Can you help? – AMR.Solutions https://amr.solutions Antimicrobial Resistance Solutions with Dr. John H. Rex Fri, 25 Sep 2026 10:14:24 +0000 en-US hourly 1 https://amr.solutions/wp-content/uploads/2022/04/Fire-Extinguisher-icon-70x70.png Can you help? – AMR.Solutions https://amr.solutions 32 32 #AMRSOS! GRAM report: “at least 1.27m deaths/year directly attributable to AMR” https://amr.solutions/2022/01/20/amrsos-gram-report-at-least-1-27m-deaths-year-directly-attributable-to-amr/ Fri, 21 Jan 2022 03:39:09 +0000 https://13.43.35.2/?p=6893

17 Sep 2024 update: This is now the first of a 3-part newsletter series! See also part 2 (“R&D Implications: Global Burden of Disease is 28% Infectious!“) and part 3 (17 Sep 2024: “#AMRSOS! AMR could worsen, killing 39m during 2025-2050”). See also the 31 Aug 2026 newsletter entitled “#AMRSOS! The (human) cost of AMR: Data from 19 countries in Asia” for data from a prospective cohort study that documents the substantial impact of AMR in Asia.

Dear All,

There are days when it is hard to keep up! Not only did we have the release today of two amazing sets of RFPs from NIAID and BARDA (Vaccines! Therapeutics! Diagnostics! Bacteria! Fungi! Viruses! See this newsletter!) but we also have the impressive GRAM (Global Research on Antimicrobial Resistance) report by Murray et al. Here are the details:

  • The paper: Murray CJL, Ikuta KS, Sharara F, Swetschinski L, Robles Aguilar G, Gray A, et al. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet: https://doi.org/10.1016/S0140-6736(21)02724-0.
  • The key message: “at least 1.27 million deaths per year are directly attributable to AMR”
  • The details (well, some of the details — I quote here from the abstract):
    • “We estimated deaths and disability-adjusted life-years (DALYs) attributable to and associated with bacterial AMR for 23 pathogens and 88 pathogen–drug combinations in 204 countries and territories in 2019.
    • “We obtained data from systematic literature reviews, hospital systems, surveillance systems, and other sources, covering 471 million individual records or isolates and 7585 study-location-years. 
    • “On the basis of our predictive statistical models, there were an estimated 4·95 million (3·62–6·57) deaths associated with bacterial AMR in 2019, including 1·27 million (95% UI 0·911–1·71) deaths attributable to bacterial AMR.
    • “At the regional level, we estimated the all-age death rate attributable to resistance to be highest in western sub-Saharan Africa, at 27·3 deaths per 100 000 (20·9–35·3), and lowest in Australasia, at 6·5 deaths (4·3–9·4) per 100 000.
    • “Lower respiratory infections accounted for more than 1·5 million deaths associated with resistance in 2019, making it the most burdensome infectious syndrome.
    • “The six leading pathogens for deaths associated with resistance (Escherichia coli, followed by Staphylococcus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Acinetobacter baumannii, and Pseudomonas aeruginosa) were responsible for 929 000 (660 000–1 270 000) deaths attributable to AMR and 3·57 million (2·62–4·78) deaths associated with AMR in 2019.
    • “One pathogen–drug combination, methicillin-resistant S aureus, caused more than 100 000 deaths attributable to AMR in 2019, while six more each caused 50 000–100 000 deaths: multidrug-resistant excluding extensively drug-resistant tuberculosis, third-generation cephalosporin-resistant E coli, carbapenem-resistant A baumannii, fluoroquinolone-resistant E coli, carbapenem-resistant K pneumoniae, and third-generation cephalosporin-resistant K pneumoniae.”
  • The context: These are the most comprehensive global estimates of AMR burden since the  2016 estimates by the UK AMR Review and the magnitude of mortality due to AMR is similar (see discussion at the bottom of page 21 of the paper).
  • The graphics (31 Jan 2022 addendum): I show one graphic a bit further below, but Andrew Jack at the FT has done a superb job with graphics from this report in his 19 Jan 2022 commentary. This chart in particular delivers a sharp message:
  • Another key message: No one is safe: There are some really scary figures showing spread of highly resistant organisms. I show here the pattern of K. pneumoniae resistant to 3rd-generation cephalosporins (upper, these are the preferred first-line drugs) and carbapenems (lower, these are the backup agents … when these fail, you are in trouble). Purple is lowest rate of resistance, blue-green is < 50%, yellow-red is > 50%. As you can see, the resistant pathogens are steadily spreading: 



Wow! Wow! WOW! We’ll be referring to this one for years. MANY thanks to the impressive array of project sponsors: 

  • Institute for Health Metrics and Evaluation (IHME) (@IHME_UW)
  • University of Oxford  (@UniofOxford)
  • Wellcome Trust  (@WellcomeTrust),  (@Wellcome_AMR)
  • The Fleming Fund  (@FlemingFund)
  • UK Department of Health and Social Care (DHSC) (@DHSCgovuk),
  • Global Health Security, DHSC (@UKgovGHS)
  • The Bill and Melinda Gates Foundation  (@gatesfoundation),
  • The Lancet  (@TheLancet)
  • Dame Sally Davies, UK Special Envoy on Antimicrobial Resistance  (@UKAMREnvoy)


And, of course, the core message is that we’re in trouble. The antibacterial pipeline is thin (17 Jan 2022 newsletter), R&D for new antibacterial takes years (Dheman 2020 CID and the accompanying Rex-Outterson editorial), and (finally!) the economics of new antibiotics are horrid and require a fix in the form of substantial Pull Incentives paid to innovators upon approval of meaningful new therapies.

Our work is cut out for us! #AMRSOS! Get going!

