Wellcome Trust – AMR.Solutions https://amr.solutions Antimicrobial Resistance Solutions with Dr. John H. Rex Mon, 31 Aug 2026 15:14:56 +0000 en-US hourly 1 https://amr.solutions/wp-content/uploads/2022/04/Fire-Extinguisher-icon-70x70.png Wellcome Trust – 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.
]]> Stewardship & Access Guide from CARB-X, Wellcome, and partners: Analysis, video chat https://amr.solutions/2021/03/22/stewardship-access-guide-from-carb-x-wellcome-and-partners-analysis-video-chat/ Mon, 22 Mar 2021 14:00:55 +0000 https://13.43.35.2/?p=4719

Dear All,

Novel antibacterial agents, vaccines, and diagnostics will do little if they are not widely available and used responsibly. CDDEP’s recent report entitled “The State of the World’s Antibiotics in 2021” makes this very clear: “… more people in LMICs (low-middle-income countries) die from lack of access to antimicrobials than from resistant infection.”

Hence, CARB-X has required from the very start that all grant recipients commit to creating a Stewardship & Access Plan (SAP) within 90 days of their product entering pivotal (Phase III or the equivalent for diagnostics) clinical development. 

Although this is easy to articulate at a high level (“Please have a plan!”), the best approach to balancing access, stewardship, and innovation has long been a source of debate within the community.

As the SAP would be shared publicly once the product has obtained regulatory approval and would need to cover both Stewardship (appropriate use) and Access (Accessibility, Availability, Affordability, and Acceptability), it’s obviously an ambitious document. But, providing stewardship and access is also not something that the developer can do alone — others also have a role to play.

To support CARB-X grantees as they seek to address this task, a SAP Development Guide has been published today (press release) that provides guidance on meeting the SAP requirement. It is an impressive and thoughtful document that has been created by Wellcome Trust in collaboration with CARB-X, its funding partners, and other interested parties: US Dept of Health and Human Services Office of Global Affairs (DHHS OGA), BARDA, the Global AMR Innovation Fund (GAMRIF), UK Department of Health and Social Care (DHSC), the Bill & Melinda Gates Foundation (BMGF), Wellcome Trust, GARDP, and the Access to Medicine Foundation (ATMF).

The Guide suggests a structure for a SAP and supports this with a detailed list of points to consider (Annex B), a starter list for possible strategies (Annex C) and links to organizations that can provide support and partnering opportunities (Annex D). It is obvious that a lot of thought has gone into this! In particular, the list of plausible strategies in Annex C make this document a strong starting point on what can reasonably be expected of product developers, whether part of the CARB-X system or not.

Tim Jinks, Head of the Drug-resistant Infections Programme at Wellcome Trust said, “The SAP Development Guide represents a new benchmark for what can be expected from companies preparing to market innovative antibiotics, as they should proactively develop robust plans enabling worldwide stewardship and equitable access alongside market entry plans. We hope that these insights inform the wider pharmaceutical, scientific and global health community, as well as CARB-X awardees.”

Impressive! But it is critical to note that responsibility for implementing a SAP does not lie solely with product developers. This point is not explicitly covered in the SAP guide, but many of the actions required can only be suggested by the product sponsor and greater action is also needed from governments, donors and civil society, working with industry, to develop innovative solutions that both accelerate equitable access to new products and slow the spread of bacterial drug resistance.

In particular, delinked Pull incentives are needed both to attract R&D investment and to support the pipeline and the newly approved antibiotics to which the SAP will be applied. On this theme, Thomas Cueni, Director General and key architect of the recently announced AMR Action Fund (see this newsletter for more) said, “With the recent commitment by Industry of ~$1b for the AMR Action Fund that will support Phase 2-3 development and bring 2-4 important new antibiotics to approval by 2030, the pharmaceutical industry is definitely stepping up to meet the challenge of AMR! But, the recent market failures of newly launched antibiotics show clearly that governments need to take action now to implement the delinked incentive models that will sustain these new agents after they are approved.” 

While reviewing SAP Development Guide, you should also review the recent report from ATM entitled 2021 Access to Medicine Index. ATMF contributed to the SAP Development Guide and it is exciting to see the momentum that is building. Here is a summary provided by ATMF:

  • “The most notable progress is in planning ahead during R&D to make future products accessible: eight companies are developing approaches for systematically ensuring all R&D projects are paired with plans to increase access in poorer countries soon after launch (these have yet to be applied across late-stage projects).
  • “The industry has stepped up efforts to understand the outcomes of their access-related activities, and more companies are evaluating initiatives to build local capacity and strengthen health systems than in 2018.
  • “All 20 companies have now set specific goals and targets for improving access, and more companies are deploying business models that explicitly include people at the base of the income pyramid.
  • “There is also movement in responsible promotional practices, with three additional companies adopting rewards schemes that decouple sales agents’ incentives from sales targets only (now 12 companies).”

Hooray for CARB-X, Wellcome Trust, and their partners! The SAP requirement is a reminder that none of us are safe from AMR until we are all safe! As stated by the IACG AMR (Interagency Coordination Group on Antimicrobial Resistance) in their 2019 report to the UN Secretary-General, “Antimicrobial resistance is a global crisis that threatens a century of progress in health and achievement of the Sustainable Development Goals.”


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.
  • 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):

  • 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.
  • [NEW] 25 Mar 2021 (online, 8.30-9.30a EST, 2.30-3.30p CET, 7-8p IST): CDDEP- and WHO-sponsored webinar entitled Vaccines and AMR. The impressive speaker lineup includes Hanan Balkhy (Assistant Director General for AMR at WHO). 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.
]]> ADVANCE-ID seeks antibiotic for P2/3 development Asia! https://amr.solutions/2024/02/07/advance-id-seeks-antibiotic-for-p2-3-development-asia/ Thu, 08 Feb 2024 01:51:15 +0000 https://13.43.35.2/?p=11388

Dear All,

Yow! Led by David Paterson,  ADVANCE-ID (ADVANcing Clinical Evidence in Infectious Diseases) is a research group launched March 2023 as a network of more than 30 hospitals across Asia. The exciting news is that ADVANCE-ID have just announced that they are seeking a novel antimicrobial agent vs. MDR Gram-negatives that could be advanced in the clinic via a Phase II (or Phase III in some situations) trial in Asia.

