Following release back in June of a preview (22 June 2021 newsletter), we now have the official introduction of Cures 2.0 by the bipartisan team of U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI)! Here are the links you need:
There is a lot to like in Cures 2.0: this major legislation is divided into sections that cover Public Health, Patient-Caregiver issues, FDA, CMS, and Research. From the perspective of the AMR community, the big news is Sec. 105. entitled “Developing Antimicrobial Innovations”:
- In this section, the Cures 2.0 sponsors are collaborating with Sens. Bennet (D-CO) and Young (R-IN) and Reps. Doyle (D-PA) and Ferguson (R-GA) to include the PASTEUR Act (Pioneering Antimicrobial Subscriptions to End Up surging Resistance). In brief (more details in this 30 Sep 2020 newsletter):
- “This policy would establish a subscription model to pay for critically-needed novel antimicrobial drugs.
- “HHS would provide companies with a federal payment, that is delinked from the sales or use of those newly-developed antibiotics, to ensure a predictable return on investment and improve appropriate use of the drug.
- “The policy contains investment in programs to address antimicrobial resistance, which is critical for patient care and public health.”
Readers of this newsletter will know that I think PASTEUR is the key to reinvigorating our antibiotic ecosystem because PASTEUR levels the economic playing field:
- Without PASTEUR, companies that develop innovative antibiotics will continue to go out of business (key examples: Achaogen and the subsequent “Thanks, but no thanks” letter from Cipla to EU, and the story of Melinta).
- With PASTEUR, it will make as much sense to start an antibiotic company as to start a cancer therapy company.
PASTEUR is the answer because it (i) offers a Pull incentive in the right range (see the 1 Nov 2021 newsletter for a discussion of Kevin Outterson’s excellent new paper on the right size for such awards) and (ii) the very nature of Pull awards aligns innovation with stewardship. (If you are new to these issues, Andrew Jack’s 5-minute video explainer is a great start; see also this annotated list of newsletters on incentives).
It’s also good to recall that the DRIVE-AB project (2014-2017) surveyed 35 different types of incentives (see the report) and found that the best solutions were delinked models in which we recognize that antibiotics are the #FireExtinguishersOfMedicine and purchase them as (effectively) fire-fighting infrastructure.
Woot, woot! Many thanks to Rep. DeGette, Rep. Upton, and staff at the House Committee on Energy and Commerce for making this happen. It is fabulous to see Cures 2.0 and PASTEUR making progress towards becoming law!
With gratitude to all who put their time and energy into creating new antibiotics for current and future generations, –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 firstname.lastname@example.org.
- 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):
- 15-17 Nov 2021 (virtual, timings TBD but would expect global coverage): 3rd Call to Action on Antimicrobial Resistance: “Sharing evidence and best practice to empower national action.”
- Building on the success of the previous Call to Action on Antimicrobial Resistance (AMR) conferences held in Berlin (2017) and Ghana (2018), the governments of Denmark, Colombia, Ghana and Zambia, with the International Centre for AMR Solutions (ICARS), UN Foundation, UNICEF, and the Wellcome Trust, are together organising a follow-up event to advance the response to rising rates of drug-resistant infections.
- Go here for an expression of interest form; contact the organizers at AMRCalltoAction@wellcome.org for other details.
- 18-24 Nov 2021: World Antimicrobial Awareness Week (WAAW), sponsored by WHO. The theme is “Spread awareness, stop resistance.” Go here for details.
- [New, intriguing focus on responsible investing] 18 Nov 2021 (virtual, 2p-3.30p GMT): Featuring a keynote by Dame Sally Davies, the Investor Action on Antimicrobial Resistance (AMR) Initiative is sponsoring a webinar entitled “Investor action on antimicrobial resistance: achievements & opportunities ahead.” This intriguing webinar is sponsored by a collaborative initiative between the Access to Medicine Foundation, the UN-supported Principles for Responsible Investment, FAIRR, and the UK Government. Click here to register.
- [New] 19 Nov 2021 (virtual, 5p-6p CEST): GARDP’s next AMR Discussions webinar entitled “The roles of different actors in developing new treatments for drug-resistant infections.” Click here to register.