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

Current funding opportunities (most current list is here):

  • NIAID has released a four-pronged BAA (Broad Agency Announcement (HHS-NIH-NIAID-BAA2022-1) that covers therapeutics (antibacterial, antifungal, antiviral), vaccines (again, all 3 areas), and diagnostics. Lots of possibilities! The due date is 18 Mar 2022.
  • BARDA’s RFP to support new antibiotics for Yersinia pestis, Francisella tularensis, Burkholderia pseudomallei is open through 6 April 2022. The RFP offers from funding from LO to Phase 2. Go here for the details.
  • JPIAMR’s 14th call is now open. Entitled “Disrupting drug resistance using innovative design”, the call seeks consortia that would seek to “improve the treatment of bacterial and fungal infections (including co-infection) and/or the prevention of the emergence/spread of resistance in humans, animals or plants through the improvement of the efficacy, specificity, delivery, combinations and/or repurposing of drugs and plant protection agents.” Bacteria, fungi, human health, animal health, and plant health are all in scope! Pre-proposals are due 8 Mar 2022; full proposals would be due 5 July 2022. Go here for 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 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/).
  • 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):

  • [If you missed it, you can now watch the video] 8 Dec: “The New Winds Pushing and Pulling Antibacterial Development.” This was a GREAT program that featured talks from the UK team behind the NHS “Netflix” pilot, Kevin Outterson’s recently released report documenting the need for global Pull incentives to have a value of $2.2 – 4.8b, and speakers covering PASTEUR and work in the EU on pull incentives. The video is here — please make time to listen to this program!
  • 26 Jan 2022 (virtual, 2-3.30p CET): REVIVE (GARDP) Webinar: New technologies and strategies to overcome the challenges of sexually transmitted infections. Moderated by Amir Schroufi and Remco Peters, the program will covers strategies for managing STDs with a particular focus on the developing world. Go here to register.
  • 2-3 Feb 2022 (virtual): 10th Advances Against Aspergillosis and Mucormycosis. Registration closes on 30 Jan 2022. Go here for details.
  • 2-3 Feb 2022 (virtual): Antimicrobial Chemotherapy Virtual Conference jointly organised by GARDP with the British Society for Antimicrobial Chemotherapy (BSAC), Center for Disease Dynamics, Economics & Policy (CDDEP) and the Indian Council of Medical Research (ICMR). Click here for details.
  • [NEW] 4 Feb 2022 (virtual, 5-6.30p GMT): Launch of the GRAM (Global Research on Antimicrobial Resistance) report. Sponsored by the Institute for Health Metrics and Evaluation, the University of Oxford, the Fleming Fund, the Bill & Melinda Gates Foundation and Wellcome Trust, this report by Murray et al. is based on 471 million individual records or isolates and 7585 study-location-years’ worth of data and shows that at least 1.27 million deaths per year are directly attributable to AMR. Amazing stuff! #AMRSOS! Go here to register. If you miss it, a post-event recording will be available.
  • 7 Feb 2022 (virtual, 10a-11.30a and 3:30p-5p CET): 2-part webinar entitled Antimicrobial Consumption & Use – Data for Action as part of the WHO Global Webinar Series. Be sure to register for both session 1 and session 2! 
  • 3-6 Mar 2022 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Details are here.
  • 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.
  • 9 Mar 2022 (virtual, and in-person): BioInfect Conference, Alderley Park, UK (near Manchester). This long-running Bionow-sponsored annual conference draws a very strong audience. Go here for details.
  • 7-8 Apr 2022 (Basel and in person, we hope): The 6th edition of the annual AMR conference sponsored by the BEAM Alliance, CARB-X, the Novo REPAIR Impact Fund, the IMI Accelerator, and the European Biotechnology Network. Go here for the hold-the-date page and a way to be kept informed about the meeting. 
  • 9-13 May 2022 (Athens and online): 40th Annual Meeting of the European Society for Paediatric Infectious Diseases, 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.
  • 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.
]]> How the sausage is made: A day of advocacy for PASTEUR https://amr.solutions/2023/09/15/how-the-sausage-is-made-a-day-of-advocacy-for-pasteur/ Fri, 15 Sep 2023 19:38:40 +0000 https://13.43.35.2/?p=10329

Dear All,

Along with more than 50 others, I spent Tuesday 12 Sep 2023 on Capitol Hill visiting offices of members of Congress (Senate and House) seeking support for the PASTEUR Act.

If you’re a regular reader, you’ll know that we now have substantial bipartisan support for PASTEUR: it was re-introduced as The Pioneering Antimicrobial Subscriptions To End Up-surging Resistance (PASTEUR) Act of 2023 (H.R. 2940, S. 1355) by Senators Michael Bennet & Todd Young and by Representatives Scott Peters, Drew Ferguson, Mike Levin, & Jake LaTurner.

The goal of 12 Sep 2023 was to build that support by visiting Senate and House offices of members of Congress who were not yet co-sponsors of the Act, raise awareness, and hopefully get them to become co-sponsors and thereby ensure passage during this session of Congress.

The day was organized by 5 leading organizations: the Biotechnology Innovation Organization (BIO), the Cystic Fibrosis Foundation (CFF), the Infectious Diseases Society of America (IDSA), the Partnership to Fight Infectious Disease (PFID), and The Pew Charitable Trusts as a follow-on to their previous joint statements of support for PASTEUR,

In the course of the day, my team of five visited 6 offices (two senators, 4 representatives); collectively, over 70 offices were visited. I’ve learned that visits of this type are a well-practiced process, but the scale of this day with about a dozen teams visiting multiple offices was impressive.

In each office, we meet with staff who were willing to consider the idea for / with their member of Congress. In my team’s visits, there was consistently good awareness of the concept of AMR and an interest in hearing more about PASTEUR. The questions raised were as I would have expected:

  • What will it cost? 
  • Why is this a benefit to US citizens and / or my district?
  • Who is already supporting? 

We were ready with answers to all of this:


Especially important to me were questions on how we ensure that we’re buying useful new antibiotics. On this, it was incredibly helpful to be able to explain and support the selective nature of PASTEUR by pointing to the UK’s fabulous pilot project and to be able to back this up if needed with facts about how Canada, the EU, and Japan are in the game. Years and years of effort have gone into building those consensus ideas … many thanks are due to those involved in DRIVE-AB, the UK AMR Review, creation of the principles of STEDI, and so much more.

—
Wow! What a great day … and I am impatient but optimistic about PASTEUR! We’ve never had more co-sponsors, never visited this many offices in one day, never had such broad and deep understanding of the issues on the Hill. And, the fact that the key stakeholder groups spent so much time and energy on Hill visits last week tells you that they see value investing more at this moment.

The day ended with a reception for hill staffers … by my guess, there were > 150 attendees. We heard brief comments by several members of congress and then there was a special guest: Rob “Gronk” Gronkowski (4-time Super Bowl champion tight end) who took the time to attend and call out his support in particular to push for new options for managing Valley Fever (coccidioidomycosis). Having support from this well-known football player is incredibly helpful in terms of both public engagement and creating impact on the Hill for PASTEUR — many thanks to Gronk for making time to attend!