The press release is here and I’ve reproduced the key text below my signature. Expressions of Interest (EOIs) are due 15 Mar 2024.

Yes, that’s a VERY short timeline for a clinical collaboration! Looking at the EOI webpage, my inference is that the ADVANCE-ID team are very much testing the water to see who is interested and what is possible. So, my thought would be to raise your hand if you think this might conceivably work for you and your molecule.

Yow! 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.

From the press release with a bit of formatting for emphasis (all highlights are at my hand):

  • ADVANCE-ID is a clinical research network involving more than 50 hospitals across Asia, with a base at the National University of Singapore (NUS).
  • Its mission is to conduct high-quality clinical trials that have a global impact on management of infections.
  • With the support of a multi-million dollar grant from the Wellcome Trust, ADVANCE-ID seeks expressions of interest from companies developing novel antimicrobial agents.
  • The purpose is to conduct a Phase II clinical trial in the ADVANCE-ID network.
    • In limited circumstances (for example, when a company is planning to skip from Phase I trials directly to a Phase III trial), a Phase III clinical trial may be considered.
  • Data from the trial will be of sufficient quality to be included in a New Drug Application to be submitted to the FDA, EMA and other similar organisations.
  • The Phase II trial will be conducted in close collaboration between ADVANCE-ID and the company developing the novel antimicrobial agent.
  • It is anticipated that the award will cover the cost of a Phase II trial but depending on the complexity of the trial and other variables, the company developing the novel antimicrobial agent may need to co-contribute financially.
    • If a Phase III trial is being considered, additional funding will definitely be required, and it may be appropriate to involve other geographic locations and/or clinical research networks in the trial.

What is in scope? 

  • Phase II or III trials of novel antimicrobial agents which are being developed for treatment (including treatment adjunctive to standard of care antibiotics) or prevention of infections due to multi-resistant Gram negative bacilli.
  • Both traditional small molecules and non-traditional antimicrobial agents are eligible for consideration.
  • There is no geographic restriction as to the location of the company developing the novel antimicrobial agent.

What is out of scope? Antimicrobial agents being developed for tuberculosis, non-tuberculous mycobacteria, Neisseria gonorrhoea, Gram positive infections including Clostridium difficile, viral infections, fungal infections, or parasitic infections.

Key Dates

  • March 15, 2024: Deadline for expression of interest submission
  • Q3 2024: Successful company will be informed
  • April 1, 2025: Contracting between successful company and NUS is complete
  • Q4 2025: First patient is enrolled


Questions: Contact Professor David Paterson at david.antibiotics@gmail.com, copying in tht.dawn@nus.edu.sg

How to apply – Application will be an iterative process firstly to determine that the work proposed is within scope, and then to acquire sufficient information for applicants to be differentiated. The first step is to complete the expressions of interest form https://nus.syd1.qualtrics.com/jfe/form/SV_1Iii2XewY1spl4O


Current funding opportunities

  • 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.
  • NIAID have a BAA open through 13 Mar 2024 for projects covering vaccines, therapeutics vs. selected pathogens (specific viruses, fungi, and bacteria), and sequencing-based diagnostics. See this newsletter for further details.
  • JPIAMR have an AMR Interventions call that is open for pre-applications through 14 Mar 2024. The call covers interventions for both fungi and bacteria. Go here for full details. Note that there is an informational 24 Jan 2024 webinar for applicants.
  • 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. A closing date is not posted insofar as I can see — applications are accepted on a rolling basis; go here for more details.
  • The AMR Action Fund is open on an ongoing basis 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).


John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 6-7 Mar 2024 (Basel, Switzerland): The 8th AMR Conference 2024. Go here to register!
  • 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. 
  • 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 save the date!
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Save the date! More details to come!

Upcoming meetings of interest to the AMR community:

