Action: Develop an innovation system for novel antibiotics, diagnostics, and other tools to support equal access and responsible use.

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Literature & Resources

Critical shortage of new antibiotics in development against multidrug-resistant bacteria – Time to react is now
Freire-Moran et al. | Drug Resistance Updates | 2011

In this EMA-ECDC-ReAct analysis, a search of two commercial databases found that in 2011, of 90 possible antibacterial agents in clinical development, only 4 showed in-vitro action against Gram-negative bacteria, and none showed a novel mechanism of action. This result highlights an urgent unmet need to develop new treatments for multidrug-resistant bacterial infections, especially those caused by Gram-negative bacteria.

The Drugs Don’t Work
Davies | Penguin | 2013

This book by the Chief Medical Officer of the United Kingdom sketches an apocalyptic future in which people who contract everyday infections are locked into isolation until they recover or die. The book discusses the familiarity of antibiotics as “wonder drugs” which may lead to taking their effect for granted. It also details the dwindling range of effective antibiotics as “the new inconvenient truth,” and how it poses health risks for generations to come.

Securing New Drugs for Future Generations: The Pipeline of Antibiotics
O’Neill | Review on Antimicrobial Resistance | 2015

The current antibiotics R&D pipeline is insufficient to supply clinical needs. Out of 41 recently licensed drugs, no approved compounds and only 3 candidates currently in clinical trials meet high-priority needs, defined as effective against 90% or more highly-resistant (in this case, carbapenemase-producing) bacteria. It typically takes 15 years for a drug to come to market, and the success rate for antibiotics is between 1.5 and 3.5%. Unlike development of new drugs to improve on old ones, the commercial returns for new antibiotics is uncertain until resistance has emerged against a previous generation of drugs.

3Rs for innovating novel antibiotics: sharing resources, risks, and rewards
So, et al. | BMJ | 2012

Sharing resources, risks, and rewards (3Rs) along the value chain of new drugs can reduce barriers to antibiotic innovation. Sharing resources can improve the availability of the building blocks of scientific research, such as compound libraries and natural products as candidates for drug development. Sharing risks seeks to leverage public sector financing to enable greater innovation. Sharing rewards can help ensure fair returns on public investment and affordable end products for those in need. In concert, the 3Rs offer useful benchmarks to evaluate how public investments and incentives might shape the enabling conditions for innovation of novel antibiotics and health technologies to tackle antibiotic resistance.

New Business Models for Sustainable Antibiotics
Outterson | Chatham House | 2014

Antibiotics should be treated as a public good as they are a common pool resource that are exhaustible due to resistance. In traditional models of pharmaceutical research and development, price and volume-based sales determine return on investment. However, prioritizing quantity conflicts with the public health goal of regulating antibiotic use. Delinkage of revenue from sales volume encourages long-term coordination among stakeholders and enhances access among those in need.

Towards new business models for R&D for antibiotics
So et al. | Drug Resistance Updates | 2011

Bottlenecks at points along the pharmaceutical value chain must be addressed for antibiotic innovation. These include hit identification during drug discovery, lead optimization in pre-clinical testing, and then crossing the “valley of death” into clinical development. This conference proceeding recognized that “strategies that delink product sales from the firms’ return on investment can help ensure that the twin goals of innovation and access are met.” South-South innovation platforms alongside product development partnerships may be particularly useful and are currently underutilized to develop and produce needed innovations.