And those of you who are US citizens can reinforce the messages from Gronk and the five societies! To do so, please use this alert from IDSA. The alert is open to everyone in the US—you don’t have to be an IDSA member. Individuals can personalize the message to Congress that IDSA developed. These messages really are read by congressional staff, and if they receive a lot of them, it can significantly increase the likelihood of a Representative or Senator cosponsoring the bill. IDSA has made this alert quick and easy … so please do it now and also share this with your friends!

—
Wow! It was absolutely fascinating to have a glimpse of how the sausage is made (see footnote below my signature), to discover a fabulous bit of signage in one of offices regarding hand hygiene, and to have a chance to really appreciate the value of the years of effort that have gone into creating the multi-stakeholder support for PASTEUR. Woot, woot!

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With thanks 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.

PS: The full quote is “Laws are like sausages, it is better not to see them being made” and is generally attributed to Otto von Bismarck (1815-1898), the Prussian statesman.

Current funding opportunities (most current list is here)

  • 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.
  • 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/).
  • 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):

  • 18 Sep 2023 (virtual, 3-4p CET): Jointly hosted by the US CDC and the WHO, a webinar entitled “Fungal Diseases – Global Challenges and Opportunities” will kick-start CDC’s Fungal Disease Awareness Week (FDAW). The goal of the webinar is to provide an in-depth perspective on fungal diseases and discuss challenges related to antifungal resistance. Go here to register; the full program for the week can be seen at the FDAW webpage.
  • 19-22 Sep 2023 (Boston, USA): ASM-ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent development focused meeting … highly recommended! Go here for details and to register. 
  • 21 Sep 2023 (New York City, USA, in person 6.30-8.00p ET): In partnership with the governments of the UK and Nigeria, the Center for Global Development (CGD) will launch its final report from a CGD working group studying possible purchasing systems that will improve access, stewardship, and innovation for antimicrobials in LMICs at an event entitled “A Path Towards Affordable and Effective Antimicrobials: Six Recommendations to Improve Antimicrobial Innovation, Access, and Stewardship,” Go here for more details and to register: the event will be held at the Sixth Floor Loft (873 Broadway, Sixth Floor, New York, NY 10003). The discussion will focus on the political and operational steps needed to ensure access to and stewardship of affordable and effective antimicrobials — and you can readily see how this is is step towards building consensus around priorities for the discussion of next year’s high-level meeting (HLM) at UNGA 2024.
  • 27 Sep 2023 (virtual, 10a-11a EST):  Milken Institute webinar entitled “What’s Next for the UK’s Subscription Model in the Fight Against Antimicrobial Resistance”. 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. 
  • 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.
  • [NEW] 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.x
  • 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.
  • 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.
]]> NIAID BAA – Biodefense focus / Fireside Chat on diagnostics and more https://amr.solutions/2023/01/29/niaid-baa-biodefense-focus-fireside-chat-on-diagnostics-and-more/ Sun, 29 Jan 2023 23:26:55 +0000 https://13.43.35.2/?p=9117

Dear All,

We are swimming in Broad Agency Announcements aka BAAs! As a refresher, I recently shared a BAA from the CDC and one from BARDA — now we have another one from NIAID! There’s a strong biodefense angle here with lots of scope. Key details of each opportunity are as follows and I highly recommend you check out the BAA itself after reading this newsletter:

  • Research Area #001 – Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases. Advancing specific vaccine candidates that utilize technology platforms that ideally elicit a rapid onset of immunity following a single dose, provide a durable response and are readily adaptable to multiple emerging pathogens. Due date: 11 Apr 2023, 3p ET.
  • Research Area #002 – Development of Therapeutic Candidates for Biodefense, Antimicrobial Resistant (AMR) Infections and Emerging Infectious Diseases. Development of new therapeutics for diseases caused by NIAID Emerging Infectious Diseases/Pathogens including Category A, B and C priority pathogens and certain bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report. Due date: 11 Apr 2023, 3p ET.
  • Research Area #003 – Antiviral Program for Pandemics (APP): Development of Antivirals for RNA Viral Families of Pandemic Potential. The Antiviral Program for Pandemics aims to develop safe and effective antivirals to combat SARS-CoV-2, the virus that causes COVID-19, as well as to build sustainable platforms for targeted drug discovery and development of a robust pipeline of antivirals against viruses with pandemic potential. Due date: 13 Mar 2023, 3p ET.
  • Research Area #004 – Development of In Vitro Diagnostics for Biodefense, Antimicrobial Resistant Infections, and Emerging Infectious Diseases. NIAID is interested in supporting the development of promising diagnostics technologies in three areas for detection of signatures from biothreat pathogens and toxins, as well as pathogens causing emerging, reemerging, antimicrobial resistant infectious diseases, and for pandemic preparedness. Due date: 11 Apr 2023, 3p ET.

Note the different deadlines for each Research Area! Please share with anyone you think would be interested in this announcement. 

I’m please to see the specific Research Area on diagnostics. For those interested in that area, the Duke-Margolis team held a roundtable entitled “Advancing Bacterial Diagnostic Coverage, Reimbursement, and Utilization” last June and have recently released their meeting summary.

Further, my next guest on Fireside Chats may inspire your diagnostic thinking! I met Tina Joshi of the University of Plymouth because she asked me to be in her short educational film for young people. She then agreed to sit down for a Fireside Chat and we had a lively discussion on a variety of topics. Her work on diagnostics is fascinating and I truly enjoyed hearing her perspective on public health advocacy, particularly during the height of COVID-19. Check it out now!

This ~34 min chat was great fun. Tina’s enthusiasm for diagnostics and AMR awareness is infectious!

This ~55 min movie is an educational movie for families and 9-11 year olds on the basics of AMR. Key themes are tackling AMR, hand hygiene and how to make a difference. Well done to Tina and her team!

 

All best wishes, –jr

P.S. If you haven’t called your government representative about PASTEUR yet, this is your reminder to do it now!

