VERY exciting news on the Pull incentive front: The G7 Finance Ministers have released a statement on Actions to Support Antibiotic Development, aiming to strengthen G7 preparedness against the “silent pandemic” of antimicrobial resistance. Implicitly, this is a statement that is agreed and endorsed by the political leadership of each country — for the US, this means Treasury Secretary Yellen (and behind her, the White House).
There’s some amazing language in the statement … let’s take a look. Here are the links you need:
- The webpage about the statement
- The statement itself
- An annex that summarizes actions by country
- A statement on Shared Principles for valuation of antimicrobials
From the statement, we have this key paragraph (I’ve added line breaks and emphasis):
- “All G7 members commit to expedite their implementation of existing strategies, outlined in our respective AMR Action Plans and related strategies, and to take additional specific and appropriate steps to address the antibiotic market failure and create the right economic conditions to preserve essential existing antibiotics and ensure their access, strengthen AMR antibiotic research and development, and bring new drugs to market where they meet identified public health needs (see annex A for examples of G7 action).
- “Recognising country-specific circumstances and member state competences, possible steps could include exploring a range of market incentive options, with a particular emphasis on supporting relevant pull incentives, implementing new pilot projects, contributing to new national governance structures to develop economic strategies to strengthen antibiotic development, and exploring legislative and regulatory measures.”
Then in the Annex of ongoing by-country actions, we have of course mentions of the UK “Netflix” pilot as well as the EU’s call for Pull incentives, but the real stunner is the explicit endorsement of PASTEUR plus a statement that DHHS is preparing to simply implement the idea of PASTEUR by direct action if it doesn’t pass in Congress! Read for yourself:
- “Additionally, AMR-related legislation known as the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act was introduced in the U.S. Congress.
- “This Act aims to address shortcomings in the antibiotic development market and increase public health preparedness by keeping novel antibiotics on the market and improving appropriate use across the health care system.
- “While current contracts between the government and drug makers base payment on volume, the PASTEUR Act would establish a subscription-style model which would offer antibiotic developers an upfront payment in exchange for access to their antibiotics, encouraging innovation and ensuring the U.S. health care system is prepared to treat antibiotic resistant infections.
- [READ CLOSELY — AMAZING] “In the event that the proposed Act is not enacted into law, HHS has begun the process required to establish a novel payment mechanism with the HHS FY23 proposed legislative program.”
Last but not least, the shared valuation framework includes mention of STEDI, the importance of stewardship and access plans (the Stewardship & Access Plan (SAP) Development Guide by CARB-X gets a shout-out), and how to de-link reimbursement and volume of sales. The list of guiding principles that would be required for recipients of delinked Pull rewards is a good read:
- “publishing of global access and stewardship plans;
- “promotion of product affordability and improvement in access, particularly for low- and middle-income markets
- “maintenance of high manufacturing standards, including measures to reduce the risk of sub-standard and falsified medicines entering into circulation;
- “adherence to high environmental standards, including the proper management of manufacturing waste and pollutants;
- “maintenance of robust end-to-end supply chains and mitigation plans for supply disruption;
- “reinforcement of appropriate promotional behaviours, including removing sales incentives;
- “consideration of the other commitments made by the AMR Industry Alliance in its 2016 Davos Declaration.”
WOOT, WOOT! Stunning! I am all astonishment!
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 email@example.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):
- [KEEPING IN CALENDAR — VIDEO COMING SOON] 8 Dec: “The New Winds Pushing and Pulling Antibacterial Development.” This one has already happened but I’m going to hold it in the calendar as a reminder to watch the video from the meeting. The video is not yet posted, but should appear here soon. 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.
- 2-3 Feb 2022 (virtual): 10th Advances Against Aspergillosis and Mucormycocosis. 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.
- 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.
- [NEW] 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.