  • [Links to prior webinars are available] 7 Feb 2024 (virtual, noon-1.30p CET): WHO-sponsored webinar entitled “4th webinar of the One Health Priority Research Agenda: Intervention Pillar.” As context, the WHO Quadripartite launched its One Health Priority Research Agenda (OHPRA) on 28 June 2023. This new webinar covers one of its five pillars (Transmission; Integrated Surveillance; Interventions; Behavioural insights and change; and Economics and policy). Prior webinars can be found here; presumably the recording from today’s webinar will appear there soon.
  • 8 Feb 2024 (in person, Liverpool, UK, 8.30a – 4p): 2024 BioInfect Conference. A full-day AMR conference that includes a keynote from Lord Jim O’Neill (Chairman of the UK AMR Review). Go here for details and to register.
  • 9 Feb 2024 (in person, London): “Exploring AI’s impact on AMR,” a workshop co-organised by Imperial’s Institute of Infection, AI Network, NIHR HPRU in Healthcare Associated Infections and Antimicrobial Resistance, and the Centre for Antimicrobial Optimisation (CAMO). Go here for more details and to register.
  • 14 Feb 2024 (virtual, 8-9a EST): GARDP’s “SECURE: Improving access to antibiotics through new economic models” webinar about the SECURE project. Click here to register.
  • [HIGHLY RECOMMENDED] 15 Feb 2024 (virtual, 8.30a-10.00a EST, 2.30-4p CET, 10.30p-12.00a JST): Entitled “AMR Preparedness Index: 2024 Progress Report”, this will be the launch of a major report by the Global Coalition on Aging (GCOA) and IDSA, and sponsored by IFPMA. Speakers are global (US, EU, Brazil) and feature Dame Sally Davies (UK Special Envoy for AMR) plus a panel moderated by Andrew Jack (Financial Times, creator of a marvelous 5-minute AMR video explainer); the discussion will to cover the new report (it updates the 2021 AMR Preparedness Index), including high-level policy insights from the report in advance of the eagerly anticipated High-Level Meeting on AMR at UNGA 2024 (see 15 Apr 2023 newsletter for background on the HLM). Go here to register.
  • 27 Feb 2024 (virtual, 8.30a-9.30a EST): GARDP’s “What does the future look like if pull incentives to support antibiotic R&D are insufficient?” webinar. Go here for details. 
  • 27 Feb 2024 (in person, New York City, 3-6.30p ET): Hosted by the AMR Industry Alliance (AMRIA), “A Call-to-Action in the Fight Against AMR: Priorities for Progress at the 2024 UN High-level Meeting on AMR” is a symposium (3-5.30p) and reception (5.30-6.30p). For additional information on the event, please contact J.Schumacher@AMRIndustryAlliance.org. 
  • [HIGHLY RECOMMENDED] 4-5 Mar 2024 (virtual, noon-4.15p ET on both days): “Assessing the Burden and Potential Strategies to Address Antimicrobial Resistance” is a 2-day workshop sponsored by the National Academies that takes a deep dive into what we do and do not know about the costs (clinical and financial) of AMR. Chaired by Jomana Musmar, the deeply knowledgeable Designated Federal Officer who oversees PACCARB, it is no surprise that the agenda is excellent and includes an all-star cast of speakers. Go here to register.
  • 6-7 Mar 2024 (Basel, 6-7 Mar 2024): See Recurring Meetings list, above. 
  • 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.
  • 25-26 Mar 2024 (In person, London): “Novel Diagnostics for Infectious Diseases,” a 2-day workshop co-organised and funded by Imperial College London’s Institute of Infection, JPIAMR-funded B2B2B Network, London In Vitro Diagnostics Co-operative, NIHR Imperial Biomedical Research Centre, and DIAMONDS consortium. Go here for details and to register.
  • 26 Apr 2024 (Barcelona, Spain): ESCMID workshop entitled “Using Data Science and Machine Learning for Infection Science: A Hands-on Introduction.” Click here to register or here for more details. 
  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
  • 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.
  • 9-13 June 2024 (in person, Ascona, Switzerland): “New Approaches to Combat Antibiotic-Resistant Bacteria, 2nd Edition” is a Sunday-Thursday residential workshop focused on the deep biology of AMR. Sponsored by NCCR AntiResist (a Swiss National Science Foundation consortium), the scientific program has the feel of a Gordon Conference. Space is limited, so you are encouraged to apply promptly — go here for details.
  • 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. See Recurring Meetings list, above.
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above. 
  • 19-27 Oct 2024 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance). Now in its 8th year, Patrice Courvalin directs the program with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Seating is limited, so mark your calendars now if you are interested. Applications open in March 2024 — go here for more details.
  • 4-5 Dec 2024 (in person, Washington, DC): “Fungal Dx 2024: Fungal Diagnostics in Clinical Practice” is a 2-day in-person workshop organized by ISHAM‘s Fungal Diagnostics Working Group. The program and registration links are available at https://fungaldx.com/; the agenda is comprehensive and features an all-star global list of speakers.
]]> RFP: Climate-Sensitive Infectious Disease Modelling https://amr.solutions/2022/02/02/climate-sensitive-infectious-disease-modelling/ Thu, 03 Feb 2022 01:15:35 +0000 https://13.43.35.2/?p=7074

Dear All,

And now for something really different! With the recent GRAM report (20 Jan 2022 newsletter) showing that AMR is linked to more deaths that HIV or malaria (#AMRSOS! Andrew Jack and FT team have some great graphics for this … check them out!), we now have an absolutely fascinating call from Wellcome Trust for the development of new software tools that researchers and policymakers can use to track and predict how climate change will affect the spread of infectious diseases. Here’s what you need to know:

  • Background to get you oriented to the area:
    • Literature review of existing software tools at the intersection between climate and infectious disease + interviews with global experts
    • An excellent perspective article by Bilal Mateen (Wellcome’s Senior Manager for Digital Technology) on development of digital tools to catalyze the next generation of climate-sensitive infectious diseases (CSID) research.
  • Where: Anywhere in the world (apart from mainland China)
  • How much: Up to £500,000 for research expenses, including salaries
  • Duration: Up to 5 years
  • The RFP: Go here to apply. Deadline: 31 Mar 2022

Wow … seriously cool! Even if you don’t apply, the literature review linked above is worth a scan: a search of the literature led to identification of only 37 predictive tools. Most were focused on vector-borne disease and most were focused on a relatively constrained geographic region … only 4 had a global scale.

And it looks like this could be the first of a series of calls on the links between climate and health, all part of of Wellcome’s new strategy of advancing scientific discovery to take on the world’s most pressing health issues via a focus on four key areas: Discovery Research, Infectious Disease, Mental Health, and Climate and Health. Go, Team Wellcome!

Very exciting! Could this be you? I hope so! Get busy and apply! 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 PAR Foundation has two open calls. First, are early career grants (students at bachelor and masters level, PhD students, and individuals graduating during 2020-2022) of up to ~€30k to support 1-year projects on prevention of antibiotic resistance. Second, grants up to ~€1000k to support projects with the potential to prevent infections and antibiotic resistance among elderly. Go here for details; the deadline for both is 10 Mar 2022.
  • 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!
  • 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.
  • 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! 
  • 23 Feb 2022 (virtual, 8-9a EST): Pre-application webinar to provide more information and to answer questions. Register here.
  • 3 Mar 2022 (virtual, 2p GMT): The Longitude Prize (run by Nesta Challenges), CARB-X and FIND, have joined forces for a virtual event in March, AMR& Diagnostic Frontiers: Developing and increasing access to innovative diagnostics in and for low-and-middle-income countries (LMICs). Full agenda details and registration can be found here, including an invitation for diagnostic companies to pitch to a panel of global health representatives.
  • 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.
]]> PASTEUR action; Wellcome convenes Global R&D discussion! https://amr.solutions/2023/06/09/pasteur-action-wellcome-convenes-global-rd-discussion/ Fri, 09 Jun 2023 14:28:58 +0000 https://13.43.35.2/?p=9729

Dear All,

Two items for your attention today: an immediate action for you to take to support PASTEUR plus a launch event for a major Wellcome Trust project for your calendar. 