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.
  • CDC have announced a very eclectic BAA that covers topics as diverse as surveillance and novel endpoints! White papers are due 3 Feb 2020 — 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.
  • [NEW] 2 Feb 2023 (virtual, 10.00-14.00 ET): “Addressing The Challenges,” part 2 of a 2-part series entitled “Improving the Investigation of New Antibacterial Agents for Use in Children.” Convened by I-ACT (Institute for Advanced Clinical Trials for Children) and chaired by I-ACT’s Chief Medical Officer (Gary Noel), this webinar series features an outstanding faculty from Industry, Academia, and Regulatory (both FDA and EMA). Go here for details and to register.
  • 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.
  • [UPDATED DATES] 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.
  • 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.
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]]> Amended Indian PPL slide / SUPERBUGS Act / Novo REPAIR Global Call https://amr.solutions/2021/03/18/amended-indian-ppl-slide-superbugs-act-novo-repair-global-call/ Fri, 19 Mar 2021 01:31:32 +0000 https://13.43.35.2/?p=4642

Dear All,

Three bits of news you can use…

First, when I wrote yesterday about the new Indian Priority Pathogen List (PPL), I said that it was similar to the WHO PPL list except for the addition of Staphylococcus epidermidis (and speculated that this relates to the role of S. epidermidis in neonatal sepsis). Well, it was late and I missed something: I’ve also now realized that the Indian PPL swaps Neisseria gonorrhoeae (WHO High Priority) for N. meningitidis (Indian Medium Priority). As with the case for S. epidermidis, I’d guess this reflects local epidemiologic issues. I’ve updated the PowerPoint slide deck that summarizes all the PPLs.

Second, US Representative Mike Levin (D-CA) has proposed the SUPERBUGS Act of 2021 (Saving Us from Pandemic Era Resistance by Building a Unified Global Strategy Act of 2021 … somebody definitely had fun with that acronym!). The heart of the Act is a proposal that the USG shall “formulate a strategy for entering into agreements with foreign countries to help to develop and commercialize (including through contracts with the private sector) new drugs to address pandemics, including antimicrobial drugs.” I love it … no matter where this goes, it shows that the message regarding pandemic preparedness is permeating the political conversation! Thank you, Rep. Levin!

Finally, I have learned that the Novo REPAIR Impact Fund is going to open its next global funding call on 1 April 2021. As context, the REPAIR Impact Fund seeks to invest EUR 135 (USD 165) million over 5 years into novel therapies that are between lead optimization and phase 1 clinical trials. The Fund has already made 9 investments. Might you be next? Sharpen your pencils and go here for details: https://www.repair-impact-fund.com/investment-process/.

Woot, woot! I love the momentum! 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):

  • [IMPORTANT UPDATE] Novo REPAIR Impact Fund will open its next global call on 1 April 2021. Go here for current details.
  • [NEW] 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.
  • 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):

  • 15-18 Mar 2021 (virtual, EU afternoon timing): The Uppsala Health Summit is focusing this year on “Managing Antimicrobial Resistance through Behaviour Change.” This is a multi-disciplinary and multi-stakeholder (policy, industry, academia, civil society) program that focuses on a different topic each year. Go here to for more details.
  • 24 Mar 2021 (online, 2.30-4p CET): GARDP-sponsored webinar entitled “Discovering and developing new treatments for tuberculosis,” moderated by Lydia Nakiyingi. Go here to register.
  • 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 17th 2021; no previous JPIAMR funding required.
  • 9-12 Jul 2021 (virtual): Annual ECCMID meeting (#31)
  • 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.
  • 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.
  • 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.
]]> NHS England Antibiotic Procurement Pilot: Call for applications! https://amr.solutions/2020/06/22/nhs-england-antibiotic-procurement-pilot-call-for-applications/ Mon, 22 Jun 2020 06:00:44 +0000 https://13.43.35.2/?p=2637

Dear All,

As has been discussed in recent newsletters (link), the UK National Institute for Health and Care Excellence (NICE) and NHS England launched a joint project July 2019 to test a payment model for antibiotic products, based on a product’s value to the NHS, rather than how much is used. This goal of the project is to incentivise companies to invest in researching and developing new antibiotics while helping secure much-needed alternative treatment options for NHS patients.

This will be the world’s first serious delinked incentive for antibiotics and is a really, really big deal! For more background, see the newsletter link above as well as this summary of prior literature on delinked models (link).

As a summary, the goal of the project is to select two drugs: one that received marketing authorisation in the UK between January 2017 and December 2019; and one that will receive a new marketing authorisation between January and December 2020. Both products will then undergo a health technology assessment (HTA) by NICE throughout 2021 using adapted methods for antimicrobials. The HTA will be used to estimate the value of each of the antibiotics
.
Today’s news is that suppliers can now register their interest for the scheme on NHS England’s eTendering Service, for which the deadline is 22nd July 2020. The link to the summary notice of the tender is no longer available (2 Feb 2024 update) but companies interesting in making a tender offer to the NHS can register here.

The clock is ticking: companies that meet the qualifying criteria will then be selected by 31st July 2020. Following this date, the product selection phase will take place with decisions by Dec 2020 — the expectation is that contracts will commence from April 2022.

Further information on the announcement can be found:

  • The UK Government website (link):   
  • The NICE website (link)

This is really happening! Wow! Wow! Wow! Go, Team UK! 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:

  • Novo REPAIR Impact Fund is open for global applications through 21 Jul 2020. Go here for current details.
  • 2020 funding rounds for CARB-X have not been announced.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.


Upcoming meetings of interest to the AMR community:

