Our article in Science explores one particularly pressing area of need for biopharmaceutical innovation and the ways that the public sector can help entrepreneurs develop the next generation of therapeutics.
There’s been a bit of press on the need for new antibiotics (Maryn McKenna has a brilliant Medium post on the topic). Antibiotics are a fundamental part of modern medicine. But, partly due to their own success, resistance to commonly prescribed antibiotics (fluoroquinolones, beta-lactams, etc.) has rapidly proliferated. The CDC estimates that ~23,000 people die annually from infections caused by antibiotic-resistant bacteria.
Yet, there’s also been a noticeable decline in new antibiotics approved by the FDA in the past decade, and even fewer new antibiotics with novel mechanisms of action.
Are antibiotics harder to get through clinical trials? Who’s developing the next generation of antibiotics and other antimicrobial drugs?
To sketch a fuller picture of the past and present of antibiotic R&D, we merged compound-by-compound data from two commercial databases for the period 1990 to 2012. We found that nearly 60% of antibiotics are being developed by small- and medium-sized companies.
For each compound, we had information on when it entered clinical trials and if it had failed a trial or had been discontinued for other reasons (financial, safety concerns, etc.). We fit our data to accelerated failure time models to quantify whether and to what extent antibiotics were more or less likely to survive in clinical trials than other drugs.
The data suggest that policymakers should focus on raising the level of antibiotic drugs entering clinical trials (since they appear to survive well once they’re in trials) and supporting small companies developing innovative new antibiotics.
There are other proposals – such as prizes – which we didn’t have enough wordcount to delve into. But there are many more ways that we – consumers, government, payers, industry, clinicians, investors – can ensure that future generations have access to these lifesaving medicines. In the meantime, we should lay the groundwork for more candidates to come through the pipeline.