First, as you may recall, the Oversights & Investigations Subcommittee of the US House Energy & Commerce Committee recently held a hearing about the impact of AMR. Now the Health Subcommittee is holding a hearing on 13 June 2023 to consider a list of bills as part of the Pandemic and All Hazards Preparedness Act (PAHPA) reauthorization.

At the time of writing, the PASTEUR Act has not been included on this list but it isn’t too late. Our community needs to reach out to the Committee in order to get PASTEUR as part of the stack of bills to be considered for PAPHA. There was a previous newsletter about including PASTEUR in PAPHA and you can reference it for the content of your message to the subcommittee. Even a simple email to your local congressional representative could help get PASTEUR onto the list to be considered! For the simplest way to take action, you can use the IDSA’s online action center to connect directly with your representative and provide a pre-written message on PASTEUR that you can then modify at your own discretion. Action on this TODAY would be ideal!
 
Second, the Wellcome Trust is hosting a 3-month long discussion entitled “Reforming the R&D ecosystem for infectious disease: A Global Conversation” with the launch event happening on 13 June 2022! This specific event will be focused on Wellcome’s recent discussion paper “Towards a reformed R&D ecosystem for infectious disease” and will run for approximately 2 hours. After the presentation of the paper and a Q&A, participants will then be asked to work in small groups to begin defining the scope of the work that needs to be done. This is not your typical webinar series; active webinar participation is vital and expected!

This will be the beginning of their Global Conversation events and the overall goal is to hear from stakeholders globally about what needs to be done to improve the R&D status quo. There will also be other events throughout June, July, and August so check out the detailed schedule. If you can’t attend but still want to be provide feedback on Wellcome’s report, fill out this form after reading the discussion paper.

In brief, Wellcome proposes that we need to envision broad changes to the infectious disease R&D ecosystem by recognizing that there are systemic challenges affecting both R&D and access across multiple areas (including antibiotics), as well as cross-cutting opportunities for change to improve how and where R&D is done. Wellcome’s key areas for this work are (i) priority-setting, (ii) clinical trials and regulation, (iii) globally diverse manufacturing, and (iv) aligning innovation and equitable access. You will readily spot the elements most relevant to the R&D community but please read the paper and see if other elements strike a chord for you: it’s an exciting set of ideas that come at a good time relative to the overall arc of the global policy conversation.

To gather global input during discussions, Wellcome has partnered with CoLab International to produce an independent report capturing the issues, challenges, questions, debates and solutions proposed by participants, including those which might not fall within the scope of Wellcome’s remit for action. The summary of the feedback will be shared publicly by Wellcome later this year.

Yow! Reach out to the subcommittee and signup for Wellcome’s webinar! 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.
  • 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):

  • 10 Jun 2023 (Virtual, 3-5.30p India Standard Time): Sponsored by the AMR Declaration Trust, a webinar entitled “Engaging the Pharmaceutical Industry in Joint Efforts to Tackle Antimicrobial Resistance.” Thinking globally and acting locally, this webinar will be a conversation about the global pipeline with a focus on ideas for action in India. Go here to register.
  • [NEW] 13 Jun 2023 (Virtual, 8a-10a ET): Wellcome Trust’s “Reforming the R&D ecosystem for infectious disease: A Global Conversation” launch event as detailed in this newsletter. Go here to register and read about the entire event series here.
  • 3-5 Jul 2023 (Tours, France): 9th Symposium on Antimicrobial Resistance in Animals and the Environment (ARAE). Sponsored by INRAE (French National Research Institute for Agriculture, Food, and Environment, itself a merger of merger of INRA, the French National Institute for Agricultural Research, and IRSTEA, the French National Research Institute of Science and Technology for the Environment and Agriculture), this conference has been running since 2005. Go here for details.
  • 4-6 Aug 2023 (Bangkok, Thailand): The regional Medical Mycology Training Network Conference by ISHAM’s Asia Fungal Working Group is set to feature both hands-on workshops and clinical sessions for all those managing and working with invasive fungal infections. Go here for details. 
  • 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. 
  • 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.
  • 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.
]]> COVID-19 and the Long-Term Trajectory of AMR Efforts: Wellcome Trust Deep Dive https://amr.solutions/2020/11/15/covid-19-and-the-long-term-trajectory-of-amr-efforts-wellcome-trust-deep-dive/ Mon, 16 Nov 2020 01:10:48 +0000 https://13.43.35.2/?p=3666

Dear All (Wonkish alert! Coffee-up!),

Today we have something special: A deep-dive into the future trajectory of AMR-related work developed by Wellcome Trust. The newly released report is here and there is a webinar discussing the report on Wednesday of this week (1500-16:00 GMT on 18 Nov 2020, go here to register).

The back story on this report begins in 2016 when a UN High-Level Meeting on AMR came together as a response to many years of awareness-raising. This was only the fourth time in the history of the UN that a health topic was discussed at the General Assembly and it spurred global political momentum on the whole AMR issue. Deep background if you are interested: to get a flavor for past efforts, review this newsletter focused on ways to tell the AMR story and this newsletter focused on financing the needed work.

Beginning in 2019, Wellcome Trust set out to review progress since 2016. When COVID hit earlier this year, the review was expanded to include the impact of COVID both on AMR and on general awareness of the need for preparedness. Not surprisingly, there is both good news and bad news:

  • Successes​
    • AMR has achieved prominence on the global political agenda​
    • The AMR community is a broad, multi-sectoral coalition of actors aware of, and willing to tackle, AMR​
    • The early-stage and translational research environment is robustly funded
  • Critical gaps​
    • Activity has not always translated into meaningful action​
    • Prioritization is increasingly emerging as a gap​
    • The AMR agenda was at risk of losing momentum pre-COVID-19 – making it important to capture new momentum in global health with a clear post-COVID-19 AMR narrative

The three successes will be familiar to regular readers of this newsletter, as will the first gap. But, the gaps around prioritization and momentum identified by the report are the real novelty of the report. In brief, there are always many big issues competing for attention and the AMR community has been criticized at times for being a “talking shop” in which little happens. As a corrective, the report is saying that the AMR community must maintain momentum by applying a disciplined and focused approach to its work over the next several decades. 