  • [NEW] 25 June 2020 (online, 13:00-14:00 CEST): JPIAMR webinar. Title: “Antibiotic Use: Have antibiotics been appropriately used in the COVID-19 pandemic?” Speaker: Jesús Rodriguez Baño will moderate a global panel discussion. Go here to register.
  • 25 Jun 2020 (online, 14:00-15:00 CEST): GARDP REVIVE webinar. Title: “Putting children first in the fight against antibiotic resistance.” Speakers: Manica Balasegaram, Hanan Balkhy, Stafan Peterson. Go here register.
  • [NEW] 25 June 2020 (online, 14:30-15:30 CEST): JPIAMR webinar. Title: “AMR Research: Facilitating AMR research in the COVID-19 pandemic” Speaker: Till Bachmann will moderate a global panel discussion. Go here to register.
  • 30 Jun 2020 (online, 17:00-18:30 CEST): GARDP REVIVE webinar. Title: “Clinical development of antimicrobials – Phase 1 development challenges.” Speaker: Markus Zeitlinger. Go here to register.
  • 9 Jul 2020 (online, 09:00-10:30 CEST): GARDP REVIVE webinar. Title: “The challenges and opportunities for antimicrobial R&D in low- and middle-income countries – India case study.” Speaker: Anand Anandkumar and Kamini Walla. Go here to register.
  • 17 Jul-2 Aug 2020 (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.
  • [UPDATED] 27 Jul-31 Jul 2020 (online): Small World Initiative Instructor Training Workshop – training for undergraduate professors and high school teachers in wet lab techniques, parallel curricula, & pedagogical instruction to engage students in the hunt to find new antibiotics in soil (also covering distancing learning options). Go here to register.
  • 4 Aug 2020 (Silver Spring): FDA workshop entitled “Development Considerations of Antifungal Drugs to Address Unmet Medical Need.” Go here to register.
  • 5 Aug 2020 (Silver Spring): FDA workshop entitled “Developing Antifungal Drugs for the Treatment of Coccidioidomycosis (Valley Fever) Infection.” Go here to register.
  • September 2020. University of Sheffield (UK). Applications are being taken for a new 1-year (full-time) or 2-year (part-time) Masters of Science course in Antimicrobial Resistance. The program runs annually from September and covers microbiology, clinical practice and policy. The course webpage is here.
  • 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • 26-29 Oct 2020 (online meeting), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)
  • 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.
  • 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.
  • 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.
]]> Fireside Chat with BARDA’s Branch Chief for Antimicrobials https://amr.solutions/2023/11/12/fireside-chat-with-bardas-branch-chief-for-antimicrobials/ Sun, 12 Nov 2023 23:16:32 +0000 https://13.43.35.2/?p=10874

Note: Be sure to take advantage of the BARDA Industry Day(s) event that occurs Monday-Tuesday of this coming week … see newsletter and forward calendar for details.

Dear All,

In what could be called Part 2 of Excellent 2023 ASM/ESCMID Talks (read the newsletter on Jen Cohen’s talk on how manufacturing underpins both access and stewardship), today we have a video of the closing keynote speech from Mark Albrecht, Branch Chief of Antimicrobials at BARDA!

I was so impressed and excited by Mark’s talk that I knew it had to be shared with more than just the ~100 people who happened to still be in the room for the final hour of the meeting. It’s a masterful summary of all the work BARDA has been up to and I can’t recommend it enough to all in the AMR space.

The link to the YouTube video is evidently below this paragraph. If you look at the description box on YouTube, you’ll find timestamps to guide you through the highlights and each slide. We’ve also got a link to download a .pdf of the slides here.

The talk covers BARDA’s activities broadly but also discusses BARDA’s BAA. For more on the BAA, see the newsletter I wrote about it: Areas 3 and 7 are the ones to note in particular. If you are interested in applying for support, note especially that

  • Details on the right initial BARDA contact are in the BAA and you should not be shy about opening up a dialogue with that person — they will be pleased to chat!
  • BARDA’s Tech Watch meetings are a great way to test the waters with BARDA and the entire USG! As Mark explains during the video, BARDA will work in these meetings to steer your project to the right US government department should it not be a good fit for BARDA itself.

Finally, I’d like to remind you that BARDA Industry Day(s) event is Monday-Tuesday (13-14 Nov) of this coming week and you can attend virtually. BARDA is foundational to major game changers like CARB-X (which gets a shoutout at Slide 15 in the video!) and it is eager to extend support to others. The agenda includes a wide variety of talks that might give you ways to think about collaborating. Could it be your company? Your project? There’s only one way to find out and that is by reaching out to BARDA! 

Kudos to Mark and Team BARDA! Keep up the good work!

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)

  • 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 a 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! See also this newsletter for further comments on the BAA and its areas of interest.
  • FDA have released a BAA covering a wide variety of regulatory topics. See this newsletter for general details; also note in particular an RFP for work on urine-specific breakpoints for uUTI. Early concept papers are due 6 Nov 2023; full proposals are due 19 Feb 2024.
  • PACE (Pathways to Antimicrobial Clinical Efficacy), a £30 million initiative supporting early-stage innovation, has been created by jointly by Innovate UK, LifeArc, and Medicines Discovery Catapult (MDC). An initial round of up to £10 million in grant funding is available to support up to 12 projects focused on developing new treatments for the most threatening microbes and resistance mechanisms. Applications are welcomed from any part of the world for projects expected to last up to two years and with total funding of up to £1 million per project. Expressions of interest are invited by 24 November, and an informational webinar will be held on 31 October.
  • [NEW] The GHIT (Global Health Innovative Technology) Fund has opened two calls for proposals. Both require an Intent to Apply form no later than 10am JST on November 28, 2023 and then a Full Proposal by 10am JST on January 12, 2024. 
    • 16th Request for Proposals for the Target Research Platform to support the early-stage discovery and development of novel technologies and approaches for new drugs, vaccines, or diagnostics for malaria, tuberculosis, and Neglected Tropical Diseases. Details are found in RFP-TRP-2024-001 and the Intent to Apply form.
    • 23rd Request for Proposals for the Product Development Platform to support the development of new drugs, vaccines, or diagnostics for infectious diseases that are prevalent in the developing world. Proposed projects will need to be between eligible Japanese and non-Japanese organizations. Details are found in RFP-PD-2024-001 and the related Intent to Apply form.
  • ARPA-H have an Open BAA that is accepting applications through 14 March 2024. It is quite wide-ranging in its scope and definitely includes AMR-related projects. See this newsletter for discussion of the BAA and an AMR project that it now supports.
  • 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 PERSONAL FAVORITE 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!
  • 13-14 Nov 2023 (virtual and Washington DC, USA): BARDA Industry Day 2023. Go here for more details. 
  • 14-15 Nov 2023 (Rockville, Maryland, USA and virtual): NIAID workshop entitled “Systematic Approaches for ESKAPE Bacteria Antigen Discovery”. Go here for details.
  • 16 Nov 2023 (online, noon-1.30p CET): WHO quadripartite webinar entitled “Results from the Tracking Antimicrobial Resistance Country Self- Assessment Survey (TrACSS).” Go here to register.
  • [WAAW!] 18-24 Nov 2023 (multiple events online and globally): World Antibiotic Awareness Week (WAAW) with the One Health theme “Preventing antimicrobial resistance together” (same as for 2022). The WHO’s main webpage is here; both the US CDC and the EU ECDC have a webpage for WAAW. The WHO home page provides an events calendar; events posted thus far are wide-ranging: HIV, AMR, youth engagement, pediatrics, and equitable access, just to name a few.
  • [WAAW!] 21 Nov 2023 (virtual, 10-11a ET, 4-5p CET): “The Voice of AMR Survivors in Awareness and Advocacy,” a webinar organized as part of WAAW by the WHO Taskforce of AMR Survivors. I am very pleased to see the emergence of active AMR patient advocacy groups — we have been missing this! Go here to register for this webinar!
  • [NEW & HIGHLY RECOMMENDED] 12 Dec 2023 (virtual, 1-2.15p ET): Duke-Margolis presents the third and final installment of their webinar series for policymakers combating AMR with a webinar entitled “Improving Regulatory Practices to Sustain Antibiotic Innovation.” The webinar will feature perspectives from experts affiliated with the FDA, Industry, GARDP, CARB-X, and the Center for Global Development. HIGHLY RECOMMENDED! Go here to register; prior webinars occurred on 9 May 2023 on the Need for New Antibiotics, and on 29 Aug 2023 on Preparedness for AMR Threats (also see their related October 2023 report on Preparedness and Post-Market Incentives for Novel Antibiotics).
  • [NEW] 24 Jan 2024 (online, 9a-1p London): Webinar entitled “Priorities and next steps for tackling antimicrobial resistance in the UK”, sponsored by the Westminster Health Forum. Featured speakers include Dame Sally Davies and the focus is on the UK’s 20-year vision and 5-year action plan for AMR. Go here for details and to register.
  • 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, 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. PERSONAL FAVORITE.
  • 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. PERSONAL FAVORITE.
  • 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. PERSONAL FAVORITE.
  • 16-24 Oct 2023 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Limited details as yet on line, watch https://idweek.org/ for updates. PERSONAL FAVORITE.an
]]> A Nature Article, a PASTEUR Act Op-Ed, and a VERY Important Phone Number https://amr.solutions/2022/09/19/a-nature-article-a-pasteur-act-op-ed-and-a-very-important-phone-number/ Mon, 19 Sep 2022 14:17:33 +0000 https://13.43.35.2/?p=8443