- [New] 24 Nov 2021 (virtual, 9-10a New York / 3-4p Paris): Webinar sponsored by the Global Coalition on Aging and MSD entitled “AMR Threat to National Health Systems and Economies: A Call-to-Action.” Will feature a discussion of GCOA’s 2021 AMR Preparedness Index as well as an upcoming report entitled “Developing National Strategies to tackle Antimicrobial Resistance across countries in the Eastern Europe, Middle East and Africa (EEMEA) region.” Go here to register.
- [New, webinar on behavioral change!] 24 Nov 2021 (virtual, 10a CET and also 3.30p CET): WHO-sponsored webinar entitled “Applying behavioural and cultural insights to tackle antimicrobial resistance.” Register here for the 10a webinar, here for the 3.30p edition. I find this to be a fascinating topic … good for WHO!
- [New, major new Horizon Europe consortia opportunity and JPIAMR call] 26 Nov 2021 (virtual, 9.30a-12.30p, EU-centric timing): Webinar entitled “Horizon Europe Tackling Diseases and Antimicrobial Resistance (AMR) Webinar and Partnering – Cluster 1 / Destination 3 and 5′. Multiple calls for consortia participation (vaccines, pandemic preparedness, and more) as well as discussion of an upcoming JPIAMR Therapeutics Call that is expected to be announced on 18 Nov 2021. Go here to register.
- 1 Dec 2021 (virtual, 9a-1p UK): Westminster Health Forum policy conference “Tackling antimicrobial resistance in the UK and the UK’s role on the global stage.” Chaired by Kevin Hollinrake MP (Co-Chair, All-Party Parliamentary Group on Antibiotics, APPG-Antibiotics) and Professor the Lord Trees, Emeritus Professor, U Liverpool; and Treasurer, APPG-Antibiotics, this 5-h session includes keynotes from Dame Sally Davies and Haileyesus Getahun (WHO) and speakers spanning the UK’s AMR efforts. Go here to register.
- 1 Dec 2021 (virtual, 4-5p CET): Spotlight session at ISPOR 2021 entitled “Methods to Estimate the Value of New Antibiotics in the Context of Antimicrobial Resistance.” ISPOR is the International Society for Pharmacoeconomics and Outcomes Research and this spotlight session at their annual meeting will feature discussions of the modeling used by the UK in support of its “Netflix” delinked purchase pilot model. Go here to register if you are interested in the whole meeting; I am working to try to make this specific session free to access by streaming after the session.
- 3 Dec 2021 (Boston, in person, 9a-6.30p, COVID vaccination required): 8th annual BAARN (Boston Area Antimicrobial Research Network) meeting. Go here for details; registration link is here.
- 3 Dec 2021 (virtual, US daytime timings): Symposium entitled “Advances in Antibacterial Discovery” sponsored by the St. Jude Department of Chemical Biology and Therapeutics, is a part of the broader Bringing Chemistry to Medicine series and is supported by the St. Jude T32 Infectious Disease Therapeutics training program. Go here for details and to register.
- 8-9 Dec 2021 (virtual, 9a-noon East Coast US): ASM-ESCMID-sponsored joint conference on antimicrobial drug development. This is the 2021 online version of one of my favorite meetings and I strongly encourage attendance on both days to gain a perspective on how new reimbursement models are going to change the R&D landscape. Online agenda is here, registration link is pending so just mark your calendar for now.
- 8 Dec: “The New Winds Pushing and Pulling Antibacterial Development.” DO NOT MISS THIS ONE! Featuring 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, this promises to be a key update for the whole community.
- 9 Dec: CARB-X – GARDP Boot Camp: What Makes a Good Project Succeed? Featuring speakers with many years of R&D experience, this session makes a good companion to the 8 Dec talk and will leave you well informed on best ways to guide your search for new antibiotics.
- [New] 14 Dec 2021 (virtual, 9a-1030a EST): CDC webinar entitled “Hooves, Paws, or Feet: A Multispecies Examination of Antimicrobial Use and Stewardship Practices”. This event is the third installment of the AMR Exchange webinar series. Click here for details.
- [New] 2-3 Feb 2022 (virtual): 10th Advances Against Aspergillosis and Mucormycocosis. Registration closes on 30 Jan 2022. Go here for details.
- [New] 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.
- 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.
- 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.