Dear All,
Post-newsletter addendum: I’ve learned that USDA will host a 10 Aug 2022 (virtual, 10a-4.30p ET) workshop on AMR in food agriculture. See the meetings calendar for more details; go here to register.
I’ll confess to having missed entirely the request back in February 2022 from FDA’s Center for Veterinary Medicine (CVM) for comments on antimicrobial drug use practices in companion animals and the potential impacts of such uses on antimicrobial resistance in both humans and animals.
Well, perhaps I’m not alone in having missed this as the FDA has now extended the comment period to 14 Sep 2022 from 16 June 2022!
This call for comments speaks to the interesting distinction between livestock (the animals we routinely eat), pets (companion animals), and wildlife. For those interested in reading more, this article and this one (a bit lighter in tone) provide perspectives on this distinction. The difference is important: the discussion on eliminating veterinary antibiotics is about large-scale use in raising millions of chickens. But, what about use for a serious infection in one dog or one horse? It such a different scale of use that a different set of questions is relevant.
Whether you comment or not, it is interesting to contemplate the full list of questions for comment (see just below my signature). Broadly, I see two themes: (i) how are antibiotics currently used and (ii) what would good antimicrobial stewardship look like?
And if you do have a perspective to share, please get busy and submit your comments! 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.
Questions from FDA/CVM:
- Please describe if antimicrobial use practices in companion animals have impacted the development of antimicrobial resistance in bacterial pathogens of companion animals. Please provide information, data, and/or references to support your response.
- Please describe if antimicrobial use practices in companion animals, including extralabel use, have impacted the development of antimicrobial resistance in human bacterial pathogens. If possible, please describe whether the impact was the result of direct or indirect contact between humans and the treated companion animals. Are there specific concerns about the development of antimicrobial resistance in human bacterial pathogens when particular antimicrobial drugs or drug classes are used in companion animals? Please provide information, data, and/or references to support your response.
- How should the human medical importance of particular antimicrobial drugs or drug classes be considered when deciding whether, or under what conditions, to use such drugs in companion animals?
- How can CVM best engage with our stakeholders on promoting antimicrobial stewardship for companion animals? Examples of stakeholders include other government agencies, the pharmaceutical industry, public health organizations (both public and private entities), veterinary professional organizations, veterinary schools, veterinarians, pet owners, and veterinary diagnostic laboratories.
- How can CVM encourage the development of antimicrobial drugs consistent with the principles of antimicrobial stewardship for the treatment of infectious diseases in companion animals for which there are no FDA-approved animal drugs?
- What bacterial diseases affecting companion animals are most in need of an FDA-approved animal antimicrobial drug?
- What safety and effectiveness study design considerations present challenges for developing antimicrobial drugs to address specific infectious diseases in companion animals ( e.g., Lyme disease, sepsis, or osteomyelitis)? Are there alternative study designs that would address these challenges? If not, what role(s) could the stakeholder groups identified in question 4 play in developing such alternative study designs?
- Are there specific infectious diseases in companion animals for which topical formulations of antimicrobial drugs ( e.g., medicated shampoos, rinses, or ointments) may be a better alternative than using systemic antimicrobial drugs from the perspective of antimicrobial stewardship? If so, what role(s) could the stakeholder groups identified in question 4 play toward fostering the use of such topical antimicrobial formulations?
- Labeling:
- What information on currently approved animal drug labeling helps the veterinarian prescribe or use an antimicrobial drug in a manner consistent with the principles of antimicrobial stewardship?
- What additional information could be added to the approved animal drug labeling to improve the veterinarian’s ability to prescribe or use an antimicrobial drug in a manner consistent with the principles of antimicrobial stewardship?
- Is there a need for materials containing labeling information and/or information about antimicrobial stewardship that veterinarians could provide to the client when they prescribe an antimicrobial drug ( e.g., client information sheets or other educational handouts)?
- With respect to the use of antimicrobial drugs in companion animals, what other actions should CVM consider taking to foster greater antimicrobial stewardship?
Current funding opportunities (most current list is here)
- The AMR Industry Alliance has announced their 2022 Stewardship Prize! The program offers 10,000 CHF to recognize established, innovative approaches to AMR stewardship in low- and middle-income countries (LMICs). The 2021 prize went to the Infectious Diseases Institute (IDI) in Kampala, Uganda for their best practices in diagnostic stewardship and for their patient awareness campaigns dedicated to decreasing inappropriate use of antibiotics in their specialist HIV clinic in Kampala. Applications for the 2022 prize are due August 31, 2022. Thinking in terms of stewardship, WHO have recently released a pair of courses through the OpenWHO platform:
- Course 1 provides training on the WHO Policy Guidance on Integrated Antimicrobial Stewardship Activities
- Course 2 focuses on the WHO practical toolkit for antimicrobial stewardship programmes in health-care facilities in low- and middle-income countries
- The online training courses can be found on the dedicated channel: https://openwho.org/channels/amr
- The AMR Action Fund is now open to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to contact@amractionfund.com.