Dear All,

First, Nature published an excellent article entitled “The importance of antimicrobial resistance in medical mycology” by Gow et al. The first sentence of the introduction really packs a punch — “The age of antibiotics, spanning only 80 years, is now entering a period of progressive and widespread emergence of drug-resistant organisms that threaten to bring this era to an end“. Indeed, indeed … and as you would guess from the title, this article goes beyond our usual topic of antibacterial resistance to the the problem of antifungal resistance.

For those not familiar with the challenges of finding new antifungal agents, the essential point is that we are relatively closely related to the fungi genetically and thus “The eukaryotic biochemistry of fungi makes them particularly pernicious pathogens because of a more limited number of selective drug targets against which inhibitors can be designed…”. Recommended reading!
—
Second, Senator Todd Young of Indiana released an op-ed about the PASTEUR Act that discusses AMR in an easy to understand language. If you ever wanted to share an article with someone who was unfamiliar with the issues around AMR, this one might be a good starting point. Some of my favorite quotes from the article:

  • “Our health system must preemptively combat antibiotic resistance and ensure we do not return to an era when even a simple medical procedure could be deadly.”
  • “Currently, the drug reimbursement system in our country rewards volume, not value. The federal government pays for antimicrobials in a way that fails to drive innovation or appropriate use. The PASTEUR Act would introduce a new model for paying for novel antimicrobials—one that incentivizes the development of antimicrobials based upon the value they provide for public health, rather than the volume used.“

—
Finally, a call to action that builds on Senator Young’s op-ed! I’ve previously provided details about how to write to your Congressional representatives but now I’m asking for you to call the Capitol operator at +1-202-224-3121 and ask to speak to the offices of Rep. Pelosi, Rep. McCarthy, Sen. Schumer, or Sen. McConnell. Once connected, ask to leave a message with the Senator/Representative about both the PASTEUR Act and the FORWARD Act. If you need some inspiration as to what to say, here are my talking points:

  • Hello, my name is John Rex and I am a board-certified internist and Infectious Disease specialist who has spent 30+ years working to develop the types of drugs needed to treat lethal infections. 
  • I’m calling today to encourage you to support both the PASTEUR Act and the FORWARD Act. 
  • These two Acts will protect all of modern medicine by supporting the development of critically important new antibiotics for bacterial and fungal infections.
  • To understand the problem, ii is important to recognize that antibiotics are the fire extinguishers of medicine!
    • Infections, like fires, occur suddenly and progress quickly … and we have to prepare in advance to put them out / treat them!
    • When a fire breaks out in a house, you’re always able to reach for a fire extinguisher instantly.
    • But unlike our good support for fire extinguishers and fire departments, we don’t currently have a way to pay in advance for the antibiotics needed for highly resistant infections — and this puts all of modern medicine at risk!.
  • Because of the broken economics of new antibiotics, the global pipeline of new antibiotics is dangerously thin
  • Even now there are infections that cannot be adequately treated — and it is thus possible for a cancer patient to die of an infection even though their cancer is cured! 
  • The PASTEUR Act and the FORWARD Act are key to addressing this threat to modern medicine and I’d ask you to make them a priority. The entire modern medical system as we know it depends on antibiotics–this is a matter of life and death. 
  • Thank you!

I know it may feel uncomfortable to reach out in this way, but voices from the community really do make a difference! You can also write to them instead if you would prefer! Or in addition to! And, don’t forget about the opportunity to sign those letters to the California and Texas legislative legislative contingents. This is a critical time for FORWARD and PASTEUR: the more voices speaking out in support of both these initiatives, the better.