You should read at least the Executive Summary for yourself, but the essence is that the report sketches a potential ‘critical path’ to impact by seeing needed work in two phases: ​

  1. 2020–30: (i) Mitigation of the risk of resistance and its consequences and (ii) Expansion of the evidence base to address gaps that remain as barriers to action.
  2. Beyond 2030: Building on an established infrastructure to control resistance and its consequences, work to limit further resistance development by maintaining and scaling best practices for prevention (clean food, clean water, vaccines, etc.)

The really fascinating aspect of this paper is its clear-eyed and provocative discussion of priorities for the AMR field. The analysis is summarized by the categorization of 13 areas of possible focus across a 3×3 grid that ranks impact vs. feasibility (Exhibit 5, page 33):


Look closely at the grid: Feasibility on the y-axis, impact on the x-axis, 13 topics placed in the resulting grid, and (finally) pink shading that highlights the seven focus areas recommended by the report as highest priority. Each of the 13 topics has a detailed discussion in the report and to whet your appetite to read the full report, let’s consider just one that falls outside the highlighted pink focus area: Diagnostics.

As you can see, Diagnostics are scored as “High Impact Very Likely” but “Low Feasibility.” Hence the report suggests that it should not be ignored but that (importantly) Diagnostics should not be a make-or-break highest priority area. Why, you ask? Well, the extended notes conclude that “… both the therapeutics and the diagnostics ecosystems face similar market failures and lack of investment due to low expectations on returns. However, diagnostics suffer from additional behavioural and structural barriers to uptake, making it more difficult to resolve compared to the already complex therapeutics environment.” 

The other possible focus areas are likewise analyzed at length (see below my signature for a brief summary of the key points regarding each). Over and over, the point is that while all 13 areas have value, differences in feasibility and likely impact should not be ignored!

Putting it all together, the core message of the report is that attempting to do everything will lead to getting nothing done. Rather, we need to take stepwise-actions that are relevant, focused and feasible, and that build towards the long-term goal of controlling AMR.

And this is where COVID-19 enters into the discussion. There has been a lot of discussion of the impact of COVID-19 on AMR, often focused on emerging resistance. That’s of interest, but to my eye the bigger issue is how to use the awareness created by COVID-19 to drive work in AMR. Wellcome’s report is distinctive to my eye in that it makes the case that there is a decision-point facing the AMR community: we can reinvigorate the AMR agenda either by trying to stay focused on it as a unique problem or integrate a focused AMR agenda into the broader health security agenda. The report clearly favors the latter approach … and I agree entirely.

Wow! Great stuff! Many thanks to the team at Wellcome for this insightful and provocative commentary. I am sure we’re going to have some spirited debates as a result! 

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.

Narrative summary of the 13 areas for possible focus

  1. High feasibility; high impact very likely
    • Human Infection Prevention and Control (IPC): There is some need for additional evidence on best interventions in High/Low Income Countries, but overall IPC interventions are cost-effective and high impact.
    • Clean Water and Sanitation: WASH (Water, Sanitation, and Hygiene) are easily shown to be low-cost and high-impact.
  2. Medium feasibility; high impact very likely
    • Therapeutics: This one is divided by the report into R&D and Development. On R&D, we have “… development of new therapeutics is widely considered to be a short- and mid-term priority for the AMR response.” And on Development, we have a good summary of the Push/Pull problem and how it leads to our thin pipeline. Absolutely agreed on both counts.
    • Surveillance: Adequate surveillance is easily seen as both feasible and high impact. Good work is underway (e.g., WHO’s GLASS program).
    • Human Consumption of Antibiotics: This one seems straightforward — good stewardship along with good health infrastructure are challenging but have a strong impact when implemented.
  3. High feasibility; high impact possible
    • Vaccines: The analysis covers both human and animal vaccines noting the obvious potential for impact with both, albeit with different sorts of implementation challenges.
  4. Medium feasibility; high impact possible
    • Use in Animals: Given the high volumes of antimicrobials used in animal health, successful interventions can have a substantial impact. Good examples exist and are being implemented.
  5. Low feasibility and/or uncertain impact
    1. Medicine Quality: This is good example of something that is obviously important but just hard to manage as the required fixes include evidence generation, regulation reform, and systems engineering to detect low-quality medicines. 
    2. Clinical Trial Networks: This is one that I’ve long wished for but I also see why it is a tough sell — it doesn’t directly drive innovation and is unlikely to have an impact without an overall change in the economics of antibiotics.
    3. Environmental Contamination: The challenge here is one of information: It’s very hard to show causality. Absence of evidence is not evidence of absence, but…
    4. Food Safety and Security: The limitation here seems to focus on the ability of national governments to create and enforce effective regulatory actions to protect citizens from foodborne illnesses.
    5. Use in Plants: The issues here are (i) Awareness of the risk (AMR in plants!?) and (ii) lack of data.
    6. Diagnostics: As discussed in the body of the newsletter, market failure challenges plus structural barriers to implementation create challenges.