- INCATE (Incubator for Antibacterial Therapies in Europe) is a newly launched early-stage funding vehicle. Details are still coming into focus, but per comments on 25 Aug 2021 at the BIOCOM conference, their goal is to support ~4 companies per year with about $250k/company. Contact details are on their website (https://www.incate.net/).
- New funding rounds from CARB-X are expected soon now that funding for the next 10 years has been announced!
- 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):
- [Not to be missed!] 8 Dec 2021: “The New Winds Pushing and Pulling Antibacterial Development.” This FABULOUS program featured talks from the UK team behind the NHS “Netflix” pilot, Kevin Outterson’s recently released report documenting the need for global Pull incentives to have a value of $2.2 – 4.8b, and speakers covering PASTEUR and work in the EU on pull incentives. The video is here — please make time to listen to this program!
- [Required reading!] The stunning 4 Feb 2022 webinar for the GRAM report (Global Research on Antimicrobial Resistance “1.27 million deaths per year are directly attributable to AMR”) is now available for replay. #AMRSOS!
- 13 or 14 Jun 2022 (virtual, 14.00-17.00 (CEST) on 13 Jun, 09.00-12.00 (CEST) on 14 Jun, same agenda both days): “Supporting measures to mitigate AMR in One Health settings,” webinars sponsored by JPIAMR and ICARS that will consider at length the ‘Prevention and Intervention’ pillar of the JPIAMR’s Strategic Research and Innovation Agenda. Go here for details and to register.
- 16-18 June 2022 (Perth, Australia): Australasian Society for Infectious Diseases Annual Scientific Meeting is a hybrid event for adult and pediatric infectious disease and clinical microbiology specialists. Go here for details.
- 21 Jun 2022 (virtual, 10:00-11:00 ET | 15:00-16:00 BST): Launch of the AMR Register. Sponsored by Vivli with funding from many partners, this is the launch of an open-access repository for industry-generated surveillance data. Looks interesting! Go here to register.
- 22-23 Jun 2022 (virtual, 10a to approx. 2.30p ET on both days): Workshop entitled “Strategies for Early-Stage Programs Developing Novel Antibacterial and Antifungal Drugs.” Sponsored by NIAID’s Bacteriology and Mycology Branch (BMB), this 2-day webinar features a very strong faculty (including speakers from FDA) discussing tips and insights for early product discovery including in-depth discussions of funding opportunities. The timing is US-centered but video replay will be available. Do not miss this! Go here to register.
- 23 Jun 2022 (Virtual, 2-4p CEST): “Tackling the emerging threat of fungal drug resistance,” a webinar sponsored by JPIAMR, the Israeli MoH, and the UK MRC. Go here to register. Yes, that’s the Israeli Ministry of Health getting into AMR … perhaps in part stimulated by a 2015 report on the significant burden of fungal infections in Israel.
- 6 July 2022 (virtual, 15:00 CET/ 09:00 ET): WHO webinar entitled “Enhanced use of data to monitor safety and effectiveness of paediatric medicines”. Go here for details.
- 11-14 July 2022 (Sydney): Australian Society for Microbiology Annual National Meeting is a hybrid event that will feature a range of lectures and symposium sessions, as well as extensive opportunities for networking. Go here for details.
- 26 July 2022 (virtual, 10a-11.30a ET): REVIVE webinar entitled “New approaches for antibiotic discovery”. Go here for details.
- 24-27 July 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
- 28-31 July 2022 (Singapore): 10th International Congress of Asia Pacific Society of Infection Control is a hybrid event for professionals in the Asia Pacific region. Go here for details and to register.
- 23 August 2022 (virtual, 11a-12.30p ET): REVIVE webinar entitled the Challenges and options in developing antibiotic combinations. Go here for details.
- 12-13 Sep 2022 (virtual, 9a-5p ET): This meeting of PACCARB is going to “identify key issues and critical policy gaps through a series of facilitated discussions examining a hypothetical large-scale disease outbreak scenario based on historic examples and estimates of future AMR outbreaks.” Sounds like pandemic wargaming (Center for Health Security; pre-COVID 19 May 2020 NPR article) to me! Go here for details.
- 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
- 4-7 Oct 2022 (Dublin, Ireland): The 2022 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent meeting, especially for developers … and if you’ve missed it, the recordings from the 2021 meeting are online. Go here for details on the 2022 meeting.
- 19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
- 15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6th edition of Patrice Courvalin’s fabulous ICARe residential training course covering all things AMR is on for 2022! This is a soup-to-nuts training in AMR: it is very intense, very detailed, and always gets rave reviews from attendees. Registration is open 21 Mar 2022 to 21 June 2022 and is limited, so book your slot as soon as you can. Go here for details.
- 19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
- 25-28 Oct 2022 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.
- 17-20 Nov 2022 (Kuala Lumpur, Malaysia): The International Congress on Infectious Diseases will take place for the first time as a hybrid event. Go here for details.
- 27-30 Nov 2022 (Perth, Australia): 32nd International Congress of Antimicrobial Chemotherapy is the biennial congress of the International Society of Antimicrobial Chemotherapy (ISAC). Go here for details.