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 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.
  • [updated] 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/).
  • 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):

  • 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
  • [NEW] 21 Sep 2022 (virtual): Joint webinar from the WHO Nursing & Midwifery Department and WHO Antimicrobial Resistance Division entitled “Infection Prevention and Antimicrobial Stewardship – The Role of Nurses in Preventing AMR”. Go here for details. 
  • [FDA AdComm … don’t miss it!] 22 Sep 2022 (virtual, 8.30-5.00p ET): FDA Advisory Committee discussing an application for approval of Rebyota (Fecal Microbiota, Live) with a requested indication to “reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent Clostridioides difficile infection.” The P3 data on this product showed superiority over placebo … and the AdComm will be an important master class for everyone interested in microbiome-based therapies. 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.
  • [NEW] 13-14 Oct 2022 (virtual, 8.30a-5p ET). Workshop entitled “Accelerating the Development & Uptake of Rapid Diagnostics to Address Antibiotic Resistance.” Convened by the National Academies’ Forum on Drug Discovery, Development, and Translation, Forum on Medical and Public Health Preparedness for Disasters and Emergencies, and Forum on Microbial Threats (wow, say that 3 times fast!), this workshop has a broad-ranging agenda focused practical approaches to developing rapid, point-of-care diagnostics. Go here for details and to register.
  • 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.
  • 15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6th 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.
  • 23 Oct 2022 (Cape Town, South Africa): Symposium entitled “Tackling AMR: How implementation research is vital in a One Health approach” 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.
  • 3-7 Dec 2022 (Banff, Canada): Novel Approaches Against Emerging Antimicrobial Resistance by Keystone Symposia. Go here for details. 
  • 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.
]]> Support the FORWARD and PASTEUR Acts by signing a letter! https://amr.solutions/2022/09/02/support-the-forward-and-pasteur-acts-by-signing-a-letter/ Fri, 02 Sep 2022 17:06:42 +0000 https://13.43.35.2/?p=8232

Dear All,

I’ve written before about the FORWARD Act, a bill introduced last year into Congress with the goal of supporting research in to treatment of endemic fungal diseases with a particular focus on coccidioidomycosis (*). It’s easy to see how this bill and the PASTEUR Act are mutually supportive … both seek to build and maintain the technical and people infrastructure needed to repair gaps in our antibacterial/antifungal armamentarium. 

Today, our colleagues at the Valley Fever Institute (VFI) of Kern County Medical are continuing their advocacy work (i.e., their call to action on the 18 May 2022 “Squash Superbugs Day of Action”; their graphical call to action shown below my signature) with an open letter to California’s US Congressional delegation. The message in the letter is simple:

  1. Valley Fever (aka, coccidioidomycosis, an invasive fungal infection) is a growing problem,
  2. California takes a lot of the burden of Valley Fever,
  3. And the passage of FORWARD + PASTEUR would make a difference!

If you’d like to support this push, you can view the draft letter here and sign it here on or before 10 Sep 2022. It’s really that simple!

But wait, there’s more! And in parallel, our colleagues at the Valley Fever Center for Excellence at the University of Arizona, have crafted a similar letter addressed to Arizona’s Congressional delegation. You can read and sign the letter here.

I am told that a letter to the Texas delegation is also in the works but that can be for a subsequent newsletter. Let’s go on and get these two signed. Importantly, everyone can sign both letters — your geography does not matter! Now is the time to keep building the political momentum for PASTEUR and FORWARD!

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.

*And for complete transparency, this would be a good time for me to re-iterate that I’m not an entirely disinterested observer with respect to FORWARD and PASTEUR. As noted on my bio page, I am the Chief Medical Officer for a privately owned biotech working on a novel antifungal compound. In addition, I work broadly across Industry to drive support for innovation.

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:
  • 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.
  • [updated] 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/).
  • 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):

  • 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.
  • 15 Sep 2022 (virtual, 2-4p ET): Duke-Margolis webinar entitled “Advancing Bacterial Diagnostic Development.” The Duke-Margolis webinars are always informative … this one will focus on strategies for regulatory clearance of new diagnostics. Go here for more details and to register.
  • 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
  • [FDA AdComm … don’t miss it!] 22 Sep 2022 (virtual, 8.30-5.00p ET): FDA Advisory Committee discussing an application for approval of Rebyota (Fecal Microbiota, Live) with a requested indication to “reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent Clostridioides difficile infection.” The P3 data on this product showed superiority over placebo … and the AdComm will be an important master class for everyone interested in microbiome-based therapies. 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.
  • [NEW] 13-14 Oct 2022 (virtual, 8.30a-5p ET). Workshop entitled “Accelerating the Development & Uptake of Rapid Diagnostics to Address Antibiotic Resistance.” Convened by the National Academies’ Forum on Drug Discovery, Development, and Translation, Forum on Medical and Public Health Preparedness for Disasters and Emergencies, and Forum on Microbial Threats (wow, say that 3 times fast!), this workshop has a broad-ranging agenda focused practical approaches to developing rapid, point-of-care diagnostics. Go here for details and to register.
  • 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.
  • 15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6th 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.
  • 23 Oct 2022 (Cape Town, South Africa): Symposium entitled “Tackling AMR: How implementation research is vital in a One Health approach” 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.
  • 3-7 Dec 2022 (Banff, Canada): Novel Approaches Against Emerging Antimicrobial Resistance by Keystone Symposia. Go here for details. 
  • 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.
]]> NIAID BAA To Support In Vitro Diagnostic Product Development https://amr.solutions/2022/04/20/niaid-baa-to-support-in-vitro-diagnostic-product-development/ Wed, 20 Apr 2022 22:21:26 +0000 https://13.43.35.2/?p=7547

Dear All,

Excitingly, NIAID has released a new BAA (Broad Agency Announcement) entitled “Diagnostics Pre-Clinical Services Program.” Similar to the prior BAA for support of biopharmaceutical product development, this new BAA for diagnostic devices seeks a group who can manage a “multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) type contract” (read that slowly!) and through it offer a comprehensive array of capabilities that will move new in vitro diagnostic products forward to regulatory clearance. 

As further context for the BAA, it is instructive to look at the breadth of its task areas:

  • Task Area A: Product Development Processes and Documentation
  • Task Area B: Recombinant Proteins and Monoclonal Antibodies
  • Task Area C: Biochemical Reagents: Nucleic Acids and Oligonucleotides
  • Task Area D: Clinical Specimens and Bacterial Isolates
  • Task Area E: Next-Gen Sequencing, Immunoassays, Nucleic Acid Amplification Assays
  • Task Area F: Pre-Pilot and Pilot-Scale GMP Manufacturing Services


That’s a wide array of diagnostic ideas! As you can infer, NIAID wants these services to help a wide variety of investigators (including academics and start-up or mature companies) in a number of scientific areas to obtain critical data needed to attract additional funding, gain prospective partnerships (either for further development or to support  clinical validation studies), fulfill regulatory requirements, and complete necessary studies to satisfy regulatory requirements.

