 2013 Antibiotic Resistance Report — A superb update!

John Rex — Wed, 13 Nov 2019 18:27:10 +0000

Dear All,

I’ve been hearing rumors about this report for a couple of weeks but now it’s out! The US CDC has released their 2019 update to their 2013 Antibiotic Resistance report. Go here for the full report.

This report is clearly a labor of love on the part of Team CDC — the graphics, the patient vignettes, and the data summaries are simply superb. In particular, I think this report is an outstanding example of using everyday language to tell the AMR story. See also this recent blog (link) on ways to explain AMR to our non-technical friends and colleagues.

At a high-level, the report brings good news (lots of ongoing work with encouraging progress on many points), bad news (a lot of deaths still occur due to AMR pathogens), and a clear message that we need to continue our AMR-related work.

As a detailed summary will not do it justice, I’ll simply copy CDC’s dedication from the opening pages of the document (hint: 35,000 is CDC’s estimate of the current number of deaths/year in the US due to antibiotic-resistant infections):

This report is dedicated to the 35,000 families who have lost a loved one to antibiotic resistance and the countless healthcare providers, public health experts, innovators, and others who are fighting back with everything they have.

That says it so well … this is why we do what we do.

Read this report … and many thanks to Team CDC!

All best wishes, –jr

Upcoming meetings of interest to the AMR community:

12-19 Nov 2019 (cyberspace): CARB-X Funding Round 4 is open for Expressions of Interest (EOIs). Go here for details. This round is limited to new classes and/or new targets in early development phases (hit-to-lead through Phase 1) targeting a specific list of Gram-negative pathogens (see link, but in brief is Carbapenem-resistant Abau, Pae, E’bacteriaceae as well as FQ-R Salmonella, Shigella, and Neisseria.
14-15 Nov 2019 (Hamilton, Ontario): “Fueling the Fight Against Antimicrobial Resistance”, a 2-day Gairdner Foundation-sponsored symposium in collaboration with the Michael G. DeGroote Institute for Infectious Disease Research and the David Braley Centre for Antibiotic Discovery at McMaster University. Go here for details.
18-19 Nov 2019 (FDA, White Oak Campus): FDA-IDSA-NIAID-Pew-sponsored workshop: “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States.” Register here.
19 Nov 2019 (London): BSAC seminar entitled “Into clinical practice: Meeting the challenges of Gram-negative infection management”. A one-day conference on treatments for Gram-negative infections. Go here for details.
26 Nov 2019 (webinar, 9:30-11:00 CET): REVIVE webinar entitled “Innovation in point-of-care diagnostics for sepsis and bloodstream infections.” Go here to register.
28-29 Nov 2019 (Birmingham, UK): BSAC workshop entitled “ARM (Antibiotic Resistance & Mechanisms)”. This meeting is a research forum for UK-based researchers at all levels, including PhD students and technicians. Go here for details.
5 Dec 2019 (Monthey, Switzerland): The BioArk technology park is holding a one-day workshop on AMR. Entitled “The Ark Life Sciences Series #1”, you can get more details here.
16-18 Dec 2019 (Bangkok, Thailand): 3rd International Symposium on Alternatives to Antibiotics in Animal Production. Go here for details: https://www.ars.usda.gov/alternativestoantibiotics/
16 Jan 2020 (Washington, DC): Duke-Margolis meeting entitled (approximately) “improving Payment Policies for Antibiotics.” This meeting will run 10:30am – 4:30pm ET, details to follow.
21 Jan 2020 (London): BSAC’s 2nd Antimicrobial Chemotherapy Conference – An ABC for everyone involved in developing new antimicrobials. Go here for details.
20 Feb 2020 (London, UK): Westminster Health Forum conference entitled “Antimicrobial resistance – coordinating a global response and progress on the UK strategy.” Go here for details.
26-27 Feb 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): Gordon Research Conference (GRC) on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Go here for details.
12-13 Mar 2020 (Basel, I’m told): 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.
16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details.
18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
27-28 Jun 2020 (Bryant University, Rhode Island): Drug Resistance Gordon Research Seminar entitled “Mechanisms and Approaches to Overcoming Drug Resistance in Cancer, Infectious Disease and Agriculture” for graduate students and postdoctoral scientists. Go here for details … this immediately precedes the GRC listed just next
28 Jun-3 Jul 2020 (Bryant University, Rhode Island): Gordon Research Conference (GRC) entitled “Strategies to Disrupt Drug Resistance in Infectious Disease, Cancer and Agriculture.” Go here for details.
1-4 Sep 2020 (Dublin): Annual ASM-ESCMID Conference on Antibiotic Development #5! Mark your calendar now and go here for details.
9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
[NEW] 22-25 Sep 2020 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)

