In the Life Sciences industry, many drugs on the market today have been approved for indications for which they were not originally developed. Sometimes, discovering a new use for a drug happens by chance during a clinical trial or post-market, as more information is learned about the drug’s effects that weren’t originally predicted.
Though, in the last decade or so, the industry has identified a more systematic and rational approach to incorporating a repurposing strategy into drug discovery and development. For example, using a data-centric approach, a company can compile side effects of a drug in clinical trials or real-world practice and mine that data for clues to treating other conditions.
Another strategy is methodically testing a drug in model systems and identifying new biology around the drug that may give clues as to other diseases for which it might be efficacious. There are also computational approaches. For example, if a clinically effective drug acts via a certain molecular target, a company can use data-driven methods to identify other disease processes in which the same molecular target plays a role.
These systematic approaches present opportunities to Life Sciences companies. For example, drugs that safely pass Phase I clinical trials but fail in the later stages for efficacy represent a rich source of potential new medicines. For many companies, there’s likely a host of drugs in storage cabinets that might be beneficial to look through for new indications, instead of going back and starting from scratch.
While a more systematic approach to drug repurposing has its upsides, there have been challenges to this approach, both business and scientific. For example, companies’ drug development efforts are often siloed, and there may be internal politics to deal with when transferring drug research from one disease focus area to another within a company. At the same time, companies simply may not have the institutional knowledge around compounds, making it a methodological challenge to repurpose drugs—as one industry executive has noted, “companies do not have Vice Presidents of Failed Drugs”.
Though, in light of recent events, change may be on the horizon.
How COVID-19 is impacting drug repurposing
During the COVID-19 pandemic, companies have had to act as quickly as possible to identify and develop treatments to combat the virus. Out of necessity, the traditional drug development process—which can take up to ten years from discovery to clinical trials alone—has had to be dramatically compressed. In the interest of time, many drug companies and health care providers have quickly started trying to repurpose drugs looking for efficacy in treating COVID-19—using drugs already on the market or others that have passed clinical safety trials.
From this effort, early candidates arose including the antiviral, remdesivir, originally developed to treat hepatitis C and later Ebola. After its developer, the pharmaceutical company Gilead, tested its efficacy for use against SARS Coronavirus, the drug received emergency use authorization from the FDA for treating COVID-19. Similarly, dexamethasone, a widely used steroid for treating inflammation that has been around for decades, is being used by health care providers to reduce the damaging immune response in patients in the later and more severe stages of COVID-19 infection.
As more explorations race forward to repurpose drugs to fight COVID-19, it is raising questions around what effect this activity will have in the long term in the area of drug repurposing. This activity could potentially be a “proof of concept” that accelerates the use of newer, more systematic approaches to repurposing drugs, which extend beyond use in the COVID-19 pandemic. It is also possible that these efforts may provide solutions to push past some of the traditional barriers in drug repurposing.
The results could have significant implications for pharmaceutical companies. From a scientific standpoint, the opportunity is there for Life Sciences companies to take a more systematic approach to drug repurposing—be it more data centric, methodological, or computational in nature. As for internal politics and institutional knowledge, steps in the right direction are certainly possible.
Moving forward with repurposing
When it comes to managing data, there are often intensive processes involved in drug repurposing and specific kinds of data analyses to be done. The right partner, with expertise in the relevant bioinformatics and data science processes, can go a long way in helping manage the effort.
At Hawkins Point, we help clients with this process—from developing the data science platforms, to implementing the databases, data retrieval, and mining processes. As a drug repurposing strategy also involves new ways of operating, we help manage the accompanying changes related to people, processes, and business.
With potential changes on the horizon, companies that start their explorations early will be in a position to act on drug repurposing opportunities at the right time.