Dear All,
On the theme of global health security, today’s note covers 3 exciting, overlapping items. Here we go…
First, the G7 leaders have agreed to sign the Carbis Bay Declaration covering global health, economic stability, climate and more. Specifically related to health in a section entitled “End the pandemic and prepare for the future”, we have “… we will create the appropriate frameworks to strengthen our collective defences against threats to global health by: increasing and coordinating on global manufacturing capacity on all continents; improving early warning systems; and support science in a mission to shorten the cycle for the development of safe and effective vaccines, treatments and tests from 300 to 100 days.” That final point about shortening the R&D cycle is really interesting … these actions are already underway:
- UK will establish a new centre to develop vaccines to prevent zoonotic diseases spreading from animals to humans
- The UK has called for a 100 Days Mission to Respond to Future Pandemic Threats to speed up the time it takes to develop vaccines, treatments and diagnostics.
The “100 Days Mission” is the intriguing idea that within the 100 days from a pandemic threat being identified (defined by when WHO declares a PHEIC), we should aim for the following interventions to be available, safe, effective, and affordable:
- Accurate and approved rapid point of care Diagnostic tests;
- An initial regimen of Therapeutics; and,
- Vaccines ready to be produced at scale for global deployment.
What a concept! Ambitious? Yes! Feasible? YES!
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Second, BARDA have announced the creation of BARDA Ventures. BARDA Ventures is the venture arm of the Biomedical Advanced Research and Development Authority (BARDA) and will invest up to $500 million over 10 years to develop and commercialize technologies and medical products that could respond to future health security threats. The first step of this is $50m provided to GHIC (Global Health Investment Corporation), a non-profit established to provide long-term funding for global health research and development through financing vehicles such as the Global Health Investment Fund. Combined with BARDA’s announcement of 10 more years of funding for an Antibacterial Accelerator, we have substantial push funding from the US government. Go BARDA!
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Finally, and tying a lot of the key core ideas together, we have a new report from Access to Medicine Foundation (ATMF). Provocatively titled “Biotechs are saving the world from superbugs. Can they also save themselves?”, the title is the message:
- “The world is now heavily reliant on small- and medium-sized enterprises (SMEs) to bring life-saving new antibiotics and antifungals to market.
- “Accounting for 75% of all late-stage antibiotics and antifungals in development, they are pivotal in driving new antimicrobial innovation.
- “Yet despite this, these smaller companies often face funding shortfalls and bankruptcy, leaving promising new drugs stranded on the lab bench.
Yes, that’s on point … and if the issues here are new to you, please start with the materials summarized on the Incentives webpage. The core messages for action are:
- A call for Pull incentives of various types: “It is clear that the innovators of such drugs urgently need a stable economic and policy environment suitable for developing and responsibly delivering new antimicrobials.
- “Potential solutions include cash payments to companies for successfully developing a new product in the form of a market entry reward, subscription models where governments make regular payments in return for guaranteed, on-demand supply of effective antibiotics and antifungals, and regulatory reform to harmonise effective routes to market approval.”
- Until the various Pull award projects such as the NHS pilot and the PASTEUR Act come into full flower, Access is not going to happen (much less, Stewardship and Access):
- “SMEs have little room for error when it comes to commercialisation once research grants have expired. They are expected to navigate financial “valleys of death…”
- “At worst, it means that promising and urgently needed candidates for new medicines, diagnostics and vaccines disappear when SMEs go bankrupt”
- And on this point, the report cites yet another example of a company financial failure despite intriguing Phase 1 data (the Swiss biotech company Juvabis; for more on this theme, see also the 5 Jan 2020 newsletter on the collapse of Melinta and this 11 July 2020 newsletter about the withdrawal of the plazomicin marketing application in Europe due to the lack of economic viability for a fully developed and approvable drug).
- ATMF then brings all of this together by reviewing survival strategies being used at present by various SMEs. These are diverse and good to see, but the core message that comes through loud and clear is that this will all be too little and much too late unless we create Pull incentives at scale on a global basis!
Many thanks to the G7, BARDA, and ATMF for these actions and messages — we need to keep explaining how preparedness is the grease that protects our health and our economies! And I should also reinforce the message from the 5 June newsletter about the need for the R&D community to focus on projects that will really move the needle. Substantial Pull awards will not be provided to all products: choose wisely!
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):
- MTEC has announced an RFP seeking proposals focused on diagnostics, prevention of endemic diarrhea, and selected antivirals. Go here for the full RFP and search for “FA2.13” to find the infection-focused topics. White papers are due 17 June 2021.
- GNA NOW (part of the IMI AMR Accelerator) has an open call to identify a novel mechanism antibacterial to add to its portfolio. The selected project would receive resources equivalent up to several million € (to be defined according to project needs); see also this 11 May 2021 newsletter for details. Expressions of interest are due by 18 June 2021.
- The International Society for Infectious Diseases (ISID) is collaborating with Pfizer fund projects identifying and addressing AMR in the outpatient setting across low-income countries or under-resourced settings in middle-income countries. A total of $1 million USD is available in funding, and programs can apply for a maximum of $100,000 USD to cover program expenses over three years. Go here for details. The deadline is 18 June 2021!
- 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):
- 20-24 Jun 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.
- 24 Jun 2021 (virtual, 9-4p CET): “Promoting Innovative Antibiotic R&D in Switzerland,” an event sponsored by the Swiss National Research Programme “Antimicrobial Resistance” (NRP 72). Go here for details and to register.
- 24 Jun 2021 (virtual, 09:30 AM – 05:30 PM CEST): Workshop entitled “Advancing Data Technologies to corner AMR.” Sponsored by AMR Insights, you can register here.
- 5 Jul 2021 (online): Royal Society-sponsored webinar entitled “Advances in antimicrobial innovation.” Go here for details and to register.
- 9-12 Jul 2021 (virtual): Annual ECCMID meeting (#31)
- Grants supported by the Bill & Melinda Gates Foundation are available to support participation from persons residing in Low- and Lower-middle income countries! Go here for details. Applications are due 10 June.
- 26 Jul-30 Jul 2021 (online): Small World Initiative Instructor Training Workshop – training for undergraduate professors in the wet lab techniques, parallel curricula, & pedagogical instruction to engage students in the hunt to find new antibiotic-producing soil microbes. Go here to register.
- 14-29 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
- 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.
- 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.
- 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.