As was discussed in these prior newsletters, the EU has announced an ambitious Pharmaceutical Strategy with initiatives that include development of Pull incentives for antimicrobials among a number of other topics (see the 28 Nov 2020 newsletter for the full list):
- 28 Nov 2020 (a general announcement)
- 29 Apr 2021 (comments by Stella Kyriakides)
- 24 Jun 2021 (RFPs to support AMR-focused elements, including Pull incentives),
There is now a public consultation on reforming EU’s pharmaceutical legislation. In a 28 Sep 2021 press release, Stella Kyriakides, Commissioner for Health and Food Safety, said: “Today we take an important step for the reform of EU’s pharmaceutical legislation by the end of next year. A regulatory framework for pharmaceuticals, which is modernised and fit for purpose, is a key element of a strong European Health Union and crucial to addressing the many challenges this sector is facing. I call on all interested citizens and stakeholders to help us shape EU rules for the future, responding to patients’ needs and keeping our industry innovative and globally competitive.”
A report from a prior consultation (Jun-Jul 2020) has shaped initial work. The press release notes that the last comprehensive review of the general pharmaceutical legislation was held almost 20 years ago. Thus, this review is timely and will cover a broad range of topics (highlights are mine):
- The performance of the EU’s pharmaceutical legislation;
- Unmet medical needs;
- Incentives for innovation;
- Antimicrobial resistance;
- Future-proofing the regulatory framework for novel products;
- Improved access to medicines;
- Competitiveness of the European markets to ensure affordable medicines;
- Repurposing of medicines;
- Security of supply of medicines;
- Quality and manufacturing of medicines;
- Environmental challenges.
Wow! This is a great opportunity for you to share your views. Go here to submit comments; the deadline is 21 Dec 2021.
When thinking about your comments, you might also want to review the 25 Apr 2021 newsletter on insights from recent JPIAMR/JAMRAI work on the types of new products that would be most likely to benefit from new Pull incentives. We need to be sure that the goalposts created for EU Pull incentives are realistic … it is all too easy to wish for data that simply cannot be generated. That newsletter also includes an instructive Fireside Chat about with Christine Ardal that covers this topic. If you don’t have time for the full conversation, please jump to 11:18 to hear the discussion of EU JAMRAI’s findings about product characteristics that will earn substantial delinked reimbursements.
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 Industry Alliance is offering a Stewardship Prize of 12.5k CHF (~$13.5k at current rates) to recognize innovative new approaches to AMR stewardship in LMICs (low- and middle-income countries). Go here for more details Applications are due by 8 Oct 2021.
- 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):
- 6 Oct 2021 (virtual, 8am EST): PFID-sponsored webinar entitled “Preparing for the Next Pandemic: An International Discussion.” Moderated by Kevin Outterson, the international panel includes Dame Sally Davies. Go here to register.
- 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
- 11-12 Oct 201 (Virtual, UK-centric timings): RSTMH (Royal Society of Tropical Medicine & Hygiene) Annual Meeting 2021: “Drug-resistant infections: causes, consequences and considerations.” Go here to register.
- 13 Oct 2021 (virtual): A pair of WHO-sponsored webinars entitled “The WHO Costing and Budgeting Tool for National Action Plans on AMR.” Go here to register for the webinar with EU-/Africa-/Asia-friendly timings of 10.00-11.00 Brazzaville/11.00-12.00 CET; go here to register for the same content but with more Americas-friendly timings of 10.00-11.30 Washington DC/16.00-17.30 CET.
- 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.
- 22 Oct 2021 (virtual, 3:30 PM CET/9:30 AM ET): CARB-X webinar entitled “European Celebration of 5 Years of Progress with CARB-X: A virtual discussion of progress and plans to accelerate innovation globally.” Don’t be thrown by the word ‘European’ in the title — the early agenda does have a European flavor but the implications are global. Go here to register.
- 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.
- 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.
- 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.