In numeric terms the RFP is for up to $12m over a contract period of 1 Jul 2023 through 30 Jun 2030. Could this be of interest to you or someone you know?

Deadline for applications is 14 Jul 2022 at 3pm ET. Sharpen your pencils!

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):

  • JPIAMR’s 14th call is now open. Entitled “Disrupting drug resistance using innovative design”, the call seeks consortia that would seek to “improve the treatment of bacterial and fungal infections (including co-infection) and/or the prevention of the emergence/spread of resistance in humans, animals or plants through the improvement of the efficacy, specificity, delivery, combinations and/or repurposing of drugs and plant protection agents.” Bacteria, fungi, human health, animal health, and plant health are all in scope! Pre-proposals are due 8 Mar 2022; full proposals would be due 5 July 2022. Go here for 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 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/).
  • 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):

  • 8 Dec 2021: “The New Winds Pushing and Pulling Antibacterial Development.” This FABULOUS program featured talks from the UK team behind the NHS “Netflix” pilot, Kevin Outterson’s recently released report documenting the need for global Pull incentives to have a value of $2.2 – 4.8b, and speakers covering PASTEUR and work in the EU on pull incentives. The video is here — please make time to listen to this program!
  • The stunning 4 Feb 2022 webinar for the GRAM report (Global Research on Antimicrobial Resistance “1.27 million deaths per year are directly attributable to AMR”) is now available for replay. #AMRSOS! 
  • 23-26 Apr 2022 (Lisbon): 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). Go here for details.\
  • [NEW] 30 April 2022 (Boston): 19th Annual Microbial Sciences Symposium presented by the Microbial Sciences Initiative (MSI) at Harvard University. Go here for details.
  • 9-13 May 2022 (Athens and online): 40th Annual Meeting of the European Society for Paediatric Infectious Diseases, Go here for details.
  • [NEW] 13 May 2022 (Strasbourg, France): AC21 Workshop: “Pre-clinical development of antimicrobial peptides”, with contributions from the AC21 member universities in Stellenbosch, South Africa, Minneapolis, USA, Freiburg, Germany and Strasbourg, France as well as from other institutions. Participation is free and open to non-member institutions but registration is required. Supported by Academic Consortium 21. Go here for details.
  • 16-18 June 2022 (Perth, Australia): Australasian Society for Infectious Diseases Annual Scientific Meeting is a hybrid event for adult and pediatric infectious disease and clinical microbiology specialists. Go here for details.
  • 11-14 July 2022 (Sydney): Australian Society for Microbiology Annual National Meeting is a hybrid event that will feature a range of lectures and symposium sessions, as well as extensive opportunities for networking. 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.
  • 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
  • [NEW] 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.
  • 15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6th 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 more: https://www.icarecourse.org/
  • 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.
  • 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.
  • 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.
]]> Help Alan Carr with a point survey on COVID-19 vaccines! https://amr.solutions/2020/09/29/help-alan-carr-with-a-point-survey-on-covid-19-vaccines/ Tue, 29 Sep 2020 08:14:05 +0000 https://13.43.35.2/?p=3506

Dear All,

Once again, we’re going to have a brief change from our usual programming with this newsletter.

I hope you recognize the name Alan Carr … he is an analyst at Needham & Company (https://www.needhamco.com/) who writes regularly on the antibacterial pipeline. Go here for the most recent (14 Aug 20) newsletter on his summaries: his analyses have been invaluable on many occasions to the antibacterial community.

Alan would again (you may recall that we did this once before) like to do a point survey on COVID-19, this time focused on the R&D community view on vaccines. 

2 Oct 2020 update: Alan has now reported on the survey (link to his newsletter):

  • Most of the respondent pool (n = 122) is composed of members of industry (55%), academia (19%), and government/NGOs (18%).
  • Approximately 65% believe the FDA should set at least a 60% vaccine effectiveness threshold for approval.
  • The average preferred review period for the FDA to issue an Emergency Use Authorization after submission of full Phase 3 data is 70 days (median 60).
  • About half of the respondents plan to seek a COVID-19 vaccine immediately or within a few weeks of an Emergency Use Authorization if the first vaccine is 60% effective and 80% if it is 90% effective.
  • Of the four Operation Warp Speed vaccine technologies, there is an expectation that attenuated replicating live viral vector vaccines will be most effective and that mRNA vaccines will be least effective.
  • With respect to safety, there is an expectation that adjuvanted recombinant subunit vaccines will be most safe and attenuated replicating live vector vaccines least safe.

Thanks for participating! Stay safe! All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

Current funding opportunities (most current list is here):

  • Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
  • 2020 funding rounds for CARB-X have not been announced.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.
  • It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
  • You might also be interested in the most current lists of R&D incentives (link) and priority pathogens (link)


Upcoming meetings of interest to the AMR community (most current list is here):

  • 30 Sep 2020 (online, 2pm BST): Longitude Prize Sprint Workshop 2 entitled “Building Medtech Companies: Learn how to attract investment to fund product development and scale your company.” Details and registration are here.
  • [Registration is now open] 2 Oct 2020 (online meeting): 7th annual Boston Area Antimicrobial Research Network (BAARN) meeting. Go here for details on this (free!) online meeting.
  • 21-25 Oct 2020 (online meeting), IDWeek 2020. Go here for details.
  • 26-29 Oct 2020 (online meeting), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 27 Oct 2020 (online, 9a-5p EST): FDA Workshop entitled “Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.” Go here to register.
  • 27 Oct 2020 (online meeting), BARDA Industry Day, a discussion of U.S. Government medical countermeasure priorities. Mark your calendar now and watch this website for details.
  • 18-24 Nov 2020 (everywhere): World Antimicrobial Awareness Week. For resources, go here for WHO’s home page for the week. The focus will be on two messages: “Antimicrobials: handle with care” and “United to preserve antimicrobials.”
  • 9-12 Jul 2021 (Vienna): Annual ECCMID meeting (#31)
  • 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
  • 27 Jun-2 Jul 2021 (Ventura, CA): Gordon Research Conference entitled “Antimicrobial Peptides”. Go here for details, go here for the linked 26-27 Jun Gordon Research Seminar that precedes it.
  • 5-21 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
  • 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
  • 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students.
  • 6-11 Mar 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
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