DHHS Secretary Alex Azar, CDC, and Dame Sally Davies: An event to celebrate AMR fighters around the globe

John Rex — Mon, 16 Sep 2019 18:31:09 +0000

Dear All,

If you’re going to be in New York City on 23 Sep for the UN General Assembly, you are invited to join U.S. Health and Human Services Secretary, Alex Azar, experts from the U.S. Centers for Disease Control and Prevention, and hundreds of organizational and global leaders at an evening celebrating global AMR fighters.

The capstone to the CDC’s AMR Challenge Year, the evening will celebrate a year of progress and ~300+ One Health commitments made by governments, non-government organizations, academic, and private sector partners to take action and deliver results. This event will address the need to increase awareness of AMR by engaging and educating participants in a multi-media experience that will showcase how AMR is impacting our world, and what actions we can take to decrease the risk.

The U.S. premiere of the film Antimicrobial Resistance Fighters will also take place at this event and be introduced by Dame Sally Davies.

This unofficial side event of the 74th United Nations General Assembly in New York City will take place on Monday, September 23 from 6-9 pm. Registration is required: RSVP here.

This sounds fantastic! All best wishes, –jr

Upcoming meetings of interest to the AMR community:

[NEW] 23 Sep 2019 (New York City, NY): The capstone to the CDC’s AMR Challenge Year, DHHS Secretary Alex Azar, experts from CDC, Dame Sally Davies will celebrate at year of progress at this unofficial UN General Assembly side event. Registration is required: go here to RSVP.
3 Oct 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Natural product antibiotics: from traditional screening to novel discovery approaches.” Go here to register.
2-6 Oct 2019 (Washington, DC): IDSA’s annual IDWeek meeting.
8 Oct 2019 (London): Launch of “Reviewing Antimicrobial Resistance: Where Are We Now and What Needs to Be Done?”, a follow-up to the UK AMR Review‘s report and recommendations. Go here to register.
10 Oct 2019 (online): Deadline for feedback to the Global AMR R&D Hub on their draft Collaboration Framework. Go here to tell them what you think!
11 Oct 2019 (online): Deadline for Novo REPAIR’s 2019 US-Canada investment round. Go here for details — you need to dig all the way to the bottom of the web page.
[NEW] 16 Oct 2019 (FDA, White Oak): Advisory Committee for NDA 209445, cefiderocol lyophilized powder for intravenous administration, submitted by Shionogi Inc., for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options. Go here for details.
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.
4 Nov 2019 (FDA, White Oak): Public hearing on FDA’s proposed rules for “Use of Fecal Microbiota for Transplantation to Treat Clostridioides (Clostridium) difficile.” Go here for the online FR notice and here for the .pdf version.
7 Nov 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Converting Gram-positive-only compounds into broad-spectrum antibiotics.” Go here to register.
19 Nov 2019 (London): BSAC seminar entitled “Into clinical practice: Meeting the challenges of Gram-negative infection management”. A one-day conference on treatments for Gram-negative infections. Go here for details.
28-29 Nov 2019 (Birmingham, UK): BSAC workshop entitled “ARM (Antibiotic Resistance & Mechanisms)”. This meeting is a research forum for UK-based researchers at all levels, including PhD students and technicians. Go here for details.
16-18 Dec 2019 (Bangkok, Thailand): 3rd International Symposium on Alternatives to Antibiotics in Animal Production. Go here for details: https://www.ars.usda.gov/alternativestoantibiotics/
21 Jan 2020 (London): BSAC’s 2nd Antimicrobial Chemotherapy Conference – An ABC for everyone involved in developing new antimicrobials. Go here for details.
20 Feb 2020 (London, UK): Westminster Health Forum conference entitled “Antimicrobial resistance – coordinating a global response and progress on the UK strategy.” Go here for details.
26-27 Feb 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
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.” Go here for details.
12-13 Mar 2020 (Basel, I’m told): 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.
16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details.
18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)
1-4 Sep 2020 (Dublin): Annual ASM-ESCMID Conference on Antibiotic Development #5! Mark your calendar now, details to follow.
9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.

