As part of the AMR Multi-Stakeholder Partnership Platform monthly updates, we feature perspectives from experts on critical issues, progress, and key initiatives in our joint efforts against antimicrobial resistance (AMR).
This month, we spoke with Dr. Damiano de Felice, Chief of External Affairs at CARB-X, a global non-profit partnership accelerating the development of innovative products to prevent, diagnose and treat drug-resistant bacterial infections. He shared insights on the structural barriers to antibacterial innovation, the role of public-private partnerships, and how access and innovation must be aligned to ensure equitable impact.
Despite global awareness of the antimicrobial resistance crisis, we continue to see a dangerously dry pipeline of new antibiotics. From your perspective, what are the biggest structural barriers to revitalizing antibiotic R&D, and how can public-private partnerships help overcome them?
Developing new health products to address unmet medical needs is inherently complex. In the case of antibiotics, the scientific challenges are compounded by a lack of private capital. For example, over the past decade, U.S. antibacterial-focused biopharma companies received nearly 17 times less private investment than their oncology counterparts.
The reason is straightforward: physicians are encouraged to reserve the most effective new antibiotics as treatments of last resort to slow down the development of resistance. While this is essential for public health and future generations, it undermines the commercial viability of these products. Why would venture capital or pharmaceutical companies invest heavily in antibiotic development when most R&D projects fail and the few that succeed offer limited returns?
Public-private partnerships like CARB-X are critical to addressing this problem. To start with, we mobilize financial resources from governments and philanthropic donors to provide sustainable funding to the most promising R&D projects. But our role goes beyond funding. Most antibacterial innovators are small or micro-sized teams with limited experience in end-to-end product development. This makes them highly vulnerable to costly missteps. CARB-X has built a comprehensive global support model that offers scientific, business, and regulatory guidance throughout the development process. This approach helps developers avoid common pitfalls, consider access and stewardship early in the R&D process and ultimately bring effective products to patients faster and more efficiently.
Access to effective antimicrobials remains highly unequal across regions and countries. How can we strike a balance between incentivizing innovation and ensuring affordable, equitable access to new and existing antibiotics, especially in low- and middle-income countries?
Prioritizing the right products is fundamental. At CARB-X, we focus on accelerating the development of antibiotics, preventatives, diagnostics, and other life-saving tools that (1) target the most dangerous drug-resistant bacteria, (2) address syndromes with the highest global burden, and (3) meet critical performance criteria for a range of different healthcare settings.
We also believe that access and stewardship must be integrated into the R&D process well before a product reaches the market. That’s why all CARB-X-funded developers are contractually required to prepare a Stewardship and Access Plan. This plan outlines how they will ensure responsible use and equitable access in low- and middle-income countries (LMICs) and must be completed within 90 days of entering pivotal Phase 3 trials—or the equivalent stage for diagnostics. If the product receives regulatory approval, the plan is made publicly available.
Recognizing that many product developers lack experience with global commercialization, we collaborated with partners to publish the world’s first comprehensive Stewardship and Access Plan Development Guide. This resource helps product developers understand what is expected and how to deliver on stewardship and access commitments.
Ultimately, innovation and access are not opposing goals—they are mutually reinforcing. Innovation must be accessible to have impact, and sustainable access depends on continued innovation.
What are the most promising models or initiatives you have seen that could transform the current market failure in antimicrobial innovation—and what still needs to happen to scale them?
There is broad consensus among public and private sector experts that governments can revitalize the antimicrobial pipeline via two complementary strategies: reducing the cost of R&D and increasing the rewards for successful innovation. These are known as push and pull incentives.
Push incentives reduce the financial risk for antibiotic developers by providing support during the R&D phase. Public-private partnerships like CARB-X are a prime example. Our portfolio has helped replenish the global clinical pipeline with some of its most promising candidates. And we work closely with advanced development partners such as the United States Biomedical Advanced Research and Development Authority (BARDA), European Commission’s Health Emergency Preparedness and Response Authority (HERA), the AMR Action Fund and the Global Antibiotic Research and Development Partnership (GARDP) to ensure continuity of support as products progress beyond our portfolio. We are also excited about the launch of the Gram-Negative Antibiotic Discovery Innovator (Gr-ADI), a new initiative by Wellcome, the Novo Nordisk Foundation and the Gates Foundation to drive upstream discovery for Gram-negative pathogens—feeding into CARB-X’s pipeline.
Pull incentives reward success after market approval by expanding potential revenues. The United Kingdom’s subscription model has been a breakthrough, offering predictable returns for developers of critical antibiotics. Italy has also taken important steps: starting in 2025, new and recently approved anti-infectives classified as Reserve by WHO or targeting WHO priority pathogens will be eligible for reimbursement through the national Fund for Innovative Oncological and Non-Oncological Medicines, with up to EUR 100 million annually available.
To scale these models, we need political will (based on the recognition that antibiotic effectiveness represents a critical foundation for our economies and healthcare systems), sustained investment (from both public and private sources), and stronger international coordination to ensure we are all ‘pushing’ and ‘pulling’ in the same direction. Without a unified global framework, progress will remain fragmented. The time to act is now—before more patients are harmed and more developers exit the field.
Disclaimer: The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders, the AMR Partnership Platform, the Quadripartite organizations, or their respective members. The article has been submitted by the authors to the AMR Partnership Platform as part of its knowledge-sharing function. While the Platform facilitates dissemination, it does not assume any responsibility for the accuracy, completeness, or reliability of the information contained herein.