Current funding opportunities (most current list is here):

  • The National Institute of Allergy and Infectious Diseases (NIAID) Applicant Assistance Program (AAP) opens on October 22, 2020. This program provides no cost support for companies planning to apply for a Phase II, Fast Track, or Direct-to-Phase II SBIR or STTR Award. Go here for details.
  • Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
  • 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.
  • ARLG (Antibiotic Resistance Leadership Group, link) is currently open for applications for its 2-year ARLG Fellowship program. The application deadline is 1 Dec 2020; full details are 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):

  • 16 Nov 2020 (online, 9.30a-4.00p EST): FDA workshop entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” Go here for the FR notice and here for extended details, including registration.
  • 17 Nov 2020 (online, 17:00-18:30 CET): GARDP-sponsored webinar entitled “Discovery of new antibacterials using artificial intelligence (computational chemoinformatics)” moderated by Laura Piddock. Go here to register.
  • [NEW] 18 Nov 2020 (online, 15:00-16:00 GMT, London): Wellcome Trust-sponsored webinar entitled “The Global Response to AMR.” This will be the launch of a report by Wellcome on progress and gaps in addressing AMR since the 2016 UN High-Level AMR Meeting. Go here to register.
  • 18 Nov 2020 (online, 14:30-15:30 CET): GARDP-sponsored webinar entitled “Drugs don’t work: What can be done to fight the threat of antibiotic resistance for effective cancer treatments?” moderated by Ingrid Stenstadvold Ross (CEO, Norwegian Cancer Society). Go here to register.
  • 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.”
  • 19 Nov 2020 (online, 9-10.30am EST) webinar chaired by Jeremy Knox entitled “Responding to difficult-to-treat infections: Role and responsibilities of governments, researchers, clinicians, industry and patients”, the final webinar in a 4-part series sponsored by Wellcome Trust entitled “AMR in the Light of COVID-19 Webinar Series; From hypothetical to reality: How COVID-19 foretells a world without antibiotics.” Go here to register.
  • 20-22 Nov 2020 (online, 13:00-18:00 GMT: Global AMR Youth Summit sponsored by the World Health Students’ Alliance (WHSA). Go here to register.
  • 20 Nov 2020 (online, 10:30a-noon CET): GARDP-sponsored webinar entitled “Saving childrens’ lives – treating neonatal sepsis” moderated by Peter Beyer (Senior Advisor on AMR, WHO). Go here to register.
  • [NEW] 2 Dec 2020 (online, 3 sessions spanning 5am-5.15p GMT): Global AMR Hub-sponsored conference entitled “Translating AMR R&D mapping into policy and action.” Go here for the full program
    • 5-7.15a GMT: “Identifying research gaps to address antimicrobial resistance relevant to the Asia Pacific Region”
    • Noon-2.15p GMT: Filling AMR R&D gaps in animal health at country, regional and global level
    • 3p-5.15p GMT: Working together to fill AMR R&D gaps – collaboration and partnerships
  • [NEW] 3 Dec 2020 (online, 9-10:30a CET; 5-6:30p KST): Multi-sponsored webinar entitled “Evidence to Action – Advancing the Antimicrobial Resistance agenda during a pandemic.” Go here to register. Co-hosted by the International Vaccine Institute (IVI), the International Centre for Antimicrobial Resistance Solutions (ICARS), and the Embassy of Denmark in Korea, this webinar includes Dame Sally, Hanan Balkhy (WHO), and the Minster of Health from both South Korea and Denmark! 
  • 26-28 Jan 2021 (online, runs ~7.30a-5.00p Central each day): 4th Annual Texas Medical Center Antimicrobial Resistance and Stewardship Conference. Sponsored by McGovern Medical School, ARLG, and the Gulf Coast Consortia, the agenda includes both poster sessions and keynotes. The call for abstracts closes 18 Dec 2020. Go here for more details.
  • 10-12 Mar 2021 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register; abstract deadline is 15 Nov 2020.
  • 9-12 Jul 2021 (Vienna): Annual ECCMID meeting (#31)
  • 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 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.
  • [Webinar streaming link posted] 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students. Bonus feature: For obvious reasons, the course didn’t happen in 2020! But as a celebration of the course’s 5th year, a webinar version was held on 29 Oct 2020: go here to stream it. 
  • 6-11 Mar 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
]]> Consultants for WHO’s SECURE, Wellcome-ICARS-Danish Gov’t AMR event https://amr.solutions/2021/07/17/consultants-for-whos-secure-wellcome-icars-danish-govt-amr-event/ Sat, 17 Jul 2021 21:17:43 +0000 https://13.43.35.2/?p=5765

Dear All, See below my signature:

  • A 6-month consultancy with WHO to support the the SECURE initiative, a program to assist countries in accessing and sustainably managing new and existing antibiotics needed to cope with antimicrobial resistance (AMR). There’s not much online (yet) about SECURE: the best description I can find is in the Terms of Reference for the consultancy. Deadline: 6 Aug 2021
  • A 4-month consultancy to support Wellcome Trust, the Danish Government, and the International Centre for AMR Solutions (ICARS) in holding a third Call to Action on Antimicrobial Resistance (AMR) virtual event in November 2021. Previous Call to Action events were in Berlin and Ghana; this 3rd event will be virtual and will have a focus on Asia and Latin America. Deadline: 25 July 2021


Perhaps one of these is for you! 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.

— WHO consultancy —
The World Health Organization’s (WHO) GCP Department – in collaboration with other partners (GARDP, UNICEF, CHAI) – is developing a novel access initiative, named SECURE. SECURE will support countries in accessing and sustainably managing new and existing antibiotics to manage antimicrobial resistance (AMR).
 
Time: September 2021-February 2022 (6 months full-time)
Location: Anywhere
Experience: 5+ years of professional experience in access to medicines, AMR and/or the set-up of new global health initiatives (minimal, more experienced candidates welcome to apply: pay rate based on experience)

https://www.ungm.org/Public/Notice/134842

Questions? Reach out on: vanma@who.int

— Wellcome-ICARS-Danish Government consultancy —
Wellcome Trust, the Danish Government and the International Centre for AMR Solutions (ICARS), working with fellow co-hosts, are looking to hold a third Call to Action on Antimicrobial Resistance (AMR) virtual event in November 2021.
 
As a result, we want to engage one or two individuals with experience of working with/within LMIC governments in Asia and/or Latin America developing and implementing AMR National Action Plans (NAPs) to play a strategic role supporting the development (inc. associated content) and delivery of the third Call to Action event alongside the event co-hosts. This role will be part of a team and will complement expertise coming from other territories.
 