India bans food ag use of colistin / CDC updates report on US use of antibiotics

John Rex — Thu, 22 Aug 2019 18:33:18 +0000

Dear All, Two mid-week notes:

First (and huge!), India’s Ministry of Health issued a notification last week prohibiting the “manufacture, sale and distribution of the drug colistin and its formulations for food-producing animals, poultry, aqua farming and animal feed supplements” because such use is “likely to involve risk to human beings.” You can find this on multiple news sources: Here are two: link and link. Wow! A complete and total ban is an impressive step.

Second, CDC has released its 2018 update on antibiotic use in the US (link). The new report highlights new antibiotic stewardship data, programs, and resources since the July 2017 report. Selected points:

Outpatient antibiotics: Even when antibiotics are needed, prescribers often favor drugs that may be less effective and carry more risk over more targeted first-line drugs recommended by national guidelines.
Inpatient antibiotics: Use of the most powerful antibiotics increased significantly from 2006 to 2012, by nearly 40 percent for carbapenems and more than 30 percent for vancomycin.
Top-line summary (and no surprise!): The United States has made some progress in improving antibiotic prescribing and use in human health, but many opportunities remain.

This is encouraging to see. The only build I’d offer on the report is that I wish it had said more about using vaccines to reduce antibiotic use. Vaccines don’t cover things like UTI, but we should be encouraging them where they are relevant. For further background, you could start with the Feb 2016 paper from the UK AMR Review (link) or this 2016 paper by Utt & Wells (link).

One step at a time, we are making progress. Onward! –jr

Upcoming meetings of interest to the AMR community:

[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 Sep 2019 (Cambridge): CeBIL Annual Symposium 2019: Legal Innovation to Support the Development of Anti-Microbial Drugs. For more details and to register, go here.
6-8 Sep 2019 (Bilbao, Spain): 5th ESCMID conference on Vaccines. Check back here for details.
10 Sep 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Models for antimicrobial R&D: Advanced and complex in vivo models for infectious disease research.” Go here to register.
3 Oct 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Natural product antibiotics: from traditional screening to novel discovery approaches.” Go here to register.
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.
19 Nov 2019 (London): BSAC seminar entitled “Into clinical practice: Meeting the challenges of Gram-negative infection management”. A one-day conference on treatments for Gram-negative infections. Go here for details.
28-29 Nov 2019 (Birmingham, UK): BSAC workshop entitled “ARM (Antibiotic Resistance & Mechanisms)”. This meeting is a research forum for UK-based researchers at all levels, including PhD students and technicians. Go here for details.
16-18 Dec 2019 (Bangkok, Thailand): 3rd International Symposium on Alternatives to Antibiotics in Animal Production. Go here for details: https://www.ars.usda.gov/alternativestoantibiotics/
21 Jan 2020 (London): BSAC’s 2nd Antimicrobial Chemotherapy Conference – An ABC for everyone involved in developing new antimicrobials. Go here for details.
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.” Go here for details.
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.
16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details.
18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)

Pew’s SPARK goes live / FDA on Master Protocols and Adaptive Designs / CDC’s Fungal Awareness Week

John Rex — Tue, 02 Oct 2018 08:30:17 +0000

Dear All: Potpourri! Four things of note…

First, Pew’s SPARK (Shared Platform for Antibiotic Research and Knowledge) has now gone live. Seeking to address a core issue in Pew’s Scientific Roadmap for Antibiotic Discovery, SPARK is a cloud-based sharing tool for data on how molecules enter and stay inside of Gram-negative bacteria. To learn more, mark your calendar for a 23 Oct webinar on the SPARK.

Second and third, FDA has released draft guidance documents on the design of both Master Protocols for Expedited Development of Oncology Drugs and of Adaptive Clinical Trials. Personally, I find both of these ideas to represent tantalizing ways that we as a community might design more efficient trial programs and networks.

