August 26 2020
The rise of COVID-19 represents an unprecedented situation for pharma. With the scramble to find a vaccine, R&D productivity is more important than ever, which makes it especially concerning that pharma still struggles with a widely recognized productivity crisis.
Over the last decade, pharma R&D costs steadily increased, while drug approval rates stagnated. In 2018, it cost ~$2.17 billion to bring a new drug to market, almost double the ~$1.18 billion recorded in 2010. In the same period, annual forecast peak sales were halved, from ~$816 million to ~$407 million. The result was a decrease in returns from 10.1% to 1.9%.
Perhaps even more troubling, given the threat COVID-19 poses to public health, research is also taking longer. Average project lengths increased from 9.7 years in the 1990s to 10-15 years through the 2000s and 2010s. Industry experts commonly blame clinical trial inefficiencies and the industry’s shift into more high-risk, high-reward research areas.
There is, however, another key contributor that has long gone overlooked. Avoidable Experiment Expenditure (AEE) significantly contributes to increased project lengths and decreased ROI. AEE refers to all inefficiencies and productivity challenges in designing and carrying out experiments. Experiments are the lifeblood of preclinical R&D, yet irreproducibility rates exceed 50%, costing life science organizations ~$48 billion annually worldwide.
Given the tens of billions being invested in COVID-19 research, there is increased urgency to address AEE. Up to half of the global investment may be wasted, significantly delaying vaccines and treatments.
Inappropriate reagents are responsible for 36% of all unproductive experiments
A prime example of AEE is hydroxychloroquine, which was one of several candidates rushed to clinical trials. Hydroxychloroquine was thought to hold promise as a treatment but has since been found ineffective and potentially fatal. Initial studies were conducted in a monkey kidney cell line but not verified in representative human cells where it later failed. Worse, that study has been the basis of several other res...
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