Responsibilities would include:

  • working as a member of the agenda delivery team to shape the session content for the event. Using your own experience, expertise, and networks to bring this together with the event co-hosts and other stakeholders to design the agenda, taking a solution focused approach.
  • lead or co-lead on the development and delivery of specific sessions of the agenda (details will be determined once the outline agenda has been agreed), using your experience of NAP implementation and networks of AMR policy experts, collaborating with event co-hosts and relevant stakeholders.
  • supporting delivery of the event over the conference dates, e.g. briefing/supporting speakers, moderating small group discussions.

It is expected that the role will run from August to end of November and that each consultant will allocate 20-25 hours per month. 
How to apply:
Please submit a one-page expression of interest, along with a CV (no more than 2pgs) which sets out how you meet the desired skills/experiences. In this document, please provide one or two examples of work that you have done to support the implementation of AMR national action plans. Please highlight how you personally contributed to deliver of the activity and the insights this provided. 
Applications should be emailed to Ghada Zoubiane (gzoubiane@icars-global.org) by not later than CoP 25th July 2021.
Short-listed applications will be invited for a short online interview currently planned on 2nd and 3rd of August 2021 to discuss experience and skills.
 
For more information please visit: https://web.archive.org/web/20210716165913/https://icars-global.org/job-ad-freelancer-independent-consultant-for-virtual-conference/
 

Current funding opportunities (most current list is here):

  • CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (more than 80 total awards, and counting, as they include contracting from prior rounds). New rounds from CARB-X will occur only after new funding is obtained in 2021.
  • It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
  • In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).


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

  • 20 Jul 2021 (virtual, 16.30-18.00 BST): BSAC-sponsored webinar entitled “Diagnostic-driven strategies for antimicrobial resistance in the UK” that will highlight AMR priorities and diagnostic needs for the UK’s NHS. Go here to register.
  • 26 Jul-30 Jul 2021 (online): Small World Initiative Instructor Training Workshop – training for undergraduate professors in the wet lab techniques, parallel curricula, & pedagogical instruction to engage students in the hunt to find new antibiotic-producing soil microbes. Go here to register.
  • 27 Jul 2021 (virtual, 5-6.30p CEST / 11a-12.30p EDT): GARDP-sponsored webinar entitled “Discovering and developing new treatments for fungal infections.” Go here to register.
  • 14-29 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
  • 24-26 Aug 2021 (virtual, timings not stated but presumably EU-centered): The 5th 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. The in-person version of this meeting is consistently excellent; the video-based version will have to do for 2021. 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. 
  • 5-8 Nov 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.
  • 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.
  • 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.
]]> Wellcome Trust RFP: Landscape Report on Early antibiotic development https://amr.solutions/2020/12/04/wellcome-trust-rfp-landscape-report-on-early-antibiotic-development/ Fri, 04 Dec 2020 14:38:10 +0000 https://13.43.35.2/?p=3818

Dear All,

The Wellcome Trust Drug-Resistant Infections team wants to understand what researchers in academia and SMEs need to enable them to be better able to make progress with their early antibiotic discovery projects. Although some programs are now in place (e.g., the accelerator support provided by CARB-X), what are the remaining barriers? 

To help answer this question and then to inform their work, Wellcome are seeking proposals to conduct a landscape review and produce a report that would cover topics such as:

  • What expertise and resources are needed at the early/translational stages of product development?
  • What is the best way to offer access to training to develop relevant skills?
  • What are the incentives and disincentives for academics to engage in antibiotic R&D?


Per the just-released RFP, Wellcome are looking for organizations with relevant knowledge of the field who are also experienced in conducting landscape reviews. The deadline for expressions of interest is 17.00 GMT on 16 December 2020. Selected partners will be asked to submit a full proposal by 20 January 2021.

This sounds like a very interesting project! Might your team be in a position to take this on? 

And while you consider this, please take a look at the other ideas and activities summarized on the homepage for the Drug-Resistant Infections team. It’s a treasure trove of links to key reports, patient stories, and more.

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 National Institute of Allergy and Infectious Diseases (NIAID) Applicant Assistance Program (AAP) opens on October 22, 2020. This program provides no cost support for companies planning to apply for a Phase II, Fast Track, or Direct-to-Phase II SBIR or STTR Award. Go here for details.
  • Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
  • CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (75 total awards, and counting and they conclude contracting on prior rounds), including future options on those awards. New rounds from CARB-X will occur only after new funding is obtained in 2021.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.
  • It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
  • Finally, you might also be interested in the most current lists of R&D incentives (link) and priority pathogens (link)


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

  • 26-28 Jan 2021 (online, runs ~7.30a-5.00p Central each day): 4th Annual Texas Medical Center Antimicrobial Resistance and Stewardship Conference. Sponsored by McGovern Medical School, ARLG, and the Gulf Coast Consortia, the agenda includes both poster sessions and keynotes. The call for abstracts closes 18 Dec 2020. Go here for more details.
  • 10-12 Mar 2021 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register; abstract deadline is 15 Nov 2020.
  • 9-12 Jul 2021 (Vienna): Annual ECCMID meeting (#31)
  • 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
  • 27 Jun-2 Jul 2021 (Ventura, CA): Gordon Research Conference entitled “Antimicrobial Peptides”. Go here for details, go here for the linked 26-27 Jun Gordon Research Seminar that precedes it.
  • 5-21 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
  • 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
  • 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students. Bonus feature: For obvious reasons, the course didn’t happen in 2020! But as a celebration of the course’s 5th year, a webinar version was held on 29 Oct 2020: go here to stream it. 
  • 6-11 Mar 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
]]> Research opportunity: Two RFPs from Wellcome Trust in support of the UN IACG https://amr.solutions/2017/12/06/research-opportunity-two-rfps-from-wellcome-trust-in-support-of-the-un-iacg/ https://amr.solutions/2017/12/06/research-opportunity-two-rfps-from-wellcome-trust-in-support-of-the-un-iacg/#respond Wed, 06 Dec 2017 19:52:57 +0000 https://13.43.35.2/?p=395 Dear All:

I have just learned that Wellcome Trust is seeking applications to address an RFP (Request for Proposal) for two pieces of work designed to support the recently created UN Interagency Coordination Group (IACG) on AMR.