Master Protocols have been used in Oncology to permit one protocol to to be used to study a test agent against multiple diseases (so-called “Basket Trials”) and to allow multiple drugs to be studied simultaneously against a specific disease (“Umbrella Trials”). We’ve not yet seen use of an Umbrella Trial for antibacterials, but the Basket Trial concept sounds a lot like the idea from FDA’s Unmet Need Guidance on how data on infections at more than one body site could be pooled.
Adaptive Clinical Trial Designs offer the potential to adjust the size of a trial, drop study arms, change randomization between study arms, and more. But, there are also many pitfalls in the design of same and I’ve not seen them used for antibacterials. It’s something we should explore further, I think.
Both guidance documents are in draft with comments requested. Our statistical colleagues need to get busy reading!

Finally, CDC’s first post-UNGA activity is Fungal Disease Awareness Week. At that link, you’ll find data types of fungal infections, environmental mould challenges after a disaster, CDC’s outbreak investigations, and much more. But, please do keep in mind that not all fungi are bad … Tom Volk’s discussions of the fungi necessary for a merry Christmas reminds us of the ways fungi are also useful.

All best wishes, –jr

Opportunities of interest for the AMR community

11 Oct 2018 deadline: Novo’s REPAIR Impact fund has re-opened for proposals during the window 4 Sep – 11 Oct. Read more and apply here.
24 Oct 2018 deadline: IMI AMR Accelerator programme Pillar A within IMI Call 15: Capability-building network to manage the whole accelerator and strengthen AMR science. This is a two-stage call, with letter of intent from applicants expected on 24 Oct 2018.
24 Oct 2018 deadline: IMI AMR Accelerator programme Pillar B: Tuberculosis drug development network within IMI Call 15: Tuberculosis drug development network to collaboratively progress TB compounds and validate new tools for TB drug development. This is a two-stage call, with letter of intent from applicants expected on 24 Oct 2018.
24 Oct 2018 deadline: IMI Call 16: A series of individual programs where a single EFPIA partner works with a consortium to progress compounds for for TB, non-tuberculous mycobacteria, and Gram-negatives. This is a one-stage call, with full proposal from the EFPIA and applicant consortium expected on 24 Oct 2018.

Upcoming meetings of interest to the AMR community:

[NEW and ONGOING] 1-5 Oct 2018 (CDC): Fungal Disease Awareness Week
3-7 Oct 2018 (San Francisco): ID Week
6-14 Oct 2018 International Course on Antibiotics and Resistance (ICARe, Les Pensières, Annecy, France)
[NEW] 23 Oct 2018 (online webinar): Introduction to Pew’s SPARK platform (Shared Platform for Antibiotic Research and Knowledge)
23 Oct 2018 (New York City): New York Academy of Sciences workshop entitled “New Therapeutic Strategies to Combat Antibacterial Resistance“
26 Oct 2018 (London): EMA information day for SMEs: “Regulatory toolbox for medicines and combined devices developers”. Here is the current agenda. Webcast will be available. More details from sme@ema.europa.eu.
29-30 Oct 2018 (Washington: BARDA Industry Days, a 2-day conference on countermeasure development for the US Government
7-9 Nov 2018 (Seville, Spain): Better Methods for Clinical Studies in Infectious Diseases and Clinical Microbiology: A Hands-on Workshop
8 Nov 2018 (Alderley Park, UK): Bionow’s 1-day Bioinfect conference
13 Nov 2018 (London): All-Parties Parliamentary Working Group on AMR meeting. Online materials here.
16 Nov 2018 (Berlin): Max Planck Institute for Innovation and Competition is organizing a conference on life sciences and innovation. Online materials here.
21 Nov 2018 (London): NICE- & APBI-sponsored masterclass: “Using non randomised data to estimate treatment effects in NICE submissions”. Details here.
29-30 Nov 2018 (Birmingham, UK): BSAC (British Society Antimicrobial Chemotherapy): Antibiotic Resistance Mechanisms Workshop for Researchers
7 Dec 2018 (Boston, MA) BAARN, Boston Area Antimicrobial Resistance Network 2018 symposium, 8:30am to 7pm at The Starr Center (185 Cambridge Street, Boston, MA). This is an excellent networking opportunity, especially for those based in the Boston area. Details not yet online.
14-15 Mar 2019 (Berlin): BEAM– and ND4BB-ENABLE-sponsored Berlin Conference on Novel Antimicrobials and AMR Diagnostics. Details here.
21-22 Mar 2019 (Birmingham, UK): BSAC Spring Conference.