A Nonprofit Drug Development Model Is Part of the Antimicrobial Resistance (AMR) Solution.

Antibiotics underpin modern medicine and are critical for pandemic preparedness. Push funding has revitalized the preclinical antimicrobial resistance (AMR) pipeline and government funding via CARB-X and BARDA, as well as private sector-led investment via the AMR Action Fund, will help several new antibiotics obtain regulatory approval. Nevertheless, revenues generated by new antibiotics are not considered sufficiently profitable by commercial developers to address unmet need. The question remains: Who could viably fund development and secure global equitable access for new antibiotics? Public health need should be the primary driver for antibiotic development. Improved prioritization and government oversight by funders who allocate public resources are a needed first step. In this framework, nonprofit research and development organizations, with support from public funders, and unconstrained by commercial profitability requirements are well positioned to work with public and private actors to viably provide new antibiotics to all in need.

Challenges and Opportunities with Antibiotic Discovery and Exploratory Research.

Discovery and exploratory research can identify new antibiotics and biological targets. However, failure rates are high, and funding is insufficient to solve the scientific challenges and attract researchers to antibacterial R&D. Novel methods, including artificial intelligence, have been applied to early-stage research, but these have yet to deliver new antibiotics. The Global Antibiotic Research & Development Partnership (GARDP) is investing in discovery and exploratory research and an R&D education and outreach program. GARDP's efforts, including application of novel R&D methods and new global networks of R&D researchers to develop new antibiotics, is helping address antimicrobial resistance sustainably over the long-term.

A trustworthy AI reality-check: the lack of transparency of artificial intelligence products in healthcare.

Trustworthy medical AI requires transparency about the development and testing of underlying algorithms to identify biases and communicate potential risks of harm. Abundant guidance exists on how to achieve transparency for medical AI products, but it is unclear whether publicly available information adequately informs about their risks. To assess this, we retrieved public documentation on the 14 available CE-certified AI-based radiology products of the II b risk category in the EU from vendor websites, scientific publications, and the European EUDAMED database. Using a self-designed survey, we reported on their development, validation, ethical considerations, and deployment caveats, according to trustworthy AI guidelines. We scored each question with either 0, 0.5, or 1, to rate if the required information was "unavailable", "partially available," or "fully available." The transparency of each product was calculated relative to all 55 questions. Transparency scores ranged from 6.4% to 60.9%, with a median of 29.1%. Major transparency gaps included missing documentation on training data, ethical considerations, and limitations for deployment. Ethical aspects like consent, safety monitoring, and GDPR-compliance were rarely documented. Furthermore, deployment caveats for different demographics and medical settings were scarce. In conclusion, public documentation of authorized medical AI products in Europe lacks sufficient public transparency to inform about safety and risks. We call on lawmakers and regulators to establish legally mandated requirements for public and substantive transparency to fulfill the promise of trustworthy AI for health.

Shortage of essential antimicrobials: a major challenge to global health security.

The lack of access to safe and effective antimicrobials for human populations is a threat to global health security and a contributor to the emergence and spread of antimicrobial resistance (AMR). The increasingly common shortages of antimicrobials are an additional threat to the emergence of AMR. While the threat of such drug shortages is most acutely experienced in low-income and middle-income settings, their consequences impact the quality and effectiveness of antimicrobials worldwide. Furthermore, there is a need for robustly conducted studies examining the impact of these increasingly prevalent shortages on patient outcomes and on the emergence and spread of AMR. In this review, we have mapped common drivers for antimicrobial shortages and propose strategies for rethinking the regulation, supply and pricing of antimicrobials to secure their sustainable access across diverse healthcare systems and to help minimise the unintended consequences of weak and ineffective supply chains. Greater government involvement in antimicrobial manufacture and supply is essential to ensure no one is left behind. Dedicated demand systems need to be developed for antimicrobials which take into consideration evolving AMR patterns, burden of diseases, pandemic events and supply and demand issues and facilitate implementation of strategies to address them. Interventions, ranging from advocacy and forecasting to public-private collaborations, new economic models and international consortia working across countries and supply chains, will help assure access to safe and effective antimicrobials to all populations around the globe and ensure that shortages no longer contribute to AMR.

Panel 2.14: contribution of non-governmental actors.

This is a summary of the presentations and discussion of Panel 2.14, Contribution of Non-Governmental Actors, of the Conference, Health Aspects of the Tsunami Disaster in Asia, convened by the World Health Organization (WHO) in Phuket, Thailand, 04-06 May 2005. The topics discussed included issues related to the role of media and communication as pertaining to the responses to the damage created by the Tsunami. It is presented in six sections: (1) Background; (2) Key questions; (3) Discussion; (4) What have we learned?; (5) Conclusions; and (6) Recommendations. The what have we learned section is presented in the categories of: (1) needs assessments; (2) coordination; (3) filling gaps; and (4) capacity building.