  • RFP #1 is for a review of the roles, responsibilities and remit of UN organisations in relation to AMR, identifying what agencies are doing now as well as where they might further engage in order to increase engagement on AMR.
  • RFP #2 is for an assessment of the global indicator framework for Sustainable Development Goals (SDGs) and targets for the 2030 Agenda for Sustainable Development, identifying where AMR-specific and AMR-sensitive indicators could be included in the SDG targets/indicators to broaden their scope to include AMR.

This is an important but specialized project! Please forward this email to anyone who you think might be interested. Contact details and the full RFP are provided in the document at this link. The stated deadline is 15 Dec. Recognizing that this is a tight window, I’d suggest reaching out to the contact provided in the document if you have further queries.
​
All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://13.43.35.2/blog/

Further background details
During the 71st Session of the United Nations (UN) General Assembly, Member States adopted the Political Declaration of the High Level Meeting on Antimicrobial Resistance (AMR). The declaration recognised the magnitude of AMR as a global problem and called for the UN Secretary General to establish an ad hoc Interagency Coordination Group (IACG) on AMR. The IACG was established earlier this year, creating six sub-groups to review progress on AMR and support the development of recommendations to be fed back to the UN Secretary General during the 73rd session of the UN General Assembly.

The Wellcome Trust are supporting the work of sub-group five who will focus on sustainable development goal (SDG) alignment, global governance post 2019 and UN roles and responsibilities. Sub-group five has a number of areas where they wish to commission work, the outputs from which will be used to inform thinking on AMR and their recommendations back to the UN Secretary General.

The Request for Proposal (RFP) document provides full details of the first two pieces of work Wellcome Trust is seeking to commission on behalf of IACG sub-group five.

The first commission is a review of the roles, responsibilities and remit of UN organisations in relation to AMR, identifying what agencies are doing now as well as where they might further engage in order to increase engagement on AMR.

The second commission is an assessment of the global indicator framework for SDGs and targets for the 2030 Agenda for Sustainable Development, identifying where AMR specific and AMR sensitive indicators could be included in the SDG targets/indicators to broaden their scope to include AMR.

Please note these commissions have been included under the same RFP as suppliers are welcome to submit a proposal for both pieces of work to be done in parallel, however this is not essential and individual bids are also encouraged.

Upcoming meetings of interest to the AMR community:

]]> https://amr.solutions/2017/12/06/research-opportunity-two-rfps-from-wellcome-trust-in-support-of-the-un-iacg/feed/ 0 Wellcome Trust: RFP to develop a business plan for a sustainable clinical trial network https://amr.solutions/2018/03/05/wellcome-trust-rfp-to-develop-a-business-plan-for-a-sustainable-clinical-trial-network/ https://amr.solutions/2018/03/05/wellcome-trust-rfp-to-develop-a-business-plan-for-a-sustainable-clinical-trial-network/#respond Mon, 05 Mar 2018 19:50:47 +0000 https://13.43.35.2/?p=389 Dear All:

Just released today is an RFP (see text just below my signature) to develop a business plan for the design, funding, and implementation of a sustainable clinical trial network for developing new antibacterial agents. 

The core of this idea emerged in early 2016 based on debates about the potential value of a network focused on a specific infection (e.g., nosocomial pneumonia) in which a standing protocol randomized subjects to a well-accepted standard comparator (probably a carbapenem) or a rotating series of investigational agents. A group of us summarized the key elements of the idea in this 2016 paper in Clinical Infectious Diseases. Here’s a visual illustration of the concept:

Picture

Figure legend from the CID paper: Shown are 3 years in the life of a network. To start the network, a target infection is chosen, a standard protocol is prepared, and a widely registered excellent standard comparator (control A) is selected. After a brief run-in period, test drugs are flexibly added and removed from the network. A constant control arm (control A) is envisioned, but alternative controls can also be used as needed to address issues such as blinding (control B paired with test 2). Multiple agents can be in the network simultaneously. It is also assumed that data on control agents can be shared across drugs.

The goal of the network is to reliably provide sponsors with a data from a properly powered and designed non-inferiority study that would serve as the basis for registration. When combined with implementation by the sponsor of a separate MDR/XDR study, you have the essence of a Tier B trial program.

The network study would be implemented in UDR (Usual Drug Resistance) settings in which a standard comparator such as a carbapenem would be acceptable. Sharing of controls and elimination of study startup delays for each new drug are estimated to reduce cost and time by ~40% for drugs using the network. Continuity for sites and investigators is provided by the ongoing nature of the network.

First discussed in early 2016, it is exciting to see Wellcome taking the next step towards making this concept a reality! Contact details are provided below should you or a colleague be interested in taking up this challenge. Expressions of interest are due by 12 March.

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://13.43.35.2/blog/

Wellcome Trust RFP (Request for proposals)
We’re looking to commission an organisation or consortium with understanding of the development and operations of clinical trial networks.
 
This follows our report on the importance of clinical trial networks for antibiotic development, and how they should be developed.
 
The purpose of this commission is to develop a business plan for the design, funding and implementation of a sustainable clinical trial network for infectious diseases centred specifically on antibiotic development.
 
The network should be able to:

  • generate comparative data on new agents quickly and efficiently
  • evaluate more than one investigational agent at a time using a standardised master protocol for each infection.

 
Our aim is that the findings from this work will inform the development of a new clinical trials network, helping to reduce costs, get clinical trials up and running more quickly, and lead to shorter late-stage trials.
 
Supporting documents, including a detailed timeline can be found on our website.
 
For more information or to express your interest, please email CTNetwork@wellcome.ac.uk. The deadline for expressing interest is Monday 12 March, 23:59 GMT.

Upcoming meetings of interest to the AMR community:

]]> https://amr.solutions/2018/03/05/wellcome-trust-rfp-to-develop-a-business-plan-for-a-sustainable-clinical-trial-network/feed/ 0